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March 2015 VOL. 3 • NO. 3

20 Tips for

Managing Concussions

PAIN

S

InsidePatientCare.com

Management

21 Q  uestions

Answered with Janis Orlowski, MD, MACP

A Call to Action: America’s Painful Addiction PAGE 13

34 P harmacy

Accreditation: Establishing Discipline and Consistency

50 P roducts &

Services Showcase

© 2015 Novellus Healthcare Communications, LLC an affiliate of

CE AVAILABLE PAGE 24


Medical Directors • Physician Assistants • Nurse Practitioners • Pharmacists • Chain Headquarters • Independents

Retail pharmacies and clinics are quickly becoming an extension of primary care. Inside Patient Care: Pharmacy & Clinics is tailored to meet the growing needs of the entire healthcare team and provides practical information to treat and care for patients inside the pharmacy and retail clinics.” Donald J. Dietz, RPh, MS

Vice President Pharmacy Healthcare Solutions, Inc. Editor-in-Chief Inside Patient Care

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Inside Patient Care: Pharmacy & Clinics™ is an independent journal that provides practical information for the entire healthcare team treating and caring for patients inside the pharmacy and retail clinics.

S

InsidePatientCare.com

As primary care expands to provide optimal access to quality care, Inside Patient Care: Pharmacy & Clinics™ offers a forum for the team treating and coordinating patient care in pharmacies and retail clinics, including medical directors, physician assistants, nurse practitioners, pharmacists, and C-level executives, to implement the best therapeutic options, navigate the healthcare system, and achieve professional success.

AIN PA P

March 2015 VOL. 3 • NO. 3

20 Tips for

Managing Concussions

Management

21 Questions

Answered with Janis Orlowski, MD, MACP

A Call to Action: America’s Painful Addiction PAGE 13

34 Pharmacy

Accreditation: Establishing Discipline and Consistency

50 Products &

Services Showcase

© 2015 Novellus Healthcare Communications, LLC an affiliate of

CE AVAILABLE PAGE 24

Each issue of the journal includes resources that will enable the retail healthcare team to provide optimal patient care—how to screen, diagnose, and treat patients; answer questions on prevention and wellness; deliver acute treatment; monitor and manage chronic conditions; make efficient use of healthcare resources; and attract, retain, and engage patients, shoppers, and customers.

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MISSION STATEMENT Inside Patient Care: Pharmacy & Clinics™ is an independent journal that provides practical information for the entire healthcare team treating and caring for patients inside the pharmacy and retail clinics. As primary care expands to provide optimal access to quality care, Inside Patient Care: Pharmacy & Clinics™ offers a forum for the team treating and coordinating patient care in pharmacies and retail clinics, including medical directors, physician assistants, nurse practitioners, pharmacists, and C-level executives, to implement the best therapeutic options, navigate the healthcare system, and achieve professional success. Each issue of the journal includes resources that will enable the retail healthcare team to provide optimal patient care, including how to screen, diagnose, and treat patients; answer questions on prevention and wellness; deliver acute treatment; monitor and manage chronic conditions; make efficient use of healthcare resources; and attract, retain, and engage patients, shoppers, and customers. Contact information: For subscription information and editorial queries, please contact: info@insidepatientcare.com; tel: 732-992-1895; fax: 732-992-1881.

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March 2015 Volume 3 Number 3

INSIDE

Pain Management

16 PATIENT DESCRIPTIONS DEEPEN UNDERSTANDING OF FIBROMYALGIA FLARES

PAIN

Management

COLUMNS PAGE

9

THE FIRST WORD

Donald J. Dietz, RPh, MS

And other concise reviews of studies on pain management in rheumatology

The Impact of New Technology on Pharmacy

Patient Care

20 FIVE TIPS FOR MANAGING CONCUSSIONS

PAGE

42

Patient and caregiver education is key to recognize and respond to concussions in children and adolescents.

21 QUESTIONS ANSWERED

Janis Orlowski, MD, MACP, Chief Health Care Officer of the Association of American Medical Colleges, discusses the latest report published by the association on the physician workforce shortage.

The Pharmacy 34 PHARMACY ACCREDITATION: ESTABLISHING DISCIPLINE AND CONSISTENCY

Accreditation points to a new level of minimally acceptable standards for the pharmacy industry.

38 QUESTIONS ANSWERED

David Neu, President of Good Neighbor Pharmacy, discusses the role of independent pharmacies in the community, and provides some tips for new and veteran community pharmacy store owners.

HEALTHCARE POLICY

STARTS ON PAGE

13

COVER STORY I PAIN MANAGEMENT

A Call to Action: America’s Painful Addiction ❚ An  overview of the US healthcare costs associated with opioid use ❚ Understand the issues associated with illicit drugs ❚ Differentiate drug abuse and misuse, from patients who are truly suffering ❚ Balance analyzing prescriptions entering the pharmacy and ensuring no harm is done to the patient by denying legitimate pain prescriptions ❚ Assessing patients’ needs

Janet K. Astle, BS Pharm, EdD

If Not You, Then Who? Taking Advantage of the Opportunity for Change

2 CALL FOR SUBMISSIONS 4 INSIDE PATIENT CARE ONLINE 6 EDITORIAL BOARD 7 LETTER FROM THE EDITOR 11 THE VITALS 24 FREE CE ACTIVITY 44 DRUG UPDATE 50 PRODUCTS & SERVICES SHOWCASE

Inside Patient Care: Pharmacy & Clinics, ISSN (requested), is published 12 times a year by Novellus Healthcare Communications, LLC, 1249 South River Rd, Suite 202A, Cranbury, NJ 08512. Copyright © 2015 by Novellus Healthcare Communications, LLC. All rights reserved. Inside Patient Care: Pharmacy & Clinics is a trademark of Novellus Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the Publisher. Printed in the United States of America.

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INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ March 2015

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the Editorial Board

The board members contribute expertise and analysis that help shape the content of Inside Patient Care: Pharmacy & Clinics

“ PAGE 9

The pharmacy should be able to use the e-prescribing route in reverse to communicate back to the prescriber.”

Editor-in-Chief Donald J. Dietz, RPh, MS Vice President Pharmacy Healthcare Solutions, Inc Pittsburgh, PA

James S. Beaumariage, RPh Principal Beaumariage Consulting, LLC Franklin, MA John O. Beckner, RPh Senior Director, Strategic Initiatives National Community Pharmacists Association Alexandria, VA Mitch Betses, RPh Senior Vice President Retail Pharmacy Services CVS Caremark Corporation Woonsocket, RI Ami Bhatt Senior Director, Operations Health & Wellness, Wal-Mart Bentonville, AR Thomas R. Bizzaro, RPh Vice President, Health Policy and Industry Relations First Databank Indianapolis, IN Rebecca Wheeler Chater, RPh, MPH, FAPhA Executive Healthcare Strategist Ateb, Inc, Raleigh, NC Scott R. Drab Professor, Department of Pharmacy & Therapeutics, School of Pharmacy University of Pittsburgh, Pittsburgh, PA Albert Garcia Executive Vice President Navarro Health Services, Medley, FL Mark J. Gregory, RPh Vice President Healthcare Solutions Ateb, Inc , Raleigh, NC

6

Kevin James, RPh, MBA Vice President of Payer Strategy US Bioservices, Frisco, TX Alexandra Jung Principal, Advisory Services Ernst & Young, LLP; former Senior Vice President Corporate Strategy, Walgreens Jack Kelly, RPh Chief Business Development Officer, Pharmacist Partners, CKO Scott L. Kemme Vice President/General Manager, Chain Segment McKesson Pharmacy Systems & Automation Livonia, MI Kevin Letz, DNP, MBA Chairman/Founder Advanced Practice Provider Executives

—Donald J. Dietz, RPh, MS

Elliott M. Sogol, PhD, RPh, FAPhA Vice President Professional Relations Pharmacy Quality Solutions, Inc Springfield, VA

EDITORIAL CONSULTANTS PEDIATRICS Marc Drummond, PsyD, MBA Clinical Psychologist, Managing Partner Creekside Natural Therapeutics

Stacie Lampkin, PharmD, BCPA, AE-C Assistant Professor D’Youville College School of Pharmacy Women and Children’s Hospital, Buffalo, NY

Tripp Logan, PharmD Vice President Logan & Seiler, Inc, Charleston, MO

GASTROINTESTINAL HEALTH

Stephen C. Mullenix, RPh Senior Vice President Public Policy & Industry Relations NCPDP, Scottsdale, AZ

WELLNESS

Richard J. Ptachcinski, PharmD, FCCP President American Pharmacotherapy, Pittsburgh, PA

Lisa Cervantes, PA-C

UW Health Clinics, Digestive Health Center, Madison, WI

Barbara Campbell, RPh, CCN

Pharmacist and Certified Clinical Nutritionist People Rx, Austin, TX DERMATOLOGY

Debra Shelby, PhD, DNP

Ernie Richardsen, RPh, MBA Group Vice President Pharmaceutical Purchasing and Clinical Services Rite Aid Corporation, Camp Hill, PA

President National Academy of Dermatology Nurse Practitioners

Debbie Sheppard Vice President, Sales and Marketing Ateb, Inc, Raleigh, NC

Kim Curry, PhD, ARNP-C

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ March 2015

IMMUNIZATION

Clinical Associate Professor College of Nursing, University of Florida Gainesville, FL

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Letter from the Editor The Physician Workforce Shortage and What It Means for Team-Based Care by FREDERIQUE H. EVANS, MBS, Editorial Director, Inside Patient Care: Pharmacy & Clinics

More questions are being raised in light of the recent physician workforce shortage projections released by the Association of American Medical Colleges (AAMC) earlier this month, including how it will impact patient care, and community pharmacies and clinics. }} }} “THE DOCTOR SHORTAGE is real— it’s significant—and it’s particularly serious for the kind of medical care that our aging population is going to need,” Darrell G. Kirch, MD, President and CEO of AAMC, said in an announcement released by the association. The report, which was published earlier in March, includes information on the current and projected future supply of physicians, as well as the current and projected future demand for physicians, and the current and projected future adequacy of physician supply. A microsimulation was used to project the supply of, and demand for, healthcare services and physicians. The supply model also simulated the likely career decisions of physicians, including current numbers, specialty mix and demographics of new entrants to the physician workforce, retirement and mortality patterns, and patterns of patient care hours worked. The report lists key trends likely to affect the supply and demand for healthcare services and physicians for the next decade. Overall, the demand for physicians was found to grow faster than supply, with a projected shortfall of between 46,100 and 90,400 physi-

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cians by 2025. Shortfalls in primary care are projected to range between 12,500 and 31,100 physicians by 2025, with demand for non–primary care physicians exceeding supply by 28,200 to 63,700 physicians. In addition, the report indicates that expanded medical coverage from the Affordable Care Act—when it is fully implemented—will likely increase demand by approximately 16,000 to 17,000 physicians (2.0%) over the increased demand resulting from changing demographics. The lower ranges of the projected shortfalls reflect the rapid growth in supply of advanced practice clinicians, and the increased role of these clinicians in patient care delivery. However, even in these scenarios, physician shortages are projected to persist, the authors of the report emphasized. Finally, because of new data and the dynamic nature of projected assumptions, the projected shortfalls of physicians in 2025 are smaller than shortfalls previously projected. In this issue of Inside Patient Care: Pharmacy & Clinics, we had the opportunity to speak with Janis Orlowski, MD, MACP, Chief Health Care Officer of AAMC, and discuss the physician workforce shortage report

in more detail, including the implication of the data as it relates to community pharmacists and clinicians, as well as other questions the report raises (see “Questions Answered with Janis Orlowski, MD, MACP,” on page 21). “Between now and 2025 there is a continued demand for the physician workforce, but not as much as in other scenarios because the pharmacy and retail clinics tend not to be staffed by physicians,” she explained. “There is a preponderance of other health professionals in addition to physicians contributing to the demand for medical care.” Take some time to read through this issue and think about the impact of the physician shortage on your patients and business. Healthcare is transforming. Look to Inside Patient Care: Pharmacy & Clinics to provide practical information on how to provide optimal access to quality care, implement best practices, navigate the healthcare system, and achieve professional success. ❚

Reference

IHS Inc; for Association of American Medical Colleges. The complexities of physician supply and demand: projections from 2013 to 2015. www.aamc.org/down load/426242/data/ihsreportdownload.pdf. Published March 2015. Accessed April 7, 2015.

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ March 2015

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Call for submissions

?

Do you have a best practice to share?

In your background as a retail pharmacist, chain executive, independent pharmacy owner, physician assistant, or nurse practitioner, it’s likely there’s one clinical and/or business experience – and maybe more – that other colleagues inside the pharmacy and clinics across the nation would want to read about.

High-interest topics include the solution you found to a pharmacy management challenge, reimbursement, patient counseling across different therapeutic areas, clinical advances, regulatory changes, and business impacts on retail pharmacies.

Send us your ideas!

Submit a 750- to 1500-word original article, previously unpublished and submitted exclusively to Inside Patient Care: Pharmacy & Clinics, that your fellow colleagues will want to read.

Submit to: info@InsidePatientCare.com IP submissions_Asize_030215


The First Word The Impact of New Technology on Pharmacy by DONALD J. DIETZ, RPH, MS, Editor-in-Chief, Inside Patient Care: Pharmacy & Clinics

The pharmacy should be able to use the e-prescribing route in reverse to communicate back to the prescriber.”

W

hile shopping for a new automobile for the first time in 7 years, my wife and I were in awe over the advances in technology. Little time was spent “under the hood” discussing the car’s engine and power. More time was spent discussing safety features, internal climate control, various audio options, and ways to use our phone safely when driving. Bragging about the number of cup holders has been replaced by the number of USB ports to charge our electronic devices. Trying not to be overwhelmed, I asked the salesperson whether most customers used all of this new technology. Although he was not positive, he believed that most people became comfortable with a few features, ignoring the rest, and only using a small portion of the technological advances. I believe those in our profession may employ the same decision process, and use only select features of available technology in our retail pharmacy practices. Electronic prescribing (e-prescribing) is one area where this is top-of-mind, because

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5 factors to consider: ❚ The impact of e-prescribing on retail pharmacy ❚ Using e-prescribing to communicate back to the prescriber ❚ The SCRIPT Standard, developed by NCPDP ❚ Impact of New York legislation on other states ❚ Providing proper training

of the I-STOP (Internet System for Tracking Over-Prescribing) legislation, which would require all prescriptions issued in New York, including those for controlled substances, to be transmitted electronically by March 27, 2015.1

Using e-Prescribing The New York legislature requested a 1-year moratorium on the e-prescribing mandate. The state’s Medical Society asked for the delay

to provide all prescribers enough time to properly install the needed software and obtain the required certifications for transmitting controlled substance prescriptions electronically.2 Governor Andrew Cuomo recently signed legislation to postpone it for a year. Through monitoring this gamechanging legislation that would virtually eliminate paper prescriptions in New York, my thoughts turned to the impact it would have on retail pharmacy. Almost all retail pharmacies are able to accept electronic prescriptions, including ones for controlled substances. Most of the attention regarding this new change to electronic prescriptions has rightly focused on the prescriber, as they are the issuer of the prescription. However, this technological enhancement also has implications that will impact retail pharmacy. There are often situations where a pharmacy is unable to dispense a prescription, including when drug products are not in stock or an inordinate period of time is needed to obtain a medication (eg, over the weekend for an acute pain medica-

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ March 2015

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The First Word tion). Suspected misuse or clinical Drug Utilization Reviews may also result in dispensing delays. When this happens with a paper prescription in most pharmacies today, we return the hard copy prescription to the patient with an explanation. If appropriate, the pharmacist may help them locate the product at another pharmacy in the chain, or at another nearby pharmacy. What happens if this is an electronic prescription? I am aware of a retail pharmacy chain that cannot provide a hard copy of an electronically received prescription for the patient to take to another pharmacy. How, then, is the pharmacy going to electronically communicate to the prescriber that they could not dispense the prescription? The pharmacy should be able to use the e-prescribing route in reverse to communicate back to the prescriber. Although it is probably not mandatory that the return communication to the prescriber be electronic, it would be desirable if the processes pharmacists and prescribers are asked to use are consistent.

Be Aware, Prepare for Change The SCRIPT Standard developed by the National Council for Prescription Drug Programs (NCPDP) supports many different types of transactions between prescribers and pharmacies.3 These transaction types include ones that allow the pharmacy to send a message to the prescriber requesting a new prescription for a patient, or additional refills for an existing prescription. Another transaction type can be used when the pharmacy needs to request a change in the original prescription, such as allowing for generic substitution. My guess is that many systems are able to perform these transactions, but many of the pharmacies and prescribers using those systems are not adequately

10

trained to use this technology. Plus, if all systems used in the prescriber’s office or pharmacy are not set up to use these transaction types, then these electronic messages cannot be sent or received successfully, leaving these parties with the “old-school” methods of using the telephone and sending faxes to communicate with each other. Although there is technical capability for the pharmacy practice management system to notify the prescriber that a prescription has been filled, partially dispensed,

Although it is probably not mandatory that the return communication to the prescriber be electronic, it would be desirable if the processes pharmacists and prescribers are asked to use are consistent. or not dispensed, this technology is not widely used today. Pharmacy systems also have the functionality to suggest an alternative to a prescribed medication. However, even if the pharmacy community jumped on board to use this feature, my belief is that most prescriber systems do not capture or easily report this back to the physician’s office for action, because it would not be information that is generally acted on by the prescriber. These options could provide the means for the commu-

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ March 2015

nication desired if the systems at the pharmacy and prescriber’s office are set up to use them. However, this may not happen until the ability to send and receive these types of messages is considered a required element for e-prescribing. Even if this capability existed in pharmacy and prescriber systems, users at both ends would need to know how to send and receive the messages, and would need training if they did not know how to do this. Mandatory e-prescribing may be­­ come a reality in New York next year. If it is successful at reducing fraudulent prescribing activity, expect other states to pass similar legislations to move away from paper prescriptions. Now is the time to think about how this change would impact your retail pharmacy workflow and procedures. My suggestion is to identify challenges that would arise and present them to your management team, along with any suggestions on how to solve the workflow or customer service issues. There may be a need to involve your pharmacy’s software system vendor. A final suggestion is to make sure proper training is available; it is important that all users receive thorough training, provided by the software vendor or a corporate trainer, to ensure complete and proper use of their system. ❚

References

1. Res 1232-2012. Internet System for Tracking Over-Prescribing Act. http://legistar.council.nyc.gov/ LegislationDetail.aspx?ID=1050966&GUID=9BE15E 6C-410C-42C1-9826-DE7814FEFC7C&Options=&Search=. Accessed March 10, 2015. 2. Medical Society of the State of New York. http:// www.mssny.org/MSSNY/Governmental_Affairs/State_ Advocacy/MSSNY-Testimony-2015.aspx. Accessed March 10, 2015. 3. National Council for Prescription Drug Programs. Problem Solving and Innovation. www.ncpdp.org/stan dards. Accessed March 10, 2015.

Mr Dietz is Editor-in-Chief of the journal, and Vice President of Pharmacy Healthcare Solutions, Inc, Pittsburgh, PA.

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theVitals ACIP UPDATES 9vHPV GUIDELINES The Advisory Committee on Immunization Practices (ACIP) released updated guidelines for the use of the 9-valent human papillomavirus (9vHPV) vaccine (Petrosky E et al. MMWR Morb Mortal Wkly Rep. 2015;64:300-304). These updates come amid their February annual meeting. The committee recommended 9vHPV (Gardasil 9; Merck and Co, Inc) as 1 of 3 HPV vaccines used for routine vaccination for patients 11 or 12 years of age. In addition, they recommend vaccination of women 13 to 26 years of age, as well as men 13 to 21 years of age who have not been previously vaccinated. The vaccination is also recommended for men through 26 years of age who have sex with men, and for immunocompromised patients—including patients with HIV—who were not previously vaccinated. The recommendations were based on a review of clinical trial data on the efficacy, immunogenicity, and safety of 9vHPV from October 2013 to February 2015 by the ACIP HPV Vaccine Work Group. Evidence and work group discussions were presented to ACIP before recommendations were made at their annual meeting. The recommendations also include information on HPVassociated disease; 9vHPV efficacy, immunogenicity, and safety, as well as the health impact and cost-effectiveness of the vaccine; administration/ special populations; precautions and contraindications; cervical cancer screening; and future policy issues.

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Examining the News Affecting Pharmacy & Clinics

FDA WARNS ABOUT CARDIOVASCULAR EFFECTS OF HEPATITIS C COMBINATION THERAPY WITH AMIODARONE The US Food and Drug Administration (FDA) has issued a warning that serious slowing of the heart can occur when the antiarrhythmic drug amiodarone is taken together with the hepatitis C drug ledipasvir/sofosbuvir (Harvoni) or with sofosbuvir (Sovaldi) in combination with another direct-acting antiviral for the treatment of the hepatitis C virus (HCV) (FDA Drug Safety Communication. March 24, 2015). In addition, the FDA is recommending that healthcare professionals should not prescribe either Harvoni or Sovaldi in combination with another direct-acting antiviral (eg, daclatasvir or simeprevir, with amiodarone). This safety communication is based on an FDA review of submitted postmarketing adverse-event reports, which indicated that patients could develop serious and life-threatening symptomatic bradycardia when either Harvoni or Sovaldi was combined with another direct-acting antiviral taken together with amiodarone. In one case, the death of a patient was from cardiac arrest; in other cases, 3 patients required the placement of a pacemaker to regulate their heart rhythms. Other patients recovered after discontinuing either the HCV drugs or amiodarone, or both. The cause of these events could not be determined, the FDA reported. The FDA further recommends that in cases where alternative treatment options are unavailable, heart monitoring should occur in an inpatient hospital setting for the first 48 hours, followed by monitoring in a doctor’s office or self-monitoring of the heart rate every day through at least the first 2 weeks of treatment. Patients taking these combination medications should seek medical attention immediately if they experience signs or symptoms of symptomatic bradycardia, including near-fainting or fainting, dizziness or lightheadedness, malaise, weakness, excessive tiredness, shortness of breath, chest pains, and/or confusion or memory problems.

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theVitals MOTIVATIONAL INTERVIEWS EFFECTIVE IN REDUCING OBESITY Motivational interviewing (MI) and counseling by providers and registered dietitians (RDs) to caregivers of overweight children between 2 and 8 years of age positively impacts obesity, according to a study published online ahead of print in Pediatrics. To date, limited data existed evaluating the impact of MI on pediatric obesity. “This is among the first large-scale trials to show statistically significant reductions in BMI [body mass index] by using MI delivered by PCPs [primary care providers] and RDs,” according to Kenneth Resnicow, PhD, Department of Health Behavior & Health Education, School of Public Health, University of Michigan, Ann Arbor, and colleagues. As part of a randomized controlled trial, the investigators evaluated child BMI percentile at 2-year follow-up among 42 practices from the Pediatric Research in Office Settings network of the American Academy of Pediatrics assigned to 1 of 3 groups. The groups consisted of usual care, including BMI percentile at baseline and 1- and 2-year follow-up (Group 1); 4 provider-delivered MI counseling sessions to parents of the index child over 2 years (Group 2); and 4 provider-delivered MI sessions and 6 RD-provided MI sessions (Group 3). At the primary outcome of interest, the adjusted BMI percentiles were 90.3 (Group 1), 88.1 (Group 2), and 87.1 (Group 3), with the Group 3 mean significantly lower than in Group 1 (P = .02). “How the intervention can be brought to scale (in particular, how to train physicians to effectively use MI and how best to train RDs and integrate them into primary care settings) merits future research,” they concluded.

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INCREASE SEEN IN HYPERTENSION-RELATED DEATH

Recent data released by the Centers for Disease Control and Prevention indicate a 23.1% increase in hypertension-related death. “The age-adjusted hypertension-related death rate increased 23.1%, whereas the rate for all other causes combined decreased 21.0% from 2000 through 2013,” the investigators found (Kung H-C and Jiaquan X. NCHS Data Brief. March 2015. No. 193). In addition, they found that the rates for hypertension-related death increased for men and women between 45 and 64 years of age, and >85 years of age, during that time frame. The data were collected using national multiple cause-of-death data files from the National Vital Statistics Systems from 2000 to 2013. The data included information collected from death certificates filed by the 50 states and the District of Columbia in the United States. Hypertension-related mortality was defined as any mention of hypertension on death certificates. Decedents ≥45 years of age were included in the analysis. Overall, the report indicates that approximately 1 in 6 patients with hypertension-related deaths had hypertension as the underlying cause of death, and the rest of the patients had hypertension as a contributing cause of death for other underlying causes. “This report provides a comprehensive picture of the burden of hypertension-related mortality in the United States from 2000 through 2013,” the authors concluded.

BUSINESS NEWS 5 FACTS ABOUT THE UNITEDHEALTH GROUP MERGER WITH PBM 1/ UnitedHealth Group’s free-standing pharmacy care services business, OptumRx, will be combining with Catamaran Corporation, a pharmacy benefit management (PBM) company.

2/ OptumRx has a clinical synchronization approach that connects pharmacy and care management systems, processes and teams to create higher quality, more consistent and compliant patient outcomes, as well as savings for individuals and plan sponsors.

3/ UnitedHealth Group will acquire Catamaran’s outstanding common stock for $61.50 per share, cash. The acquisition is expected to be accretive to UnitedHealth Group’s net earnings, approximately $0.30 per share in 2016. 4/ The acquisition will diversify the customer and business mix of OptumRx, and accelerate its technology leadership and flexible service offerings. It is also expected to create significant value for their combined customer base beyond the scale, and enhanced service. 5/ The transaction is expected to take place in the fourth quarter of 2015 (UnitedHealth Group press release; March 30).

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ March 2015

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INSIDE

RHEUMATOLOGY

Concise reviews of studies on pain management [16]

Pain Management

Cover Story

A Call to Action: America’s Painful Addiction by ATTILA MIHALIK, PHARMDc

The United States—one of the most developed and technologically advanced nations in the world— continues to struggle with healthcare costs.1-4 }} }} IN 2013, THE UNITED STATES spent almost $3 trillion on healthcare.1,2,5 Compared with other nations, the United States had the highest healthcare spending per gross domestic product, 17.9%.1 Part of this problem is the ever-increasing number of prescriptions and their diversion, specifically in the opioid class.4 In 2012, healthcare providers wrote 259 million painkiller prescriptions, enough for every adult in the country to receive their own pill bottle.6 As a country comprising approximately 5% of the global population, the United States consumes 80% of the world’s opioid supply.1,2,4 Even though these drugs continue to get prescribed, healthcare professionals should be aware of the issues associated with illicit drugs.

Confronting Substance Abuse Pain medicine, drug overprescribing,

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drug overdose, and healthcare costs have all significantly increased in the past decade.4,5,7 According to the Centers for Disease Control and Prevention (CDC), drug overdose was the leading cause of injury leading to death in 2012.7 In the past 20 years alone, opioid painkiller use has increased by at least 10-fold.8 Substance abuse treatment admission rate was 6 times higher in 2009 than in 1999.9 The Department of Justice estimates that the direct and indirect costs of illicit drug use exceeded $193 billion.10 The majority suffers at the expense of illicit drug users who become savvy with the system and how to abuse it.11 In 2010, more than 12 million individuals used painkillers nonmedically.12 One of the most significant cases of wrongful prescribing was the Florida “Pill Mill” brothers, where Christopher and Jeffrey George successfully created

KEY POINTS ❚ The United States consumes 80% of the world’s opioid supply ❚ The Department of Justice estimates that illicit drug use costs exceeded $193 billion ❚ Substance abuse treatment admission rate was 6 times higher in 2009 than in 1999

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Inside Pain Management an oxycodone distribution center. In 2 years, more than 20 million oxycodone pills were prescribed, making it the largest organization in illegal painkiller distribution in the United States.13 According to South Florida’s District Attorney, 32 people were charged as part of the criminal organization.

Healthcare professionals, especially community pharmacists, need to be aware of the individual and his or her particular situation leading to pain management therapy. Although most painkillers are prescribed by primary care physicians abusing their scope of practice, according to the CDC, most prescriptions are obtained through friends, relatives, or other sources.11 The Cardinal Health distribution center in Lakeland, FL,14 raised numerous red flags, including 2 CVS pharmacies in Sanford, FL, that ordered more than 3 million dosage units of oxycodone in 1 year; the average pharmacy orders about 69,000 units, according to the US Food and Drug Administration.14 After a Drug Enforcement Administration investigation of CVS and Cardinal Health’s ban on supplying controlled substances in Florida, the Drug Enforcement Administration resolved the issue with various reporting requirements and settling lawsuits with both companies. Monitoring controlled substances is very important in retail pharmacy and clinics. The industry is intertwined, from distributors to prescribers to dispensers, and it is everyone’s responsibility that proper medication get to the patients who rightly need it.

Battling Abuse and Misuse Transformation and change must occur inside of the healthcare professional team for drug abuse and misuse

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to improve. Although state prescription drug monitoring programs are improving across the nation, they are still not enforced everywhere.15 By requiring these programs through legislation, physician shopping or early refills can be avoided, leading to less wrongfully written and dispensed medications. As patients become more involved in their daily health, healthcare professionals, such as pharmacists and retail clinicians, must take the time to educate them about the risks and benefits of pain treatments, alternatives, and proper abuse treatments. By providing these services—keeping in mind the proper level of health literacy—patients are much less likely to have problems from abuse or misuse.16 Furthermore, it is critical for physicians, pharmacists, physician assistants, nurses, and other healthcare professionals to follow best practices, such as monitoring medication combinations, using lowest effective doses, and screening for possible abuse potential and mental health problems.6 Healthcare professionals, especially community pharmacists, need to be aware of the individual and his or her particular situation leading to pain management therapy. By understanding what type of pain the patient is experiencing, some treatments may be more optimal than others.

Conclusion Although some patients may be at risk for medication abuse, healthcare professionals must use their best judgment to not reject those who are truly suffering. I practice in a small town with 2 pharmacies. The primary population is on the lower socioeconomic side. The pharmacy has low medication adherence for blood pressure, diabetes, and other chronic diseases. This impacts the completeness and accuracy of many profiles within our computer system. Many uncertainties can arise about new pain prescriptions, especially because the major medical centers are far from

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Inside Pain Management the town. Even though it is important to carefully analyze all prescriptions that enter our pharmacy, it is equally important to ensure that there is no harm done to patients by denying their legitimate pain prescriptions. I challenge you to consider the following argument by Sir William Blackstone for patients abusing pain medicine to those who need it and are possibly turned away: “It is better that 10 guilty persons escape than that one innocent suffer.” ❚

References

1. The World Bank. World DataBank. http://databank. worldbank.org/data/home.aspx. Accessed March 5, 2015. 2. United Nations Statistics Division. National Accounts Main Aggregates Database. http://unstats.un.org/unsd/snaa ma/dnllist.asp. Updated December 2014. Accessed March 5, 2015. 3. United Nations Development Programme. Human Development Reports. http://hdr.undp.org/en/content/ human-development-report-2014. Updated 2014. Accessed March 5, 2015. 4. Manchikanti L, Fellows B, Ailinani H, et al. Therapeutic use, abuse, and nonmedical use of opioids: a ten-year perspective. Pain Physician. 2010;13:401-435. 5. Centers for Medicare & Medicaid Services. National health expenditures 2013 highlights. www.cms.gov/ Research-Statistics-Data-and-Systems/Statistics-Trendsand-Reports/NationalHealthExpendData/downloads/high lights.pdf. Accessed February 3, 2015. 6. Centers for Disease Control and Prevention. Opioid painkiller prescribing. www.cdc.gov/vitalsigns/opioid-pre

scribing. Updated July 1, 2014. Accessed February 3, 2015. 7. Centers for Disease Control and Prevention. Prescription drug overdose in the United States: fact sheet. www. cdc.gov/homeandrecreationalsafety/overdose/facts.html. Updated January 9, 2015. Accessed February 3, 2015. 8. American Society of Interventional Pain Physicians. The American Society of Interventional Pain Physicians (ASIPP) fact sheet. www.asipp.org/documents/ASIPP FactSheet101111.pdf. Accessed February 3, 2015. 9. Centers for Disease Control and Prevention. Morbidity and Mortality Weekly Report (MMWR). www.cdc.gov/ mmwr/preview/mmwrhtml/mm6043a4.htm. Published November 4, 2011. Accessed January 22, 2015. 10. US Department of Justice. The economic impact of illicit drug use on American society. www.justice.gov/ archive/ndic/pubs44/44731/44731p.pdf. Published April 2011. Accessed February 3, 2015. 11. Centers for Disease Control and Prevention. Policy impact: prescription painkiller overdoses. www.cdc.gov/ homeandrecreationalsafety/rxbrief/. Updated July 2, 2013. Accessed February 3, 2015. 12. Substance Abuse and Mental Health Services Administration. Results from the 2010 National Survey on drug use and health: summary of national findings, NSDUH Series H-41, HHS Publication No. (SMA) 11-4658. Rockville, MD: Substance Abuse and Mental Health Services Administration; 2011. 13. US Department of Justice. Thirty-two indicted in Broward and Palm Beach counties in second coordinated pill mill takedown. www.justice.gov/usao/fls/ PressReleases/2011/110823-04.html. Published August 23, 2011. Accessed March 5, 2015. 14. US Drug Enforcement Administration. DEA revokes two CVS retailers’ ability to sell controlled substances. www.dea.gov/divisions/mia/2012/mia091212.shtml. Published September 12, 2012. Accessed March 5, 2015. 15. Rutkow L, Turner L, et al. Most primary care physicians are aware of prescription drug monitoring programs, but many find the data difficult to access. Health Aff (Millwood). 2015;34:484-492. 16. Gill PS. Prescription painkillers and controlled substances: an appraisal of drug information provided by six US pharmacies. Drug Health Patient Saf. 2013;5:29-36.

Mr Mihalik is a PharmD candidate 2015 at Duquesne University Mylan School of Pharmacy, Pittsburgh, PA.

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Acetaminophen Lacks Effectiveness in Knee Osteoarthritis And other concise reviews of studies on pain management in rheumatology

Despite being the most common over-the-counter treatment for pain related to knee osteoarthritis (OA), acetaminophen was found inferior to other commonly used pain medications in a large network meta-analysis. }} }} INTRA-ARTICULAR (IA) TREATMENTS were superior to oral nonsteroidal anti-inflammatory drugs (NSAIDs) for pain relief in this study. Lead author Raveendhara R. Bannuru, MD, and colleagues at Tufts Medical Center in Boston, MA, noted that the superiority of IA treatments may be associated with the placebo effect. “The information from this study, along with the safety profiles and relative costs of included treatments, should be helpful to clinicians when making care decisions tailored to individual patient needs,” they explained. In the absence of definitive head-tohead trials of medications used to treat knee OA, the authors conducted a large meta-analysis to assess the comparative effectiveness of commonly used drugs in this setting. They reviewed a total of 33,243 participants in 137 randomized controlled trials published between 1980 and 2014; each trial compared 2 or more treatments for knee OA and reported at

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least 1 measure of pain, function, or stiffness. Studies were drawn from searches of MEDLINE, EMBASE, Web of Science, Google, Scholar, and Cochrane Central Register of Controlled Trials, as well as unpublished data. Treatments studied included acetaminophen, diclofenac, ibuprofen, naproxen, celecoxib, IA corticosteroids, IA hyaluronic acid, oral placebo, and IA placebo. An absolute change of 20 points on a scale from 0 to 100 on the OA Research Society International Outcome Measures in Rheumatology responder criteria was deemed clinically significant. Reported outcomes differed in these trials; 129 trials with 32,129 participants contributed to the analyses of pain-related outcomes, 76 trials (24,059 participants) contributed to the analyses of physical function outcomes, and 55 trials (18,267 participants) contributed to the analyses of stiffness outcomes. Age of participants ranged from 45 to 76 years, and the proportion of

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Inside Pain Management women ranged from 3% to 100%. All interventions were statistically superior to placebo for pain-related outcomes. The most efficacious pain relief occurred with IA hyaluronic acid and the least was acetaminophen; effect sizes (standard mean differences) were 0.63 and 0.18, respectively. All treatments except acetaminophen met the prespecified criteria for clinically significant improvement. All active treatments except celecoxib were statistically superior to acetaminophen; IA treatments were more effective than oral treatments. All interventions were significantly superior to oral placebo for function, except IA corticosteroids. Naproxen, ibuprofen, diclofenac, and celecoxib were statistically significantly better than acetaminophen for functional outcomes. IA hyaluronic acid was significantly better than IA placebo and IA corticosteroids. In addition, all oral treatments were significantly superior to acetaminophen for stiffness. IA hyaluronic acid was significantly better than IA placebo for stiffness.

PATIENT DESCRIPTIONS DEEPEN UNDERSTANDING OF FIBROMYALGIA FLARES Fibromyalgia flares are associated with intense pain, flulike aches and exhaustion, and other phenomena such as “brain fog,” as confirmed by the first-ever qualitative analysis of these periods of symptom exacerbation. Furthermore, according to the 44 people who responded to the survey, the patients tried many coping techniques, from medications to massage and from meditation to humor. One of the most common coping strategies described by the respondents was to avoid all forms of activity, which surprised the investigators. “Avoiding everything may indicate a lack of knowledge of or ability to use healthy coping strategies, and therefore, future research could evaluate the potential effects of teaching patients healthy coping strategies as one method to deal with symptom

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Traditional nonselective NSAIDs were associated with more gastrointestinal (GI) adverse events and withdrawals compared with oral placebo and acetaminophen; GI adverse events were similar between acetaminophen and celecoxib. The short exposure time of 2 to 3 months probably affected reporting on adverse cardiovascular events, the authors noted. Transient local reactions were the most commonly reported adverse events related to IA treatments, and the frequency was similar among IA therapies. The network meta-analysis did not investigate combination therapies, even though these are commonly used to treat knee OA. “The large number of possible therapy combinations and scarcity of trials comparing these treatments prompted us to restrict our analysis to monotherapies,” the authors wrote. Bannuru RR, Schmid CH, Kent DM, et al. Comparative effectiveness of pharmacologic interventions for knee osteoarthritis: a systematic review and network meta-analysis. Ann Intern Med. 2015;162:46-54.

flare,” according to Ann Vincent, MD, Associate Professor of Medicine, Mayo Clinic, Rochester, MN, and colleagues. The team administered the survey to

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Inside Pain Management “Future research could evaluate the potential effects of teaching patients healthy coping strategies as one method to deal with symptom flare.”

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Mayo Clinic patients with fibromyalgia at a ratio of 4:1 of women:men to reflect the gender proportion of the illness; 77% of the respondents were women, and 93% were non-Hispanic white. “This is a qualitative study and this [the survey results] is what patients reported they do,” Dr Vincent explained when asked about the specific clinical implications of optimizing coping strategies. Future research could include a larger, more diverse patient population to assess the characteristics of fibromyalgia flares quantitatively, the study authors added. The 7 items in the qualitative questionnaire were designed to probe the unique characteristics of flares. The questions included, “Do you experience any new symptoms during a fibromyalgia flare that are not typical of your everyday fibromyalgia symptoms?” and “How do you cope with a fibromyalgia flare?” In the respondents’ descriptions of flare triggers, the most common theme was “stress, stress, stress” related to work and life in general. They also said “overdoing it” can cause flares; this included physical exercise and variations in normal activity such as attending social events. Inadequate or poor-quality sleep

and weather changes were the other most common triggers. Sleep is particularly problematic for patients because flare-ups reduce sleep quality, causing a continuing feedback loop. A key characteristic of flares is an intensification of symptoms to the point of being disabling. Many survey respondents described full-body aching and exhaustion, similar to having the flu, and also severe pain, which could be so intense that, as one patient described, it made them not want to move or be touched. Respondents also described severe and disabling fatigue and other symptoms such as “fogginess in my head,” severe headaches or migraines, and difficulty with emotional regulation. Among the respondents, 77% turned to medications as treatment—principally acetaminophen and ibuprofen—and 22.7% reported using massage. Many also reported using meditation, breathing exercises, and hot or cold therapy. Three other major coping strategies were getting more rest or staying home, avoiding all activities including social interactions, and “waiting it out.”

ADVERSE EVENTS ON BIOLOGICS COMMON IN JUVENILE IDIOPATHIC ARTHRITIS The occurrence of adverse events (AEs), including serious adverse events (SAEs), is more common in children with juvenile idiopathic arthritis (JIA) on biologic therapy than has been previously reported. More than 90% of children experienced at least 1 AE on biologics, and more than one-third suffered an SAE over long-term follow-up in a retrospective, observational study reported in Rheumatology. Although AEs and SAEs were more frequent than assumed, these events seldom led to drug discontinuation. “Our data show a wide spectrum of AEs during biologic therapy as they ap-

pear in a real-life setting,” explained Maarit Tarkiainen, MD, Children’s Hospital, University of Helsinki, Finland, and colleagues. “One of the strengths of the study is that we included all AEs, whether known to be related to the biologic agent or not, regardless of how many times or when they appeared in a single patient. Moreover, we did not rely on surveys or survey-based registries, but assessed all the available information in patient records, which seemed to be a more reliable method of collecting information.” Other strengths of the study included long-term follow-up of more than 4 years in the majority of patients. The main limitation was the retrospective

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ March 2015

Vincent A, Whipple MO, Rhudy LM. Fibromyalgia flares: a qualitative analysis. Pain Med. 2015 Jan 13. [Epub ahead of print]

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nature of the study and not defining causality of AEs with accuracy. The study included 348 consecutive patients with JIA treated at 3 different tertiary centers in Finland. This amounted to 1516 patient-years: 710 patient-years on etanercept, 591 on infliximab, 188 on adalimumab, 8 on rituximab, 5.3 on anakinra, 6 on abatacept, 4 on tocilizu­ mab, and 1 on golimumab. Median follow-up of an individual patient on biologics was 50.5 months (range, 1-154.7 months). Median age at end of follow-up was 15.9 years (range, 3.8-29 years). Ninety-five percent (n = 330) were on disease-modifying antirheumatic drugs (DMARDs) prior to biologics, and 97% received DMARDs during treatment with biologics. Ninety-two percent (n = 319) reported at least 1 AE. Patients without an AE had a significantly shorter median follow-up compared with those who had an AE: 18.8 months versus 52.3 months, respectively (P <.0001). AEs totaled 2902 and 169/100 patient-years. Infections were the most common AE, reported in 274 patients (79%). Other common AEs included infusion or injection site reactions (n = 105, 30.2%), flare of uveitis (n = 43, 12.4%), and mild elevation of alanine aminotransferase (ALT) <3 times upper limit of normal (n = 49, 14.1%).

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SAEs were reported in 121 patients (35%) during follow-up, with a total of 173 events and 11.4/100 patient-years. A total of 44 patients (12.6%) had a serious infectious AE. The occurrence of serious infections was significantly higher with ritixumab compared with all other antitumor necrosis factors, with a relative risk of 6.16 (P = .008). A total of 32 patients had more than 1 SAE. Drug therapy was continued unchanged in 150 patients (87%) despite an SAE. In some of these cases, there was a short pause in therapy. No cases of malignancies or tuberculosis were found. Newonset uveitis was reported in 9 patients, psoriasis or psoriasiform lesions in 13 patients, and inflammatory bowel disease in 6 patients. These data support the use of biologics in juvenile patients, Dr Tarkiainen stated. “Most common SAEs were leucopenias and ALT elevations. After these, drug therapy could most often be continued after a short pause. SAEs during treatment with biologics in juvenile patients can mostly be controlled by experienced pediatric rheumatologists,” she added. ❚ Tarkiainen M, Tynjälä P, Vähäsalo P, Lahdenne P. Occurrence of adverse events in patients with JIA receiving biologic agents: long-term follow-up in a real-life setting. Rheumatology (Oxford). 2014 Dec 10. [Epub ahead of print]

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Patient Care 5 TIPS FOR MANAGING CONCUSSIONS

Children and adolescents are among those patients with the greatest risk for a concussion. The following tips offer methods for properly recognizing and responding to concussions in this patient population:

1 Recognition

2 SelfReported Symptoms

3 Signs Reported by Caregivers

Although signs and symptoms of a concussion can take time to appear and become evident, look for signs of (1) any forceful blows to the head or body resulting in rapid movement of the head; and (2) any change in the patients’ behavior, thinking, or physical functioning.

Patients may report several symptoms that can be associated with a concussion, including emotional symptoms, thinking/ remembering symptoms (eg, having difficulty thinking clearly or concentrating), sleeprelated symptoms, and physical symptoms (eg, headaches, nausea, vomiting, or numbness). Signs and symptoms observed by caregivers of patients who may have had a concussion include the patient appearing dazed or stunned, being confused about events, answering questions slowly, and repeating questions.

4 When to Seek Help

5 Management

â

Caregivers and patients should be aware of symptoms that worsen over time. Patients should be taken to the emergency department immediately if they display symptoms such as one of their pupils being larger than the other, drowsiness or inability to be woken up, or the presence of a headache that worsens or does not go away. Patients with a concussion should take rest breaks as needed, spend fewer hours at school, be provided more time to complete tests or assignments, receive help with schoolwork, and reduce the time they spend reading, writing, or on the computer.

MORE ONLINE

More patient tips are available online at InsidePatientCare.com Source: Centers for Disease Control and Prevention. www.cdc.gov/headsup/pdfs/custom/headsupconcussion_fact_sheet_for_schools.pdf. Accessed March 11, 2015.

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Patient Care Questions Answered with Janis Orlowski, MD, MACP In a recent interview with Inside Patient Care: Pharmacy & Clinics, Dr Orlowski, Chief Health Care Officer of the Association of American Medical Colleges, discussed the physician workforce shortage, measures set in place to address the shortage, and its impact on community pharmacists and clinicians. What is your background at AAMC? A: I am the Chief Health Care Officer at the Association of American Medical Colleges (AAMC). I have been with AAMC for about 15 months. I previously worked as a senior administrator at 2 academic medical centers and was a senior director at AAMC before becoming the Chief Health Care Officer. I spent many years as a senior executive dean at an institution in Chicago, and then was recruited here to Washington, DC, where, again, I had a senior leadership role in an academic medical center. I joined AAMC to work on some of the national policy issues—for example, the Affordable Care Act— and a number of the other pressing matters that were coming to the floor.

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They were looking for someone with significant experience in healthcare administration. That’s what initially brought me to AAMC. The position of Chief Health Care Officer became available a couple of months after I was there, and I was so named at the end of November 2014. AAMC has 3 mission areas; it’s looking at medical education (education platform), scientific affairs (research platform), and healthcare affairs, (clinical platform). I oversee AAMC’s work, policy work, and constituent work in the clinical environment. It can range from how academic medical centers are making changes in clinical care delivery, to how you integrate medical students and residents into your clinical care system effectively and with high quality, to interpro-

fessional education and key development. Within my division, we also have the AAMC Center for Workforce Studies. We have a large policy group, and I have a group that works on some of the new alternative payment mechanisms. Could you provide an overview of the recent physician workforce shortage report? A: Since early 2000, AAMC has had concerns regarding the accuracy of the physician workforce projections. At that time there were 2 very disparate studies available, one saying that there was an oversupply, and one saying that there’s a big undersupply. Also at that time, AAMC’s board made a commitment to set up a workforce center to evaluate the issue. For about 15 years or so,

we’ve had a center for workforce. We contracted with a group called IHS Inc, a global economic analytic corporation. They helped us with microsimulation studies, which is a new way for us to take a look at the many scenarios for demand for physician services. Then we looked at many, many scenarios of physician supply based on publicly available data. We used US Census data to look at overall growth in the decade’s population, and growth in different sectors. I think this study was a very good, very scientific way to address workforce scenar­ios. We decided to demonstrate the shortage with a range rather than with a specific number. That’s because there are a couple of changes in healthcare delivery that are new, and we are look-

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Patient Care ing at what their effect may be on healthcare delivery. The bottom line is that we are projecting, by the year 2025, a physician short­age of between 46,000 and 90,000. That range is based on how we see the different scenarios playing out. Rather than having a report come out every 3 to 5 years, we are now committed to coming out with annual updates, because there is too much movement in today’s healthcare staffing models. Looking at that 46,000 to 90,000 shortage, we asked, “Where is the shortage?” It looks like there’s a shortage of somewhere around 12,000 to 31,000 in primary care. Then the larger shortage, up to about 63,000 or 65,000, is in specialty care. We then asked the question, “Why are we seeing a decrease, still a shortage but a decreased one, in the shortage of primary care?” I think that there are 2 answers for that. One is that with an aging population—and the decade census shows a significant increase in those individuals >65 years—they tend to see more specialists. The second thing that we’re seeing is the integration of other health professionals into the primary care workforce. I think that is

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WE ARE SEEING IS THE INTEGRATION OF OTHER HEALTH PROFESSIONALS INTO THE PRIMARY CARE WORKFORCE.

2025 there is a continued demand for the physician workforce, but not as much as in other scenarios because the pharmacy and retail clinics tend not to be staffed by physicians. There is a preponderance of other health professionals in addition to physicians contributing to the demand for medical care.

one of the other reasons we see the shortage in the primary care specialty still being present, but not as severe as what we had noted in the past.

What is the role of community pharmacists and clinicians in the healthcare team? A: We are working with interprofessional groups to take a look at the appropriate development of an interprofessional team. What roles do the pharmacists play? What roles do the nurse practitioner, physician assistant, physician, social worker, and the in-hospital pharmacist play? This work is carried out by the Interprofessional Education Consortium (IPEC). We are carrying out significant, ongoing work at the AAMC and with other professional organizations in regard to interprofessional teams.

What is the implication of the data as it relates to community pharmacists and retail clinicians? A: We just modeled what the change in demand would be for the retail clinics scenario. For example, in one of the scenarios, we actually look at the retail clinic efforts that we see under way, the change in having more retail clinics. We took a look at the scenario and asked, “What if the 10 most common low intensity, low severity, illnesses were completely handled by retail clinics? What would be the demand for the physician workforce in that scenario?” That’s an example of one of the many different scenarios that we took a look at and supplied. Between now and

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ March 2015

How can retail pharmacists and clinicians help alleviate challenges associated with workforce shortages? A: I think that we have seen—with the retail pharmacists as well as

with the retail clinics— that there is an appropriate use of these 2 forms of healthcare delivery for a number of different healthcare situations. They tend to be the lower acuity (for example, look at vaccination rates). I think from a public health standpoint, pharmacists have been very helpful in the wider distribution of vaccines to the population. I also think that if you take a look at some of the clinics, there is good, immediate availability of healthcare personnel for low-acuity illnesses. I think that their role, and the scope of their role, continues to be defined as we see the remodeling of healthcare delivery. What other questions have the physician workforce shortage raised? A: One has to do with physician hours or physician retirement. Since 2008 we’ve seen a delay in physician retirement just as there has been a delay in other professions. We are taking a look at that and asking, “Is this going to be an ongoing trend?” Physician retirement has always been at an age that is older than most other professions, but it’s been stable for decades and decades. Since 2008 we’ve seen a shift of 2 additional years. We don’t

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Patient Care know if that’s going to reverse itself now that the financial difficulties seem to be improving, or if this is a new trend related to people living longer and finding satisfaction in their jobs and working longer. That’s one of the many trends that we’re looking at. We are also looking at the trend of the total number of advanced practice clinicians, nurse practitioners, and physician assistants. There are a tremendous number of these other health professionals who are in the pipeline and will be graduating in the next couple of years. The question is, “Will all of them be integrated into the workforce, or will any of these professions reach a natural cap?” Let me give you an example. We see nurse practitioners involved in primary care, but we also see nurse practitioners involved in specialty care. If we take a look at the ratio of nurse practitioners in specialty care, the question is, “Do you reach a certain saturation point at which you know that the advanced practice clinician will not be doing surgery so that there’s only so much work that can be done as a ratio to the number of surgeons?” That’s a workforce issue that we are looking at right now: is there a cap on

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WE NEED TO TAKE A LOOK AT CARE DELIVERY TEAMS AND IMPROVING THE EFFICIENCY OF CARE DELIVERY. WE NEED TO TAKE A LOOK AT THE INTEGRATION OF TECHNOLOGY INTO CARE DELIVERY. the number of advanced practice clinicians, or can we continue integrating as many advanced practice clinicians as are graduating to. What are some misconceptions about the physician workforce shortage? A: People have really liked the idea that we have taken a look at many different scenarios for demand and supply; we’re getting significant positive feedback on that. However, one of the concerns being raised is that this is a national study, and a national number. You have to be aware that there are local maldistribution issues that can make this shortage worse, or can make the

shortage less severe in certain areas. What measures are being set in place to address the projected physician workforce shortage? A: We think that there needs to be a multipronged effort. I would say we need to take a look at care delivery teams and improving the efficiency of care delivery. We need to take a look at the integration of technology into care delivery. We are also recommending a modest increase in the number of resident physicians paid for and trained, increasing it by 3000 per year. However, that number will not close the gap on any of the projections that we have. That’s why we say it’s a modest increase; but we think that there should be this multipronged approach of transformation in healthcare delivery, increased efficiency, use of technology, and then a slight increase in the number of physicians who are graduating and entering a residency. Do you have any concluding remarks? A: I appreciate the ability to talk about this study, and, as I mentioned, we will be having annual updates. We look forward to monitoring differing models of high-quality

care staffing and would appreciate support in advocating for a modest increase in training positions for physicians. We are asking individuals to put forward any questions or thoughts that we might be able to utilize in an annual update. If your community has any additional recommendations that you want to forward to this study, we would be happy to take those into consideration. ❚

Dr Orlowski is Chief Health Care Officer, Association of American Medical Colleges.

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Continuing Education Release date: March 31, 2015 Expiration date: March 31, 2016 Estimated time to complete activity: 0.5 hour Jointly provided by Postgraduate Institute for Medicine and Center of Excellence Media, LLC.

This activity is supported by an independent educational grant from AstraZeneca. TARGET AUDIENCE This activity has been designed to meet the educational needs of community clinical and retail pharmacists. EDUCATIONAL OBJECTIVES After completing this activity, the participant should be better able to: • Explain the role of community pharma­ cists in ensuring safe and effective medication use • Review factors that can impact clinical outcomes, including patient, disease, and medication • Utilize strategies to improve patient care, including patient education and medication adherence counseling • Describe the ways that community pharmacists can help their patients achieve optimal health and value through the knowledge and application of traditional and nontraditional care • Provide accurate and appropriate counsel as part of the treatment team FACULTY Johanna Sierra, PharmD PGY1 Pharmacy Resident Department of Pharmacotherapy and Translational Research University of Florida College of Pharmacy Gainesville, FL Katherine Vogel Anderson, PharmD, BCACP Clinical Assistant Professor Department of Pharmacotherapy and Translational Research University of Florida Colleges of Pharmacy and Medicine Gainesville, FL Pharmacist Continuing Education Accreditation Statement Postgraduate Institute for Medicine is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Credit Designation Postgraduate Institute for Medicine designates this continuing education activity for 0.5 contact hour(s) (0.05 CEUs) of the Accreditation Council for Pharmacy Education. (Universal Activity Number - 0809-999915-118-H01-P) Type of Activity: Knowledge

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Empowering Community Pharmacists as Health Consultants: Noncancer Pain by JOHANNA SIERRA, PHARMD, and KATHERINE VOGEL ANDERSON, PHARMD, BCACP

P

ain is an unavoidable part of the human experience. According to the National Institutes of Health, pain affects more Americans than diabetes, heart disease, and cancer combined.1 Noncancer pain is defined by the International Association for the Study of Pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage.”2 This definition acknowledges that pain is an emotional as well as a sensory occurrence. There is no way to objecDisclosure of Conflicts of Interest Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers, and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to PIM policy. PIM is committed to providing its learners with high-quality CME/ CE activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest. The faculty reported the following financial relationships or relationships to products or devices they or their spouse/ life partner have with commercial interests related to the content of this CE activity: Name of Faculty or Presenter

Reported Financial Relationship

Katherine Vogel Anderson, PharmD, BCACP

Nothing to disclose

Johanna Sierra, PharmD

Nothing to disclose

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ March 2015

tively measure pain because it is a subjective experience, influenced by each patient’s physical, psychological, social, and cultural background.3 In clinical practice, pain is regarded as the fifth vital sign and the most common reason to see a physician.4 However, it can be complex to assess, and the urgency by patients and physicians to adequately manage pain has resulted in a rise in prescription opioids, and opioid-related death.4 Studies show that >25% of adults in the United States report some form The planners and managers reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CE activity: The following PIM planners and managers—Laura Excell, ND, NP, MS, MA, LPC, NCC; Trace Hutchison, PharmD; Samantha Mattiucci, PharmD, CCMEP; Jan Schultz, RN, MSN, CCMEP; and Judi Smelker-Mitchek, RN, BSN—hereby state that they or their spouse/life partner do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months. Center of Excellence Media, LLC: Susan Berry hereby states that she or her spouse/life partner do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months. Instructions for Credit There is no fee for this activity. To receive credit after

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Continuing Education of persistent chronic pain, and 100 million Americans experience chronic pain.5 Causes of noncancer pain that a community pharmacist may encounter in his or her practice include arthritis (osteoarthritis, rheumatoid arthritis), headache (chronic daily, tension, migraine), chronic lower back pain, neck pain, diabetic peripheral neuralgia, fibromyalgia, inflammatory bowel disease, and sciatica.6 However, in some instances, there is no obvious cause for chronic pain, and this may be frustrating for both patients and providers. A 2011 report by the Institute of Medicine indicated that the annual value of lost productivity due to pain ranged from $297.4 billion to $335.5 billion.5 Therefore, it is critical to treat the cause of pain in addition to managing associated symptoms. Traditionally, the role of the community pharmacist has been product-oriented with limited clinical responsibility. As the most accessible healthcare professional in the community, a pharmacist can take the initiative to help patients understand the causes of their pain, management of symptoms, and reading this CE activity in its entirety, participants must complete the posttest and evaluation. The posttest and evaluation can be completed online at http://ce.lynxcme. com/COE176-4. Upon completion of the evaluation and scoring 75% or better on the posttest, you will immediately receive your certificate online. If you do not achieve a score of 75% or better on the posttest, you will be asked to take it again. Please retain a copy of the certificate for your records. If you have any questions regarding the CE certification for this activity, please contact Postgraduate Institute for Medicine at: information@pimed.com or 303-799-1930. Pharmacists: Upon successfully completing the posttest with a score of 75% or better and the activity evaluation form, transcript information will be sent to the NABP CPE Monitor Service within 4 weeks. Media: Printed report Disclosure of Unlabeled Use This educational activity may contain discussion of pub-

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appropriate use of medications. In addition, pharmacists may advocate for the patient as part of the healthcare team.

Conducting Pain Assessments Patients frequently do not receive adequate pain relief because their pain is not properly assessed or pharmacologic therapy does not comply with evidence-based practice.3 A community pharmacist has the advantage of seeing patients regularly, thereby establishing a trusting relationship that allows patients to be forthcoming with details regarding their pain. This also allows for close monitoring of the patient’s pain and positive or negative progression.6 There are many pain assessment tools that can be used to determine a patient’s pain in a matter of minutes, including specific tools for patients who have language or health literacy barriers. One tool consistently used in both inpatient and outpatient settings for adult and pediatric patients is the Wong-Baker FACES® Pain Rating Scale (Figure).7 This scale features a series of faces that the patient can choose from that graphically depict his or her pain. The first lished and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications. The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings. Disclaimer Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

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Continuing Education Figure. Wong-Baker FACES® Pain Rating Scale7

0

2

4

6

8

10

No Hurt

Hurts Little Bit

Hurts Little More

Hurts Even More

Hurts Whole Lot

Hurts Worst

©1983 Wong-Baker FACES® Foundation. Visit us at www.wongbakerFACES.org. Used with permission. Originally published in Whaley & Wong’s Nursing Care of Infants and Children. ©Elsevier Inc.

face shows no pain (0) and the last face shows the most severe pain (10). The numeric pain intensity scale and the numeric pain distress scale are also effective for pain assessment.4 These tools enable the patient to gauge pain intensity and distress on a scale of 0 (no pain) to 10 (worst pain imaginable/ unbearable pain). The visual analog scale allows patients to mark on a straight, continuous line where they think their pain is, starting with “no pain” on the left end of the line, and ending at “worst pain” on the right end of the line.5 It should be noted that pain scales provide an overall evaluation of pain, but not an assessment of individual components related to pain. For example, the numeric pain score does not reflect where the pain begins, whether it radiates, or what provides relief. Therefore, it is important to ask patients about intensity, location, onset, duration, variation, and quality of their pain.4 The immediate focus when assessing pain is the physical pathology arising from injury or disease; a patient’s psychological and social well-being are

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rarely assessed.4 The American Pain Society recommends a multidimensional approach to pain evaluation be given at initial and follow-up visits.6 This includes use of assessment tools such as the Brief Pain Inventory or the shortform McGill Pain Questionnaire.8,9 Both of these forms take 5 minutes to complete, can be self-administered, and provide information on pain intensity, pain interference, or mood/cognitive effects of pain.8,9 Pain interference includes the impact that the patient’s pain is having on physical and/or social activity, sleep, or relationships.4 Another pain inventory questionnaire that allows patients to rate how pain affects various aspects of daily life, such as sleep, mood, enjoyment of life, relationships, and work, is the Roland-Morris Disability Questionnaire (RMDQ).10 It is a widely used health status measure for lower back pain. The RMDQ is scored by adding up the number of items checked by the patient. Scores may vary from 0 (no disability) to 24 (maximum disability).10 There are relatively high correlations found between RMDQ scores and pain rat-

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Continuing Education ings.10 It is recommended to avoid the use of single-dimensional pain assessment tools in patients with chronic pain except to rate the intensity of specific pain episodes.6,11

Recent Advances in Care Although the precise mechanism of pain is not fully understood, an imbalance of the principal neurotransmitters, serotonin and norepinephrine, in the endogenous pain inhibitory pathways has been found to contribute to persistent pain.12 Persistent pain is the result of sensitivity changes throughout the brain and spinal cord, in both the ascending and descending pain pathways.12 Insight into the neurotransmitter system and chemical messengers associated with pain transmission has led to the use of innovative drugs such as antidepressants. Numerous studies have demonstrated the analgesic effect of antidepressants in the treatment of chronic pain.13 Tricyclic antidepressants (amitriptyline, nortriptyline), which inhibit norepinephrine and serotonin reuptake, have strong data demonstrating their pain-inhibiting effects.13 A review of studies with selective serotonin reuptake inhibitors (SSRIs; eg, sertraline, citalopram, fluoxetine, paroxetine, escitalopram) has shown inconsistent efficacy when used for the treatment of migraine or tension headaches, diabetic neuropathy, and fibromyalgia.13 However, serotonin norepinephrine reuptake inhibitors (SNRIs; eg, duloxetine, venlafaxine, milnacipran) have shown the most promise because of their binding affinity to serotonin and norepinephrine transporters and reuptake inhibition in the synaptic cleft.12 Duloxetine has now received approval by the US Food and Drug Administration (FDA) for the treatment of diabetic peripheral neuropathic pain, fibromyalgia, and chronic

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musculoskeletal pain (eg, osteoarthritis and chronic lower back pain).14 Numerous studies have suggested sex differences in pain perception, which has resulted in new directions for research. For example, medications called kappa-opioids provide good relief from acute pain in women, yet increase pain in men.15 Studies of experimentally

Numerous studies have demonstrated the analgesic effect of antidepressants in the treatment of chronic pain. induced pain have produced a very consistent pattern of results, with women exhibiting greater pain sensitivity, enhanced pain facilitation, and reduced pain inhibition compared with men.16 This has led researchers to believe that women not only experience clinical pain differently than men, but are at increased risk for chronic pain.16 With these advances, the healthcare team can approach pain with further insight and provide individualized care.

Patient Education Counseling patients on medications is an expected and required daily activity of the community pharmacist; however, pharmacists can go beyond the usual drug information and focus on the key issues surrounding pain. In pain management, the patient must understand exactly what is happening to fully conceptualize his or her pain experience.11 Patients desire an accurate diagnosis with a clear explanation, comprehensive pain management, and advice regarding that management.17,18 In addition, many patients wish to be involved in the decision-making process.17 Therefore, patients can benefit

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Continuing Education from education regarding the anatomy and physiology of the affected part(s), the multifaceted nature of chronic pain, the difference between acute and chronic pain, triggers and flare management, the role of exercise and physical therapy, realistic expectations about a diagnosis and cure, and goal setting.6 Per Institute for Clinical Systems Improvement (ICSI) guidelines, the goal of treatment is to improve function through the development of long-term self-management skills, including fit-

Patients desire an accurate diagnosis with a clear explanation, comprehensive pain management, and advice regarding that management. ness and a healthy lifestyle in the face of pain that may persist.11 Pharmacists can help reinforce the concepts of focusing on functional improvement in pain by making a plan and setting goals to increase a patientâ&#x20AC;&#x2122;s strength and range of movement, and adjusting pharmacotherapy appropriately by monitoring pain disability.11,18,19 This ultimately will help the patient return to his or her usual activity level or work sooner.6,11 Patients with chronic pain may also benefit from education on sleep hygiene, exercise, meditation or relaxation strategies, tobacco cessation, and weight loss.11,20 Addressing these topics allows patients to take into consideration other factors that may be contributing to their pain. When patients with moderate to severe noncancer pain completed a questionnaire and telephone interview, their satisfaction with treatment was low, particularly with regard to their

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lack of knowledge and understanding of their chronic pain and associated management.18 Pharmacists can help fill this knowledge gap by educating patients on the various ways to classify types of pain and the hallmark characteristics of each type, so that patients may more accurately identify the kinds of pain they are experiencing and thus be properly managed, educated, and counseled. The ICSI guidelines classify pain by the following 4 types: (1) neuropathic, (2) muscle, (3) inflammatory, and (4) mechanical/compressive.11 The most recognized characteristic of neuropathic pain (eg, sciatica from nerve root compression, diabetic peripheral neuropathy, trigeminal neuralgia, and postherpetic neuralgia) is usually described as a burning or shooting/stabbing sensation.11 The physical findings a patient may present with include numbness in the affected region, sensitivity to a non-noxious stimulus (eg, light touch or rubbing [allodynia]), or coolness of the skin.11 One of the most common pain clinic diagnoses, fibromyalgia, is a centrally mediated neuropathic pain syndrome characterized by widespread musculoskeletal aching, stiffness, and tenderness.11 Skeletal muscle pain is regional muscle soft tissue pain in â&#x2030;Ľ1 muscles in a region of the body, characterized by loss of range of motion and tenderness at muscle sites that causes referred pain.11 Treatment consists of identifying and managing perpetuating factors (posture, repetitive actions, occupational factors) and restoring muscle balance and function through physical therapy techniques rather than with medication management.11 To hasten recovery, patients may consider trigger point injections or acupuncture as adjunctive treatment.6,11 Inflammatory pain (eg, arthritis, infection, tissue injury, postoperative

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Continuing Education pain) is also known as nociceptive pain because of the mechanism of transmission through inflammatory mediators activating primary sensory nerves that carry pain information to the spinal cord.11 Clinical features include heat, redness, and swelling at the pain site and a history of injury or known inflammation.11 Pharmacologic treatment involves managing the inflammatory process with antibiotics, immunomodulating agents, and nonsteroidal antiinflammatory drugs (NSAIDs) or corticosteroids.11 Mechanical/compressive pain, usually identified by radiologic findings, includes fracture, obstruction, dislocation, or compression of tissue by tumor, cyst, or bony structure.11 It is also a type of nociceptive pain because mechanical pressure or stretching directly stimulates the pain-sensitive neurons.11 As this pain is normally aggravated by activity and temporarily relieved by rest, treatment options include decompression or stabilization of the area.11 Multiple guidelines recommend that patients try ≥1 nonopioid analgesic or adjuvant medications before considering opioid therapy.6,11,20 As such, patients should be counseled on maximum daily limits of over-the-counter (OTC) nonopioid drugs. Acetaminophen (APAP) should be limited to 4000 mg/day for healthy patients and 2500 mg/day for patients with liver disease. Given the number of APAP-containing combination products available, patients need to be aware of the APAP content of all OTC and prescribed medications. In 2014, the FDA required that all combination products not exceed 325 mg of APAP per dosage form.21 There are general precautions regarding NSAIDs that patients should be aware of to avoid gastrointestinal toxicity.22 Use of a proton pump inhibitor (lansoprazole 15 mg or 30 mg), in

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combination with an NSAID for 12 weeks, has been shown to decrease the occurrence of peptic ulcers by 80% or 82%, respectively.23 Use of misoprostol 800 µg/day has also reduced the risk of peptic ulcers by 93%.23 Celecoxib is now available generically, but in very high-risk patients (those with previous NSAID-associated ulcer bleeding) it was not associated with fewer peptic ulcers compared with diclofenac plus omeprazole.24 In addition, cardiovascular risk must be assessed prior to prescribing a cyclooxygenase-2 inhibitor as there is an increased risk of myocardial infarction.24,25 In general, patients should be counseled to avoid using NSAIDs or celecoxib if their risk for cardiovascular events is high.26 All NSAIDs can lead to or worsen renal impairment, increase blood pressure, and exacerbate heart failure.22

Multiple guidelines recommend that patients try ≥1 nonopioid analgesic or adjuvant medications before considering opioid therapy. Patients can benefit from understanding that the new advances discussed earlier have led to a wide scope of nontraditional medications to be used in pain management. Community pharmacists must be careful not to assume the indication for certain medications, such as SSRIs and SNRIs, which may be used off-label for a range of chronic pain states, with or without coexisting depression, as adjuvant pain medications. These mechanism-specific treatments for neuropathic pain, inflammatory pain, bone pain, and muscle dysfunction include tricyclic antidepres-

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Continuing Education sants, SNRIs, SSRIs, anticonvulsants, baclofen, cyclobenzaprine, propranolol, bupropion, triptans, and topical creams and patches.11 One commonly prescribed topical medication indicated for osteoarthritis is diclofenac sodium 1% gel.27 Patients should be counseled that this formulation may cause sun sensitivity as well as topical side effects at the application site, such as dry skin or contact dermatitis.27 Patients should also be advised to avoid skin-to-skin contact with other people until diclofenac gel has dried and avoid washing any area where the drug is applied, including treated hands, for at least 30 minutes to 1 hour after application.27 Another commonly prescribed top-

Typically, opioids are started at a low dose and then titrated slowly over 8 to 12 weeks (with monitoring and follow-up every 2-4 weeks). ical medication for relief of localized neuropathic pain syndromes is lidocaine in the form of a cream or a patch.11 Anticonvulsants (eg, gabapentin, pregabalin, oxcarbazepine, topiramate, valproic acid) are primarily used for neuropathic or lancinating pain.6 Pharmacists can play a central role in optimizing the benefits of these alternative therapies by improving adherence through patient education.18 Opioid pain medications may be considered when pain is moderate to severe. Clinical evidence suggests that opioids are likely to be effective when pain is not responsive to initial therapies, medical risk of opioid therapy is low, and the patient is likely to be responsible using the drug.11 The Four As (Analgesia, Adverse drug effect, Activity, and Adherence) highlight the goals of opi-

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oid therapy to “provide partial analgesia, and maintain or improve function with acceptable side effects” and should be assessed at each visit by a member of the healthcare team.11 The patient should also be educated about the dose titration plan. Typically, opioids are started at a low dose and then titrated slowly over 8 to 12 weeks (with monitoring and follow-up every 2-4 weeks).11 Community pharmacists can improve adherence by not only educating patients regarding common side effects (eg, constipation, nausea/vomiting, and sedation) but also preemptively counseling on appropriate OTC options for symptom relief. Patients should be informed that resolution of opioid-induced constipation generally does not occur with continued exposure, and it is best treated with a combination stool softener and laxative stimulant.6 A recent FDAapproved medication for the treatment of opioid-induced constipation in adult patients with chronic noncancer pain is naloxegol.28 It is an opioid antagonist that functions peripherally in the gastrointestinal tract with limited central nervous system penetration. Naloxegol has been shown to be efficacious in patients who have taken opioids for at least 4 weeks.28 It is metabolized primarily by the cytochrome (CY)P3A enzyme system; therefore, dose adjustments are recommended in patients being treated with CYP3A4 inhibitors or inducers. The most common adverse events associated with naloxegol in clinical trials were abdominal pain, diarrhea, nausea, flatulence, vomiting, and headache.28 However, nausea or vomiting tends to diminish over days or weeks of continued opioid exposure, and there are both oral and rectal formulations available for treatment.6 Other FDA-approved agents used for opioid-induced constipation include methylnaltrexone and lubiprostone.

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Continuing Education Sedation following opioid initiation can be transient or lasting. Therefore, at initiation of opioids or dose changes, patients should be counseled regarding driving, work safety, and concomitant use of other sedating drugs or substances (eg, alcohol).6 Nonpharmacologic options for pain management include exercise therapy, transcutaneous electrical nerve stimulation (TENS), massage therapy, cognitive behavioral therapy (CBT), acupuncture, relaxation, and stress management.11 Patients should be taught self-management techniques to help manage their pain, including use of ice, heat, and massage relaxation.11 TENS has limited evidence of effectiveness and is recommended to be used in conjunction with an active exercise program.11 However, a cost-effective OTC unit is accessible to patients, the IcyHot® SmartRelief™ System. It is marketed as the “first wireless OTC pain solution indicated for chronic pain.” The SmartRelief unit is smaller than a credit card and can be adjusted to 63 different intensity levels.29 The controller unit electrode that generates the impulses comes separate from the electrode pad, so a new pad can be used each time.29 Although reduction in pain scores were found and there is support from randomized controlled trials for massage therapy, the optimal amount of sessions and duration remains to be determined.11 Community pharmacists can encourage patients to seek cognitive behavioral approaches in the management of chronic pain, as these are considered to be among the most helpful.11 The goals of CBT are to improve physical functioning, assist patients in returning to work, and reduce disability, pain-related fear/avoidance, and psychological distress and depression.11 Another complementary management strategy is acupuncture, with the best

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evidence being for patients with fibromyalgia, headache, back pain, neck pain, or osteoarthritis.11

Interventions to Prevent Abuse/ Dependence on Opioids Community pharmacists are all too familiar with the potential for aberrant drug-related behavior, drug abuse, or drug misuse, especially with opioids.18 To help prevent deviant behavior, pharmacists should ensure that a single provider is prescribing and consequently supervising opioid therapy for each patient. The most appropriate physician to be prescribing opioids is the primary care provider, who is familiar with the patient’s medical history and should have completed a comprehensive biopsychosocial assessment.11 This assessment should include pain history plus administration of an opioid assessment tool to recognize potential risks for addiction, abuse, or misuse.11 Pharmacists can use assessment tools such as the Opioid Risk Tool (ORT) or

Community pharmacists are all too familiar with the potential for aberrant drug-related behavior, drug abuse, or drug misuse, especially with opioids. the Screener and Opioid Assessment for Patients with Pain (SOAPP).6,11 The ORT is a short questionnaire with 5 items that assess family and personal history of substance abuse.30 The SOAPP is a longer questionnaire (14 items) that utilizes a 5-point scale.31 Following assessment, the pharmacist should engage the patient in discussion of the importance of adherence to prescribed dosing, the potential for cognitive

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Continuing Education impairment, and the likelihood of physical dependence or addiction.11 Patients who are at high risk (ORT score ≥8) for diversion or abuse, or exhibit these behaviors, should be referred to a pain or addiction specialist.11 Community pharmacists are in a position to use statewide prescription monitoring programs to further assess patient fill patterns and identify any misuse or overutilization of opioids.6 If a patient is noncompliant, has escalation of opioid doses, or has increasing pain not responding to increasing opioids, the pharmacist can assess whether this is reflecting in­

More invasive techniques that are sometimes needed include nerve blocks, neurosurgical procedures, or implantation of drug delivery systems. adequate pain control or is a behavioral problem, which would indicate that the patient is not a candidate for opioid therapy.6 Discontinuation of opioid therapy would be necessary, which would require tapering or weaning off the medications.6 The withdrawal symptoms associated with discontinuation of opioids can be very unpleasant; however, a taper or wean can be achieved in an outpatient setting in patients without severe medical or psychiatric comorbidities.6 Discontinuation can be done slowly, at a 10% dose reduction per week, or more rapidly, as a 25% to 50% dose reduction every few days.6

Using a Specialist Referral Network to Improve Patient Care Although most types of pain can be treated through simple, low-technology approaches, community pharmacists can help patients recognize the need for

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a specialist referral. Such referrals are most beneficial to a substantial minor­ ity of patients with pain who do not respond adequately to other approaches and need to be evaluated by the appropriate medical/surgical consultant.11 These patients may require coordination of drug and nondrug therapies or more complex and sophisticated medical regimens, such as using adjuvant drugs to enhance pain relief, reduce side effects of analgesics, or treat depression.11 More invasive techniques that are sometimes needed include nerve blocks, neurosurgical procedures, or implantation of drug delivery systems.3 When complex pain treatment measures exceed the capabilities of the primary practitioner or community pharmacist, consultation with an expert in pain medicine becomes necessary.2,5 However, the specialist should assume the role of consultant and regularly communicate with the primary care provider, who should continue to see the patient on a regular schedule and continue to act as the prescribing clinician.11 The same principles of using expert pain consultation and treatment, including pharmacotherapy, technology, and nondrug measures, also apply to all conditions that can cause severe pain.11 Applying these principles in an integrated, individualized manner can restore and maintain quality of life in patients with acute pain as well as those with other chronic painful conditions, including HIV/AIDS, diabetes with neuropathy, headache, and severe arthritis.11

Conclusion Effective communication between all healthcare professionals and the patient is key to managing pain. Pharmacistconducted medication reviews, in cooperation with medical practitioners, optimize medication use and improve

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Continuing Education quality of life.18 The accessibility of community pharmacists enables them to assist patients with noncancer pain by conducting pain assessments, medication reviews, and counseling on a regular basis. ❚

References

1. National Institutes of Health. Fact sheet: pain management. Updated March 29, 2013. http://report.nih.gov/nih factsheets/ViewFactSheet.aspx?csid=57. Accessed February 15, 2015. 2. International Association for the Study of Pain, Task Force on Taxonomy. Part III: pain terms—a current list with definitions and notes on usage. In: Merskey H, Bogduk N, eds. Classification of Chronic Pain. 2nd ed. Seattle, WA: IASP Press; 1994:209-214. www.iasp-pain.org/Taxonomy. Accessed March 4, 2015. 3. Jamison RN, Edwards RR. Integrating pain management in clinical practice. J Clin Psychol Med Settings. 2012;19:49-64. 4. Morone NE, Weiner DK. Pain as the fifth vital sign: exposing the vital need for pain education. Clin Ther. 2013;35:1728-1732. 5. Institute of Medicine. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington, DC: National Academies Press; 2011. www. iom.edu/Reports/2011/Relieving-Pain-in-America-ABlueprint-for-Transforming-Prevention-Care-EducationResearch.aspx. Accessed March 4, 2015. 6. Chou R, Fanciullo GJ, Fine PG, et al. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain. 2009;10:113-130. 7. Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988;14:9-17. 8. Cleeland CS. Measurement of pain by subjective report. In: Chapman CR, Loeser JD, eds. Advances in Pain Research and Therapy: Issues in Pain Management (Vol 12). New York, NY: Raven Press; 1989:391-403. 9. Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987;30:191-197. 10. Roland M, Morris R. A study of the natural history of back pain. Part I: development of a reliable and sensitive measure of disability in low-back pain. Spine (Phila Pa 1976). 1983;8:141-144. 11. Hooten WM, Timming R, Belgrade M, et al, for the Institute for Clinical Systems Improvement. Assessment and Management of Chronic Pain. Updated November 2013. www.icsi.org/_asset/bw798b/ChronicPain.pdf. Accessed March 4, 2015. 12. Marks DM, Shah MJ, Patkar AA, et al, Serotoninnorepinephrine reuptake inhibitors for pain control: premise and promise. Curr Neuropharmacol. 2009;7:331-336. 13. Onghena P, Van Houdenhove B. Antidepressant-induced analgesia in chronic non-malignant pain: a meta-analysis of 39 placebo-controlled studies. Pain. 1992;49:205-219. 14. Cymbalta® (duloxetine hydrochloride) [prescribing information]. Indianapolis, IN: Eli Lilly and Company; 2014.

15. Kvachadze I, Tsagareli M, Dumbadze Z. An overview of ethnic and gender differences in pain sensation. Georgian Med News. 2015(238):102-108. 16. Gear RW, Miaskowski C, Gordon NC, et al. The kappa opioid nalbuphine produces gender- and dose-dependent analgesia and antianalgesia in patients with postoperative pain. Pain. 1999;83:339-345. 17. Verbeek J, Sengers MJ, Riemens L, et al. Patient expectations of treatment for back pain: a systematic review of qualitative and quantitative studies. Spine (Phila Pa 1976). 2004;29:2309-2318. 18. Jouini G, Choiniere M, Martin E, et al. Pharmaco­ therapeutic management of chronic noncancer pain in primary care: lessons for pharmacists. J Pain Res. 2014;7:163-173. 19. Malhotra A, Mackey S. Outcomes in pain medicine: a brief review. Pain Ther. 2012;1:5. 20. Nuckols TK, Anderson L, Popescu I, et al. Opioid prescribing: a systematic review and critical appraisal of guidelines for chronic pain. Ann Intern Med. 2014;160:38-47. 21. US Food and Drug Administration. Acetaminophen prescription combination drug products with more than 325 mg: FDA statement—recommendation to discontinue prescribing and dispensing. January 14, 2014. www.fda.gov/safety/ medwatch/safetyinformation/safetyalertsforhumanmedical products/ucm381650.htm. Accessed February 10, 2015. 22. Antman EM, Bennett JS, Daugherty A, et al. Use of nonsteroidal antiinflammatory drugs: an update for clinicians: a scientific statement from the American Heart Association. Circulation. 2007;115:1634-1642. 23. Graham DY, Agrawal NM, Campbell DR, et al. Ulcer prevention in long-term users of nonsteroidal anti-inflammatory drugs: results of a double-blind, randomized, multicenter, active- and placebo-controlled study of misoprostol vs lansoprazole. Arch Intern Med. 2002;162:169-175. 24. Chan FK, Hung LC, Suen BY, et al. Celecoxib versus diclofenac plus omeprazole in high-risk arthritis patients: results of a randomized double-blind trial. Gastroenterology. 2004;127:1038-1043. 25. McGettigan P, Henry D. Cardiovascular risk and inhibition of cyclooxygenase: a systematic review of the observational studies of selective and nonselective inhibitors of cyclooxygenase 2. JAMA. 2006;296:1633-1644. 26. Lanza FL, Chan FK, Quigley EM. Guidelines for prevention of NSAID-related ulcer complications. Am J Gastroenterol. 2009;104:728-738. 27. Voltaren Gel (diclofenac sodium topical gel) 1% [prescribing information]. Parsippany, NJ: Novartis Consumer Health; October 2009. 28. Movantik (naloxegol) tablets, for oral use [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2014. 29. IcyHot® SmartRelief™ TENS Therapy [user manual]. www.smartrelief.com/wp-content/uploads/2014/02/IH_ SmartRelief_Inst_Manual.pdf. Accessed March 2, 2015. 30. Webster LR, Webster RM. Predicting aberrant behaviors in opioid-treated patients: preliminary validation of the Opioid Risk Tool. Pain Med. 2005;6:432-442. 31. Butler SF, Budman SH, Fernandez KC, et al. Crossvalidation of a screener to predict opioid misuse in chronic pain patients (SOAPP-R). J Addict Med. 2009;3:66-73.

Johanna Sierra

Katherine Vogel Anderson Dr Sierra is a PGY1 Pharmacy Resident Department of Pharmacotherapy and Translational Research University of Florida College of Pharmacy Gainesville, FL; and Dr Vogel Anderson is a Clinical Assistant Professor Department of Pharmacotherapy and Translational Research University of Florida Colleges of Pharmacy and Medicine Gainesville, FL.

COE176-4

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QUESTIONS ANSWERED

David Neu, President of Good Neighbor Pharmacy [38]

The Retail Pharmacy Pharmacy Accreditation: Establishing Discipline and Consistency by MATT MANNING, PHARMD

With an evolving landscape and an increasing demand for quality-related outcomes, the healthcare market continues to push businesses and providers toward more quality-focused models. }} KEY POINTS ❚ Pharmacists and businesses must be able to provide reassurance that their patients are receiving high-quality care ❚ The leading accreditation bodies in the industry are URAC and ACHC ❚ Accreditation points to a new level of minimally acceptable standards for the pharmacy industry

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}} PHARMACIES AND PHARMACY services must be able to show they are quality providers and guarantee high-quality services that lead to successful therapeutic outcomes. Similarly, payers are demanding more evidence that their patients are receiving a high quality of care that will ultimately lead to cost-­ savings. With the implementation of the Affordable Care Act, an average of 12 million people are expected to be covered over the course of 2015.1 In addition, average annual enrollments are expected to increase to 21 million people in 2016 and then to 24 million to 25 million people each year between 2017 and 2025.1 That said, the call for increased participation from pharmacists has never been more apparent or needed. Programs and initiatives that focus on integrating medication therapy man-

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ March 2015

agement and reconciliation services and increasing patient involvement are key to helping improve quality, but how are these services validated? In addition, how are payers assured that their patients are receiving consistent quality management across the board? These are not just high-priority questions for payers, but also for patients. Because the push for increasing patient involvement is a key factor to success, the nation’s pharmacists and national businesses must be able to provide reassurance that their patients are receiving high-quality care. How can these businesses show payers and patients that their models work? The answer, in part, may lie in accreditation.

Accreditation in the Healthcare Industry According to the Utilization Review

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Inside the Retail Pharmacy

Figure. Locations with URAC Specialty Pharmacy Accreditation

Figure. Locations with URAC Specialty Pharmacy Accreditation

Figure. Locations with URAC Specialty Pharmacy Accreditation

*For 2015, total includes all locations classified as “In Process.” URAC I Indicates Utilization i Accreditation Commission. Source: Pembroke Consulting analysis of URAC Directory of Accredited Companies, December 2014. Published on Drug Channels (www.DrugChannels.net) on February 3, 2015. This chart originally appears as Exhibit 35 in the 2014-15 Economic Report on Retail, Mail, and Specialty Pharmacies, January 2015. http://drugchannelsinstitute.com/productions/industry_report/pharmacy/..

Reprinted with permission from Drug Channels Institute.

Reprinted with permission from Drug Channels Institute.

Reprinted with permission from Drug Channels Institute. Accreditation Commission (URAC), they validate whether an organization a leading organization in the field, is committed to providing the high“accreditation is an evaluative, rigorest quality of care to patients. From ous, transparent, and comprehensive accountable care organizations and drug process,” wherein a healthcare organitherapy management programs to dental zation has its systems, processes, and networks, the broad range of programs performance examined by an impareligible for accreditation is continuously tial, external accrediting organization.2 growing. This is done to ensure that business is conducted in accordance with national standards and in a manner that fulfills predetermined criteria. Accreditation is by no means a new topic, but it is gaining momentum; a quick Internet search for URAC or the Accreditation Commission for Health Care (ACHC) brings to light just how active these organizations are within the healthcare An excellent example of the growth industry. in accreditation can be seen in the Businesses are becoming increasingFigure,3 which highlights the growth in specialty pharmacy accreditations ly aware of the need for and potential conducted through URAC from 2008 advantages of accreditation. Currently, to 2015. This Figure was specifically the leading accreditation bodies in the developed to highlight the growth in industry are URAC and ACHC, and

Businesses are becoming increasingly aware of the need for and potential advantages of accreditation.

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Inside the Retail Pharmacy specialty pharmacies, and the increase in self-proclaimed specialty pharmacies authenticating their services. The Figure focuses on the number of specialty pharmacies accredited annually, as well as the total number of specialty pharmacies accredited to date. Comparing the approximately 100 specialty pharmacies set to become accredited by the end of 2015, with the fewer than 50 that were accredited in 2014, the evidence is clear that specialty pharmacies will continue to focus on accreditation as a means for certifying their services. Keep in mind, though, that

Accreditation points to a new level of minimally acceptable standards for the pharmacy industry. this chart does not include the specialty pharmacy accreditations issued by ACHC. Because URAC and ACHC are nationally recognized, one would imagine that for pharmacies receiving accreditations from such reputable organizations, it could open up the doors to previously closed channels and ultimately lead to a healthy return on investment. One of the best examples of how accreditation is influencing the industry can be seen through the recent actions taken by a leading pharmacy benefits manager (PBM).

Changing the Pharmacy Landscape The PBM Catamaran Corporation is taking an approach that may be replicated often in the near future. It is critical for a PBM the size of Catamaran to instill as much consistency into their process as possible. To implement such discipline within their system, they require that specialty pharmacies processing claims for their patients go through an accreditation process if they wish to stay within Catamaran’s network. Outside

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INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ March 2015

pharmacies that have yet to be accredited will be required to transfer the prescriptions of Catamaran participants to either BriovaRx or another pharmacy that is accredited. The impact their actions have will be significant considering that they are one of the largest managers of pharmacy benefits in the market. In addition, requiring accreditation accomplishes a few different tasks: First, it serves as a model for their preferred network and increases the claims being processed through their specialty pharmacy sites; second, it will reduce the number of claims being relayed by different pharmacies; and lastly, it will develop structure in the level of patient care and handling of medications by outside pharmacies. As a way to validate that outside pharmacies servicing their patients abide by the same standards as BriovaRx— Catamaran’s in-house specialty pharmacy—they require that outside specialty pharmacies servicing their patients complete a credentialing process. The goal is to instill consistency and accountability into the marketplace. In addition to credentialing specialty pharmacies, Catamaran aims to introduce similar requirements to surrounding compounding pharmacies. In response to the rising costs of compounded medications, Catamaran launched the Safe & Effective Compound Reassurance Effort, which sought to manage by implementing prior authorizations for select agents and excluding certain bulk chemicals. This effort reportedly reduced costs related to compounds by 27% in a single quarter.4 In addition, Catamaran recently partnered with United Compounding Management, an independent compounding management company, and is in the process of implementing the Network Compound Credentialing Program, which is the industry’s first compound credentialing program, according to Catamaran.4 The focus of the program is similar to the specialty pharmacy network, and will include the

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Inside the Retail Pharmacy development of claims processing standards, medication exclusions, and other additional requirements. Catamaran will require that participants meet the standards of the Pharmacy Compounding Accreditation Board, a division of the ACHC, to be considered for network participation. This accreditation is just one of the many requirements Catamaran has set for compounding pharmacies, with the goal to establish consistency within the growing compounding market and to develop a cost-beneficial network that is more manageable.

Setting Standards for Value-Based Care What does this mean for the dispensing pharmacist? Accreditation points to a new level of minimally acceptable standards for the pharmacy industry. Pharmacists can expect to eventually take part in some form of accreditation. Whether it applies to community, compounding, or any of the other certifications available, accreditation is set to become more of a standard practice than a choice. Although these accrediting bodies work independently, credentialing is becoming more of a standard than an option, and is opening the doors to a multitude of questions: When will accreditation become a requirement for all PBMs and payers? When will nonaccredited community pharmacies begin being carved out of networks? Moving forward, one can expect that PBMs and payers will continue using pharmacy accreditation as leverage when develop-

ing their networks to become even more favorable. In addition to other accreditations, CVS Pharmacy was recently granted the new Community Pharmacy Accreditation through URAC, making them the first pharmacy to be awarded the certification.5 The next step will likely be PBMs and payers restricting participant access, or influencing patient choice in favor of accredited community pharmacies. Evidence shows that it has already occurred within the specialty and compounding markets, and as value-based services become an expectation, more standardized protocols will need to be integrated. Having gold standard accrediting bodies certify these services gives patients confidence in their treatment, pharmacies confidence in their services, and payers confidence in the management of their participants. ❚

References

1. Congressional Budget Office. The budget and economic outlook: 2015 to 2025. www.cbo.gov/sites/default/files/cbo files/attachments/49892-Outlook2015.pdf. Published January 26, 2015. Accessed March 9, 2015. 2. URAC. Accreditation & measurement. www.urac.org/ accreditation-and-measurement/accreditation-and-measure ment/. Accessed March 2, 2015. 3. Fein AJ. The specialty pharmacy boom continues. www.drugchannels.net/2015/02/the-specialty-pharma cy-boom-continues.html. Published February 3, 2015. Accessed March 2, 2015. 4. Drug Benefit News. Catamaran tests next phase of managing compounds with credentialing program. http:// ucmrx.com/wp-content/uploads/2015/02/Drug-BenefitNews_1_23_2015.pdf .Published January 23, 2015. Accessed March 3, 2015. 5. URAC. CVS/pharmacy earns first-ever community pharmacy accreditation from URAC. www.urac.org/news/ cvspharmacy-earns-first-ever-community-pharmacy-accredi tation-from-urac/. Published July 31, 2014. Accessed March 9, 2015.

Dr Manning is a Pharmacy Operations Specialist for ReCept Pharmacy, LP, Fort Worth, TX.

GET YOUR RETAIL PHARMACY AND CLINIC PROFILED! We want to interview PAs, NPs, and Medical Directors from around the country. The process is easy – just a short phone interview and some photos. Contact: info@insidepatientcare.com for information

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Inside the Retail Pharmacy

Questions Answered with David Neu, President of Good Neighbor Pharmacy In a recent interview with Inside Patient Care: Pharmacy & Clinics, David Neu, Executive Vice President of Retail Strategy, and President of Good Neighbor Pharmacy, discussed the role of independent pharmacies in the community and provided some tips to new and veteran community pharmacy store owners.

David Neu

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What is your background at Good Neighbor Pharmacy? A: In my 30+ years with the company, I have had a long-standing and deep relationship with Good Neighbor Pharmacy, and have been its constant champion and close connection with our independent pharmacy customers. With over 3000 member stores, Good Neighbor Pharmacy has been helping independent pharmacies for more than 30 years and has been named a top pharmacy group by J.D. Power for the past 3 years, as well as the highest in customer satisfaction for the second year in a row. Over the years, our primary focus has been to build and operate branding, advertising, and patient care hubs for independent retail pharmacies to help them compete in a highly competitive marketplace. This includes backroom operations ranging from managed care to branding to patient programs, as well as training and equipping them to do that, primarily in areas where it doesnâ&#x20AC;&#x2122;t really make sense for member stores to invest in individually. With our scale, we can amortize that across the full base.

INSIDE PATIENT CARE: PHARMACY & CLINICS â?&#x161; March 2015

How are pharmacies transforming to become healthcare delivery companies? A: There are several primary areas where retail pharmacies are transforming into healthcare delivery companies. Todayâ&#x20AC;&#x2122;s community pharmacist may offer support for disease management or more specialized nonpharmaceutical products for diseases prevalent in the communities they serve. Services ranging from diabetes and nutrition counseling to chronic obstructive pulmonary disease (COPD) therapies, immunizations, to other preventive care measures. The recent increase in interest and emphasis on medication therapy management is following the patient into the new healthcare environment. The Star Community Rating System that has hit the marketplace has emerged as the foundation for how payers will rate the ability of a pharmacy to drive medication safety and medication adherence with the patient, and be considered a highperforming, quality pharmacy in that spectrum. For us, there is a lot of focus on providing awareness, training, and resources to the independent and com-

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Inside the Retail Pharmacy munity pharmacies so they can improve that quality of service for the patient. We also focus on what happens when a patient enters the pharmacy, as the pharmacies we work with are also merchants. We provide services that help them improve the profitability of their store for the different types of patients and different demographics they serve. What new service offerings are being introduced in pharmacies? A: We know that technology is very important to reaching the consumer and providing more information from our pharmacies. That’s not novel thinking; that’s industry thinking. We have put together a Good Neighbor Pharmacy consumer mobile application that is available on Apple and Android devices where patients can refill their prescriptions. They can put together refill reminders on their phone to alert them when to take their prescriptions. One of the goals of the app is to provide an extension of the pharmacy to patients on the go: quick reference information, refill reminders, pharmacy contact information. We are continually releasing new versions of the app with expanded capabilities. They can get background information on certain disease states. They can also find a store that is close to them with the locator service that’s built in. We also do some things with partnerships to make sure that they are ready to deal with things like Star Ratings. We use reporting services from EQuIPP to bring to life how each individual pharmacy is doing on the Star Ratings, and create a benchmark on which we can help them improve. How are Good Neighbor pharmacists involved in clinical services? A: This is an area where pharmacists really feel a connection. They want to contribute at a higher level clinically with patients. We provide training materials and resources so that they are prepared whether they are treating a patient with asthma who is trying to stay out of the

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emergency department, or a patient with type 2 diabetes who they are trying to help manage his or her total lifestyle. It’s more than just filling the prescription. The trust of their patients is crucially important to them. Many have taken extra training and participated in clinical internships. At our annual gathering of Good Neighbor Pharmacy members, ThoughtSpot, we offer several continuing education courses for pharmacists and their technicians. The most highly attended session last year focused on Star measures. This year, we are once again offering certifications in immunizations, medication therapy management services, diabetes care, and cardiovascular disease risk management. Throughout the year, we also offer certification opportunities around the country. Our goal is to help organize and enable our member stores to perform these emerging services in an efficient way, not just the initial touch in the store, but also the follow-up after the patient leaves, as well as training materials for them to have those same conversations with the physicians in their area who are prescribing. Business coaches work with pharmacies to identify their top prescribers and those who they can contact to potentially generate additional business.

They want to contribute at a higher level clinically with patients.

What trends in pharmacies have you observed? A: The trends that they are feeling are not branded, and pharmacies are feeling quite a bit of pressure on reimbursement. Part of that is because of the change in healthcare coverage. Part of it is the ongoing consolidation of various players in healthcare who are trying new ways of providing value to the employers, and of translating that down to a coverage model. There is a lot of change, a lot of consolidation, taking place in the industry driving some of that. We try to help them with that reimbursement pressure, for example, by providing medication pricing. When medication prices are out of the norm, pharmacies call us, and if the medication pricing does not match

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ March 2015

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Inside the Retail Pharmacy The days that pharmacists can just market to and solicit people who walk in the door have really changed.

the way they are buying that product, we reach out to the pharmacy benefit managers or the payers, and discuss adjusting medication prices. Another component is the changing consumer. Consumers are moving toward a more electronic environment. The days that pharmacists can just market to and solicit people who walk in the door have really changed. I don’t say they’re changing, I say they’ve changed: how they connect through social media, how they connect electronically, how they understand how those patients made it into their pharmacy, and then the regimen that patients are on and the different choices that patients have for adhering to that regimen, whether it is through a mail order or other nontraditional healthcare providers. We try to capture as much of that information as possible, and get the pharmacist trained to be as efficient as possible. The growth is interesting, although I think that the National Community Pharmacists Association would say that the number of independent pharmacies is within what I would call a reasonable flat range. We have had some stores that have been sold to chains, and in some cases, some stores have closed. Right now we probably have as many closures as we do openings, but I see a trend that is moving up. I do think that retail pharmacies are looking at the different sites of care, or the different channels, such as long-term care or specialty. They are not coming in as just a traditional pharmacy, but they are trying to find ways to connect more broadly. As one of the largest providers of specialty pharmacy, Good Neighbor Pharmacy helps these pharmacies finds ways to connect with them. We help them with long-term care. We help them with alternate care channels, which we also serve. Could you describe a typical new pharmacy owner and the services provided to help a pharmacy be successful? A: A new pharmacy owner is generally

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INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ March 2015

someone who is 5 to 10 years out of pharmacy school and who has some experience working, learning the business, as well as the profession of pharmacy itself. They are generally looking to get into a pharmacy that is in an area with some potential upside. We help them from a real estate perspective to do that. They are generally looking to come into an established pharmacy, earning an equity piece over time, or just a fresh startup. In the fresh startups, they are looking for store setup and design services, which we provide. They are also looking for help advertising, kicking off their new store in the community, which we help them with generally through our cluster groups that operate in those areas. They want to make sure that they get immediate access to the managed care plans, which we put them on in short order because we contract on behalf of all the pharmacies. We are their central point of managed care contracting. We get them in the loop immediately so that they can get up and running. Then they grow their business from there. What are some essential tips new and current pharmacy owners should know? A: It depends on the type of pharmacy that they are starting in. If, for example, they are starting in a small apothecary shop, I believe it is usually very helpful for them to try to pick a location that is close to some acute care settings, so that they have some access to the ambulatory patient who may be leaving a hospital outpatient facility and coming into their pharmacy as the next natural step. I think that they need to have a very high level of expertise and clinical training to provide those services that, in a small apothecary shop, are more sought after. If it is someone moving into a larger store that has a more significant front end, we encourage them to get some experience from a pharmacy that is also a merchant, that has a big front end of over-the-counter health and beauty aids, and that understands how to manage inventory and margin.

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Inside the Retail Pharmacy Importantly, we get a business coach from AmerisourceBergen in there to help them set up the store in a way that the retail component can be as impactful as the clinical and quality-of-care aspect. Could you discuss the 3 biggest challenges that you see in community pharmacy? A: The number one challenge right now is reimbursement, because that really impacts community pharmacies. It is so much a part of their operating income that every dollar of reimbursement that is taken out is a net dollar, right out of their bottom line. The second is not to get excluded from health plan networks. There is going to be more and more pressure on whether, in certain states, restricted or performance networks are allowed. In some cases, they will believe they don’t need to be part of a network because it is an open access state. In other areas, they have to join or they are going to be excluded. It is not one size fits all. Exclusion from healthcare networks is a tremendous pressure point, a fear area. If it is a large plan, they can lose 25% or 50% of their prescriptions overnight. The third challenge is their competitors. They are competing with large chains that have a lot of resources financially in infrastructure. They need to have a competitive look and feel. How their stores are geared up so that they are as much of a clinical quality-of-care setting as they are a pleasurable and attractive retail storefront is important. They have to meet both of those needs to ensure that the patients keep coming in because the patients have a choice. They can choose from multiple pharmacies and groups that have those same plans. In my opinion, those are the 3 biggest challenges that probably keep them up at night. What are some opportunities in the industry? A: I am really bullish about community pharmacy. They have a unique value

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proposition because of their agility, not only their learning agility but their ability to adapt to what's going on in healthcare. Community pharmacy has a history of being resilient, of being leaders in their community in multiple ways. There are stories upon stories about what the independent pharmacies have done for communities, not only for healthcare but in times of crisis. The floods and hurricanes and the ways that they have been a call to action are really quite extraordinary. I believe that with the right partners, if they really piece together their offering with the right people, they can have a very valuable value proposition. It is one that is time-tested. Some people want to go to chains and some people want a community proprietor feel. They want that kind of a local business owner feel. There are consumers for everything. I am very bullish that as this is promoted more and more at the schools of pharmacy, we will see more people interested in getting into retail pharmacy.

Community pharmacy has a history of being resilient, of being leaders in their community in multiple ways.

How do you see the relationship between physicians, NPs, PAs, clinics, and pharmacists evolving? A: The electronic transmission of prescriptions is finally starting to get some traction here. There has been quite a bit of activity through Surescripts and other partners in the industry as this evolves, but the recent changes in healthcare have really affected this in a much different way. I don’t think it’s an option anymore. People realize that they must get electronically connected. Of all the things that are going to happen, I think that is going to be a big influencer. I think that, because of the workload of the primary care physician, more and more patients are either going to be in clinics or pharmacies looking for care. It is, for me, the biggest growth area. They are trusted professionals, and I think the patients have said in surveys that they are going to be taking advantage of that in the future; another very bullish trend. ❚

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Inside

Healthcare Policy If Not You, Then Who? Taking Advantage of the Opportunity for Change by JANET K. ASTLE, BS PHARM, EDD

IN HER ADDRESS TO Amnesty International, Harvard graduate and awardwinning author Margaret Atwood once warned, “Powerlessness and silence go together.”1 Likewise, President John F. Kennedy once stated, “There are risks and costs to a program of action. But they are far less than the long range risks of comfortable inaction.” If their assertions are correct, then why are so many of us content to sit back and let others carry the banner? Is it because we as pharmacists and healthcare providers are disinterested? Or do we think that the responsibility for change and advocacy rests with our employers or our professional associations? Perhaps we believe that the current status quo, including job security and a predictable paycheck, will continue to endure.

Changes in Pharmacy and Healthcare We are already seeing trends to the contrary

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with a flattening pharmacist job market. The increased use of automation and centralized fill, which allows for more accurate, efficient, and economical dispensing, has decreased the need for dispensing pharmacists. A movement toward the credentialing and licensing of technicians also challenges the need for highly paid pharmacists to fulfill tra­ ditional dispensing roles. Some have even suggested that the profession may see the ultimate development of a 2-class system of dispensing and nondispensing pharmacists, with a significant salary gap between the 2 roles.2 Notwithstanding the current trends, healthcare is evolving at a pace that is arguably more rapid than it has been at any other time in our history, particularly because of the implementation of the Affordable Care Act. Pressure to contain costs and at the same time improve health outcomes for our patients continues to

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ March 2015

PROVIDERS ACROSS THE BOARD ARE HELD ACCOUNTABLE THROUGH METRICS THAT CONTRIBUTE TO PERFORMANCE SCORES. mount. Providers across the board are held accountable through metrics that contribute to performance scores. Star ratings, for example, are assigned by the Centers for Medicare & Medicaid Services (CMS) to compare quality of care among health plans. Payment models are shifting from a fee-for-service structure to a system of bundled payments for defined episodes of care. Delivery efficiency and minimization of complications result in more robust margins for healthcare systems.

With Accountability Comes Opportunity The emergence of accountable care organizations (ACOs) is one example of alternative payment models. CMS defines ACOs as “groups of doctors, hospitals, and other health care providers, who come together voluntarily to give coordinated high quality care to their Medicare patients.”3 ACOs that deliver highquality care and minimize costs are rewarded by sharing in the costsavings it achieves for the program. These pay-forperformance models represent the new wave of reimbursement. Where does pharmacy fit into the picture? The shifting healthcare paradigm not only presents challenges, but also offers significant opportunities, as long as we are versatile enough to take advantage of them. One such approach is to ensure pharmacy’s engagement with ACOs. Evidence of our ability to enhance patient

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Healthcare Policy outcomes and contribute to cost-savings can be quite attractive to an ACO whose margins are maximized when minimizing costs associated with quality patient care. Pharmacy needs to have a seat at that table. Pharmacy can also positively contribute in boosting Star Ratings awarded to insurance plans. Research demonstrates that patient adherence rates on 3 separate outcome measures, including hypertension, cholesterol, and oral diabetes medications, can positively enhance an insurance plan’s Star Ratings through pharmacist involvement.4 Pharmacy can also enhance Star Ratings by improving the use of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers in patients with diabetes. Partnerships between pharmacy and health insurance plans can result in enhanced patient outcomes, elevating the health plan’s status. Pharmacy needs to share in these rewards.

Benefits of Achieving Provider Status The Association of American Medical Colleges projects that a shortfall of more than 91,000 physicians may exist by the year 2020.5 Medically underserved populations

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PROVIDER STATUS WOULD ALLOW PHARMACISTS TO PROVIDE REIMBURSABLE SERVICES TO MEDICALLY UNDERSERVED COMMUNITIES CONSISTENT WITH STATE SCOPE OF PHARMACY PRACTICE LAWS. and areas will be most severely impacted. One way to remedy the problem is being addressed by the introduction of the Pharmacy and Medically Underserved Areas Enhancement Act into Congress. These bills would amend the Social Security Act to recognize pharmacists as providers under Medicare Part B. Unlike physicians and the vast majority of healthcare professionals, pharmacists are not recognized as providers under Medicare Part B. Provider status would allow pharmacists to provide re­ imbursable services to medically underserved com­munities consistent with state scope of pharmacy practice laws. Providing healthcare screen-

ings, administering immunizations, engaging in collaborative care agreements, performing medication reconciliation in transitions of care, delivering medication therapy management services, and assisting patients in disease state management will not only allow pharmacists to practice at the top of our license, but will also result in the very best care that we can provide to our patients.6

Garnering Support for Provider Status Legislation It is essential that pharmacists advocate on behalf of provider status legislation. The American Pharmacists Association is taking the lead on this initiative. Its website, www.pharmacist.com, offers a treasure trove of information relative to provider status. Grassroots advocacy efforts, including phone calls and faceto-face meetings with legislators, are especially effective. Alternatively, personal letters or e-mails can also serve to communicate your position. Invite legislators to visit your practice site; most do not have a full appreciation of the services that pharmacists are qualified to provide, nor do they understand the barriers that we face. Getting comfortable with advoca-

cy is vital not only for the issues that we face today, but also for the challenges that may present themselves tomorrow. We have a prime opportunity to elevate pharmacy practice to the full scope of our education. The challenge is to not squander this opportunity. Our silence will leave other healthcare professionals to fill the void. If not you, then who? ❚

References

1. Atwood M. Second Words: Selected Critical Prose. Toronto, ON: House of Anansi Press; 2005:396. 2. Romanelli F, Tracy TS. A coming disruption in pharmacy? Am J Pharm Educ. 2015;79:Article 01. 3. Centers for Medicare & Medicaid Services. Accountable care organizations (ACO). www.cms.gov/Medicare/ Medicare-Fee-for-Service-Payment/ ACO/index.html. Updated January 6, 2015. Accessed March 16, 2015. 4. Leslie RS, Tirado B, Patel, BV, Rein PJ. Evaluation of an integrated adherence program aimed to increase Medicare Part D star rating measures. J Manag Care Spec Pharm. 2014;20:11931203. 5. American Pharmacists Association. Pharmacists and unmet need. www. pharmacist.com/sites/default/files/files/ PAPCC_Unmet_Need.pdf. Accessed March 16, 2015. 6. Avalere Health LLC. Exploring pharmacists’ role in a changing healthcare environment. http://avalere.com/exper tise/life-sciences/insights/exploringpharmacists-role-in-a-changing-healthcare-environment. Published May 2014. Accessed March 16, 2015.

Dr Astle is Assistant Dean for Student Services, Duquesne University Mylan School of Pharmacy, Pittsburgh, PA.

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Inside

Drug Update Trulicity (Dulaglutide): A New GLP-1 Receptor Agonist Once-Weekly Subcutaneous Injection Approved for the Treatment of Patients with Type 2 Diabetes by LORETTA FALA, MEDICAL WRITER

Diabetes, a chronic disease that is often accompanied by multiple comorbidities and health complications, is the seventh leading medical cause of death in the United States. In fact, the mortality rate for patients with diabetes is 1.5 times higher than for individuals without diabetes.1 }} }} DIABETES AFFECTS an estimated 29.1 million individuals in the United States—an alarming 9.3% of the US population.1 In addition, an estimated 37% of US adults aged ≥20 years have prediabetes, according to the 2009-2012 National Health and Nutrition Examination Survey data.1 The prevalence of diabetes is projected to increase from 1 in 10 adults today to 1 in 3 adults by 2050, coinciding with the aging

of the baby boom generation during the next few decades.2 Type 2 diabetes mellitus accounts for approximately 90% to 95% of all cases of diabetes. Diabetes is a major cause of heart disease and stroke. In addition, diabetes is the leading cause of kidney failure, nontraumatic lower-limb amputations, and new cases of blindness in US adults.1 Furthermore, patients with diabetes are at an increased risk for other

Copyright © 2015 American Health & Drug Benefits. Used with permission. All rights reserved.

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INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ March 2015

complications, including nerve disease, nonalcoholic fatty liver disease, periodontal disease, erectile dysfunction, hearing loss, depression, and pregnancy complications.1 The total estimated cost for patients with diagnosed diabetes in 2012 totaled $245 billion, including $176 billion in direct medical costs and $69 billion in indirect costs (ie, increased absenteeism, reduced productivity, lost productivity as a result of early mortality, and the inability to work resulting from disability).3

These 2012 costs represent a 41% increase from diabetes-related costs of $174 billion in 2007. Overall, the medical expenses for patients with diabetes are 2.3 times higher than for individuals without diabetes.3 According to the American Diabetes Association (ADA), diabetes management is complex, generally requiring multiple risk reduction strategies in addition to glycemic control.4 Diabetes management demands an ongoing, patient-tailored approach that considers

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Drug Update the whole patient—glycemic control to prevent or reduce microvascular complications, as well as strategies to address obesity and prediabetes as the underlying risk factors for diabetes and for related macrovascular complications. These approaches generally include dietary and other behavioral and lifestyle changes, which are impor­ tant aspects of diabetes care.4 Adequate glycemic control has been shown to reduce the morbidity and mortality of diabetes by decreasing chronic complications.4 Lowering the hemoglobin (Hb) A1c levels to 7% or below reduces microvascular complications, and, if reached soon after the diagnosis of diabetes, is associated with a longterm reduction in macrovascular disease.4 The ADA’s 2013 position statement on the standards of care for diabetes recommends a target HbA1c level of <7% for the majority of adult patients with diabetes.4 The ADA acknowledges that the stringency of this goal may need to be modified based on the patient’s duration of diabetes, comorbidities, age, known cardiovascular or advanced microvas­ cular complications, and other patient-­specific factors.4 In a 2013 consensus statement, the American

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Table 1. AWARD-3 Clinical Trial: Dulaglutide Monotherapy versus Metformin, at Week 26 Dulaglutide 0.75 mg (N = 270)a

Dulaglutide 1.5 mg (N = 269)a

Metformin 15002000 mg (N = 268)a

Baseline, %

7.6

7.6

7.6

Change from baseline (adjusted mean), %

–0.7

–0.8

–0.6

Baseline, mg/dL

161

164

161

Change from baseline (adjusted mean), mg/dL

–26

–29

–24

Baseline, kg

92.7

92.7

92.4

Change from baseline (adjusted mean), kg

–1.4

–2.3

–2.2

Efficacy parameter Mean HbA1c level

Mean fasting serum glucose

Mean body weight b

Patients included in the analysis are a subset of the intent-to-treat population who had at least 1 postbaseline assessment; the primary analysis included 265 patients in each of the treatment arms. b Umpierrez G, et al. Diabetes Care. 2014;37:2168-2176. HbA1c indicates glycated hemoglobin. Source: Trulicity (dulaglutide) injection prescribing information; September 2014. a

Association of Clinical Endocrinologists (AACE) recommended an HbA1c target goal of <6.5% in the majority of patients with type 2 diabetes, with the caveat that this goal may be too aggressive for some patients and not aggressive enough for other patients (ie, younger patients for whom a lower target may prevent later complications).5 The AACE also states that lifestyle modification and antihyperglycemic pharmacotherapy should aim to reach clinical and biochemical glucose targets, avoid hypoglycemia, assist with weight loss and minimize weight gain in obese

individuals, and reduce or avoid increasing cardiovascular disease risk.5 Despite the progress made in the number of US adults who reach the target HbA1c level of <7%, there is room for more improvement.6 Ongoing clinical management, patient engagement, education, and the development of novel therapies may help to improve glycemic control and outcomes for patients with diabetes.6 The ADA recommends metformin as the initial therapy for type 2 diabetes; if another treatment or a com­ bination therapy is warranted,

available agents include sulfonylureas, thiazoli­ dinediones, dipeptidyl peptidase (DPP)-4 inhibitors, glucagon-like peptide (GLP)-1 receptor agonists, insulin, and other agents.7 The development of the GLP-1 receptor agonist and the DPP-4 inhibitor classes, both of which target the incretin system, represents an important advancement ­­in the management of type 2 diabetes.8 The long-acting GLP-1 receptor agonists improve glycemic control and help to promote weight loss. Furthermore, based on their glucosedependent mechanism of

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ March 2015

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Inside

Drug Update Table 2. AWARD-5 Clinical Trial: Dulaglutide versus Sitagliptin as Add-On Therapy to Metformin, at Week 52 Dulaglutide 0.75 mg (N = 281)

Efficacy parameter Mean HbA1c level Baseline, % Change from baseline (adjusted mean), % Difference from sitagliptin, % Patients reaching HbA1c <7%, % Mean fasting plasma glucose Baseline, mg/dL Change from baseline (adjusted mean), mg/dL Difference from sitagliptin, mg/dL Mean body weight Baseline, kg Change from baseline (adjusted mean), kg Difference from sitagliptin, kg

Dulaglutide 1.5 mg (N = 279)

Sitagliptin 100 mg (N = 273)

8.2

8.1

8.0

–0.9

–1.1

–0.4

–0.5 (95% CI, –0.7 to –0.3)a

–0.7 (95% CI, –0.9 to –0.5)a

49b

59b

33b

174

173

171

–30

–41

–14

–15 (95% CI, –22 to –9)

–27 (95% CI, –33 to –20)

85.5

86.5

85.8

–2.7

–3.1

–1.5

–1.2 (95% CI, –1.8 to –0.6)

–1.5 (95% CI, –2.1 to –0.9)

Multiplicity adjusted 1-sided P <.001. P <.002 dulaglutide compared with sitagliptin. CI indicates confidence interval; HbA1c, glycated hemoglobin. Source: Trulicity (dulaglutide) injection prescribing information; September 2014. a

b

action, the GLP-1 receptor agonists have a low risk for hypoglycemia.8

Dulaglutide: A New Once-Weekly Option On September 18, 2014, dulaglutide (Tru­ licity; Eli Lilly), a onceweekly subcutaneous injection, was approved by the US Food and Drug Administration (FDA) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.9 Dulaglutide is a GLP-1

46

receptor agonist that was shown to reduce fasting and postprandial glucose after a single dose.10 Dulaglutide is not recommended as first-line therapy for patients whose diabetes is inadequately controlled with diet and exercise.10 In addition, dulaglutide is not recommended in patients with type 1 diabetes, diabetic ketoacidosis, or a preexisting severe gastrointestinal disease. Dulaglutide has not been studied in patients with a history of

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ March 2015

pancreatitis or in combination with basal insulin.10 According to Mary Parks, MD, Deputy Director, Office of Drug Evaluation II in the FDA Center for Drug Evaluation and Research, “Type 2 diabetes is a serious chronic condition that causes blood glucose levels to rise higher than normal. Trulicity is a new treatment option, which can be used alone or added to existing treatment regimens to control blood sugar levels in the

overall management of type 2 diabetes.” 9 The FDA requires a Risk Evaluation and Mitigation Strategy program for dulaglutide to inform healthcare professionals about dulaglutide’s serious associated risks.9 The FDA also requires several postmarketing studies to be conducted on dulaglutide, including a clinical trial to evaluate the dosing, efficacy, and safety of dulaglutide in pediatric patients; a study to assess the potential effects on sexual maturation, reproduction, and central nervous system in immature rats; a case registry for at least 15 years to investigate the incidence of medullary thyroid carcinoma in relation to dulaglutide; a trial comparing dulaglutide and insulin glargine in patients with type 2 diabetes and renal impairment; and a cardiovascular outcomes clinical trial in relation to dulaglutide.9

Dosing and Administration Dulaglutide is administered once weekly at any time of the day via subcutaneous injection into the abdomen, thigh, or upper arm.10 The initial dose of dulaglutide is 0.75 mg administered subcutaneously once weekly. This dose can be increased to 1.5 mg once weekly for

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Drug Update additional glycemic control. If a dose is missed, dulaglutide should be administered within 3 days of the missed dose. The day of the weekly administration can be changed if necessary, as long as the last dose was administered ≥3 days before. Dulaglutide can be administered with or without food.10 Dulaglutide is available in 2 single-dose pen solutions and in 2 single-dose prefilled syringe solutions for injection—0.75 mg/0.5 mL and 1.5 mg/ 0.5 mL.10

Mechanism of Action Dulaglutide is a human GLP receptor agonist with 90% amino acid sequence homology to the endogenous human GLP-1 fragment 7-37.10 Dulaglutide activates the GLP-1 receptor, a membrane-bound cell-surface receptor that is coupled to adenylyl cyclase in pancreatic beta cells. By increasing intracellular cyclic adenosine monophosphate in beta cells, dulaglutide leads to glucose-­dependent insulin release. Dulaglutide also decreases glucagon secretion and slows gastric emptying.10 Clinical Studies Dulaglutide has been studied as monotherapy and in combination

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with several antihyperglycemic medications, including metformin, metformin and sulfonyl­ urea, metformin and thiazolidinedione, and prandial insulin with or without metformin.11,12 These studies evaluated treatment with dulaglutide 0.75 mg and dulaglutide 1.5 mg. Uptitration was not performed in any of the clinical trials. Patients were initiated with dulaglutide 0.75 mg or dulaglutide 1.5 mg, and these doses were maintained for the duration of the clinical trials.11,12 In patients with type 2 diabetes, dulaglutide was shown to reduce HbA1c levels from baseline compared with placebo.10 No overall differences in glycemic effectiveness were observed across the demographic subgroups, including age, sex, race and ethnicity, and the duration of diabetes.10

AWARD-3: Dulaglutide versus Metformin The safety and efficacy of dulaglutide monotherapy versus metformin were evaluated in the AWARD-3 trial, a 52-week, double-blind study (26-week primary end point) with 807 patients: the median age was 56 years, and the mean duration of type 2 diabetes was 3 years.11 All the patients had inade-

BY INCREASING INTRACELLULAR CYCLIC ADENOSINE MONOPHOSPHATE IN BETA CELLS, DULAGLUTIDE LEADS TO GLUCOSEDEPENDENT INSULIN RELEASE. quate glycemic control with diet and exercise, or with diet and exercise and 1 antidiabetic agent used at the submaximal dose.11 The patients were randomized to receive dulaglutide 0.75 mg once weekly, dulaglutide 1.5 mg once weekly, or metformin 1500 mg to 2000 mg daily after a 2-week washout period.11 Approximately 90% of patients who had previously received an antidiabetic agent were receiving metformin at a median dose of 1000 mg daily, and approximately 10% of patients were receiving sulfonylurea.11 As shown in Table 1, treatment with dulaglutide 0.75 mg or 1.5 mg once weekly resulted in the reduction of HbA1c levels from baseline at the 26-week primary time point. The decrease from baseline in fasting serum glucose levels was similar

with dulaglutide 0.75 mg, with dulaglutide 1.5 mg, and with metformin.11 The decrease in body weight from baseline was similar with dulaglutide 1.5 mg and with metformin, but it was smaller with dulaglutide 0.75 mg compared with metformin. A greater percentage of patients who received dulaglutide 0.75 mg or dulaglutide 1.5 mg reached HbA1c levels of <7.0% and ≤6.5% compared with patients who received metformin (P <.05, all comparisons).11

AWARD-5 Trial: Dulaglutide versus Sitagliptin This 104-week, double-blind, placebo-controlled study (with a 52-week end point) evaluated the safety and efficacy of dulaglutide versus sitagliptin as an add-on therapy to metformin.10,12 This study included 972 patients; the patients’ mean age was 54 years and the mean duration of type 2 diabetes was 7 years. Patients were randomized to receive placebo (after 26 weeks, patients in the placebo treatment group received blinded sitagliptin 100 mg daily for the remainder of the study), dulaglutide 0.75 mg once weekly, dulaglutide 1.5 mg once weekly, or sitagliptin 100 mg daily, all

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ March 2015

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Inside

Drug Update as add-on therapies to metformin. Randomization occurred after an 11week lead-in period to allow for a metformin titration period, followed by a 6-week glycemic stabilization period.10 Treatment with dulaglutide 0.75 mg and with dulaglutide 1.5 mg once weekly, in combination with metformin, demonstrated a significant reduction in HbA1c levels compared with placebo at 26 weeks, and compared with sitagliptin at 26 weeks and at 52 weeks (Table 2).10,12 At 26 weeks, the percentage of patients who reached <7.0% HbA1c levels was significantly higher in patients who received dulaglutide 1.5 mg (61%) or dulaglutide 0.75 mg (55%) compared with patients who re­ ceived sitagliptin (38%; P <.001, for both comparisons).12 At 52 weeks, the least squares mean changes from baseline in fasting plasma glucose levels were significantly greater with dulaglutide 1.5 mg and with dulaglutide 0.75 mg compared with sitagliptin (P <.001, for both comparisons).12 Furthermore, dulaglutide 0.75 mg and dulaglutide 1.5 mg showed a significantly greater mean change in body weight from baseline at 52 weeks compared with sitagliptin (P <.001, for both comparisons).12

48

Adverse Events The most common adverse reactions reported in ≥5% of patients who received dulaglutide are nausea, diarrhea, vomiting, abdominal pain, and decreased appetite.10 Contraindications Dulaglutide is contraindicated in patients with a personal history or a family history of medullary thyroid carcinoma or in patients with multiple endocrine neoplasia syndrome type 2. Dulaglutide should not be used ­if the patient has a history of serious hypersensitivity to dulaglutide or any of its drug components.10 Drug Interactions Dulaglutide slows gastric emptying and may affect the absorption of concomitantly administered oral drugs.10 Warnings and Precautions Boxed warning. In rodent studies, dulaglutide caused an increase in the incidence of thyroid C-cell tumors after lifetime exposure.10 It is not known whether dulaglutide causes thyroid C-cell tumors in humans.10 Thyroid C-cell tumors in animals. Patients should be counseled about the risk for medullary thyroid carcinoma with the use of dulaglutide.10

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ March 2015

DULAGLUTIDE SHOULD NOT BE USED IF THE PATIENT HAS A HISTORY OF SERIOUS HYPERSENSITIVITY TO DULAGLUTIDE OR ANY OF ITS DRUG COMPONENTS. Pancreatitis. Pancreatitis-related adverse reactions were reported with dulaglutide. Dulaglutide should be promptly discontinued if pancreatitis is suspected and should not be restarted if pancreatitis is confirmed.10 Hypoglycemia. Lowering the dose of the sulfonylurea or insulin may be warranted when dulaglutide is used with an insulin secretagogue (eg, sulfonylurea) or insulin to reduce the risk for hypoglycemia.10 Hypersensitivity reactions. Dulaglutide should be discontinued if a hypersensitivity reaction is suspected. Patients should be monitored and treated promptly until the signs and symptoms of hypersensitivity resolve.10 Renal impairment. Renal impairment should be monitored in patients with

renal impairment who report severe adverse gastrointestinal reactions.10

Use in Specific Populations Pregnancy. There are no adequate and well-­ controlled studies of dulaglutide in pregnant women.10 Nursing mothers. It is not known whether dulaglutide is excreted in human milk.10 Pediatric use. The safety and efficacy of dulaglutide have not been established in pediatric patients. It is not recommended in young patients aged <18 years. Geriatric use. No overall differences in the safety or efficacy of dulaglutide were detected between patients aged ≥65 years and younger patients, but greater sensitivity of some older individuals cannot be ruled out.10 Hepatic impairment. There is limited experience with dulaglutide in patients with any hepatic impairment.10 Renal impairment. No dosage adjustment is recommended for patients with renal impairment. Renal function should be monitored in patients with renal impairment and severe adverse gastrointestinal reactions.10 Gastroparesis. Dulaglutide slows gastric emptying.10

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Drug Update Medical Directors • Physician Assistants • Nurse Practitioners • Pharmacists • Chain Headquarters • Independents

Diabetes Care. 2012;35:1364-1379. lation: dynamic modeling of incidence, Conclusion 3342 patients with type 2 Erratum in: Diabetes Care. 2013;36:490. mortality, and prediabetes prevalence. With the recent FDA diabetes, treatment with Popul Health Metr. 2010;8:29. 8. Garber AJ. Long-acting glucagon-like peptide 1 receptor agonists: 3. American Diabetes Association. approval of dulaglutide, a dulaglutide resulted in Economic costs of diabetes in the U.S. a review of their efficacy and tolernew, once-weekly subcugreater reductions from in 2012. Diabetes Care. 2013;36:1033ability. Diabetes Care. 2011;34(suppl Retail pharmacies and clinics are quickly becoming an 1046. Erratum in: Diabetes Care. 2):S279-S284. taneous injection became baseline in HbA1c levels 9. US Food and Drug Administration. 2013;36:1797. comparedof with placebo, available as an adjunct to extension primary care. Inside Patient Care: Pharmacy FDA approves Trulicity to treat 4. American Diabetes Association. Standards of medical care in diabetype 2 diabetes. Press release. with no overall differencdiet and exercise for adult & Clinics is tailored to meet the growing needs of the entire 18, 2014. www.fda. tes—2013. Diabetes Care. 2013; September es in glycemic reductions patients with type 2 36(suppl 1):S11-S66. gov/NewsEvents/Newsroom/Press healthcare teamage, andsex,provides practical toAnnouncements/ucm415180.htm. treat across race/ diabetes. Dulaglutide, a 5. Garber AJ, information Abrahamson MJ, Accessed 22, 2014. Barzilay JI, et al. American Association ethnicity, or duration GLP-1 receptor and agonist, ”September care for patients insideofthe pharmacy and retail 10. Trulicity (dulaglutide) injection of Clinical Endocrinologists’ com- clinics. disease. ❚ provides a once-weekly [prescribing information]. Indianapolis, prehensive diabetes management IN: Eli Lilly and Company; September algorithm 2013 consensus statement. treatment option that can 2014. Endocr Pract. 2013;19(suppl 2):1-48. Donald J. Dietz, RPh, MS be used as monotherapy References 11. Umpierrez G, Tofé Povedano S, 6. Cheung BM, OngVice KL, President Cherny SS, et 1. Centers for Disease Control and Pérez al. Diabetes prevalence and therapeuor as an add-on therapy Pharmacy Healthcare Solutions,Manghi Inc. F, et al. Efficacy and Prevention. National diabetes stasafety of dulaglutide monotherapy vertic target achievement in the United Editor-in-Chief to existing treatment tistics report: estimates of diabetes sus metformin in type 2 diabetes in a States, 1999 to 2006. J Med. InsideAm Patient Care regimens. A once-weekly and its burden in the United States, randomized controlled trial (AWARD2009;122:443-453. 2014. 2014. www.cdc.­ gov/diabetes/ 3). Diabetes Care. 2014;37:2168-2176. 7. Inzucchi SE, Bergenstal RM, Buse treatment may provide an pubs/statsreport14/national-diabetes12. Nauck M, Weinstock RS, JB, et al. Management of hyperglyceattractive option for pa­ report-web.pdf. Accessed August 5, Umpierrez GE, et al. Efficacy and safemia in type 2 diabetes: a patient-cen2014. tered approach: position statement of ty of dulaglutide versus sitagliptin after tients with diabetes. 2. Boyle JP, Thompson TJ, Gregg EW, 52 weeks in type 2 diabetes in a ranthe American Diabetes Association In 6 clinical studies et al. Projection of the year 2050 burdomized controlled trial (AWARD-5). (ADA) and the European Association den of diabetes in the US adult popuDiabetes Care. 2014;37:2149-2158. for the Study of Diabetes (EASD). that included a total of

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As primary care expands to provide optimal access to quality care, Inside Patient Care: Pharmacy & Clinics™ offers a forum for the team treating and coordinating patient care in pharmacies and retail clinics, including medical directors, physician assistants, nurse practitioners, pharmacists, and C-level executives, to implement the best therapeutic options, navigate the healthcare system, and achieve professional success.

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Each issue of the journal includes resources that will enable the retail healthcare team to provide optimal patient care—how to screen, diagnose, and treat patients; answer questions on prevention and wellness; deliver acute treatment; monitor and manage chronic conditions; make efficient use of healthcare resources; and attract, retain, and engage patients, shoppers, and customers.

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Products and Services And other news from the US Food and Drug Administration

New Drugs/Devices The following are some of the recent approvals announced by the US Food and Drug Administration (FDA): • Zarxio (filgrastim-sndz) is the first biosimilar product approved in the United States. The drug is biosimilar to Amgen Inc’s Neupogen (filgrastim), and is approved for the same indications, including patients with severe neutropenia. • Cresemba (isavuconazonium sulfate), a new intravenous antifungal product, was approved for adult patients with invasive aspergillosis and invasive mucormycosis. The drug belongs to a class of drugs called azole antifungal agents, which target the cell membrane of a fungus. • Avycaz (ceftazidime-avibactam) is a new intravenous antibacterial drug product approved to treat adult patients with complicated abdominal infections, in combination with metronidazole, and patients with complicated urinary tract infections, including pyelonephritis, who have limited or no alternative treatment options.

50

THE FIRST GENERIC VERSION OF FUSILEV (LEVOLEUCOVORIN CALCIUM; SPECTRUM PHARMACEUTICALS, INC) FOR INJECTION HAS BEEN APPROVED BY THE FDA. • ResQCPR System, a system of 2 devices for first responders to use while performing cardiopulmonary resuscitation (CPR) on patients who are experiencing cardiac arrest, was approved. The device may improve the patient’s chances of surviving cardiac arrest.

New Generic The following is a recent first-time generic drug approval by the FDA: • The first generic version of Fu­ silev (levoleucovorin calcium; Spectrum Pharmaceuticals, Inc) for injection has been approved by the FDA. The generic drug name is levoleucovorin calcium

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ March 2015

injection, 10 mg/mL, and is manufactured by Sandoz, Inc.

New Rulings, Announcements The following are some recent FDA rulings and announcements: • US v Specialty Compounding LLC, et al. US District Judge Lee Yeakel entered a consent decree of permanent injunction between the United States and Specialty Compounding LLC, of Cedar Park, TX, and co-owners. Specialty Compounding manufactured purportedly sterile injectable drug products that tested positive for bacterial contamination. The consent decree prohibits the company and its owners from manufacturing, holding, or distributing sterile drugs until they comply with the Federal Food, Drug, and Cosmetic Act and its regulations, in addition to other requirements. ❚ Sources: (1) US Food and Drug Administration. New and generic drug approvals. www.fda.gov/ Drugs/NewsEvents/ucm130961.htm. Updated March 17, 2015. Accessed March 18, 2015; (2) US Food and Drug Administration. Press an­ nouncements. www.fda.gov/NewsEvents/News room/PressAnnouncements/default.htm. Updated March 17, 2015. Accessed March 18, 2015.

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Empowering Community Pharmacists as Health Consultants: Ten Hot Topics to Foster Delivery of Quality Patient Care A 10-PART SERIES

The publishers of Inside Patient Care are proud to present Empowering Community Pharmacists as Health Consultants: Ten Hot Topics to Foster Delivery of Quality Patient Care series. ™

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Topics include: • Diabetes • Detection and Control of Hypertension: Role of the Community Pharmacist

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IPC March 2015, Vol 3, No 3  
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