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Vol 10 No.3 Summer 2013

Summer 2013

Pharmacy Journal of New England 9th Annual New England Pharmacists Convention Eight Tips For Planning Your Retirement Financial Forum

No Refills On Saturday Rx and the Law

The Advancing Treatment Horizon for Relapsed/Refractory Multiple Myeloma Continuing Education


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Pharmacy Journal

Vol 10 • No. 3 Pharmacy Journal of New England • Summer 2013

of New England

Editors

Dear Readers, The summer temperatures were not the only thing heating up this summer in New England. At times, it seems that the practice of pharmacy is the rope in a tug of war contest. More and more, state association offices are fielding calls from concerned pharmacists who are frustrated with workplace issues including new guidelines, immunizations, third party payment issues and prescription quotas. As the New England Pharmacist Convention approaches, we would like to remind you that YOUR state pharmacy association is here to help navigate these difficult times of change. There is no better opportunity than the regional convention on September 19 & 20 at the MGM Grand Hotel to receive updates on cutting edge CE topics, network with colleagues, support the student pharmacists who are the next generation of pharmacy, and visit vendors and exhibitors who are critical to our profession. The registration brochure for the Convention appears in this edition. Please print those pages and send in your registration today!

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

Managing Editor Ellen Zoppo

Editorial Advisory Panel Todd Brown, R.Ph., MHP Thomas Buckley, R.Ph., MPH Sean Jeffery, Pharm.D. John Parisi, R.Ph., CDE Matthew Machado, Pharm.D.

Design & Production Interfacive LLC. www.interfacive.com The Pharmacy Journal of New England is owned and published by the Massachusetts Pharmacists Association and the Connecticut Pharmacists Association. Opinions expressed by those of the editorial staff and/or contributors do not necessarily reflect the views or policies of the publisher.

Sincerely, Margherita R. Giuliano, RPh Executive Vice President Connecticut Pharmacists Association

David Johnson Executive Vice President Massachusetts Pharmacists Association

Readers are invited to submit their comments and opinions for publication. Letters should be addressed to the Editor and must be signed with a return address. For rates and deadlines, contact the Journal at (860) 563-4619. Pharmacy Journal of New England 35 Cold Spring Road, Suite 121 Rocky Hill, CT 06067-3167 members@ctpharmacists.org

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U.S. News

Submitting Articles to the Pharmacy Journal of New England™

New England States

The Pharmacy Journal of New England™ is the product of a partnership between the Connecticut Pharmacists Association and the Massachusetts Pharmacists Association. The Journal is a quarterly publication.

9th Annual New England Pharmacists Convention Rx and the Law, Financial Forum From the Colleges Continuing Education for Pharmacists

All submitted articles are subject to peer review. In order to maintain confidentiality, authors’ names are removed during the review process. Article requirements must conform to the Uniform Requirements for Manuscripts Submitted to Biomedical Journals (Ann Intern Med 1982;96 (1part1):766-71). We strongly encourage electronic submissions. PJNE does not assume any responsibility for statements made by authors.

Please submit manuscripts to: PJNE 35 Cold Spring Rd., Suite 121 Rocky Hill, CT 06067 or email to: ezoppo@ctpharmacists.org

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U.S. News Senate draft proposal would clarify FDA authority over high-risk compounding

• Wholesaling regulations would allow only the company that compounded products to sell them, and all drugs would be labeled “not for resale.”

New Senate draft legislation introduced April 26 would give FDA greater authority over compounding pharmacies and distinguish clearly between traditional compounding pharmacies and compounding manufacturers.

Although state boards of pharmacy would continue to license and regulate traditional compounding pharmacies, the bill would increase communication between states and FDA and encourage communication among states, according to a summary of the draft proposal. For example, if FDA received a complaint from a state regulatory agency about a traditional pharmacy or product, FDA would inform the state pharmacy board.

Drafted by a bipartisan group from the Senate Health, Education, Labor, & Pensions (HELP) Committee led by Chair Tom Harkin (D-IA), Ranking Member Lamar Alexander (R-TN), Pat Roberts (R-KS), and Al Franken (D-MN), the draft legislation “clarifies a national, uniform set of rules for compounding manufacturers while preserving the states’ primary role in traditional pharmacy regulation,” according to a statement from the committee. The draft legislation defines compounding manufacturers as entities that compound sterile drugs without patient-specific prescriptions and sell the drugs across state lines, whereas traditional pharmacies compound drugs based on specific prescriptions for individual patients. In addition, “any entity that pools sterile products or repackages sterile, single-use, preservative-free vials” is a compounding manufacturer, the draft proposal states, and cannot be licensed as a pharmacy.

FDA Investigating Deaths After Olanzapine Pamoate Injections

Following are highlights of the draft proposal:

Kate Traynor

• Compounded drugs would be considered new drugs that are subject to the Federal Food, Drug, and Cosmetic Act. Compounders would not be allowed to compound complex dosages or biologic products made from live organisms. They would also be prohibited from compounding variations of marketed FDA-approved drugs unless the products fulfill a specific patient need or drug shortages occur. In addition, the bill would prohibit compounding of products that are subject to certain Risk Evaluation and Mitigation Strategies unless the compounders use comparable safety controls.

BETHESDA, MD 18 June 2013—Two patients died within days after injection with an appropriate dosage of olanzapine pamoate, a long-acting formulation of the antipsychotic medication, FDA announced today.

• Compounding manufacturers would be required to register with FDA, inform the agency what products they have made, and compound drugs under a pharmacist’s direct oversight. They would also have to comply with current Good Manufacturing Practices, investigate and report adverse events, and label compounded products. • Compounding manufacturers with more than 25 employees would pay an annual fee of $15,000 (with an inflation adjustment) to defray the cost of FDA inspections. 2

“By clarifying FDA authority over high-risk compounding practices, this bill will enhance protections for patients taking compounded drugs and help prevent crises like last year’s tragic meningitis outbreak,” Harkin said in the committee’s statement. The HELP Committee is soliciting feedback from stakeholders on the draft legislation’s merits and potential unintended consequences, as well as how to improve the draft proposal. www.pharmacist.com/senate-draft-proposal-would-clarifyfda-authority-over-high-risk-compounding.

According to the agency, both patients died 3–4 days after their injection and had very high levels of the drug in their bloodstream after death. Olanzapine overdosage is associated with delirium and mild-to-severe sedation, including coma, and other adverse events. Postinjection delirium sedation syndrome (PDSS) refers to delirium and sedation that have been found to affect a small percentage of patients following the administration of olanzapine pamoate. A boxed warning in the labeling (PDF) for olanzapine pamoate notes that patients are at risk for PDSS each time they are given an injection of the drug. A risk evaluation and mitigation strategy (REMS) program (PDF) for olanzapine pamoate that was established in 2009 seeks to minimize patients’ risks for PDSS.


Pharmacy Journal of New England • Summer 2013

The REMS program for olanzapine pamoate, which is marketed as Zyprexa Relprevv by Eli Lilly and Company, includes mandatory enrollment of prescribers and patients. The REMS program also places restrictions on the drug’s dispensing and administration. The program does not apply to other formulations of olanzapine. FDA reminded prescribers that patients are at risk for severe drowsiness, confusion, and disorientation and must be observed for at least 3 hours after the administration of each injection of olanzapine pamoate. All prescribers should follow the REMS program’s requirements and the recommendations in the drug’s labeling, FDA stated. According to FDA, no deaths from PDSS were reported in clinical studies of olanzapine pamoate, and it is unclear whether the two patients whose deaths prompted today’s warning died from PDSS. The investigation into the deaths is ongoing. www.ashp.org/menu/News/PharmacyNews/NewsArticle.aspx ?id=3917

Compounding Legislation Clears First Senate Hurdle Kate Traynor

The Senate Health, Education, Labor and Pensions (HELP) Committee on May 22 passed legislation to improve the safety of sterile compounding and give FDA explicit authority over a new class of drug makers called compounding manufacturers. Senate bill 959, the Pharmaceutical Compounding Quality and Accountability Act, defines compounding manufacturers as entities that compound sterile drug products without a prescription and sell them across state lines or offer to do so. Under the terms of the act, compounding manufacturers would be regulated by FDA and have to follow many of the procedures expected of traditional drug manufacturers, which would remain under FDA’s purview. The act would leave traditional compounding under state supervision. So-called anticipatory compounding by traditional compounders would be permitted if the practice is allowed under state law. Anticipatory compounding would involve “limited quantities” of medication made for a patient when there is a history of the medication’s use and the pharmacy and prescriber have an established relationship with the patient.

The bill’s next stop is to the full Senate for consideration. ASHP stated its support (PDF) for the Senate’s bill and urged the House to draft and pass similar legislation. Janet Woodcock, chief of FDA’s drugs division, on May 9 had urged Congress to act on the bill to help protect patients from tragedies such as last year’s outbreak of fungal infections that were blamed on products made by the New England Compounding Center (NECC). “In the absence of changes, these tragedies will happen again. There is no doubt about this,” Woodcock said. Exemptions for hospitals. The act states that pharmacies within health systems would not be considered compounding manufacturers. Hospitals would remain regulated as traditional pharmacies, even if they ship medications to out-of-state facilities that are part of the health system. Under the terms of the act, any entity other than a hospital or health system that pools sterile products or repackages sterile, preservative-free vials would also be classified as a compounding manufacturer. These exemptions are opposed by the International Academy of Compounding Pharmacies (IACP). IACP Chief Executive Officer David G. Miller, during May 9 testimony before the HELP Committee, pressed for equal treatment of all pharmacies that perform the same drug manipulations as compounding manufacturers. Kasey K. Thompson, vice president of ASHP’s office of policy, planning, and communications, called the idea of grouping hospitals with compounding manufacturers “an applesto-oranges comparison.” “A hospital is a patient care entity that’s preparing a product or doing procedures for the patients they serve. They’re not preparing a large amount of product and storing it in a warehouse for long periods of time. They’re preparing that product in clean-room conditions, taking it to the floor, administering it to that patient by licensed health care professionals who are accountable for that patient,” Thompson said during the hearing. National Association of Boards of Pharmacy Executive Director Carmen P. Catizone also agreed with the exemption for hospitals. He noted that hospitals are closed systems that generate a patient-specific medication order for each drug dose and check for contraindications, drug interactions, and other potential problems before administering the medications.

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U.S. News

continued

If adverse events occur, hospitals have systems in place to identify the cause, contain the problem, and take appropriate actions to protect patients, Catizone said. Compounded drugs. Hospitals have a special interest in the regulation of sterile compounding because they both prepare such products and purchase them from compounding pharmacies. A recent federal survey of 298 acute care hospitals found that 92% of respondents had used compounded sterile products last year. Overall, according to the survey, 95% of hospitals said they made at least some compounded sterile products onsite. But 79% of hospitals reported that they purchased at least some compounded sterile products from outside pharmacies. The survey respondents reported that over 99% of compounded sterile products were prepared from sterile ingredients. Nonsterile-to-sterile compounded drugs accounted for 1% of compounded products used at the hospitals, and roughly a third of them made those products onsite. Medications made by NECC that were associated with fungal infections were produced using nonsterile-to-sterile compounding practices, according to the report. The report stated that 56% of acute care hospitals either changed their practices for the outsourcing of compounded sterile products or planned to do so in response to the outbreak. About 80% of hospitals said they had decreased the outsourcing of compounded sterile products, and half said they had increased their capacity to produce these medications inhouse. Compounding manufacturers. According to a HELP committee memo, the initial version of the Senate bill “clarifies a national, uniform set of rules for compounding manufacturers, while preserving the states’ primary role in traditional pharmacy regulation.” Specifically, the act would require compounding manufacturers to register with FDA each year and report to the agency twice annually the identity and amount of all compounded products sold in the preceding six months. All compounding done by compounding manufacturers would be directly overseen by a pharmacist who is licensed in the state where the compounding takes place. Unlike traditional compounders, compounding manufacturers would be required to follow current good manufacturing practices (cGMPs) that relate to the methods, facili4

ties, and controls used in the manufacture, processing, packaging, and holding of drug products. Compounding manufacturers and traditional compounders would remain exempt from cGMP requirements for drug labeling and new drug applications. Compounding manufacturers would be required to provide specific information on product labels, including the statement “This is a compounded drug.” The act would prohibit wholesalers from selling any compounded drugs and allow compounders to sell their products only to the health care entities that treat the patients who will use the drugs. The products must be labeled “Not for resale.” The act would require compounding manufacturers to investigate adverse events and report them to FDA within 15 days after the compounding manufacturer learns of the event. And FDA would be given explicit authority to inspect the compounding manufacturer’s facilities and examine its records. FDA officials had asked for these provisions during multiple appearances before Congress. At presstime, the bill had not been scheduled for action on the Senate floor. HELP Committee Chairman Tom Harkin of Iowa pledged to work with Senate leaders to schedule a vote on the bill “in a timely manner.” www.ashp.org/menu/News/PharmacyNews/NewsArticle.as px?id=3915

Study: Wiser medication use could cut health costs By Linda A. Johnson, Associated Press

If doctors and patients used prescription drugs more wisely, they could save the U.S. health care system at least $213 billion a year, by reducing medication overuse, underuse and other flaws in care that cause complications and longer, more-expensive treatments, researchers conclude. The new findings by the IMS Institute for Healthcare Informatics improve on numerous prior efforts to quantify the dollars wasted on health care. Numerous experts previously have estimated that tens of billions, perhaps hundreds of billions of dollars, could be better used each year to improve patient care and outcomes and to slow down spending by government health programs, insurers and consumers.


Pharmacy Journal of New England • Summer 2013

The institute, part of data analysis and consulting firm IMS Health, used its proprietary data on prescriptions written by doctors — many of which patients never fill — plus other information to produce a current, more reliable estimate of avoidable costs solely related to medication use. IMS arrived at the $213 billion figure based on six categories in which doctors, patients or both could be making better use of medication, from getting a prompt diagnosis when new symptoms arise to taking medicines as directed by the doctor. Across the six categories, the researchers generally focused on spending on a handful of very common or very expensive diseases — from high cholesterol and blood pressure to HIV and diabetes — for which costs of care and complications are well documented. “There’s even larger avoidable costs if we were to look at all disease areas” where patients aren’t getting optimal care, Murray Aitken, the institute’s executive director, told The Associated Press in an exclusive interview. “There’s a big opportunity for improvement.” The $213 billion equals nearly 8 percent of the more than $2.7 trillion the U.S. spent on health care last year. Those billions could pay for the health care of more than 24 million Americans currently uninsured, according to IMS. And Aitken said more-appropriate use of medication — taking it exactly as prescribed, not taking antibiotics for viral illnesses, preventing medication errors and the like — could prevent 6 million hospitalizations, 4 million trips to the emergency room and 78 million visits to doctors and other outpatient care providers each year. “Those are staggering numbers,” Aitken said. The report, titled “Avoidable Costs in Healthcare,” found the biggest area of waste is patients not taking medicines prescribed by their doctor, either at all or as directed. IMS estimates the cost of such “non-adherence” at about $105 billion a year Reasons for the longstanding problem include patients fearing drug side effects, not understanding complications that can occur without treatment, having mental health issues and not being able to afford their medicines. Price has become less of a factor, though, as there are now relatively inexpensive generic versions of drugs for most diseases. “I think there’s really good, solid evidence that if you adhere to medications, that keeps you out of the hospital,” said M. Christopher Roebuck, president of health policy consultants Rx Economics LLC.

Roebuck, who was not involved in the study, said it’s well done. But he said the estimates of potential savings are “quite conservative” for medication non-adherence and treatment delays. Those delays are blamed for racking up about $39 billion a year in avoidable care costs — due to patients putting off doctor visits and not getting medications they’re prescribed, or doctors not promptly starting treatments proven to prevent expensive complications. “We’ve got a lot of people without insurance who are not routinely going to the doctor, and even some with insurance aren’t,” Aitken said. Other areas of waste noted in the report include: • Prescribing antibiotics inappropriately, as for patients with the flu or another viral infection, costing about $35 billion annually. This can contribute to bacteria becoming resistant to antibiotics, resulting in more expensive treatment and even hospitalization with a future infection. • Medication errors, costing about $20 billion annually. Those include sloppy handwriting leading to the wrong drug or dose being dispensed and doctors not checking to see that the patient is getting better, meaning they’ve been getting the right medicine. Those errors are on the decline due to more doctors using electronic prescriptions and other changes. • Not using generic drugs when they are available, costing about $12 billion annually. That’s a decreasing problem, as strategies of health plans and pharmacies encourage patients to choose generics by setting copayments for brand-name drugs a few times higher than for the generics. Without insurance, generics can cost 90 percent less than brand-name drugs. Today, when a generic is available, it’s dispensed about 95 percent of the time. • Multiple medication confusion, costing about $1.3 billion annually. For elderly patients taking five or more medicines, it’s easy to mix up which pills should be taken when, and for those who are frail, those mistakes can cause serious harm. That problem likely will grow significantly with our aging population. The report will be shared with government, medical and policy groups and other stakeholders in the health system, Aitken said. The institute, whose clients include major drugmakers, noted that its report was prepared without funding from government or the pharmaceutical industry. news.yahoo.com/study-wiser-medication-could-cut-healthcosts-100504412.html 5


New England States Connecticut

President’s Message As I come to the close of what has been an eventful year as President, I would like to take the opportunity to thank my husband and colleagues for their understanding and support. From the many issues such as the compounding tragedy to the constantly shifting demands of insurers , our continued work at identifying potential solutions for working con- Lucrezia Finegan, RPh, President, CPA, 2012-2013 ditions in various pharmacy settings, and our efforts at redefining pharmacy services, there have been very few dull moments. For many years, the CPA has mentored students by offering rotations to University APPE students. From this, they get an inside view of how a statewide membership association operates and the value it brings while advocating on behalf of all pharmacists in all practice settings. With Connecticut now boasting two pharmacy schools, the opportunity for synergy and collaboration has grown. This summer, Deborah Reyes from the University of Saint Joseph School of Pharmacy and Jason Song from the University of Connecticut worked together on a variety of programs to prepare for the Convention, update the website, and manage the Access Health CT assister grant program, to name a few. We believe that the future of pharmacy is bright with talented students already contributing at such a high level.

The CPA website has been completely and modernized over the last 6 months and we are excited to roll it out to our members and the larger pharmacy community. The newly designed site features the Connecticut Pharmacists Foundation and the Connecticut Pharmacy Services Corporation; as well as better organized sections for Pharmacists, Patients and the Public, and Students. I encourage all of you to spend a few moments visiting the new site and let the CPA staff know what you think. At this time, I would like to welcome Dr. Philip Hritcko as he begins her term as President in September, and thank the board members who served with me during 2012-2013. I look forward to seeing everyone at the New England Pharmacists Convention on September 19 & 20 at the MGM Grand Hotel at Foxwoods. Lucrezia Finegan, RPh

Energy Competition and How It Empowers You Are you aware that Connecticut allows you to make an independent choice about your electricity supply? Before the electricity market became deregulated in the 1970s, every residential and commercial customer relied on a single, default utility, in their service area, to generate and deliver electricity supply. With electricity competition in place, this allows electricity suppliers unaffiliated with the utility to manage the supply portion of your electric bills. Electricity suppliers offer customers the choice to decide who supplies their electricity with no change to the delivery of their electricity. Now, members have a choice to decide who supplies their electricity and they can even get rewarded with Energy Plus®. Connecticut Pharmacists Association has partnered with Energy Plus to offer members a Cash Back rewards program. Connecticut Pharmacists Association members who enroll their home or business will still have their electricity delivered by their utility company, but the commodity portion of their bill will be supplied by Energy Plus. Energy Plus supplies electricity to customers in Connecticut, Illinois, Maryland, Massachusetts, New Jersey, New York, Ohio, Pennsylvania, and Texas and rewards their customers with Cash Back.* Here are the Special Details of the Energy Plus Program*:

(L-R) CPA Marketing Director Ellen Zoppo, USJ student Debbie Reyes, UConn student Jason Song and CPA Executive Vice President Marghie Giuliano.

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• For each electric home account you enroll, you’ll receive a $25 Enrollment Bonus after two months of active service AND 3% Cash Back after twelve months of active service annually on the supply portion of your electric bill.


Pharmacy Journal of New England • Summer 2013

• Business electric accounts that you enroll will receive a $50 Enrollment Bonus after two months of active service AND 5% Cash Back after twelve months of active service on the supply portion of your electric bill.

An exclusion for sterile compounding will be added to policies receiving the lower rate. Members receiving this rate whose practice includes sterile compounding should contact Pharmacists Mutual and request a policy change.

Now is the time to take a look at your electric bills and pick a supplier that is right for you. Enrolling with Energy Plus is easy. There are no sign-up fees, cancellation fees, or long-term commitments. Energy Plus is one of the nation’s fastest-growing electricity companies, serving more than 200,000 customers. As one of the only companies to offer superior customer service, green energy options and an ongoing rewards program, Energy Plus is becoming the preferred electricity company for an increasing number of homes and small businesses.*

Pharmacists Mutual expects a significant majority of its members will benefit from the lower rate.

To learn more or to enroll, visit www.EnergyPlusRewards.com/CTPharmacists6132

New Rates for Individual Pharmacist Professional Liability Coverage Pharmacists Mutual Insurance Company announces new rates for individual pharmacist professional liability coverage with most members to receive lower premium. After a comprehensive review of their claims experience, Pharmacists Mutual Insurance Company has begun filing new rates for its Individual Pharmacist Professional Liability coverage. Thomas Claude, Sr. Vice President of Underwriting and Product Development, commented that “Our overarching goals are to ensure we can honor the promises we make by charging adequate rates, provide excellent service to our members, and minimize as much as possible cross subsidies between members with different risk profiles.” As a result, Pharmacists Mutual is introducing new rate classes for individuals performing sterile compounding. Members not performing sterile compounding will receive a modest reduction in premium. Members performing sterile compounding will see a rate increase to reflect the higher risk inherent in their practice.

For more information, contact Pharmacists Mutual at 515.295.2461.

Clayton English Named Pharmacist of the Year Clayton English, Pharm.D., BCPP, an Assistant Professor at the Albany College of Pharmacy and Health Sciences’ Colchester Campus, has been named the 2013 Vermont Society of HealthSystems Pharmacists (VtSHP) Pharmacist of the Year. The award is given annually to a pharmacist who demonstrates extraordinary dedication to the profession of pharmacy, contributes to pharmacy programs, cooperates with the entire health care team, and furthers the profession of pharmacy through community service. “I’m honored to receive this award, which would not be possible without the support of the team of professionals at Fletcher Allen Health Care and, of course, the faculty and students at Albany College of Pharmacy and Health Sciences,” said Dr. English. “I’m proud to be associated with two institutions that consistently make patient care the top priority.” “Dr. English received remarkable praise as well as letters of support, from both pharmacy and physician colleagues. It was clear from these letters that he is an exceptional clinician that has had a very positive impact on his students, pharmacy and physician colleagues, and patients,” said Joseph Aloi, Pharm.D., BCPS, President of the Vermont Society of Health-System Pharmacists. Dr. English teaches (or co-teaches) the following classes at the College:

The current rate for employed pharmacists in Iowa is $144. The new rates will be $139 for members not performing sterile compounding and $299 for members engaged in sterile compounding.

Neurology/Psychology Pharmacy Skills Lab V Drugs of Abuse Complementary Alternative Medicine

The new rates have been approved in Iowa effective August 1 for new policies and October 1 for renewals. The new structure will be rolled out across the country in the next few months.

He also serves as an Adjunct Assistant Professor at the University of Vermont Medical (UVM) School - Dept. of Psychiatry and the UVM School of Nursing.

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New England States

continued

Massachusetts President’s Message Dear Colleagues, An eventful year as President of MPhA has flown by; and thanks to the work of so many, I am pleased to report that we have made significant progress on several fronts. First, I would like to thank all of the attendees, speakers, and Tim Hudd, President, MPhA, 2012-2013 sponsors who supported our annual MPhA Spring Conference held last April at the Four Points in Norwood, MA. It truly was a successful event! Many of you may identify with the organization via our educational conferences. However, we have been working hard to spearhead initiatives to promote and advance the profession. My presidency began with revelations about a mounting death toll and serious illness spreading across the nation traced to the New England Compounding Center located here in Massachusetts. Our ambitious legislative and policy agenda, including a push for provider status for pharmacists, took a back seat to working with the legislature and the Department of Public Health on policies and legislation addressing poor oversight and patient safety. In April we testified on several pharmacy related bills including the Governor's compounding pharmacy oversight bill, H39. That testimony was followed up by numerous meetings with legislators to reshape what was a purely punitive bill into a patient safety bill that provides adequate oversight with clear and transparent policies without giving a black eye to the profession.. That bill has been redrafted with many of the provisions that we requested. There is still work to be done to address several issues in the bill and between now and September when it should come up for a vote - we may be asking for your help. 8

We also led a successful effort to greatly increase the budget of the Board of Pharmacy. The Budget Conference Committee adopted a final number of just over $1.3 million. Thank you to all who participated in this effort. This money, a 750% increase of last fiscal year's budget, is covered by the fees pharmacists, technicians, and pharmacies pay in licensing fees. We have been working closely with the Department of Public Health and the Division of Professional Licensure to ensure that the Board operates in a prompt and transparent manner while ensuring public safety. MPhA organized oral and written testimony in support of H2060, a bill that would grant provider status for pharmacists. Thank you to Tracy Cole, Cam Capaccia, Jenny Van Amburgh and Dr Ann Spires MD, who each gave excellent and compelling testimony. Many others provided impressive written testimony that demonstrates that pharmacists are health care providers and should be recognized as such. We are now working with committee staff to answer their many questions about the implications of provider status so that we can get this bill moving forward. On June 25th, Board Member Matt Machado and two students from Northeastern, Erica Diamantides and Katie Zheng, provided oral testimony in support of S995, An Act authorizing certain pharmacy interns to administer immunizations. We are hopeful that the committee will act quickly on this common sense bill. Written testimony for this bill and others is available in the State section under the Advocacy tab on our website: www.masspharmacists.org. In addition we continue to pursue legislation to regulate pharmacy audits. Although the New England Compounding Center continues to color the perceptions some legislators have of the profession, we hope that a coordinated effort will result in a bill passage this session. The recent announcement by Harvard Pilgrim Health Care (HPHC) that it will discontinue coverage for compounded medications for persons over 18 years of age is a discouraging development for both compounders and the many patients who rely on these medications.


Pharmacy Journal of New England • Summer 2013

Rep. Jeffrey Sanchez, Chairman of the Joint Committee on Public Health, meets with a group of compounding pharmacists to discuss pharmacy oversight legislation at Acton Pharmacy.

MPhA Board member and MIPA Executive Director Todd Brown has been spearheading the effort to encourage HPHC to reconsider this policy and MPhA is providing our full support toward in this effort. Jim Scanlon our Governor of Community Pharmacy and Chairman Barbara Perry hosted a community pharmacy round table discussion event on June 11th, which was designed to engage pharmacists who are employed in this area of practice. We appreciate all of the pharmacists who attended this event to share their perspective on this rapidly evolving area of practice. MPhA Board Members Alicia Mam and Jim Scanlon participated in a student lead health outreach event for the Mission Hill Community. This event was designed to raise public awareness on the value pharmacists have on health.

MPhA visited 4 separate College campuses (MCPHSUniversity Boston and Worcester, Northeastern University, and Western NE College of Pharmacy) over the spring semester to engage students in legislative issues that will inevitably impact future practice. These sessions were very well received. We appreciate the hospitality shown by the Colleges. It has been a very busy year and we have worked very hard to promote and advance the profession. Thank you once again for your membership and support. You will notice the spread in this issue advertizing the 9th Annual New England Pharmacists Convention. We have a great lineup of CE and many options for you to tailor your program to your interest. And, it's a fun venue. If you've never been please consider joining us this year. I hope all of you have a safe and enjoyable summer and I hope to see you this fall! Best regards, Tim Hudd

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New England States

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New Hampshire President’s Message

As incoming president I am both enthusiastic and concerned about representing this great profession in this wonderful state. While I do not have 20+ years’ experience, I have seen all too well what overbearing corporations and hospital administrators can do to our once proud profession. Just 5 Jay Calabro PharmD RPh President NHPA years ago there was a plethora of jobs, manageable days that included pharmacist overlap, and the time necessary to have much needed patient practitioner interaction. Now jobs are in short supply, and pharmacists are being forced to work 12 to 14 hour days with no overlap. Some aren't even allowed to eat! There is a breaking point, and we as a profession have to stand up and make sure pharmacy doesn't get there. Pharmacists need to take our profession back! I hear too many of my colleagues say, "The board of pharmacy will never let that happen." Well... if A Board of Pharmacy protects the patient and the employer protects the company, who protects the pharmacist? Your State association. If we stand together we can make a change; but if we remain divided we will fall. NHPA has had a busy and very productive in 2012. A few of our many accomplishments for 2012 include: 3 pharmacist continuing education programs; all ACPE accredited. We had our second annual north country CE at the Attitash Grand Summit in Bartlett, NH. As well as 2 other CE programs at SERESC in Bedford NH. We actively participated in various legislative activities including lobbyist monitoring efforts and are attempting to pass some new rules, which will help alleviate some of the stress and rigors in the community setting. NHPA awarded 3 student scholarships totaling over $3000 and have established a 501(c) (3) charity to award bigger and better scholarships in the years to come. We issued 3 joint newsletters with NHSHP; sponsored 13 dinner socials everywhere in NH

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from Manchester to North Conway to Gorham. To improve member contact we continue to update our web site www.nhpharmacists.net and NHPA Facebook page. Thank you for your continued support and please feel free to contact us with any questions you might have, we love to hear from our members. Sincerely, Jay Calabro PharmD RPh, President NHPA

New Hampshire Pharmacists are recognized at Annual Holiday Party The Massachusetts College of Pharmacy and Health Science at Manchester sponsored the Annual Holiday Reception on December 12, 2012 at the Manchester Country Club. The celebration was sponsored with support from the NH Pharmacists Association, the NH Society of Health-System Pharmacists and the NH Independent Pharmacy Association. Due to space constraints the following two award recipients Helen C. Pervanas (2012 Cardinal Health Generation Rx Champions Award) and Maura Amrol (2012 NH Technician of the Year) were not highlighted in the winter edition. Read their accomplishments below.

2012 Award Presentations: The Generation Rx Champion Award, new for 2012, recognizes a pharmacist who has demonstrated excellence in community-based prescription drug abuse prevention. The award is intended to recognize outstanding efforts within the pharmacy community to raise awareness of this serious public health problem. It is also intended to encourage educational prevention efforts aimed at patients, youth, and other members of the community. Never has there been a more important time for pharmacists and health care providers to reach out to their communities and send a clear message that prescription drugs, when taken without a prescription, can have deadly consequences. Every 19 minutes, another American dies because of an unintentional drug overdose. Unintentional prescription drug poisonings are now the second leading cause of accidental death in the United States. And every day, another 2,500 Americans between the ages of 12 and 17 abuse a prescription drug for the first time.


Pharmacy Journal of New England • Summer 2013

Pictured from left to right: Shawn Gove, Helen C. Pervanas, Chrysanthe Nagios and Karen Burke.

Pictured from left to right: Dave Lacoste, Maura Amrol, and Charlie Fanaras.

At Cardinal Health, we passionately believe that pharmacists can play a powerful role in reversing these startling trends.

2012 NH Technician of the Year – Maura Amrol

This year’s recipient of the Cardinal Health Generation RX Champions Award is an assistant professor of pharmacy practice at the Massachusetts College of Pharmacy and Health Sciences, Manchester campus. She received both her Bachelor of Science and doctor of pharmacy degrees from MCPHS.

The NH Pharmacy Technician of the Year Awards is cosponsored by the NH Pharmacists Association, the NH Society of Health-Systems Pharmacists and the NH Independent Pharmacists Association. This award is presented annually to a pharmacy technician licensed and practicing in New Hampshire who demonstrates excellence in his/her practice setting, is motivated to learn, exhibits a professional attitude and is dedicated to the profession of pharmacy. To qualify for the award, the recipient must have made significant contributions to pharmacy technician practice, professional organizations, and/or the community.

This year’s recipient has always had an interest in medication and patient safety, and has spent the last decade raising awareness about prescription drug abuse and proper medication disposal. She has participated in many drug disposal events, provided lectures on prescription drug abuse to patients of all ages, and provided education to fellow pharmacists on medication safety. In 2009, she helped coordinate one of the first every drug take-back events in southern NH. She collaborated with the Community Alliance for Teen Safety (CATS) and MCPHS to develop web based e-learning programs on prescription drug abuse for middle school students and parents. This year’s winner also created a new student organization at MCPHS, Student Pharmacists against Rx Drug Abuse (SPARDA), for which she serves as faculty advisor. She has recently taken this dedication to medication safety to a new level, serving as a commissioner for the New Hampshire Board of Pharmacy to work with pharmacists and other healthcare professionals to promote public safety.

This year’s recipient has been working in a pharmacy practice setting for over 30 years, and has been a nationally certified technician since 2001. She currently is a member of the team at The Prescription Center, in Concord, NH, but also has experience in many practice settings. Recently, she obtained certification in specialty compounding from the Professional Compounding Center of America, in Houston, TX. The 2012 NH Technician of the Year was nominated because of her motivation and passion for learning. Additionally, she has been noted for always being a team player and excelling in her ability to train and educate new staff members.

11


New England States

continued

Legislative Update:

Senate Bill 45 - Relative to electronic prescriptions.

May 9, 2013 Prepared by Elizabeth C. Sargent Sheehan Phinney Capitol Group

Sponsored by Senator Nancy Stiles, this bill declares that a prescription subject to the 48-hour exception process under RSA 420-J: 7-b shall be considered approved and shall be filled if the exception process exceeds the 48-hour period.

The 2012 legislative session will be winding down in June. There were a number of key bills that affected pharmacists this year, and some of them were:

This bill is the result of the committee established in 2011, 117 as amended by 2012, 109.

www.gencourt.state.nh.us/legislation/2013/HB0313.html House Bill 313 – Relative to the regulation of the compounding of drugs by pharmacists. Sponsored by Representative Dan Sullivan, this bill provides for regulation of the compounding of drugs by pharmacists. Passed the House with Amendment on March 13, 2013 Passed the Senate with Amendment on May 2, 2013 It will go back to the House for concurrence www.gencourt.state.nh.us/legislation/2013/HB0334.html House Bill 334-FN - Requiring pharmacy interns to register with the pharmacy board. Sponsored by Representative Peter Schmidt, this bill requires pharmacy interns to register with the pharmacy board and comply with rules concerning the functions of pharmacy interns adopted by the board. The bill was amended in the House to include the definition of a pharmacy intern. Passed the House with Amendment on March 13, 2013 Passed the Senate on May 2, 2013 Next stop will be the Governor’s desk www.gencourt.state.nh.us/legislation/2013/SB0038.html Senate Bill 38 - Relative to pharmacy rights during an audit. Sponsored by Senator Sam Cataldo, this bill establishes the rights and procedures for the conduct of audits of the records of pharmacies. Passed the Senate with Amendment on March 21, 2013 Passed the House on May 8, 2013 Next stop will be the Governor’s desk www.gencourt.state.nh.us/legislation/2013/SB0045.html

12

Passed the Senate with Amendment on March 14, 2013 Passed the House on a division vote 247-101 Next stop will be the Governor’s desk www.gencourt.state.nh.us/legislation/2013/SB0092.html Senate Bill 92 - Prohibiting multiple prescription drug failures. Sponsored by Senator Sharon Carson, this bill prohibits a health benefit plan from requiring its covered persons to fail on medications other than what was prescribed by the person’s health care provider more than once. Passed the Senate on March 17, 2013 Introduced and referred to House Commerce and Consumer Affairs Committee The Committee voted on it last week, but they were split. They couldn’t come to agreement so they are meeting next week to work on it some more and vote again to try to get it to the floor of the House unless they retain the bill to work on it over the summer The argument for the bill is that a patient should not have to continue on step therapy if a medication does not work for them; the argument against the bill is that government should not interfere with the doctor/patient/insurance company relationship; this is a new mandate and there is already an external grievance process in place that works

NHPA Scholarship Foundation: Effective March 19, 2013 the NH Pharmacists Association Foundation Inc. received tax exempt status from Federal income tax under section 502 (c) (3) of the Internal Revenue Code. Kudos to Mike Viggiano (NHPA Treasurer) for bringing this mission to fruition. Without his dedication and commitment we would not have met this major milestone for NHPA and for the next generation of pharmacists.


Pharmacy Journal of New England • Summer 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: NHPA Scholarship Foundation PMB # 418 379 Amherst Street Nashua, New Hampshire 03063 Payee NH Pharmacists Association Scholarship Foundation.

New Hampshire recipient of the 1977 A. H. Robbins Award for outstanding community service. Don shared 60 years of marriage with his late wife Jane (McGaw) Palmer who died in 2011. He leaves behind his children, grandchildren, great-grandchildren, nieces and one great-niece. NHPA extends our deepest sympathies to his family and friends. Thank you Don for your years of service, commitment and compassion to our NH citizens.

Visit our website at www.nhpharmacists.com for more details.

Educational Highlights: In Memoriam:

Upcoming Continuing Education Conferences:

Donald R. Palmer 84, died on Saturday April 13, 2013. He was born on August 17, 1028 in Exeter, New Hampshire. Don attended Hampton schools, and graduated from Hampton Academy with the Class of 1946. After graduation he joined the US Coast Guard.

Remember, save the dates for upcoming CE programs in 2013 which are as follows:

In 1954, he graduated from Massachusetts College of Pharmacy. Upon graduation he joined Abbott Laboratories as a sales representative. In 1960, he opened Palmer’s Pharmacy in Hampton and later a second location in North Hampton. A registered pharmacist for 50 years, Don was the

September 8, 2013 December 8, 2013 SERESC, Bedford, NH Details and directions can be found on our website at www.nhpharmacists.net. Also, please join our Facebook page by searching “NHPA”.

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

13


New England States

continued

Rhode Island President’s Message

Summer has arrived and the Rhode Island Pharmacists Association has been hot with activity! On April 3rd, we held our annual Face of Pharmacy Day at the State House. RIPA and RISHP Presidents Dr. Daniel Lefkowitz and Dr. Brian Musiak, both spoke about how the profession of Daniel R. Lefkowitz, Pharm D., MBA, CDOE pharmacy is continuing to evolve and ways to make sure pharmacists stay “necessary and irreplaceable”. Interim Dean of the University of Rhode Island Dr. Paul Larrat expressed his excitement about the brand new College of Pharmacy building and the opportunities it will provide for superior learning to the students who come through the program. Catherine Cordy, Chief officer of the RI Board of Pharmacy, provided her thoughts on pharmacy safety and our duties to uphold the highest standards of practice, while Angela Olenik, a Pharm D graduate this past May, talked about how excited she was to start her career and hopefully achieve great success for herself and the profession. Additionally, Lt. Governor Elizabeth Roberts was graciously able to make an address thanking pharmacists for their contributions to the healthcare team. Overall, it was a great day for pharmacy, with demonstration tables, staffed by APPE students, preceptors, and faculty providing free services to the legislators and the public, such as hypertension and chronic disease screenings, body fat analysis, and medication therapy management and counseling.

This past April, RIPA held its first NASPA/Purdue Pharma sponsored “Know Pain, Know Gain” patient pain counseling competition at the URI College of Pharmacy. Students competed in a pain management clinical skills competition to show off their knowledge of the subject and also a chance to win a $500 prize. We had a great turnout this year, with over 20 students competing. RIPA would like to thank all those students who entered the competition, especially Ryan Bousquet, Class of 2014 who took home the grand prize. We would also like to extend special thanks to judges Jayne Pawasauskas, Pharm D, Kylie Aubin, Pharm D, and Allan Wang, Pharm D. Also volunteering their time was Daniel Lefkowitz, Pharm D, who served as moderator, Jessica Ouellette, Pharm D, competition facilitator, and Stacey Kostarides, Pharm D, acting as the “mock patient”. We look forward to hosting the event again next April. Our annual Foundation’s Spring Seminar CE event, "Protecting, Marketing, and Expanding Your Practice”, was held on May 9th at the Crowne Plaza in Warwick and was a huge success. Over 50 attendees were able to gain CE credit while learning about such interesting topics, including social media in pharmacy, robbery preparedness and prevention, doxycycline prophylaxis initiated by pharmacists for Lyme, as well as an immunization and law update. RIPA thanks speakers Dr. Cody Midlam, Detective Peter Chabot, Dr. Anita Jackson, Heather Larch, RPh, and Dr. Pat Kelly for their hard work and excellent presentations. During lunch, both vendors and student exhibitors engaged participants and passed out raffle tickets for a chance to win a brand new iPad mini, which let Linda Carver, RPh leave with more than just 5 more CE credits. Congrats Linda! In May, Dr. Norm Campbell and William Beaulieu held a Federal and Rhode Island law review session for graduating Pharm D students and pharmacists looking to get licensed in the state. The University Club on the URI campus served a wonderful breakfast, while Dr. Campbell and Mr. Beaulieu shared stories and knowledge of how to practice in an ethical and proficient manner and identified keys issues to focus on when sitting for the MPJE. Thank you Norm and Bill for extending your expertise to the next generation of pharmacists. They will definitely all benefit from it! Last, but definitely not least, our main summer event, the RI Pharmacy Foundation Golf Tournament & Raffle Drawing at lovely Montaup Country Club, was held on June 10th. Former RIPA Presidents Scott Lancellotta and

14


Pharmacy Journal of New England • Summer 2013

Dan Rowan, with help from Bill Beaulieu did a great job setting up this year’s event and over ten foursomes were able to beat out the rain and enjoy a great round of 18 holes on the beautiful Portsmouth course. We had some great scores and lots of door prizes, including gift cards, clubs, and balls were won. Of course, the post-golf dinner would not be complete without our annual raffle drawing. This year Tara Cashman Higgins won the $5000 grand prize with other winners including $1000 winner - Michael Ira Smith, $500 winner Dan Rowan, $250 winners – Celia MacDonnell & Ginger Lemay, Tony Drakos, and Brian Musiak. Thanks to everyone who participated in this year’s tournament and congrats to the winners. RIPF was able to raise a lot of money, which helps us to provide continuing education and scholarships to our members and students. It’s definitely been a busy, fun, and successful last few months. Next on the agenda is planning our upcoming Summer Kickoff meeting to map out the next year. RIPA is also excited to announce our 2013-2014 slate of officers:

Executive Committee:

Kylie Aubin, President, Dan Lefkowitz, Past President Anita Jackson, President-Elect, Lynn Pezzullo, Secretary Dan Rowan, Treasurer Councilors:

Nathan Charpentier 13-15, Kristin Strattman 13-15 Tara Higgins 13-15, Jessica Ouellette 13-14 Stefanie Florenz 12-14 , Sarah Thompson 12-14 Representatives:

Macayla Landi, Student Rep, Heather Larch, RIPF Rep The new officers will be inducted at the RIPA Annual President’s Dinner and Awards Ceremony on Thursday September 19th at Foxwoods, in conjunction with the New England Pharmacist’s Convention! Our yearly awards will also be presented that evening and we have a worthy list of outstanding recipients again this year. As always, if you are interested in being a part of any of these events or would like to join our Association, please visit our website at ripharmacists.org or our Facebook page facebook.com/RIPharmacistsAssociation. We would love to network, share stories, and continue building great relationships among our great associations and their members. Here’s to a great start to the summer and I hope to see you at the NEPC in the fall! Regards, Daniel R. Lefkowitz, Pharm D., MBA, CDOE President, Rhode Island Pharmacists Association

15


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16

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9th Annual New England Pharmacists Convention September 19th & 20th MGM Grand at Foxwoods in Mashantucket, CT Presented By The Connecticut Pharmacists Association, The Massachusetts Pharmacists Association, & The Rhode Island Pharmacists Association www.nepharmacists.org info@nepharmacists.org 17


Schedule of Events Thursday Programming September 19, 2013 7:30 a.m. – 8:00 a.m. *LY[PÄJH[L7YVNYHT9LNPZ[YH[PVU  *VU[PULU[HS)YLHRMHZ[

8:00 a.m. – 5:00 p.m. +LSP]LYPUN4LKPJH[PVU;OLYHW` 4HUHNLTLU[:LY]PJLZPU[OL *VTT\UP[`*LY[PÄJH[L;YHPUPUN 7YVNYHT

8:00 a.m. - 5:00 p.m. 7OHYTHJL\[PJHS*HYLMVY7H[PLU[Z^P[O +PHIL[LZ*LY[PĂ„JH[L;YHPUPUN7YVNYHT

12:00 p.m. – 1:00 p.m. *VU]LU[PVU*OLJR0U 9LNPZ[YH[PVU 9LN\SHY7YVNYHTTPUNZ[HY[ZH[!74

1:00 p.m. â&#x20AC;&#x201C; 2:30 p.m. :\JJLZZM\S+PHIL[LZ4HUHNLTLU[! <[PSPaPUN5L^;YLH[TLU[.\PKLSPULZ 0.15 CEUs ACPE 0106-9999-13-013-L01-P

/V[LS0UMVYTH[PVU 4.4.YHUK/V[LSH[-V_^VVKZ 4.4.YHUK+YP]L 4HZOHU[\JRL[*; 7OVUL! >LIZP[L!^^^MV_^VVKZJVT

The special room rate is $119 per night for a single/double room. To make a reservation call 1-800369-9663 or go to www.foxwoods. com Be sure to use the group code M16259 to take advantage of the special room rate.

Speaker: Debra J. Reid, PharmD, BCADM, CDE, BCACP; Assistant Clinical Professor, Northeastern University, Boston, MA Upon completion of this activity, participants should be able to: 1. Summarize changes in recent diabetes guidelines 2. Review patient factors such as comorbidities in order to tailor individualized diabetes treatment plans 3. Recap the role of the pharmacist in counseling patients with diabetes 4. Assess the placement of the new and emerging data in the continuum of care in the patient with diabetes. 2:30 p.m. â&#x20AC;&#x201C; 2:45 p.m. )YLHR

18


MGM Grand at Foxwoods Casino, September 19th and 20th, 2013

2:45p.m. – 4:15 p.m.

5:20 p.m.– 6:00 p.m.

;OL7OHYTHJPZ[»Z9VSLPU6W[PTPaPUN ;YLH[TLU[VM7Z`JOVZPZHUK 5L\YVWZ`JOV[PJ+PZVYKLYZPU[OL ,SKLYS`

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0.15 CEUs ACPE 0106-9999-13-014-L01-P

Speaker: Charles Caley, Pharm.D., BCPP, Associate Clinical Professor of Pharmacy Practice, UCONN School of Pharmacy and Institute of Living, Hartford, CT Upon completion of this activity, participants should be able to: 1. List validated assessment tools to measure treatment progress for elderly patients 2. Describe common medications used to treat psychosis and neuropsychotic disorders in the elderly 3. Select an optimal antipsychotic MVYHWH[PLU[IHZLKVULMÄJHJ`ZPKL effects, and patient comorbidities 4. Outline the pharmacist’s role in monitoring the use of antipsychotics

6:00 p.m.– 7:30 p.m.

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7:30 p.m.– 9:30 p.m. *7((UU\HS0UZ[HSSH[PVU (^HYKZ )HUX\L[ 47O((UU\HS0UZ[HSSH[PVU (^HYKZ )HUX\L[ 907( [O(UU\HS7YLZPKLU[»Z+PUULY HUK(^HYKZ)HUX\L[

Friday Programming September 20, 2013 6:00 a.m.– 8:00 a.m. *OLJR0U 9LNPZ[YH[PVU,_OPIP[VY :L[<W

6:30 a.m.– 8:00 a.m. )YLHRMHZ[:`TWVZP\T! 6WLU[V[OLÄYZ[H[[LUKLLZ ;OL*YLLWPUN,WPKLTPJ;OL9PZLVM 7YLZJYPW[PVU+Y\N(KKPJ[PVUPU(TLYPJH

4:20 p.m. – 5:20 p.m.

0.15 CEUs ACPE 0106-9999-13-016-L04-P

0.1 CEUs ACPE 0106-9999-13-015-L03-P (Law CE)

Speaker: Michele Matthews, Pharm.D., CPE, Clinical Pharmacy Specialist, Pain Management Center, Brigham and Women’s Hospital ,Boston, MA, & Associate Professor of Pharmacy Practice, MCPHS

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Speaker: Adele Pietrantoni, RPh; CMS, Framingham, MA Upon completion of this activity, participants should be able to: 1. Detail the ACA timeline (what has happened, what is going to happen) 2. Describe how the ACA affects Medicare Part D and other insurance coverage 3. Outline useful provisions related to pharmacists and their patients 4. Provide information on the Marketplace (who is eligible, when does coverage begin) 5. Describe how pharmacists can help their patients and where everyone can go to get help

8:00 a.m. – 8:15 a.m.

>LSJVTL!1HTLZ.HNUVU7OHYT+ )*7:7YLZPKLU[47O("7OPSPW4 /YP[JRV7OHYT+*(*797O" 7YLZPKLU[*7(HUK2`SPL(\IPU 7OHYT+7YLZPKLU[907( 8:15 a.m. - 9:15 a.m. Keynote Address: Effecting Change 0.1 CEUs ACPE 0106-9999-13-017-L04-P Speaker: Armon B. Neel, Jr., PharmD author of “Are Your Prescriptions Killing You?: How to Prevent Dangerous Interactions, Avoid Deadly Side Effects, and Be Healthier with Fewer Drugs” Upon completion of this activity participants should be able to: 1. Describe the history of pharmacy practice over the last 50 years 2. Develop a strategy that encompasses evolving pharmacy practice as a pathway to pharmacy practice for the 21st century 3. Identify the successes and challenges to implementing change

9:25 a.m.– 10:25 a.m. *\[[PUN,KNL4LKPJPUL! 7OHYTHJVNLUL[PJZVU[OL/VYPaVU 0.1 CEUs ACPE 0106-9999-13-018-L04-P

Speaker: Larisa H. Cavallari, PharmD, BCPS, FCCP; Associate Professor, University of Illinois Chicago College of Pharmacy, Chicago, Illinois

Upon completion of this activity, participants should be able to: 1. State the epidemiology and burden associated with prescription drug addiction 2. Examine management factors and strategies for addiction treatment 3. Discuss communication methods and techniques to ensure the optimal care of patients undergoing addiction treatment

Upon completion of this activity, participants should be able to: 1. Summarize the guidelines by the Clinical Pharmacogenetics Implementation Consortium 2. Discuss potential barriers and ILULÄ[Z[VPTWSLTLU[PUNJSPUPJHS pharmacogenetic practice 3. Review examples of institutions that have adopted clinical practice pharmacogenetic testing

7:15 a.m. - 8:15 a.m.

10:25 a.m. - 11:00 a.m.

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19


Schedule of Events Friday Programming September 20, 2013 continued 11:00 a.m. - 12:00 p.m. 7YLZJYPW[PVU+Y\N+P]LYZPVU+L[LJ[PVU HUK7YL]LU[PVU"+\L+PSPNLUJLHUK +,( 0.1 CEUs ACPE 0106-9999-13-019-L03-P (Law CE)

Speaker: Deborah B. Komoroski, Regional Compliance Manager, H. D. Smith Upon completion of this activity, participants should be able to: 1. Identify commonly abused pharmaceuticals and common drug diversion techniques encountered at pharmacies 2. Describe the most effective method of reporting prescription drug fraud and abuse to law enforcement and regulatory agencies 3. Understand DEA expectations and federal regulations related to pharmacists corresponding responsibility for due diligence 4. Be familiar with how to access Prescription Monitoring Programs and utilize other resources that will assist the pharmacy employees in combating Rx fraud and abuse

Student Programming ;LJOUPX\LZ

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11:15 a.m. - 12:30 p.m. *HYLLY7H[O!

CEUs ACPE 0106-9999-13-022-L02-P

10:00 a.m. â&#x20AC;&#x201C; 11:00 a.m. 0U[LY]PL^PUN

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2:00 p.m. -3:00 p.m. ;YHJR0!<WKH[LVU(U[PJVHN\SH[PVU 4HUHNLTLU[MVY=;, 0.1 CEUs ACPE 0106-9999-13-020-L01-P

Speaker: John Fanikos, RPh, MBA, Assistant Director of Pharmacy at Brigham and Womenâ&#x20AC;&#x2122;s Hospital, Boston. Upon completion of this activity, participants should be able to: 1. State the epidemiology, economic burden, and safety goals associated with Venous Thromboembolism (VTE) 2. Identify patient populations at risk for developing VTE 3. Examine strategies for appropriate anticoagulation therapy including understanding differences between traditional and novel oral anticoagulants 4. Recognize the role of the pharmacist in coordination of care for patients requiring anticoagulation ;YHJR00!(K]HUJLZPU[OL[YLH[TLU[VM 7\STVUHY`(Y[LYPHS/`WLY[LUZPVU7(/ 0.1 CEUs ACPE 0106-9999-13-021-L01-P

*VU[PU\PUN,K\JH[PVU *YLKP[Z The Connecticut Pharmacists Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Attendees can earn up to 11.5 hours (1.15 CEUs) of continuing education credit which includes 2 hours (0.2 CEUs) in pharmacy law.

20

Speaker: Kevin Horbowicz, PharmD, BCPS, Boston Medical Center, Boston, MA Upon completion of this activity, participants should be able to: 1. Discuss the pathophysiology and JSHZZPĂ&#x201E;JH[PVUVM7(/ 2. Summarize appropriate medication [OLYHW`IHZLKVU7(/JSHZZPĂ&#x201E;JH[PVU 3. Recommend strategies to assist patients better self-manage their disease

Speaker: Linda Spooner, PharmD, RPh, BCPS; Associate Professor of Pharmacy Practice, MCPHS, Boston, MA Upon completion of this activity, participants should be able to: 1. Select appropriate antiretroviral therapy (ART) for a treatment-naĂŻve /0=PUMLJ[LKPUKP]PK\HSIHZLKVUH patient case 2. Describe crucial patient counseling points that are included when LK\JH[PUN/0=WVZP[P]LPUKP]PK\HSZ about their ART 3. Review the role of newer ARTs in [OLTHUHNLTLU[VM/0=PUMLJ[PVUPU the year 2013 4. Identify key web resources that provide up to date ART information ;YHJR0=!5L^,UNSHUK*VSSLNLÂş7LW[V )V^SÂť:[\KLU[ 7OHYTHJPZ[:LSM*HYL *OHTWPVUZOPW 0.1 CEUs ACPE 0106-9999-13-023-L04-P

Speaker: Jeffrey Bratberg, Pharm.D., URI College of Pharmacy Upon completion of this activity, participants should be able to: 1. Identify products (and active ingredients) routinely used for safe and effective use in self-care conditions ,_WSHPU[OLLMĂ&#x201E;JHJ`KVZHNL adverse effects, and administration of non-prescription medicines 3. Counsel on non-pharmacologic measures for the treatment of common self-care ailments

You may attend any track. You do not have to stay in the same room for all 4 sessions.


;YHJR=!+L]LSVWPUNHUK,TWV^LYPUN ; YHJR=!+L]LSVWPUNHUK,TWV^LYPUN 7YLJLW[VYZ[V;LHJO 7YLJLW[VYZ[V;LHJO ,_[LUKLK;YYHJR!OV\YZ!WTÂś! ,_[LUKLK;YHJR!OV\YZ!WTÂś! WTPUJS\KLZIYLHR WTPUJS\KLZIYLHR 0.2 CEUs ACPE0106-9999-13-028-L04-P

3:10 pp.m. .m. - 4:10 p.m. p.m. ;YHJR0!<UKLYZ[HUKPUN[OL*OHUNPUN ; YHJR0!<UKLYZ[HUKPUN[OL*OHUNPUN / VYPaVUVU7OHYTHJVSVNPJHS /VYPaVUVU7OHYTHJVSVNPJHS 4 HUHNLTLU[MVY([YPHS-PIYPSSH[PVU(- 4HUHNLTLU[MVY([YPHS-PIYPSSH[PVU(- 0.1 CEUs ACPE 0106-9999-13-024-L01-PP

Speaker: William L. Baker, Bakerr,, Pharm.D., UCONN Schools of Pharmacy & Medicine, Farmington, CT Upon completion of this activity activity,, participants should be able to: epidemiology, 1. Summarize the epidemiology, burden, and impact of (AF) burden, current and emerging 2. Analyze current pharmacologic therapy for AF recommendations including guideline recommendations and clinical data 3. Illustrate management strategies in deciding when to switch medication therapies including clinical, economic, and monitoring factors to ensur e the ensure optimal car e of patients with AF care 4. Recognize the rrole ole of the pharmacist in coor dination of car e coordination care and adher ence to therapy for patients adherence with AF ;YHJR00!5L^(K]HUJLZHUK:JPLUJLPU ; YHJR00!5L^(K]HUJLZHUK:JPLUJLPU [OL4HUHNLTLU[VM*67+ [OL4HUHNLTLU[VM*67+ 0.1 CEUs ACPE 0106-9999-13-025-L01-P

Speaker: Nicole Asal, PharmD, Professor ofessor at BCPS Clinical Assistant Pr URI College of Pharmacy & Clinical Providence ovidence V VA A Pharmacy Specialist, Pr Medical Center activity,, Upon completion of this activity participants should be able to: Compare features 1. Compar e and contrast the featur es differentiate that dif ffer ferentiate COPD and asthma current 2. Review the curr ent evidence current on curr ent and emerging COPD medication regimens regimens 3. Discuss lifestyle strategies pharmacists can recommend recommend to their patients with COPD 4. Demonstrate how medication therapy management can be applied to patients with COPD

;YHJR000!;\ILYJ\SVZPZ!<[PSPaPUN[OL ; YHJR000!;\ILYJ\SVZPZ!<[PSPaPUN[OL 7OHYTHJPZ[ 7OHYTHJPZ[ 0.1 CEUs ACPE 0106-9999-13-026-L01-P

Speaker: aker: Booth Wainscoat, Wainscoat, DO; Hartford Hartford, Hartfor d Hospital, Hartfor d, CT activity,, Upon completion of this activity participants should be able to: 1. Identify patients at risk of being ted with Tuber Tuberculosis (TB) infected Tuberculosis from including risks of transitioning from latent to active TB 2. Recognize signs and symptoms of active TB Compare and contrast latent TB, 3. Compare drug-resistant TB active TB, and drug-resistant treatment options treatment treatment changes in 4. Understand treatment ;)WH[PLU[Z^P[OJVUJ\YYLU[/0= ;)WH[PLU[Z^P[OJVUJ\YYLU[/0= ;YHJR0=!,K\JH[PUN7H[PLU[ZHIV\[ ; YHJR0=!,K\JH[PUN7H[PLU[ZHIV\[ 4LKPJH[PVU,YYVY7YL]LU[PVU 4 LKPJH[PVU,YYVY7YL]LU[PVU 0.1 CEUs ACPE 0106-9999-13-027-L05-P

Speaker: Donna Hor Horn, n, R.Ph., DPh, Dir rector ec ctorr, Patient Safety- Community Director, macy ISMP, ISMP P,, Horsham, PA PA Pharmacy activity, Upon completion of this activity, participants should be able to: 1. Describe distinctions between preventable risks and unpreventable unpreventable preventable errors errors 2. Explain how patient education reduce strategies can be used to reduce preventable risks and why medication preventable adherence is a patient safety issue adherence 3. Discuss strategies for explaining the risks associated with a medication to patients 4. Discuss how low health literacy increases medication risks increases

Speaker: Jenny A. V Van a Amburgh, an Amburrgh, gh, APhA, BCACP PharmD, RPh, F APhA FAPhA, Professor and Assistant Dean Clinical Professor fairs Northeaster n for Academic Af ffairs N Affairs Northeastern University - Bouve College of Health Sciences - School of Pharmacy .D., CACP P,, Philip Hritcko, Pharm.D., CACP, RPh., Assistant Dean for Experiential Education & Associate Clinical Pr ofessor UCONN School of Professor Pharmacy Upon completion of this activity activity,, participants should be able to: 1. Describe the generations of ovide ef ffective fective lear ners and how to pr learners provide effective feedback 2. Explor e different difffer ferent lear ning styles of Explore learning inventory tools learning 3. Integrate a variety of active learning and assessment techniques in the learning practice to enhance learning 4. Describe the importance precepting and mentoring of precepting in pharmacy students/r esidents students/residents professional development. 5. professional +LĂ&#x201E;ULMV\YJYP[PJHSYVSLZYLX\PYLKVM +LĂ&#x201E;ULMV\YJYP[PJHSYVSLZYLX\PYLKVM preceptor when teaching critical a preceptor problem solving problem oles 6. Determine which of these rroles appropriate when would be most appropriate assisting a pharmacy student and/or resident utilizing case examples resident 4:20 pp.m. .m. - 5:20 p.m. p.m. ;YHJR0!(:WSP[7LYZVUHSP[`!<WKH[L ; YHJR0!(:WSP[7LYZVUHSP[`!<WKH[L V U[OL5L^+PHNUVZ[PJHUK:[H[PZ[PJHS VU[OL5L^+PHNUVZ[PJHUK:[H[PZ[PJHS 4HU\HS=LYZPVU+:4 4HU\HS=LYZPVU+:4 0.1 CEUs ACPE 0106-9999-13-029-L01-P

Speaker:Megan Ehr Ehret, ret, et PharmD, MS, et, BCPP, BCPP P, Associate Pr Professor, ofessor fessorr, University of Connecticut Upon completion of this activity, activity, participants should be able to: 1. Summarize the changes in the DSM-5 compared compared to the DSM-4 2. Understand the controversies controversies surrounding surrounding the release release of the new DSM-5 3. Examine potential implications that the new DSM-5 may have on psychiatric practice 21


Schedule of Events ;YHJR00!<WKH[LZPU7LKPH[YPJ(Z[OTH 0UJS\KPUN3VUN[LYT,MMLJ[Z 0.1 CEUs ACPE 0106-9999-13-030-L01-P

Speaker: Kathleen B. Kopcza, Pharm.D., BCPS, Clinical Pharmacy Specialist, Pediatrics Director, Baystate Health Upon completion of this activity, participants should be able to: 1. Examine the diagnostic evaluation of childhood asthma and the value of environmental control 2. Determine appropriate pharmacotherapy of childhood asthma including long-term implications 3. Summarize recent updates of national guidelines regarding treatment of asthma ;YHJR000!;VW:OV[!9LJVTTLUKH[PVUZ[V 0UJYLHZL0TT\UPaH[PVU9H[LZ

9LNPZ[YH[PVU 0UMVYTH[PVU Please complete all portions of the registration form. If you register after August 31st, there will be an additional $10 fee. 6USPUL9LNPZ[YH[PVU

Please go to www.nepharmacists.org to register. Deadline for online registration is August 31, 2013. -H_VY4HPS

Fax form with credit card information to 781-933-1109. Please make all checks payable to the New England Pharmacists Convention. Mail form to NE Convention, c/o MPhA., 500 W. Cummings Park, Suite 3475, Woburn, MA 01801.

0.1 CEUs ACPE 0106-9999-13-031-L01-P

Speaker: Jeffrey Bratberg, PharmD,

9LNPZ[YH[PVU8\LZ[PVUZ

URI, Kingston, RI

Please contact MPhA at 781-933-1107 or at

Upon completion of this activity, participants should be able to: 1. Discuss changes in Centers for Disease Control and Prevention (CDC) and Advisory Committee on Immunization Practices (ACIP) immunization recommendations 2. Utilize evidence-based strategies to JVTT\UPJH[L]HJJPULYPZRZHUKILULÄ[Z [VWH[PLU[ZHUKWHYLU[ZPUÅ\LUJLKI`HU[P vaccination messages 3. Explore methods to overcome barriers to adult immunizations

info@nepharmacists.org

;YHJR0=!¸2UV^7HPU2UV^.HPU¹ 7OHYTHJ`7H[PLU[7HPU*V\UZLSPUN *VTWL[P[PVU 0.1 CEUs ACPE 0106-9999-13-032-L01-P

Moderator: Upon completion of this activity, participants should be able to: 1. Identify common medications and treatments used in pain management 2. Illustrate main counseling points and strategies for patients with pain 3. Describe common barriers for providing optimal pain management 22

Cancellations must be made in writing to MPhA. Registration cancellations received prior to 8/31/13, will be refunded less a $25 processing charge per registrant. Cancellations received after 8/31/13 will not be refunded.


To Register On-line, please visit www.nephar macists.org g.

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ply for members of CP CPA, PA, A, MPhA MPh (MA), Member rates apply 5/7(907(=;7(HUK47(9? 5 /7(907(=;7(HUK47(9?

+LSP]LYPUN4LKPJH[PVU;OLYHW`4HUHNLTLU[PU[OL + LSP]LYPUN4LKPJH[PVU;OLYHW`4HUHNLTLU[PU[OL *VTT\UP[` -YPKH`*, * VTT\UP[` -YPKH`*,

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(includes CE, Reception, Friday br eakfast, breakfast, lunch & exhibit hall) Member $160.00

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Non- Member $210.00

(includes CE and Reception) Non- Member $109.00

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(includes CE, br eakfast, lunch & exhibit hall) breakfast, Non-Member $169.00

Member $119.00

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Diabetes Registration Deadline: August 31, 2013 Member $399.00 Non- Member $459.00

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Member $89.00

MTM Registration Deadline: August 31, 2013 Member $395.00 Non-Member $455.00

Student: $35.00 ZLSLJ[PVUZKVUV[PUJS\KL*LY[PÄJH[L7YVNYHTZVY)HUX\L[+PUULY ZLSLJ[PVUZKVUV[PUJS\KL*LY[PÄJH[L7YVNYHTZVY)HUX\L[+PUULY

00UZ[HSSH[PVU (^HYKZ)HUX\L[ UZ[HSSH[PVU (^HYKZ)HUX\L[ (includes Foundation cocktail rreception eception with one fr ee drink ticket) free

Select Banquet:

#__________

MPhA $60.00 per person #__________

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MTM Registration Deadline: August 31, 2013 Member $329.00

CP CPA PA $60.00 per person

Non- Member $379.00

RIPA RIP PA A $60.00 per person

#__________

RIPA RIP PA A $100.00 per couple #__________ free ee with Please note: Foundation cocktail rreception eception fr Conference Thursday rregistration egistration or Full Confer ence rregistration. egistration. $30.00 per person #_____

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$35.00 per person #_____

Diabetes Registration Deadline: August 31, 2013 Member $325.00

Non-Member $389.00

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____________ Printed Name of Contact: _____________________________________________________________________ Address: City: __________________________________________State: _______ Zip: _____________ ____________ Mailing Address: _____________________________________Email: _______________________________________ _______________________________________ T elephone: ____ ____________ Telephone: Association & Member Member Number: Number:_______________________________________________________________ _______________________________________________________________ Practice Setting_______________________________________________________________________________ Setting_______________________________________________________________________________ _____________ Optional

: [\KLU[Z6US`! :[\KLU[Z6US`! University/College___________________________________________________Y _________Y Year of Grad.______________ Grad.__ _____________ University/College___________________________________________________Year Curr ently Enr olled Currently Enrolled

7H`TLU[4L[OVK! Credit Credit Card: Card:

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(payable (payable to New England Pharmacists Convention)

Credit Card Card #:___________________________Security Code#: ________ Expiration Date: ______________ ____________ Credit Card Holders Name:__________________________________________________________________________ ____________ Card Signature:____________________________________________________ Date: __________________________ Signature:____________________________________________________ _____________

23


&HUWLÀFDWH3URJUDPV

®

The American Pharmacists Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

7OHYTHJPZ[ 7H[PLU[*LU[LYLK+PHIL[LZ*HYL*LY[PÄJH[L;YHPUPUN7YVNYHT:LW[LTILY !HT[V!WT The Pharmacist and Patient-Centered Diabetes Care is a newly revised, intensive educational experience designed to equip pharmacists with the knowledge, skills, and confidence needed to provide effective, evidencebased diabetes care. Five self-study modules provide comprehensive instruction in current diabetes concepts and standards of care. The live seminar incorporates case studies and hands-on skills training focused on the situations most likely to be encountered—as well as the services most needed—in community and ambulatory care practice settings. Participants will gain experience evaluating and adjusting drug therapy regimens for patients with type 1 and type 2 diabetes, counseling patients about lifestyle interventions, analyzing and interpreting self-monitoring of blood glucose results, and assessing the overall health status of patients to identify needed monitoring and interventions. SEMINAR LEARNING OBJECTIVES: • Evaluate the overall health status of patients with diabetes in terms of recommended monitoring and interventions, and formulate strategies for closing gaps in care. • Propose modifications to a patient’s drug therapy regimen rooted in evidence-based algorithms for diabetes management. • Recommend dietary interventions to support optimal glycemic control and weight loss (when indicated) in patients with diabetes.

• Analyze and interpret a patient’s self-monitoring of blood glucose results and use the results to identify needed changes in the diabetes management plan. • Demonstrate proper technique for measuring blood pressure, administering injections, obtaining fingerstick samples for blood glucose monitoring, operating blood glucose meters, and performing monofilament foot testing. • Integrate the varied aspects of comprehensive diabetes care into efficient, sensitive, respectful pharmacist– patient interactions that support optimal patient selfmanagement. • Describe ways in which pharmacists can keep abreast of new developments and take advantage of professional opportunities in diabetes care SEMINAR AGENDA: Welcome & Introduction Comprehensive Care Needs Intensifying Drug Therapy Nutrition Counseling Insulin Therapy Hands-On Assessments Special Situations in Diabetes Management Next Steps and Resources Closing Remarks

FACULTY Kristen Rychalsky, PharmD Inpatient Clinical Pharmacist VA Connecticut Healthcare System CONTINUING PHARMACY EDUCATION (CPE) CREDIT: RELEASE DATE: 2/1/2012 Successful completion of the live seminar component involves passing the final exam with a grade of 70% or higher and demonstrating competency in blood pressure testing, self-injection techniques, diabetic foot exam, and blood glucose testing. Successful completion of these components will result in 8 contact hours of continuing pharmacy education credit (0.8 CEUs). ACPE UAN: 202-999-12-107-L04-P Successful completion of the self-study component involves passing the self-study assessment with a grade of 70% or higher and will result in 15.0 contact hours of continuing pharmacy education credits (1.5 CEUs). ACPE UAN: 202-999-12-108-H04-P The Pharmacist & Patient-Centered Diabetes Care was developed by the American Pharmacists Association and is co-sponsored by the American Association of Diabetes Educators.

+LSP]LYPUN4LKPJH[PVU;OLYHW`4HUHNLTLU[:LY]PJLZ:LW[LTILY !HT[V!WT Delivering Medication Therapy Management Services is an innovative and interactive training program that explores the pharmacist’s role in providing MTM services to patients. This activity teaches pharmacists the essential skills necessary to become a successful MTM practitioner. The certificate training program will enhance pharmacists’ clinical expertise in evaluating complicated medication regimens, identifying medication-related problems, and making recommendations to patients, caregivers, and health care professionals. GOALS OF THIS PRACTICE-BASED PROGRAM: • Advance public health and patient care through improved medication use. • Provide training to enhance pharmacists’ ability to effectively provide MTM services. • Motivate increased numbers of pharmacists to establish MTM services. • Communicate benchmark practices for providing MTM services. Delivering Medication Therapy Management Services certificate training program is conducted in three parts – self-study activity and pre-seminar exercise; live interactive seminar; post-seminar exercise. A Certificate of Achievement will be awarded to participants who successfully complete all program components, including an evaluation form.

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For a complete list of learning objectives, please go to APhA’s website, www.pharmacist.com/ctp/MTM. For all APhA accreditation information and policies please visit www.pharmacist.com/education. SEMINAR AGENDA: The Patient Interview Pre-Seminar Case Review: Communication Barriers Case Study: William Documentation The Medication Therapy Review Case Study: Carl Setting Therapeutic Goals Medication-Related Action Plan Standardized Case Review: Toni Recommendation to Other HealthCare Professionals Cultural Sensitivity The Senior Patient Case Study: Donna Staying Current Standardized Case Review: Toni Implementation SWOT Analysis Setting Business Goals and Recruiting Patients Billing Concepts, CPT Coding, and Measuring Outcomes Take Home Points and Post-Seminar Assignment Patient Case Assessment Discussion Evaluation and Adjournmen

FACULTY: Meghan Wilkosz, PharmD, Clinical Pharmacy Specialist – Acute Medicine VA Connecticut Healthcare System West Haven, CT Susan Holden, PharmD Clinical Pharmacist VA Boston Healthcare System West Roxbury, MA CONTINUING PHARMACY EDUCATION (CPE) CREDIT: RELEASE DATE : 2/1/2012 Successful completion of the self-study component will result in 10.0 contact hours of continuing pharmacy education credits (1.0 CEUs). ACPE UAN: 202-999-12-002-H04-P Successful completion of the live seminar component will result in 8 contact hours of continuing pharmacy education credit (0.8 CEUs). ACPE UAN: 202-999-12-001-L04-P Successful completion of the post-seminar exercise will result in 3.0 contact hours of continuing pharmacy education credit (0.3 CEUs). ACPE UAN: 202-999-12-003-H04-P Activity Requirements: Internet connectivity and Adobe Acrobat Reader are required for participation in this activity.


Pharmacy Marketing Group

Rx and the Law

a. The pharmacist is unable to contact the prescriber after reasonable effort.

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.

b. Failure to refill the prescription might result in an interruption of therapeutic regimen or create patient suffering.

No Refills On Saturday Pat was working a long shift on Saturday at the Anytown Pharmacy. He was hoping for an uneventful day. Sometime after lunch, Mrs. Jones came in for a refill of her Keppra. When Pat looked at Mrs. Jones’ profile, he saw that there weren’t any refills remaining. To make matters worse, Mrs. Jones’ physician, Dr. Brown, had just recently retired and closed his practice. With no refills left and no one to call, Pat’s afternoon just got longer. The solution to Pat’s dilemma depends on his state’s pharmacy laws. Many states have regulations that deal with situations where no additional refills are authorized. In the old days, many pharmacists would give the patient enough medication to get them through until Monday when the physician’s office opened. However, there was no legal authority for doing this. That is not always true today. Consider this excerpt from a statute from Ohio1 that allows a pharmacist to dispense medication when a prescription is out of refills;

c. The pharmacist informs the patient or the patient’s representative at the time of dispensing, and the practitioner at the earliest convenience that prescriber reauthorization is required. The major difference is that the quantity is not limited to a 72 hour supply. The limitation is for a period of time reasonably necessary to secure an authorization. In contrast, Alaska doesn’t have a similar provision. In fact, their regulation3 says; If there are no refill instructions on the prescription drug order, or if all refills authorized on the original prescription drug order have been dispensed, a pharmacist shall obtain authorization from the prescribing practitioner before dispensing a refill. But remember, Pat’s dilemma is a little more complicated than these laws address. Pat has no one to call on Monday morning; Dr. Brown has retired. Again, depending on state law, Pat may have his answer. Iowa has a regulation4 that provides;

(4) The amount of the drug that is dispensed or sold under this section does not exceed a seventy-two hour supply as provided in the prescription.

Prescription drug orders and medication orders shall be valid as long as a prescriber/patient relationship exists. Once the prescriber/patient relationship is broken and the prescriber is no longer available to treat the patient or oversee the patient’s use of a prescription drug, the order loses its validity and the pharmacist, on becoming aware of the situation, shall cancel the order and any remaining refills. The pharmacist shall, however, exercise prudent judgment based upon individual circumstances to ensure that the patient is able to obtain a sufficient amount of the prescribed drug to continue treatment until the patient can reasonably obtain the service of another prescriber and a new order can be issued.

If Pat was practicing in Ohio and believed that the Keppra was needed to continue therapy for Mrs. Jones’ chronic condition, then Pat could dispense a 72 hour supply. If Pat was practicing in Iowa, then a similar law2 would apply. The relevant parts are;

In this situation, Pat has little anxiety taking care of Mrs. Jones until she can make an appointment with her new physician. The first lesson we can learn from Pat’s dilemma is to make sure that we are familiar with our own state’s laws and regulations and to know where to look for these answers.

2. A pharmacist may exercise professional judgment by refilling a prescription without prescriber authorization if all of the following are true:

What if we aren’t lucky enough to practice in a state where laws have been passed to address these situations? We, as well as Pat, are then faced with a legal and ethical dilemma.

(3) In the exercise of the pharmacist's professional judgment: (a) The drug is essential to sustain the life of the patient or continue therapy for a chronic condition of the patient. (b) Failure to dispense or sell the drug to the patient could result in harm to the health of the patient.

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Pharmacy Marketing Group We are forced to use our professional judgment. Any further dispensing, which is a violation, must be weighed against the potential harm to Mrs. Jones. Is the medication essential to Mrs. Jones’ health? Is she likely to suffer harm if she goes without her Keppra? Essentially, this is performing the triage required in Ohio and Iowa. What is the correct answer? That will depend on the circumstances presented. A pharmacist can’t be forced to break the law, that is, to dispense a prescription drug without a valid prescription5. But there could be circumstances where the pharmacist might want to put the patient’s welfare ahead of their own. That is the exercise of one’s professional judgment. That exercise will be easier and less stressful to perform if the pharmacist is prepared with a knowledge of their own state’s laws and regulations. 1. ORC 4729.281 2. Iowa Code 155A.29 3. 12 AAC 52.470 4. IAC 657-8.20 (155A) 5. Chiney v. American Drug Stores Inc., 21 S.W.3d 14 (Mo.App. W.D., May 2, 2000) © 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.

Eight Tips For Planning Your Retirement A few simple steps to help you get started on the right foot Planning financially for retirement may feel overwhelming. For some, that feeling is what keeps them from really focusing on and implementing a plan. If you haven’t started planning for your retirement – do yourself a favor and make TODAY the day you begin.

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1. The earlier the better. Time is definitely one of your greatest allies. A person who begins contributing a modest amount to a retirement plan in their early twenties could end up on par with someone who contributes much more aggressively but does not start until their mid-thirties. Even if you have to start small, start now. Whatever amount you can afford to set aside for later, do it – and let it grow. If you don’t have the luxury of starting young, don’t waste time worrying about it. Start now. You’ll never again be younger than you are today.

2. Be smart about what you’ll need. Yes, it’s true – the senior discount is alive and well, and the general cost of living may be less for those who have retired. But don’t forget, there are other costs to consider. Your healthcare costs, for example, may be greater in retirement simply because you’re not as healthy as you were in your youth. Additionally, you’ll want to take inflation into account. If you plan your retirement based on the cost of living and income of your 30’s, by the time you hit your retirement years, you may find you greatly underestimated your needs.

3. Be smart about how long you’ll need it. When Social Security was being developed, in the 1930’s, a male retiring in the United States was really only expected to live about 12 years past his date of retirement.1 However, the average life expectancy of a United States citizen has risen fairly steadily throughout the last fifty years.2 Depending on when you retire, you may need to plan for 20 or more years of income.

4. Take advantage of tax-deferred contributions. It sounds like a no-brainer, but sometimes people determine how much they can afford to contribute to a retirement account based on their net income, rather than their gross income. You may decide you can only afford $50 less per paycheck, net. But remember that some contributions, like those to your 401(k) for example, may be made with pre-tax dollars. That means you can afford to contribute a bit more from your gross income and still only “miss” $50 from your net income. This is an important consideration.


Pharmacy Journal of New England • Summer 2013

5. Take advantage of matching contributions.

8. Get help.

If your employer offers a 401(k) match – consider scrimping here and there in order to take maximum advantage of it. It’s a very positive domino effect. The more you contribute, the more you earn in matching contributions (up to the maximum allowable amount). Think of it this way – if your employer offers a 50% match, then for every $100 you don’t contribute, you’re missing out on $50 in “free money”. You’re also missing out on the growth potential of that money as well.

These retirement tips are intended to help you get started down a path toward, potentially, a more successful retirement. But they’re just that – a starting point. While it’s definitely important to educate yourself and understand your finances, seeking the assistance of a financial professional may be one of the best moves you could make.

6. Do the math.

Pro Advantage Services, Inc./Pharmacists Mutual is independent of Berthel Fisher & Company Financial Services Inc. Berthel Fisher & Company Financial Services, Inc. does not provide legal or tax advice. Before taking any action that would have tax consequences, consult with your tax and legal professionals. This article is for informational purposes only. It is not meant to be a recommendation or solicitation of any securities or market strategy.

This might be the most important retirement tip of all. Block off some time to sit down and do some calculations. Consider the different levels of contributions you could make and calculate how far those could take you by the time you reach retirement. Once you see what you COULD achieve, you may be more motivated to increase your contributions.

Provided by courtesy of Pat Reding, CFP of Pro Advantage Services Inc., in Algona, Iowa. For more information, please call Pat Reding at 1-800-288-6669. Registered representative of and securities offered through Berthel Fisher & Company Financial Services, Inc. Member NASD & SIPC

1. google.com/publicdata?ds=wb-wdi&met=sp_dyn_le00_in&idim=country:USA&dl= en&hl=en&q=life+expectancy [10/29/10] 2. www.newretirement.com/Planning101/Retiring_Too_Soon.aspx [10/25/10]

7. Trim the fat. Keep careful track of your spending for one month (if you bank online, you may have access to tools that help you do this). After one full month, sit down and take a careful look at what you spent money on. Did it all make sense? Was some of it frivolous? Any regrets? Taking a close look at exactly where your money is going is often the best way to discover areas that need improvement, and ways you could adjust your spending habits. Add up all the money you feel you spent unnecessarily, then add that amount to the contribution math you did previously … how much further might that extra monthly contribution have taken you?

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From the Colleges University of Connecticut School of Pharmacy Dear Friends

Pharm.D. Student Researcher of the Month

As many of you may know, Dr. Robert McCarthy stepped down as dean of the School of Pharmacy as of June 30, 2013. I am honored to serve as interim dean while the university conducts a national search for a new dean. This search is proceeding quickly; the university has hired a nationally recognized search firm (Isaacson, Miller) to assist the search committee which will be chaired by Dr Gregory Weidemann, dean of the College of Agriculture and Natural Resources. I encourage each of you to share your thoughts and/or nominations for the dean position with the search firm or search committee. I will keep the friends of the school informed as the search progresses.

The UConn Rho Chi Honor Society and the School of Pharmacy Honors and Professional Research Committee announced the following recipients of the Student Researcher of the Month Award: April 2013 – Michael Ha, Advisor: Dr. John Morris; May 2013 – Chien Lo, Advisors: Drs. Richard Gannon and Michael Nailor.

I would be remiss if I did not thank Dr. McCarthy for his 11 years of dedicated service to our school. The school has become one of the nation’s premier schools of pharmacy due in large part to Dr. McCarthy’s tireless efforts on our behalf. My goals for the year are to ensure we lose no momentum, pass on no opportunity, and solidify and organize our current outstanding efforts such that we put the best foot forward to potential candidates for the permanent dean position. My task has been made much easier by the outstanding efforts of Dr. McCarthy.

News From The Associate Dean On May 11, 2013, the Class of 2013 graduated with 93 PharmD students, nine with honors and 13 as Urban Service Track Scholars. Approximately 95% of this class have confirmed job or residency commitments. The Class of 2017 will begin their first year of UConn pharmacy school on August 26, 2013. This is a highly qualified class of 102 students who will enter with a math/science prerequisite GPA of 3.4; the majority of students completed their pre requisite coursework at UConn. Eleven students have previously earned bachelor degrees and one student will have a master’s degree prior to being enrolled into the Pharm.D. Program.

28

NIH Study Section Chair Dr. Amy Anderson, professor of medicinal chemistry has been appointed chair of the Drug Discovery and Mechanisms of Antimicrobial Resistance Study Section at the Center for Scientific Review, National Institutes of Health

School Faculty Continue Their Tradition of National Leadership and Recognition Dr. Sean Jeffery, clinical professor, is currently serving as president of the American Society of Consultant Pharmacists; Dr. Lisa Holle, assistant clinical professor, is currently serving as president of the Hematology Oncology Pharmacy Association; and Dr. Philip Hritcko, assistant dean for experiential education and associate clinical professor has been elected speaker of the House of Delegates of the American Association of Colleges of Pharmacy. Dr. William Baker received the American College of Clinical Pharmacy Young Investigator Award and Dr. Craig Coleman received the best publication by a pharmacist award from the American Society of Health-System Pharmacists.


Pharmacy Journal of New England • Summer 2013

University of Saint Joseph School of Pharmacy $548,000 for 2 years. Dr. Ola Ghoneim is the Lead Principal Investigator, while Dr. Ashraf Khalil, of Qatar UniversityCollege of Pharmacy is Co-lead Principal Investigator. The title of the research project is “Microwave-Assisted Organic Synthesis and Pharmacological Evaluation of NArylpiperazine Analogs as Serotonergic Ligands: A Novel Potential Treatment for Children with Autism Spectrum Disorders”. Newly synthesized N-arylpiperazines will be incorporated into a hybrid serotonergic ligand via a metabolizable linker. This will be followed by pharmacological screening of the synthesized compounds in vitro at both 5HT transporter and 5-HT1B/1D autoreceptors. APPE Student Ashley Riendeau Reviews Antibiotic Regimens At Waterbury Hospital.

P3 Students begin their Advanced Practice Rotations The Class of 2014 began their final year of schooling with the start of their Advanced Pharmacy Practice Experience (APPE) rotations. Students will be visiting sites in Alaska, Nevada, Arizona, Florida, California, Texas, Washington DC and thirteen other states. Students are reporting their successes including interventions, reviews, presentations and immunizations. Also, the students are returning to the Hartford Campus twice a rotation to present cases and listen to speakers on topics such as Drug Abuse in Teens, International outreach, Alzheimer advocacy, pharmacy organizations as well as practical topics such as CV writing and personal financial management.

Dr. Dora E. Wishkirchen published in the International Journal of Antimicrobial Agents Dr. Dora E. Wishkirchen has had the following article published in the International Journal of Antimicrobial Agents. Impact of various conditions on the efficacy of dual carbapenem therapy against KPC-producing Klebsiella pneumoniae Dora E. Wiskirchena, Jared L. Crandonb, David P. Nicolaub,c,

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 recently got a research grant award from Qatar National Research Fund-National Priority Research Program for

Dr. Sanjaykumar Gayakwad assumes duty as Assistant Professor at University of Saint Joseph Dr Sanjay Gayakwad assumed duty on April 22nd 2013 as Assistant Professor in Pharmaceutical Sciences at University of Saint Joseph (USJ) School of Pharmacy at Hartford, Connecticut 06103. He got his PhD from Mercer University, College of Pharmacy and Health Professions at Atlanta, GA. His areas of specialty are Pharmaceutics, Biopharmaceutics and Pharmacokinetics. He moved to USJ from Department of Pharmaceutical Sciences, School of Pharmacy & Health Professions, University of Maryland Eastern Shore, Princess Anne, MD.

Dr. Prashant Mandela assumes duty as Assistant Professor at University of Saint Joseph Dr. Prashant Mandela joined University of Saint Joseph, School of Pharmacy, on July 1, 2013, as an Assistant Professor in Biochemistry and Pharmacology in the Department of Pharmaceutical Sciences. His areas of expertise include Pharmacology, Physiology, Cardiovascular Biology, Neurobiology and Endocrinology. His research interests are in modeling neuropsychiatric and neuroendocrine disorders in rodents, identifying the altered molecular circuits, and targeting these circuits to achieve a therapeutic outcome. He obtained his Ph.D. Degree in Pharmacology from University of Mississippi Medical Center, Jackson, Mississippi. Before joining USJ, he was a postdoctoral associate at the University of Connecticut Health Center.

29


From the Colleges

continued

Northeastern University School of Pharmacy Bouvé College of Health Sciences Greetings alumni, colleagues and friends. We are pleased to provide readers of the Pharmacy Journal of New England with this update of recent activities at Northeastern University School of Pharmacy.

Faculty News: Recent Appointments and Recognitions:

Jennifer S. Bhuiyan, PharmD, Assistant Clinical Professor John Devlin, PharmD, named Distinguished Scholar and Fellow of the National Academies of Practice Margarita DiVall, PharmD, named to the Editorial Board of the American Journal of Pharmaceutical Education Danielle Gingras, PharmD, Assistant Clinical Professor Tonya Konry, PhD, Assistant Professor Thomas M. Matta, PharmD, Assistant Clinical Professor Steven D. Pizer, PhD, Associate Professor Jenny Van Amburgh, PharmD, named Distinguished Scholar and Fellow of the National Academies of Practice Anita Young, EdD, appointed to the Continuing Pharmacy Education Commission of the Accreditation Council for Pharmacy Education

Promotions: Debra Copeland, PharmD, Associate Clinical Professor John Devlin, PharmD, Professor Jason Lancaster, PharmD, Associate Clinical Professor Jenny Van Amburgh, PharmD, Clinical Professor

Grants: Mansoor Amiji, PhD, awarded $35,108 by Children’s Hospital/Harvard Medical School for his work in collaboration with Dr. Morris White entitled “Hepatic Insulin Resistance and Metabolic Disease”.

30

Kathy Bungay, PharmD; Carla Bouwmeester, PharmD; Christine Chim, PharmD; John Devlin, PharmD; Michael Conley, PharmD; and Debra Reid, PharmD; awarded $1,200 from the National Association of Chain Drug Stores for the NACDS Foundation & Million Hearts 2013 for the “Heart to Heart Community Health Fairs Initiative”. Heather Clark, PhD, awarded $304,255 by the National Institutes of Health for her work entitled “Polymer-Free Nanosensors to Visualize Biochemical Dynamics in Dendritic Spines”. Richard Deth, PhD, awarded $47,500 by A2 Corporation for his work entitled “Opiate Peptide Effects on DNA Methylation and Gene Expression” and $34,000 for his work entitled “Characterization of Multiple Opiate Signaling Pathways”, and $40,000 from the Autism Research Institute for his work entitled “Metabolic Factors Affecting Gamma Synchrony: A Collaborative Research Proposal”. Vladimir Torchilin, PhD, awarded $9,630 by Immix Biopharma LLC for his work entitled “Testing the Construct Targeting CA IX Receptor and Delivering NFkb Inhibitor to Cancer Cells”.

Faculty Awards and Honors: Elizabeth Hirsch, PharmD, received the Schumacher Award for distinguished scholarship. Vladimir Torchilin, PhD, received the lifetime achievement award from the Journal of Drug Targeting which recognizes scientists who have made exceptional and sustained contributions to drug delivery and targeting. Barbara Waszczak, PhD, received the Bouvé College Distinguished Educator Award for commitment to teaching excellence. Lin Zhu, PhD, received the American Cancer Society’s Ellison Foundation Postdoctoral Fellowship Award.


Pharmacy Journal of New England • Summer 2013

Student News: Brendan Harmon received a travel scholarship to attend the Parkinson’s Action Network annual meeting in Washington, DC. Leslie Kolbig received a Provost Undergraduate Research Award to present her work entitled “Are First-Year Health Science Students ready for Inter-professional Education?" to be presented at the 2013 Annual Meeting of the American Association of Colleges of Pharmacy. Bich Ngoc (Jade) Hoang, PharmD student, was selected to receive the prestigious Harold D. Hodgkinson Award. The award is based on distinguished scholastic achievement with due consideration of character, personality, qualities of leadership, cooperative work experience, and service in voluntary organizations and activities. Shardool Jain received the John L. Neumeyer Research Award at Northeastern University and the first prize award at the American Association of Pharmaceutical Sciences for his work on anti-inflammatory gene therapy.

The school successfully launched a new Professional Science Master’s degree program in Biomedical Nanotechnology. On May 11, 2013, the Kappa Psi Pharmaceutical Fraternity re-chartered its Northeastern University Gamma Lambda chapter, with a ceremony that included national officers, Northeastern alumni and friends/colleagues from other pharmacy schools in New England.

Continuing Pharmacy Education: For more information on our ongoing programs, please visit our web-site: http://www.rxce.neu.edu. We look forward to providing you with regular updates on news and events from the School of Pharmacy. We greatly appreciate your comments and suggestions about new ways the school and its faculty and students can serve you and the profession. If you are an alumnus and would like to update your information, please go to the following website: www.northeastern.edu/alumni/update/index.html

Malav Trivedi received first place in the Northeastern University Annual RISE Program for research. The Beta Tau chapter of Rho Chi received a 2013 Chapter Proposal Award from the national office for their submission entitled “Professional Speed Dating for Pharmacy Students: Tips for Success”.

School News On May 17, the Center for Drug Discovery presented the eleventh annual symposium, “Current Trends in Drug Abuse Research,” as part of the center’s National Institute on Drug Abuse-funded training program. The twenty-ninth Annual John W. Webb Lecture will be held on October 28, 2013 on the Northeastern campus. The lecture is jointly sponsored by the ASHP and Northeastern and is supported by the Massachusetts General Hospital and the Massachusetts Society of Health-System Pharmacists. This year’s Webb Lecturer is Ray R. Maddox, PharmD, FASHP, Director of Clinical Pharmacy, Research and Pulmonary Medicine, St. Joseph’s/Candler Health System, in Savannah, GA. 31


Continuing Education for Pharmacists The Advancing Treatment Horizon for Relapsed/Refractory Multiple Myeloma By Houry Leblebjian, PharmD, BCOP, DFCI Clinical Oncology Specialist

Multiple myeloma (MM) is a plasma cell disorder, characterized by accumulation of clonal plasma cells in the bone marrow. MM accounts for 10% of all hematological malignancies and is the second most common hematologic cancer after non-Hodgkin’s lymphoma. The American cancer Society has estimated that 22,350 new MM cases will be diagnosed in 2013, and an estimated 10,710 deaths from the disease will occur.1 MM is considered a non-curable cancer with a median age of diagnosis of 69 years. In the majority of patients, the malignant plasma cells produce a monoclonal protein (M-protein or paraprotein), which is an immunoglobulin (Ig) or a fragment of one that has lost its normal function. The majority of M-proteins are IgG (~50%) and IgA (~20%). The proliferation of myeloma cells causes displacement of the normal bone marrow. In MM, the major clinical findings include anemia, monoclonal Ig (M-protein) in serum, abnormal bone radiographs (bone resorption seen as diffuse osteoporosis and/or characteristic lytic lesions), hypercalcemia, and renal insufficiency or failure.2-3 Current treatment for MM includes combination chemotherapy, proteasome inhibitors, immunomodulatory drugs (IMiDs), high-dose chemotherapy, and stem cell support. The standard first-line therapy for transplant eligible MM patients with an adequate performance status is induction treatment with proteasome inhibitor and/or IMiDs followed by autologous stem cell transplantation (ASCT).4 ASCT is now used as front-line treatment in younger patients and in patients with high performance scores. Allogeneic transplantation offers the advantage of a graft that is not contaminated with tumor cells and a graftversus myeloma effect.5 However, only 5%-10% of MM patients are candidates for allogeneic transplantation and this therapeutic approach is associated with a high rate of treatment-related deaths.4 MM patients who are not eligible for transplantation receive standard first-line therapy that includes any of the abovementioned regimens or alkylatorbased chemotherapies.6 Post induction therapy or post transplant, MM patients receive maintenance therapy to achieve longer remissions. Agents used for maintenance include thalidomide, lenalidomide or bortezomib.

32

Despite advances in understanding the molecular pathogenesis of MM and promising new therapies, almost all patients who survive their original presentation and treatment eventually relapse. While MM patients with relapsed disease may achieve responses to subsequent antimyeloma therapies, the duration of response decreases with successive relapses until refractory disease develops.7 Currently, there is no standard treatment for patients with relapsed/refractory MM, however both disease-related and patient-related factors should be considered when selecting a treatment. Disease-related factors include the quality and duration of response to prior therapies, and the aggressiveness of the relapse. Patient-related factors include preexisting toxicities, comorbid conditions, quality of life, age, and performance status.8-9 The current article will discuss the treatment of relapsed/refractory MM including the efficacy and safety of the novel agents, and the use of adjunctive/supportive care in MM patients. In the relapsed/refractory setting, conventional or high dose chemotherapy has been a longstanding approach to salvage treatment with regimens that included different combination of melphalan, high dose corticosteroids, vincristine, doxorubicin, cyclophosphamide, etoposide or cisplatin. Current salvage regimens listed by the NCCN include novel agents like bortezomib, lenalidomide, thalidomide used alone or in combination regimens.2,9

Proteasome Inhibitor Bortezomib Bortezomib (Velcade®), a 26S proteasome inhibitor, has demonstrated response rates of 25%-35% as a single agent in phase I/II trials for relapsed/refractory MM. However, adverse events (AEs) occurring in 30% to 70% of patients include anorexia, constipation, thrombocytopenia, neutropenia, pyrexia, vomiting, and anemia.10 Of particular importance, treatment-associated peripheral neuropathy was frequently reported.11 Furthermore, phase I/II clinical trials with bortezomib in combination with other therapies, including dexamethasone, dexamethasone/doxorubicin, lenalidomide, and melphalan/ prednisone have shown successful results. Bortezomib in combination with oral or IV melphalan showed ≥ PR (partial response) of 47-68% and in combination with low dose cyclophosphamide and dexamethasone showed ≥ PR of 82%.9,12-13


Pharmacy Journal of New England • Summer 2013

The phase III study APEX was designed to determine whether bortezomib provided benefit to patients with relapsed or refractory MM relative to treatment with highdose dexamethasone. The study was also designed to determine the safety and tolerability of bortezomib relative to high-dose dexamethasone, and whether treatment with bortezomib was associated with superior clinical benefit and quality of life relative to high-dose dexamethasone. A total of 669 patients were enrolled. Median TTP was 6.2 months for the bortezomib arm and 3.5 months for the dexamethasone arm (P<.0001). CR (complete response) + PR was 38% with bortezomib vs. 18% with dexamethasone (P<.0001). Most common side effects of bortezomib (i.e., incidence ≥30%) observed in subjects are weakness, fatigue, and general discomfort; gastrointestinal effects such as constipation, diarrhea, nausea, vomiting and anorexia, fever, peripheral neuropathy; thrombocytopenia, and anemia (Table 1).14-15 A phase III trial compared bortezomib administered through the conventional intravenous (IV) route versus the subcutaneous (SC) route in 222 patients. Subcutaneous bortezomib had noninferior efficacy versus the intravenous one. However, patients receiving subcutaneous bortezomib had a significant reduction in peripheral neuropathy (38% with SC vs 53% with IV; p=0.03).16

Immunomodulatory Agents Thalidomide and Lenalidomide Because of increased angiogenesis in myeloma, thalidomide (Thalomid®) was evaluated in refractory myeloma patients as an antiangiogenic agent.17 Thalidomide has been used as a single agent in the treatment of relapsed patients with MM. Response rate for monotherapy is approximately 30% with a progression-free survival (PFS) in the range of 5 to 9 months. Thalidomide has been successfully combined with many conventional agents for relapsed/refractory MM in phase I/II trials. The addition of cyclophosphamide to thalidomide and dexamethasone led to higher response rates (≥ PR 57-84%). Efficacy of thalidomide is also improved when added to melphalan (≥ PR 59%), or melphalan/dexamethasone regimens (PR 70%).9 Lenalidomide (Revlimid®) is a derivative of thalidomide. In vitro, lenalidomide is 50,000 at inhibiting tumor necrosis factor alpha.17 As a monotherapy in refractory patients, phase I and II studies have reported response rates of 29%39%. Adverse effects include thrombocytopenia and neu-

tropenia. Two phase III trials have studied combination of lenalidomide with dexamethasone (Table 1). Both studies showed improved PR, CR, TTP and OS (overall survival) for patients treated with lenalidomide plus dexamethasone.18-19 These results were further confirmed by a pooled analysis of both studies, which demonstrated better overall response (60.6% vs 21.9%; p<0.001), median TTP (13.4 months vs 4.6 months; p<0.001) and median OS (38 months vs 31.6 months; p=0.045).20 Interestingly, peripheral neuropathy does not seem to be an issue with lenalidomide in contrast to thalidomide. Lenalidomide has also shown efficacy in combination with cyclophosphamide/ dexamethasone (≥PR 65%), and cyclophosphamide/ prednisone (≥MR 64.3%) in phase I/II trials in relapsed/refractory MM.21-22

Newly Approved Drugs One of the new drugs approved for salvage therapy in MM is carfilzomib. Carfilzomib is a second generation proteasome inhibitor that binds selectively and irreversibly to the proteasome. In preclinical studies carfilzomib lacked the neurotoxic effects which are seen with bortezomib. The FDA granted accelerated approval of carfilzomib for the treatment of patients who had received at least 2 prior therapies, including bortezomib and an immunomodulatory agent, and have shown progression on or within 60 days of completion of the last therapy.23 The approval was based on the results of the open label, single arm phase II study in which 266 patients received single agent carfilzomib intravenously twice weekly for 3 of 4 weeks. The overall response rate (ORR) seen in the trial was 23.7%, median duration of response was 7.8 months, and median OS was 15.6 months. Common adverse events reported were fatigue, anemia, nausea, and thrombocytopenia. Serious adverse events seen were pneumonia, cardiac arrest and congestive heart failure.24 Many phase III trials on carfilzomib are ongoing. The ASPIRE trial is a phase III trial comparing lenalidomide plus low dose dexamethasone with or without carfilzomib in patients who have received 1 to 3 prior therapies for relapsed MM. The ENDEAVOR trial is a phase III trial which will evaluate the combination of carfilzomib with low dose dexamethasone versus bortezomib and low dose dexamethasone.23 Pomalidomide, an analogue of thalidomide, is another new therapy approved for relapsed/refractory MM. It is a new immunomodulatory agent that is indicated for patients with MM who have received at least 2 prior therapies including 33


Continuing Education for Pharmacists lenalidomide and bortezomib and have demonstrated disease progression on or within 30 days of completion of the last therapy. The FDA approved pomalidomide based on the phase II study M-002 which included 221 patients with relapsed/refractory MM. Patients who received pomalidomide and low dose dexamethasone had â&#x2030;Ľ PR of 34% with a median duration of response of 8.3 months. The median OS was 16.5 months. The most common grade 3 or 4 adverse events were neutropenia, anemia, pneumonia, thrombocytopenia, fatigue and dyspnea. In addition, 2% of patients developed blood clots. A phase III trial which compares pomalidomide and low dose dexamethasone to pomalidomide and high dose dexamethasone in relapsed/ refractory patients is ongoing.25

Adjunctive/Supportive Care Bone disease (osteopenia or osteopotosis) is common in patients with MM. Complications of bone disease are a major cause of deteriorating quality of life and performance status. Clinical trials have demonstrated that bisphosphonates like pamidronate, zoledronic acid) reduce the incidence of new bone lesions and pathologic fractures in MM. Supportive therapy with analgesics should be introduced for pain, avoiding nonsteroidal anti-inflammatory drugs because of the potential of kidney damage. Local radiotherapy can also be used for palliation of bone pain. Osteonecrosis of the jaw is one of the adverse events of bisphosphonates that need to be monitored, in addition to calcium and vitamin D supplementation to prevent electrolyte imbalances.

Table 1:& Selected phase of lenalidomide and bortezomib for relapsed/refractory MM & & III &studies & & & & & & &

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

Other adjunctive therapies for these patients include treatment of hypercalcemia, prevention of infection, anticoagulation, and treatment of anemia. Hypercalcemia is treated with bisphosphonates, hydration, diuretics, and glucocorticoids. To prevent infection, intravenous immunoglobulin should be considered for patients with recurrent infections, pneumococcal and influenza vaccines should be recommended too. Patients who are on bortezomib should receive antiviral therapy to prevent shingles reactivation. Patients on high dose corticosteroids need prophylactic therapy with antibiotics to prevent pneumocystis carinii pneumonia. Anticoagulation with aspirin or other anticoagulants are required for patient on thalidomide, lenalidomide, and possibly pomalidomide to prevent venous thromboembolism. For patients with anemia, especially those with renal failure, erythropoiesis stimulating agents are recommended.3,9

Conclusion:

8. Lonial S, Mitsiades CS, Richardson PG. Treatment options for relapsed and refractory multiple myeloma. Clin Cancer Res. 2011;17(6):1264-1277. 9. Jakubowiak A. Management strategies for relapsed/refractory multiple myeloma: current clinical perspectives. Semin Hematol. 2012;49 Suppl 1:S16-32. 10. Richardson PG, Barlogie B, Berenson J, et al. A phase 2 study of bortezomib in relapsed, refractory myeloma. N Engl J Med. 2003;348(26):2609-2617. 11. Mitchell BS. The proteasome--an emerging therapeutic target in cancer. N Engl J Med. 2003;348(26):2597-2598. 12. Berenson JR, Yang HH, Sadler K, et al. Phase I/II trial assessing bortezomib and melphalan combination therapy for the treatment of patients with relapsed or refractory multiple myeloma. J Clin Oncol. 2006;24(6):937-944. 13. Popat R, Oakervee H, Williams C, et al. Bortezomib, low-dose intravenous melphalan, and dexamethasone for patients with relapsed multiple myeloma. Br J Haematol. 2009;144(6):887-894. 14. Richardson PG, Sonneveld P, Schuster M, et al. Extended follow-up of a phase 3 trial in relapsed multiple myeloma: final time-to-event results of the APEX trial. Blood. 2007;110(10):3557-3560. 15. Richardson PG, Sonneveld P, Schuster MW, et al. Bortezomib or high-dose dexamethasone for relapsed multiple myeloma. N Engl J Med. 2005;352(24):24872498. 16. Moreau P, Pylypenko H, Grosicki S, et al. Subcutaneous versus intravenous administration of bortezomib in patients with relapsed multiple myeloma: a randomised, phase 3, non-inferiority study. Lancet Oncol. 2011;12(5):431-440.

MM is a malignant neoplasm of plasma cells that accumulate in the bone marrow leading to bone destruction and marrow failure. Many clinical trials are ongoing to test the safety and efficacy of newer agents. These include second generation proteasome inhibitors like marizomib and MLN 9708, histone deacetylase inhibitors panobinostat and vorinostat, the monoclonal antibodies elotuzumab and siltuximab, and the Akt inhibitor perifosine.23,26

17. List AF. Lenalidomide--the phoenix rises. N Engl J Med. 2007;357(21):21832186.

However, MM remains an incurable disease. A clear unmet medical need still exists for additional novel therapeutic options for the treatment of relapsed/refractory MM.

21. Morgan GJ, Schey SA, Wu P, et al. Lenalidomide (Revlimid), in combination with cyclophosphamide and dexamethasone (RCD), is an effective and tolerated regimen for myeloma patients. Br J Haematol. 2007;137(3):268-269.

18. Dimopoulos M, Spencer A, Attal M, et al. Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. N Engl J Med. 2007;357(21):2123-2132. 19. Weber DM, Chen C, Niesvizky R, et al. Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America. N Engl J Med. 2007;357(21):21332142. 20. Dimopoulos MA, Chen C, Spencer A, et al. Long-term follow-up on overall survival from the MM-009 and MM-010 phase III trials of lenalidomide plus dexamethasone in patients with relapsed or refractory multiple myeloma. Leukemia. 2009;23(11):2147-2152.

References:

22. van de Donk NW, Wittebol S, Minnema MC, Lokhorst HM. Lenalidomide (Revlimid) combined with continuous oral cyclophosphamide (endoxan) and prednisone (REP) is effective in lenalidomide/dexamethasone-refractory myeloma. Br J Haematol. 2010;148(2):335-337.

2. Anderson KC, Alsina M, Bensinger W, et al. NCCN clinical practice guidelines in oncology: multiple myeloma. J Natl Compr Canc Netw. 2009;7(9):908-942.

23. Moreau P. The future of therapy for relapsed/refractory multiple myeloma: emerging agents and novel treatment strategies. Semin Hematol. 2012;49 Suppl 1:S33-46.

1. Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin. 2013;63(1):11-30.

3. National Comprehensive Cancer Network (NCCN) clinical practice guideline in oncology: Multiple Myeloma. (Version 2.2013). 4. Kyle RA, Rajkumar SV. Multiple myeloma. N Engl J Med. 2004;351(18):18601873. 5. Gahrton G, Svensson H, Cavo M, et al. Progress in allogenic bone marrow and peripheral blood stem cell transplantation for multiple myeloma: a comparison between transplants performed 1983--93 and 1994--8 at European Group for Blood and Marrow Transplantation centres. Br J Haematol. 2001;113(1):209-216. 6. Kenealy M, Prince HM. Current status of new drugs for the treatment of patients with multiple myeloma. Intern Med J. 2006;36(12):781-789. 7. Siegel DS. Relapsed/Refractory multiple myeloma: defining refractory disease and identifying strategies to overcome resistance. Semin Hematol. 2012;49 Suppl 1:S3-15.

24. Siegel DS, Martin T, Wang M, et al. A phase 2 study of single-agent carfilzomib (PX-171-003-A1) in patients with relapsed and refractory multiple myeloma. Blood. 2012;120(14):2817-2825. 25. Jagannath S, Hofmeister C, al. E. Pomalidomide (POM) with Low-Dose Dexamethasone (LoDex) in Patients (Pts) with Relapsed and Refractory Multiple Myeloma Who Have Received Prior Therapy with Lenalidomide (LEN) and Bortezomib (BORT): Updated Phase 2 Results and Age Subgroup Analysis [abstract]. Blood (ASH Annual meeting abstracts). 2012;120:450. 26. Jakubowiak A. Novel therapies for relapsed/refractory multiple myeloma: how can we improve on "salvage" therapy?--introduction. Semin Hematol. 2012;49 Suppl 1:S1-2. 27. Orlowski RZ, Nagler A, Sonneveld P, et al. Randomized phase III study of pegylated liposomal doxorubicin plus bortezomib compared with bortezomib alone in relapsed or refractory multiple myeloma: combination therapy improves time to progression. J Clin Oncol. 2007;25(25):3892-3901.

35


Continuing Education Quiz The Advancing Treatment Horizon for Relapsed/Refractory Multiple Myeloma 1) Which one of the following results would not be considered a poor prognostic feature in a patient with newly diagnosed multiple myeloma? i) t(4;14) ii) Beta-2 microglobulin of 7mg/L iii) t(11;14) iv) Deletion 13 2) What are the 2 criteria in the International Staging System used in staging patients with multiple myeloma? i) Hemoglobin and albumin ii) B2M and albumin iii) B2M and calcium iv) Albumin and M-protein 3) A 60 year old transplant eligible multiple myeloma patient can receive all of the following except: i) Bortezomib/dexamethasone ii) Bortezomib/lenalidomide/dexamethasone iii) Melphalan/prednisone iv) Lenalidomide/dexamethasone 4) What is the most appropriate treatment for myeloma patient who relapsed post transplant? i) Bortezomib based therapy ii) Lenalidomide based therapy iii) Conventional chemotherapy like DCEP iv) Decision is based on what patient received previously and co-morbidities

Mail to: CPA 35 Cold Spring Road, Suite 121 Rocky Hill, CT 06067

5) In which one of these patients is it most urgent to start treatment? i) Incidental finding of a high M-spike during lab work ii) IgG of 2g/dL and bone marrow biopsy showing 20% plasma cells with no other symptoms iii) IgG of 4g/dL and bone marrow biopsy of 10% and Hgb of 8g/dL and fatigue iv) IgG of 4g/dL and bone marrow biopsy of 30% but no other symptoms 6) Carfilzomib is different then bortezomib in that: i) Carfilzomib is a reversible 26S proteasome inhibitor ii) Carfilzomib can be given subcutaneously iii) Carfilzomib is approved for newly diagnosed patients iv) Carfilzomib causes less neuropathy then bortezomib 7) All of the following needs monitoring with bisphosphonates except: i) Renal function ii) Hemoglobin iii) Calcium iv) Osteonecrosis of the jaw 8) All of the following are risk factors for developing myeloma except: i) Age > 65 ii) Female sex iii) MGUS iv) African American

9) Which one of these is true regarding bortezomib: i) Antiviral prophylaxis is only recommended in patients with history of herpes zoster ii) Peripheral neuropathy is one of the adverse effects iii) Needs dose reduction with creatinine clearance < 50ml/min iv) Peripheral neuropathy is reversible so no need for dose reductions 10) In the study by Orlowski et al the combination of pegylated liposomal doxorubicin and bortezomib resulted in better overall survival and less adverse events rate then the bortezomib only group: i) True ii) False 11) When comparing lenalidomide and thalidomide, which one of the following is true: i) Lenalidomide is more potent then thalidomide ii) Lenalidomide causes more neuropathy then thalidomide iii) Anticoagulation is only needed with thalidomide iv) Myelosupression rate is higher with thalidomide 12) Histone deacetylase (HDAC) inhibitors are a new class of drugs that are being studied in multiple myeloma. All of the following are HDAC inhibitors except: i) Panobinostat ii) Romidepsin iii) Romiplostim iv) Vorinostat

DO NOT DETACH Summer-2013 (1 hour - 0.1 CEUs) ACPE Program No. 0106-9999-12-030-H01-P

Expiration Date 9/28/2015 Type of Activity: Knowledge

Your Name______________________________________________________________________ Asso. Name & Member No.______________________________Phone_______________________ Your Address____________________________________________________________________

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NABP No._____________________________________Birthdate (MM/DD)____________________ • A grade of 70% or greater is required for credit. • Re-examination will be permitted upon failure. • Credits will be uploaded to your NABP e-profile account upon passing this course. • Evaluation must be completed to receive credit. Evaluation Did the article achieve the stated objective? Completely 5 4 3 2 1 Not at all Overall evaluation of the article? Excellent 5 4 3 2 1 Poor The information presented was relevant to your practice? Yes 5 4 3 2 1 No How many minutes did it take you to read course and complete exam?_____________________ Please attach any comments or suggestions. 36

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Pharmacy Journal of New England, Summer 2013  

Pharmacy Journal of New England, Summer 2013

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