Vol 10 No.1 Winter 2012-2013
Winter 2012-2013
Pharmacy Journal of New England CDC Grand Rounds:
The Million Hearts Initiative Weekly Do I Have To Fill This Prescription? Rx and the Law
How Much Retirement Income Should You Withdraw? Financial Forum
A Model System to Promote Access to Good Quality Compounded Medicines Continuing Education
Pharmacy Journal
Vol 10 • No.1 Pharmacy Journal of New England • Winter 2012-2013
of New England
Editors
Dear Readers, As we welcome in the new year with a hope for positive relationships with new state legislatures, as well as with federal government and regulatory agencies, we wanted to take a moment to thank all of you for supporting your state associations. This Pharmacy Journal of New England is one of the tangible benefits of that membership. However, as with so many items within our profession, this too may be changing. With increasing costs and diminishing revenue streams, the Connecticut and Massachusetts Pharmacists Associations and their boards of directors, have had to take a long, hard look a the feasibility of continuing to publish the Journal in hard copy. For this Winter 2012-13 edition, it has been decided to publish in both electronic and hard copy formats.
David Johnson Margherita R. Giuliano, R.Ph., CAE
Managing Editor Ellen Zoppo
Editorial Advisory Panel Todd Brown, R.Ph., MHP Thomas Buckley, R.Ph., MPH Sean Jeffery, Pharm.D. John Parisi, R.Ph., CDE Matthew Machado, Pharm.D.
Design and Production Interfacive, Advertising & Design
It is our hope that the members will continue to utilize the Journal as a resource for home-study, keeping up on issues affecting their practice sites, and what is happening with the next generation of pharmacists via the news published by the colleges and universities.
Millbrook Printing
We will continue to solicit advertising for the new format, and welcome any support we may receive from the other state associations. To view the Journal in its new electronic format, please visit the CPA and MPhA websites to read it online or download it. We are anxious to hear your feedback!
Opinions expressed by those of the editorial staff and/or contributors do not necessarily reflect the views or policies of the publisher.
Sincerely, Margherita R. Giuliano, RPh Executive Vice President Connecticut Pharmacists Association
David Johnson Executive Vice President Massachusetts Pharmacists Association
Printing The Pharmacy Journal of New England is owned and published by the Massachusetts Pharmacists Association and the Connecticut Pharmacists Association.
Readers are invited to submit their comments and opinions for publication. Letters should be addressed to the Editor and must be signed with a return address. For rates and deadlines, contact the Journal at (860) 563-4619. Pharmacy Journal of New England 35 Cold Spring Road, Suite 121 Rocky Hill, CT 06067-3167 members@ctpharmacists.org
Submitting Articles to the Pharmacy Journal of New England™ The Pharmacy Journal of New England™ is the product of a partnership between the Connecticut Pharmacists Association and the Massachusetts Pharmacists Association. The Journal is a quarterly publication.
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U.S. News New England States Financial Forum, Rx and the Law CDC Grand Rounds: The Million Hearts Initiative Weekly From the Colleges
All submitted articles are subject to peer review. In order to maintain confidentiality, authors’ names are removed during the review process. Article requirements must conform to the Uniform Requirements for Manuscripts Submitted to Biomedical Journals (Ann Intern Med 1982;96 (1part1):766-71). We strongly encourage electronic submissions. PJNE does not assume any responsibility for statements made by authors.
Please submit manuscripts to: PJNE 35 Cold Spring Rd., Suite 121 Rocky Hill, CT 06067 or email to: ezoppo@ctpharmacists.org
Continuing Education for Pharmacists
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U.S. News FDA Approves New Orphan Drug for Rare Cholesterol Disorder On Dec. 21, the U.S. Food and Drug Administration approved Juxtapid (lomitapide) to reduce low-density lipoprotein (LDL) cholesterol, total cholesterol, apolipoprotein B, and non-high-density lipoprotein (nonHDL) cholesterol in patients with homozygous familial hypercholesterolemia (HoFH). Juxtapid is intended for use in combination with a low fat diet and other lipid-lowering treatments. HoFH is a rare inherited condition that makes the body unable to remove LDL cholesterol, often called the “bad” cholesterol, from the blood, causing abnormally high levels of circulating LDL cholesterol. In the United States, HoFH occurs in approximately one in one million individuals. For those with HoFH, heart attacks and death often occur before age 30. Juxtapid works by impairing the creation of the lipid particles that ultimately give rise to LDL. Juxtapid is a capsule taken once a day, without food, and at least two hours after the evening meal. Patients should take supplements that contain fat-soluble vitamins and essential fatty acids daily while taking Juxtapid. “Juxtapid, in addition to diet changes and other cholesterol-lowering treatments, is a new option for those suffering with HoFH and the serious health consequences resulting from this condition,” said Eric Colman, M.D., deputy director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. The safety and effectiveness of Juxtapid were evaluated in a clinical trial of 29 patients with HoFH. On average, levels of LDL cholesterol fell by approximately one-half during the first 26 weeks among those who tolerated the drug. Juxtapid carries a Boxed Warning regarding a serious risk of liver toxicity because it is associated with liver enzyme abnormalities and accumulation of fat in the liver, which could potentially lead to progressive liver disease with chronic use. Juxtapid also reduces the absorption of fat-soluble nutrients and interacts with several other medications.
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The FDA approved Juxtapid with a Risk Evaluation and Mitigation Strategy (REMS) that consists of elements to ensure safe use including prescriber and pharmacy certification and documentation of safe-use conditions consisting of a prescription authorization form that will be required to accompany each new prescription. The FDA is requiring three postmarketing studies for Juxtapid: an animal study to evaluate the potential for toxicity in children and teens; a long-term registry of patients with HoFH treated with Juxtapid to determine the longterm safety; and an enhanced pharmacovigilance program to monitor reports of malignancy, teratogenicity, and hepatic abnormalities. The most common adverse reactions in the clinical trial included diarrhea, nausea, vomiting, indigestion, and abdominal pain. Juxtapid is marketed by Cambridge, Mass.-based Aegerion Pharmaceuticals Inc.
Reumofan Plus Relabeled and Sold as WOW The U.S. Food and Drug Administration (FDA) is warning the public that the potentially harmful product Reumofan Plus, marketed as a dietary supplement, is being relabeled and sold under the name “WOW.” The product is being marketed to treat arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. FDA laboratory analysis confirmed that “WOW” contains the same prescription drug ingredients that are in Reumofan Plus, including dexamethasone (a corticosteroid), diclofenac sodium (a non-steroidal anti-inflammatory drug), and methocrabamol (a muscle relaxant). These ingredients have the potential to cause serious injury. Reumofan Plus and “WOW” products are sold on various websites, including www.gonepainfree.com and www.browerent.com. The products are manufactured by Riger Naturals S.A. In addition to websites selling “WOW,” FDA has become aware that various websites, including www.reumofanusa.com, owned by Reumofan USA, LLC, continue to sell Reumofan Plus even after previous FDA warnings.
Pharmacy Journal of New England • Winter 2012-2013
“These dangerous products should simply not be sold or distributed,” said Melinda Plaisier, FDA’s Acting Associate Commissioner for Regulatory Affairs. “FDA is prepared to take aggressive enforcement action to protect consumers from these dangerous products, including seizure, injunction, and pursuit of criminal prosecution.” Consumers currently taking or who have taken Reumofan Plus or “WOW” should immediately consult a health care professional. Consumers should not buy or start using these products. FDA is concerned that other distributors may also be relabeling Reumofan Plus products and selling relabeled products under other names. Therefore, FDA advises consumers not to use any products with “Riger Naturals S.A.” printed on the bottom of the bottle, as pictured below. FDA warned the public of the harm of Reumofan Plus on June 1, 2012, and again on August 21, 2012. Since June, FDA has received dozens of adverse event reports, many of them serious, from consumers who used Reumofan Plus. The reports include liver injury, severe bleeding, cor-
ticosteroid withdrawal syndrome, adrenal suppression, stroke, and even death. The drug ingredients in Reumofan Plus and “WOW” may interact with other medications and cause serious adverse events. Health care professionals are urged to ask their patients about the use of Reumofan Plus, “WOW,” and other similar products marketed as dietary supplements when patients present with unexplained symptoms that suggest NSAID toxicity, psychiatric changes, or the use or abrupt discontinuation of corticosteroids. Additionally, health care professionals should evaluate patients who have used Reumofan Plus and/or WOW for drug and disease interactions involving diclofenac, methocarbamol, and corticosteroids, and consider whether a corticosteroid taper regimen may be appropriate. FDA has been in contact with both Brower Enterprises and Reumofan USA, LLC about voluntarily recalling the dangerous products. At this time, neither firm has adequately alerted the public about the safety risks associated with the products.
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New England States Connecticut
us for our Business Meeting in the morning, followed by lots of insightful CE topics on New Drugs with Dr. Dan Hussar, Asthma, Law, Hemophilia, and Colo-rectal cancer. See you there!
Now that the elections are over and we have a better idea of what our political landscape looks like in Connecticut, we can look at how we can help move our profession forward. CPA’s Legislative Committee is hard at work planning for the upcoming legislative session. It’s not too late to get involved Lucrezia Finegan, RPh, – if you have an interest in pro- President, CPA, 2012-2013 moting the profession of pharmacy and the role of the pharmacist at the Capitol, join our Legislative Committee today.
CPA Schedules Their Mid-Winter Conference
President’s Message
CPA is a membership organization – we are here for you, our members. If you want to be more involved in our Association, but not sure how, we have plenty of other opportunities for you. There other committees in need of help, such as Membership, Pharmacy Practice, Awards & Nominations and more. Check out the committee page at www.ctpharmacists.org for a description of each committee. Please contact the office to join one of our committees. As I mentioned above, we are a membership organization. A membership organization is nothing without its members. This is your Association and your help is needed. Whatever your desire for your level of involvement, there is a place for you. Are you new to CPA? Or maybe you’ve just been away a while? We can partner you with a veteran member who can help guide you and help you decide what areas of the Association is the best fit for you. We also have opportunities for our student pharmacists and pharmacy technicians to get involved. (Did you know we have a pharmacy technician membership category?) Student pharmacist and pharmacy technicians are an integral part of our profession, and their contributions are important to the Association. Let your technicians know their input is also needed and encourage them to invest $40 and join as a technician member today. I look forward to the next few months as we open our legislative session, and get ready for our Annual Mid-Winter Conference on February 7th at the Aqua Turf. Come join
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Pharmacists from across New England will gather on Thursday, February 7th as a means to get ahead of the curve and earn 8 CE credits at the CPA’s annual MidWinter Conference in Southington. Last year, over 250 pharmacists spent the day earning CE credits, mingling with friends and meeting new acquaintances, as well as having access to a variety of vendor booths. “The Mid-Winter is a great venue to mix with industry vendors, get a jump-start on CE credits, and understand what is happening in the industry,” stated Marghie Giuliano, Executive Vice President of CPA. Programs for the 2013 conference will include the traditional “New Drugs of 2012” morning session, presented by Dr. Dan Hussar of the Philadelphia College of Pharmacy. Other topics to be covered include Hemophilia, Asthma, and Colorectal Cancer. John Gadea, Director of Drug Control for the State of Connecticut, will give an update on current law and regulations within the state. At the time of publication, several companies have committed to sponsorship including McKesson, Reckitt Beckiser, AmerisourceBergen, Kinray, AbbVie, University of Saint Joseph School of Pharmacy, AstraZeneca, BristolMyers Squibb, Cardinal Health, Agency for Healthcare Research & Quality and Pharmacists Mutual Insurance Company. This year, the CPA will be incorporating a passport for those in attendance to use while visiting the booths. Those with stamps from the majority of the booths will be entered into a contest to win a new iPad Mini sponsored by Energy Plus. The CPA will also run a membership drive at the MidWinter Conference, offering a $50 discount to any new member. “It is important for pharmacists to realize that CPA is the voice of the profession,” stated Burt Orland, a CPA board member and chair of the Membership Committee. “There is strength in numbers, and whether you work retail, in a hospital, or in research, the actions of the Legislature affect all of us. Membership is a vital way to ensure that your voice as a pharmacist is heard.”
Pharmacy Journal of New England • Winter 2012-2013
Massachusetts President’s Message Dear Colleagues, On behalf of the Massachusetts Pharmacist’s Association Board of Directors, I would like to take this opportunity to say “Thank you” for supporting MPhA through your membership. One of our top priorities for the upcoming year is to engage our members and keep Tim Hudd, President, MPhA, 2012-2013 all of you informed about MPhA activities and the progress our organization is making in various areas. Our Board of Directors and professional committees are comprised of extremely dedicated individuals who are working hard to promote and enhance the profession of pharmacy. These individuals have been a driving force in completing much of the hard work necessary to advance the organization. A brief description of each committee, along with the name of each committee chair has been posted on our website www.masspharmacists.org. This is a great way for members to become more involved with MPhA and your participation is always welcome. The following is brief synopsis of some of our recent activities:
Legislative Committee The Massachusetts Board of Registration in Pharmacy held a public hearing on December 4th. I would thank David Johnson, Todd Brown, Kathy Keough, Tim Fensky, Larry Forde, and members of the legislative committee for drafting a testimony on behalf of MPhA. A copy of this testimony can be found on our website on the "State" page found under the "Advocacy" Tab on the left side of the home page. David Johnson – our Executive Vice President, recently met with Dr. Madeleine Biondolillo, Bureau Director for Health Care Safety and Quality at the Massachusetts Department of Health. Dr. Biondolillo oversees both the Drug Control Program, which operates the Prescription Monitoring Program, and the Division of Professional Licensure, which includes the Board of Pharmacy. MPhA and DPH share similar goals in each of these areas: curb
prescription drug abuse, ensure that compounding practices are conducted at the highest standards, and see that the business of dispensing drug products promotes rather than inhibits the value of the pharmacist to the patient and the health care system. Regarding prescription drug abuse, we have provided input regarding the impending regulations to implement An Act Relative to Prescription Drug Diversion, Abuse and Addiction, which was signed into law by the Governor on August 18, 2012. MPhA supported this legislation, however, the law contains reporting requirements for pharmacies and other minor provisions that MPhA has addressed to ensure that they will be minimally disruptive to pharmacists while assisting the state in its efforts to effectively address this public health crisis. MPhA has engaged both DPH and the legislature to help facilitate a coordinated effort to improve oversight by devoting a greater percentage of pharmacy and pharmacist licensing fees for its original and expressed purpose of providing guidance and oversight to the profession of pharmacy. In addition, we are working to ensure that legislation will be filed to require the licensing of non-resident pharmacies (currently Massachusetts is one of three states that does not license out of state pharmacies. In November MPhA and MIPA facilitated site visits with Representative Jeffrey Sanchez, House Chairman of the Joint Committee on Public Health at Johnson Compounding and Wellness Center and Palimed Pharmacy. The purpose of these visits was to provide the Chairman with first-hand knowledge of what sterile compounding requires, why it is needed, and what would constitute effective and efficient oversight. MPhA has also been actively engaged with Congressman Markey's office and provided the Congressman with a detailed critique of the Congressman's bill to bolster FDA oversight of compounding pharmacies, and has had follow-up conversations to ensure open lines of communication to ensure that the best possible piece of legislation emerges from Washington in the coming months. MPhA has drafted and found sponsors to file a bill to list Pharmacists as health care providers in Massachusetts General laws; and we have filed a bill that would permit trained pharmacy student interns to immunize. For a look at important legislation related to pharmacy, visit our Advocacy section of the website.
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New England States Professional Affairs Committee Project #1 MPhA along with various stakeholders from around the state are working with the Massachusetts Department of Public Health to help develop a unified statewide chronic disease plan for heart disease, stroke, diabetes, and asthma. The plan will lead to the formation of a new integrated coalition, whose charge will be to improve state and local policies, systems, environments and programs. We are currently working on the Clinical Preventive Services and Population Health Management Team and have two meetings in January 2013. Project #2 MPhA has been working in collaboration with the Massachusetts Department of Public Health and the Center for Health Policy and Research at UMass Medical to evaluate whether medication and disease management provided by a pharmacist will improve clinical outcomes for chronic disease (hypertension, high cholesterol, and diabetes) and reduce health care costs. By evaluating and then reproducing existing successful models of collaboration, DPH aims to create statewide changes in systems of care for people with chronic disease. Four pharmacy practice settings were selected and followed for a period of 3 months. Efforts to publish the outcomes of this pilot are currently under way.
Nominating & Awards Committee Chairman Barbara Perry is in the process of finalizing a distinguished list of members to serve on this important committee. The charge of this group is to solicit nominations for deserving individuals who meet the predefined awards criteria. This committee then selects the recipient for each award. We will be soliciting nominations from all of you sometime in the Spring 2013.
Membership Committee Chairman Sue Holden is working on strategies for member recruitment and several initiatives to better engage MPhA members. Please watch for special dinner programs and other events which will be advertised over the upcoming year.
Save the Dates! The Face of Pharmacy 2013 Event Wednesday April 10th, 2013 Special thanks to Kathy Keough and David Johnson for scheduling this important event. The Legislative Committee will be drafting an agenda for the event over the next few weeks. More details to follow soon. 6
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The MPhA Annual Spring Conference - Thursday April 25th, 2013. Four Points in Norwood Special thanks to the Convention & Conference Planning Committee – which is in the process of finalizing the agenda for the event. More details to follow soon.
MPhA Going Green! The last paperback issue of The Pharmacy Journal of New England will be the 2012 Winter Issue. As a sign of the changing times, an electronic version of the Journal will be in circulation starting with the 2013 Spring Issue.
Vermont
President’s Message The Association is pleased to announce that Pharmacist Audits Rights bill S.200, 18 V.S.A. 9414a regarded as strongest in the nation was passed by the Legislature, signed into law by Governor Peter Shumlin, and took effect on July 1, 2012. It is anticipated the law will help to reduce some Jim Godfrey, Rph , President of the burdens of the audit process as our pharmacists strive to deliver efficient and quality healthcare to our patients. Future legislative efforts may be considered to address PBM and mail order issues. The State of Vermont has committed to healthcare reform, intending to create a Single-Payer healthcare system to serve all Vermonters. Our members and representatives will meet with the Green Mountain Care Board to provide input on the value of community pharmacy and to answer questions on the nature of drug purchasing, dispensing of prescriptions and pharmacy care, and reimbursement methods. The role that Pharmacy Benefit Managers take and especially the level of transparency required by Green Mountain Care will be critical in determining the value that the Single-Payer system gets for its pharmacy healthcare dollar. We will continue to stress our role as an important member of the healthcare delivery team. Our association is also in the process of developing an Asthma Education webinar and is working to develop an
Pharmacy Journal of New England • Winter 2012-2013
MTM program with a major insurer in our state. At our October 7th Fall Meeting in Colchester, VT we welcomed Ronald Klein, RPh as the new Executive Director for the Vermont Board of Pharmacy. As this is a newly created position, our members are happy to finally have a fulltime person available to answer questions we may have for the State Board. Our association will continue working to advance our position in the ever changing world of healthcare. Watch for future events listed on the Vermont Pharmacists Association website at vtpharmacists.com where Facebook and Twitter links may also be found.
increase in pharmacy break-ins in New England. We are greatly looking forward to our upcoming holiday meeting on December 19th, which TEVA Pharmaceuticals will graciously sponsor this year, to discuss our Association plans for the new year. As our organization is currently operating on the dedication and hard work of a small group of highly motivated individuals, I would like to take a moment to thank them and all of our supporters and members for keeping RIPA going. Reiterating what I said before, I wish all of you a happy and healthy holiday and best of luck with you plans for 2013! Professionally yours, Daniel Robert Lefkowitz, Pharm D., MBA, CDOE President 2012-2013
Rhode Island President’s Message
On behalf of the Rhode Island Pharmacists Association, we’d like to wish everyone a joyous and safe holiday season. Following the first ever installation dinner in coordination with the New England Pharmacists Convention at the Foxwoods MGM, RIPA has gotten back to business and is looking forward to a successful year. We are in the process of planning a PAC fundraiser as well as other social networking events, such as our biannual Beers with Peers, and reaching out to the RI Society of Health System Pharmacists and other health care professionals to join us and further unite these professions within our small state. Recently, 3 scholarships were awarded to three deserving students at the University of Rhode Island’s Youngken Clinic on November 8th. Ariana Houle, a P1 student, Christopher Andrade, a P2, and Michael Iafrate, a 3rd year professional student were presented their checks during a wonderful seminar on motivational interviewing by Dr. Bruce Berger. Our partnership with the National Consumers League Script Your Future medication adherence campaign continues with the Team Challenge 2.0 in February. In other competition news, we will also be hosting NASPA grant funded Pain Competition in April. Immediate Past President, Jef Bratberg is heading up naloxone CE project that has led us to gain 8 new members and we are seeing an increase in recent graduate members, as well. We are working to pass legislation to allow pharmacists to administer glucose and cholesterol screenings and a program designed around robbery preparedness due to the
CPE Monitor is a service that will allow pharmacists and pharmacy technicians to track their ACPE-accredited continuing pharmacy education (CPE) units electronically. NABP e-Profile will store a comprehensive list of your completed CPE activities and will allow you to verify compliance with CPE requirements. Initially, CPE Monitor will not track CPE from non-ACPEaccredited providers. Until this feature is added in Phase 2, non-ACPE-accredited CPE will need to be submitted directly to the board of pharmacy. What does this mean to YOU? 1. You must visit MyCPEmonitor.net or www.nabp.net to set up your NABP e-Profile and obtain a NABP ID number 2. Every time you complete an ACPE-accredited CPE program, you will be required to provide your NABP ID number and your 4 digit birth date (MMDD) in order to receive credit 3. You will no longer receive paper statements of credit for ACPE-accredited CPE programs For further information visit the MyCPEmonitor section at www.NABP.net
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Pharmacy Marketing Group
Financial Forum This series, Financial Forum, is presented by Pro Advantage Services, Inc., a subsidiary of Pharmacists Mutual Insurance Company, and your State Pharmacy Association through Pharmacy Marketing Group, Inc., a company dedicated to providing quality products and services to the pharmacy community.
How Much Retirement Income Should You Withdraw? The answer varies for everyone. Here are some important factors to consider. The big question: how much is too much? In the first few years of retirement, some couples really “live it up” … and some of them risk spending down their retirement savings. Their portfolios aren’t earning enough to make back the income they’re withdrawing. Some new retirees end up withdrawing as much as 7-10% of their retirement assets annually. A bull market tends to encourage this kind of exuberance. But what happens when the bulls don’t run? What if your portfolio only returns 1-2% this year? Can you see the potential problem? Ultimately, the answer is highly personal. There is no “standard” retirement income withdrawal rate. Your withdrawal rate should be determined in consultation with your financial advisor, who can help you evaluate some very important matters: your risk tolerance, your age and health, and your lifestyle needs. Many new retirees are told that a 4-5% annual withdrawal rate makes sense. If you withdraw 4-5% from your retirement nest egg annually and your investments steadily earn about 5-6% year-to-year, it is quite possible that your invested assets will last a quarter-century or longer given mild inflation.1 But that’s a rather stable scenario. Even more variables come into play. Consumer costs. Over the past 50 years, consumer prices have increased (on average) about 4% annually.2 So you might assume that your portfolio should generate at least a 4% annual return just to help you keep up with the cost of living. But if you retire with that assumption and inflation should spike notably higher for some reason after you retire, you may need to adjust your withdrawal rate.
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Pharmacy Journal of New England • Winter 2012-2013
Now consider the price of health care. In recent years, health care costs have increased at a much greater rate than inflation. The same goes for nursing home care. Market dips. When you are 35 or 40, your investments have time to rebound from a market downturn. When you are 70, things are different. Let’s cite an example: let’s say you are 70 years old, and you have $250,000 in your portfolio. All of a sudden, your portfolio has two really bad years: you lose 12% in Year 1 and 7% in Year 2. So at 72, your portfolio is now worth $204,600. You want to get back to $250,000 or better. How long will that take? Well, your portfolio would have to gain almost 23% in Year 3 to get back to that $250,000 level.2 So if you suffer through a couple of bad years with ill-chosen investments or ill-advised asset allocations, your nest egg may be considerably smaller and your income withdrawal rate may have to change. *This is a hypothetical example and is not intended to imply the performance of any specific investment. The merit of conservative withdrawals. With ongoing improvements in healthcare, today’s retirees stand a good chance of living into their eighties and nineties (and perhaps even longer). This is a good reason to exercise a little moderation when scheduling retirement income. The wisdom of a retirement income plan. Ideally, you will retire with the help of a financial advisor who will meet with you periodically to review your investments and income needs, and adjust your withdrawal rate over the course of your retirement. If you don’t have a personal financial advisor or a personalized retirement income plan, change that situation today and make sure you prepare for retirement with both.
Citations 1. arpmagazine.org/money/retirement_planning_made_easy.html [Jan/Feb 2008] 2. finance.yahoo.com/how-to-guide/retirement/18310 [7/25/08] Provided by courtesy of Pat Reding, CFP of Pro Advantage Services Inc., in Algona, Iowa. For more information, please call Pat Reding at 1-800-288-6669. Registered representative of and securities offered through Berthel Fisher & Company Financial Services, Inc. Member NASD & SIPC Pro Advantage Services, Inc./Pharmacists Mutual is independent of Berthel Fisher & Company Financial Services Inc. Berthel Fisher & Company Financial Services, Inc. does not provide legal or tax advice. Before taking any action that would have tax consequences, consult with your tax and legal professionals. This article is for informational purposes only. It is not meant to be a recommendation or solicitation of any securities or market strategy.
Pharmacy Journal of New England • Winter 2012-2013
Rx and the Law This series, Pharmacy and the Law, is presented by Pharmacists Mutual Insurance Company and your State Pharmacy Association through Pharmacy Marketing Group, Inc., a company dedicated to providing quality products and services to the pharmacy community.
Do I Have To Fill This Prescription? Many pharmacists have asked the question, “I have some doubts about this prescription, do I have to fill it?” We will deal with this question in terms of therapeutics and patient health. We will reserve the topic of conscientious objection for a different time. When I was a young pharmacist, a more experienced colleague at the hospital received a phone order for IV propranolol, but at an oral dosage. The other pharmacist refused to dispense it, even in the face of verbal threats from the prescriber. In the end, the order wasn’t filled and any potential harm to the patient was avoided. What should you do if faced with a prescription that you believe is harmful to the patient? This harm may come from serious side effects, drug interactions, or possible addiction to controlled substances. Some states deal directly with this question in their regulations. For example, California states that pharmacists can refuse to fill prescriptions that would be against the law or that could potentially have a harmful effect on a patient’s health.1 Indiana states that the pharmacist can refuse to fill a prescription that is contrary to law, that is against the best interests of the patient, that would aid or abet an addiction or habit, or that is contrary to the health and safety of the patient. Two general rules can be formulated from these examples. 1. Prescriptions that are illegal or invalid can’t be filled – this is one of the most difficult scenarios for a pharmacist when it comes to controlled substances. The DEA takes the position that to be valid; a prescription for a controlled substance must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. The DEA believes that the law does not require a pharmacist to dispense a prescription of doubtful, questionable, or suspicious origin. It is difficult for a pharmacist to know when the line has been crossed from legitimate treatment to addiction. I think it is safe to say that if the current prescription presented to you is causing you to ask the question, then the line is very close or perhaps already crossed. 2. Prescriptions that could harm the patient shouldn’t be dispensed – This seems obvious, but is not always easy to apply in the real world. The dosage is on the high side of normal,
the patient has had penicillin before, the drug interacts with a previous prescription, or any other scenario that you can imagine where the prescriber directs you to go ahead and fill the prescription. However, if you think there is a high probability that the patient will be harmed, no one can order you to dispense the prescription. While California and Indiana spell out the responsibility of the pharmacist in these two situations, I believe that the same responsibility exists even in jurisdictions that don’t explicitly cite it. If not, then why bother to require that drug utilization reviews be performed? And if the pharmacist is powerless to act when something is detected, again, why require them? We all know that there are some risks associated with every drug and every treatment. What we are talking about here are the large, severe risks. In the propranolol example given earlier, the pharmacist was convinced that the patient would die if he dispensed that order as prescribed. If the prescriber can overrule the pharmacist’s professional judgment in this situation, then the chances of an irreversible, negative outcome increase. But you can’t make these decisions in a vacuum. Discussion with the prescriber will probably be necessary. Perhaps discussions with the patient also will be necessary. Use the information from these discussions in conjunction with your professional knowledge, experience and judgment. As I tell pharmacists in these situations, it is much easier to defend a case where the pharmacist refuses to fill a questionable prescription than it is to defend a case where the pharmacist has doubts about what was dispensed. You don’t want your answer to the deposition question, “And what did you do when you became aware of this potential danger?” to be, “Nothing.” We can’t insure 100% safety, but we want to avoid high probabilities of serious harm. Pharmacists owe patients their highest efforts to treat their health problems and try to protect them from avoidable harm. The pharmacist’s duty to a patient does not require the pharmacist to do anything illegal. However, I do believe that it requires the pharmacist to use their professional judgment for the patient’s benefit. That may mean refusing to dispense a particular prescription. And that situation may require some intestinal fortitude on the part of the pharmacist. © Don R. McGuire Jr., R.Ph., J.D., is General Counsel at Pharmacists Mutual Insurance Company. This article discusses general principles of law and risk management. It is not intended as legal advice. Pharmacists should consult their own attorneys and insurance companies for specific advice. Pharmacists should be familiar with policies and procedures of their employers and insurance companies, and act accordingly. 1. California Code of Regulations, Division 17, Title 16, Article 2, Section 1707.6 Indiana Code 25-26-13-16
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Feature Reported by Thomas Farley, MD, New York City Dept of Health and Mental Hygiene. Anthony N. DeMaria, MD, Univ of California, San Diego. Janet Wright, MD, CDC/Center for Medicare and Medicaid Innovation (CMS Innovation Center). Patrick H. Conway, MD, Centers for Medicare and Medicaid Svcs.Amy L.Valderrama, PhD, Nicole A. Blair, MPH, Div for Heart Disease and Stroke Prevention, National Center for Chronic Disease Prevention and Health Promotion; Miriam Kelly PhD, Tanja Popovic, MD, PhD, Office of the Director, CDC. Corresponding contributor: Amy L.Valderrama, avalderrama@cdc.gov, 770-488-8218.
CDC Grand Rounds: The Million Hearts Initiative Weekly The Magnitude of the Problem Cardiovascular disease, including heart disease and stroke, is the leading cause of death and disability in the United States. Every year, approximately 2 million persons in the United States have a heart attack or stroke and, as a result of these conditions, approximately 800,000 die from cardiovascular disease1. For those persons who do survive a heart attack or stroke, many are faced with serious illness, disability, and decreased quality of life. The ongoing complications that result from cardiovascular disease greatly contribute to the economic burden on the health-care system and to society as a whole. In 2010, the cost in health-care expenditures and lost productivity in the United States from cardiovascular disease amounted to nearly $444 billion, and these costs are increasing every year2. This is especially alarming because the primary risk factors for cardiovascular disease (i.e., high blood pressure, high cholesterol, smoking, type 2 diabetes, inactivity, and obesity) are largely preventable and have effective, low-cost treatments1. If these risk factors were well-controlled through behavioral modification and/or treatment, the risk for death from heart attack and stroke could be reduced by more than half 3,4.
The Million Hearts Initiative Launched in September 2011 by the U.S. Department of Health and Human Services (HHS), Million Hearts is a national initiative that aims to prevent 1 million heart attacks and strokes by 2017. This public-private partnership, co-led 10
by CDC and the Centers for Medicare and Medicaid Services (CMS), will integrate proven and effective prevention activities to reduce cardiovascular disease. A key strategy of Million Hearts is to engage a broad set of stakeholders involved with health and health care, including clinicians, pharmacists, insurers, health-care systems, retailers, consumer groups, and others. Better alignment and coordination of existing and new prevention and treatment efforts will accelerate translation into practice, resulting in decreased burden to society and greater population health improvements. The two primary goals of Million Hearts are 1) to reduce the need for treatment by empowering persons in the United States to make healthy choices (e.g., avoid tobacco, reduce sodium intake, and reduce artificial trans fat intake) and 2) to improve care for persons who need it through focus on the “ABCS� (i.e., appropriate aspirin use for those at risk, blood pressure control, cholesterol management, and smoking cessation). Million Hearts is being implemented through parallel efforts aimed at clinical settings and communities3. Community efforts will keep the population healthy and reduce the number of persons who need treatment in the first place. Million Hearts will focus community efforts on decreasing tobacco use and exposure to secondhand smoke, reducing sodium intake, and eliminating consumption of artificial trans fats3. Examples include designated smoke-free public spaces, policies that reduce sodium and eliminate artificial trans fats in prepared food, workplace wellness programs, and media
Pharmacy Journal of New England • Winter 2012-2013
campaigns related to the hazards of smoking. These activities align with the Healthy People 2020 targets and the goals of the Prevention and Public Health Fund, the National Quality Strategy, and the National Prevention Strategy3. Clinically based prevention efforts will improve quality of care, access to care, and improve outcomes through focus on the ABCS. These efforts will include drawing the attention of health-care professionals and the systems in which they work to the ABCS, increasing and improving the use of health information technology in clinical practice, and using clinical innovations to increase the use of effective ABCS care practices. Although high achievement in the ABCS has been shown to prevent more cardiovascular disease–related deaths than other clinical preventive services, overall performance in the ABCS by persons at risk and their health-care professionals generally is low3,5. For example, less than half of persons (47%) with ischemic vascular disease are prescribed aspirin or other antiplatelet medication, less than half of persons (47%) with hypertension have their blood pressure under control, only one third of persons (33%) with high cholesterol are effectively managed, and approximately one fourth of persons (23%) who smoke get tobacco cessation counseling or medications (Table)6,7. Consequently, the estimated number of persons who smoke or have uncontrolled hypertension or cholesterol totals approximately 100 million. Improving performance on the ABCS is the means by which the majority of lives can be saved and how the greatest health value can come out of current health-care investments3.
National Prevention Efforts CMS is the largest payer of health care in the world and provides health-care coverage to nearly 105 million beneficiaries in Medicare, Medicaid, and the Children's Health Insurance Program. CMS has a critical role at the federal level in build-
ing clinical prevention strategies with a focus on health information technology and innovation in health-care delivery. Technology and innovation are central to fostering a healthcare system that delivers care that is safer, better coordinated, and patient-focused. CMS is working to standardize ABCS indicators as part of clinical quality reporting requirements among physician offices, hospitals, health departments, insurers, assisted-living facilities, and related health-care providers and systems3. Standardization will improve reporting of the ABCS and reduce the burden of reporting while enabling more efficient communication of best practices to those providing care. These also will support quality-incentive programs focused on the ABCS, such as the Physician Quality Reporting System for clinicians and for Medicare health plans and prescription drug plans. In 2011, CMS initiated the Medicare and Medicaid Electronic Health Records Incentive Program, which will provide payments to eligible health professionals and hospitals as they adopt, implement, and demonstrate “meaningful use” of certified electronic health record (EHR) technology in ways that improve the quality of care delivered. Meaningful use is the use of certified EHR technology in a manner that provides for the electronic exchange of health information to improve the quality of care and submits information on quality of care and other measures.11 Clinical decision support tools are being developed in conjunction with the EHR Incentive Program to further disseminate clinical guidelines and best practices, such as optimal medication prescribing support, screening prompts, and medication alerts. Broad use of EHR technology can improve provider communication, reduce medical errors, limit duplicate tests and screenings, and lower costs3. The Million Hearts initiative also has the opportunity to generate innovative ways to deliver health care and to improve
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patient adherence. CMS is working with the Medicare Quality Improvement Organizations and Federally Qualified Health Centers and others to develop and test new models of care, such as accountable care organizations12 and learning and action networks.13 These initiatives have a patientcentered philosophy supported by knowledge management and real-time learning functionality3. The interventions will focus on reducing the barriers to providing health care and continuous quality improvement. Tools and strategies emphasize a team-based approach to care that strives to enhance the role of pharmacists, advanced practice nurses, physicians' assistants, community health workers, cardiac rehabilitation teams, nurses, and peer wellness specialists, among others. CMS also supports innovative health-care models and structures, such as patient-centered medical homes and point-of-care counseling, and will implement payment reform initiatives that incentivize adherence to ABCS clinical quality metrics through programs such as value-based purchasing, new primary-care payment models, and accountable care organizations.
Local Prevention Efforts San Diego, California. In addition to action at the federal level, communities also have a critical role in improving clinical care and reducing cardiovascular disease risk factors in the community. For example, the Department of Health and Human Services of the County of San Diego developed a county-wide prevention initiative, including an effort to reduce risk factors for cardiovascular disease. The initiative, Live Well, San Diego! is a comprehensive effort with partners from state, local, private, professional, and community-based groups. Live Well, San Diego! is organized on a “3-4-50” concept, referring to the notion that three behaviors (i.e., poor diet, physical inactivity, and tobacco use) lead to four diseases (i.e., cardiovascular disease, type 2 diabetes, cancer, and lung disease), which account for approximately 50% of deaths8. In conjunction with local medical providers, the county adopted the goal of becoming a “Heart Attack and Stroke Free Zone” to capture public attention, extend the project to all citizens, convey ownership of the program to the public in addition to the medical community, and to capitalize on the strong sense of community pride. One specific feature of the Live Well, San Diego! initiative is the “Be There Campaign,” which focuses multimedia and social media strategies on heart attack and stroke prevention. It aims to motivate patients to reduce their risk factors to be there for loved ones. The campaign is based on risk-reduction tactics that are designed to actively engage persons in improving their own health as a way to be responsible to 12
family and friends. One method for engaging persons and increasing their participation in the campaign is through the use of new technologies, such as wireless heart monitors, pill bottles designed to measure medication adherence, exercise frequency monitors, and smartphones to report vital signs. For the first time, the top 10 health-care systems in San Diego meet monthly, share data, and discuss how treatment goals are met. Through efforts focused on engagement of the entire medical community and the integration of health programs into the initiative, San Diego County intends to create an effective population health program that can be scaled to other communities throughout the United States. New York City. New York City (NYC) established a cardiovascular disease prevention initiative focused on smoking cessation, reducing intake of artificial trans fats and sodium, and expanding the use of EHRs. In 2002, the NYC SmokeFree Air Act was enacted, prohibiting smoking in workplaces, restaurants, bars, and nightclubs. In 2011, the smoke-free ordinance was expanded to parks, beaches, public plazas, and boardwalks, and by the end of 2012, all 23 campuses of the City University of New York will become tobacco free. In addition to the smoke-free law, NYC implemented an excise tax in 2003; when combined with subsequent tax increases at the state and federal levels, the total cost of a pack of cigarettes is now $11. Ongoing cardiovascular disease prevention efforts include a mass media campaign that delivers graphic images and testimonials about the long-term suffering and harmful effects caused by tobacco use. Data from the NYC Community Health Survey (CHS) have shown that during 2002–2010, the combination of changes to local laws, excise taxes, and media messages have resulted in approximately 450,000 fewer smokers in NYC (Figure)9. The NYC Board of Health restricts the use of artificial trans fat in restaurants, and approximately 90% of NYC restaurants were in compliance in 200810. NYC also has led the National Salt Reduction Initiative (NSRI) to decrease sodium intake by 20% over the next 5 years.14 The initiative is promoted by a voluntary coalition that focuses on government-industry collaboration. To date, 28 major packaged food companies and restaurants have committed to NSRI. NYC also is supporting the ABCS through the implementation of the Primary Care Information Project (PCIP).15 The goal of the project is to facilitate improvements to the quality of primary care delivered with enhancements to health information technology. Currently, approximately 3,000 primary-care providers serving nearly 3 million patients are
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using a prevention-oriented EHR capability that provides a clinical decision support system and monitors physicianreported patient data. PCIP delivers a personalized dashboard showing physicians their performance on the ABCS. It also provides prevention and treatment recommendations and reminders to address for future improvements. PCIP EHR enhancements exemplify the health information technology meaningful use improvements underway at CMS.
References 1. Roger VT, Lloyd-Jones DM, Benjamin EJ, et al. Heart disease and stroke statistics–2012 update: : a report from the American Heart Association. Circulation 2012;125:e2–e220. 2. Heidenreich PA, Trogdon JG, Khavjou OA, et al. Forecasting the future of cardiovascular disease in the United States. Circulation 2011; 123:933–44. 3. Frieden TR, Berwick DM. The “Million Hearts” initiative–preventing heart attacks and strokes. N Engl J Med 2011;365:e27. 4. Ford ES, Ajani UA, Croft JB, et al. Explaining the decrease in U.S. deaths from coronary disease, 1980–2000. N Engl J Med 2007;356:2388–98.
Summary
5. Farley TA, Dalal MA, Mostashari F, Frieden TR. Deaths preventable in the U.S. by improvements in use of clinical preventive services. Am J Prev Med 2010;38:600–9.
Million Hearts is a large-scale, public-private initiative that aims to change the cardiovascular health of the nation by preventing 1 million heart attacks and strokes by 2017. Success can be achieved by the implementation of proven, effective interventions, health technology and systems improvements, modifications in health-care coverage and reimbursement, and innovative strategies to improve performance on the ABCS by patients, health-care professionals, and health-care systems. System and environmental changes at the local and state levels will be important to create environments that facilitate healthy choices. Considerable commitments and dedication from various partners will make the difference in reaching the Million Hearts goal.
6. CDC. Million Hearts: strategies to reduce the prevalence of leading cardiovascular disease risk factors—United States, 2011. MMWR 2011; 60:1248–51. 7. CDC. Vital signs: awareness and treatment of uncontrolled hypertension among adults—United States, 2003–2010. MMWR 2012;61:703–9. 8. County of San Diego. Live well, San Diego! Building better health: a report on year two of a ten year initiative. San Diego, California: County of San Diego; 2012. Available at http://www.sdcounty.ca.gov/dmpr/gfx/ Live_Well_Annual_Report. Accessed December 14, 2012. 9. New York City Department of Health and Mental Hygiene. Epi data brief: trends in cigarette use among adults in New York City, 2002–2010. New York, NY: New York City Department of Health and Mental Hygiene; 2011. Available at http://www.nyc.gov/html/doh/downloads/ pdf/epi/databrief12.pdf. Accessed December 14, 2012. 10. Angell S, Silver LD, Goldstein CM, et al. Cholesterol control beyond the clinic: New York City’s trans fat restriction. Ann Intern Med 2009;151:129–34. 11. Additional information available at http://www.cms.gov/regulations-andguidance/legislation/ehrincentiveprograms/meaningful_use.html and http://healthit.hhs.gov/portal/server.pt?open=512&objID=2996&mode=2. 12. Additional information available at http://innovations.cms.gov/initiatives/aco/index.html. 13. Additional information available at http://www.cfmc.org/provider/provider_lans.aspx. 14. Additional information available at http://www.nyc.gov/html/doh/html/cardio/cardiosalt-initiative.shtml. 15. Additional information is available at http://www.nyc.gov/html/doh/html/pcip/pcip.shtml.
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From the Colleges University of Connecticut School of Pharmacy Dear Friends: We welcomed the ACPE visiting team October 9-11, following 18 months of preparation including the development of a self-study. I am pleased to report that we received very positive feedback about our pharmacy program. The team designated a number of notable practices: professionalism of our student body; Experiential Education; Student Affairs; dual degree programs; development; assessment; student participation on school committees; and library access for preceptors. The ACPE Board will receive the team’s report at their meeting in January; as what is termed an “historic school,” we are eligible for an 8-year accreditation term; formerly, the maximum term was 6-years, which we received after our last review. I want to thank Dr. Lauren Schlesselman who led our self-study effort and the many students, faculty, staff, and alumni who served on one of the subcommittees.
Pharmacy Student Home Medication List Pilot
Former graduate student Dr. Kristyn Greco’s recent manuscript that was published this year was one of the ten most downloaded papers published in the last three months in the highly-respected Journal of Pharmaceutical Sciences; this is indicative of both the quality and importance of Dr. Greco’s paper given that 75-100 papers were published in the journal during this period. Dr. Greco’s major professor was Dr. Robin Bogner.
APhA-ASP Awards
Morris Nominated to NRC Committees
Our APhA-ASP chapter received two awards at the Region 1 Midyear Regional Meeting this fall. The chapter received the regional award for Operation Immunization (third year in a row!) and the Chapter Challenge award.
Dr. John Morris has been nominated to serve on two new NRC committees that will work in parallel to conduct scientific peer reviews of both the styrene assessment and formaldehyde assessment in the National Toxicology Program’s 12th Report on Carcinogens.
Student Researcher of the Month Award Our chapter of the Rho Chi Honor Society, in conjunction with School of Pharmacy Honors and Professional Student Research Committee, has established the Student Researcher of the Month Award. The award highlights professional students who have made scholarly research contributions. The first award was made in November to Audrey Corman (Faculty Research Advisor: Dr. Kyle Hadden).
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Dr. Kristyn Greco, Pharm.D./Ph.D
Pharmacy Practice faculty member and assistant department head Dr. Kevin Chamberlin, assisted by other UConn Health Center based faculty and students, are partnering with Dempsey Hospital pharmacists on the Pharmacy Student Home Medication List Pilot Project. Pharmacy students are validating patients’ home medication lists; a pharmacist then contacts the medical team regarding any issues that may need to be addressed so that accurate medication reconciliation upon discharge can be accomplished.
Dr. Kristyn Greco
Academic and Health Policy Conference on Correctional Health Fellowship Award Dr. Meghan Ehret has received a fellowship award for the 6th Academic and Health Policy Conference on Correctional Health. Winter well! Robert L. McCarthy, Ph.D. Dean, Professor & Vice Provost for Engagement
Pharmacy Journal of New England • Winter 2012-2013
University of Saint Joseph School of Pharmacy Dear Colleagues: Warm greetings from the University of Saint Joseph School of Pharmacy family. We are doing well and we hope all of you are also. The Class of 2015 is now happily engaged in their intensive P1 year. The entire student body is fully engaged in activities that foster acculturation into the profession of Pharmacy and good citizenship. They are very active in giving back to the community, including participation in such charitable causes as the Prescription Drug Take-Back event, Walk to Cure MS, and YMCA Healthy Kids Day, among many others.
blood pressure screening and smoking information booth for soldiers at the CT National Guard’s AVCRAD in Groton, CT. Smoking cessation materials were provided by the American Cancer Society, the Department of Defense, and the University of Saint Joseph School of Pharmacy. More information can be obtained from Drs. Soldato or Forcello at smokingcessation@usj.edu
Preceptor and student evaluations continue to reflect the bond that is being formed between the school and our pharmacy colleagues – for that please accept our gratitude for your commitment and support. Following are a few briefs from the school. And again, thank you. Joseph R. Ofosu, Pharm.D., R.Ph. Dean and Professor
In conjunction with the American Cancer Society’s Great American Smokeout which was held on November 15th of this year, University of Saint Joseph Pharmacy students took part in raising awareness about the health risks of smoking in various parts of the state. On November 16th, students provided free blood pressure screenings and counseling on healthy lifestyle and information about quitting smoking (including possible products and tips) to patrons before the Hartford Whales hockey game at the XL Center. On November 18th, students also hosted a
In August 2012, Sukhvir Kaur, Assistant Professor of Pharmacy Practice and Administration, took a one-week exploratory trip to Guyana, South America in pursuit to build a pharmaceutical care experience for the P2 pharmacy students in our program. Travels were made to Georgetown and the villages of Rupununi. In the multidisciplinary team, medical care was provided to more than 100 Guyanese people. It was truly an eye opening experience where the Health Care Centers in the villages of Rupununi are in critical need for medications, working equipment such as a refrigerator to house insulin and vaccines. University of Saint Joseph is committed to providing medical care in Guyana with years of service and strong affiliations with Saint Joseph Mercy Hospital, Georgetown Public Hospital and University of Guyana. At School of Pharmacy, we are working on to build an elective course named Pharmaceutical Care in Guyana as a transformational experience offered to our pharmacy students at the completion of their second professional year.
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Massachusetts College of Pharmacy and Health Sciences - Boston Dear Colleagues, It appears that we have survived the midpoint in another school year and students are eager to begin their Holiday break! I took some time this year and wrote a piece in our school newspaper urging students to actually take a break from classes to recharge their batteries. I am beginning to notice that students are using the holidays to continue to work -- as we all did -- an incredible number of hours , and then return back to classes in January worse off than when they left. I cannot help but wonder if these highenergy, driven students are missing out on family time by not being there to enjoy the time off -- but then again, maybe my age is showing. Please accept our best wishes and glad to you and yours over the Holiday season! Sincerely, Douglas Pisano Dean and Associate Provost for Pharmacy Education
Eleventh Annual New England Regional Residency Showcase The MCPHS student chapter of the American Society of Health-System Pharmacists (ASHP) held its 11th annual New England Regional Residency Showcase on November 8 in the Griffin Academic Center. More than 35 residency programs and nine fellowship programs participated, and students from both SOP-Boston and SOPWorcester/Manchester attended. The showcase provided a forum for the 350 students in attendance to learn more about residency and fellowship programs by speaking directly with directors and preceptors of the programs, and current residents and fellows. The showcase also allowed the programs to acquaint themselves with the pharmacy students of Massachusetts.
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Also in attendance were more than 150 students from Northeastern University, University of Connecticut, University of New England, University of Rhode Island, Albany College of Pharmacy, University of Washington, Wilkes University, Shenandoah University. The residency showcase was organized by Dr. Trisha LaPointe, advisor of the MCPHS student chapter of ASHP.
MCPHS Launches Honors Program The School of Pharmacy-Boston at MCPHS has launched its newly developed Honors Program in the Doctor of Pharmacy Program. The Honors Program was designed as an enrichment of the Doctor of Pharmacy curriculum that expands educational opportunities for highly motivated and academically talented students. Honors Students complete program requirements beginning in the fourth year (PY2), participate in an Honors Seminar during the fourth and fifth (PY3) years, and complete a research project under the guidance of a faculty research advisor in the fifth and sixth (PY4) years. The first group of accepted Honors students is from the PharmD Class of 2014: Francis Cannata, Joseph Faulhaber, Michael Fiore, Janet Kim, Cassandra Letho, Stephanie Lewis, Jagoda Misniakiewicz, Shatha Mufti, Chandni Patel and Elizabeth Travis. We wish them all of the best!
Faculty News Our faculty have also been burning the midnight oil since the last edition of the Journal. Dr. Kristin Zimmerman received the “People’s Choice Award” for authoring the best poster in the category Innovation in Pharmacy Practice at the 8th Annual New England Pharmacists Convention at the MGM Grand – Foxwoods. Award recipients were selected based on the
Pharmacy Journal of New England • Winter 2012-2013
number of votes submitted by conference attendees from all over New England. Many of our faculty, including Drs. Eman Atef, Monica Chuong, David Williams, Barbara LeDuc, Tim Maher, Khaled ElSaid, Mattia Migliore, Ahmed Mehanna, and Steven Kerr, as well as Susan Jacobson and Nick Campagna, have presented posters and professional abstracts at numerous national and international meetings as well as having published book chapters, scholarly manuscripts and served as Journal Reviewers in their academic discipline. Dr. Gerard D’Souza, assistant professor of Pharmaceutics, has been awarded the Scientific Contribution Award at the 3rd World Congress on Targeting Mitochondria 2012 in
Berlin, Germany. He received the honor for a podium presentation titled: Functional expression of green fluorescent protein in mitochondria of rat cells following liposome mediated delivery of a linear DNA construct. This is the only meeting in the world where scientists gather to discuss their research. Dr. D’Souza has published one of the very few papers in the world on this topic. In addition, Dr. Enrique Seoane, in collaboration with Dr. Rosa Rodriguez-Monguio and Jing Hao, have been awarded the 2012 APHA Medical Care Section Student Presentation Award for the paper, Public Health Implications and Economics of Combination Drugs: A Review of the Literature on Fluticasone propionate/salmeterol at the 140th American Public Health Association Annual Meeting in San Francisco.
Massachusetts College of Pharmacy and Health Sciences Worcester/Manchester Dear Colleagues
completed a sabbatical leave (MayOctober 2011) at the Liggins Institute, University of Auckland, New Zealand, where she tested therapeutic compounds for breast cancer in in vitro cell models. Dr. Friel has been a principal investigator or co-principal investigator on seven grants. She also has three patents or pending patent applications.
The new academic year is upon us and has opened quite smoothly for us at MCPHS-Worcester/Manchester. We have a full class on both campuses and it is filled with dedicated students who are eager to become practicing pharmacists. The faculty continue to be very engaged with the students both inside and outside the classroom while they also pursue their scholarly interests. The following are some of the highlights over the past few months. All the best, Michael J. Malloy, Dean and Professor
Dr. Carolyn Friel is New Department Chair for Pharmaceutical Sciences After a national search, Dr. Carolyn Friel was appointed as Chair of the Department of Pharmaceutical Sciences, effective July 1, 2012. Dr. Friel is an associate professor of Medicinal Chemistry. She is a longterm member of this department and SOP-W/M. She began her academic career at MCPHS in July 2000. Dr.
Dr. Carolyn Friel
Friel was among the faculty members who welcomed the inaugural PharmD class in the Fall of 2000. Dr. Friel received a BS in Pharmacy from the University of Rhode Island and a PhD degree in Biomedical Sciences with specialization in Medicinal Chemistry from Northeastern University.
Dr. Friel has extensive teaching experience and has received several teaching awards, including the 2011 Trustees’ Award for Teaching Excellence. She has served on several leadership positions on committees at the department, SOPW/M, and college levels. Furthermore, she serves as a member and/or an officer at pharmacy and research-related professional organizations.
MCPHS Hosts Visiting Scholar
Mr. Emmanuel S. Adabor, MS, of the Kwame Nkrumah University of Dr. Friel’s scholarly interests focus on Science and Technology, Ghana, was two areas: health information literacy of recently a Visiting Scholar in the SOPelementary aged children, and design W/M Department of Pharmaceutical and synthesis of therapeutic comSciences. His visit was sponsored by the pounds for breast cancer. Last year, she Novartis Institutes for Biomedical 17
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Research, the research arm of the global pharmaceutical company. As an Applied Mathematician, the objectives of his visit were: • To review gene (and gene product) expression dysregulation in breast cancer • To apply Bayes’ theorem to the problem of inferring regulatory relationships among gene products in breast cancer • To examine inferred regulatory networks for molecular insights into the etiology of breast cancer His mentor was associate professor Dr. George AcquaahMensah. In addition to his studies, he spent some teaching time with a group of APPE students on an elective research rotation, and also presented an overview of his work to the department. Mr. Adabor returned home on September 15 to begin his PhD studies in Applied Mathematics.
Grant Awards Dr. Robert Campbell, Sinan Mufu, and Kai-tak Wan received a National Science Foundation grant in the amount of $260,000 to conduct a multi-year collaborative research, Mechano-lipidomics and Mechano-cytosis of Drug Delivery. Funding Period: 10/1/2012 – 10/1/2015.
Colleen Massey, Dr. Timothy Dy Aungst, Dr. Donna Bartlett, Dr. Paula Evans, Dr. Jennifer Donovan, and Dr. Abir Kanaan received a 2012 Million Hearts Grant from the National Association of Chain Drug Stores (NACDS) Foundation in the amount of $1,000. Funding Period: 9/1/2012 – 9/30/2012. Colleen Massey, Dr. Paula Evans, and Dr. Donna Bartlett of the MCPHS Pharmacy Outreach Program received a $11,230 grant from the Central Massachusetts Agency on Aging, Title III, for a project titled “Ask the Pharmacist: Medication Management and Safety Project.” Funding period: 10/1/2012 – 9/30/2013.
Awards Dr. Reema Zeineldin received the 2012 Teacher of the Year Recognition by the American Association of Colleges of Pharmacy (AACP) during the 2012 AACP Annual Meeting, Kissimmee, FL. Dr. Monina R. Lahoz was one of four recipients of the Clear: Conversations Project Awards from the National Network of Libraries of Medicine - New England Region (NN/LM-NER). Awardees were provided the guide and materials to conduct an interactive workshop that teaches patients to take control of their health visits.
University of New England School of Pharmacy UNE College Of Pharmacy Doctoral Students Have Added Advantage Of Learning To Formulate Medications For Use In Veterinary Applications
“Many drugs do not come formulated for a certain species or a specific animal use, so veterinarians commonly order compounded drug prescriptions for their patients,” said
The inaugural class of the University of New England College of Pharmacy will graduate in May 2013 prepared to serve customers of all needs, including the medication needs of veterinary patients. Students in their third year of a four year program have the opportunity to take an elective class in veterinary pharmacy that includes training in the safe production of compounded veterinary drug prescriptions. A lab this year for the Class of 2014 was co-organized by Steve Hauke, RPh, veterinary pharmacist and owner of PetScripts in Yarmouth. Hauke provided valuable focus and guidance during two separate laboratory exercises in November where students learned how to safely and effectively fill orders for custom compounded veterinary prescriptions. 18
UNE College of Pharmacy students of the Class of 2014 Katelyn Richard and Okechukwu Emmanuel work in a lab on the Portland Campus with Steve Hauke, RPh, (far right) veterinary pharmacist and owner of PetScripts of Yarmouth.
Pharmacy Journal of New England • Winter 2012-2013
UNE Assistant Professor Cory Theberge, Ph.D. “These compounded preparations are increasingly sought by costconscious pet owners in retail and community pharmacies, so pharmacists with animal-specific drug formulation skills are emerging as valuable additions to retail and community pharmacy teams.” Theberge added, “The laboratory component of the elective class is beneficial because veterinarians really appreciate pharmacists who can offer constructive input when
managing the medication needs of a wide range of species and sizes of animals.” The University of New England is an innovative health sciences university grounded in the liberal arts, with two distinctive coastal Maine campuses and unique study abroad opportunities. UNE has internationally recognized scholars in the sciences, health, medicine and humanities, and offers more than 40 undergraduate, graduate and professional degree programs.
Northeastern University School of Pharmacy Bouvé College of Health Sciences Greetings alumni, colleagues and friends. We are pleased to provide readers of the Pharmacy Journal of New England with this update of recent activities at Northeastern University School of Pharmacy. On the weekend of November 2 - 4, Northeastern’s School of Pharmacy celebrated its 50th anniversary. The weekend, which included multiple events, brought together generations of graduates, faculty, staff, university leaders, along with current students, to commemorate the school’s proud history and look ahead toward its promising future. A panel discussion, hosted by the Health Sciences Entrepreneurs kicked off the 50th anniversary celebration on November 2 with alumni community pharmacists highlighting opportunities for entrepreneurs in independent community pharmacy. On November 3, more than 275 people attended a grand celebration of the impact university leaders, faculty and students have made on the School of Pharmacy over the last half-century. Alumni enjoyed tours of the school’s new home and research labs at 140 The Fenway. The evening’s gala event recognized several distinguished honorees who have made profound contributions to the school over the years, George and Margo Behrakis, Joseph and Nancy Fleming, and John and Evelyn Neumeyer. The festivities concluded with a White Coat Ceremony for the Doctor of Pharmacy program’s Class of 2016. Alumni George Behrakis and Afton Wagner (NCPA) were the keynote speakers at the ceremony. Our students, alumni, faculty, staff, and friends are at the core of all that we are celebrating. We look forward to reconnecting with many of you during this milestone year. Please visit www.northeastern.edu/bouve/pharmacy/anniversary.
Members from the class of 2016 participate in the annual White Coat Ceremony as part of the school’s anniversary festivities in November.
Faculty News: Recent Appointments and Recognitions: Todd Brown, RPh, MHP, has been elected as a member of the MPhA Board of directors, serving as Academy Governor of Academia. Karen Horbowicz, PharmD has been elected as a member of the MPhA Board of directors, serving as Academy Governor of Independent Pharmacy. Anita Young, EdD, has been named to the Continuing Pharmacy Education Commission for the Accreditation Council for Pharmacy Education (ACPE).
Grants: Heather Clark, PhD, awarded $300,000 by Defense Advanced Research Project Agency (DARPA) for her work in developing neural nano-sensors measuring cellular biochemistry. 19
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John Devlin,PharmD, awarded $32,350 by Hospital Maisonneuve-Rosemont for his work entitled “The effect of dexmedetomidine nocturnal sleep protocol on delirium incidence, sleep quality and healthcare costs in critically ill patients: A prospective randomized, double-blind, pilot study.”
Arun Iyer, PhD, received the Nagai Post-Doctoral Research Achievement Award from the Controlled Release Society. The award recognizes an individual who has made outstanding post-doctoral contributions in the field of controlled release drug delivery.
Student News:
Roger A. Edwards, ScD, awarded $150,000 by the Charles H. Hood Foundation Child Health Research Awards Program for his work entitled "Expanding Use of a Computer Agent to Support Breastfeeding"; a subcontract with the New York City Department of Health & Mental Hygiene for work on "Maternal Infant Reproductive Health Baby-Friendly Hospital Initiative"; and a subcontract for work on "Enabling Continuity of Care for Breastfeeding Support in Massachusetts.” Alexandros Makriyannis, PhD, awarded $330,983 from the National Institutes of Health for his work entitled “Serotonin 5HT2C Agonist Drugs with 5HT2A/2B Antagonist Activity” and $134,873 from NIH for his work entitled “Anandamide Carrier Proteins as Drug Targets”. Nathaniel Rickles, PhD, PharmD and David Zgarrick, PhD, awarded a grant from the NACDS Foundation to support the development of a community pharmacy residency program with Walgreens.
Faculty Awards and Honors: Elizabeth Hirsch, PharmD, received the Society of Infectious Disease Pharmacists (SIDP) Young Investigator Research Award in the amount of $10,000. She will be working with Dr. Eliopoulos at Beth Israel Deaconess Medical Center to collect and test urinary isolates against the antibiotic Fosfomycin. Karen Horbowicz, PharmD, received the 2012 Innovative Pharmacy Practice Award from the Massachusetts Pharmacists Association. Nathanial Rickles, PhD, PharmD, Judith Barr, ScD and David Zgarrick, PhD; were invited to host the 19th International Social Pharmacy Workshop (ISPW) at Northeastern in 2014 Vladimir Torchilin, PhD, received the 2012 Alec D. Bangham Lifetime Achievement Award at the Liposome Research Days conference in Hangzhou, China. Jenny Van Amburgh, PharmD, received the 2012 Nathan Goldberg Award from the Massachusetts Pharmacists Association.
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The student team from Northeastern University claimed the first place position in the 2012 ACCP Clinical Pharmacy Challenge where over 80 schools competed. Pictured here with Northeastern faculty member John Devlin, PharmD, are Northeastern pharmacy student winners Libbi Rice, Matt Lord and Adam MacLasco PharmD students Quinn Bott, Libbi Rice, John Oh, Veejaye Sinha, and Nohemie Boyer, under the advisement of faculty member Roger Edwards, ScD, were selected as finalists for Best Student Poster at the American College of Clinical Pharmacy Annual Conference with submission of their undergraduate capstone project: "Cost-effectiveness of Fidaxomicin for the Treatment of Severe Clostridium difficile Infection in Hospitalized Patients in North America." In addition, twenty student posters from Dr. Edwards’ class were presented at the ASHP Midyear Clinical meeting in Las Vegas. Emily Heath, a P4 student, was awarded a Provost's Undergraduate Education Grant for the project she is working on titled "Pharmacist and Pharmacy Student Conducted Medication Reconciliation on an Internal Medicine Service at an Urban Teaching Hospital". She presented her work at the ASHP Clinical Midyear meeting in Las Vegas. Pharmacy student Brian Raux received a Provost’s Undergraduate Research Award for the project: "iPads as Fomites in the Clinical Setting" with faculty advisor Betsy Hirsch.
Pharmacy Journal of New England • Winter 2012-2013
Basem Sadaka Receives Award Basem Sadaka received a Provost’s Undergraduate Research Award for the project: "Activity of Fosfomycin Against Contemporary Urinary Pathogens" with faculty advisor Betsy Hirsch. Pharmacy students Rachel Filipek and David Thompson presented a research poster titled “Clinical Experience with Oral Fosfomycin for Urinary Tract Infections” at the ASHP Midyear Clinical Meeting in Las Vegas. This project was done in collaboration with Monica Golik Mahoney and Chris McCoy at Beth Israel Deaconess Medical Center during a clinical research APPE with faculty member Betsy Hirsch. Jillian Casale received a Provost’s Undergraduate Research Award for the project “Impact of a virtual patient pilot program on Student Pharmacists’ learning outcomes” with faculty advisor Mark Douglass.
School News The 6th annual Bouvé Health Fair and Flu Clinic, sponsored by the Phi Delta Chi fraternity, was held October 17, 2012. Free vaccinations were administered to over 1,100 students, faculty, and staff and over 50 pints of blood were collected. Multiple health and wellness programs were displayed during the day-long event.
The twenty-eighth John W. Webb Lecture was held on October 22, 2012 on the Northeastern campus. The lecture is jointly sponsored by the ASHP and Northeastern and was supported by the Massachusetts General Hospital and the Massachusetts Society of Health-System Pharmacists. This year’s lecturer was Toby Clark, retired Hospital Pharmacy Director and Professor, College of Pharmacy at the University of Illinois College Of Pharmacy in Chicago. The title of Professor Clark’s address was “Leading Healers to Exceed”.
Continuing Pharmacy Education: We hope to see you next year on April 11, 2013 at the 2nd Annual Alumni Anniversary Continuing Pharmacy Education Program. The Critical Care Symposium will be held on May 2, 2013. For more information on these programs or any of our ongoing programs, please visit our web-site: http://www.rxce.neu.edu . We look forward to providing you with regular updates on news and events from the School of Pharmacy. We greatly appreciate your comments and suggestions about new ways the school and its faculty and students can serve you and the profession. If you are an alumnus and would like to update your information, please go to the following website: http://www.northeastern.edu/alumni/update/index.html
Western New England University College of Pharmacy Office of the Dean Greetings! We are very pleased to share news with you about Western New England University College of Pharmacy’s activities and plans. The learners in the Classes of 2015 and 2016 have been busy in the classroom, at community outreach programs, and at their IPPE rotations (Class of 2015).
Activities and Outreach Western New England University College of Pharmacy faculty and learners participated in the “Senior Spectacular 2012: Get Ready for Retirement and Beyond” at the Basketball Hall of Fame in Springfield, MA, on Saturday, November 3, 2012. This free community event, featuring exhibits, informational seminars, workshops, demonstrations and entertainment, targeted approximately 700 older adults and caregivers. College of Pharmacy learners and
faculty provided blood pressure screening services, information on heartburn and high blood pressure (through Million Hearts and American Pharmacists Association’s 21
From the Colleges
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(APhA) Operation Heart), and answered medication questions (through “Ask Your Pharmacist” counseling). On Saturday, November 10, 2012, learners and faculty participated in APhA’s Operation Heart at the YMCA in Northampton, MA during the health fair and inaugural Building a Healthy Community 5K run/1 mile walk to benefit the food bank. The learners and faculty were busy doing blood pressure screening and promoting hypertension awareness and healthy life styles. The College of Pharmacy learners and faculty members were also involved in Operation Self Care (Heartburn Awareness) at the Fall Fling on Western New England’s campus on November 13, 2012. They were educating the University’s employees about high blood pressure awareness. The College’s chapter of APhA-ASP is involved in the “Script Your Future” interprofessional program sponsored by American Association of Colleges of Pharmacy (AACP); it will be working with students from the physician assistant program at Bay Path College in providing a program on medication adherence during February 2013.
(ACCP) conference in Florida on October 21-24, 2012. The poster was titled “Impact of Medicare Part D on Community Pharmacy: A Multi-State, Multi-Region Survey.” Natalia Shcherbakova, PhD, Assistant Professor of Pharmaceutical & Administrative Sciences, gave a talk at the Center for Quality of Care Research at Baystate Medical Center, Springfield, MA on “Medication use patterns of antiepileptics and epileptic events" on September 19, 2012. Melissa Mattison, PharmD, Clinical Assistant Professor of Pharmacy Practice, presented a poster titled: “DeIntegrating the Self-Care Module: Back to a Traditional Curriculum” at the Non-prescription Medicines Academy sponsored by Proctor and Gamble in Cincinnati, OH on September 27-30, 2012. Lucia Rosé, PharmD, Clinical Assistant Professor of Pharmacy Practice, presented a Category I CME titled: “Asymptomatic Bacteriuria” to physicians and physician assistants at Cooley Dickinson Hospital, Northampton, MA on October 26, 2012.
Publications Ronny Priefer, PhD, Professor of Pharmaceutical & Administrative Sciences, published an article titled “Evaluation of a chiral cubane-based Schiff base ligand in asymmetric catalysis reactions” in Beilstein Journal of Organic Chemistry, October 22, 2012.
Appointments Dr. Shcherbakova is serving as an abstract reviewer for APhA Section on Economic, Social & Administrative Sciences for the National Meeting in March 2013.
Certifications Dr. Rosé received her American Academy of HIV Medicine HIV Pharmacist™ (AAHIVP) certification. On November 8, 2012 a group of 40 faculty, staff, and learners assembled for our second annual bowling night. A pizza dinner was followed by some intense candlepin action; learners designed uniforms emblazoned with their team names (“Pinicillin”, “Bowl Movement”) and enjoyed the camaraderie with each other during a well-earned break from their schoolwork.
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Thank You On behalf of the faculty, staff, administration and learners, our thanks to you for your continued support and encouragement! If you have any questions about our program, please don’t hesitate to contact me (erobinson@wne.edu) or visit our website at www.wne.edu/pharmacy.
Faculty News
All my best and best wishes in 2013!
Presentations/Lectures Shamima Khan, PhD, MBA, Assistant Professor of Pharmaceutical & Administrative Sciences, presented a poster at the American College of Clinical Pharmacy
Evan T. Robinson, R.Ph., PhD. Dean, College of Pharmacy
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Continuing Education for Pharmacists A Model System to Promote Access to Good Quality Compounded Medicines This continuing education monograph is adapted from the United States Pharmacopeial Convention (USP) series of white papers prepared by the Council of the Convention (CoC) titled "Focus On: Future Directions for USP." The learning objectives and assessment questions were developed by National Alliance of State Pharmacy Association's (NASPA) Continuing Education Advisory Panel. No financial support was received for this activity.This activity may appear in other state pharmacy association journals. Council of the Convention Section on the Quality of Compounded Medicines Loyd V. Allen, Jr., Ph.D., Section Chair (University of Oklahoma College of Pharmacy), Dawn M. Boothe, D.V.M., Ph.D. (Member-at-Large) Lucinda L. Maine, Ph.D. (American Association of Colleges of Pharmacy), Rebecca P. Snead, R.Ph. (National Alliance of State Pharmacy Associations)
Goals: The goals of this lesson are to describe non-governmental and governmental approaches to provide compounding standards and conformity assessments to these standards, and provide an overview of a proposed model system of standards and conformity assessments to standards that assure access to good quality compounded preparations.
Objectives: At the conclusion of this lesson, successful participants should be able to: 1. Understand the non-governmental and governmental approaches to provide compounding standards and conformity assessments to these standards. 2. Understand some of the non U.S. approaches to pharmacy compounding regulations. 3. Understand the proposed model system of standards and conformity assessments to standards that could assure access to good quality compounded preparations.
Introduction Extemporaneous compounding of preparations is a worldwide practice dating back centuries. Today, compounding is commonly defined as the preparation of a medicine in accordance with a licensed practitioner’s prescription or medication order. This definition evolves from a triad—the prescribing practitioner, the compounding professional, and the patient/consumer.
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Historically, what was once viewed as an art is now deeply rooted in the scientific study of how to prepare and assess compounded preparations, together with provision of stability data to allow assignment of a beyond-use date (BUD). In the following white paper, USP’s Council of the Convention Section on the Quality of Compounded Medicines provides a general description of non-governmental and governmental approaches to provide compounding standards and conformity assessment to these standards. Conformity assessments may be conducted by various parties—first (compounding group/individual), second (purchasing group/individual), or third (group/individual independent of first or second party). While data are limited, all types of conformity assessments are likely to be conducted in the United States. The white paper then articulates a proposal for a model system of standards and conformity assessments to standards that assure access to good quality compounded preparations.1
United States Non-Governmental Approaches 1. USP: Preparation And Process Standards
The compounding of the most “fully established and best understood” preparations for patient use was a founding principle for USP’s volunteer practitioners in 1820. USP still takes an active role in supporting the public’s access to the type of customized therapy offered by compounding and works to ensure the quality of such therapy by creating national standards
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and guidelines for compounding both sterile and nonsterile medications. These standards are process standards in that they provide appropriate techniques and procedures to guide practitioners in compounding. They also are product standards (commonly referred to as preparation standards to distinguish compounded formulations from manufactured products) to allow testing, both of the materials used in a compounded preparation and also the compounded preparations themselves, to assess quality and establish a BUD. Taken together, these preparation and process standards appear in official compendia of the United States—the United States Pharmacopeia (USP) and National Formulary (NF). Just like manufactured medicines, compounded preparations must comply with the product standards in the USP and NF, which are recognized as official compendia in federal food and drug law. In addition, a number of States recognize USP’s process standards for compounding and require compliance with these standards. These legal requirements are discussed further below. In the 2005-2010 cycle, USP supported two Expert Committees that provided these compounding standards. The Compounding Pharmacy Expert Committee of USP’s Council of Experts is composed of 10 experts, with proven extemporaneous compounding expertise representing varied pharmacy environments such as hospital, ambulatory, academia, veterinary practice, and private practice. The Sterile Compounding Expert Committee of USP’s Council of Experts is composed of 12 experts, also representing a wide range of pharmacy disciplines and infection control. These two Expert Committees: 1) develop compounded preparation monographs that can be used every day by pharmacists to prepare medications for patients requiring customized drug therapy, and 2) develop and revise General Chapters that describe good compounding practices.
As an emanation of the standards from USP’s two Expert Committees in the Council of Experts, USP supports several compounding constituencies through publication of the Pharmacists’ Pharmacopeia (P2), now in its second edition. P2 contains more than 115 compounding monographs, for use in both humans and animal patients, and 75 supporting General Chapters, all of which were excerpted from the USP and NF. In USP’s ongoing effort to develop more preparation monographs, academic and other laboratories are performing method development and stability studies for both sterile and nonsterile preparations. When these studies are completed, they provide information to support decisions of the compounding Expert Committees relative to a BUD designation. Currently, 17 compounded preparations are under study. USP also is reaching out to professional organizations and others to obtain candidate formulations, materials, tests, procedures, and acceptance criteria for the two compounding Expert Committees. The total universe of formulations needed for compounded preparations is unknown, but is well over 1,000. USP is attempting to focus on those that are most commonly compounded or that present the most significant risk. 2. Process Standards/Conformity Assessments For Site Accreditation
The Pharmacy Compounding Accreditation Board (PCAB) was launched in 2004 by eight pharmacyrelated organizations (including USP) as a voluntary accrediting body to assess compounding pharmacies against high quality standards for compounding. The founders of PCAB, and the pharmacists they represent, believed that standards against which compounding pharmacies can be tested are not only good for patients, but also good for the practice of pharmacy.2 To date, PCAB has accredited 65 compounding pharmacies. Each PCAB-accredited pharmacy undergoes a rigorous review of its policies and procedures and an onsite inspection against PCAB standards, which incorporate USP standards.
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Continuing Education for Pharmacists The pharmacies that have achieved the milestone of PCAB accreditation have demonstrated their commitment to quality standards and procedures. However, participation levels in PCAB are less than hoped for among U.S. pharmacies, which include approximately 3000 to 4000 pharmacies that emphasize compounding capability. This may be attributed to the rigor of
their assessment of pharmacy practitioners’ competence prior to licensure. Certification through the Board of Pharmaceutical Specialties (BPS) is one additional conformity assessment for practitioners. BPS certification is a voluntary process by which a pharmacist's education, experience, knowledge, and skills in a particular practice area are confirmed as
the accreditation process and the absence of “drivers” that would compel pharmacies to seek accreditation, e.g., reimbursement and insurance. Nevertheless, PCAB in recent months has seen an upswing in applications with over 140 pharmacies awaiting survey. Emerging “drivers” include professional organizational endorsements of PCAB (beyond PCAB’s governing board institutions), including the American Medical Association, American Veterinary Medical Association, American Animal Hospital Association, American Association of Equine Practitioners, and others, as well as incentives offered by liability insurers.
well beyond what is required for licensure; however, there is currently no BPS specialty in compounding.
In 2008, PCAB established a separate Accreditation Committee that now oversees the accreditation process, and more recently began the first formal review of PCAB standards since their adoption in 2004. The revised standards are expected to be available before the end of 2009. 3. Conformity Assessments For Practitioners
There are several organizations and accreditation activities that speak to conformity assessments for practitioners. The Accreditation Council for Pharmacy Education (ACPE) is the national agency responsible for the accreditation of professional degree programs in pharmacy. ACPE sets accreditation standards and guidelines for pharmacy education and conducts conformity assessment of institutions. Standardized assessment of practitioner competence also occurs through the North American Pharmacists Licensure Examination (NAPLEX) developed by the National Association of Boards of Pharmacy (NABP). NAPLEX is used by boards of pharmacy as part of
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United States Government Approaches 1. Federal
The role of federal law and regulatory oversight of compounding has proven to be one of the most problematic for FDA, particularly in recent years. As a general rule, FDA has tended to avoid involvement with activities that relate to the practice of medicine and pharmacy, both of which traditionally are regulated at the level of the states in the U.S. However, FDA pays close attention to the quality of products regardless of whether they are manufactured products or compounded preparations. Sorting out the scope of state versus federal authority, and the demarcation between compounding and drug manufacturing, has proven elusive. Congressional efforts to resolve the issue have so far failed. For now, there is a legal and regulatory stalemate, leaving compounding practitioners and regulatory authorities in a state of uncertainty. The federal legal history leading up to this point helps illuminate the current situation. In FDA’s view, compounded drugs in interstate commerce are “drugs” under the Federal Food, Drug, and Cosmetic Act (FDCA), and are potentially subject to the full panoply of requirements (including pre-approval prior to marketing, such as a New Drug Application (NDA), good manufacturing practices (GMPs) required for manufacturing, and compliant labeling). In recognition of the role of compounding, FDA has generally, in the exercise of its enforcement discretion,
Pharmacy Journal of New England • Winter 2012-2013
excused such compounded drugs from most requirements otherwise applicable to “drugs.” In particular, under FDA Compliance Policy Guidance (CPG) 460.200, eligible compounding has been exempted from: the adulteration provisions of the FDCA with respect to GMPs; the misbranding provisions regarding labeling with adequate directions for use; and the new drug requirements, that is, approval of an NDA or Abbreviated New Drug Application (ANDA). In 1997, Congress sought to codify many aspects of FDA’s compounding policy and generally provide a
limited regulatory exemption from certain requirements of the FDCA for compounding. Section 127 of the FDA Modernization Act (FDAMA), which added §503A to the FDCA, in large part reflected CPG 460.200, and, among other things, provided that bulk drug substances used for compounding must comply with USP or NF requirements. To identify the compounding eligible for the less stringent regulatory requirements of 503A, Congress stipulated that such eligible compounders could not “advertise or promote the compounding of any particular drug, class of
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Continuing Education for Pharmacists drug, or type of drug,” although the “compounding
to ensure compliance. State boards also issue licenses
service” itself could be advertised and promoted. These limits on advertising were found by the 9th Circuit U.S. Court of Appeals in the Western States decision to be unconstitutional; moreover, the 9th Circuit held that the advertising restriction was not severable from the rest of FDCA 503A, thereby leaving at least the 9th Circuit in a pre-FDAMA condition (in terms of the application of the overall FDCA). The Supreme Court later affirmed Western States, but declined to consider the severability issue. More recently, the 5th Circuit declined the request of pharmacists to find that compounded drugs are exempt from the “new drug” provisions of the FDCA, but also found that the unconstitutional advertising restrictions of FDCA 503A are severable (leaving what some now call a “503A safe harbor”).
to pharmacists—evaluating their competence to practice—and to pharmacies. When needed, state boards also investigate complaints. There are times when states recognize standards from non-governmental third parties; for example, several states recognize USP for sterile and nonsterile compounding and, to a more or lesser degree, other USP standards related to compounding, drug product labeling and packaging.
Thus, in the 5th Circuit, 503A, absent the advertising provision, applies to eligible compounders. Elsewhere in the country, FDA’s current compounding policy continues to be reflected in the CPG it issued in the wake of the Western States decision.3 While these federal uncertainties are sorted out, USP continues to play an important role: 1) state law may incorporate USP process standards (e.g. General Chapters <797> Pharmaceutical Compounding – Sterile Preparations and <795> Pharmaceutical Compounding – Nonsterile Preparations) in regulating the practice of compounding, and 2) compounded preparations remain “drugs” under the FDCA and must comply with any applicable USP monographs if they use the name recognized in USP-NF. 2. State
In the U.S., pharmacy practice, including compounding, is regulated at the state level by state boards of pharmacy. Each state establishes and enforces its own laws and regulations governing the practice of pharmacy and performs routine inspections of pharmacies
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In an effort to maintain a certain level of consistency among the states, NABP offers to boards of pharmacy model language that may be used when developing state laws or board rules. The current set of model regulations also contains the NABP Model Rules for Pharmacy Interns, Institutional Pharmacy, Pharmacist Care, Nuclear/Radiologic Pharmacy, and Sterile Pharmaceuticals.
Non-U.S. Approaches 1. Argentina
In Argentina, the Health Department regulates the practice of pharmacy compounding. Legal difficulties abound for compounding practitioners because there are few established regulations to guide compounding practices and the guidelines that do exist are based on outdated legislation. Technical and scientific advances in drug therapy are not considered in the guidelines. Even though the regulatory framework may be lacking in certain respects, some restrictions do exist that ultimately limit patient access to medicines. For example, several dosage forms and therapeutic categories—such as troches, nasal preparations, and ophthalmics—are excluded and hormone replacement therapies, as well as medicines the U.S. would term over-the-counter, are not permitted to be compounded. In addition, Olanzapine (Zyprexa for schizophrenia/acute manic episodes) is the only drug that cannot be used in compounding.
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2. Brazil
The Brazilian National Health Surveillance Agency (ANVISA) regulates compounded pharmaceuticals. In 2005, ANVISA proposed new rules for compounding pharmacies, including: • Disallowing compounded drugs of the same formulation as manufactured products; • Setting limits on the marketing of products to the general public; and • Requiring the pharmacist to provide the patient with more product information, including the drug formulation, adverse effects, and duration of treatment. Veterinary pharmaceuticals are regulated by a number of different agencies, including the Ministry of Agriculture and the Ministry of Agriculture, Cattle and Supplying. Brazil appears to be one of the most advanced countries in regards to compounding. Brazil has 306 Schools of Pharmacy and graduates 14,000 pharmacists per year. In contrast the U.S. has slightly over 100 Schools of Pharmacy. There are 7,211 pharmacies in Brazil that are solely engaged in compounding and 16,000 compounding pharmacists. Brazil offers Continuing Education (CE) on compounding over standard TV channels throughout the country. ANFARMAG is Brazil’s National Association of Compounding Pharmacies and has a membership of over 4,000 pharmacists. 3. Germany
Federal Law, primarily the Arzneimittelgesetz, and subordinate federal directives, primarily the Apothekenbetriebsordnung, regulates the practice of pharmacy compounding in Germany. Extemporaneous preparation is mandatory when a prescription requiring compounding is presented to a community pharmacy. All dosage forms can be compounded; however, preparations that are difficult to compound (e.g. cytotoxic preps, injectables) can be compounded only after a pharmacist has completed
special training. Over-the-counter (OTC) compounding is allowed and occurs frequently. There is a list of preparations that both community pharmacies and hospitals are not allowed to prepare, such as allergens used to trigger an allergic response in a patient. Beyond-use dating for 243 standardized formulas is provided in the Neues Rezeptur-Formularium (NRF). There are 21,570 pharmacies in Germany. 4. Spain
In Spain, regional governments regulate the practice of pharmacy compounding. Four levels of compounding exist: 1) Dispensing; 2) Topical; 3) Oral, rectal and vaginal; 4) Sterile. Beyond-use dates for compounded preparations are based on literature and references, such as USP-NF. Health authorities in Spain have a very restrictive attitude toward pharmaceutical compounding. Compounded medicines are generally regarded as the last resource and authorized almost exclusively when all other therapeutic alternatives have failed. Pharmacies that only engage in compounding are not allowed. If a pharmacy only performs Level 1 compounding; i.e., dispensing, it must subcontract with a pharmacy that does other levels of compounding because it is against the law to refuse to serve any patient that enters a pharmacy. “Elaboracion a terceros” (third-party compounding) is the term used when a pharmacy contracts with another pharmacy specializing in higher-level compounding. Spanish patients receive most of their prescription medicines free or at little cost. However, compounded preparations are reimbursed according to a drug list that, according to Spanish practitioners, is currently out of date. Pharmacists are allowed to compound OTCs for sale in their own pharmacies, with the only limitation being that the medicine must be described in the Formulario Nacional (National Formulary). Additional specialized training is not required to be a compounding pharmacist. AEFF is the Spanish Association of Compounding Pharmacists.
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Continuing Education for Pharmacists A Model System The goal of any model system is to assure access to good quality compounded medicines, assist compounding practitionersâ&#x20AC;&#x201D;pharmacists and physiciansâ&#x20AC;&#x201D;in delivering such preparations to patients, and ensure patient safety, above all. While a number of standards, including USPâ&#x20AC;&#x2122;s, exist to help ensure that compounded medicines are of good quality, the lack of strong conformity assessments to such standards leaves both practitioners attempting to provide access to good quality compounded medicines as well as patients/consumers who receive them at risk. In this setting, the Council of the Convention Section on Quality of Compounded Medicines offers the following model system of standards and conformity assessments, in which USP would play a primary role in developing monographs and process standards and could play a role in other areas as well.
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1. People, Process And Preparation Standards
Ingredient and Preparation Standards (Product) Optimally, a preparation monograph in USP exists for all compounded preparations in the U.S. Compounding monographs are prioritized so that standards for the most frequently compounded articles are developed first. The Compounding Expert Committee, working with compounding practitioners, associations and others, develops a preparation monograph. The Committee takes into account safety and other considerations, such as intended use in target species. This input is obtained through a variety of sources, including FDA (whose views are represented by FDA liaisons to the Committee), NABP, and other practitioner and board associations. As noted above, conformance to such monographs is required under the FDCA.
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Compounding Sites Standards (Practice and Process) Optimally, practitioner associations and others, including associations representing state practitioner boards such as NABP, develop standards for all compounding sites (both in community and hospital locales where compounding is practiced, as well as practitioner office practices). Practice standards (<795>, <797>, and others) developed by USP for compounding are recognized in state regulations and accreditation standards (similar to the treatment of compounding provided by NABP in its Model Pharmacy Act and Pharmacy Rules). Practitioner Training and Accreditation (People) Adequate professional education and training curricula are adapted in schools of pharmacy to ensure that competencies in compounding are acquired and are supported by assessment through NAPLEX and licensure requirements through the state boards. An independent certifying body, such as BPS, builds an accreditation to define specialty certification of compounding practitioners. Optimally, all practitioners who compound complex or sterile preparations beyond a certain frequency are certified. 2. Conformity Assessments
Site Accreditation Through Congressional and/or judicial and regulatory determinations, the line between compounding and manufacturing is clarified, with the states retaining responsibility for regulation of compounding and FDA retaining responsibility for regulation of manufacturing. State boards of pharmacy (and other disciplines’ boards), working with PCAB or equivalent national practitioner associations, are responsible for conformity assessments of all compounding sites. When appropriate, a state board may deem non-governmental bodies, such as PCAB or equivalent associations, suitable to accredit traditional compounding sites. Optimally, all sites engaging in significant compounding activity require accreditation. Adverse Event Reporting
ed by the Patient Safety Act of 2005, is provided and maintained to ensure the capture of adverse events associated with compounded preparations, for deliberation and analysis regarding quality and safety.
Summary As a general matter, compounding remains both a responsibility for practitioners (those who prescribe compounded medicines as well as those who compound them) and an opportunity for their patients. At the same time, assurance that manufacturing does not occur under the guise of compounding is critically important. This white paper argues for a model system, building on good systems in the U.S. and other countries, that recognizes the interests of all parties in assuring access to good quality compounded preparations. ABOUT USP and NASPA The United States Pharmacopeia (USP) is an official public standards–setting authority for all prescription and over–the–counter medicines and other health care products manufactured or sold in the United States. USP also sets widely recognized standards for food ingredients and dietary supplements. USP sets standards for the quality, purity, strength, and consistency of these products–critical to the public health. USP's standards are recognized and used in more than 130 countries around the globe. These standards have helped to ensure public health throughout the world for close to 200 years. More information can be found at www.USP.org The National Alliance of State Pharmacy Associations (NASPA) promotes leadership, sharing, learning, and policy exchange among state pharmacy associations and pharmacy leaders nationwide, and provides education and advocacy to support pharmacists, patients, and communities working together to improve public health. NASPA was founded in 1927 as the National Council of State Pharmacy Association Executives (NCSPAE). More information can be found at www.naspa.us. Reprinted with permission. Copyright 2009, The United States Pharmacopeial Convention. All rights reserved. 1. This paper is intended to address both compounding for human use and compounding for veterinary use. However, there are some significant differences between the two, including differences in the relevant laws. The federal laws regulating veterinary compounding are found in the Animal Drug Amendment of 1968 and the Animal Medicinal Drug Use Clarification Act of 1996 (and related regulations and guidances) which are intended to protect consumers of foods of or from animals, as well as the animals themselves that might be treated with drugs, including compounded preparations. As with compounding for human use, there is controversy surrounding the distinction between legitimate compounding and manufacturing; the scope of the FDA’s role in regulating veterinary compounding; and the efficacy, safety, and appropriate labeling of these products, as well as other issues. A detailed discussion of the particular considerations that apply in the veterinary context is beyond the scope of this paper, but USP is committed to providing standards for compounding of preparations for both human and animal use, and the information and model system proposed herein is generally applicable to both human and veterinary compounding. 2. Pharmacy Compounding Accreditation Board, www.pcab.info 2009. 3. www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ ucm074398.htm.
An adverse event reporting system that offers strong Federal confidentiality and privilege protections, as provid31
Continuing Education Quiz Theory and Practice of Compounding Otic Preparations 1. Today’s definition of compounding evolves from a triad which includes all of the following EXCEPT: a. Patient b. Manufacturer c. Compounding professional d. Prescribing practitioner 2. Who may perform conformity assessments? a. Patient b. Pharmacy benefit manager c. Purchasing group d. None of the above 3. In compounding, product standards are also commonly referred to as a. Preparation standards b. Compounding standards c. Item standards d. Formulary standards 4. The Compounding Pharmacy Expert Committee of USP’S Council of Experts is composed of how many experts? a. 2 b. 5 c. 10 d. 12 5. The Sterile Compounding Expert Committee of USP’s Council of Experts is composed of how many experts? a. 2 b. 5 c. 10 d. 12
Mail to: CPA 35 Cold Spring Road, Suite 121 Rocky Hill, CT 06067
6. The Pharmacists’ Pharmacopeia contains which of the following a. 115+ compounding monographs for use in humans only b. 75 supporting general chapters excerpted from the USP and NF c. Both A+B d. B only 7. Which of the following regarding the Pharmacy Compounding Accreditation Board (PCAB) is true? a. PCAB was launched in 2004 by USP b. In 2008 PCAB established a separate Accreditation Committee to oversee the accreditation process c. PCAB accreditation does not necessarily include an onsite inspection d. There are approximately 1000 pharmacies in the United States that have compounding capability. 8. In the U.S. pharmacy practice, compounding is regulated at the state level by who? a. State pharmacy association b. State board of pharmacy c. Pharmacy Compounding Accreditation Board d. Food and Drug Administration
9. Which of the following countries does NOT allow “compounding only” pharmacies? a. Argentina b. Brazil c. Germany d. Spain 10. Which of the following countries does not allow Olanzapine to be used in compounding? a. Argentina b. Brazil c. Germany d. Spain 11. The most important goal of a model system is to a. Assure access to good quality compounded medicines b. Assist compounding practitioners c. Ensure patient safety d. Provide direction on good compounding technique 12. Competencies in compounding are assessed through which examination a. NAPLEX and state board requirements b. BPS and state board requirements c. MPJE and state board requirements d. State board requirements only
DO NOT DETACH Winter-2013 (1.5 hours - 0.15 CEUs) ACPE Program No. 0106-0000-12-062-H04-P
Expiration Date 12/28/2015 Type of Activity: Knowledge
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NABP No._____________________________________Birthdate (MM/DD)____________________ • A grade of 70% or greater is required for credit. • Re-examination will be permitted upon failure. • CE Certificates will be mailed upon passing course. • Evaluation must be completed to receive credit. Evaluation Did the article achieve the stated objective? Completely 5 4 3 2 1 Not at all Overall evaluation of the article? Excellent 5 4 3 2 1 Poor The information presented was relevant to your practice? Yes 5 4 3 2 1 No How many minutes did it take you to read course and complete exam?_____________________ Please attach any comments or suggestions. 32
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