20Ways WINTER Hospital 2021

WINTER 2021

I M P R O V I N G PAT I E N T CARE & PHARMACY COST CONTAINMENT H E A L T H

20 Unique Products & Services

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I N F U S I O N

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Decision-Making for Drug Diversion A Case Study From Medacist page 70

Discover 20 products and services that will help your pharmacy improve patient care or contain costs.

Drug Diversion Industry Expert Q&A, Market Leaders Buyer’s Guide, and More page 60

7 Case Studies Waste Management, Veltek Associates, Inc., Culturelle, IMI, Azina, Modular Devices Inc., and More

Robert Fink, Pharm.D., MBA, FACHE, FASHP, BCNSP, BCPS Chief Pharmacy Executive ~U ofL Health, Louisville, KY

ARE YOU

COMPLIANT?

WE’VE GOT YOU COVERED

Your One-Stop Compliance Shop.

Everything You Need to be USP <797> & <800> Compliant.

DISINFECTANTS & CLEANERS

GLOVES & PPE

PHARMACY SUPPLIES

CHEMO RATED PRODUCTS

SPEAK DIRECTLY WITH A PRODUCT EXPERT 888.909.7700 | pharma-choice.com info@acutecareonline.com Poway, CA

A

COMPANY

P ROV I DI NG T H E H IG H E ST QUA L I T Y OF P H YS IC A L PHARMACEUTICAL INVENTORIES SINCE 1979 Utilizing Decades of Knowledge & Experience Why Choose Capital for Your Pharmaceutical Inventory Needs?

• Teams of experts conduct the inventory within a few hours.

• Eliminate the need for overtime or coordination of staffing to accommodate inventory process.

• Teams conduct pharmacy inventories daily, not annually.

• Teams work seamlessly around the pharmacy staff ensuring that the “snapshot” is a true representation of the inventory on-hand.

• Minimal interruption to the pharmacy staff and operations.

• Competent inventory specialists that can work with finance and/or external audit firms to validate the inventory.

• Collaboration with the pharmacy to provide an accurate report in a timely manner.

• Expert valuation and pricing of the inventory by an independent party.

To schedule your next inventory, please call 1-800-345-0849 or email customerservice@capitalinventory.com.

SMART THINKING.

AVAILABLE PRODUCTS Description SmartPak® provides a revolutionary delivery system for these essential drugs, offering faster, easier preparation more economically.

It’s also safer. The SmartPak bag system is a convenient alternative to using multiple glass vials. No glass means no breakage during handling. SmartPak saves time and labor with less waste. SmartPak — the smart choice for your pharmacy service.

Cefazolin 100 grams Cefazolin 300 grams

Ceftriaxone 100 grams

Vancomycin 100 grams Cefepime 100 grams

NDC

List#

66288-1100-1

1100

66288-1300-1

1300

66288-6100-1

6100

66288-7100-1

7100

66288-8100-1

8100

www.samsonmt.com Toll Free (877) 418-3600 PO BOX 2730, Cherry Hill, NJ 08034 Telephone (856) 751-5051 Fax (856) 751-5044

Contents Innovative. Dedicated. Proven.

Your true partner for 340B program administration and compliance.

Verity Solutions® is a recognized leader in 340B program optimization. We drive continually improved solutions and vigilantly address regulatory changes so that our customers can dedicate fewer resources to program administration and more resources to community wellness.

Results you can believe in.

Partner with us to simplify 340B program management, confidently optimize federal pricing benefits, and benefit from the knowledge and support of our expert team.

1.800.581.1378 info@verity340b.com www.verity340b.com

VERIT Y 340B® SP L IT B IL L ING | C ONTRACT P HARMACY SP ECIALT Y C ONTRACT P HARMACY | C OM P L IANCE MANAG EM ENT | P U RCHASE ANALY TICS | VHU B®

Verity Solutions — Invested in Your 340B Program Success

Partner with us to simplify 340B administration, confidently optimize federal pricing benefits, and benefit from the dedication and knowledge of our expert team.

Point-of-Sale to Support Your Outpatient Pharmacy Operations — Retail Management Solutions

FUNCTIONALITY YOU NEED. SERVICE YOU TRUST. POINT-OF-SALE MADE CRAZY EASY.

Customized Software

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WHY CHOOSE RMS? RMS is dedicated to helping pharmacies improve patient outcomes through innovative point-of-sale solutions. RMS’ solutions are flexible, scalable, and customizable to meet the needs of any pharmacy.

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Email us at sales@rm-solutions.com, or give us a call at 877-767-1060.

Implement programs like meds-to-beds and will-call

Scan this QR code to learn more about RMS © 2021 Verity Solutions Group, Inc.

page 33

Meeting 797> Requirements Requirements Meeting Your Your USP USP<<797> Veltek Simple Veltek Makes Makes Itit Simple

C CLEANING LEANINGAND AND DISINFECTING ISINFECTINGPP RODUCTS D RODUCTS

EENVIRONMENTAL NVIRONMENTAL MONITORING ONITORING M QUIPMENT EEQUIPMENT

GOWNING OWNING G

USP 800 Gown

Cleanroom Garments

VAI every aspect necessary for full compliance including: VAIcovers covers every aspect necessary for full compliance

including:

Consultation on maintaining aseptic processes onsetting settingupupand and maintaining aseptic processes • ■Consultation our easy easy to useto disinfectants in pre-measured containers RTU containers SimpleMix –– Veltek’s use disinfectants in pre-measured • ■SimpleMix® Easy2Gownsterile sterile garment garment system system • ■■Easy2Gown Easytotouse use SMA portable SMA air samplers MicroPortable® ICS - Veltek’s Viable Cleanroom Air Monitoring device • ■Easy RTU Sterile & Non-Sterile cleaners & disinfectants available in a large assortment cleaners & disinfectants available in a large assortment of packaging sizes • Sterile of packaging sizes ®

SCAN HERE

TO CONTACT US

Veltek Associates, Inc. 15 Lee Boulevard Malvern, PA 19355-1234

With VAI’s innovative product line, Meeting USP<797> requirements is just a phone call away…IT’S THAT SIMPLE!

1-888-4-STERILE H E A LT H C A R E

www.sterile.com @STERILE.COM

SMA MicroPortable® ICS From VAI® Offers Superior Precision and Control

Combining experience, innovation, performance, GMP manufacturing, GLP testing services, and unrelenting service has propelled VAI as the ultimate innovative leader in the market.

page 41

Integrated Temperature Monitoring to Support Safe Storage of Vaccines and Medications With Helmer Scientific

Integrated Temperature Monitoring with i.C3® Information System

Continuous monitoring supports safe storage of vaccines and medications

Intelligent diagnostic information and data in one secure location Monitor and optimize performance with a finger stroke Constant monitoring ensures uniform temperature

Continuous monitoring offers safety and security of stored product.

Available on i.Series medicalgrade refrigerators, -30 freezers, and ultra-low freezers

Learn More helmerinc.com/ic3videos

© 2021 Helmer Inc. All rights reserved

© 2020-2021 Helmer Inc. All rights reserved.

20Ways_TabAd-GX-iC3-winter-2021.indd 1

10/4/2021 4:28:39 PM

page 35

C AS E S T U DY PIKEVILLE MEDICAL CENTER AND AZINA PARTNER TO CREATE INNOVATIVE PHARMACY CAPABILITIES

INTRODUCTION AND INTENDED OUTCOME Pikeville Medical Center (PMC), a 348-bed facility located in southeastern Kentucky, has been dedicated to providing quality care in Kentucky for 97 years.

Kandi Justice COO ~ Pikeville Medical Center

Today, PMC employs 3,000 individuals and offers more than 400 services, including every major specialty and most sub-specialties. Technology and innovation, combined with service and vision, are rapidly driving PMC toward its goal of being a national leader in health care.

page 43

Case Study: Azina

Pikeville Medical Center and Azina partner to create innovative pharmacy capabilities.

Thought Leader Video Series

It’s this objective that prompted PMC to partner with Azina (formerly SPARx, the specialty pharmacy division of Comprehensive Pharmacy Services) to improve drug access for patients, innovate all services, enhance patient care, and increase revenue.

“We wanted to leverage our existing retail pharmacy to build an innovative specialty pharmacy,” explains Kandi Justice, COO, Pikeville Medical Center. “Our goal was to provide specialty medications to patients quickly and efficiently. This would enable us to greatly improve the patient experience, as well as keep revenue in-house, instead of relying on numerous third-party pharmacies.”

John Petts, PharmD Vice President ~ Azina

She adds, “Our existing retail pharmacy was a small, 500-square-foot space that used an outdated pharmacy management system to process all prescriptions manually.

The pharmacy didn’t have inside access for patients — only a very crowded drive-thru kiosk. We knew we needed to completely overhaul our pharmacy capabilities, and we turned to Azina for help. There was no question that their decades of experience working with hospitals and health systems would be invaluable to us. It became a very strong and collaborative partnership.”

azina.com

page 36-39

page 44-45

WINTER 2021

I

H E A LT H S Y S T E M • I N F U S I O N

3

ENGINEERING CONTROL REQUIREMENTS for USP-797 and USP-800 Compliance USP 797: Applies to Non-hazardous and Hazardous Drugs USP 800: Additional Requirements for Hazardous Drugs

DRUG TYPE

Sterile Non-Hazardous

Non-Sterile Hazardous

Sterile Hazardous

Horizontal Laminar Flow Cabinet

Powder Weighing Station with Ducting

Class II A2 Biosafety Cabinet w/Ducting

PRIMARY Engineering Control (PEC)

Esco Models: LHG (Horizontal): General compounding LVG (Vertical): Put large machine inside

SECONDARY Engineering Control (SEC)

ISO 8 ante 20 ACPH 0.01 “WG positive pressure

For BUD > 12 hrs

ISO 7 buffer 30 ACPH 0.02 “WG positive pressure

Laminar Flow Cabinet

Esco Models: PW1 (Compact): Single exhaust HEPA ADC (Full-sized): Double exhaust HEPA

Esco Models: AC2 (Compact): Low ceiling, Mobile labs LA2 (Full-sized): Best comfort & safety

ISO 7 buffer 30 ACPH 0.01-0.03 “WG neg. pressure ducted

ISO 7 buffer 12 ACPH 0.01-0.03 “WG neg. pressure ducted Compounding Ventilated Enclosure

ISO 7 ante 30 ACPH 0.02 “WG positive pressure

Biosafety Cabinet, Ducted

ALSO AVAILABLE FROM ESCO Cleanroom Pass Boxes

Esco Models: EPB-SS: Passbox, Full Stainless Steel BIOPASS: Passbox, with H2O2 Decon

Downflow Booth

Esco Model: DFB: Downflow Booth

503B cGMP Isolators

Esco Models: GPPI: General Processing Isolator ACTI: Aseptic Containment Isolator

215-441-9661 Horsham, PA, USA • ETI.Admin@escolifesciences.com • www.escolifesciences.com

340B Program Results Delivered.

Period.

Split-Billing

Contract Pharmacy

Superior Technology Intuitive Accumulation Optimize Purchase Orders

Dynamic Dashboard Real-Time Data Exceptional Reporting

Referral Program Increase Claim Capture Close the Loop Remain Compliant

Adding Value 340Basics will change the way your 340B program operates with superior customer service and complete program administration.

Partnering with 340Basics will allow your organization more time to focus on patients while increasing 340B savings. This will enable you to invest in new technology, expand staff, improve and/or upgrade equipment, and grow services, all while increasing access to care in your community. www.340Basics.com || info@340Basics.com || 888-356-6225

CONDUCTING IN-HOUSE ACTIVE MICROBIAL AIR SAMPLING MAY BE EASIER AND MORE ECONOMICAL THAN YOU REALIZE! REALIZE! THE TRIO.BAS™ MONO IS A TIME-TESTED SOLUTION TO A ROBUST ENVIRONMENTAL MONITORING PLAN. WHY SHOULD YOU SAMPLE MORE FREQUENTLY? Active microbial air sampling provides a consistent method to trend microbial bioburden over time. Sudden changes signaling increased bioburden will allow quick mitigation of lapses in systems or processes.

Want to see it in action? Hands-on or virtual demonstrations are available

800.266.2222 Sales@HardyDiagnostics.com HardyDiagnostics.com/TRIOBAS

What’s Inside Can Save Lives. Keep it Safe.

Choose cold chain products proven worldwide for continued performance and stability even in high ambient temperatures of +32°C (Precision models) and +43°C (Premium models).

Learn more at www.bmedicalsystems.com

Blood Bank Refrigerators • Plasma Freezers • Contact Shock Freezers Laboratory / Pharmacy Refrigerators and Freezers Ultra-Low Temperature Freezers • Transport Boxes

B Medical Systems North America LLC 14560 Bergen Boulevard, Suite 200, Noblesville, IN 46060 bmedicalusa@bmedicalsystems.com | Toll Free: (888) 456-7099

Select models ENERGY STAR® Certified

Contents Leiters. We Are Compounding Health™

Helping you deliver better medicine to more people.

With increasing regulatory pressure and drug shortages, access to quality medicine is more important than ever.

Leiters is an FDA-registered 503B outsourcing provider of high-quality, compounded sterile preparations including: Pre-filled syringes, IV bags and vials ON-Q* Pain Relief System fill services Opioid-free surgical pain services medications Ophthalmology medications and services including FDA-compliant repackaged Avastin®

COMPOUNDING HEALTH™ www.leiters.com | 800.292.6772

ON-Q* is a registered trademark of Avanos Medical, Inc., or its affiliates.

Avastin® is a registered trademark of Genentech, Inc.

RXInsider 20 Ways Summer_April2020_FA1.indd 1

Case Study: Veltek Associates, Inc.

C ASE ST U DY ENVIRONMENTAL MONITORING IN COMPOUNDING PHARMACIES: FACTORS TO CONSIDER

Leiters is a trusted FDAregistered 503B outsourcing provider of compounded sterile preparations committed to providing healthcare professionals and their patients with the highestquality medications.

Environmental monitoring in compounding pharmacies: factors to consider.

INTRODUCTION

Cleanroom environmental monitoring in hospital pharmacies and 503A compounding facilities has been a topic of debate over the years. The requirements for viable and total particles air monitoring outlined in USP<797> differ from the recommendations in USP<1116> and sound aseptic techniques generally anticipated by the FDA in a classified drug manufacturing area.5 The differences between these guidance’s cause a wide range of opinions about the frequency and need for viable and total particle air monitoring in hospital pharmacies and other 503A facilities. Of course, like most things the answer is never one sided and the best course for action is most likely somewhere in the middle for these facilities. In this article, we will discuss the importance of environmental monitoring for safe aseptically produced drug products, the differences in regulatory guidance, sources of contamination, strategies for implementing a program, and the equipment your facility may consider if taking more control of your monitoring program — all while saving money in the process.

Jeff Meek Manager of North America Sales, Healthcare Division/ Central Region Manage ~ Veltek Associates, Inc.

WHAT IS ENVIRONMENTAL MONITORING AND WHY IS IT IMPORTANT?

For the scope of this article, we are focusing on viable and total particle air sampling, but that is not to discount the importance (and requirement) of surface, compressed gases, and personnel sampling.

Environmental monitoring is a process that is used to monitor the microbial and particulate levels in a classified area. Environmental monitoring of classified areas is a critical step in determining the effectiveness of a facilities engineering controls and to prove the effectiveness of a facilities gowning, cleaning, and disinfecting procedures. The results from your environmental monitoring program are your pharmacies “report card” on just how well your overall program is implemented. Routine environmental monitoring gives the data needed to trend the environmental quality of your classified areas and act when needed.1 EM results also provide sound scientific data to support your rotation scheme between a disinfectant and sporicidal agent. Currently, we rely on an arbitrary time frame for rotation provided by the working compendium. Is the required monthly rotation scheme sufficient specific to your facility? Based on your data trending analysis it may or may not be. Although quite an overkill, some pharmacies apply a sporicide daily for all applications. Generally sporicidal agents are more aggressive on equipment. Their elevated concentration over disinfectants is also unhealthy for worker exposure. Your EM results can support whether in fact this is necessary by determining the species generally detected. Routinely identifying the flora specific to your facility helps us to understand the potential source of the contamination whether it by people related bugs, water bourn bugs, or from outside soil to pinpoint a few. Conducting volumetric testing semi-annually will not provide the sound scientific trending data to support any decision.

SOURCES OF CONTAMINATION

There are many sources of microbial and particulate contamination in the cleanroom. These are broken down into primary and secondary sources of contamination. Primary sources of contamination such as personnel, supplies introduced into the cleanroom, and water bring contamination into the classified area.

Secondary sources of contamination are where these contaminates end up settling. Examples of secondary sources of contamination are surfaces, the air, and potentially any equipment used in compounding sterile preparations within your own pharmacy. Primary sources of contamination are controlled by a combination of functioning engineering controls and meticulous personnel training in gowning, cleaning, disinfecting, and hand hygiene. Formulating a sound cleaning and disinfecting program will control secondary sources of contamination but keep in mind that cleaning and disinfecting addresses contamination after the day’s activity. Simply put, if we do not let the contamination in, we would not need to address it. Naturally, all those performing routine cleaning and disinfecting should be competent to execute the facilities plan and the products selected to

sterile.com

4/21/20 11:44 AM

P ROV I DI NG T H E H IG H E ST QUA L I T Y OF P H YS IC A L PHARMACEUTICAL INVENTORIES SINCE 1979 Utilizing Decades of Knowledge & Experience Why Choose Capital for Your Pharmaceutical Inventory Needs?

• Teams of experts conduct the inventory within a few hours.

• Eliminate the need for overtime or coordination of staffing to accommodate inventory process.

• Teams conduct pharmacy inventories daily, not annually.

• Teams work seamlessly around the pharmacy staff ensuring that the “snapshot” is a true representation of the inventory on-hand.

• Minimal interruption to the pharmacy staff and operations.

• Competent inventory specialists that can work with finance and/or external audit firms to validate the inventory.

• Collaboration with the pharmacy to provide an accurate report in a timely manner.

• Expert valuation and pricing of the inventory by an independent party.

To schedule your next inventory, please call 1-800-345-0849 or email customerservice@capitalinventory.com.

page 47

page 50-53

Capital Inventory, Inc. — Accurate and Dependable Pharmacy Inventory Services

Steri-Tamp® Tamper-Evident Sterile Seals by Allied Pharmacy Products, Inc.

THE MOST INNOVATIVE TAMPER-EVIDENT SEALS IN HOSPITAL PHARMACY TODAY

Our decades of experience working specifically with pharmacy inventory make us uniquely qualified to provide accurate valuations through a streamlined process. Our clients can trust that we will be transparent, supportive, and reliable in every interaction.

• Sterile & Paper Free (USP 797 Compliant).

NEW ISMP & USP 800 IV Bag Seals

IV Bag Port Seals

• Maintains a 100% sterile barrier* with 3X greater adhesion.

The only single-use, tamper-evident seal that both provides and maintains a 100% sterile barrier.

• Helps prevent contamination of drugs and provides added protection to pharmacists.

• Will not fall off, even in cold storage conditions (down to -20 degrees centigrade).

Vial Seals

• Patented dual-layer indicates true tamperevidence, with “OPENED” marking.

• Cost-effective, allows pharmacy to recycle medication and protects patients from dosing errors.

• Dispensing and application training videos available on our website to help with JCAHO training.

Tamper-Clear Syringe Seal®

• Available in major wholesalers and distributors.

Red Syringe Seal

*Tested in Nelson Labs, Salt Lake City, UT

Visit our website to learn more: www.steri-tamp.com

page 49

20Ways MISSION To educate pharmacy management on products and services that serve to improve patient care or improve a pharmacy’s financial bottom line, while distilling and presenting this relevant information via 20 product profiles.

page 55

QUARTERLY ISSUES Winter 2021/2022

Fall 2021 FA L L 2 0 2 1

I T Y , C O M M U N

T Y , S P E C I A L

&

L T C

E D I T I O N

H E A L T H

S Y S T E M

20 Unique 20 UniqueDecis & Drugion-Making Products &Productsfor Diversion Services Services &

I N F U S I O N

E D I T I O N

A Case Study From

Discover 20 products and services that will help your pharmacy improve patient care or contain costs.

Drug Diversion

Industry Expert Q&A, Market Leaders Buyer’s Guide, and More page 60

7 Case Studies

and Discover 20 products your services that will help patient care pharmacy improve or increase profitability.

Medacist page 70

C O M M U N I T Y ,

Celebrating 10 Years RXinsider Reflects on the Past Decade With Retail Management Solutions

S P E C I A L T Y ,

&

L T C

20 Unique Products & Services Discover 20 products and services that will help your pharmacy improve patient care or increase profitability.

Long-Term Care Delivery/Back-Up Pharmacy Services

Long-Term Care Delivery/Back-Up Pharmacy Services

Market Industry Expert Q&A, and More Leaders Buyer’s Guide, page 56

Industry Expert Q&A, Market Leaders Buyer’s Guide, and More page 56

2 Case Studies

2 Case Studies

Innovatix and Temptime

I M P R O V I N G PAT I E N T CARE & PHARMACY COST CONTAINMENT

E D I T I O N

Innovatix and Temptime

2021 CIRCULATION

Issue Focus: Retail, Specialty, & LTC

Issue Frequency: Spring, Fall, & Winter

Circulation Per Issue: 26,500+ 18,000+ Owners (Independents) 1,500+ Long-Term Care Pharmacies 2,500+ Retail Chain Executives 2,500+ Industry Executives 2,000+ Trade Show Handouts

SUMMER 2021

I M P R O V I N G PAT I E N T CARE & PHARMACY P R O F I TA B I L I T Y

WINTER 2021

Waste Management, Veltek Associates, Inc., Culturelle, IMI, Azina, Modular Devices Inc., and More

Issue Focus: Hospital & Infusion

Issue Frequency: Summer & Winter

Circulation Per Issue: 12,200+ 6,500+ Hospital Directors 2,200+ Clinical Consultants 2,500+ Industry Executives 1,000+ Trade Show Handouts

Spring 2021

Summer 2021

WINTER 2022

IENT PAT I M P R O V I N GI M P R OCV Y A I N G PAT I E N T A RA M CARE & P HC RE & B I L I T YP H A R M A C Y P R O F I T ACOS T CON TAIN MEN T

H E A L T H

S Y S T E M

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20 Unique Products & Services

Spring 2021

Community • Specialty • LTC

20 Unique Products & Services

Discover 20 products and services that will help your pharmacy improve patient care or contain costs.

Discover 20 products and services that will help your pharmacy improve patient care or increase profitability.

Environmental Monitoring Industry Expert Q&A, Market Leaders Buyer’s Guide, and More page 52

Drug Distributors & Wholesalers Industry Expert Q&A, Market Leaders Buyer’s Guide, and More

4 Case Studies

Leiters, Stericycle, Shields Health Solutions, and Visante

IMPROVING PAT I E N T C A R E & PHARMACY P R O F I TA B I L I T Y

page 50

8 Thought Leader Videos

Celebrating 10 Years

Eight Video Series Including Micro Merchant Systems, SPARx, ARxIUM, and Mission Critical Delivery Solutions

page 28

First Financial Bank Case Study First Financial Bank PPP Loan Supports Creekside Pharmacy During Pandemic page 38

RXinsider Reflects on the Past Decade With Helmer Scientific

Robert Fink, Pharm.D., MBA, FACHE, FASHP, BCNSP, BCPS Chief Pharmacy Executive ~ UofL Health, Louisville, KY

Health System • Infusion & Community • Specialty • LTC

Community • Specialty • LTC

Visit 20Ways ONLINE at RXinsider.com/20Ways

Health System • Infusion

Community • Specialty • LTC

OUR TEST, YOUR CURE . . .

ENSURING A H E A LT H Y WO R LD

ACC combi nes robust re a ge nt s, a na ly sis a nd techni cal s ervi ce exp e r t ise , t o prov ide y ou w it h div e r se s ol uti ons for e ndot ox in a nd gluc a n t e st ing.

Associates of Cape Cod, Inc.

Your Endotoxin & Glucan Experts

A s s o c i a t e s o f C a p e C o d , I n c . - a S e i k a g a k u G ro u p C o m p a n y

MKT#21-107

MEDCOAT® is an amazing new product that will revolutionize the way you take medications.

MEDCOAT® covers pills and capsules with a coating camouflaging the bad taste of any medicine. It’s sugar free and has no artificial flavors or colors added. This coating stimulates saliva production aiding in the swallowing process. The special coating applicator is easy to use and can work on any size shaped pill or capsule. MEDCOAT® alleviates the need of crushing tablets or adding flavoring which can alter medicines efficacy.

NATURAL GREAT TASTE • MEDCOAT® covers pills and capsules with a coating camouflaging the bad taste of any medicine.

• Sugar, Soy and Gluten Free • No artificial flavors or colors in MEDCOAT® Citrus lemon/lime or Strawberry flavors.

SAFETY • Contains only food ingredients that are not known to interact with drugs.

• No known contraindications with any drugs.

• Many pills should not be crushed and using MEDCOAT® will allow many patients to take the pill without the needing to do this first.

EFFICACY • Pills and capsules are covered in a slippery coating making it easy to swallow them.

• Perfect for coating pills with sharp edges or ones that have been halved or quartered.

• The special coating applicator is easy to use and can work on any size and shape of pill or capsule.

• Alleviates the need of crushing pills or adding flavoring which can alter medicines efficacy.

• MEDCOAT® dissolves quickly once swallowed.

ADDED BENEFITS • Helps patients take the right dose of their prescribed medications by alleviating the need to crush or cut pills.

• Encourages patients to complete their prescribed and non-prescribed medicine regimens.

• One MEDCOAT® applicator can coat up to three pills depending on the size.

• Allows doctors to prescribe the pill version of a patient’s medication rather than the liquid form, which is often bad tasting and dosed improperly.

ORDERING INFORMATION Item Number

Product

1018514

Citrus Flavor (lemon/lime)

1018515

Strawberry Flavor

1018513

Cola Flavor

Call us today to place your order or for a free sample at 1-888-832-0322, M-F: 8:00 a.m. – 4:30 p.m. ET. www.medcoatusa.com.

WHY GUESS ON DOSAGE, JUST USE HURRICAINE ONE! An Innovative Non-Aerosol Unit Dose Topical Anesthetic Spray • Meets Joint Commission Standard for the most ready-to-administer form available.* 0.5 mL each

• Fast onset. Short duration.

Virtually no systemic absorption.

• Utilizes bar code medication administration (BCMA) to accommodate point-of-care scanning.

• Virtually eliminates adverse events resulting from preventable medication errors, ensuring the “5 Rights” are met: √ Right Drug √ Right Patient √ Right Dose √ Right Route √ Right Time • Single unit-of-use packaging eliminates the potential for cross-contamination.

• Increases billing accuracy and improves supply chain costs. *Joint Commission Standard: MM.05.01.11, EP4

ORDERING INFORMATION NDC#

0283-0610-11

0283-0610-26

AMERISOURCE BERGEN

10090081

10090082

CARDINAL HEALTH

CIN 4362547

CIN 4363370

MCKESSON

1410125

1411925

MORRIS & DICKSON

086611

086629

PRODUCT

HurriCaine ONE® Unit Dose Non-Aerosol Spray Box of 2, 0.017 fl. oz.

(0.5 mL) each

HurriCaine ONE Unit Dose Non-Aerosol Spray Box of 25, 0.017 fl. oz.

(0.5 mL) each

If HurriCaine ONE is not yet available through your wholesaler, request it by name and NDC Number.

MAKE THE SWITCH TODAY.

Call 1-800-238-8542 to place your order or for more information. www.beutlich.com HurriCaine ONE is a registered trademark of Beutlich® Pharmaceuticals, LLC. MCHC1 879 1021

REDEFINING THE RETURNS INDUSTRY The value of doing business with GRx far exceeds the industry standard.

GRx offers a full suite of comprehensive business solutions and advanced data intelligence for pharmacy customers.

INDUSTRY EXPERTS

35 years of industry experience as a leading returns service provider

ADVANCED ANALYTICS

Dynamic data analytics providing revenue producing strategies

VALUE THROUGH SERVICE

Brings financial optimization to the pharmacy to exceed its business goals

COMPLETE TRANSPARENCY

Fully transparent credit reconciliation with no hidden fees

SERVICE OPTIONS

World class onsite or mail in service available nationwide

Call or visit us online:

1.800.473.2138 | GuaranteedReturns.com 100 Colin Drive, Holbrook, NY 11741 | Email: info@guaranteedreturns.com

K IN STOC NOWINE

1 to 46 cu.ft.

C FOR VACAGE STOR

Advanced Temperature Control

Intelligent microprocessor controls with a 2-8ºC range & +/-1ºC variation

Fast Temperature Recovery Optimized forced air cooling

Built-In Display

Multiple Alarms

Trusted Security

Antimicrobial Handles

EcoFriendly

Digital display of the current & high/low temperature with a buffered temperature probe

Audible alerts for temperature spikes, door open, & power failure

Keyed or keyless locks

Flexible Interior

DDLReady

ADA Height Option

Ventilated drawers, interior lockers, or adjustable shelves

Access port & remote contacts allow easy connection to external logging systems

32” high choices for use under lower ADA compliant counters

Silver ion coating to reduce the spread of germs

Uses environmentally-friendly hydrocarbons for a greener footprint

Accucold products are available through a host of high quality dealers To discuss your storage needs, contact our product specialists: Ike Goldstein 1.888.4.MEDLAB ext. 204 ikeg@accucold.com

Christian Geddes 1.888.4.MEDLAB ext. 268 christiang@acccucold.com ACCUCOLD DIVISION FELIX STORCH, INC. ISO 9001:2015 CERTIFIED 770 Garrison Avenue, Bronx, NY 10474 USA • TEL 1.888.4-MEDLAB FAX 844.478.8799 • info@accucold.com • accucold.com

Contents DRUG DIVERSION

American Health Packaging, Offering A Broad Portfolio Of Barcoded UnitDose Products

Now Available from American Health Packaging As a leading manufacturer of serialized, barcoded unit-dose medications, our growing product formulary continues to support your patient safety and pharmacy efficiency initiatives. Review the most recent additions below, now available through partner wholesalers and GPOs. For the full product catalog, visit www.americanhealthpackaging.com.

Unit dose oral solids AB #

Cardinal Health #

McKesson #

Morris & Dickson #

Product description

Strength

UD size

NDC 11

10254220

3703665

2302917

981878

Budesonide Capsule (Enteric Coated)

3 mg

20 UD

60687-0596-32

612515

Calcium Acetate Capsule

667 mg

100 UD

68084-0479-01

981910

Famotidine Tablet

20 mg

100 UD

60687-0595-01

10124030

4907010

2027480

10254113

5703590

3790623

10260469

5740444

2349314

106591

Febuxostat Tablet

40 mg

30 UD

60687-0538-21

10258312

4149654

3274917

956623

Fenofibrate Capsule (Micronized)

200 mg

30 UD

68084-0329-21

10260081

5740352

2346641

104364

Fenofibrate Tablet

48 mg

30 UD

60687-0618-21

10258877

5728696

2334258

040410

Fenofibrate Tablet

145 mg

30 UD

60687-0629-21

10254284

5704143

3901725

982025

Fluphenazine HCl Tablet

5 mg

100 UD

68084-0846-01

3901741

982033

10252050

5688189

1584887

921783

Gabapentin Capsule

100 mg

100 UD

60687-0580-01

10252051

10254285

5688197

5704150

1584903

921791

Gabapentin Capsule

300 mg

100 UD

60687-0591-01

921817

Gabapentin Capsule

400 mg

100 UD

60687-0602-01

981886

Hydrochlorothiazide Tablet

25 mg

100 UD

60687-0593-01

10252014

5688205

1584911

10254190

5703012

2302966

Fluphenazine HCl Tablet

10 mg

100 UD

68084-0950-01

10258311

5724828

2329746

032094

Hydromorphone HCl Tablet (CII)

2 mg

100 UD

60687-0579-01

10258383

5724836

2329761

032110

Hydromorphone HCl Tablet (CII)

4 mg

100 UD

60687-0590-01

10254966

5709282

2303436

10261602

5743703

2358067

109579

Lorazepam Tablet

2 mg

100 UD

60687-0649-01

10260085

5736483

2343838

103572

Omeprazole DR Capsule

40 mg

100 UD

60687-0608-01

10258394

4858015

2016327

257253

Potassium Chloride ER Tablet

10 mEq

100 UD

68084-0632-01

5728688

2333243

039784

Propranolol HCl Tablet

10 mg

100 UD

60687-0587-01

10258893 10254155

5703574

045013

Ketorolac Tromethamine Tablet

10 mg

3691490

981803

10254131

5703582

3693793

981845

Rifampin Capsule

300 mg

100 UD

60687-0586-01

5726450

2329555

035055

Ropinirole Tablet

0.25 mg

100 UD

60687-0577-01

10258196

5726468

2329571

035220

Ropinirole Tablet

1 mg

100 UD

60687-0588-01

10260130

5736178

2343168

102426

Sennosides and Docusate Sodium Tablet

8.6 mg / 50 mg

100 UD

60687-0622-01

5728233

2333557

10258623

10258624

5728241

2333581

5728258

2333649

10259425

5731617

2338465

039560

150 mg

Valsartan Tablet

039602

40 mg

Valsartan Tablet

039594

Valsartan Tablet

114736

30 UD

60687-0104-21

10258214

10258635

Rifampin Capsule

30 UD

Valacyclovir Tablet

30 UD

60687-0575-21

60687-0612-21

80 mg

100 UD

60687-0623-01

160 mg

100 UD

60687-0634-01

500 mg

30 UD

68084-0215-21

Liquid unit dose AB #

Cardinal Health #

McKesson #

Morris & Dickson #

Product description

Cup delivery

Cup strength

Pack size

10260982

5742325

2354959

108985

Acetaminophen Oral Solution

10.15 mL

325 mg / 10.15 mL

100 ct

60687-0571-56

NDC 11

10260983

5742333

2354967

108993

Acetaminophen Oral Solution

20.30 mL

650mg / 20.30 mL

100 ct

60687-0571-37

10249925

5676135

1574276

914382

Atovaquone Oral Suspension

5 mL

750 mg / 5 mL

42 ct

60687-0534-78

10261209

5743026

2356897

109017

Hydromorphone HCl Oral Solution

5 mL

5 mg / 5 mL

30 ct

60687-0566-86

10258469

5725668

2328805

034397

Midazolam HCL Syrup (CIV)

2.5 mL

5 mg / 2.5 mL

30 ct

60687-0576-10

10258500

5725676

2328821

034371

Midazolam HCL Syrup (CIV)

5 mL

10 mg / 5 mL

30 ct

60687-0576-86

10251651

5699970

3579828

971820

Milk of Magnesia Saline Laxative (Magnesium Hydroxide)

30 mL

2400 mg / 30 mL

100 ct

60687-0429-76

800.707.4621 americanhealthpackaging.com

Hitting the mark

AHP unit dose simplifies one of the most complex parts of your job – reliably obtaining ready to dispense medications – in a format that promotes positive outcomes for your patients.

AD202110-0093

Case Study: UofL Health and Medacist — Decision-Making for Drug Diversion

C ASE ST U DY

Decision-Making for Drug Diversion A Leadership Guide to Procuring a Drug Monitoring System BACKGROUND UNIVERSITY OF LOUISVILLE HEALTH (UofL Health) is a fully integrated regional academic health system with five hospitals, four medical centers, nearly 200 physician practice locations, more than 700 providers, the Frazier Rehab Institute, and Brown Cancer Center.

INTRODUCTION Robert Fink, Pharm.D., MBA, FACHE, FASHP, BCNSP, BCPS Chief Pharmacy Executive ~ UofL Health, Louisville, KY

With a responsive line of barcoded unit-dose oral solutions, a growing liquid unit-dose offering, as well as individually wrapped inhalants, American Health Packaging continues to support pharmacy efficiency.

UofL Health’s reputation is its most valuable asset and is directly related to the conduct of its officers and team members. Being on the leadership team brings a commitment to steward the integrity of the health system and ensure patient safety. These responsibilities are ever-present when developing and overseeing a drug diversion program.

A leadership guide to procuring a drug monitoring system.

This case study examines executive decision-making regarding drug diversion at UofL Health. The study profiles Robert Fink, the chief pharmacy executive, who provided insight into leadership’s recent decision to purchase a system to elevate detection and eliminate diversion.

“We consider a single dose a loss, and we have no tolerance for not knowing where that dose went,” said Fink. “We are always in a mindful, vigilant state as we can’t have anyone impaired working with a patient.

We will investigate every loss in an extremely fair and thorough way.”

The system-wide Drug Diversion Response Team at UofL Health has three components. The first is an executive committee comprising Fink; Shari Kretzschmer, senior vice president and chief nursing officer; and Shelly Denham, senior vice president of compliance, risk and audit services. The triad reviews each case, and at least two of three must be involved in any investigation to eliminate unilateral decisions.

Secondly, a broader diversion team exists managed by a nurse solely dedicated to investigations who reports to the pharmacy manager responsible for regulatory and accreditation compliance for the entire system. They are the daily users of the monitoring system, conducting audits and surveillance. If an investigation is needed, they collaborate with the pharmacy manager, nurse, and HR business partner at the specific location with oversight from the executive committee.

The third entity involves a large multidisciplinary committee comprised of physicians, nurses, pharmacists, and HR business partners from every location. They have insight into investigations and approve policies and procedures and quality assurance programs.

Each member of a diversion team brings a unique skill set and perspective to the overall program.

Tom Miller, CEO of UofL Health is ultimately responsible for all controlled substances in the health system.

As head of pharmacy services, Fink quarterbacked the rigorous process to choose a drug diversion system, and together with the chief medical officer, made the final decision.

INTENDED OUTCOME www.medacist.com

UofL Health’s purpose is to provide a culture of exceptional care and achieve the highest standards of quality and safety. Mitigating drug diversion is critical to accomplishing the mission of the health system.

page 70-73

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VERSI DRUG DI

Q&A Buyer’s Guide

ON Q&A

American Health Packaging 2550-A John Glenn Avenue Columbus, OH 43217 (800) 707-4621 americanhealthpackaging.com

GRx 100 Colin Drive Holbrook, NY 11741 (800) 473-2138 www.guaranteedreturns.com

Maxpert Medical 6106 Bausch Road Galloway, OH 43119 (866) 231-1222 Maxpertmedical.com

PharmID 2157 N. Northlake Way, Suite 230 Seattle, WA 98103 (206) 922-3589 Pharmid.com

American Rx Group 6321 Bury Drive, #19 Eden Prairie, MN 55346 (855) 269-1750 americanrxgroup.com

GTC Consulting 7603 Achterman Road Pleasant Plain, OH 45162 (513) 815-8779 www.gtcconsults.com

Medacist 1492 Highland Avenue, Unit 4/5 Cheshire, CT 06410 (866) 633-5393 www.medacist.com

Protenus 1629 Thames Street, 2nd Floor Baltimore, MD 21231 (410) 995-8811 www.protenus.com

ANiGENT 17736 Edison Avenue Chesterfield, MO 63005 (833) 264-4368 Anigent.com

national Inter Asteres Inc.

e John Burk NarcX President 523 E 1750 N, Suite 300 Vineyard, UTciati 84059 on Asso 307-2514 lity Diversion (800) Narcx.com

Health Care Logistics P.O. Box 25 Circleville, OH 43113 (800) 848-1633

Faci HealthGohcl.com

Rx Destroyer 701 Blackhawk Drive, Suite F Burlington, WI 53105 (888) 608-5160 RxDestroyer.com

identifyingReturns RxCarbon LLC National Pharmaceutical HelioMetrics responsible for is also then 4164 team, 1207 S. White Chapel NW Urbandale Drive 5000 W 36th Street, Suite 225 4110 Sorrento Valley Boulevard specialist the drug diversion the The diversion Boulevard, Suite 150B 50322 Minneapolis, MN 55416trends, notifyingUrbandale, IAtion San Diego, CA 92121 with diversion investiga potential incidents South Lake, TX 76092 (800) 470-7725 conducting (612) 444-3242 and conducting the (858)the 777-8600 think that y, this includes if applicable, (866) 436-9264 www.heliometrics.net www.asteres.com pharmacwww.NPReturns.com Q. Do you healthcare nursing and that can provide ion within assistance of and anyone www.rxcarbon.com of drug divers drug diverters Pharma Logistics Infinity Laboratories BD (Becton, Dickinson primary person off since fallen interviews of They are the and Company) medicati Rxpert Solutions 1801 W. Butterfield Road on 1585 South Perry Street, Suite B the incident. facilities have to mic? as involving ncies of the1pande Becton Drive diverted personnel Castleinsight 950 Boardwalk, Suite 305 Rock, CO 80104 resolving discrepa Libertyville, IL 60048 the advent tasked with re facilities Franklin Lakes, NJ 07417 San Marcos, CA 92078 (888) 729-7427 Most healthca drug diversion (303) 730-7330rations. not. y detecting Definitel administ and ng 847-6800 (201) (760) 705-4078 www.pharmalogistics.com of monitori of the COVID Infinitylaboratories.com round for a from the jobs bd.com/diversion the urgent needs www.rxpert.solutions the best backg to address isFacility list?

Pharmacolog, Inc. International Health facility What their Q. specia in , Diversion Associationbe a diversion ist,1950 RxSafe CPS Solutions, LLC 150 N. Michigan Avenue, Suite a diversion specialist problem. a nurse, pharmac person to s are IL in place, 655was Metro Place S., Suite 450 specialist eitherP.O. Box 28 2453 Cades Way, Suite A Chicago, 60601 seen several been diversion that whatever likely have most I , means n. has This etc.,43017 technicia OH 45106 Dublin, y (708) Vista, CA 92081 359-7302 withBethel, Typically team, OH ing job. diluted. So, cases a pharmac and/or a diversion d(800) who do an outstand the very least (513) 623-3278 and in some (760) 593-7161 at968-6962 www.pharmacolog.com ns in this role the diverting eliminate or allows rily technicia it y tent, tempora Ihfda.orgpharmac www.cpspharm.com Rxsafe.com next to non-exis on.

Pharmacyion Services Group team monitoring likely to divert medicati divers International Medicalexactly is a 77 Datarithm Stericycle Cypress Lane cause more latitude can even ic e What pandem employe Q. on?FL 32751 COVID Industries 7037 theRoad functi 2355 Waukegan Road Maitland, of Fly s, the g stress prior addiction 2981 Gateway how do they (407) 383-3301 , or13057 andDrive The mere added the level of addressin East Syracuse, Bannockburn, IL 60015 divertingNY important to facility. tendency of very re is the team with Pompano A Beach, FL 33069 (877) 273-5112 those ons.

(866) 783-7422 diversion within a healthca medicati problem PharmWaste Technologiesy and stealing (954) 917-9570 www.datarithm.co www.stericycle.com up of pharmac temptation of the drug diversion very least 3317made 109th Street, Suiteent, A legal, atory the Imiweb.com at mand is managem The team that theInc. EnlivenHealth, such as risk a Swisslog Healthcare Urbandale, IA 50322 think team, but if Q. Do you a controlled KeySourcenursing personnel. Others (515) a part of the 590 Middlefield Road loss of 11325 Main Street theft/ y a team of s, can also be 276-5302 ing obviousl resource is ented 7820 Palacehuman Drive report Mountain View, CA 94043 this person the Broomfield, CO 80020 exists, www.pwaste.com is being docum oftentimes be Cincinnati, OH 45249 specialist (800) 764-0300 diversion substance Enlivenhealth.co specialist will rities? diversion PharmaLink Inc. autho The state also.

(800) 842-5991 think www.swisslog-healthcare.com don’t member to DEA and Euclid Medical Products ed above I #200 meeting. 8285 Bryan Dairy Road, assemble KeySource.com First, as mention familiar with diversion one to call the to be able to Largo, FL 33777 nts need No, I do not. 339 Mill Street called TouchPoint Medical l that are of participa typically signs personne team Masters Pharmaceutical OH 44606 200 Touchpoint Drive Diversion e and are (800) 257-3527 recognize the adequately trainedApple Creek,would unresolved thosePharma Way a very short timefram of 3600 facilities re(800) 727-2543 diversion or Odessa, FL 33556 www.pharmalinkinc.com within s, since many inside healthca there is an obvious designed to notify the (800) 947-3901 the incident/ Mason, OH 45036 when report www.euclidmedicalproducts.com together meeting is diversion and d. to discuss the www.touchpointmed.com (800) 982-7922 error. This been reassigne for the team medication people have . The manner and www.mastersrx.com list, diversion timely a drug in l team ion specia potentia of a bona resolving the a drug divers next steps in te after each incident Q. What is should debrief critiquing both he/she opera team incident, does diversion d. and how facility? T E M • I N F U S I O N diversion to examine the entire ent is warrante 62 W I N Thealth E R 2 0 2care 1 I H E A LT H S Y S is fide to monitor and where improvem within the whose job decisions good someone the is the by dpecialist d substances A diversion ration of controlle augmented daily, the administ employees. This is typically a re pinpointing can assist in institution’s healthca programs that re facility. by various software the healthca problem within drug diversion

60

WINTER

2021

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H E A LT H

SYSTEM

O • INFUSI

Industry Expert Q&A, Drug Diversion Market Leaders Buyer’s Guide, and more.

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Your partner in pharmacy compliance since 1992 USP <797> USP <71> USP <800> Left: GM7030 PATT2®, Personal Aseptic Technique test kit, 3mL ampules, 20mL vials, 100mL partially filled minibag.

Below: ET1000 EnviroTest® TSA with Lecithin & Tween 80 growth media paddles for surface, air, or glove fingertip sampling.

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page 75

Temptime Temperature Intelligence® Solutions — Monitoring Devices and Integrated Solutions for Medication Shipments, Storage, and Pharmacy Facilities

TEMPERATURE INTELLIGENCE®

Monitoring solutions to maintain the vaccine cold chain Get visibility into medication temperatures onsite and in transit Keeping refrigerated medication—including COVID-19 vaccines— within the right temperature range is critical for maintaining their efficacy. That’s why CDC guidelines recommend using digital data loggers to monitor temperatures as vaccines travel to patient administration sites. Temptime’s S-400 electronic temperature sensors capture the temperature data you need, 24/7, while also alerting you to excursions.

Learn more about how Temptime can help you preserve valuable vaccine supplies and meet CDC guidelines: temptimecorp.com/vaccine-monitoring

Providing the devices and information to accurately monitor temperature-sensitive medications.

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page 67 DRUG DIVERSION

Visante — HighPerforming Pharmacy is Who We Are

Pharmacy consulting designed for optimal growth

We help you achieve extraordinary results in all areas of health system pharmacy

Strategic Planning & Implementation

Compliance that Improves Care

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We collaborate with you to deliver innovative solutions that will elevate your organization to peak performance levels.

Our team of compliance experts will improve confidence, enhance care and ensure patient, worker and community safety.

Making the most of opportunities to manage costs and increase revenue is core to our consulting. We help you improve financial performance across your organization.

Visante consultants bring you expertise in all areas of hospital and health system pharmacy: • Comprehensive Strategic Assessments • 340B Program Solutions • Specialty Pharmacy Programs • Revenue Cycle and Drug Reimbursement Strategies

Connect with Visante today to learn how we can help you reach your goals. Visit us at visanteinc.com, or call 866-388-7583. © Visante Consulting, LLC, 2021. All Rights Reserved.

• Supply Chain Strategies • Drug Diversion Programs • Drug Compounding Excellence

TM

Transforming healthcare through pharmacy.

We're in the business of advancing pharmacy. Our consultants work with hospitals and health systems combining a wealth of expertise with personalized and comprehensive support to optimize your pharmacy operations and deliver better patient care.

Case Study: Piedmont Healthcare and Waste Management’s PharmEcology® Services

C ASE ST U DY PIEDMONT HEALTHCARE AND WASTE MANAGEMENT’S PHARMECOLOGY® SERVICES COLLABORATE TO ENSURE USP <800> COMPLIANCE

OVERVIEW Back in 1905, Dr. Ludwig Amster and Dr. Floyd Wilcox McRae founded Piedmont Hospital. At that time, they were considered pioneers in patient care, fulfilling the healthcare needs of patients all over Atlanta and surrounding communities.

Skip Lynch, RPh

Director Outpatient Pharmacy Services ~ Piedmont Athens Regional

Chelsea Parry, Pharm.D., BCPS Oncology Pharmacist Specialist ~ Piedmont West Infusion Center

Fast forward to 2021, and Piedmont Healthcare is still a recognized leader in delivering expert care. In fact, Piedmont now cares for 2.7 million patients across 800 locations, serving communities that comprise 70% of Georgia’s population. What began as a single hospital more than a century ago has grown into an integrated healthcare system of 11 hospitals, 34 urgent care centers, 25 QuickCare locations, and 555 physician practice locations.

Collaborate to ensure USP <800> compliance.

There is no question that Piedmont is committed to continuous improvement and making a positive difference in every life they touch. Building their reputation of excellence and enhancing services is a top priority. And this mission holds true with regards to hazardous waste and hazardous drug management.

“When the USP <800> standards were first published, we wanted to comply on a system-wide level,” explains Skip Lynch, Piedmont’s director of outpatient pharmacy services. “So we searched for a solution that could serve our entire healthcare system. PharmEcology not only offered a comprehensive solution, but provided us with a very strong partnership that would allow us to meet our specific needs.”

With the help of PharmEcology’s USP <800> Consultation Program, Piedmont is well on its way to protecting all healthcare personnel from hazardous drugs as well as ensuring a safe and healthy environment.

TACKLING CHALLENGES According to numerous studies, acute and chronic health effects can occur from occupational exposure to more than 200 hazardous drugs (HDs) commonly used in healthcare settings.

As a result, the National Institute for Occupational Safety and Health (NIOSH) defined criteria for identifying these hazardous drugs. Based on this information, the United States Pharmacopeia (USP), an independent, scientific nonprofit organization, developed the USP General Chapter <800> standards for handling hazardous drugs to minimize the risk to public health. The goals of these standards include:

www.pharmecology.com

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H E A LT H S Y S T E M • I N F U S I O N 15

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Meets CDC guidelines and prepared for NSF 456 standard Blu-Wave® cooling technology for precise temperature uniformity Low cost of ownership Unique sizes, combinations and customizations Made in the USA since 1955

Vaccine safety and integrity are at the forefront of a patient’s well-being and health. Migali Scientific® has been manufacturing high-performance refrigerators and freezers since 1955. Our cutting edge Blu-Wave® cooling technology delivers rapid temperature recovery and uniformity, ensuring vaccine and medication safety and efficacy. Scan QR CODE to learn why more hospitals and practitioners are choosing Migali Scientific refrigerators and freezers.

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Comprehensive environmental monitoring is critical to a hospital’s ability to earn trust in its adherence to safety protocols.

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Unit Dose Done Right P 8.5 x 11.indd 1

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page 83 DRUG DIVERSION

With the Right Reverse Distribution Partner

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At Pharma Logistics we honor the challenges of today’s pharmaceutical market and provide our customers with a full-service reverse distribution experience that is focused on ease of use, regulatory compliance and financial accountability. When you partner with Pharma Logistics, you get access to: Build business intelligence.

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Expedited Cashflow

Our Rapid Credit Program offers customers a cost-effective solution AND delivers credits within 14 days from when the product is received in our warehouse compared to the industry standard of 12+months.

C AS E S T U DY CLINICALLY STUDIED CULTURELLE ® BENEFITS PATIENTS AND MAKES FINANCIAL SENSE SUMMARY

Pharmacists at health systems and long-term care facilities can now include on the pharmaceutical protocol the most clinically studied probiotic for patients experiencing: • Antibiotic associated diarrhea • Acute-infectious diarrhea • Traveler’s diarrhea Numerous human clinical trials have shown that supplementation with Lactobacillus rhamnosus GG, delivered in many Culturelle® dietary supplement products from i-Health, a division of DSM, significantly benefits the patients with these conditions.

Margaret Haldeman, Ph.D. Global Research & Development, Probiotics ~ i-Health, Inc.

page 93

Pharma Logistics Delivers Credit, Compliance, and Convenience to Improve Profitability

Improve Your Hospital Pharmacy Business

Recently renamed Lacticaseibacillus rhamnosus GG,1 Lactobacillus rhamnosus GG is still commonly referred to as Lactobacillus GG. Clinical data demonstrates that Lactobacillus GG reduces diarrhea resulting from travel to foreign countries,2, 3 side effects of antibiotics,4-9 and dysbiosis due to viral and bacterial intestinal infections,10-12 including Clostridium difficile infection.13-15

Trade Show & Meeting Calendar

Your reliable partner in pharmaceutical reverse distribution. Our Rapid Credit, Onsite, and Box and Ship services ensure hospital and pharmacy organizations can optimize inventory and supply chain.

page 85

page 94-99

Case Study: i-Health and Culturelle®

Sentry Data Systems, a Craneware Company — Expect More With a Trusted 340B Leader

As many as

76%

Clinically studied Culturelle® benefits patients and makes financial sense.

of pharmacy claims require intervention

Claims Manager Plus This sophisticated pharmacy claims solution automates the process

A pioneer in providing automated technology solutions that help providers manage 340B compliance, produce better quality, reduce the total cost of care, and reach more underserved patients.

of claim intervention to help you streamline claims processing while managing complex reporting requirements. And the savings potential is significant:

This unit-dose hospital pack under the brand of Culturelle® comes with the reassurance for the pharmacist and physician that they are prescribing the most extensively studied probiotic strain since its identification in 1985. The outcome is that the patients feel better quickly, physicians see that the overall digestive system is working better, and pharmacists provide a clinically studied strain.

The purchasing officer also recognizes the value and quality of the Culturelle® suite of products.

Overall, Culturelle® products may contribute to improved patient care and pharmacy efficiencies.

432

$14M

Average hours saved per employee per year

Average total cost savings per year

DATA-DRIVEN DECISION MAKING FOR PHARMACIST & PHYSICIAN Pharmacists play a crucial role when they are counseling physicians on options for patients experiencing digestive conditions. One of the more common health problems for physicians to address is when they prescribe antibiotics to heal a bacterial infection. The antibiotic often affects the balance of gut microbiota, causing distressing diarrhea. Furthermore, studies have shown that antibiotics can disturb the microbiome for up to one year.16, 17

Let Claims Manager Plus help you close the gap. For more information or to schedule a demo, visit sentryds.com/closingthegap

Clinical research indicates Lactobacillus rhamnosus GG reduces diarrhea and minimizes the adverse effects of the antibiotic.4-6 With this medical knowledge, pharmacists can provide the physician with data on why prescribing a probiotic is safe and effective. The findings also support that Lactobacillus GG, delivered in many Culturelle® products, helps with nausea, taste disturbances, and bloating, all side effects that can contribute to non-compliance.

Together, We are

When pharmacists and physicians join other colleagues on the Pharmacy and Therapeutics (P&T) committee to add to their www.culturellehcp.com

© Copyright 2022 Sentry Data Systems, Inc. All rights reserved. No unauthorized reproduction.

For Professional Use Only

page 101

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1

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4:35 PM

The Solution to Prevent Pharmaceutical Waste from Winding Up Here.

C

M

Simple. No worries. The highest level of technology.

Best of all — full compliance.

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Clinicians simply put both the non-hazardous and the RCRA hazardous pharmaceutical waste in the same black container.* Clean Harbors, the largest hazardous waste incineration company in North America, will pickup, transport and dispose your pharmaceutical waste, while keeping you fully compliant. We handle every step of the process. Because we own several proprietary incinerators, we do not require the same segregation as other providers.

CMY

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Are you prepared for changes to subpart P in the EPA’s hazardous pharmaceutical regulations? Ensuring compliance with waste segregation protocols can be difficult, both to train and enforce, putting your facility at risk for non-compliance. * Due to DOT regulations, there are certain waste items that must be collected separately.

For more information: 855.MED.WSTE (633.9783) or healthcareservices@cleanharbors.com, healthcare.cleanharbors.com

© 2020 Clean Harbors. All rights reserved.

Clean Harbors — Experts in Pharmaceutical Waste Disposal and Environmental Services

Here to help keep your healthcare facility in compliance with complex state and federal regulations — while managing your environmental and waste disposal needs from beginning to end.

DRUG DIVERSION

OneContainer®

Improve your Solid Oral Unit Dose needs with our comprehensive Bar Coding, Packaging, and Labeling Solutions — designed by healthcare professionals, for healthcare professionals.

BoxPicker® Automated Pharmacy Storage System From Swisslog Healthcare Creates a More Efficient Pharmacy Workflow

Reach Higher Standards of Care Humber River Hospital prioritizes quality care delivery through industryaccuracy, and safety measures.

Swisslog Healthcare plays a key role in delivering this vision. Our solutions streamline pharmacy operations.

Our PillPick® Automated Packaging and Dispensing System and BoxPicker® Automated Pharmacy Storage System allowed Humber River Hospital realize:

Optimize pharmacy workflows with the market’s proven robotic storage and retrieval system to virtually eliminate picking errors, increase efficiency, and improve medication safety.

Reduced — Medication picking errors by more than 50% — Pharmacy technician labor to pick and package unit dose medications by more than 30% Gained — Pharmacy technician time for medication reconciliation and other direct care activities Increased Inventory control by

Realize your vision. swisslog-healthcare.com/humberriver-rx

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page 103

page 91

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H E A LT H S Y S T E M • I N F U S I O N 21

Expert Products For Expert Care®

Specialty Medication Preparation & Medication Safety Products

RESPONSIVE TO YOUR NEEDS FAST ORDER SHIPPING EXPERT PRODUCTS EXPERT SERVICE

CONNECT WITH US: (866) 231.1222 | MAXPERTMEDICAL.COM | INFO@MAXPERTMEDICAL.COM

Contents C AS E S T U DY

THE CAP THAT PROTECTS CHILDREN Prep-Lock™ Tamper Evident Caps Deter Drug Diversion INTENDED OUTCOME

The theft of controlled substances or other medications meant for the patient can occur at various points in the supply chain. The installation of drug security methods at healthcare facilities continues to increase each year because of the rise and risk of drug diversion. Mitigating diversion is a priority for every health provider, and ensuring patient safety is the goal of every drug diversion method.

Julie Lasseigne, PharmD Pediatric Pharmacy Director ~ Children’s Hospital of Alabama

This case study examines why one of the simplest drug diversion solutions is also one of the most successful. Tamper evident caps are an effective tool in addressing drug diversion. Specifically, this analysis details why this product works for Children’s Hospital of Alabama (Children’s).

The success story became evident when Children’s converted to the ENFit Connector Standard to reduce enteral tubing misconnections. This conversion opened the opportunity for pharmacy leadership to purchase and prioritize tamper evident caps for the ENFit syringes, adding additional protection to the medication and Children’s.

BACKGROUND

Children’s has a progressive pharmacy department that utilizes technology and clinical knowledge to provide care for a diverse patient population. It’s lead by Julie Lasseigne, pediatric pharmacy director for Children’s, who views the health and safety of children as her foremost responsibility.

Lasseigne is known for solving problems and working collaboratively. She looks at this issue with zero tolerance and takes a 360° approach to combat it.

“Drug diversion is about understanding the behavior, making it difficult to access the drug, and implementing deterrents,” said Lasseigne. “I’m continually aware that compounded preparations are at their greatest risk for diversion when they leave the custody of our pharmacy.”

Case Study: IMI and Children's of Alabama — The Cap That Protects Children Prep-Lock™ Tamper Evident Caps deter drug diversion.

ZERO PROBLEMS; ZERO COMPLAINTS

Northwell Health relies on Modular Devices Inc.

Northwell Health Relies on Modular Devices Inc. BACKGROUND AND INTENDED OUTCOME Northwell Health is New York state’s largest healthcare provider. It compasses 23 hospitals, 74,000 employees, and more than 700 outpatient facilities. The vast integrative healthcare network continually expands and upgrades facilities to improve the health of the patients and communities it serves.

Alfonso Traina Vice President of Cleanrooms ~ Modular Devices Inc.

In the fall of 2019, Northwell leadership assigned specific areas for upgrading, including the compound pharmacy in their Staten Island hospital. Great care and concentration had to go into the decision because of the protections needed for the life-saving work performed in this lab.

This location serves cancer patients who need individualized chemotherapy. Disruption for these patients and the more than 1,000 daily hazardous and traditional intravenous (I.V. medications) produced in this lab was not an option during construction.

Leadership landed on bringing in a vendor with a trailer that could convert into a lab. However, this trailer-chemotherapy lab had to come with an immaculate level of cleanliness. The mobile cleanroom had to provide incontestable evidence that it would be particulate-free and sterile to compound hazardous and non-hazardous pharmaceuticals and provide ample protection for staff and patients.

Otto VonEilbergh Director, Capital Projects, Corporate Facilities Services ~ Northwell Health

This 14-year employee knows the pharmaceutical needs of Children’s. And the hospital needed tamper evident caps for their pharmaceutical security program.

Equally as necessary, the self-contained unit had to ensure continuity of care. Tight timelines and stringent compliance were priorities. And a vendor had to assure seamless operations among logistical, productions, and entry requirements.

This case study analyzes the hospital leadership’s decision to contract with a vendor to lease a cleanroom. It examines the criteria applied to choose a vendor and how the vendor addressed the challenges, complexity, and requirements of installing and servicing a modular relocatable compound pharmacy.

THE CHALLENGE

“If the employee is having a bad day and feel like they need the drug, we want them to see that cap and think that it’s not worth taking it. The cap signals not to make that bad choice because you’ll get caught,” said Lasseigne.

Construction is disruption, which is an anathema for a hospital. Leadership at Northwell Health wanted a short lead time to open a modular lab, while upgrading facilities. Beyond all the regulatory requirements that they must meet, the facilities staff wanted an environmentally friendly lab that minimizes a carbon footprint.

CHALLENGES

Drug diversion presents numerous safety and reputational risks for a hospital. Financially, hospitals bear the cost of diverted drugs, internal investigations, and follow-up care for affected patients.

The government can fine the facility in excess of $4 million for inadequate safeguards.1 By their daily access to controlled substances, it is estimated that 15%

Otto VonEilbergh, director, capital projects, corporate facilities services, Northwell Health, now knows first-hand all the intricate details of moving a unit that is 14 feet wide and 60 feet long and

www.imiweb.com

www.portable-cleanroom.com

DRUG DIVERSION

Increase Safety in Your Hospital and Community Stericycle’s CsRx containers mitigate drug diversion in your hospital.

Our MedDrop collection kiosks and Seal&Send envelopes TM

TM

provide your patients and community safe solutions to dispose unused medications. SafeDrop provides safety and efficiency to TM

your immunization program and patients’ home injection therapies.

Comprehensive Regulated Waste Management

Case Study: Zero Problems; Zero Complaints

C ASE ST U DY

We protect what matters.

for your Pharmacy

CsRx Controlled Substance Waste Service • Heightens your organization’s drug diversion program • Deactivates controlled substance wastage

Seal&Send Medication Envelopes and MedDrop Drug Collection Kiosks

SafeDrop Sharps Mail Back Containers

• Increases your organization’s community stewardship

• Cost-effective and convenient

• Mitigates drug diversion in your community

• FDA and DOT compliant, USPS approved

• Protects the environment, keeping drugs out of waterways • DEA compliant

Learn more at Stericycle.com © 2021 Stericycle, Inc. All rights reserved.

page 104-107

page 112-115

Safeguard Your Organization, Community, and the Environment With Stericycle Solutions

Download the 20Ways App

RXinsider.com/20ways

Stericycle’s CsRx Controlled Substance Waste Service can serve as a central component to prevent drug diversion in your hospital.

page 109 DRUG DIVERSION

CPS Partnerships to Drive Pharmacy Performance Excellence Tailored solutions. Proprietary tools.

Extensive expertise.

For healthcare leaders who seek a partner in driving performance excellence, CPS delivers partnerships that drive financial, operational, and clinical success through the pharmacy.

Pharmacy Management

Specialty and Ambulatory Pharmacy

We empower healthcare organizations to advance the standard of care by: •

Implementing best practices and proprietary technologies to drive value and enhance the patient experience

•

Leveraging a deep bench of subject-matter experts

•

Continually improving the way healthcare is delivered

•

Driving performance to reduce costs, increase revenues, and elevate the status of internal leaders and teams

Let’s discuss opportunities to improve the financial and clinical performance of your pharmacy.

Pharmacy Consulting

340B Program Solutions

Telepharmacy

Supply Chain and Materials Management

CPS partnerships empower hospitals and health systems to advance the standard of care by elevating the performance capabilities of their pharmacy leaders and teams.

PT, OT, ST Rehabilitation

contactus@cpspharm.com • 800.968.6962 • www.cpspharm.com

03876-20 Winter Ways Fall - FP Ad and Profile_F.indd 1

10/6/21 11:47 AM

page 111 PUBLISHER RXinsider, LTD RXinsider CEO: Gregory Cianfarani, RPh DESIGN AND PRODUCTION Design & Layout Multimedia Marketing and Operations

Lora Bourque Eric Simmons Samantha Roy Alexa DiLuca Kristin Fennessey

SALES AND BUSINESS DEVELOPMENT Chris Kolkhorst, Vice President chris.kolkhorst@rxinsider.com Shaun Russell shaun.russell@rxinsider.com Mike Rahme mike.rahme@rxinsider.com Matt Payne matt.payne@rxinsider.com Jillian Melly jillian.melly@rxinsider.com Email sales@rxinsider.com Toll-Free Phone 800.972.2083 Fax 646.329.9766 Website www.RXinsider.com

20Ways is an official publication of RXinsider

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Editorial – views expressed in articles or profiles in the 20Ways are those of the author(s) and do not necessarily reflect the policies and opinions of RXinsider, our editorial board(s), our advisory board(s), or staff. Advertising – products, services, and educational institutions advertised in 20Ways do not imply endorsement by RXinsider.

Copyright © 2021 RXinsider LTD. All rights reserved.

Reproduction without permission is prohibited.

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CUSTOMIZED USP <797> PRODUCT TESTING & E N V I R O N M E N TA L MONITORING

Sterility Testing Particulate Testing Endotoxin Testing Compliance On Demand™ Kits

EMPQ Validated Potency Testing Environmental Monitoring

element.com contact.us@element.com +1 888 786 7555

WE HELP YOU TURN YOUR IDEAS

INTO REALITY Founded in 1970, Uniweb’s expertise is the design and manufacturing of quality fixtures that go beyond the retail pharmacy doors. Whether it is new construction, relocation or a renovation, Uniweb offers a complete line of fixture solutions and dedicated designers to guide you through the process.

Our TEAM For over 50 years, Uniweb has helped retailers improve their existing space by re-imagining their approach and employing our high-density fixture line. Uniweb RX systems hold up to 50% more product storage in the same footprint over conventional stick-built systems, generating more profit to the bottom line!

Uniweb manufactures modular rooms, wall storage panels, retail displays, RX fixtures, OTC options, counters, locking units and adjustable height workstations. Uniweb products provide unlimited flexibility, and unmatched strength, utility and appearance, at an affordable price.

Our ADVANTAGE

Corona CA 800.486.4932

uniwebinc.com

Uniweb has maintained a 10 day build-time for standard equipment and 4-6 week production for custom RX equipment and modular rooms.

Uniweb delivers significantly shorter lead times, adaptable designs, and long-lasting products.

Uniweb has maintained a lower surcharge, passing those savings on to our customers.

Uniweb Does it ALL! DESIGN * CRAFT * SHIP * INSTALL!

Methylprednisolone Acetate Injectable Suspension

Available Now from Amneal Pharmaceuticals

Because consistent supply is what you Demand.

Our ever-expanding portfolio includes new dosage forms and complex injectables that you can count on.

We take pride in delivering vital medicines like Methylprednisolone Acetate Injectable Suspension, USP into the hands of those who need them most. When they need them most. With over 250 generic products, we provide customers and patients with value, true accessibility, and quality. This is how We make healthy possible.

Methylprednisolone Acetate Injectable Suspension Pack NDC

Dosage Strength

Pack Size

70121-1573-01

40 mg/mL

1 mL Single-Dose Vial

70121-1573-05

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25 x 1 mL Single-Dose Vials

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80 mg/mL

1 mL Single-Dose Vial

70121-1574-05

80 mg/mL

25 x 1 mL Single-Dose Vials

Not made with natural rubber latex

Preservative free

Order from your wholesaler/distributor or contact Amneal: 866.525.7270 or CustomerRelations@amneal.com

amneal.com Images are for reference only; actual product may vary. © 2021 Amneal Pharmaceuticals LLC. All rights reserved. MAIAD-01

Made For You The Arisure Closed System Transfer Device is designed to protect you and your team from exposure to harmful vapors when compounding, transporting, and delivering hazardous drugs. Arisure has received ONB clearance from the US FDA for its use as a Closed System Transfer Device (CSTD).

1. Mechanically and Microbiologically Closed 2. Needle-Free and Easy to Use 3. Minimal Workflow Disruption

13MM, 20MM, 28MM

C LOS E D M A L E LU E R

Arisure Closed Vial Adapter

WITH CAP

VA LV E

YM-050

YM-058

YM-004

Case Quantity: 100

Case Quantity: 100

Case Quantity: 100

YM-051, YM-053, YM-054 Case Quantity: 50

FEMALE NEUTRAL

ARISURE DRY SPIKE

Exclusive Distributor: Progressive Medical, Inc. (PMI) 997 Horan Drive • Fenton, MO 63026 Ordering Information: Tel: 314.961.5786 • Fax: 314.961.4535 cs@progressivemedinc.com • progressivemedinc.com

USP <800> RESOURCES Leading Pharmacy Suppliers of USP <800> Compliant Solutions These leading pharmacy suppliers offer product and service solutions to help your pharmacy and/ or cleanroom achieve USP <800> compliance.

Contact these companies directly for more details on how they can help you meet the mandate of USP <800> compliance.

www.RXinsider.com/USP800

Rees Scientific

© 2021 RXinsider LTD. All rights reserved.

PHARMECOLOGY®

Innovative. Dedicated. Proven.

Your true partner for 340B program administration and compliance.

Results you can believe in.

Verity Solutions® is a recognized leader in 340B program optimization. We drive continually improved solutions and vigilantly address regulatory changes so that our customers can dedicate fewer resources to program administration and more resources to community wellness.

Partner with us to simplify 340B program management, confidently optimize federal pricing benefits, and benefit from the knowledge and support of our expert team.

1.800.581.1378 info@verity340b.com www.verity340b.com

VER ITY 340B ® SPL IT BI L L I NG | C O NTRACT PHARMACY SP ECIALTY C ONTRACT PHARMACY | C O M P LIANCE MANAGEMENT | P U RCHASE ANALYTI CS | VHUB ®

© 2021 Verity Solutions Group, Inc.

2 0WAY S TO I M P R O V E PAT I E N T C A R E & P H A R M A C Y C O S T C O N TA I N M E N T

Verity Solutions — Invested in Your 340B Program Success Partner with us to simplify 340B administration, confidently optimize federal pricing benefits, and benefit from the dedication and knowledge of our expert team.

CEO:

George Puckett Founded: 2015 Employees: 100 Toll-Free Phone: (800) 581-1378 Phone: (425) 947-1922 Address: 12131 113th Avenue NE, #200 Kirkland, WA 98034 Website: www.verity340b.com

Company Background Verity Solutions is a leader in 340B program administration.

Recognized as Best in KLAS: 340B Management Systems for the last four years, our mission is to make every aspect of 340B program management clear and easy to understand. We believe in optimizing program benefits through predictable automation and outstanding support so that every customer can maximize their savings. Hundreds of integrated healthcare systems, acutecare hospitals, community health centers, federally qualified health centers, pharmacies, and other 340B-eligible covered entities throughout the United States rely on Verity 340B® software and services to successfully manage their 340B program.

Product Overview Our powerful V340B® cloud-based software platform provides comprehensive solutions for split billing, contract pharmacy, specialty contract pharmacy, compliance management, purchase analytics, and pharmacy network management (VHUB®). Our depth of in-house technical and software development resources and our highly skilled account management team are closely aligned to adapt as changes arise in the 340B program swiftly. We offer: • Agile Software Platform: Built and deployed with security, performance, scalability, and agility as primary goals.

The Verity 340B platform is HITRUST certified and HIPAA compliant.

• Intuitive Application: Designed with our users in mind, we maintain ongoing feedback and collaboration with our clients. This collaboration steers our continual software and services development.

What Sets Verity Solutions Apart?

With increasing 340B regulatory complexity and demand for audit preparedness, it's more important than ever to have the right solution for your 340B program management — and the right partner. n Highlights • Industry leading core functionality of our V340B® platform with optional, patent-pending add-on modules to enhance all aspects of 340B operations in challenging and unique environments.

• Rapid implementation for both split billing and contract pharmacy solutions to help covered entities meet challenging timeline needs.

• Access to your own unique 340B program test environment — before and after implementation. Test environment runs continually in parallel to your live system.

• Easy and exportable reporting functionality including detailed data for manufacturer or HRSA audits.

• Transition from one electronic medical record (EMR) to another without downtime (contingent upon receipt of dispense file from the covered entity).

• Multiple wholesaler support with controlled substances ordering system (CSOS) — efficiently place orders with both EDI (electronic data interchange) and non-EDI vendors.

• Two-week sprint release cycles ensure timely software updates driven by customer feedback, regulatory changes, and user needs.

• F lexible and “winners only” contract pharmacy pricing models. No true-ups.

• Verity Care Card Program — directly pass 340B savings to uninsured and underinsured patients.

• Referral capture opt-in functionality to compliantly add meaningful savings lift to your 340B program.

• Responsive customer service provided by our in-house staff.

• 80% of our customer support cases resolved within two hours. 95% resolved within 24 hours.

• Responsive Support: Designated account managers provide focused support, training, audit readiness, and regular business reviews to maximize your 340B program success and help you maintain compliance.

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Meeting 797> Requirements Requirements Meeting Your Your USP USP<<797> Veltek Simple Veltek Makes Makes Itit Simple

C CLEANING LEANINGAND AND DISINFECTING ISINFECTINGPP RODUCTS D RODUCTS

EENVIRONMENTAL NVIRONMENTAL MONITORING ONITORING M QUIPMENT EEQUIPMENT

GOWNING OWNING G

USP 800 Gown

Cleanroom Garments

VAI every aspect necessary for full compliance including: VAIcovers covers every aspect necessary for full compliance

including:

Consultation on maintaining aseptic processes onsetting settingupupand and maintaining aseptic processes • ■Consultation – our easy to use disinfectants in pre-measured containers RTU containers ■ SimpleMix • SimpleMix® – Veltek’s easy to use disinfectants in pre-measured Easy2Gownsterile sterile garment garment system system • ■■Easy2Gown Easy to use portable SMA air samplers to use SMA MicroPortable® ICS - Veltek’s Viable Cleanroom Air Monitoring device • ■Easy RTU Sterile & Non-Sterile cleaners & disinfectants available in a large assortment cleaners & disinfectants available in a large assortment of packaging sizes • Sterile of packaging sizes ®

SCAN HERE

TO CONTACT US

Veltek Associates, Inc. 15 Lee Boulevard Malvern, PA 19355-1234

With VAI’s innovative product line, Meeting USP<797> requirements is just a phone call away…IT’S THAT SIMPLE!

1-888-4-STERILE H E A LT H C A R E

www.sterile.com @STERILE.COM

2 0WAY S TO I M P R O V E PAT I E N T C A R E & P H A R M A C Y C O S T C O N TA I N M E N T

SMA MicroPortable® ICS From VAI® Offers Superior Precision and Control Combining experience, innovation, performance, GMP manufacturing, GLP testing services, and unrelenting service has propelled VAI as the ultimate innovative leader in the market.

President & CEO: Arthur L. Vellutato, Jr. Founded: 1981

Employees: 200+ Phone:

(610) 644-8335

Address: 15 Lee Boulevard

Malvern, PA 19355

Website: sterile.com

Company Background

For nearly 40 years, Veltek Associates, Inc. (VAI®) has pioneered the design and manufacture of hundreds of cleanroom solutions that surround contamination control. These innovations, many of them landmarks in the industry’s history, allow our customers to overcome challenges, and reach their business goals. Plus, VAI® clients have more than a solutions provider, they have a partner and trusted advisor. With today’s complex research challenges, new competition, and increasing government regulations, a true partnership is more important than ever.

For us, it’s simple. Innovation is about listening to industry challenges directly from our customers and not stopping until we find the answer.

Together with our clients, we have been developing new solutions for the cleanroom industry for more than 40 years attaining over 150 worldwide patents. Our innovations have allowed our clients to do remarkable things — from biotechnology breakthroughs to pharmaceutical discoveries — that help millions of people every day. From our early days of developing the first sterile garments to our latest innovations, VAI® develops products that revolutionize and simplify aseptic manufacturing.

Product Overview

VAI®’s Environmental Control Monitoring Division (ECMD) addresses the needs of the healthcare, pharmaceutical, biotechnology, semiconductor, and electronics industries with a complete range of facility wide viable environmental monitoring equipment.

VAI®’s viable air monitoring equipment is designed to sample a quantifiable amount of air for viable contamination using our patented Sterilizable Microbial Atrium (SMA®) and a standard media plate. Air is directed from the environment to impact onto a media plate contained inside of the Atrium. The media plate is then incubated and tested to determine the number of viable organisms per cubic foot or liter of air.

Additional Product Modules

n SMA MicroPortable® ICS The SMA MicroPortable® ICS provides continuous air monitoring for viable particles at quality control sample points. The SMA MicroPortable® ICS regulates air flow through a SMA Atrium®. A SMA Atrium is a stainless-steel device that directs air from the environment to impact onto a media plate. The media plate is then tested to determine the amount of viable contamination in the environment. It is battery powered and compact, which allows it to be easily moved to desired air sampling points.

It combines the sampling capability of the SMA Atrium with calibrated air flow and a touchscreen interface.

The SMA MicroPortable® ICS provides strict regulation of air flow and will alarm the operator if the air flow deviates beyond the acceptable range. The system also monitors and indicates a variety of operational parameters including the sample’s volume and elapsed time. It’s a networked device that may be remotely accessed by operators and administrators. The device can export event history to a removable USB flash drive. Event history includes sampling and calibration events.

VAI® offers on-site calibration and repair services. Please contact us for details.

Additional Product Lines

VAI ® offers full circle contamination control products and services.

• Cleaners, disinfectants, and sporicides (sterile and non-sterile).

• Disposable garments: USP<797> and USP<800> compatible options.

• Cleanroom ready wipers: low-linting dry and saturated.

• Cleanroom documentation: Core2Write®, CleanPrint10®, Core2Print®.

Markets Served

VAI® serves the following markets:

• Hospitals and Health Care Systems • 503A Compounding Facilities • 503B Outsourcing Facilities • Pharmaceutical Manufacturing • Biotech

SMA OneTouch® ICS and SMA OneTouch® Command Systems are used to control calibrated and timed vacuum sequences to connected SMA® Atriums. Both systems allow you to start, stop, and monitor the sample cycle from within a controlled environment while locating the flow center and vacuum pump in a non-controlled environment.

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CAS E S TU DY PIKEVILLE MEDICAL CENTER AND AZINA PARTNER TO CREATE INNOVATIVE PHARMACY CAPABILITIES

INTRODUCTION AND INTENDED OUTCOME Pikeville Medical Center (PMC), a 348-bed facility located in southeastern Kentucky, has been dedicated to providing quality care in Kentucky for 97 years.

Kandi Justice COO ~ Pikeville Medical Center

Today, PMC employs 3,000 individuals and offers more than 400 services, including every major specialty and most sub-specialties. Technology and innovation, combined with service and vision, are rapidly driving PMC toward its goal of being a national leader in health care.

It’s this objective that prompted PMC to partner with Azina (formerly SPARx, the specialty pharmacy division of Comprehensive Pharmacy Services) to improve drug access for patients, innovate all services, enhance patient care, and increase revenue.

“We wanted to leverage our existing retail pharmacy to build an innovative specialty pharmacy,” explains Kandi Justice, COO, Pikeville Medical Center. “Our goal was to provide specialty medications to patients quickly and efficiently. This would enable us to greatly improve the patient experience, as well as keep revenue in-house, instead of relying on numerous third-party pharmacies.”

John Petts, PharmD Vice President ~ Azina

She adds, “Our existing retail pharmacy was a small, 500-square-foot space that used an outdated pharmacy management system to process all prescriptions manually.

The pharmacy didn’t have inside access for patients — only a very crowded drive-thru kiosk. We knew we needed to completely overhaul our pharmacy capabilities, and we turned to Azina for help. There was no question that their decades of experience working with hospitals and health systems would be invaluable to us. It became a very strong and collaborative partnership.”

36 36

azina.com

CAS E S TU DY

“

We could not have reached this high level of accreditation without Azina’s help and support.

Their expertise in this area was invaluable to us.”

Kandi Justice COO ~ Pikeville Medical Center

GETTING TO WORK The first step was to conduct a thorough assessment of PMC’s pharmacy operations.

“The team examined the medical center’s existing technology, infrastructure, equipment, staffing, workflow, dispensing systems, and customer service frameworks to develop a detailed redesign plan,” explains John Petts, PharmD, Azina vice president. “We had our work cut out for us — especially during a global pandemic. While the pandemic definitely created roadblocks for our team, we were able to navigate these barriers and get started immediately.”

The next phase of the project involved working with a team of architects and engineers to design and oversee the construction of a new 7,100-square-foot pharmacy design to include a 1,200 square-foot retail pharmacy and a specialty pharmacy space.

The redesign entailed several key pieces, including: • • • • • • • •

A new workflow structure to increase the speed and efficiency of medication pick-up.

New refrigeration systems.

A stronger, integrated 340B program to increase drug access.

Improved staffing.

The creation of a private consultation area for patients.

Installing software and robotic automation to count and label all drugs.

Adding an inventory management system.

New, updated software.

Once the redesign of the retail pharmacy was underway, the team began work on building a specialty pharmacy. “As the region’s only specialty pharmacy, we wanted to develop a unique and much-needed service for patients who have rare or complex health problems, including cancer, Crohn’s disease, hepatitis C, HIV, multiple sclerosis, osteoporosis, psoriasis, and rheumatoid arthritis,” explains Lina Abdallah, PMC director of outpatient pharmacy.

In addition to focusing on the administration of medications used to treat these complex and rare health conditions, PMC’s new specialty pharmacy also concentrated on the special handling of these medications, such as refrigeration, as well as support with prior authorization, financial assistance, education, adhering to drug regimens, and side effect management.

“Our aim was to improve the overall patient experience by connecting chronically ill patients to the care they require. We needed to provide them with specialty medications — including limited distribution drugs from key drug manufacturers — close to where they live and where they receive treatment,” says Abdallah. “Now, they no longer need to wait days, and even weeks, to receive their meds by mail.”

The Azina team also worked hand in hand with PMC to achieve dual accreditation — URAC and ACHC. This dual accreditation is extremely important for PMC’s specialty pharmacy.

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CAS E S TU DY “While achieving these accreditations can typically take up to three years, we were able to receive this high standard of care in just 11 months with Azina’s guidance,” explains Abdallah. “This accreditation is crucial because it establishes PMC as a qualified care provider for all of our patients.”

Adds Justice, “We could not have reached this high level of accreditation without Azina’s help and support. Their expertise in this area was invaluable to us.”

ACHIEVING SUCCESS Since the beginning of PMC’s pharmacy improvement project, the medical center has experienced impressive results, becoming a national model for innovation.

PMC has been able to achieve a time to fill of 2.26 days which is well below the industry average.

Furthermore, PMC’s patient satisfaction rates, which were targeted at 80%, achieved a whopping 96%. Call abandonment rates, which were targeted at 5% or less, came in at 2.2%. And average hospital revenue and gross margin numbers increased significantly.

The partnership between PMC and Azina exemplifies a very successful collaboration — even during a global pandemic. “We set out to improve patient care and increase revenue for the hospital, but we achieved so much more,” explains Justice. “Azina’s expertise, guidance, support, skills, and turnkey solutions have been absolutely critical to our success. We have accomplished so much.”

She adds, “Complex diseases often bring many complications for patients, so our job is making life easier for them. It comes down to being there when patients need us most.

And we are now able to do just that.”

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azina.com

Develop and drive

high performance outpatient programs to keep your patients on one care continuum The Azina team provides expertise in specialty pharmacy services, empowering healthcare organizations to own their own specialty pharmacy and associated revenue stream.

Financial Opportunity Analysis

Dual Accreditation

Pharmacy Operations

LDD and Payor Access

Everything from A to Z in Your Approach 800-968-6962 | azina.com

FUNCTIONALITY YOU NEED. SERVICE YOU TRUST. POINT-OF-SALE MADE CRAZY EASY.

Innovative Training

Customized Software

WHY CHOOSE RMS? RMS is dedicated to helping pharmacies improve patient outcomes through innovative point-of-sale solutions. RMS’ solutions are flexible, scalable, and customizable to meet the needs of any pharmacy.

Turn-Key Hardware

24/7 U.S. Based Customer Support

WITH RMS, YOU CAN...

Make informed business decisions using robust reporting Centralize and streamline pharmacy operations Integrate with your choice of pharmacy management systems

Email us at sales@rm-solutions.com, or give us a call at 877-767-1060.

Implement programs like meds-to-beds and will-call

Scan this QR code to learn more about RMS

2 0WAY S TO I M P R O V E PAT I E N T C A R E & P H A R M A C Y C O S T C O N TA I N M E N T

Point-of-Sale to Support Your Outpatient Pharmacy Operations — Retail Management Solutions Improve patient outcomes, streamline pharmacy management, and meet pharmacy goals with a point-of-sale solution tailored for your organization and integrated to your choice of over 30 pharmacy management systems.

President & CEO: Brad Jones Founded: 1998 Toll-Free Phone:

(877) 767-1060 (360) 438-8276 Fax: (360) 438-8284 Address: 4535 Lacey Boulevard SE Lacey, WA 98503 Website: www.rm-solutions.com Phone:

Company Background

Founded in 1998, with a mission to help pharmacies understand and use technology-based tools to run a successful business, Retail Management Solutions continues to lead point-of-sale innovation. Giving pharmacies access to tools and technology to improve patient outcomes, streamline operations, and improve profits.

RMS’ POS systems are created exclusively for pharmacies. We listen to our customers, partners, and industry requirements to provide timely, point-ofsale based solutions to solve the challenges faced by pharmacies today.

Product Overview

RMS offers a range of point-of-sale products that are both flexible and scalable to meet the needs of any pharmacy. While our easy-touse till application is at the forefront of day-to-day activities, running a successful pharmacy goes far beyond collecting a payment. There are many ways in which an RMS system can help. n At the Register: RMS customers have freedom to choose from over 30 pharmacy system partners, all with integrations that make prescription sales fast, easy, and accurate. Signatures for HIPAA, safety caps, prescription acknowledgment, etc. are captured at the time of sale and are always easily accessible when needed for reporting and audits.

Built-in date of birth verification processes and additional prescription for pickup notifications bring added patient safety and convenience to every transaction.

Additionally, every RMS system includes built-in will-call management.

Batch multiple prescriptions together into a single bag. Store according to your organizational preferences. Scan a single barcode at checkout.

This easy-to-use option improves patient safety and saves time.

Beyond prescription sales, OTC product sales are as simple as scanning the item barcode. Custom items can also be created for easy sale of unique products, gift items, etc. Payroll deduct can be added to any implementation for easy employee sales.

Sales can be processed in many different ways to meet the unique needs of your pharmacy. Whether you need standard retail lanes, Meds-to-Beds technology, an option for drive-thru payments and signatures, curbside pickup solutions, or an easy way to track deliveries. You can mix and match to create the perfect technology scheme. n Improving Patient Outcomes: Improving patient outcomes and increasing customer satisfaction are goals at the heart of most organizations today. Nutrient Depletion notifications at the register help you to improve patient wellness by making supplement recommendations based on prescription induced nutrient depletion.

Meds-to-Beds technology and support help you to align your pharmacy with organizational goals. Point of sale tailored for bedside interactions and full transaction processing help you work towards increasing patient compliance and reducing readmittance rates as a result. n Easy Compliance: RMS credit card processing capabilities include options for validated P2PE, allowing the potential for reduced PCI scope.

Processing integrations also include options for EMV, tokenization, NFC, and FSA/HSA card acceptance.

Every RMS system includes optional integration with NPLEx for Pseudoephedrine tracking as well as signatures, ID capture, and tracking for HIPAA, safety caps, prescription acknowledgment, etc. n Headquarters and Management: Point-of-sale applications extend beyond the customer interaction to help you run your pharmacies more efficiently. Enterprise-level multi-location management unlocks powerful tools for policy, pricing, employee, and customer management. Data fed back to the headquarters saves time and resources.

For pharmacies managing retail departments, RMS’ inventory management solutions open the door for advanced management of front-end product with wholesaler interfaces, automated purchasing and receiving, price updates, and integrated signs and labels.

A host of reports, both canned and customizable, are available. From cash management and employee performance to A/R balances, and more.

RMS systems give you the data you need to drive important decisions and run pharmacies efficiently. n When You Need Support: All customers have access to the RMS support line, staffed by our in-house team of U.S.-based technical specialists, 24 hours a day, seven days a week. The RMS customer center is available at any time to request support, access the customer knowledgebase, and more.

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Integrated Temperature Monitoring with i.C3® Information System

Continuous monitoring supports safe storage of vaccines and medications

Intelligent diagnostic information and data in one secure location Monitor and optimize performance with a finger stroke Constant monitoring ensures uniform temperature Available on i.Series medicalgrade refrigerators, -30 freezers, and ultra-low freezers

Learn More helmerinc.com/ic3videos

© 2021 Helmer Inc. All rights reserved

© 2020-2021 Helmer Inc. All rights reserved.

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Integrated Temperature Monitoring to Support Safe Storage of Vaccines and Medications With Helmer Scientific Continuous monitoring offers safety and security of stored product.

President & CEO: Bruce King

Vice President of Sales & Marketing: Lori Gabrek Founded: 1977 Employees: 300 Toll-Free Phone:

(800) 743-5637 Phone: (317) 773-9073 Address: 14400 Bergen Boulevard, Noblesville, IN 46060 Website: www.helmerinc.com

Company Background

Helmer Scientific is a manufacturer and worldwide distributor of medicalgrade cold storage and laboratory processing equipment. We have over 40 years of experience in providing high-quality temperature-controlled environments, with our products used in over 130 countries throughout the world. We serve customers from our US-based headquarters, which also houses our R&D center and advanced FDA GMP manufacturing operation. Helmer is an industry leader for pharmacy and vaccine cold storage solutions.

Product Overview

i.Series® takes Helmer’s GX Solutions medical-grade refrigeration to the next level. Featured on i.Series® temperature-controlled storage products, the i.C3® Information Center provides intelligent diagnostic information and temperature data, while providing security features to keep the information safe. It consolidates everything you need to know about the status of your storage device in one secure location. With the i.C3®, you can monitor and optimize performance with just a finger stroke. Want to know who’s been opening the door? Simple, check the Access Control Log. With intuitive prompts and messages, it’s never been easier to set parameters, track performance, and download storage data.

The i.C3® Information Center is integrated into i.Series® medical-grade refrigerators and -30°C freezers, as well as ultra-low freezers. Whether you’re storing vaccines or medications, it’s critical to have constant monitoring to ensure uniform temperature throughout the space — safeguarding the integrity of the stored items.

The i.C3 Information Center enables users to conveniently monitor unit performance, address alarms and alerts, and view and download historical temperature data. The i.C3® Information Center can also help facilities and vaccine providers meet CDC guidelines for vaccine storage and Vaccines for Children (VFC) requirements.

Features & Options

n System Status Console: Monitor the status of the unit with one quick glance at the touch screen home screen, including: current temperature

and alarm conditions; minimum and maximum temperatures; unacknowledged alarms; and historical temperature data. n Interactive Temperature Graph: When you need more information, the interactive temperature graph provides a visual history of performance with shortcuts to the Event Log for more detailed information including: • The One Touch Quick Info feature, which enables users to touch graph for point-in-time detail.

• A zoom feature, which provides a close-up of a selected time period.

• Jump forward and back buttons can access two months of data. n Event Log and Detail Screen With Event Acknowledgement: The 100 most recent events can be viewed on the Event Log screen.

Simply touching an event enables users to drill down to specific information on the Event Log Detail screen, including: • Alarm type.

• Start and end date/time of alarm.

• Monitoring and compressor probe maximum and minimum temperatures during the event.

• i.ACT™ Event Acknowledgement function captures corrective action with signature, date, and time-stamp. n Min/Max Display and Reset: This display shows the highest and lowest temperature occurrence right on the home screen. This function is especially helpful for vaccine storage applications. n Data Transfer Center: Data is simply downloaded via the USB port in the side of the i.C3® Information Center. Extended downloading capabilities and formats offer: • Up to three months of graphs and log data via PDF reports.

• 10 years of log data via CSV reports.

• One-day and seven-day alarm event data providing detailed log information for each event.

• One-day and seven-day graphs for primary monitoring probe temperature readings. n Automatic Alarm Testing: Peltier-based technology utilizes self-test probes that warm or cool to accurately test temperature alarms without affecting the temperature inside the cabinet. n Guardian Plus™ Protection: Protect settings and limit access to keep products secure. Guardian Plus™ includes password protected set points to ensure that proper temperatures are maintained. In addition, Integrated Access Control (optional for refrigerators and -30°C freezers) restricts access to the cabinet with an electromagnetic lock controlled by PIN entry.

• Access Control keypad can be set as an alternative home screen.

• Access Control log provides an audit trail of door entries and includes the user ID, date, time, duration, and method of entry.

• Key override.

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T H O U G H T L E A D E R Video Series

THOUGHT LEADER VIDEO SERIES

Azina Join Michael Heinrichs, Senior Vice President of Business Development, Keith Cook, President, Doug Massey, Senior Vice President of Operations, and Eugene Queener, Vice President of Ambulatory & Infusion, as they discuss a specialty and ambulatory pharmacy solution designed to unleash the powerful potential inside hospitals and health systems.

THOUGHT LEADER VIDEO SERIES

Accreditation Commission for Health Care (ACHC) Join Josè Domingos, Matt Hughes, Renee White, Ralph McBride, Jon Pritchett, Megan Reed, and Greg Stowell as they discuss Accreditation Commission for Health Care (ACHC), for providers, by providers.

www.achc.org

www.azina.com

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THOUGHT LEADER VIDEO SERIES

Mission Critical Delivery Solutions: When Failure is Not an Option Join Kyle Janssen, President & Owner of Community Pharmacy, Mackenzie Farr, Chief Operating Officer & Pharmacist at Community Pharmacy, Ted Johanson, President & CEO, Mission Critical Delivery Solutions, Inc., and John Fiene, Medical Courier, Mission Critical Delivery Solutions, Inc., as they discuss Mission Critical Delivery Solutions: “When failure is not an option.”

www.MissionCriticalDelivery.com

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THOUGHT LEADER VIDEO SERIES

Micro Merchant Systems Join Brian J. Courtney, Pharm.D., Chief Revenue Officer, Ketan Mehta, CEO, Samir Haleem, Director of IT, Sheila Dawalt, National Sales Manager, Heba Macksoud, Pharmacy Owner, and Boris Niyazov, Pharmacist, as they discuss Micro Merchant Systems, PrimeRx™ Pharmacy Management System in a 12-part video series.

www.micromerchantsystems.com

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THOUGHT LEADER VIDEO SERIES

Advancing the Business of Pharmacy

Sentry Data Systems | Expect More

Join Kristin Fox-Smith, MPA, Tammy Zukowski, MBA, and Jim Jorgenson, MS, RPh, FASHP, CEO, as they discuss Advancing the Business of Pharmacy in a 12-part video series.

Join Lidia Rodriguez-Hupp, Joel Hennenfent, PharmD, MBA, BCPS, FASHP, Lisa Scholz, PharmD, MBA, Kenosha Chastang, JD, PRS, MBA, Lateef Durosinmi, and Bill Sander, PharmD, as they discuss Sentry Data Systems.

www.visanteinc.com

www.sentryds.com

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THOUGHT LEADER VIDEO SERIES

CPS TELEpharmacy Join Savannah Meier, Vice President of Business, Paresh Patel, Division President of Telepharmacy, Karen Alesch, Director of Pharmacy Operations, Bhavesh Patel, Director of Pharmacy Operations, Bob Phillips, Human Resources, and Aalap Modi, Director of Clinical Care Services as they discuss CPS TELEpharmacy solutions.

T H O U G H T L E A D E R Video Series

THOUGHT LEADER VIDEO SERIES

THOUGHT LEADER VIDEO SERIES

The Compliance Team Join Caitlin Warner, Provider Relations, Jack Haire, Director of DMEPOS & Pharmacy Services, Sandy Canally, RN, Founder & CEO, Steve Simmerman, COO, and Scott Muscarella, Vice President of Marketing, as they discuss Exemplary Provider Accreditation in a 12-part video series.

www.cpspharm.com/cps-telepharmacy

www.thecomplianceteam.org

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Helping you deliver better medicine to more people.

With increasing regulatory pressure and drug shortages, access to quality medicine is more important than ever.

Leiters is an FDA-registered 503B outsourcing provider of high-quality, compounded sterile preparations including: Pre-filled syringes, IV bags and vials ON-Q* Pain Relief System fill services Opioid-free surgical pain services medications Ophthalmology medications and services including FDA-compliant repackaged Avastin®

COMPOUNDING HEALTH™ www.leiters.com | 800.292.6772

ON-Q* is a registered trademark of Avanos Medical, Inc., or its affiliates.

Avastin® is a registered trademark of Genentech, Inc.

2 0WAY S TO I M P R O V E PAT I E N T C A R E & P H A R M A C Y C O S T C O N TA I N M E N T

Leiters. We Are Compounding Health™ Leiters is a trusted FDA-registered 503B outsourcing provider of compounded sterile preparations committed to providing healthcare professionals and their patients with the highest-quality medications.

President & CEO: Robin Smith Hoke Founded: 1926 Employees: 215 Toll-Free Phone:

(800) 292-6772 (720) 697-5140 Fax: (408) 288-8252 Address: 13796 Compark Boulevard, Englewood, CO Website: leiters.com Phone:

Company Background

Leiters, founded in 1926, is an FDA-registered 503B outsourcing provider of high-quality compounded sterile preparations and pharmacy services.

Leiters has a long history of evolving and innovating to meet the latest regulatory requirements and market needs.

All sterile preparations are produced under Section 503B of the FD&C Act (503B Guidance), follow Current Good Manufacturing Practices (cGMP) and USP <797>. The Leiters facility consistently upholds all standards based on the audits conducted by the FDA, States of California and Florida Boards of Pharmacy, multiple health systems, group purchasing organizations, and other independent accreditation organizations.

The Leiters team of experts in sterile pharmaceutical manufacturing, repackaging, and compounding provide a sophisticated understanding of what it takes to elevate the quality and consistency of supply in pharmaceutical outsourcing. Leiters combines a highly experienced team, with robust processes, in a new state-of-the-art outsourcing facility to ensure delivery of the highest quality products and services.

Product Overview

Leiters provides ready-to-use compounded sterile preparations and pharmacy services across the continuum of healthcare, including hospitals, surgery centers, physician offices, and clinics. n Hospital Products • Prefilled operating room syringes and I.V. bags.

• PCA (patient-controlled analgesia) prefilled syringes.

• Surgical Pain Services portfolio including opioid free medications. n Ophthalmology Products • Prefilled syringes, vials, and dropper bottles including: injections, antibiotics, dilating agents, and topical anesthetics.

• FDA-Compliant† Repackaged Avastin® Service. n ON-Q* Pump Fill Service • Pharmacy fill service for the Avanos Medical opioid sparing ON-Q* Pain Relief System.

• Prefill pump services offered for both Bupivacaine HCl and Ropivacaine HCl.

Additional Information

We combine our team, robust processes, and state-of-the-art outsourcing facility to ensure the highest-quality medications for healthcare professionals and their patients. Through three key pillars, people, place, and product, we are elevating the standards in pharmaceutical outsourcing.

Key Business Partners

Leiters is partnered with many market leading innovative healthcare companies that compliment what we do. The products and services offered by these companies may provide additional value to your organization. Our business partners include: Avanos Medical, Besse Medical, Cardinal Health OptiFreight®, CPS Solutions, LLC, Eye Connect International, Hibernation Therapeutics, Kit Check, and Prodigy Health.

Trade Shows/Meetings Attended

Leiters supports and attends a variety of regional and national industry trade shows and conferences. Please visit leiters.com to view a list of 2021-2022 events we’ll be attending.

GPO Affiliations

Leiters provides its products and services to many leading health systems, community hospitals, clinics, and physician offices. In addition, we currently have national contracts with: HealthTrust, Intalere, JDJ Consulting, Kaiser, Premier, The Resource Group, US Retina, and Vizient.

Please contact us for additional information regarding our contracts.

Ordering Information

Leiters offers four convenient ways to place your order.

1. Phone: (800) 292-6772 2. Fax: (408) 288-8252 3. Email: orders@leiters.com 4. Visit the Leiters Online Ordering Portal: orders.leiters.com

Site Visits

We don’t want to simply tell you about what we do, we want to show you! We invite you to visit our facility to better understand the cGMP regulations, sterile manufacturing processes, and automation we use to elevate the quality of our products and services. Come join the growing list of organizations who have visited our facilities. To schedule a site visit or learn more about how Leiters is Compounding Health™, please visit leiters.com.

COMPOUNDING HEALTH™ is a registered trademark of Leiters. Avastin® is a registered trademark of Genentech, Inc. ON-Q* is a registered trademark of Avanos Medical, Inc., or its affiliates. 1BUD is from date compounded. † Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application Guidance for Industry https://www.fda.gov/downloads/drugs/guidances/ucm434176.pdf

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P ROV I DI NG T H E H IG H E ST QUA L I T Y OF P H YS IC A L PHARMACEUTICAL INVENTORIES SINCE 1979 Utilizing Decades of Knowledge & Experience Why Choose Capital for Your Pharmaceutical Inventory Needs?

• Teams of experts conduct the inventory within a few hours.

• Eliminate the need for overtime or coordination of staffing to accommodate inventory process.

• Teams conduct pharmacy inventories daily, not annually.

• Teams work seamlessly around the pharmacy staff ensuring that the “snapshot” is a true representation of the inventory on-hand.

• Minimal interruption to the pharmacy staff and operations.

• Competent inventory specialists that can work with finance and/or external audit firms to validate the inventory.

• Collaboration with the pharmacy to provide an accurate report in a timely manner.

• Expert valuation and pricing of the inventory by an independent party.

To schedule your next inventory, please call 1-800-345-0849 or email customerservice@capitalinventory.com.

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Capital Inventory, Inc. — Accurate and Dependable Pharmacy Inventory Services

Our decades of experience working specifically with pharmacy inventory make us uniquely qualified to provide accurate valuations through a streamlined process. Our clients can trust that we will be transparent, supportive, and reliable in every interaction.

Founder:

William Straub Sr. President: Shannon McArthur Founded: 1979 Employees: 75 Toll-Free Phone: (800) 345-0849 Phone: (770) 928-7202 Fax: (770) 928-2287 Address: 9725 Main Street Woodstock, GA 30188 Website: www.capitalinventory.com

Company Background

William Straub Sr. founded Capital Inventory, Inc. during the late 1970s in Alexandria, VA. The company relocated to Georgia in the early 1980s and now serves the entire nation, including Alaska, Guam, Hawaii, Puerto Rico, and the U.S. Virgin Islands from its office in the Atlanta, GA area.

Capital Inventory, Inc. has been in business for over 42 years, providing service to thousands of hospitals, university medical centers, regional medical centers, and health systems. Capital Inventory exclusively services hospital, outpatient, specialty, and infusion pharmacies. Our inventory experts are in pharmacies daily and year-round. Employees of Capital Inventory are employed full-time and receive complete benefit packages.

Employees undergo extensive and continuing education including pharmacy practices, drug information, and HIPAA regulations. You can be confident and secure as all of Capital Inventory’s employees undergo an extensive background check including felony, misdemeanor, and sex offender. Our employees are 12-panel drug tested regularly and at a minimum of twice a year. All testing is conducted by third-party specialty companies. Additionally, employees are required to be current with all vaccinations including yearly Influenza and TB testing.

Product Overview

Our people are the difference. Our teams speak “NDC fluently” and understand the dynamics of pharmacy operations. The physical inventory process is seamless and unobtrusive as team leaders strategically place the team in locations throughout the pharmacy to ensure accuracy and efficiency. Before completion of an inventory service, our teams actively work with finance and/or independent auditors while on-site to validate the accuracy of the inventory data collected. Beyond the physical inventory, the data is then received, analyzed, and formatted into a report that includes all pertinent information to allow for accurate and precise analysis of the inventory data. Let our team of experts provide your next inventory valuation with precision, accuracy, and confidence.

n What to Expect on Inventory Day Upon arrival, the Capital Inventory team will be introduced to the pharmacy and staff. Our team leader and a pharmacy representative will map the pharmacy and its respective areas. Team members are then assigned to the designated areas and proceed entering each NDC number and QTY into our proprietary hand-held data gathering computer.

Once all areas are completed, the raw inventory data is then transmitted to an independent team for review and analysis. n What to Expect Post Inventory Day Items will be priced according to GPO/Wholesaler Cost Data and Direct Purchase/Secondary Wholesaler Cost Data. Upon review the data will be adjusted, compiled, and valuated. Finally, the inventory data will be delivered electronically as an Excel file. n What to Expect After Receipt of Inventory Data If it is identified that adjustments are needed, we have an easy stepby-step way to apply the indicated changes. When submitted, the adjustments can be made and returned within 24-48 hours. Unlike other companies that do not allow adjustment to the inventory data, we will adjust the data as requested to ensure the final value is a true representation of the on-hand inventory.

Features

n Why outsource your inventory service?

• Inventories average three to five hours with our team of experts.

• Our teams conduct pharmacy inventories daily.

• Minimal interruption for the pharmacy staff and operation.

• Teams work seamlessly to ensure that the “snapshot” is a true representation of the inventory.

• Eliminating the need for overtime and/or coordination of staffing to accommodate.

• Expert valuation and price application of the inventory by an independent party.

• Competent inventory specialists accustomed to working with finance and/or external auditors for validation.

• A collaboration with pharmacy to provide accurate reporting in a timely manner.

GPO Affiliations

Premier; The Resource Group; Health Trust

More Information

To learn more about Capital Inventory and how we can help you with our inventory services, please contact us at (800) 345-0849 or customerservice@capitalinventory.com.

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CAS E S TU DY ENVIRONMENTAL MONITORING IN COMPOUNDING PHARMACIES: FACTORS TO CONSIDER INTRODUCTION

Jeff Meek Manager of North America Sales, Healthcare Division/ Central Region Manage ~ Veltek Associates, Inc.

Cleanroom environmental monitoring in hospital pharmacies and 503A compounding facilities has been a topic of debate over the years. The requirements for viable and total particles air monitoring outlined in USP<797> differ from the recommendations in USP<1116> and sound aseptic techniques generally anticipated by the FDA in a classified drug manufacturing area.5 The differences between these guidance’s cause a wide range of opinions about the frequency and need for viable and total particle air monitoring in hospital pharmacies and other 503A facilities. Of course, like most things the answer is never one sided and the best course for action is most likely somewhere in the middle for these facilities. In this article, we will discuss the importance of environmental monitoring for safe aseptically produced drug products, the differences in regulatory guidance, sources of contamination, strategies for implementing a program, and the equipment your facility may consider if taking more control of your monitoring program — all while saving money in the process.

WHAT IS ENVIRONMENTAL MONITORING AND WHY IS IT IMPORTANT?

For the scope of this article, we are focusing on viable and total particle air sampling, but that is not to discount the importance (and requirement) of surface, compressed gases, and personnel sampling.

Environmental monitoring is a process that is used to monitor the microbial and particulate levels in a classified area. Environmental monitoring of classified areas is a critical step in determining the effectiveness of a facilities engineering controls and to prove the effectiveness of a facilities gowning, cleaning, and disinfecting procedures. The results from your environmental monitoring program are your pharmacies “report card” on just how well your overall program is implemented. Routine environmental monitoring gives the data needed to trend the environmental quality of your classified areas and act when needed.1 EM results also provide sound scientific data to support your rotation scheme between a disinfectant and sporicidal agent. Currently, we rely on an arbitrary time frame for rotation provided by the working compendium. Is the required monthly rotation scheme sufficient specific to your facility? Based on your data trending analysis it may or may not be. Although quite an overkill, some pharmacies apply a sporicide daily for all applications. Generally sporicidal agents are more aggressive on equipment. Their elevated concentration over disinfectants is also unhealthy for worker exposure. Your EM results can support whether in fact this is necessary by determining the species generally detected. Routinely identifying the flora specific to your facility helps us to understand the potential source of the contamination whether it by people related bugs, water bourn bugs, or from outside soil to pinpoint a few. Conducting volumetric testing semi-annually will not provide the sound scientific trending data to support any decision.

SOURCES OF CONTAMINATION

There are many sources of microbial and particulate contamination in the cleanroom. These are broken down into primary and secondary sources of contamination. Primary sources of contamination such as personnel, supplies introduced into the cleanroom, and water bring contamination into the classified area.

Secondary sources of contamination are where these contaminates end up settling. Examples of secondary sources of contamination are surfaces, the air, and potentially any equipment used in compounding sterile preparations within your own pharmacy. Primary sources of contamination are controlled by a combination of functioning engineering controls and meticulous personnel training in gowning, cleaning, disinfecting, and hand hygiene. Formulating a sound cleaning and disinfecting program will control secondary sources of contamination but keep in mind that cleaning and disinfecting addresses contamination after the day’s activity. Simply put, if we do not let the contamination in, we would not need to address it. Naturally, all those performing routine cleaning and disinfecting should be competent to execute the facilities plan and the products selected to 50

sterile.com

CAS E S TU DY It is important to evaluate the risk level associated with the compounding done at a facility using risk assessment tools and use this risk assessment to define the EM sampling frequency.

perform the task should be chosen based on efficacy, safety, compatibility, and ultimate performance for the application intended. Failure to properly execute a sound cleaning and disinfectant program well is in direct correlation to a sound environmental monitoring program. It is for this reason that a well-designed EM program is so very important to be able to identify an inappropriate level of secondary contamination and act before it leads to product contamination.

DIFFERENCES IN REGULATORY GUIDANCE

The differences in regulatory guidance are where debate happens among the contamination control community. USP<797> requires a minimum frequency of six months for viable and total particle air monitoring in ISO 5, 7, and 8 classified areas “in operation” state.2 While USP<1116> calls for daily monitoring of ISO 5 and 7 areas, along with twice weekly monitoring of the ISO 8 area.3 Many State Boards of Pharmacy have created their own Code for Regulations on the subject, but the clear majority also follow the USP<797> compendium guidelines. There is quite a large gap between daily monitoring and monitoring every six months. The facilities that follow USP<797> usually comply with the minimum standard and argue this is acceptable because of their shorter beyond-use dating when compared to cGMP pharmaceutical manufacturing expiration dates. Although this may be true, it is extremely difficult to develop any trending data when sampling once every six months. If the facility did not have any other need for semi-annual monitoring (e.g., new equipment, exceeded action level, suspect contamination) the facility would miss out on two entire seasons on collecting data. Depending on where the facility is located, it could be a lost opportunity to collect EM data for any solid trending analysis. For some compounders, they opine that daily sampling is not feasible, especially when many only engage in low-risk compounding.

For all other compounders, the answer lies somewhere in the middle. It is important to evaluate the risk level associated with the compounding done at a facility using risk assessment tools and use this risk assessment to define the EM sampling frequency. Medium and high-risk compounding may justify more environmental monitoring to ensure accurate data is collected and appropriate actions are taken to rectify any contamination risk. If your facility determines sampling more often is an appropriate risk mitigation step, then a best practice would be to do air monitoring monthly along with increased surface sampling.

This gives better trending data which can be used to improve your contamination control program.

IN HOUSE OR OUTSOURCE?

Taking ownership of one’s program certainly has its benefits. The clear benefit is that you remain in full control of your own program. From implementation to execution and everything in between you have the necessary equipment to perform your own EM testing on your own time schedule. The real-time data from points you deem appropriate supports your program and helps formulate dynamic procedures based on the testing results achieved. Understandably, there will be some trepidation in bringing the program inhouse. There are EM equipment manufacturers that will provide the necessary equipment and will support your program from implementation and set-up to micro identification and a suggested corrective course of action if needed. By owning the equipment outright, you know the integrity of the equipment put in use inside your classified areas that ultimately produce sterile product for patient care. Consider this, not all third-party EM companies are alike. The non-sterilizable equipment brought into your facility by outside testing firms for EM testing was previously used in other facilities. Not to mention the physical handling, storage, and transport of the unit out in the field. The fact is that much of the available equipment used inside the classified area have internal components exposed to outside air which physically cannot be wiped down with a biocidal agent. In the healthcare setting we work, it is all about risk assessment and eliminating any low hanging fruit related to potential risk which can possibly cause patient harm through compromised or adulterated sterile preparations.

The guidelines state that at a minimum, semi-annual viable testing be performed. Some operations may seek additional testing voluntarily or be mandated to perform additional tests involuntarily if micro counts exceed action levels and retesting is required. The cost for these third-party tests adds up very quickly. However, it is common to see a return on investment (ROI) in just one, or two, years’ time when you compare the initial cost outlay for the necessary EM equipment compared with EM outsource testing two to three times per year. Once the facility gets over the initial planning and implementation phase of an environmental monitoring program, it becomes a routine and manageable process. With the help of a competent EM equipment manufacturer, these challenges can be easily overcome to take control of your environmental monitoring program, gather more data, and eliminate the cost of third-party environmental sampling all together.

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CAS E S TU DY STRATEGIES FOR IMPLEMENTING A SAMPLING PROGRAM

No matter what your goals, choosing the right partner can help you select the correct product for your specific needs.

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sterile.com

When developing a sampling plan, it is important to first conduct a risk assessment to determine the sampling frequency and what points pose the greatest risk to your compounded sterile products (CSPs) and thus are most practical to sample. There are many strategies for conducting a risk assessment, here we will talk about two: one for surface sampling and the other for viable and non-viable air monitoring.

The first is a touch point risk assessment where during an observation period touch points are observed, documented, and analyzed afterword to determine the frequency the surfaces were touched and if these surfaces have high enough risk to justify surface sampling. The second is a traffic flow risk assessment to determine where viable and non-viable monitoring should take place. The traffic flow risk assessment is done by observing the flow of personnel, materials, waste, and finished product. This flow pattern is analyzed to determine high-risk areas to perform viable and non-viable air monitoring. These can include the areas adjacent to pass-throughs, spaces between or bordering ISO 5 areas, and inside the ISO 5 area.4 Partnering with the right equipment manufacturer can help you with the risk assessment process and work with you to develop a strategy to effectively use their viable and total particle air samplers.

EQUIPMENT FOR IN-HOUSE VIABLE & TOTAL PARTICLES AIR MONITORING

There are many factors when selecting the appropriate equipment for your environmental monitoring program. These can include reporting features, wireless connectivity, battery vs AC powered, the ability of the unit to be disinfected, and cost. Again, the right EM equipment manufacturer should help make the selection process easy due to their inherent knowledge of the available equipment, the necessary guidelines for use, along with practical application and knowledge of aseptic best techniques. No matter what your goals, choosing the right partner can help you select the correct product for your specific needs.

The viable EM unit for volumetric air testing most used for hospital pharmacy and 503A compounders is a handheld portable device due to its size and convenience. For classified areas, keep in mind the inherent risk of these units is that they are not sterilizable and disrupt unidirectional airflow. For these reasons, the FDA would not accept handheld units inside an ISO 5 drug manufacturing area. Their position for 503A’s appear far less stringent and do not disallow this practice, provided testing is performed immediately after compounding is finished. From a risk perspective, there are EM equipment available that can draw the necessary vacuum to the atrium “head” that sits outside of the ISO 5 PEC to draw sufficient vacuum.

The sterilizable head is the only component that sits inside the PEC so there is no issue of potential cross contamination or disrupted airflow.

Handheld units that are considered for the hospital pharmacy and 503A cleanroom industry should be validated for their physical and biological efficiency and provide strict regulation of air flow and alarm the operator if the air flow deviates beyond the acceptable range. The system should monitor and indicate a variety of operational parameters including the samples volume and elapsed time. Ideally, consider a network device that may be remotely accessed by operators and administrators for convenience. These devices can export event history to a removable USB flash drive which captures sampling and calibration events.

An alternative to the handheld devices for your viable air monitoring is the utilization of a standalone Control Center. These units designed for isolators are used to control calibrated and timed vacuum sequences to individual or multiple SMA Atriums (sampling points) within an isolator system. In addition, the control center for isolators provides strict regulation for airflow and will visually and audibly alarm if the proper air flow is not maintained. Control centers for isolators assure the non-aspiration or return of possible contaminates from the exterior environment to the isolator by providing connections for a purge pump.

Total particle counters for the hospital and 503A marketplace should be chosen for convenience of use and application. The typical configuration is a handheld device with the appropriate flow rate and in compliance with the ISO 21501-4, but they are also available in a table-top or wall mount design. Either way, the device should promote a large touch screen with user friendly software for ease of use. Users should be able to view data including records and reports. Data should also be easily transferred to a facility monitoring system, printer, USB, or compatible software for proper record keeping status. Data may be transferred via ethernet, USB, or wireless RS 485 and RS 232 type ports. Handheld and table-top units can usually be powered by battery or plugged directly into a charger. Wall mount models must be connected to facility power. These units are fast, efficient, and accurate. Again, the right supplier should provide guidance and direction to which unit is best suited for your specific operation.

References: 1 Compounding Sterile Preparations. American Society of Health-System Pharmacists, 2017.

2 USP<797> Pharmaceutical Compounding – Sterile Preparations 3 USP<1116> Microbiological Evaluation of Clean Rooms and Other Controlled Environments 4 Gonzalez Ramirez, Karen. Risk-Based Viable and Non-Viable Monitoring Sampling Plan for Microbial Control Program within ISO 7 Cleanroom. 2017 5 Guidance for Industry – Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice.

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2 0WAY S TO I M P R O V E PAT I E N T C A R E & P H A R M A C Y C O S T C O N TA I N M E N T

Steri-Tamp® Tamper-Evident Sterile Seals by Allied Pharmacy Products, Inc. The only single-use, tamper-evident seal that both provides and maintains a 100% sterile barrier.

National Sales Manager: Alex Meadow Founded: 2010 Phone:

(516) 374-8862

Address: 100 Tec Street, Unit F

Hicksville, NY 11801

Website: www.steri-tamp.com Email: info@steri-tamp.com

Company Background

Allied Pharmacy Products, Inc. was founded in 2010 with the focus on improving the preparation and dispensing of intravenous medication in the hospital pharmacy and compounding settings. Steri-Tamp® was developed by a pharmacist who understood the need for better tamperevidence and sterility in IV preparation. Allied Pharmacy Products, Inc. has always been responsive to pharmacists’ requests, which continues to contribute to expanding our product line.

Product Overview

The Steri-Tamp® sterile product line is comprised of seven innovative tamper-evident seals. Steri-Tamp IV Bag Port Seals are available in blue, red, and CHEMO (yellow). The vial seals are available in 13 mm (red), 20 mm (silver), and 28 mm (blue). Steri-Tamp Belly Button Bag Seals (green) are the only seals that will adhere to the port of a Hospira/ICU Medical “belly button” bag, as well as the top of a 13 mm vial.

Steri-Tamp's recently released USP 800 and ISMP specific IV Bag Port Seals help address labeling recommendations for paralytic agents or hazardous drugs in a single workflow.

Unlike other seals on the market, Steri-Tamp seals provide true tamperevidence. Using dual-layer technology, the seals help to alert hospital staff if a bag or vial has been used or modified. If the top foil layer is removed, the “opened” layer is revealed and the top layer cannot be reapplied. Due to the 3X stronger adhesive, Steri-Tamp is able to provide a 100% sterile barrier.

• Protects the point of entry of IV admixture bags from contamination and accidental double dosing.

• Using a simple “twist” method, the seal adheres to itself and the port ensuring no air channels.

• The green Belly Button Bag Seal is the only seal specifically designed to cover the “belly button” port, which is located in the middle of the Hospira bag. The seal can also be used on a 13 mm vial top. n Steri-Tamp® Vial Seals • Designed to lay flat on the vial top preventing bacteria from entering the vial. The seal should not overlap the edges.

• Helps to maintain the integrity of the medication.

• Sized specifically to fit 28 mm, 20 mm, and 13 mm vial tops. A seal should only be applied to its corresponding vial size. n Steri-Tamp® Syringe Seals • Non-sterile solutions to provide tamper-evidence for syringes and other medical containers.

• The new Tamper-Clear Syringe Seal® provides clear visibility to the barrel of the syringe and allows barcodes to be scanned.

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Steri-Tamp also offers two non-sterile syringe seals. Their increased tensile strength allows you to remove easily from the liner and manipulate over any desired container (syringes, pill bottles, inhalers, EpiPens, insulin pens, medication boxes, etc.) without the seal breaking before it is applied. Our new Tamper-Clear Syringe Seal® will now allow you to see through to the markings on the syringe and scan the barcodes on syringes, inhalers, insulin pens, etc.

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Available through major wholesalers and distributors. Visit our website, www.steri-tamp.com, for order information or to watch dispensing and application training videos.

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H E A LT H S Y S T E M • I N F U S I O N 55

Now Available from American Health Packaging As a leading manufacturer of serialized, barcoded unit-dose medications, our growing product formulary continues to support your patient safety and pharmacy efficiency initiatives. Review the most recent additions below, now available through partner wholesalers and GPOs. For the full product catalog, visit www.americanhealthpackaging.com.

Unit dose oral solids McKesson #

Morris & Dickson #

Product description

Strength

UD size

NDC 11

3703665

2302917

981878

Budesonide Capsule (Enteric Coated)

3 mg

20 UD

60687-0596-32

4907010

2027480

612515

Calcium Acetate Capsule

667 mg

100 UD

68084-0479-01

10254113

5703590

3790623

981910

Famotidine Tablet

20 mg

100 UD

60687-0595-01

10260469

5740444

2349314

106591

Febuxostat Tablet

40 mg

30 UD

60687-0538-21

10258312

4149654

3274917

956623

Fenofibrate Capsule (Micronized)

200 mg

30 UD

68084-0329-21

10260081

5740352

2346641

104364

Fenofibrate Tablet

48 mg

30 UD

60687-0618-21

10258877

5728696

2334258

040410

Fenofibrate Tablet

145 mg

30 UD

60687-0629-21

10254284

5704143

3901725

982025

Fluphenazine HCl Tablet

5 mg

100 UD

68084-0846-01

10254285

5704150

3901741

982033

Fluphenazine HCl Tablet

10 mg

100 UD

68084-0950-01

10252050

5688189

1584887

921783

Gabapentin Capsule

100 mg

100 UD

60687-0580-01

10252051

5688197

1584903

921791

Gabapentin Capsule

300 mg

100 UD

60687-0591-01

10252014

5688205

1584911

921817

Gabapentin Capsule

400 mg

100 UD

60687-0602-01

10254190

5703012

2302966

981886

Hydrochlorothiazide Tablet

25 mg

100 UD

60687-0593-01

10258311

5724828

2329746

032094

Hydromorphone HCl Tablet (CII)

2 mg

100 UD

60687-0579-01

10258383

5724836

2329761

032110

Hydromorphone HCl Tablet (CII)

4 mg

100 UD

60687-0590-01

10254966

5709282

2303436

045013

Ketorolac Tromethamine Tablet

10 mg

30 UD

60687-0104-21

10261602

5743703

2358067

109579

Lorazepam Tablet

2 mg

100 UD

60687-0649-01

10260085

5736483

2343838

103572

Omeprazole DR Capsule

40 mg

100 UD

60687-0608-01

10258394

4858015

2016327

257253

Potassium Chloride ER Tablet

10 mEq

100 UD

68084-0632-01

10258893

5728688

2333243

039784

Propranolol HCl Tablet

10 mg

100 UD

60687-0587-01

10254155

5703574

3691490

981803

Rifampin Capsule

150 mg

30 UD

60687-0575-21

10254131

5703582

3693793

981845

Rifampin Capsule

300 mg

100 UD

60687-0586-01

10258214

5726450

2329555

035055

Ropinirole Tablet

0.25 mg

100 UD

60687-0577-01

10258196

5726468

2329571

035220

Ropinirole Tablet

1 mg

100 UD

60687-0588-01

10260130

5736178

2343168

102426

Sennosides and Docusate Sodium Tablet

8.6 mg / 50 mg

100 UD

60687-0622-01

10258624

5728233

2333557

039560

Valsartan Tablet

40 mg

30 UD

60687-0612-21

10258623

5728241

2333581

039602

Valsartan Tablet

80 mg

100 UD

60687-0623-01

10258635

5728258

2333649

039594

Valsartan Tablet

160 mg

100 UD

60687-0634-01

10259425

5731617

2338465

114736

Valacyclovir Tablet

500 mg

30 UD

68084-0215-21

AB #

Cardinal Health #

10254220 10124030

Liquid unit dose AB #

Cardinal Health #

McKesson #

Morris & Dickson #

Product description

Cup delivery

Cup strength

10260982

5742325

2354959

108985

Acetaminophen Oral Solution

10.15 mL

325 mg / 10.15 mL

100 ct

60687-0571-56

10260983

5742333

2354967

108993

Acetaminophen Oral Solution

20.30 mL

650mg / 20.30 mL

100 ct

60687-0571-37

10249925

5676135

1574276

914382

Atovaquone Oral Suspension

5 mL

750 mg / 5 mL

42 ct

60687-0534-78

10261209

5743026

2356897

109017

Hydromorphone HCl Oral Solution

5 mL

5 mg / 5 mL

30 ct

60687-0566-86

10258469

5725668

2328805

034397

Midazolam HCL Syrup (CIV)

2.5 mL

5 mg / 2.5 mL

30 ct

60687-0576-10

10258500

5725676

2328821

034371

Midazolam HCL Syrup (CIV)

5 mL

10 mg / 5 mL

30 ct

60687-0576-86

971820

Milk of Magnesia Saline Laxative (Magnesium Hydroxide)

30 mL

2400 mg / 30 mL

100 ct

60687-0429-76

10251651

5699970

Hitting the mark

3579828

AHP unit dose simplifies one of the most complex parts of your job – reliably obtaining ready to dispense medications – in a format that promotes positive outcomes for your patients.

Pack size

NDC 11

800.707.4621 americanhealthpackaging.com AD202110-0093

2 0WAY S TO I M P R O V E PAT I E N T C A R E & P H A R M A C Y C O S T C O N TA I N M E N T

American Health Packaging, Offering A Broad Portfolio Of Barcoded Unit-Dose Products With a responsive line of barcoded unit-dose oral solutions, a growing liquid unitdose offering, as well as individually wrapped inhalants, American Health Packaging continues to deliver on their commitment to supporting pharmacy efficiency.

President:

Bruce Bennett Toll-Free Phone: (800) 707-4621 Address: Columbus, OH 43217 Website: www.americanhealthpackaging.com

Company Background

Located in Columbus, Ohio, American Health Packaging (AHP) is an industry leader in manufacturing serialized, barcoded unit-dose (UD) medications provided for the healthcare marketplace. As a UD manufacturer, AHP’s commercially-available UD products are available to hospital, institutional, and long-term care pharmacies nationwide through partner GPOs and wholesalers.

AHP’s reputation for quality is supported by a 30+ year history of broad manufacturing expertise — operating a facility that is registered with the FDA, fully adherent to cGMP guidelines, and licensed by the DEA to package Schedule II-V controlled substances. Synonymous with unit dose, following years of success and leadership in the production of oral solids, AHP expanded their offering in 2017 to include liquid unit-dose cups and inhalants in 2019.

Product Overview

AHP is committed to supporting pharmacy efficiency through a diverse range of both high-utilization and niche treatments. Producing nearly 600 UD oral solid SKUs for the healthcare marketplace, AHP’s broad selection of products are produced with quality components and printed with legible barcodes that facilitate effective execution of BPOC initiatives. Their wide selection of products reduces the gap between what pharmacies are forced to repackage themselves, and what is commercially available on the market — supporting health systems nationwide in their efforts to create efficiencies throughout the chain of care.

AHP’s tailored offering of UD oral liquids provide similar efficiency, safety, and cost-savings benefits as their oral-solids products. Product features include right-sized packaging, thoughtful tray design, differentiated labelling, and accurate barcodes. AHP’s unit-dose inhalants provide efficiency and feature individually-wrapped vials and pouches barcoded to the dose level. AHP oral solids, liquids, and inhalants include major therapeutic classes and product groups to meet unique pharmacy needs.

They are continuously evolving to meet the changing demands of caregivers and staff to support more effective medication procurement strategies.

As facilities nationwide compete to demonstrate they provide the highest quality of care, AHP UD supports caregivers as they strive to promote positive outcomes for patients. Pharmacies simultaneously strive to be cost-effective as they provide necessary resources for caregivers.

Additional Product Modules

AHP UD supports these objectives while providing cost-savings opportunities. Sourcing pre-packaged UD allows pharmacies to obtain adequate supply while mitigating capital expenses, such as those related to repackaging equipment, bulk supply, and labor.

Benefits for Health Systems

n Patient Safety: Ensuring the right medication is given to the right

patient at the right time — and in the right strength — is imperative.

Pharmacies can facilitate effective execution of these “rights” by providing caregivers with as many products in a pre-packaged UD format as possible. Removing repackaging tasks from the pharmacy eliminates a potential point of failure during the UD process as medications arrive to pharmacies ready to dispense. n Pharmacy Efficiency: Pharmacies strive to process orders and supply the proper medications to caregivers for their patients as quickly as possible. Adding potentially-complex repackaging steps to the procurement process not only harms the ability of pharmacy to supply caregivers effectively, but also removes clinicians from their core patient care competencies. In addition, pre-packaged UD often allows for products to be sourced more quickly than third-party repackaging can support. n Cost-Savings Opportunity: Health systems that choose to package on-site must consider all direct costs, such as purchasing capital equipment for packaging areas and paying highly-trained clinical professionals to perform, manage, and support non-core work. AHP UD products allow for pharmacies to avoid these costs while also shifting the potential costs associated with packaging errors. The pre-packaged format also prevents additional fees that may result from utilizing thirdparty repackaging services. n Liability Management: Pharmacy repackaging operations can be subject to distractions from a variety of sources. An active pharmacy environment can encourage lapses in concentration and present opportunities for staff error. Since these errors may vary in gravity and place liability on the facility and caregivers, mitigation of risk is key. Unit dose from American Health Packaging can help shift liability burden away from staff.

Hitting the Mark for BCMA, USP <800> Support

Effective execution of BCMA initiatives require medications that scan correctly at the bedside. With a robust oral-solids portfolio — and growing offering of unit-dose liquids — AHP UD provides reliable access to UD treatments. AHP products promote safety towards BPOC and efficiency in pharmacy while freeing up internal resources. AHP UD supports pharmacies as they strive for compliance with USP General Chapter <800> guidelines.

As pharmacies craft effective procurement strategies to meet the needs of their facilities, protecting patients and caregivers alike from potential harm while handling hazardous drugs is a priority. AHP's UD portfolio has a number of NIOSH/USP <800> products already packaged for bedside dispensing which supports compliance to USP <800> handling procedures.

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H E A LT H S Y S T E M • I N F U S I O N 57

DRUG DIVERSION Q&A

Q&A

John Burke President International Health Facility Diversion Association

Q. Do you think that the incidents of drug diversion within healthcare facilities have fallen off since the advent of the pandemic?

Definitely not. Most healthcare facilities diverted personnel from the jobs of monitoring and detecting drug diversion in their facility to address the urgent needs of the COVID problem.

This means that whatever was in place, a diversion specialist, and/or a diversion team, etc., has likely been either temporarily eliminated or at the very least diluted. So, with monitoring likely next to non-existent, it allows the diverting employee even more latitude to divert medication.

The mere added stress of the COVID pandemic can cause those with the tendency of diverting or prior addictions, the temptation of stealing medications.

Q. Do you think that the mandatory reporting of theft/loss of a controlled substance is being documented to DEA and state authorities?

No, I do not. First, as mentioned above I don’t think adequately trained personnel that are familiar with diversion inside healthcare facilities would recognize the signs of diversion and report the incident/s, since many of those people have been reassigned.

Q. What is a drug diversion specialist, and how does he/she operate within the healthcare facility?

A diversion specialist is someone whose job is to monitor daily, the administration of controlled substances by the institution’s healthcare employees. This is typically augmented by various software programs that can assist in pinpointing a drug diversion problem within the healthcare facility.

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H E A LT H S Y S T E M • I N F U S I O N

The diversion specialist is also responsible for identifying potential diversion trends, notifying the drug diversion team, if applicable, and conducting the investigation with the assistance of nursing and pharmacy, which includes conducting interviews of drug diverters and anyone who can provide insight into the incident. They are the primary person tasked with resolving discrepancies involving medication administrations.

Q. What is the best background for a person to be a diversion specialist?

Typically, most diversion specialists are a nurse, pharmacist, and in some cases a pharmacy technician. I have seen several pharmacy technicians in this role who do an outstanding job.

Q. What exactly is a diversion team and how do they function?

A diversion team is very important to the level of addressing the drug diversion problem within a healthcare facility.

The team is at the very least made up of pharmacy and nursing personnel. Others such as risk management, legal, or human resources can also be a part of the team, but if a diversion specialist exists, this person is obviously a team member also. The diversion specialist will oftentimes be the one to call the meeting.

Diversion team participants need to be able to assemble within a very short time frame and are typically called together when there is an obvious diversion or unresolved medication error. This meeting is designed to notify the team in a timely manner and for the team to discuss the next steps in resolving the potential drug diversion. The diversion team should debrief after each incident of a bona fide diversion to examine the entire incident, critiquing both the good decisions and where improvement is warranted.

Q. Is drug diversion in the operating room a real problem?

Healthcare facilities need to make sure that in each incident of a bona fide diversion within their facility, they make sure to test the diverter for blood-borne pathogens.

This is oftentimes overlooked, and yet may be very important. Protecting patients that have been in contact with a diverter who has a communicable disease as quickly as possible is crucial.

Absolutely. The diversion of drugs inside healthcare facilities operating rooms has always been commonplace.

First, the drugs are some of the most powerful and addicting drugs that exist anywhere, and those who work in the OR are specialists in administering them to patients. Those employees in the OR that have addiction issues are experts in the administering of these dangerous drugs to themselves, most of the time, however overdose deaths do occur.

Q. Why is detecting and reporting drug diversion within a healthcare facility so important? When detected why not just fire the offender and move on?

There are many valid and important reasons.

As mentioned above, there is little chance of testing the diverter for blood-borne pathogens, thus the inability to protect your own patients.

A. Diverters will likely move on to the next facility, endangering the lives of their patients and the welfare of the next institution.

B. The diverter themselves, are very unlikely to overcome their addiction without assistance and mandatory discipline. You may very well be attributing to the overdose death of this employee or damage to a patient by doing nothing.

C. It can be illegal! Some states, like Ohio, require reporting to law enforcement and the regulatory board involved or you can be prosecuted criminally.

D. Failure to report to DEA Diversion can result in serious sanctions on your facility, both monetary and the dispensing of controlled substances, or both.

E. Large scale legal action can be taken against your facility for not reporting properly when a significant diversion problem occurs in another facility that could have been avoided if your institution had taken the proper action.

BIOGRAPHY

Pharmacy is key here, as they need to closely monitor the administration of controlled substances in the OR. Ideally, any wastage needs to be returned to the pharmacy where random or for-cause sampling can be done. Employees in the OR need to know this is an option that the pharmacy can invoke at will.

DRUG DIVERSION Q&A

Q. What else should be done when a diverter is identified?

In recent years, some of the most egregious OR diversions have taken place, not by those authorized to administer controlled substances, but those with a valid reason to be in the OR but not authorized to administer drugs of any kind. They were able to access their drugs of choice by diverting medication that was left unattended by a person that was authorized to possess and administer the drug.

In those instances, the diverter injected themselves and then refilled the syringe with saline or tap water. Therefore, the authorized healthcare professional was unaware of the tampering and the diversions continued.

In these cases, it is essential that all authorized administers of these drugs keep strict control of their medications and not leave them anywhere that others can access. It is possible that some training by looking at the case of David Kwiatkowski might stir awareness as to how important securing their medications can be, and thus avoiding a tragedy at your institution.

John Burke, President, International Health Facility Diversion Association

Mr. Burke has been in law enforcement for almost 50 years, with 32 years with the Cincinnati Police Department, where he formed and commanded the Pharmaceutical Diversion Unit. He has a background in all facets of drug diversion and previously wrote a monthly article in an industry publication on prescription drug abuse for over 15 years. He is the past president of the National Association of Drug Diversion Investigators (NADDI).

He is the owner and president of Pharmaceutical Diversion Education Inc., which provides education, expert witness, and consulting to healthcare facilities and law enforcement. He is also the co-founder of the International Health Facility Diversion Association (IHFDA) and serves as its president.

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DRUG DIVERSION Buyer's Guide

DRUG DIVERSION Buyer’s Guide American Health Packaging 2550-A John Glenn Avenue Columbus, OH 43217 (800) 707-4621 americanhealthpackaging.com

GRx 100 Colin Drive Holbrook, NY 11741 (800) 473-2138 www.guaranteedreturns.com

Maxpert Medical 6106 Bausch Road Galloway, OH 43119 (866) 231-1222 Maxpertmedical.com

Protenus 1629 Thames Street, 2nd Floor Baltimore, MD 21231 (410) 995-8811 www.protenus.com

American Rx Group 6321 Bury Drive, #19 Eden Prairie, MN 55346 (855) 269-1750 americanrxgroup.com

GTC Consulting 7603 Achterman Road Pleasant Plain, OH 45162 (513) 815-8779 www.gtcconsults.com

Medacist 1492 Highland Avenue, Unit 4/5 Cheshire, CT 06410 (866) 633-5393 www.medacist.com

Rx Destroyer 701 Blackhawk Drive, Suite F Burlington, WI 53105 (888) 608-5160 RxDestroyer.com

ANiGENT 17736 Edison Avenue Chesterfield, MO 63005 (833) 264-4368 Anigent.com

Health Care Logistics P.O. Box 25 Circleville, OH 43113 (800) 848-1633 Gohcl.com

NarcX 523 E 1750 N, Suite 300 Vineyard, UT 84059 (800) 307-2514 Narcx.com

Asteres Inc. 4110 Sorrento Valley Boulevard San Diego, CA 92121 (858) 777-8600 www.asteres.com

HelioMetrics 5000 W 36th Street, Suite 225 Minneapolis, MN 55416 (612) 444-3242 www.heliometrics.net

National Pharmaceutical Returns 4164 NW Urbandale Drive Urbandale, IA 50322 (800) 470-7725 www.NPReturns.com

RxCarbon LLC 1207 S. White Chapel Boulevard, Suite 150B South Lake, TX 76092 (866) 436-9264 www.rxcarbon.com

BD (Becton, Dickinson and Company) 1 Becton Drive Franklin Lakes, NJ 07417 (201) 847-6800 bd.com/diversion

Infinity Laboratories 1585 South Perry Street, Suite B Castle Rock, CO 80104 (303) 730-7330 Infinitylaboratories.com

Pharma Logistics 1801 N. Butterfield Road Libertyville, IL 60048 (888) 729-7427 www.pharmalogistics.com

International Health Facility Diversion Association P.O. Box 28 Bethel, OH 45106 (513) 623-3278 Ihfda.org

Pharmacolog, Inc. 150 N. Michigan Avenue, Suite 1950 Chicago, IL 60601 (708) 359-7302 www.pharmacolog.com

CPS Solutions, LLC 655 Metro Place S., Suite 450 Dublin, OH 43017 (800) 968-6962 www.cpspharm.com Datarithm 7037 Fly Road East Syracuse, NY 13057 (877) 273-5112 www.datarithm.co EnlivenHealth™ An Omnicell Innovation 11125 Forest Pines Drive Raleigh, NC 27614 (919) 882-4940 Enlivenhealth.co Euclid Medical Products 339 Mill Street Apple Creek, OH 44606 (800) 727-2543 www.euclidmedicalproducts.com

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International Medical Industries 2981 Gateway Drive Pompano Beach, FL 33069 (954) 917-9570 Imiweb.com KeySource 7820 Palace Drive Cincinnati, OH 45249 (800) 842-5991 KeySource.com Masters Pharmaceutical 3600 Pharma Way Mason, OH 45036 (800) 982-7922 www.mastersrx.com

H E A LT H S Y S T E M • I N F U S I O N

Pharmacy Services Group 77 Cypress Lane Maitland, FL 32751 (407) 383-3301 PharmWaste Technologies 3317 109th Street, Suite A Urbandale, IA 50322 (515) 276-5302 www.pwaste.com PharmaLink Inc. 8285 Bryan Dairy Road, #200 Largo, FL 33777 (800) 257-3527 www.pharmalinkinc.com PharmID 2157 N. Northlake Way, Suite 230 Seattle, WA 98103 (206) 922-3589 Pharmid.com

Rxpert Solutions 950 Boardwalk, Suite 305 San Marcos, CA 92078 (760) 705-4078 www.rxpert.solutions RxSafe 2453 Cades Way, Suite A Vista, CA 92081 (760) 593-7161 Rxsafe.com Stericycle 2355 Waukegan Road Bannockburn, IL 60015 (866) 783-9816 www.stericycle.com Swisslog Healthcare 11325 Main Street Broomfield, CO 80020 (800) 764-0300 www.swisslog-healthcare.com TouchPoint Medical 200 Touchpoint Drive Odessa, FL 33556 (800) 947-3901 www.touchpointmed.com Visante 101 E 5th Street, #2220 St. Paul, MN 55101 (866) 388-7583 www.visanteinc.com

DRUG DIVERSION Market Leaders

Visit RXinsider’s Virtual Trade Show to Research the Leaders in

Drug Diversion www.RXinsider.com

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WasteLog® Tools and Solutions for Drug Diversion and Prevention

WasteLog® can verify the identity and concentration of liquid controlled substances in an instant. Preventing drug diversion in the OR requires a quick and reliable method of monitoring and controlling your wastes and returns. With its flexibility, efficient workflow and ease of use, WasteLog® can become an essential part of any Drug Diversion Program.

• Instant verification of narcotics prior to waste procedure.

• Non-destructive sample allows for follow-up testing.

• Mobile for use between departments or facilities.

• Export test results to Data Analytics software.

• Low dose concentrations can be analyzed.

• Measurement graphics immediately available on screen for qualitative analysis.

• Uses the latest absorption spectroscopy technology.

• Creation of new calibrations on-site.

• No monthly subscription fees.

www.pharmacolog.com | +1 708 359 7302

Behind Every Good Pharmacist, is a Great Resource.

Pharmacy Case Studies take an in-depth look at specific products and services that help pharmacies improve patient care, profitability, and cost containment. Available in our digital library and within each issue of 20Ways.

RXinsider.com

DRUG DIVERSION SPECIALISTS RXPERT SOLUTIONS gives you access to a pharmacist with decades of hospital pharmacy experience and a passion for implementing practical long-term solutions to improving medication safety.

Theresa “Terri” Vidals has been a pharmacist for over 30 years with 15 years of experience in medication safety and drug diversion monitoring.

While she leads with compassion for healthcare professionals suffering from substance abuse problems, Terri’s steadfast approach allows her to nail down the hard questions during investigation interviews. She founded Rxpert Solutions so that all facilities would have access to her expertise in lieu of on-site personnel, as well as to bridge the gap while on-site personnel are developing their own expertise.

THERESA VIDALS, B.S. PHARM F O U N D E R O F R X P E RT S O L U T I O N S

www.rxpert.solutions (760) 705-4078 | tvidals@rxpert.solutions

FDA Registered | Iso Certified

Your partner in pharmacy compliance since 1992 USP <797> USP <71> USP <800> Left: GM7030 PATT2®, Personal Aseptic Technique test kit, 3mL ampules, 20mL vials, 100mL partially filled minibag.

Below: ET1000 EnviroTest® TSA with Lecithin & Tween 80 growth media paddles for surface, air, or glove fingertip sampling.

Media Fill Hazardous Drug Handling Validation Surface and Fingertip Testing Sterility Testing Qimedical.com

info@qimedical.com

Tel. 800.837.8361

2 0WAY S TO I M P R O V E PAT I E N T C A R E & P H A R M A C Y C O S T C O N TA I N M E N T

Q.I. Medical, Inc.™ Your Partner in USP <797> Pharmacy Compliance Providing quality assurance products to hospitals and pharmacies practicing sterile compounding, with a singular focus on pharmacy compliance. Our long-standing regional distribution partners are able to provide exceptional in-person service and training.

President & CEO: Brady K. Schwarz Founded: 1992 Toll-Free Phone:

(800) 837-8361 Phone: (530) 272-8700 Fax: (530) 272-8702 Address: 1415 Whispering Pines Lane, Suite 150 Grass Valley, CA 95945 Website: www.qimedical.com

Company Background Q.I. Medical, Inc. was founded in 1992 with a focus on providing the sterile compounding industry with testing kits and products to assure proper technique and quality is maintained in their facility.

We have a broad network of distribution partners throughout North America, Canada, and other international markets. These distribution partners provide in-person servicing and education to accounts to comply with USP guidelines.

Additional Product Lines Additional products are available for validation of hazardous drug handling, automated compounder manipulation validation, filter integrity testing, and vial adaptors. n Support Equipment Includes: • Incubators • Sterile Filters • Vial Blocks • UV Lights

Ordering Information

To learn more about how Q.I. Medical, Inc. can help your facility, please contact us at (800) 837-8361 or email info@qimedical.com.

Product Overview Our cost-effective, disposable products are available for various needs in the compounding pharmacy. Aseptic technique validation kits are available for low, medium, and high-risk settings. We also sell multiple à la carte sizes of vials, bags, tubes, and syringes of growth media for facilities looking to create a custom media fill test that mimics their day-to-day practice.

In regard to environmental monitoring/gloved fingertip sampling, our EnviroTest™ paddle is ideal for both. The rectangle shape and built in hinge allow for testing critical areas such as edges and corners of a hood and behind latch handles. Sterility testing products are available in both USP 71 approved methods of testing. For the full filtration method, the QT Micro™ and QT Junior™ systems work for both small and large volume solutions.

For the direct inoculation methods, our TuffTest 2™ product is ideal.

All Q.I. Medical growth media is challenged with a battery of USP specified organisms and lot specific Certificate of Analysis (CofA) are available for download.

All products are sold through regional stocking distributors in order to provide fast local service and support.

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Pharmacy consulting designed for optimal growth

We help you achieve extraordinary results in all areas of health system pharmacy

Strategic Planning & Implementation

Compliance that Improves Care

Financial Results

We collaborate with you to deliver innovative solutions that will elevate your organization to peak performance levels.

Our team of compliance experts will improve confidence, enhance care and ensure patient, worker and community safety.

Making the most of opportunities to manage costs and increase revenue is core to our consulting. We help you improve financial performance across your organization.

Visante consultants bring you expertise in all areas of hospital and health system pharmacy: • • • •

Comprehensive Strategic Assessments 340B Program Solutions Specialty Pharmacy Programs Revenue Cycle and Drug Reimbursement Strategies

Connect with Visante today to learn how we can help you reach your goals. Visit us at visanteinc.com, or call 866-388-7583. © Visante Consulting, LLC, 2021. All Rights Reserved.

• Supply Chain Strategies • Drug Diversion Programs • Drug Compounding Excellence

TM

Transforming healthcare through pharmacy.

2 0WAY S TO I M P R O V E PAT I E N T C A R E & P H A R M A C Y C O S T C O N TA I N M E N T

Visante — High-Performing Pharmacy is Who We Are We're in the business of advancing pharmacy. Our consultants work with hospitals and health systems combining a wealth of expertise with personalized and comprehensive support to optimize your pharmacy operations and deliver better patient care.

President & CEO: James Jorgenson Founded: 1999 Toll-Free Phone:

(866) 388-7583

space to ensure program optimization; program implementation and development of internal oversight structure and maintenance; and split billing RFP guidance, implementation, and program re-designs.

Address: 101 E 5th Street, #2220

Visante’s experienced team members are all Apexus 340B University graduates, many of whom have completed the Advanced Ops Certificate.

Website: www.visanteinc.com

n Sterile and Non-Sterile Compounding Compliance That Drives Safe,

St. Paul, MN 55101

Company Background

Visante is a multidisciplinary, clinician-composed consulting firm specializing in all aspects of the business of pharmacy. We believe in moving the practice of pharmacy forward through innovative solutions that deliver lasting results. Far too often we’ve seen pharmacy and medication management underutilized or under-resourced, resulting in a negative impact on finances and patient care. We’re in the business of reversing that. We’re in the business of advancing pharmacy.

By diagnosing and solving complex problems, we help organizations more effectively deliver optimized and compliant medication related services. Our 60-plus consultants include experienced pharmacists, nurses, physicians, IT professionals, and business experts, all working together to ensure you get the right solutions for your unique needs. No matter what your specific challenge is, we always know what matters most — delivering safe, high-quality, cost-effective patient care so you can continue to grow.

Featured Services

n Comprehensive Pharmacy Assessment Optimizes Financial and Clinical Results

We put our extensive experience and knowledge to work to assess your current operations and help you take your pharmacy to the next level.

We have the right combination of skills to evaluate all the moving parts and recommend improvements that will help you provide better patient care while improving your bottom line. We listen and work closely with you to support your objectives, delivering a personalized pharmacy plan for optimal growth, including a complete evaluation of your current program; opportunity analysis for safety, clinical, operational, and financial improvements; strategic planning support based on identified opportunities; and program enhancement design and implementation. n 340B Solutions for Total Compliance and Lasting Success Visante’s independent, external audit support continues to provide transparency to your 340B processes, allowing you to recognize compliance gaps while also focusing on new opportunities within the program.

Visante provides: internal and external audit support, on-site HRSA audit support, and corrective action plan guidance in the event of HRSA audit findings; gap analysis and targeted recommendations, focusing on long-term strategy in the mixed-use and contract pharmacy

High-Quality, Cost-Effective Care

Safely compounded medications are essential to quality patient care.

Hospitals face the challenge of optimizing care while also meeting safety requirements and managing cost. We will prepare you for compliance with USP Chapters <795>, <797>, <800>, and <825>. We’ll also assist you in preparing for compounding related inspections by the CMS, FDA, DEA, and Joint Commission/DNV. Our consulting services include: USP <795>, <797>, <800>, and <825> gap assessment and facility design; 503A, 503B assessment, facility design, and implementation support; and home infusion compounding services.

When it comes to pharmacy compounding, we don’t settle for basic compliance — and you shouldn’t either. Our processes are designed to assist you and your team to be successful. n Drug Diversion Prevention Protects Your Patients and Yourself Drug diversion problems continue to escalate with opioid addiction at epidemic levels. Our program takes a comprehensive multidisciplinary approach to identify drug diversion risk points in your medication use processes. Minimize risk through assessment of pharmacy operations, informatics, automation, nursing, and perioperative processes to identify and strengthen points of vulnerability.

Our drug diversion experts have real-life experience in hospitals and health systems and understand the challenges hospitals face today and in the future. n Expand Your Specialty Pharmacy Services and Quality of Care A clearly defined specialty pharmacy strategy can help improve patient care and optimize your bottom line. Developing a specialty pharmacy strategy or expanding your existing services can be a complex process, but our team of experts guides you through each phase and delivers lasting ROI. Our specialty pharmacy consulting capabilities include: operational assessment and pro forma models; multi-year business and strategic plans; facility design including workflow and automation options; implementation and project management; accreditation support (URAC/ ACHC/CPPA); contract pharmacy strategy, if applicable; wraparound strategy to include consideration for site of care challenges (infusion); and home infusion and DME strategies and business planning.

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CAS E S TU DY

Decision-Making for Drug Diversion A Leadership Guide to Procuring a Drug Monitoring System BACKGROUND UNIVERSITY OF LOUISVILLE HEALTH (UofL Health) is a fully integrated regional academic health system with five hospitals, four medical centers, nearly 200 physician practice locations, more than 700 providers, the Frazier Rehab Institute, and Brown Cancer Center.

INTRODUCTION Robert Fink, Pharm.D., MBA, FACHE, FASHP, BCNSP, BCPS Chief Pharmacy Executive ~ UofL Health, Louisville, KY

UofL Health’s reputation is its most valuable asset and is directly related to the conduct of its officers and team members. Being on the leadership team brings a commitment to steward the integrity of the health system and ensure patient safety. These responsibilities are ever-present when developing and overseeing a drug diversion program.

This case study examines executive decision-making regarding drug diversion at UofL Health. The study profiles Robert Fink, the chief pharmacy executive, who provided insight into leadership’s recent decision to purchase a system to elevate detection and eliminate diversion.

“We consider a single dose a loss, and we have no tolerance for not knowing where that dose went,” said Fink. “We are always in a mindful, vigilant state as we can’t have anyone impaired working with a patient.

We will investigate every loss in an extremely fair and thorough way.”

The system-wide Drug Diversion Response Team at UofL Health has three components. The first is an executive committee comprising Fink; Shari Kretzschmer, senior vice president and chief nursing officer; and Shelly Denham, senior vice president of compliance, risk and audit services. The triad reviews each case, and at least two of three must be involved in any investigation to eliminate unilateral decisions.

Secondly, a broader diversion team exists managed by a nurse solely dedicated to investigations who reports to the pharmacy manager responsible for regulatory and accreditation compliance for the entire system. They are the daily users of the monitoring system, conducting audits and surveillance. If an investigation is needed, they collaborate with the pharmacy manager, nurse, and HR business partner at the specific location with oversight from the executive committee.

The third entity involves a large multidisciplinary committee comprised of physicians, nurses, pharmacists, and HR business partners from every location. They have insight into investigations and approve policies and procedures and quality assurance programs.

Each member of a diversion team brings a unique skill set and perspective to the overall program.

Tom Miller, CEO of UofL Health is ultimately responsible for all controlled substances in the health system.

As head of pharmacy services, Fink quarterbacked the rigorous process to choose a drug diversion system, and together with the chief medical officer, made the final decision.

INTENDED OUTCOME

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www.medacist.com

UofL Health’s purpose is to provide a culture of exceptional care and achieve the highest standards of quality and safety. Mitigating drug diversion is critical to accomplishing the mission of the health system.

CAS E S TU DY

“

We have a CEO who understands the devastation of addiction and makes combating it an imperative. Equally, he is a leader with high standards and zero tolerance for drug diversion.

He expects a high level of accountability from everyone.”

Robert Fink, Pharm.D., MBA, FACHE, FASHP, BCNSP, BCPS Chief Pharmacy Executive ~ UofL Health, Louisville, KY

The code of conduct at UofL Health provides the foundation for a diversion plan. It states when employees face an ethical dilemma, take action. Employees need to speak up if any suspect activity.

“We are fortunate to have a CEO with broad experience who understands the critical need to combat drug diversion,” said Fink. “Equally, he is a leader with high standards and zero tolerance for drug diversion. He expects a high level of accountability from everyone.”

Every day at UofL Health, the main objective is to target risk within the medication-use process and identify risk areas across the health system at every level of responsibility.

CHALLENGES Drug diversion has a devastating effect on the entire health system and undermines every department.

Fentanyl and other powerful controlled substances are commonplace, allowing a potential diverter to take them. Issues such as imprecise documentation, failure to physically witness a coworker’s controlled substance waste, temporary storage of medications in unsecure locations, or failure to complete required paperwork can allow diversion to happen.

“For a Grand Rounds presentation, I researched fines levied against health systems from the DEA. Every fine had two commas in them, and as each one displayed, they set a new record amount because of their failures,” said Fink. “There are steep consequences for not solving challenges.”

DECISION-MAKING CRITERIA The UofL Health leaders understood the growing prevalence of drug diversion in healthcare facilities and developed a road map to strengthen its tools to eliminate it. A key strategy included a more robust system to deliver actionable intelligence on the medication process.

The multidisciplinary community sought greater clarity and confidence in their decision-making and wanted intelligence and documentation to substantiate diversion activity. These factors and more led to look at several drug diversion monitoring solutions including RxAuditor Investigate.

“There is no singular decision-maker on an incidence. We take a collaborative approach to investigate a case under the principles of trust and verify. This was the same approach when deciding on a system,” said Fink.

After an extensive search lasting months, they narrowed the field to three finalists. Undergoing further analysis to align with overall system needs, UofL Health selected RxAuditor Investigate from Medacist as their drug diversion monitoring solution of choice. The committee’s decision ultimately came down to Medacist excelling at: analytics, compatibility, high standards, flexibility, investigations, compliance, and cost-effectiveness.

However, before choosing the RxAuditor Investigate solution, leadership put Medacist through their paces to learn how it could support UofL Health. The selection phase involved leadership: • Assessing three in-depth presentations on functionality.

• Scrutinizing a live demonstration utilizing a test hospital.

• Ensuring that the reporting and dashboards worked for leadership.

• Verifying that RxAuditor Investigate could interface with existing systems.

• Validating the accuracy of data analytics.

“RxAuditor Investigate met our needs,” Fink said. “Medacist had the stronger record in drug diversion technology solutions.”

Medacist’s solutions currently protect 67% of the U.S. patient population and more than 3 million clinicians across more than 2,000 facilities nationwide. They hold the only U.S. patent for drug diversion analytics.

The case study provides details on how Medacist met UofL Health’s measures that led to the contract.

The criteria are a blueprint for other health systems when choosing a drug monitoring system.

www.medacist.com

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CAS E S TU DY

“

AFFORDABILITY AND FLEXIBILITY

RxAuditor Investigate met our needs at all levels and from A to Z. Medacist had the stronger record in drug diversion technology solutions.”

Robert Fink, Pharm.D., MBA, FACHE, FASHP, BCNSP, BCPS Chief Pharmacy Executive ~ UofL Health, Louisville, KY

“

When it came to integrating with other systems, RxAuditor Investigate was the bestof-breed system for us.

The configuration with our pharmacy system works seamlessly.”

Robert Fink, Pharm.D., MBA, FACHE, FASHP, BCNSP, BCPS Chief Pharmacy Executive ~ UofL Health, Louisville, KY

“What put Medacist over the top was that relationships matter,” said Fink. “We were dealing with conflicting system priorities, and the team at Medacist were willing to work with us.

Their professionalism spoke volumes. We can’t thank them enough for their flexibility.”

The team could see the savings stemming from lessening the time an employee spends in labor-intensive investigations and reducing expensive medication losses. The tool’s efficiencies make it cost-effective.

Specifically, auditing consistency translates into a data reduction of 70% and labor savings of 30-40 hours per month. RxAuditor Investigate came as one single expense with no additional fees for hardware, software, or support.

COMPATIBILITY UofL Health underwent a series of technology reviews and changes across the enterprise in 2020.

Many pharmacy automation platforms didn’t have a monitoring system, or installing one was costprohibitive. IT even looked at building a surveillance system when leadership stepped in and said to review vendors, and Medacist won the account.

Interfacing with existing systems at UofL Health was a prerequisite. Leadership wanted transparency and standardization — a packaged solution for other systems, pharmacy automation, electronic health records (EHR), and time and attendance.

“When it came to integrating with other systems, RxAuditor Investigate was the best-of-breed system for us,” said Fink. “The configuration with our pharmacy system works seamlessly.”

ANALYTICS RxAuditor Investigate is powered by Medacist’s Genesis™ analytics platform. This detection engine powers machine learning algorithms developed to identify diversion through pattern recognition — confirmed by actual diversion events and enriched by multiple other data sources.

The team has access to role-based configurable dashboards to see an overall snapshot, care area, or at-risk individual.

INVESTIGATIONS With RxAuditor Investigate, the previous need to perform time-consuming manual audits is eliminated by incorporating autonomous diversion auditing by evaluation, scoring, and ranking of risk — thus reducing false positives and curating a targeted list of at-risk individuals.

“When we conduct investigations, we appoint a nurse dedicated to ensuring each step of our monitoring cycle is complete,” said Fink. “The nurse also manages the program for controlled substance compliance.”

If local law enforcement, DEA, or Boards of Pharmacy and Nursing are supporting an investigation at UofL Health, the team can readily retrieve reports and provide meticulous records for those agencies.

RESULT The concluding theme is that a high level of accountability occurs at UofL Health regarding drug diversion. A major reason is because RxAuditor Investigate helps safeguard patients and provides leadership with accurate information to act on diversion.

The system from Medacist is supporting leaders across the enterprise, streamlining operations to make the facilities more efficient. The diversion teams now access a comprehensive platform of analytics and tracking technology, saving time and reducing liability.

After the installation, Medacist conducted an in-service to members of the Drug Diversion Response Team. Leadership received positive feedback, and the staff was specifically pleased with the performance and transparency of the system.

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www.medacist.com

“It’s about hiring good people and giving them RxAuditor Investigate to do their job,” Fink said.

“From start to finish, we are ensuring accountability.”

IF YOU CAN, YOU MUST The opioid epidemic isn't going away – and Medacist is here to help.

As our country continues to battle an evolving pandemic, our frontline workers and healthcare providers need our help.

Now more than ever. Thriving in the shadows of COVID-19, the ongoing opioid epidemic calls for a more pointed and direct solution against drug diversion.

Our mission is to provide best-in-class solutions, period. Built on stronger data to deliver unparalleled insights, our RxAuditor InvestigateTM eliminates the guesswork so clients never have to operate on a "hunch" ever again.

RxAuditor InvestigateTM offers a full platform of drug diversion analytics and tracking technology which allows for time savings, reduces liability, and most importantly, ensures patient safety.

THE LEADER

In Drug Diversion Analytics

PHARMACY ANALYTICS EXPERIENCE Serving our clients for the past 23 Years!

ONLY U.S. PATENT In Drug Diversion

UNPARALLELED SERVICE

Exceptional customer support

SCHEDULE A DEMO OF RxAUDITOR INVESTIGATE TODAY.

info@medacist.com

© 1997-2021, Medacist Solutions Group, LLC. All rights reserved. U.S. Patent No. 6,842,736 entitled 'Drug Auditing Method and System' Medacist

DROP BOXES... not winter burrows!

GoHCL.com • 1.800.848.1633

2 0WAY S TO I M P R O V E PAT I E N T C A R E & P H A R M A C Y C O S T C O N TA I N M E N T

Health Care Logistics® By Design — Real Solutions, Right Away Customers achieve measurable results with high-quality cabinets and storage containers, functional equipment, and full-color graphics designed to their exact specifications.

President & CEO: Gary Sharpe Founded: 1978 Toll-Free Phone:

(800) 848-1633 (740) 477-3755 Address: P.O. Box 25 Circleville, OH 43113 Website: goHCL.com Phone:

Company Background Unique and hard-to-find products are the lifeblood of our business. That includes manufactured solutions made by skilled technicians in our central Ohio facilities. By Design is where our manufacturing talent converts customer ideas into highquality cabinet, metal, plastic, or print products made to their exact specifications. Best of all, we deliver those made-to-order solutions in five working days or less.

Product Overview Our goal is firm ­— create functional products to improve everyday workflow — there are no limits to our design capabilities. We can turn virtually any idea into reality without outrageous upcharges or extended shipping schedules. Start with a no-obligation, no-cost digital proof for a cabinet, metal, plastic, or print project today!

Product Specifications n Cabinets by Design Cabinets, shelving, and storage units for those who want to renovate existing spaces or outfit newly constructed areas with high-quality pieces made to their exact specifications.

The process starts with our free 3D Design Service, which provides a virtual layout of the targeted space paired with unique solutions that showcase specific design goals. We can create performancerich products in multiple sizes, styles, and colors that make it easier than ever to achieve a customized brand.

Cabinets by Design offers the quickest, easiest, and most affordable way to maximize organization and efficiency. All units ship in five working days or less so customers can get the look they want without the wait.

n Metals by Design and Plastics by Design One-of-a-kind items manufactured to match individual customer requests. Modifications to stock products are also available. These allow customers to work more efficiently and produce better results.

From stainless steel storage containers, lock boxes, and utility trays to specially sized plastic lock boxes and dividers, we have the engineering and manufacturing capabilities to design and modify products or create affordable replacements that meet the everyday needs of our customers.

We can create and modify functional products using stainless steel, aluminum, acrylic, PETG, polycarbonate, polystyrene, HDPE, and PVC. There are no limits to our design capabilities.

Whether customers want to simplify USP compliance or better manage changing trends, we can design a solution and deliver it quickly. n Printing and Graphics by Design From labels, magnets, and clings to banners, signs, and stamps, our print specialists can create solutions for any situation.

Prevent the confusion that results from the unknown by communicating a consistent message for all products across all departments. Choose the size, color, and style of your message and our print team will create it.

Kicking off a marketing campaign? We can help with an assortment of fun promotional materials. Our print experts can hot stamp a customer logo, message, or facility information on a variety of products. Our process ensures a professional finish with lasting results. We can print as few as 50 or as many as 1,000+ — and quick!

Ordering Information

It’s easy for customers to begin their design journey. Complete a cabinets, metal, or plastics options request form, view our Print By Design options, or call our product specialists at (800) 848-1633 to discuss options.

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TEMPERATURE INTELLIGENCE®

Monitoring solutions to maintain the vaccine cold chain Get visibility into medication temperatures onsite and in transit Keeping refrigerated medication—including COVID-19 vaccines— within the right temperature range is critical for maintaining their efficacy. That’s why CDC guidelines recommend using digital data loggers to monitor temperatures as vaccines travel to patient administration sites. Temptime’s S-400 electronic temperature sensors capture the temperature data you need, 24/7, while also alerting you to excursions.

Learn more about how Temptime can help you preserve valuable vaccine supplies and meet CDC guidelines: temptimecorp.com/vaccine-monitoring

zebra.com | temptimecorp.com

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Temptime Temperature Intelligence® Solutions — Monitoring Devices and Integrated Solutions for Medication Shipments, Storage, and Pharmacy Facilities Providing the devices and information to accurately monitor temperaturesensitive medications, indicating if they have been exposed to temperature events that could impact their effectiveness in treating patients.

President:

Anders Gustafson Founded: 1987 Employees: 90 Phone: (973) 630-6000 Fax: (973) 630-6100 Address: 116 The American Road Morris Plains, NJ 07950 Website: www.temptimecorp.com

Company Background

More than 30 years ago, Temptime Corporation developed the first miniaturized technology to monitor time-temperature exposure of vials containing the oral polio vaccine. Since then, the company has deepened its commitment to public health by expanding its suite of easy-to-use, patient-centric temperature monitoring solutions to include those designed for both pharmacy and patient use. In 2019, Zebra — an innovator at the edge of enterprise solutions with expertise in healthcare, among other industries — acquired Temptime.

Product Overview

Through Temptime’s manufacturing facility, Zebra offers a comprehensive range of temperature monitoring solutions to meet the cold chain needs of specialty pharmacies and their patients. Their products include: • Visual, low-cost, chemically-based heat and freeze indicators for blood products, vaccines, biologics, and other medication during storage.

• Heat and freeze indicators for monitoring medication during shipment.

• Sophisticated electronic, wireless temperature and humidity monitoring systems with cloud-based data storage and sharing.

Zebra strives to improve supply chain efficiency, global health, and patient care through the effective deployment of devices and solutions that identify temperature excursions and provide information to take action.

Product Specifications

The M-300 and S-400 programmable dataloggers are ideal for monitoring temperatures during transport or storage, letting users: • View and share temperature data with a free mobile app.

• Customize alarm limits, datalogging intervals, startup options, and more.

• Store unlimited data on the cloud and generate reports with a complementary web app. n Package Performance Qualification Testing

For specialty pharmacies, Package Performance Qualification (PPQ) testing ensures that the shipment packaging is able to provide the necessary temperature range for the required period of time during transport of critical and often lifesaving medications to patients. More than that, PPQ testing is also required for certain pharmacy accreditations, such as URAC. These wireless monitoring devices help specialty pharmacies simplify PPQ testing while providing data and information to optimize packouts. Customized Third-Party PPQ Testing services also help meet the requirements of pharmacy networks that make third-party validation testing a condition of participation. n TransTracker® Shipment Indicators TransTracker® visual temperature indicators monitor medication heat and freeze events during shipment. They are easy-to-read and understand, so patients can tell at a glance if medication has been handled within the appropriate temperature range. These devices instill a higher level of patient confidence so that unnecessary, costly reshipments due to suspected temperature damage can be reduced or eliminated. These cost-effective, single-use indicators also help specialty pharmacies comply with state regulations.

n Wireless Monitoring Systems The family of wireless Bluetooth®-enabled sensors monitor and record temperature data 24 hours a day, seven days a week.

Testimonial

The W-200 is designed for facilities and warehouses, monitoring both temperature and humidity in medication storage areas to help with accreditation compliance and regulatory requirements. Data can be accessed remotely using a web-based application and customized alerts notify users instantly if any areas have exceeded temperature limits.

* Based on “Experience of Specialty Pharmacies in TransTracker Product-in-Use Patient Research” with over 8,000 patient responses.

97% of medication recipients said they prefer a specialty pharmacy that uses the TransTracker® indicator in its shipments.*

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CAS E S TU DY PIEDMONT HEALTHCARE AND WASTE MANAGEMENT’S PHARMECOLOGY® SERVICES COLLABORATE TO ENSURE USP <800> COMPLIANCE

OVERVIEW Back in 1905, Dr. Ludwig Amster and Dr. Floyd Wilcox McRae founded Piedmont Hospital. At that time, they were considered pioneers in patient care, fulfilling the healthcare needs of patients all over Atlanta and surrounding communities.

Skip Lynch, RPh

Director Outpatient Pharmacy Services ~ Piedmont Athens Regional

Chelsea Parry, Pharm.D., BCPS Oncology Pharmacist Specialist ~ Piedmont West Infusion Center

Fast forward to 2021, and Piedmont Healthcare is still a recognized leader in delivering expert care. In fact, Piedmont now cares for 2.7 million patients across 800 locations, serving communities that comprise 70% of Georgia’s population. What began as a single hospital more than a century ago has grown into an integrated healthcare system of 11 hospitals, 34 urgent care centers, 25 QuickCare locations, and 555 physician practice locations.

There is no question that Piedmont is committed to continuous improvement and making a positive difference in every life they touch. Building their reputation of excellence and enhancing services is a top priority. And this mission holds true with regards to hazardous waste and hazardous drug management.

“When the USP <800> standards were first published, we wanted to comply on a system-wide level,” explains Skip Lynch, Piedmont’s director of outpatient pharmacy services. “So we searched for a solution that could serve our entire healthcare system. PharmEcology not only offered a comprehensive solution, but provided us with a very strong partnership that would allow us to meet our specific needs.”

With the help of PharmEcology’s USP <800> Consultation Program, Piedmont is well on its way to protecting all healthcare personnel from hazardous drugs as well as ensuring a safe and healthy environment.

TACKLING CHALLENGES According to numerous studies, acute and chronic health effects can occur from occupational exposure to more than 200 hazardous drugs (HDs) commonly used in healthcare settings.

As a result, the National Institute for Occupational Safety and Health (NIOSH) defined criteria for identifying these hazardous drugs. Based on this information, the United States Pharmacopeia (USP), an independent, scientific nonprofit organization, developed the USP General Chapter <800> standards for handling hazardous drugs to minimize the risk to public health. The goals of these standards include:

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CAS E S TU DY

“

When the USP standards were first published, we wanted to comply on a system-wide level.

PharmEcology not only offered a comprehensive solution, but provided us with a very strong partnership ...”

Skip Lynch, RPh

Director Outpatient Pharmacy Services ~ Piedmont Athens Regional

• Helping to increase awareness.

• Providing uniform requirements regarding the management of hazardous drugs.

• Reducing the risk posed to patients and the healthcare workforce.

Specifically, this chapter describes the responsibilities of personnel handling hazardous drugs; facility and engineering controls; procedures for deactivating, decontaminating, and cleaning; spill control; and documentation. The standards apply to all healthcare personnel who receive, prepare, administer, transport, or come in contact with hazardous drugs and the environments in which they are handled.

PHARMECOLOGY’S USP <800> CONSULTATION PROGRAM In order to help healthcare organizations understand the difference between the handling of hazardous drugs and managing the disposal of hazardous waste pharmaceuticals, PharmEcology created the USP <800> Consultation Program.

“In addition, PharmEcology assists organizations in creating their HD list and conducting their Assessment of Risk of HDs by taking advantage of our robust pharmaceutical database, which maintains information specific per NDC for hazardous drug handling and hazardous pharmaceutical waste disposal,” explains Monica Livingston, PharmEcology’s senior program and implementation manager. “We supported Piedmont's compliance with USP Chapter <800> through the use of project management and functional risk minimization tools.”

She adds, “Navigating the complex regulations for handling hazardous drugs and pharmaceutical disposal can be extremely time-consuming and confusing. PharmEcology has developed tools and programs to help organizations not only stay up to date and compliant, but to also implement best practices when it comes to disposing of pharmaceutical waste and handling hazardous drugs.”

The first step in the process began with Piedmont providing a data file of their 12-month purchase history of all pharmaceuticals, including NDC, generic name, brand name, dosage form, and manufacturer.

PharmEcology analyzed this data based on their proprietary NIOSH hazardous drug handling database algorithms. This resulted in a comprehensive analysis that included a list of all current NIOSH hazardous drugs (at the NDC level) and an initial Assessment of Risk, incorporating the recommendations for Personal Protective Equipment (PPE) based on USP <800> requirements and recommendations by NIOSH. The PharmEcology team then met with Piedmont’s pharmacy leadership and members of Piedmont’s USP <800> team, made up of pharmacists, pharmacy techs, and nursing staff.

“The objective of these on-site visits was to discuss the details surrounding the standards of USP Chapter <800>, the differences and similarities between hazardous drugs and hazardous pharmaceutical waste, the design and objectives of our consulting program, and how our database interfaces with Piedmont data and supports their activities to meet compliance,” explains Kathy Skibinski, PharmEcology’s manager of regulatory and compliance.

She adds, “In addition, we held workshops on how to use proprietary PharmEcology USP <800> Consultation tools and shared information, guiding Piedmont to engage their USP <800> team in discussions related to requirements of their personnel for using PPE to minimize their exposure to hazardous drugs. This was an important step because staff needed to understand exactly what type of PPE was required of them during the preparation and administration phases of handling hazardous drugs.”

Next, Piedmont discussed their operational approach to minimize risk of exposure to these hazardous drugs by their employees — and how that was reflected in their PPE requirements

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CAS E S TU DY during the preparation and administration of hazardous drugs. These requirements are influenced by the type and extent of handling and manipulation of HDs during these activities, as well as the HD itself and dosage form. Hence, an analysis of data at the NDC level is necessary.

The data analysis, coupled with on-site visits, allowed Piedmont to customize their Assessment of Risk for current and future drug data. “This Assessment of Risk enables Piedmont to make decisions on the proper usage of PPE and containment strategies,” explains Livingston.

“After giving PharmEcology access to our files, they took the data and applied it to their extensive database,” explains Lynch. “The result was a comprehensive list of about 400 medications.

We then created three risk levels, which we further defined with PPE requirements based on the drug, dosage form, and handling per staff type.” These decisions are now customized and applied to future HDs added to Piedmont’s formulary via the PharmEcology USP <800> Portal.

In addition to the data analysis, each client has several proprietary tools available to them via the PharmEcology USP <800> Portal. The Functional Risk Minimization tool provides a list of all types of personnel who have the potential to be exposed to hazardous drugs and summarizes all phases of hazardous drug handling, from receipt to disposal. These factors, coupled with a list of potential actions that may be taken to protect employees, helps the organization justify decisions in their Assessment of Risk process.

The last tool to be implemented was PharmEcology’s Comprehensive Compliance Management Document, which itemizes all of the required standards of USP Chapter <800>. It serves as a project management tool that assigns project tasks to individuals, charts progress, and documents support of completion toward USP <800> compliance.

“PharmEcology’s tools and programs have been extremely helpful in keeping us compliant,” explains Chelsea Parry, Piedmont’s oncology pharmacist specialist. “Because Piedmont is such a large healthcare system, we depended on PharmEcology’s web-based portal to keep us organized and on task during the daunting process.”

NEXT STEPS While the identification and assessment phase is complete, Piedmont is currently working on the next phase, which includes rolling out the new changes, as well as developing and implementing training for all staff.

“Our first phase is complete — for now. However, the project is essentially ongoing because NIOSH consistently adds new drugs to their hazardous list,” says Lynch. “In fact, normal-use drugs that we’ve been using for the past 50 years — such as the blood thinner, Coumadin — are now being considered hazardous. Basically, USP <800> has forced the industry to take a closer look at drugs that were historically considered to be normal use. But these drugs are now being carefully examined and categorized as potentially harmful to staff and patients.”

Adds Parry, “When we began this project, we had no idea what was involved. We were not prepared for the extensive amount of analyzing and sequencing work that was required

by USP <800>. But PharmEcology provided us with a unique tool that helped simplify the complex process. They also worked closely with us, helping us navigate each step of the project.

We consider them to be a true partner.”

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PharmEcology’s NEW USP <800> Assessment of Risk Portal...

...Clarity in a world of gray.

Your data...

Your decisions...

PharmEcology’s Custom Portal… Done!

Call 877-247-7430 or email info@pharmecology.com for a free demo.

PHARMECOLOGY®

Trusted Hospitals put their trust in

Comprehensive environmental monitoring is critical to a hospital’s ability to earn trust in its adherence to safety protocols. ISO-MED is your trusted partner in that effort, with a full range of products that not only maintain a sterile cleanroom, but test for compliance with a clean compounding environment.

Why ISO-MED? We’ve been a trusted hospital supplier for over a decade with our solid combination of quality, selection, service and convenience.

Order online:

iso-med.com

Call for fast reordering:

800-797-1405 1220 Graphite Drive, Corona, CA 92881 USA | 800-797-1405 | sales@iso-med.com | www.iso-med.com

2 0WAY S TO I M P R O V E PAT I E N T C A R E & P H A R M A C Y C O S T C O N TA I N M E N T

Trusted Hospitals Rely on ISO-MED Comprehensive environmental monitoring is critical to a hospital’s ability to earn trust in its adherence to safety protocols. ISO-MED is your trusted partner in that effort, with a full range of products that not only maintain a sterile cleanroom, but test for compliance with a clean compounding environment.

President:

David Lowrie Founded: 2010 Toll-Free Phone: (800) 797-1405 Fax: (951) 547-1681 Address: 1220 Graphite Drive Corona, CA 92881 Website: www.iso-med.com

Company Background Since 2011, ISO-MED, INC., a medical supply distributor, has been a trusted hospital supplier with a solid combination of quality, selection, service, and convenience. We supply quality products for pharmacy cleanrooms and other medical industries in the United States.

We provide high-grade supplies for cleanrooms, laboratories, home-care, and more. We strive to achieve and maintain compliant sterile compounding environments.

Product Overview ISO-MED maintains the largest and broadest portfolio of on-theshelf warehouse supplies.

We offer customized supply plans, a seamless e-commerce customer experience, easy ordering with matching manufacturer, and dependable purchasing/supplier aggregation services.

With one-on-one scheduled training services, we increase the efficiency of your purchasing processes, consolidate your portfolio, and link your on-site supply demand to your inventory management processes.

Offering value-added services, we provide consistent customer service and on-time delivery with a streamlined transaction process. We are driven to help healthcare-oriented organizations save money.

Features & Options ISO-MED not only has products that help a hospital conform to cleanroom standards, but we also offer the following products for testing cleanliness. n ICR Plus TSA LT Contact Plates Environmental monitoring for isolators and cleanrooms (surface and air monitoring). n Tryptic Soy Agar Added measure to assure sterility in your environmental monitoring program! Hardy Diagnostics contact plates are recommended for use in the cultivation of microorganisms from environmental surfaces.

Additional Product Modules n Premier Product Offerings • PPE Product Selection • HD Spill Kit • Chemotherapy Gowns and Supplies • Cleaning and Disinfection Solutions For every cleanroom or critical environment cleaning and disinfection program, ISO-MED offers several brands and ISO-MED, INC. formularies.

Markets Served • Hospital • Compounding • Infusion • Retail Ordering Information

Contact us by phone at (800) 797-1405 or email sales@iso-med.com to gain access to our exclusive online ordering platform.

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Improve Your Hospital Pharmacy Business With the Right Reverse Distribution Partner

What Can Pharma Logistics Do For Your Hospital?

At Pharma Logistics we honor the challenges of today’s pharmaceutical market and provide our customers with a full-service reverse distribution experience that is focused on ease of use, regulatory compliance and financial accountability. When you partner with Pharma Logistics, you get access to:

Precision Reporting

Build business intelligence.

With access to customizable and dynamic enterprise-wide reporting, our online Customer Portal drives process improvements through efficient and effective data reporting tools to help you build business intelligence and make better decisions. clean

Dedicated Support Team Credit Assurance

Expedited Cashflow

Support at every step.

Your Customer Advocate’s focus is to support you through the implementation of services by offering a unique combination of quality service, partnered with industry leading software to help you reduce the volume of returned goods while making you more cost-efficient and profitable.

Guaranteed credits.

Our Service Fee Guarantee ensures our customers receive the service and credit rate expected.

Receive credit in 14 days.

Our Rapid Credit Program offers customers a cost-effective solution AND delivers credits within 14 days from when the product is received in our warehouse compared to the industry standard of 12+months.

collect

comply

Pharma Logistics brings efficiency and 24/7 visibility to the returns process so you can focus on patient care and the community.

Call 888-729-7427 or visit www.pharmalogistics.com.

2 0WAY S TO I M P R O V E PAT I E N T C A R E & P H A R M A C Y C O S T C O N TA I N M E N T

Pharma Logistics Delivers Credit, Compliance, and Convenience to Improve Profitability

Pharma Logistics is your reliable partner in pharmaceutical reverse distribution.

Our Rapid Credit, Onsite, and Box and Ship services ensure hospital and pharmacy organizations can optimize inventory and supply chain, remain compliant, and boost their return on investment.

President & CEO: Michael Zaccaro Founded: 1996 Employees: 170 Toll-Free Phone:

(888) 729-7427 (847) 837-5079 Address: 1801 N. Butterfield Road Libertyville, IL 60048 Website: www.pharmalogistics.com Fax:

Company Background

Founded in 1996 by Michael Zaccaro, Pharma Logistics is a pharmaceutical returns company dedicated to client-focused service.

Our mission is to make the returns process as easy as possible for our clients. Our superior service has earned the trust of a broad range of clients including hospital pharmacies, the Department of Defense, independent pharmacies, pharmacy chains, and physicians’ offices.

Our services help ensure customer compliance with federal and state regulations, and improve their investment on the credit return process.

Product Overview

We offer easy and hassle-free services to streamline your facility’s pharmaceutical returns process to save you time and labor. Our online client portal provides real-time job tracking and analytics on expected returns. n Reverse Distribution Services • Rapid Credit: Credit within 14 days.

• Onsite Service: Trained representatives come on-site to check paperwork, ensure proper packaging, and prepare shipments for carrier pickup.

• Box and Ship Service: Manually pack and ship your own returns with prepaid labels and boxes.

• PharmaWaste: Send your non-hazardous, non-controlled pharmaceutical waste to us so we can handle the EPA compliant disposal process.

Features & Options

At Pharma Logistics, we specialize in pharmaceutical reverse distribution, handling the return credit process for retail pharmacies, hospital pharmacies, and other healthcare providers across the nation. Whether you need to get your credits quickly, are looking for a convenient way to ship your expired drugs, or would like more visibility into your returned products, Pharma Logistics delivers seamless service to ensure compliance and improve profitability.

n Pharma Logistics Pharmacy Benefits • Faster Credits: Supports cash flow and ROI for your pharmacy.

• Singular source for creditable and non-creditable pharmaceuticals.

• Quickly boost cash flow.

• Spend less time on accounting; reduce your reconciliation time up to 25 hours per month.

• Precision processing allows for line item reconciliation, delivering greater return credit accuracy.

• Our 100% Credit Promise: If you don’t receive 100% of the estimated return value, we’ll pay the difference of your service fee.

• Online client portal offers real-time visibility and return analytics.

Online Analytics

Beware, not every vendor can show exactly where your credit is in the return process and how much you can expect to collect.

Unlike most vendors, Pharma Logistics provides you with our online client portal for 24 hours a day, seven days a week data access.

Our portal improves your ROI by saving hours of labor, and enables your pharmacy to quickly track your return jobs and credits in real-time. n Real-Time Analytics Include: • Expected Return Value (ERV) Calculation • Dashboard Showing Status of all Returns and Disposals • Line-Item Reporting • Credit Tracking • Expected and Paid Credits • Data Export to Support Compliance and Financial Reporting

Additional Product Lines

n Consumer Drug Take-Back Services Pharma Logistics provides compliant, cost-effective consumer Drug TakeBack Kiosks and Replacements Kits to encourage the safe disposal of unwanted pharmaceutical products.

• Benefit: Helps protect your community from prescription drug abuse and accidental poisoning; reduces the dangers of pharmaceutical waste.

Markets Served

We serve hospitals, independent pharmacies, retail pharmacies, government, and closed door pharmacies.

Ordering Information

Call (888) 729-7427, email plcustomerservice@pharmalogistics.com, or visit www.pharmalogistics.com. We will make sure you get all the information you need to make the best decision for your pharmacy.

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CAS E S TU DY CLINICALLY STUDIED CULTURELLE ® BENEFITS PATIENTS AND MAKES FINANCIAL SENSE SUMMARY

Pharmacists at health systems and long-term care facilities can now include on the pharmaceutical protocol the most clinically studied probiotic for patients experiencing: • Antibiotic associated diarrhea • Acute-infectious diarrhea • Traveler’s diarrhea

Margaret Haldeman, Ph.D. Global Research & Development, Probiotics ~ i-Health, Inc.

Numerous human clinical trials have shown that supplementation with Lactobacillus rhamnosus GG, delivered in many Culturelle® dietary supplement products from i-Health, a division of DSM, significantly benefits the patients with these conditions.

Recently renamed Lacticaseibacillus rhamnosus GG,1 Lactobacillus rhamnosus GG is still commonly referred to as Lactobacillus GG. Clinical data demonstrates that Lactobacillus GG reduces diarrhea resulting from travel to foreign countries,2, 3 side effects of antibiotics,4-9 and dysbiosis due to viral and bacterial intestinal infections,10-12 including Clostridium difficile infection.13-15 This unit-dose hospital pack under the brand of Culturelle® comes with the reassurance for the pharmacist and physician that they are prescribing the most extensively studied probiotic strain since its identification in 1985. The outcome is that the patients feel better quickly, physicians see that the overall digestive system is working better, and pharmacists provide a clinically studied strain.

The purchasing officer also recognizes the value and quality of the Culturelle® suite of products.

Overall, Culturelle® products may contribute to improved patient care and pharmacy efficiencies.

DATA-DRIVEN DECISION MAKING FOR PHARMACIST & PHYSICIAN Pharmacists play a crucial role when they are counseling physicians on options for patients experiencing digestive conditions. One of the more common health problems for physicians to address is when they prescribe antibiotics to heal a bacterial infection. The antibiotic often affects the balance of gut microbiota, causing distressing diarrhea. Furthermore, studies have shown that antibiotics can disturb the microbiome for up to one year.16, 17

Clinical research indicates Lactobacillus rhamnosus GG reduces diarrhea and minimizes the adverse effects of the antibiotic.4-6 With this medical knowledge, pharmacists can provide the physician with data on why prescribing a probiotic is safe and effective. The findings also support that Lactobacillus GG, delivered in many Culturelle® products, helps with nausea, taste disturbances, and bloating, all side effects that can contribute to non-compliance.

When pharmacists and physicians join other colleagues on the Pharmacy and Therapeutics (P&T) committee to add to their 86

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CAS E S TU DY

“

Culturelle® has a 20-year history of providing digestive and immune benefits that support health, including relief from diarrhea.

Lactobacillus rhamnosus GG’s efficacy and safety have been established in multiple trials in adults, children, and infants.”

Margaret Haldeman, Ph.D. Global Research & Development, Probiotics ~ i-Health, Inc.

formulary, they are now including Lactobacillus GG in that review because of the evidence and comprehensive way it aids the patient with digestive problems, especially when patients receive antibiotics.

Specifically, when Lactobacillus GG, a live microorganism, is administered in adequate amounts, it confers a health benefit on the host. Lactobacillus GG promotes the balance of the intestinal microbiota, providing digestive assistance and immune support.18-19 Lactobacillus rhamnosus GG exerts its effects by: • • • •

Binding to sites in place of pathogens.

Influencing epithelial barrier function.

Blocking proinflammatory molecules.

Releasing antimicrobial substances.

All this activity contributes to the strength of the epithelial barrier, which in turn provides a defense against potential toxins, pathogens, and inflammatory responses.20 With Culturelle® products delivering Lactobacillus GG, pharmacists and physicians offer multiple advantages for their patient, including, but not limited to, the following factors: n EVIDENCE-BASED AND SAFE PROBIOTIC STRAIN Probiotic strains differ, and the variances in those strains may be critical in delivering benefits to the patient. Lactobacillus rhamnosus GG is associated with supporting the digestive and immune systems.

Lactobacillus GG contains the most clinically studied probiotic strain in the world. It has been demonstrated in more than 1,000 scientific studies and 200 clinical studies.21 The probiotic passes the highest testing standards and limited adverse events in the wide range of clinical studies.19 Lactobacillus GG is also the most clinically studied probiotic in children and infants.22 Lactobacillus GG significantly reduces common side-effects associated with various antibiotics, ultimately improving compliance and reducing the risk of acquired antibiotic resistance. Reduced risk of upper respiratory infection has also been demonstrated in children.23, 24 “Culturelle® has a 20-year history of providing digestive and immune benefits that support health, including relief from diarrhea,” said Margaret Haldeman, Ph.D., Global Research & Development, Probiotics, i-Health, Inc. “Lactobacillus rhamnosus GG’s efficacy and safety have been established in multiple trials in adults, children, and infants.”

ALIGNMENT WITH MEDICAL PROFESSIONALS

Authoritative medical societies, listed below, have endorsed the use of Lactobacillus rhamnosus GG to manage acute gastroenteritis.25 They also recognize other benefits such as preventing nosocomial diarrhea,26 treating gastrointestinal conditions,8, 9 and relieving pain related to gastrointestinal disorders in children.27 • • • •

American Gastroenterological Association (AGA) Cochrane Database of Systematic Reviews European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) European Paediatric Association/ Union of the National European Paediatric Societies and Associations (EPA/UNEPSA) • Journal of the American Academy of Pediatrics (AAP) • Journal of the American Medical Association (AMA) • World Gastroenterology Organization (WGO)

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CAS E S TU DY THE DIFFERENCE CULTURELLE ® MAKES WITH C. DIFF Clostridioides difficile (or C. diff) is the most common healthcare-associated infection, causing nearly 500,000 infections every year and an estimated 29,000 deaths (reference cdiff.org). Those leading long-term and acute-care settings know that C. diff is dangerous to their patient and the provider’s reputation.

“C. diff occurs most often in people over 65 years old who are receiving antibiotics.

While it’s known as a hospital-acquired infection, a significant number of cases are community-acquired with antibiotic use being the most common denominator,” said Haldeman.

C. difficile Colitis is a severe form of antibiotic-associated diarrhea. Not only do patients experience undue distress as the antibiotic therapy targets pathogens and also impacts the host’s commensal bacteria, but it is also life-threatening.

The antibiotic disturbs the balance of the gut microbiota and impedes the function of beneficial microorganisms, allowing certain pathogenic bacteria to become overactive.16 Although antibiotic therapy is standard for primary C. difficile colitis, the frequency of relapse can be as high as 20 percent.

If the patient has multiple relapses, involving diarrhea and reappearance of the organism, with its cytotoxin in the stool, they can experience detrimental consequences to their overall health. To counter this negative result, a physician would prescribe Lactobacillus GG as it has reduced the relapse rate of C. difficile in two clinical trials.13, 14

COST SAVINGS The team at Culturelle® offers a tool whereby each institution can estimate potential cost savings for Lactobacillus rhamnosus GG and C. diff. The tool pulls from the number of institutional C. diff infections and calculates the economic burden for the facility. Moreover, it uses published clinical results for the efficacy of Lactobacillus GG to reduce C. diff infections, along with an estimate for the number intended to treat with Culturelle® products. The result is a model that estimates the financial benefit of a Lactobacillus rhamnosus GG protocol. If you would like a demonstration of the Confidential tool, please email margaret.haldeman@dsm.com. #

LGG CDI FINANCIAL MODELING TOOL Patients with Primary CDI

Cost per Patient with Recurrent CDI Pharmacy Outpatient Inpatient

Data Source Lessa, F. C., et al., Burden of Clostridium difficile Infection in the United States, 2015, New England Journal of Medicine 372(9): 825Recurrence 834.

10

Patients with Recurring CDI Cost per Patient with Primary CDI Pharmacy Outpatient Inpatient

Proof Source Link

2 $71,980 $6,759 $21,544 $43,677

$719,800

$131,953 $11,074 $32,051 $88,828

$263,906

Economic Burden of CDI

Direct Costs Direct Costs Direct Costs Direct Costs

Feuerstadt, P., et al., Healthcare resource utilization and direct associated with index and recurrent Clostridioides infection: a real-world data analysis, Journal of Medical DirectEconomics, Costs 2020, 23:6, 603-609, DOI: Direct10.1080/13696998.2020.1724117 Costs Directmedical Costs costs Directdifficile Costs

$983,706

% of LGG Reduces Primary CDI

69

% of LGG Reduces Recurrent CDI

84

Potential Cost Savings

Morrow LE, et al, Probiotic prophylaxis of ventilator-associated blinded, randomized, controlled trial. Am J Respir Crit Care Med. 2010;182(8):1058-1064. doi:10.1164/rccm.200912Bennett Bennett, Recurrence R. et al, Treatment of Relapsing Clostridium difficile Diarrhea with Lactobacillus GG, Nutrition Today: November 1996 Volume 31 - Issue 6 - p 39S Morrow pneumonia: Primary CDI a

223,138 42,225 718,343

Patient Prophylaxis Selection

Total ICU Admissions/Antibiotic Proxy % of ICU Patients receiving Antibiotics Approximate number of patients needed to prophylax

50

Total Number of Patients for Prophylaxis

ICU Admissions Leapfrog Data Group

2006 1003 1003

Cost of LGG for ALS Cost of LGG as a percent of savings

$10,030 1%

Total Savings

$708,313

LGG will work more effectively if used in a comprehensive management plan for CDI

CONCLUSION

Pharmacists can turn to the leading national probiotic brand when physicians have a patient with digestive disorders involving diarrhea. Evidence-based Lactobacillus rhamnosus GG delivered by Culturelle® is solving the problem when antibiotics attack normal gut microbiota needed for digestive health.

Culturelle® Digestive Probiotic Capsules Hospital Pack is driven by science, trusted by physicians,22 and backed by research. The cost-effective capsule has been on the market, demonstrating a 20year history of safety and efficacy in all age groups.

The Lactobacillus rhamnosus GG strain is the differentiator in the multiple benefits for the patient’s immune system. Because of the strong science, pharmacists offer Culturelle® products in their formulary in over 1,000 healthcare facilities across the United States.

88

www.culturellehcp.com Culturelle® is a trademark of

Order from your wholesaler today!

Barcoded Unit-Dose Hospital Packs Available

Culturelle® has Lactobacillus rhamnosus GG, which helps the digestive system work better & supports the immune system by restoring the natural balance of good bacteria in the digestive tract.* Formulated with naturally sourced Lactobacillus rhamnosus GG which is scientifically proven to work in harmony with the human body.* Able to survive stomach acid and bile Helps manage relapsing Clostridium difficile colitis* Helps manage antibiotic-associated gastrointestinal side effects* FOR PROFESSIONAL USE ONLY Culturelle® and Purely Probiotics® are trademarks of

Visit CulturelleHCP.com for more info

* THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE, OR PREVENT ANY DISEASE.

1.

Zheng J, Wittouck S, Salvetti E, et al. A taxonomic note on the genus Lactobacillus: Description of 23 novel genera, emended description of the genus Lactobacillus Beijerinck 1901, and union of Lactobacillaceae and Leuconostocaceae. International journal of systematic and evolutionary microbiology. Apr 2020;70(4):2782-2858. doi:10.1099/ijsem.0.004107

2.

Hilton E, Kolakowski P, Singer C, Smith M. Efficacy of Lactobacillus GG as a Diarrheal Preventive in Travelers. Journal of travel medicine. 1997;4(1):41-43.

3

. Oksanen PJ, Salminen S, Saxelin M, et al. Prevention of travellers' diarrhoea by Lactobacillus GG. Annals of Medicine. 1990;22(1):53-56.

4.

Armuzzi A, Cremonini F, Bartolozzi F, et al. The effect of oral administration of Lactobacillus GG on antibiotic-associated gastrointestinal side-effects during Helicobacter pylori eradication therapy.

Aliment Pharmacol Ther. Feb 2001;15(2):163-9. doi:10.1046/j.1365-2036.2001.00923.x

5.

Armuzzi A, Cremonini F, Ojetti V, et al. Effect of Lactobacillus GG Supplementation on Antibiotic-Associated Gastrointestinal Side Effects during Helicobacter pylori Eradication Therapy: A Pilot Study.

Digestion. 2001;63(1):1-7. doi:10.1159/000051865

6.

Cremonini F, Di Caro S, Covino M, et al. Effect of different probiotic preparations on anti-helicobacter pylori therapy-related side effects: a parallel group, triple blind, placebo-controlled study. The American Journal of Gastroenterology. 2002;97(11):2744-2749. doi:10.1111/j.1572-0241.2002.07063.x [doi]

7.

Siitonen S, Vapaatalo H, Salminen S, et al. Effect of Lactobacillus GG yoghurt in prevention of antibiotic associated diarrhoea. Annals of Medicine. 1990;22(1):57-59.

8.

Videlock EJ, Cremonini F. Meta analysis: probiotics in antibiotic associated diarrhoea. Alimentary Pharmacology & Therapeutics. 2012;35(12):1355-1369.

9.

Rodgers B, Kirley K, Mounsey A. PURLs: prescribing an antibiotic? Pair it with probiotics. The Journal of family practice. 2013;62(3):148-150. doi:jfp_6203g [pii]

10.

Isolauri E, Juntunen M, Rautanen T, Sillanaukee P, Koivula T. A human Lactobacillus strain (Lactobacillus casei sp strain GG) promotes recovery from acute diarrhea in children. Pediatrics. 1991;88(1):90-97.

11.

Manley KJ, Fraenkel MB, Mayall BC, Power DA. Probiotic treatment of vancomycin resistant enterococci: a randomised controlled trial. Medical Journal of Australia. 2007;186(9):454-457. doi:10.5694/j.1326-5377.2007.tb00995.x

12.

Szachta P, Ignys I, Cichy W. An evaluation of the ability of the probiotic strain Lactobacillus rhamnosus GG to eliminate the gastrointestinal carrier state of vancomycin-resistant enterococci in colonized children. Journal of clinical gastroenterology. 2011;45(10):872-877. doi:10.1097/MCG.0b013e318227439f [doi]

13

. Gorbach SL, Chang TW, Goldin B. Successful treatment of relapsing Clostridium difficile colitis with Lactobacillus GG. Lancet. 1987;2(8574):1519.

14

. Bennett RG, Gorbach SL, Goldin BR, et al. Treatment of Relapsing Clostridium difficile Diarrhea with Lactobacillus GG. Nutrition Today. 1996;31(6):39S.

15.

Morrow LE, Kollef MH, Casale TB. Probiotic prophylaxis of ventilator-associated pneumonia: a blinded, randomized, controlled trial. American journal of respiratory and critical care medicine.

2010;182(8):1058-1064.

16.

Jernberg C, Löfmark S, Edlund C, Jansson JK. Long-term impacts of antibiotic exposure on the human intestinal microbiota. Microbiology. 2010;156(11):3216-3223.

17.

Schwartz DJ, Langdon AE, Dantas G. Understanding the impact of antibiotic perturbation on the human microbiome. Genome medicine. Sep 28 2020;12(1):82. doi:10.1186/s13073-02000782-x 18.

Segers ME, Lebeer S. Towards a better understanding of Lactobacillus rhamnosus GG--host interactions. Microbial cell factories. 2014;13 Suppl 1:S-S7. Epub 2014 Aug 29. doi:10.1186/1475-2859-13-S1-S7 [doi] 19.

Capurso L. Thirty years of Lactobacillus rhamnosus GG: A review. Journal of clinical gastroenterology. 2019;53:S1-S41.

20.

K Gogineni V, Morrow LE. Probiotics: Mechanisms of Action and Clinical Applications. Journal of Probiotics & Health. 2013;1(1):1-11. doi:10.4172/2329-8901.1000101 21.

Dronkers TM, Ouwehand AC, Rijkers GT. Global analysis of clinical trials with probiotics. Heliyon. 2020;6(7):e04467.

22.

i-Health. Data on file. 2021; 23.

Hojsak I, Snovak N, Abdovic S, Szajewska H, Misak Z, Kolacek S. Lactobacillus GG in the prevention of gastrointestinal and respiratory tract infections in children who attend day care centers: a randomized, double-blind, placebo-controlled trial. Clinical nutrition (Edinburgh, Scotland). 2010;29(3):312-316. doi:10.1016/j.clnu.2009.09.008 [doi]

www.culturellehcp.com Culturelle® is a trademark of

89

OneContainer®

The Solution to Prevent Pharmaceutical Waste from Winding Up Here.

Simple. No worries. The highest level of technology.

Best of all — full compliance.

Clinicians simply put both the non-hazardous and the RCRA hazardous pharmaceutical waste in the same black container.* Clean Harbors, the largest hazardous waste incineration company in North America, will pickup, transport and dispose your pharmaceutical waste, while keeping you fully compliant. We handle every step of the process. Because we own several proprietary incinerators, we do not require the same segregation as other providers.

Are you prepared for changes to subpart P in the EPA’s hazardous pharmaceutical regulations? Ensuring compliance with waste segregation protocols can be difficult, both to train and enforce, putting your facility at risk for non-compliance. * Due to DOT regulations, there are certain waste items that must be collected separately.

For more information: 855.MED.WSTE (633.9783) or healthcareservices@cleanharbors.com, healthcare.cleanharbors.com

© 2020 Clean Harbors. All rights reserved.

2 0WAY S TO I M P R O V E PAT I E N T C A R E & P H A R M A C Y C O S T C O N TA I N M E N T

Clean Harbors — Experts in Pharmaceutical Waste Disposal and Environmental Services Here to help keep your healthcare facility in compliance with complex state and federal regulations — while managing your environmental and waste disposal needs from beginning to end.

President & CEO: Alan S. McKim Founded: 1980

Employees: 14,000+ Stock Symbol: CLH Toll-Free Phone:

(855) 633-9783 (781) 792-5000 Address: 42 Longwater Drive Norwell, MA 02061 Website: healthcare.cleanharbors.com Phone:

Company Background For more than 40 years, Clean Harbors has helped thousands of healthcare institutions of all sizes manage their environmental and waste disposal needs. Our programs indemnify your institution and reduce your risk. We have the in-house experience, expertise, and resources to handle your complete pharmaceutical and hazardous waste program — beginning to end. Clean Harbors is the only environmental services provider that has the ability to manage 100% of your pharmaceutical and hazardous waste, spill cleanups, and facility maintenance within a company-owned network of 100+ service centers, 50 hazardous waste disposal facilities, and the largest hazardous waste incineration capacity in North America. This ability helps keep transportation and disposal costs down. You can also leverage our recycling facilities to reduce the volume of hazardous waste. Clean Harbors employees have one goal — to deliver the highest level of service to protect your institution and the environment.

and federal levels. And because our pharmaceutical waste programs are managed 100% in-house, you are ensured the most reliable “hands-on” service in the industry, customized for your operation — whether you’re a single hospital or a network of facilities in an IDN or GPO.

Services • Pharmaceutical Waste Management • Hazardous Waste Management • OneContainer Pharmaceutical Waste Program • Formulary/Inventory Review • InSite Services • Sharps Management • Medical Mailback • Emergency Response Services • Transportation and Disposal Services • Field Services • Employee Training and Storage Area Setup Ordering Information For additional information or to order, call us at (855) 633-9783 or email healthcareservices@cleanharbors.com.

Compliance Management Made Easy As a healthcare provider, we recognize that providing quality care to patients and their families is your utmost concern. When faced with so many state and federal regulations, hospitals can’t afford to compromise their operations.

The Environmental Protection Agency (EPA) and your state environmental regulatory agency requirements pose significant compliance challenges to hospitals, which can impact efficiency and your bottom line. Clean Harbors is well-versed and stays current in environmental standards and regulations at the state

WINTER 2021

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Unit Dose Done Right Brightly Colored Labels Call Attention to Meds Requiring Special Handling

Unit Dos e Bar Cod , ing, Pharma c Nursing y & Supply Experts !

• Cold Seal • Tamper-Evident • Moisture Resistant • Ultraviolet Inhibitant • Reduces Cross Contamination • Ideal for Meds Covered by USP 800 • 6 and 12-month Beyond-Use Dating • 1-D and 2-D Bar Coding • Flexible Label and Report Formatting • Multiple Sizes and Shapes to Fit Your Meds & Storage Needs

Scan QR Code for more information and pricing.

Simple. Reliable.

800.523.8966

MediDose.com

2 0WAY S TO I M P R O V E PAT I E N T C A R E & P H A R M A C Y C O S T C O N TA I N M E N T

Medi-Dose, Inc./EPS, Inc. Delivers Bar Coding, Packaging, and Labeling Pharmacy Solutions Improve your Solid Oral Unit Dose needs with our comprehensive Bar Coding, Packaging, and Labeling Solutions — designed by healthcare professionals, for healthcare professionals.

President:

Robert Braverman

Founded: 1971 Employees: Private Toll-Free Phone: (800) 523-8966 Phone:

(215) 396-8600 (800) 323-8966 Address: 70 Industrial Drive Ivyland, PA 18974 Website: www.medidose.com Toll-Free Fax:

Company Background Medi-Dose/EPS was founded in 1971 when Milton Braverman, a former pharmaceutical company territory manager, saw the need for inexpensive, manual unit dose packaging allowing a hospital to convert from traditional dispensing. He developed the Medi-Dose System to package, handle, and dispense predetermined amounts of medication so they would be accessible for one regular dose. Comprehensive bar coding and labeling identification is accomplished using our innovative MILT 4 software. Because of the continued success of the MediDose System, Medi-Dose/EPS expanded its product line to include the TampAlerT System, offering tamper-evident liquid packaging without the need for heat tunnels and accessory sealing equipment, as well as a full line of supplies and disposable products designed specifically for the pharmacy and health care professional.

Product Overview Medi-Dose provides Tamper-Evidence as well as UV and Moisture Resistance for one-year beyond-use dating. Our MILT® 4 software maintains packaging logs and lets you design and print your Lid-Label® Covers with color, bar codes, tall man lettering, and graphics. You can format the labels any way you want, directly from your own computer and printer!

Medi-Dose works well in any pharmacy operation and can be used with all classifications of drugs (chemo meds, meds covered

by USP 800, compounded drugs, controlled substances, etc.).

It’s affordably priced for all pharmacy budgets. For the best in manual unit dose packaging, check out Medi-Dose!

Features & Options

n Packaging and Labeling Solutions

• Simple to use — no extensive training needed.

• 1-D and 2-D bar coding — including NDC, lot numbers, and expiration dating.

• Ideal for hazardous medications and USP 800 drugs.

• Tall Man Lettering and dynamic formatting options.

• Built-in NDC lookup database and extensive image library.

• Packaging logs and error reporting.

• Six-month and one-year beyond-use dating.

• UV and moisture resistance.

• Tamper-Evidence.

• 15 styles of blisters to accommodate virtually all meds.

• No machinery or space requirements.

• Inexpensive — no capital outlay required.

Product Specifications

n Accompanying Labeling Software

• MILT 4 • MILT 3.0 • MILT 2.6 • Medi-Dose 2000

Trade Shows/Meetings Attended ASHP Midyear, ASHP Summer, Joint Forces Pharmacy Seminar, National Pharmacy Purchasing Association, EAHP, IACP, and various state, regional, and pharmacy compounding conferences.

Ordering Information For additional information, please contact us at (800) 523-8966, visit our website at www.medidose.com, or email us at info@medidose.com.

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T R A D E S H O W & M E E T I N G E v e n t Calendar

Behind Every Good Pharmacist, is a Great Resource.

Event Calendar

Trade Shows, Meetings, & Expositions Due to COVID-19, all trade shows and meetings are subject to change. Please confirm with the individual organization for updates.

RXinsider’s Virtual Pharmacy Trade Show 24 / 7 / 365 450+ Booths, 89 Aisles www.rxinsider.com ASHP Midyear Clinical Meeting and Exhibition December 5-9, 2021 Virtual Event Midyear.ashp.org 340B Coalition Winter Conference January 31-February 2, 2022 San Diego, CA 340bwinterconference.org 2022 PDS Super-Conference February 17-19, 2022 Orlando, FL www.pdsconference.com American College of Apothecaries Annual Conference & Expo 2022 February 23-26, 2022 Wyndham Grand Rio Mar Puerto Rico acainfo.org/ace

2022 FAH Conference and Business Exposition March 6-8, 2022 Washington Hilton Hotel Washington, DC www.fahexpo.com APhA Annual Meeting & Exposition March 18-21, 2022 San Antonio, TX www.pharmacist.com/ Conferences/AnnualMeeting NACDS Annual Meeting April 23-26, 2022 Palm Beach, FL Annual.nacds.org Veterinary Pharmacy Conference June 10-11, 2022 Raleigh, NC vetmeds.org/vpc ASHP Summer Meetings and Exhibition June 11-15, 2022 Phoenix, AZ www.ashp.org/Meetingsand-Conferences/SummerMeetings-and-Exhibition

Continued on page 99 For listing and advertising details, please contact sales@RXinsider.com or call 800.972.2083.

94

WINTER 2021

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With 80+ aisles, the Virtual Pharmacy Trade Show is pharmacy’s one-stop destination to research and connect with leading providers of products and services.

RXinsider.com

We provide support in addressing your 340B operational and compliance challenges Prepare for a government or manufacturer audit

Stay compliant with changes to Medicare Part B reimbursements

Compare split-billing software vendors

Connect with 340B hospitals around the country

Member Benefits Advocacy As your voice in Washington, we encourage you to join our advocacy efforts to protect 340B, which includes creating an Impact Profile document illustrating how your savings support your safety-net mission. Our staff is ready to help your hospital engage in advocacy through the development of op-eds and social media campaigns.

Webinars You and your staff will be invited to 340B related webinars throughout the year on topics ranging from audit prep and findings to recertification. We host over a dozen webinars each year and encourage your team to join us.

Real-Time 340B Information Stay in-the-know and up to date through our email alerts, members-only bi-weekly Bulletin, and the 340B Informed blog.

Technical Assistance (TA) Calls Take advantage of this invaluable resource by speaking with a member of our legal and/or pharmacy teams. Our staff is able to answer questions on topics ranging from audit prep and diversion to adding child sites and drafting policies and procedures.

340B Health Website The website has sample forms, letters and P&Ps, as well as policy guides and member best practices. Miss a webinar?

No problem, past webinars are housed on our website. Find our audit and compliance resource centers along with a calendar of upcoming events.

The Exchange Access our secure online member discussion forum 24/7 for answers to your most pressing 340B related questions, hear ideas and best practices, and grow your network.

Individual Membership

National Conferences

Through your hospital’s membership, you are eligible to join this supplemental program which provides professional development and networking opportunities.

340B Health, along with our 340B Coalition partners, provides you unparalleled access to information and networking opportunities at our summer and winter conferences. 340B Health and 340B Coalition members receive discounts to both events.

Questions? Contact Shane Kelley at (202) 552-5864 or email shane.kelley@340bhealth.org.

Programs

Meet

Face-to-Face with Your Customers ECRM’s Pharmacy & Medical Programs set you up for success with pre-scheduled, private, one-on-one meetings with partners that matter to your business.

Contact our SVP of Pharmacy & Medical Markets, Michael Castillo to learn how at 440-528-0441 or mcastillo@ecrm.marketgate.com

Behind Every Good Pharmacist, is a Great Resource.

The Pharmacy Market BUZZ is a daily news feed, designed to keep the pharmacy community informed on the latest industry news, products, services, and trends that impact both patient care and the bottom line of a pharmacy.

RXinsider.com

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Event Calendar

Trade Shows, Meetings, & Expositions Due to COVID-19, all trade shows and meetings are subject to change. Please confirm with the individual organization for updates.

Continued from page 94

ECRM Health System/ Institutional Pharmacy Program June 13-16, 2022 Location TBA ecrm.marketgate.com/ sessions

ASCP Annual Meetings & Exhibition November 3-6, 2022 JW Marriott San Antonio Hill Country Resort & Spa San Antonio, TX www.ascp.com/page/events

McKesson ideaShare July 6-10, 2022 Washington, D.C. mckessonideashare.com

ASHP Midyear Clinical Meeting and Exhibition 2022 December 4-8, 2022 Las Vegas, NV www.ashp.org/meetingsand-conferences/midyearclinical-meeting-andexhibition

Cardinal Health RBC July 13-16, 2022 Mandalay Bay Las Vegas, NV www.rbc.cardinalhealth.com AACP Annual Meeting 2022 July 23-27, 2022 Grapevine, TX www.aacp.org/events

All told, APC represents tens of thousands of compounders and patients: pharmacists, technicians, students, researchers, and suppliers, as well as the men, women, and even the animals they care for.

APC has launched a nationwide media campaign. Our goal: stopping restrictions on compounded hormone therapy — treatment that has done wonders for millions of women and men for decades.

T R A D E S H O W & M E E T I N G E v e n t Calendar

The Alliance for Pharmacy Compounding is the only organization in the U.S. focused solely on advocating for pharmacy compounding.

The threat to cBHT is a threat to th patients and to the pharmacies that serve them.

APC and the coalition we're we' building are stepping up to counter that threat — and whatever comes next. (Read about our media campaign, and contribute to it, at A4PC.org/cbht.)

NACDS Total Store Expo August 27-29, 2022 Boston, MA Tse.nacds.org

We’re stronger and more effective when you’re our member. Join APC and let us be your advocate.

For listing and advertising details, please contact sales@RXinsider.com or call 800.972.2083.

A4PC.org/join WINTER 2021

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H E A LT H S Y S T E M • I N F U S I O N 99

As many as

76% of pharmacy claims require intervention

Claims Manager Plus This sophisticated pharmacy claims solution automates the process of claim intervention to help you streamline claims processing while managing complex reporting requirements. And the savings potential is significant:

432

Average hours saved per employee per year

$14M Average total cost savings per year

Let Claims Manager Plus help you close the gap. For more information or to schedule a demo, visit sentryds.com/closingthegap

Together, We are © Copyright 2022 Sentry Data Systems, Inc. All rights reserved. No unauthorized reproduction.

2 0WAY S TO I M P R O V E PAT I E N T C A R E & P H A R M A C Y C O S T C O N TA I N M E N T

Sentry Data Systems, a Craneware Company — Expect More With a Trusted 340B Leader Sentry Data Systems, a Craneware company, is a pioneer in providing automated technology solutions that help providers manage 340B compliance, produce better quality, reduce the total cost of care, and reach more underserved patients.

Founder:

Travis Leonardi Founded: 2003 Employees: 350+ Toll-Free Phone: (800) 411-4566 Toll-Free Fax: (866) 221-4337 Address: 800 Fairway Drive, Suite 400 Deerfield Beach, FL 33441 Website: www.sentryds.com

Company Background

Since 2003, Sentry Data Systems has been providing healthcare organizations with 340B management and compliance solutions that help you make better business decisions. We deliver passion, expertise, and partnership every step of the way. As a company always at the forefront of innovation, we pair our solutions with a strong support team that helps you navigate complex waters and deliver on your mission.

One example of our commitment to innovation is our standalone sister company, Agilum Healthcare Intelligence. Agilum’s revolutionary, proprietary longitudinal database combines objective, near real-time data with actionable analytics to deliver real-world evidence and enable the leap to value-based care.

In July 2021, Sentry became part of Craneware, an Edinburgh, Scotlandbased healthcare technology company that created the industry’s first automated chargemaster management solution in 1999. With the acquisition, Craneware offers an unmatched portfolio of solutions to the U.S. healthcare industry, including 340B compliance and expertise, strategic pricing, claims analytics, patient engagement, and revenue recovery and retention. Together, we are transforming the business of healthcare.

Product Overview

Sentry can help you maximize your 340B benefit with powerful solutions that deliver the precision, compliance, insight, and savings you need to run a successful program. We offer: • The only fully integrated, longitudinal 340B audit record.

• The industry’s only dedicated, 100% Apexus-certified audit team.

• Proactive support, with almost 30% of our staff focused on customer success.

• Longstanding industry leadership and advocacy on Capitol Hill. n Sentinel Hospital Procurement and 340B Compliance Sentinel uses proven methodologies and a robust feature set to take control of hospital pharmacy mixed-use costs, contracts, and compliance.

• Offers full visibility into hospital pharmacy operations and more control of the procurement cycle, with advanced ordering, auditing, inventory management, and reporting functions.

• Optimizes 340B programs with a longitudinal patient database, ®

providing a larger and more precise pool of eligibility.

• Tracks dispensations from multiple sources, connecting the dots in the data and offering in-depth insights into the inventory. n Sentrex® 340B Contract Pharmacy Management Simplifying an array of complex compliance challenges, Sentrex helps you manage your 340B contract pharmacy relationships and expand medication access to more patients.

• Automates 340B drug replenishment to help reduce inventory cost.

• Offers flexible configuration options that can be tailored to reflect each organization’s own unique processes and parameters.

• Tracks drug cost savings by NDC, pharmacy location, and prescription type. n Sentrex330™ for Clinics Sentrex330™ helps community health centers expand 340B benefits to as many eligible patients as possible and remain compliant while reducing burden on staff.

• Automates tracking of 340B dispensations and replenishment with the ability to review and adjust claims eligibility.

• Supports patient assistance plans to allow for sliding scale fee.

• Manages patients and providers in real time to ensure prescription eligibility.

Expect Innovation

Claims Manager Plus: A solution to help you

accelerate payment and minimize denials of pharmacy claims while managing complex reporting requirements.

CRCA™ P&T: Agilum’s proprietary, longitudinal database provides real-world, near real-time data to deliver actionable insight into drug spending, utilization, and outcomes.

Expect Service

Senturion™ Services is a trusted extension of your team, with over 20 years of hospital pharmacy operations experience. We offer consulting expertise in areas including: orphan drugs, audit compliance, and data integrity.

Expect Transparency

Referral Verification System™: This service reviews referral prescriptions

initially marked as ineligible to connect the dots, ensure 100% compliance, and help you maximize 340B benefits.

Closing the Gap on Hospital Drug Billing Claims

Find out how Claims Manager Plus can help streamline your claims processing and manage complex reporting requirements by visiting sentryds.com/closingthegap and requesting a free demo today!

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Reach Higher Standards of Care Humber River Hospital prioritizes quality care delivery through industryaccuracy, and safety measures.

Swisslog Healthcare plays a key role in delivering this vision. Our solutions streamline pharmacy operations.

Our PillPick® Automated Packaging and Dispensing System and BoxPicker® Automated Pharmacy Storage System allowed Humber River Hospital realize: Reduced — Medication picking errors by more than 50% — Pharmacy technician labor to pick and package unit dose medications by more than 30% Gained — Pharmacy technician time for medication reconciliation and other direct care activities Increased Inventory control by approximately 30%

swisslog-healthcare.com/humberriver-rx

Realize your vision. swisslog-healthcare.com/humberriver-rx

2 0WAY S TO I M P R O V E PAT I E N T C A R E & P H A R M A C Y C O S T C O N TA I N M E N T

BoxPicker® Automated Pharmacy Storage System From Swisslog Healthcare Creates a More Efficient Pharmacy Workflow Optimize pharmacy workflows with the market’s proven robotic storage and retrieval system to virtually eliminate picking errors, increase efficiency, and improve medication safety.

CEO:

Stephan Sonderegger President: Cory Kwarta Founded: 1915 Employees: 500-1,000 Toll-Free Phone: (800) 764-0300 Address: 11325 Main Street, Broomfield, CO 80020 Website: www.swisslog-healthcare.com

Company Background

Swisslog Healthcare connects the medication supply chain, bringing together automated transport and pharmacy automation solutions in more than 3,000 healthcare institutions worldwide. These connections are made possible through: • Proven pharmacy robotics.

• Enterprise medication management software.

• The industry’s most trusted pneumatic tube systems.

• Front-of-house autonomous service robots.

• A pharmacy-driven delivery tracking system.

Through an agnostic approach to integration, Swisslog Healthcare enables forward-thinking health systems to create a connected medication ecosystem. Learn more at www.swisslog-healthcare.com.

Product Overview

BoxPicker reinvents medication storage by streamlining workflow and storing medication inventory in one central and secure location.

BoxPicker decreases the opportunity for picking errors by limiting accessible medication and requiring barcode scanning with any medication movement. With the ability to include refrigerated modules and multiple operator stations (including inside the ante-room), Swisslog Healthcare can configure a BoxPicker to fit any pharmacy operation.

• Elevated Efficiency. Hourly productivity and picking performance are increased through multi-user, multi-tasking, automated storage, and retrieval. Multiple workstations allow simultaneous operation by several technicians. Integration with existing hospital information and cabinet vendor systems enables the BoxPicker to pick medication three picks ahead of the operator. As an option, when paired with Pharmacy Manager, medications stored outside the automation can be managed and organized to allow optimal workflow and efficiency where orders are separated, prioritized, and routed to the correct location for dispensing or stocking.

• Ultimate Medication Control and Safety. BoxPicker requires scan in and scan out tracking that decreases opportunity for error, and secure access ensures inventory control and audit capabilities.

BoxPicker minimizes access to the number of different medications per user, therefore reducing picking errors.

• Custom Configuration and Scalable Technology, Including

Cleanroom Access, Dual-Temp, and Fully Refrigerated Options.

The modular design and flexible operator station placement allow pharmacies to configure the solution to meet their current and future needs. Additionally, the BoxPicker offers refrigerated modules or operator stations built in the anteroom for direct medication access from the cleanroom suite. This supports USP <797> compliance by providing a secure pass-through to anterooms, and positive-pressure airflow ensures environmental integrity. High-density storage and retrieval allows for greater storage within a smaller footprint without floor reinforcement.

To learn more about BoxPicker, visit swisslog.com-healthcare.com/boxpicker

Testimonial

“ Working with Swisslog has improved our day-to-day workflow. It has made us more efficient and more accurate. Before BoxPicker, when we were manually picking, an entire room could be handled incorrectly. Now with the process automated, it greatly reduces our chance for human error.”

— Voltaire Tadeo, Senior Medication Management Analyst, University of California — San Francisco

Additional Product Lines

n Pharmacy Manager is a medication management software designed

with growing health systems in mind. It takes the lead on incoming and outgoing orders, becoming the central point of truth for pharmacy inventory control. Pharmacy Manager can manage the inventory of all the medications within the enterprise and improve the pharmacy workflow by streamlining orders, managing expiration dates, and minimizing waste.

n PillPick® Automated Packaging and Dispensing System decreases

human touches in bar coding, packaging, storing, dispensing, and returning unit-dose medications. The patented PickRing™ delivers patientspecific medication on a single ring ready for administration, reducing the opportunity for missed medications and speeding up administration time.

n AutoCarousel® Semi-Automated Pharmacy Storage System transforms medication management by reducing labor, drug waste, missing medications, and picking mistakes. AutoCarousel is accurate and reliable, and the vertical design ensures maximal storage in a compact footprint, reclaiming valuable pharmacy space.

n AutoPack™ Automated Oral Solid Packager allows pharmacies to pre-

package tablets for unit dose dispense. Additionally, through integration with hospital information systems, orders can be filled on demand, including cabinet replenishment orders, patient-specific cart fill, or STAT orders.

AutoPack further minimizes human touches and maximizes productivity.

n Savioke Relay® Autonomous Service Robot is the first autonomous

service robot designed to work around people in busy hospitals. Highly useful for hospitals without a pneumatic tube system or for “Do Not Tube” items, this healthcare robot handles deliveries quickly, safely, and reliably, increasing productivity by allowing staff to focus on high-value tasks, while improving their overall experience and ultimately patient outcomes.

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C ASE S T UDY

THE CAP THAT PROTECTS CHILDREN Prep-Lock™ Tamper Evident Caps Deter Drug Diversion INTENDED OUTCOME

The theft of controlled substances or other medications meant for the patient can occur at various points in the supply chain. The installation of drug security methods at healthcare facilities continues to increase each year because of the rise and risk of drug diversion. Mitigating diversion is a priority for every health provider, and ensuring patient safety is the goal of every drug diversion method.

Julie Lasseigne, PharmD Pediatric Pharmacy Director ~ Children’s Hospital of Alabama

This case study examines why one of the simplest drug diversion solutions is also one of the most successful. Tamper evident caps are an effective tool in addressing drug diversion. Specifically, this analysis details why this product works for Children’s Hospital of Alabama (Children’s).

The success story became evident when Children’s converted to the ENFit Connector Standard to reduce enteral tubing misconnections. This conversion opened the opportunity for pharmacy leadership to purchase and prioritize tamper evident caps for the ENFit syringes, adding additional protection to the medication and Children’s.

BACKGROUND

Children’s has a progressive pharmacy department that utilizes technology and clinical knowledge to provide care for a diverse patient population. It’s lead by Julie Lasseigne, pediatric pharmacy director for Children’s, who views the health and safety of children as her foremost responsibility.

Lasseigne is known for solving problems and working collaboratively. She looks at this issue with zero tolerance and takes a 360° approach to combat it.

“Drug diversion is about understanding the behavior, making it difficult to access the drug, and implementing deterrents,” said Lasseigne. “I’m continually aware that compounded preparations are at their greatest risk for diversion when they leave the custody of our pharmacy.”

This 14-year employee knows the pharmaceutical needs of Children’s. And the hospital needed tamper evident caps for their pharmaceutical security program.

“If the employee is having a bad day and feel like they need the drug, we want them to see that cap and think that it’s not worth taking it. The cap signals not to make that bad choice because you’ll get caught,” said Lasseigne.

CHALLENGES

Drug diversion presents numerous safety and reputational risks for a hospital. Financially, hospitals bear the cost of diverted drugs, internal investigations, and follow-up care for affected patients.

The government can fine the facility in excess of $4 million for inadequate safeguards.1 By their daily access to controlled substances, it is estimated that 15%

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CAS E S TU DY Children’s is

the ONLY medical center in Alabama dedicated solely to the care and treatment of children.

It’s a Not-for-Profit

of pharmacists, 10% of nurses, and 8% of physicians are challenged with alcohol and/or drug dependency.2 The challenge that Children’s addresses every day and remains ever-vigilant is preventing the risk of inadequate dose or contamination by a clinician under the influence. The protection and safety of children involve employing multiple anti-diversion methods.

CONVERSION AT CHILDREN’S

Adhering to the recommendations from Global Enteral Device Supplier Association (GEDSA), Children’s converted to the safer ISO 80369-3 compliant connectors, commonly called ENFit®, in the spring of 2021. ENFit gives every enteral delivery set, extension set, syringe, and feeding tube a specific connector unique to enteral feeding, reducing the likelihood of misconnections and accidental disconnection.

The use of slip tip syringes is no longer ISO compliant for device applications like enteral feeding.

Therefore, the adoption of a new standard prompted the move to tamper evident caps for ENFit syringes.

Medical Center that

“We met our conversion timeline as GEDSA’s manufacturers ended production of legacy feeding tubes and cross-application connectors on July 1,” said Lasseigne. “Our team also took this time to strengthen our diversion efforts."

serves as a teaching

SUPPLIER DECISION

hospital for pediatric programs at the University of Alabama at Birmingham.

U.S. News & World Report Ranked it Among

ONE OF THE BEST Pediatric Medical Centers

Lasseigne heads a multidisciplinary committee at Children’s to deploy multifaceted security programs. From high-tech systems to educational programs, Children’s continues to seek vendors to stop drug diversion.

Children’s decision to go with International Medical Industries (IMI) for tamper evident caps for ENFit syringes was an obvious decision. IMI, with its Prep-Lock™ Tamper Evident Cap Line, had specifically designed a product for ENFit. IMI also was a reliable vendor in good standing with Children’s since 2015. They had a proven reputation in the market with more than 85% of the top 503B compounding facilities trusting IMI to secure their preparations.

Beyond the strong purchasing relationship with IMI, Children’s chose their tamper evident caps because they exceeded expectations with the following areas of importance.

SAFETY AND INTEGRITY

Prep-Lock Tamper Evident Caps greatly reduce the risk of Children’s being compromised either accidentally or intentionally. The ENFit syringe cap possesses built-in tamper-evident technology.

Compatible with low dose and standard ENFit syringes, IMI provides an additional level of security and integrity from when the product leaves the pharmacy until administered by an authorized clinician.

Once tamper evident caps are installed, they cannot be removed without evidence of potential tampering or contamination, ensuring the integrity of syringe contents. Guarding ENFit syringes with Prep-Lock Tamper Evident Caps enhances medication safety protocols and improves patient safety.

“Product integrity is paramount when it involves medication for children,” said Lasseigne. “Tamper evident caps advance our drug diversion philosophy and enhances patient care.”

EASY AND EFFECTIVE

www.imiweb.com

Prep-Lock products are a trustworthy, high-quality solution. They prevent leakage and ensure that patients receive the full, intended dose. Easy installation and prompt product availability make incorporation of tamper evident caps practically effortless.

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CAS E S TU DY A simple twist of the wrist equips syringes with a physical barrier to diversion, misuse, and tampering, whether intentional or unintentional, raising confidence in the integrity of medications for both pharmacist and clinicians.

“IMI delivers a product that is easy to use for my team and cost-efficient with the new GEDSA standard,” said Lasseigne. “Tamper evident caps also prove that a simple method can have a big impact to eliminate diversion at Children’s.”

DETECTION AND DETERRENCE

IMI provides Children’s with clear visibility into a probable incident. A detached or missing outer sleeve indicates that a potential comprise has occurred, initiating an audit and analysis on the situation.

“When the out of the ordinary happens with controlled substances, we question why. Caps are an active deterrent to diversion and allow us to see that a syringe has been tampered with, making them an essential component to our security program.”

STANDARDIZATION AND COMPLIANCE

USP provides standards for the sterile preparation of pharmaceutical compounding to help ensure patient benefit and reduce risks such as contamination, infection, or incorrect dosing. Although not technically required by DEA, tamper evident caps strengthen and supplement DEA and USP guidelines. And the technology has become an industry model for securing syringes.

Incorporating the IMI caps into in-house procedures standardizes all the syringes throughout Children’s, providing consistent care and streamlining processes. IMI products supply needed controls for medication integrity, and dosing accuracy.

“Consistency within pharmacy operations is always the goal, and deploying ways to reduce diversion with pediatric doses helps us achieve that goal.”

RESULTS

Tamper evident technology in a drug security program is a simple, effective way to provide additional security to compounded preparations and controlled substances. Prep-Lock™ Tamper Evident Caps from IMI reduces the risk of Children’s being compromised either accidentally or intentionally. The standard of care is elevated with a product that guards the ENFit syringes.

“Caps for ENFit syringes are a low-cost solution for a high-confidence program at Children’s. For us, it is as simple as we like IMI, and the product works,” said Lasseigne.

CONCLUSION

Drug diversion concerns are driving the need to secure and protect syringe contents. Prep-Lock Tamper Evident Caps provide an active deterrent to diversion and misuse at Children’s. The caps also help ensure that medications arrive at patients uncompromised and make a clear statement about how seriously Children’s takes drug security.

“Eliminating the opportunity to divert protects our patients and our hospital’s reputation,” said Lasseigne. “The team at IMI designed the caps for simplicity and protection. They deliver on both.”

Journal of Hospital Medicine Vol 14 | No 7 | July 2019 – https://www.journalofhospitalmedicine.com/jhospmed/article/202732/hospital-medicine/diversion-controlled-drugs- hospitals-scoping-review 2 MR Baldisserri, Impaired Healthcare Professional. Critical Care Medicine. 2007 35(suppl):S106-16.

1

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INNOVATION IN SECURE DRUG DELIVERY PREP-LOCK™ TAMPER EVIDENT CAPS

Help ensure the safe delivery of your compounds, comply with growing regulations, and enhance patient care.

Strengthen <797> Compliance Ensure the integrity of your compounds with Prep-Lock™ Tamper Evident Caps.

Maintain Sterility Evidence of access indicates the potential compromise of content sterility.

Mitigate Diversion Serves as an active deterrent to potential diversion and misuse.

Prep-LockTM Tamper Evident Caps are available for a variety of devices.

• IV Syringes • Oral Syringes • IV Bags

Contact us for Free Evaluation Samples IMIWEB.COM |

• ENFit® Syringes • CADD Cassettes

MADE IN THE USA

1.800.344.2554

© 2021 International Medical Industries, Inc. All rights reserved.

Companies and products mentioned herein may be trademarks or registered trademarks of their respective trademark owners.

IMI-501-AA-61 R2

Increase Safety in Your Hospital and Community Stericycle’s CsRx containers mitigate drug diversion in your hospital.

Our MedDrop collection kiosks and Seal&Send envelopes TM

TM

provide your patients and community safe solutions to dispose unused medications. SafeDrop provides safety and efficiency to TM

your immunization program and patients’ home injection therapies.

Comprehensive Regulated Waste Management for your Pharmacy

We protect what matters.

CsRx Controlled Substance Waste Service • Heightens your organization’s drug diversion program • Deactivates controlled substance wastage

Seal&Send Medication Envelopes and MedDrop Drug Collection Kiosks

SafeDrop Sharps Mail Back Containers

• Increases your organization’s community stewardship

• Cost-effective and convenient

• Mitigates drug diversion in your community • Protects the environment, keeping drugs out of waterways • DEA compliant

Learn more at Stericycle.com © 2021 Stericycle, Inc. All rights reserved.

• FDA and DOT compliant, USPS approved

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Safeguard Your Organization, Community, and the Environment With Stericycle Solutions Stericycle’s CsRx Controlled Substance Waste Service can serve as a central component to prevent drug diversion in your hospital. Stericycle’s Safe Community Solutions provide your patients with safe and convenient disposal of sharps waste and unused medications.

President & CEO: Cindy J. Miller Founded: 1989

Employees: 15,000+ Stock Symbol: SRCL Toll-Free Phone:

(866) 783-9816 (844) 752-6211 Address: 2355 Waukegan Road Bannockburn, IL 60015 Website: www.stericycle.com Phone:

Company Background Stericycle supports the leading role that pharmacists hold as healthcare providers in our communities. For over three decades, Stericycle has introduced innovative products and services for regulated medical waste management and is a pioneer in offering pharmaceutical waste solutions that help drive safety, regulatory compliance, and environmental sustainability.

Product Overview n Increase Efficiency, Safety, and Your Organization’s Community Stewardship

Stericycle’s Safe Community Solutions increase your patient engagement by offering convenient disposal of unused consumer medication and sharps waste generated by home injectable therapies. CsRx Controlled Substance Waste Service helps mitigate drug diversion within your healthcare organization.

• MedDrop™ Drug Collection Kiosks help prevent prescription drug abuse in your community and reduce the environmental risk that results from improper disposal.

Customers and patients appreciate the convenience and anonymity of returning unused medications to the same place they received them. Add additional value to retain customers and promote brand loyalty with Stericycle’s MedDrop medication collection kiosks.

• SafeDrop™ Sharps Mail Back Kits include everything needed to properly collect and safely dispose of sharps.

With a convenient auto-replenishment option, Stericycle makes it easy to manage container inventory. SafeDrop provides efficient and compliant disposal of sharps waste generated at your facility and serves as a driving component of successful COVID-19, influenza, and other immunization programs.

Additionally, your patients can use the SafeDrop Mail Back program to safely store and dispose of sharps waste generated through their injectable therapies at home.

• CsRx® Controlled Substance Waste Service supports your organization’s internal diversion prevention efforts. CsRx is a solution for safely disposing controlled substance wastage immediately after patient administration, to mitigate drug diversion and protect the environment.

Stericycle: Your Trusted Partner

Stericycle has partnered with thousands of pharmacies of all sizes to provide easy-to-use regulated waste disposal services that help:

• Keep employees safe and healthy and protect your brand — by safeguarding your staff, community, and organization through compliant disposal solutions.

• Add customer value in store — by driving foot traffic and brand loyalty through safe in-store disposal solutions.

• Extend customer satisfaction at home — by prolonging

enhanced customer experience and extending your brand’s reach through secure in-home disposal solutions.

To learn more, visit www.stericycle.com/en-us/solutions/specialtyservices/consumer-take-back-solutions today.

Protect your employees, customers, and community.

• Seal&Send™ Medication Mail Back Envelopes allow consumers to package and mail their unwanted or expired medications to Stericycle in secure, anonymous, prepaid envelopes via USPS. Seal&Send envelopes are particularly useful for rural and homecare patients to safely and sustainably dispose of unused medications simply by placing in a mailbox.

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Partnerships to Drive Pharmacy Performance Excellence Tailored solutions. Proprietary tools.

Extensive expertise.

For healthcare leaders who seek a partner in driving performance excellence, CPS delivers partnerships that drive financial, operational, and clinical success through the pharmacy.

Pharmacy Management

Specialty and Ambulatory Pharmacy

Pharmacy Consulting

340B Program Solutions

Telepharmacy

Supply Chain and Materials Management

We empower healthcare organizations to advance the standard of care by: •

Implementing best practices and proprietary technologies to drive value and enhance the patient experience

•

Leveraging a deep bench of subject-matter experts

•

Continually improving the way healthcare is delivered

•

Driving performance to reduce costs, increase revenues, and elevate the status of internal leaders and teams

Let’s discuss opportunities to improve the financial and clinical performance of your pharmacy.

PT, OT, ST Rehabilitation

contactus@cpspharm.com • 800.968.6962 • www.cpspharm.com

2 0WAY S TO I M P R O V E PAT I E N T C A R E & P H A R M A C Y C O S T C O N TA I N M E N T

CPS CPS partnerships empower hospitals and health systems to advance the standard of care by elevating the performance capabilities of their pharmacy leaders and teams.

President & CEO: Frank Segrave Founded: 1971

Employees: 2,500 Toll-Free Phone:

(800) 968-6962 Address: 655 Metro Place S., Suite 450 Dublin, OH 43017 Website: cpspharm.com

Company Background

Founded more than 50 years ago, CPS Solutions, LLC (CPS) forms partnerships with healthcare leaders and their teams to achieve excellence by elevating their clinical, operational, financial, and regulatory performance standards. CPS helps healthcare leaders and decisionmakers tackle complex problems through a tailored suite of solutions.

With services that are both robust and scalable, CPS partner hospitals leverage expertise and proprietary technologies to drive performance and address their unique coverage gaps. More than 2,500 CPS healthcare professionals serve over 800 partner locations through leadership in inpatient pharmacy management and consulting, specialty and ambulatory pharmacy, 340B, telepharmacy, supply chain and materials management, and PT/OT/ST rehabilitation.

Product Overview

CPS helps hospitals and health systems identify and fill critical performance gaps, improve performance, and mitigate risk — all while serving hospital leadership in achieving their strategic vision for producing the best possible experience for patients and staff. CPS partnerships focus on delivering value-added solutions that assist providers in achieving a best-in-class culture while fostering indispensable, long-term relationships.

Product Lines

n CPS Pharmacy Management and Consulting Solutions: CPS Pharmacy Management and Consulting Solutions provide robust support for hospital leaders seeking to transform their pharmacies into centers of excellence. With deep resources, proprietary technologies, and decades of experience, CPS resource solutions are supported by subject matter experts who generate transformational improvement and yield measurable ROI. Each partnership brings tailored services to meet the unique needs of each site while prioritizing their top initiatives, such as cost savings, regulatory compliance, waste mitigation, and antimicrobial stewardship. CPS emphasizes collaboration to position healthcare leaders to realize their vision of success. n CPS TELEpharmacy: Delivers seamless 24 hours a day, seven days a week, 365 days a year remote licensed pharmacy support to provide local pharmacy teams with additional supportive operational

bandwidth. Remote order entry and verification provides support via HIPAA-compliant connections to help with processing, entry, and verification of incoming orders. Readmission-focused transitions of care supports existing admission, discharge, and follow-up care routines.

Telepharmacy solutions have been proven to reduce readmissions, lower costs, and improve clinical outcomes. CPS’ telepharmacy solution serves organizations nationwide by enabling their in-house pharmacy teams to meet various challenges, including staffing shortages, patient surges, and cost reductions. n CPS 340B Solutions: A leader in 340B program compliance since inception in 1992, the CPS 340B Solutions team partners with covered entities to help them optimize their programs. CPS supports covered entities in achieving compliance while maintaining audit preparedness.

CPS 340B Optimization guides covered entities as they strive to make the most of their program via improved referral capture, program expansion, identification of purchasing opportunities, and more. n CPS Rehabilitation Services: Brings a patient-focused, datadriven approach for departments seeking to improve performance and outcomes. With an emphasis on compliance and operational efficiency, the CPS Rehabilitation Services team delivers excellence while exceeding expectations to delivering operational excellence through physical, occupational, speech rehabilitation, and management services. n CPS Supply Chain Solutions: Guides materials management in helping facilities achieve new levels of quality and performance through a range of value-added services. CPS leverages proprietary software to maintain visibility to performance via real-time cost savings monitoring, department goal tracking, KPI benchmarking, and vigilance to upcoming contract renewals. CPS positions materials management teams for success through collaboration with supply chain partners to mitigate shortages and other critical issues. n Azina: A division of CPS, Azina helps hospitals and health systems transform their specialty and ambulatory care at the local level while driving revenue and improving patient outcomes. With the TherigySMT software solution, Azina is well-positioned as a leader in the specialty and ambulatory industry. Through Azina, CPS offers clients solutions that cover the entire continuum of care, revolutionizing specialty and ambulatory pharmacy solutions by driving substantially lower costs, new sources of revenue, better patient outcomes, and healthier patients.

Contact CPS

CPS empowers healthcare organizations through beneficial partnerships that help leaders propel their sites forward. CPS supports hospitals to achieve operational excellence, drive clinical quality, attain continuous regulatory compliance, and improve bottom-line performance — all while supporting staff, caregivers, and patients. For more information, visit cpspharm.com.

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CAS E S TU DY ZERO PROBLEMS; ZERO COMPLAINTS Northwell Health Relies on Modular Devices Inc. BACKGROUND AND INTENDED OUTCOME Northwell Health is New York state’s largest healthcare provider. It compasses 23 hospitals, 74,000 employees, and more than 700 outpatient facilities. The vast integrative healthcare network continually expands and upgrades facilities to improve the health of the patients and communities it serves.

Alfonso Traina Vice President of Cleanrooms ~ Modular Devices Inc.

In the fall of 2019, Northwell leadership assigned specific areas for upgrading, including the compound pharmacy in their Staten Island hospital. Great care and concentration had to go into the decision because of the protections needed for the life-saving work performed in this lab.

This location serves cancer patients who need individualized chemotherapy. Disruption for these patients and the more than 1,000 daily hazardous and traditional intravenous (I.V. medications) produced in this lab was not an option during construction.

Leadership landed on bringing in a vendor with a trailer that could convert into a lab. However, this trailer-chemotherapy lab had to come with an immaculate level of cleanliness. The mobile cleanroom had to provide incontestable evidence that it would be particulate-free and sterile to compound hazardous and non-hazardous pharmaceuticals and provide ample protection for staff and patients.

Otto VonEilbergh Director, Capital Projects, Corporate Facilities Services ~ Northwell Health

Equally as necessary, the self-contained unit had to ensure continuity of care. Tight timelines and stringent compliance were priorities. And a vendor had to assure seamless operations among logistical, productions, and entry requirements.

This case study analyzes the hospital leadership’s decision to contract with a vendor to lease a cleanroom. It examines the criteria applied to choose a vendor and how the vendor addressed the challenges, complexity, and requirements of installing and servicing a modular relocatable compound pharmacy.

THE CHALLENGE Construction is disruption, which is an anathema for a hospital. Leadership at Northwell Health wanted a short lead time to open a modular lab, while upgrading facilities. Beyond all the regulatory requirements that they must meet, the facilities staff wanted an environmentally friendly lab that minimizes a carbon footprint.

Otto VonEilbergh, director, capital projects, corporate facilities services, Northwell Health, now knows first-hand all the intricate details of moving a unit that is 14 feet wide and 60 feet long and

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CAS E S TU DY converting it into a high-tech, high-touch critical resource for a hospital. VonEilbergh managed the cleanroom installation, vendor details, and lab requirements.

1

“Getting a mobile unit through the streets and over the bridges in New York is a monumental undertaking. Various government entities require numerous permits and transport licensing,” said VonEilbergh.

2

The facilities team required a leveled foundation that would hold more than a 60 thousand pound trailer. It needed sterile materials and an uninterruptible power and water supply. They also had a lengthy list of to-dos to prepare for the State Board of Pharmacy to commission the mobile lab for compounding pharmaceuticals. The team continually balanced the need for speed with a systematic, measured approach to safeguards.

3

Northwell could not perform all of the requirements mentioned above without a vendor. Moreover, they were installing the lab in the middle of an unprecedented pandemic.

4 5

“For much of 2020, New York was at the epicenter of COVID-19. Everything went toward increasing patient capacity and acquiring equipment while still installing a lab,” said VonEilbergh. “To say we had challenges would be an understatement.”

6

THE DECISION TO CONTRACT WITH MODULAR DEVICES INC.

7

The vendor requirements were numerous, which shortlisted the manufacturers. Northwell searched for a proven record in design, build, and certification of turnkey cleanroom installations. Vendors had to demonstrate how they could deliver a secure environment, uphold USP regulations, and maintain the production of compound pharmaceuticals with a written guarantee.

8 1. Mechanical Room 2. Positive Pressure Sterile Non-Hazardous Compounding Room with (2) 4' Laminar Flow Hoods 3. Non-Hazardous Gowning Room with Eyewash 4. Main Workroom, Non-Classified Space, with Refrigerator and Interlocking Passthrough to Sterile Compounding Room 5. Hazardous Gowning Room with Eyewash Sink 6. Hazardous Unpack/Storage Room with Refrigerator and Pass-through to HZ Compounding Room 7. Negative Pressure Hazardous Compounding Room with (2) 4' BSC's 8. Redundant HZ exhaust

The clear choice became Modular Devices Inc. because of their vast experience in mobile labs, their array of services, and a complete understanding of the constraints and their plan on addressing them.

“The rental fees were reasonable for our marketplace,” said VonEilbergh. “Their statement of work met our requirements for this high-revenue department.”

Specifically, the chief pharmacy officer at Northwell Health applied the following criteria that solidified the contract with Modular Devices Inc.

PROVIDE A SUPERIOR PRODUCT Northwell Health’s mobile pharmacy was highly engineered and met all codes. It provided real-time data logging and an alarm for out-of-range temperatures, humidity, and pressures.

Pollutants such as dust, airborne microbes, aerosol particles, and chemical vapors could not survive in this environment.

“Our modular units are pre-built at our factory and delivered as ready-to-use, negative pressure containment, and isolation rooms,” said Alfonso Traina, vice president of cleanrooms, Modular Devices Inc. “The materials stand up to anything — marine-grade components, fiberglass, stainless steel. All the components can be boiled but not melted.”

“This cleanroom worked for us in every way. Modular Devices Inc. exceeded our expectations — from the interlocking system that provided additional safety measures to providing the latest digital equipment,” said VonEilbergh. “They seamlessly installed a sterile compounding pharmaceutical lab tailored to our unique needs. They met all the numerous New York regulations, including maneuvering a 60-foot trailer over the Verrazzano-Narrows Bridge."

www.portable-cleanroom.com

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CAS E S TU DY DESIGN WITH THE CUSTOMER IN MIND The pharmacy and facilities staff at Northwell Health noticed how the mobile unit on the concrete slab appeared nondescript. Upon initial inspection, they expected a 1980s infrastructure, but ended up walking through a sophisticated lab that looked like mission control at NASA. The well-laid-out design offered ergonomic functionality that delighted the pharmacy technicians.

“

This cleanroom worked for us in every way. Modular Devices Inc. exceeded our expectations — from the interlocking system that provided additional safety measures to providing the latest digital equipment. They seamlessly installed a sterile compounding pharmaceutical lab tailored to our unique needs.

They met all the numerous New York regulations, including maneuvering a 60-foot trailer over the VerrazzanoNarrows Bridge.”

Otto VonEilbergh Director, Capital Projects, Corporate Facilities Services ~ Northwell Health

“The bright white stainless covered every corner, exuding security and spotlessness,” said VonEilbergh. “The engineering team at Modular Devices Inc. also included smaller details that made big differences, such as the perfect placement for storage racks and digital displays.”

The engineers at Modular Devices Inc. applied its design-build method, which minimizes risk and expedites the project timeline by overlapping the design and construction phases.

DELIVER A FULL-SERVICE COMPOUND PHARMACY “Modular Devices Inc. delivered on day one with turnkey capabilities. The only thing we had to do was turn on the water and connect the network and phones,” said VonEilbergh. “They provided an engineering timeline and coordinated with us four months ahead. Then, they delivered as promised.”

Modular Devices Inc. offerings didn’t stop with the fully functioning lab. They also oversaw all maintenance and certification programs. With their partner firms, pharmacy staff has access to ongoing training and emergency service.

“With over 1,000 designs in our portfolio, our team at Modular Devices Inc. understood the production needs of compounding hazardous chemotherapy as well as the non-hazardous vitamin therapies,” said Traina. “We were committed to alleviating any burden for the patient and staff.”

ENSURE COMPLIANCE AND SAFETY One of the most highly regarded areas of expertise for Modular Devices Inc. is ensuring compliance and certification with USP 797, the anticipated USP 800, and cGMP. Before departing for New York, the cleanroom underwent a thorough quality control regimen and pre-certification. And upon completion of installation, Traina and the team prepared Northwell Health for inspection.

The mobile cleanroom met all regulations and codes, and the New York State Board of Pharmacy commissioned the lab. The commitment from Modular Devices Inc. didn’t stop after inspection.

The team remotely monitors the lab from their headquarters in Columbus, Ohio. From downing to chemotherapy production, Modular Devices Inc. looked at all angles to ensure excellent safety protocols.

“I was impressed with the airlocks and humidity control infrastructure. And I was pleased when I received a call from Alfonso saying check your pressures. Alfonso knew before we knew to review a setting,” said VonEilbergh. “They also supplied each room with a hands-free interlocking door with red and green light indicators to ensure the integrity of differential pressures.”

MAINTAIN FLEXIBILITY AND DEADLINES Modular Devices Inc. are the only mobile cleanroom provider that offers standard and customized mobile cleanrooms equally suited as either short or long-term rentals or a purchased unit.

The Staten Island location went with a lease agreement.

“Whether there is a need for a short-term solution to bridge the gap during an equipment change-out or upgrades, we’ll deliver a turnkey solution quickly,” said Traina.

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CAS E S TU DY The mobile cleanrooms came with 40% more space than other cleanrooms on wheels, providing more functional flexibility for personnel and workflow. Modular Devices Inc. can build their product in a fraction of the time as they control the entire production at their facility, eliminating delays caused by local permit approvals or subcontractor scheduling.

“Modular Devices Inc. met all deadlines and sped up the timeline,” stressed VonEilbergh. “And all of this was done during COVID-19. They just stepped up and worked through it, just like we did at the hospital.”

THE RESULTS The can-do team at Modular Devices Inc. provided exact specifications for the interim mobile compounding pharmacy, and then delivered on every one of them. Northwell Health even incorporated many of the design elements into their system, such as putting your hand up to the light beam to enter an area, having a highly controlled pass-through for pharmaceutical carts, and implementing motorized doors rather than a hinged door.

Upon delivery, the New York Board of Pharmacy conducted an inspection and approved the unit to compound both hazardous and traditional I.V. solutions for patients.

Northwell Health received a one-stop vendor for everything and beyond for a cleanroom.

The products, services, and maintenance for the compounding pharmacy never faltered during the most tumultuous time for the hospital.

Although the hospital’s upgraded areas are complete, the mobile unit is still in use today because leadership extended the lease. Modular Devices Inc. are actively monitoring the unit and providing support to the pharmacy technicians.

CONCLUSION In a highly-regulated, highly-scrutinized industry during COVID-19, Modular Devices Inc. instilled trust, complied with all regulations, and exceeded expectations.

Modular Devices Inc. invested in up-front, customer-focused initiatives, such as certification and enhanced capabilities, which serve the full-spectrum needs of compounding pharmacies today and in the future.

“This was a hospital dealing with an overwhelming crisis. Their focus had to be on the patient, so our team did everything we could to lessen any burden and make sure the pharmacy department had everything they needed,” said Traina.

“Alfonso and team were the bridge that allowed us no loss of volume and productivity,” said VonEilbergh. “More than anything, we maintained continuity of care.”

www.portable-cleanroom.com

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© 2021 International Medical Industries, Inc. All rights reserved.

Companies and products mentioned herein may be trademarks or registered trademarks of their respective trademark owners.

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HALO Closed System DrugTransfer Device A true closed system.

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1. Health and Human Services, Federal Drug Administration, 510(k) Clearance Letter, July 24, 2015.

2. Bartel SB, Tyler TG, Power LA, Multicenter evaluation of a new closed system drug-transfer device in reducing surface contamination by antineoplastic hazardous drugs, Am J Health-Syst Pharm. 2018; 75:199-211.

3. NIOSH Alert: Preventing occupational exposure to antineoplastic and other hazardous drugs in health care settings. http://www.cdc.gov/niosh/docs/2004-165/ Publication No. 2004-165. Washington DC: NIOSH; 2004.

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