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Pharmacists are becoming more accountable today for the prescriptions they fill, including opioid analgesics, as their role evolves in patient care. Rulings from certain legal cases determined that the pharmacists in question should have screened prescriptions for their appropriateness and warned patients about potential problems, such as opioid toxicity in non-tolerant patients. These pharmacists faced sanctions and/or criminal charges. Pharmacists are leveraging better access to more extensive patient information and patient counseling techniques to help optimize drug therapy outcomes. Pharmacists have a responsibility to ensure, as best they can, that only legitimate prescriptions are filled. Please visit http://www.uiwpharmacyreview. com/index.php/uiwpr/article/view/16/25 for an article you may find interesting on legal precedents in patient care. Keeping customers educated and well-informed is just one of the many ways that we invest in the future.
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MISSION STATEMENT Inside Patient Care: Pharmacy & Clinics™ is an independent journal that provides practical information for the entire healthcare team treating and caring for patients inside the pharmacy and retail clinics. As primary care expands to provide optimal access to quality care, Inside Patient Care: Pharmacy & Clinics™ offers a forum for the team treating and coordinating patient care in pharmacies and retail clinics, including medical directors, physician assistants, nurse practitioners, pharmacists, and C-level executives, to implement the best therapeutic options, navigate the healthcare system, and achieve professional success. Each issue of the journal includes resources that will enable the retail healthcare team to provide optimal patient care, including how to screen, diagnose, and treat patients; answer questions on prevention and wellness; deliver acute treatment; monitor and manage chronic conditions; make efficient use of healthcare resources; and attract, retain, and engage patients, shoppers, and customers. Contact information: For subscription information and editorial queries, please contact: info@insidepatientcare.com; tel: 732-992-1895; fax: 732-992-1881. RETA #1 AM IL CL ONG INIC IANS
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Call for submissions
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INSIDE
WOMEN’S
COLUMNS
Health
Patient Care 20 FIVE TIPS TO MAINTAIN BONE HEALTH
PAGE
11
THE FIRST WORD
Encouraging patients to take control of their health, these tips will provide some basic tools to start a discussion with patients and raise awareness about the importance of bone health.
Donald J. Dietz, RPh, MS Dress the Part to Achieve Professional Success
21 HEPATITIS C TREATMENT: LOOKING BACK, AND MOVING FORWARD
4 CALL FOR SUBMISSIONS
Raising awareness in the community, as well as knowing the best way to screen, diagnose, and treat hepatitis C is key to address this disease.
6 EDITORIAL BOARD 7 FROM THE TRENCHES 9 LETTER FROM THE EDITOR
25 FDA ISSUES SAFETY COMMUNICATION ABOUT CARDIOVASCULAR RISKS OF TESTOSTERONE REPLACEMENT
STARTS ON PAGE
15
And other concise reviews of studies on men’s health.
30 FAILURE TO PROPERLY COMMUNICATE CHANGE IN COUMADIN DOSAGE
The Pharmacy
38 DIVERSIFYING PHARMACY REVENUES: OPPORTUNITIES FOR GROWTH AND DIFFERENTIATION
There are many opportunities for pharmacies to evolve their business to stay in line with, and lead, in a changing marketplace.
42 UPCOMING CHANGES IN PREGNANCY AND LACTATION PRODUCT LABELING
Although physicians and pharmacists will need to spend more time reading the pregnancy and lactation sections to better understand the risks of certain drugs, all parties will benefit from greater access to the information.
13 THE VITALS 33 FREE CE ACTIVITY 45 DRUG UPDATE 50 PRODUCTS & SERVICES
COVER STORY I WOMEN’S HEALTH
Patients Taking Misoprostol Misunderstood: How to Manage Patients with Miscarriages ❚B ecome familiar with the different
❚
❚ ❚ ❚
indications of misoprostol, its efficacy, and the different modes of administration L earn about the side effects of misoprostol and adverse events associated with miscarriages C ommunicate with patients and address any questions and/or concerns U nderstand the issues patients with miscarriages face C ounsel patients on future fertility
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. RETA #1 AM IL CL ONG INIC IANS
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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 11
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
Patients want to know that the pharmacy is clean, and that their prescriptions are being handled in a hygienic way.”
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 National Director Managed Markets & Trade Relations Arbor Pharmaceuticals, LLC Scott L. Kemme Vice President/General Manager, Chain Segment McKesson Pharmacy Systems & Automation Livonia, MI
Ami Bhatt Senior Director, Operations Health & Wellness, Wal-Mart Bentonville, AR
Kevin Letz, DNP, MBA Chairman/Founder Advanced Practice Provider Executives
Thomas R. Bizzaro, RPh Vice President, Health Policy and Industry Relations First Databank Indianapolis, IN
Tripp Logan, PharmD Vice President Logan & Seiler, Inc, Charleston, MO
Rebecca Wheeler Chater, RPh, MPH, FAPhA Executive Healthcare Strategist Ateb, Inc, Raleigh, NC
Stephen C. Mullenix, RPh Senior Vice President Public Policy & Industry Relations NCPDP, Scottsdale, AZ
Scott R. Drab Professor, Department of Pharmacy & Therapeutics, School of Pharmacy University of Pittsburgh, Pittsburgh, PA
Richard J. Ptachcinski, PharmD, FCCP President American Pharmacotherapy, Pittsburgh, PA
Albert Garcia Executive Vice President Navarro Health Services, Medley, FL Mark J. Gregory, RPh Vice President Healthcare Solutions Ateb, Inc , Raleigh, NC
Ernie Richardsen, RPh, MBA Group Vice President Pharmaceutical Purchasing and Clinical Services Rite Aid Corporation, Camp Hill, PA Debbie Sheppard Vice President, Sales and Marketing Ateb, Inc, Raleigh, NC
—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 Erin J. Hoffman, MPAS, PA-C Assistant Professor Nebraska Medical Center, Omaha, NE
Stacie Lampkin, PharmD, BCPA, AE-C Assistant Professor D’Youville College School of Pharmacy Women and Children’s Hospital, Buffalo, NY
GASTROINTESTINAL HEALTH
Lisa Cervantes, PA-C
UW Health Clinics Digestive Health Center, Madison, WI WELLNESS
Barbara Campbell, RPh, CCN
Pharmacist and Certified Clinical Nutritionist People Rx, Austin, TX DERMATOLOGY
Debra Shelby, PhD, DNP
President National Academy of Dermatology Nurse Practitioners IMMUNIZATION
Kim Curry, PhD, ARNP-C
Clinical Associate Professor College of Nursing, University of Florida Gainesville, FL
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from the
“
Trenches ”
We as healthcare providers have a responsibility to educate ourselves and our staff about the transgender population.” Marc Drummond, PSYD, MBA
Healthcare Providers and the Transgender Community To the Editor The clinical challenge published in the April issue of Inside Patient Care: Pharmacy & Clinics was an interesting case study. Gender identity has been receiving a lot of media coverage recently; a great deal of the coverage surrounds legal issues specific to gender-neutral amenities for transgender people. At the state level, legislation is being proposed to limit access to gender-segregated amenities (eg, public restrooms). Discrimination issues are driven by fear and lack of understanding. Although we often discuss issues surrounding how transgender people are treated in the general public, we neglect to discuss how this patient population can be made to feel marginalized in the medical field. Mutual trust and respect are the core of a successful therapeutic relationship. A federal court recently ruled that discrimination against patients on the basis of their gender identity is now prohibited.1 Protections against discrimination within Title VII of the Civil Rights Act of 1964—which apply to the healthcare field—will also include gender identification, and impacts all healthcare providers that accept Medicare or Medicaid funding.2
The Affordable Care Act has provided transgender patients with greater access to health insurance; many of these individuals may have been denied services in the past because of preexisting health conditions. However, greater access to health insurance does not translate to greater access to healthcare. The transgender population is often met with resistance, possibly because many people may have misconceptions about this community. Although the antidiscrimination provisions have been made clear, an insurance company’s responsibility and scope of coverage is still unclear. Procedures and/or medications may be denied because they are seen as cosmetic, regardless of medical documentation to the contrary. Education surrounding transgender issues has been a footnote in most medical training programs. A majority of providers who specialize in the care of this population are located in major medical centers in larger cities. Because the transgender community now has greater access to healthcare, it will create a vacuum in which there will be a dearth of medical professionals who are able to competently care for their specialized needs. We as healthcare providers have a RETA #1 AM IL CL ONG INIC IANS
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Allergies
April 2015 VOL. 3 • NO. 4
16 Questions
New Allergic Rhinitis Guidelines Provide Clinicians Evidence-Based Summaries of Quality Improvement Opportunities
Answered with Allergy & Asthma Network
PAGE 13
21 SSRIs and the
Risk for Upper Gastrointestinal Bleeding
25 Clinical Challenge:
It’s Sarah, not Stephen!
36 The Benefits
of Geriatric Certifications
“
Education, awareness, and increased sensitivity are key components to successfully treat members of the transgender community with the highest level of success.” DONALD J. DIETZ, RPH, MS, EDITOR-IN-CHIEF
CE AvAIlABlE pAGE 29
© 2015 Novellus Healthcare Communications, LLC an affiliate of
responsibility to educate ourselves and our staff about the transgender population. Ethically, it is incumbent for us to increase our understanding of this patient population and their unique medical needs so that we can effectively treat them. We must advocate and ensure that all of our patients are treated with the highest level of respect.
TELL US
fevans@the-lynx-group.com Or mail to: Letters to the Editor Inside Patient Care: Pharmacy & Clinics 1249 South River Road Suite 202A Cranbury, NJ 08512
Marc Drummond, PsyD, MBA CLINICAL PSYCHOLOGIST AND MANAGING PARTNER CREEKSIDE NATURAL THERAPEUTICS
References
Letters may be edited for length and style. Unless you specify otherwise, we will assume your letter is for publication. Submission of a letter or e-mail constitutes permission of Inside Patient Care: Pharmacy & Clinics, its licensees, and its assignees to use it in the journal’s various print and electronic publications and in collections, revisions, and any other form of media.
1. District Court, Minnesota 2015. Rumble v Fairview Health Services. Case No. 14-cv-2037 (SRN/FLN). http:// scholar.google.com/scholar_case?case=13873135761293950 230&hl=en&as_sdt=2006. Accessed April 28, 2015. 2. US Equal Employment Opportunity Commission. Title VII of the Civil Rights Act of 1964. www.eeoc.gov/laws/ statutes/titlevii.cfm. Accessed April 28, 2015.
In Reply I thank Dr Drummond for his comments on the clinical challenge we published last month. With the legal and healthcare issues impacting the transgender community, providers need to have a heightened awareness of the
transgender community to address their very specific and growing needs. Retail pharmacies and the clinics within their walls strive to provide the best customer service to all customers and should do so in a personalized manner. An increased sensitivity, followed by training of employees about proper communication, is needed in the retail setting. Areas of key focus should include patient reception, prescription drop-off and pickup, and in-pharmacy counseling. Sensitivity to claims rejections, and handling of prior authorizations with physicians and/or insurers to help transgender patients obtain coverage for medication or service provided. Education, awareness, and increased sensitivity are key components to successfully treat members of the transgender community with the highest level of success. Donald J. Dietz, RPh, MS EDITOR-IN-CHIEF, INSIDE PATIENT CARE: PHARMACY & CLINICS VICE PRESIDENT OF PHARMACY HEALTHCARE SOLUTIONS, INC
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 1 AMON RETAIL CLINICG IANS #
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Letter from the Editor Healthcare Provider Status Gaining Traction for Pharmacists by FREDERIQUE H. EVANS, MBS, Editorial Director, Inside Patient Care: Pharmacy & Clinics
The state of Massachusetts has recently introduced a bill seeking to recognize pharmacists as healthcare providers. }} }} IT IS AN EXCITING TIME for pharmacists and other healthcare providers who are now being given greater opportunities to engage with one another to provide optimal access to quality care (see “5 Facts About HB 2041,” on page 14). The provider status for pharmacists is a key component to ensuring continuation of care for patients. In this month’s featured article, Paige Schultz, PharmDc, and colleagues discuss how to manage miscarriage patients who have been prescribed misoprostol (see “Patients Taking Misoprostol Misunderstood: How to Manage Patients with Miscarriages,” on page 15). The article also includes our first commentary authored by a patient, which highlights the importance of continuity of care, as well as the need for communication among healthcare professionals and between them and their patients. In addition, pharmacists, clinicians, and physicians are in an ideal position to raise awareness in their community. With the recent human immuno deficiency virus (HIV) outbreak reported in the state of Indiana (see “Outbreak of HIV in Indiana Linked to Oxymorphone Injection,” on page
14), which was associated with syringesharing of opioid oxymorphone injections, it is important to educate patients, raise awareness, and provide access to care. “The outbreak highlights the vulnerability of many rural, resource-poor populations to drug use, misuse, and addiction, in the context of a high prevalence of unaddressed cormorbid conditions,” according to the report published in a recent Morbidity and Mortality Weekly Report. Among those infected with HIV, approximately 85% were found to be coinfected with hepatitis C. In this issue, Lisa Cervantes, PA-C, discusses hepatitis C treatment and suggests that this infectious disease should be considered a public health problem (see “Hepatitis C Treatment: Looking Back, and Moving Forward,” on page 21). Specifically, she discusses screening, differentiation between genotypes, as well as new treatment regimens. With the growing responsibilities of healthcare professionals, it is important for pharmacists, nurse practitioners, physician assistants, and physicians to be aware of upcoming changes in guidelines to implement the best practices. To this end, we feature an arti-
cle by Ann Johnson, PharmD, who discusses the changes in pregnancy and lactation product labeling, which will go into effect on June 30 (see “Upcoming Changes in Pregnancy and Lactation Product Labeling,” on page 42). “Although physicians and pharmacists will now need to spend more time reading the pregnancy and lactation sections to better understand the risks certain drugs pose to the mother, fetus, and child, all parties will benefit from the increased availability of information,” she explained. This issue also provides key information on how to achieve professional success, with a featured article focusing on diversifying pharmacy revenues by Kevin C. Day, PharmD, and John O. Beckner, RPh (see “Diversifying Pharmacy Revenues: Opportunities for Growth and Differentiation,” on page 38). It includes key opportunities for changes, including point-ofcare testing, clinical trial recruitment, and pharmacogenomic testing. We hope you will enjoy reading through this issue of Inside Patient Care: Pharmacy & Clinics, and look forward to receiving your comments about the issue, or specific articles we have published. ❚ RETA #1 AM IL CL ONG INIC IANS
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The First Word Dress the Part to Achieve Professional Success by DONALD J. DIETZ, RPH, MS, Editor-in-Chief, Inside Patient Care: Pharmacy & Clinics
“
As healthcare professionals, our attire can impact our patients’ well-being, protect our personal comfort and safety, and reduce the risk of spreading infectious pathogens.”
D
ress how you want to be addressed; words to live by in the retail pharmacy. Regardless of whether you are a new graduate still comfortable in informal college attire, or a senior pharmacist who is tired of “getting dressed up,” how you dress affects the way your patients, peers, and superiors view you. Imagine entering a physician’s office and seeing 2 male physicians. One is dressed in neatly pressed black pants, a collared dress shirt, and tie. The second physician is wearing a faded and stretched-out polo shirt over jeans. Without knowing anything else about these men, who would you rather receive medical advice from? Whether or not it is intentional, people judge others based on their clothing and appearance, and even more so in a professional work environment. Adhering to a professional dress code is important because of more than just how others may judge you. As healthcare professionals, our attire can impact our patients’ well-being, protect our personal comfort and
3 factors to consider: ❚ How you dress affects the way your patients, peers, and superiors view you ❚ Attire can impact patients’ well-being and protect personal comfort and safety ❚ Your attire can reduce the risk of spreading infectious pathogens
safety, and reduce the risk of spreading infectious pathogens.
Pharmacy Dress Codes Some pharmacy chains have dress codes for employees, including pharmacists, students, and technicians. Dress codes are protected by US law, and privately owned companies have a legal right to ask you to follow a dress code. Employees can be fired for not abiding by their company’s dress code, but we would not advocate this as a first offense measure. Requiring separate grooming standards for men and women is also allowed, and does
not constitute sexual discrimination. Regardless of gender, frayed, wrinkled, dirty, stained, or torn clothing is never acceptable in the pharmacy setting. Although it may seem like common sense, it must be said that any clothing with words or pictures that could be construed as offensive should not be worn. Aside from general “dos” and “don’ts” listed in a company’s dress code policy, there are few resources that address the topic of professional attire for pharmacists. A 2012 study in the Journal of Pharmacy Practice examined patients’ attitudes toward community pharmacist attire. Patients stated that they preferred that pharmacists not wear jeans or casual shoes, or have “visible body art.”1 This study found that patients preferred community pharmacists to wear a shirt, tie, dress shoes, white coat, and name tag. Despite patient preference, ties are not always practical—or even preferred—in the pharmacy setting. Because of their tendency to brush across counters, ties can potentially cause contamination issues, and may pick up a great deal of RETA #1 AM IL CL ONG INIC IANS
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The First Word Medical Directors • Physician Assistants • Nurse Practitioners • Pharmacists • Chain Headquarters • Independents
particulate drug matter, unless they athletic shoes, flip-flops, or open- Conclusion Although these guidelines may are kept tucked inside a white coat. toed shoes. seem like common sense to many, For women, dress pants or skirts The White Coat current cultural norms (at or below the knee)Retail are acceptpharmacies and clinics are quickly becoming an require that Finally, we must discuss the white they be repeated. Respect is earned able, as are dress shirts and sweaters. extension primary care. Inside Patient and Care The vast majority of patients not: Pharmacy given. It may not matter to Shorts, mini-skirts, sundresses, tank ofcoat. surveyed (>86%) in the 2012 study a patient that you have a doctorate if tops, shirts with plunging necklines, & Clinics is tailored to meet the growing needs of the entire and T-shirts or sweatshirts are not felt that a pharmacist wearing a you dress slovenly. Although dressteam and information treat white provides coat equated practical feelings of “coming the parttooffers no guarantee, it appropriate for healthcare the pharmacy setting. fort, inside confidence, trust, and profeswill get you one step”closer to gaining and care for patients the pharmacy and retail clinics. Focusing on Footwear sionalism.”1 The key is that it is sup- the respect of your patients and your What we often hear debated when posed to be white (ie, the color of coworkers. ❚ discussing pharmacy-appropriate a Northeastern blizzard). It should Donald J. Dietz, RPh, MS Vice President Reference attire is footwear. For pharmacists on not look like the gray-stained and Pharmacy Healthcare Solutions, Inc. 1. Khanfar NM, Zapantis A, Alkhateeb FM, et al. Patient their feet for 8, 10, or even upwards tattered travesty I once wore while Editor-in-Chief attitudes toward community pharmacist attire. J Pharm Inside Patient Care of 12 hours a day, functionality often working as an intern. Patients want Pract. 2013;26:442-447. trumps fashion. We suggest footwear to know that the pharmacy is clean, that is professional, comfortable, and and that their prescriptions are being in good condition, including con- handled in a hygienic way. We sugservative walking shoes, dress shoes, gest having multiple white coats to Mr Dietz is Editor-in-Chief of the Oxfords, or dress flats. Pharmacists make frequent laundering easier and journal, and Vice President of Pharmacy Healthcare Solutions, Inc, Pittsburgh, PA. should refrain from wearing flashy less onerous.
“
Inside Patient Care: Pharmacy & Clinics™ is an independent journal that provides practical information for the entire healthcare team treating and caring for patients inside the pharmacy and retail clinics. As primary care expands to provide optimal access to quality care, Inside Patient Care: Pharmacy & Clinics™ offers a forum for the team treating and coordinating patient care in pharmacies and retail clinics, including medical directors, physician assistants, nurse practitioners, pharmacists, and C-level executives, to implement the best therapeutic options, navigate the healthcare system, and achieve professional success. Each issue of the journal includes resources that will enable the retail healthcare team to provide optimal patient care—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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theVitals POTASSIUM MAY LOWER BLOOD PRESSURE IN TEENS Including more potassium as part of a healthy diet during childhood may help lower blood pressure in adolescents, according to a study published in JAMA Pediatrics. “The beneficial effects of dietary potassium on both systolic and diastolic blood pressures suggest that consuming more potassiumrich foods during childhood may help suppress the adolescent increase in blood pressure,” Justin R. Buendia, BS, Department of Medicine, Boston University School of Medicine, Boston, MA, and colleagues found. In the prospective, National Heart, Lung, and Blood Institute’s Growth and Health Study, investigators sought to evaluate the effect of dietary sodium, potassium, and the potassium-to-sodium ratio on blood pressure in adolescents. Overall, 2185 black and white girls who were aged 9 to 10 years at the beginning of the study received follow-ups for ≤10 years. The study participants had complete data for early-adolescent to midadolescent diet and blood pressure. The primary end points were mean systolic and diastolic blood pressures throughout adolescence and at the end of the study. The authors found no evidence that higher sodium intakes had an adverse effect on the blood pressures of the study participants. However, mixed models indicated that adolescents consuming ≥3500 mg/d had generally lower diastolic blood pressure, compared with individuals consuming <2500 mg/d. Higher potassium intake inversely correlated with blood pressure change throughout adolescence and at the end of the study. Source: Buendia JR, Bradlee ML, Daniels SR, et al. Longitudinal effects of dietary sodium and potassium on blood pressure in adolescent girls. JAMA Pediatr. 2015 Apr 27 [Online ahead of print].
Examining the News Affecting Pharmacy & Clinics
HEALTHCARE SPENDING ON THE RISE FOR CHILDREN WITH DIABETES Data from the Health Care Cost Institute (HCCI) indicate that healthcare spending for privately insured children with diabetes rose almost 4% in 2013, and was almost $10,700 higher than for patients without diabetes.
“Diabetes is a costly chronic condition in the United States, medical costs and productivity loss attributable to diabetes were estimated to be $245 billion in 2012,” the report explained. The HCCI report compares the per capita spending for children diagnosed with diabetes, and looks at health spending for individuals with diabetes by age and gender. The data set includes almost 40 million individuals from all 50 states and the District of Columbia, who are aged <65 years and have employer-sponsored insurance. The study population included 5.3% of patients with type 1 or type 2 diabetes in 2013. Diabetes diagnosis was determined using the Dictionary of Disease Management Terminology methodology for identifying healthcare activity associated with diabetes. Overall, healthcare spending for children with diabetes increased between 2011 and 2013, with the dollar amount increase in per capita spending for children between 2012 and 2013 almost double the increase for young adults aged 19 to 25 years ($1361 and $753, respectively). This rise in spending for children with diabetes was associated with higher spending on insulin. Per capita healthcare spending was also significantly higher in patients with diabetes ($14,999) compared with patients without diabetes ($4305). Out-of-pocket costs were also more than double in patients with diabetes ($1922) compared with patients without diabetes ($738). The report also indicated that insured women with diabetes between the ages of 19 and 54 years had higher per capita spending than men with diabetes. Pre-Medicare adults with diabetes between the ages of 55 and 64 years had the highest per capita spending for any age-group. Source: Health Care Cost Institute. Per Capita Health Care Spending on Diabetes: 2009-2013. www.healthcostinstitute.org/files/HCCI%20Diabetes%20Issue%20Brief%205-7-15.pdf. Published May 2015. Accessed May 7, 2015. RETA #1 AM IL CL ONG INIC IANS
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theVitals OROPHARYNGEAL EXERCISES HELP SNORING Healthcare professionals may be able to recommend a noninvasive treatment option for their patients who snore. “Snoring is extremely common in the general population, and may indicate obstructive sleep apnea,” Vanessa Ieto, PhD, Sleep Laboratory, Pulmonary Division, Heart Institute, University of Sao Paulo Medical School, Brazil, and colleagues explained in a study published online first in Chest. “However, snoring is not objectively measured during polysomnography, and no standard treatment is available for primary snoring, or when snoring is associated with mild forms of obstructive sleep apnea.” As part of the study, investigators randomized patients for 3 months of treatment with daily oropharyngeal exercises, or nasal dilator strips with respiratory exercises (control). Oropharyngeal exercises included pushing the tip of the tongue against the roof of the mouth and sliding the tongue backward; sucking the tongue upward against the roof of the mouth, and pressing the entire tongue against the roof of the mouth; forcing the back of the tongue against the floor of the mouth while keeping the tip of the tongue in contact with the bottom front teeth; and elevating the back of the roof of the mouth and uvula while pronouncing the vowel “A.” Thirty-nine patients were included in the study. The mean age of the patient population was 46 years, body mass index was 28.2 kg/m2, Apnea-Hypopnea Index was 15.3 events per hour, and the Epworth Sleepiness Scale and Pittsburgh Sleep Quality Index scores were 9.2 and 6.4, respectively. Twenty patients were included in the control. Patients in the study group and the control group were similar at the start of the study. Treatment with oropharyngeal exercises led to a significant decrease in the Snore Index and Total Snore Index. In particular, snoring frequency was decreased by 36%, and total snoring power was reduced by 59%. Source: Ieto V, Kayamori F, Montes MI, et al. Effects of oropharyngeal exercises on snoring: a randomized trial. Chest. 2015 May 7 [Online ahead of print].
OUTBREAK OF HIV IN INDIANA LINKED TO OXYMORPHONE INJECTION The Indiana State Department of Health started an ongoing investigation of an outbreak of the human immunodeficiency virus (HIV) in January following 11 confirmed cases in a rural county of southeastern Indiana. The cases occurred among residents in the same community, and were linked to syringe-sharing of opioid oxymorphone injections. Overall, 135 patients were diagnosed with HIV as of late April in a community of 4200 people. “The outbreak highlights the vulnerability of many rural, resource-poor populations to drug use, misuse, and addiction, in the context of a high prevalence of unaddressed cormorbid conditions,” Caitlin Conrad, from the Indiana State Department of Health, Indianapolis, and colleagues stated in the May 1 issue Morbidity and Mortality Weekly Report. “The outbreak also demonstrates the importance of timely HIV and hepatitis C surveillance activities, and rapid response to interrupt disease transmission.” Patients diagnosed with HIV had a mean age of 35 years, and 54.8% were men. In addition, data indicate that 80% of the patients reported injection drug use, 3% did not report injection drug use, and 17% were not interviewed to determine injection drug use. In addition, 84.4% of the patients were coinfected with hepatitis C. Trends in the community indicated that injection drug use is a multigenerational activity, with as many as 3 generations of a family and multiple community members injecting together. The daily numbers of injections ranged from 4 to 15, with the number of injection partners ranging from 1 to 6 per injection event.
HEALTHCARE POLICY
5 FACTS ABOUT HB 2041 1/ The Massachusetts bill was sponsored by Rep Angelo J. Puppolo, Jr, and seeks to recognize pharmacists as healthcare providers.
2/ It would amend the definition of “health care provider” in their General Laws to include registered pharmacists. 3/ The bill includes coverage for patients diagnosed with ≥1 chronic disease, for drug therapy management services from a registered pharmacist, and pharmacists to be paid for these services as part of a collaborative drug therapy management agreement with a physician. 4/ It promotes collaboration between physicians and pharmacists in the management of certain diseases, including asthma, chronic obstructive pulmonary disease, diabetes, hypertension, hyperlipidemia, congestive heart failure, human immunodeficiency virus or AIDS, and osteoporosis.
5/ The bill would also allow registered pharmacists to administer medication prescribed by a supervising physician, including drugs and biological products. Sources: (1) The General Court. Bill H.2041. https://malegislature.gov/Bills/189/House/H2041. Accessed May 7, 2015. (2) Yap D; American Pharmacist’s Association. Massachusetts bill would recognize pharmacists as health care providers. www.pharmacist.com/massachusetts-bill-would-recognize-pharmacists-health-care-providers. Published April 28, 2015. Accessed May 7, 2015.
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INSIDE
Women’s Health
Cover Story
Patients Taking Misoprostol Misunderstood: How to Manage Patients with Miscarriages by PAIGE SCHULTZ, PHARMDc; JAMIE FERY, PHARMDc; STACIE J. LAMPKIN, PHARMD, BCACP, AE-C; and NICOLE E. CIERI, PHARMD, BCPS
Misoprostol is a synthetic prostaglandin E1 analogue that has labeled uses for the prevention of nonsteroidal anti-inflammatory drug (NSAID)-induced gastric ulcers and the medical termination of pregnancies.1 }} }} MISOPROSTOL also has off-label uses, and is recommended by the American College of Obstetricians and Gynecologists (ACOG) for the treatment of incomplete or missed abortions.1 Medically, an incomplete abortion is defined as a failed pregnancy in which a woman has not passed all of the fetal tissue, whereas a missed abortion is when a woman has a nonviable fetus in her uterus.2 Both of these conditions are the result of a spontaneous abortion; the preferred term is miscarriage, because abortion is typically assumed to be an elective pregnancy termination.3 For pharmacists and patients, this nomenclature can be misleading. A misoprostol prescription with an indication for abortion can indicate either an elective abortion or miscarriage. Regardless of indication, judgments and as-
sumptions should never be made when dispensing misoprostol. To tailor counseling to the appropriate indication, it is vital to clarify its use. This can be done by asking the patient, “What did the doctor tell you this medication was for?” When the indication is determined to be a miscarriage, it can be an uncomfortable topic to discuss. Unfortunately, miscarriages in the first trimester occur in 1 in 4 women, and rates may be even higher in older women.3 Because of this high frequency, pharmacists may find it challenging to dispense to and counsel patients who are receiving misoprostol for a miscarriage. Pharmacists in the community setting have the final patient interaction prior to them taking a medication in a situation that is emotionally draining. Counseling may require the pharmacist to step
KEY POINTS ❚ Misoprostol is FDA approved for pharmacologic termination of a pregnancy and has an off-label use for the treatment of an incomplete or missed abortion ❚ It is vital that pharmacists or retail clinicians make no assumptions or judgments about the use of medications and treat patients respectfully ❚ Pharmacists can refer women to additional resources such as support groups and online blogs to help them cope RETA #1 AM IL CL ONG INIC IANS
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Inside Women’s Health Table 1. Routes of Administration4 Routes of Administration
Directions for Use
Oral
Pills are swallowed immediately after being placed inside of the mouth
Sublingual
Pills are placed under the tongue and then swallowed after 30 minutes
Vaginal
Pills are placed in the deepest portion of the vagina and the woman should lie down for 30 minutes
outside of their comfort zone. Although the topic may be uncomfortable, it is essential to counsel on expectations of treatment, including side effects, and to address any additional concerns the patient may have about their miscarriage.
Misoprostol Efficacy and Administration According to ACOG, misoprostol has a complete expulsion rate in approximately 66% to 99% of women who receive the medication for incomplete or missed miscarriages.2 The treatment is most effective when initiated immediately after the miscarriage.4 Guidelines
recommend a single dose of 600 mcg orally or 400 mcg sublingually for incomplete abortions, and 800 mcg vaginally4 or 600 mcg sublingually for missed abortions.2 However, vaginal administration may not be preferred because of the potential for decreased absorption secondary to vaginal bleeding.4 Keep in mind that regardless of the route of administration, the medication dosage form is a tablet. It is vital to ensure patients understand how to administer their medication via the specified route of administration (Table 1).4 For a missed abortion, a woman may repeat the dose every 3 hours for up to 2 additional doses, if needed.1,2 Additional doses are not recommended in incomplete abortion cases. Patients should follow up with their physicians 1 to 2 weeks after treatment to confirm the evacuation of the fetus and the completion of the miscarriage.2,4 In cases where the initial misoprostol treatment cycle did not succeed, surgical removal of the fetal tissue may be considered, or a second misoprostol treatment regimen may be
PATIENT VOICE PATIENTS TAKING MISOPROSTOL MISUNDERSTOOD Kaitie Richardson, BS, Financial Services/Banking Professional, provides a patient’s perspective on her experience with misoprostol and the importance of managing patients with a miscarriage
I
have always appreciated—frankly, always expected—that my pharmacist asked whether I had any questions about the medications I was taking. Unfortunately, in a time when I needed it most, it was not offered. I am sharing my miscarriage experience as a complement to the “Misoprostol Patients Misunderstood: How to Manage Patients with Miscarriages” article, to hopefully spread awareness and reduce the chance of a negative experience for other women who may have been/are misunderstood during a miscarriage. Going through a miscarriage is a significant emotional rollercoaster. For me, it all began during my 12-week ultrasound appointment, where I was shocked to find out the baby didn’t
have a heartbeat. The physician prescribed medication to manage my missed abortion, including pain medication, antibiotics, and misoprostol. When my doctor explained what was happening, I was so overwhelmed with emotion that I was not paying much attention, much less asking any questions. I dropped off my prescription at the pharmacy shortly after the appointment. I had been crying in the car before I arrived, and I am sure I looked visibly upset. After a short while, I went back to pick up the medications, including misoprostol. I was never asked if I had any questions about the medication or if I needed to speak with the pharmacist in a more private area. Instead, I felt like I was being judged for picking up the misoprostol—as if it was my decision to end my pregnancy. My perception of the transaction was that they just assumed I knew what I was doing with the medication because I had
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Inside Women’s Health prescribed.5 A universal recommendation has not yet been established, and there is no consensus on the efficacy of multiple treatment cycles. Advantages of misoprostol are that it allows for a less invasive and more economic route of postmiscarriage care compared with surgical evacuation of the uterus, which was used historically. It is not suitable for all miscarriages; ACOG recommends misoprostol in women whose uterine size is less than 12 weeks of gestation.2
Misoprostol Side Effects Most patients will experience vaginal bleeding that is heavier than a typical menses.6 However, heaviness and length of bleeding will vary from woman to woman. Heavy bleeding may last approximately 4 days and may continue to a lighter bleeding or spotting. Regardless of the heaviness, the median bleeding time has been reported to be 12 days and the duration may last longer than 30 days.6 Because bleeding is likely to occur when using misoprostol, patients
Table 2. Internet Forum Information for Patients7-11 Internet Forum Name
URL
Unspoken Grief
Unspokengrief.com
After a Miscarriage: Surviving Emotionally
AmericanPregnancy.org/pregnancy-loss
Miscarriage Support Group
Miscarriage.supportgroups.com
M.E.N.D.: Mommies Enduring Neonatal Death
Mend.org
Center for Loss in Multiple Birth
Climb-support.org
should be counseled regarding common bleeding patterns, and informed that this may vary among patients. Other possible side effects include abdominal cramping, nausea, vomiting, fever and chills, and diarrhea—but these are seen less often.5 For pain management of abdominal cramping, over-the-counter ibuprofen or other NSAIDs should be recommended, provided that the patient does not have contraindications for their use.2 If these analgesics are not sufficient in treating the pain, refer the patient to a healthcare provider.
already spoken to my doctor and chosen to end my pregnancy. Being in the mental state that I was in, I took 4 pills every few hours (the instructions on the bottle were to take 4 pills orally 3 times daily), not taking into account that I should have been spreading it out over a 24-hour period, and not for the hours I was awake. Could I have spoken up and simply asked the pharmacist to clarify? Yes; however I felt very judged and embarrassed, and I didn’t feel comfortable speaking up. Furthermore, I was never counseled on the side effects of the medication or what to expect. Misoprostol is a very harsh medication. I experienced a lot of vomiting and diarrhea; however, the stomach cramping was not as awful as I expected. The entire process was very draining and I slept a lot; it was probably more emotionally than physically draining. I knew once I took that first dose that meant the baby was going to be forced out. But I had no idea what to expect—was it going to happen in 20 minutes, an hour? The waiting game was difficult to bear. For me, the placental sac passed after 9 hours and then a lot of tissue continued to pass for the next couple of days. It didn’t end there; it took about 1.5 months for the bleeding to completely stop and during this time I had numerous ultrasounds, check-ups, and 2 more rounds of misoprostol.
One of these rounds consisted of the same pills, but they were inserted vaginally. Once again, I was not counseled on the medication or how to use it. Looking back at my experience, I think it is imperative for pharmacists not to judge patients when dispensing prescriptions regardless of indication. My overall miscarriage and pharmacy experience could have been greatly improved with some simple customer service and counseling. A warm greeting makes such a difference. Then, taking the time to make sure to ask if we have any questions about the medication and provide counseling on how to use it and what to expect from it. When a patient tells you they have a miscarriage, it might be uncomfortable or you might not know what to say. However, acknowledging the miscarriage and saying “I am sorry for your loss” goes a long way, and in my case, would have been welcomed. Finish the interaction with a genuine, “I hope you feel better.” Do not be afraid to talk to a patient about their miscarriage. We have questions, and we want you to ask us how we are doing, so that we feel comfortable asking these questions. We want to feel like you care. And if you feel like something should be said, chances are we are waiting for you to say it.
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Inside Women’s Health Adverse Events Due to Miscarriage With miscarriage being such an emotional time, patients may not have a clear understanding of why the remnants of the pregnancy need to be evacuated or know the more severe adverse events of miscarriage to watch out for, including infection and hemorrhage.2,4 Patients with miscarriages are at risk for infections due to dilation of the cervix. Antibiotic prescriptions are more commonly prescribed for patients with postsurgical abortion, although they may also be prescribed to miscarriage patients taking misoprostol. It is important that all miscarriage patients be counseled to be aware of signs of infection, including
After receiving counseling on more severe adverse events of miscarriage, patients may be concerned, and their concerns must be addressed. vaginal discharge with strong odor, fever, chills, and/or abdominal/uterine cramping.4 If they experience any of these symptoms, they should contact their physician or obstetrician right away. Hemorrhage is also a concern with miscarriages. It can be a result of damage to the reproductive organs or coagulopathy. As the patient passes the contents of the uterus, vaginal bleeding will occur. If the patient experiences abnormally heavy and prolonged bleeding, she should contact her obstetrician immediately. After receiving counseling on more severe adverse events of miscarriage, patients may be concerned, and their concerns must be addressed. Patients need to know to monitor for these signs and symptoms to reduce the risk for complications through early detection.
Miscarriage Counseling Interaction with a pharmacist can
positively impact the emotional outcomes of a patient with a miscarriage. It should be acknowledged by expressing words of sympathy for the loss of her child (eg, “I am sorry for your loss”); this can help put the patient at ease and provide an opportunity for discussion. Psychological outcomes improve if the emotional issues are discussed. However, be mindful that a woman may be confused, anxious, and/or depressed. She may be blaming herself for the miscarriage, due to the misconceptions that stress, exercise, or sexual activity could lead to early pregnancy loss.3 When appropriate, pharmacists can encourage women and their families to consider additional counseling by providing patients with information about available resources, such as support groups, Internet forums, or remembrance events. Forums can be helpful resources for women to read about other miscarriage stories, and possibly share their own experiences. Examples of forums that can be recommended can be found in Table 2.7-11 October is National Miscarriage Awareness month; there are many events held during this time for a woman and her family to remember their lost child. The annual Wave of Light is on October 15 at 7 pm in your time zone; participants can light a candle for at least 1 hour to honor those lost to miscarriage, stillbirth, or neonate death. Finally, try to be aware of options that are available in your patient care area, so you may better suit your patient and her family’s needs.
Future Fertility It is important to clarify that misoprostol will have no impact on future fertility.3 Many women may not realize that ovulation can occur as soon as 2 weeks after a miscarriage.2,4 There is no recommended amount of time that a woman should wait to reattempt pregnancy.4 However, each patient should consult with their physicians to determine when the most ideal time would be for her to try and conceive. Recommen-
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Inside Women’s Health dations may vary among physicians and should be individualized per patient. In addition, patients who are emotionally unstable may not be psychologically prepared to become pregnant soon after their miscarriage. In these patients, contraception options should be discussed and put into practice to prevent a possible unwanted pregnancy. The use and compliance of contraception is higher in patients who are counseled on its importance at the initiation of misoprostol treatment.2 Contraceptive medications and misoprostol can be initiated at the same time with no interactions.4
Conclusion When a prescription for misoprostol is brought into your pharmacy, it can be for either an elective abortion or a spontaneous miscarriage. The terms abortion and miscarriage may be used interchangeably, so communication is necessary to understand why the patient is taking misoprostol. Regardless of the indication, pharmacists should provide a judgment-free environment and counsel patients on the medication (see “Patient Voice” on page 16). These interactions should begin with providing comforting words to the patient, and transition into
the use of misoprostol and encouraging discussion about miscarriage. By following these best practices, pharmacists will be able to make a difference in the emotional well-being of patients receiving misoprostol for a miscarriage. ❚
References
1. Lexicomp Online, Lexi-Drugs Online, Hudson, OH: Lexi-Comp, Inc.; 2015; December 22, 2014. 2. The American Congress of Obstetricians and Gynecologists. Misoprostol for post abortion care. ACOG Committee Opinion. 2009;1-4: No 427. 3. Prine LW, Macnaughton H. Office management of early pregnancy loss. Am Fam Physician. 2011;84:75-82. 4. World Health Organization, Department of Reproductive Health and Research. Safe abortion: technical and policy guidance for health systems. 2nd ed. http://apps.who. int/iris/bitstream/10665/70914/1/9789241548434_eng.pdf ?ua=1. Published 2012. Accessed February 5, 2015. 5. Allen R, O’Brien BM. Uses of misoprostol in obstetrics and gynecology. Rev Obstet Gynecol. 2009;2:159-168. 6. Davis AR, Hendlish SK, Westhoff C, et al. Bleeding patterns after misoprostol vs surgical treatment of early pregnancy failure: results from a randomized trial. Am J Obstet Gynecol. 2007;196:31.e1-7. 7. Unspoken Grief. http://unspokengrief.com/. Updated February 5, 2015. Accessed February 5, 2015. 8. American Pregnancy Association. After a miscarriage: surviving emotionally. http://americanpregnancy.org/preg nancy-loss/miscarriage-surviving-emotionally/. Updated January 2014. Accessed April 20, 2015. 9. Miscarriage Support Group. http://miscarriage.support groups.com/. Updated February 3, 2015. Accessed February 5, 2015. 10. M.E.N.D. www.mend.org/support/. Updated 2013. Accessed April 20, 2015. 11. Center for Loss in Multiple Birth, Inc. www.climb-sup port.org/. Updated 2015. Accessed April 20, 2015.
Paige Schultz Ms Schultz and Ms Fery are Student Pharmacists; Drs Lampkin and Cieri are Clinical Assistant Professors at D’Youville College School of Pharmacy, Buffalo, NY.
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 RETA #1 AM IL CL ONG INIC IANS
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Inside Patient Care
Women’s Health 5 TIPS TO MAINTAIN BONE HEALTH Adequate calcium consumption and weightbearing physical activity build strong bones, optimize bone mass, and may reduce the risk for osteoporosis later in life. The following are tips to maintain bone health for women: 1 Know the Risk Factors for Osteoporosis
2 Be Mindful of What You Eat
This disease is characterized by low bone mass and deterioration of bone tissue that affects both men and women. Several risk factors associated with the disease include being a woman, white, postmenopausal, older adults, small in body size, eating a diet low in calcium, and physical inactivity. Controllable lifestyle factors, including diet, can make a difference in bone mass. Calcium and vitamin D consumption are particularly important for healthy bones. Foods high in calcium include dairy products, dark green leafy vegetables, calcium-fortified foods, and nuts. Exercise is important for bone health throughout life because it increases or preserves bone mass, and reduces the risk of falling, as is maintaining a healthy body weight. Some weight-bearing physical exercises to consider include walking/jogging/running, weight lifting, and climbing stairs.
3 Exercise
4 Quit Smoking
5 Know What Medications You Are Taking
â
Smoking can reduce bone mass and increase fracture risk; heavy alcohol use has also been associated with reduced bone mass and increased fracture risk.
Several medications and prescriptions can affect bone health, and further assessments of bone health and other risk factors for bone diseases may be necessary if these medications are used.
MORE ONLINE
More patient tips are available online at InsidePatientCare.com
Sources: Centers for Disease Control and Prevention. Calcium and bone health. www.cdc.gov/nutrition/everyone/basics/vitamins/calcium.html. Updated April 6, 2011. Accessed May 7, 2015; Office of the Surgeon General (US). Bone health and osteoporosis: a report of the Surgeon General. www.ncbi.nlm.nih.gov/books/NBK45513/ pdf/TOC.pdf. Accessed May 7, 2015.
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Infectious Disease Hepatitis C Treatment: Looking Back, and Moving Forward by LISA CERVANTES, PA-C
Approximately 2 million to 4 million people in the United States, and 3% of the world’s population, are thought to be infected with the hepatitis C virus (HCV).1 }} }} THE ESTIMATED number of people infected with HCV is thought to be much lower than the actual number; HCV does not usually cause symptoms, and the patient may not become aware that he or she has been infected for many years.2 HCV is transmitted through the blood, and the most common risk factor in the United States is intravenous (IV) drug use. Many patients with HCV are incarcerated or homeless, and may have poor access to healthcare. Other risk factors include intranasal drug use, blood transfusions (prior to 1992), dialysis, tattoos and body piercings with unsterile instruments, and healthcare occupations.2 Because the human immunodeficiency virus (HIV) is spread in similar
ways, many patients are coinfected with HCV and HIV. However, HCV is not readily spread sexually, and only occurs in 7% to 10% of cases.
HCV Screening and Viral Load Tests Preventive health professionals have recommended that all people with the risk factors for HCV, as well as anyone born between 1945 and 1964, be screened.2 Screening consists of drawing blood to ascertain the presence of HCV antibodies. If the results are negative, no other testing is needed, but if they are positive, the patient has been exposed to the virus,2 and an HCV RNA polymerase chain reaction (viral load) test should be conducted.3 Because HCV can be
present in the blood for many years without symptoms, the damage can progress, and patients risk developing fibrosis and cirrhosis.1 Approximately 20% of patients with HCV develop cirrhosis, and, annually, about 1% of the patients with cirrhosis develop hepatocellular carcinoma.1 Because of these risks, pharmaceutical companies and healthcare researchers have been looking for effective treatments for HCV ever since the virus was discovered in 1989.4
HCV Genotypes Until October 2014, treatment for HCV was based on subcutaneous interferon alfa. Treatment regimens were usually dictated by the patient’s HCV genotype; genotype 1—by far the most com-
mon in the United States, at roughly 70% to 75%— was the most difficult to eradicate,5 genotype 2 the easiest, and genotype 3 was somewhere in between. Genotypes 4, 5, and 6 are not seen frequently in the United States.6,7 Patients with chronic neurologic, psychiatric, cardiopulmonary, hematologic, or renal diseases were not eligible for treatment because of possible adverse effects.8 This HCV treatment was less effective in patients who were black, male, aged ≥45 years, coinfected with HIV/HCV, or obese.
Development of New Treatment Regimens The first patients treated in the early 1990s with interferon monotherapy had a 6% chance of being successfully treated. RETA #1 AM IL CL ONG INIC IANS
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Infectious Disease In the late 1990s, ribavirin tablets were added to the regimen,9 and the chance of sustained virologic response (SVR; defined as no detectable HCV RNA >24 weeks after completion of the treatment10) improved to 40% to 60%.11 In 2001, a pegylated version of interferon alfa was approved by the US Food and Drug Administration (FDA), and the SVR rate improved slightly. Patient adherence improved because the new formulation afforded onceweekly dosing instead of injections 3 times a week.12 Treatment ranged from 24 to 48 weeks in length, and many side effects, such as severe fatigue, loss of appetite, depression and suicidality, muscle and joint pain, anemia, leukopenia, and thrombocytopenia, were common. These adverse events were even more pronounced with the addition of boceprevir or telaprevir, approved by the FDA in 2011.13 Patients on these medications had to be observed very closely, and many required erythropoietin and granulocyte colonystimulating factor injections.14 Women who could become pregnant and men who could father a child had to be observed carefully because of the
BECAUSE THERE ARE VERY FEW SIDE EFFECTS ASSOCIATED WITH HARVONI, PATIENTS TOLERATE IT VERY WELL, AND THEIR COMPLIANCE IS HIGH. teratogenic potential of ribavirin.15 In November and December 2013, simeprevir and sofosbuvir, respectively, were approved by the FDA.16 For the first time, all-oral regimens were available for genotypes 2 and 3. Pegylated interferon alfa and ribavirin were still a part of the approved regimen for genotype 1, although treatment was shortened to 12 weeks instead of the original 24 to 48 weeks. SVR was achieved in >90% of patients, and patients with cirrhosis were treated in the same way as patients without cirrhosis. At the same time, the COSMOS trial revealed very high SVR rates ranging from 79% to 93% and 93% to 100% in genotype 1 patients treated with
sofosbuvir plus simeprevir, with or without ribavirin.5 Although this combination was not approved by the FDA specifically, the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) recommended the sofosbuvir plus simeprevir regimen for genotype 1 patients. The difference between the AASLD/ IDSA regimen and the indications approved by the FDA caused significant problems for getting sofosbuvir plus simeprevir approved for patients. For a 12-week supply, both simeprevir and sofosbuvir had prices in the range of $66,000 to $84,000, respectively, and the combination treatment cost approximately $150,000.17,18 Many insurance companies, as well as Medicare and Medicaid, balked at paying these prices, and most insurers required patients to have compensated cirrhosis (ie, no hepatic encephalopathy, jaundice, ascites19) to be eligible for coverage of treatment with simeprevir or sofosbuvir. One conclusion of the research conducted to get these medications approved was that genotype 3 was more difficult to treat than previously thought.20 In a study by Zeuzem and colleagues,
criteria for SVR in patients receiving sofosbuvir and ribavirin was met in only about 85% of patients after 24 weeks of treatment.21
Harvoni Combination Therapy In October 2014, Harvoni (ledipasvir and sofosbuvir) was approved by the FDA.22 It is thought to be 99% effective in treating genotype 1 HCV, and is only approved for use in genotype 1 patients. The Harvoni regimens provide significant advantages versus the previouslyused medications. Harvoni is dosed at 1 tablet a day for 8, 12, or 24 weeks.23 For treatment-naïve patients without cirrhosis and with a pretreatment viral load <6 million IU/mL, treatment can last for 8 weeks. In patients where previous treatment has failed and without cirrhosis, treatment lasts for 12 weeks. In patients where previous treatment failed and with cirrhosis, treatment lasts for 24 weeks. Because there are very few side effects associated with Harvoni, patients tolerate it very well, and their compliance is high.24 Few drug interactions are associated with Harvoni. The most significant ones include several anticonvulsants, rosuvastatin, and other antivirals. Because the ledipasvir
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Infectious Disease component of Harvoni can be absorbed less well in patients who are receiving proton-pump inhibitors or histamine 2 blockers, the recommendation is for the patient to take the proton-pump inhibitors or histamine 2 blockers at the same time as Harvoni, because absorption is decreased at higher gastric pH.
Viekira Pak In December 2014, Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets packaged with dasabuvir tablets) was approved by the FDA for treating HCV genotype 1.25 This regimen is packaged with very clear instructions for how to take the tablets: 2 tablets, containing ombitasvir, paritaprevir, and ritonavir at 12.5 mg, 75 mg, and 50 mg, respectively, are taken morning and night, and 1 tablet, containing 250 mg of dasabuvir sodium monohydrate, is taken in the morning and at night as well. All of the tablets must be taken with food.26 Genotypes 1a and 1b are treated differently, with ribavirin added only for all genotype 1a patients, and for genotype 1b patients with cirrhosis. Patients with genotype 1a who have cirrhosis are treated for 24 weeks, and patients with other genotype categories receive
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treatment for 12 weeks. There are drug interactions with Viekira Pak, including alanine aminotransferase elevations in patients using ethinyl estradiol–containing medications.26 Anticonvulsants and some statins and antivirals can decrease the therapeutic activity of Viekira Pak. Because some patients must receive simultaneous treatment with ribavirin, contraindications and drug interactions of ribavirin must also be noted. Women of childbearing age and their male partners must be warned about the chances for birth defects in children conceived while either parent is taking ribavirin.15 All patients should be monitored for anemia, with intervention taken as needed (ie, if hemoglobin <10.0 g/dL). Although it is a bit more complicated to use, Viekira Pak has efficacy rates comparable to Harvoni.27 All patient groups⎯other than patients with cirrhosis⎯with genotype 1a had SVR rates of 95% to 96%, and patients with cirrhosis with genotype 1a had an SVR of 89%. Perhaps because of the additional precautions and monitoring needed, Viekira Pak is priced a little lower than Harvoni ($94,500), at about $84,000 for 12 weeks of medication.28
ALTHOUGH ONLY 20% OF PATIENTS WITH HCV WILL EVENTUALLY DEVELOP CIRRHOSIS, IT HAS BEEN CHALLENGING TO PREDICT WHICH INDIVIDUALS WILL. The Future of HCV Treatment The approvals of Har voni, sofosbuvir, simeprevir, and Viekira Pak have changed the landscape of HCV treatment, but there is still a lot left to do. Healthcare providers now have potent weapons with which to fight HCV; in the past, limitations to treatment included the patient’s ability to tolerate treatment. Now, the limitations for who can be treated are mostly caused by the cost of the medications. Identification of patients with HCV is essential, and having safe, effective, and affordable medications to treat them is necessary. Although only 20% of patients with HCV will eventually develop cirrhosis, it has been challenging to predict which individuals will. These patients
cost our healthcare system millions of dollars for their management, up to and including liver transplantation. With new outbreaks of IV drug use, more young people are being infected, and may, in turn, spread it to other people. The best outcome for patients, and our healthcare system, would be to consider HCV a public health problem, and eradicate it completely. As long as some individuals are infected, everyone is at risk. ❚
References
1. World Health Organization. Hepatitis C. Surveillance and control. www.who.int/csr/disease/hepatitis/ whocdscsrlyo2003/en/index4.html. Accessed May 5, 2015. 2. Centers for Disease Control and Prevention. Hepatitis C FAQs for the public. www.cdc.gov/hepatitis/C/ cFAQ.htm. Updated April 15, 2015. Accessed May 5, 2015. 3. US Department of Veterans Affairs. Laboratory tests and hepatitis C. www. hepatitis.va.gov/provider/reviews/labo ratory-tests.asp. Accessed May 5, 2015. 4. Centers for Disease Control and Prevention. Hepatitis C: 25 years since discovery. www.cdc.gov/knowmore hepatitis/media/pdfs/hepc-timeline.pdf. Updated August 22, 2014. Accessed May 5, 2015. 5. Spach DH, Kim HN. Treatment of HCV genotype 1. www.hepatitisc. uw.edu/go/treatment-infection/treat ment-genotype-1/core-concept/all. Updated January 25, 2015. Accessed May 5, 2015. 6. Spach DH, Kim HN. Treatment of HCV genotype 4. www.hepatitisc. uw.edu/go/treatment-infection/treat ment-genotype-4/core-concept/all. Updated February 11, 2015. Accessed May 5, 2015. 7. Spach DH, Kim HN. Treatment of HCV genotype 5 or 6. www.hep atitisc.uw.edu/go/treatment-infection/ treatment-genotype-5-or-6/core-con cept/all. Updated January 18, 2015. Accessed May 5, 2015. 8. Wilkins T, Malcolm JK, Raina D, et al. Hepatitis C: diagnosis and treatment. Am Fam Physician. 2010;81: 1351-1357.
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Infectious Disease
Ms Cervantes is Physician Assistant, University of Wisconsin Hospital and Clinics, Digestive Health Center, Madison, WI.
9. Jensen DM. Advances in combination regimens in the management of HCV infection. Gastroenterol Hepatol (NY). 2014;10:134-136. 10. Yee HS, Chang MF, Pocha C, et al. Update on the management and treatment of hepatitis C virus infection: recommendations from the Department of Veterans Affairs Hepatitis C Resource Center Program and the National Hepatitis C Program Office. Am J Gastroenterol. 2012;107:669-689. 11. World Health Organization. Pegylated interferon alpha 2a. www. who.int/selection_medicines/com mittees/expert/19/applications/ Pegyinterferon_6_4_3_A_Ad.pdf. Accessed May 6, 2015. 12. Ward RP, Kugelmas M. Using pegylated interferon and ribavirin to treat patients with chronic hepatitis C. Am Fam Physician. 2005;72:655-662. 13. Tungol A, Rademacher K, Schafer JA. Formulary management of the protease inhibitors boceprevir and telaprevir for chronic hepatitis C virus. J Manag Care Pharm. 2011;17:685-694. 14. Belperio PS, Backus LI, Ross D, et al. A population approach to disease management: hepatitis C direct-acting antiviral use in a large health care system. J Manag Care Pharm. 2014;20: 533-540. 15. Copegus [package insert]. San Francisco, CA: Genentech, Inc; 2002.
16. US Food and Drug Administration. FDA approves Sovaldi for chronic hepatitis C. www.fda.gov/NewsEvents/ Newsroom/PressAnnouncements/ ucm377888.htm. Updated October 1, 2014. Accessed May 6, 2015. 17. Hepatitis C Online. Simeprevir (Olysio). www.hepatitisc.uw.edu/pdf/ page/treatment/drugs/simeprevir-drug. Accessed May 6, 2015. 18. Hepatitis C Online. Sofosbuvir (Sovaldi). www.hepatitisc.uw.edu/pdf/ page/treatment/drugs/sofosbuvir-drug. Accessed May 6, 2015. 19. Thornton K. Evaluation and prognosis of patients with cirrhosis. www. hepatitisc.uw.edu/pdf/evaluation-stag ing-monitoring/evaluation-progno sis-cirrhosis/core-concept/all. Updated February 3, 2014. Accessed May 6, 2015. 20. Tapper EB, Afdhal NH. Is 3 the new 1: perspectives on virology, natural history and treatment for hepatitis C genotype 3. J Viral Hepat. 2013;20:669677. 21. Zeuzem S, Dusheiko GM, Salupere R, et al. Sofosbuvir and ribavirin in HCV genotypes 2 and 3. N Engl J Med. 2014;370:1993-2001. 22. US Food and Drug Administration. FDA approves first combination pill to treat hepatitis C. www. fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm418365.
htm. Updated October 10, 2014. Accessed May 6, 2015. 23. Gilead Sciences Inc; Gilead Sciences Canada, Inc. Product monograph. Harvoni (ledipasvir/sofosbuvir) tablets. www.gilead.ca/pdf/ca/harvoni_ pm_english.pdf. Published October 14, 2014. Accessed May 6, 2015. 24. Gilead Sciences Inc. Application for inclusion of ledipasvir/sofosbuvir (Harvoni) tablets on the WHO Model List of Essential Medicines. www.who. int/selection_medicines/committees/ expert/20/applications/LedipasvirFDC. pdf. Published November 28, 2014. Accessed May 6, 2015. 25. US Food and Drug Administration. FDA approves Viekira Pak to treat hepatitis C. www.fda.gov/NewsEvents/ Newsroom/PressAnnouncements/ ucm427530.htm. Updated December 22, 2014. Accessed May 6, 2015. 26. Viekira Pak [package insert]. North Chicago, IL: AbbVie Inc; 2014. 27. Gritsenko D, Hughes G. Ledipasvir/ sofosbuvir (Harvoni): improving options for hepatitis C virus infection. PT. 2015;40:256-276. 28. Loftus P. FDA approves AbbVie’s hepatitis treatment. The Wall Street Journal. www.wsj.com/articles/fdaapproves-abbvies-hepatitis-treatment1419019392. Published December 19, 2014. Accessed May 6, 2015.
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Men’s Health FDA Issues Safety Communication About Cardiovascular Risks of Testosterone Replacement And other concise reviews of studies on men’s health
The FDA has announced that it will require prescription testosterone product labels to include a warning about a possible increased risk of heart attacks and strokes in patients using the medication, }} }} AS WELL AS REQUIRE manufacturers of these products to change the labeling so that approved uses of the medications are clear. The agency is also encouraging healthcare professionals to prescribe testosterone therapy only for men whose low testosterone levels are caused by certain medical conditions and confirmed with appropriate laboratory testing.1 According to the FDA announcement, testosterone replacement therapy is approved for men with low testosterone levels caused by disorders of the testicles, pituitary gland, or brain, which cause hypogonadism. Genetic
problems, chemotherapy, or infection may be at the root of some of these disorders.1 The agency cautioned against testosterone replacement therapy to treat age-related low testosterone. “[The] FDA has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging,” the announcement indicates. “The benefits and safety of this use have not been established.” “Based on our findings, we are requiring labeling changes for all prescription testosterone products
to reflect the possible increased risk of heart attacks and strokes associated with testosterone use,” the announcement continues. “Healthcare pro fessionals should make patients aware of this possible risk when deciding whether to start or continue a patient on testosterone therapy.” It goes on to say that patients should seek medical attention if, while using testosterone, they experience heart attack or stroke symptoms. Manufacturers of approved testosterone products will be required to conduct well-designed clinical trials that address more clearly the question
of whether users of these medications are at an increased risk of heart attack or stroke. In 2013, 2.3 million people in the United States received a prescription for testosterone, up considerably from the 1.3 million in 2009.2 Further, the most common diagnostic code related to testosterone therapy is the nonspecific diagnosis of “testicular hypofunction, not elsewhere classified”; however, only 72% of men prescribed testosterone had testosterone-level testing prior to being prescribed the hormone.2 The agency’s announcement, dated March 3, 2015, follows on RETA #1 AM IL CL ONG INIC IANS
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Men’s Health could mitigate that risk, he said. “I certainly sympathize with the FDA in seeing that there are a large portion of the men who are getting testosterone therapy in the United States without getting their testosterone levels checked first and are not being monitored according to guidelines,” said Dr Shoskes. “But I am surprised and deeply disappointed in the FDA’s ruling.” the heels of a nearly unanimous September 2014 vote of 2 of its advisory committees that supported labeling to clarify medical indications for testosterone therapy, as well as a June 2014 joint statement by the FDA and the Center for Drug Evaluation and Research.2-4 The joint statement outlined a requirement for manufacturers to include in testosterone product labeling that there is a risk of venous thromboembolism, including deep vein throm bosis and pulmonary embolism. After hearing from medical, corporate, and government experts, as well as from the general public, members of the 2 committees voted 20 to 1 in favor of label changes stating that testosterone is only indicated in men with valid medical condi-
tions that cause testicular dysfunction rather than men with normal, age-related hypogonadism.4 The decision was not binding, but in this case, the FDA acceded to the strength of the vote and to the precautionary principle. The committees were charged with examining the cardiovascular safety of testosterone therapy after a paper was published showing an increased risk of stroke, heart attack, and death in older hypogonadal men.5 Other studies and meta-analyses have demonstrated both an increased and decreased risk of cardiovascular disease and/or death rate associated with testosterone. One meta-analysis demonstrated a connection between funding sources and study outcomes, stating, “in trials not funded by the pharmaceutical industry the
risk of a cardiovascularrelated event on testosterone therapy was greater… than in pharmaceutical industry funded trials.”6 Response to the announcement from the urology community has been mixed. Daniel Shoskes, MD, Professor of Surgery, Department of Surgery, Cleveland Ler ner College of Medicine of Case Western Reserve University, and Director, Novick Center for Clinical and Translational Research, Glickman Urological & Kidney Institute, Cleveland Clinic, is among those who are concerned. He noted concerns with the paper used as the basis for the ruling, as well as evidence that having low testosterone is a risk factor for cardiovascular health problems. Testosterone replacement therapy
References
1. US Food and Drug Administration. FDA Drug Safety Communication: FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke with use. www. fda.gov/Drugs/DrugSafety/ucm436259. htm. Published March 3, 2015. Accessed April 6, 2015. 2. US Food and Drug Administration. Testosterone replacement therapy. www.fda.gov/downloads/Advisory Committees/CommitteesMeeting Materials/Drugs/ReproductiveHealth DrugsAdvisoryCommittee/UCM 416461.pdf. Published September 17, 2014. Accessed April 6, 2015. 3. US Food and Drug Administration. Testosterone Products: FDA/CDER statement - risk of venous blood clots. www.fda.gov/safety/medwatch/ safetyinformation/safetyalertsforhumanmedicalproducts/ucm402054.htm. Published June 20, 2014. Accessed April 6, 2015. 4. US Food and Drug Administration. FDA News. FDA advisory panel rejects testosterone replacement therapy. www.fdanews.com/articles/ 167396-fda-advisory-panels- reject-tes tosterone-replacement-therapy. Published September 26, 2014. Accessed April 6, 2015. 5. Vigen R, O’Donnell CI, Barón AE. Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels. J Am Med Assoc. 2013;310:1829-1836. 6. Xu L, Freeman G, Cowling BJ, Schooling CM. Testosterone therapy and cardiovascular events among men: a systematic review and meta-analysis of placebo-controlled randomized trials. BMC Med. 2013;11:108.
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Men’s Health PROSTATE CANCER THERAPIES INCLUDED IN NEW ONCOLOGY CARE MODEL A new payment model announced by the US Department of Health & Human Services offers providers the potential to receive at least $160 per month for patients who are undergoing chemotherapy treatment. The per-beneficiary, permonth (PBPM) allocation is part of a 2-pronged approach that also includes a performancebased payment to incentivize practices to reduce costs and improve care for this patient population. Hormonal therapies, including antiandrogen therapy used for the treatment of prostate cancer, are among the therapeutic regimens eligible for inclusion under this model. The goal of this new model, known as the Oncology Care Model (OCM) and developed by the Centers for Medicare & Medicaid Services (CMS) Innovation Center, is to provide highquality, well-coordinated, appropriately incentivized oncology care while controlling expenses and reducing costs, according to information provided by CMS. It also aligns with the US Department of Health & Human Services’ goal of moving toward provider
payments that are based on quality of care, rather than quantity. It is estimated that more than 1.6 million people are diagnosed with cancer annually, the majority of whom are at least 65 years old and Medicare beneficiaries. “Based on feedback from the medical, consumer and business communities, we are launching this new model of care to support clinicians’ work with their patients,” Patrick Conway, MD, CMS Chief Medical Officer and Deputy Administrator for Innovation and Quality, stated in a release announcing the new care model. “We aim to provide Medicare beneficiaries struggling with cancer with high-quality care around the clock and to reward doctors for the value, not volume, of care they provide. Im-
proving the way we pay providers and deliver care to patients will result in healthier people.” Through this model, CMS will provide qualifying providers with the $160 PBPM care management payment for each eligible beneficiary receiving chemotherapy and the care related to it. Payments will be made for the duration of a 6-month episode, hinged on the initiation of treatment with a preset list of chemotherapy drugs. Medications on this list include antiandrogen therapies that are used in the treatment of prostate cancer, as well as other hormone therapies related to treating this disease. A complete list of eligible drugs is provided in the program application, which is available by visiting the CMS website. The PBPM payment will remain constant for
OCM’s designated 5-year performance period, and comes in addition to feefor-service payments. Eligible practices can be physician groups or solo practitioners who administer cancer chemotherapy and who are enrolled in Medicare. They must also meet the following requirements to participate in OCM and receive payment: • Provide core functions of patient navigation • Document a care plan that encompasses the Institute of Medicine Care Management Plan • Give patients aroundthe-clock access to an appropriate clinician who has real-time access to patient medical records • Treat patients according to nationally recognized clinical guidelines
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Men’s Health • Use data to drive quality improvement • Use electronic health records and attest to stage 2 of Meaningful Use by the third year of participation. As part of their participation, practices must also report data quarterly to the CMS Innovation Center on eligible, participating beneficiaries. The Innovation Center will monitor participating practices to ensure that patients are accessing and receiving highquality care, practices have the necessary infrastructure in place to deliver comprehensive care, and practices are submit-
ting required data. Monitoring by the Innovation Center may include site visits, tracking and analysis of data, patient surveys, and medical record audits. Payments may be billed to Medicare for the entire 6-month chemotherapy episode, whether or not the patient receives chemotherapy treatment for the full 6 months; payments cannot be billed to Medicare once the patient enters hospice. After an episode ends, another 6-month episode may be started if chemotherapy treatment is still active and being billed. Management of
patients who are not receiving chemotherapy will not be eligible for this model. The program is voluntary for oncology practices and payers, and CMS is asking for nonbinding letters of intent to gauge interest, due April 9 for payers and May 7 for practices. Those who submit completed, timely letters of intent will be eligible to submit final applications (due June 18). CMS is also encouraging participation from other payers, including commercial insurers, state Medicaid agencies, and other government payers. The agency will
publicly post a list of payers who have submitted letters of intent and agreed to the posting; the agency will also post a list of practices, based on the same conditions. Payers and practices will then have an opportunity to discuss and coordinate collaboration within the OCM. Provider applications will be evaluated using a process that favors those who are partnering with approved payers. The program is slated to begin in spring 2016, and applicants will be notified of their selection status within 6 months from the date they submit their application.
UROLOGY ASSOCIATION PRESSES FOR DELAYING TRANSITION TO ICD-10 The American Urological Association (AUA) is continuing to put pressure on the US government to postpone an imminent transition to the International Classification of Diseases, Tenth Revision (ICD-10) until more practices have time to adjust to the new set of billing codes. In his testimony to a US House of Representatives subcommittee as a member of the AUA, William J. Terry, Sr, MD, outlined the organization’s concerns with ICD-10 implementation.
Released earlier this year, the transcript of Dr Terry’s testimony in February demonstrates the association’s concerns with an implementation date for the new codes of October 1, 2015, including increased adminis trative and financial burdens that urology practices may incur. “I hope that you will keep in mind the concerns of practicing physicians—particularly those in small practices—balanced with proven advantages of ICD-10 on direct patient care and weighed against the consequences of a poorly executed implementation,”
Dr Terry said in his testimony. “This is what I always discuss with my patients when sharing in the decision on various treatment options; ‘Do the benefits outweigh the risks?’ ” The association is also asking the Centers for Medicare & Medicaid Services (CMS) to release the results of testing it has done on some practices in order to shed light on the ease or difficulty of using ICD-10. “We urge CMS to release the details of its end-to-end testing, as well as its contingency plans should providers not be prepared on Octo-
ber 1, 2015. We urge Congress to delay implementation of the ICD-10 code set and appoint a committee to better study the ‘risks and benefits,’ ” Dr Terry stated, according to a summary of his testimony. In the summary, he said that if a delay is impossible, Congress should consider legislating a period during which physicians can use ICD-10 or keep using ICD-9. Sim ilar sentiments were voiced in a March 2015 letter to CMS Acting Administrator Andrew Slavitt from the AUA and more than 50 other national medical associa-
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Men’s Health tions, including the American Medical Association, as well as 47 state medical associations. They stated that the ICD-10 transition is “one of the largest technical, operational, and business implementations in the healthcare industry in the past several decades.” The signatory organizations urged the following: • Because only 89% of claims were accepted in the March 2014 end-to-end test and 76% in the November 2014 test, and the number of practices tested was very small, CMS should release more detailed end-toend testing results, including the type and size of providers who tested use of ICD-10, the number of claims tested by each practice, the percentage of claims processed successfully, details about problems that occurred, and what steps need to be taken to correct the problems • The Physician Quality Reporting System and Meaningful Use qual ity reporting periods straddle October 1, and CMS has not discussed how it plans to address the reporting of these metrics after the transition to ICD-10. The organizations urged CMS to clarify how it
plans to ensure that the measure calculations for these programs are not adversely impacted by the transition, ensure that crosswalks do not attribute increased costs to a physician’s ValueBased Modifier score when switching to ICD-10, and that the changes in measure specifications will be stable and budget-neutral for providers • CMS should commit to providing advance payments to physicians who are experiencing a severe financial hardship as a result of the change to ICD10, particularly if the issue originates on Medicare’s end, and should work with the Office of the National Coordinator for Health Information Technology to provide information about electronic health record–vendor readiness for ICD-10 codes • CMS should ensure that it will not audit claims simply for code specificity. The actual financial cost for practices to implement ICD-10 has been a source of study and debate. An article published in the Journal of the American Health Information Management Association pegged the
THE ACTUAL FINANCIAL COST FOR PRACTICES TO IMPLEMENT ICD-10 HAS BEEN A SOURCE OF STUDY AND DEBATE. cost of implementation for small practices at $1960 to $5900.1 A paper released in February 2014 that was prepared by Nachimson Advisors for the American Medical Association, however, suggested a range of costs to providers depending on the size of the practice: $56,639 to $226,105 for a small group practice (3 providers, 2 administrators); $213,364 to $824,735 for a medium group practice (10 providers, 1 coder, 6 administrators); and $2 million to $8 million for a large group practice (100 providers, 64 coding staff). This 2014 report was an update of a study on the same topic that Nachimson Advisors first released in 2008.2,3 Dr Terry said that physicians are resigned to implementation of ICD10 but hope that CMS will put in place measures to mitigate some of the potentially devastating
effects on healthcare practices. Jonathan Rubenstein, MD, Director of Coding and Compliance with Chesapeake Urology, Baltimore, MD, and a member of the AUA Coding & Reimbursement Committee, echoed some of Dr Terry’s concerns, and noted that the AUA will work hard to help its members prepare for this transition. “While there is controversy on the exact financial burden this will place on providers and practices, we know the burden will be great,” Dr Rubenstein said. “The AUA will continue to support its members and assist them in their preparations for this transition to ICD-10.” CMS declined to comment for this story.
References
1. Kravis TC, Belley S, Smith DM, Averill RF. Cost of converting small physician offices to ICD-10 much lower than previously reported. J AHIMA website. http://journal.ahima. org/wp-content/uploads/Week-3_ PDFpost.FINAL-Estimating-the-Costof-Conversion-to-ICD-10_-Nov-12. pdf. Published November 12, 2014. Accessed April 2, 2014. 2. Nachimson Advisors, LLC. The cost of implementing ICD-10 for physician practices – updating the 2008 Nachimson Advisors Study. A report to the American Medical Association. February 12, 2014. 3. The impact of implementing ICD10 on physician practices and clinical laboratories: a report to the ICD-10 coalition. Nachimson Advisors, LLC. Nachimson Advisors website. www. nachimsonadvisors.com/Documents/ ICD-10%20Impacts%20on%20 Providers.pdf. Published October 8, 2008. Accessed April 2, 2015. RETA #1 AM IL CL ONG INIC IANS
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Malpractice News Failure to Properly Communicate Change in Coumadin Dosage And other malpractice news The Case The plaintiff’s decedent was placed on Coumadin in January 2002 due to her chronic pulmonary emboli. Dr Heather Heiman with Northwestern Medical Faculty Foundation became the decedent’s primary physician in August 2004. In January 2005 Dr Heiman saw the 80-yearold decedent for a follow-up visit after a recent hospitalization for heart failure and shortness of breath. Dr Heiman ordered a blood draw to check international normalized ratio (INR) levels, which came back at the elevated level of 3.7. Dr Heiman sent an email to nurse Susan Brankle to contact the decedent and inform her to reduce her Coumadin. Nurse Brankle documented that she informed the dece-
dent and called in a prescription for 4 mg tablets. The decedent was admitted to a hospital 5 days later with significantly elevated INR levels and a spinal bleed which caused paralysis. She was transferred for nursing home care and died in June 2005. The plaintiff claimed that Dr Heiman’s instructions were ambiguous, that a repeat INR should have been performed in 2 or 3 days, and that Brankle did not properly instruct the decedent, and that Brankle should have notified the family and the visiting nurse of the medication change. The defendant claimed that Dr Heiman had given proper instructions and that the plan to repeat the INR in 13 days was proper. Nurse Brankle also claimed that
the decedent was properly instructed. The defendants also claimed that the decedent had properly managed her Coumadin through 11 dose changes, so there was no reason to notify the family or visiting nurse. The Verdict Settlements were reached prior to trial with the other hospital for $5000 and 2 physicians for $35,000. A defense verdict was returned after trial. Estate of Alice Bowen, deceased v. Northwestern Medical Faculty Foundation. Cook County, IL. Circuit Court, Case No. 07L-6249.
Failure to Have Man Go to the Emergency Room When Wife Reports Lethargy The Case The plaintiff’s decedent had suffered from chronic pain since 1999 due to severe periph-
eral vascular disease. He received treatment from numerous pain medicine specialists at various times during the ensuing 10 years. The treatment included non-narcotic pain medications, as well as narcotic pain medications, including morphine, oxycontin, fentanyl, hydrocodone, and methadone. On several occasions during those years the decedent ingested more than the prescribed narcotics, which necessitated hospitalizations. The decedent began treatment with family practice physician John A. Panozzo in June 2004 while also continuing treatment with pain specialists. In April 2009 the decedent was diagnosed with a kidney stone and Dr Panozzo referred him to a urologist. A litho-
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Malpractice News STAKEHOLDER PERSPECTIVE TAKE-HOME POINTS Donald J. Dietz, RPh, provides insight on the role of pharmacists in medical malpractice Several messages resonate from these unfortunate cases that resulted in 3 patients losing their lives. The healthcare providers in these cases appeared to be well-meaning, and believed they made rational, appropriate medical decisions based on their knowledge of their patients’ respective situations. As pharmacists, physician assistants, and nurse practitioners, we may want to consider these learning opportunities for future encounters with patients: • Always ask your patient what other medications they are taking, to ascertain whether multiple prescribers are treating them, and because they may be receiving multiple prescriptions to treat the same condition. • Ensure all telephone communications are as clear as possible, with no possibility for misinterpretation. When receiving a phone-in prescription order, always transcribe it immediately, and always repeat it back to the caller for confirmation. If it does not make good clinical sense, or if there is any doubt when you prepare to dispense the prescription later, please call the prescriber back to confirm. • As more electronic health record/electronic medical record
tripsy procedure was performed by the urologist to dissolve the stone and the decedent developed postoperative bleeding outside his kidney. The decedent took his narcotic medications at home for the pain, including hydrocodone and oxycontin. The pain, however, persisted and he went to an emergency room and was hospitalized. The decedent subsequently developed respiratory depression after more pain medication was administered in the emergency room and
he required intubation. After the plaintiff was extubated he complained of severe pain and threatened to leave the hospital against medical advice. Dr Panozzo then prescribed a Duragesic Fentanyl patch which was intended to be on for 72 hours and then be replaced with a new patch. Dr Panozzo also prescribed oral narcotics as needed for breakthrough pain, as well as an anti-anxiety medication. During the remainder of his hospitalization the decedent had no breath-
(EMR) systems are incorporated into practice, it is essential to completely document interventions, including follow-up treatments and lab tests. • Prescribers accessing EMRs to prevent duplicate medications and testing will lower healthcare costs and potentially reduce adverse outcomes. Pharmacists, physician assistants, and nurse practitioners should welcome and strive for access to EMRs, to provide better, more comprehensive patient care. • These examples demonstrate that it is worth the extra time and effort to communicate instructions to another family member, caregiver, or supporting healthcare practitioner when you are unsure whether a patient understands or will follow the medication instructions or treatment prescribed. To avoid situations like these during future patient encounters in our pharmacies or clinics, we may want to consider extra steps for providing necessary, important communication to ensure positive outcomes. Mr Dietz is Editor-in-Chief of the journal, and Vice President of Pharmacy Healthcare Solutions, Inc, Pittsburgh, PA.
ing problems while awake or asleep while receiving supplemental oxygen and monitoring. The decedent was discharged home and the next day the decedent’s wife called Dr Panozzo reporting that the decedent looked tired, lethargic, and glassy-eyed and she questioned his medications. Dr Panozzo claimed that he told the woman to take off the Fentanyl patch without replacing it, discontinue Ativan which the decedent had been prescribed,
as well as all narcotic medications and then monitor the decedent. Dr Panozzo also claimed that the wife was told to take the decedent to an emergency room if he worsened. The wife disputed Dr Panozzo’s version of the conversation. After the call the decedent did not get worse or exhibit any breathing problems before he went to sleep around midnight. He was found dead in bed the next morning. The plaintiff claimed that Dr Panozzo should RETA #1 AM IL CL ONG INIC IANS
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Malpractice News have instructed the wife to take the decedent to the emergency room immediately at the time of her call the previous night. The plaintiff claimed that the combination of the drugs the decedent was using caused a synergistic heightened risk of respiratory distress and that the risk of respiratory distress increased while he was asleep, which with his COPD and presumed sleep apnea caused his death. The defendant claimed that the decedent did not suffer respiratory distress in the hospital and that he was on less medications after his discharge than while he was in the hospital. The defendant maintained that the decedent must have taken additional narcotics from his home supply contrary to instructions, since his oxycontin supply could
not be accounted for after his death. The Verdict A defense verdict was returned. Estate of Wayne Stahr, deceased v. Dr John A. Panozzo, Primary Health Associates, PC. Cook County, IL. Circuit Court, Case No. 11L-4482.
Failure to Monitor Woman’s Use of Fentanyl Patches in Light of History of Drug Abuse The Case The plaintiff’s decedent, age 34, died from an overdose of Fentanyl in September 2001. The Fentanyl had been prescribed to her by pain management physician Narinder Khosla. Several weeks prior to her death, the decedent had been hospitalized after she was found chewing on Fentanyl patches. At that time the decedent’s psychiatrist, Gregory Bishop,
was consulted and recommended inpatient substance abuse, which the decedent refused. The decedent was then discharged from the hospital with orders to follow-up with Dr Bishop and to discontinue use of Fentanyl. The decedent returned to Dr Khosla, who was unaware of the hospitalization, and provided the decedent with another prescription for Fentanyl patches. The decedent’s death was due to chewing on the patches. The plaintiff claimed that Dr Khosla was negligent in providing the decedent, a long-time drug abuser and addict, with the Fentanyl patches. The plaintiff also alleged negligence by Dr Khosla in failing to refer the decedent to an addictionologist and failing to perform urine drug screens
while the decedent was in his care. The plaintiff claimed that Dr Bishop was negligent in failing to inform Dr Khosla of the hospitalization and order to discontinue the use of the Fentanyl. The defendants denied liability, arguing that the decedent’s mother was aware that the decedent had been chewing on patches the day before her death and made no effort to contact a medical provider. The Verdict A defense verdict was returned. Linda Newman, Adminx of the Estate of Sarah Serrano v. Pain Clinic of North Central Ohio, Inc, et al. Erie County, OH. Court of Common Pleas, Case No. 2012CV0750.
Reprinted with permission from Medical Malpractice Verdicts, Settlements and Experts, Lewis Laska, Editor, Nashville, Tennessee, 800-298-6288.
DO YOU HAVE A CLINICAL CHALLENGE TO SHARE? We are currently accepting clinical challenges, including a case and a commentary explaining best practice. We want to hear from pharmacists, nurse practitioners, physician assistants, and medical directors about how they have managed patients/customers. Contact: info@insidepatientcare.com with your clinical challenge 1 AMON RETAIL CLINICG IANS #
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Continuing Education Release date: May 15, 2015 Expiration date: May 31, 2016 Estimated time to complete activity: 0.5 hour Jointly provided by Postgraduate Institute for Medicine and Center of Excellence Media, LLC.
This activity is supported by an independent educational grant from AstraZeneca. TARGET AUDIENCE This activity has been designed to meet the educational needs of community clinical and retail pharmacists. EDUCATIONAL OBJECTIVES After completing this activity, the participant should be better able to: • Explain the role of community pharma cists in ensuring safe and effective medication use • Review factors that can impact clinical outcomes, including patient, disease, and medication • Utilize strategies to improve patient care, including patient education and medication adherence counseling • Describe the ways that community pharmacists can help their patients achieve optimal health and value through the knowledge and application of traditional and nontraditional care • Provide accurate and appropriate counsel as part of the treatment team FACULTY Rebecca J. Mahan, PharmD, CGP Assistant Professor of Pharmacy Practice Geriatrics Division Texas Tech University Health Sciences Center School of Pharmacy Abilene, TX Pharmacist Continuing Education Accreditation Statement Postgraduate Institute for Medicine is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Credit Designation Postgraduate Institute for Medicine designates this continuing education activity for 0.5 contact hour(s) (0.05 CEUs) of the Accreditation Council for Pharmacy Education. (Universal Activity Number - 0809-999915-121-H01-P) Type of Activity : Knowledge
Empowering Community Pharmacists as Health Consultants: Polypharmacy by REBECCA J. MAHAN, PHARMD, CGP
P
olypharmacy is a growing problem in healthcare, especially for adults ≥65 years old. There is no consensus definition for polypharmacy; it can refer to the inappropriate use of a single medication or to strict definitions based on the number of medications taken by a single patient, commonly 5 or more.1-3 The causes of polypharmacy include coexisting medical conditions, the involvement of multiple providers, and the use of medications to treat side effects of other medications, often referred to as a prescribing
cascade.2,3 It is estimated that 20% to 65% of adults ≥65 years of age take at least 1 potentially inappropriate medication.4 Polypharmacy places a patient at increased risk for adverse drug events, hospitalization, and medication nonadherence. In one study, the risk of adverse events increased from 13% in patients taking 2 medications to 58% in those taking 5 medications and up to 82% in those taking 7 or more medications.3 A second study found that outpatients taking 5 or more medications had an 88% higher likelihood for
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 COIs 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.
or their spouse/life partner have with commercial interests related to the content of this CE activity:
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:
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.
Name of Faculty or Presenter
Reported Financial Relationship
Rebecca J. Mahan, PharmD, CGP
Nothing to disclose
The planners and managers reported the following financial relationships or relationships to products or devices they
The following PIM planners and managers—Laura Excell, ND, NP, MS, MA, LPC, NCC; Trace Hutchison, PharmD; Samantha Mattiucci, PharmD, CCMEP; Jan Schultz, RN, MSN, CCMEP; and Judi Smelker-Mitchek, RN, BSN—hereby state that they or their spouse/life partner do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months.
Instructions for Credit There is no fee for this activity. To receive credit after reading this CE activity in its entirety, participants must complete the posttest and evaluation. The posttest and
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Continuing Education adverse events compared with those taking fewer medications.1 The impact of polypharmacy is widespread, affecting patients, their caregivers, and the healthcare system. Patients can become overwhelmed in trying to balance complicated dosing regimens and may even stop taking medications because of the sheer complexity of the task. According to the Centers for Medicare & Medicaid Services estimates, polypharmacy costs the United States $50 billion annually.5 A typical patient can obtain care from numerous healthcare professionals, and community pharmacists are a vital member of any patient care team. In fact, pharmacists are often the single provider of medication access for a patient. As a result, they are in a unique position to empower themselves and the patient to combat polypharmacy issues.
Case Study JC is an 81-year-old man who was recently discharged from the hospital for a stroke. He has been coming to your pharmacy for years, and his wife fears he is taking too many medications. evaluation can be completed online at http://ce.lynxcme. com/COE176-6. 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 published and/or investigational uses of agents that are not
He has a medical history of hypertension, chronic obstructive pulmonary disease (COPD), diabetes, cognitive impairment, and depression. To his wife’s knowledge, he has no known drug allergies. She has not filled any of the new medications prescribed at the hospital because her husband has not yet followed up with his primary care physician (PCP) since his stroke. She provides you with the medication information shown in the Table. There are several questions that should be considered in this case. These include: How many providers is the patient currently seeing? Are there any duplications of therapy? Do all medications have an indication based on medical history? Are any medications being used to treat the side effects of another medication? Community pharmacists are a bridge for the patient and their PCP when it comes to discussing medication issues. When a potential issue is identified, the pharmacist should inform the PCP, as well as maintain open lines of communication with the patient about what is being recommended to the physician. Sending a current medication list to 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. Current Medications Prescribed to an 81-Year-Old Patient Medication Donepezil 5 mg Aspirin 81 mg Fluticasone propionate 250 mcg/salmeterol 50 mcg inhalation powder
Directions
Prescriber
Added at hospital
1 tablet PO daily
Hospitalist
Yes
1 tablet PO daily
Self-prescribed
1 inhalation PO BID
PCP
1 tablet PO daily
Cardiologist
Bisoprolol 5 mg Rosuvastatin 40 mg
1 tablet PO daily
Hospitalist
Yes
Apixaban 5 mg
2 tablets PO daily
Hospitalist
Yes
Hydrochlorothiazide 25 mg
1 tablet PO daily
PCP
Furosemide 40 mg
1 tablet PO BID
Cardiologist
Metformin 500 mg
2 tablets PO daily
Endocrinologist
Metoprolol tartrate 25 mg
½ tablet PO BID
Hospitalist
Multivitamin
1 tablet PO daily
Self-prescribed
Esomeprazole 40 mg
1 capsule PO QAM
Hospitalist
Oxybutynin XL 5 mg
1 tablet PO daily
PCP
Albuterol inhalation
1 puff q4h as needed
PCP
Sertraline 50 mg
1 tablet PO HS
PCP
Simvastatin 40 mg
1 tablet PO HS
Cardiologist
Tiotropium 18 mcg
Inhale contents 1 capsule PO daily
Hospitalist
Yes Yes
Yes
BID indicates twice daily; HS, half strength; PCP, primary care physician; PO, by mouth; q4h, every 4 hours; QAM, every morning.
the PCP will ensure that he or she sees the full medication picture and will promote patient care. This intervention requires little time by the pharmacist, which can be a precious commodity in the community setting. Because the risk for adverse events increases with polypharmacy, identification of medications used to treat the side effects of another medication is paramount. When new medications are prescribed to treat side effects such as these, a prescribing cascade can ensue, leading to a plethora of unnecessary medications for the patient. In older adult populations, patients are particularly susceptible to anticholinergic effects of medications, which result in constipation, dry mouth, urinary incontinence, and cognitive impairment.6
Anticholinergic drugs can be identified with many tools, such as the Beers Criteria.6 If a patient starts a medication with anticholinergic side effects, they may later ask their pharmacist about constipation medications or call about a prescription refill in a confused state. If this occurs, the pharmacist should contact the PCP to discuss alternative medications with a safer side-effect profile. Another scenario may involve a patient with dementia who has been prescribed olanzapine (by a psychiatrist) for repeatedly striking out at her caretaker. After a few months, the patient’s daughter brings in a prescription from the PCP for sliding-scale insulin. You note that the patient has never had a history of diabetes and confirm this with her daughter. Here, olanzapine may be RETA #1 AM IL CL ONG INIC IANS
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Continuing Education causing hyperglycemia, and the PCP may not be aware that this drug was prescribed by the psychiatrist. Instead of filling the sliding-scale insulin, the pharmacist is in a position to call the PCP to discuss the possibility that the patient’s hyperglycemia is related to olanzapine use and recommend transitioning to a different antipsychotic agent that carries less metabolic risk.
For a patient taking a complicated drug regimen with 4-times-daily dosing, adherence is estimated at only 50%. The Beers Criteria can also serve as a guide for choosing the safest therapy for older adults that avoids unnecessary side effects or exacerbations of other disease states.6 The STOPP criteria are similar to Beers Criteria in that they identify medications that may be inappropriate in older adults. The STOPP criteria can be used with the START criteria, which were developed to guide medical professionals to medications that may be indicated for older adults.7 Being familiar with all of these tools arms the pharmacist with evidence-based recommendations to discuss with a patient’s PCP when making potential treatment decisions. Medication adherence should be assessed for all patients when determining treatment plans. Therapeutic goals cannot be evaluated accurately for a patient who is prescribed 12 medications and chooses to only take 6, or who misses half of his or her doses. Studies indicate that patient adherence to medications is greatest after initiation or hospitalization and gradually declines over time. Reasons for discontinuing medication include not feeling that it
is necessary, intolerable side effects, cost of therapy, and complicated dosing regimens.8 For a patient taking a complicated drug regimen with 4-times-daily dosing, adherence is estimated at only 50%.8 Medication nonadherence can be identified by speaking with the patient and by a review of medication dispensing records. Many pharmacies have started to implement adherence programs aimed at helping patients stay on track and may even provide percentages of medications filled on time. In taking a proactive approach, pharmacists can counsel patients on new medications that have particularly confusing directions or administration to ensure the best possible adherence.
Case Study Resolution Based on the medication list, JC has seen—and has had prescriptions written by—4 different providers. The specialists may share office notes and updates among each other, or there may be no communication whatsoever, increasing the patient’s risk for drug interactions. If he were to take all of the medications as prescribed, he would have a daily pill burden of 18, in addition to the inhalations that are needed to manage his COPD. In reviewing his medication list, there are multiple instances of duplication of therapy. He has 2 ß-blockers and 2 statins. Consumption of 2 ß-blockers places him at high risk for bradycardia, and taking 2 statins increases the risk for acute renal failure and myopathy, all situations that may result in rehospitalization. Knowing why he has duplication is difficult to determine from the medication list. Potential reasons include incomplete medication reconciliation at admission, not including his prior ß-blocker and statin when listing his previous medications, or the medications may have been switched to
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Continuing Education formulary while JC was in the hospital and not switched back at discharge. Based on the known medical history, there are no known indications for furosemide, oxybutynin, or esomeprazole. In evaluating the use of furosemide, the pharmacist should assess other medications as a potential cause of edema, such as amlodipine or gabapentin. JC is not currently taking medications that may cause edema, and he has hypertension. Although not considered first-line treatment per guidelines, furosemide may be prescribed for his hypertension. In addition, the use of oxybutynin is concerning because of its anticholinergic effects. Looking at the medications, the pharmacist may note that furosemide increases urinary frequency, which may have been mistaken for urinary incontinence. Of note, the furosemide was prescribed by a cardiologist, whereas the oxybutynin was prescribed by the PCP. Esomeprazole was started during the recent hospitalization. If JC was limited in mobility or at risk for ulcers, a proton pump inhibitor may have been prescribed prophylactically while he was in the hospital. After gathering the above information, the pharmacist can contact the PCP to discuss the duplications and identify potentially unnecessary medications for JC. For the duplication issue, the PCP could recommend which medication the patient should continue using. If discussion with the PCP indicates that JC does not have a medical condition requiring furosemide, oxybutynin, or esomeprazole, discontinuation of those medications may be warranted. In addition, the pharmacist should offer to fax a full medication profile to the PCP in preparation for the hospital follow-up appointment. Once decisions have been made, the pharmacist may counsel JC and/or his wife regarding changes and recommendations going forward.
Conclusion As a community pharmacist, the patient case presented here is likely one that you have seen repeatedly. For patients who use 1 pharmacy to fill all of their prescriptions, you may be the medical professional who knows the most about where the patient has been within the healthcare system and are in a unique situation to address the continuum of care. In promotion of patient safety and effective use of medications, pharmacists can work as partners with a patient’s PCP in maintaining open lines of communication regarding prescriptions from all prescribers. In instances that are less urgent, a pharmacist may choose to discuss recommendations with the patient, who can then pass the information to their PCP at the next appointment. Polypharmacy is not only a patient issue, but a concern that affects the entire healthcare system. Armed with the appropriate tools, pharmacists are excellent patient advocates with a unique educational background to best assess safe and effective medication use. ❚ References
1. Maher RL, Hanlon J, Hajjar ER. Clinical consequences of polypharmacy in elderly. Expert Opin Drug Saf. 2014;13:57-65. 2. Wimmer BC, Dent E, Visvanathan R, et al. Polypharmacy and medication regimen complexity as factors associated with hospital discharge destination among older people: a prospective cohort study. Drugs Aging. 2014;31:623-630. 3. Patterson SM, Cadogan CA, Kerse N, et al. Interventions to improve the appropriate use of polypharmacy for older people. Cochrane Database Syst Rev. 2014;10:CD008165. 4. Reeve E, Wiese MD, Hendrix I, et al. People’s attitudes, beliefs, and experiences regarding polypharmacy and willingness to deprescribe. J Am Geriatr Soc. 2013;61:1508-1514. 5. Lyles A, Culver N, Ivester J, Potter T. Effects of health literacy and polypharmacy on medication adherence. Consult Pharm. 2013;28:793-799. 6. American Geriatrics Society 2012 Beers Criteria Update Expert Panel. American Geriatrics Society updated Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2012;60:616-631. 7. O’Mahony D, O’Sullivan D, Byrne S, et al. STOPP/ START criteria for potentially inappropriate prescribing in older people: version 2. Age Ageing. 2015;44:213-218. 8. Pasina L, Brucato AL, Falcone C, et al. Medication non-adherence among elderly patients newly discharged and receiving polypharmacy. Drugs Aging. 2014;31:283-289.
COE176-6
Dr Mahan is Assistant Professor of Pharmacy Practice, Geriatrics Division, Texas Tech University Health Sciences Center School of Pharmacy, Abilene, TX. RETA #1 AM IL CL ONG INIC IANS
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PRODUCT LABELING
Upcoming Changes in Pregnancy and Lactation Product Labeling [42]
The Retail Pharmacy Diversifying Pharmacy Revenues: Opportunities for Growth and Differentiation by KEVIN C. DAY, PHARMD, and JOHN O. BECKNER, RPH
As reimbursements continue to shrink, profitability is a growing challenge for pharmacies across the country. Luckily, there are many opportunities for pharmacies to evolve their business to stay in line with, and lead in, a changing marketplace. }} }} MANY PHARMACIES are now offering differentiated products and services designed to attract new business, provide alternative sources of revenue, and most importantly, offer value to the patients they serve. Discussing diversification of pharmacy practice and revenue streams causes many to raise eyebrows, and for good reason. We have been talking about new opportunities—from medication therapy management and direct patient care, to team-based collaboration and ambulatory care—for decades, with no substantial change. The current challenges in the marketplace—falling reimbursement, in creasing costs, and intensifying competition—paired with growing opportunities
through changing state and federal laws, have escalated those discussions and primed the landscape for growth and diversification. Opportunities for change include point-of-care testing, clinical trial recruitment, and pharmacogenomic testing. Medication synchronization is another opportunity for growth and differentiation.
Opportunities for Change
1/
Point-of-care testing. Point-of-care testing involves performing a diagnostic test outside of a laboratory that produces a rapid, reliable result to aid in disease screening, diagnosis, and/or patient monitoring. Most of these tests can be completed with a small blood sample
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Inside the Retail Pharmacy and appropriate testing equipment. A pharmacy’s ability to legally complete these tests depends on some state restrictions, and the Clinical Laboratory Improvement Amendments (CLIA) waived test systems, available through the US Food and Drug Administration,1 the Centers for Medicare & Medicaid Services,2 and the Centers for Disease Control and Prevention.3 Several of these tests are also best used in conjunction with a collaborative practice agreement. These tests break down into 2 large segments: (1) rapid tests for viruses (eg, influenza A and B, and group A streptococci), and (2) more traditional laboratory tests (eg, cholesterol, blood glucose, warfarin, hormone, and vitamin levels). A new point-of-care testing certificate is being launched by the National Association of Chain Drug Stores, and may be of interest to pharmacists who hope to provide these tests.4 The point-of-care tests for influenza A and B, and group A streptococci, have existed for many years, but have only recently been studied for feasibility and effectiveness in the community pharmacy setting.5,6 Point-of-care testing for infectious diseases provides an excellent opportunity for community pharmacies to enhance revenue by expanding patient care services while improving health at patient and population levels. It allows for the screening and diagnostic process to be completed during a single encounter, thereby improving access to care, counseling, and patient outcomes. It can also improve the prevention and treatment of disease. These tests for influenza A and B, and group A streptococci, are administered via a nasal and throat swab, respectively, and both are CLIA waived tests. Each test takes just a few minutes for screening, administration, and generating results. As a revenue stream, both of these tests can have a flat administration fee that would more than cover the costs of the tests and employees’ time. More importantly, these tests can open up more opportunities, especially within
the scope of a collaborative practice agreement. Many early adopters of these tests are in states that have more liberal collaborative practice agreement regulations, such as Michigan and Nebraska. These regulations allow a collaborating physician to sign off on a protocol through which a pharmacist can evaluate a patient for eligibility of the test, administer the test to those eligible, read results, and immediately start treatment if the test is positive.7 This takes a $25 test (doubled for testing of influenzas A and B) and adds a prescription for oseltamivir (Tamiflu), and/or over-thecounter medication recommendations to reduce bothersome symptoms. The same methodology can work through a similar collaborative agreement for Streptococcus testing and other tests that have recently come along, including those for hepatitis C, human immunodeficiency virus, and Helicobacter pylori.
Point-of-care testing for infectious diseases provides an excellent opportunity for community pharmacies to enhance revenue. Pharmacies have been participating in varying levels of point-of-care laboratory testing for years; everything from blood pressure screenings, hormone levels, cholesterol screenings, and running in-house anticoagulation testing. As collaborative practice agreements become more mainstream, providers begin to be paid based on performance metrics, and patients approach healthcare as informed consumers, these opportunities will continue to grow. Offering services such as point-of-care testing on a single-stop, single-fee basis can improve patient health (because far too many patients do not get regular screenings for which they are indicated), improve health plan quality metrics (which can then be used as leverage for reimburseRETA #1 AM IL CL ONG INIC IANS
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Inside the Retail Pharmacy ment), and, of course, provide a new revenue stream.
2/
Clinical trial recruitment. A widely unknown, diversified revenue model is to partner with research agencies that are contracted to recruit patients for clinical trials. Several of these groups will pay per referral for sending a patient to them to enroll in a clinical trial, often with essentially no work on the referrer’s part. As we know, pharmaceutical manufacturers are spending millions of dollars on thousands of research and development projects for a wide variety of disease states. Many manufacturers outsource the recruitment process for wider access to random samples, and to potentially reduce selection bias. These recruitment companies are often hard-pressed to find volunteers, and it makes sense for healthcare professionals, including pharmacists and other healthcare professionals, to be a source for these referrals.
One way to remove workflow challenges is by instituting a medication synchronization program and appointment-based model of practice. 3/ Pharmacogenomic testing. Person-
alized medicine, pharmacogenomics, and precision medicine are all buzzwords surrounding the increasingly prevalent genetic testing being requested and required for medication prescribing. From better predicting the efficacy of codeine and clopidogrel to required biomarkers for expensive cancer medications, understanding the effects of genetic variation on medications is becoming increasingly important and prevalent. Several pharmacies have started working with a laboratory, local physicians, and payers to include genomic
testing in medication therapy management programs. There are no point-ofcare tests available for this information, but some may be able to collect genetic samples with a cheek swab and send it to a laboratory for analysis, making it so that the patient only needs to visit the pharmacy. As the costs of genetic evaluation continue to decrease and the number of medications known to be affected grows, this opportunity becomes more and more important. President Obama’s most recent State of the Union address and accompanying budget called for the collection and study of 1 million patients’ complete DNA.8,9 This research, along with thousands of private investigations, will undoubtedly lead to more indications for genomic testing.
Rolling into Medication Synchronization These 3 diversified revenue options may seem overwhelming, but the time is ripe for a reimagining of the pharmacy workflow system, and the revenues that support it. When community pharmacy first entered the immunization arena, the process of providing this service also seemed overwhelming. Now, it fits relatively seamlessly into workflows across the country, regardless of prescription volume. These other clinical offerings can do the same with the right systems and goals. One way to remove workflow challenges is by instituting a medication synchronization program and appointment-based model of practice. A system that reduces patients’ visits to a store to once a month and removes a vast majority of incoming phone calls frees up time to work in other services. It also allows pharmacists to meet with patients at a preset time during which many will find they are able to add services, from immunizations to medication therapy management, and even tests such as hemoglobin A1c, cholesterol, vitamin D, and genetic screening. These appointments are a natural
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Inside the Retail Pharmacy place for these (and other) programs, References 1. US Food and Drug Administration. Clinical laboratobecause patients generally have set ry improvement amendments (CLIA). www.fda.gov/Medi aside, or are willing to set aside, 20 to 30 calDevices/DeviceRegulationandGuidance/IVDRegulatory Assistance/ucm124105.htm. Updated April 16, 2014. minutes every months to sit down Medicalfew Directors • Physician Assistants •Accessed Nurse April Practitioners 17, 2015. • Pharmacists • Chain Headquarters • Independents for additional services. 2. Centers for Disease Control and Prevention. Clinical
“
laboratory improvement amendments (CLIA). http://wwwn. cdc.gov/clia/. Updated October 14, 2014. Accessed April 17, 2015. 3. Centers for Medicare & Medicaid Services. Clinical laboratory improvement amendments (CLIA). www.cms.gov/Regu lations-and-Guidance/Legislation/CLIA/index.html?re direct=/ clia/. Updated March 5, 2015. Accessed April 17, 2015. 4. National Association of Chain Drug Stores. Upcoming trainings. http://nacds.learnercommunity.com/upcom ing-trainings. Accessed April 17, 2015. 5. Gubbins PO, Klepser ME, Dering-Anderson AM, et al. Point-of-care testing for infectious diseases: opportunities, barriers, and considerations in community pharmacy. J Am Pharm Assoc (2003). 2014;54:163-171. 6. Fanous AM, Kier KL, Rush MJ, Terrell S. Impact of a 12-week, pharmacist-directed walking program in an established employee preventive care clinic. Am J Health Donald J. Syst Dietz, RPh, MS Pharm. 2014;71:1219-1225. Vice President 7. Akinwale TP, Adams AJ, Dering-Anderson AM, Klepser Pharmacy Healthcare Solutions, Inc. ME. Pharmacy-based point-of-care testing for infectious Editor-in-Chief diseases: considerations for the pharmacy Inside curriculum. Curr Patient Care Pharm Teach Learn. 2015;7:131-136. 8. Obama BH. Remarks by the President in State of the Dr Day is Executive ResUnion Address. January 20, 2015. www.whitehouse.gov/ ident; and Mr Beckner is the-press-office/2015/01/20/remarks-president-state-union-ad dress-january-20-2015. Accessed April 22, 2015. Senior Director, Strategic 9. Office of Management and Budget. Fiscal year 2016 Initiatives, National Combudget of the US Government. www.whitehouse.gov/sites/ munity Pharmacists Associadefault/files/omb/budget/fy2016/assets/budget.pdf. Accessed April 22, 2015. tion, Alexandria, VA.
A Call to Action We are all well awareRetail of the pharmacies chaland clinics are quickly becoming an lenges facing pharmacy and the rest of the healthcare industry. extension However, byof primary care. Inside Patient Care: Pharmacy offering these differentiated services, we & Clinics is tailored to meet the growing needs of the entire have an excellent opportunity to move healthcare team and provides practical information to treat the practice of pharmacy forward, pracpatients inside the pharmacy and retail clinics.” tice at the top ofand our care license,for provide the best care for our patients, and help revolutionize the delivery of healthcare in our country. Start today by reviewing your state law on collaborative practice agreements, and look into getting your pharmacy certified for CLIA waived tests. Then you can decide which revenue streams you would like to pursue, and begin making the connections needed to make them a reality. ❚
Inside Patient Care: Pharmacy & Clinics™ is an independent journal that provides practical information for the entire healthcare team treating and caring for patients inside the pharmacy and retail clinics. As primary care expands to provide optimal access to quality care, Inside Patient Care: Pharmacy & Clinics™ offers a forum for the team treating and coordinating patient care in pharmacies and retail clinics, including medical directors, physician assistants, nurse practitioners, pharmacists, and C-level executives, to implement the best therapeutic options, navigate the healthcare system, and achieve professional success. Each issue of the journal includes resources that will enable the retail healthcare team to provide optimal patient care—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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Inside the Retail Pharmacy
Upcoming Changes in Pregnancy and Lactation Product Labeling by ANN JOHNSON, PHARMD
In December 2014, the US Food and Drug Administration (FDA) published the Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling, better known as the Pregnancy and Lactation Labeling Rule (PLLR).1 }} KEY POINTS ❚ Manufacturers of prescription drug products approved after June 30, 2001, must revise their product labeling within 3 to 5 years ❚ Manufacturers of products approved before June 30, 2001, are only required to remove the pregnancy category from their product labeling by June 30, 2018 ❚ For many women with chronic conditions such as depression, asthma, or diabetes, prescription use is unavoidable during pregnancy
}} SINCE THE 1970s, prescription drugs have been categorized as A, B, C, D, or X, depending on their risk of use during pregnancy.2 Effective June 30, 2015, these letter designations will be replaced with the new labeling requirements.2
Labeling Changes Coming into Effect June 30, 2015 Manufacturers of prescription drug products approved after June 30, 2001, must revise their product labeling to comply with the new PLLR sections within 3 to 5 years, whereas manufacturers of products approved before June 30, 2001, are only required to remove the pregnancy category from their product labeling by June 30, 2018.2 This means that products approved prior to June 30, 2001, will not have any information regarding safety of use in pregnancy and lactation on their labels. For products approved after June
30, 2001, data for the labeling updates are expected to come from already conducted clinical studies and pregnancy exposure registries.3 Labeling for over-the-counter drugs will not change, because the new rules only apply to prescription products. Prescription products currently available will be revised during an implementation phase, and product applications submitted to the FDA for approval on or after June 30, 2015, will need to use the new formatting for pregnancy and lactation in their labeling.3
Changes to Drug Labeling Subsections Currently, product labeling associated with pregnancy and nursing is available in 3 subsections of the prescribing information (PI), sections 8.1 to 8.3. The new labeling will comprise the same 3 subsections, but with
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Inside the Retail Pharmacy different information. Sections 8.1 and 8.2 (Pregnancy, and Labor and Delivery, respectively) will be combined to create the new section 8.1 (Pregnancy). The current section 8.3 (Nursing Mothers) will be incorporated into the new section 8.2 (Lactation), along with new information about how drugs affect a mother’s milk supply. The new section 8.3 (Females and Males of Reproductive Potential) will contain information not previously required in a product’s PI, including the need for pregnancy testing and recommendations for contraception.1 According to the PLLR, each of the subsections will be required to have specific subheadings, when applicable.4 The PLLR provides a much more rigid structure for presenting information concerning drugs’ effects on pregnancy, lactation, and fertility than the old PIs did, and this should better equip pharmacists to counsel patients. When applicable, section 8.1 will now include information on the drug’s pregnancy exposure registry. The section will also include contact details and information necessary for people interested in enrolling in, or obtaining more information about, the registry.4 Pregnancy exposure registries collect information from women who receive a medication during pregnancy and compare their information with that of women who have not taken that medication during pregnancy. Because clinical trials are not done on pregnant women, this enables manufacturers to collect more in-depth data about a drug postlaunch, to improve the quality of information available for patients and healthcare practitioners. In the past, pregnancy registry information was not required to be included in a drug’s PI. Many drugs have scientifically acceptable pregnancy registries, including those used to treat cancer, asthma, epilepsy, human immunodeficiency virus (HIV), and multiple sclerosis, to name a few.5 If a pregnancy registry is available for a particular drug, the
registry should also be mentioned in the Patient Counseling Information section of the PI, along with a reference to section 8.1, where the contact information necessary for enrollment is located.6 Although a pregnancy exposure registry is not required, a Risk Summary section describing the drug’s risk of adverse outcomes on fetal development is required under the PLLR. This information will be based on human, animal, and drug pharmacology data.6 The Clinical Considerations subheading will present information to aid in prescribing and risk–benefit counseling, when applicable. Areas covered may include disease-associated maternal or fetal risk, dose adjustments during and after pregnancy, maternal and fetal adverse effects, and labor or delivery information.6 Pharmacists may find this section most helpful for obtaining counseling tips for patient discussions.
Historically, PIs have provided little data on the risk of taking a medication while breastfeeding. The last subheading in section 8.1 (Data) will describe what data, if any, were used to substantiate the scientific information presented in the Risk Summary and Clinical Considerations sections. The information will be divided into 2 separate sections for human and animal data.6 Although retail pharmacists may be less interested in the data and clinical studies supporting the PI, clinicians and other healthcare professionals in research fields may find these sections especially helpful. Historically, PIs have provided little data on the risk of taking a medication while breastfeeding. Although the PI may previously have included information on whether a drug was excreted into the breast milk, the effects of the drug on the child and on the mother’s milk RETA #1 AM IL CL ONG INIC IANS
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Inside the Retail Pharmacy production were seldom included. The new labeling will change that. Section 8.2 (Lactation) will provide a risk summary on the presence of a drug and/or its metabolites in milk, the effects on the child being breastfed, and effects on milk production. If applicable, clinical considerations on minimizing exposure and monitoring for adverse effects will also be included. The Data subsection will include the scientific basis for the data presented under the Risk Summary and Clinical Considerations sections.4
This creates an excellent counseling opportunity for pharmacists to speak with patients about the correct dosing of oral contraceptives.
Dr Johnson is a consultant, Pharmacy Healthcare Solutions, Inc, Pittsburgh, PA.
Because of the current emphasis on the importance of breastfeeding, these new data will prove extremely useful for pharmacists counseling patients. New mothers are often extremely vigilant in the care of their children and the risks of drug exposure, and this is one area in which pharmacists can be subject matter experts and provide an even higher level of patient care. Many new drug products have stipulations surrounding contraception requirements and fertility side effects. Although these data may have previously been available in a Risk Evaluation and Mitigation Strategy program, the data were not required to be in the PI. Under the PLLR, if a product requires pregnancy testing, contraception use, or has an effect on fertility, the data will be included in section 8.3 (Females and Males of Reproductive Potential).4 This creates an excellent counseling opportunity for pharmacists to speak with patients about the correct dosing of oral contraceptives, and/or the importance of over-the-counter contraceptive agents. Updated drug PIs in regard to preg-
nancy, lactation, and reproductive potential have been needed for a long time. Advocates have pleaded with the FDA to make these changes for the past decade. Although the single-letter pregnancy designations may have provided a quick guide for physicians and pharmacists, this methodology oversimplified the process. The majority of women will take ≥1 medication during their pregnancy; research has shown that approximately 5% of women will take drugs to treat hypertension alone during their pregnancy.7 Most physicians and pharmacists will recommend limiting medication use while pregnant, but for many women with chronic conditions such as depression, asthma, or diabetes, prescription use is unavoidable. Although physicians and pharmacists will now need to spend more time reading the pregnancy and lactation sections to better understand the risks certain drugs pose to the mother, fetus, and child, all parties will benefit from the increased availability of information. ❚
References
1. US Food and Drug Administration. Pregnancy and lactation labeling final rule. www.fda.gov/Drugs/ DevelopmentApprovalProcess/DevelopmentResources/ Labeling/ucm093307.htm. Updated December 4, 2014. Accessed February 6, 2015. 2. Traynor K. Changes coming to pregnancy labeling. Am J Health Syst Pharm. 2015;72:175-176. 3. US Food and Drug Administration. Questions and answers on the pregnancy and lactation labeling rule. www.fda.gov/Drugs/DevelopmentApprovalProcess/ DevelopmentResources/Labeling/ucm093311.htm. Updated December 3, 2014. Accessed February 6, 2015. 4. US Food and Drug Administration. Outline of Section 8.1-8.3 on drug labeling. www.fda.gov/Drugs/ DevelopmentApprovalProcess/DevelopmentResources/ Labeling/ucm425415.htm. Updated December 3, 2014. Accessed February 6, 2015. 5. US Food and Drug Administration. List of pregnancy exposure registries. www.fda.gov/ScienceResearch/ SpecialTopics/WomensHealthResearch/ucm134848.htm. Updated February 5, 2015. Accessed February 6, 2015. 6. US Department of Health & Human Services, US Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologic Evaluation and Research. Pregnancy, lactation, and reproductive potential: labeling for human prescription drug and biological products – content and format. www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ UCM425398.pdf. Published December 2014. Accessed February 6, 2015. 7. American Heart Association. More pregnant women taking high blood pressure drugs, yet safety unclear. http:// newsroom.heart.org/news/more-pregnant-women-takinghigh-238172. Published September 10, 2012. Accessed February 6, 2015.
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Drug Update Otezla (Apremilast), an Oral PDE-4 Inhibitor, Receives FDA Approval for the Treatment of Patients with Active Psoriatic Arthritis by LORETTA FALA, MEDICAL WRITER
Psoriatic arthritis, a progressive, potentially debilitating type of arthritic inflammation, affects approximately 7 million people in the United States.1,2 }} }} AN ESTIMATED 15% to 30% of patients with psoriasis will develop psoriatic arthritis.1,3 Psoriasis, a chronic, relapsing disease characterized by thick patches of inflamed, scaly skin resulting from excessive proliferation of skin cells, affects up to 2.6% of people in the United States.2 Both psoriatic arthritis and psoriasis are chronic autoimmune diseases.1 The symptoms of psoriatic arthritis, like the symptoms of psoriasis, may flare and subside, varying from
person to person.3 In some cases, the arthritis precedes skin disorders. Psoriatic arthritis can affect any joint in the body; it may affect 1 or more joints (eg, 1 or both knees), and it may affect fingers and toes.3 Some patients also develop dactylitis, a condition in which the fingers and toes swell profusely.3 Many patients with psoriatic arthritis are affected by the joint disease and the psoriasis that often accompanies it.4 Psoriatic arthritis affects women and men equally.5
Copyright © 2014 American Health & Drug Benefits. All rights reserved.
Although it generally develops between the ages of 30 years and 50 years, psoriatic arthritis can also start in childhood.3 An estimated 40% of patients with psoriatic arthritis have a family member with the disease, suggesting that heredity may play a key role. Psoriatic arthritis may also be triggered by an infection, including a streptococcal throat infection.3 The chronic pain, fatigue, limitations in physical function, and work disability associated with psoriatic arthritis can have a profound effect on the patient’s
health-related quality of life.6 Furthermore, the risk for cardiovascular disease and other comorbidities is greater in patients with psoriatic arthritis and other inflammatory diseases than in individuals without these diseases.2,4 Psoriatic arthritis can also have a substantial impact on a patient’s psychological well-being, because of the itching, pain, and potential for social rejection encountered by many patients.2,4 Psoriatic arthritis imposes a considerable economic burden on patients and society. Based on a 2010 review of the litRETA #1 AM IL CL ONG INIC IANS
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Drug Update Table 1. Apremilast Dosage Titration Schedule for Patients with Psoriatic Arthritis Day 1
Day 2
am
10 mg
Day 3
Day 4
Day 5
Day 6 and thereafter
am
pm
am
pm
am
pm
am
pm
am
pm
10 mg
10 mg
10 mg
20 mg
20 mg
20 mg
20 mg
30 mg
30 mg
30 mg
Source: Otezla (apremilast) tablets prescribing information; March 2014.
erature, in the United States, direct annual medical costs associated with psoriatic arthritis total nearly $1.9 billion.4 In this review of 49 studies, patients with psoriatic arthritis had a lower health-related quality of life compared with the general population.4 Moreover, the direct and indirect costs associated with psoriatic arthritis, including lost productivity and disability, increase with worsening disease activity (ie, joint involvement and psoriatic skin lesions) and worsening physical function.4 Evidence shows that persistent inflammation associated with psoriatic arthritis causes joint damage over time. Consequently, early diagnosis of psoriatic arthritis is essential, because early detection and treatment may prevent further damage to the joints.3 The therapeutic goals for patients with psoriatic arthritis are to alleviate symptoms, control inflammation in affected joints, and prevent joint pain and disability.7 Treatment depends on
the severity of the disease, the number of joints involved, and the associated skin symptoms.1 During the early stages of psoriatic arthritis, nonsteroidal anti-inflammatory drugs (NSAIDs) and cortisone may be used to manage mild inflammation. For patients with erosive disease or for those in whom NSAIDs fail to work, the disease-modifying antirheumatic drugs (DMARDs), including methotrexate, sulfasalazine, leflunomide, and a number of biologic agents may be used to slow the progression of psoriatic arthritis and spare the joints and other tissues from permanent damage.1,7 Until recently, the US Food and Drug Administration (FDA)-approved treatments for psoriatic arthritis included corticosteroids, several tumor necrosis factor blockers, and an interleukin-12/ interleukin-23 inhibitor.8
A Novel Oral Therapeutic Option for Psoriatic Arthritis On March 21, 2014, the FDA approved apremilast (Otezla; Celgene) for
the treatment of adults with active psoriatic arthritis. An oral inhibitor of phosphodiesterase (PDE)-4, apremilast is the first oral therapy to receive FDA approval for the treatment of adult patients with active psoriatic arthritis.8 According to Curtis Rosebraugh, MD, MPH, Director of the Office of Drug Evaluation II at the FDA Center for Drug Evaluation and Research, “Relief of pain and inflammation and improving physical function are important treatment goals for patients with active psoriatic arthritis. Otezla provides a new treatment option for patients suffering from this disease.”8
Mechanism of Action Apremilast is a smallmolecule inhibitor of PDE-4 specific for cyclic adenosine monophosphate (cAMP). Inhibition of PDE-4 results in increased intracellular cAMP levels. The specific mechanism by which apremilast exerts its therapeutic effect in patients with psoriatic arthritis is not well defined.9
Dosing and Administration To reduce the risk of gastrointestinal symptoms, it is recommended that apremilast is titrated to the recommended dose of 30 mg twice daily, to be taken orally starting on day 6. The recommended initial dosage titration of apremilast from day 1 to day 5 is shown in Table 1.9 Coadministration of apremilast with food does not alter the extent of absorption of this drug.9 The recommended dose for patients with severe renal impairment is 30 mg once daily. For initial dose titration in these patients, titration should follow the morning schedule in Table 1; the afternoon doses should be skipped.9 Apremilast is available in 10-mg, 20-mg, and 30-mg tablets.9 Clinical Trials The safety and efficacy of apremilast were demonstrated in 3 multicenter, randomized, double-blind, placebocontrolled trials of similar design.9 In these studies (ie, PsA-1, PsA-2, PsA3), a total of 1493 adult
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Drug Update Table 2. Apremilast versus Placebo: Proportion of Patients with Psoriatic Arthritis and ACR Response at Week 16 PsA-1 study
PsA-2 study
Placebo ± DMARDs (N = 168)
Apremilast 30 mg twice daily ± DMARDs (N = 168)
ACR20, %
19
ACR50, % ACR70, %
Patients with ACR response at week 16
PsA-3 study
Placebo ± DMARDs (N = 159)
Apremilast 30 mg twice daily ± DMARDs (N = 162)
Placebo ± DMARDs (N = 169)
Apremilast 30 mg twice daily ± DMARDs (N = 167)
38a
19
32a
18
41a
6
16
5
11
8
15
1
4
1
1
2
4
Significantly different from placebo (P <.05). ACR indicates American College of Rheumatology; DMARD, disease-modifying antirheumatic drug; PsA, psoriatic arthritis. Source: Otezla (apremilast) tablets prescribing information; March 2014. a
patients with active psoriatic arthritis (≥3 swollen joints and ≥3 tender joints) despite previous or current treatment with DMARD therapy were randomized to receive placebo, apremilast 20 mg twice daily, or apremilast 30 mg twice daily.9 Enrolled patients had a diagnosis of psoriatic arthritis for at least 6 months. The primary end point was the percentage of patients who achieved American College of Rheumatology (ACR)20 response at week 16.9 An ACR20 is defined as a 20% improvement in tender and swollen joint counts and a 20% improvement in 3 of the 5 remaining ACR core set mea sures (ie, patient and physician global assessments, pain, disability, others.)10 An ACR50 represents a 50% improvement in both measures; an ACR70, a 70% improvement in
both measures.10 In these studies, placebo-controlled efficacy data were also collected and analyzed through week 24. If patients’ tender and swollen joint counts had not improved by at least 20%, they were considered nonresponders at week 16. Placebo nonresponders were rerandomized 1:1 in a blind fashion to either apremilast 20 mg twice daily or 30 mg twice daily, after titration. Patients receiving apremilast continued their initial treatment. At week 24, all remaining patients receiving placebo were rerandomized to either 20 mg twice daily or to 30 mg twice daily.9 Patients enrolled across the 3 clinical studies had a median duration of psoriatic arthritis disease of 5 years, with a variety of psoriatic arthritis subtypes, including symmetric polyarthritis (62%), asymmetric oligoarthritis (27%),
PATIENTS RECEIVING APREMILAST ± DMARDS SHOWED GREATER REDUCTIONS IN SIGNS AND SYMPTOMS OF PSORIATIC ARTHRITIS COMPARED WITH PLACEBO ± DMARDS. distal interphalangeal joint arthritis (6%), arthritis mutilans (3%), and predominant spondylitis (2.1%). Patients received concomitant therapy with at least 1 DMARD (65%), methotrexate (55%), sulfasalazine (9%), leflunomide (7%), low-dose oral corticosteroids (14%), and NSAIDs (71%). Previous treatment with
small-molecule DMARDs was reported in only 76% of patients, and previous treatment with biologic DMARDs was reported in 22% of patients, including 9% who failed previous biologic DMARD treatment.9 The proportion of patients who achieved a clinical response (ie, ACR20, ACR50, or ACR70 responses) in studies PsA1, PsA-2, and PsA-3 are shown in Table 2. Patients receiving apremilast ± DMARDs showed greater reductions in signs and symptoms of psoriatic arthritis compared with placebo ± DMARDs as demonstrated by the proportion of patients who achieved an ACR20 response at week 16.9 Apremilast 30 mg twice daily also demonstrated improvement for each ACR component versus placebo at week 16 in study PsA-1, as shown in Table 3. These results RETA #1 AM IL CL ONG INIC IANS
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Drug Update Table 3. Study PsA-1 of Patients with Psoriatic Arthritis: Mean Change in ACR Components from Baseline with Apremilast, at Week 16 Placebo (N = 168)
Apremilast 30 mg twice daily (N = 168)
166
164
Baseline
23
23
Mean change at week 16b
–2
–7
166
164
13
13
–2
–5
165
159
ACR component Number of tender jointsa Sample size, N a
Number of swollen joints
c
Sample size, N Baselinec Mean change at week 16
b
Patient’s assessment of pain (VAS)d Sample size, N Baselined
61
58
Mean change at week 16b
–6
–14
Patient’s global assessment of disease activity (VAS)d Sample size, N
165
159
Baseline
59
56
Mean change at week 16b
–3
–10
d
Physician’s global assessment of disease activityd Sample size, N
158
159
Baselined
55
56
Mean change at week 16b
–8
–19
165
159
HAQ-DI scoree Sample size, N Baseline
1.2
1.2
–0.09
–0.2
Sample size, N
166
167
Baseline
1.1
0.8
Mean change at week 16a
0.1
–0.1
e
Mean change at week 16b CRPf f
Scale, 0-78. Mean changes from baseline are least square means from analyses of covariance. c Scale, 0-76. d 0 = best; 100 = worst. e 0 = best; 3 = worst; the HAQ-DI measures the subject’s ability to perform daily activities, including dressing, eating, walking, griping, maintaining hygiene. f Reference range, 0-0.5 mg/dL. ACR indicates American College of Rheumatology; CRP, C-reactive protein; HAQ-DI, health assessment questionnaire disability index; PsA, psoriatic arthritis; VAS, visual analog scale. Source: Otezla (apremilast) tablets prescribing information; March 2014. a
b
from study PsA-1 were consistent with those observed in studies PsA-2 and PsA-3. In study PsA-1, apremilast 30 mg twice daily also showed a greater improvement in mean change from baseline for the health assessment questionnaire disability index (HAQ-DI) score at week 16 compared with the placebo group. The proportions of HAQ-DI responders (≥0.3 improvement from baseline) at week 16 were 38% for the apremilast (30 mg twice daily) group compared with 27% for the placebo group. Consistent results were observed in studies PsA-2 and PsA-3.9
Safety The most common adverse reactions associated with apremilast occurring in ≥5% of patients were nausea (8.3%), diarrhea (7.7%), and headache (5.9%). In addition, upper respiratory tract infections were reported in 3.9% of patients and vomiting in 3.2%.9 Similarly, the most common reasons leading to treatment discontinuation with apremilast were diarrhea (1.8%), nausea (1.8%), and headache (1.2%). In clinical trials, the proportion of pa tients with psoriatic arthritis who discontinued
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Drug Update treatment because of any adverse reaction was 4.6% for patients taking apremilast 30 mg twice daily and 1.2% for patients receiving placebo.9
Warnings and Precautions Contraindications. Apre milast is contraindicated in patients with a known hypersensitivity to apremilast or any of the excipients in the formulation.9 Drug interactions. Use of apremilast with strong cytochrome P450 enzyme inducers (eg, rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended, because it may result in a loss of efficacy of apremilast.9 Depression. Patients should be advised of the potential emergence or worsening of depression, suicidal thoughts, or other mood changes. The risks and benefits of treatment with apremilast should be weighed carefully in patients with a history of depression
and/or suicidal thoughts or behavior.9 Weight decrease. The patient’s weight should be monitored regularly. If unexplained or clinically significant weight loss occurs, discontinuation of apremilast should be considered.9
Use in Specific Populations Pregnancy. Adequate and well-controlled studies with apremilast have not been conducted in pregnant women. Apremilast should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.9 Nursing mothers. It is not known whether apremilast or its metabolites are present in human milk. However, because many drugs are present in human milk, caution should be exercised when apremilast is administered to a nursing woman.9 Severe renal impairment. Increased systemic exposure of apremilast has been observed in patients
with severe renal impairment; a reduction in dose to 30 mg once daily is recommended.9
Conclusion The FDA approval of apremilast marks the availability of the first oral treatment option for patients with active psoriatic arthritis. Having an oral option can be important for patients who are unable or unwilling to use other therapeutic options. The safety and efficacy of apremilast, a novel PDE-4 inhibitor, were demonstrated in 3 randomized, double-blind, placebo-controlled trials that involved 1493 patients. In all 3 studies, a statistically significant proportion of patients receiving apremilast achieved an ACR20 response at week 16 compared with placebo. Treatment with apremilast 30 mg twice daily also resulted in improvement for each ACR component, including tender joints, swollen joints, and physical function. ❚
References
1. Cleveland Clinic Foundation. Psoriatic arthritis. http://my.cleveland clinic.org/orthopaedics-rheumatology/ diseases-conditions/hic-psoriatic-ar thritis.aspx. Accessed May 1, 2014. 2. National Institutes of Health. Psoriasis. Fact sheet. Updated Octo ber 2010. http://report.nih.gov/NIH factsheets/Pdfs/Psoriasis%28NIAMS %29.pdf. Accessed April 28, 2014. 3. Emery P, Ash Z. American College of Rheumatology. Psoriatic arthritis. Updated September 2012. www. rheumatology.org/Practice/Clinical/ Patients/Diseases_And_Conditions/ Psoriatic_Arthritis/. Accessed May 1, 2014. 4. Lee S, Mendelsohn A, Sarnes E. The burden of psoriatic arthritis: a literature review from a global health systems perspective. P T. 2010;35:680-689. 5. Gelfand JM, Gladman DD, Mease PJ, et al. Epidemiology of psoriatic arthritis in the population of the United States. J Am Acad Dermatol. 2005;53:573-577. 6. Armstrong AW, Schupp C, Wu J, Bebo B. Quality of life and work productivity impairment among psoriasis patients: findings from the National Psoriasis Foundation survey data 20032011. PLoS One. 2012;7:e52935. 7. Mayo Clinic staff. Psoriatic arthritis: treatment and drugs. January 29, 2014. Accessed May 1, 2014. 8. US Food and Drug Administration. FDA approves Otezla to treat psoriatic arthritis. Press release. March 21, 2014. www.fda.gov/newsevents/newsroom/ pressannouncements/ucm390091.htm. Accessed April 23, 2014. 9. Otezla (apremilast) tablets [prescribing information]. Summit, NJ: Celgene Corporation; March 2014. 10. Felson DT, Anderson JJ, Boers M, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727-735.
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Products and Services And other news from the US Food and Drug Administration
New Drugs, Devices The following are some of the recent approvals announced by the US Food and Drug Administration (FDA): • Kybella (deoxycholic acid) was recently approved for the treatment of adults with moderate-to-severe fat below the chin (submental fat). This treatment is not approved or recommended for the treatment of fat outside of the submental area. Kybella is administered as an injection into the fat tissue in the submental area. Patients may receive up to 50 injections in a single treatment, with up to 6 single treatments administered ≥1 month apart.
KYBELLA (DEOXYCHOLIC ACID) WAS RECENTLY APPROVED FOR THE TREATMENT OF ADULTS WITH MODERATE-TOSEVERE FAT BELOW THE CHIN (SUBMENTAL FAT).
New Generic The following is a recent first-time generic drug approval by the FDA: • The first generic versions of Abilify (aripiprazole) have recently been approved by the FDA. Generic aripiprazole is an atypical antipsychotic drug approved to treat schizophrenia and bipolar disorder. Several companies— Alembic Pharmaceuticals Ltd,
New Rulings, Announcements The following are some recent FDA rulings and announcements: • The FDA has issued a proposed rule requesting additional scientific data supporting the safety and effectiveness of certain active ingredients used in healthcare antiseptics marketed under the over-the-counter drug monograph. This rule was based on
Hetero Labs Ltd, Teva Pharmaceuticals, and Torrent Pharmaceuticals Ltd—have received FDA approval to market generic aripiprazole in multiple strengths and dosage forms.
new scientific information and concerns expressed by outside scientific and medical experts on an FDA advisory committee. • The FDA is filing a consent decree against Medtronic, Inc, and 2 of its officers for repeatedly failing to correct violations related to the production of SynchroMed II implantable infusion pump systems, which are medical devices that deliver medication to treat primary or metastatic cancer, chronic pain, and severe spasticity. Patients who are implanted with a SynchroMed II implantable infusion pump system should maintain regular follow-up appointments with their physicians. Patients who hear a device alarm or experience a change or return of symptoms should contact their physicians immediately. ❚ Sources: (1) US Food and Drug Administration. New and generic drug approvals. www.fda.gov/ Drugs/NewsEvents/ucm130961.htm. Updated May 6, 2015. Accessed May 7, 2015; (2) US Food and Drug Administration. Press announcements. www.fda.gov/NewsEvents/Newsroom/Press Announcements/default.htm. Updated May 7, 2015. Accessed May 7, 2015.
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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. As primary care expands to provide optimal access to quality care, Inside Patient Care: Pharmacy & Clinics™ offers a forum for the team treating and coordinating patient care in pharmacies and retail clinics, including medical directors, physician assistants, nurse practitioners, pharmacists, and C-level executives, to implement the best therapeutic options, navigate the healthcare system, and achieve professional success. Each issue of the journal includes resources that will enable the retail healthcare team to provide optimal patient care—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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