Pharmacy Journal of New England, Fall 2013 by CT Pharmacists Association

Vol 10 No.4 Fall 2013

Fall 2013

Pharmacy Journal of New England Important Changes for Influenza Vaccination in 2013-2014 9th Annual New England Pharmacists Convention Financial Considerations Financial Forum

Workers Compensation Rx and the Law

GLP-1 Agonists Therapy, Safety & Tolerability Continuing Education

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Pharmacy Journal

Vol 10 • No. 4 Pharmacy Journal of New England • Fall 2013

of New England

Editors

Letter to our Readers It has been a year since the tragedy of New England Compounding Center resulted in 39 deaths and over 600 people sickened due to contaminated injections. In the last year, there have been many articles, accusations, grieving families, and commentary on the larger picture concerning the reputation of pharmacy. As we have repeatedly stated, the bottom line is that pharmacists must obey the laws and regulations, and meet the required standards for whatever practice of pharmacy in which they are involved. If this happens, then the public is protected and the pharmacist has a successful practice in serving their patients. We know that the vast majority of our pharmacist members do that every day, in every practice setting. So where do we go from here? In the last 12 months we have seen NECC file bankruptcy, lawsuits erupt blaming a variety of people ranging from former Governor Mitt Romney to the NECC’s cleaning company. A recent news story noted that NECC’s problems fall into the habitual offender category. They date as far back as 1999, the year after the company commenced operations, and that “the tragedy reflects blatant disregard for best practices—ones well within the NECC’s control—and a shocking, on-going failure to react to clear danger. It is a tragedy of failed organizational ethics.” In November, the United States Congress recently approved a bill that will put in place new federal standards for pharmaceutical compounders. The bill, which passed the Senate Monday on a voice vote and will be on its way to the President’s desk, is summarized here. It’s a compromise bill that makes it voluntary for pharmacies that compound drugs on a large scale to register as so-called outsourcing facilities. Those that do register, will be under greater government oversight and subject to more frequent federal inspections. Your state associations are actively involved with the development of legislation – advocating for language that makes sense as well as objecting to language that duplicates efforts or is not applicable to the important work that compounding pharmacists do every day. If you would like to participate in upcoming legislative discussions, please call your state association offices. Sincerely, Margherita R. Giuliano, RPh Executive Vice President Connecticut Pharmacists Association

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06 12 22 26 30 42

David Johnson Executive Vice President Massachusetts Pharmacists Association

David Johnson Margherita R. Giuliano, R.Ph., CAE

Managing Editor Ellen Zoppo

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U.S. News New England States 9th Annual New England Pharmacists Convention Important Changes for Influenza Vaccination in 2013-2014 Pharmacy Marketing Group: Rx and the Law, Financial Forum From the Colleges Continuing Education for Pharmacists 1

U.S. News Lawmakers urge greater oversight of compounding pharmacies Matthew Perrone The Associated Press

Congress has taken a half step toward increasing federal oversight of so-called compounding pharmacies that custom mix medications in bulk, a year after a meningitis outbreak from contaminated steroid pain injections killed at least 64 people and sickened hundreds more. The Senate approved the bill by voice vote, sending it to the White House, where President Barack Obama is expected to sign it into law. The legislation also creates a national system for tracking prescription drugs from manufacturers to retail pharmacies, first through serial numbers on bottles and later through electronic codes. The House passed it in September. More than 750 people were sickened by last year’s outbreak of deadly fungal meningitis and many continue to suffer debilitating pain and nerve damage. The sickness was eventually traced to a now-closed pharmacy in Framingham, Mass., the New England Compounding Center, where inspectors found mold, standing water and other unsterile conditions. The company shipped more than 17,600 doses of the implicated steroid injection to 23 states. Jurisdiction over such large-volume compounders has been murky. Pharmacies that fill individual prescriptions from a doctor or other health professional are typically regulated by state boards, but the Food and Drug Administration regulates manufacturers of medicines. The compromise bill gives the FDA authority to inspect and close down largevolume compounders, but it doesn’t require the pharmacies to register with the FDA, as manufacturers of prescription drugs must do. The bill attempts to sort out the legal gray area that allowed the Massachusetts pharmacy and similar businesses to skirt both state and federal regulations. The measure clarifies the FDA’s authority over high-volume compounding pharmacies that mass-produce medications, rather than fill doctors’ prescriptions. Under the bill, pharmacies can voluntarily register with the FDA and submit to federal quality standards and inspections. FDA officials previously said requiring compounding pharmacies to register with the agency was crucial to preventing future outbreaks. 2

The bill’s supporters acknowledge that a voluntary approach will succeed only if doctors and hospitals choose to do business with FDA-registered pharmacies. “Nobody will be required to register in this new category,” said Allan Coukell, drug safety expert with the Pew Charitable Trusts, which lobbied to pass the bill. “The success of the voluntary category will depend on hospitals, clinics and doctors choosing to buy from these FDA-registered facilities.” Safety advocates say the bill leaves the door open for more rogue pharmacies like the one that caused last year’s outbreak. “This voluntary approach will continue to expose patients to potentially unsafe, mass-produced compounded drugs that are not approved or evaluated by the FDA,” Rep. Rosa DeLauro, D-Conn., said after the House passed the bill. FDA officials told Congress last year that regulating businesses like the NECC has been a struggle because of a “patchwork” of conflicting court decisions over the federal agency’s authority to deal with pharmacies. Traditional compounding pharmacies, generally small operations that fill individual doctors’ prescriptions, will continue to be regulated by state pharmacy boards. Pharmacies that expand into shipping drugs without doctors’ prescriptions can voluntarily register with the FDA as “outsourcing facilities,” subject to quality standards and reporting requirements similar to manufacturers. The FDA will retain the power to shut down any outsourcing pharmacy, registered or not, that does not meet quality standards or engages in illegal compounding, such as mass-producing copies of manufactured drugs. Experts who helped craft the bill predict that nearly all large compounding pharmacies will register with the FDA as a cost of doing business. But critics question how the FDA will be able to identify businesses that aren’t following regulations. Even the compounding industry’s chief lobbying group said the bill will not stop pharmacies like the one that caused last year’s outbreak, and said it could lead to more confusion over pharmacy regulations.

Pharmacy Journal of New England • Fall 2013

“If the goal of this legislation is to prevent another NECC, which has been stated many times over, then the American public must know that this bill will not accomplish that goal. A voluntary category of outsourcing facilities is not the answer,” the International Academy of Compounding Pharmacists said in a statement.

“Our actions today reflect the most current scientific knowledge about the risks and benefits of this drug,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Given these new results, our level of concern is considerably reduced; thus, we are requiring the removal of certain prescribing restrictions.”

The voluntary approach to regulation was a compromise forged by Republicans and Democrats in the GOP-controlled House. Earlier versions of the bill drafted in the Democratic-controlled Senate would have made registration mandatory.

The FDA’s actions include requiring modifications to labeling about cardiovascular safety, requiring changes to the Risk Evaluation and Mitigation Strategy (REMS) program, and releasing a postmarket study requirement.

Despite criticisms of the approach, the bill has garnered broad support, in part because it was bundled together with separate legislation designed to track prescription drugs throughout the U.S. supply chain. The so-called track and trace system, long sought by doctors and patient groups, is designed to help authorities catch counterfeit or stolen drugs that increasingly have been making their way into the U.S. from overseas. Drugmakers will be required to add serial numbers to all drug packages within four years. After 10 years the industry must upgrade to electronic codes that can be used to track medicines from the factory to the pharmacy. Drug distributors, packagers and wholesalers will be required to verify the distribution history of the products they ship.

FDA Requires Removal of Certain Restrictions on the Diabetes Drug Avandia The U.S. Food and Drug Administration recently announced it is requiring the removal of certain restrictions on prescribing and use of the diabetes drug Avandia (rosiglitazone) to reflect new information regarding the cardiovascular risk of the medicine. Today’s actions are consistent with the recommendations of expert advisory committees. Results from the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) clinical trial showed no elevated risk of heart attack or death in patients being treated with Avandia when compared to standard-of-care diabetes drugs. These data do not confirm the signal of increased risk of heart attacks that was found in a meta-analysis of clinical trials first reported in 2007.

Once the changes are final, rosiglitazone’s indication for use will no longer be limited to certain patients. The FDA anticipates that the new indication will state that the drug may be used along with diet and exercise to improve control of blood sugar in patients with type 2 diabetes mellitus, an indication similar to other diabetes drugs currently available. Once the changes to the REMS are finalized, health care professionals, pharmacists, and patients will no longer be required to enroll in the rosiglitazone REMS program to prescribe, dispense, or receive rosiglitazone medicines. Patients will also be able to receive rosiglitazone through regular retail pharmacies and mail order pharmacies. The manufacturers of rosiglitazone drugs will be required to ensure that health care providers who are likely to prescribe rosiglitazone-containing medicines are provided training based on the current state of knowledge concerning the cardiovascular risk of these medicines. The FDA is also releasing GlaxoSmithKline (GSK) from the postmarket requirement to conduct a clinical trial, known as Thiazolidinedione Intervention with Vitamin D Evaluation (TIDE), comparing Avandia to Actos (pioglitazone), the only other approved drug in the thiazolidinedione class, and to standard diabetes drugs. The FDA has concluded that this trial is no longer necessary or feasible. In 2010, in response to data from a meta-analysis of placebo-controlled randomized trials that suggested an elevated risk of cardiovascular events in association with rosiglitazone use, the FDA announced it would restrict the drug to use in patients with type 2 diabetes who could not control their diabetes on other medications. The FDA also required GSK to convene an independent group of scientists to readjudicate key aspects of RECORD, which studied the cardiovascular safety of Avandia compared to standard diabetes drugs to provide clarity about the integrity of the study findings. 3

U.S. News

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On June 5 and 6, 2013, the readjudicated results of RECORD, which were consistent with the original findings of the trial, were discussed at a joint meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. Committee members generally agreed that the readjudication was well conducted and provided reassurance that the original study findings were accurate. A majority of the committee members voted to recommend that the REMS for rosiglitazone be eliminated or modified to lessen restrictions to use. In addition to Avandia, rosiglitazone is available in combination with other diabetes medications, including metformin under the brand name Avandamet and glimepiride under the brand name Avandaryl. For more information: • FDA Drug Safety Communication: FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes medicines • FDA: Rosiglitazone maleate (marketed as Avandia, Avandamet, and Avandaryl) Information The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

FDA Approves New Treatment for Hepatitis C Virus The U.S. Food and Drug Administration approved Olysio (simeprevir), a new therapy to treat chronic hepatitis C virus infection on November 27, 2013. Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with the hepatitis C virus have no symptoms of the disease until liver damage becomes apparent, which may take several years. Most of these people then go on to develop chronic hepatitis C. Some will also develop scarring and poor liver function (cirrhosis) over many years, which can lead to complica4

tions such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections or liver cancer. According to the Centers for Disease Control and Prevention, about 3.2 million Americans are infected with the hepatitis C virus. Olysio is a protease inhibitor that blocks a specific protein needed by the hepatitis C virus to replicate. It is to be used as a component of a combination antiviral treatment regimen. In clinical studies, Olysio was evaluated in combination with peginterferon-alfa and ribavirin, two drugs also used to treat hepatitis C virus infection. Olysio is intended for adults with compensated liver disease (a diseased liver that is still functioning), including cirrhosis, who have not received treatment for their infection (treatment naïve) or for whom previous treatment has not been effective (treatment experienced). “Olysio is the third FDA-approved protease inhibitor to treat chronic hepatitis C virus infection, and provides health professionals and patients with a new, effective treatment for this serious disease,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. In 2011, the FDA approved Victrelis (boceprevir) and Incivek (telaprevir) for the treatment of hepatitis C. Olysio was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that, if approved, would provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared to available therapies. The safety and effectiveness of Olysio were evaluated in five clinical studies of 2,026 treatment-naive and treatment-experienced participants randomly assigned to receive Olysio plus peginterferon-alfa and ribavirin or placebo plus peginterferon-alfa and ribavirin. The studies were designed to measure whether a participant’s hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment (sustained virologic response), suggesting a participant’s infection had been cured. Results showed 80 percent of treatment-naive participants given Olysio plus peginterferon-alfa and ribavirin achieved sustained virologic response, compared to 50 percent of participants receiving peginterferon-alfa and ribavirin alone. In one of the studies with treatment-experienced

Pharmacy Journal of New England • Fall 2013

participants whose infection returned (prior relapsers), 79 percent receiving Olysio plus peginterferon-alfa and ribavirin achieved sustained virologic response compared to 37 percent of participants receiving peginterferon-alfa and ribavirin alone. Another study examined Olysio’s safety and effectiveness in treatment-experienced participants, including prior relapsers, those who partially responded to prior therapy (partial responders) and those who did not respond to prior therapy (null responders). Adding Olysio improved response rates in each of these subgroups compared to peginterferon-alfa and ribavirin alone. A reduction in Olysio’s effectiveness was observed in participants infected with the genotype 1a hepatitis C virus with an NS3 Q80K polymorphism, a strain of the hepatitis C virus commonly found in the United States. Olysio’s drug label includes a recommendation to screen for the presence of the strain prior to beginning therapy and to consider alternative therapy if the strain is detected. The most common side effects reported in clinical study participants treated with Olysio in combination with peginterferon-alfa and ribavirin were rash (including photosensitivity), itching (pruritis) and nausea. Serious photosensitivity reactions resulting in hospitalization were reported. Patients will be advised to limit sun exposure and to use sun protective measures during treatment with Olysio in combination with peginterferon alfa and ribavirin. Olysio should not be used alone to treat chronic hepatitis C infection. Olysio is marketed by Janssen Pharmaceuticals, based in Raritan, N.J. Victrelis is marketed by Whitehouse Station, N.J.-based Merck, and Incivek is marketed by Cambridge, Mass.-based Vertex Pharmaceuticals.

Call To Action: NCPDP Task Groups Need You The National Council for Prescription Drug Programs (NCPDP) task groups are seeking volunteers to participate. Task group participation is open to NCPDP members and non-members alike. This is your opportunity to have a meaningful voice in the important process of transforming healthcare. Task groups meet via conference calls.

Highlighted below are some of the newer task groups or areas needing expertise. Share this list with your colleagues outside of NCPDP and encourage them to consider joining a task group that will provide value to their organizations. If you are a participant in the NCPDP Collaborative Workspace already, to join a task group, just check the task group on your NCPDP Collaborative Workspace profile. If you have not yet joined the NCPDP Collaborative Workspace, please staff below for instructions.

New Task Groups: • The WG2 Application of BUS Clarification Task Group will identify the rationale used to determine the billing unit from past QUIC forms/products reviewed and the causes that lead to product reviews to capture/document the rationale and the process followed. Contact Patsy McElroy at pmcelroy@ncpdp.org to join. • The WG2 UDI Definition Task Group will define the UDI as it applies to all applicable NCPDP standards and review the definitions of existing product identifiers used in the NCPDP standards for accuracy. Contact Patsy McElroy at pmcelroy@ncpdp.org to join. • The WG7 Formulary Management Survey Task Group will develop and conduct a survey to understand the current scope, process and challenges for both the manufacturers and payer/processors in formulary management and validation. Contact Kittye Krempin at kkrempin@ncpdp.org to join. • The WG11 Specialty Requirements for ePrescribing Task Group was formed to collaborate with WG10 Specialty and Compounding Pharmacy Services Task Group (see below). In the specialty pharmacy realm, there is often additional information needed before a prescription can be dispensed. This information is provided by the prescriber (or someone in the prescriber’s office). This information includes additional patient demographic and clinical information, order-specific clinical information and instructions related to delivery of the medication (i.e. to the patient or the clinic, nursing services required). This information would be added to the appropriate SCRIPT Standard and/or Specialized Standard transactions, depending on analysis. Calls have been scheduled on the NCPDP Events Calendar or in the Conference Call Information document found on the task group on the NCPDP Collaborative. continued on page 23

New England States Connecticut

President’s Message 2013 CPA Presidential Inaugural Address: Building Bridges I would like to thank all of you for giving me this amazing opportunity to serve as the Connecticut Pharmacists Association President. Pharmacy has given me so much: a rewarding and challenging profession, a network of talented and dedicated peers both locally, nationally and internationally and the opportunity to serve my community and Phil Hritcko, President patients. Thank you also to my family and my fellow board members, colleagues, some of whom are here this evening: my wife Lorraine, who has encouraged me throughout our time together to keep focused and challenged me to strive to meet my full potential. My brother, Father David, who has known me since day one and has seen me grow and develop throughout my life. I greatly appreciate that both of you are here today to share this moment with me. Unfortunately, both my parents are not with us anymore and recently my Dad of 91 YO passed away earlier this year. As we all know we stand on the shoulders of others to get where we are today and my parents were also a big part of my success. Thank you to my family, friends and colleagues, who while not here today are all with me every day, and their support means the world to me. Importantly, thank you to our predecessors. My career and profession are better for all their efforts. We can only hope to emulate the examples and successes you have achieved. To my immediate predecessor, Lucrezia Finegan – you have provided great leadership and energy to our profession and association during your tenure. I would also like to recognize Lucrezia for obtaining her MBA this year and the accomplishment this is given her service and work commitments. I would like to acknowledge the Association leadership and staff (Marghie & Ellen) and our CPA board members who are present here today. I look forward to working with all of you this coming year. This is an exceptional team of very talented advocates for our profession and for our State’s citizens. 6

History of Pharmacy Our roots as a profession go back over 3,000 years. You may not know this but the etymology or history of the word “pharmacy” dates back to the ancient Greek word “pharmakeia,” the occupation of sorcerers who dispense potions and poisons. They also presided over ritualistic human sacrifices “back in the day.” We have definitely come a long way since our earlier years as a profession. We are very fortunate that our predecessors were savvy enough to realize that change is an integral part of the engine that moves our profession forward into the future. In Connecticut it all started 137 years ago when in 1876 when pharmacists John K. Williams and Alfred Daggett returned home from the 23rd annual APhA meeting in Boston. They decided it would be a great idea to start a pharmacy association on the state level. They sent an invitation to 25 pharmacists in larger cities across Connecticut and met in New Haven on February 9, 1876. The newly formed Connecticut Pharmaceutical Association drafted a constitution and by-laws with the following objective: “..to secure cooperation and concert of action in the advancement and diffusion of a knowledge of Pharmacy and its collateral branches of science, and to promote the elevation of professional character of , and facilitate and open and fraternal intercourse between, its members” One of the monumental accomplishments of the CPA in its infancy was the passing of the Pharmacy Act in 1881 through the Connecticut State Legislation. This act created the Commission of Pharmacy, which would oversee the licensing of individuals and growth of the profession and does so even today. The profession of pharmacy is every-changing, and the Connecticut Pharmacists Association has always been there leading the change.

Trip to Poland Recently this past June my wife Lorraine and I went to Poland to attend a wedding and to take some vacation time and tour Poland. We visited three main cities in Poland (Warsaw, Poznan & Krakow) during our trip and had a wonderful time. I must admit a polish wedding in Poland is something that I would highly recommend, but you have to have stamina.

Pharmacy Journal of New England • Fall 2013

During our visit to Krakow we took a tour of this beautiful city that is considered the jewel of Eastern Europe. I must admit it is a breath taking city with a rich history and I would recommend everyone if they have a chance to visit this city. Since we were in this historical city we took a number of tours just to get a sense of the history and beauty of this magical place. During one of the tours we came across a pharmacy “Pod Orlem” Pharmacy @ No. 18 Zgoda Square. This pharmacy was located during WWII in the Jewish Ghetto of Krakow and was the only pharmacy allowed in this area. The owner was Tadeusz Pankiewicz a Polish Roman Catholic pharmacist who refused to leave this Jewish Ghetto. Under the German Nazi occupation of Poland during WWII, within the Krakow Ghetto there were four prewar pharmacies owned by non-Jews. Tadeusz Pankiewicz was the only owner to decline the German offer to relocate to the Aryan side of the city. He was given permission to continue operating his pharmacy as the only pharmacy in the Ghetto, and he resided on the premises. The often-scarce medications and pharmaceutical products supplied to the Ghetto’s residents, often free of charge, substantially improved their quality of life. In effect, apart from health care considerations, they contributed to survival itself. In his published testimonies, Pankiewicz makes reference to hair dyes being used by those disguising their identities and tranquilizers given to frightened children required to keep silent during Gestapo raids. The pharmacy became a meeting place for the Ghetto’s intelligentsia and a hub of underground activity. Pankiewicz and his staff risked their lives to undertake numerous clandestine operations: smuggling food and information, and offering shelter on the premises for Jews facing deportation to the camps. On February 10, 1983, Tadeusz Pankiewicz was awarded recognition as a “Righteous Among the Nations” for his wartime activities in rescuing Jews. In April of that same year he was present at the inauguration of the national heritage museum housed in the Pod Orlem Building. The pharmacy was featured in the Academy Award-winning film, Schindler’s List. The film’s director Steven Spielberg donated $40,000 for the building’s preservation, for which he was honored by the city of Krakow with its prestigious “Patron of Culture” award for the year 2004.

Phase Change As I transition from the history of the profession of pharmacy and CPA I would now like to next focus on the future of both our profession and this Association. I must admit that while we have many challenges ahead I am extremely optimistic about our future. I have read in this year’s Argus report from AACP that we are in the mists of a “phase change” as a profession. According to Robertson and others, “a phase change occurs when there is a sudden and significant change in something that is not predictable or linear in nature.” Perhaps things have been moving slowly toward the change for quite some time, but then suddenly the change occurs. Are we positioned for a phase change in medication use in our reforming healthcare system (Accountability Care Act)? I truly hope so BUT are we really ready for a phase change? Do we at this point have pharmacists in sufficient numbers to fully engage in direct patient care?...and if these pharmacists are challenged to redirect their talents from a primary focus on drug distribution to spend the majority of their time examining and intervening on patients’ drug related problems, are the majority of pharmacists in our state ready? This begs the question that we need to redouble CPA’s commitment to the partnerships that we already have with our two schools of pharmacy and the state board of pharmacy to help move the profession of pharmacy forward through this anticipated “phase change.” These relationships must be based upon a premise of trust and openness with the collective vision to advance pharmacy practice and ensure the pharmacist’s role in efforts to improve patient care. Our individual organization success will not occur without supporting and valuing those of the other two groups and playing a role in advancing their successes. In the words of Helen Keller, “Alone we can do so little; together we can do so much.” There is a perception by some is that the profession of pharmacy is too small and has no power to affect change. The reality is that everyone can do something and that collectively it can make a difference as embodied by a quote attributed to Margaret Mead “Never doubt that a small group of thoughtful, committed citizens can change the world. Indeed, it is the only thing that ever has.” Deans, faculty, pharmacists (community, hospital, etc.), staff and students need to have this same can-do attitude with respect to health care reform initiatives. So, when

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it comes to state health care policy development, pharmacy needs to work small but think BIG. Thinking BIG means including key pharmacy stakeholders such as our schools of pharmacy, boards of pharmacy, CPA and other professional societies early in the policy development process. Consensus and support within the pharmacy profession in our state will increase the likelihood of support by other key stakeholders and decision makers. So as I near the conclusion of my speech I would like to concentrate on three main goals that I would like to focus on during my tenure as President of CPA. 1. Interprofessional – I would like to reach out to other health care profession associations within our state to work collaboratively on legislation, projects and CE activities to help further our understanding of each other. 2. Outreach – I would like to expand our outreach activities as an association together with our partners to further our commitment to our communities. a. Reaching out to our Student Pharmacists at both Connecticut Schools of Pharmacy to better understand our rich history and to get more involved with our association. 3. Building Bridges – I would like to develop and/or strengthen those relationships that we have with our schools of pharmacy, board of pharmacy and state professional pharmacy societies to further our commitment to the future of pharmacy in our state. a. I would like to take this opportunity in this public forum from my bully pulpit as President of CPA to ask our two respective Dean’s (Dean Joseph Ofosu of USJ & Interim Dean John Morris of UConn) who just happen to be here this evening to make a renewed commitment to work collaboratively together in conjunction with CPA AND to encourage your faculty to join and become active members of our state association. CPA’s leadership is committed towards ensuring that the citizens of Connecticut have access to pharmacist delivered patient care services. CPA is focused on facilitating our profession’s unified voice with other pharmacy stakeholders as partners. We are also working with our colleagues in medicine, payer, and consumer communities to help them better understand and recognize the value pharmacists contribute to meeting quality, cost and outcomes goals.

As I begin my Presidential year with the Connecticut Pharmacists Association, I feel very good about our future and the collaborations that we can build together. The year ahead will not be dull by any means but fun, challenging and rewarding. Thank you for giving me this opportunity to serve you and I will commit to doing my best for all of you, the profession of pharmacy and our state association. Philip M. Hritcko, RPh., Pharm.D., CACP President, Connecticut Pharmacists Association

CPA Schedules Their Mid-Winter Conference Pharmacists from across New England will gather on Thursday, February 6th 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 2014 conference will include the traditional “New Drugs of 2013” morning session, presented by Dr. Dan Hussar of the Philadelphia College of Pharmacy. Other topics to be covered include Multiple Sclerosis, Diabetes as it relates to obesity, Cardiovascular Issues, Pharmacy Inspections and more. This year, the CPA will again be incorporating a passport for those in attendance to use while visiting the Exhibit booths. Those with stamps from the majority of the booths will be entered into a contest to win a new iPad Mini. 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 Philip Hritcko, President of the CPA. “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.” For more information or to register for this ACPE accredited conference, please visit the CPA website at www.ctpharmacists.org.

Pharmacy Journal of New England • Fall 2013

Massachusetts President’s Message Dear Colleagues, I am honored to have the opportunity to serve as the President of the Massachusetts Pharmacists Association. When I joined the Board as the Academy Governor of Managed Care, I viewed it as an opportunity to become active in the state pharmacy associa- Jim Gagnon, President tion. My initial Board meetings were spent observing, listening, occasionally contributing to discussion, but mostly learning. Over time I became familiar with the workings of the Association, its strengths, and areas of improvement. I realized the importance of advocacy on behalf of our members and the profession of pharmacy and I understood the importance of communication not only with our membership but also amongst the Board. These concepts were key components of the Association’s 3 year strategic plan which was developed in 2012 under then President Barbara Perry. Barbara believed it was important for the Association to revisit and update the strategic plan as it would keep the Association focused on the key challenges ahead and strengthen our resolve to lead change in our profession in the right direction. During the strategic planning process core values of the Association were identified. These core values guided the hard work of my predecessor, Tim Hudd. Under his leadership we improved communication with our membership; we identified opportunities and professional value to our membership; we promoted solidarity and collaboration among pharmacy associations in the Commonwealth; and we demonstrated the importance of our legislative advocacy. The events surrounding the New England Compounding Center are tragic. Through the efforts of the Association and our sister organizations, Massachusetts Independent Pharmacists Association (MIPA) and Massachusetts Society of Health-System Pharmacists (MSHP), the legislature has crafted a bill that moving forward, will protect the public and the profession. Unfortunately, this tragedy has reflected negatively on the public’s perception of the

pharmacy profession. Over the next year we will continue to educate the public and legislatures on the profession in order to regain their confidence. However, we will also return focus to the goals set during the development of the strategic plan. Legislatively, we will advocate for pharmacists to be recognized as health care providers. We will also continue to push for the ability of pharmacy interns to vaccinate under the supervision of a pharmacist that is certified to vaccinate. We will continue to develop and offer activities designed to engage our members and elevate the profession and we will continue to identify ways to improve communication with the membership as well as within the Board. Over the next year we will also improve our organizational strength by increasing membership and ensuring that our resources are aligned with the Association’s goals and actions. All of the activities and initiatives I just described would not be possible without the dedication of our hardworking Board members, as well as many committed members and individuals from our profession. I am excited about leading the Association and look forward to working collaboratively with all of you. I would like to thank Tim Hudd for his commitment, dedication, vision and leadership during the past year, David Johnson for his tireless efforts, and for all the MPhA Board members, Academy members, and Committee members for their dedication to the profession of pharmacy.

New Hampshire New Hampshire’s Prescription Drug Monitoring Program (PMP) One Step Closer to Reality By: Michael P.Viggiano, RPh, BS, MBA

New Hampshire’s Prescription Drug Monitoring Program (PDMP) that was signed into law last year as SB286, is well on its way to becoming a reality. Although the Board of Pharmacy will oversee the PDMP, it is the PDMP Advisory Council that has the responsibility of developing and implementing the program. The 15-member Advisory Council consists of professionals from their respective fields of medicine, dentistry, nursing, veterinary medicine, pharmacy, and chiefs of police. The Council also has members from the Board of Pharmacy, Dept. of Health & Human

New England States

continued

Services, the Attorney General’s Office, and two members from the Commission on Alcohol and Drug Abuse. The Advisory Council has four sub-committees: • Rules • Finance • Evaluation • Implementation/Operation These four committees have completed interviewing potential vendors who could be awarded the contract (RFP) to operate the program. They have also written the rules that we, as pharmacists, will need to work the program. Finance is charged with researching grant options to fund the program, developing tools to make the program sustainable and, true to its mission, while exploring its fiscal impact. The State of New Hampshire anticipates grant money to be awarded to fund the program by mid-September.

1. Meaghan H. Paris, Derry, NH. Enrolled at the Western New England University College of Pharmacy and entering the fourth year of the professional (PharmD) program (P4 of P6.) Award: $1,000.

The Advisory Council is working closely with the New Hampshire Department of Information Technology (DoIT) to ensure that the PMP and its databases have the proper vendor interfaces with pharmacies, hospitals, physicians, and other hardware requirements used to ensure a smooth and transparent transition.

The path that lead Meaghan to choose pharmacy as a career is an interesting one. It was in Namibia, Africa, that she was inspired. In March of 2010, she embarked on a two month adventure that could change her view of the world. While in Namibia she completed a project with the Namibia Business Coalition on AIDS (NABCOA), creating a model for a low cost health insurance plan through a public private partnership. She conducted interviews with various non-governmental organizations and explored the existing HIV/AIDS testing and counseling units to create a detailed insurance model to be implemented in the community.

By early September, the RFP will be completed and sent to prospective vendors. The rules and fiscal impact statements will be submitted to the appropriate legislative groups for approval before it is sent to JLCAR (Joint Legislative Committee on Administrative Rules). JLCAR will require that the rules the Advisory Council has developed are compatible with the law as it was explicitly written.

While in Africa Meghan contracted a virus from the water. The locals told her to see the pharmacists. She went right away thinking it would be no use. She told the pharmacist her symptoms and she knew what was wrong. She was able to prescribe the medication she needed and dispensed it right away. This is when Meaghan decided this is what she wanted to do.

At the outset, it was understood that a project of this magnitude has many intricate moving parts, calling on many busy professionals who volunteer their time and effort to work towards a common goal. Therefore, delays and setbacks could be anticipated, almost expected. Fortunately, the timeline remains on course with an anticipated vendor start date sometime in December. Remember, the law states that pharmacists (dispensers) shall register with the program. Using it will guarantee its success.

2. Morgan T. Ratte, Hudson, NH.

Scholarship Highlights Members of the NHPA Scholarship Committee met on Wednesday, August 7, 2013 at the Massachusetts College of Pharmacy and Health Sciences located at 1260 Elm Street in Manchester, NH for purposes of conducting interviews with applicants seeking scholarship awards for the 2013-2014 term. 10

Committee members in attendance: Donald Messina, Chairperson; Cheryl Abel; Paul Boisseau; Joe Clement and Lorraine Radick. A total of 6 candidates were interviewed and 3 scholarships were awarded as follows:

Enrolled at the University of Rhode Island College of Pharmacy and entering the fourth year of the professional (PharmD) program (P4 of P6.) Award: $1,000. This past January, Morgan traveled to Jamaica as part of a Mustard Seed mission trip to provide health care to children in local orphanages. This was a major undertaking with other student leaders from the pharmacy program and they worked very hard at fundraising throughout the year. The trip was so successful that they are planning on returning in 2014 and Morgan is the student who will be organizing it. Morgan is continuously in giving back to the community both at URI and in her home town.

Pharmacy Journal of New England • Fall 2013

3. Brett J. Murphy, Nashua, NH. Enrolled at the Albany College of Pharmacy and Health Sciences and entering the fifth year of the professional (PharmD) program (P5 of P6.) – Award: $1,000. Brett has participated in many professional projects and community service events including Relay for Life and Adopt-ahighway. This year the opportunity arouse for him to travel Ghana, Africa to participate in a medical mission. He took this opportunity to help others who were less fortunate. Brett has served in many leadership positions for Phi Delta Chi (President, Vice President and Professional Committee Chairman just to name a few. Congratulations to our 2013 scholarship recipients! Effective March 19, 2013, all contributions made to the NH Pharmacists Association Scholarship Fund are now tax deductible. Please help NH pharmacy students achieve their goals. Mail your contributions today to:

Rhode Island President’s Message

I am extremely excited to be assuming the role of President of the Rhode Island Pharmacist’s Association. I strongly admire all of the Presidents who have gone before me and I hope to continue to lead and encourage the growth of our organization, just as they have. Thank you, on behalf of RIPA, to former President Daniel Lefkowitz Kylie Aubin, PharmD for his continuous enthusiasm and excitement in that role. Dan exemplifies what it means to be involved, and he inspires other pharmacists to broaden their horizons and to grow as professionals. He’s also a great friend, and the main reason that I am involved with RIPA.

NHPA Scholarship Foundation PMB # 418 379 Amherst Street Nashua, New Hampshire 03063 Payee NH Pharmacists Association Scholarship Foundation. Visit our website at www.nhpharmacists.com for more details.

American Pharmacists Month On October 16, 2013, the New Hampshire Pharmacists Association in conjunction with AARP held a joint health fair at the Centennial Senior Center in Concord, NH. This is our first year the association is sponsoring a health fair for seniors to educate the public on the expanding scope of pharmacy practice. The event will have brown bag medication reviews, mini health classes such as Joint Health, Ageless Grace®, Mindful Yoga, Meditation and Tai Chi. In addition, flu shots, blood pressure and blood sugar screenings were be offered and much more.

As we move forward into a new RIPA year, there are many things to be excited about. We will continue to encourage medication compliance by working with the Script Your Future Campaign. We will continue to work with the other state associations to broaden the role of pharmacists as healthcare providers. We also hope to make it possible for our pharmacists to obtain CLIA waivers and assist customers in using at-home testing systems. We will continue to push for increased reimbursement for pharmacy services, and we will continue to get out into the community to promote the services we provide. We are looking forward to continuing out partnerships with our friends at the Department of Health, the University of Rhode Island, Rhode Island Society of Health System Pharmacists, among others. While RIPA is a strong organization, our allies make us that much stronger. We will work extremely hard to increase our membership numbers, including pharmacists, technicians, and students. Our members and our council make us what we are, and so we will build membership in order to continue RIPA’s growth and success. It is an absolute honor to become President of this great organization. I look forward to working with the council in filling the shoes of the leaders before me. I am excited to continue, and augment, the progress RIPA has experienced in promoting the profession of pharmacy and increasing the support our colleagues receive. Thank you, Kylie Aubin, PharmD President 2013-2014

9th Annual New England Pharmacists Convention 4Charlie Caley receives his Pharmacy Upsher-Smith Excellen in Innovation Award from CPA Executive Vice President Marghie Giuliano

4Gregory L. Hancock is the 2013 Bowl of Hygeia recipient for the State of Connecticut

6Rebecca Curtin Neville receives the Professional Pharmacy Performance Award from colleague Meghan Wilkosz

5 John Dobbins (l) receives the 2013 Cardinal Generation Rx Champion award from Cardinal representative Paul Plourd 4Participants at the Diabetes Certification training get â&#x20AC;&#x153;hands-onâ&#x20AC;? experience

Pharmacy Journal of New England â&#x20AC;˘ Fall 2013

September 19th & 20th MGM Grand at Foxwoods in Mashantucket, CT

5Barbara Tyczkowski, incoming CPA President Phil Hritcko, his wife Lorraine, and his brother, the Very Reverend David Hritcko enjoy the Networking Reception before the Annual Awards and Installation Dinner

6CPA Board member Bahar Matusik, her husband Steve, and Marghie Giuliano chat at the Reception

5CPA Board Members Jacqui Murphy (l) and Jean Keating (r) enjoy the Silent Auction at the Networking reception

3Daniel Leone, Mary Ann Leone, and Robert Tendler enjoy appetizers at the Networking Reception

6Kinray was a Silver Sponsor of the Convention and exhibited on Friday

9th Annual New England Pharmacists Convention 3An overview of the MGM Grand Ballroom lobby where the convention was held

4CPA President Phil Hritcko is administered the oath of office by friend and UConn colleague Peter Tyczkowski

6Jill St. Germain of Arrow Pharmacy in Hartford receives her Distinguished Young Pharmacist award from Al Martinelli of Pharmacists Mutual

3McKesson was a Platinum sponsor of the event for the second straight year

6Meghan Wilkosz, Alex Dunleavy and CPA Incoming President Karen Hoang enjoy the Networking Reception

3Connecticut Pharmacists Foundation President Cynthia E. Huge presents one of the 5 foundation scholarships distributed to the banquet to Sabrina Caico from the University of Saint Joseph

Pharmacy Journal of New England â&#x20AC;˘ Fall 2013

4UConn Interim Dean John Morris and University of Saint Joseph Dean Joseph Ofosu at the CPA Business Meeting

4Smiles all around for the pharmacists watching the Silent Auction item winners being announced

6Emmett Sullivan, past President of the CPA, shares lunch with Barbara Perry, a past President from MPhA and Lucrezia Finegan (l), who concluded her term as CPA president at the Convention

6CPA Member Jim Cangelosi and Noreen Todd from the University of Saint Joseph School of Pharmacy chat at the Reception

3MPhA Board Chairman Tim Hudd presents Tanya Iliadis with the Distinguished Young Pharmacist Award

4James Gagnon takes the reigns as President of MPhA

9th Annual New England Pharmacists Convention

4Joseph Calomo is the MPhA Presidentâ&#x20AC;&#x2122;s Pharmacist of the Year

5 Alicia Mam deCunha presents Wendy Fetterolf of Novo Nordisk with the MPhA Industry Award

3Nathan Goldberg Award Recipient Kathy McTernan with Joanne Doyle Petrongolo

5 Jeff Sinn of Cardinal Health and Thomas Pasternak the Massachusetts Generation Rx Champion Award recipient

4Evan Robinson with Massachusetts Bowl of Hygeia recipient John R. Reynolds

4Sue Holden with Allison Paquin, MA recipient of the Upsher-Smith Excellence in Innovations Award

Pharmacy Journal of New England â&#x20AC;˘ Fall 2013

2nd Annual New England Pharmacists Convention Poster Competition â&#x20AC;&#x153;The Peopleâ&#x20AC;&#x2122;s Choice Awardsâ&#x20AC;?

Abstract

Posters were judged by attendees equipped with a grading rubric, and winners were selected in two categories.

Purpose: The objective of this study was to measure the impact and effectiveness of a student led interactive educational session on clinician knowledge of inhaler devices for COPD.

Category 1: Successful Integration of Pharmacy Students in a Practice Setting First Place: Evaluating the impact of an interprofessional educational session led by PharmD students on nursesâ&#x20AC;&#x2122; perceived knowledge of inhaler devices for chronic obstructive pulmonary disease. Timothy R Hudd, BS, PharmD., AE-C; Kathryn Conti, PharmD Candidate 2014; Sokankelly Lim, PharmD Candidate 2014; Stella Shnayderman, PharmD Candidate 2014; Enrique Seoane-Vazquez, PhD., MCPHS University

Methods: A five item pre / post questionnaire using a 5 point Likert scale was prepared and validated using expert opinion. Questions assessed each participantâ&#x20AC;&#x2122;s level of confidence with using a metered dose inhaler (MDI) and various dry powdered inhalers (DPIs). Participants rated their level of confidence when educating patients on important aspects of therapy such as appropriate technique, associated adverse effects, and differences between MDIs and DPIs. Additionally, participants were asked to rate the perceived benefit from the session. Pre and post differences were assessed using paired t-test (statistical significance =0.05).

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First Place: Role of a Clinical Pharmacy Specialist (CPS) at Veterans Affairs Boston Healthcare System (VABHS) in an Oral Chemotherapy Pharmacy Clinic (OCPC).

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First Place: Evaluating the impact of an interprofessional educational session led by PharmD students on nursesâ&#x20AC;&#x2122; perceived knowledge of inhaler devices for chronic obstructive pulmonary disease.

Results: Seven nurse clinicians with an average of 10.7 years (SD Âą9.9 years) of practice experience participated. Improvement was reported in each area of assessment: differences between (MDIs) and (DPIs) [pre 2.86Âą1.21 vs. post 5.00Âą0.00 (p= 0.002)]; proper inhalation technique MDI [pre 4.00 Âą 1.15 vs. post 5.00 Âą0.00 (p= 0.031)]; proper inhalation technique - DPI [pre 3.43 Âą1.13 vs post 5.00 Âą0.00 (p= 0.005)]; and on possible adverse effects of treatment [pre 3.14 Âą0.90 vs post 4.43 Âą0.53 (p= 0.002 )]. All nurses considered educational presentations provided by pharmacy students to be beneficial (pre and post = 5.00 Âą0.00]. Conclusion: Post-survey responses suggest clinicians were more confident in their knowledge of inhaler devices and in their ability to educate patients on appropriate technique following an educational session led by PY3 Pharm.D. students.

Category 2: Innovation in Pharmacy Practice First Place: Role of a Clinical Pharmacy Specialist (CPS) at Veterans Affairs Boston Healthcare System (VABHS) in an Oral Chemotherapy Pharmacy Clinic (OCPC)

Jameson B. Wood, PharmD; Chung Hyangsook, RPh; Rita El Hachem, PharmD; Nikhil J. Bilkha, PharmD; Kelly Tammaro, PharmD, BCOP.

Abstract There are at least 33 oral chemotherapy medications in use and counting, with numerous agents currently pending FDA approval. As these medications are taken in an outpatient setting, a perceived misconception is that they require less therapeutic monitoring, when in fact, these medications can potentially be more dangerous. With our current average monthly cost estimated at $2,500 to $7,000, the financial impact of oral oncology medications is an impeding concern for the VABHS pharmacy department. At VABHS, we have a team composed of four part-time hematology/oncology CPS staffing a formal OCPC managing both the cost and outcomes of therapy with these agents. All oral oncology medications require pharmacy intervention prior to initiation. A patient is initially seen by a hematology/ oncology CPS to teach proper administration, storage, and management of side effects. Oral oncology medications are generally restricted to a maximum 30-

Pharmacy Journal of New England • Fall 2013

day supply and are solely dispensed by the OCPC team. Patients are either seen in clinic or followed up via telephone by appointment, and laboratory results are monitored according to treatment guidelines. Updated progress notes and routine laboratory assessments must be provided by outside physicians in order to continue medication therapy through the VABHS OCPC. Benefits from this clinic model include effective resource management and increased patient safety, as we continue our goal of providing the highest level of patient care to enhance the experience, health, and wellbeing of our veterans. This model can provide insight and guidance on establishing an OCPC at other medical centers.

Supporting References: 1. American Society of Clinical Oncology. Clinical pharmacists in oncology practice. J Oncol Practice. 4(4);172-4;2008. 2. Parker P, et al. The expanding role of the oncology pharmacist. Oncol Issues. 17(6):34-6;2002. 3. News Report. Oncology practices recruit pharmacists for efficiency, savings. Am J Health Syst Pharm. 63:1774-5;2006. 4. Ruder AD, et al. Is there a benefit to having a clinical oncology pharmacist on staff at a community oncology clinic? J Clin Oncol. 2007 ASCO Annual Meeting Proceedings (Post-Meeting Edition). 25(18S);19570.

Category 1: Successful Integration of Pharmacy Students in a Practice Setting Submissions:

Utilization of Electronic Communication to Facilitate Pharmacy Students’ Learning during Medical Work Rounds Katelyn Parsons, PharmD1; Adam B. Woolley, PharmD, BCPS2 1Department of Pharmacy Practice, Western New England University; 2 Department of Pharmacy Practice, Northeastern University A new look at remediation for P2 and P3 year pharmacy students for a core comprehensive disease management course J. Andrew Skirvin, Pharm.D., BCOP; Jenny A. Van Amburgh, PharmD, FAPhA, BCACP; Mark Watanabe, Pharm.D., BCPP; Michael Gonyeau, Pharm.D., BCPS. Northeastern University, Bouve College of Health Sciences School of Pharmacy.

Integration of pharmacy students in an acupuncture clinic Chris Campbell, Pharmacy Student, Michelle Jacobs, PharmD, CDE, Mark Drews, MD, Christopher Lehmann, Lic Ac, MAOM, School of Pharmacy, Bouvé College of Health Sciences, Northeastern University Million Hearts/ Team Up Pressure Down Pioneer Challenge: An Educational Institution Partnering with Community Pharmacies Melissa Mattison, PharmD, Courtney Doyle-Campbell, PharmD, Beth Welch, PharmD, Western New England University, College of Pharmacy Evaluating the Perceived Value of PharmD candidates in delivery of Medication Therapy Management (MTM) Amee D. Mistry, PharmD Associate Professor of Pharmacy Practice, Matthew R. Machado, PharmD Associate Professor of Pharmacy Practice, MCPHS University

Category 2: Innovation in Pharmacy Practice Submissions:

Availability of Medication Guides in Various Languages among FDA Approved REMS Programs Dalar Nazarian, PharmD Candidate, Kristina Bundra, PharmD Candidate, and Christy Harris PharmD, BCPS, BCOP, MCPHS University - Boston Implementation of Pharmacist Review of Radiology Orders for Contrast Media and Nuclear Agents Gillian Kuszewski, PharmD, BCPS,Yale-New Haven Hospital- Saint Raphael Campus, New Haven, CT A Consumer-Led Intervention to Improve Pharmacists’ Attitudes Toward Mental Illness: A Pilot Study Alison DaCosta, Pharm.D. Candidate, 2014; Nathaniel M. Rickles, Pharm.D., Ph.D., BCPP, Northeastern University New England Institute of Ambulatory Care Pharmacists (NEIAP): First Annual Spring Forum Tanya Iliadis, Pharm.D., AE-C, Pamela Sherry, Pharm.D., Jennifer Allen, Pharm.D., Bethany Lessard, Pharm.D., BCPS, Laura Carr, Pharm.D., Kathy Zaiken, Pharm.D. Impact of Pharmacist Run Hypertension Clinic- First 3 Months Courtney Doyle-Campbell, PharmD, Western New England University Analysis of clinical pharmacist impact on low density lipoprotein cholesterol values in patients with cardiovascular disease through a live, primary care-based intervention program Ricky Thumar, Pharm.D., Kathy Zaiken, Pharm.D., MCPHS University 19

9th Annual New England Pharmacists Convention Feasibility of Implementing Group Visits for Patients with Diabetes at a FQHC Look-Alike Jennifer Crowley, PSIV1; Olayinka Edwards MSII2; Amy Eklund, DSII3, Jennifer Granger MBA, MPH4; Devra K. Dang PharmD, BCPS, CDE1 University of Connecticut School of Pharmacy, Storrs, CT1; University of Connecticut School of Medicine, Farmington, CT2; University of Connecticut School of Dental Medicine, Farmington, CT3; United Community and Family Services, Norwich, CT4 Comparison of perceived importance of travel medicine and immunization certification coursework in the first and last professional years of a Doctor of Pharmacy Program. Sheila Seed, PharmD, MPH; Linda Spooner, PharmD, BCPS; Cheryl Abel, PharmD; Kaelen Dunican, PharmD; Ann Lynch, PharmD, Lola Adebukunola Adenuga, PharmD, MCPHS University-Worcester/Manchester Pharmacist Initiation of Post-Exposure Doxycycline for Lyme Prophylaxis Anita N. Jackson, Pharm.D., K. Kelly Orr, Pharm.D.. Jeffrey Bratberg, Pharm.D., University of Rhode Island College of Pharmacy Implementation of an opioid safety review council at an urban community health center Gina Lento, PharmD Student, Samantha Mok, PharmD Student, Michelle Jacobs, PharmD, CDE School of Pharmacy, Bouvé College of Health Sciences, Northeastern University, Boston, MA Whittier Street Health Center, Roxbury, MA

Utilization of a Clinical Psychiatric Pharmacist in a Community Primary Care Clinic: Another Method for Primary Psychiatry Richard J. Silvia, Pharm.D., BCPP, Associate Professor of Pharmacy Practice, MCPHS University, School of Pharmacy- Boston Assessment of Pharmacy Manpower and Services in New England Natalia Shcherbakova, PhD, Evan Robinson, PhD, Louise Backer, MBA, Western New England University College of Pharmacy Effect on COPD exacerbation rates after the conversion from separate corticosteroid and long-acting beta agonist inhalers to a combination inhaler: a pilot study. Katelyn Parsons, PharmD; John Roefaro, PharmD; Anita Daryanani, PharmD; Kathy Ching; Bethany Bersani; Errol Baker, PhD; Marilyn Moy, MD, MSc The effectiveness of a clinical pharmacist providing collaborative drug therapy in a private practice. Steven Sparkes, PharmD Candidate 2014, Francis Harte, MD, Jennifer Goldman-Levine, PharmD, CDE, BC-ADM, FCCP, MCPHS University Utilization of pharmacists in latent tuberculosis management to meet regulatory requirements and target causes of incomplete therapy Sarah Culbreth, PharmD, BCPS.

Avoid diminishing the value of your pharmacy. Don’t leave money on the table when you transition the ownership of your business. CONSIDER THESE IMPORTANT ISSUES...

1. Confidentiality is CRITICAL to maintaining business value. The more people who know about a sale (employees, suppliers, customers), the less value it will ultimately have. Limit your conversations to trusted advisors, associates and family members. 2. Connect to the largest group of QUALIFIED BUYERS to create the highest price, by leveraging the highest level of interest in your business. Limiting your buyer pool (e.g. ONLY your wholesaler's customers), limits your ability to sell and sale price. 3. DO NOT engage in conversations, information sharing or negotiations with ANY buyer without professional representation, particularly if contemplating a sale to a chain. Thirteen years of experience selling pharmacies has shown us time after time that direct engagement rarely—if ever—gets the independent owner the best price or the best deal.

Your Local Specialist Jack Collins, R.Ph. jackc@buy-sellapharmacy.com Tel: 1-(203)-395-6243

Completely confidential!

1-(877)-360-0095 www.buy-sellapharmacy.com

2012 Recipients of the “Bowl of Hygeia” Award

Pharmacy Journal of New England • Fall 2013

John Harmon Alabama

Lyle Fibranz Alaska

Hal Wand Arizona

Donald L. Hedden Arkansas

Melvin K. Renge, Jr California

Jeannine Dickerhofe Colorado

Paul Limberis Colorado*

Scott Wolak Connecticut

Kimberly Couch Delaware

Angela D. Adams Florida

William Moye Georgia

Kelly S.M. Go Hawaii

Randy Malan Illinois

Gerald Roesener Indiana

Eugene Lutz Iowa

Marvin E. Bredehoft Kansas

George Hammons Kentucky

Roxie Stewart Louisiana

Joe Bruno Maine

Frank Nice Maryland

Edward S. Radock Massachusetts

Gregory Baise Michigan

Larry Leske Minnesota

Waymon Tigrett Mississippi

Matt Hartwig Missouri

Jim Seifert Montana

Edward M. DeSimone, II Nebraska

Joe Kellogg Nevada

George Bowersox New Hampshire

Frank Breve New Jersey

Kenneth Corazza New Mexico

Nasir Mahmood New York

Beverly Lingerfeldt North Carolina

Dennis DelaBarre North Dakota

Mimi Hart Ohio

John Foust Oklahoma

Marcus Watt Oregon

Richard Smiga Pennsylvania

Santa E. Nieves Puerto Rico

Michael Simeone Rhode Island

Julian Reynolds South Carolina

Galen Jordre South Dakota

Marion Crowell Tennessee

Dennis Song Texas

Lloyd J. Thomas Utah

Empsy Munden Virginia

Michelle Valentine Washington

Eric Belldina West Virginia

Gary Bongey Wisconsin

Tonya Woods Wyoming

The “Bowl of Hygeia”

The Bowl of Hygeia award program was originally developed by the A. H. Robins Company to recognize pharmacists across the nation for outstanding service to their communities. Selected through their respective professional pharmacy associations, each of these dedicated individuals has made uniquely personal contributions to a strong, healthy community. We offer our congratulations and thanks for their high example. The American Pharmacists Association Foundation, the National Alliance of State Pharmacy Associations and the state pharmacy associations have assumed responsibility for continuing this prestigious recognition program. All former recipients are encouraged to maintain their linkage to the Bowl of Hygeia by emailing current contact information to awards@naspa.us. The Bowl of Hygeia is on display in the APhA Awards Gallery located in Washington, DC. Boehringer Ingelheim is proud to be the Premier Supporter of the 2012 & 2013 Bowl of Hygeia program. *2011 recipient awarded in 2012

Feature

By Kimberly Tynik Pharm D. Student and Jennifer Girotto, PharmD Associate Clinical Professor of Pharmacy Practice, University of Connecticut School of Pharmacy

Important Changes for Influenza Vaccination in 2013-2014 For the 2013-2014 influenza season there are two new available types of vaccinations: quadrivalent and recombinant trivalent influenza vaccines. Trivalent vaccines will contain A/California/7/2009 (H1N1)-like virus, A/Victoria/361/2011 (H3N2) like, and a B/Massachusetts/2/2012-like virus.1,2 The quadrivalent vaccines will contain the same strains as the trivalent plus a B/Brisbane/60/2008-like virus.1,2 If patients ask, the A strains remain the same as 2012-2013, but both of the B strains are new. Table 1 provides a summary of the available influenza vaccines for the 2013-2014 year.1,2 It should be noted that there are many new vaccines available this year. 22

Specifically, there are 2 new trivalent inactivated influenza vaccines (IIV3) (FluBlok速 and Flucelvax速).1-4 The first, FluBlok速 is a recombinant hemagglutinin antigen (HA) vaccine (RIV3) indicated for persons aged 18 through 49 years.3 A gene that encodes for hemagglutinin antigen (HA) is inoculated into a baculovirus, and the replicating baculovirus quickly produces large amounts of HA. There are 2 main benefits of the RIV3, first it can be used in patients allergic to eggs and secondly it can be produced more quickly than traditional influenza vaccines, if needed. The second new trivalent vaccine, Flucelvax速 is a cell culture-based inactivated influenza vaccine (ccIIV3); which is indicated for persons aged 18 years and older.1,2,4 ccIIV3 contains influenza virus grown in Madin-Darb canine kid-

Pharmacy Journal of New England • Fall 2013

ney (MDCK) cell cultures (although the beginning process still has a risk of some egg contamination). The main benefit of ccIIV3 is that there is a quicker vaccine start up in cases of a pandemic.1,4 This is the first year that any of the influenza vaccines marketed are quadrivalent. As previously mentioned, they contain 4 influenza antigens (2 A and 2 B).1,2 As with any new influenza vaccine the long term safety and efficacy of these vaccines has yet to be tested.2 There are both inactivated (Fluarix® Quadrivalent, FluLaval® Quadrivalent, and Fluzone® Quadrivalent; IIV4) and live attenuated (Flumist® Quadrivalent Intranasal; LAIV4) quadrivalent vaccines for the 2013-2014 season. Although these are new, they are similar to the trivalent brand names, but contain the second B antigen.6,7,8,9 Also this year, Flumist® the cold-adapted, live attenuated, intranasal vaccine, is only being marketed as a quadrivalent vaccine.1,2 The Advisory Committee on Immunization Practices (ACIP) and the American Academy of Pediatrics continue to recommend routine annual vaccination against influenza for all persons without contraindications aged 6 months and older.1,2 Further, both groups reinforce their recommendation that health-care providers begin offering the 2013-2014 influenza vaccine as soon it becomes available, preferably by October.1,2 As summarized in Table 2, adults and children 9 years old or older only need 1 doses of vaccine each season. Children less than 9 years old , however should receive a total of 2 doses of influenza vaccine, separated by at least 1 month their first flu season.1,2 Further, if a child less than 9 years of

Table 1. Available Influenza Vaccines 2013-2014 Season

Vaccine Category, Route

Brand name (Manufacturer)

Ages Recommended

Dose

IIV3, Intramuscular

Fluzone® (Sanofi Pasteur)

6 – 35 mos. old

0.25 mL

≥36 mos. old

0.5 mL

Afluria

Fluarix

(CSL Limited)

≥9 years old

(GlaxoSmithKline)

≥3 years old

Flucelvax® (Novartis Vaccines)

≥18 years old

FluLaval

(ID Biomedical Corporation of Quebec)

≥3 years old

Fluvirin (Novartis Vaccines)

≥4 years old

FluBlok

18-49 years old

(Protein Sciences, RIV3)

Fluzone High-Dose ®

≥65 years old

(Sanofi Pasteur)

IIV3, Intradermal

Fluzone Intradermal ®

(Sanofi Pasteur)

IIV4, Intramuscular

18-64 years old

0.1mL

6 - 35 mos old

0.25 mL

≥36 mos old

0.5 mL

Fluzone Quadrivalent ®

(Sanofi Pasteur)

Fluarix Quadrivalent ®

≥3 years old

(GlaxoSmithKline)

FluLaval Quadrivalent ®

(ID Biomedical Corporation of Quebec)

LAIV4, Intranasal

≥3 years old

FluMist Quadrivalent ®

(MedImmune)

2-49 years old

0.2mL

IIV3= Inactivated Trivalent Influenza Vaccine; IIV4= Inactivated Quadrivalent Influenza Vaccine; RIV3= Recombinant Trivalent Influenza Vaccine; LAIV4 Live-attenuated Quadrivalent Influenza Vaccine;

age did not receive the recommended 2 doses in their first year, they will need to receive 2 doses this flu season, unless they have had at least 2 doses anytime since July 2010.1,2 Figure 1 simplifies the assessment for the number of doses of influenza vaccine in pediatric patients.1,2 Doses of the trivalent and quadrivalent are the same. As shown in Table 1, intramuscular vaccines administered to older children, adolescents and adults have doses standardized to 0.5mL; while children aged 6 months through 36 months receive doses standardized to 0.25 ml.1,2 The intradermal

IIV3(Fluzone® Intradermal) is administered as a 0.1mL injection using the prefilled microinjector.10 LAIV4 is administered as 0.1mL into each nostril, for a total dose of 0.2mL.9 ACIP and AAP have updated their recommendations on administering influenza vaccinations to patients with egg allergies to accommodate the newly approved vaccines. All persons with a history of egg allergy that report their reaction as only hives should receive vaccination with either RIV3 or an inactivated influenza vaccine (IIV). RIV3 is currently only approved for those 18 through 49 23

Feature

continued

Table 2. Number of Doses of Influenza Vaccine Needed Based on Age of Patient

Age

Number of vaccine doses

>/= 9 years old

1 dose

< 9 years Never vaccinated before

2 doses, separated by at least 4 weeks

Vaccinated in prior year(s) and received < 2 doses since 7/1/10 Vaccinated in prior year(s) but received >/= 2 doses since 7/1/10

2 doses, separated by at least 4 weeks 1 dose

years of age. Patients that cannot receive RIV3 (due to age, other contraindications, or unavailability of the vaccine) may, as in prior years, be able to receive IIV with additional safety measures. Note that the ccIIV3 contains less egg contamination than other IIV, but it is not completely without egg in the processing and can be treated like other IIV’s when giving vaccinations of patients with egg allergy.1,2 ACIP reinforces that the LAIV should not be administered to anyone with an egg allergy regardless of severity due to lack of experience.1 ACIP and APP continue to stress the benefit of vaccinating pregnant women with IIV to protect both the pregnant woman and the baby.1,2 Although LAIV should not be given to pregnant women, it can be safely used in postpartum women.1 Also, women who are pregnant do not need to avoid those recently vaccinated with the LAIV.1 It is important to note that at this time, although there are many variations of the influenza vaccine available (i.e. trivalent, quadrivalent, high dose, intradermal, etc), the ACIP does not have any preferential recommendations between any type or brand when there are multiple vaccines indicated for a given patient. At the end of August, Sanofi released initial results of the outcomes for 30,000 patients aged 65 years and older comparing the high dose versus standard dose vaccine. It was noted that their high dose influenza vaccine was 24.2% more effective than the traditional influenza vaccine.11 The full study has not been released at

this time. There may be significant limitations that we are unaware of, but it does provide promising initial data that the high-dose vaccine has a higher likelihood to be clinically effective in elderly patients.11 In the case of vaccine backorder, patients should not be withheld vaccine if other appropriate influenza vaccines are available.1,2 Further, for pediatric patients it is preferred to provide them the same vaccine for both doses, when 2 are needed. In cases when the vaccine used for the initial administration is not available, a different brand or type (i.e. IIV3 or IIV4) should be used to not delay full vaccination.2 It should be noted that if the child (under 9 years old) only receives 1 dose of the IIV4 they may not have the same level of protection against the additional influenza B strain.2 References: 1. Grohskopf LA, Shay DK, Shimabukuro TT, et al. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2013–2014. MMWR Recomm Rep. 2013;62:1-43. 2. American Academy of Pediatrics, Committee on Infectious Diseases. Recommendations for Prevention and Control of Influenza in Children, 2013-2014. Pediatrics 2013 [epub ahead of time Sept 2, 2013]. 3. Flublok influenza virus vaccine [package insert]. Meriden, CT: Protein Sciences Corporation; 2013 4. Flucelvax influenza virus vaccine [package insert]. Cambridge, MA: Novartis Vaccines and Diagnostics, Inc; 2013 5. Centers for Disease Control and Prevention. Cell-based Flu Vaccines: Questions & Answers. Available online: http://www.cdc.gov/flu/protect/vaccine/cell-based.htm (Accessed 9/4/2013) 6. Fluarix Quadrivalent influenza virus vaccine [package insert]. Dresden, Germany: GlaxoSmithKline Biologicals; 2013 7. FluLaval Quadrivalent influenza virus vaccine [package insert]. Quebec City, Canada: ID Biomedical Corporation of Quebec; 2013 8. Fluzone Quadrivalent influenza virus vaccine [package insert]. Swiftwater, PA: Sanofi Pasteur Inc.; 2013 9. Flumist Quadrivalent Intranasal influenza virus vaccine [package insert]. Gaithersburg, MD: MedImmune, LLC 10. Fluzone Intradermal vaccine [package insert]. Swiftwater, PA: Sanofi Pasteur Inc.; 2013. 11. Reuters Health Information. Sanofi Trial Shows Fluzone High-Dose Flu Vaccine Efficacy in Elderly. Available at www.medscape.com/viewarticle/810013. Accessed (9/5/2013)

Pharmacy Journal of New England • Fall 2013

U.S. News continued • The WG11 Prescription Delivery Task Group will discuss pended DERFs 001162 (hospital delivery) and 001163 (patient residence use). Calls have been scheduled on the NCPDP Events Calendar or in the Conference Call Information document found on the task group on the NCPDP Collaborative.

Outreach from Current Task Groups: • The WG10 Specialty and Compounding Pharmacy Services Task Group is defining operational tools for electronic communication between various parties that provide specialty pharmacy services, including PBM, Payers, Providers (including MD), Manufacturers and Quality Care Associations and directions of future specialties. This task group is coordinating work with the appropriate WG1 Task Group and WG11 Specialty Requirements for ePrescribing Task Group. Further information will be provided to the task groups. • The WG11 Implementation of Structured and Codified Sig Task Group is examining commonly used sig strings to build examples and guidance for use of structured sig for implementers. They will also be looking at educational opportunities. Contact Lynne Gilbertson at lgilbertson@ncpdp.org to join. • WG1 Vaccine Services Task Group is identifying the barriers slowing the adoption and expansion of vaccine administration services in pharmacy, to develop “best practice” recommendations for vaccine administration services, including pharmacy benefit billing & processing, medical benefit eligibility verification and billing, registry reporting, pharmacy certification/credentialing, and provider communications in pharmacy & health departments, to assess the impact of vaccine regulatory requirements on pharmacy operations and services, and to develop data communication and process standards supporting the advancement of vaccine administration services by pharmacies and health departments. This task group is looking for processor/payer participation. Contact Lynne Gilbertson at lgilbertson@ncpdp.org to join.

• The WG1 Transaction ID Task Group is building additional guidance for submission and processing of reversal transactions. Contact Lynne Gilbertson at lgilbertson@ncpdp.org to join. • The WG1 Benefit Integration Task Group is creating a new standard for the exchange of accumulator dollars in order to maintain a total accumulator amount comprised of various business types like medical and pharmacy. Contact Teresa Strickland at tstrickland@ncpdp.org to join • The WG14 Long Term and Post Acute Care ePrescribing Task Group is building guidance on the implementation of the SCRIPT transactions in long term care. As of November 2014, the Medicare Modernization Act LTC exemption is lifted and SCRIPT version 10.6 is required for entities that exchange electronic prescribing between organizations. The task group is seeking participation from facility EMR vendors, physician EMR vendors and LTC pharmacies and their vendors. Contact Teresa Strickland at tstrickland@ncpdp.org to join. • The WG9 Supplemental Payer Part D Reconciliation Standardization Task Group is identifying a standardized process for Part D plans to communicate to supplemental payers when they have made a change to a claim they paid (real-time or paper) that has a potential impact to the beneficiary’s liability and that occurs after the point of sale. Contact Kittye Krempin at kkrempin@ncpdp.org to join.

Pharmacy Marketing Group

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.

Workers Compensation Workers Compensation laws currently exist in all 50 states and the District of Columbia. They are important to both pharmacy owners and pharmacy employees. But do we understand what these laws provide and how they came to be? In most cases, these questions aren’t confronted until a claim occurs. It is much better to become educated prior to a claim for a number of reasons. For the owner, it is important to know your responsibilities prior to the claim to make sure that you have met them. For employees, it is important to know what to do when an injury occurs and what benefits you will be eligible to receive. In most situations involving personal injury, the laws of negligence apply. These laws are a mixture of statutory law and Common Law principles. Prior to Workers Compensation laws, employee injuries were handled as negligence cases. However, this presented many hurdles to the employee. The cases were difficult to win because the employer had good defenses available to them. If the employee contributed to the injury, or some other employee was the cause of the injury, then the employer was not liable. The employer could also assert that the employee knew the job was dangerous when they took it and assumed the risk. These cases were also difficult for the employee financially because they were not working and they didn’t have the resources available to them that the employer did. Employers were afraid of these claims because if the employee were successful, there were no limits on the amounts they could recover. In 1910, the state of New York created the first Workers Compensation program in the United States1. These statutes create trade-offs between the employer and the employees. Workers Compensation is a statutory creation,

so there are no Common Law principles involved in it. As a practical result, Workers Compensation is statedefined and differs in detail from state to state. Therefore, this article can only discuss this topic at a high level. You will need to explore on your own for the details of your state’s program. The trade-offs are these. The employee is entitled to compensation and/or benefits for job-related injuries or diseases without the necessity of proving fault on the part of the employer. It is a no-fault system. These benefits are outlined in the statute and remove the specter of a run-away jury verdict for the employer. Workers Compensation becomes the exclusive remedy for the employee, so they no longer have the right to sue their employer for their injury. The intent was to provide a system that was fair to both sides and that provided benefits to the employee in a timely manner. In effect, the system was designed to be easier, cheaper, and more efficient than courts. Generally, Workers Compensation provides benefits to the employee only in certain circumstances. The cause of their injury must be related to their employment and the occurrence must have taken place while engaged in work-related activities. While this looks simple on the surface, there have been many disputes over causation and over what is a work-related activity. As a result, there is more litigation that occurs in Workers Compensation claims than was originally foreseen. However, it takes place in front of an Administrative Law Judge instead of in a court. Many times this is still faster and less expensive than the regular court system. As an employer, it is very important to know when you are required to provide Workers Compensation benefits to your employees. In most states, this is done by setting a threshold of a minimum number of employees that trigger the responsibility. Failure to provide the benefits can result in fines and penalties being assessed against the owner. Providing the benefits doesn’t always mean going out and buying Workers Compensation insurance. Many states allow the employer to self-insure, while a few states require that the employer buy the coverage from a state-run plan.

Pharmacy Journal of New England • Fall 2013

It is incumbent upon the owner to know what the requirements are and follow them. As an employee, it is important to know whether you are included in the Workers Compensation plan (some states exempt certain types of workers) and what you should do if you are injured on the job. Most states require a First Report of Injury be made as soon as possible. Sometimes this might even be required within 24 to 48 hours. Failure to report injuries timely could jeopardize the coverage. It is crucial that all injuries be reported at the time that they occur. Occasionally the employee thinks that the situation is very minor and doesn’t report it to the employer. The problem is that if the injury worsens and becomes significant days later, it may be difficult to prove that the injury was job related or that it occurred while on the job. Workers Compensation as it exists today may not be a perfect system. But it is a fact of modern life. Employers and employees should familiarize themselves with the responsibilities and benefits that they may have under their state’s program. 1. Commercial Insurance, 2nd Edition, A. Flitner & J. Trupin, 2007, page 12-3. © Don R. McGuire Jr., R.Ph., J.D., is General Counsel, Senior Vice President, Risk Management & Compliance 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.

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.

Financial Considerations for 2014 What changes should we consider making for next year? 2014 is really not too far away. Fall is the time of year when the financially savvy start to look for ways to reduce their taxes and make year-end moves in pursuit of key financial objectives.

What might the big picture hold? Absent a crystal ball, let’s turn to the September edition of the Wall Street Journal’s Economic Forecasting Survey. The WSJ asks 52 economists for their take on things each month, and here is how they see 2014 shaping up for America: GDP of 2.8%, a jobless rate declining from the present 7.3% to 6.6% by the end of next year and consumer inflation of 2.5% or less through the end of 2015. These analysts also see the Federal Reserve keeping the benchmark interest rate at 00.25% for all of 2014. As for the yield on the 10-year note, their consensus projection has it hitting 3.28% in June 2014 and 3.57% in December 2014. They also see home prices rising 5.22% YOY in 2014 after a 7.85% gain across 2013. Oil, they think, will average $102.73 a barrel on the NYMEX this December, declining to $98.17 a barrel next December. For its part, the International Monetary Fund projects 3.8% inflation-adjusted global growth next year, and a 4.3% tumble for global non-fuel commodities in U.S. dollar terms. These are all macro forecasts worth keeping in mind.1,2 Now, how about your picture? Beyond these macro forecasts that may affect your business and personal finances, what moves might you consider? Can you max out your IRA or workplace retirement plan contribution? If you have, congratulations (especially if you benefit further from an employer match). If you haven’t, you still have the chance to put up to $5,500 into a traditional or Roth IRA for tax year 2013, $6,500 if you are 50 or older this year, assuming your income levels allow you to do so. (Or you can spread that maximum contribution across more than one IRA.) Traditional IRA contributions are tax-deductible to varying degree. The contribution limit for participants in 401(k), 403(b) and most 457 plans and the Thrift Savings Plan is $17,500 for 2013, with a $5,500 catch-up contribution allowed for those 50 and older.3,4 Incidentally, the FY 2014 federal budget set out by the White House proposes some changes to IRAs & 401(k)style plans in 2014. First, if an individual’s total taxdeferred retirement savings through these plans is great enough to produce yearly retirement income of $205,000 for the individual and his/her surviving spouse, then fur27

Pharmacy Marketing Group ther contributions to such accounts would be nixed. (Today, it would take savings of nearly $3.5 million to produce such a retirement income stream.) Second, the Stretch IRA strategy would basically vanish: the FY 2014 budget proposes that all IRA inheritors follow the 5-year rule, in which an inherited IRA balance is reduced to zero by the end of the fifth year after the year in which the original IRA owner dies. (Disabled IRA inheritors and certain other beneficiaries would be exempt from the 5-year rule.)5 Should you go Roth in 2014? The younger you are, the more sense a Roth IRA conversion may make. If you have a long time horizon to let your IRA grow, have the funds to pay the tax on the conversion, and want your heirs to inherit tax-free distributions from your IRA, it may be worth it. If you think you will pay less tax in the future or you might die with a large charitable bequest, then it may not be a wise move. Can you harvest portfolio losses before 2014? This is the time of year to think about tax loss harvesting â&#x20AC;&#x201C; dumping the losers in your portfolio. You can claim losses equivalent to any capital gains recognized in a tax year, and you can claim up to $3,000 in additional losses beyond that, which can offset dividend, interest and wage income. If your losses exceed that limit, they can be carried over into future years. It is a good idea to do this before December, as that will give you the necessary 30 days to repurchase any shares should you wish.6 In terms of taxes, should you delay a big financial move until 2014? Talk with a tax professional about the impact that selling or buying a home or business might have on your 2013 taxes. You may want to wait. Receiving a bonus, getting married or divorced, exercising a stock option, taking a lump-sum payout â&#x20AC;&#x201C; these events have potentially major tax consequences as well. Business owners may want to consider whether to make a capital purchase or not.

Look at tax efficiency in your portfolio. Investors were strongly cautioned to do this at the end of 2012 as the fiscal cliff loomed; it is a good idea before any year ebbs into the next. You may want to put income-producing investments inside an IRA, for example, and direct investments with lesser tax implications into brokerage accounts. Finally, do you need to change your withholding status? If major change has come to your personal or financial life, it might be time. If you have married or divorced, if a family member has passed away, if you are self-employed now or have landed a much higher-salaried job, or if you either pay a lot of tax or get unusually large IRS or state refunds, you will want to review this with your tax preparer. Pat Reding and Bo Schnurr may be reached at 800-288-6669 or pbh@berthelrep.com. Registered Representative of and securities and investment advisory services offered through Berthel Fisher & Company Financial Services, Inc. Member FINRA/SIPC. PRISM Wealth Advisors LLC is independent of Berthel Fisher & Company Financial Services Inc. This material was prepared by MarketingLibrary.Net Inc., and does not necessarily represent the views of the presenting party, nor their affiliates. All information is believed to be from reliable sources; however we make no representation as to its completeness or accuracy. Please note - investing involves risk, and past performance is no guarantee of future results. The publisher is not engaged in rendering legal, accounting or other professional services. If assistance is needed, the reader is advised to engage the services of a competent professional. This information should not be construed as investment, tax or legal advice and may not be relied on for the purpose of avoiding any Federal tax penalty. This is neither a solicitation nor recommendation to purchase or sell any investment or insurance product or service, and should not be relied upon as such. All indices are unmanaged and are not illustrative of any particular investment. Citations. 1 online.wsj.com/public/resources/documents/info-flash08.html?project=EFORECAST07 [9/12/13] 2 forbes.com/sites/billconerly/2013/09/02/economic-assumptions-for-your-2014business-plan/ [9/2/13] 3 irs.gov/Retirement-Plans/Plan-Participant,-Employee/Retirement-Topics-IRAContribution-Limits/ [9/12/13] 4 shrm.org/hrdisciplines/benefits/articles/pages/2013-irs-401k-contributionlimits.aspx [10/19/12] 5 blogs.marketwatch.com/encore/2013/09/09/budget-talks-could-alter-401k-irarules/ [9/9/13] 6 dailyfinance.com/2013/09/09/tax-loss-selling-dont-wait-december-dump-losers/ [9/9/13]

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From the Colleges University of Connecticut School of Pharmacy Dear Friends The School of Pharmacy welcomes the incoming Class of 2017; they are among the most qualified of our incoming students. We are fortunate that we are able to recruit a diverse and highly qualified student body. This year, the School is moving forward on a variety of initiatives. As part of the Universities $1.7 B in funding for Next Generation CT we are preparing a strategic vision for the School that will integrate our goals with those of the University. We anticipate an expansion of our basic science activities through the Department of Pharmaceutical Sciences and our clinical activities through the Department of Pharmacy Practice. We have hired two new faculty in outcomes research and are currently searching for two new faculty in basic science, one in pharmacogenetics and the other in medicinal chemistry. As Next Generation CT initiatives unfold, we anticipate several new faculty positions opening within the School over the next few years.

The School continues its efforts to enhance human health through our scholarly activities. Diane Burgess recently received $1 M in grants from the FDA to investigate novel drug delivery forms. Thomas Buckley recently received a $500K grant from the Connecticut Department of Public Health to enhance the role of pharmacist in efforts to prevent and control disease. This grant was in collaboration with Angelo DeFazio of Arrow Pharmacies and highlights our efforts to work collaboratively with the community to enhance the profession. Together these grants highlight our vision of bridging drug discovery to development to optimal clinical practice. Finally, I will note that our national search for a new Dean is moving forward on schedule. We anticipate completion of the search and naming the new Dean in early 2014. Warm regards. John B. Morris, Ph.D. Interim Dean

University of Saint Joseph School of Pharmacy Dr. Ola Ghoneim Receives Half a Million Dollar Research Grant Dr. Ola Ghoneim, Assistant Professor of Pharmaceutical Sciences, University of Saint Joseph-School of Pharmacy was recently awarded a research grant award from Qatar National Research FundNational Priority Research Program for 2 years. Dr. Ola Ghoneim is the Lead Principal Investigator, while Dr. Ashraf Khalil, of Qatar University-College of Pharmacy is Co-lead Principal Investigator. The title of the research project is â&#x20AC;&#x153;Microwave-Assisted Organic Synthesis and Pharmacological Evaluation of N-Arylpiperazine Analogs as Serotonergic Ligands: A Novel Potential Treatment for Children with Autism Spectrum Disordersâ&#x20AC;?.

Pharmacy Journal of New England • Fall 2013

Preceptor Of The Year Awards

Career Day

The University of Saint Joseph (USJ) School of Pharmacy recently sponsored an event to recognize and honor the 2013 Preceptors of the Year. As experiential education professionals, pharmacist preceptors teach students practicerelated skills necessary to provide quality pharmacist care. In addition to serving as teachers, pharmacist preceptors mentor student pharmacists, promoting personal and professional growth. Pictured here (left to right) are: Noreen Todd, M.H.A., R.Ph., coordinator of Experiential Education at the USJ School of Pharmacy; 2013 Community Pharmacy Preceptor of the Year Award Winner Joseph E. Bordonaro Jr., R.Ph. of Bordonaro’s Pharmacy, Portland, Conn.; 2013 Institutional Pharmacy Preceptor of the Year Award Winner Bekim S. Jashanica, Pharm.D., of Griffin Hospital, Derby, Conn.; Joseph R. Ofosu, Pharm.D., R.Ph., professor and dean of the USJ School of Pharmacy; and John Parisi, R.Ph., C.D.E., director of Experiential Education at the USJ School of Pharmacy.

The USJ SOP first “Career Day” for the graduating class of 2014 was held on October 4th. Six companies participated, interviewing 29 members of the Class of 2014. 103 interviews were completed. Steve Seaward and Valerie Wilson from the USJ Career Development Office were on hand to provide last minute tips on interview techniques and resume writing.

Class of 2016 The Class of 2016 began their schooling in August. 85 women and men (57% female) were awarded their White Coats during a ceremony at the Hoffman Auditorium in the Bruyette Athenaeum on the West Hartford campus. The average age of the incoming students is 25 years old, reflecting the School’s requirement of a Bachelor of Science degree before admittance. Seventeen states and several foreign countries are represented.

From the Colleges

continued

Massachusetts College of Pharmacy-Worcester/Manchester School of Pharmacy It was an extremely active spring 2013 for both faculty and students. The highlight was graduation for all our seniors and they are anxiously looking forward to taking the boards and moving onto their professional careers as pharmacists. Meanwhile the rest of the students are busy completing the summer semester and looking forward to their IPPE and APPE rotations. The faculty continue to be actively engaged in educating all the students while also working diligently on making the most of their Scholarly opportunities. I wish you all wonderful New England summer. All the best, Michael J. Malloy, PharmD, Dean and Professor

Second Annual SOP-W/M Research Day The 2nd Annual SOP-W/M Research Day was held on April 11 on the Worcester campus. The event, organized by Drs. Kaelen Dunican, Alice Gardner, Helen Pervanas, and Reema Zeineldin, showcased the research projects conducted by PharmD students during their APPE elective rotations, graduate students, residents and fellows. Thirtytwo posters presented a wide range of research projects, including pre-clinical, clinical, and education research. Overall, the event was well-received by the large crowd that attended.

Grant Awards Dr. Helen Pervanas received a $1000 grant from Campus Compact of New Hampshire to fund a research project titled “Using student pharmacists to promote drug and alcohol prevention in teens at a local Boys and Girls Club”. Funding period: 2-1-2013 to 6-30-2013. Lahoz MR, Evans P, Bond I, Aungst T. “Improving the Health Information Literacy Skills of Older Adults and Caregivers, Health Professions Students, and Public Librarians.” National Institutes of Health, National Library of Medicine, National Network of Libraries of Medicine – New England Region (NN/LM-NER) Health Information Outreach Program Award. $24,821 ($22,321 direct costs). May 1, 2013 – April 30, 2014. 32

Awards 2013 MCPHS University Summer Undergraduate Research Fellows

The Summer Undergraduate Research Fellowship (SURF) Advisory Board is happy to announce the 2013 SURF Fellowship awardees. The selection process is highly competitive and it is an honor to be selected an MCPHS University undergraduate research fellow. The W/M awardees are: Charles Callahan (2015), Research Fellow in Pharmacy Education/Therapeutics, School of Pharmacy – Manchester. Mentors: Cheryl Abel, PharmD and Cheryl Durand, PharmD Lindsay Hom (2014), Research Fellow in Pharmacy Education/Therapeutics, School of Pharmacy – Worcester. Mentor: Ryan Attwood, PharmD Steven Richards, Research Fellow in Pharmaceutical Sciences, School of Pharmacy – Worcester. Mentor: Robert Campbell, PhD Dr. Evan Horton received the MCPHS Department of Pharmacy Practice Academic of the Year Award which recognizes a faculty member for excellence in the areas of Teaching, Scholarship, and Service. Dr. Ann Lynch received the MCPHS Faculty Preceptor of the Year Award. Dr. Lynch offers an advanced community pharmacy rotation at Walgreens Pharmacy. Dr. Helen Pervanas received the MCPHS One Year Faculty Service Award for her community outreach around prescription drug abuse prevention. Dr. Carroll-Ann W. Goldsmith received the Campus Compact for New Hampshire Presidents’ Good Steward Award in March for her public service efforts that have focused on advancing interest in the sciences and science careers among New Hampshire’s youth. She secured funding to establish the Access to College program in 2008 through the Sciences program and has continued to spearhead this program. Each year up to 40 underserved 8th graders from Manchester’s McLaughlin Middle School

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have visited the Manchester campus of MCPHS University. This program is a collaborative achievement including faculty, staff and students who worked together to make it a great success each year. Dr. Robert Campbell received the MCPHS Department of Pharmaceutical Sciences Academic of the Year Award which recognizes a faculty member for excellence in the areas of Teaching, Scholarship, and Service.

Dr. Reema Zeineldin received the 2013 MCPHS Faculty Research/Scholarship Poster Award in the category of Scholarship of Integration at the 3rd Annual Faculty Scholarship Showcase held on May 7 at the 10 Lincoln Ballroom. Spooner, Linda received Honorable Mention in the 2013 Pharmacy Today One to One Patient Counseling Recognition.

Promotions & New Hires Dr. Jeffrey Fong, promoted to Associate Professor of Pharmacy Practice Dr. Reema Zeineldin, promoted to Associate Professor of Pharmaceutical Sciences Dr. Matt Silva, promoted to Professor of Pharmacy Practice Dr. Jennifer Donovan, promoted to Professor of Pharmacy Practice Dr. Mimi Mukherjee joined the Department of Pharmacy Practice in the Spring of 2013. Dr. Timothy Aungst completed his 2-year fellowship program in MCPHS Pharmacy Outreach and joined the Department of Pharmacy Practice in the Spring of 2013. Carolyn Friel and Robert Campbell.

Dr. Tereance Myers joined the Department of Pharmaceutical Sciences in the Spring of 2013.

Publications CW Goldsmith, A Li. The effects of yoga on anxiety and stress. Altern Med Rev. March 2012; 17:21-35. Aungst TD. Medical Applications for Pharmacists Using Mobile Devices. Ann Pharmacother. Epub 2013 July 2. Misra S, Lewis TL, Aungst TD. Medical application use and the need for further research and assessment for clinical practice: creation and integration of standards for best practice to alleviate poor application design. JAMA Dermatol. 2013;149(6):661-2.

Paper Presentations

Reema Zeineldin and Provost George Humphrey.

Bond I, Friel C, Lahoz MR. Development and use of ageappropriate health information literacy assessment tools for pre-teens. 5th International Conference on Qualitative and Quantitative Methods in Libraries, Rome, Italy. June 4-7, 2013.

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Poster Presentations Sullivan K, Sawicki J, Abraham G. Utilizing a trigger report to track adverse drug event rates: a pilot project. Poster presented at ASHP Summer Meeting & Exhibition, 2013 June. Yu S (2014), Abel C, Goldsmith C. An interactive workshop to help refugees navigate pharmacy in the U.S. American Pharmacists Association Annual Meeting and Exposition. Los Angeles, CA. March 2013. Yu S (2014), Farrell S (2014), Abel C, Goldsmith C. An evaluation of public participation in recent medication take-back programs in NH. American Pharmacists Association Annual Meeting and Exposition. Los Angeles, CA. March 2013. Sayed M, Huang HE, Rhorer M, Oladeinde O, Zeineldin R. Role of Rac1 in ovarian cancer. American Association of Pharmaceutical Scientists-North East Regional Discussion Group (AAPS-NERDG). Rocky Hill, CT. April 2013.

Abdulghani A, Zeineldin R. Employing the inflammatory environment for drug release from lipid particles in ovarian cancer. American Association of Pharmaceutical ScientistsNorth East Regional Discussion Group (AAPS-NERDG). Rocky Hill, CT. April 2013. Lahoz MR, Friel C, Bond I. Health information literacy outreach program for sixth grade students. Institute for Healthcare Advancement (IHA) 12th Annual Health Literacy Conference, Irvine, CA. May 2013.

Podium Presentations Lahoz MR, Wooding F, Evans P, Bond I, Pang N. Results of hands-on computer lessons to teach the elderly to find authoritative health websites. Medical Librarian Association (MLA) Annual Meeting, Boston, MA. May 2013.

Massachusetts College of Pharmacy and Health Sciences - Boston Dear Colleagues,

Preceptor Appreciation Day

Recently there have been some important changes that have occurred on the Boston campus of MCPHS University. Our former Dean of the School of Pharmacy Boston and Associate Provost of Pharmacy Education, Dr. Douglas Pisano, has become the Acting Vice President of Academic Affairs and Provost. In this capacity he will have oversight of the academic affairs of all of our programs. As a result, I have been appointed as the Acting Dean for the School of Pharmacy Boston after leading the centralized office of Pharmacy Experiential Education for the last several years.

On September 12, the Office of Experiential Education and Office of Continuing Education at MCPHS University sponsored the 9th Annual Pharmacy Appreciation Day at the Doubletree Hotel in Westborough, Mass. This day-long, complimentary educational program was held for our clinical preceptors who provide our students with high quality rotation opportunities. This year we had a record turnout and more than 250 preceptors attended from all over New England.

As you can see below our faculty have been very busy with their research and service in addition to all the teaching that they provide to our students. Also in this issue we celebrate the efforts of our adjunct faculty who serve as clinical preceptors for the student rotation. I hope that the upcoming year is a very good one for all of you. Sincerely, Paul DiFrancesco, EdD Acting Dean

The preceptors were able to obtain a total of five ACPE approved continuing education credits, listed to speakers present on a diverse set of topics and network with each other as well as representatives from MPHS University. One of the highlights of the day was the presentation of the MCPHS University Preceptor of the Year Awards which were presented during the luncheon to seven preceptors from all three campuses and who represent a number of different practice sites. The 2013 award winners were: Kerrie Blatnick, Target Pharmacy, Preceptor of the Year, Manchester Campus

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Nicole Clark, Hallmark Health, Institutional Preceptor of the Year, Boston Campus

David Schnee, PharmD, Board Certification in Ambulatory Care Pharmacy(BCACP)

Katja Swift, CommonWealth School of Herbal Medicine, Specialty Elective Preceptor of the Year, Boston Campus

Dhiren Patel, PharmD, Board Certification in Ambulatory Care Pharmacy (BCACP)

Chris Casale, Community Pharmacy, Div. of Walgreens, Community Preceptor of the Year, Boston

Steven Crosby was appointed as an Associate Editor for Clinical Case Reports, a newly-established open-access Journal through Wiley publishing

Sue Otocki, Milford Regional Medical Center, Institutional Preceptor of the Year Worcester Campus Gary Cohen, PharMerica – Specialty Elective Preceptor of the Year, Worcester Campus Dick Paglia, Walgreens – Community Preceptor of the Year, Worcester Campus Pictured left to right: Kerrie Blatnick, Nicole Clark, Katja Swift, Chris Casale, Sue Otocki, Gary Cohen, Richard “Dick” Paglia.

Awards and Achievements Tim Hudd completed his 2012-13 term as President of MPhA and now Chairman of the Board Lana Dvorkin-Camiel, PharmD recipient of MCPHS Trustees Award for Teaching Excellence presented at MCPHS Boston Commencement May 11, 2013.

Abstracts published Bhatt SH., Seoane-Vazquez E. “Comparison of adherence to three times a day low dose unfractionated heparin for venous thromboembolism prophylaxis between surgical and medically ill patients.” ISTH 2013, Amsterdam, Netherlands. Grgurich PE, Palmer E, Gray A. Evaluation and Identification of Opportunities for Improvement of a Daily Awakening and Spontaneous Breathing Trial Protocol in Clinical Practice. Presented as a poster at the Society of Critical Care Medicine Annual Congress, 2013. Taglieri C, Crosby S, Ferullo J. Assessment of a Communication Skills Laboratory on student perception of competence and performance. Submitted and accepted for poster presentation at the AACP annual meeting, July 2013.

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Journal Articles Published Goldman-Levine JD, Patel D, Schnee D. Insulin degludec: A novel insulin analogue. Ann Pharmacother. 2013;47(2):269-277. Goldman-Levine JD. Introduction. In Individualizing therapy for the patient with type 2 diabetes: Focus on insulin, emerging therapies, and patient management. US Pharmacist 2013;(suppl):4-6. Goldman-Levine JD. Basal insulin: Historic use and emerging therapies. In Individualizing therapy for the patient with type 2 diabetes: Focus on insulin, emerging therapies, and patient management. US Pharmacist 2013;(suppl): 7-14. Riche D, Goldman-Levine JD. Uncovering and Managing Hypoglycemia: The Pharmacists Role. In Individualizing therapy for the patient with type 2 diabetes: Focus on insulin, emerging therapies, and patient management. US Pharmacist 2013;(suppl): 21-29. Goldman-Levine JD. Canagliflozin: A new drug for type 2 diabetes. Diabetes Self-Management. 2013; July/Aug:30-32. Dvorkin Camiel L, Goldman-Levine JD. Herbal products for the treatment of type 2 diabetes. Practical Diabetology. 2013;32(2):25-30. Sparkes S, Goldman-Levine JD, Harte F. Does the addition of a clinical pharmacist to an internal medicine practice improve glycemic control, blood pressure and LDL levels? Presented at the 3rd Annual Innovations Conference, Center for Primary Care, Harvard Medical School, Boston, 10/13. Sparkes S, Harte F, Goldman-Levine JD. The effectiveness of a clinical pharmacist providing collaborative drug therapy in a private practice. Presented at the New England Pharmacists Convention, Mashantucket, CT, 9/13. Cornbower A, Dell’Orfano H, Matta L, Cheng JWM. Evaluation of potassium sparing diuretics on renal function in decompensated heart failure patients: an exploratory pilot study at a tertiary academic medical Enter. JPCS; 2013(7):1-8. Cheng JWM. Azilsartan/Chlorthalidone Combination Therapy in Blood Pressure Control. Integrated Blood Pressure Control 2013;6:39-48. Sylvester K, Cheng J, Mehra M. Esomeprazole and Aspirin fixed combination for the prevention of cardiovascular events. Vascular Health and Risk Management 2013; 9:245-54. 36

Dvorkin Camiel L, Kostka-Rokosz MD, Medeiros E. Pharmacy students' experience and comfort with herb/dietary supplement (HDS) questions and information resources in the work setting. Currents in Pharmacy Teaching and Learning 2013;5(3):213-217. Krikorian SA, Shafai G, Shamim K. Management of iron deficiency anemia of chronic kidney disease: update on intravenous iron therapy. US Pharm 2013;38(8):22-26. Krikorian SA, Shamim K. Adherence Issues for Oral Antineoplastics: A Focus on Prevention and Management of Side Effects Related to Targeted Therapies. American Journal of Lifestyle Medicine 2013;7(3):206-222. Almukadi, H., Wu, H., Böhlke, M., Kelley, C.J., Maher, T.J., Pino-Figueroa, A.: The macamide N-3-methoxybenzyllinoleamide is a time-dependent fatty acid amide hydrolase (FAAH) inhibitor. Amer. J. Molec. Neurol. Wu, H., Kelley, C.J., Pino-Figueroa, A., Vu, H.D., Maher, T.J.: Macamides and synthetic analogs as in vitro fatty acide amide inhibitors. Bioorg. Med. Chem.

Book Chapters Josephine Babiarz authored three chapters in FDA Regulatory Affairs, 3rd edition book. Seger, A., Amato, M. (2012). Interview Day: In: Getting the Residency (Caballero, J., Clauson, K., Benavides, S. eds): Bethesda, MD, ASHP, 2013. Ferullo, JW., Campagna, NA., Crosby, SJ., Scanlon, JM. Pharmacy business and staff planning. In MA. ChisholmBurns, AM. Vaillancourt, M. Shepherd, Eds., Pharmacy Management, Leadership, Marketing, and Finance, Chapter 8 (pp. 105-126), 2nd Edition, Burlington, MA: Jones & Bartlett Learning. Matthews ML, Grimes J. Ulcerative colitis. In: The Five Minute Clinical Consult 2014. Domino F ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2013. Matthews ML, Kellerman R. Addison’s disease. In: The Five Minute Clinical Consult 2014. Domino F ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2013 Matthews ML, Kedian K. Vertigo. In: The Five Minute Clinical Consult 2014. Domino F ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2013.

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Posters Kostka-Rokosz MD, Dvorkin Camiel L, McCloskey WW. Incorporating Social Media Into a Required Drug Literature Evaluation Course – Second Year Analysis. American College of Pharmacy Annual Meeting, Chicago, IL, July 2013. Dvorkin Camiel LD, Goldman-Levine JD, Kostka-Rokosz MD, McCloskey WW. Use of Twitter as a Personal Learning Network (PLN)/Backchannel Tool in Over-theCounter Drugs/Self Care Course. Poster Presentation. American College of Pharmacy Annual Meeting, Chicago, IL, July 2013. Tim Hudd – Best poster at the 2013 New England Pharmacists Convention for Student Integration within a practice setting. Title: Evaluating the impact of an interprofessional educational session led by PharmD students on nurses’ perceived knowledge of inhaler devices for chronic obstructive pulmonary disease Authors: Timothy R Hudd, BS, PharmD., AE-C; Kathryn Conti, PharmD Candidate 2014; Sokankelly Lim, PharmD Candidate 2014; Stella Shnayderman, PharmD Candidate 2014; Enrique Seoane-Vazquez, PhD.

Peer-Reviewed/Invited Presentations: Paper/Podium Spencer, S. Kiritsy, P. , Scholl, L. Violette, E. Connors; Perceived Relevance of Psychology Courses among Students Enrolled in Health Professions Programs; 25th Annual Convention Association for Psychological Science (Washington DC, May, 2013) Krikorian S, Chervinsky K, Caughey T, Weissmann L. Assessing the Impact of a Pharmacist Intervention on Oral Antineoplastic Adherence Rates, Armenian Medical World Congress, Hollywood CA, July 2013. Krikorian S. Intravenous Iron Utilization during Epoetin Therapy in Anemia of Chronic Kidney Disease. Armenian Medical World Congress, Hollywood CA, July 2013. Newsome, GC, L. Wachtman, MM Migliore, A. Aly, N. Silva, S. Westmoreland, J. Rowlett, BL Waszczak. Intranasal GDNF for Parkinson's disease: Next steps in preclinical development. Soc. Neurosci. Abstr. #856.10, 2012. B.L. Waszczak, L. Wachtman, G.C. Newsome, A. Aly, N. Silva, S. Westmoreland, J. Rowlett and M.M. Migliore. Intranasal GDNF for Parkinson’s disease: next steps in preclinical development. EB Abstr. #1177.10

Western New England University College of Pharmacy Greetings from Western New England University College of Pharmacy! I am excited to share with you some of the great things taking place within the College of Pharmacy. The College of Pharmacy family has grown to 45 committed faculty, staff, and administrators and three classes of learners enrolled. Our founding classes of learners are unique in that they enrolled in an evolving program and have contributed profoundly to its evolution; they are entrepreneurs and trail blazers! Our learners and the faculty are very proud of their accomplishments, our commitment to the community through giving back, the great work of our faculty and staff, and the engaged participation of our friends and colleagues who have supported us throughout our development. Clearly our success is a collective success, borne from the commitment of dedicated individuals and supported by a University steadfast in the development of a quality program.

As you read about our activities, we hope you gain some perspective about what excites us as we move forward. Ralph Waldo Emerson best summed up how our program has evolved in the quote “Do not go where the path may lead, go instead where there is no path and leave a trail.” On behalf of the trailblazing learners, faculty, staff, and administration I encourage you to visit our website (www.wne.edu/pharmacy) to keep abreast of our activities.

Class of 2017 White Coat Ceremony The 76 members of the Class of 2017 participated in their White Coat Ceremony in August 2013. This was the third annual event where the entering College of Pharmacy learners donned their professional garments. The Ceremony serves as the first step in the College of Pharmacy’s efforts to promote professionalism; the learners not only transition from dependent learners to independent practitioners, they will also develop the professional traits necessary to enter the profession with altruism, duty, and compassion. 37

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Ms. Margaret Dempsey Clapp, longtime Chief Pharmacy Officer, Massachusetts General Hospital, was the keynote speaker. She told the Class of 2017 that there is a sacred covenant of trust between the pharmacist and the patient, to prevent harm, to heal, and to be an advocate for the patient. She emphasized that this is especially true with the changing healthcare field.

Western New England University College of Pharmacy’s Chapter of Student National Pharmaceutical Association (SNPhA) sponsored a flu clinic at the Costco Pharmacy in West Springfield in January 2013. The clinic allowed learners to counsel numerous patients on the importance of becoming vaccinated.

The Class of 2017 learners eagerly embraced their oath and started their first semester of classes.

Activities and Outreach Western New England College of Pharmacy learners logged a total of 3,749 volunteer service hours (minimum 20 hours per learner) in a variety of University and community settings during the 2012-13 academic year. Here is a sampling of their activities and accomplishments: 38

In February 2013, faculty and learners participated in a health fair in Springfield, MA. The health fair’s focus was on high blood pressure awareness and was titled: “Why Blood Pressure Matters?” Learners and faculty performed blood pressure screenings and consulted attendees on high blood pressure prevention and treatment.

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selected by a committee of staff and alumni. The winners were chosen based on their academics, extracurricular activities, and community service. Alana and the others were recognized at the Skookum Awards Dinner during Family & Friends Weekend in October.

During March and April, several learners were involved with the Thomas J. O’Connor Animal Control & Adoption Center in making a difference in the lives of the animals there. Learners helped with a can and bottle drive that raised $2,400.

Program” at PerformRX in Philadelphia, PA, and traveled to the Academy of Managed Care Pharmacy Educational Conference in San Antonio in October 2013. Only seven students were selected nationally to participate in the program.

The Western New England University College of Pharmacy’s chapter of Academy of Student Pharmacists (APhA-ASP) entered the PharmFlix video contest as part of the APhA 2013 Annual Meeting in Las Angeles, CA, under the supervision of faculty adviser David Baker, Assistant Professor of Pharmaceutical and Administrative Sciences, and studentdirector Tim Pchelka, Class of 2016, won the Best Picture award in the Make Your Mark video contest sponsored by the American Pharmacists Association. To view the video, please go to the following link: www.youtube.com/watch?v=7uHJOVk 5y-w&noredirect=1.

Hannah Facchiano, Class of 2015, participated in the “CVS Management Summer Internship.” During the internship she gained a better understanding of management; at the conclusion of the program, Hannah presented her findings to some members of CVS Corporate Office.

Briana Santaniello, Class of 2015, participated in the “2013 Academy of Managed Care Pharmacy Foundation/Pfizer Managed Care Pharmacy Summer Internship

Meaghan Paris, Class of 2016, was awarded the “International Academy of Compounding Pharmacists Annual Meeting Attendance Scholarship” to attend its “Compounders on Capitol Hill” session meeting in Arlington, VA in July 2013. Meaghan worked with Dr. Shabnam Sani on the submission. Alana Regan, Class of 2016, was selected as one of the Western New England University (WNEU) 2013 Skookum Award winners. She, along with 14 others from WNEU, was nominated by staff and faculty and

Christine Galinski, Class of 2015, was named a Walmart Scholar, a nationwide scholarship award for students who have demonstrated a strong interest in enhancing their preparation for a career in academic pharmacy. The award enabled her to attend the American Association of Colleges of Pharmacy seminars in Chicago, IL in July 2013. Daniel Kennedy, PhD, Assistant Professor of Pharmaceutical and Administrative Sciences is Ms. Galinski’s academic mentor. Grant Stebbins, Class of 2015, received the Massachusetts Society of Health-Systems Pharmacists Student Excellence Award. Gregory Lewis, Class of 2015, represented the College of Pharmacy at the American Pharmacists Association National Patient Counseling Competition in New Orleans in March 2013. Several College of Pharmacy learners and faculty members presented posters at the July 2013 AACP meeting in Chicago, IL. A sampling of those includes: • Erika Prouty, Class of 2015; Michael Derkits, Class of 2014; Dr. Kennedy; and Joshua Spooner, PharmD, Assistant Dean of Student Affairs and Associate Professor of Pharmacy Practice: An Analysis of Supplemental Applications to Pharmacy Programs in the United States

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• Christine Galinski, Class of 2015; Patricia Horosz, Class of 2015; Dr. Kennedy; and Dr. Spooner: Comparison of Introductory Pharmacy Practice Experiences Among U.S. Pharmacy Programs • Grant Stebbins, Class of 2015; Erica Wegrzyn, Class of 2015; Dr. Kennedy, and Dr. Spooner: A Study of Community Service Curriculum Requirements in US Doctor of Pharmacy Programs • Nathan J Harnois, Class of 2015, and Dr. Kennedy: The Role and Responsibilities of Pharmacy Student Government Associations in US Pharmacy Programs • Jeffrey Rovatti (WNE undergraduate); Victoryn Williams, Class of 2016; Ryan Gilmore (WNE undergraduate); Ronny Priefer, PhD, Professor of Pharmaceutical and Administrative Sciences; and Shannon Kinney, PhD, Assistant Professor of Pharmaceutical and Administrative Sciences: Cytotoxic and Growth Inhibitory Effects of Phytoestrogens from Soy in Cancer Cells

Continuing Pharmacy Education and Preceptor Development Conference The College of Pharmacy hosted its third annual Continuing Pharmacy Education and Preceptor Development Conference on June 11, 2013. Ninety-four pharmacists from the local Massachusetts and Connecticut area attended. Sessions included a Pharmacy Law Update, Reach Every Student, JNC8: What to Expect, and Immunization Update. College of Pharmacy faculty presented at the conference.

Faculty News We have several new additions to the College of Pharmacy:

Gregory Herman, Clinical Assistant Professor of Ambulatory Care, received his PharmD from the University of Michigan and his MBA from the University of Phoenix. His PGY-2 residency was in Outpatient Geriatrics and Primary Care Specialty at the VA Hospital in Boston and his PGY-1 residency was in Inpatient Acute Care at the Massachusetts General Hospital. His practice site is UMASS Memorial Medical Center. Mark Klee, Clinical Assistant Professor of Internal Medicine, received his bachelors of Pharmacy and PharmD from MCPHS and completed his ASHP General Pharmacy Practice residency at Buffalo General Hospital. Dr. Klee’s practice site is Wing Memorial Hospital. Maya Leiva, Clinical Assistant Professor of Hematology/Oncology, received her BS in microbiology from San Francisco State University and her PharmD from Loma Linda University. Her practice site is Cooley Dickinson Hospital. Jared Ostroff, Clinical Assistant Professor of Ambulatory Care, received his PharmD from Albany College of Pharmacy and completed a PGY-2 Geriatric Pharmacy residency at Durham VA Medical Center and a general residency at the Jesse Brown VA Medical Center in Chicago, IL. His practice site is Holyoke Health Center. Katelyn Parsons, Clinical Assistant Professor of Ambulatory Care, earned her BS in Pharmacy and PharmD from the University of Connecticut. She completed her PGY-1 Pharmacy residency program at the VA Boston Healthcare System. Dr. Parsons’ practice site is at MassMutual.

Kim Tanzer, Assistant Dean of Experiential Affairs and Associate Professor of Pharmacy Practice, received her BS in Pharmacy from University of Maryland and her PharmD from Massachusetts College of Pharmacy and Health Sciences (MCPHS). At the College of Pharmacy at Western New England, she will be responsible for coordinating the introductory and advanced pharmacy practice experiences (IPPEs and APPEs), which account for roughly 30% of the curriculum.

Jilla Sabeti, Assistant Professor of Pharmacology in the Department of Pharmaceutical & Administrative Sciences, earned her PhD in Pharmacology from the University of Colorado Health Sciences Center and completed postdoctoral training in neurophysiology at The Scripps Research Institute. Dr. Sabeti’s research interests involve investigating several receptor systems in the brain as potential targets of addiction therapeutics and memory-based interventions that could potentially benefit recovery from addiction or other psychiatric diseases.

Courtney Doyle-Campbell, Clinical Assistant Professor of Ambulatory Care, received her BA in Biochemistry and Neuroscience from Smith College and her PharmD from the University of Connecticut. Her current practice site is Riverbend Health Center in Chicopee, MA.

Corey Scheer, Clinical Assistant Professor in Psychiatry, earned her PharmD from the University of Connecticut. She completed her PGY-2 in Psychiatry at the Tuscaloosa Veterans Affairs Medical Center in Tuscaloosa, AL and her PGY-1 in community pharmacy practice at the University of

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Rochester Medical Center in Rochester, NY. Dr. Scheer’s practice site is Mercy Medical Center, Providence Hospital. Some of the College of Pharmacy faculty activities are listed below:

Presentations/Lectures Ron Priefer, PhD, Professor of Pharmaceutical and Administrative Sciences, spoke at the 2013 AACP National Meeting on “Challenges of performing meaningful, welldefined research using undergraduates and/or Pharm.D. students.” He also made two podium presentations at the American Chemical Society (ACS) National Meeting in New Orleans in April 2013 on “Thermolytic and photolytic decay profile of dibenzyloxy disulfides and dibenzyl sulfites” and “Multilayering of pseudo-polyelectrolytes.” Dr. Priefer traveled to the 14th Tetrahedron Symposium in Vienna, Austria in June 2013 to present “Dibenzyloxy disulfides and sulfites: thermolytic and photolytic decay” and “Thermo-stability, rearrangements, and catalysis of cubane compounds.” Daniel Kennedy, PhD, Assistant Professor of Pharmaceutical and Administrative Sciences presented “Identification of novel antagonists of protein disulfide isomerase for inhibition of thrombus formation” at the International Society of Hemostasis and Thrombosis in Amsterdam, the Netherlands in June 2013. His research team was: Flaumenhaft R, Galinski CN, Nag PP, Scalise AA, Dockendorff C, Pu J, Passam FH, Khodier C, von Hessem L, VerPlank L, Dandapani S, Munoz B, Kennedy DR. Dr. Kennedy also presented his paper “Macro-scale acoustophoretic separation of lipid particles from red blood cells” at the International Congress of Acoustics in Montreal in June 2013. His research team was: Dutra B, Rust MJ, Kennedy DR, Masi L, Lipkens B. Clinton Mathias, PhD, Assistant Professor of Pharmaceutical and Administrative Sciences presented at the American Association of Immunologists Meeting in May 2013 in Honolulu. His topic was “The dietary component, curcumin, inhibits the proliferation, survival and function of bonemarrow derived mast cells” and his research team was Shah S, Statham R, Kinney S, Mathias CB. At the same meeting, Dr. Mathias presented “Frequent ingestion of the curry spice curcumin inhibits mastocytosis and suppresses intestinal anaphylaxis in a murine model of food allergy.” His research team was Shah S, Statham R, Gambrah A, Henchey E, Schneider SS, Kinney S, Mathias CB.

Natalia Shcherbakova, PhD, Assistant Professor of Pharmaceutical and Administrative Sciences presented “Acute care utilization in patients with epilepsy on antiepileptic monotherapy” at the 18th Annual Meeting of the International Society for Pharmacoeconomics and Outcomes Research in New Orleans in May 2013. Dr. Shcherbakova also presented at the American Pharmacists Association Meeting in Los Angeles in March 2013. Her topic was “Medication use patterns of antiepileptics and epileptic events.”

Appointments Dr. Daniel Kennedy was installed as Secretary of the Biology section at the AACP Annual Meeting in July 2013. At the same meeting, James Knittel, PhD, Chair and Professor of Pharmaceutical and Administrative Sciences was installed as Chair of the Chemistry section and David Baker, RPh, MBA, and JD, Assistant Professor of Pharmaceutical and Administrative Sciences, was installed as Chair of the History of Pharmacy SIG. Shannon Kinney, PhD, Assistant Professor of Pharmaceutical and Administrative Sciences is serving on the Garver Neuroscience Award Committee in the Department of Neuroscience. Mr. Baker was appointed to the Massachusetts Pharmacists Association Nominations and Awards Committee for 2013. He was also elected Treasurer of the Massachusetts Pharmacists Association Foundation Board for the year. Dr. Shcherbakova was invited (and accepted) to be on the AACP Social and Administrative Sciences Section Special Committee of the National Experiential Consultation Licensure Exam. She also served as an abstract reviewer for APhA Section on Economic, Social & Administrative Sciences for the national meeting in March 2013. Dr. Priefer was invited (and accepted) to be an Editorial Board Member of the Chemistry Central Journal. In the next edition, I will share more of the College of Pharmacy’s activities! All my best and best wishes in 2014! Evan T. Robinson, R.Ph., PhD. Dean, College of Pharmacy

Continuing Education for Pharmacists GLP-1 Agonists Therapy in Individuals with Type 2 Diabetes Mellitus: A Review of Safety and Tolerability Authors: Lalita Prasad, PharmD, MS, BCPS, Assistant Professor of Clinical and Administrative Sciences, Sullivan University College of Pharmacy Kristal L.Williams, PharmD, CDE, Assistant Professor of Pharmacy Practice, Butler University College of Pharmacy and Health Sciences Acknowledgements: Tracy Costello, assistant professor of pharmacy practice, Butler University College of Pharmacy and Health Sciences

Reprinted with permission of the authors and the Indiana Pharmacists Alliance where this article originally appeared. This activity may appear in other state pharmacy association journals. GLP-1 Agonists Therapy in Individuals with Type 2 Diabetes Mellitus: A Review of Safety and Tolerability is one in a series of continuing education articles authored and generously contributed to the Pharmacy Journal of New England as published by the Connecticut and Massachusetts Pharmacists Associations, by the Indiana Pharmacists Alliance.

Learning Objectives: 1. Explain the role of the incretin system in the development of diabetes and discuss the place in therapy for GLP-1 agonists. 2. Compare and contrast the adverse effects and safety profiles of the two FDA-approved GLP-1 agonists, exenatide and liraglutide. 3. Discuss the appropriate use and recommendations of GLP-1 agonists in terms of their safety profile. 4. Discuss the patient education that should be provided upon prescribing and/or dispensing exenatidine and liraglutide based on the REMS system. 5. Discuss the proposed mechanism and risk factors the GLP-1 agonist safety concerns. Recent medication advances in the treatment of type 2 diabetes mellitus (T2DM) have evolved around the incretin system, specifically with a focus on the glucagon-like peptide-1 (GLP-1) hormone. Research has shown that GLP-1 hormones and receptors play an integral and multifactorial role in the homeostasis of glucose via pancreatic and extrapancreatic mechanisms.1,2,3 GLP-1 hormones exert their effects by binding to structurally distinct receptors which are located in the - and -pancreatic islet cells, in addition to the kidneys, lungs, heart, brain, and the nervous system.1,2 Through a constellation of activities, such as stimulating insulin synthesis and release, decreasing hepatic gluconeogenesis, increasing insulin sensitivity and glucose uptake, decreasing glucagon secretion, increasing satiety and decreasing gastric emptying, the native GLP-1 hor42

mones aid in regulating both post-prandial and fasting glucose concentrations.1,2,3 However, shortly after release from the distal L cells of the gastrointestinal tract in a nutrientdependent manner, biologically active native GLP-1 hormones are rapidly cleaved at the N-terminal into an inactive form by the dipeptidyl peptidase 4 (DPP4) enzyme.1,2,3 This cleavage of the biologically active GLP-1, results in a half-life of approximately 1.5 minutes and limits the glucose-lowering action of GLP-1.1,2 In addition to degradation by the DPP4 enzyme, the physiological activity of native GLP-1 is further limited by itsâ&#x20AC;&#x2122; rapid clearance from circulation via the kidney.2 Furthermore, studies have shown the incretin effect, which is the phenomenon that the increase in insulin secretion after oral ingestion of glucose is greater than that seen with IV glucose administration, particularly in postprandial states, is blunted in individuals with T2DM, impeding the achievement of euglycemia, further supporting their use as a viable treatment option.1,3,4 Clinical investigations found that intravenous administration of recombinant human GLP-1 resulted in increased insulin secretion, decreased glucagon release, and subsequently lowered fasting and postprandial levels in individuals with T2DM. While these findings did demonstrate the positive therapeutic outcomes that are associated with restoring and enhancing the incretin action of GLP-1 hormones, clinical use was limited by a short-half life and inconvenient route of administration.1-4 In addition to the aforementioned glucose lowering effects, findings suggest GLP-1 hormones have a positive impact on B-cell proliferation and reduces apoptosis.2,4 Additionally, although further studies are needed, it appears that the both exenatide and liraglutide exhibit the ability to preserve beta cell function and improve cardiac function, including but not limited to improving blood pressure, lipid concentrations, myocardial function, and cardiac output, specifically by reducing left ventricular end diastolic pressure, all of which are possible concomitant medical conditions in patients

Pharmacy Journal of New England • Fall 2013

with T2DM.2,4 Thus, the development of chemically enhanced GLP-1 receptor (GLP-1R) agonists with superior pharmacokinetic profiles and resistance to DPP4 enzyme degradation has become the pharmacological target for the treatment of T2DM.2,4 To date, there are two chemically modified GLP-1R agonists available in the United States, exenatide and liraglutide. Exenatide (Byetta®, Amylin Pharmaceuticals Inc, San Diego, California, and Eli Lilly, Indianapolis, Indiana), a synthetically modulated version of GLP-1 made from the venom of the Gila-monster, was Federal Drug Administration (FDA) approved in April 2005 for monotherapy or combination therapy with metformin, a thiazolidinedione (TZD), or a sulfonylurea to improve glycemic control in patients with T2DM.5 In October 2011, exenatide received FDA approval for its’ use in combination with glargine insulin.5 Exenatide shares 53% homology with native human GLP-1 hormones.2,3,5 Liraglutide (Victoza®, Novo Nordisk Inc, Princeton, New Jersey), on the other hand, is designed by recombinant DNA technology, shares 97% homology to native human GLP-1 hormones, and was FDA-approved in January 2010 as adjunct to diet and exercise to improve glycemic control in patients with T2DM.2,3,6 It is important to mention that unlike exenatide, the manufacturer does not recommend liraglutide as monotherapy.5 Exenatide and liraglutide, which are available via subcutaneous administration, mimic all of the glucose lowering actions of native human GLP-1 hormones.1-4 Specific dosing information can be found in table 1. According the to American Association of Clinical Endocrinologists/American College of Endocrinology (AACE/ACE) Glycemic Control Algorithm for individuals with T2DM published in 2009, GLP-1R agonists are indicated as an option for 1st line therapy, particularly in individuals with elevated post-prandial glucose concentrations.7 Furthermore, it recommends GLP-1R agonists as an option for the second component of dual therapy, in combination with metformin, the cornerstone of therapy, or a TZD.7 Despite their attractive efficacy, as demonstrated by A1c reductions of approximately 0.8 and 1.5% for exenatide twice daily and liraglutide once daily respectively, their associated weight loss, and unique multifactorial mechanism of action, the safety profile of GLP-1R ago-

nists emerges as a concern.3,8 Efficacy, tolerability, and their adverse effect profiles, are some of the key parameters considered when initiating and titrating medication therapy. Clinical trials and post-marketing surveillance for both exenatide and liraglutide have demonstrated concerns with patient tolerability and safety, specifically in regards to gastrointestinal intolerances, pancreatitis, and the possibility of thyroid malignancies.3,8 The purpose of this article is to review the safely profile of GLP-1R agonists and to educate the pharmacist regarding recommendations for their safe use in the treatment of diabetes.

Gastrointestinal Intolerances Gastrointestinal (GI) disturbances, specifically nausea and vomiting, are the most common treatment emergent side effects associated with the use of GLP-1R agonists.3,9,10,11 These GI side effects are most commonly experienced upon medication initiation and dose escalations.8 In most cases, GLP-1R agonist induced nausea and vomiting was transient and classified as mild to moderate.3,10 The nausea associated with GLP-1R agonists is thought to be related to a multitude of effects, including peak drug concentrations at the time of medication exposure, slowed gastric emptying, and stimulation of neutral GLP-1R receptors.10,12 In several studies, GLP-1R agonist associated nausea and vomiting were reported at a higher incidence than non-GLP-1R agonist comparators, such as sulfonylureas, metformin, and TZDs.8 The LEAD-6 study, which compared exenatide 5 mcg twice daily titrated up to 10 mcg twice daily after 4 weeks, to liraglutide 0.6 mg titrated up to 1.8 mg after 2 weeks, demonstrated the duration of GLP-1R agonist induced nausea and vomiting was prolonged with shorter acting agents. In this study, the majority of the liraglutide-treated patients were nausea-free by week 6, compared to week 22 for the twice daily exenatide group.13 Similarly, in the DURATION-1 trial, which evaluated 2 mg exenatide once weekly to 10 mcg exenatide twice daily, a significantly less proportion of patients experienced treatment related-nausea with the long –acting formulation when compared to twice-daily administration.12 Clinical trials report the incidence of nausea between 33 – 57.1% and of vomiting between 12 – 17.4% for exenatide 10 mcg twice daily.9 Nausea rates observed in phase 3 trials of lirglutide 1.8mg daily, were less than those reported with twice daily exenatide and ranged from 7 – 40%.8 For 43

Continuing Education for Pharmacists some individuals, the GI disturbances limited the use of GLP-1R agonist therapy, as witnessed by the GIinduced discontinuation rates of 3 – 9% for exenatide 10 mcg twice daily.9 Strategies to prevent or alleviate GI intolerances associated with GLP-1R agonists include titrating doses conservatively after initiating therapy.10 For exenatide, if nausea occurs upon dosage escalation, maintenance at the lower initial dose of 5 mcg twice daily is appropriate; however, for liraglutide the target dose should be at least 1.6 mg daily, as lower doses are ineffective for glycemic control.5,6 Patients should also be counseled that nausea is most often transient, to eat smaller meals to prevent gastrointestinal intolerances, and, if on exenatide twice daily, to administer the injection immediately prior to meal-time.3 One of the mechanisms by which GLP-1R agonists lower post-prandial glucose concentrations is by delaying gastric emptying. As a result, GLP1R agonists may not be appropriate for individuals with gastroparesis, an autonomic disorder often complicated by hyperglycemia. Exenatide use is not recommended in patients with gastroparesis.5 While the product information for liraglutide does not currently provide any recommendations for its’ use in patients with gastroparesis secondary to insufficient data, the medication guide for Liraglutide instructs patients to inform their healthcare provider if they have or experience symptoms of gastroparesis.6

Table 1: GLP-1 Prescribing Information

GLP-1 Agonist

Adult Dosing

Dosing in Renal Impairment

Exenatide (Byetta®)5

5 mcg twice daily for 30 days then, if tolerated, titrate to 10 mcg twice daily thereafter

Severe renal impairment (creatinine clearance <30 ml/min) or end-stage renal disease: Avoid therapy

Inject subcutaneously within 60 minutes before breakfast and dinner (separate doses by at least 6 hours)

Moderate renal impairment (creatinine clearance 30 to 50 ml/min): Apply caution when initiating or increasing therapy

Available in pre-measured pens of 5- and 10 mcg

Normal renal function: Monitor patients carefully for the development of kidney dysfunction, and evaluate the continued need suspect exenatide induced kidney dysfunction Liraglutide (Victoza®)6 Available in pre-measured pen with a dose titration feature

0.6 mg daily for 7 seven days, then increase to 1.2 mg or 1.8 mg

No renal adjustment needed. Exercise caution when initiating or increasing therapy

Inject subcutaneously daily regardless of timing of meals Note: 0.6 mg daily is ineffective for glycemic control

Hypoglycemia The possibility of hypoglycemia is an ongoing concern for medications with insulin secreting properties, such as GLP-1 agonists, sulfonylureas, and meglitinides, as well as insulin. In clinical trials the incidence of hypoglycemia amongst treatment groups for both exenatide and liraglutide were generally comparable to placebo; and when mild to moderate hypoglycemia was noted, it was associated with sulfonylurea use.1,12,13 Furthermore, despite the improved glycemic outcomes of the long-acting agents, the risk of hypoglycemia with liraglutide daily and exenatide once weekly was less than that observed with sulfonylureas and twice daily exenatide.14 It is hypothesized that the

lower risk of hypoglycemia with GLP-1R agonists is related two distinct characteristics. One characteristic is its’ glucose-dependent mechanism of action. The other is the fact that when an individual’s blood glucose concentration is <65mg/dl (hypoglycemia), GLP-1R agonists do not inhibit the secretion and action of glucagon, thus allowing for a rise in glucose.15 Although, the 2009 American Diabetes Association and the European Association for the Study of Diabetes (ADA/EASD) diabetes management algorithm classifies GLP-1R agonists as less validated tier 2 therapies, it recommends these medications, particularly exenatide (the only FDA-approved GLP-1R agonist at the time of algorithm publi-

Pharmacy Journal of New England â&#x20AC;˘ Fall 2013

cation) as a preferred adjunctive therapy for those individuals with hazardous employment, such as vehicle or machinery operators (i.e. truck, bus, or forklift drivers and airline pilots, etc.) or construction workers in whom hypoglycemia is less desired.16 In clinical trials, patients treated with exenatide monotherapy experienced mild to moderate hypoglycemia at a rate of 4-9%, while 0-12% of patients on liraglutide experienced mild to moderate hypoglycemia, which was lower than the incidence observed with glimepiride monotherapy, where hypoglycemia occurred in 24% of patients.15 However, due to the hypoglycemic risk with concomitant therapy, the prescribing information for GLP-1R agonists includes a recommendation to reduce the dose of secretagogues when used in combination.5,6 Presently, only exenatide is FDA-approved for combination therapy with insulin glargine. Itsâ&#x20AC;&#x2122; prescribing information, likewise recommends considering a dosage reduction for the insulin dose, which should be considered upon GLP-1R agonist initiation and dose escalation to lower the risk of hypoglycemia.5

Pancreatitis And Pancreatic Cancer Post-marketing surveillance reports of acute pancreatitis in patients treated with exenatide prompted the FDA to investigate the causality, and subsequently include pancreatitis as a precaution to the product information for GLP1R agonists (both exenatide and liraglutide). Thirty cases of exenatide-induced acute pancreatitis and six cases of hemorrhagic or necrotizing pancreatitis were cited in the FDA Adverse Reporting System (AERS) in 2008.5 A retrospective chart review utilizing the AERS database was conducted between 2004 and the third quarter of 2009 to determine if there is sufficient data correlating pancreatitis to exentatide use.17,18 Although there were several limitations to the methodology used, the study found a >6-fold increase in the risk of pancreatitis with the exentadine group when compared to the control group (which consisted of patients treated with TZDâ&#x20AC;&#x2122;s, rosiglitazone and two meglitinides: nateglinide and repaglinide).17,18 These findings however, were inconsistent with other data analyses and retrospective reviews, which reported similar incidences of proposed exenatide-induced pancreatitis to the comparators used.17,18 One of these studies, a retrospective review of pharmacy claims data, evaluated the incidence of pancreatitis over a one-year period of 28,000 prescriptions. In this study, 0.13% of the patients treated with exenatide experienced acute pancreatitis, which was compara-

Table 2: Overview of REMS with Exenatide & Liraglutide20-24

REMS Requirements Safety Concerns

Exenatide

Pancreatitis / Pancreatic Cancer

Thyroid Cancer

n/a

Kidney Impairment

Liraglutide

n/a

ble to rates observed with other diabetes treatments, such as metformin or sulfonylureas.19 An additional concern is the risk association between pancreatitis and pancreatic cancer. Regarding pancreatic cancer event rates, the FDA AERS study found a 2.9-fold increase when compared to control agents.18 Regarding possible liraglutide-induced pancreatitis, in clinical trials a total of 7 cases were reported, including acute pancreatitis, chronic pancreatitis, and necrotizing pancreatitis with deaths occurring in five, two, and one case(s), respectively.6 The overall occurrence of pancreatitis was higher in the liraglutide-treated group than that observed with the comparator agents (2.2 vs. 0.6 cases per 1000patient-years).6 Despite these reports, an absolute causation of GLP-1R agonists and pancreatitis has been difficult to establish, as both diabetes and obesity are associated with their own risks of pancreatitis. The risk of developing pancreatitis in an individual with T2DM confers a 2.8-fold increase when compared to individuals without T2DM.15 Obese individuals with T2DM are likely to be prescribed a GLP-1R agonist due to a positive impact on weight reduction and glycemic control; however, these patients are also at a high risk of developing pancreatitis secondary to their concomitant medical conditions. Other risk factors for pancreatitis are hypertriglyceridemia, excessive alcohol intake, gallstones, and history of pancreatitis.20 Specific to exenatide therapy, the incidence of pancreatitis was observed upon dose escalation to 10 mcg twice a day.20 Recommendations are to observe patients for pancreatitis after a dose escalation for both products. 20,21 Both exenatide and liraglutide have boxed warnings in their label information regarding pancreatitis.5,6 As a mandate from the FDA, Amylin Pharmaceuticals Inc. must conduct six post-marketing studies on exenatide to further explore the mechanism, incidence, and risk factors for the 45

Continuing Education for Pharmacists development of acute pancreatitis with and without hemorrhagic and necrotizing complications.22 Practitioners should exercise caution when prescribing GLP-1R agonists for patients at risk of developing pancreatitis and should educate patients of warning signs of pancreatitis and inform them to immediately discontinue therapy and seek medical attention if pancreatitis is suspected.22 If pancreatitis is confirmed, GLP-1 therapy should not be re-initiated.3,5 This is a key educational parameter that should be reinforced by the pharmacist upon medication dispensing.

Thyroid The development of malignant thyroid tumors was found in pre-clinical animal studies amongst rodents who received liraglutide doses that were 8 times higher than the recommended human doses.6,23 In clinical trials, 5 cases of papillary thyroid carcinoma occurred in liraglutide-treated patients, compared to 1 case reported in the non-liraglutide group.c These findings raised concerns about the development of C-cell hyperplasia and medullary thyroid cancer in humans, prompting the prescribing information for liraglutide to carry a boxed warning for thyroid C-cell hyperplasia.23 Although this specific type of cancer is rare in humans, and the FDA warning states that the human relevance of these findings is unclear, liraglutide therapy is contraindicated in patients with a family history of medullary thyroid cancer or in patients with a history of multiple endocrine neoplasia syndrome 2.6 The proposed mechanism by which liraglutide causes C-cell hyperplasia, and possibly cancer, is through increased stimulation of calcitonin release, which is a biomarker for medullary cancer. A 2-year study evaluating calcitonin concentrations in liraglutide-treated patients did not show a difference when compared to other anti-diabetes medications; however, when compared to placebo, concentrations were elevated.21,23 In an effort to attain definitive information regarding the association of liraglutide and thyroid cancer in humans, the FDA has mandated that the manufacturer, Novo Nordisk, institute two surveillance systems. One is to establish a cancer registry to monitor the incidence of medullary thyroid cancer over the next 15 years and the other is to conduct a 5-year epidemiological study, using a large healthcare claims database, to compare the development of thyroid cancer among liraglutide-treated patients to those who are liraglutide na誰ve.21,23 46

The FDA AERS database study also evaluated the present data correlating thyroid cancer to exenatide use.18 It found a statistically significant increase of thyroid cancer in the exenatide-treated group.18 Therefore, Amylin Pharmaceuticals Inc. acknowledges the presence of benign C-cell tumors in rats treated with the exenatide, and has included this information in the package insert.5

Altered Kidney Function Post-marketing reports of both altered and worsening kidney function exist for both exenatide and liraglutide. In November 2009, the FDA released information for healthcare professionals regarding 78 cases of altered kidney function associated with exenatide therapy.24 Between April 2005 and October 2008, 62 cases of acute renal failure and 16 cases of renal insufficiency were noted. Although some cases were reported in individuals with pre-existing renal disease or with at least one risk factor for kidney disease, revisions were made to the product labeling regarding the evaluation for and dosing in kidney dysfunction.24 The product information for liraglutide acknowledges post-marketing reports of increased serum creatinine, acute renal failure, and the development or worsening of chronic renal failure, which in some cases, required hemodialysis.6 Unlike exenatide however, liraglutide is not renally excreted and does not require renal dosage adjustments.5 Common GLP-1R associated side effects, including nausea, vomiting, diarrhea, and subsequent dehydration, may increase the risk of kidney abnormalities.5,6 Exenatide and liraglutide manufacturers recommend caution when initiating or increasing the dose in patients with renal impairment.5,6

REMS The Risk Evaluation and Mitigation Strategy (REMS), was developed by the FDA in an effort to be proactive on patient safety measures once a medication concern is identified. The REMS program is designed to provide both practitioners and patients with information regarding medication safety concerns. In most cases, the REMS will include a communication plan for practitioners and a medication guide for patients. Practitioner information highlights safety considerations, current findings, and makes recommendations regarding appropriate pharmacotherapy for specific patient populations. The patient medication guide informs the individual about possible risk(s), warning signs, and appropriate action to take in the

Pharmacy Journal of New England â&#x20AC;˘ Fall 2013

event of a concern. Both exenatide and liraglutide have a REMS. Table 2 outlines the REMS with these agents. Recent advances in the understanding of the pathogenesis of diabetes have focused on the multiple hormonal deficiencies that result in clinical hyperglycemia. The GLP-1R agonists represent a novel class of treatment agents that add promise to the diabetes treatment armamentarium, as they target these underlying hormonal defects, and may even have the potential to delay disease progression by preserving beta-cell functioning.2,4 Despite their overall benefit on glycemic control, widespread use may be limited by their toxicity profiles. Health care practitioners, including pharmacists, should be aware of treatment-related toxicities, and assess the risk vs. benefit when initiating or escalating therapy with these agents. A clear understanding of patient risk factors for the development of adverse effects, as well as familiarity with the signs and symptoms of potential treatment-related toxicities can aid in disease management. In summary, the GLP-1R agonists can provide an effective means for glycemic control, when used in the proper clinical situation.

12. Drucker DJ, Buse JB, Taylor K, Kendall DM, Trautmann M, Zhaung D, et al. Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomized, open-label, non-inferiority study. Lancet. 2008;372(9645):1240-1250. 13. Buse JB, Rosenstock J, Sesti G, Schmidt WE, Montanya E, Brett JH, et al. Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26 week randomized, parallel-group, multinational, open-label trial (LEAD-6). Lancet. 2009; 374(9683):39-47. 14. Aroda VR, Ratner R. The safety and tolerability of GLP-1 receptor agonists in the treatment of type 2 diabetes: a review [published online ahead of print June 2, 2011]. Diabetes Metab Res. doi:10.1002/dmrr.1202. 15. Campbell RK, Cobble ME, Reid TS, Shomali ME. Safety, tolerability, and nonglycemic effects of incretin-based therapies. Supplement to The Journal of Family Practice. 2010;59(9 Suppl 1):S-5-S9. 16. Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R, et al. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2009;32(1):193-203. 17. Elashoff M, Matveyenko AV, Gier B, Elashoff R, Butler PC. Increased incidence of pancreatitis and cancer among patients given glucagon like peptide-1 based therapy. [published online ahead of print February 18,2011]. Gastroenterology. doi: 10.1111/j.1464-5491.2010.03085.x. 18. Elashoff M, Matveyenko AV, Gier B, Elashoff R, Butler PC Pancreatitis, Pancreatic and thyroid Cancer with Glucagon-like Peptide-1 based therapies. Gastroenterology 2011;141(1):150-156. doi:10.1053/j.gastro.2011.02.018 19. Dore DD, Seeger JD, Chan KA. Use of a claims-based active drug safety surveillance system to assess the risk of acute pancreatitis with exenatide or sitagliptin compared to metformin or glyburide. Curr Med Res Opin. 2009; 25(4):1019â&#x20AC;&#x201C;1027.

References

20. Information for Healthcare Professionals: Exenatide (marketed as Byetta) 8/2008 Update http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatients andProviders/ucm124713.htm Accessed 10.26.11

2. Drucker DJ. The biology of incretin hormones Cell Metabolism 2006:3; 153-165

21. Victoza: Victoza (liraglutide [rDNA origin]) Injection: REMS - Risk of Thyroid Ccell Tumors, Acute Pancreatitis [Posted 06/13/2011] http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedi calProducts/ucm258826.htm Accessed 10.26.11

1. Pinkney J, Fox T, Ranganath L. Selecting GLP-1 agonists in the management of type 2 diabetes: differential pharmacology and therapeutic benefits of liraglutide and exenatide. Ther Clin Risk Manag. 2010;6:401-411.

3. Kruger DF, Bode B, Spollett GR. Understanding GLP-1 Analogs and Enhancing Patient Success. Diabetes Educ. 2010;36(suppl 3):44S-72S. 4. Nauck, MA Incretin-Based Therapies for Type 2 Diabetes Mellitus: Properties, Function, and Clinical Implications. The American Journal of Medicine. 2011;124:S3-S18. 5. Byetta [package insert]. San Diego, CA: Amylin Pharmaceuticals; 2011. 6. Victoza [package insert]. Princeton, NJ: Novo Nordisk; 2010. 7. Rodbard HW, Jellinger PS, Bloomgarden ZT, AACE/ACE Glycemic Control Algorithm Consesus Panel. Statement by the American Association of Clinical Endocrinologists/American College of Endocrinology (AACE/ACE) Consesus Panel on Type 2 Diabetes Mellitus: an algorithm for glycemic control. Available at: http://www.aace.com/pub/pdf/GlycemicControlAlgorithm.pdf. Accessed May 4, 2011. 8. Gilbert Mp, Pratley RE. Efficacy and Safety of Incretin-Based Therapies in Patients with Type 2 Diabetes Mellitus. The American Journal of Medicine. 2009;122:S11-S24 9. Gentilella R, Bianchi C, Rossi A, Rotella CM. Exenatide: a review from pharmacology to clinical practice. Diabetes, Obesity and Metabolism 2009;11:544-556. 10. Ellero C, Han J, Bhavsar S, Cirincione BB, DeYoung MB,Gray AL, et al. Prophylactic use of anti-emetic medications reduced nausea and vomiting associated with exenatide treatment: a retrospective analysis of an open-label, parallelgroup, single-dose study in healthy subjects. Diabet Med. 2010;27(10):1168-1173. 11. Joffe D. Liraglutide: A once-daily human glucagon-like peptide-1 analogue for type 2 diabetes mellitus. Am J Health-System Pharm. 2010; 67(16):1326-1336.

22. Byetta Safety Update for Healthcare Professionals: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatients andProviders/DrugSafetyInformationforHeathcareProfessionals/ucm190406.htm. Accessed 10.26.11 23. Questions and Answers - Safety Requirements for Victoza (liraglutide). http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatients andProviders/ucm198543.htm Accessed 10.26.11 24. Information for Healthcare Professionals: Reports of Altered Kidney Function in patients using Exenatide (Marketed as Byetta)http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforP atientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm188656.h tm. Accessed 10.26.11

About the Authors Dr.Williams is assistant professor of pharmacy practice, Butler University College of Pharmacy and Health Sciences, clinical instructor, Indiana University School of Medicine, and family medicine residency program clinical pharmacist, Indiana University Health Methodist Family Medicine Center, Indianapolis. Dr. Prasad is assistant professor of clinical & administrative sciences, Sullivan University College of Pharmacy, and clinical pharmacist, University of Louisville Adult Internal Medicine Clinic, University of Louisville Hospital, Louisville.

Continuing Education Quiz GLP-1 Agonists Therapy in Individuals with Type 2 Diabetes Mellitus: A Review of Safety and Tolerability 1. Glucagon like peptide-1 (GLP-1) are peptide hormones secreted from the: (Objective 1) a. Gastrointestinal tract b. Kidney c. Liver d. Muscle e. Pancreas 2. Which of the following mechanisms play a role in the development of type 2 diabetes? (Objective 1) a. Abnormal glucagon production b. Altered hepatic gluconeogenesis c. Decreased insulin secretion d. Increased insulin resistance e. All of the above 3. Which of the following statements are TRUE regarding GLP-1 agonists and the side effect of nausea? (Objective 3) a. Commonly experienced upon medication initiation b. Commonly experienced upon dose escalation c. Often transient and classified as mild to moderate d. Occurs at a higher rate with GLP-1 agonist compared to other cornerstone therapies e. All of the above

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4. According to the manufacturer recommendations, which of the following medications should be adjusted by a dosage reduction upon initiation of GLP-1 agonist in an effort to decrease the incidence of hypoglycemia? (Objective 3,5) a. Glipizide b. Insulin c. Nateglinide d. a and b e. all of the above 5. HB, 55-year old female with type 2 diabetes and mild renal impairment, recently completed 2 weeks of liraglutide therapy. Her practitioner is interested in increase her dose from 1.2 mg daily to 1.6 mg daily. Which of the following GLP-1 agonist associated side effects should be evaluated upon the dosage increase? (Objective 3) a. Thyroid Cancer b. Pancreatitis c. Kidney Dysfunction d. b and c e. All of the above 6. The proposed mechanism for C-cell hyperplasia and papillary thyroid carcinoma is: (Objective 5) a. Currently unknown b. Induction dehydration secondary to nausea, vomiting, and diarrhea c. Inhibition of glucagon release d. Stimulation of calcitonin release e. Stimulation of -cells on the thyroid gland

7. Both exenatide and liraglutide require a REMS for which of the following safety concerns? (Objective 4) a. Hypoglycemia b. Nausea and vomiting c. Pancreatitis d. Thyroid Cancer e. Kidney Impairment 8. Patients with which of the following medical conditions and/or factors should not be a candidate for GLP-1 agonist therapy? (Objective 3,5) a. Gastroparesis b. Moderate creatinine clearance (30 – 50 ml/min) c. Machinery operator (i.e. airline pilot) d. Family history of hypertriglyceridemia e. Metformin use 9. In the glycemic control algorithm developed by the American Association of Clinical Endocrinologist and the American College of Endocrinology (AACE/ACE), GLP-1 agonists are recommended as 1st line therapy particularly for individuals with which of the following conditions/factors? (Objective 1) a. Elevated fasting blood glucose concentrations b. Elevated post-prandial blood glucose concentrations c. BMI > 40 kg/m2 d. b and c e. all of the above

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