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PHYSICIANS • NP/PAs • PHARMACISTS

InsidePatientCare.com

February 2015 VOL. 3 • NO. 2

GASTROINTESTINAL

20 Tips for

Food Safety

29 Q  uestions

Answered with James Beaumariage

Health

New IBS Guidelines Offer Evidence-Based Pharmacologic Treatment Options PAGE 13

33 D  istinguishing

Between Different Colonoscopy Preparation Agents

38 Team-Based Care

as an Analogue to Pharmacists’ Scope of Practice

51 New Products

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

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

PHYSICIANS

Feb ruar y 201 5 VOL . 3 • NO. 2

20 Tips for

• NP/PAs • PHARMAC

ISTS

InsidePa

GASTROINT

Food Safety

29 Question s

Answered wit h James Beauma riage

33 Distingu ishing

Between Differ ent Colonoscopy Preparation Ag ents

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New IBS G ui Pharmacol delines Offer Eviden ce ogic Treatm ent Options -Based

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

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• Improving Women’s Health with Pharmacist-Led Osteoporosis Screening and Medication • Closing the Loop: Pharmacist-Assisted Management of Asthma • Pharmacist’s Perspective on the Management of Irritable Bowel Syndrome • Pharmacist Involvement in the Management of Chemotherapy-Induced Nausea and Vomiting • Community Pharmacist Intervention in Noncancer Pain Management • Common Dermatologic Conditions: Pharmacists’ Perspectives • Spectrum of Rheumatologic Diseases: Pharmacists’ Perspectives • Community Pharmacists’ Role in Medical Management: Case-Based Illustration of Polypharmacy in the Geriatric Population

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Call for submissions

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Do you have a best practice to share?

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

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

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February 2015 Volume 3 Number 2

INSIDE

Gastrointestinal Health

GASTROINTESTINAL

COLUMNS

Health

17 RECENT LABELING CHANGES FOR PROTON PUMP INHIBITORS

PAGE

9

THE FIRST WORD

Community pharmacists play an important role in ensuring appropriate use of PPIs, especially because of adverse events associated with prolonged treatment.

Donald J. Dietz, RPh, MS

Change Is on the Horizon for Pharmacy

Patient Care

PAGE

Patient education is key to preventing foodborne illness. These tips offer some methods for food safety.

HEALTHCARE POLICY

38

20 FIVE TIPS FOR FOOD SAFETY

Robert E. Henry

21 THE LATEST DIET TRENDS AND WHAT PATIENTS NEED TO KNOW TO MAKE HEALTHY AND EFFECTIVE CHOICES

STARTS ON PAGE

13

Retail pharmacists and clinicians are in an ideal position to counsel patients on the risks associated with certain diet trends and eating plans.

The Pharmacy

COVER STORY I GASTROINTESTINAL HEALTH

29 QUESTIONS ANSWERED

James S. Beaumariage, RPh, Principal at Beaumariage Consulting, LLC, discusses current trends in pharmacy education, and ways to effectively communicate with patients.

33 DISTINGUISHING BETWEEN DIFFERENT COLONOSCOPY PREPARATION AGENTS

New IBS Guidelines Offer Evidence-Based Pharmacologic Treatment Options ❚

A  n overview of the American Gastroenterological Association guidelines

 Understand the safety and efficacy of the 9 pharmacological options for IBS

36 NEGLIGENCE IN DISPENSING METHOTREXATE

 How to choose the best treatment options

Money

Assessing patients’ needs

Retail pharmacists and clinicians should address patient concerns, and consider other disease states, as well as other medications when choosing the best preparation agent.

And other medical malpractice news.

41 HOW TO CHOOSE A 529 COLLEGE SAVINGS PLAN

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Team-Based Care as an Analogue to Pharmacists’ Scope of Practice

4 CALL FOR SUBMISSIONS 6 EDITORIAL BOARD 7 LETTER FROM THE EDITOR 8 INSIDE PATIENT CARE ONLINE 11 THE VITALS 24 FREE CE ACTIVITY 44 DRUG UPDATE 51 NEW PRODUCTS

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

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ February 2015

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the Editorial Board

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

“ PAGE 9

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

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

6

Our dilemma in retail is managing the pharmacist resources for prescription dispensing, immunizations, and clinical services.”

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

—Donald J. Dietz, RPh, MS

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

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

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

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

GASTROINTESTINAL HEALTH

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

WELLNESS

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

Lisa Cervantes, PA-C

UW Health Clinics, Digestive Health Center, Madison, WI

Barbara Campbell, RPh, CCN

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

Debra Shelby, PhD, DNP

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

President National Academy of Dermatology Nurse Practitioners

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

Kim Curry, PhD, ARNP-C

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ February 2015

IMMUNIZATION

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

InsidePatientCare.com


Letter from the Editor Herd Immunity: What Will It Take for Patients to Get Immunized? by FREDERIQUE H. EVANS, MBS, Editorial Director, Inside Patient Care: Pharmacy & Clinics

With the spread of measles, it is difficult to ignore the important role of retail pharmacists and clinicians in driving immunization, and dispelling common misconceptions surrounding vaccines. }} }} ACCORDING TO THE Centers for Disease Control and Prevention (CDC), 18 states have reported cases of measles, with most of them being part of a large, ongoing, multistate outbreak linked to an amusement park in California.1 Although measles was eliminated from the United States in 2000, the number of cases has ranged from as low as 37 in 2004 to as high as 644 in 2014.2 The reasons attributed to this increase include more measles cases than usual in countries Americans often travel to, leading to more cases coming into the United States, and/ or more spreading of measles in US communities with pockets of unvaccinated people.2 Current concerns and beliefs that may be barriers to the measles, mumps, and rubella (MMR) immunization in these communities include concerns about an increased risk for febrile seizures, and beliefs that the vaccine may cause inflammatory bowel disease (IBD) or autism.3 The CDC cites 2 recent studies indicating a very small risk for febrile seizures after the first vaccination of MMR and varicella in patients between ages 12 and 47 months.4 However, despite common belief, data have not shown a link between the MMR vaccination and

InsidePatientCare.com

It is important to have an open discussion with patients and caregivers. IBD or autism.5,6 The MMR vaccine also has a good safety profile, and, as with all vaccines, may be associated with minor reactions, including pain and redness at the injection site, headache, fatigue, or a vague feeling of discomfort.3 As retail pharmacists, clinicians, and healthcare providers, it is impor­ tant to have an open discussion with patients and caregivers about the risks associated with vaccines, and to dispel potential misconceptions. It is also important to provide all the information needed for patients to make an informed decision, including the role of immunization in the community and vaccine safety. In this issue of Inside Patient Care: Pharmacy & Clinics, we provide an interview with James S. Beaumariage, RPh, who discusses ways he effectively communicates with his patients, including asking the right questions and building a rapport with them (see

“Questions Answered: Going Beyond the Mechanism of Action and Getting Through to Patients” on page 29). We hope you will enjoy this issue of Inside Patient Care: Pharmacy & Clinics. Contact us and tell us what you think it will take for patients to get immunized. We would also like to hear about the methods you find useful when communicating with patients, and some misconceptions you have had to dispel during your career as a retail pharmacist, healthcare provider, or clinician. ❚

References

1. Centers for Disease Control and Prevention. Measles cases and outbreaks. www.cdc.gov/measles/casesoutbreaks.html. Updated February 2, 2015. Accessed February 10, 2015. 2. Centers for Disease Control and Prevention. Frequently asked questions about measles in the US. www.cdc.gov/measles/about/faqs.html. Updated February 3, 2015. Accessed February 10, 2015. 3. Centers for Disease Control and Prevention. Measles vaccination. www.cdc.gov/vaccines/vpd-vac/measles/ default.htm#concerns. Updated February 7, 2013. Accessed February 10, 2015. 4. Centers for Disease Control and Prevention. Two options for protecting your child against measles, mumps, rubella, and varicella. www.cdc.gov/vaccines/ vpd-vac/combo-vaccines/mmrv/vacopt-factsheet-par ent.htm. Updated May 7, 2010. Accessed February 10, 2015. 5. National Centre for Immunisation Research & Surveillance. MMR vaccine, inflammatory bowel disease and autism. www.ncirs.edu.au/immunisation/ fact-sheets/mmr-vaccine-ibd-autism-fact-sheet.pdf. Published December 2009. Accessed February 10, 2015. 6. Centers for Disease Control and Prevention. Autism spectrum disorder (ASD). www.cdc.gov/ncbddd/autism/ topics.html. Last updated March 13, 2014. Accessed February 10, 2015.

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The First Word Change Is on the Horizon for Pharmacy by DONALD J. DIETZ, RPH, MS, Editor-in-Chief, Inside Patient Care: Pharmacy & Clinics

Change is never easy, but this is the opportunity we have been seeking for more than 2 decades, and it is a chance for us to demonstrate our clinical value.”

T

he retail pharmacy prescription department has traditionally been measured by the number of dispensed prescriptions. Other common pharmacy metrics are closely related to the number of prescriptions processed, including labor cost per prescription, staffing hours, gross profit margins, inventory management, abandoned prescriptions, and return-to-stock measurements. This prescription-based focus ex­ tends beyond the corporate office, district manager, and pharmacistin-charge. Do you remember the last time you were together socially with pharmacist friends, such as at an alumni event or pharmacy association meeting? My guess is that after exchanging pleasantries and asking about the family, the conversation revolved around work and the pharmacy, including trends in increasing or decreasing prescription volumes, third party insurance issues, or rising generic prices. In recent conversations with pharmacists, another topic discussed was the number of immunizations

InsidePatientCare.com

4 factors to consider: ❚ Pharmacy metrics ❚ Medication therapy management ❚ Comprehensive case reviews ❚ Improving medication adherence

provided at their pharmacy. In one discussion, a pharmacist told me that although she enjoyed interacting with patients, the interactions interrupted the prescription workflow process. She conceded that although this interaction is beneficial to patients and professionally rewarding, administering immunizations and simultaneously dispensing prescriptions created stressful staffing challenges and resulted in difficulty allocating personnel at the pharmacy.

Instigating Change Our dilemma in retail is managing

the pharmacist resources for prescription dispensing, immunizations, and clinical services. Data from Medicare Part D plans indicate a paltry 11% completion rate of eligible medication therapy management (MTM) cases.1 The Centers for Medicare & Medicaid Services has announced that comprehensive medication reviews (CMRs) will become part of the Medicare Part D Star Rating measures in 2016. Even more interesting, the 2016 Star Ratings will be based on CMR completion rates in 2014, with 2015 cases included in the 2017 ratings. Medicare Part D plans will need to exert an increased focus on CMR completion rates, which includes integrating retail pharmacies. Although most pharmacies have not embraced MTM and the completion of CMRs in retail pharmacies in the past 9 years, there is more evidence that an accelerated need for pharmacist-provided clinical services is on the horizon, as future Medicare D payments will be tied to value or quality. In late January, the US Depart­

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ February 2015

9


The First Word ment of Health Human & Services (HHS) announced a goal of using alternative payment models (eg, accountable care organizations or bundled payment arrangements) to tie 30% of traditional fee-for-service Medicare payments to value or quality.2 The HHS goal of tying 30% of payments to quality-based models would go into effect by the end of 2016, with payments increasing to 50% by the end of 2018.2 I believe that one avenue for Medicare D plans to achieve these goals is to increase the level of pharmacy clinical services.

Setting Goals Beyond Medicare Many experts believe that tying Medicare Part D payments to quality will require the involvement of community pharmacies. It is the government’s hope that this model will transcend Medicare Part D and impact commercial and Medicaid patients.2 Finally, we are moving closer to achieving a pharmacist provider status legislation in both the House of Representatives and the Senate. Initially targeting underserved areas, if this legislation passes, it will be a landmark moment for pharmacists. For more information about this opportunity, please see the Health Policy article on page 38. It is my belief that a more rapid adoption of pharmacist-provided clinical services is in the foreseeable future for retail pharmacy. How

do you prepare for this transition? Completion of eligible Medicare Part D MTM or CMR cases is a good first step. Focusing on improving medication adherence for patients receiving long-term medications for chronic conditions—which involves patient counseling—will certainly be bene-

We are moving closer to achieving a pharmacist provider status legislation in both the House of Representatives and the Senate. ficial. Understanding ways that you can help improve Medicare Part D Star Ratings by focusing on patients currently receiving targeted hypertension, diabetes, cholesterol, and high-risk medications is another beneficial step. Medicare Part D plans will consider many options in order to meet these value-based payment goals, including ones involving retail pharmacies. Retail pharmacy management will need to evaluate and experiment with staffing models and

services that enable pharmacists to provide clinical services while still dispensing prescriptions and without overstressing the retail pharmacy environment. Expect experimentation that involves centrally controlled activities (eg, Central Fill or hub-based MTMs), as well as activities that are integrated with clinical services provided at the retail pharmacy. It will not be a smooth process. Retail pharmacies will need to try a variety of models to determine which one works best in varying retail settings. Yes, there will be flawed models that will need to be discarded, but this is how we will learn and improve. Dispensing retail pharmacists should expect to start seeing new processes and opportunities in the near future. Change is never easy, but this is the opportunity we have been seeking for more than 2 decades, and it is a chance for us to demonstrate our clinical value. ❚

References

1. Hoey, Douglas. Sections of a Recent Letter Entitled Not Crying Wolf This Time. PFOA. www.pfoai.org/ news/348-sections-of-a-recent-letter-entitled-not-cryingwolf-this-time. Published February 3, 2015. Accessed February 6, 2015. 2. Better, Smarter, Healthier: in historic announcement, HHS sets clear goals and timeline for shifting Medicare reimbursements from volume to value [news release]. Washington, DC: US Department of Health & Human Services Press Office; January 26, 2015. www.hhs.gov/ news/press/2015pres/01/20150126a.html. Accessed February 4, 2015.

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

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

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INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ February 2015

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theVitals ALASKA STATE HAPPIEST IN THE UNITED STATES According to the GallupHealthways Well-Being Index, residents from the state of Alaska have the highest well-being ranking in the nation. The other states ranking in the top 3 include Hawaii and South Dakota, with West Virginia ranking last for the sixth consecutive year, and Hawaii and Colorado being the only 2 states ranking in the top 10 every year since 2008. These data were compiled from more than 176,000 interviews conducted with US adults across all 50 states between January and December 2014. The WellBeing Index is calculated on a scale of 0 to 100, with 0 being the lowest possible well-being. In addition, the metrics affecting well-being include 5 specific elements: (1) purpose, with the person liking what they do each day and being motivated to achieve their goals; (2) social, having supportive relationship and love in their life; (3) financial, managing their economic life to reduce stress and increase security; (4) community, liking where they live, feeling safe, and having pride in their community; and (5) physical, having good health and enough energy to get things done daily. Source: Gallup-Healthways Well-Being Index. Alaska Leads US States in WellBeing for First Time. www.well-beingin dex.com/alaska-leads-u.s.-states-in-wellbeing-for-first-time. Published February 18, 2015. Accessed February 24, 2015.

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Examining the News Affecting Pharmacy & Clinics

LONG-TERM BENZODIAZEPINE USE STILL COMMON According to a recent study published in the February issue of JAMA Psychiatry, long-term use of benzodiazepine remains common in older patients. “Although concern exists regarding the rate of benzodiazepine use, especially long-term use by older adults, little information is available concerning patterns of benzodiazepine use in the United States,” reported Mark Olfson, MD, MPH, Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, NY, and colleagues. The investigators sought to describe benzodiazepine prescription patterns in the United States, focusing on patient age and duration of use. Using the 2008 LifeLink LRx Longitudinal Prescription analysis, which includes 60% of retail pharmacies in the United States, Dr Olfson and colleagues performed a retrospective descriptive analysis of benzodiazepine prescriptions. Outcomes of interest included the percentage of adults filling ≥1 benzodiazepine prescriptions by sex and age-group. Among patients receiving the drug, the investigators evaluated the corresponding percentages with long-term (≥120 days) benzodiazepine use, as well as prescription of a long-acting benzodiazepine, and benzodiazepine prescriptions from a psychiatrist. Approximately 5.2% of US adults between 18 and 80 years of age used benzodiazepines in 2008, with the percentage of patients who used it increasing with age (2.6% in patients 18-35 years; 5.4%, 36-50 years; 7.4%, 51-64 years; and 8.7%, 65-80 years). In addition, the investigators found that the use of the drug was almost twice as prevalent in women compared with men, and that the proportion of long-term benzodiazepine use increased with age, whereas the proportion of patients who were prescribed the drug from a psychiatrist decreased with age. Dr Olfson and colleagues concluded that more vigorous clinical interventions supporting judicious use of benzodiazepines are needed to potentially decrease rates of long-term benzodiazepine use in older patients. Source: Olfson M, King M, Schoenbaum M. http://archpsyc.jamanetwork.com/article.aspx?articleid=2019955& resultClick=3. Published February 2015. Accessed February 24, 2015.

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ February 2015

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theVitals THE BOURBON VIRUS IDENTIFIED The Centers for Disease Control and Prevention (CDC) has identified a new virus, the Bourbon virus, which may be associated with the death of a 50-year-old man. The patient was from the county of Bourbon, Kansas, and experienced multiple tick bites while working outside. He fell ill over the next 2 days, went to a physician on day 3, was hospitalized, and died of a myocardial infarction 11 days after he became sick. The virus belongs to a group of viruses called Thogotoviruses, and although viruses in this group can be found all around the world, few of them can make people sick. Although the CDC does not fully know how the virus may be transmitted, based on similar viruses, it is possible that the Bourbon virus may be transmitted by tick or insect bites. Since there is only 1 case in the United States that may be associated with this virus, the symptoms for the Bourbon virus are still being researched. Clinical signs and symptoms reported by the patient who recently died in Kansas included fever, fatigue, anorexia, nausea, vomiting, and a maculopapular rash. The patient also had thrombocytopenia and leukopenia. Treatment with doxycycline was not effective. To reduce the chance of becoming infected with the Bourbon virus, the CDC recommends using the regular precautions when outdoors to avoid tick and bug bites, such as using insect repellent, wearing long sleeves and pants, avoiding bushy and wooded areas, and performing thorough tick checks after spending time outdoors. Sources: Ellis R. Man’s death leads to discovery of new virus in Kansas, CDC reports. www.cnn. com/2015/02/20/health/new-virus-discovered. Published February 20, 2015. Accessed February 24, 2015; Centers for Disease Control. Bourbon virus. www.cdc.gov/ncezid/dvbd/bourbon/index.html. Updated February 19, 2015. Accessed February 24, 2015.

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HEALTH POLICY 5 Facts About HR 471 1/ HR 471 is called the Ensuring Patient Access and Effective Drug Enforcement Act of 2015 2/ Introduced to the House by Representative Tom Marino on January 22, 2015 3/ The bill amends the Controlled Substances Act to define factors that may be

relevant to and consistent with public health and safety, and an imminent danger to public health or safety

4/ It requires an order to show why registration should not be denied, revoked, or suspended

5/ The bill also directs the Secretary of Health & Human Services to submit a

report identifying obstacles to legitimate patient access to controlled substances, issues with diversion of controlled substances, and how the collaboration between federal, state, local, and tribal law enforcement agencies and the pharmaceutical industry can benefit patients and prevent diversion and abuse of controlled substances

Sources: Congressional Research Service. Summaries for the Ensuring Patient Access and Effective Drug Enforcement Act of 2015. www.govtrack.us/congress/bills/114/hr471/summary. Accessed February 24, 2015; Congress.Gov. H.R.471 - Ensuring Patient Access and Effective Drug Enforcement Act of 2015. www.congress. gov/bill/114th-congress/house-bill/471. Updated February 22, 2015. Accessed February 24, 2015.

SMALLPOX VACCINE USE, POSTEVENT VACCINATION PROGRAM The Centers for Disease Control Division of High-Consequence Pathogens and Pathology, National Center for Emerging and Zoonotic Infectious Diseases, recently released a report pertaining to the clinical guidance for the use of smallpox vaccines in a postevent vaccination program. The report outlines recommendations for clinical use of the 3 smallpox vaccines stored in the US Strategic National Stockpile for people who are exposed to smallpox, or who are at high risk for smallpox infection during a postevent vaccination program following an intentional or accidental release of the virus. Smallpox vaccines are made from live vaccinia viruses that protect against smallpox disease, but they do not contain the variola virus, which is the causative agent of smallpox. The 3 smallpox vaccines stockpiled are ACAM2000, Aventis Pasteur Smallpox Vaccine, and IMVAMUNE. Persons who are exposed to the smallpox virus are at high risk for developing and transmitting smallpox, and should be vaccinated with a replication-competent smallpox vaccine—unless they are severely immunodeficient. People without a known smallpox virus exposure may still be at high risk for smallpox infection depending on the magnitude of the outbreak, and the effectiveness of the public health response. In this case, the person will be defined by public health authorities and should be screened for contraindications relative to smallpox vaccination (eg, atopic dermatitis, human immunodeficiency virus infection, other immunocompromised states, vaccine or vaccine-component allergies). Patients with relative contraindications should be vaccinated with IMVAMUNE when it is available and authorized for use by the US Food and Drug Administration.

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ February 2015

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INSIDE

PROTON PUMP INHIBITORS Recent labeling changes for proton pump inhibitors [17]

Gastrointestinal Health

Cover Story

New IBS Guidelines Offer EvidenceBased Pharmacologic Treatment Options by DREW RINGELING, PHARMDc

Irritable bowel syndrome (IBS) is a functional disorder of the gastrointestinal system.1 }} }} IT IS A CHRONIC CONDITION that can be characterized by abdominal discomfort with altered bowel pattern for >3 months.1,2 IBS is diagnosed clinically because there is no known biomarker associated with the disorder. This makes estimating the prevalence of the disorder a difficult task, as clinicians use a variety of tools to make their diagnoses.1 However, it is estimated that approximately 10% to 15% of the adult population is affected by the disease.3 It is more commonly found in women and prevalence of the disorder also decreases with age, as most patients range in age from 15 to 65 years.4 The Rome III diagnostic criteria for functional gastrointestinal disorders allow clinicians to diagnose patients with IBS, and further classification is based on patients’ stool consistency. Constipation (C) is the predominant symptom seen in patients with IBS-C, whereas patients with IBS-D frequently

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experience diarrhea (D). A mixed (M) pattern of both diarrhea and constipation is classified as IBS-M.1 According to the Rome III diagnostic criteria, patients must experience abdominal discomfort >3 days per month for the past 3 months to be diagnosed with IBS.1 This abdominal pain must also be relieved with defecation or associated with a change in stool frequency/ consistency.5

American Gastroenterological Association Guidelines Because IBS affects a wide range of patients and can manifest as a variety of symptoms, choosing the appropriate therapy can be challenging. The American Gastroenterological Association (AGA) recently updated their guidelines on the pharmacologic management of IBS to provide clinicians with an evidence-based tool designed to find the most appropriate

KEY POINTS ❚ Approximately 10% to 15% of adults are affected by IBS ❚ The Rome III diagnostic criteria for functional gastrointestinal disorders allow clinicians to diagnose patients ❚ Because IBS presents with a wide variety of symptoms, it is difficult to treat

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Inside Gastrointestinal Health Table. Recommendations for 9 Drugs in the Management of IBS3

IBS type

Strength of recommendation

Quality of evidence

Number of studies analyzed in review

Linaclotide

C

Strong

High

2

Lubiprostone

C

Conditional

Moderate

2

None

PEG

C

Conditional

Low

1

None

Rifaximin

D

Conditional

Moderate

3

Alosetron

D

Conditional

Moderate

8

Global relief of symptoms Reduced abdominal pain

Loperamide

D

Conditional

Very low

2

Reduced abdominal pain Stool consistency improvement

Clinically meaningful results Reduced abdominal pain Increased spontaneous bowel movements

None

TCAs

IBS symptoms

Conditional

Low

8

Global relief of symptoms

SSRIsa

IBS symptoms

Conditional

Low

5

None

Antispasmodics

IBS symptoms

Conditional

Low

22

Global relief of symptoms

SSRIs are not to be used. IBS indicates irritable bowel syndrome; IBS-C, IBS with constipation; IBS-D, IBS with diarrhea; IBS-M, IBS with a mixed pattern of constipation and diarrhea; PEG, polyethylene glycol; TCAs, tricyclic antidepressants; SSRIs, selective serotonin reuptake inhibitors. a

therapy for their patients.3 The goal is that these guidelines will allow physicians and patients to better weigh each option and choose the drug best suited for the patient’s needs. The AGA guidelines are categorized into a series of 9 questions, each specific to a drug used in the management of

These guidelines will allow physicians and patients to better weigh each option and choose the drug best suited for the patient’s needs. IBS. The effects of each drug were also analyzed for their clinical meaningfulness (threshold >10%).5 The strength of each recommendation and rate the quality of evidence used to make each recommendation were also indicated. The recommendations are classified as either “strong” or “conditional (weak).”3,5 Strong recommendations

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indicated that most patients would want to choose this therapy option, and adherence to this option could also be used as a performance indicator for clinicians. A strong recommendation also implied that it can be adapted as policy in most cases. Conditional recommendations suggested that although the majority of patients would want the treatment, a significant amount of patients would not. See the Table for a list of the 9 drugs and the strengths of their recommendations. Clinicians would be encouraged to examine the evidence behind this type of recommendation to help the patient make a decision regarding their therapy.

IBS-Constipation The first question in the guideline addressed whether linaclotide should be used in patients with IBS-C. The AGA strongly recommends using linaclotide (vs no drug treatment) based on high-quality evidence. Specifically, two phase 3, randomized controlled trials (RCTs) showed that linaclotide provided clinically meaningful relief of

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Inside Gastrointestinal Health abdominal pain and increased the number of spontaneous bowel movements. These studies used the US Food and Drug Administration (FDA) responder outcome for IBS-C (ie, patients with >30% reduction in abdominal pain and an increase of at least 1 spontaneous bowel movement per week) as the primary end point,5 which has been shown to be clinically meaningful, and has excellent specificity and reasonably high sensitivity. In addition, investigators in a third study found that linaclotide resulted in a global improvement of symptoms. The guidelines do note that cost and a small risk of diarrhea may discourage patients from using this treatment option. The next recommendation pertained to lubiprostone. The AGA conditionally recommends the use of lubiprostone (vs no drug treatment) in patients with IBS-C. The quality of this evidence was found to be moderate based on the results of 2 RCTs, which demonstrated that lubiprostone significantly improved global outcomes and reduced abdominal pain; however, these outcomes were not clinically significant. In addition, lubiprostone was not associated with an increased rate of spontaneous bowel movements compared with placebo.5 Polyethylene glycol (PEG) laxatives were also evaluated, and the AGA conditionally recommended using them (vs no drug treatment) in patients with IBS-C. This recommendation was supported by low quality evidence; only 1 study was found that evaluated the use of PEG laxatives in patients with IBSC.1 PEG showed no benefit in relieving symptoms or in reducing abdominal pain, but this may be the result of limitations in trial design.5 Because there is an abundance of evidence showing PEG’s efficacy in the treatment of chronic constipation, it is still an option for patients with the need for specific symptom relief.

IBS-Diarrhea Treatment options for patients with

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IBS-D were also addressed, and the AGA considered the use of rifaximin in patients with IBS-D. Based on moderate quality evidence, they conditionally recommended using rifaximin (vs no drug treatment) in patients with IBS-D. The FDA responder end point for IBS-D (ie, patients with >30% reduction in abdominal pain and >50% reduction in number of days per week with at least 1 loose stool) was evaluated in 2 of 3 RCTs analyzed.5 Rifaximin showed a lower failure rate of the FDA responder in the relief of global symptoms, and in the relief of abdominal pain. However, these results were not found to be clinically significant.5 The AGA guidelines also discussed the use of alosetron in patients with IBS-D and conditionally recommended it (vs no drug treatment) in patients with IBS-D to improve global symptoms. Alosetron improved abdominal pain and IBS-related global symptoms in multiple RCTs evaluated. However, because global relief of symptoms was only measured in 2 of the 8 studies con-

Loperamide was conditionally recommended for the treatment of patients with IBS-D. ducted, evidence for its use was rated moderate.5 Global relief, along with reduction in abdominal pain, was found to be clinically significant in these studies. The AGA stated that for women with IBS-D who have severe abdominal pain and did not respond to traditional therapy, alosetron would be an appropriate option.5 Loperamide was conditionally recommended for the treatment of patients with IBS-D, but this recommendation was supported by very low quality evidence. Only 2 small trials evaluated the use of loperamide specifically for IBS, and neither defined the diagnostic

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Inside Gastrointestinal Health criteria used.5 In these studies, loperamide did not yield a significant benefit in global relief of symptoms; however, abdominal pain and stool consistency were significantly improved.5 Because of an abundance of data showing its efficacy in reducing stool frequency, the AGA suggests it may be useful in patients with IBS-D.

According to the AGA guidelines, selective serotonin reuptake inhibitors (SSRIs) should not be used in patients with IBS.

Mr Ringeling is a PharmD candidate at the Lake Erie College of Osteopathic Medicine School of Pharmacy, Erie, PA.

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Other General Recommendations The use of tricyclic antidepressants (TCAs) in patients with IBS was given a conditional recommendation based on low quality evidence. Eight RTCs were included in the review, and uncertainty regarding blinding was a limitation in many of these studies. TCAs were shown to improve global relief of symptoms and provide abdominal pain relief, although pain relief was not clinically meaningful.5 Withdrawal from therapy because of adverse effects was also significantly higher with TCAs, although this is low quality evidence as the population was not specifically patients with IBS.5 According to the AGA guidelines, selective serotonin reuptake inhibitors (SSRIs) should not be used in patients with IBS. This is a conditional recommendation based on low quality evidence. The efficacy of SSRIs in IBS was evaluated in 5 RCTs. Each study included a global assessment of efficacy, although the method used differed between each study.5 SSRI use resulted in a lower failure rate of symptom relief, but this result was not significant. Abdominal pain relief was also evaluated; SSRIs did not significantly reduce pain when compared with placebo.5 The final question addressed by the AGA was the use of antispasmodics.

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ February 2015

They conditionally recommended using antispasmodics (vs no drug treatment) in patients with IBS, based on low quality evidence. Antispasmodics were associated with a clinically meaningful improvement in global symptoms and the improvement in abdominal pain compared with placebo.5 However, risk for bias was significant and variation among the trials was a major concern. Also, most studies evaluating these older drugs predate Rome diagnostic criteria; therefore, the definition of IBS varied between each study.5 It is important to note that these drugs are classically used for postprandial symptoms in IBS, but no RCTs have directly looked at this indication.5

Conclusion These guidelines, built with the hopes of providing clinicians with a tool on which to base treatment choices, evaluate the safety and efficacy of 9 pharmacologic options for IBS. It should be noted that overall quality of the studies is determined to be low.5 Reasons for this are numerous: diagnostic criteria change over time, and IBS does not have biomarker or quantitative primary end points that can be measured in all studies.5 Although IBS presents with a wide variety of symptoms and is difficult to treat, these guidelines should help clinicians make an appropriate treatment decision that is aligned with the patient’s needs and values. ❚ References

1. Canavan C, West J, Card T. The epidemiology of irritable bowel syndrome. Clin Epidemiol. 2014;6:71-80. 2. Brandt LJ, Chey WD, Foxx-Orenstein AE, et al. An evidence-based position statement on the management of irritable bowel syndrome. Am J Gastroenterol. 2009;104(suppl 1):S1-S35. 3. Weinberg DS, Smalley W, Heidelbaugh JJ, Sultan S. American Gastroenterological Association Institute Guideline on the pharmacological management of irritable bowel syndrome. Gastroenterology. 2014;147:1146-1148. 4. World Gastroenterology Organisation. WGO practice guideline - irritable bowel syndrome: a global perspective. www.worldgastroenterology.org/assets/downloads/en/ pdf/guidelines/20_irritable_bowel_syndrome.pdf. Published April 20, 2009. Accessed December 22, 2014. 5. Chang L, Lembo A, Sultan S. American Gastro­ enterological Association institute technical review on the pharmacological management of irritable bowel syndrome. Gastroenterology. 2014;147:1149-1172.

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Inside Gastrointestinal Health

Recent Labeling Changes for Proton Pump Inhibitors by DONNA D. HUYNH, PHARMD, BCPS, and LINH B. VAN, PHARMD, BCPS

Proton pump inhibitors (PPIs) are among the most commonly prescribed medications for upper gastrointestinal disorders.1 }} }} THE OVER-THE-COUNTER (OTC) status of omeprazole and lansoprazole makes them highly accessible to many patients. Although generally regarded as safe, in the past several years PPIs have been associated with a number of adverse events,2 prompting the US Food and Drug Administration (FDA) to issue several labeling updates,3 including vitamin B12 (cyanocobalamin) deficiency,4-7 acute interstitial nephritis (AIN),4-8 Clostridium difficile–associated diarrhea (CDAD),9 and hypomagnesemia.10

Vitamin B12 Deficiency In 2014, the FDA approved labeling updates for several PPIs regarding the increased risk of vitamin B12 deficiency with prolonged use.4-7 Cyanocobalamin is an essential, water-soluble vitamin that cannot be manufactured endogenously.11 Be­cause dietary cyanocobalamin is protein-bound and requires acid-activated, proteolytic digestion in the stomach

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to be absorbed,2,12 PPI-induced achlor­ hydria may lead to cyanocobalamin malabsorption and deficiency.12 Left untreated, cyanocobalamin deficiency may also have irreversible consequences,13 including neurologic manifestations such as paresthesias, gait abnormalities, and cognitive or behavioral changes.11 However, results from case reports and observational studies have been inconsistent regarding the association of PPI use and cyanocobalamin deficiency.2,12 Risk factors include prolonged PPI use for >3 years14 and, potentially, age and nutritional status.2,11,12 The FDA states that diagnosis should be considered if clinical symptoms consistent with cyanocobalamin deficiency arise.14

Acute Interstitial Nephritis AIN was also added to the label of some PPIs in 2014.4-8 Cases of AIN have been reported with all PPIs and are attributed to a hypersensitive reaction to the PPI or its metabolite.15,16 Although AIN can occur at any time during use,

KEY POINTS ❚ Recent FDA labeling updates regarding adverse events for PPIs include vitamin B12 deficiency, AIN, CDAD, and hypomagnesemia ❚ Community pharmacists play an important role in ensuring appropriate use of PPIs, especially because of adverse events associated with prolonged treatment ❚ Community pharmacists and clinicians should counsel patients to contact their healthcare provider if they experience persistent diarrhea or oliguria

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Inside Gastrointestinal Health a review of 60 cases determined that the mean duration of PPI use before the diagnosis of AIN was 13 weeks.16 Symptoms of AIN are nonspecific (eg, vomiting, pain, oliguria, and fever) and necessitate a renal biopsy to confirm diagnosis.15 The FDA recommends the discontinuation of PPI if AIN is diagnosed.14

Community pharmacists should determine the indication from the prescriber and/or patient before dispensing a PPI, and ensure that patients are using OTC PPIs appropriately. Clostridium difficile–Associated Diarrhea In 2012, the FDA issued a safety alert regarding the increased risk for CDAD with the use of PPIs.9 The risk for CDAD among patients who took PPIs was estimated to be 1.4 to 2.75 times higher than in patients who did not take PPIs, according to a review of 28 observational studies.9 PPIs were found to be associated with an increased risk for healthcare-associated and community-associated C difficile infections (CDIs).17,18 Chitnis and colleagues found that 31% of patients with community-associated CDIs who were not exposed to antibiotics within 12 weeks of diagnosis received PPIs.18 In addition to adults, the increased risk for CDIs was observed in hospitalized children receiving PPIs, compared with children not receiving PPIs (odds ratio [OR], 4.52; 95% confidence interval [CI], 1.4-14.4).19 The mechanism by which PPIs may increase the risk of CDAD has not been determined.19 Proposed mechanisms include loss of a protective host mechanism because of an increase in gastric pH and increased expression of toxin A.19,20 The FDA recommends that patients

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use the lowest effective dose of PPI for the shortest duration of treatment.9 Furthermore, patients are advised to contact their healthcare provider immediately if they experience diarrhea that does not improve.9

Hypomagnesemia In 2011, the FDA approved labeling updates of PPIs to include the risk of hypomagnesemia with prolonged use.10 Severe hypomagnesemia can lead to life-threatening adverse events such as heart arrhythmias and seizures.10,21 A recent meta-analysis of observational studies found an increased risk for hypomagnesemia with PPI use (pooled adjusted OR, 1.484; 95% CI, 1.1031.997), although significant heterogeneity existed among the studies.22 Zipursky and colleagues found a 43% increased risk of hypomagnesemia with PPI use, and an even higher risk with concurrent diuretic use (adjusted OR, 1.73; 95% CI, 1.11-2.70).21 The mechanism by which PPIs may cause hypomagnesemia has not been determined. Proposed mechanisms involve impairment of intestinal absorption of magnesium.21-23 Risk factors may include prolonged use of PPIs for >3 months,10 and concomitant use of other drugs that are associated with hypomagnesemia.10,23 The FDA recommends monitoring magnesium levels in patients with risk factors for hypomagnesemia.10 PPIs have changed the landscape of treatment for upper gastrointestinal tract disorders. Conclusion For most patients, the overall benefits of treatment outweigh the risks of adverse events. Nonetheless, community pharmacists should determine the indication from the prescriber and/ or patient before dispensing a PPI, and ensure that patients are using OTC PPIs appropriately. Because cyanocobalamin deficiency and hypomagnesemia are associated with prolonged use, it is important to reassess the need for PPI treatment during each refill request.

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Inside Gastrointestinal Health Patients should also be advised to contact a healthcare provider if they experience persistent diarrhea or oliguria. ❚

References

1. Consumer Reports Best Buy Drugs. Using the proton pump inhibitors to treat heartburn and stomach acid reflux. www.consumerreports.org/health/resources/pdf/best-buydrugs/PPIsUpdate-FINAL.pdf. Updated July 2013. Accessed February 5, 2015. 2. Reimer C. Safety of long-term PPI therapy. Best Pract Res Clin Gastroenterol. 2013;27:443-454. 3. US Food and Drug Administration. December 2014. Drug safety labeling changes. www.fda.gov/Safety/MedWatch/ SafetyInformation/ucm429250.htm. Updated January 15, 2015. Accessed February 3, 2015. 4. US Food and Drug Administration. Aciphex (rabeprazole sodium) delayed-release tablets. www.fda.gov/ ­­ Safety/MedWatch/SafetyInformation/Safety-Related DrugLabelingChanges/ucm307179.htm. Published December 2014. Accessed February 5, 2015. 5. US Food and Drug Administration. Dexilant (dexlansoprazole) delayed-release capsules. www.fda.gov/Safety/ MedWatch/SafetyInformation/ucm280145.htm. Published December 2014. Accessed February 5, 2015. 6. US Food and Drug Administration. Nexium (esomep­ razole magnesium) delayed-release capsules, 20 mg and 40 mg; delayed-release oral suspension, 10 mg, 20 mg, and 40 mg. www.fda.gov/Safety/MedWatch/SafetyInformation/ ucm290945.htm. Published December 2014. Accessed February 5, 2015. 7. US Food and Drug Administration. Prevacid (lansoprazole) delayed-release capsules and Prevacid Solutab (lansoprazole) delayed-release orally disintegrating tablets. www. fda.gov/Safety/MedWatch/SafetyInformation/ucm280120. htm. Published December 2014. Accessed February 5, 2015. 8. US Food and Drug Administration. Protonix (pantoprazole sodium) for delayed-release oral suspension and delayed-release tablets. www.fda.gov/Safety/MedWatch/ SafetyInformation/Safety-RelatedDrugLabelingChanges/ ucm307256.htm. Published December 2014. Accessed February 5, 2015. 9. US Food and Drug Administration. FDA drug safety communication: Clostridium difficle-associated diarrhea can

be associated with stomach acid drugs known as proton pump inhibitors (PPIs). www.fda.gov/Drugs/DrugSafety/ ucm290510.htm. Updated February 15, 2013. Accessed February 3, 2015. 10. US Food and Drug Administration. Proton pump inhibitors. www.fda.gov/safety/medwatch/safetyinformation/ ucm258810.htm. Updated June 15, 2011. Accessed February 3, 2015. 11. Langan RC, Zawistoski KJ. Update on vitamin B12 deficiency. Am Fam Physician. 2011;83:1425-1430. 12. Heidelbaugh JJ. Proton pump inhibitors and risk of vitamin and mineral deficiency: evidence and clinical implications. Ther Adv Drug Saf. 2013;4:125-133. 13. Parikh N, Howden CW. The safety of drugs used in acid-related disorders and functional gastrointestinal disorders. Gastroenterol Clin North Am. 2010;39:529-542. 14. Prevacid [package insert]. Deerfield, IL: Takeda Pharmaceuticals USA, Inc; 2014. 15. Sampathkumar K, Ramalingam R, Prabakar A, et al. Acute interstitial nephritis due to proton pump inhibitors. Indian J Nephrol. 2013;23:304-307. 16. Sierra F, Suarez M, Rey M, et al. Systematic review: proton pump inhibitor-associated acute interstitial nephritis. Aliment Pharmacol Ther. 2007;26:545-553. 17. Freedberg DE, Abrams JA. Clostridium difficile infection in the community: are proton pump inhibitors to blame? World J Gastroenterol. 2013;19:6710-6713. 18. Chitnis AS, Holzbauer SM, Belflower RM, et al. Epidemiology of community-associated Clostridium difficile infection, 2009 through 2011. JAMA Intern Med. 2013;173:1359-1367. 19. Mezoff EA, Cohen MB. Acid suppression and the risk of Clostridium difficile infection. J Pediatr. 2013;163:627-630. 20. Biswal S. Proton pump inhibitors and risk for Clostridium difficile associated diarrhea. Biomed J. 2014;37:178-183. 21. Zipursky J, Macdonald EM, Hollands S, et al. Proton pump inhibitors and hospitalization with hypomagnesemia: a population-based case-control study. PLoS Med. 2014;11:e1001736. 22. Park CH, Kim EH, Roh YH, et al. The association between the use of proton pump inhibitors and the risk of hypomagnesemia: a systematic review and meta-analysis. PLoS ONE. 2014;9:e112558. 23. Florentin M, Elisaf MS. Proton pump inhibitor-induced hypomagnesemia: a new challenge. World J Nephrol. 2012;1:151-154.

Donna D. Huynh Dr Huynh and Dr Van are Clinical Pharmacists, First Databank, Inc, South San Francisco, CA.

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Inside

Patient Care 5 TIPS FOR FOOD SAFETY More than 48 million Americans become sick from and 3000 die of foodborne illnesses every year. The following tips offer methods for food safety and foodborne illness prevention:

1 Wash Your Hands

2 Clean Surfaces, Utensils

3 Wash Fruits, Vegetables

Make sure to wash your hands before handling food and cooking. Scrub your hands using soap and running water for 20 seconds; don’t forget to wash the back of your hands, the space between your fingers, and under your nails.

Surfaces and cutting boards should be cleaned after each use with a bleach solution, whereas utensils and small cutting boards should be cleaned using hot, soapy water. Simply rinsing utensils, countertops, and cutting boards with water is not enough to stop bacteria from spreading. Wash your fruits and vegetables, even if you plan to peel them. Bacteria can spread from the outside of the fruits or vegetables to the inside as you cut and peel them. Note that meat, poultry, or eggs should not be washed.

4 Avoid CrossContamination

5 Cook/ Refrigerate

â

Keep raw meat, poultry, seafood, and eggs separate from other foods because even after you have cleaned your hands and surfaces thoroughly, they can still spread illness-causing bacteria to readyto-eat foods.

To make sure that your food has reached its safe, minimum cooking temperature, use a food thermometer—it is not enough to simply check the color and texture of the food. Because illness-causing bacteria can grow in many foods within 2 hours (1 hour during summer heat), it is important to refrigerate food promptly.

MORE ONLINE

More patient tips are available online at InsidePatientCare.com Sources: Centers for Disease Control and Prevention. Prevention and education. www.cdc.gov/foodsafety/prevention.html. Accessed February 5, 2015; Centers for Disease Control and Prevention. CDC and food safety. www.cdc.gov/foodsafety/cdc-and-food-safety.html. Accessed February 5, 2015.

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Patient Care The Latest Diet Trends and What Patients Need to Know to Make Healthy and Effective Choices by PATRICIA LININGER, MSED

There is an overabundance of information bombarding the masses and circulating via magazines, the Internet, and on social media regarding the latest diet trends and healthy eating plans. }} }} THE CONSEQUENT discussions are rampant and often contradictory on what the best strategies for weight loss and weight management are, creating confusion for many patients. Other patients may be initially confident that one of the new diet plans they have read about will result in the leaner and healthier outcomes they are hoping for, but soon after starting it, they feel too deprived. This results in their abandonment of the plan before achieving any measurable success. Retail pharmacists and clinicians are in an ideal position to counsel these patients on healthier and more easily achievable nutrition plans and on the risks associated with certain diet trends, such

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as those requiring the elimination of entire food groups. They can provide patients with alternate options with validated health benefits, such as clean eating and consuming adequate fiber with fruits and vegetables and with intact whole grains.

Diet Trends As previously mentioned, some popular trends in diet plans require the elimination or the minimization of entire food groups, such as eliminating or drastically limiting all carbohydrates, all meats, or all fat or dairy products, without providing alternative foods that can adequately supply the nutrients that will be missed. For example, diets requiring high protein consumption

with no or very few carbohydrates limit some necessary nutrients for optimal health and adequate energy. Unfortunately, many of these diet plans that limit or eliminate beneficial food groups are often still touted as being the quick solution for weight loss. Gluten-free diets, for example, are recommended for patients with gluten sensitivities, celiac disease, or Crohn’s disease—but eliminating all grain products without replacing them with other fibrous foods, can result in the elimination of micronutrients and therefore, is not recommended. Furthermore, it is not necessary for everyone to eliminate every type of grain. Whole intact grains have a valuable place in a healthy

diet for most individuals. Community pharmacists and clinicians should counsel patients who are considering eliminating food groups (eg, all grains or carbohydrates) from their diet to ensure the replacement of the macro- and micronutrients that will be eliminated. They can offer suggestions for healthier eating plans that provide all of the nutrients necessary for optimal health and functioning, which may include consuming whole and intact grains and/or other foods that provide adequate fiber and the micronutrients usually found in grains.

Healthy Trend: Clean Eating As a nutrition, health, and wellness strategist, I

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Patient Care naturally align with the clean eating agenda, believing that simple, whole, and natural plantbased foods that are nutrient and fiber rich and free from toxins, chemicals, and hormones are the healthiest choices. Allowing for a gradual conformity to this clean eating plan can help to avoid the stress of a major change in the initial stage, because stress can become a harmful toxin in itself. Once tastes adapt and cravings have diminished, which can happen fairly quickly, whole and healthy foods often become personal favorites and then there are fewer struggles or feelings of deprivation. At that time, greater compliance naturally occurs. The clean eating agenda is not a new diet fad; however, it has recently become a topic of greater interest for many people. Fortunately, after several years, high-protein diets that require consumption of low or no carbohydrates seem to finally be losing their popularity, and nutritional habits that are healthy overall seem to be taking hold.

Healthy Trend: Fiber-Rich Diet with Fruits and Vegetables Another healthy trend that goes hand in hand with clean eating is the

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THE CLEAN EATING AGENDA IS NOT A NEW DIET FAD; HOWEVER, IT HAS RECENTLY BECOME A TOPIC OF GREATER INTEREST FOR MANY PEOPLE. fiber-rich diet. There can be little debate that to achieve and maintain good health, fiber-rich and nutrient-dense fruits and vegetables (complex carbohydrates) are a must. These valuable macronutrients contain many beneficial and health-promoting vitamins and micronutrients, along with a substantial amount of fiber that is essential for optimal functioning, energy utilization, and optimal health. The research data are promising that increasing fruit and vegetable consumption can lead to dramatic whole-body health improvements and disease prevention.1-3 In fact, studies over the years have linked an increase in the consumption of fruits and vegetables to a lower risk for several common diseases and

degenerative disorders, including coronary heart disease, macular degeneration, diabetes, and certain cancers.1-3 Although a definitive association between increased fruit and vegetable consumption and cancer prevention has not been firmly established, the data suggest that further studies are warranted.3 If that promising evidence is not enough to encourage the masses to boost their fruit and vegetable intake, keep in mind that this healthy, albeit nondepriving eating habit, can also lead to weight loss. Of course, it is common knowledge that being at a healthy weight can further improve health and diminish risk factors for disease. A review of 22 studies on dietary fiber demonstrated that consuming an additional 14 g of fiber daily resulted in significant weight loss.4 In another study by Fitzwater and colleagues, 69% of obese adults who were advised to eat a diet high in carbohydrates but low in fat, consisting of unlimited fruits and vegetables, lost a significant amount of weight in <4 months and continued to lose weight for the duration of the study.5 In another interesting study on families with â&#x2030;Ľ1 obese parent and nonobese child, one group

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

was instructed to increase their consumption of fruits and vegetables, a second group was instructed to decrease their intake of foods high in fat and sugar.6 The outcome of the group consuming increased fruits and vegetables was a more significant weight reduction than that of the group following the decreased high-fat and high-sugar foods protocol. It is also worth noting that the group consuming more fruits and vegetables also decreased their consumption of foods high in fat and sugar.6

Healthy Trend: Eating Intact Whole Grains In addition to the health benefits associated with fibrous fruits and vegetables, another highly beneficial source of fiber, which is often ignored, is whole grains. Grains have developed a bad reputation, first during the high-protein/low-carbohydrates craze, and now with the gluten-free/ wheat elimination diets. However, whole grains are an excellent source of healthy, viscous fiber that have been associated with weight loss, health promotion, and disease prevention. A fully intact grain is a healthy fiber that slows the absorption and digestion of foods, elimi-

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Patient Care nating sugar spikes, which can lead to an increase in insulin sensitivity. According to a study by Jenkins and colleagues, viscous fiber was linked to a marked 20% reduction in glycemic response.7 The problem is, some whole grain products found on grocery store shelves are actually less than whole. In many cases, they have been crushed and/ or partially processed, sometimes missing the viscous outer portion. Unfortunately, as long as they still have more than half of the grain included after the partial processing or disassembling of the grain, they can still be listed as whole grain product, even though their high-fiber, slow-digesting, and health-bestowing attributes may have been compromised. However, when intact, whole grain fiber has been associated with lower risks of many of the same diseases as fruits and vegetables.8,9 It is also significant to mention that although there is no conclusive evidence available at this time, it is reasonable to assume that additional long-term studies may reveal a link between increased intakes of viscous fiber found in whole and intact grains with a reduced risk for colon cancer. In addition to the health

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FIBER-RICH DIETS THAT INCLUDE INTACT WHOLE GRAINS AND PLENTY OF FRUITS AND VEGETABLES CAN PROVIDE MANY HEALTH BENEFITS, DISEASE PREVENTION, AND WEIGHT LOSS. benefits listed above, the viscosity of whole grain fibers can increase satiety, resulting in decreased calorie consumption and greater ease when seeking weight loss. The slower digestion of this fiber provides extended energy and because of the more optimal glucose response, it can likely result in less fat storing. Adding whole grains, particularly intact grains and sprouted grains, can result in an efficient and clean digestive system that is better prepared for optimal energy utilization and fat loss.

Conclusion As patients seek advice on the healthiest eating habits amid the current/popular trends, retail pharmacists and

clinicians are in a position to inform patients of the benefits and efficacy of incorporating healthy habits, such as clean eating, which is the consumption of whole, simple, and unprocessed foods, and those grown and raised without toxins, chemicals, and hormones. Additionally, fiber-rich diets that include intact whole grains and plenty of fruits and vegetables can provide many health benefits, disease prevention, and weight loss. ❚

References

1. Hung HC, Joshipura KJ, Jiang R, et al. Fruit and vegetable intake and risk of major chronic disease. J Natl Cancer Inst. 2004;96:1577-1584. 2. Ma L, Dou HL, Wu YQ, et al. Lutein and zeaxanthin intake and the risk of age-related macular degeneration: a systematic review and meta-analysis. Br J Nutr. 2012;107:350-359. 3. Story EN, Kopec RE, Schwartz SJ, et al. An update on the health effects of tomato lycopene. Annu Rev Food Sci Technol. 2010;1:189-210. 4. Howarth NC, Saltzman E, Roberts SB. Dietary fiber and weight regulation. Nutr Rev. 2001;59:129-139. 5. Fitzwater SL, Weinsier RL, Wooldridge NH, et al. Evaluation of long-term weight changes after a multidisciplinary weight control program. J Am Diet Assoc. 1991;91:421-426, 29. 6. Epstein LH, Gordy CC, Raynor HA, et al. Increasing fruit and vegetable intake and decreasing fat and sugar intake in families at risk for childhood obesity. Obesity Res. 2001;9:171-178. 7. Jenkins AL, Jenkins DJ, Wolever TM, et al. Comparable postprandial glucose reductions with viscous fiber blend enriched biscuits in healthy subjects and patients with diabetes mellitus: acute randomized controlled clinical trial. Croat Med J. 2008;49:772-782. 8. Jacobs DR Jr, Andersen LF, Blomhoff R. Whole-grain consumption is associated with a reduced risk of noncardiovascular, noncancer death attributed to inflammatory diseases in the Iowa Women’s Health Study. Am J Clin Nutr. 2007;85:1606-1614. 9. Mellen PB, Walsh TF, Herrington DM. Whole grain intake and cardiovascular disease: a meta-analysis. Nutr Metab Cardiovasc Dis. 2007;18:283290.

Ms Lininger is a Corporate Health Educator, HealthFitness Inc, and the owner of “Unleash Your Vibrance, LLC,” a health, wellness, and nutrition coaching business.

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Continuing Education Release date: February 20, 2015 Expiration date: February 28, 2016 Estimated time to complete activity: 0.7 hours Jointly provided by Postgraduate Institute for Medicine and Center of Excellence Media, LLC.

This activity is supported by an independent educational grant from AstraZeneca. TARGET AUDIENCE This activity has been designed to meet the educational needs of community clinical and retail pharmacists. EDUCATIONAL OBJECTIVES After completing this activity, the participant should be better able to: • Explain the role of community pharmacists in ensuring safe and effective medication use • Review factors that can impact clinical outcomes, including patient, disease, and medication • Utilize strategies to improve patient care, including patient education and medication adherence counseling • Describe the ways that community pharmacists can help their patients achieve optimal health and value through the knowledge and application of traditional and nontraditional care • Provide accurate and appropriate counsel as part of the treatment team FACULTY Nichole R. Klatt, PhD Assistant Professor, Department of Pharmaceutics University of Washington, Seattle, WA Pharmacist Continuing Education Accreditation Statement Postgraduate Institute for Medicine is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Credit Designation Postgraduate Institute for Medicine designates this continuing education activity for 0.7 contact hour(s) (0.07 CEUs) of the Accreditation Council for Pharmacy Education. (Universal Activity Number - 0809-999915-004-H01-P) Type of Activity: Knowledge

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Empowering Community Pharmacists as Health Consultants: Irritable Bowel Syndrome by NICHOLE R. KLATT, PHD

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rritable bowel syndrome (IBS) is a common condition, occurring in ≥11% of individuals worldwide.1,2 Interestingly, the highest prevalence of IBS has been identified in developed countries, with prevalence rates in the United States as high as 20%.1 IBS occurs in both adults and children, with prevalence being 25% lower in patients older than 50 years of age compared with those who are younger. Approximately 50% of patients report Disclosure of Conflicts of Interest Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers, and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to PIM policy. PIM is committed to providing its learners with high-quality CME/ CE activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest. The faculty reported the following financial relationships or relationships to products or devices they or their spouse/ life partner have with commercial interests related to the content of this CE activity: Name of Faculty or Presenter Nichole R. Klatt, PhD

Reported Financial Relationship Consulting fees from Immusoft Corporation

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ February 2015

having first experienced IBS-related symptoms before they were 35 years of age.1 Overall, more women than men report these symptoms.1 Essentially, the term IBS is used to describe chronic and/or recurrent gastrointestinal (GI) issues that are not diagnosed as inflammatory bowel disease (IBD) such as ulcerative colitis, celiac disease, or Crohn’s disease. The condition is characterized by a large array of GI dysfunctions, including The planners and managers reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CE activity: The following PIM planners and managers—Laura Excell, ND, NP, MS, MA, LPC, NCC; Trace Hutchison, PharmD; Samantha Mattiucci, PharmD, CCMEP; and Jan Schultz, RN, MSN, CCMEP—hereby state that they or their spouse/life partner do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months. Center of Excellence Media, LLC: Susan Berry hereby states that she or her spouse/life partner do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months. Instructions for Credit There is no fee for this activity. To receive credit after

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Continuing Education bowel symptoms, upset stomach, pain, gas and bloating, nausea, and vomiting. IBS can be divided into 3 subtypes, based on a patient’s bowel habits: IBS with constipation, IBS with diarrhea, or mixed IBS, in which the patient experiences a combination of constipation and diarrhea.1,2 The chronic pain and discomfort associated with IBS can be highly disruptive and interfere with quality of life. It can also be an embarrassing problem that affects a patient’s willingness to travel, interact socially, or engage in sexual activity.1-3 In addition, stress may dramatically increase IBS-related symptoms, leading to a perpetual cycle of ailments.4,5 A high percentage of patients may also experience intestinal comorbidities (eg, dyspepsia, gastroesophageal reflux disease, anal incontinence) and extraintestinal comorbidities (eg, headache, back pain, dysuria, asthma, palpitations, sleep difficulties, chronic fatigue syndrome).4 Therefore, IBS results in increased healthcare costs and decreased productivity, with high rates of missed workdays or school days for many patients.6 reading this CE activity in its entirety, participants must complete the posttest and evaluation. The posttest and evaluation can be completed online at http://ce.lynxcme. com/COE176-3. Upon completion of the evaluation and scoring 75% or better on the posttest, you will immediately receive your certificate online. If you do not achieve a score of 75% or better on the posttest, you will be asked to take it again. Please retain a copy of the certificate for your records. If you have any questions regarding the CE certification for this activity, please contact Postgraduate Institute for Medicine at: information@pimed.com or 303-799-1930. Pharmacists: Upon successfully completing the posttest with a score of 75% or better and the activity evaluation form, transcript information will be sent to the NABP CPE Monitor Service within 4 weeks. Media: Printed report Disclosure of Unlabeled Use This educational activity may contain discussion of pub-

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Addressing Barriers to Diagnosis and Management Because there are usually no physical signs to definitively diagnose IBS, diagnosis is often a process of ruling out other conditions. As a result, IBS is often diagnosed arbitrarily or not diagnosed at all.1,2 Over the past several decades, formal criteria have been devel-

IBS results in increased healthcare costs and decreased productivity, with high rates of missed workdays or school days for many patients. oped with the aim of more accurately diagnosing patients with this condition (Table).1,7-10 However, there is debate over the usefulness of these criteria in everyday practice, and physicians often use other findings, such as bloating and psychological stress, to make a diagnosis of IBS.1 One of the difficult aspects of diaglished and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications. The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings. Disclaimer Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

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Continuing Education Table. Comparison of the Manning and Rome Diagnostic Criteria for Irritable Bowel Syndrome1 Manning (1978)7 ≥2 of the following symptoms: • Abdominal distension • Pain relief with defecation • Frequent stools with pain • Looser stools with pain • Passage of mucus • Sensation of incomplete evacuation

Rome I (1989)8

Rome II (1999)9

≥3 months of continuous or recurrent abdominal pain: Relieved with defecation or Associated with change in stool consistency With ≥2 days of the following on ≥25% of days: • Altered stool frequency • Altered stool form • Altered stool passage • Passage of mucus • Bloating or abdominal distension

≥12 weeks in past 12 months of continuous or recurrent abdominal pain or discomfort With ≥2 of the following: • Relief with defecation • Altered stool frequency • Altered stool form • Onset of symptoms ≥12 months before diagnosis

Rome III (2006)10 ≥3 days per month in past 12 weeks of continuous or recurrent abdominal pain or discomfort With ≥2 of the following: • Relief with defecation • Altered stool frequency • Altered stool form • Onset of symptoms ≥6 months before diagnosis

Source: Canavan C, West J, Card T. Clin Epidemiology. 2014;6:71-80. Reprinted with permission.

nosing and managing IBS is that it presents with a range of symptoms and there is no consistent marker for diagnosis.1,3 Further confounding the complexity of IBS etiology is the spectrum of severity and varied frequency of symptom recurrence in patients.

Another barrier to the diagnosis and effective management of IBS is the sensitive nature of addressing GI issues in general. Signs and symptoms of IBS include constipation, diarrhea, abdominal distension, pain with bowel movements, incomplete stool evacuation or sensation thereof, recurrent abdominal pain, chronic loose or altered stool, nausea, vomiting, bloating, excess gas, and other GI dysfunctions. These symptoms do not correspond to GI structural malformation or clinical diagnosis of IBD, nor do they concur with alarming signs such as weight loss, anemia, fever, or GI

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mass or bleeding.11 Another barrier to the diagnosis and effective management of IBS is the sensitive nature of addressing GI issues in general. Many patients are reluctant to openly and honestly discuss problems related to bowel movements. In fact, in the United States, it is estimated that only 30% of individuals with symptoms of IBS seek medical attention from their primary care physician.1 Community pharmacists are in an ideal position to assist patients with IBS. The first step is to identify patients who may have the condition; these may be individuals who purchase overthe-counter stomach aids such as bismuth subsalicylate, calcium carbonate, and antacids. Once a patient has been identified, a discussion about symptoms and treatment options can be initiated. However, it is imperative for community pharmacists to realize the potentially sensitive and/or embarrassing nature of the problem and act discreetly. They should speak in a low voice, refer to medications by generic names, and avoid approaching individuals who are in groups.

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Continuing Education Management Strategies and Patient Education Poor diet, stress, psychological disorders, obesity, smoking, drug abuse, and alcohol use have all been shown to induce IBS.1,3,4,12 Therefore, a healthy lifestyle is the best strategy for reducing symptoms. Moderate exercise (eg, yoga, swimming) can be beneficial for controlling weight-associated comorbidities and decreasing stress. Pharmacists can provide patients with literature on smoking cessation products and programs, as well as strategies for eliminating the use of alcohol and/or drugs. They can also refer patients to additional helpful resources, such as weight loss programs, meditation centers, and professionals who can provide services such as psychotherapy. Pharmacists may suggest to patients that they chart their meal consumption in a diary to identify specific foods or classes of food that cause IBS symptoms. High-fiber and/or low-carbohydrate diets should be discussed, because these have been shown to alleviate symptoms in many patients.2,13,14 In addition, there is substantial evidence that decreasing fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) will lessen the severity of IBS-related symptoms.2,13,15 FODMAPs are found in several carbohydrate-rich food sources, including fruits, vegetables, dairy, grains, and sweeteners. Possibly the most effective strategy for managing IBS is enhancing the microbiome with prebiotics and probiotics. These supplements have gained popularity in recent years because numerous studies have demonstrated their efficacy in enhancing digestive function and decreasing GI-related diseases, including IBS.16-18 A healthy microbiome consists of primarily beneficial bacteria in the GI tract.

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Dysbiosis, an alteration of the microbiome to harbor harmful bacteria, can occur in patients treated with antibiotics or after infectious pathogen exposure in the GI tract. Dysbiosis can become chronic and induce IBS.19-21 Thus, pharmacists should counsel patients who receive antibiotics and suggest consumption of prebiotics and probiotics to reduce the likelihood and severity of dysbiosis and IBS.

When suggesting probiotic and/or prebiotic therapy, it is essential that community pharmacists guide patients to consume them on a daily basis. Prebiotics, such as fructooligosaccharides (FOS), are used to induce the number or activity of beneficial bacteria, and have also shown efficacy in treating IBS and IBD.18,22,23 Combination treatment with probiotics and prebiotics may be particularly effective and produce a synergistic effect.24 When suggesting probiotic and/or prebiotic therapy, it is essential that community pharmacists guide patients to consume them on a daily basis. The rationale is that bacteria do not tend to colonize in the GI tract; therefore, discontinuation will likely result in a reversal to symptomatic IBS. There is a wide range of available probiotics and prebiotics with variable effectiveness. Bifidobacterium and Lactobacillus strains of probiotic bacteria (and combinations thereof) tend to produce excellent results, and FOS-containing prebiotics are highly effective for inducing beneficial bacteria.20,22,23,25 Additional factors that may contribute to IBS include infectious organisms, host

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Continuing Education and genetic factors, and psychological factors such as anxiety, depression, and a history of sexual abuse.3-5 It is important for pharmacists to educate patients on these potential factors, so necessary interventions can be implemented.

Conclusion IBS is a complex condition that can substantially impact patient quality of life. Community pharmacists can improve outcomes in those with IBS by recognizing warning signs and symptoms, and sensitively engaging patients. Being aware that IBS has multiple symptoms and underlying causes is impor­ tant in choosing the most appropriate intervention for each patient. Providing information on factors that influence IBS may help patients adopt healthier lifestyles. In addition to lifestyle changes, adjunct treatments, such as increased fiber intake and probiotic/prebiotic therapy, can be used to relieve symptoms. It is also important to promote the understanding that IBS should not be stigmatized, and although it is associated with psychological distress, the condition has very real and sometimes severe physiological symptoms that are exceedingly disruptive to daily life. Increased knowledge of IBS causes, symptoms, and effective management strategies can significantly enhance quality of life in a large population of patients. ❚ References

Dr Klatt is an Assistant Professor, Department of Pharmaceutics, University of Washington, Seattle, WA.

1. Canavan C, West J, Card T. The epidemiology of irritable bowel syndrome. Clin Epidemiology. 2014;6:71-80. 2. Miller LE. Study design considerations for irritable bowel syndrome clinical trials. Ann Gastroenterol. 2014;27:338-345. 3. Cremonini F, Talley NJ. Irritable bowel syndrome: epidemiology, natural history, health care seeking and emerging risk factors. Gastroenterol Clin North Am. 2005;34:189-204. 4. Riedl A, Schmidtmann M, Stengel A, et al. Somatic comorbidities of irritable bowel syndrome: a systematic analysis. J Psychosom Res. 2008;64:573-582. 5. Al Omran Y, Aziz Q. The brain-gut axis in health and disease. Adv Exp Med Biol. 2014;817:135-153. 6. Kennedy TM, Jones RH, Hungin APS, et al. Irritable bowel syndrome, gastro-oesophageal reflux, and bronchial hyper-responsiveness in the general population. Gut. 1998;43:770-774.

7. Manning AP, Thompson WG, Heaton KW, et al. Toward positive diagnosis of the irritable bowel. Br Med J. 1978;2:653-654. 8. Saito YA, Locke GR, Talley NJ, et al. A comparison of the Rome and Manning criteria for case identification in epidemiological investigations of irritable bowel syndrome. Am J Gastroenterol. 2000;95:2816-2824. 9. Thompson WG, Longstreth GF, Drossman DA, et al. Functional bowel disorders and functional abdominal pain. Gut. 1999;45(Suppl 2):II43-II47. 10. Longstreth GF, Thompson WG, Chey WD, et al. Functional bowel disorders. Gastroenterology. 2006;130:14801491. 11. Andresen V, Whorwell P, Fortea J, Auziere S. An exploration of the barriers to the confident diagnosis of irritable bowel syndrome: a survey among general practitioners, gastroenterologists and experts in five European countries. United European Gastroenterol J. 2015;3:39-52. 12. Henrich JF, Knittle K, De Gucht V, et al. Identifying effective techniques within psychological treatments for irritable bowel syndrome: a meta-analysis. J Psychosom Res. 2014 Dec 19. [Epub ahead of print]. 13. Ahmad OF, Akbar A. Dietary treatment of irritable bowel syndrome. Br Med Bull. 2015 Jan 19 [Epub ahead of print]. 14. Moayyedi P, Quigley EM, Lacy BE, et al. The effect of fiber supplementation on irritable bowel syndrome: a systematic review and meta-analysis. Am J Gastroenterol. 2014;109:1367-1374. 15. Khan MA, Nusrat S, Khan MI, Nawras A, Bielefeldt K. Low-FODMAP diet for irritable bowel syndrome: is it ready for prime time? Dig Dis Sci. 2014 Nov 20 [Epub ahead of print]. 16. Marteau PR, de Vrese M, Cellier CJ, Schrezenmeir J. Protection from gastrointestinal diseases with the use of probiotics. Am J Clin Nutr. 2001;73(2 suppl):430S-436S. 17. Madsen KL. The use of probiotics in gastrointestinal disease. Can J Gastroenterol. 2001;15:817-822. 18. Looijer-van Langen MA, Dieleman LA. Prebiotics in chronic intestinal inflammation. Inflamm Bowel Dis. 2009;15:454-462. 19. Aguilera M, Cerda-Cuellar M, Martinez V. Antibioticinduced dysbiosis alters host-bacterial interactions and leads to colonic sensory and motor changes in mice. Gut Microbes. 2014;22:1-14. 20. Tojo R, Suarez A, Clemente MG, et al. Intestinal microbiota in health and disease: role of bifidobacteria in gut homeostasis. World J Gastroenterol. 2014;20:15163-15176. 21. Shankar V, Hamilton MJ, Khoruts A, et al. Species and genus level resolution analysis of gut microbiota in Clostridium difficile patients following fecal microbiota transplantation. Microbiome. 2014;2:13. 22. Guandalini S, Magazzù G, Chiaro A, et al. VSL#3 improves symptoms in children with irritable bowel syndrome: a multicenter, randomized, placebo-controlled, double-blind, crossover study. J Pediatr Gastroenterol Nutr. 2010;51:24-30. 23. Ewaschuk JB, Dieleman LA. Probiotics and prebiotics in chronic inflammatory bowel diseases. World J Gastroenterol. 2006;12:5941-5950. 24. Klatt NR, Canary LA, Sun X, et al. Probiotic/prebiotic supplementation of antiretrovirals improves gastrointestinal immunity in SIV-infected macaques. J Clin Invest. 2013;123:903-907. 25. Vlasova AN, Chattha KS, Kandasamy S, et al. Lactobacilli and bifidobacteria promote immune homeostasis by modulating innate immune responses to human rotavirus in neonatal gnotobiotic pigs. PLoS One. 2013;8:e76962.

COE176-3

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GI HEALTH

INSIDE

Distinguishing colonoscopy preparation agents [33]

MALPRACTICE NEWS

Negligence in dispensing methotrexate [36]

The Retail Pharmacy Questions Answered: Going Beyond the Mechanism of Action and Getting Through to Patients In a recent interview with Inside Patient Care: Pharmacy & Clinics, James S. Beaumariage, RPh, Principal, Beaumariage Consulting, LLC, Nashville, TN, discussed key issues and trends in pharmacy education, and ways to effectively communicate with patients. What are some key issues and trends in the pharmacy education curriculum? A: The situation is, today, that a pharmacist can graduate from pharmacy school and qualify, have the requisite internship hours, to sit for the board exams without having been an employee of a pharmacy. A lot of the expansion from the 5-year curriculum into the 6-year curriculum was really providing academic oversight to what, in my generation, we did as interns. When I went to pharmacy school, it was a 5-year program. You had to have 1500 hours to sit for the board examinations; approximately 400 to 500 of those hours were through controlled or managed externships. It was 4 to 6 weeks at the beginning of your last 2 semesters of school.

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The balance was spent working in a real pharmacy environment, whether that was a retail drugstore, a hospital pharmacy, long-term care facility, or any number of pharmacies. You were on your own. That entailed working nights, working evenings, and working holidays. An overwhelming majority, I would suggest, of my pharmacy classmates had part-time jobs. They may have done it during school, maybe not. But certainly on holidays, summers, weekends, a lot of kids would go home and work in a drugstore, or at a hospital pharmacy. They got the real-world exposures, and understood that as a pharmacist you are going to be working on a holiday. You are going to be working Sundays, every other weekend. They also understood that when it was raining outside on Saturday

James S. Beaumariage

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Inside the Retail Pharmacy afternoon, you cleaned the shelves and things of that nature. In today’s curriculum, in the last year you are in pharmacy school, it’s really a series of rotations of internships. A lot of those are rather clinical. I just know, having managed innumerable drugstores and pharmacists over

At the end of the day, the goal of the pharmacist is to provide medications to the patient, but also ensure that they take them home and take the medication. the years, that the interns who are in those programs tend to get treated with white gloves. They are 9:00 to 5:00— “Oh, go ahead and go out to lunch.” Unfortunately, I think we are doing them a disservice, because they are not really being exposed to the reality of the role and the life of a pharmacist, particularly in a retail environment. What happens to these students who do go into retail? A: There are young pharmacists who have had exposure to the real-world retail background. They know what they are getting into and they have a vocation—this is their vocation. They wanted to do that. Others came at it from a very academic perspective, and, although they are brilliant, may be taken aback by it. Some pharmacists don’t realize some of those things that need to be done. Among the staff in the pharmacy, the pharmacist is looked up to as the leader, the manager in a sense of the word. They may not have that title, but they need to lead their shift. They need to provide the general direction of the staff. But if they don’t know things need to be done, there are those staff members who will wait until you tell them to do something. Now others will take the initiative

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and say, “Hey, we’ve got to do this,” or, “Hey, we have to do that.” But there are a lot who don’t. They don’t have that real-world background and experience to know what needs to be done. At the end of the day, the goal of the pharmacist is to provide medications to the patient, but also ensure that they take them home and take the medication. A lot of that is in how you approach that customer or that patient. You have to talk in their terms and help them to understand, “Look, the medicine works. Your job is to take it, and I’m here to help you. To remind you or help you to find ways to remind yourself.” How do you level with the patient and get them to take their medication? A: I had a situation with a farmer with type 2 diabetes, who wasn’t taking his medicine. He’s a big, strapping guy, and he’s scared to death of needles. He says, “How can I remember to take my medicine?” I just said to him, “You’ve got to take it twice a day. What have you been doing twice a day since you were 4 years old? Do you have cows?” “Yeah” “Do you milk them? How often?” “Twice a day.” “Do you have a milk book?” A milk book is where they record how many pounds of milk they get. It’s how they get paid. “Put the bottle on the milk book, out in the barn. Take it every time you go to your milk book.” “OK. I can do that.” Sometimes, you have to go beyond the mechanism of action and the clinical discussion point and get real. Just talk to the patient. Say, “Hey, look.” Do it in a way that they can remember. That’s the ultimate objective, for them to take the medicine. If the medicine works, they just have to take it. That is something that I found naturally, and I always have looked for pharmacists who could come across that way. Do you think that students should get more exposure to patients? A: Preceptors really do need to get stu-

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Inside the Retail Pharmacy dents in front of patients—real-world patients, not a demonstration project or some program in the school environment. And not only get them in front of patients, but also encourage them. My understanding of patient counseling as it is presented in school, it is for pharmacists to follow a certain regimen. You do this. Then you do that. At the end of the day, you have to be able to take those skills, put them into a conversation, not a regimen. You just have to walk out and talk to the person, and say, “Hey, Mary. How’s it going? How are the grandkids? Good. Great. Hey, look. You are starting this new medicine. You have got to be sure to take it every day. Here’s how my mom remembers how to take hers.” Spin it, so that it is not overly professional, overly esoteric. It is not you telling them, but rather it is you chatting with them. Once you create that dialogue, they are going to do whatever you tell them to do because it’s presented differently. A lot of that’s personality, honestly. How can retail pharmacists effectively communicate with patients? A: It’s a self-appraisal. Are you cut out to do that or not? Not everybody is. It does not make them a bad pharmacist, from a technical and professional perspective. But if they recognize that that is the case, then they really need to work with their technicians to try to bring them up a notch so that they know how to do that. That is very possible, too. I have worked with terrific technicians over the years, who could nearly run the pharmacy in many respects. It was interesting. As a young man, I came into a town, I didn’t live there, nobody knew me, and took over a very busy store. As soon as my technician told a customer, “This guy’s really good” or “We like Jim a lot,” I was gold. It is the same way on compliance, really. In other words, there is reinforcement. Often that is very important. Many times the technician

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staff may have been in the pharmacy and generally is more familiar with the customer, because they are out there at the register. Whereas the pharmacist isn’t always available to do that with today’s volumes. It is very important that you work as a team, and that your technician staff support whatever message the pharmacist delivers. Is there a role for community pharmacy to provide support to caregivers? A: I think that first you have to recognize that the healthcare system is very deliberate, and they have to be from a cost-containment perspective. They are pushing people down, down the healthcare continuum.

We as healthcare providers, although we are going to serve a gatekeeper role into primary care, we are also going to need to serve as a support mechanism for caregivers. In other words, people are released from the hospital much sooner than they had been in the past—if they even go to a hospital. There are a lot of procedures that are now done in outpatient, day surgery–type situations. The drive—particularly as patients age—is to keep them at home as long as they possibly can, or longer than they have in the past. There is a general shift in a sense out of the healthcare system into the home environment. We are seeing a trend where families are becoming much more involved and required to participate in their parents’ or elders’ healthcare. We as healthcare providers, although we are going to serve a gatekeeper role into primary care, we are also going to need to serve as a support mechanism for caregivers. It’s interesting, and if you

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Inside the Retail Pharmacy stop to think about it, as an adult, you are a caregiver. You only get off the caregiver hook for about 4 or 5 years. The first 20 or so years of your children’s lives, you are their caregiver, and it seems as though, at least from personal experience, there is only approximately a 4- to 5-year gap until you need to become a caregiver for your parents.

If we can, as an industry, position ourselves to be a better provider of care and support for the caregiver, I think that’s absolutely key. I think that the pharmacy industry is the most accessible element of healthcare from a patient access and convenience perspective, the industry really needs to position itself to support caregivers. If you think about it, you can encompass both ends of that spectrum. From the parents of children to the children of parents, that is becoming much closer. Drug delivery, drug therapy, and drug misadventures. Your parents simply taking their medicine correctly becomes an ever-increasing problem. It is a significant problem and it is the reason why people are entering the other facets of healthcare, including going to the emergency department, being hospitalized, and going into assisted living. If we can, as an industry, position ourselves to be a better provider of care and support for the caregiver, I think that’s absolutely key. You start thinking about packaging. How do we package? Is it really easy for your 78-year-old mother who is starting to show signs of dementia to go home with 11 vials of medication, and take them correctly? I would suggest not.

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To read the full interview, please visit our website.

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What is the role of pharmacists in medication reconciliation after hospitalization? A: Start and stop is a huge issue. The

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ February 2015

other piece of it is, and it is really a function of the managed care world in that to the extent that older adults, the elderly, or the preelderly, now is a much later age than it used to be. One of the things that is out there today is that a lot of retirees have a 90-day prescription drug benefit. When they access and they refill their medications, they are getting a 90-day supply. But in that 90 days it’s not at all uncommon for their physician to have changed the directions. Their vial still says take it 3 times a day; however, their doctor, who they visited a month ago, said to taper it to 2 a day. They may or may not have remembered to do that. I have seen situations, personally, where postsurgery, we had a visiting nurse in to set up my father’s medication for him. She’s reading off the prescription vials, and where he was to have actually discontinued a medication for 4 weeks, he continued taking that medication because the physician’s notes, the follow-up notes from his physician visit, never got to the visiting nurse. Despite that level of care, despite that healthcare provider coming out into the home environment, and the costs associated with that, they’re still not getting dosed properly. I think that starts to get into interoperability in terms of the electronic data interchange information coming out of the physician’s office to, for a visiting nurse–type situation, etc. It’s a real dilemma, and you don’t really stop to think about it. Or a lot of people don’t until you experience it. There’s a huge challenge there, and I think there’s an opportunity there for pharmacy to play a role. Again, it gets into interoperability and connectivity. To the extent that a pharmacy is able to reach out and touch a consumer at home to remind them to get a prescription refill, could they have a means by which they announce or they remind a patient of a dose? ❚

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Inside the Retail Pharmacy

Distinguishing Between Different Colonoscopy Preparation Agents by LAUREN MILLER, PHARMDc

Bowel preparations are used to empty the colon before colonoscopies. }} }} THE EFFECTIVENESS of the bowel preparation determines the accuracy of the colonoscopy. Inappropriate bowel preparation leads to a third of incomplete procedures, negatively impacting colon cancer screenings.1,2 The ideal preparation should empty the colon rapidly without causing damage to the gastrointestinal mucosa, or shift fluid-electrolyte balance.1 Other features of an ideal preparation include patient-specific considerations such as product tolerability and cost.

Choosing the Right Agent None of the preparations currently available meet all of the ideal criteria, which is why it is important for pharmacists and retail clinicians to evaluate several factors when considering agents. Physicians tend to choose preparations based on optimum patient compliance, whereas patients prefer preparations with a low fluid volume, that is palatable, and available at a lower cost.1 Comorbid conditions and medica-

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tions should also be taken into consideration for each patient when choosing a bowel preparation, to ensure that it is safe to use.

Options Available There are several prescription and over-the-counter (OTC) bowel preparations available for patient use. Prescriptions are more commonly used and include polyethylene glycol (PEG) derivatives such as HalfLytely, GoLYTELY, and Colyte.1 Other prescriptions include the sodium phosphate derivatives OsmoPrep and Visicol. Although these options require a prescription, they are more likely to be used than OTC products. OTC agents available include magnesium citrate and a PEG derivative, Miralax (PEG-3350). Although these options are more accessible for patients, they must be used in conjunction with a stool softener (eg, bisacodyl).1,3 There are 3 types of bowel preparations, which are differentiated based on

KEY POINTS ❚ Patients prefer preparations low in fluid volume, palatable, and available at a lower cost ❚ The gold standard for colonoscopy preparations are PEG derivatives ❚ Addressing patient concerns in addition to other disease states and medications is important when choosing the best preparation agent

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Inside the Retail Pharmacy their mechanism of action. The gold standard for colonoscopy preparations are PEG derivatives.1 PEG is an isosmotic agent, and is safe and effective to cleanse the bowels without causing major shifts in the fluid-electrolyte balance. The standard PEG preparation is a 4-L solution that patients consume in 8-oz proportions at 10-minute intervals. Two examples of this formulation are available on the market: GoLytely and Colyte.1,2 These agents cost between $25 to $50 and coverage is dependent on the patient’s insurance plan.4 In addition to keeping osmotic balance, other benefits associated with these agents include no

Newer variations of PEG to help improve patient compliance and tolerability of preparation have been brought to the market. change in the colonic mucosa, making it safe to use in patients with irritable bowel syndrome. They are also generally well tolerated by patients.1 Some disadvantages include the salty taste and large volume the patient must consume. Cautions associated with the use of these agents include concurrent use with angiotensin-converting enzyme inhibitors (ACEIs) or potassium-sparing diuretics, and elderly patients or patients with diabetes.5 Although adverse effects are often rare, nausea, vomiting, and increased plasma volume have been reported.3 Newer variations of PEG to help improve patient compliance and tolerability of preparation have been brought to the market. Sulfate-free derivatives were developed to improve the smell and salty taste of the preparations, including NuLYTELY and TriLyte.1 They have the same mechanism of action as PEG, as well as a comparable cleansing effect, but have increased tolerability because

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INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ February 2015

they are more palatable to patients. Another derivative was created to help address the patient concerns about the large volumes of PEG that have to be consumed.1 HalfLytely was developed as a 2-L solution that is used in conjunction with bisacodyl tablets. The decreased volume has been shown to decrease patient concerns of cramping and bloating while providing equal efficacy in colonoscopy preparation.1 The other prescription available for colonoscopy preparation is sodium phosphate (NaP). NaP was developed as a hyperosmotic agent in both tablet and aqueous formulation.1 It works by drawing water into the bowel lumen to promote cleansing.1 The tablet formulation, Visicol, is taken as 32 to 40 tablets split between the night before and the day of the procedure.1 OsmoPrep, the liquid form, is taken as 2 doses of 30 to 45 mL, 10 to 12 hours apart.1-3 Both dosages of NaP are expensive, with OsmoPrep costing almost $600.4 Benefits of using this agent include the smaller volume and improved taste for patients, but it is associated with downfalls of significant fluid/electrolyte shifts and side effects that can mimic inflammatory bowel disease (IBD).1,2 Before recommending this agent, patients’ other comorbid conditions need to be addressed.2 Because NaP can cause phosphate nephropathy, it should be used with caution in patients with renal failure or who are receiving an ACEI/ angiotensin II receptor blocker.1,2 Other conditions to use caution with include children aged <5 years, hepatic dysfunction, recent myocardial infarction/ unstable angina, congestive heart failure, or IBD. NaP is contraindicated in several of these conditions because of its adverse effects, such as colonic ulcers, dehydration, and hyperkalemia.1-3 Prescribers should thoroughly evaluate patients’ underlying conditions before recommending this agent. OTC agents available for patients include a long-term saline laxative, magnesium citrate.1 Magnesium citrate

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Inside the Retail Pharmacy is a hyperosmotic agent similar to NaP that increases intestinal motility by increasing the volume of the intestinal lumen.1 It is typically prescribed in 1.5-L bottles the night before the procedure and 1.5-L bottles the morning of the procedure.6 As an OTC agent, magnesium citrate is more affordable and easier for patients to access, but it also comes with some precautions. Because of the hyperosmotic mechanism, significant fluid-electrolyte shifts can be seen with this agent, as well as several drug and disease state interactions. Magnesium is renally excreted and contraindicated for use in kidney, liver, and congestive heart failure. Caution should be exercised because of the side effects this agent can have (eg, cramping, irregular heart rhythm, and fluid retention).3,6 Miralax is a PEG derivative that was developed as an OTC agent and is being used more often in conjunction with bisacodyl for bowel preparation.1 Miralax is a low-volume PEG agent without added electrolytes. It has shown equal efficacy to the 4-L PEG agents with improved tolerance related to the decrease in volume consumed. Miralax is taken as 1 capful every 10 minutes in 8 oz of liquid until 2 L have been administered.1 This OTC agent is a cost-effective and easily accessible option for patients. The side effect profile and safety of Miralax is comparable to PEG, making it an effective option for colonoscopy preparation.

Patient Tips and Precautions Patient counseling for bowel preparations is an important part of ensuring effective cleansing for the procedure. Some key elements that should be discussed with patients are ensuring that they complete the whole preparation, and to drink plenty of fluids.6 Drinking fluids—especially those with calories— ensures that the patient will not become dehydrated and/or experience a drop in their blood sugar as a result of their increased excretion. Other counseling

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tips that can help with tolerability of preparations include refrigerating the agent, drinking it through a straw, and adding flavoring, such as Crystal Light, to the preparation. When recommending the addition of flavoring, make sure to remind patients to avoid anything with red or purple dye, because these colors can be mistaken for blood during the colonoscopy.6

Addressing patient concerns in addition to other disease states and medications is important when choosing the best preparation agent. Addressing patient concerns in addition to other disease states and medications is important when choosing the best preparation agent. Each patient should be evaluated separately, and the risk versus benefit of each agent should be weighed. Cost and product accessibility are also important considerations when prescribing these agents. Discussing key features of the preparation prescribed is important to ensure an effective preparation has been chosen. Any side effects that can be expected, as well as administration and adherence counseling, are important factors that can ensure effective cleansing is achieved. ❚

References

1. World Laparoscopy Hospital. Guidelines for the bowel preparation prior to colonoscopy. www.laparoscopyhospital. com/Bowel%20preparation%20prior%20to%20colonoscopy. html. Accessed December 15, 2014. 2. ASGE Technology Committee, Mamula P, Adler DG, et al. Colonoscopy preparation. Gastrointest Endosc. 2009;69:1201-1209. 3. Lexicomp. Hudson, OH: Lexi-Comp, Inc. Accessed 2014. 4. Fingertip Formulary. Parsippany, NJ: Fingertip Formulary, LLC; 2013. 5. Hayes A, Buffum M, Hughes J. Diabetic Colon Preparation for GI Procedure” VAMC San Francisco. 6. Gastrointestinal Associates and Endoscopy Center. Bowel prep. www.msgastrodocs.com/resources/bowel-prep. Accessed December 15, 2014.

Ms Miller is a 2015 PharmD candidate at Ohio Northern University, Ada, OH.

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Inside the Retail Pharmacy

Negligence in Dispensing Methotrexate

And other medical malpractice news The Case The plaintiff, age 62, was administered methotrexate, and maintained that she received an excessive dosage from what her physician had ordered (1 dose/week), and was administered 1 dose daily for 8 days. The plaintiff claimed that her hair fell out, she developed mouth sores, and suffered acute kidney failure. The plaintiff recovered, but claimed that she was at increased of kidney failure in the future. The plaintiff alleged negligence in dispensing the medication. The defendant claimed that any error was solely the fault of the hospital’s nursing staff in misreading the physician’s order. The defendant argued that he was not required to check a physician’s order each time it refilled to the automated dispensing machine. According to the Trial Reporter of Central and Northern Arizona, a confidential settlement was reached with the hospital prior to trial. A $600,000 verdict was returned at trial with the jury finding the defendant 20% at fault, and the hospital 80% at fault. The plaintiff was to receive $120,000 from the defendant. The Verdict Hospital settles for confidential amount prior to $120,000 net verdict against pharmacy Wilson v. Fuller-Selle, LLC, d/b/a Pharmacare Services, Maricopa County (AZ) Superior Court, Case No. CV 2012000908.

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INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ February 2015

Failure to Inform Patient of Risk of Not Taking All of Prescribed Antibiotic The Case The plaintiff’s decedent, age 84, went to Palisades Medical Center in January 2010. The decedent was suffering from pulmonary edema, caused by congestive heart failure, was admitted, and placed under the care of internist Hilda Roque-Dieguez. Three days later the decedent was prescribed an antibiotic in response to lower-leg cellulitis. The decedent was also diagnosed with bacteremia and she developed sepsis. The woman died in early March 2010, while hospitalized. Several defendants were initially named in this suit, but the matter went to trial as to Dr RoqueDieguez only. The plaintiff claimed that the defendant failed to properly monitor the decedent’s intake of the antibiotic for cellulitis, and failed to fully inform her regarding the risks of not taking the full amount. The decedent missed several doses of the antibiotic, which the plaintiff claimed caused the decedent to develop bacteremia and sepsis, contributing to her death. The plaintiff claimed that an alternative antibiotic should have been prescribed or the decedent should have been fully informed of the risks of not taking the antibiotic prescribed. The plaintiff claimed that the

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Inside the Retail Pharmacy defendant was aware that the decedent was missing doses. The defendant claimed that she did inform the decedent of the risks of not taking the antibiotic. The defendant also claimed that the woman’s death was due to pre-existing cardiac conditions and that sepsis had not been confirmed. According to a published account a defense verdict was returned. The Verdict New Jersey Defense Verdict Angel Diaz, o/b/o Estate of Emilia Diaz v. Palisades Medical Center Corp, Pauline J. Nualla, RN, and Hilda RoqueDieguez, MD, Hudson County (NJ) Superior Court, Case No. L-000109-12.

Improper Prescription of Halobetasol, Multiple Other Prescriptions Blamed for Blisters The Case The plaintiff, age 50, went to her long-time primary care physician in August 2010 to seek treatment for fever blisters, as well as to refill her medications. The plaintiff had a history of eczema, fever blisters, and facial acne. She was given refills on prescriptions for Clindamycin 1% lotion for her acne, Halobetasol 0.05% ointment for her eczema, and Zovirax 5% cream and Valcyclovir 500 mg tablets for her fever blisters. The plaintiff had these prescriptions filled the same day. In January and February 2011, the plaintiff suffered a severe breakout of blisters on her face. The plaintiff could not leave home and was too embarrassed to work for 2 weeks. The plaintiff alleged negligence in the prescription of Halobetasol for facial acne and also in prescribing multiple medications at 1 time. The defendant argued that the Halobetasol was not prescribed for her face, but for the eczema on her elbows. The defendant claimed that the plaintiff had confused her medications, causing her to use the wrong medication on her face. The defendant also claimed that, in December 2010, the plaintiff had received large amounts of prescrip-

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STAKEHOLDER PERSPECTIVE IDENTIFYING OPPORTUNITIES FOR IMPROVEMENT Donald J. Dietz, RPh, MS, provides insight on the role of pharmacists in medical malpractice Retail pharmacists perform a valuable role in safeguarding the appropriate use of prescription pharmaceuticals. These 3 recent cases are examples where patients were harmed by the inappropriate use of prescription pharmaceuticals. As is often the case, there are multiple external factors involved that led to patient harm that extended well beyond the pharmacist’s role. Our goal is to call attention to situations where pharmacists could intervene and prevent untoward medical events. In the first case, methotrexate’s multiple dosing regimens lead to dispensing confusion. When preparing a prescription for initial dispensing and the medication has multiple dosing administrations, the pharmacist may want to verify the product, strength, and administration schedule with a prescriber prior to dispensing. Pharmacists should also pay close attention to high-dose alerts and other Drug Utilization Review messages for these products. The takeaway for pharmacists in the second case is to communicate the importance of how to take a prescription at the initiation of therapy. With an antibiotic, the pharmacist can play an important role by conveying the importance of not missing doses. Pharmacists should also educate patients about what to do when a dose is missed and ensure the patient knows that the medication must be taken until completely finished.

The third case identifies opportunities for pharmacists to counsel patients when multiple prescriptions are issued at the same time. In this situation, the patient was to receive 4 prescription products for 3 different dermatological conditions. In addition, the patient had received a recent corticosteroid prescription from a different prescriber to systemically treat a sinus infection. The learning opportunity here includes ascertaining if the patient is on any other prescription or over-thecounter medications when new therapy is initiated. Furthermore, with multiple dermatological conditions, it would be an excellent opportunity to review with the patient which prescription is used to treat each condition, how and where it is to be applied, and what are signs that the medication is working as prescribed. Conversely, pharmacists should educate patients on what side effects to be aware of during the course of treatment. It is always easier to retrospectively examine situations and identify opportunities for improvement. The goal here is to help us proactively identify challenging situations you may encounter in your pharmacy or clinic, and realize the importance of taking the extra time to help prevent untoward events. Mr Dietz is Editor-in-Chief of the journal, and Vice President of Pharmacy Healthcare Solutions, Inc, Pittsburgh, PA.

tion steroids to treat a sinus infection from a different physician, arguing that the plaintiff’s breakout could have been caused by the influx of additional steroids into the system. The Verdict Texas Defense Verdict Rosetta Ross v. Yaa Amoah-Honny, MD, Harris County (TX) District Court, Case No. N/A. Reprinted with permission from Medical Malpractice Verdicts, Settlements and Experts, Lewis Laska, Editor, Nashville, Tennessee, 800298-6288.

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Inside

Healthcare Policy Team-Based Care as an Analogue to Pharmacists’ Scope of Practice The Strategy of Legislative Bill HR 592 by ROBERT E. HENRY

TEAM-BASED CARE is the type of fulfillment HR 592 set out to achieve, not technically increasing pharmacists’ scope of practice, but fulfilling it in a very curious way. Despite the extraordinary diversity in their makeup, all interprofessional provider teams share the quality of overcoming barriers to any provider’s scope of practice. Each team is defined by the patient’s needs. Team-based care dem­ on­ strates how pharmacists, physician assistants (PAs), and nurse practitioners (NPs) can treat patients in a wide array of creative care settings. Proliferation of teambased care would make the passage of HR 592 almost superfluous. Whatever it is or will do to alter the healthcare system, it bears watching and provides lessons in interprovider collaboration and tapping into our knowledge, technology, and di-

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verse skill sets to raise the value of patient care.

Definition, Rationale, Personal Qualities, and Goals Team-based care is predicated on the assertion that an interprofessional team can address the needs of a patient or group of patients and achieve outcomes and value beyond the capacity of any single provider: physician, pharmacist, or any other provider or healthcare professional. This also entails attaining value-based care—value being the balance of cost, quality, and access. “The clinician operating in isolation is now seen as undesirable in health care—a lone ranger, a cowboy, an individual who works long and hard to provide the care needed, but whose dependence on solitary resources and perspective may put the patient at risk,” according to a 2012 semi-

TEAM-BASED CARE DEMONSTRATES HOW PHARMACISTS, PHYSICIAN ASSISTANTS (PAS), AND NURSE PRACTITIONERS (NPS) CAN TREAT PATIENTS IN A WIDE ARRAY OF CREATIVE CARE SETTINGS. nal paper from the Institute of Medicine (IOM).1 This discussion paper was largely embraced the following year by the American College of Physicians position paper.2 It proposed—but wisely refrained from presuming to mandate—standards in definition, and criteria for defining team-based care, the values its participants

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ February 2015

should possess, and goals.1 The following excerpts from the IOM discussion paper provide essential insights into the vision of team-based care and its objective and subjective attributes1: • Proposed Definition: Team-based healthcare is the provision of health services to individuals, families, and/ or their communities by at least 2 health providers who work collaboratively with patients and their caregivers—to the extent preferred by each patient—to accomplish shared goals within and across settings to achieve coordinated, high-quality care. • Proposed Rationale: The high-performing team is now widely recognized as an essential tool for constructing a more patient-centered, coordinated, and effective healthcare delivery system.

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Inside

Healthcare Policy • Proposed Personal Qualities Required of Team Members: Honesty, discipline, creativity, humility, and curiosity. • Proposed Principal Goals: Shared goals, clear roles, mutual trust, effective communication, and measurable processes and outcomes.

Organization of Care Teams Care teams are organized in highly individ­ ualized ways that are tailored to meet the circumstances and needs of patients and caregivers. Its ability to succeed comes from a commitment to the highest ideals of medicine, supported by evidencebased medicine, personalized medicine tech­niques, improved technology, and advances in knowledge of disease states, treatment options, and patient engagement techniques. Each team member is responsible for a particular aspect of the patient’s care. This makes the structure of team-based care heterogeneous and diverse to the extreme. Moving Toward Personalized Medicine Reaching into each patient’s individual needs and interests drives the team’s structure as well as the leader elected by its members. A team treat-

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A TEAM OF PROVIDERS AND SUPPORT MEMBERS APPROPRIATE TO THE PATIENT’S NEEDS IS MORE IMPERATIVE THAN EVER. ing a patient on a multiple drug regimen would logically have a pharmacist directing drug utilization to ensure drug optimization and adherence; such a team might well elect the pharmacist as its team leader. This interprofessional treatment of select patients with special needs is a timely development, providing new efficiencies appropriate not only to new skill sets and technologies required for its execution, but also for changing healthcare needs. For example, consider the ominous rise of multimorbidity as the baby boom generation approaches and reaches retirement age; this condition exists primarily in patients aged ≥65 years. Multimorbidity is the presence of several chronic and/or acute conditions in a patient. Far more complicated to treat than

the comorbid patient, multimorbid patients require care according to guidelines/best practices for each condition. The complexity of ensuring care, counseling, adherence, and engaging patients and caregivers in management and lifestyle modification, if necessary, underscores just 1 situation where team-based care will cut through the Gordian knot challenging successful patient care. A team of providers and support members appropriate to the patient’s needs is more imperative than ever.

Essential Function of Medical Process If team-based care is growing and essential for the fulfillment of the medical process, it seems axiomatic to increase pharmacists’ scope of practice as well. Seeing pharmacists engaged in these in-depth provider care teams, the impulse arises to borrow President Ronald Reagan’s famous proclamation in reference to the Berlin Wall: “Tear down that wall!” The changes in the political landscape at the time made the Berlin Wall an anachronism that was no longer tenable. Thus, it provides a useful parallel to the imminent fall of limitations on pharmacists’ scope of practice.

Team-based care is emerging in both national and local initiatives; increased pharmacists’ scope of practice is sure to follow, and soon. The team-based care model is still in its infancy, with exploratory models being devised to meet diverse conditions and patient needs. This is a Golden Age of free expression in team-based care, the period before standards are circumscribed. What holds teams together are 2 characteristics: collaboration, and an intense desire to heal by bringing order out of the chaos of multiple factors challenging patient health. Team-based care transcends the pettiness that has plagued the debate over pharmacists’ scope of practice. Its fresh, sensible vision for collaboration and willingness to experiment with multiple approaches to synthesizing diverse skill sets is a shot in the arm to a healthcare system often stagnated by costs, indifference, divisiveness, and its own bureaucratic regulations. This brief look at teambased care brings perspective to one of the “modest proposals”—HR 592— seeking to increase pharmacists’ scope of practice. The American Society of Health-System Pharmacists issued a fact sheet

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ February 2015

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Inside

Healthcare Policy PHARMACISTS’ SKILLS MUST BE USED TO THEIR FULL EFFECT.

about HR 592 which who “get it” to take the states that although the initiative and pursue an bill does not technically enlightened, progressive increase pharmacists’ toward multiprofesMedical Directors • Physician Assistants • Nurse Practitioners • Pharmacists • Chain Headquarterspath • Independents scope of practice, it was sional provider care. Valdesigned to achieve this ue awaits. ❚ effect indirectly.3 There is so much potential and for clinics are quickly becoming an Retail pharmacies References of how and why interpropharmacists, PAs, and 1. Mitchell PH, Wynia MK, Golden R, extension of primary care. Inside Patient Care: Pharmacy et al; Institute of Medicine. Core prinNPs, now often working fessional collaboration is ciples & values of effective team-based & Clinics is tailored to meet the growing needs of the entire together in pharmacy reneeded and indeed alhealth care. www.iom.edu/Global/Per­ spectives/2012/~/media/Files/Per spechealthcare teamtoand provides practical tail clinics, deliver optiready beinginformation implemented. to treat tives-Files/2012/Discussion-Papers/ care inside throughthe pharmacy This is changing the de-clinics. ” and caremal forpatient patients and retail VSRT-Team-Based-Care-Principlesinterprofessional teambate from whether a paValues.pdf. Published October 2012. Accessed January 6, 2015. work before we even aptient should be treated by 2. Doherty RB, Crowley RA; Health Donald J. Dietz, RPh, MS proach the ultimate cola physician,Vicepharmacist, and Public Policy Committee of the President Healthcare Solutions, Inc. American College of Physicians. Prinlaboration, team-based PA, or NP,Pharmacy to whether Editor-in-Chief ciples supporting dynamic clinical care Mr Henry is President of they all might bePatient treating care. Inside Care teams: an American College of PhysiGlendabough Productions certain patients in an incians position paper. Ann Intern Med. Inc, Founding Editor-in2013;159:620-626. Conclusion telligent division of labor. 3. American Society of Health-System Chief of American Health Pharmacists’ skills must The genesis of team-based Pharmacists. Provider status legislation: & Drug Benefits, and H.R. 4190. Frequently asked questions. be used to their full effect. care shows that this is the Strategic Editor of Inside www.ashp.org/DocLibrary/Advocacy/ Their day is coming, and future of healthcare. It Patient Care: Pharmacy HR-4190-FAQs.pdf. Accessed January & Clinics. team-based care is a vision now remains for those 6, 2015.

CISTS PHYSICIANS • NP/PAs • PHARMA

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

om

GASTROINTESTINAL

February 2015 VOL. 3 • NO. 2

20 Tips for

Food Safety

29 Questions

Answered with James Beaumariage

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

Health

e-Based New IBS Guidelines Offer Evidenc Pharmacologic Treatment Options PAGE 13

33 Distinguishing

Between Different Colonoscopy Preparation Agents

38 Team-Based Care

as an Analogue to Pharmacists’ Scope of Practice

51 New Products

CE AVAILABLE PAGE 24

© 2015 Novellus Healthcare Communications, LLC an affiliate of

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

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INSIDE

Money How to Choose a 529 College Savings Plan by W. BEN UTLEY, CFP, and LAWRENCE B. KELLER, CFP, CLU, CHFC, RHU, LUTCF

Section 529 college savings plans are tax-advantaged college savings vehicles, and one of the most popular ways to save for college today. }} }} KNOWN OFFICIALLY as “qualified tuition programs,” 529 college savings plans have changed the world of tuition savings, much like the way 401(k) plans changed the world of retirement savings a few decades ago. While a 529 plan may be the best vehicle to save for college, you will need to understand the basics in order to make the right choice.

The Basics of 529 Plans Congress created 529 plans in 1996 and named them after Section 529 of the Internal Revenue code. A 529 plan is state-operated and offers tax advantages as well as other potential incentives to ease saving for college or postsecondary training for a designated beneficiary, such as a child or grandchild. Eligible educational institutions generally include colleges, universities, vocational schools, or other postsecondary educational institutions eligible to participate in a student aid program administered by the US Department of Education.

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When establishing a 529 plan, you can name anyone as a beneficiary, including a relative, a friend, or yourself. There are no income restrictions on you as the contributor, or on the beneficiary, and there is also no limit to the number of 529 plans you can establish. College savings plans are established by individual states and typically managed by an experienced financial institution that the state has designated. All 50 states and the District of Columbia sponsor at least 1 type of 529 plan. The main advantage to these plans is that earnings are not subject to federal tax—and generally not subject to state tax—when the designated beneficiary uses the money for “qualified higher education expenses” (eg, tuition, fees, books, room and board). If you make a nonqualified withdrawal (ie, a withdrawal used for something other than the beneficiary’s qualified higher education expenses), then the earnings portion of the withdrawal will be taxed at the federal level rate of the person

KEY POINTS ❚ Know the basics of 529 plans ❚ Learn how your state’s tax breaks works ❚ Think about the amount of money you will have in the plan

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ February 2015

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Inside Money who receives the distribution (usually the account owner). State taxes will likely apply in addition to a penalty; specifically, the earnings portion of the withdrawal will be subject to a 10% federal penalty. The majority of plans are open to residents of any state. This means you can shop for the plan with the best money manager, overall performance record, investment options, fees, and customer service. Keep in mind, however, that many states limit their tax benefits to residents who participate in an in-state college savings plan.

The majority of plans are open to residents of any state. This means you can shop for the plan with the best money manager, overall performance record, investment options, fees, and customer service. Opening a 529 plan is simple: complete a short application, designate a beneficiary, and contribute the required minimum amount. Most plans also offer automatic deductions or electronic fund transfers to make future saving even easier. Once the account is open, you or anyone else can contribute as much money to the account as you wish, subject to the plan’s specific limits. Some plans may require a minimum amount to open the account, have a minimum amount for each contribution, or restrict the total contributions allowed per year. All plans have total lifetime contribution limits; however, most states generally have limits in excess of $300,000. You can roll over your existing college savings plan account to a new 529 plan account once every 12 months without any federal tax penalty and without having to change the beneficiary. There may be state income tax consequences (and, in some cases,

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INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ February 2015

state-imposed penalties) that result from such a rollover. This option lets you leave a plan with few investment choices or one that has earned poor returns for a plan with more investment flexibility or a better track record. If you are satisfied with the plan but want to change the way your existing assets are invested, this can be done twice each calendar year, or whenever the account beneficiary changes. You do have the ability to change how your future contributions are allocated at any time. If your child receives a college scholarship, you can withdraw money without penalty as long as your withdrawals during the year don’t exceed the annual scholarship amount. However, you will owe federal and state income taxes on the earnings portion of each withdrawal. If the beneficiary doesn’t use the money in the account for college, you can use the savings for graduate school or other higher education later, transfer the balance without penalty to another eligible family member (including a parent, step-sibling, half-sibling, or, in some cases, an inlaw of the original beneficiary), or simply make a nonqualified withdrawal as described earlier. Section 529 plans yield another valuable break: estate taxes. Contributions to the plan are considered a completed gift under estate tax code, so your contribution qualifies for the $14,000 annual gift tax exclusion amount. In fact, you can contribute up to $70,000 per child and then elect to treat the contribution as if it were made over a 5-year period. Now that you understand the basics, let’s look at the steps you will need to take as you do your financial planning for college.

1/ Determine whether your state of­-

fers a tax advantage for 529 plan contributions. Colorado, Georgia, Idaho, Iowa, Kansas, Louisiana, Maryland, Michigan, Mississippi, Missouri, Montana, Nebraska, New Mexico, New

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Inside Money York, Ohio, Oklahoma, Oregon, Rhode Island, South Carolina, Utah, Virginia, West Virginia, and Wisconsin offer tax benefits for 529 contributions made by taxpayers residing in those states.

2/ Learn how your state’s tax break

works. Contact your tax specialist and ask these 3 questions: • How much money do I need to contribute to my state’s 529 plan to get the maximum tax benefit? • How much will I save in taxes when I make my contribution? • What is the deadline for making a contribution? Note that some states will only allow you to deduct calendar year contributions from your tax return, while others will allow you to contribute up until the time your return is filed (as is the case with IRA contributions). If you discover this article in March, this means you might still have a chance to save taxes if you forgot (or didn’t know) to make a contribution last year.

3/

Research investment results and expenses for in-state and out-of-state plans. If your state offers a tax break for 529 plan contributions, it might seem like this is the best option. But what if the performance of your state’s plan is poor? The cost of lower returns may outweigh the benefit of the tax break, so do a little digging and run a quick calculation.

4/

Calculate the performance gap. This is the difference in total return between your in-state plan and the outof-state plan.

5/

Think about the amount of money you will have in the plan. If you are targeting a 4-year private university at a cost of $200,000 per student, and your family has nothing saved today, the average balance between now and then will probably be about $100,000.

6/ Calculate the opportunity cost of InsidePatientCare.com

using the in-state plan. Multiply the average amount you’ll have invested by the performance gap. Amount Invested × Performance Gap = Opportunity Cost

Even though the tax benefits, creditor protection, and kid-friendly usability were intended for everyone’s benefit, these features make 529 plans the best way to save for college. 7/

Let the opportunity cost help you choose your plan. If the tax benefit outweighs the opportunity cost, consider using your state’s plan. If the opportunity cost is much larger than the tax benefit, then the out-of-state plan might be a better choice. We say “might be” because there’s one more thing you need to consider as you choose your plan: asset protection. Some state plans confer a measure of protection against the claims of creditors, and in some states this protection only extends to physicians who live in that state and contribute to the in-state 529 plan. The law on this issue varies from state to state, so you might want to seek legal counsel if you are at all concerned about the protections your plan may (or may not) afford. Joseph F. Hurley, CPA, founder of www.savingforcollege.com and the nation’s expert on saving for college, hails the 529 plan as the best way to save for college. Even though the tax benefits, creditor protection, and kid-friendly usability were intended for everyone’s benefit, these features make 529 plans the best way for families of pharmacists or retail clinicians to save for college, too. Choosing the right 529 plan is not as easy as it appears, but these steps will help you make the right choice for your family. ❚

W. Ben Utley Mr Utley, CFP, is the lead advisor with Physician Family Financial Advisors. Mr Keller, CFP, CLU, ChFC, RHU, LUTCF, is the founder of Physician Financial Services.

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Drug Update Zydelig (Idelalisib): First-in-Class PI3 Kinase Inhibitor Approved by the FDA for the Treatment of 3 Hematologic Malignancies by LISA A. RAEDLER, PHD, RPH

Chronic lymphocytic leukemia (CLL), a cancer of B-cell lymphocytes, is the most common type of leukemia in Western adult patients.1 According to the Leukemia and Lymphoma Society, more than 15,600 Americans were diagnosed with CLL in 2013.2 }} }} CLL IS A DISEASE of the elderly.3 The incidence of CLL increases significantly among individuals aged ≥50 years, with only a small fraction of patients diagnosed in their 30s and 40s.2 The majority of patients with CLL are diagnosed without symptoms, and typically learn that they have CLL after routine blood work.4 As it advances, CLL can cause severe fatigue, swollen lymph nodes, enlarged spleen, shortness of

breath, and infections.4 The clinical course of CLL is heterogeneous. Although some patients with CLL live for decades with no treatment, others have disease that is rapidly aggressive.3 The survival of patients with CLL ranges from approximately 1 year to more than 20 years.5 According to the American Society of Clinical Oncology, the 5-year overall survival (OS) rate for patients with CLL of all stages is approximately 79%.5

Copyright © 2014 American Health & Drug Benefits. Used with permission. All rights reserved.

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The cost burden associated with CLL is significant. Based on a recent cost analysis conducted in Germany, the total per-patient costs for patients with CLL is €9753 (approximately $12,202) annually compared with €4807 (approximately $6014) annually for individuals in a control group of the same age and sex.6 In this study, the economic burden of CLL was primarily driven by inpatient costs and by drug costs. From a societal perspective, productivity loss was the highest cost associated with a CLL diagnosis.6

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Small Lymphocytic Lymphoma According to the World Health Organization, CLL and small lymphocytic lymphoma (SLL) are different clinical manifestations of the same disease.7 The term CLL is used when there is a leukemic component in peripheral blood, whereas SLL is used when lymph nodes or other tissues are infiltrated by CLL cells that appear to be without the leukemic component.2,7 Only 5% of patients pre­ sent with clinical features of SLL.2 CLL and SLL affect people of the same

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Drug Update age-groups, have common signs and symptoms, and are generally slow-growing conditions.8 The treatment for both malignancies is also similar.8

Follicular Lymphoma Follicular lymphoma is the second most common subtype of non-Hodg­ kin lymphoma (NHL), comprising approximately 20% of all NHL cases.8 Follicular lymphoma is characterized by a translocation between chromosome 14 and chromosome 18, which causes the overexpression of BCL-2 and increased resistance to treatment.8 Although an indolent NHL, follicular lymphoma can transform into an aggressive phenotype, at which point it should be managed using therapies that are appropriate for aggressive forms of NHL, including combinations of chemotherapy and anti-CD20 monoclonal antibodies.9 Evolving Treatments for Chronic Lymphocytic Leukemia In the past several years, major advances have been made in understanding the pathophysiology of CLL, including biologic factors that influence its clinical course. As a result, treatment approaches have evolved to target the underlying

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disease pathology.3 The International Workshop on CLL recommends treating CLL if patients present with active progressive disease manifested as bulky progressive adenopathy or bone marrow failure.2,10 Initial treatment of patients with symptomatic CLL typically includes chemotherapy combined with a targeted drug––either rituximab or another CD20-targeted monoclonal antibody.2,11 Medications that can be used for the treatment of patients with relapsed and/or refractory CLL include alem­tuzumab, bendamustine, chlorambucil, fludarabine, ibrutinib, lenalidomide, obinutuz­ umab (in combination with chlorambucil), ofatumumab, and rituximab.12 Several of these are new therapies that were approved in 2013 and 2014 for use in patients with previously untreated CLL and in relapsed or refractory CLL; these include ibrutinib, obinutuzumab, and ofatumumab.13-15

Idelalisib: First-inClass PI3 Kinase Inhibitor Approved by the FDA On July 23, 2014, the US Food and Drug Administration (FDA) approved idelalisib (Zydelig; Gilead Sciences), an oral phos-

INHIBITION OF CHEMOTAXIS AND ADHESION, AND REDUCED CELL VIABILITY HAVE BEEN OBSERVED IN LYMPHOMA CELLS THAT WERE TREATED WITH IDELALISIB. phatidylinositol 3-kinase delta (PI3Kδ) inhibitor, for the treatment of 3 types of hematologic malignancies, including patients with relapsed CLL, to be used in combination with rituximab when ri­ tuximab can be used alone because of the presence of comorbidities, as well as patients with relapsed follicular lymphoma or patients with relapsed SLL after 2 previous systemic therapies.16 The FDA approved idelalisib for the treatment of CLL under the prescheduled review process, and used its accelerated approval program to approve the indications for the treatment of patients with relapsed follicular lymphoma and for patients with relapsed SLL, based on the surrogate end points of tumor response rate and duration of response. An im-

provement in survival or disease-related symptoms has not been established for idelalisib in these 2 malignancies.16 Idelalisib was approved with a Risk Evaluation and Mitigation Strategy program to ensure that healthcare providers who prescribe idelalisib are informed of the risk for fatal and serious toxicities associated with idelalisib.16

Mechanism of Action Idelalisib is a potent and selective inhibitor of the PI3Kδ, an enzyme that is expressed in normal and malignant B-cells.17,18 Idelalisib inhibits several cell-signaling pathways, including B-cell receptor signaling and CXCR4 and CXCR5 signaling, which are involved in trafficking and homing of B-cells to the lymph nodes and to the bone marrow.18 In cell lines derived from malignant B-cells and in primary tumor cells, idelalisib induced apoptosis and inhibited proliferation. Inhibition of chemotaxis and adhesion, and reduced cell viability have been observed in lymphoma cells that were treated with idelalisib.18 Dosing and Administration The recommended dos­­ age of idela­ lisib for all 3 indications is 150 mg administered orally twice

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Drug Update Table 1. Idelalisib versus Placebo: Survival and Response Results in Patients with Relapsed CLL in Study 116 Efficacy parameter

Idelalisib plus rituximab (N = 110)

Placebo plus rituximab (N = 110)

P value

Median PFS, months

NR (95% CI, 10.7-NR)

5.5 (95% CI, 3.8-7.1)

P <.001

PFS, %

93

46

P <.001

Overall survival, %

92

80

P = .02

Overall response, %

81

13

P <.001

CI indicates confidence interval; CLL, chronic lymphocytic leukemia; NR, not reached; PFS, progressionfree survival. Sources: Zydelig (idelalisib) tablets prescribing information; 2014. Furman RR, et al. N Engl J Med. 2014;370:997-1007.

daily. Idelalisib tablets can be taken with or without food and should be swallowed whole.18 Treatment with idela­ lisib should be continued until disease progression or unacceptable toxicity. The optimal and safe dosing regimen for patients who take idelalisib for more than several months is unknown.18

Key Clinical Trials Study 116: Phase 3­ Clinical Trial in Relapsed CLL

The approval of idela­ lisib in combination with rituximab for the treatment of patients with relapsed CLL was based on Study 116, a randomized, double-blind, placebo-controlled phase 3 clinical trial.17 This clinical trial enrolled 220 patients with relapsed CLL who required treatment and were unable to tolerate standard chemoimmunotherapy as a result

46

of coexisting medical conditions, reduced renal function, or significant neutropenia or thrombocytopenia resulting from previous therapy with cytotoxic agents.17,18 Patients received idel­ alisib plus ri­ tuximab or placebo plus rituximab until disease progression or unacceptable toxicity. Idelalisib was administered orally at 150 mg twice daily.17,18 Patients in both arms received 8 doses of rituximab (first dose, 375 mg/m2; subsequent doses, 500 mg/m2 every 2 weeks for 4 infusions, and every 4 weeks for 4 infusions). The median duration of exposure to idelalisib was 5 months.17,18 The primary end point was progression-free survival (PFS), which was defined as the interval from randomization to disease progression or death from any cause (whichever came first), using the

Kaplan-Meier method.17 The primary end point was assessed by an Inde­ ­­­ pendent Review Commit­ tee. The secondary end points included overall response rate (ORR) and complete response rates, lymph-node response, and OS. Study 116 was stopped for efficacy following the first prespecified interim ­analysis.17,18 Patient population. The patients’ median age was 71 years, with 78% of patients aged ≥65 years. The majority of patients were male (66%), and Caucasian (90%). The median time since CLL diagnosis was 8.5 years.17,18 Overall, 40% of patients in Study 116 had moderate-to-severe renal dysfunction, defined as creatinine clearance <60 mL per minute, and 35% of patients had poor bone marrow function, defined as grade ≥3 anemia, thrombocytopenia, or neu­ tropenia. Almost two­

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ February 2015

thirds of the patients had advanced-stage CLL, and more than 40% had 17p deletion or TP53 gene mutations.17,18 Patients in both arms had received a median of 3 previous therapies, including regimens containing rituximab, fludarabine, cyclophosphamide, and bendamustine.17,18 Efficacy. At 24 weeks, the PFS rate was 93% in patients receiving idela­ lisib plus rituximab compared with 46% in patients receiving placebo plus ri­ tuximab (Table 1).17 The adjusted hazard ratio (HR) for progression or death in the idelalisib plus rituximab group was 0.15 (95% confidence interval [CI], 0.08-0.28; unadjusted P <.001).17,18 Study 116 was stopped for efficacy following the first prespecified interim analysis.17,18 Results of a second interim analysis continued to show a significant PFS improvement for idel­ alisib plus rituximab over placebo plus rituximab (HR, 0.18; 95% CI, 0.10-0.32; P <.001; Table 1). In the idelalisib plus rituximab group, the median duration of PFS was not reached; in the placebo plus rituximab group, the median duration of PFS was 5.5 months. The PFS benefit for idelalisib and rituximab was similarly favorable in all prespeci-

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Drug Update fied subgroups, including those that were stratified according to the presence or absence of the 17p deletion or TP53 gene mutation and immunoglobulin heavy chain variable mutational status.17,18 At 12 months, the OS rate in the idel­alisib plus rituximab group (92%) was significantly higher than the OS rate in the placebo plus rituximab group (80%; HR for death, 0.28; 95% CI, 0.09-0.86; P = .02). In the idelalisib plus rituximab group, the ORR was 81% (95% CI, 71%-88%) compared with 13% (95% CI, 6%-21%) in the placebo plus rituximab group (P <.001). All responses were partial responses (Table 1).17 DELTA Study: Phase 2 Clinical Trial in Relapsed Follicular Lymphoma

The safety and efficacy of idelalisib in patients with relapsed follicular lymphoma were evaluated in the DELTA clinical trial, a single-arm, multicenter clinical trial that included 72 patients with relapsed follicular lymphoma.18,19 In this clinical trial, idelalisib was administered orally at 150 mg twice daily until evidence of disease progression or unacceptable toxicity. The study’s primary end

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point was Independent Review Committee–assessed ORR. Tumor response was assessed using revised response criteria for malignant lymphoma, as recommended by the International Working Group.18,19 Patient population. The patients’ median age was 62 years.18,19 The majority of the patients were male (54%), Caucasian (90%), and had a baseline Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (92%). The patients’ median time since diagnosis was 4.7 years. The patients had received at least 2 previous treatments and experienced disease relapse within 6 months after treatment with ri­ tuximab and an alkylating agent. The median number of previous treatments was 4 (range, 2-12) and included rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP); bendamustine and rituximab; and rituximab plus cyclophosphamide, vincristine, and prednisone. At baseline, 33% of patients had extra­ nodal disease, and 26% of patients had bone marrow involvement.18,19 Efficacy. Among the 72 patients with relapsed follicular lymphoma who received idelalisib, the ORR was 54% (95% CI, 42%-66%), including 6

Table 2. DELTA Trial: Response Rate in Patients with Relapsed FL or SLL Receiving Idelalisib Response

Idelalisib 150 mg twice daily, N (%)

Relapsed FL (N = 72) Overall response

39 (54)

Complete response

42 (8)

Partial response

33 (46)

Relapsed SLL (N = 26) Overall response Complete response Partial response

15 (58) 0 15 (58)

FL indicates follicular lymphoma; SLL, small lymphocytic lymphoma. Source: Zydelig (idelalisib) tablets prescribing information; 2014.

complete responses (8%) and 33 partial responses (46%) (Table 2). The median duration of response was not evaluable (range, 0+ to 14.8+ months). The median time to response was 1.9 months (range, 1.6-8.3 months).18 An improvement in survival or disease-related symptoms has not been established for idelalisib in patients with relapsed follicular lymphoma.16,18 The continued approval of idelalisib for the treatment of patients with relapsed follicular lymphoma may be contingent on the verification of clinical benefit in confirmatory clinical trials.18 DELTA Study: Phase 2 Clinical Trial in Relapsed Small Lymphocytic Lymphoma

The safety and efficacy of idelalisib in pa-

tients with relapsed SLL was also evaluated in the DELTA clinical trial.18,19 Overall, 26 patients with relapsed SLL received 150 mg of idelalisib orally twice daily until evidence of disease progression or unacceptable toxicity. The primary end point was Independent Review Committee–assessed ORR. Tumor response was assessed using revised response criteria for malignant lymphoma, as recommended by the International Working Group.18,19 Patient population. The patients’ median age was 65 years.18 The majority of patients were male (73%), Caucasian (81%), and had a baseline ECOG performance status of 0 or 1 (96%). The patients had received at least 2 previous treatments, and their disease had relapsed

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Drug Update Table 3. Grade ≥3 Adverse Reactions Reported with Idelalisib versus Placebo in Patients with CLL Idelalisib plus rituximab, N (%) (N = 110)

Placebo plus rituximab, N (%) (N = 108)

18 (16)

14 (13)

Sepsis

8 (7)

4 (4)

Diarrhea

6 (5)

0

Rash

4 (4)

1 (1)

Pyrexia

3 (3)

1 (1)

Chills

2 (2)

0

Stomatitis

2 (2)

0

Bronchitis

1 (1)

1 (1)

Headache

1 (1)

0

Adverse event Pneumonia

CLL indicates chronic lymphocytic leukemia. Source: Zydelig (idelalisib) tablets prescribing information; July 2014.

within 6 months after treatment with rituximab and an alkylating agent. The patients’ median time since SLL diagnosis was 6.7 years. The median number of previous treatments was 4 (range, 2-9) and included bendamustine plus rituximab; fludarabine, cyclophosphamide, and rituximab; and R-CHOP. At baseline, 27% of patients had extranodal disease.18,19 Efficacy. Among the 26 patients with relapsed SLL who received idel­ alisib, the ORR was 58% (95% CI, 37%-77%), and all responses were partial responses (Table 2). The median duration of response was 11.9 months (range, 0+ to 14.7+ months). The median time to response was 1.9 months (range, 1.6-8.3 months).18,19

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An improvement in survival or disease-related symptoms has not been established for idelalisib in relapsed SLL. The continued approval of idel­ alisib for the treatment of patients with relapsed SLL may be contingent on the verification of clinical benefit in confirmatory clinical trials.16,19

Adverse Events The majority of adverse events among patients receiving idelalisib plus rituximab were consistent with those expected for patients with relapsed CLL who had received extensive previous therapy.17 In Study 116, serious adverse events were reported in 49% of the patients who received idel­ alisib plus rituximab.17,18 The most frequent serious adverse events included

pneumonia, pyrexia, sepsis, febrile neutropenia, and diarrhea (Table 3). Adverse reactions leading to the discontinuation of idelalisib therapy occurred in 10% of the patients; the most common of these reactions included hepatotoxicity and diarrhea or colitis.17,18 Dose interruption of idelalisib was required in 35% of patients with relapsed CLL.18 Overall, 15% of the patients needed dose reductions as a result of adverse events or laboratory abnormalities; the most common reasons for dose reductions included elevated transaminase levels, diarrhea or colitis, and rash.18 The safety data for idel­ alisib also reflect drug exposure in 146 adult patients with indolent NHL who received idelalisib 150

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ February 2015

mg twice daily in clinical trials. The patients’ median duration of exposure to idelalisib was 6.1 months (range, 0.3-26.4 months). Overall, 50% of these patients experienced serious adverse events, including pneumonia, diarrhea, and pyrexia.18 In addition, dose interruption or discontinuation of idelalisib occurred in 53% of the patients with indolent NHL; the most common reasons for interruption or discontinuation of idel­alisib included diarrhea, pneumonia, and elevated transaminase levels.18

Contraindications Idelalisib is contraindicated in patients with a history of serious allergic reactions, including anaphylaxis and toxic epidermal necrolysis.18 Warnings and Precautions

Boxed warning. Idel­ alisib carries a boxed warning indicating that the drug may cause fatal and/or serious intestinal perforation, hepatoxicity, diarrhea or colitis, and pneumonitis. Patients should be monitored for the development of these adverse events, and idel­ alisib therapy should be discontinued if intestinal perforation is suspected.18 Hepatotoxicity. In clinical trials, 14% of pa-

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Drug Update tients who received idela­ lisib experienced fatal and/ or serious hepatotoxicity. In addition, elevations in transaminase levels greater than 5 times the upper limit of normal have been observed. These findings were typically noted within the first 12 weeks of treatment with idelalisib and were reversible with dose interruption.18 After resuming idela­ lisib treatment at a lower dose, 26% of patients experienced recurrence of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevations. Idelalisib treatment should be discontinued if recurrent hepatotoxicity occurs.18 The use of idelalisib concurrently with other drugs that may cause liver toxicity is not recommended.18 Transaminase levels should be monitored in all idelalisib recipients according to the following schedule18: • Every 2 weeks for months 1 to 3 • Every 4 weeks for months 4 to 6 • Every 1 to 3 months thereafter. Weekly monitoring is­­ appropriate if ALT or AST levels rise above 3 times the upper limit of normal until liver toxicity resolves. Idelalisib should be withheld if ALT or AST levels are greater than 5 times the upper

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limit of normal. Total bilirubin, AST, and ALT levels should be monitored weekly until abnormalities resolve.18 Severe diarrhea or colitis. Across clinical trials, severe diarrhea or colitis (grade ≥3) occurred in 14% of patients receiving idelalisib. Diarrhea can occur at any time and responds poorly to antimotility agents. Concurrent use of idelalisib and other medications that cause diarrhea should be avoided.18 After interruption of idelalisib therapy and, in some instances, the use of corticosteroids, the median time to resolution of diarrhea ranged from 1 week to 4 weeks.18 Pneumonitis. Patients taking idela­lisib have experienced fatal and serious pneumonitis. Pneumonitis should be suspected in patients who are taking idelalisib and present with pulmonary symptoms, including cough, dyspnea, hypoxia, interstitial infiltrates on a radiologic exam­ ination, or a decline of >5%­ in oxygen saturation.18 For patients with possible pneumonitis, idela­ lisib should be interrupted until an etiology for lung symptoms has been determined. Patients with pneumonitis that is believed to be caused by idelalisib have discontinued idelalisib therapy and received corticosteroids.18

Intestinal perforation. In clinical trials, fatal and serious intestinal perforations have occurred in patients taking idela­ lisib. Some patients had moderate-to-severe diarrhea at the time of perforation. Patients should immediately report new or worsening abdominal pain, chills, fever, nausea, or vomiting. Idelalisib should be permanently discontinued in patients who experience intestinal perforation.18 Severe cutaneous reactions. Overall, 1 case of toxic epidermal necrolysis was reported in a study of idelalisib plus bendamustine and rituximab. Patients receiving idelalisib have also reported other severe or life-threatening (grade ≥3) cutaneous reactions, including exfoliative dermatitis, rash, rash erythematous, rash generalized, rash macular, rash maculopapular, rash papular, rash pruritic, exfoliative rash, and skin disorders. Patients should be monitored for the development of severe cutaneous reactions, and idelalisib should be discontinued if they occur.18 Anaphylaxis. Serious allergic reactions, including anaphylaxis, have been reported in patients taking idel­alisib. Idelalisib should be permanently discontinued if this occurs, and appropriate sup-

portive measures should be instituted.18 Neutropenia. Across clinical trials, 31% of patients receiving idel­ alisib experienced treatment-emergent grade 3 or 4 neutropenia. Blood counts should be monitored a minimum of every 2 weeks for the first 3 months of therapy and at least weekly in patients whose neutrophil counts are <1.0 Gi/L.18 Embryofetal toxicity. Idelalisib may cause fetal harm when administered to a pregnant woman.18 If idelalisib is used during pregnancy, or if a patient becomes pregnant while taking this drug, she should be made aware of the potential hazard to the fetus. While taking idel­ alisib, women of reproductive potential should avoid becoming pregnant. Effective contraception can be used during idel­ alisib treatment and for at least 1 month after the last dose.18

Use in Specific Populations Pregnancy. Idelalisib is a pregnancy category D teratogen and may cause teratogenicity and/ or embryofetal lethality. Women should avoid becoming pregnant while taking idelalisib.18 Nursing mothers. Be­ cause many drugs are excreted in human milk and because of the potential

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Drug Update for idelalisib-related adverse events in nursing infants from idelalisib, nursing or idelalisib should be discontinued based on the importance of the drug to the mother.18 Pediatric use. The safety and effi­cacy of idelalisib in pediatric patients have not been established.18 Geriatric use. In clinical trials of idel­alisib for relapsed CLL, relapsed follicular lymphoma, and relapsed SLL, 63% of patients receiving the agent (131 of 208) were aged ≥65 years. No meaningful differences in efficacy were observed among age cohorts.18 When patients aged ≥65 years with relpased CLL were compared with younger patients, older patients had a higher incidence of discontinuation as a result of an adverse reaction (11% vs 5%), higher incidence of serious adverse events (51% vs 43%), and higher incidence of death (3% vs 0%).18 When patients aged ≥65 years with indolent NHL were compared with younger patients, older patients had a higher incidence of discontinuation as a result of an adverse event (28% vs 20%). In addition, older patients had a higher incidence of serious adverse reactions (64% vs 37%) and a higher incidence of death

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BASED ON A SIGNIFICANT PFS BENEFIT, IDELALISIB JOINS IBRUTINIB AS AN FDA-APPROVED ORAL AGENT FOR USE IN PATIENTS WITH RELAPSED CLL. (11% vs 5%).18 Hepatic impairment. Safety and efficacy data are not available in patients with baseline ALT or AST values greater than 2.5 times the upper limit of normal, or bilirubin values greater than 1.5 times the upper limit of normal. Patients with baseline hepatic impairment should be monitored for signs of idelalisib toxicity.18

Conclusion Idelalisib, the first FDA-approved PI3Kδ inhibitor, is an effective and safe treatment option for patients with relapsed CLL, relapsed follicular lymphoma, or relapsed SLL. Based on a significant PFS benefit, idelalisib joins ibrutinib as an FDA-approved oral agent for use in patients with relapsed CLL. In relapsed follicular lymphoma and relapsed SLL, idelalisib was ap-

proved under the accelerated approval program based on ORR data. Clinical trials to collect data verifying the clinical benefit of idelalisib in these 2 indolent lymphomas are under way.20 Additional clinical trials are evaluating the combination of idelalisib plus ofatumumab and idelalisib plus obinutuzumab for the treatment of patients with previously untreated CLL. Idelalisib is also being studied in combination with bendamustine and rituximab for the treatment of patients with previously untreated and relapsed hematologic malignancies.20 ❚

References

1. Leukemia & Lymphoma Society. Chronic lymphocytic leukemia. www. lls.org/#/diseaseinformation/leuke mia/chroniclymphocyticleukemia/. Accessed September 11, 2014. 2. Leukemia & Lymphoma Society. Chronic lymphocytic leukemia: incidence. www.lls.org/#/diseaseinforma tion/leukemia/chroniclymphocyticleu kemia/incidence/. Accessed September 11, 2014. 3. Gribben JG. How I treat CLL up front. Blood. 2010;115:187-197. 4. Leukemia & Lymphoma Society. Chronic lymphocytic leukemia: signs and symptoms. www.lls.org/#/disea seinformation/leukemia/chroniclym phocyticleu kemia/signssymptoms/. Ac­­ cessed September 11, 2014. 5. Cancer.net. Leukemia—chronic lymphocytic—CLL: statistics. Reviewed July 2014. www.cancer. net/cancer-­t ypes/leukemia-chron ic-lymphocytic-cll/statistics. Accessed September 11, 2014. 6. Blankart CR, Koch T, Linder R, et al. Cost of illness and economic burden of chronic lymphocytic leukemia. Orphanet J Rare Dis. 2013;8:32. 7. Harris NL, Jaffe ES, Diebold J, et al. World Health Organization classification of neoplastic diseases of the hematopoietic and lymphoid tissues: report of the Clinical Advisory Committee meeting—Airlie House, Virginia, November 1997. J Clin Oncol.

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1999;17:3835-3849. 8. Leukemia & Lymphoma Society. Non-Hodgkin lymphoma: treating specific indolent subtypes. www.lls.org/#/ diseaseinformation/lymphoma/nonhod gkinlymphoma/treatment/indolentnhl subtypes/specificindolentsubtypes/. Ac­­ cessed September 11, 2014. 9. Leukemia & Lymphoma Society. Treatment for aggressive NHL subtypes. www.lls.org/#/diseaseinforma­ tion/lymphoma/nonhodgkinlympho ma/treatment/aggressivenhlsubtypes/. Accessed September 11, 2014. 10. Hallek M, Cheson BD, Catovsky D, et al. Guidelines for the diagnosis and treatment of chronic lymphocytic leukemia: a report from the International Workshop on Chronic Lymphocytic Leukemia updating the National Cancer Institute–Working Group 1996 guidelines. Blood. 2008;111:5446-5456. Erratum in: Blood. 2008;112:5259. 11. Leukemia & Lymphoma Society. Chronic lymphocytic leukemia: treatment: chemotherapy and drug therapy. www.lls.org/#/diseaseinformation/leu kemia/chroniclymphocyticleukemia/ treatment/chemotherapydrugtherapy/. Accessed September 11, 2014. 12. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): non-Hodgkin’s lymphomas. Version 4.2014. August 22, 2014. www.nccn.org/professionals/physician_ gls/pdf/nhl.pdf. Accessed October 3, 2014. 13. Gazyva (obinutuzumab) injection [prescribing information]. South San Francisco, CA: Genentech, Inc; June 2014. 14. Imbruvica (ibrutinib) capsules [prescribing information]. Sunnyvale, CA: Pharmacyclics, Inc; July 2014. 15. Arzerra (ofatumumab) injection [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; April 2014. 16. US Food and Drug Administration. FDA approves Zydelig for three types of blood cancers. Press release. July 23, 2014. www.fda.gov/newsevents/ newsroom/pressannouncements/ ucm406387.htm. Accessed September 11, 2014. 17. Furman RR, Sharman JP, Coutre SE, et al. Idelalisib and rituximab in relapsed chronic lymphocytic leukemia. N Engl J Med. 2014;370:997-1007. 18. Zydelig (idelalisib) tablets [prescribing information]. Foster City, CA: Gilead Sciences, Inc; July 2014. 19. Gopal AK, Kahl BS, de Vos S, ­­et al. PI3Kδ inhibition by idelalisib in patients with relapsed indolent lymphoma. N Engl J Med. 2014;370:10081018. 20. ClinicalTrials.gov. Idelalisib. Search results. http://clinicaltrials.gov/ ct2/results?term=idelalisib&Search= Search. Accessed September 11, 2014.

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New Drugs The following are some of the recent approvals announced by the US Food and Drug Administration (FDA): • Lenvima (lenvatinib; Eisai Inc) was approved to treat patients with progressive, differentiated thyroid cancer whose disease progressed despite receiving radioactive iodine therapy. Lenvima received priority review and orphan product designation. • Dutrebis (lamivudine, raltegravir; Merck & Co, Inc) was approved for use in combination with other antiretroviral products for adults and pediatric patients (≥6 years, ≥30 kg). According to the manufacturer, Dutrebis will not be made commercially available at this time. • Ibrance (palbociclib; Pfizer, Inc) was granted accelerated approval for the treatment of patients with metastatic breast cancer. Ibrance received breakthrough therapy designation because it may offer substantial improvement over available therapies. • Lucentis (ranibizumab injection; Genentech, Inc) was approved for expanded use to treat diabetic retinopathy in patients with diabetic macular edema.

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• Vyvanse (lisdexamfetamine di­ mesylate; Shire US, Inc) was approved for expanded use to treat adult patients with bingeeating disorders. This is the first FDA-approved medication for this condition.

New Generic The first generic version of Nexium (esomeprazole magnesium delayed-release capsules; Teva Pharmaceutical Industries Ltd) has been approved by the FDA for the treatment of adults and children aged ≥1 years with gastroesophageal reflux disease. Esomeprazole is a proton pump inhibitor that reduces the amount of acid in the stomach. In addition, esomeprazole capsules were also approved to reduce the risk of gastric ulcers associated with the use of nonsteroidal anti-inflammatory drugs, and to treat Helicobacter pylori infection with certain antibiotics, as well as conditions where the stomach makes too much acid, including Zollinger-Ellison syndrome. The FDA announcement also indicated that the generic capsules will be dispensed with patient Medication Guides providing important information about the uses and risks of the medication. In particular, the most serious risks

THE FIRST GENERIC VERSION OF NEXIUM HAS BEEN APPROVED BY THE FDA FOR THE TREATMENT OF ADULTS AND CHILDREN AGED ≥1 YEARS WITH GASTROESOPHAGEAL REFLUX DISEASE. associated with esomeprazole included severe diarrhea and a warning that people taking multiple daily proton pump inhibitors for a long period of time may have an increased risk for bone fractures. Headaches, diarrhea, nausea, flatulence, abdominal pain, sleepiness, constipation, and dry mouth were the most common side effects reported by patients taking Nexium in clinical trials. ❚ Sources: US Food and Drug Admini­ stration. New and generic drug approvals. www.fda. gov/Drugs/NewsEvents/ucm130961.htm. Last updated February 19, 2015. Accessed February 20, 2015; US Food and Drug Admini­stration. Press announcements. www.fda.gov/NewsEvents/ Newsroom/PressAnnouncements/default.htm. Updated February 20, 2015. Accessed February 20, 2015.

INSIDE PATIENT CARE: PHARMACY & CLINICS ❚ February 2015

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

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

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

ACISTS PHYSICIANS • NP/PAs • PHARM

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

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GASTROINTESTINAL

February 2015 VOL. 3 • NO. 2

20 Tips for

Food Safety

29 Questions

Answered with James Beaumariage

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

Health

nce-Based New IBS Guidelines Offer Evide ns Pharmacologic Treatment Optio PAGE 13

33 Distinguishing

Between Different Colonoscopy Preparation Agents

38 Team-Based Care

as an Analogue to Pharmacists’ Scope of Practice

51 New Products

CE AVAILABLE PAGE 24

© 2015 Novellus Healthcare Communications, LLC an affiliate of

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

InsidePatientCare.com Inside Patient Care is a publication of Novellus Healthcare Communications, LLC, an affiliate of The Lynx Group. © 2015 All rights reserved.

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IPC Feb 2015, Vol 3, No 2  
IPC Feb 2015, Vol 3, No 2  

Inside Patient Care: Pharmacy & Clinics | February 2015 | Volume 3 | Number 2

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