Inside Pharmacy April 2014

Pharmacists • Chain Headquarters • Independents • Physician Assistants • Nurse Practitioners April 2014 • Volume 2 • Number 2 TM

Transforming Retail Pharmacies into Healthcare Delivery Companies™

Patient-Centered Care

Exploring Quality-of-Care Metrics in Patients with Asthma

Inside Retail Pharmacy OTC Analgesics: A Closer Look at Recent Updates

Electronic Prior Authorization Helping Patients Get Faster Fills

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

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Transforming Retail Pharmacies into Healthcare Delivery Companies™

Call for submissions

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Do you have a retail pharmacy best practice to share?

In your background as a retail pharmacy manager, it’s likely there’s one business experience – and maybe more – that pharmacy managers 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 pharmacy.

Step out from “behind the counter” and send us your ideas!

Submit a 750- to 1500-word original article, previously unpublished and submitted exclusively to Inside Pharmacy, that your fellow pharmacy managers will want to read.

Submit to: FEvans@the-lynx-group.com IP submissions_Asize_050714

PUBLISHING STAFF

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

Senior Vice President/Group Publisher Nicholas Englezos nenglezos@the-lynx-group.com

APRIL 2014 • VOL 2 • NO 2

Executive VP/Managing Director Chuck Collins ccollins@engagehc.com

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Director, Client Services Ron Gordon rgordon@the-lynx-group.com

Transforming Retail Pharmacies into Healthcare Delivery Companies™

Editorial Directors Dalia Buffery dbuffery@the-lynx-group.com Frederique H. Evans fevans@the-lynx-group.com Strategic Editor Robert E. Henry Associate Editor Lara J. Lorton Editorial Assistants Jennifer Brandt Cara Guglielmon Production Manager Melissa Lawlor The Lynx Group President/CEO Brian Tyburski

TABLE OF CONTENTS THE FIRST WORD

6 The Role of Technicians in Cultivating Pharmacists’ Care Donald J. Dietz, RPh, MS

Chief Operating Officer Pam Rattananont Ferris Vice President of Finance Andrea Kelly Associate Director, Content Strategy & Development John Welz

INSIDE HEALTHCARE

10 The Time Is Now for Congress to Cement Pharmacists’ Roles with Provider Status Charles E. Collins, Jr, MS, MBA

Associate Editorial Director, Projects Division Terri Moore Director, Quality Control Barbara Marino Quality Control Assistant Theresa Salerno Director, Production & Manufacturing Alaina Pede

INSIDE PATIENT CARE

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Patient-Centered Care: Metrics to Measure Quality of Care in the Community Setting for Patients with Asthma Elliott M. Sogol, RPh, PhD, FAPhA

Director, Creative & Design Robyn Jacobs Creative & Design Assistant Lora LaRocca

Continued on page 4

Director, Digital Media Anthony Romano Meeting & Events Planner Linda Sangenito Web Content Managers David Maldonado Anthony Trevean Digital Programmer Michael Amundsen

Mission Statement

Office Coordinator Robert Sorensen

Inside Pharmacy is an independent journal founded on the principle of valuebased, patient-centered, evidence-based healthcare. As retail pharmacies transform into healthcare delivery companies, Inside Pharmacy offers a forum for pharmacists, chain headquarters, independent pharmacies, physician assistants, and nurse practitioners, to navigate the healthcare system and achieve professional success. Each issue of the journal includes resources to support the entire healthcare team inside the pharmacy, including how to attract, retain, and engage customers; answer patient questions on prevention and wellness, acute treatment, and monitoring and management of chronic conditions; and empower retail clinicians in a value-based healthcare system.

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Senior Project Managers Andrea Boylston Jini Gopalaswamy Project Coordinators Jackie Luma Deanna Martinez IT Specialist Carlton Hurdle Executive Administrator Rachael Baranoski

Vol 2, No 2

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Pharmacists • Chain Headquarters • Independents • Physician Assistants • Nurse Practitioners APRIL 2014 • VOL 2 • NO 2 TM

Transforming Retail Pharmacies into Healthcare Delivery Companies™

TABLE OF CONTENTS

(Continued from page 3)

INSIDE RETAIL PHARMACY

13 OTC Analgesics: A Closer Look at Recent Updates Julie L. Olenak, PharmD

INSIDE PHARMACY MANAGEMENT

17 Electronic Prior Authorization: Helping Patients Get Faster Fills Julie Hessick, RPh

INSIDE CARDIOMETABOLIC: DIABETES

19 Rx for Technology: BlueStar for Diabetes Matthew Hershberger; and Ann E. Johnson, PharmD

Inside Pharmacy, ISSN (requested), is published 6 times a year by Engage Healthcare Communications, LLC, 1249 South River Rd, Suite 202A, Cranbury, NJ 08512.

Copyright © 2014 by Engage Healthcare Communications, LLC. All rights reserved. Inside Pharmacy is a trademark of Engage 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.

Address all editorial correspondence to: fevans@the-lynx-group.com Telephone: 732-992-1895

INSIDE HEALTHCARE OPERATIONS

22 Pharmacists in Public Health: A Call to Action

Jennifer L. Bacci, PharmD

POSTMASTER: CORRESPONDENCE REGARDING SUBSCRIPTIONS OR CHANGE OF ADDRESS should be directed to CIRCULATION DIRECTOR, Inside Pharmacy, 1249 South River Rd, Suite 202A, Cranbury, NJ 08512. Fax: 732-992-1881. YEARLY SUBSCRIPTION RATES: One year: $99.00 USD; Two years: $149.00 USD; Three years: $199.00 USD.

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Fax: 732-992-1881 Inside Pharmacy 1249 South River Rd, Suite 202A Cranbury, NJ 08512 The ideas and opinions expressed in Inside Pharmacy do not necessarily reflect those of the Editorial Board, the Editors, or the Publisher.

Publication of an advertisement or other product mentioned in Inside Pharmacy should not be construed as an endorsement of the product or the manufacturer’s claims. Readers are encouraged to contact the manufacturers about any features or limitations of products mentioned.

Neither the Editors nor the Publisher assume any responsibility for any injury and/or damage to persons or property arising out of or related to any use of the material mentioned in this publication.

April 2014

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EDITORIAL ADVISORY BOARD

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

James S. Beaumariage, RPh Chief Operating Officer NuScript Rx Nashville, TN

John O. Beckner, RPh District Manager Giant Food Stores Richmond, 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 Discount Pharmacies Medley, FL

Mark J. Gregory, RPh Senior Vice President of Store Operations Kerr Drug, Inc. Raleigh, NC

Kevin James, RPh, MBA Vice President, Managed Markets Avella Specialty Pharmacy Phoenix, AZ

Scott L. Kemme Vice-President/General Manager, Chain Segment McKesson Pharmacy Systems & Automation Livonia, MI

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

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

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

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

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

Vol 2, No 2

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THE FIRST WORD

The Role of Technicians in Cultivating Pharmacists’ Care

By Donald J. Dietz, RPh, MS, Editor-in-Chief

A

s each issue of Inside Pharmacy is prepared, we focus on providing relevant material and topics that enable the retail pharmacist to provide better patient care. As pharmacists, we have the leading role in this endeavor. The Oscars acknowledge the role of the supporting actors and actresses in making an award-winning film. Similarly, pharmacists should acknowledge and cultivate the supporting role that a good pharmacy technician provides to a pharmacist in delivering exemplary patient care.

If your pharmacy is about to embark on a medication synchronization effort, involving the input of an engaged pharmacy technician to help identify patients for the program is key.

An Expanding Role We need to look beyond the typical job description of a pharmacy technician. I propose we focus on the roles that technicians provide that go beyond accurate data entry, inventory management, keeping the pharmacy orderly, and providing good customer service.

What do I mean exactly when I state that you need to look beyond these essential responsibilities? Let me describe a few examples. First, think about the pharmacy technician who identifies a situation of low health literacy. Not being able to read the prescription directions will most likely lead to poor outcomes. Alerting the pharmacist of these situations so that he or she can counsel and provide the extra care needed to ensure the patient knows how to properly take their medication is key. Without a keen focus by an astute technician, these opportunities can be missed.

In a similar vein are situations when a pharmacy technician identifies that a patient is taking too much or too little of their medication based on refill patterns that are outside of the norm. Calling these situations to the attention of the pharmacist provides the oppor-

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tunity for the pharmacist to engage the patient, address any problems, and verify that the prescriptions are being taken properly.

If your pharmacy is about to embark on a medication synchronization effort, involving the input of an engaged pharmacy technician to help identify patients for the program is key. The technician may have regular contact with the patients and may detect when getting to the pharmacy frequently is a burden to the patient.

Technicians may also know those patients who would rather visit frequently, often for the social interaction.

An Invaluable Role The value of an empathetic, caring technician extends beyond the pharmacy counter. Consider the technician who helps direct customers to over-thecounter (OTC) items outside the pharmacy department. Directing the patient to “Aisle 5” for a dental item is what is expected of every technician. Alerting the pharmacist of a parent struggling with what OTC pain reliever to give their sick child is when the technician helps the pharmacist provide better care.

In addition, the technician who knows when to tell the pharmacist to move a prescription to the top of the workflow queue is invaluable. This is especially true when it involves an acutely ill patient waiting for their medication or a return visit from a patient, and the prescription is not yet ready.

Technicians like those I described above can be invaluable to your pharmacy and to you in identifying situations where you can truly impact and help your patients. If you have technicians like these in your pharmacy, please acknowledge their efforts and thank them for helping you provide the best patient care possible.

We should also seek to develop these skills in our existing and future pharmacy technicians. I am sure there are many other examples of wonderful services your supporting “actors” and “actresses” provide to help you in your role as a healthcare provider. I invite you to share your exemplary technician success stories with our readers by e-mailing them to the editorial staff of Inside Pharmacy (fevans@the-lynx-group.com).

My goal is to share more ideas on the valuable role pharmacy technicians play in enabling us to provide the best care to our patients every day. n

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Vol 2, No 2

While all albuterol may be the same

ONE QUICK-RELIEF INHALER IS

ProAir HFA (albuterol sulfate) offers a complete package of helpful features including a built-in dose counter ®

1

Patients know how many puffs are left1 and when to refill • A longer-duration, less forceful, warmer plume 2 may give patients more time to inhale • Storage flexibility and portability1,3,4 means no need to reprime if dropped •

ProAir HFA (albuterol sulfate) Inhalation Aerosol is indicated in patients 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.

Important Safety Information Inhaled albuterol sulfate can produce paradoxical bronchospasm that may be life-threatening. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister • Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma • ProAir HFA, as with all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders (especially coronary insufficiency, cardiac arrhythmias, and hypertension), convulsive disorders, hyperthyroidism, and diabetes •

Please see Brief Summary of Prescribing Information on next 2 pages.

References: 1. ProAir HFA Prescribing Information. Horsham, PA: Teva Respiratory, LLC; May 2012. 2. McCabe JC, Koppenhagen F, Blair J, Zeng X-M. ProAir HFA delivers warmer, lower-impact, longer-duration plumes containing higher fine particle dose than Ventolin® HFA. J Aerosol Med Pulm Drug Deliv. 2012;25(2):104-109. 3. Everard ML, Devadason SG, Summers QA, Le Souëf PN. Factors affecting total and “respirable” dose delivered by a salbutamol metered dose inhaler. Thorax. 1995;50(7):746-749. 4. Graham SJ, Ormsby ED, Lovering EG. Single spray drug content in a metereddose aerosol formulation and a collection scheme for content uniformity. Pharm Forum. 1992;18(6):4400-4403.

ProAir® is a registered trademark of Teva Respiratory, LLC. ©2013 Teva Respiratory, LLC PRA-40216

Potential drug interactions can occur with betablockers, diuretics, digoxin, or monoamine oxidase inhibitors, and tricyclic antidepressants • Do not exceed the recommended dose • Adverse events, which occurred at an incidence rate of at least 3% with ProAir HFA, include headache, tachycardia, pain, dizziness, pharyngitis, and rhinitis •

To learn more about ProAir HFA, visit

ProAirHFA.com/hcp

BRIEF SUMMARY OF PRESCRIBING INFORMATION FOR PROAIR® HFA (ALBUTEROL SULFATE) INHALATION AEROSOL For Oral Inhalation Only SEE PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 Bronchospasm PROAIR HFA Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease.

1.2 Exercise-Induced Bronchospasm PROAIR HFA Inhalation Aerosol is indicated for the prevention of exerciseinduced bronchospasm in patients 4 years of age and older.

4 CONTRAINDICATIONS PROAIR HFA Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to albuterol and any other PROAIR HFA Inhalation Aerosol components. Rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate [see Warnings and Precautions (5.6)].

5 WARNINGS & PRECAUTIONS 5.1 Paradoxical Bronchospasm PROAIR HFA Inhalation Aerosol can produce paradoxical bronchospasm that may be life threatening. If paradoxical bronchospasm occurs, PROAIR HFA Inhalation Aerosol should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister.

5.2 Deterioration of Asthma Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of PROAIR HFA Inhalation Aerosol than usual, this may be a marker of destabilization of asthma and requires re-evaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.

5.3 Use of Anti-inflammatory Agents The use of beta-adrenergic-agonist bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids, to the therapeutic regimen.

5.4 Cardiovascular Effects PROAIR HFA Inhalation Aerosol, like other beta-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of PROAIR HFA Inhalation Aerosol at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, PROAIR HFA Inhalation Aerosol, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

5.5 Do Not Exceed Recommended Dose Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma. The exact cause of death is unknown, but cardiac arrest following an unexpected development of a severe acute asthmatic crisis and subsequent hypoxia is suspected.

5.6 Immediate Hypersensitivity Reactions Immediate hypersensitivity reactions may occur after administration of albuterol sulfate, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. The potential for hypersensitivity must be considered in the clinical evaluation of patients who experience immediate hypersensitivity reactions while receiving PROAIR HFA Inhalation Aerosol.

5.7 Coexisting Conditions PROAIR HFA Inhalation Aerosol, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines. Clinically significant changes in systolic and diastolic blood pressure have been seen in individual patients and could be expected to occur in some patients after use of any beta-adrenergic bronchodilator.

Large doses of intravenous albuterol have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.

5.8 Hypokalemia As with other beta-agonists, PROAIR HFA Inhalation Aerosol may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. The decrease is usually transient, not requiring supplementation.

6 ADVERSE REACTIONS Use of PROAIR HFA may be associated with the following: • Paradoxical bronchospasm [see Warnings and Precautions (5.1)] • Cardiovascular Effects [see Warnings and Precautions (5.4)] • Immediate hypersensitivity reactions [see Warnings and Precautions (5.6)] • Hypokalemia [see Warnings and Precautions (5.8)]

6.1 Clinical Trials Experience A total of 1090 subjects were treated with PROAIR HFA Inhalation Aerosol, or with the same formulation of albuterol as in PROAIR HFA Inhalation Aerosol, during the worldwide clinical development program.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adult and Adolescents 12 Years of Age and Older: The adverse reaction information presented in the table below concerning PROAIR HFA Inhalation Aerosol is derived from a 6-week, blinded study which compared PROAIR HFA Inhalation Aerosol (180 mcg four times daily) with a double-blinded matched placebo HFA-Inhalation Aerosol and an evaluator-blinded marketed active comparator HFA-134a albuterol inhaler in 172 asthmatic patients 12 to 76 years of age. The table lists the incidence of all adverse events (whether considered by the investigator drug related or unrelated to drug) from this study which occurred at a rate of 3% or greater in the PROAIR HFA Inhalation Aerosol treatment group and more frequently in the PROAIR HFA Inhalation Aerosol treatment group than in the matched placebo group. Overall, the incidence and nature of the adverse events reported for PROAIR HFA Inhalation Aerosol and the marketed active comparator HFA-134a albuterol inhaler were comparable.

Adverse Experience Incidences (% of Patients) in a Six-Week Clinical Trial*

Body System/Adverse Event (as Preferred Term)

Marketed Matched active comparator Placebo PROAIR HFA HFA-134a HFA-134a Inhalation albuterol Inhalation Aerosol inhaler Aerosol (N = 58) (N = 56) (N = 58)

Body as a Whole

Headache

7

5

2

Cardiovascular

Tachycardia

3

2

0

Musculoskeletal

Pain

3

0

0

Nervous System

Dizziness

3

0

0

14 5

7 4

9 2

Respiratory System Pharyngitis Rhinitis

* This table includes all adverse events (whether considered by the investigator drug related or unrelated to drug) which occurred at an incidence rate of at least 3.0% in the PROAIR HFA Inhalation Aerosol group and more frequently in the PROAIR HFA Inhalation Aerosol group than in the placebo HFA Inhalation Aerosol group.

Adverse events reported by less than 3% of the patients receiving PROAIR HFA Inhalation Aerosol but by a greater proportion of PROAIR HFA Inhalation Aerosol patients than the matched placebo patients, which have the potential to be related to PROAIR HFA Inhalation Aerosol, included chest pain, infection, diarrhea, glossitis, accidental injury (nervous system), anxiety, dyspnea, ear disorder, ear pain, and urinary tract infection.

In small cumulative dose studies, tremor, nervousness, and headache were the most frequently occurring adverse events.

Pediatric Patients 4 to 11 Years of Age: Adverse events reported in a 3-week pediatric clinical trial comparing the same formulation of albuterol as in PROAIR HFA Inhalation Aerosol (180 mcg albuterol four times daily) to a matching placebo HFA inhalation aerosol occurred at a low incidence rate (no greater than 2% in the active treatment group) and were similar to those seen in adult and adolescent trials.

6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of PROAIR HFA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Reports have included rare cases of aggravated bronchospasm, lack of efficacy, asthma exacerbation (reported fatal in one case), muscle cramps, and various oropharyngeal side-effects such as throat irritation, altered taste, glossitis, tongue ulceration, and gagging.

The following adverse events have been observed in postapproval use of inhaled albuterol: urticaria, angioedema, rash, bronchospasm, hoarseness, oropharyngeal edema, and arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles). In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as: angina, hypertension or hypotension, palpitations, central nervous system stimulation, insomnia, headache, nervousness, tremor, muscle cramps, drying or irritation of the oropharynx, hypokalemia, hyperglycemia, and metabolic acidosis.

7 DRUG INTERACTIONS Other short-acting sympathomimetic aerosol bronchodilators should not be used concomitantly with PROAIR HFA Inhalation Aerosol. If additional adrenergic drugs are to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects.

7.1 Beta-Blockers Beta-adrenergic-receptor blocking agents not only block the pulmonary effect of beta-agonists, such as PROAIR HFA Inhalation Aerosol, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-adrenergic-blocking agents in patients with asthma. In this setting, consider cardioselective beta-blockers, although they should be administered with caution.

7.2 Diuretics The ECG changes and/or hypokalemia which may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of beta-agonists with nonpotassium sparing diuretics. Consider monitoring potassium levels.

7.3 Digoxin Mean decreases of 16% and 22% in serum digoxin levels were demonstrated after single dose intravenous and oral administration of albuterol, respectively, to normal volunteers who had received digoxin for 10 days. The clinical significance of these findings for patients with obstructive airway disease who are receiving albuterol and digoxin on a chronic basis is unclear. Nevertheless, it would be prudent to carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and PROAIR HFA Inhalation Aerosol.

7.4 Monoamine Oxidase Inhibitors or Tricyclic Antidepressants PROAIR HFA Inhalation Aerosol should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of albuterol on the cardiovascular system may be potentiated. Consider alternative therapy in patients taking MAO inhibitors or tricyclic antidepressants.

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Teratogenic Effects: Pregnancy Category C: There are no adequate and well-controlled studies of PROAIR HFA Inhalation Aerosol or albuterol sulfate in pregnant women. During worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been reported in the offspring of patients treated with albuterol. Some of the mothers were taking multiple medications during their pregnancies. No consistent pattern of defects can be discerned, and a relationship between albuterol use and congenital anomalies has not been established. Animal reproduction studies in mice and rabbits revealed evidence of teratogenicity. PROAIR HFA Inhalation Aerosol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

In a mouse reproduction study, subcutaneously administered albuterol sulfate produced cleft palate formation in 5 of 111 (4.5%) fetuses at an exposure approximately eight-tenths of the maximum recommended human dose (MRHD) for adults on a mg/m2 basis and in 10 of 108 (9.3%) fetuses at approximately 8 times the MRHD. Similar effects were not observed at approximately one-thirteenth of the MRHD. Cleft palate also occurred in 22 of 72 (30.5%) fetuses from females treated subcutaneously with isoproterenol (positive control).

In a rabbit reproduction study, orally administered albuterol sulfate induced cranioschisis in 7 of 19 fetuses (37%) at approximately 630 times the MRHD. In a rat reproduction study, an albuterol sulfate/HFA-134a formulation administered by inhalation did not produce any teratogenic effects at exposures approximately 65 times the MRHD [see Nonclinical Toxicology (13.2)].

8.2 Labor and Delivery Because of the potential for beta-agonist interference with uterine contractility, use of PROAIR HFA Inhalation Aerosol for relief of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk. PROAIR HFA Inhalation Aerosol has not been approved for the management of pre-term labor. The benefit:risk ratio when albuterol is administered for tocolysis has not been established. Serious adverse reactions, including pulmonary edema, have been reported during or following treatment of premature labor with beta2-agonists, including albuterol.

8.3 Nursing Mothers Plasma levels of albuterol sulfate and HFA-134a after inhaled therapeutic doses are very low in humans, but it is not known whether the components of PROAIR HFA Inhalation Aerosol are excreted in human milk.

Caution should be exercised when PROAIR HFA Inhalation Aerosol is administered to a nursing woman. Because of the potential for tumorigenicity shown for albuterol in animal studies and lack of experience with the use of PROAIR HFA Inhalation Aerosol by nursing mothers, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

8.4 Pediatric Use The safety and effectiveness of PROAIR HFA Inhalation Aerosol for the treatment or prevention of bronchospasm in children 12 years of age and older with reversible obstructive airway disease is based on one 6-week clinical trial in 116 patients 12 years of age and older with asthma comparing doses of 180 mcg four times daily with placebo, and one single-dose crossover study comparing doses of 90, 180, and 270 mcg with placebo in 58 patients [see Clinical Studies (14.1)].

The safety and effectiveness of PROAIR HFA Inhalation Aerosol for treatment of exercise-induced bronchospasm in children 12 years of age and older is based on one single-dose crossover study in 24 adults and adolescents with exerciseinduced bronchospasm comparing doses of 180 mcg with placebo [see Clinical Studies (14.2)].

The safety of PROAIR HFA Inhalation Aerosol in children 4 to 11 years of age is based on one 3-week clinical trial in 50 patients 4 to 11 years of age with asthma using the same formulation of albuterol as in PROAIR HFA Inhalation Aerosol comparing doses of 180 mcg four times daily with placebo. The effectiveness of PROAIR HFA Inhalation Aerosol in children 4 to 11 years of age is extrapolated from clinical trials in patients 12 years of age and older with asthma and exercise-induced bronchospasm, based on data from a single-dose study comparing the bronchodilatory effect of PROAIR HFA 90 mcg and 180 mcg with placebo in 55 patients with asthma and a 3-week clinical trial using the same formulation of albuterol as in PROAIR HFA Inhalation Aerosol in 95 asthmatic children 4 to 11 years of age comparing a dose of 180 mcg albuterol four times daily with placebo [see Clinical Studies (14.1)].

The safety and effectiveness of PROAIR HFA Inhalation Aerosol in pediatric patients below the age of 4 years have not been established.

8.5 Geriatric Use Clinical studies of PROAIR HFA Inhalation Aerosol did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see Warnings and Precautions (5.4, 5.7)].

All beta2-adrenergic agonists, including albuterol, are known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

10 OVERDOSAGE The expected symptoms with overdosage are those of excessive betaadrenergic stimulation and/or occurrence or exaggeration of any of the symptoms listed under ADVERSE REACTIONS, e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats per minute, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and insomnia.

Hypokalemia may also occur. As with all sympathomimetic medications, cardiac arrest and even death may be associated with abuse of PROAIR HFA Inhalation Aerosol.

Treatment consists of discontinuation of PROAIR HFA Inhalation Aerosol together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of PROAIR HFA Inhalation Aerosol.

The oral median lethal dose of albuterol sulfate in mice is greater than 2,000 mg/kg (approximately 6,800 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis and approximately 3,200 times the maximum recommended daily inhalation dose for children on a mg/m2 basis).

In mature rats, the subcutaneous median lethal dose of albuterol sulfate is approximately 450 mg/kg (approximately 3,000 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis and approximately 1,400 times the maximum recommended daily inhalation dose for children on a mg/m2 basis).

In young rats, the subcutaneous median lethal dose is approximately 2,000 mg/kg (approximately 14,000 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis and approximately 6,400 times the maximum recommended daily inhalation dose for children on a mg/m2 basis). The inhalation median lethal dose has not been determined in animals.

Mktd by: Teva Respiratory, LLC Horsham, PA 19044 Mfd by: IVAX Pharmaceuticals Ireland Waterford, Ireland Copyright Š2012, Teva Respiratory, LLC All rights reserved.

PROAIRÂŽ is a registered trademark of Teva Respiratory, LLC

Manufactured In Ireland

PA0512BS-A

Rev 05/12

INSIDE INSIDE HEALTHCARE HEALTHCARE

The Time Is Now for Congress to Cement Pharmacists’ Roles with Provider Status

By Charles E. Collins, Jr, MS, MBA

I

recently attended the back-to-back American Pharmacists Association (APhA) and the Academy of Managed Care Pharmacy meetings. I was especially pleased to see the thousands of attendees, and encouraged by the energy and enthusiasm for the pharmacy profession at both meetings.

As with many associations and organizations, both of these professional groups are focusing their attention and efforts on a select set of priorities over the next few years. Although the 2 organizations have different objectives and primary audiences (retail setting and payer environment, respectively), there was a common theme to these priorities—a united front if you will—around the efforts of gaining provider status.

As it turns out, there are multiple pharmacy organizations (22 to be exact) as well as a few pharmacy retailers backing this provider status movement through the recently formed Patient Access to Pharmacists’ Care Coa-

There is no other healthcare profession that has a more complete comprehensive understanding of medication adherence and appropriate medication use than the pharmacist. lition (PAPCC) group. This coalition, as well as others, has been the catalyst behind, and the major support for, the recent House of Representatives’ legislation H.R. 4190. This bill, introduced on March 11, 2014, would recognize pharmacists as healthcare providers, and allow patient access to and payment for Medicare Part B services in medically underserved communities.

Here, at Inside Pharmacy, our goal is to have pharmacists “come from behind the counter,” engage the patient, and be the healthcare provider that we know they already are. As our mission statement demonstrates, Inside Pharmacy is well-aligned with the efforts of PAPCC. Mr Collins is the Executive Vice President of Engage Managed Markets, a division of The Lynx Group, and Inside Pharmacy.

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Although provider-status discussions and initiatives have been around for years, H.R. 4190 would amend the Social Security Act (SSA) of 1935, and provide pharmacists the opportunity to fully serve their communities. For years, pharmacists have been considered part of the healthcare team, but have not been treated or recognized on par with other healthcare providers such as physicians, physician assistants, and certified nurse practitioners. Because of this “nonprovider” status, there are simply too many pharmacy-capable services that are not being utilized, especially in underserved areas of our country. With a looming physician shortage and everchanging healthcare delivery models, such as patientcentered medical home (PCMH) and the fast-growing accountable care organizations (ACOs), can we truly afford the status quo for pharmacists?

We are all acutely aware that healthcare delivery in the United States is quite expensive. Pharmacists can play a vital role in providing key services that are more cost-effective than traditional venues. However, according to a recent APhA publication, many health plans, both state and private, often refer to the nonprovider status of pharmacists in Medicare Part B as a reason for not covering services or reimbursement for their respective members. Thus, many individuals are often blocked from receiving valuable services such as medication adherence and appropriate medication use from pharmacists. There is no other healthcare profession that has a more complete comprehensive understanding of these specific areas than the pharmacist.

Due to the Affordable Care Act, we will continue to see new models of healthcare delivery evolve. I have already mentioned PCMH and ACOs. Over the past year, we have seen the government’s public exchange take hold while the private exchanges continue to flourish. These new models will bring new questions and new delivery of services. With high-deductible health plans and consumer-driven healthcare on the rise, the demand for pharmacy services will be at an all-time high.

The time is absolutely now to make this change to the SSA and grant provider status to pharmacists. As this legislation moves forward, other stakeholders will likely follow and recognize pharmacists not only for the valuable services they provide but also as the healthcare providers they are. n

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INSIDE PATIENT CARE

Patient-Centered Care: Metrics to Measure Quality of Care in the Community Setting for Patients with Asthma

By Elliott M. Sogol, RPh, PhD, FAPhA

I

mproving medication use and management is a complex process. There are a variety of external factors that can influence a pharmacist/patient exchange of information (counseling session), including how the patient interprets the information, or even the attentiveness of the patient during the counseling session. These factors will impact each patient differently.

Think of the situation where a parent is working with a pharmacist because their child has just been diagnosed with asthma. Each parent (and child) may react differently to the information they receive, and this can be challenging in terms of medication use and management. Providing information on how to properly use an inhaler is not an easy skill that patients can master just from hearing about breathing in and coordinating the dose of the medication.

To make matters worse, if a chamber and/or a mask are also needed for a young child, this can add to the complexity of the appropriate skills needed by the patients. Of course, this challenge does not only apply to parents and children; adult patients with asthma (those new to therapy and those who have been on therapy) also need information regarding the appropriate use of their medications, management of the disease, and progression of the disease.

The Role of Pharmacists What should pharmacists add to the workflow process to assist patients with asthma and their caregivers? What metrics can we examine in the community setting to help determine how our patient’s therapy is working?

To address these questions, let us review areas that pharmacists can impact and what experts are indicating pharmacists can do.

The National Heart, Lung, and Blood Institute National Asthma Education and Prevention Program, Expert Panel Report 3: Guidelines for the Diagnosis and Dr Sogol is Vice President Professional Relations, Pharmacy Quality Solutions, Inc.

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Management of Asthma recommends that educational interventions be performed by pharmacists.1 The expert panel concluded “that use of interventions provided by pharmacists is feasible, may help improve self-management skills and asthma outcomes, and merits more clinical studies of pharmacists’ providing education interventions.”1

What metrics can we examine in the community setting to help determine how our patient’s therapy is working?

The panel also stated that an important part of patient education is the pharmacist’s encouragement of adherence.1 In addition, we are aware that for many patients, education needs to run across a variety of topics, including disease-management counseling, disease-progression discussions (and prevention of progression), demonstration of appropriate techniques for inhaled medication use, periodic review of the techniques, and the review of medication use both in longterm maintenance and rescue (short-acting beta agonist [SABA]) medications.1

Measuring Therapy and Outcomes It is important to understand that we have the tools, knowledge, and skills to communicate with our patients.

In addition, we can look for metrics that we can easily measure in the community pharmacy setting.

The Pharmacy Quality Alliance (PQA), a nonprofit organization that develops medication management and use metrics,2 has developed 2 metrics that can assist pharmacists in reviewing medication use and management for patients with asthma.3 PQA metrics include the following: • The percentage of patients with asthma who were dispensed more than 3 canisters of a SABA inhaler over

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a 90-day period and who did not receive controller therapy during the same 90-day period • Suboptimal control: the percentage of patients with persistent asthma who were dispensed more than 3 canisters of a SABA inhaler during the same 90-day period • Absence of controller therapy: the percentage of patients meeting the numerator for the “suboptimal control” rate who did not receive controller therapy during the same 90-day period.

Although individual pharmacies may have difficulty gathering the data across the aggregate of patients with asthma they serve, there are ways we can use these measures in the community setting and follow individual patient’s adherence and medication use. A pharmacy would need to review claims data and medication history to determine how well they are doing across the metric and all patients with asthma. However, if pharmacists look at individual patient’s use of SABA inhalers over time, they can use this as an intermediary outcome metric on suboptimal control and possible absence of controller therapy or controller therapy that needs adjustment.

We can practice patient-centered care for all our patients and take time to focus on patients with asthma.

Of course, we need to also look at the adherence rate on controllers if the patient is on a controller medication before making recommendations of therapy changes. Recommending a change for a maintenance medication without checking for adherence to the regimen may only exacerbate the problem with an alternative therapy.

Working Toward Patient-Centered Care We can use the following example of how we can track this at the pharmacy on an individual patient level. By alerting our technicians that anytime a SABA is dispensed—they should also review the last 2 refill dates—pharmacists can quickly see who may be overusing the inhaler. If a patient is using 3 canisters over a 90-day period, the pharmacy could establish a process whereby the technician highlights this usage for the pharmacist indicating the need for a counseling session. The pharmacist can determine how the patient is doing through a couple of questions, discuss the frequency use of the inhaler, and why/when/how the patient is using the inhaler.

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This way, we can use our educational background and professional judgment to make recommendations to the patient and/or contact their prescriber about any concerns. This example provides us the opportunity to practice patient-centered care and review a patient’s medication use for all SABAs. This is one way to identify which patients need additional therapy.

Recommendations could include reviewing the techniques the patient is using to verify that they are actually getting the medication, discussing possible triggers, and emphasizing the importance of reviewing their asthma to get it under control.

There are numerous patient education materials that are available from manufacturers. Many have nonproduct-specific materials that highlight disease state facts and general medication use of a rescue inhaler, including understanding that the number of times an inhaler is used is an indication of asthma control for some patients.

A recent study by Slejko and colleagues suggests that in the United States, patients with asthma overuse quick-relief inhalers and underuse control medications.4 The investigators surveyed 9782 patients with lifetime asthma and 8837 patients with reported current asthma. Overall, 4521 patients used a quick-relief inhaler for asthma symptoms, and approximately 15% used more than 3 canisters of this type of medication in the past 3 months. In addition, among these patients using quick-relief inhalers, 60% were using daily control medication, whereas 28% had never used long-term control medication. Of those who had a recent exacerbation, 29% were using daily preventive medication, whereas 54% had never used long-term control medication.4 The question is: do you know if your patients fit with the study results? If they do, can you help them regulate their asthma more appropriately?

We can practice patient-centered care for all our patients and take time to focus on patients with asthma.

The process discussed here is a relatively efficient way of providing care to patients with asthma by reviewing their use of SABAs as a means to help them understand the importance of appropriate medication use and management of their medications. n

References

1. National Heart, Lung, and Blood Institute. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma (EPR-3 2007). www.nhlbi.nih.gov/guidelines/ asthma/asthgdln.pdf. Accessed April 17, 2014.

2. Pharmacy Quality Alliance. PQA mission and strategic objectives. http://pqaalliance. org/about/default.asp. Accessed April 17, 2014.

3. Pharmacy Quality Alliance. PQA measures. http://pqaalliance.org/measures/default. asp. Accessed April 17, 2014.

4. Slejko JF, Ghushchyan VH, Sucher B, et al. Asthma control in the United States, 2008-2010: indicators of poor asthma control. J Allergy Clin Immunol. 2013 Dec 9.

Epub ahead of print.

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INSIDE RETAIL PHARMACY

OTC Analgesics: A Closer Look at Recent Updates

By Julie L. Olenak, PharmD

P

ain is one of the most common conditions that patients attempt to self-treat with over-thecounter (OTC) medications. In 2012, approximately $3.9 billion was spent on internal analgesics.

Topical analgesics are reported to make up $516 million in OTC sales.1 In recent years, several additional warnings about both systemic and topical analgesics have been brought forward. OTC topical and systemic agents are effective components to self-treat pain in appropriate patients.

Pharmacists should be familiar with the new recommendations regarding these agents.

Systemic Analgesics There are multiple OTC analgesics available for patients. Systemic analgesics are approved by the US Food and Drug Administration (FDA) for 10 days of use for self-treatment of pain. After that time period, patients are encouraged to seek a medical evaluation.2 It is important to remember that patients presenting with inflammation should, in the absence of a contraindication, use a nonsteroidal anti-inflammatory drug (NSAID) such as ibuprofen, naproxen, or aspirin. Acetaminophen (APAP), while effective for the treatment of pain and fever, does not have significant anti-inflammatory properties. Table 1 presents currently available OTC systemic analgesics and doses.3-9 Acetaminophen Updates There have been several recent changes regarding both prescription and nonprescription products containing APAP. In response to concerns that liver injuries occurred because of inadvertent overdoses of APAP, the FDA mandated that manufacturers of prescription pain medications, including APAP, contain no more than 325 mg in each tablet, capsule, or other dosage unit.10 Although the announcement was made in 2011, it did not go into effect until January 2014. The FDA recommended that healthcare professionals discontinue prescribing and dispensing prescription combination drug

products containing more than 325 mg.11 The FDA also stated that there were no data showing more benefit of pain relief with higher amounts of APAP in the individual dose of the pain medicine to outweigh the risk.

With the rising concern that multiple drugs (ie, prescription pain medications, cold/cough/allergy medications, headache relievers, and sleep agents) available to consumers contained APAP, in 2011, the manufacturer of Tylenol (McNeil-PPC, Inc, Fort Washington, PA) announced that it was going to voluntarily alter their dosing language on OTC labels of regular and extra-strength products. The maximum daily dose recommended changed on both products, and the dosing interval on the extra-strength product was altered.12 The label change has created some confusion for patients and pharmacists regarding the true maximum dose of APAP. The FDA recommendation for the adult maximum daily dose of APAP remains 4000 mg daily. In August 2013, the manufacturer of Tylenol Extra Strength (McNeil-PCC, Inc) announced that as a safety measure it would be placing a reminder on the

KEY POINTS Starting in January 2014, manufacturers of prescription pain medications must limit acetaminophen to 325 mg in each tablet

➤

Although voluntary dosing label changes on overthe-counter acetaminophen have occurred, the FDA-approved maximum daily dose is still 4000 mg

➤

An FDA Advisory Committee met in February 2014 to review if the cardiovascular warning of naproxen should be altered to indicate a lower risk.

Although there are some studies that indicate a lower risk, the committee voted against the change since the evidence is not definitive

➤

Patients using topical analgesics should be warned to discontinue use if burning, pain, swelling, or blistering of the skin occur

➤

Dr Olenak is Associate Professor, Wilkes University School of Pharmacy, Clinical Pharmacist, Medicine Shoppe Pharmacy.

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Table 1 Available Over-the-Counter Adult Systemic Analgesics

and Doses Maximum Medication Dose Daily Dose Acetaminophena Regular Strength3 650 mg, every 4-6 hours Extra Strength4 1000 mg, every 6 hours Arthritis/8-hour5 1300 mg, every 8 hours

3250 mg 3000 mg 3900 mg

Ibuprofen6

200-400 mg, every 4-6 hours 1200 mg

Naproxen7,b

220 mg, every 8-12 hours

Aspirin Regular Strength8 325-650 mg, every 4 hours Extra Strength9 1000 mg, every 6 hours

660 mg 4000 mg 4000 mg

US Food and Drug Administration–approved maximum daily dose of acetaminophen is 4000 mg. b For the first dose, 2 tablets can be taken within the first hour. a

caps. The cap states “contains acetaminophen, always read the label” and it started to appear in fall 2013. An additional product change that occurred in 2012 was the removal of infant-strength APAP (80 mg/0.8 mL).

All pediatric APAP products available now are the 160-mg/5-mL concentration.13 Pharmacists should verify with customers who are calling the pharmacy for advice regarding pediatric APAP dosing formulations which strength product they have. Customers may still have in-date previously available products with the higher concentration of 80 mg/0.8 mL.

Pharmacists should verify with customers who are calling the pharmacy for advice regarding pediatric APAP dosing formulations which strength product they have.

In August 2013, the FDA warned consumers that if they were taking APAP and developed a rash, they should stop taking the medication and seek immediate medical attention. The rare, but serious, skin reactions included Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis. Reported initial symptoms may include flu-like symptoms followed by a rash and blistering. These are serious reactions that can require hospitalization and, in some cases, lead to death.14 The FDA required this warning for prescription products, but said they would work with OTC manufacturers to get the warnings added. At the time this manuscript was prepared, the warnings were not yet

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added to OTC products. NSAIDs, however, already include these warnings on their labels.14

FDA Advisory Committee Review In 2005, the FDA added black box warnings to all NSAIDs in light of data showing an increased risk of myocardial infarction, stroke, and gastrointestinal events. These emerging data on cardiovascular risks was first associated with cyclooxygenase-2 selective NSAIDs. The FDA recently convened an advisory committee because evidence since 2005 suggests that naproxen carries a lower cardiovascular risk.15 Additional topics addressed at the meeting included: a discussion of an ongoing study addressing cardiovascular risk with NSAIDs, and if the OTC current label implying that short-term use is safe and appropriate. The FDA Advisory Committee, which met in February 2014, included the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee. After a review of the evidence, the advisory committee, by split vote (16-9), voted against altering the cardiovascular warning on the label of naproxen to indicate that it is safer than other OTC NSAIDs. The primary reason cited was that the data were not definitive. The data reviewed primarily included observational studies and meta-analyses, highlighting a 2013 article published in Lancet.16 An FDA representative pointed out that they have never supported a label change based on meta-analyses alone.17 A second topic discussed during this FDA Advisory Committee meeting included whether a long-term trial assessing cardiovascular safety should continue.

In 2005, when the coxibs first brought significant attention to cardiovascular risk, Pfizer initiated the PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety vs Ibuprofen or Naproxen) study. The FDA Advisory Committee was asked to review if they felt the study should continue in light of the new data since 2005.15 A split decision led to the conclusion that without definitive evidence, naproxen is safer and the trial should not be stopped or have patients reconsent.17 Initially, it was thought that the results would be reported in 2013, but as a result of slow enrollment, results are not expected until July 2016.

The results of this trial will provide long-term data that will further contribute to the discussion of cardiovascular safety regarding those 3 agents.

The third major discussion related to OTC NSAIDs included a discussion on the current labeling regarding cardiovascular risk. The FDA changes in 2005 led to statements on OTC NSAID labels indicating that they should not be used right before or after heart surgery

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and that the risk of heart attack or stroke may increase if you use more than directed or longer than directed.6,7,15 The statement to not use OTC NSAIDs before or after heart surgery is consistent with labeling for prescription NSAIDs that include a contraindication to use in postoperative coronary artery bypass graph surgery. The second statement regarding increased risk with prolonged use was in part because the conclusion reached at the 2005 advisory meeting was that lowdose, short-term, acute use of NSAIDs did not appear to have an increased risk of serious cardiovascular events.15 The concern is that the language can give the impression that there is no risk with short-term use. A review of the available data was presented in the FDA briefing document regarding time to cardiovascular events.15 The advisory committee voted (14-11) that the language should be reconsidered because the risk occurs without a latency period and short-term use does not guarantee a risk-free period.15,18 There is no consistent evidence on whether taking aspirin offsets the increased cardiovascular events associated with NSAIDs.15

Topical Analgesics OTC topical analgesics are often overlooked by patients who are self-treating pain. They are effective agents that should be considered by patients and healthcare providers when selecting OTC treatment.

Their use is supported by inclusion in several treatment guidelines.19 They offer the advantage of avoiding systemic adverse effects when used appropriately.

Topical analgesics are FDA approved to be used in the self-treatment of pain for 7 days.20 Table 2 lists examples of available topical agents and dosing frequency.

Many products available on the market are composed of combinations of topical analgesics.

Application of Topical Pain Relievers In September 2012, the FDA warned patients that topical pain relievers (ie, menthol, methyl salicylate, capsaicin) may cause skin injuries. The chemical burns ranged from first- to third-degree burns. Importantly, it was noted that many of the reactions occurred within 24 hours of the first application. The FDA warning included a notice for patients who experience “pain, swelling, or blistering of the skin where an OTC topical muscle and joint pain reliever was applied, to stop using the product and seek medical attention immediately.”21,22 Several tips were provided regarding the area where the medication was applied, including avoid tight bandaging; do not apply heat; and do not apply to damaged, broken, or irritated skin. In addition, the

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Table 2 Over-the-Counter Topical Analgesic Drugs

and Dosing Frequency FDA-Approved Medication Strengths Dosing Frequency Camphor

3%-11%

Capsaicin

0.025%-0.25%

Histamine dihydrochloride

0.025%-0.1%

Menthol

1.25%-16.0%

Methyl salicylate

10%-60%

Trolamine

10%-15%

Apply to affected area up to 3-4 times daily

FDA indicates US Food and Drug Administration.

Source: Reference 20.

patient should avoid having the medication come in contact with the eyes and mucous membranes (ie, nose, mouth, genitals).

These recommendations apply to all topical analgesics. Warn patients that these medications, by way of their mechanism of action, can create a local warmth or cooling effect, but should not burn.21,22

The FDA required this warning for prescription products, but said they would work with OTC manufacturers to get the warnings added. At the time this manuscript was prepared, the warnings were not yet added to OTC products.

Conclusion Pharmacists play an important role in often being the first healthcare provider that patients encounter.

Patients may often approach their pharmacist with information they have heard through various news outlets. It is vital to stay up to date with current recommendations and changes. Unfortunately, these updates come from multiple sources, leading the pharmacist to self-identify how they will accomplish this. Listservs through organizations, subscriptions to online resources (ie, Pharmacist’s Letter, Medscape), or purchasing textbooks with online updates e-mailed to users (ie, Handbook of Nonprescription Drugs) can be efficient methods to stay up to date. n References

1. Consumer Healthcare Products Association. OTC Sales by Category 2009-2012. www.chpa.org/OTCsCategory.aspx. Accessed March 1, 2014.

2. US Food and Drug Administration. Rulemaking history for OTC internal

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analgesic drug products. Proposed rule: Tentative Final Monograph. www.fda.gov/ downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Over-theCounterOTCDrugs/StatusofOTCRulemakings/UCM078460.pdf. Published 1988.

Accessed March 24, 2014.

3. McNeil Consumer Healthcare. Tylenol Regular Strength Tablets. www.tylenol.com/ products/tylenol-regular-strength-tablets. Accessed March 24, 2014.

4. McNeil Consumer Healthcare. Tylenol Extra Strength Caplets. www.tylenol.com/ products/tylenol-extra-strength-caplets. Accessed March 24, 2014.

5. McNeil Consumer Healthcare. Tylenol 8 hour Caplets. www.tylenol.com/products/ tylenol-8-hr-caplet. Accessed March 24, 2014.

6. Pfizer Consumer Healthcare. Advil. 2013. www.advil.com/advil#tablets. Accessed February 24, 2014.

7. Bayer Healthcare. Aleve. 2014. http://labeling.bayercare.com/omr/online/aleve-tab lets.pdf. Accessed March 24, 2014.

8. Bayer Healthcare. Bayer Aspirin Regular Strength. 2012. http://labeling.bayercare. com/omr/online/genuine-bayer-aspirin.pdf. Accessed March 24, 2014.

9. Bayer Healthcare. Bayer Aspirin Extra Strength Back and Body. 2012. http://label ing.bayercare.com/omr/online/bayer-back-and-body.pdf. Accessed March 24, 2014.

10. US Food and Drug Administration. FDA drug safety communication: prescription acetaminophen products to be limited to 325 mg per dosage unit; boxed warning will highlight potential for severe liver failure. www.fda.gov/drugs/drugsafety/ucm239821. htm. Published January 31, 2011. Accessed February 1, 2014.

11. US Food and Drug Administration. Acetaminophen prescription combination drug products with more than 325 mg: FDA statement - recommendation to discontinue prescribing and dispensing. www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm381650.htm Published January 14, 2014.

Accessed January 15, 2014.

12. McNeil Consumer Healthcare. Tylenol for Healthcare Professionals: products and dosages. 2014. www.tylenolprofessional.com/products-and-dosages.html. Accessed February 3, 2014.

13. McNeil Consumer Healthcare. Tylenol for Healthcare Professionals: news and events. www.tylenolprofessional.com/news-and-announcements.html. Accessed

March 24, 2014.

14. US Food and Drug Administration. www.fda.gov/downloads/ForConsumers/ ConsumerUpdates/UCM363067.pdf. Published August 1, 2013. Accessed January 30, 2014.

15. US Food and Drug Administration. FDA briefing document joint meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee. www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ ArthritisAdvisoryCommittee/ucm383178.htm. Accessed February 20, 2014.

16. Bhala N, Emberson J, et al; Coxib and traditional NSAID Trialists’ (CNT) Collaboration. Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials.

Lancet. 2013;382:769-779.

17. Gever J. FDA NSAID Panel Nixes Naproxen Heart Safety Claim. www.medpage today.com/PainManagement/44253. Published February 11, 2014. Accessed February 25, 2014.

18. O’Riordan M. FDA advisory panel votes against CV safety claim for naproxen. www.medscape.com/viewarticle/820470. Published February 11, 2014. Accessed February 25, 2014.

19. Olenak JL. Chapter 7: Musculoskeletal Injuries and Disorders. In: Krinsky D, et al.

Handbook of Nonprescription Drugs. 17th ed. Washington, DC: American Pharmacists Association; 2012:101-117.

20. US Food and Drug Administration. External analgesic products for over-the-counter human use; establishment of a monograph and notice of proposed rulemaking. www. fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ Over-the-CounterOTCDrugs/StatusofOTCRulemakings/UCM077916.pdf. Published 1979. Accessed March 4, 2014.

21. US Food and Drug Administration. Rare cases of serious burns with the use of overthe-counter topical muscle and joint pain relievers. www.fda.gov/Drugs/DrugSafety/ ucm318858.htm. Published September 13, 2012. Accessed February 23, 2014.

22. US Food and Drug Administration. Topical pain relievers may cause burns. www. fda.gov/ForConsumers/ConsumerUpdates/ucm318674.htm. Published September 12, 2012. Accessed February 23, 2014.

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

TM tioners

Pharmacists • Chain

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Headquarters • Indepe

2 • Numbe r 2 April 2014 • Volume TM

Transforming Retail Pharm

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Transforming Retail Pharmacies into Healthcare Delivery Companies™

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f-Care Metrics in Exploring Quality-o ma Patients with Asth

Inside Retail Pharmacy

Closer Look OTC Analgesics: A at Recent Updates

Electronic Prior Authorization Get

Helping Patients Faster Fills

an affiliate of

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© 2014 Engage Healthca

LLC

Inside Pharmacy is an independent journal founded on the principle of value-based, patient-centered, evidence-based healthcare. As retail pharmacies transform into healthcare delivery companies, Inside Pharmacy offers a forum for pharmacists, chain headquarters, independent pharmacies, physician assistants, and nurse practitioners, to navigate the healthcare system and achieve professional success. Each issue of the journal includes resources to support the entire healthcare team inside the pharmacy, including how to attract, retain, and engage customers; answer patient questions on prevention and wellness, acute treatment, and monitoring and management of chronic conditions; and empower retail clinicians in a value-based healthcare system.

www.InsidePharmacyOnline.com Inside Pharmacy is a publication of Engage Healthcare Communications, an affiliate of The Lynx Group. © 2014 All rights reserved.

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INSIDE PHARMACY MANAGEMENT

Electronic Prior Authorization: Helping Patients Get Faster Fills

By Julie Hessick, RPh

R

etail pharmacies are faced with juggling patient care and the burden of administrative responsibilities associated with dispensing medications.

One of these responsibilities is related to the prior authorization process, which can be troublesome. Prior authorization can delay the patient from receiving their medication and result in inadequate control of disease.1 Most patients, and their physicians, do not realize the prescribed medication is not covered and requires a prior authorization until the pharmacy receives a claim rejection. Recent innovations are moving healthcare toward electronic prior authorizations (ePAs), which can significantly improve patient care and efficiencies in the pharmacy.2

Why Do Health Plans Use Prior Authorization Programs?

Several health plans implement prior authorizations to help contain pharmaceutical costs and ensure the safety of their patients.3 For example a health plan may require a medical review before approving the medication, or they may require a trial and failure of a preferred, more cost-effective medication before approval of a second-line or nonpreferred agent.3 They may also request a prior authorization to confirm a particular medication is prescribed according to US Food and Drug Administration indications, and within evidence-based clinical guidelines.3 Additional examples of common reasons health plans require prior authorizations include3: • High-cost and specialty medications • Brand name medications with generic equivalents • Lifestyle medications (eg, weight loss, cosmetic, erectile dysfunction) • Quantity limits based on duration of therapy or maximum dosages.

What Is the Impact on the Pharmacy and the Patient?

An estimated 110 million prescriptions are abandoned at US pharmacies annually.4 This contributes to significant revenue loss for the entire realm of pharmaMs Hessick is PBM/Plan Account Manager at CoverMyMeds.

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cies, including chain, independent, and specialty pharmacies.

On the other side of the counter— of the 110 million prescriptions abandoned—over half of the patients do not fill an alternate prescription.4 Interrupting or delaying the start of a patient’s medication can decrease adherence and lead to therapeutic abandonment. This, in turn, has a negative impact on a patient’s overall health, including uncontrolled vitals, disease progression, abnormal laboratory values, and poor therapeutic outcomes.

Interrupting or delaying the start of a patient’s medication can decrease adherence and lead to therapeutic abandonment. This has a negative impact on a patient’s overall health, including uncontrolled vitals.

How Does ePA Improve the Process?

In the past, the only means for a physician to start a prior authorization was to contact the health plan and request the authorization by phone or fax.2 Recently, the National Council for Prescription Drug Programs (NCPDP) adopted a new ePA standard to make the prior authorization process more efficient.5 The NCPDP is a trade association responsible for the development and implementation of pharmacy transaction standards.6

KEY POINTS Recent innovations are moving healthcare toward ePAs

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High-cost and specialty medications, brand name medications, are some of the common reasons health plans require prior authorization

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A physician or a pharmacy can initiate the prior authorization prospectively, at the point of care, or retrospectively, after the claim rejects

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The pharmacy and the physician office will gain efficiencies when using ePAs

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They have set the industry standards that govern the electronic adjudication of prescription drug claims, which helps streamline the prior authorization workflow, and is comparable to the electronic prescribing standard that prescribers use.6 The ePA standard provides real-time prior authorization submission, review, and approval, allowing healthcare providers to submit prior authorization requests in a much faster, simpler way.5 Figure Workflow of the ePA Process Patient Pharmacy Physician Offices • Initiate PA or complete pharmacy initiated PA • Receive status electronically

• Initiate PA and direct to PBM or physian office • Receive status electronically

Electronic submission and status • Eligibility and data validation • Auto-approval

The Figure illustrates the workflow of the ePA process. A physician or pharmacy can initiate the prior authorization prospectively at the point of care, or retrospectively, after the claim rejects. The NCPDP standard is a 4-part transaction that occurs between the physician and the plan, and can involve the pharmacy.7 After the required information for the prior authorization request is received and reviewed by the plan, an outcome can be transmitted back to the physician and pharmacy.5 This real-time submission will increase the pharmacy efficiencies, and improve the ability of a patient to quickly receive their medication and begin therapy.5

What Does ePA Mean to the Pharmacy?

There are several ways a pharmacy can start an ePA and send it to the prescriber for completion. These include websites, the pharmacy’s claims adjudication provider, or pharmacy software vendor.2 These processes are built into the pharmacy’s workflow and do not require submission by phone or fax.2 Electronic methods give the pharmacy direct access to a real-time response once the ePA is submitted by the prescriber and the outcome is finalized.2 Allowing patients to get the medication they need and when they need it can prevent prescription abandonment, increase patient adherence, and improve therapeutic outcomes for the patient.

The pharmacy and the physician office will gain efficiencies when using ePAs, ultimately benefiting patients by getting them on their prescribed medication faster and not disrupting the pharmacy’s workflow. n References

Health Plan • Access requests and respond with outcome

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1. State Pain Policy Advocacy Program. Standardization of prior authorization process for medical services white paper. http://sppan.aapainmanage.org/assets/standardizationprior-auth-whitepaper.pdf. Accessed April 17, 2014.

2. American Medical Association. Electronic prior authorization toolkit. www. ama-assn.org/ama/pub/advocacy/topics/administrative-simplification-initiatives/ electronic-transactions-toolkit/prior-authorization.page? Accessed April 17, 2014.

3. Academy of Managed Care Pharmacy. What is prior authorization and why is it an essential managed care tool? www.amcp.org/prior_authorization/. Accessed April 17, 2014.

4. Shrank WH, Choudhry NK, Fischer MA, et al. The epidemiology of prescriptions abandoned at the pharmacy. Ann Intern Med. 2010;153:633-640.

5. National Council for Prescription Drug Programs. NCPDP announces availability of standardized transactions for ePA in SCRIPT standard. Press release. July 22, 2013. www.ncpdp.org/NCPDP/media/pdf/pressrelease/072213_NCPDP_ePA_FINAL.pdf.

Accessed April 17, 2014.

6. National Council for Prescription Drug Programs. Frequently asked questions. www. ncpdp.org/About-Us/FAQ. Accessed March 9, 2014.

7. National Council for Prescription Drug Programs. SCRIPT electronic prior authorization transactions overview. www.ncpdp.org/NCPDP/media/pdf/NCPDP_SCRIPT_ ePA_Standard.pdf. Accessed April 17, 2014.

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INSIDE CARDIOMETABOLIC: DIABETES

Rx for Technology: BlueStar for Diabetes

By Matthew Hershberger; and Ann E. Johnson, PharmD

D

iabetes affects 25.8 million people or 8.3% of the American population, with an additional 79 million patients classified as having prediabetes.1 Of those 25.8 million people, approximately 90% to 95% have type 2 diabetes. In 2012, the total cost-burden of diabetes, including both direct medical costs and reduced productivity, was $245 billion.2 Fortunately, recent medical innovations have resulted in several new classes of diabetes treatments, including glucagon-like peptide-1 (GLP-1) agonists, dipeptidyl peptidase-4 (DPP-4) inhibitors, and sodium-glucose co-transporter-2 (SGLT2) inhibitors. Some patients may also be turning to a new class of diabetes treatment known as mobile prescription therapy. This class contains digital health solutions indicated for the self-management of diabetes. The first product of this kind is BlueStar (WellDoc, Baltimore, Maryland), a US Food and Drug Administration (FDA)-cleared prescription-only therapy for adults with type 2 diabetes.3 Approved by the FDA in 2010, BlueStar is now being commercialized, so pharmacists should have a basic understanding of the product and be ready to discuss it with their patients as an option for diabetes management support.3,4 It provides coaching and support for patients using both computers and mobile devices.3 Unlike other health-related applications and software packages, BlueStar is only available by prescription because its software is powered by evidence-based algorithms based on an individual’s treatment plan.3 This mobile prescription therapy has been evaluated through controlled trials. In the first trial, the investigators assessed how hemoglobin A1c levels were affected by a cell phone– and web-based diabetes management and therapy optimization product.5 Thirty patients were recruited and randomized to receive either the intervention tool or standard care. After 3 months, the intervention group achieved statistically significant improvements in A1c levels, with an average decrease of 2.03% compared with 0.68% in the control group. Healthcare professionals reported that the system reduced logbook review time, facilitated treatment decisions, and provided organized data.

The second study tested whether adding real-time

Mr Hershberger is a sixth year Pharmacy Student, Duquesne University, Pittsburgh, PA; and Dr Johnson is Pharmacist Consultant, Pharmacy Healthcare Solutions, Inc.

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coaching and clinical decision support would further reduce the mean reduction in A1c levels compared with standard diabetes management.6 This trial included 163 patients with type 2 diabetes and progressed over a 12-month treatment period. After 12 months, patients in the intervention group had a mean reduction in A1c levels of 1.9% compared with 0.7% in the control group.

BlueStar is similar to a drug in that the physician can prescribe the product for 1 month with additional refills to supplement medication therapy as needed.

The pharmacy will adjudicate the claim, and the manufacturer is then notified so that they can dispatch a certified diabetes educator to get the patient started, help them download BlueStar to their smart phone and/or computer, reconcile medications, and teach the patient how to use the software.

Recent medical innovations have resulted in several new classes of diabetes treatments such as mobile prescription therapy.

When using this tool, patients can enter their diabetes medication regimen, glucose readings, and lifestyle information, such as diet and exercise, to receive automated, real-time, and longitudinal coaching. The automated coaching is based on the American Diabetes Association and American Association of Diabetes Educators educational guidelines.7 The providers who are involved with the patient’s care receive an analyzed summary of the patient’s data that can then be used to modify treatments and aid in conversation with the patient.7 BlueStar is Health Insurance Portability and Accountability Act compliant as well.8 It is similar to the free app, MyFitnessPal, which tracks diet and exercise, in that real-time tracking by the patient is necessary to reap the best results. Unlike MyFitnessPal, however, BlueStar allows the integration of medication information and glucose readings in addition to diet and exercise data, which can provide a more holistic approach to patients’ health.8 It also provides information on diabetes, coaching support, medication reminders, testing reminders, and appointment dates.

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That being said, BlueStar may work best for highly motivated patients, since patient input and participation is necessary for best results. As dispensing pharmacists, your role in encouraging patients to actively use these disease-management tools is essential. Patients should be encouraged to routinely monitor their glucose readings, diet, and exercise information to better manage their disease.

As dispensing pharmacists, your role in encouraging patients to actively use these disease-management tools is essential.

Although the exact cost of BlueStar is still unknown, it is expected to be about one-third to one-half the price of a branded diabetes medication.9 It is listed in Medi-Span with an average wholesale price of $222 and a wholesale acquisition cost of $185.10 Net pricing will vary based on each health plan and rebates with pharmacy benefit managers, according to the manufacturer.8 A few Fortune 500 companies such as Ford Motor Company, Rite Aid, and DexCom have already said that they were going to offer pharmacy coverage of BlueStar for their employees.11 WellDoc is currently hiring a direct sales force to market directly to prescribers, so pharmacists may be seeing more prescriptions for the product in the coming months.12 Similar to other therapies, there are some barriers to using BlueStar, primarily because patients still need to log their blood glucose readings. BlueStar does not link with a glucometer to automatically upload the readings, but this could change with the advent of more meters with wireless capabilities. In addition, it is not currently

available nationwide, but is being piloted around the United States and will undergo a regional rollout later this year.13 However, in the meantime, if providers are interested in BlueStar, they can register via an e-mail list that will notify them when the product is available in their area.3 n

References

1. Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates in general information on diabetes and prediabetes in the United States, 2011. Atlanta, GA: US Department of Health & Human Services, Centers for Disease Control and Prevention; 2011.

2. American Diabetes Association. Economic costs of diabetes in the United States in 2012. Diabetes Care. 2013;36:1033-1046.

3. BlueStar. What is BlueStar? www.bluestardiabetes.com/?page_id=357. Accessed March 4, 2014.

4. Fiore K. Will docs write Rx for apps? MedPage Today. January 16, 2014. www. medpagetoday.com/Endocrinology/GeneralEndocrinology/43841. Accessed April 21, 2014.

5. Quinn CC, Clough SS, Minor JM, Lender D, Okafor MC, Gruber-Baldini AL. WellDoc mobile diabetes management randomized controlled trial: change in clinical and behavioral outcomes and patient and physician satisfaction. Diabetes Technol Ther. 2008; 10:160-168.

6. Quinn CC, Shardell MD, Terrin ML, Barr EA, Ballew SH, Gruber-Baldini AL. Cluster-randomized trial of a mobile phone personalized behavioral intervention for blood glucose control. Diabetes Care. 2011;34(9):1934-1942.

7. Diatribe. Welldoc announces the launch of BlueStar, a software-based product for type 2 diabetes. July 22, 2013. http://diatribe.org/issues/56/new-now-next/5.

Accessed April 21, 2014.

8. Maas A. Mobile prescription therapy offers novel approach to diabetes treatment. Atlantic Information Services Health. July 26, 2013. http://aishealth.com/ archive/ndbn072613-01. Accessed April 21, 2014.

9. Moukheiber Z. Trailblazer WellDoc to sell first mobile prescription therapy.

Forbes. June 14, 2013. http://www.forbes.com/sites/zinamoukheiber/2013/06/14/ trailblazer-welldoc-to-sell-first-mobile-prescription-therapy/. Accessed April 21, 2014.

10. Medi-Span. PriceRx Drug Price Analysis. Indianapolis, IN: Wolters Kluwer Health; 2013. Accessed March 4, 2014.

11. Dolan B. WellDoc’s BlueStar secures first mobile health reimbursement.

MobiHealthNews. June 13, 2013. http://mobihealthnews.com/23026/welldocs-bluestar-secures-first-mobile-health-reimbursement/. Accessed April 21, 2014.

12. Moukheiber Z. WellDoc raises $20 million to market first mobile prescription for diabetes management. Forbes. January 10, 2014. www.forbes.com/sites/ zinamoukheiber/2014/01/10/welldoc-raises-20-million-to-market-first-mobileprescription-for-diabetes-management/. Accessed April 21, 2014.

13. Newman HL. You need a prescription to use this app. Slate. January 7, 2014. www.slate.com/blogs/future_tense/2014/01/07/you_need_a_prescription_to_use_ this_diabetes_mobile_health_tracking_monitoring.html. Accessed April 21, 2014.

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“The time is now for you to ‘step out from behind the counter’ and engage your patients.”

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Inside Pharmacy is an independent journal founded on the principle of value-based, patient-centered, evidence-based healthcare. As retail pharmacies transform into healthcare delivery companies, Inside Pharmacy offers a forum for pharmacists, chain headquarters, independent pharmacies, physician assistants, and nurse practitioners, to navigate the healthcare system and achieve professional success. Each issue of the journal includes resources to support the entire healthcare team inside the pharmacy, including how to attract, retain, and engage customers; answer patient questions on prevention and wellness, acute treatment, and monitoring and management of chronic conditions; and empower retail clinicians in a value-based healthcare system.

www.InsidePharmacyOnline.com Inside Pharmacy is a publication of Engage Healthcare Communications, an affiliate of The Lynx Group. © 2014 All rights reserved.

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INSIDE HEALTHCARE OPERATIONS

Pharmacists in Public Health: A Call to Action

By Jennifer L. Bacci, PharmD

T

he US healthcare system is plagued by high costs, variable quality, and limited access to care.1 The passage and enactment of the Patient Protection and Affordable Care Act was facilitated by the transition of focus from quantity to the provision of high-quality, interdisciplinary care, and prevention of costly diseases.2 Prevention requires a focus on public health and population-based care. The Institute of Medicine defines public health as “fulfilling society’s interest in assuring conditions in which people can be healthy.”3 There will be a shortage of public health professionals by the year 2020. This shortage will require other healthcare professionals, including pharmacists, to embrace public health responsibilities in order to meet the health needs of the United States and global populations. Organizations both within and outside of the pharmacy profession are now seeking to promote pharmacist involve-

Pharmacists are also actively involved in educating the public on syringe exchange, illness prevention, and safe medication disposal. ment in public health activities. The American Public Health Association outlined public health functions that could be performed by pharmacists.4 Public health is now included in the American Association of Colleges of Pharmacy Center for the Advancement of Pharmacy Education outcomes.5 In addition, public health has been recognized as a competency that employers expect of new pharmacy graduates.6 The Centers for Disease Control and Prevention (CDC) has recognized how pharmacists can affect public health efforts through the prevention and control of disease.7 Furthermore, Healthy People 2020 states that pharmacists can assist in prevention efforts because of their direct access to patients.8 The American Society of Health-System Pharmacists Dr Bacci is Community Pharmacy Research Fellow, University of Pittsburgh School of Pharmacy, Pittsburgh, PA.

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has identified public health activities in which health-system pharmacists should be involved: population-based care, disease prevention and medication safety, health education, public health policy, and research and training.4 All pharmacists should be participating in these public health activities regardless of their practice setting. Community and ambulatory care pharmacists have already implemented interventions aimed at primary and secondary prevention. Primary prevention targets education and awareness, whereas secondary prevention targets early detection and treatment.

Pharmacists are now authorized to administer the influenza vaccine in all 50 states.9 The CDC reports that a pharmacy was the second most common place of vaccination among adults aged >18 years during the 20112012 influenza season based on data from the Behavioral Risk Factor Surveillance System and the National Flu Survey.10 Some pharmacies now provide travel health clinics where certified pharmacists administer travel vaccines and preventive medications through collaborative practice agreements (CPAs). Pharmacists are also actively involved in educating the public on syringe exchange, illness prevention, and safe medication disposal.

One study demonstrated that these programs are able to expand the public’s access to clean syringes because they reach different populations of injection drug users.11 Secondary prevention efforts by pharmacists revolve around screening. Pharmacies have implemented screenings for colorectal cancer and diabetes.12 In addition, the CDC has created the “Get Smart” campaign to educate the public on appropriate antibiotic use.13 The CDC is targeting outpatient healthcare providers, inpatient healthcare providers, and community pharmacists to be involved in this campaign. The activities mentioned above are all microlevel. Microlevel activities are activities that occur at a provider or implementation level.4 These examples demonstrate that pharmacists have been able to successfully implement public health activities within their practices.

Public health activities also occur on a macrolevel, or planning level. Macrolevel activities include assessing and prioritizing a community’s health needs, formulating public health priorities, and conducting research about public health activities.4 Pharmacists should be participating more in the development of public health policy.

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Pharmacists in Public Health: A Call to Action

As medication experts, pharmacists should be contributing to policies regarding: • Emergency planning, service delivery, and pharma­ ceutical inventories • Handling and disposal of hazardous drugs • Prescription drug monitoring programs • Immunization practices and registries • Needle exchange programs • Collaborative drug therapy management and CPAs • Disease prevention and management.

Many tools are publicly available to guide healthprogram planning and evaluation. These tools include: • The State Program Evaluation Guides, by the CDC Division for Heart Disease and Stroke Prevention14 • The Community Tool Box15 • Redesigning the Health Care Team: Diabetes Prevention and Lifelong Management, by the National Diabetes Education Program16 • A Framework for Program Evaluation, by the CDC.17 How can you get involved? There are plenty of opportunities for you to get involved, whether you are a practitioner or an academic. Work with management and other pharmacists at your practice to develop and implement patient education programs such as medication safety, medication adherence, disease prevention and control, tobacco cessation, exercise, healthy nutrition, and/or poison prevention. Become a certified immunization provider by completing the American Pharmacists Association training program. Educate your community leaders about public health initiatives. Serve on your local National Disaster Medical System assistance team, National Pharmacy Response Team, or Medical Reserve Corps. Advocate for public health policy through state and national professional associations, state and local boards of health, and State Boards of Pharmacy.4 Pursue advanced educational opportunities and certifications in public health. There are residency and fellowship programs in public health and policy throughout the country and several schools and colleges of pharmacy offer a dual Doctorate in Pharmacy and Master in Public Health (MPH) degree program. Graduate degree programs in public health include the MPH, Master of Health Administration, and Master of Science in Public Health. There are 2 public health certifications currently offered: Certified Health Education Specialist or Certified in Public Health (CPH). Pharmacists who obtain a graduate degree from an accredited public health school or program can obtain their CPH through examination from the National Board of Public Health Examiners.18

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KEY POINTS Work with management and other pharmacists at your practice to develop and implement patient education programs

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Become a certified immunization provider by completing the American Pharmacists Association training program.

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In anticipation of the shortage of public health professionals in the coming years, pharmacists have the responsibility to contribute to public health efforts by providing population-based care, disease prevention and control programs, and health education, and by contributing to public policy efforts.4 As pharmacy transitions from dispensing to patient care, it is critical that pharmacists expand their services into public health to ensure that the health needs of the US population are met. n

References

1. Giberson S, Yoder S, Lee MP; US Public Health Service. Improving patient and health system outcomes through advanced pharmacy practice. A report to the US Surgeon General. www.usphs.gov/corpslinks/pharmacy/sc_comms_sg_report.aspx.

Accessed March 10, 2014.

2. American Public Health Association. Why do we need the Affordable Care Act? www.apha.org/NR/rdonlyres/19BEA341-A7C3-4920-B2BC-65BDC846B803/0/ WhyWeNeedtheACA_Aug2012.pdf. Accessed February 26, 2014.

3. Committee for the Study of the Future of Public Health. The future of public health. Washington, DC: National Academies Press; 1988:7.

4. American Society of Health-System Pharmacists. ASHP statement on the role of health-system pharmacists in public health. Am J Health-Syst Pharm. 2008;65(5):462467.

5. American Association of Colleges of Pharmacy. CAPE Educational Outcomes 2013. www.aacp.org/resources/education/cape/Pages/default.aspx. Accessed February 26, 2014.

6. Vlasses PH, Patel N, Rouse MJ, Ray MD, Smith GH, Beardsley RS. Employer expectations of new pharmacy graduates: implications for the pharmacy degree accreditation standards. Am J Pharm Educ. 2013;77(3):47.

7. Morrison CM, Glover D, Gilchrist SM, et al. Centers for Disease Control and Prevention. A program guide for public health. Partnering with pharmacists in the prevention and control of chronic diseases. www.cdc.gov/dhdsp. Accessed February 26, 2014.

8. US Department of Health and Human Services. Healthy People 2020 framework. www.healthypeople.gov/HP2020/Objectives/framework.aspx. Accessed March 10, 2014.

9. American Pharmacists Association and Academy of Managed Care Pharmacy.

Pharmacist-provided immunization compensation and recognition: white paper summarizing APhA/AMCP stakeholder meeting. J Am Pharm Assoc. 2011;51(6):704-712.

10. Centers for Disease Control and Prevention (CDC). Surveillance of influenza vaccination coverage — United States, 2007–08 through 2011–12 influenza seasons.

MMWR Morb Mortal Wkly Rep. 2013;62(ss04):1-29.

11. Rudolph AE, Crawford ND, Ompad DC, et al. Comparison of injection drug users accessing syringes from pharmacies, syringe exchange programs, and other syringe sources to inform targeted HIV prevention and intervention strategies. J Am Pharm Assoc. 2010;50(2):140-147.

12. Farris KB, Johnson KA. Pharmacists in public health: it’s a good start! J Am Pharm Assoc. 2010;50(2):128-130.

13. Centers for Disease Control and Prevention. Get smart: know when antibiotics work. www.cdc.gov/getsmart/index.html. Accessed February 26, 2014.

14. Centers for Disease Control and Prevention. State program evaluation guides. www.cdc.gov/dhdsp/programs/nhdsp_program/evaluation_guides/index.htm. Accessed February 26, 2014.

15. Community Tool Box. Work group for community health and development. http://ctb.ku.edu/en. Accessed February 26, 2014.

16. National Diabetes Education Program. Redesigning the health care team: diabetes prevention and lifelong management. http://ndep.nih.gov/publications/Publication Detail.aspx?PubId=113#main. Accessed February 26, 2014.

17. Centers for Disease Control and Prevention. A framework for program evaluation. www.cdc.gov/eval/framework/index.htm. Accessed February 26, 2014.

18. Truong HA, Patterson BY. Professional and educational initiatives, supports, and opportunities for advanced training in public health. Am J Pharm Educ. 2010;74(7):122.

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