Pharmacy Journal of New England, Spring 2013

Vol 10 No.2 Spring 2013

Spring 2013

Pharmacy Journal of New England Vaccines:

Schedules, Changes & Resources

Parents, Alzheimer’s & Money: Easing into a Difficult Conversation Financial Forum

Discovery 101 Rx and the Law

Updates in the Management of Stable Chronic Obstructive Pulmonary Disease Continuing Education

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Pharmacy Journal

Vol 10 • No. 2 Pharmacy Journal of New England • Spring 2013

of New England

Editors

Dear Readers, There has been an increased focus over the last year or so on adherence and waste, especially in the mail order arena. Concern over the costs, as well as the environmental impact of so many unused drugs in the various public waste streams, has spawned many “best practice” conversations. In addition, it has also become evident that teen drug abuse often starts at the family medicine cabinet, which leads to another whole train of thought about an effective means of preventing drug accumulation in households.

Many communities now incinerate their trash which is an effective means of keeping drugs out of watercourses and water treatment facilities. Pharmacies and state associations often provide helpful links and resources to aid in the collection of these unwanted meds. In addition, the annual Take Back Day, sponsored by the Drug Enforcement Agency is scheduled for April 27, 2013.

We urge all readers to do your part by publicizing the importance of these Take Back Days in your various communities. Please take a minute to visit the NCPA website for information on their “Dispose My Meds” program or the DEA’s website for an up to date listing of where the Take Back Days are occurring in your region. Post in your stores, on your websites and share via your social networking sites if you have the opportunity. This is just another way that pharmacists can take care of their patients.

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

David Johnson Executive Vice President Massachusetts Pharmacists Association

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.

Readers are invited to submit their comments and opinions for publication. Letters should be addressed to the Editor and must be signed with a return address.

For rates and deadlines, contact the Journal at (860) 563-4619.

Pharmacy Journal of New England 35 Cold Spring Road, Suite 121 Rocky Hill, CT 06067-3167 members@ctpharmacists.org

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

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U.S. News New England States Financial Forum, Rx and the Law Vaccines: Schedules, Changes & Resources

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

From the Colleges Continuing Education for Pharmacists

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U.S. News Drastic budget cuts put public’s health at risk, says APHA The following is a recent statement from Georges Benjamin, MD, executive director of the American Public Health Association regarding the impact of the sequestration on our nation’s health. The sequestration will reduce resources for many public health programs that currently provide accessible health resources.

“The American Public Health Association expressed grave concern over drastic across-the-board budget cuts, known as sequestration. This law raises the risks to our health by undermining many of the public health protections we have in place today. A projected 5 percent reduction in resources to the U. S. Centers for Disease Control and Prevention, the Health Resources and Services Administration and many other public health agencies is in essence a cut to state and local communities that will compromise our nation’s health, security and economic growth.

“Sequester means 424,000 fewer HIV tests conducted by CDC’s health department grantees, 7,400 fewer patients having access to HRSA’s AIDS Drug Assistance Program that provides life-saving HIV medications and about 25,000 fewer breast and cervical cancer screenings for poor, high-risk women. These cuts would also reduce food inspections, decrease public health emergency preparedness and response capabilities, reduce funding for states to monitor air quality, reduce mental health services for those in need, put the public at greater risk of infectious disease outbreaks and negatively impact many other critical public health programs.

“These are essential public health services that save lives and protect our health. They are not the driver of our nation’s debt and have already been ravaged by deep cuts during the recent recession. To decimate programs that hold the greatest potential for growth and health security is a matter of failed policy. Public health is part of the economic solution since they help reduce the need for more expensive health and social services.

“We need a balanced approach to deficit reduction that does not compromise core public health services and inappropriately leaves people exposed to preventable health threats.”

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For more about APHA, visit www.apha.org. www.apha.org/about/news/pressreleases/2013/sequestration+release.htm

NCPA Statement on 60 Minutes’ Coverage of Meningitis Tragedy, Pharmacy Compounding In response to a story featured on “60 Minutes” on the 2012 meningitis outbreak and the New England Compounding Center (NECC), National Community Pharmacists Association (NCPA) CEO B. Douglas Hoey, RPh, MBA recently issued the following statement: “This story appropriately shines a spotlight on the terrible patient suffering that occurred as a result of the irresponsible actions of NECC, and it reinforces the need to ensure proper oversight by health officials. The accounts of former NECC employees that were reported in the story persuasively reinforce the views of NCPA and others that NECC was in fact evading necessary regulation in part by purporting to be a compounding pharmacy.

“As congressional hearings and investigations have made clear, prior to the tragic meningitis outbreak, the Food and Drug Administration (FDA) and the Massachusetts Board of Pharmacy had adequate authority to take action against NECC. They could have acted to mitigate or potentially even prevent patient suffering. Sadly, they did not.

“Every day thousands of patients benefit tremendously from the services of compounding pharmacies.

Compounding pharmacies help avert allergic reactions to mass-produced drugs, flavor medication for a child’s consumption and meet countless veterinary needs. The FDA itself has endorsed compounding pharmacies’ role in alleviating drug shortages, such as with Tamiflu during the 2009 H1N1 flu outbreak, or in the compounding of the drug Makena used in preterm births. In addition, some estimates put the number of intravenous medications used in hospitals made by compounding pharmacies at 40 percent. Without these providers, many thousands of patients would not have access to these medications and parts of the U.S. health care system would come to a standstill.

Unfortunately, “60 Minutes’” account did not reflect any of these facts.

Pharmacy Journal of New England • Spring 2013

“As a country, we must strike the right balance to go after rogue entities like NECC while preserving patients’ access to the safe and essential compounded medications that their physicians prescribe. If more resources and training are required, such as for boards of pharmacies and their investigators, then those needs must be accommodated.

NCPA members and staff pledge to continue to work constructively with policymakers and health officials toward these goals.”

The National Community Pharmacists Association (NCPA®) represents the interests of America’s community pharmacists, including the owners of more than 23,000 independent community pharmacies. Together they represent an $88.5 billion health care marketplace, dispense nearly 40% of all retail prescriptions, and employ more than 300,000 individuals, including over 62,000 pharmacists.

To learn more go to www.ncpanet.org or read NCPA’s blog, The Dose, at http://ncpanet.wordpress.com/. https://www.ncpanet.org/index.php/news-releases/1601ncpa-statement-on-60-minutes-coverage-of-meningitistragedy-pharmacy-compounding

NCPA: Mail Order Waste All Too Common; Documented by Federal Officials Pharmacist and Senior Vice President for Government Affairs John Coster, RPh, PhD of the National Community Pharmacists Association (NCPA) issued the following statement regarding a study on the role that mail order waste plays in unnecessary health care spending that was released by the lobby for pharmacy benefit managers (PBMs, which own the vast majority of mail order pharmacies): “Community pharmacists, one of America’s most-trusted professionals, have repeatedly voiced our concerns and those of our patients regarding wasted medications and other health care products furnished by mail order facilities. In many of these instances, patients complain about being unable to turn off the mail order spigot despite their requests. More recently, pharmacists began documenting scores of these episodes in a compilation entitled ‘Waste Not, Want Not,’ that is related to a voluntary drug disposal program run by community pharmacists (Dispose My Meds).

“PCMA has a lot of words about this issue, but we have the evidence. Talk to people who have dealt with mail, and more often than not, they will tell you about their own personal story—or that of a relative—having a closet full of medications that they didn’t order and can’t use—all because of mail order companies’ desire to pump as much medications into the mail—including controlled substances—to collect reimbursement for the cost of the unwanted or unneeded drugs from the plan sponsor, dispensing fees, and lucrative manufacturer rebates.

“Medicare officials, reflecting their concerns and those raised by pharmacists, attested just last month to consumer complaints regarding mail order waste. This follows previous statements and reports by federal health officials affirming mail order waste, such as in the provision of diabetes test supplies.

“The study released by the PBM lobby actually provides fresh evidence of the outsized role that mail order plays in pharmaceutical waste. While mail order accounted for 19 percent of Medicare prescriptions reviewed in the study, those prescriptions accounted for 32 percent of the waste.

In other words, mail order prescriptions continue to generate considerably more wastage per prescription than other pharmacy options.

“While mail order waste may be alive and well, the good news is that policymakers and plan sponsors can adopt simple steps to mitigate this problem. For starters, patients should be able to choose a pharmacy that best meets their own health needs, without co-pay incentives for mail order.

A face-to-face health care experience makes it far less likely that patients would be auto-shipped medications that they didn’t request and don’t need.”

Federal officials document waste through mail order autoshipping: • Medicare has received complaints from beneficiaries about auto-shipping of excessive or unneeded medical products, noting that: “CMS has received complaints that beneficiaries have had medications delivered that had been previously discontinued or were otherwise unwanted and unnecessary at the time of delivery. ...

Once the prescription is delivered, pharmacies are unable to return the medication to stock and generally do not reverse the claim if the patient does not want the prescription. Consequently, automatic delivery practices are 3

U.S. News

continued

potentially generating significant waste and unnecessary additional costs for beneficiaries and the Part D program overall. ... In a related issue, CMS has received complaints indicating that some mail-service pharmacies automatically deliver new prescriptions that were phoned in or e-prescribed from the physician’s office without confirming that the patient wants the prescription filled and delivered.”

• The Office of Inspector General has documented similar incidences in the provision of diabetes test supplies (DTS). Recently, in front of the House Small Business Committee, a Medicare official testified that from a selected group of beneficiaries that ceased ordering DTS in 2011, 60 percent of these beneficiaries had over 10 months’ worth of diabetes testing supplies on hand, likely as a result of mail order auto-shipping.

Study Shows Medicare Savings when Local Pharmacies Fill 90-Day Prescriptions, Compared with Mail Order. A study examining millions of Medicare Part D prescription drug event (PDE) data has found that community pharmacies provide 90-day medication supplies at lower cost than mail order pharmacies and that local pharmacists substitute lower-cost generic drugs more often when compared to mail order pharmacies. Read more here.

The National Community Pharmacists Association (NCPA®) represents the interests of America’s community pharmacists, including the owners of more than 23,000 independent community pharmacies. Together they represent an $88.5 billion health care marketplace, dispense nearly 40% of all retail prescriptions, and employ more than 300,000 individuals, including over 62,000 pharmacists.

To learn more go to www.ncpanet.org or read NCPA’s blog, The Dose, at http://ncpanet.wordpress.com

CRE are lethal bacteria that pose a triple threat: • Resistance: CRE are resistant to all, or nearly all, the antibiotics we have - even our most powerful drugs of last-resort.

• Death: CRE have high mortality rates – CRE germs kill 1 in 2 patients who get bloodstream infections from them.

• Spread of disease: CRE easily transfer their antibiotic resistance to other bacteria. For example, carbapenemresistant klebsiella can spread its drug-destroying weapons to a normal E. coli bacteria, which makes the E.coli resistant to antibiotics also. That could create a nightmare scenario since E. coli is the most common cause of urinary tract infections in healthy people.

Currently, almost all CRE infections occur in people receiving significant medical care. CRE are usually transmitted from person-to-person, often on the hands of health care workers. In 2012, CDC released a concise, practical CRE prevention toolkit with in-depth recommendations to control CRE transmission in hospitals, longterm acute care facilities, and nursing homes.

Recommendations for health departments are also included. CRE can be carried by patients from one health care setting to another. Therefore, facilities are encouraged to work together, using a regional “Detect and Protect” approach, to implement CRE prevention programs.

In addition to detailed data about the rise of CRE, the Vital Signs report details steps health care providers, CEOs and chief medical officers, state health departments and patients can take now to slow, and even stop, CRE before it becomes widespread throughout the country.

www.ncpanet.org/index.php/news-releases/1597-ncpamail-order-waste-all-too-common-documented-by-federalofficials

www.cdc.gov/media/dpk/2013/dpk-vs-hai.html

New CDC Vital Signs: Lethal, Drugresistant Bacteria Spreading in U.S. Healthcare Facilities

The Centers for Disease Control and Prevention (CDC) recently completed an analysis of drug overdose deaths and published its findings in a research letter, “Pharmaceutical Overdose Deaths, United States, 2010,” in the Journal of the American Medical Association (JAMA). The CDC issued the following press release regarding the increase in drug overdose deaths for the 11th consecutive year:

Drug-resistant germs called carbapenem-resistant Enterobacteriaceae, or CRE, are on the rise and have become more resistant to last-resort antibiotics during the past decade, according to a new CDC Vital Signs report.

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These bacteria are causing more hospitalized patients to get infections that, in some cases, are impossible to treat.

Opioids drive continued increase in drug overdose deaths

Pharmacy Journal of New England • Spring 2013

CDC’s analysis shows that 38,329 people died from a drug overdose in the United States in 2010, up from 37,004 deaths in 2009. This continues the steady rise in overdose deaths seen over the past 11 years, starting with 16,849 deaths in 1999. Overdose deaths involving opioid analgesics have shown a similar increase. Starting with 4,030 deaths in 1999, the number of deaths increased to 15,597 in 2009 and 16,651 in 2010.

In 2010, nearly 60 percent of the drug overdose deaths (22,134) involved pharmaceutical drugs. Opioid analgesics, such as oxycodone, hydrocodone, and methadone, were involved in about 3 of every 4 pharmaceutical overdose deaths (16,651), confirming the predominant role opioid analgesics play in drug overdose deaths.

CDC researchers analyzed data from CDC’s National Center for Health Statistics 2010 multiple cause-of-death file, which is based on death certificates.

The researchers also found that drugs often prescribed for mental health conditions were involved in a significant number of pharmaceutical overdose deaths.

Benzodiazepines (anti-anxiety drugs) were involved in nearly 30 percent (6,497) of these deaths; antidepressants in 18 percent (3,889), and antipsychotic drugs in 6 percent (1,351). Deaths involving more than one drug or drug class are counted multiple times and therefore are not mutually exclusive.

“Patients with mental health or substance use disorders are at increased risk for nonmedical use and overdose from prescription painkillers as well as being prescribed high doses of these drugs,” said CDC Director Tom Frieden, M.D., M.P.H. “Appropriate screening, identification, and clinical management by health care providers are essential parts of both behavioral health and chronic pain management.”

Additional steps are being taken at the national, state and local levels, as well as by non-governmental organizations, to help prevent overdoses from prescription drugs.

In particular, the federal government is:

• Educating health care providers and the public about prescription drug abuse and overdose.

• Requiring that manufacturers of extended-release and long-acting opioids make educational programs available to prescribers about the risks and benefits of opioid therapy, choosing patients appropriately, managing and monitoring patients, and counseling patients on the safe use of these drugs.

• Using opioid labeling as a tool to inform prescribers and patients about the approved uses of these medications.

• Developing, evaluating and promoting programs and policies shown to prevent prescription drug abuse and overdose, while making sure patients have access to safe, effective pain treatment.

Promising steps that many states are taking include: • Starting or improving prescription drug monitoring programs, which are electronic databases that track all prescriptions for opioids in the state.

• Using prescription drug monitoring programs, public insurance programs, and workers’ compensation data to identify improper prescribing of opioids.

• Setting up programs for public insurance programs, workers’ compensation programs, and state-run health plans that identify and address improper patient use of opioids.

• Passing, enforcing and evaluating pill mill, doctor shopping and other state laws to reduce prescription opioid abuse.

• Encouraging state licensing boards to take action against inappropriate prescribing.

• Increasing access to substance abuse treatment.

For more information about prescription drug overdoses in the United States, please visit www.cdc.gov/HomeandRecreationalSafety/Poisoning. www.cdc.gov/media/releases/2013/p0220_drug_overdose_d eaths.html

• Tracking prescription drug overdose trends to better understand the epidemic.

• Encouraging the development of abuse-deterrent opioid formulations and products that treat abuse and overdose.

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U.S. News

continued

New norovirus strain causing most norovirus outbreaks in United States The following press release from the Center for Disease Control and Prevention discusses the new strain of norovirus found to be the leading cause of norovirus cases in the United States from September to December 2012.

A new strain of norovirus called GII.4 Sydney was the leading cause of norovirus outbreaks in the United States from September to December 2012, according to a study published in Morbidity and Mortality Weekly Report released recently by the Centers for Disease Control and Prevention. The new strain was detected in Australia in March 2012, and caused outbreaks in that country and several other countries.

CDC researchers analyzed 2012 data collected through CaliciNet on norovirus strains associated with outbreaks in the United States. They found that of the 266 norovirus outbreaks reported during the last four months of 2012, 141 were caused by the GII.4 Sydney strain.

“The new strain spread rapidly across the United States from September to December 2012,” said Dr. Aron Hall, epidemiologist, CDC’s Division of Viral Diseases (DVD).

“The proportion of reported outbreaks caused by this strain increased dramatically from 19 percent in September to 58 percent in December.”

Norovirus is very contagious. In the United States, norovirus is the number one cause of acute gastroenteritis, which leads to diarrhea and vomiting. Each year, more than 21 million people in the United States get infected and develop acute gastroenteritis; approximately 800 die.

Young children and elderly adults have the highest risk for severe illness.

Norovirus spreads primarily from infected people to others through direct contact. It also spreads through contaminated food, water, and surfaces. Norovirus infections are common during this time of the year. Most outbreaks occur from November to April, and activity usually peaks in January.

“New norovirus strains often lead to more outbreaks but not always,” said Dr. Jan Vinjé, director of CaliciNet. Over the past decade, new strains of GII.4 have emerged about every 2 to 3 years. “We found that the new GII.4 Sydney strain replaced the previously predominant GII.4 strain.”

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Better surveillance in the United States and abroad have helped to detect new strains of norovirus sooner. Early identification of new strains helps to alert the public and health professionals to better prevent infections and control outbreaks.

Health professionals should remain vigilant to potential increases in norovirus infection this season due to GII.4 Sydney. They should follow standard prevention and control measures for norovirus. People should know that the best ways to help prevent norovirus infection include washing hands with soap and water, disinfecting surfaces, rinsing fruits and vegetables, cooking shellfish thoroughly, and not preparing food or caring for others while ill.

“Right now, it’s too soon to tell whether the new strain of norovirus will lead to more outbreaks than in previous years. However, CDC continues to work with state partners to watch this closely and see if the strain is associated with more severe illness,” said Dr. Hall.

For more information on norovirus, visit CDC’s norovirus Web site at www.cdc.gov/norovirus. www.cdc.gov/media/releases/2013/p0125_norovirus.html

FDA approves Lymphoseek to help locate lymph nodes in patients with certain cancers The U.S. Food and Drug Administration recently approved Lymphoseek (technetium Tc 99m tilmanocept) Injection, a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes.

Lymph nodes filter lymphatic fluid that flows from the body’s tissues. This fluid may contain cancer cells, especially if the fluid drains a part of the body containing a tumor.

By surgically removing and examining the lymph nodes that drain a tumor, doctors can sometimes determine if a cancer has spread.

Lymphoseek is an imaging drug that helps locate lymph nodes; it is not a cancer imaging drug. Lymphoseek is the first new drug used for lymph node mapping to be approved in more than 30 years. Other FDA-approved drugs used for lymph node mapping include sulfur colloid (1974) and isosulfan blue (1981).

Pharmacy Journal of New England • Spring 2013

“Removal and pathological examination of lymph nodes draining a primary tumor is an important diagnostic evaluation for some patients with breast cancer or melanoma,” said Shaw Chen, M.D., deputy director of the Office of Drug Evaluation IV in the FDA’s Center for Drug Evaluation and Research. “To use Lymphoseek, doctors inject the drug into the tumor area and later, using a handheld radiation detector, find lymph nodes that have taken up Lymphoseek’s radioactivity.”

Lymphoseek’s safety and effectiveness were established in two clinical trials of 332 patients with melanoma or breast cancer. All patients were injected with Lymphoseek and blue dye, another drug used to help locate lymph nodes.

Surgeons subsequently removed suspected lymph nodes for pathologic examination. Confirmed lymph nodes were examined for their content of blue dye and/or Lymphoseek. Results showed Lymphoseek and blue dye had localized most lymph nodes, although a notable number of nodes were localized only by Lymphoseek.

The most common side effects identified in clinical trials was pain or irritation at the injection site.

Lymphoseek is marketed by Navidea Biopharmaceuticals, Inc. based in Dublin, Ohio. www.fda.gov/NewsEvents/Newsroom/PressAnnouncement s/ucm343525.htm

First Recombinant Flu Vaccine Approved The following was recently released by the FDA regarding the licensing approval of Flublok, the nation’s first trivalent seasonal influenza vaccine that contains recombinant viral proteins instead of antigens derived from live virus.

Limited amounts of Flublok will be available during the current flu season, according to Meriden, Connecticutbased Protein Sciences Corporation.

Flublok is indicated for use in adults 18–49 years of age and is administered as a single, 0.5-mL dose, according to the product’s labeling (PDF).

The proteins in Flublok are derived from a recombinant baculovirus vector and expressed in a continuous insect cell line.

The vaccine will be supplied in cartons of 10 single-dose vials for intramuscular injection. The vials should be refrigerated and protected from light. If freezing occurs, the vaccine should be discarded.

According to FDA, Flublok must be used within 16 weeks after its production. The agency urged health care providers to carefully check the expiration date before administering the vaccine.

In clinical trials, the most commonly reported adverse events associated with Flublok were injection-site reactions.

Flublok is the second FDA-approved cell-based vaccine for protection against seasonal influenza. Flucelvax, by Novartis Vaccines, was licensed in November. Flucelvax is derived from live virus grown in a canine cell line and is not a recombinant vaccine.

Efficacy data for Flublok came from a placebo-controlled clinical trial involving 4648 patients that was conducted during the 2007–08 flu season.

Flublok’s overall efficacy during the study was 44% against all strains of circulating viruses.

According to the labeling, the efficacy of Flublok against the three strains used in the vaccine could not be determined because 96% of the viruses isolated during the study did not match the vaccine strains.

The Centers for Disease Control and Prevention (CDC) reports that during the 2007–08 flu season, 66% of influenza type A H1N1 viruses characterized by the agency matched the vaccine strain, as did 23% of influenza type A H3N2 viruses and 2% of influenza type B viruses.

CDC’s initial estimates from the current flu season indicate that the available vaccines are about 60% effective for the prevention of influenza. www.ashp.org/menu/News/PharmacyNews/NewsArticle.as px?id=3848

Each dose of the vaccine contains 45 g of purified recombinant hemagglutinin corresponding to the hemagglutinin antigens from each of the influenza virus strains selected for the flu season’s trivalent vaccines.

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New England States Connecticut

President’s Message What is CPA? The mission of the Connecticut Pharmacists Association is to advance the practice and interests of pharmacy in the state of Connecticut. What does this mean to you? What is your CPA membership getting you?

Most of you probably know Lucrezia Finegan, RPh, about our more commonly used President, CPA, 2012-2013 benefits, such as our CE program discounts, newsletter, networking opportunities, internet resources (such as our website, which is currently in the process of being revamped for you – please stayed tuned), and group liability insurance discounts.

How about the advocacy that CPA provides on your behalf?

Did you know that we have a lobbyist devoted to monitoring pharmacy issues at the state capitol? Your CPA legislative committee is hard at work looking for ways to advance the profession of pharmacy through legislation. The profession of pharmacy is changing around us. It’s too easy to sit back and let others decide how pharmacy is going to be practiced as we move forward and how pharmacists fit into the changing healthcare system. If we allow legislators, who don’t know our profession, to make those decisions for us without our input, we may not have a place in that new model.

We’re here to make sure that you have a place in this new healthcare landscape. CPA is working hard to ensure that pharmacists are recognized for the value they can provide to the whole healthcare team. We represent pharmacists, technicians and student pharmacists in all practice settings throughout the State of Connecticut. We also keep a pulse on national issues and happenings that can affect you.

Are you new to the profession, or are you looking to change practice settings? CPA has a couple of tools available to help you make that transition. We have a career center on our website that you can use to search for new opportunities. We are also in the process of developing a mentorship program, which can pair you with a mentor in the practice area you’re considering. This can be a great opportunity for both new 8

practitioners and those of you considering a practice change.

It’s also a good way for current practitioners to share their knowledge and leadership by becoming a mentor.

The Connecticut Pharmacists Foundation is also hard at work making sure our student pharmacists are receiving much needed resources by providing scholarships. Our annual Foundation wine tasting event is scheduled for May 18th. We’ve held the event at different vineyards each time and each one has been a lot of fun. I hope you’ll be able to join us on May 18th – please be sure to mark your calendars.

I urge you all to get more involved. Special thanks to all those who attended our Pharmacy Day at the Capitol on Tuesday, March 12th. The Connecticut Pharmacists Association is nothing without its members. We’re here to serve you, but we also need your help. Your continued membership, your involvement on one of our committees, your involvement in Pharmacy Day, or the upcoming NBC Connecticut Health and Wellness Festival, your attendance at the wine tasting – all of these are an important way you can help to advance your profession.

Massachusetts President’s Message Dear Colleagues, This year the volatile political atmosphere surrounding the practice of pharmacy has forced us to shift priorities and plans in order to implement an effective legislative and regulatory strategy. With legislative hearings looming, we canceled our Face of Pharmacy originally scheduled for April 10th and Tim Hudd, President, MPhA, adopted a more targeted 2012-2013 approach. In addition to regular visits with state Senators, Representatives, and Administration Officials, we have been enlisting members and leading pharmacists in their areas of expertise in preparation for public hearings on several important bills that could significantly impact our profession. With thanks owed to several faculty members at each of our schools of pharmacy, an impressive number of students have been eager to get engaged in the political process. This Spring, we are coordinating interested

Pharmacy Journal of New England • Spring 2013

students at each school who will meet directly with their elected officials. These students have been meeting to discuss the bills that will be promoted, the legislative process in MA, and effective political advocacy. MPhA Executive VP, David Johnson, and faculty will accompany small groups of students to meet with legislators. The small groups are organized around a visit between one or more MA student and their senator or representative. The visits will include a tour of the state house and further exploration of the legislative process. We hope this will enhance the educational experience for both the elected officials and the students. The two bills the students will promote are H.2060, An Act Recognizing Pharmacists as Healthcare Providers, and S995, An Act Authorizing Certain Pharmacy Interns to Administer Immunizations. One of our top priorities is to continue to create opportunities for members to serve their profession through MPhA initiatives. Therefore, if you wish to visit the state house with David Johnson to advocate for these or other pieces of pharmacy related legislation, contact David at djohnson@masspharmacists.org.

Government and Legislative Affairs Committee In addition to the coordination of the advocacy efforts mentioned above, the committee is participating in the drafting of written testimony on several key bills, most importantly, H.39, the Governor's bill on the oversight of pharmacies. Members can download a copy of this testimony and the text of the bill from the State Advocacy section of the MPhA website.

A hearing on this bill and a similar bill, Senator Montigny's S.1053, H2060, and 9 additional pharmacy related bills was held at the state house on April, 2nd.

The Committee has recruited an impressive lineup to testify in favor of H.2060, An Act Recognizing Pharmacists as Healthcare Providers, which includes pharmacists, physicians, patients, public health organizations, and healthcare administrators.

Finally the committee is monitoring the regulatory process for the implementation of Chapter 244 of the Acts of 2012. This law has made significant changes to the Prescription Monitoring Program. A hearing was held on March 22nd on proposed regulations directed at prescribers. Regulations for pharmacists related to continuing education requirements and a pamphlet to be included with each dispensed Schedule II and III medication will follow later this calendar year.

Professional Affairs Committee MPhA along with various stakeholders from around the state are working with the Massachusetts Department of Public Health to help develop a unified statewide chronic disease plan for heart disease, stroke, diabetes,and asthma. The plan will lead to the formation of a new integrated coalition, whose charge will be to improve state and local policies, systems, environments and programs. We are currently working on the Clinical Preventive Services and Population Health Management Team.

Nominating & Awards Committee Chairman Barbara Perry has finalized a distinguished list of members to serve on this important committee. The charge of this group is to solicit nominations for deserving individuals who meet the predefined awards criteria. This committee then selects the recipient for each award. The committee is now soliciting nominations from all of you sometime in the Spring 2013. Please visit our website to nominate a deserving pharmacist today!

Academy of Students Identifying future leaders of the Pharmacy Profession is more important than ever. In the new year David Johnson has been on the campus of Northeastern, and David and I went to MCPHS- Worcester to speak to student groups about political advocacy, important legislation at the state and federal level, and ways in which students can become involved. Similar events are planned at Western New England University College of Pharmacy and MCPHS-Boston in April to discuss political advocacy, important legislation at the state and federal level, and ways in which students can become involved.

MPhA's Spring Conference Our Spring Conference is around the corner! Thursday, April 25th, at the Four Points by Sheraton on Rte 1 in Norwood. We have a great lineup and we've doubled the room size to ensure your comfort! Sign up online at www.masspharmacists.org.

MPhA Foundation Board Elects Officers On March 19th, the Board of Directors for the MPhA Foundation elected Catherine Taglieri, PharmD, BSP, as its President and David Baker, B.S.Pharm., M.B.A., J.D., as its Treasurer. Congratulations to Cathy and Dave, and a heartfelt thank you to outgoing President Amy Levy, M.H.P., B.S., R.Ph., and long time Treasurer and Charter Member Georgiann Koutrouba, R.Ph., for their excellent service.

Sincerely, Timothy Hudd, BS, Pharm.D., R.Ph., AE-C

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The Connecticut Pharmacists Foundation Presents the third annual Wine-Tasting Reception to benefit the Scholarship Fund and other community focused programs sponsored by the Foundation.

Saturday, May 18, 2013, 6:00 pm - 9:00 pm Cassidy Hills Vineyard, 454 Cassidy Hill Road Coventry, CT 06238 www.cassidyhillvineyard.com

$45 per person includes wine tasting & appetizers Enjoy a summer afternoon with friends, a variety of wines, musical entertainment, and the opportunity to win a variety of raffle prizes.

Sponsorship Levels Available Platinum Level $1,500 includes 10 guests, a display table, signage at event, and website presence Gold Level $1,000 includes 8 guests, signage at the event Silver Level $750 includes 4 guests and signage at event Bronze Level (for individual sponsorship only) $500 includes 2 guests and signage at the event

Yes, I/We will attend.

Our tax deductible donation is enclosed.

No, I/We cannot attend.

Our tax deductible donation is enclosed.

Name(s) ________________________________________________________________ Additional Guest Names ___________________________________________________ Address ________________________________________________________________ E-Mail - Phone ___________________________________________________________ Please return form and payment by May 15, 2013.

For more information, please call the office at 860-563-4619.

The Connecticut Pharmacists Foundation is recognized as a 501c3 entity by the IRS #65-1193552.

A portion of your donation is tax deductible.

Pharmacy Journal of New England • Spring 2013

AmyVachon and MarianneLee

Atrius Health’s Marianne Lee and Amy Vachon, Co-Directors of the Clinical Pharmacy Program

by Jackie Stanley, Pharm.D.

Atrius Health is non-profit alliance of six health care practice groups, including Dedham Medical Associates, Granite Medical, Harvard Vanguard Medical Associates, Reliant Medical Group, Southboro Medical Group and South Shore Medical Center. Atrius serves nearly one million adult and pediatric patients at 50 practice locations. Atrius Health’s medical groups include more than 1,000 physicians and 1,425 other medical professionals who provide over 3.8 million annual visits including primary care and over thirty-five specialties such as pediatrics, obstetrics, oncology, dental services, and behavioral health. Atrius also has its own pharmacies and labs at many of its locations.

For its major insurance payors, Atrius operates on a capitated fee system for insurance payment. This is different than a traditional fee-for-service system. In a capitated system, an insurance plan gives the medical group a set amount of money to cover a patient’s medical costs whether or not a patient actually seeks care. If there is money left over after healthcare costs the medical group gets to keep what is left over and if costs exceed fixed payments they are absorbed by Atrius, so there is incentive for judiciously managing healthcare costs.

Marianne Lee, PharmD, and Amy Vachon, PharmD, Atrius Health's Co-Directors of the Clinical Pharmacy Program sat down with Jackie Stanley of the

Massachusetts Pharmacists Association at the Watertown site of Harvard Vanguard Medical Associates and described their many responsibilities and the many contributions of the clinical pharmacy program. First of all, Marianne, Amy and their team of eleven clinical pharmacists promote cost-effective formulary prescribing. They manage the multi-million-dollar annual pharmacy expense by promoting evidence-based, cost effective prescribing practices, as well as providing timely communications to clinicians in resolving medication-related issues. The clinical pharmacists interact with clinicians in a host of specialties and sites, and manage relationships with multiple payers whose complex formularies impact patient and clinician behavior. Clinical pharmacists will conduct comprehensive medication reviews of patients who are using nonpreferred drugs and make suggestions to providers to consider a switch to a formulary medication if appropriate.

The pharmacists “flag” these recommendations in the clinicians’ schedules one day prior to each patient’s appointment so the providers can efficiently and easily evaluate and discuss them with patients during appointments. The clinical pharmacists also provide academic detailing to the providers regularly to address new disease guidelines and opportunities for cost savings.

Although most of their work is done behind the scenes, clinical pharmacists will meet with patients upon referral to review, discuss, and educate patients about their medication therapy. The pharmacists will provide medication recommendations during team roster reviews of patients who have not reached their clinical goals for measures such as blood pressure, lipid values or HgbA1C. These team roster reviews are highly efficient, allowing the clinical pharmacists to influence medication management for as many as twenty patients in an hour. In addition, the clinical pharmacists provide Medication Therapy Management to high risk cardiovascular and diabetes patients.

Dr. Lee and Dr. Vachon describe one of their biggest challenges as identifying how to maximize their efficiency in the face of so many opportunities for clinical pharmacy to optimize high quality, cost-effective patient care. For their contributions to the practice of pharmacy Dr. Lee and Dr. Vachon received the MPhA President's Pharmacist of the year award for 2012.

11

New England States

continued

New Hampshire Welcome President Jay Calabro: Jay Calabro is the pharmacy manager of the Wal-Mart pharmacy in North Conway New Hampshire. He received his undergraduate degree in Biology from Quinnipiac University in Hamden, CT. From there he went on the get his Doctor of Pharmacy at Northeastern University. While attending Northeastern Jay sat on the Massachusetts pharmacists association board, as it’s “governor of students”. Upon graduation he decided it was time for a change of scenery and moved north to New Hampshire’s White Mountain region. There he serves as a regional leader for “partners in prevention” A state funded group that helps eliminate drug and alcohol abuse. He has organized several health fairs at his pharmacy, to raise awareness for uninsured patients on many different disease states, including diabetes and high blood pressure. He currently resides in Bartlett, NH with his wife Lauren and new Son Dylan.

Welcome Joel Brown Technology Chair:

PharmD at MCPHS-Manchester and works as a Clinical Pharmacist in the Investigational Pharmacy at DartmouthHitchcock in Lebanon, NH. The Investigational Pharmacy works with medical teams, clinical researchers and drug manufacturers to facilitate clinical trials and of drugs and drug-delivery systems. Before becoming a pharmacist Joel spent 10 years in brain research, earning a PhD in Neuroscience from the University of Pitts burgh and working as a NIH Postdoctoral fellow at Dartmouth College.

Outside of work, Joel is a competitive runner and plays keyboard in a local rock band. He will marry his fiancée Megan Robillard (also a DHMC pharmacist) this spring and they will reside in Hanover, NH.

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.

Gold Certificate This year, the NH Board of Pharmacy recognized two New Hampshire Pharmacists who have been licensed in the State of New Hampshire for 50 continuous years. The ceremony included the presentation of a framed gold certificate. The “Gold Certificate” itself has been around for well over 30 years, the presentation only became formal in the past 5 years. The gold certificate is a replica of their licenses which are engraved with their names, as well as a signed citation from the Honorable Governor Lynch. The gold certificates of licensure were presented by Vahrij Manoukian, President, New Hampshire Board of Pharmacy to each of the recipients. This year’s recipients are listed below: Paul Auger Paul Boisseau

Joel is the Technology Chair on the NHPA board. He is working to modernize the Association’s presence on the web and social media, online registration processes for NHPA membership and CE conferences. Joel earned his 12

Pharmacy Journal of New England • Spring 2013

2012 Awards Presentations: 2012 Distinguished Young Pharmacist Award—Tonya Carlton

2012 New Hampshire Pharmacist of the Year—Karl Herzig

Pictured from left to right: Donald Messina and Karl Herzig Pictured from left to right: Geoff and Tonya Carlton and Gary Wingate

The Distinguished Young Pharmacist Award is sponsored

by Pharmacists Mutual Companies. This award is presented annually to a pharmacist licensed in New Hampshire who has practiced ten years or less, practices in a community, institutional, or consulting pharmacy and who has actively participated in national pharmacy associations, professional programs, state association activities and/or community service.

This year’s distinguished young pharmacist is a staff pharmacist at Wentworth-Douglas Hospital in Dover, NH. Since her graduation from MCPHS – Worcester, she has precepted numerous pharmacy students. In addition, she has helped build the foundation of the residency program at Wentworth-Douglas Hospital and precepts residents on several rotations.

This year’s recipient has always had a passion for providing education to her patients and healthcare team members alike. She routinely participates in cardiac rehabilitation teaching sessions. In March of 2012, she became a certified pain educator. She has also served on many committees, including the Pain Management Task Force, Palliative Care Team, and Collaborative Practice Committee. In addition to these duties, this distinguished young pharmacist has been active in pharmacy organizations, helping to plan the New Hampshire Society of Health System Pharmacists CE event in September 2012.

Not only has the recipient of this year’s award impacted the community of pharmacy, she has also coordinated bake sales for local organizations and helped educate preschoolers and seniors about medication safety.

The NH Pharmacist of the Year award is co-sponsored by the NH Pharmacists Association, the NH Society of Health-Systems Pharmacists and the NH Independent Pharmacists Association. The award is presented annually to a pharmacist licensed and practicing in New Hampshire who demonstrates professional excellence, good citizenship and dedication to the profession. The recipient must have demonstrated service to his/her practice setting either through sustained exemplary service, or a single outstanding achievement that has impacted pharmacy practice or individual patient care.

The 2012 New Hampshire Pharmacist of the Year award winner was the director of pharmacy at Littleton Regional Hospital in Littleton, NH for over 30 years. When he first started in this position, the pharmacy was little more than a room with plywood shelving. Since then, he has overseen multiple expansions of the pharmacy department. He has ushered in a multitude of new services, including the use of computers as well as automated dispensing cabinets and oncology services. Through all these changes, this award recipient has never lost focus on what matters most: the wellbeing of his patients. Since his retirement, he has continued to engage in pharmaceutical care by working per diem at both the hospital and community pharmacy levels.

This year’s recipient of the NH Pharmacist of the Year award was nominated for his continued commitment to patient care throughout the ever changing world of pharmacy. His coworkers at Littleton Regional Hospital describe him as a dedicated pharmacist who always stood up for what was right.

13

New England States

continued

In addition, he is acting as a board member for the Hospice of Littleton Area, a Health Officer for the Town of Lisbon, NH, and a faculty member for the Institute of Medication Awareness. In addition, he is known for his membership in local community theater organizations and for playing Santa Claus to local children.

During his tenure on the Board, he served on a number of committees including the Joint Pharmaceutical Formulary and Credentialing Committee for Optometry; the NH Child Fatality Review Board; the ad hoc Committee for Electronic Prescription Monitoring of Controlled Substances; and the Committee on Pharmacist-In-Charge Requirements and Duties.

2012 Bowl of Hygeia Award— George Bowersox

He also volunteered as a pharmacy consultant to develop programs aimed at safe medication use for seniors and for this effort was awarded the 2006 AARP “Community Partner of the Year” award.

He has served as a committee member on the National Association of Boards of Pharmacy ‘Committee on Resolutions’ and the ‘Committee on Law Enforcement and Legislation’.

Pictured from left to right: Paula Troie and George Bowersox

The “Bowl of Hygeia” Award is presented annually by participating pharmacy associations in each of the fifty states, the District of Columbia, Puerto Rico, and the ten Canadian provinces. The recipients are selected by their respective associations for their outstanding record of community service. The Bowl of Hygeia award is sponsored by the American Pharmacists Association Foundation and the National Alliance of State Pharmacy Associations.

In 1959, Charles D. Dockham from Laconia, NH, was the first pharmacist honored by NHPA with one of pharmacy’s most prestigious awards. To honor all those who have gone before, I would like to ask all previous recipients of the “Bowl of Hygeia” Award who are present today to stand and be recognized.

This afternoon’s Bowl of Hygeia Winner will receive a plaque honoring him for winning this award. The recipient will also receive a lapel pin that will identify him as a member of a group of outstanding pharmacists, now numbering over 2,500.

These pharmacists have distinguished themselves through their actions. Today, we honor a Hudson pharmacist in recognition of his service to the community and to the profession.

The 2012 Bowl of Hygeia recipient served ten years as a Commissioner on the NH Board of Pharmacy, where he held the position of Board President from 2007 to 2009.

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While on the Board, the 2012 Bowl of Hygeia recipient helped to develop legislation allowing for the re-dispensing of certain unused medications to help benefit NH citizens who could not afford their medications. As a result of this new legislation, he has volunteered to work on a pilot project with SeaCare Community Health to establish New Hampshire’s first charitable pharmacy which is now in operation and staffed by nine, part-time, volunteer pharmacists all managed by today’s Recipient.

He also serves as consultant pharmacist for the Merrimack River Medical Community Substance Abuse Center.

Through these actions and many more, this award winner has demonstrated his passion and commitment to serving his community.

This Long Island University School of Pharmacy graduate has clearly earned recognition as a selfless and dedicated individual to his family, the community and the practice of pharmacy.

The NHPA board members wish to congratulate all 2012 recipients for their commitment and dedication to the profession of pharmacy. Their awards are well-deserved.

Due to space constraints the other two award recipients Helen C. Parvanas (2012 Cardinal Health Generation Rx Champions Award) and Maura Amrol (2012 NH Technician of the Year) will be highlighted in the spring edition due to space constraints.

Pharmacy Journal of New England • Spring 2013

Lastly, NHPA would like to recognize and thank this year’s NH Pharmacy Awards Committee-- Paul Boisseau, Joe Clement, Maryann Cooper, Cynthia Dougherty, Dave Lacoste, Don Messina, Paula Troie, Kristine Willett, and Gary Wingate.

Educational Highlights: Passing the Gavel There was the passing of the gavel ceremony. Lorraine Radick, Immediate-Past President presented a new engraved gavel to our incoming President for 2013 Jay Calabro.

Congratulations and best wishes for success to the 2013 executive board members below: Jay Calabro, President Lorraine Radick, Immediate Past-President Cheryl Durand, Vice-President Michael Viggiano, Treasurer Lindsey Laliberte, Secretary

Upcoming Continuing Education Conferences: Spring CE Program at Attitash On June 8, 2013, NHPA will sponsor its third annual CE program at the Grand Summit Hotel in Bartlett, New Hampshire. We will be offering two free dinner speaker programs both on Friday, June 7 and Saturday, June 8, 2013.

Please join use for an educational and fun filled weekend.

Remember, save the dates for upcoming CE programs in 2013 which are as follows: June 8, 2013 Attitash Grand Summit Hotel, Bartlett, NH 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”.

Vermont

President’s Message I am pleased to announce The Vermont Pharmacists Association (VPA) is participating in a pilot project with Blue Cross and Blue Shield of Vermont (BCBSVT) to provide MTM services to a population of patients on 15 or more medications each. The pilot will utilize software by Aprexis Health Solutions, a Vermont company, and MTM will be provided by a Jim Godfrey, RPh, President network of community pharmacists assembled by VPA in coalition with our sister organization Vermont Retail Druggists. In addition to pharmacy data, medical diagnoses are available on the Aprexis platform, and BCBSVT anticipates the pilot will demonstrate a net savings in medical and pharmacy claims. The cost-effectiveness of pharmacist intervention will be quantifiable since the Aprexis platform tracks pharmacist time spent with patients.

The VPA is tracking a number of bills in state legislative committees including those related to opiod and controlled substance addiction, methamphetamine precursors, law enforcement access to prescription records, and provision of medications for patient choice in end of life care.

Starting in 2013, continuing education programs presented at VPA spring and fall meetings are being provided by the Albany College of Pharmacy and Health Sciences (ACPHS), which has a campus in Colchester, VT. Our recent spring VPA meeting was well attended and featured MTM continuing education. Watch our website vtpharmacists.com for upcoming details on our fall meeting date. Also on our website is the monthly VPA newsletter being edited by a VPA Student Chapter member from the ACPHS, Colchester, VT campus.

The Vermont pharmacy license renewal deadline is July 31, 2013. Now is the time check that you have the required 30 hours of continuing education credits, 10 of which must be live. Begin preparing for the 2015 renewal year by planning to attend the upcoming fall VPA meeting.

Jim Godfrey, RPh President

15

New England States

continued

Rhode Island President’s Message

Greetings from the Rhode Island Pharmacists Association! We hope you all made it through the winter and are ready to enjoy springtime in New England. I just wanted to take a moment to tell you all about the wonderful experience I had this year at the APhA conference in Los Angeles. It was an honor to represent Rhode Daniel R. Lefkowitz, Pharm D., Island in the House of Delegates, MBA, CDOE alongside RIPA council member, Dr. Anita Jackson, assistant clinical professor at the University of Rhode Island. There, we supported the introduction of new policy brought to the table by Dr. Jef Bratberg, Associate Professor at URI, regarding the use of “take-home” naloxone to reduce opioid overdoses and death. After Dr. Jackson was done presenting her poster “Pharmacist Initiation of Post-Exposure Doxycycline for Lyme Prophylaxis (co-authored by Dr. Jef Bratberg and Dr. Kelly Orr), she was able to join her colleagues as we congratulated Dr. Norman Campbell as he received an Honorary President Award.

Overall, it was truly inspiring to be surrounded by such enthusiastic and motivated pharmacists and pharmacy students, whose passion for the profession of pharmacy is so apparent and contagious.

As many of you know, it is that time of year when our events really start to kick-off and we have another exciting line-up for 2013.

Our annual Face of Pharmacy Day is was held on Wednesday April 3rd at the Rhode Island State House, our 10th year bringing students, preceptors, faculty and the Association’s professional and student membership together to allow legislators to “see” pharmacy practice and support legislative changes to permit wider adoption and implementation of clinical pharmacy services. Along with a short speaking program featuring RIPA and RISHP Presidents Dr. Daniel Lefkowitz and Dr. Brian Musiak, we invited both Governor Lincoln Chaffee and Lt. Governor Elizabeth Roberts to make an address. Catherine Cordy, Chief of the RI Board of Pharmacy, Interim Dean of the University or Rhode Island Dr. Paul Larrat, and Pharm D Candidate for the class of 2013, Angela Olenik were also scheduled to share their thoughts on the advancement of our profession. Demonstration tables, staffed by APPE students, preceptors, and faculty will provide free services to the legislators such as hypertension and chronic disease screenings, body fat analysis, and medication therapy management and counseling. Other tables will highlight progressive and successful prac16

tices of pharmacy in the state, including representatives from the state’s pharmacy associations. Featured bills this year include controlled substance e-prescribing and the Prescription Monitoring Program, syringe disposal at pharmacies, and most importantly, including CLIA-waived laboratory tests (glucose screening, HIV tests, cholesterol tests, etc.) in our state Pharmacy Practice Act. We hope to have a great turnout again and look forward to boldly representing the practice of pharmacy in Rhode Island.

Also on the agenda for the coming months are the NASPA/Purdue Pharma sponsored “Know Pain, Know Gain” patient pain counseling competition and continuing education program where students will get to compete in a pain management clinical skills competition for a monetary prize while also providing members and others in attendance with CE credit.

Our student representative, Mike Iafrate is planning an RIPA sponsored career roundtable event where pharmacy students will be able to go from station to station to meet with pharmacists working in a variety of practice settings from community to hospital, industry to corporate, long-term care to nuclear, armed forces and many more. We hope to provide these students with some guidance and insight on to the many possible career paths that await them in their bright futures.

“Protecting, Marketing, and Expanding Your Practice” is the title of this year’s Rhode Island Pharmacy Foundation Spring Seminar to be held on May 9th. Topics this year include social media in pharmacy, robbery preparedness and prevention, doxycycline prophylaxis initiated by pharmacists for Lyme, as well as an immunization and law update. We have a great group of speakers this year and hope to invigorate the state’s pharmacists with some “out of the box” education.

Of course we couldn’t leave out our main summer event, the RI Pharmacy Foundation Golf Tournament & Raffle Drawing at lovely Montaup Country Club in Portsmouth. We had a blast last year enjoying the sun and the greens. Better get your raffle ticket now before they are sold out and you miss out on the big prize!

As you can see, we have a lot planned for the coming months. If you are interested in being a part of any of these events 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 all of our great associations. I hope every one of you enjoys a rejuvenating start to spring and a successful and eventful season for you, your family, and your Association.

Regards, Daniel R. Lefkowitz, Pharm D., MBA, CDOE President, Rhode Island Pharmacists Association

Pharmacy Marketing Group

Financial Forum This series, Financial Forum, is presented by Pro Advantage Services, Inc., a subsidiary of Pharmacists Mutual Insurance Company, and your State Pharmacy Association through Pharmacy Marketing Group, Inc., a company dedicated to providing quality products and services to the pharmacy community.

Parents, Alzheimer’s & Money Easing into a Difficult Conversation Every eighth American aged 65 and older has Alzheimer’s disease, and 43% of Americans aged 85 and older have it, according to the Alzheimer’s Association. Consider those percentages in light of the Social Security Administration’s estimate that about 25% of today’s 65-year-olds will live past age 90. These shocking statistics have serious implications for family wealth.1,2 Your choices. What are your options when it comes to helping a parent out with money management?

Informally, you can “lend a helping hand” and check in with mom and dad to make sure that bills and premiums are paid, and deadlines are met. But if you elect to formally take the financial reins, you are looking at a twophase process:

Pharmacy Journal of New England • Spring 2013

You can get a power of attorney and assume some of the financial responsibilities. A power of attorney is a detailed and strictly constructed legal document that gives you explicitly stated measures of financial authority. If you try to handle financial matters for your parent(s) without a valid power of attorney, the financial institution involved may reject your efforts.3 A durable power of attorney lets you handle the financial matters of another person immediately. The alternative - a springing power of attorney - only takes effect when a medical diagnosis confirms that person’s mental incompetence. Copies of the power of attorney should be sent to any financial institution at which your parents have accounts or policies. It may be wise to get a durable power of attorney before your parent is unable to make financial decisions; many investment firms require the original account owner to sign a form to allow another party access to an account owner’s invested assets.4 You are going to have to hunt for information, such as...

• Where mom or dad’s income comes from (SSI, pensions, investments, etc.)

• Where the wills, deeds and trust documents are located.

• Who the designated beneficiaries are on insurance policies, IRAs, etc.

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

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Pharmacy Marketing Group • Who the members of mom or dad’s financial team or circle are. You need to talk with them; they need to talk with you.

• The crucial numbers: checking and savings accounts, investment accounts, insurance policies, PIN numbers and of course Social Security numbers.

• It will also help to learn about their medical history and prescriptions.

If the disease progresses to the point where your mom or dad can’t make competent financial decisions, then you are looking at a conservatorship. In that case...

You can act to become your mom or dad’s conservator.

This means going to probate court. You or your parent can initiate a request for conservatorship with a family law attorney; if the need is more immediate, you or your family’s attorney may petition the court. In either case, you will need to show documentation that your parent is no longer financially competent. You must provide medical documentation of his or her dementia to the court as well.

The court will interview the involved parties, look at the documentation and perform a background check on the proposed conservator. This is all pursuant to a hearing at which the court presents its decision. If conservatorship is granted, the conservator assumes control of some or all of the protected party’s income and assets.5 How do conservatorships differ from guardianships? A guardianship gives a guardian control over many aspects of a protected person’s life. A conservatorship limits control to the management of the protected person’s assets and financial affairs.5 What if I don’t want to assume this kind of responsibility?

Some wealth management firms offer daily money management as an option in a “family office” suite of services.

The firms make home visits to help with bill paying, filing medical claims and other recurring tasks; carefully scrutinize anyone offering this service. (Visit aadmm.com for the American Association of Daily Money Managers.)6 The other choice is to give a relative, a financial services professional, or a family lawyer durable or springing power of attorney or limited or full conservatorship. Such a decision must not be made lightly.

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Keep your parents away from unprincipled people. These steps may prove essential, yet they will not shield your family from scam artists. Be on the lookout for new friends and acquaintances. If your instincts tell you something is wrong, investigate.

Citations 1 - www.alz.org/downloads/facts_figures_2011.pdf [2011] 2 - money.usnews.com/money/blogs/planning-to-retire/2010/07/22/predicting-yourown-life-expectancy [7/22/12] 3 - www.law-business.com/powers-of-attorney [4/27/12] 4 – http://www.kiplinger.com/magazine/archives/managing-your-parentsmoney.html [4/27/12] 5 - dhs.sd.gov/gdn/guardianshipfaqs.aspx [6/2/12] 6 - www.smartmoney.com/retirement/planning/talking-to-mom-about-alzheimersand-her-money-1335192298522/ [5/7/12] Provided by courtesy of Pat Reding, CFP of Pro Advantage Services Inc., in Algona, Iowa. For more information, please call Pat Reding at 1-800-288-6669.

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

Rx and the Law This series, Pharmacy and the Law, is presented by Pharmacists Mutual Insurance Company and your State Pharmacy Association through Pharmacy Marketing Group, Inc., a company dedicated to providing quality products and services to the pharmacy community.

Discovery 101 Ask anyone who works in the claims department at an insurance company and they will tell you that the Discovery phase of litigation is the most time-consuming and expensive part of the process. But if you don’t work in the claims department or a law firm, could you readily explain what Discovery is and why it is so costly?

Discovery is defined by Rules 26 to 37 of the Federal Rules of Civil Procedure.1 Discovery is a process where opposing sides in the litigation share information about the case with each other. This process is mandatory, although compliance with the rules is generally self-enforced by the parties. This sharing of information takes many forms and helps each side to evaluate the strengths and weaknesses of their case prior to trial.

Pharmacy Journal of New England • Spring 2013

These forms include; 1. Depositions by Oral Examination, 2. Depositions by Written Questions, 3. Interrogatories to Parties, 4. Producing Documents, Electronically Stored Information, and Tangible Things, or Entering onto Land, for Inspection and Other Purposes, 5. Physical and Mental Examinations, and 6. Requests for Admissions.

Depositions, whether written or oral, are one of the largest cost drivers in the Discovery process. Little use of Depositions by Written Questions is seen in most cases, so I will concentrate on Deposition by Oral Examination. The main reason that this exchange consumes so much time and money is that virtually anyone connected with the case can be deposed. The parties, employees of the parties, fact witnesses, and expert witnesses can all be deposed.

Depending on the complexity of the case, the deposition can be a half day, whole day or potentially even multiple days. Coordinating witnesses’, parties’, and attorneys’ schedules can be a nightmare. This is multiplied in multiple defendant cases or class action cases. Depositions are important because they give a preview of what a witness is going to say on the stand at trial. Witness testimony is crucial to evaluating a case. Preparation for a deposition, taking the deposition and analysis of the answers is time consuming for your attorney. If the number of Depositions is large, Discovery is well on its way to being the most expensive part of litigation.

Interrogatories are written questions that can only be submitted to the opposing party. They cannot be used to gain information from witnesses or other non-parties. There is a limit to the number of Interrogatories that can be served on the opposition. Many times Interrogatories are used to gather background facts such as date of birth, address, work history, arrest records, etc. As with Deposition questions, it is permissible to object to questions, but the objecting party must have a good faith basis to object beyond just not wanting to answer.

Producing Documents, Electronically Stored Information, and Tangible Things, or Entering onto Land, for Inspection and Other Purposes is comprised of 2 parts.

The inspection of land and/or buildings occurs when relevant, but the bigger issue here is documents. In the not too distant past, this rule dealt almost exclusively with documents. Not so today. This rule encompasses not only paper documents, but e-documents, e-mail, spreadsheets, photos, drawings, and almost anything else that you can imagine.

Recent changes to the rule require that electronic documents be produced electronically to preserve the metadata.

Metadata and its implications are a topic of their own, but

be aware that metadata can have a dramatic impact on the evidentiary value of the documents themselves. When the case involves a complex issue and/or a long running issue, it doesn’t take too long these requests for production to take on a life (and an expense) of their own.

Parties may also request that the opposing party undergo a physical or mental examination. This is not automatic. The request must be approved by the court. The examination must be relevant to some issue in the case, so this cannot be requested without reason. This is usually used in situations where the party wants an independent opinion on, or verification of, the opposing party’s condition.

The last form of Discovery is the Request for Admission.

This is a written request to the opposing party asking them to admit the truth of some facts, application of the law to the facts, or the genuineness of documents. As you might have guessed by now, the item in question must be relevant to the case at hand. The responding party must admit as requested, deny or object to the request. Making an admission under this rule renders the issue decided and the issue is not debated at trial. This rule has the potential to actually shorten a trial.

Discovery is self-governed by the parties and the rules provide deadlines for responding to the various forms of requests. Also, the parties cooperate to establish an overall schedule for Discovery to take place so that depositions, etc. are completed during a reasonable timeframe.

Disputes about discovery make their way in front of a judge. The judge can order the parties to participate in Discovery and can impose further sanctions, up to and including dismissal of the case, for failure to do so.

Discovery is a very important part of the litigation process, but it can be very time-consuming and expensive to comply with. This is especially true for the pharmacist defendant who has to take time away to be deposed or spend valuable time searching for and organizing records. Your attorney does realize the impact that Discovery has on your life, but your attorney also knows the potential downside for failure to comply.

1. I will use the Federal rules for this article because they are consistent nationwide.

Many states mimic them for their own rules, but you should make sure which approach your state takes. © 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.

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Feature Updated Immunization Schedules and Recommended Changes for Children and Adults 2013

By Jennifer Girotto, PharmD, Associate Clinical Professor of Pharmacy Practice. University of Connecticut School of Pharmacy Reliable Internet Vaccination Resources for Pharmacists

By Daniel Ventricelli, PharmD candidate, Robyn Pisacane PharmD candidate, and Jennifer Girotto PharmD University of Connecticut School of Pharmacy

Vaccines:

Schedules, Changes & Resources Updated Immunization Schedules and Recommended Changes for Children and Adults 2013 In January of 2013, the Centers for Disease Control and Prevention released the updated immunization schedules.

This review will focus on the recent changes in the schedule content and organization. Clinical vaccine changes include pneumococcal, pertussis, meningococcal, and measles mumps and rubella (MMR).

Format The first significant change to the immunization schedules is the format. This year for more consistency, the child and adolescent schedules have been merged into one schedule.

Influenza For the 2013-2014 influenza season, there will be both trivalent (inactivated) and quadrivalent (inactivated and live-intranasal). All of the quadricvalent will contain 2 influenza A and 2 influenza B strains. Due to these changes in the expected influenza vaccines for the upcoming year, the 2013 immunization schedule has changed their abbreviations for influenza vaccination.1 The new abbreviation is now IIV (inactivated influenza vaccine) rather than TIV (trivalent inactivated influenza vaccine).1

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Pneumococcal Vaccinations (PPSV23 & PCV13) In 2012, two significant changes to the recommendations for vaccinations occurred (Table 1). First, guidance for revaccination with pneumococcal pure polysaccharide vaccine (PPSV23) was clarified so that adult patients who remain immunocompromised or are functionally or physically asplenic are to receive a second dose of PPSV23 5 years after the first dose. The important clarification was that the majority of these patients will now receive 3 lifetime doses of PPSV23 (2 under the age of 65 years, and 1 dose after 65 years). The ACIP reinforced that all other patients at higher than average risk for invasive pneumococcal disease are still recommended only to receive 1 dose of PPSV23 prior to the age of 65 years (and after the age of 2 years) and a second dose after turning 65 years old (and at least 5 years from the first dose) for a maximum total of 2 lifetime doses.3 The second significant change is the addition of a recommendation to use pneumococcal conjugate vaccine (PCV13) in a select group of children, teens, and adults at very high risk for invasive pneumococcal disease. Patients that are specifically included in the recommendation include those that are immunocompromised, are physically or functionally asplenic, have a CSF leak, or have cochlear implants.2 This recommendation is to provide a single dose of PCV13 to children, teens and adults who have never

Pharmacy Journal of New England • Spring 2013

Table 1. Pneumococcal Vaccination of Patients 2 years old through 64 years old

Single Dose of PPSV23

Two Doses of PPSV23

PCV13 Single dose

CSF Leak Cochlear Implant

Anatomic or functional asplenia (e.g. sickle cell disease), immunocompromised (e.g. immunodeficiency, renal failure, cancer, solid organ transplant)

PCV13 NOT Recommended outside of routine childhood schedule

Chronic heart disease, chronic lung disease (including asthma if > 18 yrs), diabetes, chronic liver disease, alcoholism, and smoker (if > 18 yrs)

N/A

PPSV23 – 23 valent pneumococcal polysaccharide vaccine, PCV13 – pneumococcal conjugate vaccine, CSF – cerebral spinal fluid received one previously.3, As noted in Table 1 this would be in addition to the dose(s) of PPSV23 that the patient is recommended to receive.

When both PPSV23 and PCV13 are indicated and the patient has not received either, it is preferred that the PCV13 be administered first. It is important to note that although both of these vaccines are inactivated, they are not recommended to be given together at the same visit, in fact they should be spaced by 8 weeks (if PCV13 given 1st) or 1 year (if PPSV23 administered 1st).3

Pertussis Two-thousand and twelve was a significant year for pertussis disease with over 41,000 cases and 14 infant deaths reported. There are two changes to the recommendation both aimed at preventing the infant from coming down with pertussis disease.1,5 First, the Tdap vaccine is now recommended to be given to pregnant women at each and every pregnancy.

The dose is suggested to be given

between 27 and 36 weeks gestation to provide the baby optimal protection during the period they are at highest risk of severe disease. Secondly, the Tdap vaccine is now recommended to be given routinely as a once lifetime dose to elderly, just like it is for all patients 11 years old and older. It is preferred that Boostrix is used in patients > 64 years old, as it is FDA approved in this age group, while Adacel is not.1

Meningococcal Vaccination There is a new meningococcal vaccine that was approved in 2012. MenCYTT/Hib. is a vaccine that provides protection against both H. influenzae and N. meningococcus (strains C and Y).1, The hib component is the same that is included in routine childhood vaccination. This meningococcal portion of the vaccine is different from the other meniningococcal conjugate vaccines that are currently available for 2 reasons. First MENCY-TT/Hib is approved down to the age of 6 weeks and secondly it provides coverage only against the C and Y strains

(as compared to MCV4 which includes the C and Y, but also A and W135). This new vaccine is recommended to be given as a 4 dose series to infants with physical or functional asplenia (including sickle-cell disease) or with terminal complement pathway deficiency.1,6 Additionally, it may be used in infants 6 weeks through 18 months if they are in communities with meningococal outbreaks of the C or Y strains.6 The recommendations strongly stress that the MCV4 and not this MCY-TT should be used for patients going traveling to subSaharan to provide coverage for all 4 strains of meningococcal disease.6

Measles, Mumps, and Rubella There are currently 2 provisional recommendations for the use of MMR vaccine. First MMR vaccination will be recommended routinely for all HIV infected patients greater than 12 months of age without severe immune suppression. The degree of immune suppression in patients with HIV is defined by the CD4% in children < 5 years old and by both the CD4% and CD4 count in older children and adults. Specifically, patients are considered to not have severe immune suppression if their CD4% is ≥ 15% for > 6 months and/or the CD4 ≥ 200 lymphocytes/mm3 for greater than 6 months. If patients with perinatal acquired HIV received the vaccine during a period when they would have been considered to have severe immune suppression they should be revaccinated with the 2 dose vaccine series after having met the CD4%/count criteria.7 The second significant change to the recommendations for the MMR vaccination is what should be considered as adequate immunity to each of the 21

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components of the vaccine.7 As this is still a provisional recommendation the specifics may change, but are available online at the Centers for Disease Control and Prevention.7 One of the specific changes includes that being born prior to 1957 is sufficient immunity for all of the components, the adult vaccination schedule age that the MMR is recommended stops half-way through the 50-59 year old category.1,7

References: 1. Centers for Disease Control and Prevention. Advisory Committee on Immunization Practices (ACIP) Recommended Immunization Schedules for Persons Aged 0 Through 18 Years and Adults Aged 19 Years and Older — United States, 2013. MMWR 2013; 62 (Early Release): 1-19.

2. Neale T. ACIP: Four Vaccines Added for Next Flu Season. Medpage Today (2/21/13). Available online: www.medpagetoday.com/MeetingCoverage/ACIP/37485 (accessed 2/27/2013) 3. Centers for Disease Control and Prevention. Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine for Adults with Immunocompromising Conditions: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2012;61:816-819.

4. Brown M. ACIP Expands PCV13 Vaccine Recommendations to include Immunocompromised Kids, Teens. Additions to VFC Program Among Other Committee Actions. AAFP News Now. Available Online at: www.aafp.org/online/en/home/publications/news/news-now/health-of-public/20130226acipmeeeting.html (accessed 2/27/13).

5. Centers for Disease Control and Prevention. Updated Recommendations for the Use of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular pertussis Vaccine (Tdap) in Pregnant Women – Advisory Committee on Immunization Practices (ACIP) 2012. MMWR 2013;62: 131-135.

6. Centers for Disease Control and Prevention. Infant Meningococcal Vaccination: Advisory Committee on Immunization Practices (ACIP) Recommendations and Rationale. MMWR 2013;62: 52-54.

7. Centers for Disease Control and Prevention. ACIP Provisional Recommendations: Prevention of Measles, Rubella, Congenital Rubella Syndrome (CRS), and Mumps.

Available online: www.cdc.gov/vaccines/recs/provisional/downloads/mmr-Oct2012.pdf (accessed February 15, 2013).

Reliable Internet Vaccination Resources for Pharmacists As pharmacists in most states, including Connecticut, are expanding their practice to include the administration of immunizations, it is very important that pharmacists are familiar with informative resources when questions do arise. Unfortunately, while the internet provides many valuable resources for healthcare practitioners, not all websites provide trustworthy information. Table 1 provides the websites that are summarized below as some of the key reliable sources of immunization information available.

As most pharmacists are already aware The Centers for Disease Control and Prevention, provides the annual pediatric, catch-up, and adult immunization schedules. In addition to their vaccine schedules, they also maintain many sources of up to date information related to vaccines and guidelines. Specifically, the recommendations of their advi22

sory committee (Advisory Committee on Immunization Practices, ACIP), including the background and rational, are published in the Morbidity and Mortality Weekly Report (MMWR), which is searchable from the CDC website. Once published in this journal the recommendations furnished by the ACIP are considered formal. The website also keeps up to date information on vaccine shortages, recalls, storage requirements and state laws. Further, the CDC offers online education to pharmacists and other healthcare professionals in the form of webcasts, broadcasts and self-study materials. It is a reliable source to obtain the most up to date vaccine information statements for each vaccine. You may even find yourself recommending that patients go to the CDC’s website as they have information for the public as well. The patient may utilize many of the other resources on the webpage for further education such as the common questions and answers section or vaccine material in foreign languages.

The CDC website also has a link to an electronic version of “The Pink Book. The Pink Book, which is the CDC's reference text on vaccines and preventable diseases is currently in its 12th edition second printing (May 2012) and can be accessed online (for free) or purchased as a text. This book provides individual chapters on vaccine basics, adverse events, and storage as well as vaccine preventable disease summaries. Each vaccine preventable disease chapter includes epidemiology, pathogenesis, laboratory and clinical disease specific information. For each vaccine it provides history, current vaccine data, recommendations for use, adverse reactions, storage, as well as specific precautions or contraindications for use. In addition, the Pink Book provides a multitude of appendices that simplify information into tables. Commonly sought out appendices include: minimum ages and intervals for vaccination, recommendations for specific populations (e.g. healthcare workers, immunocompromised patients, table of precautions and contraindications, vaccine excipient information, latex information, administration route and dose, medical management of vaccine reactions, and vaccine adverse event reporting system (VAERS).

The Immunization Action Coalition (IAC) is an organization, which works jointly with the CDC towards the goal of increasing immunization rates and distributing educational information to healthcare professionals and the public. The organization offers an array of helpful and informative handouts as well as vaccine information sheets in many different languages including Spanish, Vietnamese, French

Pharmacy Journal of New England • Spring 2013

and Chinese to name a few. Handouts that pharmacist may find useful, include those in the “clinic” section such as forms for screening various populations, checklists for contraindications, and information regarding the importance of vaccinations. Located on the bottom of the websites home page is a guide that provides an A-Z index to help locate anything you may need to search for as well as a link specifically directed to pharmacists. The pharmacist link will direct you to the American Pharmacists Association’s immunization center.

The Infectious Disease Society of America (IDSA) represents a group of physicians, scientists and other health care professionals who specialize in infectious diseases. The IDSA website provides links to websites of important immunization organizations such as the American Academy of Pediatrics Immunization, the Department of Health and Human Services, the Vaccine Adverse Event Reporting System (VAERS), the National Vaccine Injury Compensation Program (VICP), the Advisory Committee on Immunization Practices (ACIP) and the Centers for Disease Control (CDC) vaccination recommendations and schedules. You also have the ability to research topics of interest such as Lyme Disease, Immunization, Emerging Infections and Antimicrobial Resistance.

The Centers for Medicare and Medicaid Services (CMS) provide some limited immunization information on their website. The information provided by the CMS is related to, “coverage, billing, delivery, and the promotion of seasonal influenza, pneumococcal and hepatitis B vaccinations.” CMS provides facts about influenza, pneumococcal, pneumonia and hepatitis B,

including information such as prevalence, morbidity and mortality figures.

The website goes on to detail Medicare and Medicaid coverage of these immunizations. The site is also equipped with links to patient handouts, public service announcements, and documents for healthcare providers regarding these 3 vaccinations. The CMS website also provides links to many important resources such as the Centers for Disease Control and Prevention (CDC) and the Immunization Action Coalition (IAC).

The United States Department of Health and Human Services (HHS), in partnership with the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH), maintains the website. While the website is more patient oriented, it does provide information related to immunizations that pharmacists may find useful.

Specifically, the website covers how vaccines work to prevent disease and comments on the safety and efficacy of vaccinations. There are tabs to all vac-

cine preventable diseases; each tab provides information such as who should receive the vaccine, disease state specific information, as well as links to the CDC and FDA resources. What may be most useful for pharmacists are the links and information they may provide to parents regarding the Vaccines for Children (VFC) program that may be used to cover immunizations for children who are uninsured or underinsured.

The Children’s Hospital of Philadelphia (CHOP) website provides pediatric specific vaccine related information.

This resource promotes the importance of immunizations, in children as well as adults. Additionally there are statements on each vaccine which provide a brief summary of the childhood diseases they help to prevent. These statements are followed by links to both the CDC and American Academy of Pediatrics for further information. Perhaps the most useful, and unique, information this resource provides is a short guide to treating mild reactions, such as fussiness, fever, and pain, to immunizations in children.

Table 1: Immunization Websites The Centers for Disease Control and Prevention (CDC) www.cdc.gov The Pink Book www.cdc.gov/vaccines/pubs/pinkbook/index.html Immunization Action Coalition (IAC) www.immunize.org The Infectious Disease Society of America (IDSA) www.idsociety.org The Centers for Medicare and Medicaid Services (CMS) www.cms.gov The United States Department of Health and Human Services (HHS) www.vaccines.gov The Children’s Hospital of Philadelphia (CHOP) www.chop.edu/healthinfo/immunizations-1.html

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From the Colleges University of Connecticut School of Pharmacy Dear Friends:

Mental Health Consumers and Community Pharmacists Dr. Charles Caley, in his role as president of the College of Neurologic & Psychiatric Pharmacists Foundation, partnering with the National Alliance on Mental Illness (NAMI), played an integral role in the development of a survey report that “characterizes the interactions and relationships between mental health consumers and community pharmacists.”

Compounding Competition Nine teams participated in this year’s school compounding competition, with Mel Masse, Meg Fletcher, and Dan DeCarlo emerging as winners to represent us at the National Competition in Florida in March.

Pharm.D. Student Researcher of the Month

After 11 amazing years, in February I informed Provost Choi of my decision to step down as dean at the end of June. I have been privileged to hold a position that only six other individuals have held during our nearly 90 years of existence. These years have been marked by many highlights, including moving into our new building in 2005, but what I will remember most are the people I have gotten to know along the way. Our UConn pharmacy family includes not only our students, faculty, staff, and alumni, but the scores of others who, because of their commitment to helping the school meet its mission of education, scholarship, patient care, and service, have made us one of the nation’s premier schools of pharmacy.

To the many people who have supported our school over these years, I offer a heartfelt “thank you.” When I became dean, I promised Dean Karl Nieforth that I would do my best to leave our school at least a bit better than I found it; I hope that I have been able to accomplish that goal.

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The UConn Rho Chi Honor Society and School of Pharmacy Honors and Professional Research Committee announced the following recipients of the Student Researcher of the Month Award: Patrick Brooks (December, Dr. Lu); Steven Lemieux (February, Dr. Hadden); and Michele Miller (March, Dr. Hadden).

ASHP Clinical Skills Competition Monika Zmarlicka and Cynthia Gagliardi were national finalists for the 2012 ASHP Clinical Skills Competition.

Pharm.D. Research Grants The recipients of the Pharm.D. Research Grants for Fall 2012 were: Anastasia Shmukle for “Consequences of HSP Reduction due to Over Expressed TNIP1” (Dr. Brian Aneskievich) and Nanda Kommineni for “Formulation of Double Walled PLGA Microspheres” (Dr. Diane Burgess).

Eastern AHEC Award Katelyn O'Brien received the Eastern AHEC Excellence Award.

Fulbright Scholar Returns Dr. Carolina Ghanem's recent application to Fulbright to return to UConn for some follow-up work with Dr. Jose Manuatou has been awarded.

Outstanding Alumnus Award Dr. Sean Jeffery has been named an outstanding alumnus by The Ohio State University College of Pharmacy.

Best, Robert L. McCarthy, Ph.D., Dean and Professor

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

University of Saint Joseph School of Pharmacy Dear Colleagues: Sincere greetings from our state of the art facility in Downtown Hartford. University of Saint Joseph is doing well and making our mark every day through the activities of our students, faculty, and preceptors. All these have been possible due to your energy and warm support.

Thank you!

We are looking forward to the arrival of our Class of 2016.

The students continue to actively engage in community, health and wellness activities. The faculty also continues to engage in scholarship, teaching, practice and beneficial community activities. Please enjoy reading these few briefs and know that you are highly appreciated.

Best, Joseph Ofosu Pharm.D., R.Ph., Dean and Professor

Immunization Training 62 P2 students completed the APhA Immunization certification in February. This will allow the students to immunize patients while on their APPE rotations. Faculty members Jennifer Tan PharmD and Dora Wiskirchen PharmD, APhA Certified Immunization Instructors, spent two days providing the classroom and practical instruction needed to complete the class.

In addition, faculty members Janine Douglas PharmD and Sukhvir Kaur PharmD participated in the practical training.

NBC 30 Health Fair On March 9th and 10th, over 40 students and faculty participated in the NBC Health and Wellness Festival. The students assisted in various health screenings plus provided information on health related issues. Working with students from UCONN and with the support of the CT Pharmacists Foundation, the students practiced their communication skills and utilized their pharmaceutical knowledge to answer questions from patients about their medication therapy.

New Faculty Lisa DeGennaro, PharmD, CDE has been appointed as an Assistant Professor in the Department of Pharmacy Practice and Administration. Dr. DeGennaro received her PharmD from the University of Connecticut and completed a pharmacy practice residency at Saint Francis Hospital and Medical Center. She has practiced at Saint Francis over the last decade, most recently as the Manager of

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USJSP continued Clinical Pharmacy Services and Pharmacy Residency Director. Dr. DeGennaro will contribute to the classroom and experiential education of our pharmacy students and will begin a clinical practice at the Diabetes & Outpatient Nutrition Counseling Center at MidState Medical Center in Meriden.

Dora Wiskirchen, Pharm.D.

Dora Wiskirchen, Pharm.D., Assistant Professor, Department of Pharmacy Practice and Administration , recently had published Comparative Pharmacokinetics, Pharmacodynamics, andTolerability of Ertapenem 1 Gram/Day Administered as a Rapid 5-Minute Infusion versus the Standard 30-MinuteInfusion in Healthy Adult Volunteers (Pharmacotherapy 2013;33(3):266–274). She was involved with the conduct of the study, data analysis and interpretation, statistical analysis, and manuscript preparation.

New Faculty Appointments: Prashant Mandela, PhD, has been appointed as Assistant Professor in Pharmacology / Biochemistry in the Department of Pharmaceutical Sciences. Dr Mandela received his Ph.D. in Pharmacology from the University of Mississippi Medical

Center, Jackson, MS. He is currently a post-doctoral research associate at the University of Connecticut Medical Center, as well as an adjunct instructor at the University of Saint Joseph.

He will contribute to the classroom education of our pharmacy students in Pharmaceutical Sciences, and carry out research on Kalirin, a factor associated with Huntington’s disease.

Sanjaykumar Gayakwad, PhD, has been appointed as Assistant Professor in Pharmacokinetics / Pharmaceutics in the Department of Pharmaceutical Sciences. Dr. Gayakwad earned his Ph.D. in Pharmaceutical Sciences from Mercer University, Atlanta, GA. He will be involved in teaching pharmaceutics and pharmacokinetics. His research interests are in the development of nanoparticles for oligonucleotide drug delivery and transdermal systems for the delivery of biologics.

Massachusetts College of Pharmacy and Health Sciences - Boston Greetings!

I thought I’d share a bit of what our faculty and students are doing in the community as we educate students to be the best pharmacists that they can be! Currently, there’s some healthy research being done that focuses on community pharmacy practice. Some of our ongoing projects which measure the effect of a pharmacist’s intervention in patient care include: • The promotion of immunization awareness and administration in community pharmacy settings to demonstrate whether pharmacists can increase vaccination rates (pneumonia, shingles, and Tdap).

• A Community Pharmacist Based Recommendations of Vitamin Supplementation in Women of Childbearing 26

Potential project.

• Implementation of a Pharmacist-based Pediatric Callback Program for Commonly Prescribed Antibiotic to increase adherence and compliance regarding antibiotic regimens for pediatric patients, and, • A project to demonstrate the value of MTM to student pharmacists in their last year of school by developing a comprehensive medication review for eligible patients.

Students are required to assess the appropriateness of medications, counsel patients on their usage, determine missing therapies, as well as areas of concern for nonadherence.

We are also focusing our curriculum on the education of student pharmacists to provide advanced patient care in community settings. For example, we have integrated the

Pharmacy Journal of New England • Spring 2013

APhA immunization certificate into the curriculum. All MCPHS students have the option to get certified. We have a newly established Advanced Community APPE experience in which students are trained and then help execute MTM through Outcomes® and Mirixa®. Our business plan competition centers on teams of students developing innovative ideas that could be incorporated into pharmacies, particularly community pharmacies and is supported by the national chains, local independent community pharmacies and other business leaders. In our Advanced Practice Management course, we include simulated practice labs in Communication, Community, Institutional and Physical Assessment and include training and assessment in providing MTM, Drug information requests and toxicology assessments.

The laboratory sessions prepare students for many of the aspects of pharmacy practice in advance of early experiential and advanced experiential rotations.

Community Pharmacy Setting.” J Am Pharm Assoc. 2012;52:535-540 Mistry, AD, Machado, MR. “Identifying Physical Assessment Skills and their Relative Importance in Faculty-Based Pharmacy Practice Settings within the Same Region”.

Journal of Pharmacy Technology March/April 2012;28(82-87) Navarrete, JN, Machado MR, Mistry AD. “Assess the impact of a community pharmacist's role in increasing or modifying calcium and vitamin D supplementation intake in women on osteoporosis treatment or at risk of osteoporosis treatment” US Pharm.

2012;37(9):37-43.

Community Pharmacy Residency Programs We are also pleased to report that the School continues to offer a number of community pharmacy residency programs. Each has an assigned faculty member at the site. Our Walgreens / MCPHS-Boston Community

Pharmacy Residency program was established in 2000 and is dually accredited by APhA and ASHP. Some 20 residents have successfully completed this residency program at the 2 Walgreens Patient Care Centers: Waltham, MA and Chelsea, MA. The Cardinal Health/Sullivan’s Pharmacy/MCPHS Two-Year Community Pharmacy Management Specialized Residency Program was established in 2010. Two residents have successfully completed the program at Sullivan’s Pharmacy and Medical Supplies: Roslindale, MA. We are also very pleased to be able to offer a two year Fellowship opportunity at Johnson Compounding & Wellness Center in Waltham, MA

National Heartburn Awareness Challenge For the first time in our history, the APhA-ASP chapter won the National Heartburn Awareness Challenge! This award is given to the chapter that proves to be the most creative with

Research In the past three years, the School has published some of this research that focuses on community pharmacy practice in some of the leading professional and academic journals. These publications include: Mistry, AD, Machado MR, Lee, KW. “Developing a Weight Management Program in a Community Setting” Journal of Pharmacy Technology Sept/Oct 2011 27:5(229-238) Bosse, N, Machado, M, Mistry, A. “Evaluating the Efficacy of an Overthe-Counter (OTC) Intervention Follow-up Program Within the 27

From the Colleges

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MCPHS - Boston continued heartburn related activities, the most effective in reaching out to various patient populations, as well as educating patients about the risks of chronic heartburn. Our chapter held numerous educational events within the community, had a mini-golf contest to help educate children about heartburn, as well as our legendary “Lord of the Wings” wing eating contest to help secure the national award! In addition to beautiful plaque, the chapter was also awarded $500.

John A. Gans APhA Foundation Scholarship This year we were also fortunate enough to have a student receive the John A. Gans APhA Foundation Scholarship.

The APhA Foundation Student Scholarship Program recognizes students who choose to invest their time in their school’s APhA - ASP chapter to help shape the future of the profession while managing the demands of a full-time pharmacy curriculum. Applicants were evaluated on their potential to become leaders for the profession of pharmacy, as demonstrated by involvement in school and community activities and academic performance. Benjamin Laliberte was awarded a $1000 scholarship at the Opening General Session at the Annual Meeting in LA. He was one of 12 recipients of the scholarship.

Scholarship Faculty members Matt Machado and Amee Mistry had an abstract published in JAPhA, which focused on the promotion and assessment of expanded vaccination services in a community pharmacy setting.

In addition both faculty members, Matt Machado and Amee Mistry were recognized for their role in OTC counseling through previous research that was conducted at Walgreens. Their paper, “Efficacy of an over-the-counter intervention follow-up program,” was referenced during the OTC update at the annual APhA convention in Los Angeles.

All in all, the School has been very active in supporting and encouraging many of the professional endeavors that promote community pharmacy and the profession as a whole.

We are proud of our students and faculty. We are proud of the accomplishments of the University and look forward continuing to update you on the activities of the School!

Sincerely, Douglas Pisano Dean and Associate Provost for Pharmacy Education

Massachusetts College of Pharmacy and Health Sciences Worcester/Manchester Dear Colleagues

ASHP Clincal Pharmacy Challenge

It has been an extremely active fall and spring for both faculty and students. The first-year students have settled in well and our APPE students are looking forward to graduating, taking the boards, and moving onto the next stage of their professional career. The faculty are actively engaged in educating all the students while also working diligently on making the most of their Scholarly opportunities. I wish you all a productive and successful spring semester.

Maria Taghir and Diana Piekielniak ( class of 2013) won the College’s chapter of the ASHP clinical skills competition. They went on to represent the college at the Midyear Clincal Meeting in Las Vegas, Nevada.

All the best, Michael J. Malloy, Dean and Professor

(From left) Maria Tahir and Diana Piekieniak

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Pharmacy Journal of New England • Spring 2013

47th Annual Midyear Clinical Meeting of the American Society of Health-System Pharmacists (ASHP) The MCPHS University’s School of Pharmacy had a strong showing at the 47th annual Midyear Clinical Meeting December 2-6 in Las Vegas, Nevada. Forty-one posters authored by MCPHS students and faculty were presented at the meeting (listed below). Associate professor of Pharmacy Practice Linda Spooner was also a speaker and a session moderator for the session titled “Hepatitis C in 2012: A clinical pharmacist’s role in successful treatment”. Faculty and students were also involved in a number of recruitment, networking, and career development sessions throughout the meeting.

Awards Risa Bernstein (2013) was the recipient of MCPHS SURF Research Excellence Award for the SURF poster presentations on October 22, 2012 at MCPHS-Boston. SURF mentors are Dr. Alice Gardner and Dr. Alok Sharma.

Dr. Helen Pervanas was awarded the Cardinal Health Generations Rx Award on December 11 at the MCPHS/NH Board of Pharmacy Annual Holiday Reception. The Cardinal Health Generation Rx Champions award program recognizes excellence in community-based prescription drug abuse prevention at state pharmacy associations. This award honors a pharmacist who has demonstrated outstanding commitment to raising awareness of the dangers of prescription drug abuse among the general public and among the pharmacy community.

The award is also intended to encourage educational prevention efforts aimed at patients, youth, and other member of the community.

Publications Machado M, Gammal R. Adult vaccinations attitudes survey. Pharmacy Journal of New England. 2012;9:7-10.

Attwood RJ, Garofoli AC, Baudoin MR, Smith VD, Woloszyn AV, Berg AK, Hess EP, Russi CS, Rudis MI. Impact of emergency department clinical pharmacist response to an automated electronic notification system on timing and appropriateness of antimicrobials in severe sepsis or septic shock in the emergency department. Ann Emerg Med. 2012 Oct; 60(4):S118.

Presentations Invited Presentations

Kaelen Dunican (on behalf of Cheryl Abel, Adriana Cabrera, Stephanie Conway, Alicia Desilets, and Ann Lynch) presented “Integrating Self Care and Nonprescription Therapeutics into Pharmacy Skills Laboratories" at the AACP Annual Meeting. July 16, 2012.

Kissimmee, FL. Poster Presentations

Attwood RJ, Garofoli AC, Baudoin MR, Smith VD, Woloszyn AV, Berg AK, Hess EP, Russi CS, Rudis MI. Impact of an ED Clinical Pharmacist Response to an Automated Electronic Notification System on Timing and Appropriateness of Antimicrobials in Severe Sepsis or Septic Shock in the Emergency Department. American College of Emergency Physician's Scientific Assembly.

October 9, 2012. Denver, CO. Bernstein R, Gardner A, Sharma A. Role of Short Acting Beta2-agonist Enantiomers in the Regulation of Early and Late Signaling Events in Normal Human Airway Smooth Muscle Cells. MCPHS SURF Awards Banquet. October 22, 2012. Boston, MA. Mehta J, Acquaah-Mensah GK. Regulatory Targets of CDKN2A in Lung Epithelial Cells. Abstract 14. 2012 Annual Meeting of the Northeast Chapter of the Society of Toxicology. October 19, 2012. Newport, RI. SOP-W/M faculty members co-authored the following posters presented at the 47th Annual Midyear Clinical Meeting of the American Society of Health-System Pharmacists (ASHP), December 2012, Las Vegas, NV. Acheampong F, Kanaan A, Sullivan K, Neill M, Abraham G. Impact of computerized clinical decision support for antimicrobial dosing in in-patients with renal insufficiency.

Chowdhury T, Carey K, Knee A, Heelon M. Comparing self-reported medication adherence to pharmacy refill history in ambulatory care patients with heart failure.

Cooper MR, Goldsmith CW, Durand C, Pervanas H, Steinberg M. Knowledge of cancer screening recommendations among health fair attendees.

Dietle A, Cole T, Upchurch H, Carey KM. Impact of clinical pharmacy services in uncontrolled diabetic patients at a federally qualified health center.

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MCPHS -Worcester/Manchester continued Dolley SM, Morin AK, Lorberg B. Assessment of concomitant antipsychotic therapy at an inpatient psychiatric service.

Steinberg M, Cooper M. Effect of an oncology pharmacy elective course oh fostering student interest in oncology pharmacy as a career specialty.

Horton E, Carey K, Cross J, Pesaturo A, Taylor E, Kopcza K. Development of a pharmacy-school affiliated longitudinal advanced pharmaceutical practice experience at a large academic institution.

Steinberg M, Cooper M. Evaluation of the preparative and reflective thoughts of post-graduate biopharmaceutical industry fellows’ teaching experiences in a doctor of pharmacy.

Houng D, Njoroge M, Tran MT, Donovan JL. Evaluation of peri-ablation anticoagulation with dabigatran at a large academic medical center.

Jarvis C, Conway S, Silva M. Pharmacist analysis of a quality improvement registry to identify possible interventions in a patient centered medical home.

Lepage J, Durand C, Simonian C, Tuiskula K, Sullivan K. Implementation of a faculty-precepted institutional advanced pharmacy practice experience at a large academic medical center.

Livings SE, Cross J, Knww A, Schimmel J, Tenholder E. Evaluation of the treatment of uncomplicated cellulitis in hospitalized, adult patients.

Rodriguez A, Wong M, Sherman D, Silva M. Evaluation of pediatric fluoride prescribing in a community health center.

Rollins B, Lee D, Silva M. Pens or syringes?

A time saving analysis.

Sargent K, Njoroge M, Donovan JL. Ticagrelor usage in patients with acute coronary syndromes (ACS) at one leading cardiac care institution.

Steinberg M, Horton E, Willett K. One year assessment of admission interviews conducted by all faculty members in an accelerated Doctor of Pharmacy program.

Szerszen M, Carey K, Adams DK. Evaluation of diabetic ketoacidosis management and associated medication errors.

Patents US Patent Number 8,334,107 "Detection systems utilizing supported lipid bilayers" issued on December 18, 2012 to Gabriel P Lopez, Reema Zeineldin, Menake Piyasena.

Sabbaticals Dr. Alice Gardner will be on a sabbatical leave starting June 1, 2013 to November 30, 2013 at Woolcock Institute of Medical Research, Sydney, Australia. She plans to study the signaling pathways in airway tissue from asthmatic and non-asthmatic patients.

The Second Annual SOP-W/M Research Day The SOP-W/M will proudly showcase the scholarship of our Doctor of Pharmacy Students, Graduate Students, Residents and Fellows at the Second Annual SOP-W/M Research Day. The event will be held on Thursday, April 11, 2013 from 4:30 p.m. to 5:30 p.m. on the MCPHSWorcester campus.

Class of 2012 NAPLEX™ Passing Rate of First-time Candidates Number First Time Candidates

Number Passed Exam

Worcester/Manchester Passing Rate

National Passing Rate

State Passing Rate

Test Window: May 1 – August 31, 2012

30

NAPLEX

190

186

97.89%

97.19%

94.44%

MPJE

214

196

91.59%

93.94%

93.57%

Pharmacy Journal of New England • Spring 2013

University of New England School of Pharmacy Congratulations Professor Teter!

Dr. Christian Teter's chapter, "Substance-Related Disorders", is published in the third edition of Pharmacotherapy: Principles and Practice. Pharmacotherapy: Principles and Practice is one of the most frequently required and essential textbooks in pharmacy curriculums. Chapters in this text are authored by nationally recognized experts in their fields. Here is the full citation for Dr. Teter's book chapter.

Teter CJ. Chapter 36 Substance-Related Disorders.

Pharmacotherapy: Principles and Practice, 3rd edition.

Editors: Chisholm-Burns MA, Wells BG, Schwinghammer TL, Malone MP, Kolesar JM, DiPiro JT. The McGraw-Hill Companies (2013).

Steven Sutton Publishes in 'molecular Pharmaceutics' Journal Steev Sutton, Ph.D., chair of the Department of Pharmaceutical Sciences, recently co-authored an article titled, "Solid Nanocrystalline Dispersions of Ziprasidone with Enhanced Bioavailability in the Fasted State" in the journal Molecular Pharmaceutics.

Ziprasidone [Geodon (c) is an atypical antipsychotic that requires the patient to take this medicine with at least 500 calories for optimal absorption and, therefore, efficacy. This publication outlined the research and development that went into creating a reduced food effect formulation, which is expected to result in an optimal efficacy without regard to meals.

Citation Aarde, S. M.; Angrish, D.; Barlow, D. J.;Wright, M. J.;Vanderwater, S. A.; Creehan, K. M.; Houseknecht, K. L.; Dickerson, T. J.; Taffe, M. A. Mephedrone (4-methylmethcathinone) supports intravenous self-administration in Sprague-Dawley and Wistar rats. Addict. Biol., 2013, in press.

Dean Gayle A. Brazeau, Ph.D., has been elected by her peers to serve as Secretary of the American Association of Colleges of Pharmacy (AACP) Council of Deans. Congratulations Dean Brazeau!

The Discovery Of Nucleosomes The discovery of nucleosomes by Don Olins, Ph.D., and Ada Olins, Ph.D., both research professors in the Department of Pharmaceutical Sciences, was recently cited in a review article and timeline compilation of landmark discoveries and concepts on molecular and cellular aspects of chromatin that was published online.

In 1974, the Olins, by employing the electron microscope, discovered the nucleosome, the primal chromatin packaging structure. They found that when visualized by this technique, chromatin appears to be a “string of beads,” where each bead is one nucleosome containing eight histone molecules, around which two coils of DNA are wrapped. The nucleosome is fundamental to higher levels of chromatin packaging, and is the site of chemical modifications that possess genetic regulatory functions.

The Olins currently are engaged in research that is concerned with the higher levels of chromatin packaging, specifically focusing on the mechanisms that place genetically silent chromosomal regions (“heterochromatin”) at the periphery of the cell nucleus.

Read the review article and timeline: http://link.springer.com/article/10.1007/s00412-012-03892/fulltext.html

Steven Sutton wins $40,000 NIH sub-award Steven (Steev) C. Sutton, Ph.D., associate professor and chair of the College of Pharmacy's Department of Pharmaceutical Sciences, has been awarded an NIH sub-award from the National Institute for Pharmaceutical Technology and Education (NIPTE) for the Development of the FDA Reviewer Training Module "Biophysical Foundation of Pharmacokinetics and Biopharmaceutics.”

This $40,000 award will run from January through June, 2013.

31

From the Colleges

continued

UNESP continued Edward Li, Speaker at American Society of Health System Pharmacists Midyear Meeting Edward Li, Pharm.D., BCOP, associate professor in the College of Pharmacy, was a speaker at the 47th American Society of Health System Pharmacists (ASHP) Midyear Clinical Meeting on December 3, 2012, 11:30 a.m. to 1:30 p.m., in Las Vegas, Nevada.

The title of Li's presentation is "The Role of Biologics in Patient Care and an Overview of Biosimilar Science." The talk will be broadcast live via webcast.

Li is a nationally recognized expert on the clinical and policy issues regarding biologics and FDA approved versions of innovator biopharmaceutical products. His recent publication, "Projecting future drug expenditures 2012," was a feature article in the American Journal of Health-Systems Pharmacists.

The ASHP Midyear Meeting is the largest annual meeting of pharmacists in the world, with more than 20,000 attendees from over 80 countries.

Edward Li Co-Authors Annual Forecast of National Drug Expenditures Edward Li, Pharm. D., BCOP, associate professor in the College of Pharmacy, co-authored a special feature article that was been published online in the American Journal of Health-System Pharmacy.

The article provides this year’s annual forecast of national drug expenditures. Previous years’ forecasts have been frequently cited in professional journals, news media, and legislative reports.

Li’s article is scheduled to appear in the upcoming print version of the publication.

Citation: Hoffman JM, Li E, Doloresco F, et al. Projecting Future Drug Expenditures in U.S. Nonfederal Hospitals and Clinics—2013. Am J Health-Syst Pharm. 2013; 70:e1-e15.

Meghan Sullivan And UNE Academy Of Student Pharmacists Receive Monetary Award For Community Health Fairs Meghan Sullivan, Pharm. D., assistant professor in the College of Pharmacy, and the UNE Academy of Student Pharmacists have been awarded $1,000 for "Heart to Heart Community Health Fairs" by the National Association of 32

Chain Drug Stores Foundation in partnership with the Million Hearts initiative, which was created by the U.S. Department of Health and Human Services.

The health fairs are community events that aim to educate people about heart health issues. The fairs include blood pressure screening, cholesterol education, and smoking cessation information. These events enable student pharmacists at UNE to provide preventative care to members of the community.

The College of Pharmacy was among fifteen award recipients that were selected from nearly 70 applicants.

Steven Sutton Contributes Chapter To New Book Steven (Steev) C. Sutton, Ph.D., associate professor and chair of the College of Pharmacy's Department of Pharmaceutical Sciences, has contributed the chapter “Biopharmaceutics and Veterinary Drug Delivery” to the ebook Long Acting Animal Health Drug Products Advances in Delivery Science and Technology.

Meghan Sullivan Leads Recruitment Effort For Community Pharmacy Resident Assistant Professor in the College of Pharmacy, Meghan Sullivan, PharmD, led the recruitment effort for a PGY1 (post-graduate year one) community pharmacy resident at the 47th American Society of Health-System Pharmacists Midyear Clinical Meeting, held earlier this month in Las Vegas.

This new post-graduate residency program is the direct result of a $50,000 educational grant that the UNE College of Pharmacy and Martin's Point Health Care were awarded from the National Association of Chain Drug Stores Foundation.

The UNE College of Pharmacy will now have a sustained presence at regional and national residency showcases.

Sarah Smith And Ed Li Earn Board Of Pharmacy Specialties Certifications Assistant Professor Sarah Smith, PharmD, BCACP, and Associate Professor Edward Li, PharmD, BCOP, of the College of Pharmacy recently earned board certification through the Board of Pharmacy Specialties. Smith passed the Ambulatory Care Board Certification exam (BCACP), while Li passed the recertification exam for the Oncology Pharmacy Board Certification (BCOP).

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

Board Certification through the Board of Pharmacy Specialties recognizes the highest specialized training, knowledge and skills in pharmacy. The Board Certification credentials distinguish a pharmacist as an expert in his or her field.

With this new cohort of Board Certified faculty, the Department of Pharmacy Practice at UNE now has 15 faculty Board Certifications in total including the disciplines of oncology, pharmacotherapy, nutrition, ambulatory care, and psychiatric pharmacotherapy.

Andrea Deschambeault, PharmD, BCPS Emily Dornblaser, PharmD, BCPS Erin Koepf, PharmD, BCACP Matthew Lacroix, PharmD, BCPS Edward Li, PharmD, BCOP Leslie Ochs, BSPharm, MS, PhD, PharmD, BCPS Lisa Pagnucco, BSPharm, PharmD, BCACP Paige Parsons, PharmD, BCACP Stephen Rolfe, PharmD, BCPS David Romerill, PharmD, BCPS, BCNSP Devon Sherwood, BSPharm, PharmD, BCPP Sarah Smith, PharmD, BCACP Christian Teter, PharmD, BCPP Wesley Zemrak, PharmD, BCPS

Pharmacy students present research at American Society of Health-System Pharmacists meeting Twenty-two students from the College of Pharmacy presented 18 research posters at the 47th American Society of Health-System Pharmacists Midyear Clinical Meeting, held early this month in Las Vegas, Nevada.

The students and their research posters were:

Amin P, Sherwood D. Sleep duration in psychiatric patients administered diphenhydramine at an acute psychiatric care facility.

Bhaskar S, Li E. An Alternate Categorization and Codification of Anti-Cancer Agents Based on Mechanism of Action.

Barker J, Li E. Patterns of Care with Anticancer Therapies for Patients with Metastatic Renal Cell Carcinoma in Maine.

Mathew S, Li E. Hospital Management of Outpatient Oncology Treatment Decisions: 2011-2012.

Bourret E, Tu C, McCall K, Holt C. Predictors of prescription drug overdose death in Maine Prescription Monitoring Program data from 2005â&#x20AC;&#x201C; 2010.

Dionne B, Malinowski A, Lakoma LD, Allen GP. In vitro evaluation of monotherapy vs combination antimicrobial therapy against Pseudomonas aeruginosa.

Foster TJ, Cha J, Allen GP. Assessment of the recommended dosing regimens of polymyxins in multidrug resistant Acinetobacter baumannii using the mutant prevention concentration (MPC) and an in vitro pharmacodynamic model.

Malinowski A, Lakoma LD, Ogbueze J, Paplaskas AM, Allen GP. Evaluation of antimicrobial resistance selection in multidrug resistant Neisseria gonorrhoeae.

Ofodile CC, Allen GP. Evaluation of azithromycin, ceftriaxone, and fluoroquinolone resistance selection in Salmonella Choleraesuis, S. Paratyphi, and S. Typhimurium.

Paplaskas AM, Malinowski A, Allen GP. Evaluation of colistin, doxycycline, tigecycline, polymyxin B, and fosfomycin resistance selection in carbapenemaseproducing Klebsiella pneumoniae.

Ragonesi MB, Allen GP. Comparative activities of azithromycin, ciprofloxacin, levofloxacin, and moxifloxacin against mutant Salmonella enterica serovar Typhi in an in vitro pharmacodynamic model.

Abdirhmon N, Smith S. Adherence to a specified montelukast criteria for use within the Maine Veterans Affairs Medical Center: a medication utilization evaluation.

Nguyen V, Smith S. Appropriateness of ketorolac administration to veterans in the emergency department: a retrospective medication utilization evaluation.

Lee C, Parsons P, Ochs L, Koepf E. Review of claims data to assess medication use patterns for pediatric asthma patients in Maine.

Nguyen D, Redwanski J. Prevalence and trends of pharmacy robberies in Maine.

Evans A, Dornblaser E. A retrospective review of incidence of nephrotoxicity in patients receiving standard infusion vs extended infusion pipercillin-tazobactam with and without vancomycin therapy.

Patel V, Flash G, Zemrak W. Evaluation of IV acetaminophen as the primary analgesic strategy following cardiac surgery.

Williams N, Teter C. Mercy hospital recovery center virtual alcohol and drug abuse treatment program: a novel approach to the treatment of substance use disorders (SUD).

33

From the Colleges

continued

Albany College of Pharmacy and Health Sciences Albany College of Pharmacy and Health Sciences Faculty Member Receives $353,400 Grant for Leukemia Research Karen Glass, Ph.D., assistant professor in the Department of Pharmaceutical Sciences at Albany College of Pharmacy and Health Sciences’ Vermont Campus, has been awarded a three-year research grant totaling $353,400 from the National Institutes of Health (NIH). Dr. Glass will seek to identify new ways to prevent and treat a type of leukemia called Acute Myeloid Leukemia (AML).

What is AML? AML is a cancer of the blood and bone marrow. In AML patients, cells that would typically develop into white blood cells, important for the immune system, grow at an abnormal rate, thereby interfering with the production of normal blood cells.

Research Project Substances such as proteins regularly bind to our DNA, and in so doing, cause genes to be expressed or repressed (these binding substances are called “transcription factors”). The resulting series of interactions contribute to a range of bodily processes, one of which is the development of blood cells, including bone marrow cells.

Genetic mutations, however, can cause these cellular processes to break down. In AML, there is a mutation known as chromosomal translocation, where a chromosome breaks and incorrectly re-fuses to another chromosome.

Factors including environmental toxins, benzene exposure, and drugs used for chemotherapy may cause AML-related translocations, but in many cases, scientists are still unclear on the specific triggers. There is also much to be learned as to which specific combinations of gene mutations lead to AML and other forms of disease.

With support from students at the College, Dr. Glass will be studying the factors that regulate gene activity in AML and explore if these factors can be manipulated to treat or possibly prevent disease.

34

Karen Glass, Ph.D.

Quote from Dr. Glass “There is no single factor, but rather a series of events, which leads to a disease such as AML,” said Dr. Glass.

“If we can better understand the basic mechanisms controlling gene expression and how chromosomal translocations lead to AML and other cancers, then we will be able to diagnose and treat AML patients more effectively. We may also be able to apply this knowledge in the treatment of other cancers and diseases.”

The project described above is supported by the National Institute of General Medical Sciences of the National Institutes of Health under Award Number R15GM104865. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About Albany College of Pharmacy and Health Sciences Founded in 1881, Albany College of Pharmacy and Health Sciences is a private, independent institution committed to graduating the best health care minds in the world. The College’s Vermont Campus is located in Colchester and is home to the only pharmacy program in the state of Vermont. The school’s main campus is located in Albany, New York. For more information, please visit www.acphs.edu.

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35

Continuing Education for Pharmacists Updates in the Management of Stable Chronic Obstructive Pulmonary Disease Author: Jessica S.Triboletti, PharmD, BCACP, Clinical Pharmacy Specialist, Primary Care, RL Roudebush Veterans Affairs Medical Center (Indianapolis, IN) Original article published by the Indiana Pharmacists Alliance (IPA).This activity may appear in other state pharmacy association journals.

Goal To review disease characteristics and discuss updates in the management of Chronic Obstructive Pulmonary Disease (COPD).

Objectives At the conclusion of this lesson, participants should be able to: 1. Recall treatment algorithms and common pharmacologic agents used for treatment of COPD. 2. Interpret strategies identified in the 2011 GOLD guideline update which are used to assign patients into treatment groups.

3. Given a case example, appropriately assign a patient into a treatment group and select appropriate pharmacologic and non- pharmacologic therapy.

4. List advantages and disadvantages involved in using phosphodiesterase-4 inhibitors for the management of severe COPD. Chronic Obstructive Pulmonary Disease (COPD) is a disease of the lungs characterized by persistent airflow limitation that is not fully reversible. Medications used in the management of COPD are not curative, but the disease is treatable with proper use of available therapeutic agents and preventable by reducing exposure to risk factors.

Several guideline updates and new medications for COPD management have emerged in recent years.

Brief Review of Pathophysiology and Disease State Background Airflow limitation due to COPD is progressive and associated with abnormal inflammatory response to noxious particles or gases. The airflow limitation is caused by several disease processes including small airway disease and parenchymal destruction. Small airway disease refers to airway inflammation and subsequent remodeling, whereas 36

parenchymal destruction refers to loss of alveolar attachment and decreased elastic recoil. Together, these processes result in mucus hypersecretion, air trapping, and ultimately airflow limitation. Each of these components may be present to varying degrees in each individual patient, and therefore each patient’s COPD symptoms and traits are somewhat unique. The term “chronic bronchitis” is often used to refer to the small airway component of COPD, and is defined in the clinical setting as presence of cough or sputum production for a duration of greater than or equal to three months for at least two consecutive years.

The term “emphysema” has historically been used interchangeably with COPD, but in actuality it refers more specifically to destruction of gas exchanging surfaces of alveoli.

Patients affected by COPD often have comorbidities related to their respiratory condition. Extrapulmonary effects of COPD secondary to ongoing shortness of breath include unintentional weight loss, nutritional deficits, and skeletal muscle dysfunction. COPD patients have also been associated with a higher occurrence of myocardial infarction, angina, osteoporosis, respiratory infection, depression, diabetes, and sleep disorders. Additionally, a higher incidence of lung cancer has been found in patients with COPD, however it is not known if the two are directly linked or if it is due to common risk factors.

Prevention of COPD progression is a key component of disease state management, and the primary method of preventing progression is to reduce or eliminate exposure to risk factors. The number one risk factor associated with COPD worldwide is tobacco smoking. The effect of tobacco smoking on COPD is dose related (i.e. higher number of pack- years smoking, higher risk and severity of COPD). Additional risk factors for COPD include indoor and outdoor air pollution, and occupational exposure to dusts and chemicals. Environmental risk factors aside, sev-

Pharmacy Journal of New England • Spring 2013

eral host factors can cause predisposition to COPD including abnormal lung growth and development, prior respiratory infections, and alpha-1 antitrypsin deficiency.

Respiratory dysfunction and airflow limitation is evaluated using a combination of symptom assessment and spirometry, a type of pulmonary function test (PFT) that measures volume and speed of inhalation and exhalation.

Diagnosis of COPD should be considered in any individual with dyspnea, chronic cough (productive or nonproductive), and/or sputum production. Guidelines also recommend spirometry as a part of diagnosis, with a ratio of Forced Expiratory Volume in One Second (FEV1) to Forced Vital Capacity (FVC) less than 70% (FEV1/FVC < 0.7) as the diagnostic criteria. Less than 70% is the threshold that suggests airflow limitation is not fully reversible.

Spirometry is the gold standard for COPD diagnosis because it is widely accessible, easily reproducible, and relatively inexpensive.

The primary clinical guidelines utilized in COPD management are entitled Global Initiative for Chronic Obstructive Lung Disease (GOLD). The GOLD guideline is a global initiative and consists of a consensus report that is updated annually. GOLD guidelines are available at www.goldcopd.com. There were several updates included in the most recent GOLD guideline. To summarize, treatment objectives were organized into two groups: immediately relieve and reduce impact of symptoms and reduce risk of adverse events that impact health in the future. FEV1 was deemed an unreliable marker of severity of symptoms on its own, therefore higher emphasis was placed on symptom scoring and two validated symptom scoring surveys were recommended for use in clinical practice. The term “stage”was replaced with the term “grade” when classifying COPD severity, and a new assessment system that draws together impact of patient symptoms and assessment of future risk was introduced.1

Symptom Scoring and Assessment The December 2011 GOLD Guideline update suggests a stronger emphasis on symptom scoring based on patients perception of impact on daily life activities when compared to previous years. They endorse two validated symptom scoring surveys: the Modified Medical Research Council Questionnaire for Assessing the Severity of Breathlessness

(mMRC) and the COPD Assessment Test (CAT) (Refer to Figures 1 and 2). GOLD guidelines suggest that one of these two surveys is administered to each patient as a part of the diagnostic and staging process. Both of the surveys are relatively simple and short in length; however the CAT is comprehensive of various aspects of COPD while mMRC focuses more specifically on severity of breathlessness. The clinical utilization of these surveys has not yet been fully established. For the mMRC test, scores range from zero to four, with zero being minimal symptoms and four being severe symptoms. CAT test scores range from zero to forty, with zero being minimal symptoms and forty being severe symptoms. These symptom scores are used as part of the algorithm for placing the individual into a treatment group and selecting appropriate therapy.1

Determining COPD Grade In addition to obtaining a symptom score, the guidelines also suggest placing the patient into a “grade” category (Refer to Table 1). The grade is based on the results of spirometry, specifically the percent of predicted FEV1.1

Using Symptom Score and COPD Grade to Determine Treatment Group Both the symptom score and COPD Grade are used to determine treatment group. In addition, the number of COPD exacerbations the individual has experienced in the previous twelve months is also considered (Refer to Figure 3).1 The symptom scoring surveys are listed along the bottom axis. Based on the patients symptom score, the severity of symptoms can be determined. Subsequently, along the vertical axis, the GOLD Grade is used to specify “low” or “high” risk. If the patient has had two or more COPD exacerbations in the past year, that automatically places them in the “higher risk” category.1

COPD Maintenance and Treatment The first step in COPD treatment is reduction of exposure to risk factors, specifically tobacco cessation when applicable. Smoking is associated with a greater rate of airflow decline and increased mortality associated with COPD. Tobacco cessation has been shown to be the most successful and cost effective method of preventing disease progression, and is an area where pharmacists can serve an important role. It is also imperative that COPD patients receive appropriate vaccination with annual trivalent 37

Continuing Education for Pharmacists influenza vaccine as well as pneumococcal vaccine to reduce risk of respiratory infection.

An important education point for patients with regard to COPD is that none of the existing medications have been shown to modify the long-term decline in lung function, therefore pharmacotherapy is used to decrease symptoms, complications, or both. Goals of therapy for COPD are to prevent disease progression, relieve symptoms, improve exercise tolerance, improve health status, prevent and treat exacerbations and complications, reduce mortality, and minimize adverse effects of treatment. Along with elimination or minimization of risk factors, pharmacologic therapy is warranted for patients in all treatment groups. After the appropriate treatment group is determined, pharmacologic therapy can be individualized for the patient.1 Group A

It is suggested that patients who are included in treatment Group A (low risk, less symptoms) initiate treatment with a short-acting bronchodilator such as a short-acting beta agonist or short-acting anticholinergic. Short-acting bronchodilators are used for acute relief of intermittent symptoms (“rescue medication”). Short-acting bronchodilators increase FEV1 by altering airway smooth muscle tone, widening airways, and improving emptying of the lungs. If symptom relief is not sufficient with one short-acting bronchodilator, a combination of both can be used to maximize the bronchodilation effect through two different mechanisms. Combination products may also be helpful in challenging adherence situations.1 The most common short-acting beta agonist is albuterol (via inhaler or nebulization) which has a short onset of action (less than five minutes) and relatively short duration of action (less than four hours). Adverse effects such as tachycardia, tremor, insomnia and headache are predictable and dose dependent. Trade names for albuterol inhalers include Proair® and Ventolin®.1 Ipratropium (Atrovent®) is the most common short-acting anticholinergic (via inhaler or nebulization). Ipratropium has an onset of action of approximately fifteen minutes and duration of action about six to eight hours. It is generally well tolerated with adverse effects including dry mouth and metallic taste.1

38

Combination products of short-acting beta agonist plus short-acting anticholinergic include Combivent® inhaler, and Duoneb® solution for nebulization. Traditional Combivent® inhalers are currently being transitioned to Combivent Respimat® inhalers, which are propellant-free.

Traditional aerosolized Combivent® will only be available for a limited time, and will be completely phased out by the end of 2013. The Food and Drug Administration has ordered this change under the Clean Air Act and it is consistent with the changes that have taken place with other inhalers containing Chlorofluorocarbon (CFC) based on the Montreal Protocol, intended to help protect the ozone layer. While most CFC inhalers have already made the transition, Combivent® was granted an extension to accommodate the challenges in converting a medication with more than one ingredient.2,3 It is important for pharmacists to become familiarized with the differences between traditional Combivent® inhalers and Combivent Respimat® as patients may need assistance in learning to use their new device. The Respimat® device must first be prepared by removing the clear base and recording the discard date (3 months from date of cartridge insertion) on the device. A new cartridge should be inserted into the device, piercing a hole so that medication can be released. The clear base is then replaced and should not be removed again for the entire duration that the inhaler is used. It needs to be primed by holding the inhaler upright and turning the clear base in the direction of the white arrows. The orange cap is flipped open and a dose is released by pressing the dose-release button. After a spray is visible, the device is ready for use. It is important to note that Respimat® inhalers contain 120 doses compared to 200 doses in the traditional inhalers. However, only one puff is required per dose compared to two puffs via the traditional inhaler. There is no need to shake the device prior to inhaling a puff of medication. Patients may notice that the spray does not feel as powerful as a puff from the traditional CFC inhaler. The device contains a dose counter and displays a “red zone” when there is a one week supply of medication remaining.2 Theophylline is the most commonly used methylxanthine and is mentioned in the guideline as an alternative therapy for treatment of COPD. Use of this agent, however, has fallen out of favor due to serious adverse effects, variable metabolism, drug interactions, and need for therapeutic monitoring.1

Pharmacy Journal of New England • Spring 2013

Group B

A long-acting bronchodilator should be added for patients who are included in treatment Group B (low risk, more symptoms). Regular use of long-acting bronchodilators (“controller medication”) for patients with chronic symptoms is more effective and convenient for patients, as it reduces the need for repeated use of short-acting agents.

Long-acting agents are not effective during acute episodes of shortness of breath. As with short-acting bronchodilators, mechanisms of action of different types of agents can be combined to maximize bronchodilation effect.1 Long-acting beta agonists relax airway smooth muscle tissue by stimulating beta-2 adrenergic receptors. The onset of action is between five and twenty minutes and the duration is generally twelve hours. The most commonly used long-acting beta agonists include formoterol (Foradil®), salmeterol (Serevent®) , and arformoterol (Brovana®).

Indacaterol (Arcapta Neohaler®) is the newest addition to this class, and is unique in that its duration of action is approximately twenty-four hours, therefore dosed once daily. It is delivered via inhaler device that punctures a medication-containing capsule prior to inhalation. Adverse effects of long-acting beta agonists are similar to those of short-acting beta agonists. There is no evidence that the boxed warning for increased asthma- related deaths with use of long-acting beta agonists applies to the COPD population.1,4 Long-acting anticholinergics block acetylcholine’s effect on muscarinic receptors. The typical onset of action is fifteen minutes and duration is twenty- four hours. There is currently only one long-acting anticholinergic available (tiotropium, Spiriva®). Similar to indacaterol, it is delivered via inhaler device that punctures a medication- containing capsule prior to inhalation. Adverse effects of long-acting anticholinergics are similar to those of short-acting anticholinergics. Use of concomitant long and short acting anticholinergics is not recommended due to increased risk of systemic anticholinergic adverse effects.1 Group C

According to GOLD guidelines, when patients progress into treatment Group C (high risk, less symptoms), an inhaled corticosteroid should be added to their regimen.

Inhaled corticosteroids reduce the frequency of COPD exacerbations and may decrease the rate of decline in lung function, but do not improve COPD-related mortality.1

Commonly used inhaled corticosteroids include mometasone (Asmanex Twisthaler®), fluticasone (Flovent®), and budesonide (Pulmicort Flexhaler®). They are dosed twice daily and are commonly utilized as part of a combination product with a long-acting beta agonist. Patients should be counseled to rinse their mouth after each use in an effort to reduce risk of developing oral candidiasis infection.

With higher doses of inhaled corticosteroid use, increased risk of osteoporosis and pneumonia have been observed.

Combination inhaled corticosteroid plus long-acting beta agonist include budesonide/formoterol (Symbicort®), mometasone/formoterol (Dulera®), and fluticasone/salmeterol (Advair®).1 Use of oral corticosteroids in maintenance therapy is not recommended due to a poor risk to benefit ratio. Chronic use of oral corticosteroids is associated with muscle weakness, elevated blood pressure, elevated blood glucose, weight gain, and mood changes, and therefore are reserved for the setting of short-term use for COPD exacerbations.1 Group D

Patients in treatment Group D (high risk, more symptoms) have the most severe disease and are typically maximized on inhaled therapy. At this point in the course of the disease, patients benefit from treatment with short-acting beta agonist, long-acting beta agonist, long- acting anticholinergic, and inhaled corticosteroid.1 For patients who have persistent uncontrolled symptoms despite maximal inhaled therapy, there is a novel agent available that is taken by mouth once daily. Roflumilast is the only medication currently available in the class of phosphodiesterase-4 (PDE4) inhibitors.

It is thought to work by reducing inflammation in lung tissue through inhibition of breakdown of intracellular cyclicAMP. Roflumilast (Daliresp®) is indicated for decreasing risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.1,5,6 When roflumilast originally pursued approval in 2010, it was declined by the FDA. It showed a moderately improved FEV1 over baseline, but a 14% discontinuation rate due to gastrointestinal adverse effects and several adverse psychiatric adverse effects were observed including three completed suicides and two suicide attempts in active drug groups during clinical trials. After more data was col39

Continuing Education for Pharmacists lected, roflumilast was approved in 2011. Information was obtained primarily from eight placebo-controlled clinical trials involving 9394 patients. Roflumilast demonstrated reduced rate of exacerbations by 15% and 18% in two 12month trials. Additionally, number of exacerbations per patient-year was 1.1 versus 1.3 (placebo) in one trial and 1.2 versus 1.5 (placebo) in another clinical trial. The patient population that received the most benefit from use of roflumilast were patients with severe COPD associated with chronic bronchitis, at least one exacerbation in the previous year, and at least a 20 pack-year history of smoking. It should be noted that in clinical studies that showed reduction in COPD exacerbations, use of an inhaled corticosteroid was prohibited.6 There are some important adverse effects to consider prior to initiating therapy with roflumilast. Common adverse effects observed in clinical studies include diarrhea (9.5%), weight decrease (7.5%), nausea (4.7%), headache (4.4%), back pain (3.2%), insomnia (2.4%), dizziness (2.1%), and abdominal pain (1-2%). In addition, several psychiatric effects were observed in clinical studies including one completed suicide and two suicide attempts in roflumilast groups versus one instance of suicidal ideation in placebo groups. Among all eight trials, 5.9% of patients treated with roflumilast reported some degree of adverse psychiatric reactions versus 3.3% in placebo groups. Given the occurrence of psychiatric adverse effects, roflumilast should be used with caution in patients with a history of mental health disorders.7-9 Roflumilast use is contraindicated in patients with moderate to severe liver impairment (Childs-Pugh class B or C).

No dosage adjustments are required for patients with renal impairment.5 For a summary of treatment recommendations for treatment groups A through D, refer to Table 2.

Conclusion COPD is a progressive respiratory disease that is associated with irreversible airflow limitation. Risk factor minimization is a key step in preventing onset and progression of COPD, therefore tobacco cessation should be kept as high priority in patients who smoke. Proper medication management is another important component of slowing disease progression and pharmacists can play an important role in collaboration with physicians and pulmonologists.

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The most recent GOLD guidelines recommended a new strategy for symptom scoring and treatment groups, which are then utilized to select appropriate medication management. Roflumilast (PDE-4 inhibitor) has been included in the most recent guideline update as a potential add-on therapy to help reduce COPD exacerbations in patients with severe COPD to associated with chronic bronchitis and a history of exacerbations.

The Indiana Pharmacists Alliance (IPA) is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education.

To receive continuing pharmacy education (CPE) credit, pharmacists MUST COMPLETE AN ONLINE QUIZ AND EVALUATION FORM. A score of 70% or above is required to receive CPE credit. The link to the quiz can be accessed from the MEMBERS page of the IPA website at www.indianapharmacists.org. This is a free service to IPA members in 2012; and non- members may be charged a fee if available online to non-members. Details will be posted online. Initial Release Date: 12/11/12. Expiration Date: 12/31/14. Questions: Call IPA at (317) 634-4968.

References 1. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease NHLBI/WHO Report: Executive Summary. Bethesda, MD: U.S. Department of Health and Human Services, Public Health Services, Public Health Service, National Institutes of Health, National Heart, Lung, and Blood Institute, December 2011 Update.

Available at: http://www.goldcopd.com.

2. Combivent® and Combivent Respimat® website information. Accessed 15 November, 2012. Available at: www.combivent.com.

3. PL Detail-document, New Formulation: Combivent Respimat. Pharmacist’s Letter/Prescriber’s Letter. September 2012.

4. Arcapta® [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; July 2011.

5. Daliresp® [package insert]. St. Louis, MO: Forest Laboratories; February 2011.

6. PL Detail-document, New Drug: Daliresp (roflumilast). Pharmacist’s Letter/Prescriber’s Letter. July 2011.

7. Gross NJ, Giembycz MA, Rennard SI. Treatment of chronic obstructive pulmonary disease with roflumilast, a new phosphodiesterase-4 inhibitor. COPD 2010;7:141-53.

8. Ulrik CS, Calverley PM. Roflumilast: clinical benefit in patients suffering from COPD. Clin Respir J 2010;4:197-201.

9. Fabbri LM, et al. Roflumilast in moderate-to- severe chronic obstructive pulmonary disease treated with long acting bronchodilators: two randomised clinical trials. Lancet 2009: 374;695-703.

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

Figure 1.

Modified Medical Research Council Questionnaire for Assessing the Severity of Breathlessness (mMRC)

Grade

Description

0

Is not troubled with breathlessness except with strenuous exercise

1

Is troubled by shortness of breath when hurrying on level ground or walking up a slight hill

2

Walks slower than people of the same age on level ground because of breathlessness, or has to stop for breath when walking at own pace on level ground

3

Stops for breath after walking about 100 meters or after a few minutes on level ground

4

Is too breathless to leave the house or is breathless when dressing or undressing

Adapted from Fletcher CM, et al. BMJ 1959;2:257-266.

Figure 2. COPD Assessment Test (CAT)

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Continuing Education for Pharmacists Figure 3. Classification of COPD Treatment Groups A, B, C, or D

Adapted from GOLD Guidlines, 2001

Table 1.

Classification of Severity of Airflow Limitation in COPD (Based on post-bronchodilator FEV1)in Patients with FEV1/FVC < 0.7

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GOLD Grade 1

Mild

FEV1 ≥ 80% of predicted

GOLD Grade 2

Moderate

50% ≤ FEV1 < 80% of predicted

GOLD Grade 3

Severe

30% ≤ FEV1 < 50% of predicted

GOLD Grade 4

Very Severe

FEV1 < 30% of predicted

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

Table 2. Treatment recommendations based on assigned groups per 2011 GOLD Guidelines.

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Continuing Education Quiz Updates In The Management of Stable Chronic Obstructive Pulmonary Disease This Test is worth: 10 points. Select multiple answers with a cross or tick: Only select one answer

Select multiple answers

1. Which of the following correctly defines chronic bronchitis in the clinical setting?*

4. Which of the following is NOT a combination product?*

A) Cough or sputum production for a duration of 6 months in 2009 and then again in 2012

A) Foradil

B) Cough or sputum production for a duration of greater than or equal to 6 months for at least 2 consecutive years

C) Duoneb

C) Cough or sputum production for a duration of greater than or equal to 3 months for at least 3 consecutive years

D) Dulera 5. All of the following adverse effects have been associated with Roflumilast except: A) Insomnia B) Hypokalemia C) Psychiatric adverse effects including suicidality

2. Pharmacists should be aware that all of the following comorbidities are associated with COPD except:*

B) Weight gain

7. Which of the following is true regarding COPD? A) Airflow limitation is reversible with proper treatment

B) Symbicort

D) Cough or sputum production for a duration of greater than or equal to 3 months for at least 2 consecutive years

A) Skeletal muscle dysfunction

INSTRUCTIONS: This page is intended to help participants REVIEW the quiz questions prior to submitting their answers online.

Please take the quiz online using the link in the members section of the website.

D) Gastrointestinal intolerance 6. Which of the following is NOT an acceptable COPD medication regimen for a patient in treatment Group D (high risk, more symptoms)?

C) Osteoporosis D) Diabetes 3. Which of the following is true regarding albuterol?* A) Short onset of action and relatively long duration of action B) Long onset of action and relatively short duration of action

A) Inhaled corticosteroid + long-acting anticholinergic + short-acting beta-2 agonist B) Inhaled corticosteroid + long-acting Beta-2 agonist + short-acting beta-2 agonist C) Inhaled corticosteroid + long-acting anticholinergic + long-acting beta-2 agonist + short-acting beta-2 agonist

B) Medications used in the management of COPD are in curative intent C) COPD symptoms are progressive in nature rather than fluctuating D) COPD is largely genetic disease and has little to do with environmental risk factors 8. The primary reason for the transition from Combivent 速 aerosolized solution to Combivent Respimat速 inhalers is which of the following?

A) The FDA mandated the change in accordance with the Clean Air Act B) There was a need for easier administration methods C) The previous aerosolized solution was not efficacious D) The previous aerosolized solution required too many puffs per dose 9. Which of the following long-acting Beta agonists is available as a once daily inhalation?

A) Salmeterol B) Formoterol

C) Short onset of action and relatively short duration of action D) Long onset of action and relatively long duration of action

*Question developed by the Connecticut Pharmacists Association

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D) Inhaled corticosteroid + long-acting anticholinergic + short-acting anticholinergic + short-acting beta-2 agonist

C) Arformoterol D) Indacaterol

Continuing Education Quiz continued 10. For which of the following medications should the patient be counseled not to swallow the medication containing capsule?

14. How much time was required to complete this article?

A) 0.5 hours

B) 1.0 hours

C) 1.5 hours

D) 2.0 hours

17. The author(s) did NOT appear to be promoting a product or company? Please use COMMENT box at the end of evaluation to explain or provide comment.

A) Fluticasone and arformoterol A) Strongly Agree

B) Arformoterol and tiotropium E) 2.5 hours

B) Agree

C) Indacaterol and tiotropium D) Fluticasone and indacaterol

15. The learning activities (e.g. case studies, quiz) were effective?

C) Neutral D) Disagree

11. Did the article help you achieve each of the stated objectives? If not, describe in the comment box at the end of the section. Refer to the article for the list of learning objectives.

A) Yes

B) NO

12. Overall evaluation of the article?

A) Very Good

B) Good

C) Neutral

D) Poor

E) Very Poor 13. Quality of the written material/content?

A) Strongly Agree E) Strongly Disagree B) Agree 18. Author(s) communicated material clearly?

C) Neutral D) Disagree

A) Strongly Agree

E) Strongly Disagree

B) Agree

16. The information in this article will help assist and reinforce my practice/treatment habits?

C) Neutral D) Disagree

A) Strongly Agree

E) Strongly Disagree Comments

B) Agree

A) Very Good Quality

C) Neutral

B) Good Quality

D) Disagree

C) Neutral

E) Strongly Disagree

D) Poor Quality E) Very Poor Quality Mail to: CPA 35 Cold Spring Road, Suite 121 Rocky Hill, CT 06067

DO NOT DETACH Spring-2013 (1.5 hours - 0.15 CEUs) ACPE Program No. 0106-0000-13-012-H01-P 1.5

Expiration Date 4/8/2016 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.

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• 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.

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