THE KENTUCKY PHARMACIST Vol. 11, No. 5 September/October 2016 News & Informat ion for Members of the Kentucky Pharmacists Ass ociation
Shape the Future of the Profession
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Guardian of the Profession in Frankfort
Table of Contents
September/October 2016
Campaign for Kentucky’s Pharmacy Future Oct. 2016 CE — Basics of Pharmacogenomics Table of Contents— Oath— Mission Statement 2 August Pharmacist/Pharmacy Tech Quiz Answer Sheet President’s Perspective 3 KPPAC Contribution Form 2016 Pharmacy School Graduates 4 The Campaign for Kentucky’s Pharmacy Future 2016 KPhA Legislative Conference 5 KPhA New and Returning Members From your Executive Director 6 Student Pharmacists Educate Teens on STIs APSC 8 Pharmacy Law Brief KPhA Emergency Preparedness 9 Pharmacy Policy Issues Provider Status: A Conversation with NASPA VP Krystalyn Weaver Naloxone Atomizer Distribution Project 10 Pharmacists Mutual Sept. 2016 CE — Is My Medication Gluten-Free? 13 Cardinal Health Sept. Pharmacist/Pharmacy Tech Quiz Answer Sheet 18 KPhA Board of Directors Kentucky Reportable Disease Regulations 19 50 Years Ago/Frequently Called and Contacted
Table of Contents
20 21 28 29 30 32 34 36 38 39 40 41 42 43
Oath of a Pharmacist At this time, I vow to devote my professional life to the service of all humankind through the profession of pharmacy. I will consider the welfare of humanity and relief of human suffering my primary concerns. I will apply my knowledge, experience, and skills to the best of my ability to assure optimal drug therapy outcomes for the patients I serve. I will keep abreast of developments and maintain professional competency in my profession of pharmacy. I will embrace and advocate change in the profession of pharmacy that improves patient care. I take these vows voluntarily with the full realization of the responsibility with which I am entrusted by the public.
Kentucky Pharmacists Association The mission of the Kentucky Pharmacists Association is to promote the profession of pharmacy, enhance the practice standards of the profession, and demonstrate the value of pharmacist services within the health care system.
Editorial Office: © Copyright 2016 to the Kentucky Pharmacists Association. The Kentucky Pharmacist is the official journal of the Kentucky Pharmacists Association published bi-monthly. The Kentucky Pharmacist is distributed to KPhA members, paid through allocations of membership dues. All views expressed in articles are those of the writer, and not necessarily the official position of the Kentucky Pharmacists Association. Editor-in-Chief: Robert McFalls Managing Editor: Scott Sisco Editorial, advertising and executive offices at 96 C Michael Davenport Blvd., Frankfort, KY 40601. Phone 502.227.2303 Fax 502.227.2258. Email ssisco@kphanet.org. Website http://www.kphanet.org.
The Kentucky Pharmacy Education and Research Foundation (KPERF), established in 1980 as a non-profit subsidiary corporation of the Kentucky Pharmacists Association (KPhA), fosters educational activities and research projects in the field of pharmacy including career counseling, student assistance, post-graduate education, continuing and professional development and public health education and assistance. It is the goal of KPERF to ensure that pharmacy in Kentucky and throughout the nation may sustain the continuing need for sufficient and adequately trained pharmacists. KPERF will provide a minimum of 15 continuing pharmacy education hours. In addition, KPERF will provide at least three educational interventions through other mediums — such as webinars — to continuously improve healthcare for all. Programming will be determined by assessing the gaps between actual practice and ideal practice, with activities designed to narrow those gaps using interaction, learning assessment, and evaluation. Additionally, feedback from learners will be used to improve the overall programming designed by KPERF.
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President’s Perspective
September/October 2016
PRESIDENT’S PERSPECTIVE Trish Freeman KPhA President 2016-2017
Reflections on Loyalty, Duty and Service
possesses a strong feeling of support and allegiance, and through duty one feels a moral commitment or obligation to someone or something. I believe it is through our sense of loyalty and duty that we, as pharmacists, find the desire to serve – serve our patients, our community and our profession. I implore those of you reading this article to spend a few minutes reflecting on how you serve others in your professional role and what opportunities for service lie in wait for you – in your practice, your community and in your professional affiliations. Service to Patients First and foremost, as pharmacists, we serve our patients. Regardless of the setting in which we practice, we strive to accurately assess their needs and concerns, recognize and attend to the difficulties and challenges they face, identify and solve their medication-related problems and support them in their endeavors to achieve better health. Service to the Community
As we serve our patients, opportunities to serve the community at large often arise. Through offering health fairs, I recently had the opportunity to represent our KPhA at the providing community education related to safe medication University of Kentucky College of Pharmacy’s White Coat use or drug abuse prevention, to participating in public Ceremony where we welcomed the class of 2020 as they health initiatives such as opioid overdose prevention and embark on their journey to join the ranks of our profession. emergency preparedness, pharmacists serve communiIn preparing my remarks for this occasion, I was asked to ties in varied and meaningful ways. reflect on the Pledge of Professionalism our students reService to the Profession cite as they receive their white coats, symbolizing the transition from student to student pharmacist. I was specifical- Finally, in our efforts to serve our patients and our community, we often recognize the value of service to our proly asked to reflect on the following passage: fession. As pharmacists, we serve our profession in myriTo accomplish this goal of professional development, ad ways, including mentoring the next generation of pharI, as a student of pharmacy should: DEVELOP a macists as preceptors, through our work in professional sense of loyalty and duty to the profession of associations such as KPhA or volunteering our time and pharmacy by being a builder of community, one able expertise on various boards and commissions that protect and willing to contribute to the well-being of others and ensure the health and well-being of the citizens of our and one who enthusiastically accepts the great Commonwealth. responsibility and accountability for membership in the I, personally, believe there is no greater reward to be profession. found than that which results from professional service to As I reflected on this, I asked myself, just what do we others. I challenge each of you over the course of the next mean by loyalty and duty? If we expect our student pharfew months to identify one new opportunity for service in macists to develop a sense of loyalty and duty to the pro2017 and commit yourself to it. Through dedicated serfession of pharmacy, then we as pharmacist members of vice, we can make a difference. Our patients, our commuour profession must embody these desired characteristics. nities and our profession all will benefit and the resultant According to Merriam-Webster, when one is loyal, one impact to our collective whole will be immeasurable.
The Campaign for Kentucky’s Pharmacy Future: The Next 50 Years http://www.kphanet.org/?page=buildingcampaign 3
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2016 Graduates
September/October 2016
Congrats Grads! OUR KPhA welcomes the newest members of the profession in Kentucky and wishes all graduates success in their chosen pursuits.
Sullivan University College of Pharmacy Class of 2016
University of Kentucky College of Pharmacy Class of 2016
Save the Date 139th KPhA Annual Meeting and Convention June 22-25, 2017 Griffin Gate Marriott Resort Lexington, KY 4
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2016 KPhA Legislative Conference
September/October 2016
OVERNIGHT ACCOMODATIONS Capital Plaza Hotel is the host hotel for the 2016 KPhA Legislative Conference. To make your reservations, call 502-227-5100 or reserve online at www.capitalplazaky.com using group code 1792. Register online at www.kphanet.org
Continuing Education* Topics include:
Addressing Substance Abuse: Perceptions of Kentucky Pharmacists Regarding Gabapentin as a Drug of Abuse
Rapid Diagnostic Testing for Influenza and Prescribing of Antiviral Therapies via Protocol in Pharmacy Practice
TB Prevention and Control in Kentucky
Tobacco Cessation via Protocol
Addressing Substance Abuse: Pharmacists Role in Harm Reduction from Opioids (naloxone, needle exchange, MAT) * Accreditation Pending
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From Your Executive Director
September/October 2016 MESSAGE FROM YOUR
EXECUTIVE DIRECTOR Robert “Bob” McFalls
While Pharmacy’s Top Legislative Priority for 2016 is now effective, Implementation Strategies Continue to Evolve for SB 117: PBM Transparency on MAC and Other Issues It wasn’t easy, and the journey was more than challenging when Kentucky pharmacists—united from different practice settings—joined with their independent colleagues in a concerted effort to ensure passage of SB 117 earlier this year. There were lots and lots of questions as KPhA and our pharmacy partners worked in good faith to address numerous concerns raised by the PBMs and their lobbyists while protecting the integrity of the legislation. Pharmacists and our lobbyist team continued working diligently to advance the bill through the legislative process. We all witnessed the welcomed result when OUR KPhA’s top legislative priority for 2016 passed the session without a dissenting vote.
will file an emergency regulation in the near future that addresses the licensure section of the law. By its very nature, an emergency regulation is effective when issued and signed by the governor. We hope that this regulation is already issued and in place by the time that you read this, outlining the process by which PBMs will be licensed in Kentucky as of January 1, 2017. In addition, we are anticipating that DOI will issue an additional set of implementing regulations. We have been provided an initial draft and provided our feedback and comments on them. We will continue to keep you informed about how DOI plans to enforce this bill. Meanwhile, we recognize that there are lots of questions on what to do, where to turn for relief, when you can expect a response from DOI, among others.
When Kentucky passed the nation’s first Pharmacy Benefit Management (PBM) transparency bill in 2013, we were ploughing new ground. Similarly, in 2016, we are one of a handful of states that now require PBMs to be separately licensed by the state, giving pharmacy providers a muchneeded, independent arbitrator through the Kentucky Department of Insurance in terms of its enforcement authority. Our bill is complicated because of its numerous provisions, requirements for PBMs on which community pharmacies are counting for its needed protections. Since the bill became effective on July 15, 2016, the Department of Insurance (or DOI) has convened stakeholders multiple times to discuss the bill’s implementation, KPhA has participated in all of these meetings, as have all of our pharmacy partners (APSC, KRF, APCI, KIPA and Epic) along with several PBM representatives. While change of this magnitude is taking somewhat longer than originally anticipated, KPhA wants you to know that DOI is continuing to work on its strategies to implement this essential law. It is clear that DOI’s primary concern is meeting the January 1, 2017 statutory deadline. Therefore, it is our understanding that DOI
Here is our advice on what you should do when you have a grievance with a PBM on reimbursement, with the MAC List or other covered provision of SB 117. Our updated law requires PBMs to have an appeals process in place, to respond to pharmacy appeals in a timely manner, to maintain and regularly update a comprehensive Maximum Allowable Cost (MAC) list, to provide disclosures on the way PBMs develop MAC pricing as well as how they determine reimbursement, among others What steps can you take now that Kentucky has the protections from SB 117? You fill a prescription and your pharmacy is underpaid. Either your pharmacy or your PSAO should file an appeal with the PBM following that specific PBM’s appeal process. The PBM is required by our new law to respond to the appeal within ten (10) calendar days. We are asking 6
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From Your Executive Director
September/October 2016
Complaints can be made on any provision of this legislation to DOI; pharmacies may also use this process to complain about other concerns for which there are legal protections. SB 117 assures this independent review process by DOI for pharmacies submitting complaints on MAC reimbursement issue, disclosure of source on a drug price data issue, lack of a comprehensive MAC List The PBM is required to provide the reason for its denial. or any other covered provision. Pharmacies can also This information will be important in helping guide your use this complaint process to file a grievance when decision to file a complaint with DOI. working with a patient on medication synchronization or Following receipt of a denial or an unsatisfactory answer to resolve concerns related to a pharmacy audit. by the PBM, your pharmacy/PSAO can decide to file a While we recognize the challenges that comes with waiting complaint with the Department of Insurance. for the final rules and regulations, OUR KPhA also affirms, DOI has a specific pharmacy provider complaint form on as expressed by many of you, that we want to have the its website that you can use for this purpose. We are strongest enforcement authority possible to assure that this advocating that this form be updated and referenced in bill is fairly implemented. Know that we will continue to advothe final regulations as the instrument that DOI will uticate to this end for the strongest possible regulations to aclize in resolving complaints. KPhA and other stakeholdcomplish this goal. Once we have more definitive inforers have also recommended that DOI adapt this process mation, we will provide training to walk pharmacists through into an interactive form that could be completed online. the protections that SB 117 can provide, including an overview on how to navigate the Pharmacy Complaint The form can be accessed at the following link: http:// Form. Know that we remain committed to working with you insurance.ky.gov/Documents/ to effect this essential outcome. PharmComplaintForm102015.pdf. DOI to ensure that both the pharmacy and the PSAO are informed about the PBM’s decision. For now, until we have a final determination from DOI, our recommendation is for pharmacies to stay in close communication with your PSAO and to request the PBMs’ responses to your pharmacy’s appeals.
The Campaign for Kentucky’s Pharmacy Future: The Next 50 Years
Leave a legacy by participating in the campaign to replace OUR KPERF/KPhA Headquarters! Learn more about options for payment and levels of recognition at http://www.kphanet.org/?page=buildingcampaign or call 502-227-2303. 7
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APSC
September/October 2016
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KPhA Emergency Preparedness
September/October 2016
Volunteer Volunteer Volunteer It’s 2016 and pharmacist, pharmacy technician and student pharmacist recruitment is underway for the Kentucky Pharmacists Association emergency preparedness program! Pharmacy professionals play a critical part in responding to emergency events such as a natural disaster or infectious disease outbreak. You may sign up as a volunteer on the KPhA website, completing a volunteer form below or simply sending an email directly to Leah Tolliver at ltolliver@kphanet.org. Please join the emergency preparedness program and help to recruit other volunteers! We need all of you! For more information on how you can be involved in the KPhA Pharmacy Emergency Preparedness Initiative, contact Leah Tolliver, KPhA Director of Pharmacy Emergency Preparedness at 502-227-2303 or by email at ltolliver@kphanet.org.
For more resources, visit YOUR www.kphanet.org and click on Resources—Emergency Preparedness.
KPhA Pharmacy Emergency Preparedness Volunteer Form
Name: __________________
____
Status (Pharmacist, Technician, Student): ___________________
Email: ______________________________ Phone: ________________________ County: Interest in serving as a volunteer: Yes____ No ____ Interest in serving as a Volunteer District Coordinator: Yes____ No _____ You also may join the Medical Reserve Corps by following the KHELPS link on KPhA Website to register (www.kphanet.org under Resources) Please send this information to Leah Tolliver, KPhA Director of Pharmacy Emergency Preparedness via email at ltolliver@kphanet.org, fax to 502-227-2258 or mail at KPhA, 96 C Michael Davenport Blvd., Frankfort, KY 40601.
Donate online to the Kentucky Pharmacists Political Advocacy Council! Go to www.kphanet.org and click on the Advocacy tab for more information about KPPAC and the donation form.
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Pharmacist Provider Status
September/October 2016
Provider Status: A Conversation with NASPA VP Krystalyn Weaver We talk a lot about the idea of pharmacists having “provider status.” But what exactly does that mean? Kentucky Pharmacists Association Executive Director Robert McFalls sat down with Krystalyn Weaver, PharmD, the vice president of policy and operations for the National Alliance of State Pharmacy Associations, to talk about that phrase — why provider status is important, what it means for pharmacists in Kentucky, and why we’re working so hard to achieve it here and nationwide.
meaning of that term somewhat complicated.
Today the federal government does not recognize pharmacists as medical “providers” — specifically in Part B of the Social Security Act. That means Medicare beneficiaries aren’t able to access pharmacists’ patient-care services such as diabetes management, smoking cessation assistance and even simple wellness visits through their Medicare benefits.
But that's the key phrase: in the world we live in now. It doesn't have to be this way.
Add to that the fact that not every pharmacist wants to provide those services. Often when I'm talking about integrating more patient-care services into our practices I get the inevitable comment: “I’m too busy in the pharmacy as it is. There is no way I can add even more activities to my day-to -day operations and still get prescriptions filled.”
As a practicing community pharmacist myself (although it’s only moonlighting), I can relate. Any pharmacist (or conAcross practice settings, provider status is seen as the great sumer for that matter) knows how busy a community pharbrass ring for pharmacists. So let’s start by defining the term: macy can be. It is, in fact, difficult to add to that workload in What is provider status, and why do we need it? the world we live in now.
Hence our goal of attaining federal “provider status." (A major step of that would be passage of the Pharmacy and Medically Underserved Areas Enhancement Act, aka H.R. 592 or S.314.) It would allow Medicare to pay for pharmacists' services in medically-underserved areas, of which Kentucky has some 82 counties so designated.
I challenge my peers not to think of the current practice environment. When we're talking about broadening pharmacists' services, think of the future. Remember that the reason we aren’t already doing this is because our payment system is broken — it doesn’t recognize the value pharmacists are capable of providing. A core premise of the provider status push is that we have to change our business model. We need to change the practice environment and make it feasible for our services to be delivered effectively. We are talking about overhauling our workflow so patientcare services become a focus, not an add-on. And yes, we're talking about new streams of revenue.
But if you dig into the “why” of that objective, it's more than just about pharmacists. It's about the fact that patients benI would also argue that considering the ever increasing efit from the valuable services pharmacists can provide. We pressures to decrease what Americans pay for prescription know that when pharmacists are on the healthcare team, drugs, that a change in our business model is likely essenoutcomes improve and costs go down. tial for pharmacies to survive. Any pharmacy owner can To sum it up, the goal is to ensure that patients’ have acattest to the fact that margins are decreasing. In order to cess to pharmacists’ brains — not just the products we dis- keep pharmacist jobs viable, we need to leverage our most pense. valuable asset: our ability to optimize medication regimens, assist patients with disease management and prevention Back to the term provider status. Medicare access is a maand decrease overall health care costs — not just get the jor step, but it's only the first step. The reality is that we right drug to the right patient at the right time (although that need to approach ensuring patient access to pharmacists’ always will be important). services from more than one angle. Though Medicare patients make up a huge population of those who would bene- If the case is so strong, what's keeping Congress? fit from pharmacists knowledge and skills, there are many That’s a great question, but it assumes that policy decisions other patients who do not have Medicare coverage. are always made with 100 percent reliance on facts and So "provider status" is broader. It encompasses any effort data. The reality is that national policy is influenced by politto get patients access to these services, which makes the ical pressures. And one of the biggest political pressures 10
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Pharmacist Provider Status we're facing today is our national debt and the ever ballooning costs of entitlement programs. Adding pharmacists services to Medicare benefits will come at an added cost to the program, at least initially. So rather than reflecting on why it hasn’t happened yet, I like to focus on why now is a good time. There has never before been more of an awareness on health policy in the larger policy environment. Policy makers are realizing that saving money is more than simply cutting costs — it's also critical to get the most value. Pharmacists are pros at keeping people healthy and maximizing the utility of a critical healthcare resource: medications. We have plenty of data to show that. More people are realizing this, so not only do we have unprecedented collaboration among pharmacy associations, wholesalers and national pharmacy chains, we are now seeing support from many outside organizations such as the Centers for Disease Control and Prevention, the National Governors Association, the Office of the Surgeon General and others.
September/October 2016 access to and coverage for pharmacists’ patient care services (which is really what we mean by “provider status,” remember). Unfortunately, it isn’t as simple as a state legislature simple granting provider status. The state environment is different than the federal one. At the federal level, a somewhat simple change of definition in law results in a massive change in the payment structure for MANY patients across the country. At the state level this almost always isn’t the case. There are often several places in state law and regulation where the term “provider status” is defined, each with a different degree of impact on patient access to pharmacists’ services. They may be important in their own way but are very unlikely to be the broader solution that a federal change would be.
Additionally, it's at the state level where scope of practice is defined, and that's an essential factor in pharmacists’ ability to provide the care they want to provide. In recent years states have made improvements to laws regulating pharmacists: broadening immunization and collaborative pracOkay, so Congress is concerned about the price tag. I tice agreements, allowing pharmacists to prescribe travel get that. Isn’t there research, though, to demonstrate medication and promoting access to public health services that the long-term savings from compensating pharmathrough pharmacies, such as smoking cessation products cists as providers is greater than the short-term costs? and hormonal contraceptives. I can imagine healthier patients and reduced hospital Finally, states can influence local payers including Mediadmissions could save Medicaid and Medicare some caid, state employee plans and private payers through legreal money. islative or regulatory action, or by simply working with those Absolutely, there are plenty of data to show that pharmapayers directly and sharing the business case with them. cists can save payers on the overall cost of healthcare in both the short and long term. There are hard data showing So are we talking about expanding pharmacists’ scope that within one year, simply paying pharmacists to provide of practice? Providing services under collaborative modest MTM services for Medicaid patients delivered a 4 practice agreements with physicians? Or simply doing to 1 return on investment. And data for the long term is stuff pharmacists can already do but currently can’t be even stronger — an average ROI as high as 12 to 1. compensated for? Unfortunately, the way new federal bills are analyzed doesn’t account for these savings. The Congressional Budget Office assigns a “score” to bills that estimates the cost of the bill to the federal budget over the next 10 years. But that score doesn’t take into account cost savings — which doesn’t help our cause one bit. We've heard that this process may be loosening a bit but the score of the federal bill will continue to be a challenge, especially in an election year.
All of the above. As we discussed before, state provider status efforts often include work to align pharmacists’ scope of practice with their clinical ability — so patients aren’t missing out on pharmacists’ care because of outdated laws. Collaborative practice agreements can allow for increased collaboration and efficiencies in care delivery — unless the state laws and regulations are so restrictive that entering into an agreement becomes a burden.
You’ve mentioned that Congress would need to enact provider status at the federal level. But what about at the state level? Is there any benefit to asking the legislature to grant pharmacists provider status here in Kentucky? What would state provider status look like?
And finally there is “stuff” pharmacists can already do and already are doing that they aren't being compensated for. It won’t be as easy as just submitting a quick claim for services; we'll need to comply with the rules and regulations other providers comply with now — including credentialing, documentation, quality assurance, etc.
Absolutely, there is a lot states can do to ensure patients
How do you think physicians will react to that? Does it 11
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Pharmacist Provider Status
September/October 2016
have to bill the patient after the fact as well. And if a claim isn’t covered, the dispute process can be lengthy and arduThe examples we currently have of physician-pharmacist ous. Obviously all of these challenges have been overcome collaborations are relatively few and far between because it by our colleagues in other health professions so they're not requires great creativity to make the relationship financially insurmountable, but they will be big changes for pharmacy. viable. But when we are able to find sustainable revenue streams to take the strain off of the system, physicians ofSounds like this is an issue pharmacists need to anticiten report favorably on working closely with pharmacists. I pate, so that when it’s enacted, our members are ready think physicians and other providers will embrace the pres- to take advantage of it on day one. What can pharmaence of pharmacists on the health care team. Let’s face it cists be doing now to prepare themselves, their prac— drugs are complicated and there are plenty of other tices and their patients for provider status? things doctors, nurses, physician assistants and nurse Pharmacists can get themselves ahead of the game by practitioners have to focus on. Having a medication expert incorporating services into their current business model on their side will make their job that much easier and allow now. Start small. Consider incorporating medication synthem to provide care to more patients. chronization into your pharmacy. Incorporate other adherHow do you see this new paradigm impacting the qual- ence interventions. Make sure to fulfill all of the Medicare ity of patient care? Part D MTM opportunities that come your way. This will It’s been said many times before but I’ll say it again: When help you to get your workflow to a better place and start to pharmacists are on the team, health outcomes improve and change patient perceptions about the level of care pharmacosts go down. I think it's a given that pharmacists’ services cists are capable of providing. change the physician–pharmacist relationship?
can improve quality. The impact pharmacists already are making, even in our broken system, is probably underappreciated. But I think if we align the incentives appropriately — and build an infrastructure that allows pharmacists to access the patient health data they need — the system can be fixed to maximize pharmacists' skills and improve patient care. Let’s talk about compensation. If, as providers, pharmacists could be compensated for a broader range of their services, what does that look like? What are the mechanics of it?
Build relationships in the community. Reach out to local physicians' offices, get to know the care managers in the local hospital and see if you can find a way to help them with medication reconciliation at discharge. Building relationships also will build a referral network. Yes, this will mean business when we are able to bill Medicare for medical services but it also will mean increased business now. If your local providers see you as the go-to pharmacy for optimal medication management, they will send their patients to you.
Try to understand the quality measurement landscape — and beyond Star Ratings. Physicians, ACOs, medical homes and hospitals are all held to different quality metrics. Learn what they are, learn what the pressure points are and think of how pharmacists can help to achieve those metrics. Also get to know the billing codes that may be available to us through Medicare. These include CPT codes, chronic care management codes, G-Codes and more. The Medicare Learning Network is a great resource. Sign up for their email list and get information sent to you In medical billing, a claim is submitted but the provider may regularly. not know for weeks if it will be paid by the insurer. Copays have to be collected at the time of service but are only esti- The original interview first appeared in Georgia Pharmacy mates of what the patient’s cost share is — meaning you magazine. I don’t want it to sound like an easy, quick transition. We'll need to adjust workflows, reimagine how we use pharmacy technicians, implement infrastructure changes to allow pharmacists to plug into the information systems hospitals and doctors use and learn how to do medical billing. And medical billing is VERY different than prescription billing, which is quick, automated and immediately tells you if a claim is covered.
KPhA Remembers KPhA desires to honor members who are no longer with us. Please keep KPhA informed by sending this information to eramey@kphanet.org . Deceased members for each year will be honored permanently at the KPhA office. 12
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Sept. 2016 CE — Gluten Free Medication
September/October 2016
Is My Medication Gluten-Free? By: Emily Kurtz, PharmD and Cassandra Hobbs, PharmD, BCACP, Sullivan University College of Pharmacy The authors declare no financial relationships that could be perceived as real or apparent conflicts of interest. Universal Activity # 0143-0000-16-009-H01-P&T 1.5 Contact Hours (0.15 CEUs) Expires 9/14/2019
KPERF offers all CE articles to members online at www.kphanet.org
Objectives: At the conclusion of this Knowledge-based article, the reader should be able to: 1. Identify sources of gluten (P&T); 2. Describe the most common gluten-associated diseases and conditions (P&T); 3. Define “gluten-free” per the FDA (P&T); 4. Understand FDA regulation pertinent to gluten content in food vs. gluten content in medication (P&T); 5. Recognize common “red-flag” inactive ingredients that indicate potential presence of gluten (P&T); and 6. Apply clinical judgment to optimize therapy for patients at risk of gluten-related adverse effects (AEs) due to presence of gluten in their medication (P). accounting for the surge in the number of people adopting a “gluten-free” lifestyle.2,4,5 The clinical presentation of NCGS includes intestinal and extraintestinal symptoms that are similar to that of CD, thus diagnosis cannot be made based on symptoms alone; HLA testing and/or small bowel biopsies are necessary to rule out CD. Studies have shown that NCGS can overlap with irritable bowel syndrome (IBS). Though the cause of NCGS is not well understood, there is adequate evidence that it is a real condition that improves with elimination of gluten from the diet.5 Some speculate that the clinical condition actually may be a result of intolerance to fermentable liposaccharides, disaccharides, monosaccharides and polyols (FODMAP) that are present in the wheat grain as opposed to the gluten component of wheat.2
What is Gluten? Gluten is a storage protein found in wheat that can invoke enterotoxicity in some individuals.1 Though gluten refers specifically to the protein in wheat, it is used as a universal term to describe the counterpart of the storage protein in grains of rye and barley as well. Enterotoxic reactions can occur due to consumption of wheat, barley, rye or any hybrid of these grains, such as triticale. Gluten-Related Disorders Potential consequences of consuming gluten can trigger a variety of conditions with intestinal and/or extra-intestinal symptoms. Table 1 summarizes key clinical features of the three most common gluten-related disorders. One of the most serious results of gluten-exposure is the development of Celiac Disease (CD) in genetically predisposed persons.1-3 CD is a permanent disease of the small intestine in which the body mounts a hyperimmune response against parts of the gluten protein, resulting in injury to the lining of the small intestine when gluten is consumed. Villous atrophy and/or crypt hyperplasia can be seen on the biopsy of the duodenum in a CD patient who has recently consumed gluten. Fortunately, the intestinal destruction is reversible with adherence to a gluten-free diet. CD can occur at any age, and classic clinical manifestations of the enteropathy include chronic diarrhea, constipation, steatorrhea, abdominal distention or pain, nausea and vomiting.2 CD can cause serious complications including malabsorption, anemia, weight loss, osteoporosis, osteopenia and growth disturbances. Nonceliac gluten sensitivity (NCGS) is a condition of unknown cause that has grown in prevalence in recent years,
Wheat allergy is a food allergy and hence the result of an IgE-mediated reaction to wheat consumption.2 The clinical manifestation of wheat allergy is characterized by a moderate-to-severe atopic dermatitis, but angioedema, bronchial obstruction, nausea, abdominal pain and severe systemic anaphylaxis also are possible. Wheat allergy is more common in children and often is outgrown by adulthood. Wheat -dependent exercise-induced anaphylaxis (WDEIA) is a variant of wheat allergy that is more prevalent in adults vs. classic wheat allergy. WDEIA may manifest as mild gastrointestinal symptoms such as diarrhea and bloating. The symptoms of WDEIA are a result of both ingesting wheatcontaining foods and exercising. Dermatitis herpetiformis (DH) is a chronic autoimmune disease that is a result of exposure to gluten in geneticallysusceptible individuals.1 DH manifests as clusters of pruritic papules and vesicles that are often symmetrical and located on the elbows, knees, lower back, buttocks, scalp, back
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Sept. 2016 CE — Gluten Free Medication
September/October 2016
Table 1: Comparison of Clinical Features of Gluten-Related Disorders1-5
patient-reported clinical symptoms and investigaNonceliac Gluten Feature of Celiac Disease Wheat Allergy tor-observed morphologiCondition Sensitivity cal effects. The amount of Symptom Days to weeks Hours to days Minutes to hours gluten causing symptoms onset or morphological effects Autoimmunity and Unknown Allergic immunity Pathogenesis innate immunity differed between individuPresence of one or HLA-DQ2 or als, but some experiNot present Not present HLA-DQ8 both enced adverse effects Auto(AEs) from consuming Present Not present Not present antibodies gluten at concentrations Almost always prebelow 20 ppm. The FDA’s Not present Not present Enteropathy sent findings suggested that 0.4 mg of gluten daily, or Yes Yes Yes GI symptoms 0.5 ppm, was not associExtraintestinal Yes Yes Yes ated with morphologic symptoms effects.1 For avoidance of Any; IBS; young or Any Usually children clinical effects, an even Patient Type middle-aged female Gluten-free diet; lower concentration of Gluten-free diet Gluten-free diet Management epinephrine 0.015 mg of gluten daily, or 0.02 ppm, was deterof hand or posterior neck. DH occurs gradually and often mined. The FDA acknowledges the apparent contradiction emerges in adulthood. in their ruling of the 20 ppm cutoff, citing the reason for their decision as lack of scientifically-validated methods to The Dilemma of Defining “Gluten-free” detect gluten at concentrations below 20 ppm.8 Though this Because of the adverse health effects that are associated cutoff cannot prevent effects in all gluten-sensitive individuwith gluten consumption, the Food and Drug Administration als, it has undoubtedly improved the risk of gluten exposure (FDA) issued regulations in 2013 regarding the criteria for a when considering that an estimated 5 percent of gluten-free food to be considered gluten-free.6-8 The ruling applies to all -labeled products before the ruling actually contained more FDA-regulated packaged foods, including dietary supplethan the recommended 20 ppm. ments. The ruling does not apply to the labeling of meats Gluten in Medication and poultry (regulated by the U.S. Department of Agriculture) or alcoholic beverages (regulated by the Alcohol and Even though the FDA is making necessary strides in the Tobacco Tax and Trade Bureau). The FDA’s rule desigregulation of gluten in the food industry, there is currently nates 20 ppm (parts per million) as the threshold for deter- no similar regulation in effect for drug products. Gluten, mining if a food may be labeled gluten-free. If a food conLatin for glue, not only functions as a storage protein but tains less than 20 ppm of gluten, the manufacturer may aids in maintaining the structure of the grain.1 This binding decide to label the product as gluten-free, but they are not required to label it as such. A study in 42 CD patients exTable 2: FDA Rules for Foods Labeled amining the histology of the duodenal mucosa in response “Gluten-Free”8 to varying amounts of gluten was influential in the FDA’s Does not contain an ingredient that is a gluten definition of gluten-free.9 Results of the study suggested -containing grain that a daily gluten intake as little as 10-50 mg/day can Does not contain an ingredient that is derived cause symptoms in CD patients. from a gluten-containing grain that has not Despite the FDA deciding that 20 ppm is an acceptable cutoff for gluten content, an earlier investigation from the FDA concluded that the presence of gluten at concentrations <1 ppm would protect the most numbers of people who are gluten-sensitive.1,7 The FDA’s conclusion was based on numerous studies of the effects of consuming different amounts of gluten in sensitive patients. Outcomes included 14
been processed to remove gluten
Does not contain an ingredient that is derived from a gluten-containing grain that has been processed to remove gluten but the final product for consumption still contains gluten in concentrations ≥ 20ppm
Any unavoidable presence of gluten in the food must be < 20 ppm.
THE KENTUCKY PHARMACIST
Sept. 2016 CE — Gluten Free Medication property is desirable when adding excipients, or inactive ingredients, to oral medications.10 Consequently, thousands upon thousands of medications contain grain-related excipients that can induce a reaction in gluten-sensitive individuals.
September/October 2016
ten intolerances asked surveyors if they suspected a gluten-associated AE from a medication.11 Surveyors Wheat identified 259 drugs, and the re Modified starch* search team investigated the gluten Pregelatinized starch* content in 39 of these reported Pregelatinized modified starch* drugs. Their results found levels of gluten greater than the 20 ppm Dextrates* A patient that adheres to a glutenthreshold in three drug products: Dextrin* free diet must research the particusertraline 50mg film-coated tablet, Dextrimaltose (if barley malt is lar drug of interest and look for ceracetaminophen/dextromethorphan/ used) tain “red-flag” ingredients that indidoxylamine liquid capsules and cate possible gluten. A list of these Caramel coloring (if barley malt omeprazole 40mg capsules. Of used) “red-flag” ingredients is provided in these three products, sertraline was Table 3.11 Often, the presence of *if source is not specified the only product that had a red-flag gluten cannot be ascertained withingredient listed (sodium starch 10,11 out also knowing the source of the inactive ingredient. glycolate). These results emphasize the importance of deFor instance, dextrin has no risk for containing gluten if poveloping stricter regulation of pharmaceutical excipients tato or corn is the source of the dextrin. Additionally, any and indicate there is still risk of consuming gluten in medimedication containing starch has potentially been in concations with no gluten-indicative red-flag ingredients listed tact with a gluten source, but starch is an excipient present on the label. As of Dec. 21, 2011, the FDA’s Center for in a multitude of medications; avoiding starch-containing Drug Research and Evaluation (CDER) issued a Federal products would be hugely limiting in terms of medications Register notice, surveying members of the general public available to achieve the therapeutic goal of treatment. If the regarding their experiences with gluten in drug products.8 source of the starch is “wheat,” then the drug product The purpose of issuing the notice is to evaluate feasible should be completely avoided by a patient with a gluten strategies that will minimize the amount of gluten a CD pasensitivity. Wheat starch is clearly stated as an ingredient tient is exposed to when taking oral medications. No official in very few medications, including aliskiren-containing prodrecommendations have been released yet. ucts, griseofulvin (Ortho-McNeil), trospium chloride (Allergan) and doxycycline DR capsules (Warner ChilWhat can Pharmacists do? cott).12 If the source of starch is listed as a “derived wheat A 2008 survey of patients with CD found that 79 percent of source,” it is likely safe for consumption by a glutensensitive individual, as this refers to sugar alcohols such as those who responded had questioned the gluten status of mannitol and xylitol.10 If not listed on the inactive ingredient an oral medication, and neither the doctor nor the hospital list, then the identification of the source of the ingredient is pharmacist was able to determine if gluten was present in their medication.11 Another survey published in a 2014 not easily accessible, and it often requires contacting the manufacturer of the medication. Unfortunately, the employ- study showed that many patients who perceived they were ees of the manufacturers who are responsible for answer- experiencing gluten-related-AEs from their medication 11 ing the inquiry may genuinely not know if gluten is present stopped taking the medication. The presence of gluten in medication is not only concerning because of the possibility in their product. Many drug manufacturers state that their suppliers for inactive ingredients are able to change without for the development of gluten-related side effects but also notice.11 In September 2015, the Gluten in Medicine Disclo- because of the risk of therapeutic noncompliance. sure Act of 2015 (H.R. 3648) was introduced by U.S. Rep- Until regulations are developed for the pharmaceutical inresentatives Tim Ryan of Ohio and Nita Lowery of New dustry, there are limited ways that healthcare professionals York.13 Similar legislation has been proposed in the past can be confident a medication does not contain gluten. As with no success. H.R. 3648 did not pass but would have the medication experts, it is a pharmacist’s duty to analyze required drug manufacturers to list a parenthesis with the medication lists of patients with CD or gluten-intolerance source of any grain-derived or starch-containing inactive and consider the risks vs. the therapeutic indication of the ingredient. drug (Table 4). Resources such as Pillbox and DailyMed
Table 3: Red-Flag Inactive Ingredients in Drug Products11
Even a medication with no red-flag ingredient can still contain detectable amounts of gluten above the 20 ppm threshold. A recent study in people with CD and other glu-
are reliable methods for searching inactive ingredients, and patients should be educated on how to use these tools. The website AllergyFreeRx, developed by pharmacists, is 15
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Sept. 2016 CE — Gluten Free Medication
September/October 2016 http://www.beyondceliac.org/SiteData/docs/NFCA% 20Glute/ 09662d869bb02629/NFCA%20Gluten%20in% 20Medications%20Guide.pdf. Accessed 5 Jan 2016.
Table 4: The Pharmacist’s Role
Evaluate presence of red-flag ingredients on the medication list of patients diagnosed with CD or other gluten-sensitivities
Educate patients on use of databases to search for inactive ingredients
Initiate contact with drug manufacturers when the source of a red-flag ingredient is unknown
Assess adherence if a patient suspects gluten is present in their medication
Evaluate therapeutic necessity of any medications with a risk for containing gluten
Recommend different manufacturers, different drug, different drug class or discontinuation of a medication suspected/confirmed to contain gluten
5. Vazquez-Roque M, Oxentenko AS. Nonceliac gluten sensitivity. Mayo Clinic Proc. Sep 2015;90(9):12721277. 6. Elli L, Roncoroni L, Bardella MT. Non-celiac gluten sensitivity: time for sifting the grain. World J Gastroenterol 2015 Jul 21;21(27):8221-8226. 7. U.S. Food and Drug Administration. FDA News Release. FDA defines “gluten-free” for food labeling. Available at http://www.fda.gov/NewsEvents/ Newsroom/PressAnnouncements/ucm363474.htm. Published 2 Aug 2013; updated 28 Aug 2013. Accessed 2 Feb 2016. 8. Forbes GM. Modifying the gluten-free threshold for foods: first do no harm. Med J Aust 2013;199(6):393.
also a useful tool that indicates the likelihood of gluten (or other allergens) present in a specific medication. The Drug Information Service (DIS) at Robert Wood Johnson University Hospital (RWJUH) has developed a growing database of specific drug products and their determination of the drug product’s gluten status.14 As of January 2015, the DIS had examined queries for the gluten content in 84 medications, but, alas, 59 of these queries were found to be inconclusive. For patients who must avoid gluten intake for fear of serious health consequences, the uncertainty of its presence in a drug product should be weighed against the therapeutic benefit from the drug. Pharmacists are accessible healthcare professionals that can aid in selecting appropriate therapy.
9. U.S. Food and Drug Administration. Questions and answers: gluten-free food labeling final rule. Available at: http://www.fda.gov/Food/GuidanceRegulation/ GuidanceDocumentsRegulatory. 10. Information/Allergens/ucm362880.htm. Updated Jun 26 2015. Accessed 2 Feb 2016. 11. Catassi C, Fabiani E, Iacono G, et al. A prospective, double-blind, placebo-controlled trial to establish a safe gluten threshold for patients with celiac disease. Am J Clin Nutr 2007;85(1):160-166.
12. Plogsted S. Gluten in medication. Celiac Disease Foundation. https://celiac.org/live-gluten-free/ glutenfreediet/gluten-medication/. Accessed 5 Jan 1. Office of Food Safety. Center of Food Safety and Ap2016. plied Nutrition. Food and Drug Administration. Health hazard assessment for gluten exposure in individuals 13. Jay L, Mangione RA, Pal S, et al. Gluten in medication: with celiac disease: determination of tolerable daily qualifying the extent of exposure to people with celiac intake levels and levels of concern for gluten. Available disease and identifying a hidden and preventable at http://www.fda.gov/Food/. cause of an adverse drug event. Published 24 Sep References
2. GuidanceRegulation/ GuidanceDocumentsRegulatoryInformation/Allergens/ ucm362880.htm. Published May 2011. Accessed 2 Feb 2016.
2014; Updated 5 May 2015. Available at http://www.beyondceliac.org/SiteData/docs/ PublicRepo/9180ed94e35ad91f/ PublicReport_revised_5_2015.pdf. Accessed 11 Jan 2016.
3. Elli L, Branchi F, Tomba C, et al. Diagnosis of gluten related disorders: celiac disease, wheat allergy and 14. Pillbox. United States National Library of Medicine, and non-celiac gluten sensitivity. World J Gastroenterol the National Institutes of Health. Data version May 11, 2015 Jun 21;21(23):7110-7119. 2015. Available at: http://pillbox.nlm.nih.gov. Accessed 5 Jan 2016. 4. National Foundation for Celiac Awareness, and the American Society of Health-System Pharmacists. What 15. Iscol J. Celiac Community Foundation of Northern California. Gluten in medication: pressing the FDA to act is celiac disease? Available at: 16
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Sept. 2016 CE — Gluten Free Medication now. Available at http://www.celiaccommunity.org/update-glutenin-drugs/. Published Jan 2016. Accessed 7 Feb 2016.
September/October 2016 Resources
16. Cruz JE, Cocchio C, Tsun Lai P, HermesDeSantis E. Gluten content of medications. American Journal of Health-System Pharmacy. 1 Jan 2015;72(1):52-60.
Allergy Free Rx: https://allergyfreerx.com/#!/ PillBox: http://pillbox.nlm.nih.gov/pillimage/search.php DailyMed: http://dailymed.nlm.nih.gov/dailymed/ Gluten Free Drugs: http://www.glutenfreedrugs.com
September 2016 — Is My Medication Gluten-Free? 1. A person with Celiac Disease should avoid consumption of which of the following grains? A. Wheat B. Barley C. Rye D. a and c E. a, b, and c
6. Which of the following common gluten-associated disorders can be diagnoses by the presence of auto-antibodies? A. Celiac disease B. Nonceliac gluten sensitivity C. Wheat allergy D. Wheat-dependent exercise-induced anaphylaxis
2. For drug products, a gluten content less than _____ is required by FDA. A. 1 ppm B. 20 ppm C. 50 ppm D. Not established
7. Food products regulated by the FDA must contain no more than ____ ppm to be considered gluten free. A. 0.5 B. 1 C. 20 D. 50
3. Which of the following inactive ingredients should raise concern if you found that it was an excipient in metoprolol prescribed for a patient with Celiac Disease? A. Dextrate (potato) B. Pregelatinized starch (corn) C. Derived wheat source D. Modified starch
8. True or False: Legislation has been introduced to assist in identifying gluten in medications. A. True B. False
4. What tool can patients use to search for their medication and see the likelihood of the medication to contain gluten? A. Pillbox B. Allergy Free Rx C. RWJUH database D. Clinical Pharmacology
9. True or False: A medication free of ‘red flag’ ingredients can be consumed by a gluten-sensitive patient with no risk of a reaction. A. True B. False
10. A patient has inquired about the potential gluten content of one of their medications. You have checked the ingredient list and recognize a red flag ingredient, dextrin, with no source identified. You check the Drug Information Service website at Robert Wood Johnson University Hospital and the results for the medication 5. A patient with Celiac Disease is experiencing mild in question are “inconclusive.” What is the most gastrointestinal symptoms despite following a appropriate next step? gluten-free diet. The doctor started the patient on A. Tell the patient the medication should not cause a omeprazole 40mg daily, hypothesizing that acid reaction. reduction may mitigate some of the nausea. After three B. Since the results are inconclusive there is nothing else weeks on omeprazole, the patient states worsening you can do at this time. nausea, new-onset fatigue and new-onset diarrhea. C. Recommend a different medication for the patient’s Considering you just read an article that found there condition. are >20 ppm of gluten present in omeprazole capsules, D. Call the manufacturer in an attempt to identify the what would you recommend to the doctor? dextrin source. A. Discontinue omeprazole B. Decrease dose to omeprazole 20mg daily C. Continue current dose of omeprazole
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Sept. 2016 CE — Gluten Free Medication
September/October 2016
This activity is a FREE service to members of the Kentucky Pharmacists Association. The fee for non-members is $30. Mail completed forms to: KPERF, 96 C Michael Davenport Blvd., Frankfort, KY 40601. Credit will be applied to your CPE Monitor Profile. Expiration Date: September 14, 2019 Successful Completion: Score of 80% will result in 1.5 contact hours or .15 CEUs. Participants who score less than 80% will be notified and permitted one re-examination. TECHNICIANS ANSWER SHEET. September 2016 — Is My Medication Gluten-Free? (1.5 contact hour) Universal Activity # 0143-0000-16-009-H01-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D E 3. A B C D 5. A B C 2. A B C D 4. A B C D 6. A B C D
7. A B C D 8. A B
9, A B 10. A B C D
Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet. Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature ____________________________________________Completion Date___________________________
Personal NABP eProfile ID #_____________________________ Birthdate ____________(MM/DD) PHARMACISTS ANSWER SHEET September 2016 — Is My Medication Gluten-Free? (1.5 contact hour) Universal Activity # 0143-0000-16-009-H01-P Name ________________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D E 3. A B C D 5. A B C 2. A B C D 4. A B C D 6. A B C D
7. A B C D 8. A B
9, A B 10. A B C D
Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet. Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature ____________________________________________Completion Date___________________________
Personal NABP eProfile ID #_____________________________ Birthdate ___________________(MM/DD) The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy Education as a provider of continuing Pharmacy education.
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Quizzes submitted without NABP eProfile ID # and Birthdate cannot be accepted.
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Kentucky Reportable Diseases Regulation
September/October 2016
Kentucky Reportable Diseases regulation requires pharmacist reporting An amendment to the Kentucky reportable diseases regulation, now called "902 KAR 2:020 is in effect. Reportable disease surveillance" has added new reporting requirements for pharmacists for tuberculosis (TB).
Note: There is a newer treatment regimen for latent TB infection that uses Isoniazid and Rifapentine. "Rifapentine" was not listed among the drugs in the regulation, but a pharmacist could decide to report the dispensing of Isoniazid and Rifapentine. For more information, see http://www.cdc.gov/ mmwr/preview/mmwrhtml/mm6048a3.htm? s_cid=mm6048a3_w.
Visit this site for the regulation: http://www.lrc.ky.gov/ kar/902/002/020.htm The section dealing with pharmacists is below: "Section 15. Tuberculosis. (1) A pharmacist shall give notice if two (2) or more of the following medications used for the initial treatment of active tuberculosis are dispensed to an inpatient in a health facility or to an ambulatory patient in a health facility or a pharmacy: (a) Rifampin or rifabutin; (b) Isoniazid; (c) Pyrazinamide; and (d) Ethambutol. (2) A report of tuberculosis shall be considered priority and shall be reported to the local health department serving the county in which the patient resides. (3) If the local health department cannot be reached, notification shall be given to the Kentucky Department for Public Health. (4) The report shall include: (a) Information required in Section 4(16) of this administrative regulation; and (b) Names of the medications dispensed." Visit this site for a reporting form:
Zika Virus subject of proposed change The Department for Public Health has filed a proposed administrative regulation to amend 902 KAR 2:020. Reportable disease surveillance. If approved, this administrative regulation will make Zika Virus Disease a permanent addition to the list of diseases that are reportable in Kentucky and will replace the emergency amendment already in effect for this purpose. The amendment classifies Zika Virus Disease notification as priority, within one (1) business day, submitted electronically, by fax or by telephone to the local health department serving the county in which the patient resides and, if submitted by phone, followed up by electronic or fax submission of a report to the local health department serving the county in which the patient resides within one (1) business day. A report submitted by fax shall be made with the EPID 200 form, which has also been revised through this proposed amendment. The proposed regulation is posted on the Kentucky Legislative website at http://www.lrc.ky.gov/ kar/902/002/020reg.htm.
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Campaign for Kentucky’s Pharmacy Future
September/October 2016
The Campaign for Kentucky’s Pharmacy Future: The Next 50 Years
96 C Michael Davenport Blvd. The Campaign for Kentucky’s Pharmacy Future: The Next 50 Years http://www.kphanet.org/?page=buildingcampaign Have an idea for a continuing education article? WRITE IT! Continuing Education Article Guidelines
The following broad guidelines should guide an author to completing a continuing education article for publication in The Kentucky Pharmacist.
Average length is 4-10 typed pages in a word processing document (Microsoft Word is preferred).
Articles are reviewed for commercial bias, etc. by at least one (normally two) pharmacist reviewers. When submitting the article, you also will be asked to fill out a financial disclosure statement to identify any financial considerations connected to your article.
Articles are generally written so that they are pertinent to both pharmacists and pharmacy technicians. If the subject matter absolutely is not pertinent to technicians, that needs to be stated clearly Articles should address topics designed to narrow at the beginning of the article. gaps between actual practice and ideal practice in Article should begin with the goal or goals of the pharmacy. Please see the KPhA website overall program – usually a few sentences. (www.kphanet.org) under the Education link to see Include 3 to 5 objectives using SMART and meas- previously published articles. urable verbs.
Include a quiz over the material. Usually between 10 to 12 multiple choice questions.
Feel free to include graphs or charts, but please submit them separately, not embedded in the text of the article.
Articles must be submitted electronically to the KPhA director of communications and continuing education (ssisco@kphanet.org) by the first of the month preceding publication.
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Oct. 2016 CE — Basics of Pharmacogenomics
September/October 2016
Basics of Pharmacogenomics By: Elijah Dawson, PharmD; Sarah M. Lawrence, PharmD, MA, CGP; Henry Cohen, PharmD, MS, FCCM, BCPP, CGPgkb; Amber Cann, PharmD, MBA, Sullivan University College of Pharmacy There are no financial relationships that could be perceived as real or apparent conflicts of interest. Universal Activity # 0143-0000-16-010-H01-P&T 1.0 Contact Hour (0.1 CEUs) Expires 9/22/2016 Goals: Describe the basic principles of pharmacogenomics and how they relate to current pharmacotherapy. Identify resources that can be used in making treatment decisions based on pharmacogenomic information.
KPERF offers all CE articles to members online at www.kphanet.org
Objectives At the conclusion of this Knowledge-based article, the reader should be able to: 1. 2. 3. 4.
Understand basic principles and theory behind genetics and genomics; Describe the “central dogma” of transcription and translation; Identify resources for information on pharmacogenomics labeling and guidelines; and Identify common gene/drug combinations for which it may be important to utilize genetic testing.
Genetic theory’s “central dogma” is that genes are read by proteins within the nucleus of a cell and are transcribed into Basics of Genetics messenger RNA (mRNA). This mRNA travels outside of the The Nobel Prize-winning discovery in 1953 of deoxyribonu- nucleus where it is translated by a large protein complex cleic acid (DNA) by Watson and Crick paved the way for known as a ribosome. Within the ribosome, every threethe current understanding of genomics. Prior to the discov- nucleotide segment of mRNA is matched with a specific ery of DNA, scientists had used “gene” to describe what amino acid. When these amino acids are added in sethey perceived as a unit of inheritance. The discovery of the quence, they form a protein or an enzyme.1 structure of DNA, and its nucleotide components, provided A person inherits two copies of each gene, one gene from the mechanism by which these units of inheritance were each parent. If each parent passes on genes that are idenpreserved and propagated over multiple generations.1 tical to each other, the person is homozygous for this seDNA is a double-helix structure composed of two strands of quence. If the two copies of the gene passed on are differribose/phosphate backbones lined with a sequence of four ent from one another, the person is considered heterozynucleotide base pairs: adenine (A), cytosine (C), guanine gous for a given sequence. The term to describe the physi(G) and thymine (T). In this sequence, nucleotide “A” binds cal representation of a trait is called the phenotype. The with “T,” and nucleotide “C” binds with “G” of the complegene or genes that lead to that specific trait are called the mentary strand to form what is known as base pairs. Every genotype. Examples of phenotype include eye and hair colgene’s function is determined by a sequence of these base or, while genotype is the entire complement of genes that pairs.1 lead to that eye or hair color.1 Introduction to Genomics
The nucleus of every cell in the human body contains a copy of an individual’s entire complement of genetic material. This DNA is divided up into 46 chromosomes (two sets of 23 chromosomes, one inherited from each parent). Each copy of the human genome contains more than 1 billion base pairs and contains 20,000 to 25,000 genes. Ribonucleic acid (RNA), another form of genetic material, is similar to DNA in that it is composed of four different nucleotides, but differs in the composition of its base pairs. Instead of binding with adenine as it does in DNA, thymine instead binds with the nucleotide uracil (U).1
Changes in gene sequence among individuals are known as polymorphisms. The most common type of polymorphism is the Single Nucleotide Polymorphism (SNP), which is a change in the sequence of a gene by a single base pair. Multiple sequences for a single gene are known as alleles. Certain types of alleles are typically annotated using star (*) annotation. In this system of annotation, the wildtype allele is annotated *1. Subsequent alleles may be annotated *2, *3 and so on. For example, the wild type of the CYP2D6 enzyme is annotated CYP2D6 *1. A patient who is homozygous would have two identical alleles of a gene an-
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THE KENTUCKY PHARMACIST
Oct. 2016 CE — Basics of Pharmacogenomics
September/October 2016
notated CYP2D6 *1/*1. A heterozygous patient would have two or more different alleles annotated CYP2D6 *1/*2.1
Table 1. Genetic Terminology
Pharmacogenomics Pharmacogenomics and pharmacogenetics are terms that are often used interchangeably; however, there are subtle differences in the two terms.2 Pharmacogenomics is a term that refers to the interaction of multiple genes in determining drug response. Pharmacogenetics refers to the effect on drug response by a single gene variant. This variation in drug response among individuals has the potential to result in highly personalized medication therapies or regimens which differs from the previous standard of “one size fits all” dosing or standardized dosing for an entire population.1 Genetic variations can have an impact on pharmacokinetic mechanisms (absorption, distribution, metabolism and excretion) as well as pharmacodynamic mechanisms (drug receptor response and biologic effect).1 Pharmacogenomic testing has the potential to avoid or possibly shorten the time it takes to settle on the correct dose of a particular agent for the desired therapeutic effect, while minimizing adverse drug reactions. Pharmacogenomic information also can be used to predict a dose response, in order to adjust medication regimens that could potentially be subtherapeutic or have a high likelihood of adverse events.1
Term
Definition
Gene
A unit of inheritance composed of sequences of DNA
Genotype
The gene or genes that govern a given trait
Phenotype
The trait that is a marker for a gene or genes
Chromosome
A bundle of DNA contributed from a parent Each person has 46 chromosomes.
Polymorphism
Genetic variation in a population represented by two or more phenotypes
Single Nucleotide Polymorphism (SNP)
A single nucleotide mutation at a given point in the genome
Allele
Multiple forms of one gene within a population
Pharmacogenomics
Broad term referring to effect of genome on drugs in the body
Pharmacogenetics
The effect of a single gene on a single drug
Biomarker
A gene which plays a role in drug exposure and clinical response
Pharmacokinetics
The body’s effects on the drug; absorption, distribution, metabolism and excretion
Pharmacodynamics
The effect that the drug has on the body
Homozygous
When only one allele type is found in a person’s genome
Heterozygous
When two or more alleles found in a person’s genome
Resources The Food and Drug Administration (FDA) currently maintains a list of pharmacogenomic biomarkers with more than 100 drugs that include genomic considerations within their labeling. This list provides drug name, therapeutic area, referenced subgroup and the area of labeling impacted. The area of labeling impacted may be contraindications, precautions, boxed warnings or other labeling areas. Some drugs, such as certain oncology agents, require genetic screening prior to administration. These requirements are reflected on drug labels and the FDA biomarker list includes these medications.3 The Pharmacogenomics Knowledgebase (PharmGKB) was implemented in 2000 and funded by the National Institutes of Health (NIH) and the National Institute of General Medical Sciences, in partnership with Stanford University. PharmGKB was created to form a repository of data from various organizations across the country on pharmacogenomics and includes information from the biomarker list compiled by the FDA. The site provides access to literature searches and guidelines and recommendations covering genetic and genomic topics relating to pharmacogenomics. Drug labelling considerations from the FDA and other organizations are catalogued, with recommended pharmacogenomic intervention levels. These rec-
ommendations are based on levels of evidence and are divided into four categories: genetic testing required (Table 2), genetic testing recommended, actionable pharmacogenomics and informative pharmacogenomics.4 Formed as a collaboration between PharmGKB and the Pharmacogenomics Research Network, the Clinical Phar-
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Oct. 2016 CE â&#x20AC;&#x201D; Basics of Pharmacogenomics
September/October 2016
Table 2: Drugs Which Require Genetic Testing
CYP2D6 and Codeine
Medication Class
Codeine, an opioid analgesic, is an inactive prodrug metabolized in the body to its active form. The enzyme encoded by the gene CYP2D6 is responsible for the metabolic conversion of codeine into morphine and morphine-6glucuronide. Both morphine and morphine-6-glucuronide are orders of magnitude greater in their affinity for opioid receptors than codeine. Patients who are faster metabolizers of codeine will have a greater likelihood of codeine toxicity while patients who do not metabolize codeine well will have a decreased analgesic effect.7
Medication
Oncology
afatinib denileukin diftitox letrozole anastrozole erlotinib nilotinib arsenic trioxide everolimus panitumumab bosutinib exemestane pertuzumab ceritinib fulvestrant trametinib cetuximab ibrutinib trastuzumab crizotinib imatinib dasatinib lapatinib
HIV medication
maraviroc
The CPIC guidelines for CYP2D6 and codeine classify allelic variation into units of activity and uses those units of activity to make recommendations. CPIC differentiates codeine phenotypic response into the four previouslyMiscellaneous carglumic acid rasburicase tetrabenazine eliglustat discussed categories of CYP450 metabolism (Table 3). tretinoin ivacaftor Based upon this classification, recommendations can be velaglucerase alfa pimozide made about the appropriateness of codeine as analgesic 3 therapy. For patients who are ultra-rapid metabolizers or Based on FDA Biomarkers in Labeling List poor metabolizers, the guideline currently recommends that macogenetics Implementation Consortium (CPIC) provides use of codeine should be avoided. Ultra-rapid metabolizers public, peer-reviewed guidelines on intervention and dosing may experience toxicity, while poor metabolizers risk reregarding specific drug/allele combinations. The guidelines duced efficacy in analgesia. Codeine labelling contains a boxed warning contraindicating its use in children to manare available on the PharmGKB website. CPIC lists 35 guidelines on the use of pharmacogenomics and provides age post-operative pain after tonsillectomy and/or adenoidectomy. These contraindications are due to the risks of resguidance from the Royal Dutch Association for the Adpiratory depression and death in ultra-rapid metabolizers.7 vancement of Pharmacy-Pharmacogenomics working group and others.5 Routine testing of the CYP2D6 genotype could be used to Anticonvulsants
carbamazepine, divalproex, valproic acid
Drugs and Genes Impacted Cytochrome P450
better determine appropriate agents for pain control. At least one facility has described the use of routine pharmacogenomic testing in the treatment protocol of acute lymphoblastic leukemia for patients in whom pain control may be an issue.8
Genomic variations in the cytochrome P450 system can have a significant impact on patientsâ&#x20AC;&#x2122; response to medications. Hepatic enzymes known as cytochrome P450 enzymes (CYP450) are involved in the Table 3. Codeine Metabolizer Phenotype metabolism of most drugs. Allelic variations in Phenotype Activity Genotype (CYP2D6) CYP450 enzymes, depending on a patientâ&#x20AC;&#x2122;s Score genotype, can alter drug metabolism. Common CYP450 enzymes in which pharmacogenomic Ultrarapid metabolizer >2 An individual carries more than differences among individuals have been shown two copies of a functional allele (e.g. *1/*1xN) to play a role include CYP2D6, CYP2C19 and CYP2C9. These three CYP enzymes play a role Extensive metabolizer 1-2 Individual carries two functional or in the metabolism of 30 percent of all drugs. reduced function allele. (e.g. *1/*1) Nomenclature for identifying the phenotypic response of CYP450 enzymes is broken into four Intermediate metabolizer 0.5 Individual carries one reduced and one nonfunctional allele (*4/*10) categories: ultra-rapid metabolizer, extensive metabolizer, intermediate metabolizer and poor Poor metabolizer 0 Individual carries two nonfunctionmetabolizer. The impact of each of these pheal alleles (*5/*5) notypes on efficacy or safety is specific to each drug/gene combination.6 Adapted from CPIC guidelines.7
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THE KENTUCKY PHARMACIST
Oct. 2016 CE — Basics of Pharmacogenomics CYP2C19 and Clopidogrel Clopidogrel is a platelet aggregation inhibitor metabolized by CYP2C19 to its active form. Decreased activation by CYP2C19, due to the presence of two dysfunctional alleles has been theorized to increase the risk of ischemia and myocardial infarction.9 The ELEVATE-TIMI trial demonstrated that approximately one-third of trial subjects did not have an appreciable reduction in platelet activity upon receiving a 300mg dose of clopidogrel.10 The CYP2C19*1 wild type is the most common allele type, while the CYP2C19*2 allele has a single nucleotide polymorphism which creates a non-functional protein incapable of activating clopidogrel. Patients who carry the non-functional alleles and are treated with clopidogrel after a percutaneous coronary intervention (PCI) were shown to have 1.5 times the risk of cardiovascular death, MI or stroke, and a threefold increase in risk for stent thrombosis compared to patients with the functional allele.9
September/October 2016 blistering and loss of epidermal layers may occur in affected patients.14 In 2007, the FDA issued a warning to all patients of Asian ancestry on carbamazepine therapy. The FDA recommends these patients receive genetic testing to determine genotypes prior to receiving the drug. The presence of one or two HLA-B*1502 alleles is considered a positive marker. The FDA recommends avoiding carbamazepine therapy in these patients, unless the benefit of the drug outweighs the risk of SJS/TEN.15 Genotype testing also may be indicated for those who have a history of antiepileptic hypersensitivity syndrome.16 VKORC1/CYP2C9 and Warfarin
The anticoagulant warfarin is known for its highly individualized dosing and the need for routine monitoring of each patient’s International Normalized Ratio (INR). Two genes are known to affect the metabolism and therapeutic effect of warfarin. The enzyme encoded by CYP2C9 is responsiIn 2010, the FDA ble for metabolizing added a boxed Table 4. Warfarin Expected Maintenance Dose Range based on Genotype warfarin to its inactive warning in VKORC1 CYP2C9 metabolites, which clopidogrel labelare then excreted *1/*1 *1/*2 *1/*3 *2/*3 *3/*3 ing that notes its from the body. The GG 5-7 mg 5-7 mg 3-4 mg 3-4 mg 0.5-2 mg diminished effects gene VKORC1 proin patients who AG 5-7 mg 3-4 mg 3-4 mg 0.5-2 mg 0.5-2 mg duces the enzyme are poor metabothat converts vitaminAA 3-4 mg 3-4 mg 0.5-2 mg 0.5-2 mg 0.5-2 mg lizers of the K epoxide to vitamin 18 drug.11 The Amer- *Adapted from Warfarin package insert K. This enzyme is the ican College of primary target of the drug warfarin. Polymorphisms in these Cardiology Foundation Task Force on Clinical Expert Contwo genes can result in variations in the metabolism of warsensus Documents and the American Heart Association farin. They also can decrease warfarin’s ability to inhibit the (ACCF/AHA) currently do not recommend routine testing of synthesis of vitamin K.17 In 2010, the FDA added a section patients being treated with clopidogrel due to insufficient on genetic dosing considerations to the label of warfarin. evidence of benefit. Instead, the ACCF/AHA recommend The label includes a table that provides three expected testing for loss-of-function alleles on a case-by-case basis, maintenance dose ranges based on each patient’s genobased on therapeutic response.12 The CPIC currently rectype (Table 4).18 ommends an alternative therapy such as prasugrel or tiThe CPIC guidelines for CYP2C9 and VCORK1 with warfacagrelor for intermediate or poor metabolizers.13 rin recommend the website www.warfarindosing.org for HLA-B*1502 and Carbamazepine estimating a stable dosage of warfarin.17 The site provides The anticonvulsant carbamazepine is used in the treatment evidence-based guidance on initial and maintenance dosof epilepsy, bipolar disorder and trigeminal neuralgia. The ing, based on multiple criteria including CYP2C9 genotype human leukocyte antigen B (HLA-B) gene is responsible for and VKORC1 haplotype. The algorithm considers many encoding a protein that enables the recognition of antigens different factors, including patient ethnicity, age and conby the immune system. One specific allele of this gene, current drug therapy. The site also provides recommendaHLA-B*1502, has been linked with an increased incidence tions for initial dose, dose adjustments and maintenance of Stevens-Johnson Syndrome (SJS) and toxic epidermal dosing.19 necrosis (TEN) in patients of south Asian or Han Chinese Genetic Testing descent who have taken carbamazepine. These adverse effects are potentially fatal skin reactions that affect large Both the FDA and the Center for Medicare and Medicaid areas on the body and mucous membranes. Excessive Services (CMS) are involved in the regulation of genetic 24
THE KENTUCKY PHARMACIST
Oct. 2016 CE — Basics of Pharmacogenomics
September/October 2016
testing. CMS is responsible for regulating laboratories that perform genetic testing. Under the Clinical Laboratory Improvement Amendment of 1988, the FDA regulates the safety and efficacy of both commercially-available genetic test kits and laboratory-developed tests (LTDs). LTDs are tests that are utilized by a single lab for genetic testing, while testing kits can be used by multiple labs.20
as 23andMe and DNA4Life are now offering home genetic testing, sold directly to consumers. In 2015, the FDA granted authorization for 23andMe’s Bloom Syndrome carrier test. This approval follows much controversy over similar DNA testing methods. This represents a truce between industry and regulators, since in 2013, the FDA ordered 23andMe to cease marketing of its services.25 The potential for growth in the direct-to-consumer test industry is enorThe Genomic Testing Registry (GTR) offers a listing of mulmous. tiple pharmacogenomic tests that can be filtered by criteria including drug response, mutation confirmation and diagno- Conclusion sis. These tests also can be filtered by the type of speciPharmacists serve as a primary source of drug information men collected — buccal swab, saliva, whole blood or isolatfor both patients and prescribers. Knowledge of phared DNA. The registry lists tests provided by private laboramacogenomics and the related resources available can be tories as well as labs in hospitals and other medical faciliutilized to assist in finding appropriate dosages and medities.21 cations. Pharmacists and pharmacy technicians, familiar Genelex is an example of a testing company available on with both the drugs and the patients, can identify patients the GTR. It offers genotyping for more than 28 actionable whose therapeutic responses may indicate pharpharmacogenomic biomarkers. Like many testing compamacogenomic problems. Pharmacies also may seek to adnies, Genelex offers tests as a panel of biomarkers or alminister or sell genetic testing to patients as an additional lows for the genotyping of a specific biomarker. Tests can service. If this service is provided, knowledge of pharbe administered via a buccal swab or whole blood specimacogenomics and resources will be critical. The drugs men. Results are generally available in three to five busilisted in this educational material are just a few of the drugs ness days. Genelex does not advertise pricing for its testin which pharmacogenomics may play a role in drug reing, but does accept third party payors and offers a finansponses. Familiarity with resources such as PharmGKB 22 cial assistance program. and the CPIC guidelines support pharmacists in their role as medication stewards. Third Party Coverage References Some third party payors cover genetic testing. Others, such 1. Gaedigk A. Chapter 2. Genetic Concepts of Pharas Medicare, have more restrictive guidelines for coverage macogenomics: Basic Review of DNA, Genes, Polyand reimbursements. CMS does not cover screening tests morphisms, Haplotypes and Nomenclature. In: Bertino but may cover tests that assist in diagnoses or help deterJS, Jr, DeVane C, Fuhr U, Kashuba AD, Ma JD. eds. mine treatment options. Drugs in which the FDA requires Pharmacogenomics: An Introduction and Clinical Pertesting before implementation of drug therapy will typically spective. New York, NY: McGraw-Hill; 2013.http:// be covered. Drugs that have a biomarker listed in the labelaccesspharmacy.mhmedical.com.suscorp.idm.oclc.org/ ing or in a clinical practice guideline also may be covered content.aspx?bookid=511&Sectionid=40849369. by CMS. For those tests not covered, prescribers may seek Accessed 2016 Jan 8. a prior authorization. Companies that offer at-home or mail2. PharmGKB FAQs. PharmGKB website. in pharmacogenomic tests also might offer patient assishttps://www.pharmgkb.org/page/faqs. accessed 2016 tance programs.23 Feb 24. In 2009, CMS decided not to broadly cover genomic testing 3. Table of pharmacogenomics biomarkers in drug labelof patients for warfarin dosing, due to a lack of evidence ing. Food and Drug Administration. Available at that testing positively impacts Medicare patient outcomes. http://www.fda.gov/Drugs/ScienceResearch/ The testing may receive coverage if it is necessary for a 24 ResearchAreas/Pharmacogenetics/ucm083378.htm. clinical trial. updated 2015 May 20; accessed 2016 Jan 20. Direct-to-Consumer Genetic Testing 4. Pharmacogenomics Knowledge Base. PharmGKB With the emergence of interest in genetic testing, some website. https://www.pharmgkb.org/index.jsp. accessed firms have begun developing tests to market directly to 2016 Feb 8. consumers. This move is not without controversy. The FDA is still struggling with regulation of the industry. Firms such 5. CPIC: Clinical Pharmacogenetic Implementation Con25
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Oct. 2016 CE â&#x20AC;&#x201D; Basics of Pharmacogenomics
September/October 2016
sortium. Pharmacogenomics, Knowledge and Implementation website. https://www.pharmgkb.org/page/ cpic. accessed 2016 Feb 8.
as Carbatrol, Equetro, Tegretol, and generics). Food and Drug Administration website. http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ucm124718.htm. updated 2013 Aug 14; accessed 2016 Feb 23.
6. Ingleman-Sundberg, M. & Sim, S.C. (2010). Pharmacogenetic biomarkers as tools for improved drug therapy; emphasis on the cytochrome P450 system. Biochemical and Biophysical Research Communications. 396:90 16. Nguyen DV, Chu HC, Nguyen DV, et.al. HLA-B*1502 -94. and carbamazepine-induced severe cutaneous adverse drug reactions in Vietnamese. Asia Pac Allergy. 7. Crews KR, Gaedigk A, Dunnenberger HM, et al. Clini2015 Apr; 5(2): 68â&#x20AC;&#x201C;77. cal Pharmacogenetics Implementation Consortium (CPIC) guidelines for codeine therapy in the context of 17. Johnson JA, Gong L, Whirl-carrillo M, et al. Clinical cytochrome P450 2D6 (CYP2D6) genotype. Clin PharPharmacogenetics Implementation Consortium Guidemacol Ther. 2012;91(2):321-6. lines for CYP2C9 and VKORC1 genotypes and warfarin dosing. Clin Pharmacol Ther. 2011;90(4):625-9. 8. Crews KR, Cross SJ, Mccormick JN, et al. Development and implementation of a pharmacist-managed 18. Warfarin [package insert]. Princeton, NJ: Bristol-Myers clinical pharmacogenetics service. Am J Health Syst Squibb Pharma Company; 1954. Pharm. 2011;68(2):143-50. 19. Warfarin Dosing. Warfarin Dosing website. 9. Sabatine MS, Mega JL. Pharmacogenomics of anhttp://www.warfarindosing.org/Source/Home.aspx. uptiplatelet drugs. Hematology Am Soc Hematol Educ dated 2015 Aug 14; accessed 2016 Feb 4. Program. 2014;2014(1):343-7. 20. Regulation of Genetic Tests. National Human Genome 10. Hochholzer W, Ruff CT, Mesa RA, et al. Variability of Research Institute website. individual platelet reactivity over time in patients treathttp://www.genome.gov/10002335. updated 2015 Apr ed with clopidogrel: insights from the ELEVATE-TIMI 17; accessed 2016 Feb 24. 56 trial. J Am Coll Cardiol. 2014;64(4):361-8. 21. GTR: Genomic Testing Registry. National Center for 11. FDA News Release: FDA Announces New Boxed Biotechnology Information website. Warning on Plavix. Food and Drug Administration webhttp://www.ncbi.nlm.nih.gov/gtr/. accessed 2016 Jan site. http://www.fda.gov/NewsEvents/Newsroom/ 29. PressAnnouncements/ucm204253.htm. updated 2013 22. Genelex: Tests page. Genelex website. Apr 24; accessed 2016 Feb 15. http://genelex.com/pharmacogenetic-tests/. accessed 12. Jneid H, Anderson JL, Wright RS, et al. 2012 ACCF/ 2016 Jan 18. AHA focused update of the guideline for the manage23. Genetic Testing: Genomic Tests and Family Health ment of patients with unstable angina/non-ST-elevation History by levels of Evidence. Center for Disease Conmyocardial infarction (updating the 2007 guideline and trol and Prevention website. http://www.cdc.gov/ replacing the 2011 focused update): a report of the genomics/gtesting/tier.htm. updated 2015 Aug 18; acAmerican College of Cardiology Foundation/American cessed 2016 Jan 29. Heart Association Task Force on Practice Guidelines. J 24. Pharmacogenomic Testing to Predict Warfarin ReAm Coll Cardiol. 2012;60(7):645-81. sponse. Center for Medicare and Medicaid Services 13. Scott SA, Sangkuhl K, Stein CM, et al. Clinical Pharwebsite. https://www.cms.gov/medicare/coverage/ macogenetics Implementation Consortium guidelines coverage-with-evidence-development/ for CYP2C19 genotype and clopidogrel therapy: 2013 pharmacogenomic-testing-to-predict-warfarinupdate. Clin Pharmacol Ther. 2013;94(3):317-23. responsiveness.html. Updated 2015 Mar 17; accessed 14. Leckband SG, Kelsoe JR, Dunnenberger HM, et al. 2016 Feb 20. Clinical Pharmacogenetics Implementation Consortium 25. Federal Drug Administration. FDA permits marketing of guidelines for HLA-B genotype and carbamazepine first direct-to-consumer genetic carrier test for Bloom dosing. Clin Pharmacol Ther. 2013;94(3):324-8. syndrome. http://www.fda.gov/NewsEvents/Newsroom/ 15. Information for Healthcare Professionals: Dangerous or PressAnnouncements/ucm435003.htm. Published Even Fatal Skin Reactions - Carbamazepine (marketed 2015 Feb 19; accessed 2016 Aug 17. 26
THE KENTUCKY PHARMACIST
Oct. 2016 CE â&#x20AC;&#x201D; Basics of Pharmacogenomics
September/October 2016
October 2016 â&#x20AC;&#x201D; Basics of Pharmacogenomics 1. What are the four base pairs that make up DNA? A. A,B,C,D B. G,T,A,C C. A,B,T,C D. K,W,A,C
6. What is the most common type of polymorphism found in the human genome? A. Single Nucleotide polymorphism (SNP) B. Trisomy 21 C. Short Tandem Repeats (STR) D. Variable Number Tandem Repeats (VNTR)
2. Which of the following is an example of a phenotype? A. CYP2C9 *1/*1 B. CYP2D6 wild type C. VKORC1 AG D. Eye color 3. In which two phenotypes is it recommended not to use codeine therapy? A. Extensive metabolizer and intermediate metabolizer B. Ultrarapid metabolizer and extensive metabolizer C. Poor metabolizer and ultrarapid metabolizer D. Poor metabolizer and intermediate metabolizer 4. Which ethnicity requires genomic testing before implementation of carbamazepine therapy? A. African American B. Han Chinese C. Caucasian D. Middle Eastern 5. Which organization compiles a list of biomarkers found in medication labelling? A. FDA B. CMS C. DEA D. CDC
7. Which organization creates guidelines with recommendations for specific drug/allele combinations? A. FDA B. CMS C. CPIC D. USGS 8. Poor metabolizers of clopidogrel demonstrate what kind of phenotypic response? A. Decreased platelet aggregation B. Increased platelet aggregation C. Higher bleed risk D. No change in platelet aggregation 9. Based on drug labelling, what would be the predicted maintenance dose range of warfarin with genotype for CYP2C9 *3/3*? A. 0.5-2 mg B. 5-10 mg C. 3-4 mg D. 1-3 mg 10. Medicare will not typically cover which type of genomic testing? A. Screening test B. Diagnosis test C. Test to determine treatment D. a and c
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THE KENTUCKY PHARMACIST
Oct. 2016 CE — Basics of Pharmacogenomics
September/October 2016
This activity is a FREE service to members of the Kentucky Pharmacists Association. The fee for non-members is $30. Mail completed forms to: KPERF, 96 C Michael Davenport Blvd., Frankfort, KY 40601. Credit will be applied to your CPE Monitor Profile. Expiration Date: September 22, 2019 Successful Completion: Score of 80% will result in 1.0 contact hours or .1 CEUs. Participants who score less than 80% will be notified and permitted one re-examination. TECHNICIANS ANSWER SHEET. October 2016 — Basics of Pharmacogenomics (1.0 contact hour) Universal Activity # 0143-0000-16-010-H01-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D 5. A B C D 2. A B C D 4. A B C D 6. A B C D
7. A B C D 8. A B C D
9, A B C D 10. A B C D
Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet. Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature ____________________________________________Completion Date___________________________
Personal NABP eProfile ID #_____________________________ Birthdate ____________(MM/DD) PHARMACISTS ANSWER SHEET October 2016 — Basics of Pharmacogenomics (1.0 contact hour) Universal Activity # 0143-0000-16-010-H01-P Name ________________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D 5. A B C D 2. A B C D 4. A B C D 6. A B C D
7. A B C D 8. A B C D
9, A B C D 10. A B C D
Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet. Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature ____________________________________________Completion Date___________________________
Personal NABP eProfile ID #_____________________________ Birthdate ___________________(MM/DD) The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy Education as a provider of continuing Pharmacy education.
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KPPAC Contribution Form
September/October 2016
Kentucky Pharmacists Political Advocacy Contribution Form Name: _________________________________ Pharmacy: ___________________________ Address: _______________________ City: ________________ State: _____ Zip: ________ Phone: ________________ Fax: __--_______________ E-Mail: __________________________________ Contribution Amount: $_________ Check ____ (make checks payable to KPPAC)
Mail to: Kentucky Pharmacists Political Advocacy Council, 96 C Michael Davenport Blvd., Frankfort, KY 40601
CONTRIBUTION LIMITS The primary, runoff primary and general elections are separate elections. The maximum contribution from a PAC to a candidate or slate of candidates is $1,000 per election.
Cash Contributions: $50 per contributor, per election. Contributions by cashierâ&#x20AC;&#x2122;s check or money order are limited to $50 per election unless the instrument identifies the payor and payee. KRS 121.150(4)
Individuals may contribute no more than $1,500 per year to all PACs in the aggregate.
Anonymous Contributions: $50 per contributor, per election, maximum total of $1,000 per election.
In-kind contributions are subject to the same limits as monetary contributions.
(This information is in accordance with KRS 121. 150)
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Campaign for Kentucky’s Pharmacy Future
September/October 2016
The Campaign for Kentucky’s Pharmacy Future: The Next 50 Years
Leave a legacy by participating in the campaign to replace OUR KPERF/KPhA Headquarters! Learn more about options for payment and levels of recognition at http://www.kphanet.org/?page=buildingcampaign or call 502-227-2303.
Donors to the campaign as of Sept. 20, 2016
Jeff Arnold Ray Bishop Fred Carrico Matt Carrico Jessika Chinn J. Leon & Margaret Claywell Chris & Katy Clifton David Dubrock Brian Fingerson Joseph L. Fink III Matt Foltz Andrew & Virginia France Trish Freeman Robert Goforth Cynthia Gray
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George & Burnetta Hammons Christopher Harlow JCAP Don & Vicki Kupper Phil & Julie Losch Joe Mashni Bob Oakley Chris & Consuelo Palutis Duane Parsons Ron & Lisa Poole Richard & Zena Slone Leah Tolliver Sam Willett Michael & Mary Ann Wyant
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Campaign for Kentuckyâ&#x20AC;&#x2122;s Pharmacy Future
September/October 2016
Join the Committee of 100 and help OUR KPhA accelerate to 50 percent of our Campaign Goal!
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KPhA New and Returning Members
September/October 2016
KPhA Welcomes New and Renewing Members July-August 2016 Valerie Akers Prestonsburg
Mellessia Driver Providence
Constance Jones Russell Springs
Jeffrey Arnold Crescent Springs
James Dunaway Henderson
Andrea Kramer Covington
Jason Baker Louisville
Debra Dunaway Henderson
Kayla Kreft Louisville
Jennifer Baker Louisville
David Eckmann Lexington
Joe Lewis Hyden
Christopher Betz Louisville
Lynne Eckmann Lexington
Alicia Logsdon Nancy
John Beville Shelbyville
Jojo Entsuah Louisville
Joey Mattingly Baltimore, Md.
Katherine Blain Louisville
Michelle Flynn Independence
Catherine Mcclish Louisville
Jacqueline Blair Mason, Ohio
Joyce Gardner Hodgenville
Jennifer McCreary Louisa
Larry Blandford Goshen
Gale Garner Paducah
Sheldon McCreary Louisa
Kara Blevins Ashland
Patricia Gooch Pikeville
Gail McDaniel Union
Lanny Branstetter Horse Cave
Len Gore Nicholasville
Velda Mcdaniel Georgetown
Stephen Britt Louisville
Wayne Gravitt Wheelwright
Pamela Meddings Crum, W. Virg.
Don Carpenter Olive Hill
Kathryn Harlan Glasgow
Lewis Michael Louisa
Katherine Carr Georgetown
Lynn Harrelson Louisville
Mark Milburn Louisville
Joseph Carr Owensboro
Shirley Henson Smithland
David Morgan Manchester
Michelle Casto-Litton Zionsville, Ind.
Julie Hinkel Fort Thomas
Crystal Morgan London
Teresa Collison Summersville
H. Harper Housman Paducah
Ann Murphy Princeton
Erin Conkright Owensboro
Robert Hughes Lexington
Daniel Nall Louisville
Johnnie Dando Liberty
Jacob Hutti Louisville
Courtney Newby Louisville
Michael Daniels Taylor Mill
Josiah Jaggers Versailles
Ronald Nix Louisville
Molly Deaton Fort Thomas
Shanna Jaggers Versailles
Myron Pass Louisville
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MEMBERSHIP MATTERS: To YOU, To YOUR Patients To YOUR Profession! Jigna Patel Owensboro Brittany Pauly Union Kenneth Pearce Danville Charles Pearson Bowling Green Andrea Pearson Bowling Green Elyse Pennington Dry Ridge Bernard Poe Owenton Thomas Ranz Louisville Ashton Reynolds Union James Rickett Williamsburg Amanda Robinson Edgewood Denise Robison Louisville Denise Rueff Louisville Bonnie Russell Elizabethtown
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KPhA New and Returning Members
September/October 2016
Larry Russell Elizabethtown
Nancy Shepherd Paducah
Jenny Sutherland Canmer
Kelly Whitaker Mayfield
Phillip Sandlin Louisville
David Shipley Henderson
Audra Swearingen Louisville
Franklin Wishnia Louisville
Angela Sandlin Louisville
Thomas Shively Owensboro
Mary Thacker Louisville
Heejung Woo Paducah
James Savage Louisville
Joe Silvers Monticello
John Vaal Edgewood
David Wren Louisville
Stanley Scates Lexington
Ronald Smith Hazard
Jonathan Van Lahr Webster
Sue Wynn Whitley City
Benjamin Scott Lexington
Francis Southall Lebanon
Stuart Waldman Louisville
Janelle Seitz Mount Vernon, Ind.
J Drane Stephens Eminence
Jeffrey Warner Jamestown
Edwin Shelton Owensboro
Shad Sutherland Canmer
Angela Whitaker Madison, Ind.
KPhA Honorary Life Members Ralph Bouvette, Leon Claywell, R. David Cobb, Gloria Doughty, Ann Amerson Mazone, Kenneth Roberts
Know someone who should be on this list? Ask them to join YOU in supporting OUR KPhA!
The Kentucky Renaissance Pharmacy Museum offers several ways way to show support of the Museum, our state's leading preservation organization for pharmacy. While contributions of any size are greatly appreciated, the following levels of annual giving have been established for your consideration.
Friend of the Museum $100 Proctor Society $250 Damien Society $500 Galen Society $1,000 Name______________________________________ Specify gift amount________________________ Address ____________________________________ City____________________Zip______________ Phone H____________________W________________ Email___________________________________ Employer name_____________________________________________________for possible matching gift. Tributes in honor or memory of_____________________________________________________ Mail to: Kentucky Renaissance Pharmacy Museum, P.O.Box 910502, Lexington, KY 40591-0502 The Kentucky Renaissance Pharmacy Museum is a non-profit 501(c)(3) business entity and as such donations are tax deductible. A notice of your tax deductible contributions will be mailed to you annually.
For more information on the Kentucky Renaissance Pharmacy Museum, see www.pharmacymuseumky.org or contact Gloria Doughty at g.doughty@twc.com.
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Student Pharmacists Educate KY Teens on STIs
September/October 2016
Student Pharmacists Educate Kentucky Teens About Sexually Transmitted Infections Author: Kady Bandy, PharmD Candidate, Sullivan University College of Pharmacy What is Operation Protect Yourself? Operation Protect Yourself is a program that pharmacy students from Sullivan University College of Pharmacy (SUCOP) have developed to provide education about sexually transmitted infections (STIs), including human immunodeficiency virus (HIV), to high school students throughout the Louisville and Southern Indiana area. The primary goal of these events is to improve awareness, and thus, potentially decrease the alarming rise of STI and HIV rates in the Kentuckiana youth population. What is Involved in the Operation Protect Yourself Educational Program? Each education event that SUCOP holds uses a combination of active learning strategies to engage students in the events, including group discussions, videos, games and experiments. For example, to demonstrate how quickly STIs can be spread, students are able to participate in a fun experiment. Students are provided with a small cup of clear liquid and are instructed to “swap fluids” with as many people as they wish in the classroom. A few students are instructed to “remain abstinent,” and not participate in the exchange, and a few students were given a cloudy liquid, representing a condom. The students were not aware that a few of the clear liquids were vinegar, an acid, and most of the cups contained water. After the exchange of fluids, a few drops of pH indicator solution is instilled in the cups to denote either STI positive (yellow) or negative (pink).
cine (Gardasil) recommendations. Students are always very competitive during this exercise, which keeps them engaged in learning the information.
Students are given the opportunity to ask any questions they have regarding STIs and HIV. Questions can be asked either confidentially via an anonymous question box, or out loud in class. The students always have very good Although only a few cups contained the STI at first, the ma- questions, and are very attentive throughout the entire event. jority of the class ends up testing “positive” for a STI after the exchange of fluids. At each school that is visited, stuWhy is it Important for High School Students to dents are very amused and surprised with this demonstra- Receive Education on STIs? tion’s results. Students are then provided with prevention According to the Centers for Disease Control and Preveneducation, such as abstinence, appropriate use of contion (CDC), one out of every four sexually active teens, agdoms, other protective barriers and birth control. es 15-24, will get an STI this year.1 Additionally, only oneTo teach about the various types of STIs and common half (51 percent) of sexually active teens report using a symptoms, students participate in a “Who Wants to Be a condom during sexual intercourse in Kentucky.2 Regarding Millionaire” game. Students are split up into teams and new HIV diagnoses in 2014, youths under the age of 19 compete against each other for a prize. The game contains accounted for 5 percent of diagnoses in Kentucky, and 9 questions that cover objectives such as: modes of transpercent (2 percent rise) in Indiana.3,4 Nationwide, youth mission of HIV, signs and symptoms of chlamydia, gonorbetween the ages of 13-24 account for 26 percent of new rhea and syphilis, and human papilloma virus (HPV) vacHIV diagnoses.5 34
THE KENTUCKY PHARMACIST
Student Pharmacists Educate KY Teens on STIs
September/October 2016
Furthermore, neighboring Scott County, Ind., has experi3. Kentucky Cabinet for Health and Family Services: Deenced a detrimental HIV outbreak since January 2015. Hispartment for Public Health. HIV/AIDS Surveillance Retorically, the rural-southeastern Indiana county had fewer port June 2014. http://chfs.ky.gov/nr/ than five cases reported annually, and as of February rdonlyres/13385b34-c9d1-42b6-b019-c0ba7a104d37/0/ 6,7 2016, there have been 188 cases reported. CDC director, hivaidsannualreportjune2014.pdf. Published 30, Jun Tom Frieden, claims that Austin, a city in Scott County, 2014. Accessed 2016 Mar 11. now has a higher incidence of HIV than, “any other country 4. Indiana State Department of Health. Semi-annual HIV/ in sub-Saharan Africa,” and had, “more people infected AIDS, STD, and Hepatitis B & C Data through Decemwith HIV through injection drug use than in all of New York ber 31, 2014. http://www.in.gov/isdh/files/At_A_Glance City last year.”8 (7).pdf. Published 2015 Jan 1. Assessed 2016 Mar 11. As pharmacists, we are among the most accessible health 5. Centers for Disease Control and Prevention. HIV care providers for patients. By integrating student pharmaamong youth. http://www.cdc.gov/hiv/group/age/youth/ cists into sexual health education in high schools, we are #footnotes. Published: unknown; updated 2015 Jun 30; hoping that teenagers will view community pharmacists as accessed 2016 Mar 14. a reliable source of sexual health information. 6. Conrad C, Bradley HR, Broz D, et al. Community outReferences: break of HIV infection linked to injection drug use of 1. Centers for Disease Control and Prevention. STDs in oxymorphone 2015. MMWR. 2015 May 1; 64(16):443Adolescents and Young Adults. http://www.cdc.gov/std/ 444. stats12/adol.htm. Published: unknown; updated 2014 7. Severson K. Health officials urge wider use of prevenJan 7; accessed 2016 Mar 11. tative medication as number of HIV outbreak cases 2. Office of Adolescent Health. Kentucky Adolescent Rerises by 4. http://www.in.gov/isdh/files/ productive Facts. U.S. Department of Health & Human ISDH_NEWS_RELEASE__Health_Officials_Urge_Wid Services. http://www.hhs.gov/ash/oah/adolescenter_Use_of_Preventative_Medication.pdf. Published health-topics/reproductive-health/states/ky.html. Pub2016 Feb 1. Assessed 11, Mar 2016. lished: unknown; updated 2014 Nov 13; accessed 2016 8. Ungar L, Kenning C. Indiana community’s HIV outbreak Mar 11. a warning to rural America. USA Today. 2015 May 17.
Join us for the 139th KPhA Annual Meeting & Convention! June 22-25, 2017 Griffin Gate Marriott Resort Lexington 35
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Pharmacy Law Brief
September/October 2016
Pharmacy Law Brief: Division of Privileging Authority within a Hospital Author: Joseph L. Fink III, B.S.Pharm., J.D., Professor of Pharmacy Law and Policy and KPhA Professor of Leadership, Department of Pharmacy Practice and Science, UK College of Pharmacy Question: I was talking with a patient recently and a question came up regarding who appoints physicians to the medical staff of a hospital and, further, once appointed, who determines what procedures they’re authorized to perform within the facility. I told her I was fairly sure that physicians are not employees of the hospital so they are not subject to the same level of control an employer would have based on the employer-employee relationship. Was my response correct? Response: You are indeed correct that the vast majority of physicians who are authorized to practice within a hospital are not employees. However, there are some more commonly encountered exceptions with certain specialties depending on the institution. Some hospitals employ the pathologist who oversees clinical laboratory activities and some employ those who staff the Emergency Department. A somewhat recent development related to that is the creation of positions known as “hospitalists,” physicians whose sole role is to treat inpatients. Those practitioners are typically employed by the institution as well. There also are hybrid relationships encountered; for example, in some instances the hospital contracts with an outside group to provide medical staffing for the Emergency Department. Under that arrangement the physicians would be employees of the medical staffing agency. When a practitioner applies to have “privileges” at a hospital, the information needed for review is collected by an office typically known as the Medical Staff Affairs Office or some similar designation. That office verifies the individual’s academic degrees, licensure status, specialty board certifications if any, and even do a search of the National Practitioner Database (discussed in this column in the September 2013 issue) to review any claims or sanctions that have been filed against the individual in his or her professional capacity.
Submit Questions: jfink@uky.edu Disclaimer: The information in this column is intended for educational use and to stimulate professional discussion among colleagues. It should not be construed as legal advice. There is no way such a brief discussion of an issue or topic for educational or discussion purposes can adequately and fully address the multifaceted and often complex issues that arise in the course of professional practice. It is always the best advice for a pharmacist to seek counsel from an attorney who can become thoroughly familiar with the intricacies of a specific situation, and render advice in accordance with the full information.
have been lawsuits filed by physicians around the country who were denied staff privileges when, say, the obstetricians currently on the staff blocked appointment of a new obstetrician due to competitive concerns. Generally, such lawsuits are couched in terms of the action being a violation of the antitrust laws that are designed to protect competition. The medical staff, acting through the Medical Executive Committee or acting collectively, forwards a recommendation to the Board of Directors/Board of Trustees of the facility regarding the proposed appointment. It is that institutional governing body that is vested with the full authority to make such appointments. That authority of the board also extends to authorizing practitioners to engage in certain activities and perform specified procedures. It may be that for such initiatives the Board is even more reliant on the expertise and recommendation of the Medical Executive Committee. For example, the Board members may act to authorize Dr. X to perform specified cardiac surgery procedures in the facility for which they have ultimate responsibility.
And while we’re addressing the Board, it is worth noting that this group has the traditional authority and responsibilOnce that information is collected and verified, it typically is ity associated with a governing board in any business entipassed on to the members of the Executive Committee of ty. Be it operated on a for-profit or not-for-profit basis, a the Medical Staff for their review and assessment. It may hospital board has additional responsibility assigned by the be that this step in the process is completed by the Execu- entity that accredits hospitals, The Joint Commission. Incitive Committee acting alone or it may be referred to a meet- dentally, this organization used to be known as the Joint ing of the full medical staff. But it is important to note that Commission on Accreditation of Hospitals (JCAH) and then the medical staff, acting collectively, do not have the aulater as the Joint Commission on Accreditation of thority to authorize practice within the facility. In fact, there Healthcare Organizations (JCAHO). It currently uses the 36
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EPIC Pharmacies
September/October 2016
shorter designation to reflect the fact that it now handles accreditation for other sorts of non-hospital health care facilities as well, e.g., ambulatory surgical centers, ambulatory care clinics, etc. Accreditation by The Joint Commission is critical if the facility hopes to qualify to receive reimbursement for care provided to Medicare beneficiaries, a population group that sometimes composes the majority of admissions at a community hospital.
The Joint Commission looks to the Board of Directors to discharge important responsibilities such as approving appointments to the clinical staff, approving the scope of services to be provided at the facility, evaluating the performance of the various operations within the facility and approving plans to enhance those services. The Joint Commission makes periodic unannounced visits to facilities to assess their operations for consistency with Joint Commission standards and expectations.
Registration is open and tentative schedule available at www.kphanet.org! KPhA sends email announcements weekly. If you arenâ&#x20AC;&#x2122;t receiving: eNews, Legislative Updates, Grassroots Alerts and other important announcements, send your email address to ssisco@kphanet.org to get on the list.
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THE KENTUCKY PHARMACIST
Pharmacy Policy Issues
September/October 2016
PHARMACY POLICY ISSUES: Prescription Drug User Fee Act Author: Noor A. Naffakh is a PY1 student at the UK College of Pharmacy. She hails from Peoria, Ill., and completed her pre-professional course work at UK. Issue: Recently I read an article about a Duchenne Muscular Dystrophy (DMD) treatment drug being fast-tracked by the FDA via PDUFA. What is PDUFA, and how “fast” is a fast track?
Have an Idea? This column is designed to address timely and practical issues of interest to pharmacists, pharmacy interns and pharmacy technicians with the goal being to encourage thought, reflection and exchange among practitioners. Suggestions regarding topics for consideration are welcome. Please send them to jfink@uky.edu.
hiring of more NDA reviewers, and it has reduced the overall time from application submission to drug approval decision. Moreover, medication access and marketing in the U.S. has greatly improved, and less frequently lags behind other countries, especially those in Europe. Overall, since the initial enactment of PDUFA, the FDA has seen a 77 percent increase in staff, a 50 percent reduction in medication review time and a 24 month reduction in priority medication review time. Take as an example the new HIV/AIDS drug (3TC) to be taken in combination with AZT approved after the enactment of PDUFA. 3TC’s FDA review time only required an astounding four and a-half months for the agency staff to reach a decision. This is a dramatic deUpon review of the arguments, Congress concluded that crease from the two whole years it took to review AZT, the most FDA funding stemmed solely from the general federal first HIV drug that was pushed through the expedited drug budget. The manufacturers and FDA reached an agreeapproval process in 1985.3 Now both drugs are considered ment that if manufacturers provided proper funding, the two of the most important medications in the health system agency could employ more staff and bring more resources and are on the “World Health Organization’s List of Essento bear, and that would consequently speed up the approval tial Medicines.”4 process for medications. Before the manufacturers committed, however, they wanted a guaranteed deadline by which So, turning back to the original question, the length of time for drug approval enabled and enhanced using PDUFA can the FDA would reach a decision. The deadline that was range from anywhere between 60 days and 12 months, agreed upon was 12 months for a regular application, and 1 six months for a priority medication application. According depending on the type of application and class of drug. to the 2017 PDUFA user fee rates, the charge to review a References new drug application requiring clinical data is roughly $2 1. "U.S. Food and Drug Administration." FY 1996 PDUFA million, and an application already containing clinical data 2 Performance Report. U.S. Food and Drug Administracosts roughly $1 million. tion, 09 Sept. 2015. Web. 26 Aug. 2016. Since 1992 PDUFA has been reauthorized every five years, each time with the goal of increasing the efficacy of the act. 2. Mezher, Michael. "FDA Unveils User Fee Rates for FY 2017." Raps. Regulatory Affairs Professional Society, 1 For example, the FDA Modernization Act of 1997 reauthorAug. 2016. Web. 26 Aug. 2016. ized PDUFA for five more years, but added a designation to the act called the FDA fast track. If a drug is approved for 3. "FDA Grants Accelerated Approval for 3TC with AZT to the fast track, the deadline for a decision could be as short Treat AIDS | HIV/AIDS News | AIDSinfo." AIDSinfo. as 60 days (This is the approval timeline given for the new HHS, 20 Nov. 1995. Web. 26 Aug. 2016. DMD treatment medication that prompted this question.) 4. "WHO Model Lists of Essential Medicines." World Has the legislation been effective? Yes, since its enactment Health Organization. World Health Organization, n.d. in 1992, PDUFA has produced enough revenue to allow the Web. 26 Aug. 2016. Discussion: The Prescription Drug User Fee Act (PDUFA) is a piece of federal legislation that was passed in 1992. This act was a response to the unrest of both HIV/AIDS activists and pharmaceutical manufacturers because of the extremely long time required for the FDA drug approval process. Activists claimed that the delays were unnecessary and cost the lives of thousands of patients with opportunistic diseases, while pharmaceutical manufacturers emphasized the lost time, money and resources while waiting to get their products available for patients to use. The FDA argued that it did not have sufficient funds and resources to speed up the process. The manufacturers and activists teamed up and brought their case to Congress for legislative action.
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THE KENTUCKY PHARMACIST
KPhA/WellCare Naloxone Atomizer Distribution Project
September/October 2016
Naloxone Atomizer Distribution Project Thanks to a grant from WellCare of Kentucky, OUR Kentucky Pharmacists Association is distributing naloxone atomizers to combat opioid overdose deaths in Kentucky. The atomizers allow naloxone to be administered like a nasal spray instead of through an injection – which can be a less intimidating way to deliver the life-saving drug. The atomizers are to be provided by Kentucky Board of Pharmacy certified pharmacists free of charge to Medicaid recipients when dispensing a naloxone kit. A state law passed last year authorizing certified pharmacists to dispense naloxone via a physician-approved protocol to people who may be at risk for an opioid overdose. In order to receive a small supply of free atomizers, a pharmacy must:
Have a naloxone-certified pharmacist on staff Have an active protocol established to offer naloxone Actively dispense naloxone to at-risk Medicaid recipients
If you are interested in becoming naloxone-certified, please visit the KPhA website to access an online, Board-approved training program offered by the Kentucky Pharmacy Education and Research Foundation. (See below.) To request your supply of atomizers, contact KPhA at 502-227-2303 or email info@kphanet.org.
KPERF Naloxone Certification Training The online training program can be found at the following link on the KPhA website: http://www.kphanet.org/?page=NaloxoneCert2015 The cost of the training is $5 for KPhA members, and $10 for non-KPhA members. After successfully completing the course, credit will be applied to your CPE Monitor Profile and you will be emailed a certificate of completion. 39
THE KENTUCKY PHARMACIST
September/October 2016
Pharmacists Mutual
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THE KENTUCKY PHARMACIST
Cardinal Health
September/October 2016
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THE KENTUCKY PHARMACIST
KPhA Board of Directors/Staff
September/October 2016
KPhA BOARD OF DIRECTORS
HOUSE OF DELEGATES
Chris Clifton, Villa Hills chrisclifton@hotmail.com
Chair
Lance Murphy, Louisville lancemurphy84@gmail.com
Trish Freeman, Lexington trish.freeman@uky.edu
President
Amanda Jett, Louisville ajett@sullivan.edu
Chris Harlow, Louisville cpharlow@gmail.com
President-Elect
KPERF ADVISORY COUNCIL
Brooke Hudspeth, Lexington brooke.hudspeth@kroger.com
Secretary
Christen S Bruening, Cincinnati, Ohio cmschenkenfelder@gmail.com
Chris Palutis, Lexington chris@candcrx.com
Treasurer
Matt Carrico, Louisville matt@boonevilledrugs.com
Jessika Chinn, Beaver Dam jessikachilton@ymail.com
Past President Representative
Vice Speaker of the House
Kim Croley, Corbin kscroley@yahoo.com Kimberly Daugherty, Louisville kdaugherty@sullivan.edu
Directors Matt Carrico, Louisville* matt@boonevilledrugs.com Kevin Chen, Lexington kevin.chen@uky.edu
Speaker of the House
Mary Thacker, Louisville mary.thacker@att.net University of Kentucky Student Representative
Chad Corum, Manchester pharmdky21@gmail.com Matt Foltz, Villa Hills mfoltz@gomedcare.com Cathy Hance, Louisville cathy@compoundcarerx.com Cassy Hobbs, Louisville cbeyerle01@gmail.com Katherine Keeney, Louisville Sullivan University KKEENE6675@my.sullivan.edu Student Representative Chris Killmeier, Louisville cdkillmeier@hotmail.com Jeff Mills, Louisville jeff.mills@nortonhealthcare.org Richard Slone, Hindman richardkslone@msn.com Sam Willett, Mayfield duncancenter@bellsouth.net * At-Large Member to Executive Committee
KPhA/KPERF HEADQUARTERS 96 C Michael Davenport Blvd., Frankfort, KY 40601 502.227.2303 (Phone) 502.227.2258 (Fax) www.kphanet.org www.facebook.com/KyPharmAssoc www.twitter.com/KyPharmAssoc www.twitter.com/KPhAGrassroots www.youtube.com/KyPharmAssoc Robert McFalls, M.Div. Executive Director rmcfalls@kphanet.org Scott Sisco, MA Director of Communications & Continuing Education ssisco@kphanet.org Angela Gibson Director of Membership & Administrative Services agibson@kphanet.org Leah Tolliver, PharmD Director of Pharmacy Emergency Preparedness ltolliver@kphanet.org Elizabeth Ramey Receptionist/Office Assistant eramey@kphanet.org
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THE KENTUCKY PHARMACIST
50 Years Ago/Frequently Called and Contacted
September/October 2016
50 Years Ago at KPhA FROM KENTUCKY AT A GLANCE Bennetâ&#x20AC;&#x2122;s Drug Store, Fulton, celebrated its 76th anniversary last month. The store, founded in 1890, is now owned by Joe Bennett, Jr., R.Ph., son of one of the founders. - From The Kentucky Pharmacist, September 1966, Volume XXIX, Number 9.
Frequently Called and Contacted Kentucky Pharmacists Association 96 C Michael Davenport Blvd. Frankfort, KY 40601 (502) 227-2303 www.kphanet.org Kentucky Board of Pharmacy State Office Building Annex, Ste. 300 125 Holmes Street Frankfort, KY 40601 (502) 564-7910 www.pharmacy.ky.gov Pharmacy Technician Certification Board (PTCB) 2215 Constitution Avenue Washington, DC 20037-2985 (800) 363-8012 www.ptcb.org
Kentucky Society of Health-System Pharmacists P.O. Box 4961 Louisville, KY 40204 (502) 456-1851 x2 (502) 456-1821 (fax) www.kshp.org info@kshp.org American Pharmacists Association (APhA) 2215 Constitution Avenue NW Washington, DC 20037-2985 (800) 237-2742 www.aphanet.org
National Community Pharmacists Association (NCPA) 100 Daingerfield Road Alexandria, VA 22314 (703) 683-8200 info@ncpanet.org Drug Information Center Sullivan University College of Pharmacy 2100 Gardiner Lane Louisville, KY 40205 (502) 413-8638 www.sullivan.edu Kentucky Regional Poison Center (800) 222-1222
KPhA Government Affairs Contribution Name: _______________________________Pharmacy: _____________________________
Email: ______________________________________________________________ Address: _____________________________________________________________ City: ___________________________________________ State: _________ Zip: ____________ Phone: ________________ Fax: __--_______________ E-Mail: _____________________________ Contribution Amount: $_________ Check ____ (make checks payable to KPhA Government Affairs)
Mail to: Kentucky Pharmacists Association, 96 C Michael Davenport Blvd., Frankfort, KY 40601
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THE KENTUCKY PHARMACIST
September/October 2016
THE
Kentucky PHARMACIST 96 C Michael Davenport Blvd. Frankfort, KY 40601
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