20Ways WINTER Hospital 2019

I M P R O V I N G PATIENT CARE &

PHARMACY COST C O N TA I N M E N T Winter 2019

Health System

•

Infusion

20 Unique Products & Services

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

503B Outsourced Compounding Facilities & Services Industry Expert Q&A, Market Leaders Buyer’s Guide, and More

8 Thought Leaders page 48

Sentry Data Systems, Comprehensive Pharmacy Services, Verity Solutions, ACHC, and More

7 Case Studies page 34

NuAire, Parata, Charles River, Visante, and Retail Management Solutions

Come Visit Us At ASHP Booth #1413

Leading Compounding Innovation in 503B Outsourcing

THE PERFECT BLEND OF QUALITY AND INNOVATION

QuVa Pharma is a leader in 503B outsourcing services, covering all 50 states, and is the comprehensive resource for your sterile outsourcing needs.

Your Partner of Choice Led by a team with deep expertise in cGMP and sterile pharmaceutical manufacturing, we work proactively every day to look out ahead for our customers and achieve higher standards than are required so that through our highest quality products, hospitals can more confidently focus on administering clinical care and efficiently running their operation.

Our cGMP processes and exemplary FDA compliance record are second-to none in the industry, and we are proud to be recognized as the partner of choice for the nation’s leading health systems.

Become a QuVa Pharma Partner To Get Started, You Can Set Up a Profile at www.quvapharma.com/customerprofile Corporate Headquarters: QuVa Pharma, Inc. 3 Sugar Creek Center Blvd Suite 250 Sugar Land, TX 77478

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CLEANMAX APPAREL FOR EVERY COMPOUNDING APPLICATION TM

Ensure the quality of your formulations by reducing the risk of contamination with CleanMaxTM, which provides 99.999% bacterial and particulate filtration efficiency, fluid resistance material, bound seams to protect from breakthrough and strikethrough, and individually wrapped packages for cleaner handling.

Lakeland CleanMaxTM garments provide the comfort, quality, and protection you expect, including: • IEST Category I Particle Cleanliness • Open Fold for Easier Donning • Sterility Assurance Level of 10-6 • USP795 and USP797 Compliance • ASTM6978 tested and approved for USP800 applications when worn in conjunction with an approved chemo-gown

Apparel Type

USP <795> — Non-Sterile

USP <797> — Sterile

USP <800> — Hazardous Drugs

Hair Cover (Bouffant)

R

R

R

Barrier Gloves (powder free)

R

R

R

Beard Cover

AS

NR

NR

Facemask

AS

R

AS

Hood*

NR

R

R

Respirator N95- N100

NR

AS

R

Full Face Shield

AS

AS

R

Frock*

R

NR

NR

Coverall*

AS

R

R

Shoe Cover*

R

R

R

Boot*

NR

R

R

Sleeves*

AS

R

R

Daily

Each Entry

Each Entry

Recommended Frequency of Change

R = Recommended NR = Not Recommended AS = Application Specific *Disposable, liquid repellant cleanroom barrier garments are recommended.

Protect Your People, Product, & Cleanroom with Lakeland CleanMax

TM

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See CleanMax garments at ASHP Midyear 2019 Clinical Meeting, Booth #461.

Contents WAY

Connecting the Medication Supply Chain Through Integrated Transport and Pharmacy Automation Solutions We live in a connected world.

But inside the walls of a hospital, connections can break down, leading to delays in care. At Swisslog Healthcare, our logistics-driven approach integrates automated transport and pharmacy solutions to connect the medication supply chain.

So you can connect with the people that matter most—your patients.

Connect with us at the ASHP Midyear Clinical Meeting Las Vegas, Nevada, December 8-12

Visit swisslog.com/ASHP2019 to get a sneak peek of what we’ll be revealing at this year’s conference.

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

Optimize pharmacy workflows with the fully automated modular storage and retrieval system.

WAY

IntelliVault, IntelliVault MTB, IntelliCab, and IntelliStock by GSL Solutions, Inc.

Safety, Accountability, Efficiency and Compliance See what others have already discovered WITH AUTOLOG™ B Y

G S L

S O L U T I O N S

CONTROLLED DRUG STORAGE, PRESCRIPTION FILLING, AND RETRIEVAL SYSTEM • Eliminates shrink and drug loss by replacing today’s “open face / open access” controlled drug storage cabinets • Replaces today’s error-prone and manual perpetual log book • Logs ALL transactions and user activities automatically • Replaces pharmacist labor with technician labor for C2 filling • Maintains complete chain of custody and pedigree from stock receiving to prescription filling and patient pick up

BEFORE

AFTER

• Payback from labor savings in as little as 1 year

™

B Y

G S L

MEDS-TO-BED

S O L U T I O N S

NEW SYSTEM TO SUPPORT STREAMLINED DISPENSING OF PRESCRIPTION MEDICATIONS AT PATIENT’S BEDSIDE • Physical chain of custody is maintained from filling of prescription through receipt by the patient

The full suite of GSL Solutions, Inc.’s products are integrated in a single software, IntelliSys™, which uses Radio Frequency Identification (RFID) to physically track medications.

• Easy integration to RN notification system and dashboard when prescription is ready • Signature Capture stores the patient’s signature confirming receipt of medications from their bedside • Real-time inventory of cabinet contents • Secure storage of patient’s home medications • Patient monographs printed on demand

STANDS ALONE OR INTERGRATES WITH INTELLICAB

THE LEADER IN WILL-CALL STORAGE

• Secure storage for will-call • Proven ROI based on labor cost savings • Improves customer service through a decrease in wait time • Sends the patient a text message when RXs are ready with AutoNotify

BEFORE

AFTER

• Integrates with Central fill • Maintains drug pedigree, lot, and expiration date when integrated with IntelliVault

See our full suite of products online Contact us: www.gslcorp.com |360.896.5354

swisslog.com/ASHP2019

page 29

WAY We’re turning 340B teams into A-teams.

As the industry’s most trusted third-party administrator for the 340B drug discount program, we can help optimize drug cost savings and meet HRSA compliance requirements for hospitals, clinics and pharmacies.

© 2019 Verity Solutions Group, Inc.

FOR 340B HOSPITALS AND HEALTH CENTERS Split Billing | Contract Pharmacy | VHUBTM for Contract Pharmacies | Compliance Manager | Purchase Analytics

Your true partner for 340B program administration and compliance

We’re changing the game in third-party administration for 340B, with unmatched product innovation, ease of use, data transparency and support to help your team maintain compliance. We’re the only 340B solution to score an “A” in the 2018 and 2019 Best in KLAS Report for 340B Management Systems, earning the title of Category Leader for two years running.

page 33

Verity Solutions – Your True Partner for 340B Program Administration and Compliance

Dedicated to providing agile and proactive solutions to those who serve the most vulnerable in our communities.

Thought Leader Video Series

page 31

page 34-35

If you’re looking to collaborate with a vendor that can help you build a winning 340B program and contribute to your organization’s bottom line, contact us to speak with a 340B program advisor and learn how to get started.

www.verity340b.com | 1.800.581.1378 | info@verity340B.com

WINTER 2019

I

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

3

THE SAFER CHOICE FOR YOUR PHARMACY

B I O S A F E T Y C A B I N E T S . H O R I Z O N TA L A N D V E R T I C A L L A M I N A R A I R F L O W W O R K S TAT I O N S .

C O N TA I N M E N T V E N T I L AT E D E N C L O S U R E S . C O M P O U N D I N G I S O L AT O R S . C U S T O M S O L U T I O N S .

Primary Engineering Controls by NuAire.

www.nuaire.com © Copyright 2019. NuAire, All Rights Reserved.

NOW YOU HAVE A CHOICE!

0.5 mL each

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SPRAy KIt – MUltIPlE USE 20% Benzocaine Oral Anesthetic • • • • • •

Eliminates pain and discomfort Fast onset (within 30 seconds) Short duration (15 minutes) Safe – available over the counter Best value among topical anesthetic sprays Great Wild Cherry flavor!

• 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 • Recyclable

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ORDERING INFORMATION NDC#

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ORDERING INFORMATION PRODUCt

0283-0610-11

10090081

CIN 4362547

1410125

086611

HurriCaine ONE® Unit Dose Non-Aerosol Spray Box of 2, 0.017 fl. oz. (0.5 mL) each

0283-0610-26

10090082

CIN 4363370

1411925

086629

HurriCaine ONE Unit Dose Non-Aerosol Spray Box of 25, 0.017 fl. oz. (0.5 mL) each

Spray – 2 oz. spray can and 1 disposable extension tube ............................................NDC 0283-0679-02 Spray Kit – 2 oz. spray can and 200 disposable extension tubes ...............................NDC 0283-0679-60 Extension tubes – Box of 200 disposable extension tubes ..................Product number 0283-1185-20

If HurriCaine ONE is not yet available through your wholesaler, request it by name and NDC Number. *Joint Commission Standard: MM.05.01.11, EP4

LLC

Extension tubes

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Contents WAY

GX Cold Storage Solutions Offer Energy Efficient Performance – Helmer Scientific

Professional Medical-grade Refrigerators

Efficient and effective.

GX Solutions from Helmer Scientific Featuring OptiCool™ Technology

GX Cold Storage Solutions Offer Energy Efficient Performance OptiCool™ technology pairs a variable capacity compressor (VCC) and natural refrigerants to efficiently manage energy consumption x 50% reduction in energy usage compared to conventional technology x ENERGY STAR® certified x Reduces operating costs and supports sustainability initiatives

En e rg y s a vi n g s Qu i e t Ope ra ti o n Su ppo rts s u s ta i n a bi l i ty i n i ti a ti ve s

L e a r n more : in fo.h e lme r in c .c om/ h e lme r / gxs olu tion s

OptiCool™ and Helmer are registered trademarks of Helmer Scientific. © 2019 Helmer Inc. All rights reserved.

20Ways-Ad-2019-Winter.indd 1

10/2/2019 10:56:26 AM

Case Study: Star-Link Enterprise Helps Pharmacies to Streamline Operations and Centralize Management of Multiple Pharmacy Locations

Case Study

Star-Link Enterprise from Retail Management Solutions helps pharmacies to streamline operations and centralize management of multiple pharmacy locations.

Health Partners operates clinic/

Primary Intended Outcome

apothecary type pharmacies with

Pharmacies with multiple locations face unique challenges in ensuring that each site maintains and updates their product files, implements price changes and promotions, and remains consistent across the brand. Furthermore, taking in and making sense of data from multiple sites is both labor intensive and time consuming.

relatively small front ends.

Optimized temperature performance reduces energy consumption by 50-65% supporting environmental sustainability and a lower cost of ownership over the refrigerator’s lifetime.

For more than half a century,

The Star-Link Enterprise edition offers companies with multiple sites the ability to centralize the management of product files, promotions, and accounts receivable.

In addition, Star-Link communicates with Star-Lite or Star-Plus POS systems for real-time communication from and between sites to the head office to give up-to the minute inventory, sales, and transaction data. Star-Link utilizes Microsoft SQL Server Reporting Services and SQL Server Analysis Services so this data can be viewed dynamically for some or all locations by deploying built-in reports or custom-built report options.

HealthPartners has been setting the standard for its high-quality health plans, hospitals, medical & dental clinics and pharmacies.

HealthPartners offers retail

The Challenge

pharmacy services in numerous

HealthPartners operates Clinic/Apothecary type pharmacies with relatively small front ends. For more than half a century, HealthPartners has been setting the standard for its high-quality Health Plans, Hospitals, Medical and Dental Clinics, and Pharmacies. At the initial implementation of Star-Link, HealthPartners offered Retail Pharmacy services in 15 medical clinics and one refill pickup site at their headquarters in Bloomington, Minnesota. All their stores have a variety of OTC products and specialty OTC products as well as candy, snacks, beverages, and greeting cards.

clinics and one refill pickup site at its headquarters in Bloomington, Minnesota.

All of its stores have a variety of OTC products and specialty OTC

beverages, and greeting cards.

With pharmacies spread throughout the city, managing the product file for even small front ends was difficult and time consuming. Each site had a pharmacy manager whose focus and training revolves around the prescription side of the business with limited interest or concern for the front end. Due to the size, no site had a front-end manager as is typically seen in pharmacies with a large front-end.

Toll free: 1.877.767.1060

As a result of this problem, price update files emailed to the stores from the head office were often not processed in a timely manner and, at some locations, not at all. Consequently, some sites experienced increased cost of goods without increasing their retail prices, resulting in reduced profit. Ensuring compliance was virtually impossible. Additionally, as time went on, product file discrepancies

products, as well as candy, snacks,

Email: sales@rm-solutions.com Web: www.rm-solutions.com

From Retail Management Solutions

page 37

WAY

An established pharmacy automation leader, Parata’s adherence packaging, vial-filling, and

888.PARATA1

workflow solutions reduce costs and medication errors and improve medication adherence.

parata.com

pharmacy teams, and patients in mind at parata.com.

Workflow & Inventory Management

Vial-Filling Robots

Pharmaceutical Inventory Management Services by Capital Inventory Pharmaceutical Inventory Experts:

Explore the technology, expertise, and people you can count on.

Explore our full portfolio of pharmacy workflow solutions designed with your business,

I N F O R M AT I O N F O R I N T E L L I G E N T P H A R M A C Y M A N A G E M E N T

WAY

Parata – Solutions to Reduce Costs, Improve Medication Adherence, and Enhance Patient Experience

Powering hospital pharmacies to help people lead healthier lives.

Adherence Packaging & Inspection

page 40-43

Cover (Vert).indd 1

Precise, Efficient, and Confident

9/27/06 3:00:09 PM

Why Outsource Your Inventory Needs?

• • • • • • • •

Secure Pick-Up Kiosks

Teams of experts conduct the inventory within a few hours.

Teams conduct inventories daily-not annually.

Minimal interruption to the pharmacy staff and operation.

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

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

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

Competent inventory specialist that can work with finance and/or external audit firm to validate the inventory.

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

The nation’s leader in pharmaceutical inventory service providing inventory data that is accurate and dependable.

To learn more about Capital Inventory and how we can help you with our inventory services please contact 1-800-345-0849 or Info@capitalinventory.com.

2020AdCampaignIdeas.indd 1

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page 39

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 45

QUARTERLY ISSUES Winter 2019 / 2020

Fall 2019

VING I M P R OI M P R O V I N G PAT I E NPTA TCIAE R E NT CARE & & PHARMACY P H ABRI LMI ATC YY C O S T TA I PROF Winter 2020

C O N TA I N M E • LTC Community • Specialty

Winter 2019

Health System

•

NT

Fall 2019

and services your pharmacy

Issue Focus: Retail, Specialty, & LTC

Issue Frequency: Spring, Fall, & Winter

Circulation Per Issue: 28,500+ 18,000+ Owners (Independents) 1,500+ Long-Term Care Pharmacies 2,500+ Retail Chain Executives 2,500+ Industry Executives 2,000+ Trade Show Handouts

C O N TA I N M E N T Summer 2019

Health System

•

Infusion

20 Unique Products & Services

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

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

Pharmacy Return Solutions & Resources

340B Resources & Software Industry Expert Q&A, Market Leaders Buyer’s Guide, and More page 38

8 Thought Leader Videos

8 Thought Leaders

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

PHARMACY COST

Community • Specialty • LTC

page 50

8

2019 CIRCULATION

&

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

Medicine Shoppe International, Buyer’s Guide, and More Eight Video Series Including Pharmacy Consulting Broker Services page 48 page 22 Sentry Data Systems, and

8 Thought Leaders

Eight Video Series Including Medicine Shoppe International, Parata, Sentry Data Systems, and Pharmacy Consulting Broker Services

2 Case Studies 7 Case Studies

Eight Video Series Including Visante, Verity Solutions, Rees Scientific, Acentrus Specialty, and More

page 22

Pharmacy Services, ACHC, and More

Verity Solutions, QS/1 and Dexcom

PATIENT CARE

20 Unique Products & Services

improve patient & Resources care or contain costs.

Solutions Pharmacy Return and More Leaders Buyer’s Guide, page 50 Industry Expert Q&A, Market503B Outsourced Compounding Facilities & Services Videos Industry Expert Q&A, Market Leaders Thought Leader Parata, Sentry Data Systems, Comprehensive

I M P R O V I N G

IMPROVING PAT I E N T C A R E & PHARMACY P R O F I TA B I L I T Y Spring 2019

Community • Specialty • LTC

Infusion

20 Unique ucts Unique Prod20 Products & Services services Discover 20 products &andServ improve ices pharmacy that will help yourDiscover y. profitabilit 20 products increase patient care or that will help

Spring 2019

Summer 2019

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

page 22

4 Case Studies

2 Case Studies

page 34

Liberty Software, GSL Solutions, Charles River, and Comprehensive Pharmacy Services

QS/1 and Dexcom

NuAire, Parata, Charles River, Visante and Retail Management Solutions

Health System • Infusion & Community • Specialty • LTC

Community • Specialty • LTC

Health System • Infusion

20 Unique Products & Services

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

Will Call Technology Industry Expert Q&A, Market Leaders Buyer’s Guide, and More page 42

8 Thought Leaders

Eight Video Series Including Visante, Rees Scientific, Pharmacy Consulting Broker Services, Rite Aid, and More

page 26

2 Case Studies

Liberty Software and Medicine Shoppe International

Community • Specialty • LTC

Visit 20Ways ONLINE at RXinsider.com/20Ways

WINTER 2019

I

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

7

Praxi Fill ™

Automated syringe ller

Syringe lling made easy!

PraxiFill™ is an automated syringe ller

Filling speed is up to 8 syringes/minute depending on syringe size.

Small footprint

intended to increase productivity of the syringe lling process by eliminating the tedious manual task of aspirating solution into the syringe and capping the lled syringe.

PraxiFill™ is designed to be used with MedXL pre-capped sterile syringes for increased efficiency and productivity.

Increase productivity

5cc,

10cc,

20cc

and

50cc

syringes

are available.

Easy to control with touch screen pad

Fast, accurate, repeatable lling and capping.

MIX - FILL - LABEL - USE

Praxi Label™

Semi-automated syringe labeller

Syringe labelling made easy!

PraxiLabel™ is a semi-automatic tabletop syringe labeler intended to increase labeling productivity as it

Small footprint

eliminates the work related injuries due to frequent hand and wrist

The labels are pre-graduated and may be printed on any heat transfer label printer.

movements involved in the syringe labeling operation.

Simple and fast change over between different sizes www.praximedsystem.com

EXPERIENCE Multiple HRSA findings challenge 340B Covered Entity to overhaul program operations.

CHALLENGE/GOALS A Covered Entity approached Visante for guidance after receiving numerous findings through a HRSA audit.

Visanteâ&#x20AC;&#x2122;s 340B team helped the CE to make significant changes to all aspects program operations, including intensive work with multiple split-billing systems.

45%

Of All Claims That Were Qualifying As 340B Eligible Were In Error

PROCESS The responsibility to manage compliance related to inventory, purchasing, and dispensation (replenishment) is complicated, and becomes increasingly complex with an increased number of split-billing vendors. In this case, the CE worked through five disparate split-billing platforms (one for mixed-use, four for retail owned and contract pharmacy relationships). Adding further difficulty, the CE did not have sufficient resources to manage any of these platforms and conduct internal audits or routine system configurations and maintenance. In order to untangle the web of multiple split-billing vendors, many with crossover within the contract pharmacy space, it was necessary to migrate to a new split-billing vendor that could provide support across BOTH mixed-use and retail owned/ contract pharmacy. This process allowed a foundation of new operational processes to support compliance and revised Policies and Procedures to govern all aspects of compliance related to the 340B Program. Billing, reimbursement, and management of Medicaid (both in state and out of state, along with Fee-For-Service and Managed Medicaid) were a focus, and the Visante team was successful in overhauling the processes that had 340B implications.

5%

Of Claims Fall Out As Ineligible

RESULTS After forming a 340B Compliance Committee of Covered Entity stakeholders, forward movement took place over the course of twelve months. This overhaul focused on the foundation of the 340B Program, and all aspects of supply chain/purchasing, billing, reimbursement, contract review and support (contract pharmacy), and split-billing maintenance and oversight. Compliance oversight was structured around the Corrective Action Plan provided to HRSA, and allowed the Covered Entity to forecast resources and tools necessary to maintain full compliance.

www.visanteinc.com

Contents WAY 503B OUTSOURCED COMPOUNDING FACILITIES & SERVICES

Providing the HighestQuality Sterile Compounded Services – PharMEDium

Discover how PharMEDium Prefilled Syringes help you achieve your goals.

Batch-level Release Testing is Performed on 100% of PharMEDium Compounded Sterile Preparations (CSPs).

Prefilled syringes offer benefits you cannot afford to ignore1

No other compounder serves pharmacists, clinicians, and patients like PharMEDium–with a certainty you only get from the leader in outsourced CSPs.

• Enhanced Safety • Optimal Productivity • Increased Satisfaction • Better Compliance • Less Waste • Best Use of Resources

pharmedium.com | 800.523.7749 1

P20639

References available on PharMEDium website at: https://www.pharmedium.com/compounded-services/operating-room-anesthesia/

Case Studies: Visante – Proven Success in Advancing Pharmacy

EXPERIENCE 340B Covered Entity Overcomes Challenges of Disparate Split-Billing Systems

EXPERIENCE

$6M

CHALLENGE/GOALS

3%

Several years had gone by without appropriate oversight for this Covered Entity with a large contract pharmacy network. Visante’s

cy ed specialty pharma Internal, integrat margin s net operating strategy improve Additional Resources and quality of care.

To Be Successful

EXPERIENCE

Our focus on continuous improvement in compounding processes and our testing program help assures every Compounded Sterile Preparation (CSP) we create is the highestquality product with optimum expiration dating.

340B Covered Entity Multiple HRSA findings challenge overhaul program operations.

audit uncovered that nearly a third of the registered contract Net Operating Annualpharmacy locations did not have active dispensations, and Increase Margin several of the contract pharmacies had effective dates on the

45%

OPA website in advance of the contract being signed.

to

OALS CHALLENGE/G y pharmacy Join multiple specialt to improve care ALS NGE/GO together ciesCHALLE

pharma after approached Visante for guidance and costs. A Covered Entity through a HRSA audit. receiving numerous findings the CE to make significant Visante’s 340B team helped operations, including changes to all aspects program split-billing systems. intensive work with multiple

PROCESS tern academic A major Midwes overcome a PROCES needed to S medical center l specialty

to of externa to manage compliance related responsibility system ed (replenishment) fragmentedThe and dispensation internal, integrat anpurchasing, inventory, increasingly complex with pharmaciesiswith and becomes . Visante complicated, case, cy strategy split-billing vendors. In this ofcy specialty pharma an increasedhnumber pharmafive split-billing platforms disparate a thoroug ed CE worked through conducted the and develop retail owned and contract and mixed-use, four forbuild forreview, (one CE assessment create andAdding further difficulty, the torelationships). plan pharmacy ve of these innovati any an to manage y resources Specialt sufficient t and did not have a Retail/Outpatien ic audits or routine system internal conduct andthe academ platforms the untangle support to to In order and maintenance.

Pharmacy configurations ilia with crossover and Hemoph split-billing vendors, many medical center web of multipleplan included it was necessary to Center. contract pharmacy space, the The Treatmentwithin provide ent, e, equipm split-billing vendor that could to a new softwar migrate ’s owned/ design space, retail and , Visante BOTH mixed-use In addition support , etc.across staff, training andallowed a foundation process billing yThis pharmacy. contract specialt and all d compliance support to processes team manage months of new operational for the first 24 to govern all aspects reimbursement revised Policies and Procedures Billing, . related to the 340B Program. of compliance of the program of Medicaid (both in reimbursement, and management with Fee-For-Service and state and out of state, along focus, and the Visante team Managed Medicaid) were a had

processes that LTS successful in overhauling the RESUwas implications.put in place,

340B’s plan was Once Visantewww.visanteinc.com saw immediate the medical center care, in continuity of improvements Committee of Covered and tion, Compliance a 340B forming satisfac After staff over patient and forward movement took place stakeholders, Entitycare and quality. focused on outcomes ofcourse of twelve months. This overhaul

RESULTS

340B Program contract pharmacy oversight is no less Were That Claims Of All challenging than oversight in the mixed-use (to include clinic and Eligiblepharmacies have As 340B floor stock)Qualifying space. Because many contract dedicated split-billing vendors, a large contract pharmacy In Error Were network often involves multiple split-billing systems which are not designed to interface/integrate. Upon our initial audit, Visante realized that there were numerous contract pharmacy locations that had no dispensing activity over the course of six months, and many that had very low dispensing volume (less than 15 dispenses total over the course of six months, for non-specialty medications). It is important to distinguish that low volumes for generic or brand medications are a different consideration than specialty medications. Additionally, there were several contract pharmacy effective dates on the OPA ed Patient website that did not correspond with the contract signature Increas dates which resulted tion in dispensing occurring prior to the official Satisfac “effective date.” Lastly, there were multiple split-billing vendors in place for contract pharmacy dispenses, and when tested against the contract pharmacy locations with minimal to low volume, it was determined that two of the split-billing platform relationships could be eliminated.

30%

5%

RESULTSOf Claims Fall Out

In just six months, the As Visante team worked with the Covered Ineligible Entity to make major changes to its contract pharmacy operations and develop a strategy that will set them up for long term success. Specifically: Visante successfully supported an update of the OPA database to remove all locations with minimal to no volume over the course of six months. The team removed a number of contract locations after determining that were multiple barriers that would take several more months or longer to overcome. Visante reviewed e-prescribing data and history to determine where prescriptions were going, and created a l Stafffocused around Covered Entity detail Medica contract ed pharmacy strategy Increas that was real and tion meaningful.

Satisfac

the Program, and all aspects of the foundation of the 340B reimbursement, contract supply chain/purchasing, billing, pharmacy), and split-billing review and support (contract Compliance oversight was maintenance and oversight.

Action Plan provided structured around the Corrective Entity to forecast to HRSA, and allowed the Covered to maintain full compliance. resources and tools necessary

page 47

Our personalized approach to each and every client challenge ensures you receive the most effective and efficient solution.

PROCESS

100%

.com

www.visanteinc

pages 9, 60, 85

www.visanteinc.com

WAY

NDIN D COM POU

503B OUTSOURCED COMPOUNDING FACILITIES & SERVICES Buyer’s Guide

SOU RCE 503B OUT

503B OUTSOURCED COMPOUNDING FACILITIES & SERVICES

Q&A

Buyer’s Guide

Hospitals & Health Pentec Health Asteria Health ImprimisRx e Vice President, 7004 Champion BoulevardRPh, FASHP, Senior 12264 El Camino Real Director, Visant 9 Creek Parkway D, FASHP, Senior y Burger, MS, Suite 100 Suite 350 Boothwyn, PA 19061 Gregor omi, Pharm Birmingham, AL 35242 San Diego, CA 92130 (866) 956-4376 es & Fred Masso s Servic System (205) 995-0505 (844) 446-6979 www.pentechealth.com ed approv www.imprimisrx.com of one or more

www.asteriahealth.com

G FACI LITIE

ICES Q & A S & SERV

other lly a copy PharMEDium also, among that are essentia s must Inc. Brookfield Medical King Guide Publications, 150 North Field Drive facilitie rcing FDA; (2) comply drugs. Outsou t type Surgicals of Supply Inc. P.O. Box 10317 Suite register with its 350 arily' (3) open Lake the differen 60 Old New Milfordd Road Napa, CA 94581 Forest, IL 60045 regulations; things: (1) 'volunt Q. What are compounde stringent cGMP (4) report adverse events entities for Suite 1B (800) 523-7749 with FDA’s (888) 546-4484 ions; outsourcing about Brookfield, CT 06804models kingguide.com FDA inspect information www.pharmedium.com operations to different products?

(203) 775-0862 g the FDA with detailed in some instance detailin provide and (5) ing Biotechnology, Inc. QuVa Pharma to FDA; KRS Global www.brookfieldmedical.com relates to patient und; and (6) It is worth reiterat States. 503A 791they Parkcompo of Commerce Boulevard 3 Sugar Creek Center Boulevard ments. the United the products nally seen in require traditio es we have in specific Central Drugs Suite 600 Suite 250 state unding practicOutsourcing 503B covers comply with Boca Raton, FL 33487 the FDA regulates drug Sugar Land, TX 77478 specific compo hospitals, whileFacility size that the clinics, and of 511 S. Harbor Boulevard (888) 502-2050 (888) 339-0874 empha to acies, 503B ant pharm It is importKrsbio.com s 503A and Building F www.quvapharma.com facilities. of under Section compounding the outsourcing & Cosmetic La Habra,Drug CA 90631 compounding all types of ls Food hospita LDTwhich Healthcovers Solutions SCA Pharma happens in 503A of the(562) 352-9630nal pharmacy FD&C Act; in traditio including what Under Section 38 Cedar sPlace 755 Rainbow Road www.centraldrugsrx.com patient acy may engage drugs forWayne, compounding NJ 07470 Suite B Act, a pharm it (1) limits its s and provided that Complete Pharmaceutics and clinics.

(862) 221-9575 Windsor, CT 06095 individual patient compounding ed

identifi unded 5829 NW 158th Street LDTRx.com for compo outsourcing (877) 550-5059 to prescriptions quantities of he current FL 33014 scapharma.com not than limitedMiami Lakes, Q. What is t pe? ptions, (2) does Leiters (877) 714-1701 makes no more g prescri y ring landsca e of receivinCompletepharm.com ate amounts) 13796 Compark BoulevardDrug Quality and Securit STAQ Pharma manufactu drugs in advanc ly or in inordin the 2013 rcing le of 80112 Englewood, 14135 East 42nd Avenue outsou approvalCO (either regular rcially availab Since the of the 503B make drugs of comme Sterile ServicesProducts (800) Unitrable 50 introduction lly copiesFagron a conside the292-6772 ents.

Act and ingredi 8710 E 34th Street N www.leiters.com y, we have seen Denver, CO 80239 that are essentia sible were ary categor (3) uses permis r 2019, there Wichita, KS 67226 Staqpharma.com ed under insanit manufacturers drugs, and or prepar . As of Octobe Medi-Fare Drug r continues strength contaminatedfagronsterile.com t of activity amoun300 s. This numbe SterRxe ®toLLC must not be be the correct facilitie must West Pine Street and ed register the drugs on its promisIdaho Avenue g, advertising, 76 FDA conditions; Hybrid Pharma Blacksburg,FDA SC 29702 labelin has made good facilitie141 s to the as and the drugs’ fluctua 503B Plattsburgh, NY 12903 1015or W.mislead Newporting.

Center Drive (800)te622-0007 to and purity; holding not be false current (844)Good 319-7799 Suite 106A medifaredrug.com the public by d protect ds outlined in promotion must landscape www.sterrx.com Deerfield Beach, FL Act, 33442so-calle unding standar FD&C current compo the The ). higher 503B of (954) 708-2771 und drugs in g Practices (cGMP better understand FDA Under Section ” may compo s Manufacturin Hybridpharma.com ptions) manufacturers and 503B facilitie them. receiving prescri is a “outsourcing has stabilized meet and exceed ies (without first there and strive to unlimited quantit unding drugs for which expectations to meet compo using specific have been unable nt drug if they are unding drugs for that the 503Bs e or compo ed by FDA, The one area addressing emerge xity of drug shortag ed on a list publish n,H outsou demands for identifi comple as 52 W I N T E R 2 0 1 9 I H E A LT S Y S T Ercing M • I N F U SisI O N immediate the r. cGMP is a ingredients, need. In additio a timely manne is a clinical acy compounders shortages in pharm which there nal to traditio und drugs cannot compo facilities, similar Section 503A, under ng operati

48

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I

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O • INFUSI

WAY

USP <800> Hazardous Drugs - Handling in Healthcare Settings Wipedown 1-2-3®’s three unique sterile saturated wipes deactivate, decontaminate, and clean to address exposure to most cytotoxic drugs. Their 12” x 12” size provides optimal saturation & coverage.

USP <797> Compounding Sterile Preparations Compliant to USP <797>, these non-shedding premium wipers are manufactured sterile for specific use in ISO 5 Cleanrooms.

Industry Expert Q&A, 503B Outsourced Compounding Facilities and Services Market Leaders Buyer’s Guide, and more.

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.

page 48-53

N

“Cleaning” the surface may just transfer the hazardous drug residue to other sources. “Deactivation” as preferred in USP <800>, renders the hazardous drug inactive. Be safe and deactivate.

Q.I. Medical, Inc.™ Your Partner in USP <797> Pharmacy Compliance

503B OUTSOURCED COMPOUNDING FACILITIES & SERVICES

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Sterile 3 Step Applicator Kit Step #1: Deactivate with HYPO-CHLOR® Wipe (5.25% Sodium Hypochlorite) Step #2: Decontaminate with THIO-WIPE® (2% USP Sodium Thiosulfate with Surfactant) Step #3: Clean with ALCOH-WIPE® (70% USP IPA)

Come see us at asHP BootH #1253

www.sterile.com • Veltek Associates Inc. 15 Lee Boulevard, Malvern, PA 19355-1234 • Phone: 610-644-8335 • Fax: 610-644-8336 Patents: www.sterile.com/patents

VAI's WipeDown® 1-2-3 Deactivates, Decontaminates, and Cleans Most Hazardous Drugs From Compounding Surfaces

page 63 WAY

PharmASSIST® Pharmacy Automation Solutions From Innovation

Enabling pharmacists to evolve their roles to patient care providers so they can positively affect patient outcomes.

WipeDown 1-2-3, with its 5.25% HYPO-CHLOR packet #1, doesn’t just “clean” but actually deactivates the HD residue from the workplace surface.

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Sentry Data Systems – Expect More With a Trusted Leader in 340B Management and Compliance

expect more with Sentry From innovative technology to expert knowledge and support, we stand ready to help you optimize your 340B benefit.

Reset your expectations for what a 340B solution provider should offer, including the trusted leadership and insight needed to set you up for success!

sentryds.com | 1.800.411.4566 © Copyright 2019 Sentry Data Systems, Inc. All Rights Reserved. No Unauthorized Reproduction. Sentry™ and Sentry Data Systems™ are trademarks of Sentry Data Systems, Inc.

Sentry Data Systems, the revolutionary leader in automated pharmacy procurement, helps healthcare providers reduce cost of care and manage compliance to build strong 340B programs and reach more underserved patients.

Case Study: Workflow Strategies to Minimize Personnel and Environmental Exposure to Hazardous Drugs in the Compounding Pharmacy

CASE STUDY Workflow Strategies to Minimize Personnel and Environmental Exposure to Hazardous Drugs in the Compounding Pharmacy

Bryan Prince, MBA Owner and Lead Consultant ~ Red Pharmacy Consultants

Handling hazardous drugs in the compounding pharmacy, per USP chapter <800> guidelines, involves strategic workflow strategies with the goal of minimizing personnel and environmental exposure. In our previous article, "Can A Class I and Class II Biological Safety Cabinet be in the Same Sterile Hazardous Room” (Learn.Nuaire.com) we discussed varying workflow methods and the potential for exposure points during the hazardous drug (HD) presterilization process. The purpose of this article is to pull all of those chemical handling and compounding workflow strategies together into a more sequential model in an effort to minimize personnel and environmental exposure. The main focus of this article is on nonsterile hazardous drug handling processes, but the principles of GLP are applicable with both sterile and nonsterile chemical handling. We would also make the assertion that there is a higher likelihood of surface and airborne contamination in the non-sterile compounding rooms due to the volume and activity of dry powders being handled.

Where Does Contamination Come From?

Over the years we have visited many pharmacies and have witnessed consistent and similar workflow processes that create chemical exposure in compounding rooms. Here are the four most common workflow processes that contribute to environmental and personnel exposure.

1. Technicians breach the face of the C-PEC while actively weighing and manipulating powders to retrieve additional materials and/or interact with formulation documentation.

2. Dry-contaminated weigh boats, wipers, and gloves are disposed in open-face trash cans in the lab environment.

3. Contaminated weighing utensils, glassware and capsule plates are removed from the C-PEC and transported across the lab to the sink.

4. Bulk-chemical containers are not wiped down prior to placing back in storage.

The good news is that all of the four exposure points listed above are easily remedied with some simple process improvements that incur little to no additional cost to the pharmacy. The biggest hurdle will probably be changing old habits to create a new culture change within the pharmacy. The following recommendations below are proven chemical handling workflow methodologies that will minimize and even eliminate personnel and environmental exposure. What we guarantee is that if you change the process it will change the results for the betterment of your pharmacy’s staff and facility.

The Integral Step 1: Planning and Staging The "Compounding Record" is commonly the first document reviewed by the technician for the purpose of planning the formulation workflow process. The compounding record outlines the chemicals and ingredients necessary to formulate the script, but sometimes it's not the best directional roadmap for consistent process replication or for safe handling procedures. The detailed steps like mixing and quality control information are usually part of the Master Formulation Record, but what is missing on the compounding record is a more detailed list of materials required, such as proper utensils, mixing vessel, additional tools, and even the number of weigh boats required. Although this attention to written detail may seem quite trivial, we would make the case that the presence of such a concise planning document can better direct technicians safety workflow habits, in an effort to avoid the points of exposure as defined in the previous section “Where Does Contamination Come From?” We would also further the case by strongly recommending more detailed safety process documents in the HD compounding rooms to satisfy USP 800 language that states, "Each entity must have a designated person who is qualified and trained to be responsible for developing and implementing appropriate procedures." The "appropriate procedures" include all stages of the HD handling process and especially during the intimate stage of active chemical handling during compounding. This goal can be easily achieved by adding new language to the Master

From NuAire

www.nuaire.com

page 57

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H E A LT H S Y S T E M • I N F U S I O N 11

FDA APPROVED

pegfilgrastim biosimilar for patients at risk for febrile neutropenia-related infection

BioSimilar.

ValueDifferent.

UDENYCA®—the pegfilgrastim biosimilar that delivers high-quality treatment and the reliable outcomes you expect with Neulasta® (pegfilgrastim), but with 32% cost savings for your patients and practice.*1-3

Learn more at UDENYCA.com *UDENYCA® wholesale acquisition cost (WAC) of $4175 per prefilled syringe vs Neulasta® WAC of ~$6200 per prefilled syringe.

INDICATION

UDENYCA® is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Limitations of Use UDENYCA® is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION: Patients with a history of serious allergic reaction to human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim products.

WARNINGS AND PRECAUTIONS: • Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.

• Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue UDENYCA® in patients with ARDS.

• Serious allergic reactions, including anaphylaxis: Permanently discontinue UDENYCA® in patients with serious allergic reactions.

• Fatal sickle cell crises: Have occurred.

• Glomerulonephritis: Evaluate and consider dose-reduction or interruption of UDENYCA® if causality is likely.

ADVERSE REACTIONS: Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity.

To report SUSPECTED ADVERSE REACTIONS, contact Coherus BioSciences at 1-800-4-UDENYCA (1-800-483-3692) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Brief Summary of Prescribing Information on the following page.

References: 1. UDENYCA® (pegfilgrastim-cbqv) package insert.

Redwood City, CA: Coherus BioSciences, Inc.; 2019. 2. First Databank, Inc. Pricing Compendia. 3. Data on file. Coherus BioSciences, Inc.; 2018.

UDENYCA is a registered trademark of Coherus BioSciences, Inc. Neulasta is a registered trademark of Amgen Inc. © 2019 Coherus BioSciences, Inc. All rights reserved. 0419-UDY-P229r1

UDENYCA® (pegfilgrastim-cbqv)

BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION The following is a brief summary of the Full Prescribing Information and does not include all the information needed to use UDENYCA® (pegfilgrastim-cbqv) injection safely and effectively.

See Full Prescribing Information for UDENYCA®.

UDENYCA® (pegfilgrastim-cbqv) injection, for subcutaneous use INDICATION: UDENYCA® is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

(See Section 1 of the Full Prescribing Information.)

Limitations of Use UDENYCA® is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. (See Section 1 of the Full Prescribing Information.)

CONTRAINDICATION: Patients with a history of serious allergic reaction to human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim products. (See Section 4 of the Full Prescribing Information.)

WARNINGS AND PRECAUTIONS: Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture. (See Section 5.1 of the Full Prescribing Information.)

Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue UDENYCA® in patients with ARDS. (See Section 5.2 of the Full Prescribing Information.)

Serious allergic reactions, including anaphylaxis: Permanently discontinue UDENYCA® in patients with serious allergic reactions. (See Section 5.3 of the Full Prescribing Information.)

Fatal sickle cell crises: Have occurred. (See Section 5.4 of the Full Prescribing Information.)

Glomerulonephritis: Evaluate and consider dose-reduction or interruption of UDENYCA® if causality is likely. (See Section 5.5 of the Full Prescribing Information.)

ADVERSE REACTIONS: Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity.

(See Section 6.1 of the Full Prescribing Information.)

To report SUSPECTED ADVERSE REACTIONS, contact Coherus BioSciences at 1-800-4-UDENYCA (1-800-483-3692) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Manufactured by: Coherus BioSciences, Inc. Redwood City, CA 94065-1442 UDENYCA is a registered trademark of Coherus BioSciences, Inc. © 2019 Coherus BioSciences, Inc. All rights reserved.

0419-UDY-P103r1

Your journey to better medicine begins here.

The world of healthcare is evolving.

With increasing regulatory pressure and the need to reduce costs while improving the patient experience, access to quality medicine is more important than ever.

Leiters is an FDA-registered and inspected 503B outsourcing provider of high-quality, cost effective solutions including: Pre-filled syringes, IV bags and vials ON-Q* Pain Relief System fill services Opioid-free surgical pain services medications Ophthalmology services including FDA compliant repackaged AvastinÂŽ COMPOUNDING HEALTHâ&#x201E;˘

Learn how at leiters.com

NOW AVAILABLE! CEFEPIME 100g

SMART THINKING.

AVAILABLE PRODUCTS 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.

Description 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 WAY

THE MOST INNOVATIVE SINGLE-USE SEALS IN HOSPITAL PHARMACY TODAY • Sterile & Paper Free (USP 797 Compliant).

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

IV Port Bag Seals

• 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).

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

Vial Seals

• 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

Check Out Our NEW Tamper-Clear Syringe Seal®

JCAHO training.

• Available in major wholesalers and distributors. *Tested in Nelson Labs, Salt Lake City, UT

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

The Steri-Tamp® Difference – SingleUse Seals With True Tamper-Evidence

WAY

Stryker Cactus Smart Sink and Cactus PharmaLock OR

A better, greener waste solution

The only single-use, tamperevident seal that provides a 100% sterile barrier. Allied Pharmacy Products, Inc. is dedicated to safer drug handling in hospital, clinic, and pharmacy settings through tamper evidence and sterility solutions.

Cactus controlled substance waste management systems

Cactus Smart Sink® System

Cactus Pharma Lock® OR System

For more information, please call 800 253 3210.

Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: Pharma Lock, Smart Sink, Stryker. All other trademarks are trademarks of their respective owners or holders. © 2019 Stryker | www.stryker.com | 9100-004-677 Rev none

Cactus_Print_AdResize_RXInsider_STR439.indd 1

4/29/19 4:08 PM

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Prep-Lock™ From IMI Guards Against Drug Diversion and Misuse INNOVATION IN

SECURE DRUG DELIVERY For 50 years IMI has manufactured innovative devices that help protect the delivery of drugs within the healthcare system. Pharmacists rely on Prep-Lock™ Tamper Evident Caps for ease of installation while clinicians appreciate the simplicity of removal for drug administration.

Prep-Lock Tamper Evident Caps for IV Syringes are the industry standard for guarding compounded sterile preparations from unauthorized access, diversion and misuse. IMI offers a variety of products that protect drug delivery including IV, Oral and Enteral devices.

CONTACT US FOR FREE EVALUATION SAMPLES MADE IN THE USA

IM I

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Your One-Stop Source for All Tamper Evident Needs – Health Care Logistics®

RXGON® Pad HD Prep Mats PROVEN TO DEACTIVATE HAZARDOUS DRUGS

Increase pharmacy productivity and safety with economical, American-made devices designed to advance the safety and security of your drug products and ultimately your patients.

GOHCL.COM • 1.800.848.1633

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USP 800.indd 1

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Unit Dose Done Right

Unit Dose Bar Cod , ing, Pharmac Nursing y & Supply Experts!

• Ultraviolet Inhibitant • Moisture Resistant • Reduces Cross Contamination • Ideal for Meds Covered by USP 800 • Tamper-Evident • Cold Seal • 6 and 12-month Beyond-Use Dating • 1-D and 2-D Bar Coding • Flexible Label and Report Formatting • Multiple Sizes to Fit Your Meds and Storage Needs

Simple. Reliable.

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MediDose.com 5/18/16 10:23 AM

Find a diverse selection of USP <800> and infection prevention solutions in one convenient location.

In addition to stock items such as cleaning tools and infection control mats, HCL can manufacture stainless steel containers and trays to help achieve your compliance goals.

page 89

Medi-Dose, Inc./EPS, Inc. Delivers Bar Coding, Packaging, and Labeling Pharmacy Solutions

Case Study: Parata's System of Compliance Packaging Scales Quickly and Integrates Smoothly

CASE STUDY Parata's System of Compliance Packaging Scales Quickly and Integrates Smoothly Pharmacies and patients benefit from pouch packaging technology.

Paul Magno, BS Pharm, RPh Manager, Outpatient Pharmacy Ambulatory Care Programs ~ Boston Medical Center

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

Paul Magno manages critical patient access programs in the Outpatient/Retail Pharmacy Department for Boston Medical Center. The Medication to Bedside, Medication Adherence Packaging, Concierge Service and My Medicine Health programs assist patients with their compliance and persistence of medication therapies. Team engagement ensures the success of these programs, but more importantly, positive impact on the health of our patients.

Paul was born in Newton, MA and raised in Waltham, MA. He received his BS in Pharmacy from the Massachusetts College of Pharmacy and Allied Health Sciences. He is completing his Masters Degree in Healthcare Administration at Louisiana State University, Shreveport.

Sebastian Hamilton, BS Pharm, RPh, MBA, Pharm.D Director Outpatient/Retail Pharmacy Services ~ Boston Medical Center Dr. Sebastian Hamilton manages the outpatient/retail pharmacy department for Boston Medical Center.

Leading a highly motivated pharmacy team of over 200, 1.3 million prescriptions a year are processed from three on campus pharmacies and an off-campus mail order pharmacy generating over $300M in total revenue a year for BMC. Dr. Hamilton, born in Harlem NY and raised in Bronx, NY, received his BS in Pharmacy from Long Island University (Brooklyn), MBA in Health Care Administration from Wilmington University, and Doctor of Pharmacy from the University of Florida (GO GATORS!). Dr. Hamilton currently serves on the Massachusetts Board of Registration in Pharmacy as a professional member.

PRIMARY INTENDED OUTCOME Poor medication compliance contributes to chronic disease complications and reduced quality of life for patients; it also greatly increases healthcare costs.

The Centers for Disease Control and Prevention estimates that inadequate compliance costs between $100 and $300 billion yearly in the United States.

Parata provides innovative medication pouch packaging technology that drives growth and efficiency for pharmacies, while providing convenience and improved well-being for patients and caregivers.

Pharmacies and patients benefit from pouch packaging technology.

THE CHALLENGE Medication compliance is crucial to improve chronic disease outcomes and reduce healthcare system costs. Research indicates that special reminder packaging incorporating the date and time for dosing, can increase medication compliance. “Our demographic struggles with taking medication,” said Paul Magno, Ambulatory Care Program Manager for Outpatient Pharmacy at Boston Medical Center. “We are the largest safety net hospital in New England, and five or six languages are used on a daily basis, adding to the challenge.”

Smaller pharmacies interested in offering compliance packaging often start out with a manual system, which can be difficult to scale when business grows.

“BMC had been using an older compliance packaging system for years, and the

parata.com

page 75

page 90-93 WAY Supporting Pharmacy Efficiency with an Evolving Product Offering

Visit us at ASHP MIDYEAR BOOTH #1428

Liquid Unit Dose

from American Health Packaging American Health Packaging delivers unit-dose products supporting patient safety and pharmacy efficiency initiatives. Products come in multiple pack sizes to provide flexibility in managing local inventory. Liquid Unit Dose cups are available through partner wholesalers and GPOs. Pull-tab labels promote ease of opening and product administration

Trade Show & Meeting Calendar

Stryker's Cactus Smart Sink System securely captures partially administered, non-hazardous controlled substances and renders them non-retrievable and unusable.

The Cactus Smart Sink System helps reduce drug diversion and improve patient safety while also reducing the impact on the environment.

Thick-gauge cups, excellent seal integrity aid in avoiding costly damage and clean up Cups and storage trays are designed to optimize limited shelf storage space

ABC 8-digit #

Cardinal Item #

McKesson Item #

Morris & Dickson #

Product Description

10211921

5517206

3795689

584466

Fluoxetine Oral Solution, USP

10188404

5465380

3917226

363275

Fluoxetine Oral Solution, USP

Unit Strength

20mg/5mL

Cup Delivery

5mL

Cup Strength

20mg/5mL

Pack Size

40 cups

60687-0244-67 60687-0417-71

20mg/5mL

5mL

20mg/5mL

5552237

3968229

752410

Hydrocodone Bitartrate & APAP Oral Solution CII

5517214

3901766

584557

Levetiracetam Oral Solution, USP

100mg/mL

5mL

500mg/5mL

Levetiracetam Oral Solution, USP

100mg/mL

5mL

500mg/5mL

50 cups

60687-0249-67

Ondansetron Oral Solution, USP

4mg/5mL

5mL

4mg/5mL

30 cups

60687-0252-86

5mg/5mL

5mL

5mg/5mL

40 cups

60687-0406-77

5mg/5mL

50 cups

60687-0406-67

50 cups

60687-0275-66

10183100

5430343

3775822

238550

10210354

5512413

3777034

568063

10219153

5528518

3949997

603993

Oxycodone HCl Oral Solution CII, USP

10219154 10209414 10211558

5528526 5508114 5515705

3950037 3751294 3935129

604306 560649 575878

Oxycodone HCl Oral Solution CII, USP Phenytoin Oral Suspension, USP

5mg/5mL 125mg/5mL

5mL 4mL

100mg/4mL

40 cups

60687-0249-77

30 cups

60687-0341-58

10212031

5520416

3909884

584904

Potassium Chloride Oral Solution, USP 10%

20mEq/15mL

15mL

20mEq/15mL

40 cups

60687-0341-64

10191061

5486220

3263035

321570

Potassium Chloride Oral Solution, USP 10%

20mEq/15mL

15mL

20mEq/15mL

50 cups

60687-0341-71

80 cups

60687-0341-07

10211557

5515713

3935137

575894

Potassium Chloride Oral Solution, USP 10%

Potassium Chloride Oral Solution, USP 10%

20mEq/15mL

20mEq/15mL

15mL

15mL

20mEq/15mL

20mEq/15mL

With a responsive line of barcoded unit-dose oral solutions – and growing liquid unit dose offering – AHP continues to deliver on their commitment to supporting pharmacy efficiency.

NDC

60687-0244-77

50 cups

7.25mg/325mg/15mL 15mL 7.25mg/325mg/15mL 50 cups

10228115 10211783

10212749

5521521

3937786

591016

Potassium Chloride Oral Solution, USP 10%

20mEq/15mL

30mL

40mEq/30mL

40 cups

60687-0341-14

10191066

5487574

3266467

465344

Potassium Chloride Oral Solution, USP 10%

20mEq/15mL

30mL

40mEq/30mL

50 cups

60687-0341-72

10214626

5525027

3944592

594978

Ranitidine Syrup (Ranitidine Oral Solution, USP)

15mg/mL

10mL

150mg/10mL

40 cups

60687-0260-23

10182932

5427489

3772381

231142

Ranitidine Syrup (Ranitidine Oral Solution, USP)

15mg/mL

10mL

150mg/10mL

50 cups

60687-0260-69

10182920

5427497

3772373

231159

Theophylline Oral Solution, USP

80mg/15mL

15mL

80mg/15mL

50 cups

60687-0258-71

T10464 19.10

Hitting the Mark American Health Packaging is a leading manufacturer of serialized, barcoded unit-dose products for hospital, institutional, and long-term care pharmacy.

americanhealthpackaging.com

|

AHP Supports Pharmacy Efficiency With an Evolving Barcoded Unit-Dose Product Offering

800.707.4621

page 78-83

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H E A LT H S Y S T E M • I N F U S I O N 17

Quality. Compliance. Support.

And above all, patient safety.

At SCA Pharma, we’re committed to meeting your sterile compounding needs for years to come. That’s why we’re laser-focused on quality, safety and exceeding compliance standards every single day, every single batch, every single dose. You can have confidence in every product in our broad and diverse portfolio. And our unique, personalized customer

Critical Medicines Your Patients Can Depend On. From The Company You Can Trust.

support means there will always be a real person on the other end of the line, ready and able to answer questions and ensure your satisfaction.

SCA Pharma is an industry leader in the 503B sterile pharmaceutical products market.

To learn more about our products, quality commitment and exceptional customer service, visit scapharma.com

PYROSATE

®

RAPID ENDOTOXIN DETECTION KIT nsed

e DA Lic OW F

N

®

cens i L FDA

New Sensitivities Of 0.03, 0.125 and 0.25 EU/mL Final Product Release Easy-To-Use Method Rapid Test Results

OCIATES OF E CO D, IN C.

ASSOCIATES OF CAPE CO D, IN C.

ists in Endotoxin lucan Detection

Specialists in Endotoxin and Glucan Detection

OCIATES OF E CO D, IN C.

Bacterial Endotoxin Testing USP Chapter <85> Compliant Associates of Cape Cod, Incorporated

ASSOCIATES OF CAPE CO D, IN C.

124 Bernard E. Saint Jean Dr., East Falmouth, MA 02536 USA 888.395.2221 • INFO@ACCIUSA.COM • WWW.ACCIUSA.COM

ed

Contents WAY

We’ve got the right protection.

Count on ISO-MED products to help with USP 797 and USP 800 compliance. We have just what it takes to both prevent contamination via the utensils and textiles themselves and to safely remove all contamination from the cleanroom.

We’re your solution partner for controlled environments.

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

Providing an unparalleled selection of specialized products, globally trusted quality and service, and delivery convenience for meeting USP <797> and USP <800> standards.

WAY 503B OUTSOURCED COMPOUNDING FACILITIES & SERVICES

ISO-MED, INC. – Your Solution Partner for USP Compliant Medical and Cleanroom Products

Keep it clean.

Snap-N-Go® and Dilute-N-Go® From Pentec Health Speed and Simplify In-House Compounding

503

We deliver the efficiency and safety of single-dose medications with the automation of critical processes and the quality controls of pharmaceutical manufacturers.

We’re like an elevator.

We eliminate steps for pharmacists.

Less steps means our product is easier and faster to use. Yet, provides safety and accuracy to make your processes more effective and efficient. Pentec’s 503B combines validated automation and process quality controls to make concentrated, single-dose products you can trust. We offer the peace of mind of a manufacturer with the efficiency of an outsourcing provider – enabling safe accurate medication, when it’s needed, where it’s needed, the way it’s needed. Less waste means greater value. To learn more please visit pentechealth.com.

www.pentechealth.com *

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*

*Must be further diluted.

page 97

Closed-System Transfer Devices (CSTDs) Closed-System Transfer Devices (CSTDs) A comparison of CSTD manufacturers.

Is your pharmacy considering the implementation of CSTDs in 2019?

The following comparison matrix was developed as a complimentary service for

~ Charles River St. Louis, Missouri

http://www.equashield.com/wp-content/uploads/2015/12/021-Equashield-Closed-SystemTransfer-Device-CSTD.pdf https://corvidamedical.com/about-new-cstd-halo/product-components/closed-syringeadaptor/ https://www.bbraunusa.com/en/products/b/onguard-closed-systemtransferdevicecstd.html http://yukonmedical.com/products/arisure-closed-system-transfer-device/

Due to <USP 800> becoming enforceable

https://www.cdc.gov/niosh/docket/review/docket288a/pdfs/ aperformancetestprotocolforclosedsystemtransferdevices.pdf https://www.ncbi.nlm.nih.gov/pubmed/?term=Comparison+of+closed+system+transfer +devices+for+turnaround+time+and+ease+of+use

for hazardous drug administration and

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4938267/

Delivering accurate, reliable compounding sterility results in days rather than weeks.

Erin received her Bachelor of Science degree in biology from Xavier University and her Master of Science degree in cell and molecular biology from the University of Illinois, UrbanaChampaign. As a Senior Technology Market Development Specialist for Charles River’s Microbial Solutions division, Erin provides innovative rapid micro solutions for endotoxin testing, microbial identification, and microbial detection (Celsis® rapid bioburden and sterility testing).

http://www.icumed.com/products/oncology/hazardous-drug-closed-systems-and-cstds/ chemolock.aspx

in December 2019, CSTDs will be required

Rapid ATP-Bioluminescence Testing

Erin Patton

https://www.businesswire.com/news/home/20180111005529/en/Baxter-Launches-ArisureClosed-System-Transfer-Device

Wayne DeHaven, PhD Director ~ Pharmetric Laboratory St. Petersburg, FL

http://www.ajhp.org/content/70/7/619.long

Wayne DeHaven earned his Bachelor's degree from the University of Florida, and his Ph.D. in pharmacology and therapeutics from the University of South Florida. He joined the food and drug administration in 2009 where he worked until 2015 when he left as acting director of the division of bioequivalence to join Pharmetric Laboratory as Director of Quality.

Contributor Melanie Gaspar PharmD Candidate 2019 MCPHS University

Case Study: Rapid ATPBioluminescence Testing

CASE STUDY

Senior Technology Market Development Specialist

References

anyone in the beginning stages of research.

recommended for hazardous drug preparation.

A comparison of CSTD manufacturers.

page 103

Delivering accurate, reliable compounding sterility results in days rather than weeks.

PRIMARY INTENDED OUTCOME Quality control testing is an essential step during sterile drug compounding, necessary to detect the presence or absence of potential contaminants and safeguard patient health. Standard methods require up to seven days for bioburden or microbial limits testing and can take more than 14 days to complete microbiological sterility testing.

Traditional testing relies on long incubation periods in order to achieve microorganism growth, followed by subjective visual assessment to determine whether a sample meets testing specifications.

Pharmetric Laboratory, based in St. Petersburg, Florida, provides sterility assurance, microbial limits, endotoxin testing, and other quality-related screening for clients within the compounding market. They utilize Charles River’s Celsis® AMPiScreen® amplified adenosine triphosphate (ATP) bioluminescence technology for rapid detection of microbiological contaminants for their compounded sterile preparations.

The Celsis® technology allows their lab to eliminate days of incubation, preserve current test protocols, and ensure confident contamination detection for microbial limits and sterility testing through an automated, growth-based assay.

THE CHALLENGE Many sterile compounded drugs have short beyond-use dates (BUDs), and changes to United States Pharmacopeia (USP) regulations support limiting BUDs even further.

Lengthy sterility testing times can lead to extended production cycles, inventory storage issues, and, ultimately, delays in getting drug products to market within BUD timeframes.

www.criver.com

page 98-99 WAY

Temptime – Temperature Monitoring Solutions for Medication Shipments, Storage, and Pharmacy Facilities

TEMPERATURE INTELLIGENCE® Increase your temperature intelligence and save valuable medication while helping protect patient outcomes.

Give patients peace-of-mind by using an easy-to-read temperature monitoring device that indicates if a heat, freeze, or dual heat-freeze event has occurred during shipment.

Remotely monitor medication storage 24/7 and get real-time notification of temperature excursions. Record and store data in the cloud to automate processes and meet pharmacy board requirements.

Tap into the future of temperature monitoring. zebra.com | temptimecorp.com

ad-RXInsider-Winter-20Ways-2019.indd 1

page 104-107

9/20/19 2:35 PM

Pharmacy Job Opportunities

Providing the tools and knowledge to accurately monitor temperature sensitive medications.

page 108-109

page 101 PUBLISHER RXinsider LTD RXinsider CEO: Gregory Cianfarani RPh DESIGN AND PRODUCTION Design & Layout Multimedia

Marketing and Operations

Lora Sosa Eric Simmons Jay DiNardi Samantha Pirraglia Jillian Melly

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 Email sales@rxinsider.com Phone 800.972.2083 Fax 646.329.9766 Website www.RXinsider.com

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Copyright © 2019 RXinsider LTD. All rights reserved. Reproduction without permission is prohibited.

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MULTIFLEX 1+2 The solution for more efficient USP/cGMP compliant air monitoring for multiple sampling sites

USP <797>, <1115>, <1116> guidelines include viable impact volumetric airborne particulate sampling as part of an effective environmental monitoring program. The TRIO.BAS family of active microbial air samplers meets USP compliance standards.

The MULTIFLEX 1+2 • • • • •

Ideal for use in Isolators/RABS Suited for facilities required to comply with quality standards and GMP, e.g: pharmaceutical, biotechnology and other critical cleanroom environments Offers versatility and unique sampling options Ideal for situations where there are a large number of sample points and sampling locations, with large staff rotations Fabricated in AISI 316 rated stainless steel

For more information, including quotes and instrument demonstrations, please contact us:

800.266.2222 Sales@HardyDiagnostics.com HardyDiagnostics.com/TRIOBAS

Innovative Contamination Solutions Teknipure is dedicated to the development, manufacturing, and distribution of innovative controlled environments consumable contamination solutions. Our products are designed to prevent, control, and remove contamination effectively and efficiently.

• Knit & Woven Wipes

Since 2008, we have responded to market needs by developing and supplying easy-to-use, well-identified, and continuously available products that are manufactured according to the most stringent standards.

Our Products

• Microfiber Mopping Systems

• Pre-Sat Wipes

• Nitrile Gloves

• Sterile Wipes

• Facemasks

• Non-Woven Wipes

• Swabs

Contact Teknipure now for inquiries and product selection assistance to meet your needs

www.teknipure.com

844.309.2376

info@teknipure.com

USP <800> RESOURCES Leading Pharmacy Suppliers of USP <800> Compliant Solutions The USP <800> compliance deadline goes into effect December 1, 2019. 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 will help you meet the mandate of USP <800> compliance.

www.RXinsider.com/USP800

Rees Scientific

Š 2019 RXinsider LTD. All rights reserved.

Connecting the Medication Supply Chain Through Integrated Transport and Pharmacy Automation Solutions We live in a connected world.

But inside the walls of a hospital, connections can break down, leading to delays in care. At Swisslog Healthcare, our logistics-driven approach integrates automated transport and pharmacy solutions to connect the medication supply chain.

So you can connect with the people that matter most—your patients. swisslog.com/ASHP2019

Connect with us at the ASHP Midyear Clinical Meeting Las Vegas, Nevada, December 8-12

Visit swisslog.com/ASHP2019 to get a sneak peek of what we’ll be revealing at this year’s conference.

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 fully automated modular storage and retrieval system to eliminate picking errors, increase security, improve patient safety, and save time.

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: Swisslog-Healthcare.com

Company Background

Swisslog Healthcare is a leading supplier of solutions and services for medication management, combining both transport and pharmacy automation. Swisslog Healthcare has installed facility-wide transport and pharmacy automation systems in more than 3,000 healthcare institutions worldwide. The company offers integrated solutions from a single source – from consulting to design, implementation to lifetime customer service.

For more information, visit swisslog-healthcare.com.

Swisslog Healthcare is a member of the KUKA Group, a leading global supplier of intelligent automation solutions.

Product Overview

BoxPicker is part of an end-to-end integrated solution of Swisslog Healthcare technology that manages medication from wholesaler to patient. BoxPicker provides pharmacies with secure, high-density storage of medications – controlling access, improving pharmacy workflow, and expediting the picking process. BoxPicker uses a robot to multitask and multiple operator stations allow for simultaneous operations, significantly boosting staff efficiency.

With the dual access points, one technician can stock medications within the system while a second technician can pick patient-specific drugs, complete refills for ADCs, or restock returns. By optimizing pharmacy workflow, the staff can spend less time locating, picking, and verifying medications and therefore focus on clinical and revenue-generating tasks.

To support the unique needs of every pharmacy, BoxPicker allows for configuration, including options for multiple modules, additional operator stations, anteroom access and ambient, refrigerated, or dual-temperature systems. This high-performance system significantly minimizes the need for static shelving, as full modules consist of 240 boxes and four highcapacity drawers for larger items. As your pharmacy’s needs evolve, you can expand your system by adding modules, rather than having to invest in another piece of equipment.

Advantages

n Fully Automated • All items are brought to a single operator station for retrieval and verification.

• Multiple operator stations allow for simultaneous operations, improving efficiency.

• Users have no exposure to internal moving parts, increasing safety.

• Picks the next three orders ahead of the user for enhanced picking productivity.

• Reallocates staff to more meaningful tasks and provides confidence that they are pulling the right medication. n Modular • Allows for easy expansion options as pharmacy needs change and grow. n Guaranteed Control • Limited access, scan in and scan out technology decreases opportunity for error.

• Password-protected operator access ensures inventory control and audit capabilities.

Additional Product Lines

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.

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.

AutoPack® Automated Oral Solid Packager allows pharmacies to pre-

package tablets for unit dose dispense. Or, through integration with hospital information systems, orders can be filled on demand, including cabinet replenishment orders or patient-specific cart fill or STAT orders.

AutoPack further minimizes human touches and maximizes productivity.

Relay® 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.

Nexus™ Technology Solutions for Translogic® Pneumatic Tube Systems

supports chain of custody management by using radio frequency identification (RFID) to track and monitor carriers. Nexus stations increase staff efficiency by automating more of the pharmacy workflow and enabling WhoTube™ personnel badge swipe technology to deliver medication in a fast and secure way.

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We’re turning 340B teams into A-teams.

As the industry’s most trusted third-party administrator for the 340B drug discount program, we can help optimize drug cost savings and meet HRSA compliance requirements for hospitals, clinics and pharmacies.

© 2019 Verity Solutions Group, Inc.

FOR 340B HOSPITALS AND HEALTH CENTERS Split Billing | Contract Pharmacy | VHUBTM for Contract Pharmacies | Compliance Manager | Purchase Analytics

Your true partner for 340B program administration and compliance

We’re changing the game in third-party administration for 340B, with unmatched product innovation, ease of use, data transparency and support to help your team maintain compliance. We’re the only 340B solution to score an “A” in the 2018 and 2019 Best in KLAS Report for 340B Management Systems, earning the title of Category Leader for two years running.

If you’re looking to collaborate with a vendor that can help you build a winning 340B program and contribute to your organization’s bottom line, contact us to speak with a 340B program advisor and learn how to get started.

www.verity340b.com | 1.800.581.1378 | info@verity340B.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

Verity Solutions – Your True Partner for 340B Program Administration and Compliance

Dedicated to providing agile and proactive solutions to those who serve the most vulnerable in our communities, we partner with covered entities to stretch scarce resources, foster compliance, respond to changing regulations, and optimize drug cost savings.

CEO:

George Puckett Founded: 2002 Employees: 80 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 an award-winning leader in software and services developed for administration of the federal 340B drug pricing program.

Since launching as a standalone company in 2015, Verity Solutions has maintained an exemplary HRSA audit track record. Our mission is to simplify the complex process of maintaining 340B program compliance resulting in critical 340B cost savings for our customers. Verity Solutions is based in Kirkland, Washington, with remote employees stationed across the nation to best serve our widespread customer base.

Product Overview

Hundreds of integrated healthcare systems, acute-care 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.

We partner with our customers over the long term. Our people and 340B solutions work together to help covered entities optimize their 340B savings and safeguard ongoing compliance and audit readiness.

Our comprehensive solutions for split billing, contract pharmacy, specialty contract pharmacy, compliance management, purchase analytics, and pharmacy network management (VHUB™) all offer: • Agile Software Platform: Built and deployed with security, performance, scalability, ease of use, fault tolerance, and agility as primary goals.

• 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.

• 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.

What Sets Verity Solutions Apart?

n Competitive Platform Differentiation Verity Solutions is the most innovative 340B software provider in the industry. The Verity 340B platform has a simple, intuitive user interface with extensive integrations across EMR, ERP/inventory, pharmacy systems, and drug wholesalers. The centralized, cloud-based platform allows for rapid response to any regulatory changes, as shown by Verity’s exemplary HRSA compliance record.

Verity employs an agile release cycle. New product updates are deployed every two weeks along with continuous development of new product features and solutions. Verity also has a dynamic, responsive, and reliable data model with 95% of all transactions processed in less than two seconds.

Transparency and traceability are key values and Verity provides comprehensive audit trails of all 340B program data. In addition, Verity’s focus on security is unmatched. The Verity340B platform is HITRUST certified and HIPAA compliant with comprehensive disaster recovery. n Competitive Feature Differentiation • Sequential Splitting*: Maintains full compliance in central distribution with a mix of 340B eligible and ineligible locations.

• NDC Optimizer*: Utilize accumulations in coordination with prior purchase history to lower costs associated with out-of-stock and NDC changes.

• Purchase Optimization*: Automatically adjusts purchase quantities to minimize expensive WAC purchases leveraging existing analytics tools.

• Shared Accumulators: Maintains independent accumulation data, but share total accumulations within a single CE, minimizing purchase costs.

• Match/Suspect Match: Contract Pharmacy tool to review and override eligibility for matched Rx and capture ‘near misses’.

• Multiple Wholesaler EDI Support: Minimizes staff labor related to invoice reconciliation from secondary suppliers and direct purchases.

• WAC Neutralization: Leverages best pricing using ‘Good WAC’.

• Compound Drug Mapping: Accumulates ingredients to maximize capture.

• Dynamic Data Remediation Tools: Library of data cleansing tools to ensure accurate drug information. * Denotes Verity Solutions patent-pending products.

Testimonial

“ I am very confident in Verity Solutions' software from a compliance standpoint.

We have another vendor's solution at a few pharmacies, and I want to move them over to Verity 340B as well because we have been so happy with it.”

— Manager, May 2019

Selected commentary collected about Verity 340B in May 2019 © KLAS 2019.

Visit https://klasresearch.com for a complete view.

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Safety, Accountability, Efficiency and Compliance See what others have already discovered WITH AUTOLOG™ B Y

G S L

S O L U T I O N S

CONTROLLED DRUG STORAGE, PRESCRIPTION FILLING, AND RETRIEVAL SYSTEM • Eliminates shrink and drug loss by replacing today’s “open face / open access” controlled drug storage cabinets • Replaces today’s error-prone and manual perpetual log book • Logs ALL transactions and user activities automatically • Replaces pharmacist labor with technician labor for C2 filling • Maintains complete chain of custody and pedigree from stock receiving to prescription filling and patient pick up

BEFORE

AFTER

• Payback from labor savings in as little as 1 year

™

B Y

G S L

MEDS-TO-BED

S O L U T I O N S

NEW SYSTEM TO SUPPORT STREAMLINED DISPENSING OF PRESCRIPTION MEDICATIONS AT PATIENT’S BEDSIDE • Physical chain of custody is maintained from filling of prescription through receipt by the patient • Easy integration to RN notification system and dashboard when prescription is ready • Signature Capture stores the patient’s signature confirming receipt of medications from their bedside • Real-time inventory of cabinet contents • Secure storage of patient’s home medications • Patient monographs printed on demand

STANDS ALONE OR INTERGRATES WITH INTELLICAB

THE LEADER IN WILL-CALL STORAGE

• Secure storage for will-call • Proven ROI based on labor cost savings • Improves customer service through a decrease in wait time • Sends the patient a text message when RXs are ready with AutoNotify

BEFORE

AFTER

• Integrates with Central fill • Maintains drug pedigree, lot, and expiration date when integrated with IntelliVault

See our full suite of products online Contact us: www.gslcorp.com |360.896.5354

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

IntelliVault, IntelliVault MTB, IntelliCab, and IntelliStock by GSL Solutions, Inc.

The full suite of GSL Solutions, Inc.’s products are integrated in a single software, IntelliSys™, which uses Radio Frequency Identification (RFID) to physically track medications while achieving efficiency in operations, reduction of labor hours, increased compliance, and higher user and patient satisfaction.

President & CEO: Shelton Louie Founded: 2000

Toll-Free Phone: (866) 477-2682 (24-Hour Support) Sales Phone: Fax: Address: Website:

(360) 896-5354 (360) 397-0496 2414 SE 125th Avenue, Vancouver, WA 98683 www.GSLcorp.com

Company Background GSL Solutions Inc’s technologies are founded by the marriage of the minds of an engineer, Steve Garrett and a pharmacist, Shelton Louie. Both understood from the very beginning that prescriptions are physical products that need to be tracked physically.

Further, they added the requirement that the technology they developed would track automatically, without repetitive scanning.

These requirements led them to use RFID in their family of products which all run on the IntelliSys platform ensuring accountability. The system is based on real-time RFID and integrates seamlessly allowing for the tracking of medications from receiving through sale. Efficiency in operations is achieved through an automated C2 log, 100% user accountability and pill tracking.

Product Overview GSL Solutions offers several products to meet the needs of a multitude of pharmacy environments: IntelliVault™, IntelliVault MTB™, IntelliCab™, and IntelliStock™. Each product can stand alone, or can work together to provide a seamless workflow. n IntelliVault The IntelliVault provides discrete stock storage and prescription filling of controlled medications (C2-C5). The user is required to use their badge to open the IntelliVault and can only access the specific medication that is needed. The physical use of the system creates the log just by using it without repetitive scanning.

Efficiency in operations is achieved through an automated C2 log (AutoLog™) with 100% user accountability and medication product tracking. The system’s inventory reporting can be configured to meet any of your internal needs and pharmacy board requirements. Reports are in real time. With the IntelliVault, technicians can fill C2 prescriptions, freeing pharmacists to focus on skilled clinical work.

n IntelliVault MTB (Meds-to-Bed) IntelliVault MTB (Meds-to-Bed) modifies the functionality of the IntelliVault for storage of home medications and the dispensing of discharge medications at the patient’s bedside. Discrete “pick to light” access ensures safety, efficiency, and accountability. n IntelliCab The IntelliCab will-call system eliminates misfiling, picking errors, and wasted space while providing safe and HIPAA compliant willcall storage, reduced transaction times, and increased customer service. Return-to-stock is performed with the touch of a button in minutes instead of hours. The IntelliCab is easy to install without construction or disruption to your operation while saving up to 50% of will call space. One of the optional AutoFeatures, AutoNotify, will automatically notify a patient when their medication is shelved in the IntelliCab. This feature can also notify patients of recalls.

When paired with the IntelliVault system, a complete chain of custody and pedigree is maintained from stock receiving to prescription filling to patient pickup. n IntelliStock IntelliStock allows for tracking of all non-controlled medication stock with full user accountability. The system performs automatic NDC verification while identifying the right stock bottle and quantity of a drug needed to fill a prescription without repetitive scanning. The system uses the oldest drugs first automatically and will not dispense any expired or recalled medications. Inventory reports are in real time and can be configured to your internal needs and pharmacy board requirements.

The full suite of GSL Solutions products are integrated in a single software to ensure full accountability with less labor, increased compliance, reduced transaction times, and elevated customer service and patient safety.

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

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

rxinsider.com/videosTLS.php

THOUGHT LEADER VIDEO SERIES

Verity Solutions: Your Comprehensive 340B Partner Join George Puckett, CEO, Scott LaChute, VP, Operations, Mark Cassidy, CTO, and Todd Behrman, VP, Product Management Marketing, as they discuss Verity Solutions: Your Comprehensive 340B Partner in a 12-part video series.

www.Verity340B.com

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THOUGHT LEADER VIDEO SERIES

Comprehensive Pharmacy Services Join Jody Miller, MBA, Business Development, Ambulatory & Specialty Pharmacy Division, Leza Hassett, RPh, MBA, Senior Director of Corporate Compliance, Karen Alesch, PharmD, Pharmacy Operations Manager, CPS Telepharmacy, and Marcia Gutfeld, Senior Regional Vice President, Operations, as they discuss how hospital pharmacy leaders drive transformation.

www.cpspharm.com

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THOUGHT LEADER VIDEO SERIES

Medicine Shoppe International, Inc

Join Connie Lane, Director of Franchise Development, Jeff Monroe, Director of Pharma Product Development, Tricia Simpson, Director of Digital & eCommerce, Katie Schoessel, Director of Marketing, Chris Chappo, Director of Pharma Product Development, and Cindy Pigg, Vice President of Managed Care, as they discuss The Medicine Shoppe International: A Cardinal Health Company in a 12-part video series.

www.cardinalhealth.com/franchise

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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

THOUGHT LEADER VIDEO SERIES

Pharmacy Consulting Broker Services: A Fully Licensed Pharmacy Broker & Consultant

Parata: Puts You Out in Front

Join Daniel Lannon, CEO/Licensed Broker, as he discusses Pharmacy Consulting Broker Services in a 12-part video series.

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

THOUGHT LEADER VIDEO SERIES

Join Lindsay Dymowski, President, Centennial Pharmacy, as she discusses Parata and their partnership with Centennial Pharmacy in a 12-part video series.

www.pharmacycbs.com

www.parata.com

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Professional Medical-grade Refrigerators

Efficient and effective.

GX Solutions from Helmer Scientific Featuring OptiCool™ Technology

GX Cold Storage Solutions Offer Energy Efficient Performance OptiCool™ technology pairs a variable capacity compressor (VCC) and natural refrigerants to efficiently manage energy consumption x 50% reduction in energy usage compared to conventional technology x ENERGY STAR® certified x Reduces operating costs and supports sustainability initiatives

E nergy sav ing s Quiet Operatio n Supports sustainability in it ia t ive s

L ea r n m o re : info.h elmerinc.com/helm e r/gx s olu t ion s

OptiCool™ and Helmer are registered trademarks of Helmer Scientific. © 2019 Helmer Inc. All rights reserved.

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GX Cold Storage Solutions Offer Energy Efficient Performance – Helmer Scientific Optimized temperature performance reduces energy consumption by 50-65% supporting environmental sustainability and a lower cost of ownership over the refrigerator’s lifetime.

President:

Bruce King

Vice President of Sales & Marketing: Lori Gabrek Founded: 1977 Employees: 300 Stock Symbol:

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

Company Background

Helmer Scientific is a manufacturer and worldwide distributor of medical-grade cold storage and laboratory processing equipment.

We have over 40 years of experience in providing high-quality temperature controlled environments, with our products being used in over 125 countries throughout the world. Helmer originated in the blood bank market where precise temperature control is essential to the successful storage and transfusion of blood products. These same principles have been applied to the design and development of the Helmer pharmacy cold storage products.

Product Overview

GX Solutions Professional Medical-Grade Refrigerators are designed for the unique needs of critical healthcare applications such as medication and vaccine storage. Only professional medical-grade refrigerators deliver optimized control in three important areas: temperature, noise, and energy management.

Energy management is important for the professional healthcare environment. Refrigeration accounts for 2-3% of a hospital’s electrical usage. GX Solutions are ENERGY STAR® certified and 50-60% more energy efficient than conventional medical-grade refrigerators.

GX Solutions are powered by OptiCool™ technology. The OptiCool™ system pairs a variable capacity compressor (VCC) and natural hydrocarbon (HC) refrigerants to efficiently manage energy consumption.

This is accomplished using intelligent sensors to monitor operating conditions. When the door of the unit is opened, the VCC runs at a higher speed to deliver optimal temperature performance. When the temperature stabilizes, the VCC runs at a lower speed, resulting in overall lower energy consumption.

Additionally, OptiCool™ technology uses a naturally occurring refrigerant that is U.S. Environmental Protection Agency (EPA) and Significant New Alternatives Policy (SNAP) compliant. This natural refrigerant is environmentally friendly, having no impact on ozone depletion and an astonishingly low Global Warming Potential (GWP) grade.

GX Solutions help reduce a healthcare facility’s footprint. By minimizing heat output, facilities are able to place refrigerators in small work areas without impact on their HVAC system. GX Solutions also aide in decreasing a facility’s carbon footprint by dramatically decreasing the global warming potential (GWP) while meeting ever-changing energy standards.

Features & Options

n Professional, Medical-Grade Performance • Best-in-class temperature management, including uniformity, recovery, and stability, to safeguard medications and provide confidence that contents are stored at the precise temperature regardless of where they are placed within the unit.

• Designed for noise-sensitive areas such as medication rooms, pharmacies, and patient rooms, GX professional medical-grade refrigerators are three times quieter than traditional models leading to better rest for patients and fewer distractions for healthcare personnel.

• Energy management reduces operating costs and supports sustainability initiatives by utilizing a variable capacity compressor (VCC) system and natural refrigerants to create a highly-efficient cooling system. n Continuous Monitoring Offers Safety and Security of Stored Product The i.C3® Information Center provides constant temperature monitoring and multiple information logs, plus security features to keep crucial refrigerator settings protected.

• Information and Event Center records performance history of the unit as well as event acknowledgement.

• Guardian Plus Protection offers protected settings and limits refrigerator access with a key lock or optional integrated electromagnetic access control.

• Data Transfer Center offers data export of temperature, event and access data via USB port as PDF reports or CSV files. n Customized Storage Options • Standard configurations include ventilated, pull-out pharmacy drawers, and ventilated shelves.

• Configure the inside of the cabinet to meet your needs with pull-out drawers, adjustable shelves, or additional ventilated, pull-out pharmacy drawers. n Medication and Vaccine Storage • Factory pre-set to 5°C for pharmacy applications.

• Supports CDC guidelines for vaccine storage.

• Remote lock adapter kits available for integration with automated dispensing cabinets.

• Quiet operation for improved work environment (UC 42 dB, Upright 47-50dB).

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Powering hospital pharmacies to help people lead healthier lives.

An established pharmacy automation leader, Parata’s adherence packaging, vial-filling, and

888.PARATA1

workflow solutions reduce costs and medication errors and improve medication adherence.

parata.com

Explore our full portfolio of pharmacy workflow solutions designed with your business, pharmacy teams, and patients in mind at parata.com.

Adherence Packaging & Inspection

Workflow & Inventory Management

Vial-Filling Robots

Secure Pick-Up Kiosks

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Parata – Solutions to Reduce Costs, Improve Medication Adherence, and Enhance Patient Experience Explore the technology, expertise, and people you can count on.

President & CEO: Rob Kill Founded: 2001

Employees: 400+ Phone:

(888) 727-2821

Address: 106 Roche Drive, Durham, NC 27712 Website:

parata.com

Company Background

Parata provides pharmacy technology solutions to reduce costs, improve health outcomes, and enhance the patient experience by offering the most comprehensive pharmacy automation portfolio with medication adherence packaging, high-speed robotic dispensing technologies, and pharmacy workflow solutions. Discover how pharmacies across all practice settings use our solutions to stay out in front at parata.com.

Product Overview

n Reduce Costs and Medication Errors Medication errors in hospitals harm approximately 1.5 million people each year in the United States. Solve for reduced errors and costs with solutions designed to save time and money.

Parata Max® and Parata Max® 2 • Automate up to 80% of oral solids to reduce labor costs.

• Reduce filling errors because Max is 100% accurate for drug and dose.* *Parata automation uses barcoding to verify a match between the inventory bottle NDC, unique to medication and strength, and the barcode on the dispensing cell. Parata automation selects the correct cell for dispensing 100 percent off the time, ensuring accurate drug and total dosage when proper processes are followed by the pharmacy.

Beacon® Pick-to-Light Inventory Workflow System • Reduce carrying cost by 35% and expired med by 75%.

• Track your entire formulary from the bottle to reduce your dispensing error rate by as much as 62%.

Centralized Prescription Filling • Reduce costs to fill a script by 70%.

• Ensure patient safety and quality by reducing medication dispensing errors. n Improve Medication Adherence and Lower Total Cost of Care 10-25% of readmissions are due to noncompliance leading to $41.3 billion in additional costs. Simplify adherence for your patients with a medication adherence program. Synchronize daily medications into med pass times improving compliance, outcomes, and readmission rates.

Pouch Packagers ATP® 2 Pouch Packager • Increase adherence because pouches make it easier for patients to stay compliant – up to 90%.

• Increase average of scripts per patient per year by up to 29%.

Inspection Technology InspectRx® Pouch Inspection System and Parata Perl • Decrease labor costs of manually handling pouches.

• Ensure accuracy and safety with speeds up to 5,600 pouches per hour.

Pouch and Blister Card Solution ATP® 2 Duo™ Blister/Pouch Packager • Deliver meds in either blister or pouch – customized packaging by patient or facility.

• Reduce waste by using packaging you’ve already got. n Enhance Patient Experience The impact of positive patient experiences improves reputation, increases loyalty, and grows revenue.

Expand your reach beyond the pharmacy counter and hours of operation without the traditional overhead costs, reduce pharmacy wait times, and create pleasant experiences for your patients.

WellSpot™ Prescription Pick-Up Locker • 24/7 convenience to increase adherence and service.

• Gain up to 70% employees script capture.

• Provide better transition of care.

SpotLight™ Wireless, Light-Guided Will Call System • Improve prescription retrieval times by 70%.

• Reduce time spent on return to stock by 90%.

Medication Adherence Packaging • Deliver medications organized by day and time of dose to increase compliance and provide convenience.

• Ensure patient safety and quality by reducing medication dispensing errors.

Testimonial

“ Beacon has allowed us, both on the quality side and on the financial side, to have a process of continual improvement. We’ve seen a reduction in dispensing errors.

We have a confidence in the accuracy of the products we dispense. In addition, we’ve been able to reduce our formulary size and reduce the inventory we have on hand.”

— Jeff Brinkley, Maury Regional Medical Center

Markets Served • Central Fill • Hospital – Inpatient • Hospital – Outpatient • Independent Retail • Long-Term Care WINTER 2019

• Mail Order • Nutraceuticals • Retail Chain • Specialty

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Case Study

Star-Link Enterprise from Retail Management Solutions helps pharmacies to streamline operations and centralize management of multiple pharmacy locations.

Health Partners operates clinic/

Primary Intended Outcome

apothecary type pharmacies with

Pharmacies with multiple locations face unique challenges in ensuring that each site maintains and updates their product files, implements price changes and promotions, and remains consistent across the brand. Furthermore, taking in and making sense of data from multiple sites is both labor intensive and time consuming.

relatively small front ends.

For more than half a century, HealthPartners has been setting the standard for its high-quality health plans, hospitals, medical & dental clinics and pharmacies.

HealthPartners offers retail pharmacy services in numerous clinics and one refill pickup site at its headquarters in Bloomington, Minnesota.

All of its stores have a variety of OTC products and specialty OTC

The Challenge HealthPartners operates Clinic/Apothecary type pharmacies with relatively small front ends. For more than half a century, HealthPartners has been setting the standard for its high-quality Health Plans, Hospitals, Medical and Dental Clinics, and Pharmacies. At the initial implementation of Star-Link, HealthPartners offered Retail Pharmacy services in 15 medical clinics and one refill pickup site at their headquarters in Bloomington, Minnesota. All their stores have a variety of OTC products and specialty OTC products as well as candy, snacks, beverages, and greeting cards.

beverages, and greeting cards.

With pharmacies spread throughout the city, managing the product file for even small front ends was difficult and time consuming. Each site had a pharmacy manager whose focus and training revolves around the prescription side of the business with limited interest or concern for the front end. Due to the size, no site had a front-end manager as is typically seen in pharmacies with a large front-end.

Toll free: 1.877.767.1060

As a result of this problem, price update files emailed to the stores from the head office were often not processed in a timely manner and, at some locations, not at all. Consequently, some sites experienced increased cost of goods without increasing their retail prices, resulting in reduced profit. Ensuring compliance was virtually impossible. Additionally, as time went on, product file discrepancies

products, as well as candy, snacks,

Email: sales@rm-solutions.com Web: www.rm-solutions.com 40

The Star-Link Enterprise edition offers companies with multiple sites the ability to centralize the management of product files, promotions, and accounts receivable.

In addition, Star-Link communicates with Star-Lite or Star-Plus POS systems for real-time communication from and between sites to the head office to give up-to the minute inventory, sales, and transaction data. Star-Link utilizes Microsoft SQL Server Reporting Services and SQL Server Analysis Services so this data can be viewed dynamically for some or all locations by deploying built-in reports or custom-built report options.

Case Study between sites became larger. Since some sites sporadically processed update files, new products were not added to the database automatically. Consequently, as new items were ordered, they were only in the database of some stores – leaving the other stores to create the items themselves. This resulted in significant inconsistencies between sites and, in some cases, items were sold at the acquisition cost rather than the retail.

databases. Sites can be managed at

Another problem with managing multiple pharmacies was gathering reports for each site and assimilating the data. This was a very labor intensive, time consuming, and manual process. Simply looking at cash balancing and daily sales data required many hours of work from many individuals. Comparing store sales required manual data entry into an Excel spreadsheet from store generated reports. Again, a very time-consuming process with results that had to be emailed across the enterprise. Reviewing front-end product detail across the chain was virtually impossible. Consequently, some sites carried products they didn’t sell in over a year, while other sites were out of stock on items they sold regularly.

the Branch, Store Group, or individual

The Decision

store level, so if competition requires

HealthPartners purchased and installed the Star-Link Enterprise system which communicates real-time with the Star-Lite and Star-Plus point-of-sale systems deployed at the individual stores. The Star-Link Product Manager allows HealthPartners to process a product update file centrally and push the information down to all sites, ensuring compliance and virtually identical databases.

Sites can be managed at the Branch, Store Group, or individual store level, so if competition requires HealthPartners to vary pricing at a specific store or a group of stores, it can do so easily. What’s more, instead of relying on individual pharmacy managers to process emailed files, HealthPartners simply forces the updates and restricts the ability of the pharmacy to make changes to the item file. In the event a new item makes it into the stores without already being part of the database, stores create the item at their location and, as they do so, the information flows up to the Star-Link Holding Tank for review by the POS manager.

The manager sees each instance of the new item and exactly how it was input by each site. The manager then either selects one of the instances to become the standard or creates the item from scratch. Once this process is complete, the updated information is sent to every site.

The Star-Link Product Manager allows HealthPartners to process a product update file centrally and push the information down to all sites, ensuring compliance and virtually identical

HealthPartners to vary pricing at a specific store or a group of stores, it can do so easily.

The Results Today, instead of one person at headquarters creating product file updates and relying on different people at separate locations to implement those updates, one person does it all. And instead of marginal compliance, there is 100% compliance. Star-Link utilizes the latest database technology from Microsoft, opening the door to unprecedented reporting capabilities. Transaction data flows real time from each site to Star-Link, giving HealthPartners immediate access to sales data across the chain. Instead of relying on pharmacy managers to run end-of-day reports and send them to headquarters to be manually input into a spreadsheet, all the data appears at Star-Link virtually instantly. Ryan Sunderman, the POS Manager for HealthPartners notes, “Prior to Star-Link implementation, pricing updates and product additions to the cash register were challenging. Now we are able to ensure our products are being sold for a profit and we are able to manage our sales by replacing products without sales with products that will sell.”

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Case Study

S TA R - L I N K The Star-Link system is both powerful and flexible allowing for centralized management while also allowing for no, partial, or full control for individual stores within the chain. It even allows for stores to be grouped into regions, zones, or branches to better target pricing strategies.

Star-Link can expand as you expand!

Star-Link incorporates Microsoft Web Services to create web-based reports so managers and executives can look at the reports whenever they wish from wherever they have access to a web browser. This eliminates the need for Star-Link software to be loaded on desktops across the enterprise, saving HealthPartnersâ&#x20AC;&#x2122; IT department time and money. Additionally, web-based reports can be tailored to a specific user and restricted to that user. Web-based reports can also be automatically created and emailed to as many individuals as desired. This feature vastly reduced the time and labor required for data analysis while exponentially increasing the amount of information available to management at the click of the mouse.

With Star-Link, HealthPartners can run store comparison reports in real time, viewing up-to-the-minute sales data. The need to manually input reports from each site is gone and the time required to make these types of entries is now spent on more important tasks. Viewing cash balancing results and over/short information for every site is a breeze. Analyzing front-end merchandise is not only possible today, it is easy. Today, management can look at everything from top selling items to items with no sales. It is simple to review margins across departments and drill down all the way to individual items and view the sales data of that individual item for each store â&#x20AC;&#x201C; all on one screen.

Furthermore, as HealthPartners has grown and expanded their operations, Star-Link has grown with them, integrating with the POS systems at over thirty HealthPartners pharmacies.

The Conclusion A centralized head office system can save time and labor costs while simultaneously increasing profit by ensuring that product files are up to date with correct products and pricing. The ability view aggregate data from across the chain can help make better decisions about what inventory to carry at which stores and compare store performance. It can even increase customer loyalty with product and promotion standardization and by centralizing accounts receivable and customer loyalty programs ensuring that customers know what to expect at each location.

The Star-Link system is both powerful and flexible allowing for centralized management while also allowing for no, partial, or full control for individual stores within the chain. It even allows for stores to be grouped into regions, zones, or branches to better target pricing strategies. Star-Link can expand as you expand to add in centralized programs such as Employee Editor, making it possible to add and update employee information directly through Star-Link; Accounts Receivable to manage customer accounts no matter which location they use; Customer Loyalty that allows customers to generate and redeem loyalty points at all applicable locations while their totals are recorded and maintained at the head office; Purchasing for ordering, transmitting, and dropshipping; and Order Desk for warehouse operations and for pharmacies looking to take advantage of economies of scale.

Toll free: 1.877.767.1060 Email: sales@rm-solutions.com Web: www.rm-solutions.com 42

Star-Linkâ&#x20AC;&#x2122;s powerful web-based reporting allows for using built-in reports or using a report builder that exports to Excel and PDF. Its real-time communication means that accurate data can be viewed virtually instantly. If the CFO wants to see the sales for each store for today, this week, this month, this quarter, or this year, he or she can do so with the click of the mouse and no one in the organization has to do anything to make that happen!

You do more than sell prescriptions.

Reduce readmittance rates

Increase profitability

Improve patient outcomes

Adhere to PCI Compliance Standards

Oversee multiple locations

Align with organizational goals

Manage inventory

Comply with federal and state regulations

Your Point-of-Sale system should too!

Discover how RMS is changing the way that pharmacies see point-of-sale and learn more about how RMS can be the solution for your pharmacy.

1.877.767.1060 | sales@rm-solutions.com | www.rm-solutions.com 43

Pharmaceutical Inventory Experts:

Cover (Vert).indd 1

Precise, Efficient, and Confident

Why Outsource Your Inventory Needs?

• • • • • • • •

Teams of experts conduct the inventory within a few hours.

Teams conduct inventories daily-not annually.

Minimal interruption to the pharmacy staff and operation.

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

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

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

Competent inventory specialist that can work with finance and/or external audit firm to validate the inventory.

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

To learn more about Capital Inventory and how we can help you with our inventory services please contact 1-800-345-0849 or Info@capitalinventory.com.

9/27/06 3:00:09 PM

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Pharmaceutical Inventory Management Services by Capital Inventory

The nation’s leader in pharmaceutical inventory service providing inventory data that is accurate and dependable.

Founder:

William Straub Sr. President: Duran Dunn Founded: 1979 Employees: 80 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

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

Capital Inventory, Inc. has been in business for over 40 years, providing service to thousands of hospitals, university medical centers, regional medical centers, and health systems. Capital Inventory exclusively services hospital, outpatient, 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 continuing education including pharmacy practices, drug information, HIPAA regulations, and blood borne pathogen. Feel confident and secure as all of Capital Inventory’s employees undergo an extensive background check including felony, misdemeanor, and sex offender. 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”, are CPhT’s, 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.

Now is the time to get to know Capital Inventory, Inc. The following will briefly explain our procedures and service capabilities. 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 a 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 step-by-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 make adjustments to the data as requested to ensure the final value is a true representation of the on-hand inventory.

GPO Affiliations • Premier • Vizient

• Amerinet • The Resource Group

• Health Trust

Ordering 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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Discover how PharMEDium Prefilled Syringes help you achieve your goals.

Batch-level Release Testing is Performed on 100% of PharMEDium Compounded Sterile Preparations (CSPs).

Prefilled syringes offer benefits you cannot afford to ignore1

No other compounder serves pharmacists, clinicians, and patients like PharMEDium–with a certainty you only get from the leader in outsourced CSPs.

• Enhanced Safety • Optimal Productivity • Increased Satisfaction • Better Compliance • Less Waste • Best Use of Resources

pharmedium.com | 800.523.7749 1

References available on PharMEDium website at: https://www.pharmedium.com/compounded-services/operating-room-anesthesia/

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Providing the Highest-Quality Sterile Compounded Services – PharMEDium

Our focus on continuous improvement in compounding processes, and our testing program, help assure every Compounded Sterile Preparation (CSP) we create is the highest-quality product with optimum expiration dating.

President:

Scott Aladeen Founded: 2003 Employees: 1,000+ Stock Symbol: ABC (NYSE) Toll-Free Phone: (800) 523-7749 Fax: (847) 234-1363 Address: 150 North Field Drive, Suite 350 Lake Forest, IL 60045

Company Background

For over 25 years, PharMEDium Services has been a leader and an innovator for outsourced, ready-to-use CSPs. PharMEDium was among the first to voluntarily register our centers as FDA Registered 503B Outsourcing Facilities after Congress enacted the Drug Quality and Security Act (DQSA) in November 2013.

Since our inception and through the years as laws, regulations, and FDA guidance standards for entities engaged in anticipatory compounding of sterile preparations have evolved, PharMEDium has been anchored by the enduring values of patient safety, flawless quality, and outstanding customer service.

The company is committed to undisputed compliance with FDA’s 503B requirements, upholding the highest ethical standards in the industry.

As part of AmerisourceBergen, PharMEDium supports the healthcare industry by enabling increased product access and delivering powerful services. Such as, consultative support in medication management process improvements that result in enhanced patient safety, operational efficiencies, decreased medication waste, and simplified compliance.

Together, we are united in our responsibility to create healthier futures.

Product Overview

Purposely, PharMEDium does not compound sterile medications from bulk drug substances. Only FDA-approved* sterile drug vials, FDAapproved sterile diluents, and FDA-cleared sterile containers are used in PharMEDium’s 503B Outsourcing Facilities to provide for the highest levels of quality assurance and patient safety.

100% of our CSP batches are tested for pH, sterility, bacterial endotoxin, and potency. PharMEDium includes stringent environmental and personnel monitoring as part of our batch release criteria. Our real-time stability verification is done both in-house and by independent FDAregistered laboratories. PharMEDium’s long-standing commitment to advancing patient safety, and our daily goals to produce the highestquality CSPs and business solutions, make all the difference to our health system partners and the patients they serve.

Hospitals and ambulatory surgery centers rely on PharMEDium Compounded Sterile Preparations (CSPs) for operating room anesthesia;

pain management; labor and delivery services; emergency and critical care medications.

Features & Options

PharMEDium has long been the industry leader in labeling and packaging of ready-touse compounded sterile preparations.

Our labels are designed to help eliminate the potential for errors in the process of dispensing and administering medications. PharMEDium’s proprietary labeling includes additional design enhancements, including the use of color coding and tall man lettering. On PharMEDium prefilled syringe labeling, the drug name appears up to eight times, making it viewable from any perspective.

Our packaging is designed to ensure the integrity of chemical composition, and sterility of the preparation through the shipping and storage process.

PharMEDium CSPs are available in containers to fit all major infusion devices available today. Our ready-to-use syringes are compatible with the most commonly used anesthesia carts and automated dispensing cabinets, including mini-drawers for controlled substances.

Testimonial

“ PharMEDium is focused on enhancing the quality assurance and quality control programs we employ to meet the highest standard for the cGMP compliance required of 503B compounders. We know we are on the right path for our business partners which will enable us to continue to expand our relationships through mutual trust and confidence in the quality and reliability of the services we deliver.”

— Scott Aladeen, President, PharMEDium Services

GPO/IDN Affiliations

PharMEDium has a team of national account managers who serve as liaisons between PharMEDium, group purchasing organizations (GPOs), and integrated delivery networks (IDNs) so customers can take advantage of GPO volume discounts and the ease of ordering direct from PharMEDium.

PharMEDium currently has GPO contracts with: Vizient, HPG, Premier, The Resource Group (TRG), ROI, and Intalere (formerly Amerinet).

Ordering Information

Hospitals and ambulatory surgery centers considering PharMEDium are invited to visit our centers and learn about the processes that have been instrumental in helping us to attain and maintain our industry leadership position. Call (800) 523-7749 to order services or to learn how PharMEDium CSPs can benefit you. *FDA-approved drug products include otherwise legally marketed sterile drug products in finished dosage form. Such commercially available drugs are produced in FDA-registered facilities subject to FDA inspection.

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503B OUTSOURCED COMPOUNDING FACILITIES & SERVICES Q & A

& Q A

Gregory Burger, MS, RPh, FASHP, Senior Vice President, Hospitals & Health Systems Services & Fred Massoomi, PharmD, FASHP, Senior Director, Visante

Q. What are the different types of outsourcing entities for compounded products?

It is worth reiterating and detailing the different models we have in the United States. 503A relates to patient specific compounding practices traditionally seen in pharmacies, clinics, and hospitals, while 503B covers the outsourcing facilities.

Under Section 503A of the Food, Drug, and Cosmetic Act, a pharmacy may engage in traditional pharmacy compounding provided that it (1) limits its compounding to prescriptions for identified individual patients and makes no more than limited quantities of compounded drugs in advance of receiving prescriptions, (2) does not make drugs (either regularly or in inordinate amounts) that are essentially copies of commercially available drugs, and (3) uses permissible ingredients. Products must not be contaminated or prepared under insanitary conditions; the drugs must be the correct strength and purity; and the drugs’ labeling, advertising, and promotion must not be false or misleading.

Under Section 503B of the FD&C Act, so-called “outsourcing manufacturers” may compound drugs in unlimited quantities (without first receiving prescriptions) if they are compounding drugs for which there is a drug shortage, or compounding drugs using specific ingredients, as identified on a list published by FDA, for which there is a clinical need. In addition, outsourcing facilities, similar to traditional pharmacy compounders operating under Section 503A, cannot compound drugs

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that are essentially a copy of one or more approved drugs. Outsourcing facilities must also, among other things: (1) 'voluntarily' register with FDA; (2) comply with FDA’s stringent cGMP regulations; (3) open its operations to FDA inspections; (4) report adverse events to FDA; (5) provide FDA with detailed information about the products they compound; and (6) in some instance comply with state specific requirements.

It is important to emphasize that the FDA regulates drug compounding under Sections 503A and 503B of the FD&C Act; which covers all types of compounding of drugs for patients including what happens in hospitals and clinics.

Q. What is the current outsourcing manufacturing landscape?

Since the approval of the 2013 Drug Quality and Security Act and the introduction of the 503B outsourcing manufacturers category, we have seen a considerable amount of activity. As of October 2019, there were 76 FDA registered facilities. This number continues to fluctuate as FDA has made good on its promise to protect the public by holding 503B facilities to the higher compounding standards outlined in current Good Manufacturing Practices (cGMP). The current landscape has stabilized, and 503B facilities better understand FDA expectations and strive to meet and exceed them.

The one area that the 503Bs have been unable to meet is the immediate demands for addressing emergent drug shortages in a timely manner. cGMP is a complexity of

The one assurance and peace of mind is FDA has oversight of the outsource manufacturing process.

Q. How should an organization decide if there is a need to outsource the compounding of medications?

There are many factors to take into account when deciding to outsource: staffing, availability of drugs on extended shortage, ready-to-use products, extended beyond use dates, and increased regulations.

In the U.S., there has been an increasing trend of turnover and vacancies amongst hospital pharmacy supportive staff, i.e., compounding staff. This has resulted in a gap in consistent and competent staff to compound medications. With the estimated onboarding and training on sterile compounding principles taking approximately six weeks beyond the training for pharmacy services, outsourcing offers a means to filling the hospital compounding staff gap.

FDA has acknowledged that outsource manufacturers provide an important channel to some drugs on shortage. In some situations, the outsourcers may become the primary source for critical medications.

The use of outsourcers could start out as episodic due to a shortage, potentially transitioning into an integral part of a healthcare facility’s operations.

Outsourcers have created some unique compounded products to gain market share: ready-to-use anesthesia syringes; patient-controlled analgesia (PCA) preparations; cardioplegia solutions; total parenteral nutrition; tamperevident controlled substances products; hazardous drug doses with integrated closed system transfer devices; concentrated drug systems for dilution; and drug filled reservoir devices. These systems offer an enhanced era of the most ‘ready-to-use’ products, thus minimizing risks to patients through the manipulation of products.

Hospitals and health-systems have had USP recently update and introduce standards surrounding pharmaceutical compounding of non-sterile and

sterile preparations. With the recent announcement

by USP to delay the doom-and-gloom-like deadline of December 1, 2019, for expected compliance, sites have a slight reprieve to strive towards compliance.

For sites choosing not to move forward with full compliance or choosing to not establish a cleanroom suite for maximum BUDs, outsource manufacturers offer a solution for bridging dating gaps.

Q. What steps should we take to start reviewing outsource manufactures?

The responsibility of choosing drugs to use in patients resides with each hospital and health-system, and more specifically on pharmacy leadership.

The diligence spent choosing a formulary candidate and a wholesaler needs to be applied to choosing an outsourcer for medications. The American Society of Health-System Pharmacists (ASHP) Foundation has developed the Outsourcing Sterile Products Preparation: Contractor Assessment Tool as a resource. This toolkit provides sites with a starting point by providing a comprehensive and organized process to assess vendors based on criteria for regulatory compliance and more importantly patient safety measures.

A review of state and FDA inspection reports should be part of assessment process. Reading through these reports gives a glimpse into how a company operates.

If an outsource manufacturer provides hazardous drugs, sites will want to make sure aspects of the 2004 NIOSH Alert Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Healthcare Settings and the finalized USP <800> Hazardous Drugs – Handling in Healthcare Settings standards are in place and documented.

503B OUTSOURCED COMPOUNDING FACILITIES & SERVICES Q & A

processes that requires a multitude of validations and absolute control of the compounding processes and it does not lend itself to addressing emergent drug shortages.

In some cases, group purchasing organizations (GPOs) have vetted all the noted critical steps on behalf of their members prior to any contracting. However, sites will want to review the summary report of GPO findings, terms of the contract with regards to quality and recalls. Through this process sites may decide the information provided may not be enough to make a decision warranting additional investigation.

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503B OUTSOURCED COMPOUNDING FACILITIES & SERVICES Q & A

Sites may choose to do an on-site inspection of a prospective company to fill gaps not filled in the paper review process. Meeting the key individuals providing products for their patients and visualizing the compounding/manufacturing processes provides a wealth of information beyond the scope of a written report. Obviously, if the site visit does not give folks the "warm-fuzzy" feeling of "I can trust this company with compounding medications for our patients," then that must be taken into account.

Inquiring about a vendor's quality and control program is key to establishing a comfort with their products.

Diligence should be spent understanding the staff training programs, product and supply selection processes, accreditations, historical product availability, supporting processes, certification of analysis reports for each batch, and the overall transparency of all documents associated with producing a batch. Creating a true ‘partnership’ with an outsourcing manufacturer is relying on them to provide the highest-quality products for patients with a transparent quality and safety program in return for purchasing their products.

An important note to keep in mind as sites set up a process to assess vendors is that the outsourcing companies are under continuous monitoring by regulatory agencies, and sites should be continuously diligent in monitoring their outsourcer(s) progress.

The burden of selecting the safest drug product for patients lies with organization purchasing the products.

Q. What aspects should be considered when contracting with an outsourcing company?

The contract or business agreement between the outsourcing company and the healthcare organization should require the compounding facility to provide real-time notification of any adverse events or recalls associated with compounded drug products.

The business agreement should also require the vendor to promptly share any communications between the facility and FDA and/or state regulators, including inspection reports and warning letters, that relate to the safety, efficacy, or quality of any compounded drugs and not just line items purchased. The business agreement should also include the facility’s commitment

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to complying with all applicable federal and state requirements, along with all relevant USP chapters, including Chapter <800>.

Q. How are state agencies involved in the process for monitoring 503B outsource manufacturers?

The FDA has full oversight over compounding manufacturers registered as a 503B and is relying on state boards of pharmacy to manage the oversight of 503A compounding pharmacies providing patient specific compounded drugs. In this collaborative approach to enhancing the safety of the commercial compounded drug supply, a sense of stability is starting to happen.

It is important to point out that states vary in the 503B outsourcer oversight process. A few have taken on the onerous process of requiring outsourcers to not only register with the FDA, but also register with various state agencies. Whereas, some states have relied on the FDA process to provide regulatory control over the outsourcers.

Hospitals will want to ensure that proper registrations are in place prior to setting up any contracts. Larger health-systems that may have facilities in multiple states will need to ensure that for each state, the outsourcer(s) meets the regulatory requirements.

The burden of regulatory compliance for outsourcers lies with the purchaser of the products.

Q. Should there be concern with all the recalls and notifications from the FDA with regards to the outsource manufacturer products?

It is not surprising to see the activity from FDA as it is the normal process utilized for the pharmaceutical industry for conventionally manufactured products.

The activities of FDA is highly visible and transparent.

FDA publicizes all activities on 503B’s from registration, to inspection, to warning letters, and to legal activities.

FDA utilizes form 483, "Inspectional Observations," to document and communicate concerns discovered during inspections. In most cases, the response to FDA observations are not publicized, and sites may want to request these documents as part of the review process.

Sites must be diligent with continually monitoring FDA, and in some cases, state regulatory activities of outsourced manufacturers.

Q. Are products from outsourcer manufacturers safe?

Products are safer today through the FDA and state oversight of the compounding processes. However, selecting a product based on the emotional need of having a product with a label versus selecting one based on reviewing the quality of the contents opens the door to potential lapses in screening products.

BIOGRAPHY

All concerns of product integrity and safety must be reported to the outsource manufacturer and through the FDA MEDWatch program.

Gregory Burger, MS, RPh, FASHP, Senior Vice President, Hospitals & Health Systems Services, Visante

Gregory Burger, MS, RPh, FASHP, is Visante Senior Vice President, Hospitals & Health Systems Services.

He provides expertise in hospital pharmacy operations management, standards and compliance, patient safety, key USP chapters (<795>, <797> and <800>), multiple

BIOGRAPHY

Sites should establish a formal mechanism for inspecting each outsourced product for product defects and reporting adverse events suspected for outsourced products. Every single dose from outsource manufacturers require the same diligence applied to conventional manufactured products (from pharmaceutical manufacturers) to identify variances from what is expected in a timely manner.

facility redesigns and launches, retail administration, automation, and specialty pharmacy, including the 340B Drug Discount Program to hospital and health systems nationwide and in Canada.

503B OUTSOURCED COMPOUNDING FACILITIES & SERVICES Q & A

If a company does not meet FDA expectations, FDA can issue a warning letter to improve processes, or even a cease and desist order to stop manufacturing and distributing products for patient use.

Fred Massoomi, PharmD, FASHP, Senior Director, Visante

Fred Massoomi, PharmD, FASHP, is Visanteâ&#x20AC;&#x2122;s Senior Director and expert in sterile compounding and hazardous drugs. He is a researcher, educator, and crusader for proper hazardous drug management and the safe disposal of pharmaceutical waste.

His specialties include hospital pharmacy management,

key USP chapters (<795>, <797>, and <800>), NIOSH hazardous drug compliance, pharmaceutical waste regulations, infectious diseases, and pharmacy automation.

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503B OUTSOURCED COMPOUNDING FACILITIES & SERVICES Buyer’s Guide

503B OUTSOURCED COMPOUNDING FACILITIES & SERVICES Buyer’s Guide Asteria Health 7004 Champion Boulevard Suite 100 Birmingham, AL 35242 (205) 995-0505 www.asteriahealth.com

ImprimisRx 12264 El Camino Real Suite 350 San Diego, CA 92130 (844) 446-6979 www.imprimisrx.com

PharMEDium 150 North Field Drive Suite 350 Lake Forest, IL 60045 (800) 523-7749 www.pharmedium.com

Brookfield Medical Surgical Supply Inc. 60 Old New Milford Road Suite 1B Brookfield, CT 06804 (203) 775-0862 www.brookfieldmedical.com

King Guide Publications, Inc. P.O. Box 10317 Napa, CA 94581 (888) 546-4484 kingguide.com

QuVa Pharma 3 Sugar Creek Center Boulevard Suite 250 Sugar Land, TX 77478 (888) 339-0874 www.quvapharma.com

Central Drugs Outsourcing Facility 511 S. Harbor Boulevard Building F La Habra, CA 90631 (562) 352-9630 www.centraldrugsrx.com Complete Pharmaceutics 5829 NW 158th Street Miami Lakes, FL 33014 (877) 714-1701 Completepharm.com Eagle 11111 S. Wilcrest Drive #S1000 Houston, TX 77099 (800) 745-8916 eagleanalytical.com Fagron Sterile Services 8710 E 34th Street N Wichita, KS 67226 fagronsterile.com Hybrid Pharma 1015 W. Newport Center Drive Suite 106A Deerfield Beach, FL 33442 (954) 708-2771 Hybridpharma.com

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KRS Global Biotechnology, Inc. 791 Park of Commerce Boulevard Suite 600 Boca Raton, FL 33487 (888) 502-2050 Krsbio.com LDT Health Solutions 38 Cedar Place Wayne, NJ 07470 (862) 221-9575 LDTRx.com Leiters 13796 Compark Boulevard Englewood, CO 80112 (800) 292-6772 www.leiters.com Medi-Fare Drug 300 West Pine Street Blacksburg, SC 29702 (800) 622-0007 medifaredrug.com Pentec Health 9 Creek Parkway Boothwyn, PA 19061 (866) 956-4376 www.pentechealth.com

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SCA Pharma 755 Rainbow Road Suite B Windsor, CT 06095 (877) 550-5059 scapharma.com STAQ Pharma 14135 East 42nd Avenue Unit 50 Denver, CO 80239 Staqpharma.com SterRx® LLC 141 Idaho Avenue Plattsburgh, NY 12903 (844) 319-7799 www.sterrx.com

503B Outsourced Compounding Facilities & Services www.RXinsider.com

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503B OUTSOURCED COMPOUNDING FACILITIES & SERVICES Market Leaders

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

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USP <800> Hazardous Drugs - Handling in Healthcare Settings Wipedown 1-2-3®’s three unique sterile saturated wipes deactivate, decontaminate, and clean to address exposure to most cytotoxic drugs. Their 12” x 12” size provides optimal saturation & coverage.

“Cleaning” the surface may just transfer the hazardous drug residue to other sources. “Deactivation” as preferred in USP <800>, renders the hazardous drug inactive. Be safe and deactivate.

USP <797> Compounding Sterile Preparations Compliant to USP <797>, these non-shedding premium wipers are manufactured sterile for specific use in ISO 5 Cleanrooms.

®

Sterile 3 Step Applicator Kit Step #1: Deactivate with HYPO-CHLOR® Wipe (5.25% Sodium Hypochlorite) Step #2: Decontaminate with THIO-WIPE® (2% USP Sodium Thiosulfate with Surfactant) Step #3: Clean with ALCOH-WIPE® (70% USP IPA)

Come see us at asHP BootH #1253

www.sterile.com • Veltek Associates Inc. 15 Lee Boulevard, Malvern, PA 19355-1234 • Phone: 610-644-8335 • Fax: 610-644-8336 Patents: www.sterile.com/patents

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VAI's WipeDown® 1-2-3 Deactivates, Decontaminates, and Cleans Most Hazardous Drugs From Compounding Surfaces WipeDown 1-2-3, with its 5.25% HYPO-CHLOR packet #1, doesn’t just “clean” but actually deactivates the HD residue from the workplace surface.

President & CEO: Arthur Vellutato Jr. Founded: 1981 Employees: 150 Toll-Free Phone:

(888) 4-STERILE Phone: (610) 644-8335 Fax: (610) 644-8336 Address: 15 Lee Boulevard Malvern, PA 19355-1234 Website: www.sterile.com

Company Background

Veltek Associates, Inc. (VAI) is the leader in contamination control for pharmaceutical, biotechnology, medical device, and USP <797> industries worldwide. VAI designs innovative solutions to address the control of particulate and microbial contamination while striving to develop meaningful technical relationships with our clients. VAI has been an industry leader since 1981 and owns numerous U.S.A. and foreign patents.

VAI’s comprehensive USP <797> contamination control program provides a guide to assuring patient protection in compounding sterile preparations.

Our full-circle approach addresses the practices and conditions required

by USP to maintain safe and compliant aseptic compounding. For each condition and practice required, VAI has an answer.

VAI is committed to continual innovation and improvement of our products to satisfy current and future regulatory requirements. Our industry experience and corporate capabilities provide the framework for continuing our leadership in contamination control. VAI’s product lines include: environmental monitoring equipment, laboratory services including antimicrobial testing, saturated wipers, dry wipers, a USP <800> compliance wipe kit, sterile disinfectants, sterile sporicides, cleaning agents, cleaning application equipment, personnel gowning, and consulting and training services.

Product Overview

VAI’s WipeDown® 1-2-3 has been specifically designed to address the risk of occupational exposure to most hazardous drugs during compounding sterile preparations, and administering, as outlined in USP <800>.

WipeDown 1-2-3 is a sterile three-step application wipe kit, that when used in sequence, provides deactivation, decontamination, and cleaning of sterile compounding surfaces from most hazardous drugs. WipeDown 1-2-3 satisfies both USP <797> compounding sterile preparations and USP <800> hazardous drugs – handling in healthcare settings. n Each Sterile WipeDown 1-2-3 Kit Includes: • Packet #1: HYPO-CHLOR®, 5.25% Sodium Hypochlorite for Deactivation

• Packet #2: THIO-WIPE®, 2% USP Sodium Thiosulfate with Surfactant for Decontamination • Packet #3: ALCOH-WIPE®, 70% USP Isopropyl Alcohol for Cleaning All three packets consist of premium wiper material that is, nonwoven, non-shedding, and 12"x12" for optimal use and saturation.

Each chemical component is formulated with water for injection and filtered at 0.2 microns with sterility assurance via aseptic fill into gamma irradiated sterile components or through gamma irradiation.

Individual kits, containing all three packets, are individually bagged and packaged into a liner bag for easy transport into sterile areas. Each kit is individually labeled with lot number and expiration, and each shipment of WipeDown 1-2-3 is supported by lot specific documentation.

Product Specifications

n Quality and Manufacturing • Lot Sterility Tested According to Current USP Compendium • Formulated With Water for Injection • Filtered at 0.2 Microns • Completely Lot Traceable • Double Bagged Sterile • All Three Chemicals are Assayed According to Current USP Compendium • Gamma Irradiated or Aseptically Filled Into Sterile Components • Delivered with Lot Specific Documentation n Features and Benefits • Packaged Neatly Folded for Easy Removal • Easy Tear Perforations on Each Wiper Packet for Easy Open • Designed to Comply With USP <797> – Sterile Kit • Ready To Use • 12"x12" • Wiper Material is Low in Particulate Shedding and Soluble Extracts • Deactivates Most Hazardous Drugs Present on Compounding Surfaces

Trade Shows/Meetings Attended

VAI will be attending ASHP’s Midyear 2019 Meeting in Las Vegas, NV from December 8th-12th. We will be displaying our WipeDown 1-23 and other USP <797> compliance products. Please come visit us at booth #1253.

Ordering Information

Contact VAI or one of VAI’s numerous healthcare distributors for ordering information on WipeDown 1-2-3 or any of our other USP <797> contamination control products.

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expect more with Sentry From innovative technology to expert knowledge and support, we stand ready to help you optimize your 340B benefit.

Reset your expectations for what a 340B solution provider should offer, including the trusted leadership and insight needed to set you up for success!

sentryds.com | 1.800.411.4566 © Copyright 2019 Sentry Data Systems, Inc. All Rights Reserved. No Unauthorized Reproduction. Sentry™ and Sentry Data Systems™ are trademarks of Sentry Data Systems, Inc.

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Sentry Data Systems – Expect More With a Trusted Leader in 340B Management and Compliance Sentry Data Systems, the revolutionary leader in automated pharmacy procurement, helps healthcare providers reduce cost of care and manage compliance to build strong 340B programs and reach more underserved patients.

• Integrates with any wholesaler to import data automatically.

• Qualifies dispensations automatically by leveraging multiple CDM and location-mapping scenarios.

President & CEO: 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

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, prescription type.

• Reduces burden on hospital and pharmacy staff with robust reporting capabilities and analytics.

• Includes the option to extract e-prescription data to connect prescribing events, improving accuracy and reducing audit risk.

Company Background

Since 2003, Sentry has been providing healthcare organizations with 340B management and compliance solutions to help you make better business decisions. We bring you more than just software solutions and technology – we deliver passion, expertise, and partnership, every step of the way. And as a company always at the forefront of innovation, it’s both our opportunity and our responsibility to pair our solutions with a strong analytical team that helps you navigate complex waters and continue to meet the needs of your underserved populations.

Product Overview

With Sentry, you can expect more. From innovative technology to expert knowledge and support, we stand ready to help you optimize your 340B benefit with powerful solutions that deliver the precision, compliance, insights, and savings you need to run a successful program.

• The only 340B vendor that can provide a fully integrated and longitudinal 340B audit record.

• Superior, proven technology and data integrity behind a robust and easy-to-use interface.

• Over 40 years cumulative audit and compliance experience with the industry’s only dedicated, 100% Apexus-certified audit team.

• Proactive support focused on your performance, with almost 30% of our staff dedicated solely to customer success.

• Long-standing industry leadership and advocacy on Capitol Hill.

Sentry Claims Manager Plus

Designed to help you accelerate payments and minimize denials for pharmacy claims, Claims Manager Plus processes claims quickly and efficiently while allowing you to remain compliant and in control for both Medicaid and Medicare 340B modifiers.

• Streamlines the adjudication process by automatically modifying claims based on your configurations.

• Identifies errors and rejections and then re-validates with real-time edits made directly in the application.

• Incorporates modifications to automatically adjust future claims without manual intervention.

Senturion™ 340B Pharmacy Services

Comprised of some of the industry’s most educated, credentialed, and experienced pharmacy experts, our Senturion Pharmacy Services team is an elevated resource to help you maximize your 340B program operations.

• Delivers actionable insights to help you identify additional savings opportunities and capture more 340B-eligible prescriptions.

• Supports you with 340B best practices, software configuration optimization, and solution-specific maintenance and analysis.

• Facilitates remote or onsite mock 340B audits to help you remain prepared and compliant.

Sentinel™ Hospital Procurement & 340B Compliance

Using proven methodologies and a robust feature set, Sentinel helps you 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 for more accurate determinations.

• Tracks dispensations from multiple sources, connecting the dots in the data and offering in-depth insights into the inventory.

Testimonial

“ Sentry Data Systems is the undeniable premier leader in 340B compliance solutions. Whether it’s their account managers, their IT team, or upper management, they are all very responsive and knowledgeable. I am very pleased to have experienced their dedication to my complete satisfaction.”

— Alexander Mansour, Director and 340B Compliance Officer, Henry Ford Health System WINTER 2019

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Nationwide network of leading health systems that support millions of lives and believe passionately in our mission

HEALTH SYSTEM NETWORK

PHARMACY BENEFIT MANAGEMENT & INTEGRATED PHARMACY CARE PROGRAMS

Industry’s most robust medical, pharmacy and total cost of care data platform for complex patients

Our health system-centric PBM plan and integrated pharmacy care programs that improve outcomes and the patient experience

Health system access and commercialization programs that optimize performance throughout the product lifecycle

COMPLEX PATIENT DATA PLATFORM MANUFACTURER PRODUCT LIFECYCLE PROGRAMS

Excelera connects manufacturers, health systems and payers through integrated programs that optimize the quality and cost of complex pharmacy patient care.

We are the preferred partner who delivers seamless access to a nationwide network of accredited health systems, the industry’s most comprehensive complex patient data platform, a health system-centric pharmacy benefit management plan and fully integrated pharmacy care programs. Through these intentionally connected offerings, we enable health systems and payers to improve the quality of care and patient outcomes; while empowering manufacturers to improve performance at every stage of the product lifecycle.

At Excelera, we are passionate about transforming the way integrated care is delivered in health system settings — and creating an environment where manufacturers, health systems, payers and patients … all win. We invite you to join us.

• Improved Access. Seamless access to complex pharmacy patients, vital medications and a nationwide network of accredited health systems.

• Capture Insights. Access to integrated medical, pharmacy and cost of care insights throughout the patient journey to improve patient experience and outcomes.

• Optimize Performance. Data-driven programs and expert guidance to manage risk and reduce the total cost of care.

Visit us at www.excelerarx.com or follow us on Linkedin.

EXPERIENCE Internal, integrated specialty pharmacy strategy improves net operating margin and quality of care.

$6M

Annual Net Operating Margin Increase

CHALLENGE/GOALS Join multiple specialty pharmacy pharmacies together to improve care and costs.

PROCESS A major Midwestern academic medical center needed to overcome a fragmented system of external specialty pharmacies with an internal, integrated specialty pharmacy strategy. Visante conducted a thorough pharmacy assessment and review, and developed an innovative plan to create and build a Retail/Outpatient and Specialty Pharmacy to support the academic medical center and Hemophilia Treatment Center. The plan included design space, software, equipment, staff, training, etc. In addition, Visanteâ&#x20AC;&#x2122;s team managed all specialty billing and reimbursement for the first 24 months of the program.

RESULTS Once Visanteâ&#x20AC;&#x2122;s plan was put in place, the medical center saw immediate improvements in continuity of care, patient and staff satisfaction, and outcomes of care and quality.

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30%

Increased Patient Satisfaction

100%

Increased Medical Staff Satisfaction

www.visanteinc.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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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.

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 ala 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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PharmASSIST® Pharmacy Automation Solutions From Innovation

Enabling pharmacists to evolve their roles to patient care providers so they can positively affect patient outcomes.

CEO:

Mary Reno Founded: 1972 Employees: 240 Stock Symbol: Private Phone: (607) 798-9376 Fax: (607) 729-5008 Address: 711 Innovation Way, Johnson City, NY 13790 Website: www.innovat.com

Company Background Innovation is the leading provider of pharmacy automation and prescription fulfillment optimization solutions to the retail, hospital, government, and mail order pharmacy markets, and the first choice of leading U.S. teaching hospitals. We are the only pharmacy automation provider that applies a data driven, engineering approach to each customized design and solution.

Together we will achieve your vision for your entire outpatient pharmacy operation.

Product Overview Our PharmASSIST® product suite covers all the bases of pharmacy fulfillment at both your outpatient pharmacies and high-volume centralized sites. Our scalable dispensing technologies and operations management platform helps you standardize your health system network’s technology infrastructure and develop a finely tuned technology growth path for the future. n PharmASSIST High Volume Solutions (HVS) Our High Volume Solutions are the most technologically advanced and most versatile pharmacy production systems in the industry today. Whatever your network’s goals and requirements, our scalable High Volume Solutions address the entire range of prescription volumes, workflow, physical space, staffing, and any other customer-specific factors. All systems encompass a completely integrated and configurable collection of highvolume robotic dispensing, workflow and operations management, conveying, collation, packing, and shipping technologies.

• HVS Quick Start: A pragmatic starting point for small to midsized sites that fill 500 to 6,000 scripts per shift.

• HVS Mid-size: Known as the “workhorse” system for mid-size sites that fill 2,000 to 12,000 scripts per shift.

• HVS Large/Custom: Customized, next-generation designs for large sites that fill 12,000 to 100,000 scripts per shift.

n PharmASSIST Symphony® for High Volume Serves as the adaptive brain of our High Volume Solutions, constantly adjusting to the alterations in workflow caused by changes in prescription demand. Harvesting its rich sources of data, Symphony continually optimizes your entire prescription production process, maintains high levels of throughput, eliminates the opportunity for errors, and enables your team to focus on performance. Symphony also extends into your inventory management and drug procurement processing, providing a more complete solution for managing perpetual inventory and automating purchasing at high-volume sites. n PharmASSIST SmartCabinet® Automates the counting of your outpatient pharmacy’s topmoving countable drugs and greatly enhances the quality of your dispensing process.

SmartCabinet’s small footprint delivers an unparalleled dispenser/space ratio with 50 dispensers in just three square feet, and the system easily scales in 50-dispenser increments. When integrated with a central fill/mail order solution, SmartCabinet helps decrease wait times and frees up staff to consult with patients at your outpatient pharmacies.

Additional Product Lines • PharmASSIST Light-Way™ will call and storage/retrieval technology, and PharmASSIST M4XL dispenser for high-volume sites.

• Compliance packaging, unit of use automation, and tabletop counting technologies.

• Consultative Design Services – wide range of services to help pharmacies optimize their pharmacy operations related processes.

Ordering Information

To learn how our PharmASSIST pharmacy automation solutions can transform your pharmacy operation, call (607) 352-2146 or email sales@innovat.com.

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CASE STUDY Workflow Strategies to Minimize Personnel and Environmental Exposure to Hazardous Drugs in the Compounding Pharmacy

Bryan Prince, MBA Owner and Lead Consultant ~ Red Pharmacy Consultants

Handling hazardous drugs in the compounding pharmacy, per USP chapter <800> guidelines, involves strategic workflow strategies with the goal of minimizing personnel and environmental exposure. In our previous article, "Can A Class I and Class II Biological Safety Cabinet be in the Same Sterile Hazardous Room” (Learn.Nuaire.com) we discussed varying workflow methods and the potential for exposure points during the hazardous drug (HD) presterilization process. The purpose of this article is to pull all of those chemical handling and compounding workflow strategies together into a more sequential model in an effort to minimize personnel and environmental exposure. The main focus of this article is on nonsterile hazardous drug handling processes, but the principles of GLP are applicable with both sterile and nonsterile chemical handling. We would also make the assertion that there is a higher likelihood of surface and airborne contamination in the non-sterile compounding rooms due to the volume and activity of dry powders being handled.

Where Does Contamination Come From?

Over the years we have visited many pharmacies and have witnessed consistent and similar workflow processes that create chemical exposure in compounding rooms. Here are the four most common workflow processes that contribute to environmental and personnel exposure.

1. Technicians breach the face of the C-PEC while actively weighing and manipulating powders to retrieve additional materials and/or interact with formulation documentation.

2. Dry-contaminated weigh boats, wipers, and gloves are disposed in open-face trash cans in the lab environment.

3. Contaminated weighing utensils, glassware and capsule plates are removed from the C-PEC and transported across the lab to the sink.

4. Bulk-chemical containers are not wiped down prior to placing back in storage.

The good news is that all of the four exposure points listed above are easily remedied with some simple process improvements that incur little to no additional cost to the pharmacy. The biggest hurdle will probably be changing old habits to create a new culture change within the pharmacy. The following recommendations below are proven chemical handling workflow methodologies that will minimize and even eliminate personnel and environmental exposure. What we guarantee is that if you change the process it will change the results for the betterment of your pharmacy’s staff and facility.

The Integral Step 1: Planning and Staging The "Compounding Record" is commonly the first document reviewed by the technician for the purpose of planning the formulation workflow process. The compounding record outlines the chemicals and ingredients necessary to formulate the script, but sometimes it's not the best directional roadmap for consistent process replication or for safe handling procedures. The detailed steps like mixing and quality control information are usually part of the Master Formulation Record, but what is missing on the compounding record is a more detailed list of materials required, such as proper utensils, mixing vessel, additional tools, and even the number of weigh boats required. Although this attention to written detail may seem quite trivial, we would make the case that the presence of such a concise planning document can better direct technicians safety workflow habits, in an effort to avoid the points of exposure as defined in the previous section “Where Does Contamination Come From?” We would also further the case by strongly recommending more detailed safety process documents in the HD compounding rooms to satisfy USP 800 language that states, "Each entity must have a designated person who is qualified and trained to be responsible for developing and implementing appropriate procedures." The "appropriate procedures" include all stages of the HD handling process and especially during the intimate stage of active chemical handling during compounding. This goal can be easily achieved by adding new language to the Master

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CASE STUDY Additional Commentary

Formulation Record and copied onto the compounding record by including references to: 1. HD Safety Handling Procedures for the chemicals and workflow process Example: Chemical bottles must be opened inside the primary engineering control.

2. Required Personal Protective Equipment (PPE) Example: A half-mask respirator with P100 cartridge filters must be worn during weighing and mixing of <name of chemical>.

3. All necessary materials needed to complete the compounded script Example: This formulary requires: 1-large weigh boat; 2-small weigh boats; 3-weighing utensils; 1-large mortar/pestle; etc.

4. Cleaning, deactivation, or decontamination processes for the HD chemicals Example: Initial bulk cleaning should be done with 70/30 Isopropyl Alcohol; Final cleaning must be done with peroxyacetic acid /hydrogen peroxidebased sporicidal disinfectant.

The language defined in points one through four above sound a lot like Standard Operating Procedures (SOP) language and it very well could be, but we contend that important SOP language is also unfortunately absent from the compounding records. SOPs are written for well intended purposes, but "repetition is the mother of skill," so without some consistent reinforcement of the intended purpose, it is possible we can sink back into old habits. One of the purposes of USP 800 is to create new habits for hazardous drug handling to make environments cleaner and keep employees safer, so we advocate a new iteration of detailed compounding records that more clearly defines purpose.

The best quality control method for interacting with formulation software is to scan one chemical and then weigh that chemical. We have witnessed varying methods of this process where a technician scans all chemicals first into the software, then loads the chemical bottles inside the CPEC. Although we commend them for trying to make the workflow process containment friendly, it overrides the software's quality control method.

â&#x20AC;&#x153;Stagingâ&#x20AC;? is an extension of planning and might be the most important strategic step towards minimizing exposure because it requires the technician to think all the way through the formulary workflow process prior to actually starting. Do not discount the importance of this front-end mental exercise in which a technician asks, "What do I need to complete this formulation from start to finish?" If the process of staging is handled correctly, then a large percent of opportunity for environmental exposure is solved because the technician has introduced all necessary materials inside the C-PEC. Now there should be no reason for them to breach containment with contaminated gloves for the reason of retrieving additional materials.

Here is a basic example of staging an encapsulation formulation: (See also Reference-1) 1. Three Chemicals 2. Three Weigh Boats 3. Three Weighing Utensils

4. Mortar and Pestle (or Mixing Vessel) Capsule Machine and Plate 5. Capsules

6. Capsule Tamper 7. Wipers for Cleaning

Space inside a compounding room is always a premium, as is the space inside the C-PEC. Staging chemical bottles, weigh boats, and utensils definitely takes up space, especially after you add-in an electronic balance and even a capsule machine. So in an effort to have enough real estate to stage all the necessary materials, it is highly recommended to use no less than a four-foot wide C-PEC to provide adequate space for the technician and for the CPEC's airflow to perform properly. Staging all the chemicals inside the C-PEC is probably a new concept for most because it is more common that we have witnessed staging of chemicals directly outside the C-PEC and retrieving as needed, which is why a wider C-PEC will entice the technician to follow the proper workflow procedure. Just to reinforce, the goal of "staging" is making sure once the technician commits to the C-PEC, they stay inside the C-PEC during the entirety of the formulation process.

Step 2: Documenting Chemicals and Weighing At this pivotal point we have fully established that all the necessary materials are staged inside the C-PEC, the technician has donned appropriate Personal Protective Equipment (PPE) and is willing to commit to the compounding formulation. Unfortunately the workflow process of documenting each step of the formulation is riddled with opportunities for contamination. Let's walk through the two most common methods of documentation, which are software-based and paper-based, and point out some opportunities for contamination, as well as solutions for minimizing exposure.

Software Documentation Interacting with the formulation software has always been a challenge because it requires the technician to actively engage the technology, which oftentimes causes contaminated hands to breach containment. Software processes that require technician interaction include: 1) Scanning the barcode on a chemical bottle; 2) Clicking the mouse to proceed to the next step; 3) Making an input on the keyboard.

Letâ&#x20AC;&#x2122;s analyze each of the active software engagement processes and offer solutions. The infrared (IR) scanner should be strategically placed to shine through the sidewall of the C-PEC. This will allow the IR beam to read and scan the bar code into the software. So staging all of the chemical bottles inside the C-PEC is still a valid solution.

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CASE STUDY The electronic balance is communicating with the formulation software and when the correct chemical weight is accepted by the software the technician usually has to click the mouse to proceed to the next step. The solution is to place a wireless mouse inside the hood near the right sidewall. Most people are right-handed and so the computer monitor workstation that displays the software should be also set up on the right side of the C-PEC for best ergonomics.

To avoid contaminating the mouse place sticky cellophane wrap (this is a dental supply product) over top of the mouse or bag the mouse in clear sandwich bag (See Reference-2 picture). Now the technician can interact with the wireless mouse inside the hood without breaching containment.

Reference-1: Proper Staging Inside the C-PEC

The keyboard is a challenge because it will not fit inside the C-PEC. The good news is that there are very few encounters with the keyboard, but it does occur. When faced with this challenge we recommend the technician spray their gloves with isopropyl alcohol (IPA) solution and wipe thoroughly to remove as much of the visible powder as possible from their gloves. Now when the technician breaches containment it is not a bad idea to have clear cellophane over the keyboard as another layer of safety. We have witnessed quite a few visibly contaminated keyboards during site visits and often recommend throwing them away because thoroughly cleaning all of the keys and crevices is impossible.

Paper Documentation Compounding pharmacies using a paper-based documentation method is more common than software, so for this reason, it is important to know how paper contributes to contamination. It is not uncommon to see nonsterile compounding rooms with reams of papers. Each one of those papers are a source for harboring contamination because paper is an organic and porous material. Moving forward towards USP 800 implementation, both the sterile HD and nonsterile HD rooms should be minimalist, which means we would strongly encourage implementing some level of digital technology over creating more paper based records.

Reference-2: Wireless Mouse Inside the C-PEC with Plastic Protective Cover

It is a safer practice to manually document chemical information (e.g. lot number, expiration date, NDC, etc.) on the compounding record prior to staging all the chemical bottles inside the C-PEC. To safely document chemical weights using the electronic balance we strongly recommend attaching a printer, but placing it outside the C-PEC. The printer's ticker-tape will document all the weights through the formulary process and not require the technician to interact with the ticker-tape paper until after formulation completion. As well, the Pharmacist-In-Charge can interact with the tickertape at a safe distance.

Handling Chemicals During Compounding Opening bulk chemical containers should only be done inside the C-PEC. Now this may seem like a logical statement but we still witness situations where a technician opens a container right off the storage shelf, maybe just to visually inspect whether or not a sufficient quantity of chemical exists to complete the current formulation, but it does happen.

So the point of opening chemicals only inside the C-PEC is worthy of reinforcing in written form on SOPs and verbal form during training. A good rule with handling chemicals is, unless a sufficient risk assessment has clearly documented that the chemical is safe to open outside of the C-PEC and requires no PPE, then always assume that the chemical has an exposure risk and requires containment.

Powder micronizes all the time, even inside a low-flow C-PEC. As each chemical is weighed in boats (or other vessel) and poured into the mixing vessel, the discarded weigh boats should stay inside the C-PEC. All mixing, manipulation, trituration, and encapsulation of dry powders should be performed inside the C-PEC. The only time it is safe to pull chemicals out of the CPEC is if they are in wet solution, such as a cream base, or in final dosage form like capsules. As well, the only time the discarded weigh boats, wipers, and gloves should be removed from the hood is if they are in a sealed bag. In a future article we will discuss waste removal and cleaning of the C-PEC, but the main point here is again, no dry materials are removed from the front face opening of the C-PEC.

Final Thoughts There are many opportunities for environmental and personnel exposure during the laborious path of HD handling and compounding. We have revealed only "qualitative" examples of exposure in this article during the active chemical handling phase. Yet our industry still lacks more "quantitative" validation through surface sampling to establish a real case for contamination acceptance. Regardless, what our goal was with this article was to identify common areas where chemical exposure can occur and to offer simple and inexpensive workflow solutions that will have a real impact on your compounding room's cleanliness. Safe chemical handling processes will yield safer workplaces and in turn produce better quality products for patients so it is important to understand the synergistic relationship between safety and quality for overall USP compliance.

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MEDICATION WORKFLOW COMPATIBLE BIOSAFETY CABINETS AND LAMINAR AIRFLOW WORKSTATIONS

M A X I M I Z E YO U R S A F E Y, P R O D U C T I V I T Y, A N D A C C U R A C Y W I T H A P R I M A R Y E N G I N E E R I N G C O N T R O L D E S I G N E D F O R Y O U R I V W O R K F L O W AU T O M AT I O N S O L U T I O N .

Primary Engineering Controls by NuAire.

www.nuaire.com © Copyright 2019. NuAire, All Rights Reserved.

THE MOST INNOVATIVE SINGLE-USE SEALS IN HOSPITAL PHARMACY TODAY • Sterile & Paper Free (USP 797 Compliant).

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

IV Port Bag Seals

• 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.

Check Out Our NEW Tamper-Clear Syringe Seal®

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

• Available in major wholesalers and distributors. *Tested in Nelson Labs, Salt Lake City, UT

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

The Steri-Tamp® Difference – Single-Use Seals With True Tamper-Evidence

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

Allied Pharmacy Products, Inc. is dedicated to safer drug handling in hospital, clinic, and pharmacy settings through tamper evidence and sterility solutions.

National Sales Manager: Alex Meadow Founded: 2010 Phone:

(516) 374-8862

Address: 100 Tec Street, Unit F Website: Email:

Hicksville, NY 11801 www.steri-tamp.com 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.

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.

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.

Features

n Steri-Tamp® IV Bag Port Seals • Offers the most fool-proof, potentially life-saving way of clarifying whether or not medication has been dispensed.

• 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/ICU Medical 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.

Perfect for sealing small oral, pediatric, and NICU syringes. n Available in 1,000 Seals Per Roll n All Seals Help to Reduce Waste, Improve Workflow, and Save You Time and Money

Testimonials

“ I really love that Steri-Tamp Seals stay on in refrigeration.”

— Pharmacy Technician

“ T he secondary layer is truly unique. I like that the top layer cannot be reapplied.”

— Pharmacist

“ Steri-tamps Clear Syringe Seal is the perfect solution for those small syringes – the nurses are happy to receive them without the graduations being covered.”

— Pharmacy Resident

Trade Shows/Meetings Attended

ASHP Midyear, EAHP (European Association of Hospital Pharmacists), and various state pharmacy conferences.

Ordering Information

Available through major wholesalers and distributors. Please visit our website for order information, and to view our dispensing and application training videos: www.steri-tamp.com.

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INNOVATION IN

SECURE DRUG DELIVERY For 50 years IMI has manufactured innovative devices that help protect the delivery of drugs within the healthcare system. Pharmacists rely on Prep-Lockâ&#x201E;˘ Tamper Evident Caps for ease of installation while clinicians appreciate the simplicity of removal for drug administration.

Prep-Lock Tamper Evident Caps for IV Syringes are the industry standard for guarding compounded sterile preparations from unauthorized access, diversion and misuse. IMI offers a variety of products that protect drug delivery including IV, Oral and Enteral devices.

CONTACT US FOR FREE EVALUATION SAMPLES MADE IN THE USA

IM I

1.800.344.2554 WWW.IMIWEB.COM

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Prep-Lock™ From IMI Guards Against Drug Diversion and Misuse

Increase pharmacy productivity and safety with economical, American-made devices designed to advance the safety and security of your drug products and ultimately your patients.

President:

Jonathan Vitello Founded: 1969 Employees: 100+ Toll-Free Phone: (800) 344-2554 Phone: (954) 917-9570 Fax: (954) 917-9244 Address: 2981 Gateway Drive Pompano Beach, FL 33069 Website: www.imiweb.com

Company Background

IMI is celebrating 50 years of working closely with pharmacists and compounding professionals to create innovative, American-made sterile products that meet very specialized needs. Throughout this time, IMI has established long standing partnerships with some of the biggest names in healthcare. Through these partnerships and directly, IMI is delivering the kind of high-quality and high-value products that pharmacy operations demand. All IMI products are manufactured in the U.S.A. under the strictest quality standards at their FDA registered, ISO 13485 certified facility. IMI is pleased to announce that it has received certification for the successful completion of a Quality Management System audit under the Medical Device Single Audit Program (MDSAP).

Product Overview

n Prep-Lock™ Tamper Evident Caps – for Sterile IV Luer Lock Syringes Compounded sterile preparations (CSPs) are at their greatest risk when they leave the custody of your pharmacy. The Prep-Lock Tamper Evident Cap greatly reduces the risk of your CSP being compromised either accidentally or intentionally. It ensures that product integrity is maintained from the time it leaves the sterile hood until it is administered by an authorized clinician.

If your facility uses an outsource compounder, chances are you are already familiar with IMI’s tamper evident cap technology. You can easily incorporate the use of this cap for your in-house preparations which will provide standardization of all syringes throughout your hospital.

Installing the tamper evident cap in your compounding operation is highly efficient. Each sterile tray of 10 caps offers the pharmacist the ability to quickly install the cap with a simple twist of the syringe. This helps to reduce the risk of touch contamination and enhances aseptic technique.

Administering a syringe is very easy for the authorized clinician. Simply pull off the outer sleeve of the tamper evident cap, unscrew the remaining luer lock cap, and discard.

A choice of three different colored caps and two outer sleeve styles allows the pharmacy the ability to color code either specific drug classes or processes.

n Prep-Lock™ Tamper Evident Caps – with Male Connector for CADD Cassettes

Drugs are prepared in a variety of devices with different connector types.

When those devices feature a female luer lock connector, the Prep-Lock Tamper Evident Cap with Male Luer Lock Connector can provide all the same safety and protection benefits found in IMI’s entire family of tamper evident products. n Prep-Lock™ Tamper Evident Additive Port Cap The Tamper Evident Additive Port Cap for select Baxter containers offers your IV Bag preparations unparalleled protection against potential tampering or misuse. They perfectly complement your overall drug safety program. The advanced design ensures a secure closure. Once the additive port cap is applied, it cannot be removed without damage to the bag. The simple one-handed installation is a preferred solution over sticky foil seals. The Additive Port Cap also serves as an indicator that medication has been added. n Prep-Lock™ Tamper Evident Caps – for ENFit® Syringes The ENFit® connector standard (ISO 80369-3) for enteral feeding devices is a welcomed feature for mitigating potential misconnections.

IMI is pleased to offer a tamper evident cap for ENFit syringes that further enhances patient safety. These innovative caps help guard against drug diversion and misuse from the time the syringe leaves the pharmacy until the time it is administered. The tamper evident cap is compatible with both standard and low dose ENFit syringes.

Additional Product Lines

IMI offers a variety of sterile devices designed for the compounding pharmacist:

• Prep-Lock™: Tamper Evident Caps for Oral Syringes • Prep-Seal™: Sterile Luer Lock Caps and Plugs • Prep-Fill™: Sterile Luer Lock Connectors • Rx-Vent™: Sterile Venting Needles • Rx-Tract™: Sterile Aspirating Needles

Trade Shows/Meetings Attended

IMI regularly participates at a variety of industry trade shows and conferences including: • American Society of Health‑System Pharmacists (ASHP) • European Association of Hospital Pharmacists (EAHP) • National Pharmacy Purchasing Association (NPPA) • International Health Facility Diversion Association (IHFDA) • Hospital Pharmacy Conference (Health Connect Partners) Contact the event website or IMI for dates and booth numbers.

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Unit Dose Done Right

Unit Do se Bar Cod , ing, Pharma cy & Nursing Supply Experts !

• Ultraviolet Inhibitant • Moisture Resistant • Reduces Cross Contamination • Ideal for Meds Covered by USP 800 • Tamper-Evident • Cold Seal • 6 and 12-month Beyond-Use Dating • 1-D and 2-D Bar Coding • Flexible Label and Report Formatting • Multiple Sizes to Fit Your Meds and Storage Needs

Simple. Reliable.

800.523.8966

MediDose.com

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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 Toll-Free Fax: (800) 323-8966 Address: 70 Industrial Drive Ivyland, PA 18974 Website: www.medidose.com

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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Pharmacy & Business working together to optimize your results No one makes pharmacy and business work together like Visante. Our consulting work with Integrated Delivery Networks, hospitals and health systems combines a wealth of expertise with personalized and comprehensive support so you can optimize your pharmacy operations and deliver better patient care.

High-performing pharmacy is who we are • 340B Program • Specialty Pharmacy • Sterile Compounding & USP Excellence • Drug Diversion Prevention

• Comprehensive Pharmacy Assessments • Pharmacy Finance and Reimbursement • Pharmacy Stars TM Compliance Tools

Learn more at visanteinc.com, or contact us at solutions @ visanteinc.com or (866) 388-7583.

© 2019 Visante, Inc. All Rights Reserved.

WE ALL HAVE DIFFERENT SKILLS! OURS IS REPACKAGING. At UDS, you can use our expert skill set allowing your pharmacy to perform more critical tasks.

TIME IS MONEY

SPEND YOURS WISELY

TIME COST

QUALITY

• DSCSA SERIALIZATION COMPLIANT REPACKAGER • USP <800> HAZARDOUS DRUG COMPLIANT REPACKAGER • CONTROL DRUG (CII-CV) REPACKAGER

Enhance patient safety and reduce overall cost at the same time.

Call us to find out how easy it is to get started!

www.unitdoseinc.com | 886.649.1145

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 For listing and advertising details, please contact Sales@RXinsider.com or call 800.972.2083

RXinsiderâ&#x20AC;&#x2122;s Virtual Pharmacy Trade Show 24 / 7 / 365 450+ Booths, 91 Aisles www.rxinsider.com ASHP Midyear Clinical Meeting and Exhibition December 8-12, 2019 Las Vegas, NV www.ashp.org/Meetingsand-Events ECRM Specialty Pharmacy Program January 8 -10, 2020 Hilton Head Marriott Resort & Spa Hilton Head, SC ecrm.marketgate.com/ sessions 340B Coalition Winter Conference February 10-12, 2020 Hilton San Diego Bayfront San Diego, CA 340bwinterconference.org ACA | ACVP Annual Conference & Expo 2020 February 19-22, 2020 The Don Cesar St. Pete Beach, FL acainfo.org/ace

PDS Super-Conference 2020 February 27-29, 2020 Rosen Shingle Creek Orlando, FL www.pdsconference. com/2020-conference 2020 FAH Public Policy Conference and Business Exposition March 1-3, 2020 Marriott Wardman Park Hotel Washington, DC fah.org/conference/fahpublic-policy-conferenceand-business-exposition HIMSS20 Conference & Exhibition March 9-13, 2020 Orange County Convention Center Orlando, FL www.himssconference.org APhA 2020 March 20-23, 2020 National Harbor, MD Aphameeting.pharmacist.com NHIA Annual Conference April 5-9, 2020 Gaylord Rockies Resort & Convention Center Aurora, CO www.nhia.org

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Pharmacy Case Studies take an in-depth look at specific products and services that help pharmacies improve patient care, profitability, and cost containment.

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H E A LT H S Y S T E M â&#x20AC;˘ I N F U S I O N

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.

Individual Membership

Through your hospitalâ&#x20AC;&#x2122;s membership, you are eligible to join this supplemental program which provides professional development and networking opportunities.

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.

National Conferences

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.

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.

Roundtables

340B Health hosts interactive roundtables throughout the year. In 2018 alone, roundtables were conducted in nearly a dozen states. These half-day seminars provide vital 340B information, create a forum for idea generation, and are always free to attend.

Questions? Contact Shane Kelley at (202) 552-5864 or email shane.kelley@340bhealth.org.

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Behind Every Good Pharmacist, is a Great Resource.

With 80+ aisles, the Virtual Pharmacy Trade Show is pharmacyâ&#x20AC;&#x2122;s one-stop destination to research and connect with leading providers of products and services throughout every pharmacy category and practice setting.

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UNCOVER NEW PRODUCTS, TECHNOLOGY AND SERVICES DRIVE EFFECTIVE INTERACTIONS BETWEEN QUALIFIED PARTNERS GAIN MARKET INSIGHT AND EDUCATION Contact Michael Castillo, SVP of Pharmacy & Medical Markets for more information 440-528-0441 | MCastillo@ECRM.MarketGate.com | ECRM.MarketGate.com

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Behind Every Good Pharmacist, is a Great Resource.

Event Calendar

Trade Shows, Meetings, & Expositions

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continued from page 78

NACDS Annual Meeting 2020 April 25-28, 2020 Scottsdale, AZ Annual.nacds.org

Cardinal Health RBC July 15 -18, 2020 Colorado Convention Center Denver, CO rbc.cardinalhealth.com

Asembia Specialty Pharmacy Summit May 4-7, 2020 Wynn & Encore Las Vegas, NV www.asembiasummit.com

AACP July 18 -22, 2020 Long Beach, CA www.aacp.org/event/ pharmacy-education-2020

2020 ACVP Veterinary Pharmacy Conference June 2020 vetmeds.org/vpc

NACDS Total Store Expo August 8-10, 2020 San Diego Convention Center San Diego, CA tse.nacds.org

ASHP Summer Meetings & Exhibition 2020 June 6-10, 2020 Seattle, WA Summer.ashp.org

IACP Compounders on Capitol Hill September 9-10, 2020 Washington, DC www.iacprx.org

McKesson ideaShare 2020 July 12-16, 2020 Austin Convention Center Austin, TX mckessonideashare.com

NCPA Annual Conference October 17-20, 2020 Nashville, TN convention.ncpanet.org

CASE STUDY VIDEO SERIES

Southern Ohio Medical Center Join leadership at Southern Ohio Medical Center, as they discuss beginning their clinic-based specialty pharmacy services in partnership with Trellis Rx, and how it has significantly enhanced the specialty medication experience for patients and providers.

trellisrx.com

All shows are subject to change.

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H E A LT H S Y S T E M • I N F U S I O N 83

Behind Every Good Pharmacist, is a Great Resource.

RXinsiderâ&#x20AC;&#x2122;s Thought Leader Video Series are informative videos comprised of multiple interviews with thought leaders throughout the pharmacy profession. Explore niche subject matter and gain insight through hundreds of thought leader videos.

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EXPERIENCE 340B Covered Entity Overcomes Challenges of Disparate Split-Billing Systems

3%

Additional Resources To Be Successful

CHALLENGE/GOALS Several years had gone by without appropriate oversight for this Covered Entity with a large contract pharmacy network. Visante’s audit uncovered that nearly a third of the registered contract pharmacy locations did not have active dispensations, and several of the contract pharmacies had effective dates on the OPA website in advance of the contract being signed.

PROCESS 340B Program contract pharmacy oversight is no less challenging than oversight in the mixed-use (to include clinic and floor stock) space. Because many contract pharmacies have dedicated split-billing vendors, a large contract pharmacy network often involves multiple split-billing systems which are not designed to interface/integrate. Upon our initial audit, Visante realized that there were numerous contract pharmacy locations that had no dispensing activity over the course of six months, and many that had very low dispensing volume (less than 15 dispenses total over the course of six months, for non-specialty medications). It is important to distinguish that low volumes for generic or brand medications are a different consideration than specialty medications. Additionally, there were several contract pharmacy effective dates on the OPA website that did not correspond with the contract signature dates which resulted in dispensing occurring prior to the official “effective date.” Lastly, there were multiple split-billing vendors in place for contract pharmacy dispenses, and when tested against the contract pharmacy locations with minimal to low volume, it was determined that two of the split-billing platform relationships could be eliminated.

RESULTS

www.visanteinc.com

In just six months, the Visante team worked with the Covered Entity to make major changes to its contract pharmacy operations and develop a strategy that will set them up for long term success. Specifically: Visante successfully supported an update of the OPA database to remove all locations with minimal to no volume over the course of six months. The team removed a number of contract locations after determining that were multiple barriers that would take several more months or longer to overcome. Visante reviewed e-prescribing data and history to determine where prescriptions were going, and created a contract pharmacy strategy focused around Covered Entity detail that was real and meaningful.

85

A better, greener waste solution Cactus controlled substance waste management systems

Cactus Pharma Lock® OR System

Cactus Smart Sink® System

For more information, please call 800 253 3210.

Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: Pharma Lock, Smart Sink, Stryker. All other trademarks are trademarks of their respective owners or holders. © 2019 Stryker | www.stryker.com | 9100-004-677 Rev none

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

Stryker Cactus Smart Sink and Cactus PharmaLock OR Stryker's Cactus Smart Sink System securely captures partially administered, nonhazardous controlled substances and renders them non-retrievable and unusable.

The Cactus Smart Sink System helps reduce drug diversion and improve patient safety while also reducing the impact on the environment.

President & CEO: Kevin A. Lobo Founded: 1941

Employees: 36,000+ Stock Symbol:

SYK (800) 367-5690 Phone: (269) 385-2600 Fax: (269) 385-2300 Address: 2825 Airview Boulevard, Kalamazoo, MI 49002 Website: www.stryker.com Toll-Free Phone:

Company Background

When Dr. Homer Stryker, an orthopaedic surgeon from Kalamazoo, Michigan, U.S.A., found that certain medical products were not meeting his patients’ needs, he invented new ones. As interest in these products grew, Dr. Stryker started a company in 1941 to produce them.

Today, we are one of the world's leading medical technology companies.

Our growth is based on a diverse array of innovative products and services in orthopaedics, medical and surgical, and neurotechnology and spine that help improve patient and hospital outcomes – which we achieve through the dedication of our more than 33,000 employees globally.

We are well-positioned to continue serving the worldwide medical community for generations to come. We think Dr. Stryker would be pleased.

Product Overview

Stryker’s Cactus Smart Sink System is an easy-to-use, “green” waste solution for partially administered, non-hazardous controlled substances pharmaceuticals. It accepts unused portions or partial doses of controlled substances and provides for a secure alternative to a sink, toilet, red sharps container, or waste bin for drug waste. This innovative and compact system helps bring medical facilities into compliance by eliminating the impact to our environment while preventing unauthorized use of partially administered DEA-regulated controlled substances.

The Cactus Smart Sink System automatically secures and renders controlled substance waste unusable and non-recoverable while providing a secured bridge from traditional drug disposal to proper and responsible disposal.

This system utilizes two replaceable cartridges: one liquid cartridge for liquid waste and one solid cartridge for capsules, tablets, and patches.

Both cartridges allow for continuous disposal over time and are designed to last up to 90 days. The system utilizes automatic timers and weight indicators providing notice when cartridges are full or have expired.

The system also allows you to choose a preferred expiration date by using the built-in timer selector switch.

The Cactus Smart Sink System helps bring medical facilities into compliance by providing a secured and environmentally friendly method of disposal.

• It facilitates properly witnessed wasting of narcotics in the open and near the drug dispensing systems where needed, improving safety and saving time.

• It allows for up-front waste documentation and facilitates this process to be completed immediately (when controlled substances are dispensed) rather than later.

• It provides for secure disposal of partially administered, nonhazardous controlled substances, as opposed to the insertion of drugs into red sharps containers.

• It reduces the opportunities for drug diversion by facilitating twoperson witnessed-wasting and by keeping partially filled vials and syringes out of red sharps containers, which have become a key source for drug diversion in medical facilities.

Features & Options

n Cactus Exclusives • Patented Proprietary Mixture: This patented technology uses

a combination of denaturants and deterrents to render drugs unusable and non-retrievable in accordance with the DEA standards for controlled substance disposal.

• Secure System: The Smart Sink and PharmaLock OR are fully

locking systems, complete with universal key sets. Additionally, the Smart Sink has an alarm system with both audible and visual alerts that notify the user when the lid is unlocked and when the cartridges have reached roughly 90% of their wasting capacity.

n Technology: Offers both audible and visual alerts that notify the user when the cartridges are roughly 90% full.

Product Specifications

n Cactus Smart Sink • Accepts both liquid and solid pharmaceutical waste. Solids are accepted in the form of tablets, capsules, and patches.

• Liquid cartridge solidifies drugs within 15 seconds with a wasting capacity of 3.2 L. • Solids cartridge features a uniquely designed pill maze and patch slot, rendering drugs acutely non-divertible with a max wasting volume of 1.7 L (approximately 1,500 pills).

• Locking lid with a universal key set for added security.

• Audible and visual alarm system that alerts user when lid is locked.

• Audible and visual alerts to notify user when cartridges are full.

• Can be wall or countertop mounted.

• Comes with antimicrobial, wipeable exterior.

• Powered by either a battery or AC adaptor unit.

D0000020373 AA.1

WINTER 2019

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H E A LT H S Y S T E M • I N F U S I O N 87

RXGON Pad HD Prep Mats ®

PROVEN TO DEACTIVATE HAZARDOUS DRUGS

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

Your One-Stop Source for All Tamper Evident Needs – Health Care Logistics® Find a diverse selection of USP <800> and infection prevention solutions in one convenient location. In addition to stock items such as cleaning tools and infection control mats, HCL can manufacture stainless steel containers and trays to help achieve your compliance goals.

President & CEO: Gary Sharpe Founded: 1978

Employees: 300+ Toll-Free Phone:

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

Company Background

What began 40+ years ago as a garage-based business at the home of founder Gary Sharpe, now encompasses five well-equipped facilities in Central Ohio and reaches customers around the globe. Employment has also grown, with more than 300 employees now dedicated to HCL’s mission of providing unmatched customer service. Complete customer satisfaction is at the heart of everything HCL does.

Product Overview

Containing HD surface contamination is a tough job. While there’s no single solution to effectively deactivate all chemo agents, Health Care Logistics offers the RXGon® Pad HD Prep Mat to significantly simplify the process. This innovative mat combines the absorption of a standard prep mat with the power of activated carbon to form a protective barrier between HD solutions and work surfaces. RXGon Pad HD Prep Mat is proven to prevent surface contamination from common marker HDs cyclophosphamide and fluorouracil by using the activated carbon in the mat to encapsulate and absorb liquids. Likewise, the poly backing shields surfaces from leaks or “bleed through.” Efficacy data and lint test results can be found at goHCL.com.

The 12"x12" low-lint mat is a versatile tool that can be used anywhere HD contamination is possible, including: • Shipping, Transport, and Storage: Studies indicate that shipping containers, transport totes, and carousel bins are a major source of HD contamination. RXGon Pad HD Prep Mat can be used to line these containers to protect staff against leaking containers and broken vials.

• Compounding and Dispensing: RXGon Pad HD Prep Mat can be used to line work surfaces in the nonsterile prep area, limiting unnecessary contamination.

• Administration: The RXGon Pad HD Prep Mat can line work surfaces to prevent contamination of the drug administration area.

Users may also place it under the IV drip to catch any accidental leaks.

• Home Health: Patients may be instructed to use the RXGon Pad HD Prep Mat under their medication bottles and when prepping pumps to limit contamination in the home.

HCL offers a complete inventory of infection prevention solutions to reduce the risk of contamination and help users improve the quality of patient care. Look for the RXGon Pad HD Prep Mat along with PPE, disinfectants and cleaners, surface and fingertip test kits, HD waste disposal options, hygiene stations, and more.

Visit gohcl.com to see how HCL can be the single-source resource for all your pharmacy essentials.

Additional Options

In addition to stock items designed to help customers achieve USP compliance, HCL provides a variety of in-house specialty design services. Design consultations are always free, there are no minimum order requirements and orders ship within seven days of approval.

• 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.

• Metals by Design and Plastics by Design: One-of-a-kind items manufactured to match individual customer requests. Product modifications are also possible. These allow customers to work more efficiently and produce better results.

• Printing and Graphics: From labels, magnets, and clings to banners, signs, and stamps, HCL’s print specialists can create solutions for any situation.

Product Specifications

HCL’s inventory includes compounding and dispensing items, infection prevention supplies, unit dose packaging materials, and much more.

The company offers small package quantities, free samples, and ships most orders the same day. HCL’s hassle-free return policy allows customers to return any product, at any time, for any reason.

Additional Product Lines

Unit Dose; Storage; IV Accessories and Injectables; Compounding and Dispensing; Seals; Plastic Bags; Refrigerators, Freezers and Accessories; Temperature Monitoring; Infection Prevention; Carts and Accessories; Pharmacy Supplies; Crushers, Cutters, and Organizers; Error Prevention

Ordering Information

Health Care Logistics offers small package quantities, no minimum order requirements, free samples, and ships most orders the same day. The company’s hassle-free return policy allows customers to return any product, at any time, for any reason. HCL’s Live Chat customer service team is available from 8 a.m. to 8 p.m. EST Monday - Friday.

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H E A LT H S Y S T E M • I N F U S I O N 89

CASE STUDY Parata's System of Compliance Packaging Scales Quickly and Integrates Smoothly Pharmacies and patients benefit from pouch packaging technology.

Paul Magno, BS Pharm, RPh Manager, Outpatient Pharmacy Ambulatory Care Programs ~ Boston Medical Center Paul Magno manages critical patient access programs in the Outpatient/Retail Pharmacy Department for Boston Medical Center. The Medication to Bedside, Medication Adherence Packaging, Concierge Service and My Medicine Health programs assist patients with their compliance and persistence of medication therapies. Team engagement ensures the success of these programs, but more importantly, positive impact on the health of our patients.

Paul was born in Newton, MA and raised in Waltham, MA. He received his BS in Pharmacy from the Massachusetts College of Pharmacy and Allied Health Sciences. He is completing his Masters Degree in Healthcare Administration at Louisiana State University, Shreveport.

Sebastian Hamilton, BS Pharm, RPh, MBA, Pharm.D Director Outpatient/Retail Pharmacy Services ~ Boston Medical Center Dr. Sebastian Hamilton manages the outpatient/retail pharmacy department for Boston Medical Center.

Leading a highly motivated pharmacy team of over 200, 1.3 million prescriptions a year are processed from three on campus pharmacies and an off-campus mail order pharmacy generating over $300M in total revenue a year for BMC. Dr. Hamilton, born in Harlem NY and raised in Bronx, NY, received his BS in Pharmacy from Long Island University (Brooklyn), MBA in Health Care Administration from Wilmington University, and Doctor of Pharmacy from the University of Florida (GO GATORS!). Dr. Hamilton currently serves on the Massachusetts Board of Registration in Pharmacy as a professional member.

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parata.com

PRIMARY INTENDED OUTCOME Poor medication compliance contributes to chronic disease complications and reduced quality of life for patients; it also greatly increases healthcare costs.

The Centers for Disease Control and Prevention estimates that inadequate compliance costs between $100 and $300 billion yearly in the United States.

Parata provides innovative medication pouch packaging technology that drives growth and efficiency for pharmacies, while providing convenience and improved well-being for patients and caregivers.

THE CHALLENGE Medication compliance is crucial to improve chronic disease outcomes and reduce healthcare system costs. Research indicates that special reminder packaging incorporating the date and time for dosing, can increase medication compliance. “Our demographic struggles with taking medication,” said Paul Magno, Ambulatory Care Program Manager for Outpatient Pharmacy at Boston Medical Center. “We are the largest safety net hospital in New England, and five or six languages are used on a daily basis, adding to the challenge.”

Smaller pharmacies interested in offering compliance packaging often start out with a manual system, which can be difficult to scale when business grows.

“BMC had been using an older compliance packaging system for years, and the

CASE STUDY THE BENEFITS OF COMPLIANCE PACKAGING Medication compliance is a complex behavior that is influenced by a number of factors, including complex dosing regimens, cognition or mental health issues, and language barriers. Research has shown that specialized compliance packaging has a positive impact on a variety of outcomes.

INCREASED MEDICATION ADHERENCE.

Patients who receive medications packaged by dose increase their compliance. One study showed that patients using adherence packaging increased their medication compliance from 62% to 90% in three months.

REDUCED MEDICATION WASTE.

Medication noncompliance results in doses that are not taken at all. A study showed that specialized packaging reduced unused doses by 29%.

IMPROVED CLINICAL OUTCOMES.

Patients who take their medications as directed and refill prescriptions on time do better. Researchers found that hypertension patients receiving medication in compliance packaging had reduced diastolic blood pressure.

INCREASED PHARMACY PROFIT.

Medication adherence services including special packaging improve the number of chronic medication fills. One study showed compliance packaging increased yearly profit per patient by approximately $350.

number of patients served was relatively small, 50 to 100 patients a month,” said Sebastian Hamilton, Director Outpatient/Retail Pharmacy Services at Boston Medical Center. “As the pharmacy program grew to over 900 patients a month, with each patient receiving on average eight medications, it became clear that we needed to better manage this program using automation.”

THE DECISION Manually packaging medications is a tedious process that requires pharmacists to complete each patient’s monthly supply. This increases labor costs and takes pharmacists away from providing direct patient care. Manual packaging is also less accurate. Boston Medical Center saw this problem emerging and took steps to correct it.

“We began to see an increase in packaging errors due to pharmacists being stressed to meet the daily volume needed for patients to continue their medication therapies without interruption,” said Hamilton. “In the interest of patient safety, it was decided not to add any more patients into the medication compliance program until we developed a process to provide this service more efficiently and safely.”

Parata’s ATP® 2 Pouch Packager packaging units offer a reduced need for manual labor combined with accuracy and scalability in a relatively small footprint. The system’s ability to streamline and automate the pharmacist medication process, which eliminates about 90% of the check time, was also important to Boston Medical Center. The inclusion of staff training and ongoing customer service also influenced the decision. “[Their status as] industry leader in adherence packaging combined with Parata’s ability to provide proper training and ongoing support were also key factors in leading us to make this purchase,” said Magno.

THE RESULTS Automated compliance packaging streamlines the process and frees up staff.

“In the past we had a very manual process, generating labels and requiring a tech to count meds into vials, which were then sent to a pharmacist to place

parata.com

91

CASE STUDY one-by-one into a pouch or card cavity,” said Magno. “Now we transmit the information electronically to the filling unit and that automatically pouches up most of our packaged meds.”

Since implementing Parata technology, Boston Medical Center has increased total output by more than 16%. “I would say that is directly related to the automated packaging units,” said Magno. “More and more complex care patients are enrolling in our program because of the adherence package benefit.”

Adherence packaging is safer, as well as more convenient for patients.

The Parata ATP unit utilizes AdherePac pouches and seals each dose in a separate, perforated area. “If a patient is traveling overnight or to a group home, they don’t need to take an entire box of pouches. They can take just what they need,” said Magno.

Boston Medical Center utilizes two differently sized ATP packaging units, as well as Parata’s BullsEye Tablet Splitter and their InspectRx® Pouch Inspector unit. The InspectRx machine works in tandem with the ATP units and identifies 12 physical characteristics to ensure medications are placed in the correct pouches. The unit also captures images of every pouch filled, creating an accurate visual record of all medications dispensed.

THE CONCLUSION Implementing Parata’s ATP units has increased Boston Medical Center’s output and reduced overhead at the same time. “We’ve been able to produce a high number of packages safely per day, our labor cost to produce packaging has reduced, and we are able to scale to meet demand safely without a proportional increase in labor costs,” said Hamilton.

Boston Medical Center has plans to expand pharmacy operations from 9:00 a.m. to 5:30 p.m. to 24 hours a day. “This means our pharmacists could do outreach to patients during the day, and the Parata units would fill pouches at night for sending out the next day,” said Magno.

TCGRx and Parata merged at the end of 2018 to offer the most comprehensive pharmacy technology portfolio.

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parata.com

Powering pharmacies to help people lead healthier lives.

From adherence packaging and vial-filling to workflow and patient experience solutions,

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engaged with patients to improve medication adherence and boost customer loyalty. Explore the most comprehensive pharmacy automation portfolio at parata.com.

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Supporting Pharmacy Efficiency with an Evolving Product Offering

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Liquid Unit Dose

from American Health Packaging American Health Packaging delivers unit-dose products supporting patient safety and pharmacy efficiency initiatives. Products come in multiple pack sizes to provide flexibility in managing local inventory. Liquid Unit Dose cups are available through partner wholesalers and GPOs. Pull-tab labels promote ease of opening and product administration Thick-gauge cups, excellent seal integrity aid in avoiding costly damage and clean up Cups and storage trays are designed to optimize limited shelf storage space

McKesson Item #

Morris & Dickson #

Product Description

5517206

3795689

584466

Fluoxetine Oral Solution, USP

20mg/5mL

5mL

5465380

3917226

363275

Fluoxetine Oral Solution, USP

20mg/5mL

5mL

ABC 8-digit #

Cardinal Item #

10211921 10188404

Cup Strength

Pack Size

NDC

20mg/5mL

40 cups

60687-0244-77

20mg/5mL

50 cups

60687-0244-67

7.25mg/325mg/15mL 15mL 7.25mg/325mg/15mL 50 cups

60687-0417-71

Unit Strength

Cup Delivery

10228115

5552237

3968229

752410

Hydrocodone Bitartrate & APAP Oral Solution CII

10211783

5517214

3901766

584557

Levetiracetam Oral Solution, USP

100mg/mL

5mL

500mg/5mL

40 cups

60687-0249-77

10183100

5430343

3775822

238550

Levetiracetam Oral Solution, USP

100mg/mL

5mL

500mg/5mL

50 cups

60687-0249-67

10210354

5512413

3777034

568063

Ondansetron Oral Solution, USP

4mg/5mL

5mL

4mg/5mL

30 cups

60687-0252-86

10219153

5528518

3949997

603993

Oxycodone HCl Oral Solution CII, USP

5mg/5mL

5mL

5mg/5mL

40 cups

60687-0406-77

10219154

5528526

3950037

604306

Oxycodone HCl Oral Solution CII, USP

5mg/5mL

5mL

5mg/5mL

50 cups

60687-0406-67

10209414

5508114

3751294

560649

Phenytoin Oral Suspension, USP

125mg/5mL

4mL

100mg/4mL

50 cups

60687-0275-66

10211558

5515705

3935129

575878

Potassium Chloride Oral Solution, USP 10%

20mEq/15mL

15mL

20mEq/15mL

30 cups

60687-0341-58

10212031

5520416

3909884

584904

Potassium Chloride Oral Solution, USP 10%

20mEq/15mL

15mL

20mEq/15mL

40 cups

60687-0341-64

10191061

5486220

3263035

321570

Potassium Chloride Oral Solution, USP 10%

20mEq/15mL

15mL

20mEq/15mL

50 cups

60687-0341-71

10211557

5515713

3935137

575894

Potassium Chloride Oral Solution, USP 10%

20mEq/15mL

15mL

20mEq/15mL

80 cups

60687-0341-07

10212749

5521521

3937786

591016

Potassium Chloride Oral Solution, USP 10%

20mEq/15mL

30mL

40mEq/30mL

40 cups

60687-0341-14

10191066

5487574

3266467

465344

Potassium Chloride Oral Solution, USP 10%

20mEq/15mL

30mL

40mEq/30mL

50 cups

60687-0341-72

10214626

5525027

3944592

594978

Ranitidine Syrup (Ranitidine Oral Solution, USP)

15mg/mL

10mL

150mg/10mL

40 cups

60687-0260-23

10182932

5427489

3772381

231142

Ranitidine Syrup (Ranitidine Oral Solution, USP)

15mg/mL

10mL

150mg/10mL

50 cups

60687-0260-69

10182920

5427497

3772373

231159

Theophylline Oral Solution, USP

80mg/15mL

15mL

80mg/15mL

50 cups

60687-0258-71

T10464 19.10

Hitting the Mark American Health Packaging is a leading manufacturer of serialized, barcoded unit-dose products for hospital, institutional, and long-term care pharmacy.

americanhealthpackaging.com

|

800.707.4621

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

AHP Supports Pharmacy Efficiency With an Evolving Barcoded Unit-Dose Product Offering With a responsive line of barcoded unit-dose oral solutions – and growing liquid unit dose offering – AHP continues to deliver on their commitment to supporting pharmacy efficiency.

President & CEO: Bruce Bennett Toll-Free Phone: Address: Website:

(800) 707-4621 Columbus, OH 43217 www.americanhealthpackaging.com

Company Background

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

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

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 “Five Rights” by providing caregivers with as many products in a pre-packaged unit dose format as possible.

Removing repackaging tasks from the pharmacy eliminates a potential point of failure during the unit-dosing process as medications arrive to pharmacies ready to dispense.

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.

n Pharmacy Efficiency

Product Overview

Pharmacies strive to process orders and supply the proper medications to caregivers for their patients as quickly as possible. Adding potentiallycomplex 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, prepackaged UD often allows for products to be sourced more quickly than third-party repackaging can support.

AHP is committed to supporting pharmacy efficiency through a diverse range of both high-utilization and niche treatments. Producing over 450 unit-dose 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.

n Cost Savings Opportunity

AHP’s tailored offering of unit-dose 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 oral solids and liquids 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.

Hitting the Mark for BCMA, USP <800> Support

As facilities nationwide compete to demonstrate they provide the highestquality of care, AHP unit dose 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.

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. American Health Packaging unit-dose 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 than may result from utilizing third-party repackaging services.

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 unit-dose 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 supports compliance to USP <800> by featuring many relevant treatments.

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H E A LT H S Y S T E M • I N F U S I O N 95

Keep it clean.

Weâ&#x20AC;&#x2122;ve got the right protection.

Count on ISO-MED products to help with USP 797 and USP 800 compliance. We have just what it takes to both prevent contamination via the utensils and textiles themselves and to safely remove all contamination from the cleanroom.

Weâ&#x20AC;&#x2122;re your solution partner for controlled environments.

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

ISO-MED, INC. – Your Solution Partner for USP Compliant Medical and Cleanroom Products Providing an unparalleled selection of specialized products, globally trusted quality and service, and delivery convenience for meeting USP <797> and USP <800> standards.

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 supplying quality products for pharmacy cleanrooms and other medical industries in the United States. We are dedicated to achieving and maintaining compliant sterile compounding cleanroom environments, laboratories, homecare, and more.

Product Overview

ISO-MED's brand of products are manufactured at the highest-quality levels and meet or exceed USP <797> and USP <800> standards for labs, compounding pharmacies, homecare, and more. Providing an unrivaled level of customer service and delivery convenience, we offer highly cost-effective purchasing options for all our valued customers!

Whether solutions are needed for the pharmacy cleanroom environment, laboratory, or homecare, ISO-MED is known for developing and distributing superior products that meet or exceed USP <800> compliance.

We are driven to help healthcare-oriented organizations save money.

USP <800> Compliant Products

n Our USP <800> Compliant, Innovative Products Include: • Apparel (Both Sterile and Non-Sterile Disposable) for Compounding Hazardous Drugs • ChemoChek Refill Kits • Chemo Spill Absorbent Pads and Prep Mats • Chemo Preparation, Administration, Safety Spill and Technique Testing Kits • Cleanroom Wipes • SafeChemo Analysis HD's • Sterile Alcohol • Sterile Chemo Prep-Mats • Sterile and Non-Sterile Chemo Gloves • Sterile Chemo Gowns • Wipe Sampling and Analysis Kits

Additional Product Lines

• Akro-Mils Storage Bins • Bottles and Adapters • Disinfectants • Gamma Irradiatable Goggles • Healthcare Plastic Bags • Malt Extract Agar • Medi-Cup Blisters: Accommodates Virtually any Medication or Storage System

• Pharmacy Bins, Labels, and Supplies • Pill Crushers and Splitters • Proximal and Distal Luer Lock Connections • Respirators • Safety, Sharps, and Biohazard Containers • Shoe Inn – Automatic Bootie • Skin and Wound Care • Sterile and Non-Sterile Gloves • Sterile Apparel for Beards, Heads, Faces, Sleeves, Feet, and Entire Body Wear

• Sterile Isopropyl Alcohol • Syringes • Tackey Mats • Tamper Evident Locks and Tape • Unit Dose Packaging: Tamper-Evident, Bar Code Ready, Inhibits Ultraviolet, and Resists Moisture

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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H E A LT H S Y S T E M • I N F U S I O N 97

Closed-System Transfer Devices (CSTDs) A comparison of CSTD manufacturers.

Is your pharmacy considering the implementation of CSTDs in 2019?

The following comparison matrix was developed as a complimentary service for

References https://www.businesswire.com/news/home/20180111005529/en/Baxter-Launches-ArisureClosed-System-Transfer-Device http://www.icumed.com/products/oncology/hazardous-drug-closed-systems-and-cstds/ chemolock.aspx http://www.equashield.com/wp-content/uploads/2015/12/021-Equashield-Closed-SystemTransfer-Device-CSTD.pdf https://corvidamedical.com/about-new-cstd-halo/product-components/closed-syringeadaptor/ https://www.bbraunusa.com/en/products/b/onguard-closed-systemtransferdevicecstd.html

anyone in the beginning stages of research.

http://yukonmedical.com/products/arisure-closed-system-transfer-device/

Due to <USP 800> becoming enforceable

https://www.cdc.gov/niosh/docket/review/docket288a/pdfs/ aperformancetestprotocolforclosedsystemtransferdevices.pdf

in December 2019, CSTDs will be required

https://www.ncbi.nlm.nih.gov/pubmed/?term=Comparison+of+closed+system+transfer +devices+for+turnaround+time+and+ease+of+use

for hazardous drug administration and

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4938267/

recommended for hazardous drug preparation.

http://www.ajhp.org/content/70/7/619.long

Contributor Melanie Gaspar PharmD Candidate 2019 MCPHS University

98

DEVICE NAME

MANUF.

YEARS ON MARKET

ONB 510(K) CLEARANCE

DIFFERENTIATION

PROS

NEEDLE-FREE VS. NEEDLE-SAFE

CONNECTION MECHANISM

OnGuard®

B. Braun

12

Yes

Every component creates an audible "click" sound when attached correctly.

Can use with any standard Luerlock syringe.

Needle-safe (needle within system).

Click-to-lock

PhaSeal®

BD

20

Yes

First CSTD cleared under ONB product code.

First completely sealed drug delivery system.

Mechanically prohibits the escape of hazardous drug, vapor, or aerosols. Ensures leakproof drug transfer thanks to elastomeric, double membranes; has a sealed expansion chamber that captures and retains hazardous drugs.

Published worldwide. Meets both the NIOSH and ISOPP definitions of a CSTD. Leakproof and airtight. Can use with any standard Luer-lock syringe. Helps improve turnaround time of hazardous drug preparation and has integrated sets.

Needle-safe (needle within system and vial spike).

Push-turn-push

Texium®

BD

13

No

For Alaris™ pump customers, the Texium system components can be integrated into the administration sets to aid in workflow and prevent accidental disconnections to the infusion line.

Utilizes mechanical valve technology to protect healthcare workers and patients.

It features a needle-free Luer-lock connection on all vial adapters, the option for bonded syringes and the SmartSite™ needle-free connector for nursing. When paired with SmartSite™, they provide a leakfree, drip-free connection and disconnection.

Needle-free

Luer-lock

Corvida Medical

3.5

Yes

Only CSTD without an internal or external vent, valve, or filter, which maximizes drug extraction using six simple pieces. Designed especially to protect the healthcare worker.

Up to 14 connections.

Air-tight and leak-proof.

Single center puncture Vial Adapter.

Ergonomic design to reduce repetitive stress injuries. Secured connections.

Needle-safe

Push together, pull apart. Larger ergonomic touch points.

Equashield II®

Equashield

9

Yes

Fully encapsulated syringe barrel serving as a pressure equalization chamber, preventing plunger rod contamination and preventing accidental removal of plunger from the back of the syringe.

Needle-safe, easy to connect (push), fully encapsulated system to prevent spills; plastic spike for device to vial.

Needle-safe (dual syringe component that pierces vial with each connection).

Red to red alignment and click-to-lock in nursing.

ChemoClave®

ICU Medical

11

Yes

Needle-free and easy-to-use. Requires no assembly of components at the bedside and includes bonded and locking mechanisms that ensure compliance. For example the secondary administration sets incorporate the CSTD bonded to the set to create a non-removable connection to prevent accidental disconnect.

System offers vial spikes with the barrier containment and aircleansing/vented containment and bag spikes that allow pharmacy to safely prepare hazardous drugs without priming lines.

Needle-free

Luer-lock

ChemoLock®

ICU Medical

5

Yes

First needle-free CSTD to receive FDA clearance.

A system with a wider fluid path that requires less push-pull forces than needle CSTD systems.

Does not increase the risk of repetitive stress injuries.

Offers both barrier technology and air-cleansing technology. Has a single-motion click-to-lock design that requires no lining up and is easy-to-use.

Needle-free

Click-to-lock, that requires no lining up.

Yukon Medical

1

No

Features an intravenous dry spike that helps provide closed access to an IV bag for addition and removal of a drug or solution. No need to inject air into the vial.

Uses a physical barrier for containment. Low attachment force eases strain during vial insertion. High flow rate allows for easy drug extraction.

Needle-free

Luer-lock

Halo®

Arisure®

99

TEMPERATURE INTELLIGENCEÂŽ Increase your temperature intelligence and save valuable medication while helping protect patient outcomes.

Give patients peace-of-mind by using an easy-to-read temperature monitoring device that indicates if a heat, freeze, or dual heat-freeze event has occurred during shipment.

Remotely monitor medication storage 24/7 and get real-time notification of temperature excursions. Record and store data in the cloud to automate processes and meet pharmacy board requirements.

Tap into the future of temperature monitoring. zebra.com | temptimecorp.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

Temptime – Temperature Monitoring Solutions for Medication Shipments, Storage, and Pharmacy Facilities Providing the tools and knowledge to accurately monitor temperature sensitive medications, ensuring that they have not been exposed to temperature events that could impact their effectiveness in treating patients.

Founded: 1987 Employees: 85 Phone:

(973) 630-6000 (973) 630-6100 Address: 116 The American Road Morris Plains, NJ 07950 Website: www.temptimecorp.com Fax:

Company Background

Founded in 1987, Temptime scientists developed the first miniaturized technology to monitor time-temperature exposure of vials containing the oral polio vaccine. Our commitment to public health is reflected in our dedication to being on the leading edge of understanding pharmacy needs, and bringing new and patient-centric temperature monitoring solutions both to the pharmacy operation and into the patient’s home.

Product Overview

Temptime has been improving global health with its range of temperature indicators and monitoring devices for over 30 years. By reducing the risk and costs associated with unpredictable temperature events in production, storage, and shipment – Temptime helps specialty pharmacies save money and increase patient confidence in medications delivered.

Our products include: • Low cost, chemically-based heat indicators and freeze indicators for application to temperature sensitive medication and biologicals.

• Heat and freeze shipment indicators for medications.

• Electronic EDGE® wireless temperature and humidity sensing systems with cloud-based data storage and sharing.

EDGE® Wireless Sensing Systems

• View and share temperature data using the free EDGEVue® mobile app.

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

• Store unlimited data on EDGECloud® and generate reports through the EDGEVue® web application.

EDGE® PQ Performance Qualification Testing

As a specialty pharmacy, you already know the importance of performance qualification (PQ) testing. For one thing, it ensures that the critical and often lifesaving medications you send to patients have not been exposed to unsafe temperatures that could impact their effectiveness. It’s also required for certain pharmacy accreditations and participation in some pharmacy networks.

Temptime’s EDGE devices help specialty pharmacies simplify performance qualification (PQ) testing to optimize pack-outs and satisfy accreditation requirements. Since some pharmacy networks are making third-party validation testing a condition of participation – Temptime also offers Third-Party PQ Testing Services.

TransTracker® Shipment Indicators

TransTracker® visual temperature indicators monitor medication heat and freeze exposures during shipment and storage. Simple to read and understand, patients can easily see if medications have been exposed to extreme temperatures – cutting down on unnecessary reshipments due to suspected temperature damage. These cost-effective, single-use indicators also help with state regulation compliance.

The EDGE family of wireless Bluetooth®-enabled sensors monitor and record temperature data 24/7.

EDGE W-200 wireless facility monitoring system monitors both temperature and humidity in medication storage areas, helping you comply with accreditation and regulatory requirements. Data can be viewed remotely using our web-based application EDGEConnect® and customizable alerts tell you instantly if any areas exceed your limits.

EDGE M-300 and EDGE S-400 programmable data loggers are ideal for monitoring temperatures during transport or storage with the ability to:

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H E A LT H S Y S T E M • I N F U S I O N 101

503

We’re like an elevator.

We eliminate steps for pharmacists.

Less steps means our product is easier and faster to use. Yet, provides safety and accuracy to make your processes more effective and efficient. Pentec’s 503B combines validated automation and process quality controls to make concentrated, single-dose products you can trust. We offer the peace of mind of a manufacturer with the efficiency of an outsourcing provider – enabling safe accurate medication, when it’s needed, where it’s needed, the way it’s needed. Less waste means greater value. To learn more please visit pentechealth.com.

www.pentechealth.com *

TM

*

*Must be further diluted.

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

Snap-N-Go® and Dilute-N-Go® From Pentec Health Speed and Simplify In-House Compounding We deliver the efficiency and safety of single-dose medications with the automation of critical processes and the quality controls of pharmaceutical manufacturers. This means minimizing waste, maximizing time and inventory, and the ability to deliver precise medications on demand.

President & CEO: Joe Cosgrove Founded: 1983

Employees: 600+ Toll-Free Phone:

(800) 223-4376

Address: 9 Creek Parkway Website:

Boothwyn, PA 19061 www.pentechealth.com

Company Background Pentec Health’s 503B sterile compounding division combines validated automation and process quality controls to make concentrated, single-dose products you can trust. We offer the peace of mind of a manufacturer with the efficiency of an outsourcing provider – enabling safe, accurate medication, when it’s needed, where it’s needed, the way it’s needed. Less waste means greater value. Our dedication to quality and patient safety spans over 35 years in the patient-specific space as a leading provider of renal nutrition for dialysis patients and intrathecal pump management for those with chronic pain or spasticity.

Our exceptional service in these industries naturally expanded into non-patient-specific compounding as the need for a trusted, innovative provider in this area became more apparent.

Product Overview Our Snap-N-Go® and Dilute-N-Go® products reduce the time it takes for pharmacists, technicians, and nurses to internally compound and administer drugs by reducing the majority of manual error-prone steps. Pentec Health’s sterile compounding solutions enable hospital pharmacies to combine the control of insourcing with the flexibility of outsourcing. Snap-N-Go and Dilute-N-Go make compounding safer, faster, and more precise while helping pharmacy and nursing staffs maintain control of patient administered medications.

Product Specifications Snap-N-Go and Dilute-N-Go products are concentrated, sterile solutions that come in single-dose vials or syringes, respectively.

When introduced into a diluent bag of choice, each vial or syringe delivers a precise dose or desired concentration that is not available commercially. In the forward positions, Snap-N-Go vials can be stored in automated dispensing machines (ADMs) for rapid retrieval, dose-tracking, and subsequent administration

to a patient by a nurse utilizing a standard vial-to-bag adaptor/ activation process. For added safety, each Snap-N-Go vial and Dilute-N-Go syringe is barcoded and includes GS1 barcode for track and trace capabilities and TALLman lettering to distinguish sound-alike, look-alike drugs from one another to prevent medication errors. Multiple safety warnings indicating the need for dilution are included on packaging and safety seals placed over each Dilute-N-Go syringe cap. Additionally, we proactively provide a Certificate of Analysis and Certificate of Conformity detailing each product’s purity, potency, sterility, and stability upon receipt of the product.

Testimonials “ Pentec offers the same benefits of buying from a manufacturer, but in single-dose solutions. It’s pretty powerful. I had never seen anything like that.” ­— Staff Pharmacist, Southeast U.S.

“ Pentec having the product in stock allows our pharmacy to go from the villain to the hero.”

— Pharmacy Director, Northwest U.S.

“ Pentec Health meets a lot of my needs, providing a reliable and safe product.”

— Pharmacy Director, Northeast U.S.

Awards & Recognition Snap-N-Go and Dilute-N-Go have received the following accolades: • Winner 2016: Marcum – Innovator of the Year • Finalist 2017: HealthTrust Innovation Summit – Innovation of the Year • Finalist 2018: Process Excellence Network Awards – Best Project Contributing to Customer Excellence • Finalist 2018 and Nominee 2017: Premier GPO – Innovation of the Year Ordering Information (866) 956-4376 | www.pentechealth.com

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H E A LT H S Y S T E M • I N F U S I O N 103

CASE STUDY Rapid ATP-Bioluminescence Testing Delivering accurate, reliable compounding sterility results in days rather than weeks.

Erin Patton Senior Technology Market Development Specialist ~ Charles River St. Louis, Missouri Erin received her Bachelor of Science degree in biology from Xavier University and her Master of Science degree in cell and molecular biology from the University of Illinois, UrbanaChampaign. As a Senior Technology Market Development Specialist for Charles River’s Microbial Solutions division, Erin provides innovative rapid micro solutions for endotoxin testing, microbial identification, and microbial detection (Celsis® rapid bioburden and sterility testing).

Wayne DeHaven, PhD Director ~ Pharmetric Laboratory St. Petersburg, FL Wayne DeHaven earned his Bachelor's degree from the University of Florida, and his Ph.D. in pharmacology and therapeutics from the University of South Florida. He joined the food and drug administration in 2009 where he worked until 2015 when he left as acting director of the division of bioequivalence to join Pharmetric Laboratory as Director of Quality.

104 104

www.criver.com

PRIMARY INTENDED OUTCOME Quality control testing is an essential step during sterile drug compounding, necessary to detect the presence or absence of potential contaminants and safeguard patient health. Standard methods require up to seven days for bioburden or microbial limits testing and can take more than 14 days to complete microbiological sterility testing.

Traditional testing relies on long incubation periods in order to achieve microorganism growth, followed by subjective visual assessment to determine whether a sample meets testing specifications.

Pharmetric Laboratory, based in St. Petersburg, Florida, provides sterility assurance, microbial limits, endotoxin testing, and other quality-related screening for clients within the compounding market. They utilize Charles River’s Celsis® AMPiScreen® amplified adenosine triphosphate (ATP) bioluminescence technology for rapid detection of microbiological contaminants for their compounded sterile preparations.

The Celsis® technology allows their lab to eliminate days of incubation, preserve current test protocols, and ensure confident contamination detection for microbial limits and sterility testing through an automated, growth-based assay.

THE CHALLENGE Many sterile compounded drugs have short beyond-use dates (BUDs), and changes to United States Pharmacopeia (USP) regulations support limiting BUDs even further.

Lengthy sterility testing times can lead to extended production cycles, inventory storage issues, and, ultimately, delays in getting drug products to market within BUD timeframes.

CASE STUDY ATP-Bioluminescence Pharmetric Laboratory clients have responded positively to AMPiScreen® amplified ATP-bioluminescence testing for their products. The benefits they report include: • Eliminating days of incubation, replacing the standard 14-day traditional sterility test with a 5- to 7-day rapid sterility test, significantly improving business processes, including a smaller inventory that moves quickly.

• Expediting payment from clients.

• Enabling lucrative projects: One compounder secured $30,000 on a military order because they were able to honor a request using a short test turn-around.

• Allowing rapid testing on various formulations, including oils and suspensions.

• Increasing competitiveness for smaller compounders.

Sample attributes pose an additional challenge to traditional test methods. Sterile compounded pharmaceutical products come in many forms; some are thin, colorless solutions, while others may be oils, gels, ointments, or even pellets. Test-sample characteristics such as cloudiness or viscosity can create hurdles during the testing process. Growth-based sterility tests rely on the ability of the lab analyst to make a subjective assessment about whether turbidity from microbial growth is present; understandably, the characteristics of certain drug products can make this assessment difficult.

“Products which create turbidity when added to a growth medium lead to increased incubation time and accurate visual reading of traditional results can be difficult,” said Wayne DeHaven, PhD, Director of Pharmetric Laboratory.

THE DECISION Charles River provides innovative technology that supports consistency and control in drug manufacturing, monitoring, and testing in order to help reduce associated risks. Their Celsis® AMPiScreen® technology detects contaminants in a drug sample through the luciferin-luciferase reaction, which manifests as a chemical conversion of organism-based energy into visible light. Ordinarily, ATP is present in all living cells, and so it makes an excellent marker for quicker detection of microbiological contamination. The Celsis® ATP-based technology can significantly reduce the usual sterility test incubation period.

For Pharmetric Laboratory, the choice to offer Celsis® rapid microbial detection through AMPiScreen® technology to their sterile compounding clients was a practical one. “In a nutshell, this approach is a lot less problematic than standard compendial testing,” said DeHaven. The inherent subjectivity of visual growth confirmation is removed and replaced with a confident yes or no answer, providing the same result as the compendial sterility test and critical information about whether to release or hold a product.

Utilizing Celsis® rapid microbial detection systems and AMPiScreen® technology can rapidly detect the presence of ultra-low levels of microbiological contamination up to 50% faster than the traditional sterility test. This ultimately reduces testing time and preserves accuracy, allowing compounders to comply with BUD regulations and protect patient safety, while also improving revenue streams. “This is a critical piece for compounders,” said DeHaven. “If a compounded product spends half of its BUD in quarantine waiting for sterility testing, you could be squeezed out of business.

The amount of time required for standard compendial testing of a compounded product almost makes no sense compared to ATP testing.”

www.criver.com 105

CASE STUDY THE RESULTS The use of rapid microbial detection systems and ATP-bioluminescence technology is well characterized in other industries, and it has been adapted for drug sterility testing more recently. Charles River’s ATP-bioluminescence test may be used in line with USP regulations regarding sterility-testing sample preparation and growth, and the process is largely similar to standard testing.

The differences between compendial testing and combined Celsis® rapid microbial detection systems and AMPiScreen® amplified ATP-bioluminescence technology lie in the method of contaminant detection and the amount of time required for incubation. “ATP-bioluminescence testing really is the perfect application for sterile drug compounding and accommodating BUDs,” said DeHaven.

Compared to standard testing, ATP-bioluminescence testing produces minimal artifacts that could lead to false-positive results. “The results of ATP-bioluminescence testing are purely objective, an indicator,” said Erin Patton, Technology Market and Development Manager at Charles River. “A numerical result shows simply and clearly that the product either meets or fails the test.” Compendial testing relies on a trained technician to provide a subjective reading of the media for colony growth and turbidity and is more prone to misinterpretation of results and error.

THE CONCLUSION Utilizing the Celsis® rapid microbial detection systems and AMPiScreen® amplified ATP-bioluminescence technology allows Pharmetric to confirm their clients’ product sterility in a matter of days versus the weeks required for traditional methods. The test produces reliable, repeatable results that meet regulatory standards.

Client education about ATP-bioluminescence technology has expanded their customer base, and Pharmetric hopes to grow the market further. “When we started offering rapid ATP-bioluminescence testing, many clients did not fully understand the science behind it,” said James A. Brown, National Director of Sales for Pharmetric Laboratory.

“Discussing method suitability woke up many people, and word is getting out that the ATP-bioluminescence test offers better science as well as faster results.”

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www.criver.com

No rapid detection solution has ever been put together like this before.

Now that we’ve done it, it’s hard to picture it any other way.

With the Celsis® detection platform for rapid sterility, we’ve created an unprecedented set of solutions, features, and options in a package that’s designed for simplicity, not complexity.

More than just an instrument, we’ve partnered with other industry suppliers to create a complete solution that makes perfect sense.

Pre-qualified, RMM-ready test consumables with Sartorius.

Pre-qualified sterility growth media with Hardy Diagnostics.

Industry-tailored services and support packages through Charles River.

Learn how Celsis redefines what it means to be an RMM at criver.com/rapidsterility ®

P H A R M A C Y Job Opportunities

We Make It Better For More Than 800 Hospitals. And So Could You. Comprehensive Pharmacy Services: We Make It Better for Our Clients … AND our Employees •

CPS is considered one of the most trusted partners to hundreds of hospital and health system pharmacies across the country.

•

We deliver tier-one analytics, robust technology solutions and deep expertise to every client we serve.

•

For our own employees, we provide a team-oriented work environment within a culture of support and best practices, competitive compensation and benefits, and continuing education.

Join the CPS team and begin a better pharmacy career in operations, clinical, regulatory, safety, purchasing, 340B, antimicrobial and more.

Search open positions and apply today at jobs.cpspharm.com.

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