Pjne spring 14 4 11 14 final

Vol 11 No.1 Spring 2014

Spring 2014

Pharmacy Journal of New England St. John’s Wort in Depression: Implications for Practice Viagra: The Little Blue Pill’s Not So Little Impact on Pharmacy How Impatience Hurts Retirement Savings Financial Forum

The Drug Quality and Security Act Rx and the Law

Treating Head Lice – Primer for the Community Pharmacist Continuing Education

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Pharmacy Journal of New England Celebrating Earth Day with Best Practices for Medication Disposal

Vol 11 • No. 1 Pharmacy Journal of New England • Spring 2014

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

Managing Editor Ellen Zoppo

Dear Readers,

Design & Production

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 26, 2014.

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,

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.

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:

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

David Johnson Executive Vice President Massachusetts Pharmacists Association

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

Contents 02 U.S. News

08 New England States 20 Feature: St. John’s Wort in Depression: Implications for Practice 26 Student Showcase: The Little Blue Pill’s Not So Little Impact on Pharmacy

28 30 38

Pharmacy Marketing Group: Rx and the Law, Financial Forum From the Colleges Continuing Education for Pharmacists 1

U.S. News Do Phone “Selfies” Spread Head Lice? It’s Possible but not Probable, Experts Say

an epidemic. It’s good for business.”Either way, there is at least one New York-based lice expert who agrees with McQuillan.

One California lice treatment professional said the number of cases among teens has jumped thanks to the popularity of side-by-side self-shot photographs taken with phones.

Other experts, however, said that while someone could get lice when they posed for a picture, it’s unlikely.

“Selfies are the new pajama party for head lice,” Licenders owner Adie Horowitz said in a release. “We’ve always taught younger kids to keep their heads apart when they play. Now we are teaching the older kids that they are just as prone to catching lice if they put their heads together.”

Are teenagers spreading head lice when they put their heads together to capture the perfect selfie? This idea grabbed headlines when Marcy McQuillan, who runs two Nitless Noggins lice treatment centers in California, told SFist about a spike in head lice among high schoolers.

The Centers for Disease Control and Prevention says there is no reliable data about how many people in the U.S. get head lice, but the parasites are estimated to affect 6 million

“Every teen I’ve treated, I ask about selfies, and they admit that they are taking them every day,” she said. So, is there really a booming lice epidemic, and are selfies the root of the problem?

Some experts who spoke to the Daily News were skeptical, but said it was possible that shooting a side-by-side selfie could spread head lice. “In all likelihood it is not the cause of an epidemic, but it is not impossible that it can happen,” Lice Treatment Center’s co-founder Liz Solovay said.

Solovay explained that a person could get head lice if he or she put his or her head next to someone whose hair has tons of live lice. However, the chances of this happening “are not high,” she said.

Nancy Gordon, CEO of head lice removal company Lice Knowing You, says she has also seen an increase in the number of cases among teenagers, but doesn’t think selfies are necessarily to blame. Instead, the infestations could be caused by the constant “togetherness” of teenage girls.“They work in close proximity,” she said. “They are constantly sharing clothes and hair products.”

She also pointed out that teens often greet each other with hugs. And if one person in a group of friends has head lice, he or she won’t tell the others, she said.

Others believe McQuillan may have had ulterior motives for spreading the information. “This is a marketing ploy, pure and simple,” Dr. Richard J. Pollack of the Harvard School of Public Health told NBC News. “Wherever these louse salons open a new branch, there always seems to be 2

to 12 million children ages 3 to 11 annually. http://www.nydailynews.com/life-style/health/selfies-blame-head-lice-teens-article1.1701724#ixzz2uvEaiD8H

Acetaminophen Use in Pregnancy may be Linked to ADHD Acetaminophen, the most common drug taken by pregnant women, may be linked to attention deficit hyperactivity disorder (ADHD) in children, according to a large but preliminary new study from Denmark.

The study, published Monday in JAMA Pediatrics, found the disorder was more likely to develop in children whose mothers took the medication while pregnant.

Experts say the study does not prove a cause-and-effect relationship and more study is needed. It is likely to prompt concerns among women who have been told that the medication – found in Tylenol and many other pain and fever remedies – is safe during pregnancy.

The study is a reminder that “anything we do in pregnancy we should not do lightly,” says one study author, Beate Ritz, an epidemiologist at the University of California-Los Angeles. She worked with researchers from the University of Aarhus in Denmark and other institutions.

The researchers looked for a link between acetaminophen and ADHD because they believe the medication might work as a hormone disruptor capable of affecting fetal brain development, Ritz says.

The study included more than 64,000 Danish children born from 1996 to 2002. The mothers of those children were called twice during pregnancy and once six months after birth and asked about painkiller use.

Pharmacy Journal of New England • Spring 2014

Thanks to thorough health records available in Denmark, the researchers were able to track children in three ways: through questionnaires on development parents completed when children were 7 years old; through diagnoses of “hyperkinetic disorder”; and through prescriptions for ADHD medications such as Ritalin.

Chapa, who was not involved in the research, says it’s important that worried pregnant women not use ibuprofen and other non-steroidal anti-inflammatory drugs (NSAIDS) as substitutes for acetaminophen.

NSAIDS can disrupt fetal development and cause other problems, he says.

Children whose mothers took acetaminophen were:

Pregnant women with a fever should still take acetaminophen to reduce it, he says, because fevers might affect fetal development. But there’s good reason to be conservative about using it for aches and pains when a warm bath, a massage or some stretching might provide relief, he says. When women find themselves using acetaminophen repeatedly, he says, they should consult their obstetricians.

• 13% more likely to show ADHD-like behaviors, such as hyperactivity and conduct problems.

• 37% more likely to be diagnosed with hyperkinetic disorder, which is the equivalent of “high end” ADHD, Ritz says.

• 29% more likely to get ADHD medications.

The associations held up even when researchers considered mothers’ mental health histories and additional factors – including fevers, infections and inflammation – that might have led women to take acetaminophen in the first place.

The associations grew stronger the more weeks mothers reported taking acetaminophen, Ritz says. She says one flaw of the study is that researchers don’t know how many pills women took.

Researchers cannot rule out that some unreported condition more common among women who took a lot of acetaminophen – for example, a genetic tendency to be highly sensitive to pain – might be the real link to ADHD, she says.

“We really should start looking at non-pharmacological ways to deal with pain,” Chapa says.

About 56% of women in the Danish study used acetaminophen during pregnancy. Usage is similar in the USA. About 11% of U.S. children ages 4 to 17 had been diagnosed with ADHD as of 2011, according the federal Centers for Disease Control and Prevention. http://www.usatoday.com/story/news/nation/2014/02/24/acetaminophen-pregnancy-adhd/5782763/

The study “should be interpreted cautiously and should not change practice,” says an accompanying editorial written by psychiatric researcher Miriam Cooper and colleagues at Cardiff University in the United Kingdom.

But the findings “underline the importance of not taking a drug’s safety during pregnancy for granted,” they wrote.

Though the study is well done, “it’s a big jump to go from an association to a cause-and-effect relationship,” says Jeff Chapa, director of maternal fetal medicine at Cleveland Clinic.

UConn School of Pharmacy P-2 student Samie Ahmed connected with his hometown State Rep, Tony Hwang, R-134 (FairfieldTrumbull) at last month’s CT Pharmacy Day. Thanks to all the pharmacists, pharmacy students, and legislators who stopped by.

3

U.S. News

continued

Bristol-Myers Hepatitis C Treatment Receives FDA Breakthrough Therapy Status Bristol-Myers Squibb Co. (BMY) said its combination therapy for hepatitis C received breakthrough therapy status from the U.S. Food and Drug Administration.

Bristol-Myers said in late February 2014 that the new designation is based on the drug maker’s ongoing Phase III clinical trial, which examines the effects of the combination of investigational NS5A replication complex inhibitor, DCV, with ASV, an investigational NS3 protease inhibitor, without ribavirin.

A breakthrough therapy designation is intended to speed up the development of drugs for serious or life-threatening conditions, according to Bristol-Myers. About 170 million people in the world are infected with hepatitis C and have heightened risk for developing serious, potentially lifethreatening liver disease.

Bristol-Myers is competing with Achillion Pharmaceuticals Inc. (ACHN) and Gilead Sciences Inc. (GILD) to bring an all-oral hepatitis C regimen to market, hoping to capitalize on what is expected to be a multibillion-dollar market for the therapy.

Bristol-Myers shares were up 50 cents to $54.63 in recent trading and are up 48% in the past 12 months. http://online.wsj.com/article/BT-CO-20140224-707631.html

FDA Eases Concern about Certain Diabetes Drugs People who take Januvia, Byetta or certain other widely prescribed medicines for diabetes can breathe a little easier - U.S. and European regulators have found no compelling evidence of a link between these drugs and pancreas problems or pancreatic cancer.

The federal Food and Drug Administration and its European counterpart started reviews last year of these medicines, which came on the market less than a decade ago, after a study suggested a safety concern.

More than 25 million Americans and 33 million people in Europe have Type 2 diabetes, which impairs production or use of insulin to break down food into energy. That causes blood sugar to rise, putting them at risk of heart and other problems.

The drugs in question, called GLP-1 medicines, help spur insulin production after meals. Nine are approved in Europe and seven in the U.S., including include Merck’s Januvia and Janumet, Novo Nordisk’s Victoza and BristolMyers Squibb’s Byetta and Bydureon.

The labels for Byetta, Januvia and Janumet already have information about the possibility of pancreatic inflammation. A study of insurance records had suggested GLP-1 drugs could double this risk.

In July, the European Medicines Agency said its review had found no new evidence of pancreas problems.

On Wednesday February 26, 2014, the New England Journal of Medicine published a report from scientists in Europe and at the FDA saying reviews of animal and human studies, plus new studies commissioned to look at this risk, had found no treatment-related adverse effects on the pancreas.

Although the review “provides reassurance,” the agencies “have not reached a final conclusion” about whether the drugs can cause pancreas problems and will “continue to investigate this safety signal,” the authors write.

CPA member and independent pharmacy owner Jeff Messina recently discussed the new legislation concerning medication synchronization.

Taped at Fort Hill Pharmacy in Groton, Connecticut, the focus of the NBC segment covered how this type of programs works and its benefits to the patient and health care system.

4

Meanwhile, the drugs’ labels appear adequate, the agencies conclude. http://hosted.ap.org/dynamic/stories/U/US_MED_DIABETES_DRUGS?SITE=AP&S ECTION=HOME&TEMPLATE=DEFAULT&CTIME=2014-02-26-19-44-34

Pharmacy Journal of New England • Spring 2014

FDA Approves Myalept to Treat Rare Metabolic Disease Last month, the U.S. Food and Drug Administration approved Myalept (metreleptin for injection) as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with congenital generalized or acquired generalized lipodystrophy.

Generalized lipodystrophy is a condition associated with a lack of fat tissue. Patients with congenital generalized lipodystrophy are born with little or no fat tissue. Patients with acquired generalized lipodystrophy generally lose fat tissue over time. Because the hormone leptin is made by fat tissue, patients with generalized lipodystrophy have very low leptin levels. Leptin regulates food intake and other hormones, such as insulin.

Patients with both types of generalized lipodystrophy often develop severe insulin resistance at a young age and may have diabetes mellitus that is difficult to control or very high levels of triglycerides in the blood (hypertriglyceridemia) that can lead to inflammation of the pancreas.

“Myalept is the first approved therapy indicated for treating the complications associated with congenital or acquired generalized lipodystrophy and provides a needed treatment option for patients with this orphan disease,” said Mary Parks, M.D., deputy director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.

The safety and effectiveness of Myalept, an analog of leptin made through recombinant DNA technology, were evaluated in an open-label, single-arm study that included 48 patients with congenital or acquired generalized lipodystrophy who also had diabetes mellitus, hypertriglyceridemia, and/or elevated levels of fasting insulin. The trial showed reductions in HbA1c (a measure of blood sugar control), fasting glucose, and triglycerides.

Anti-drug antibodies with neutralizing activity to leptin and/or Myalept may develop, which could result in severe infections or loss of treatment effectiveness. T-cell lymphoma has been reported in patients with acquired generalized lipodystrophy, both treated and not treated with Myalept, so healthcare professionals should carefully consider the benefits and risks of treatment with Myalept in patients with significant hematologic abnormalities and/or acquired generalized lipodystrophy. Myalept is contraindicated in patients with general obesity. Myalept is not approved for use in patients with HIV-related lipodystrophy or in patients with metabolic disease, including diabetes mellitus and hypertriglyceridemia, without concurrent evidence of generalized lipodystrophy.

Because of the risks associated with the development of neutralizing antibodies and lymphoma, Myalept is available only through the Myalept Risk Evaluation and Mitigation Strategy (REMS) Program. Under this REMS program, prescribers must be certified with the program by enrolling in and completing training. Pharmacies must be certified with the program and only dispense Myalept after receipt of the Myalept REMS Prescription Authorization Form for each new prescription.

Myalept is also approved with a Medication Guide and instructions for use that provides patients with important information about the medication. The guide will be distributed each time a patient fills a prescription.

The FDA is requiring seven studies (post-marketing requirements) for Myalept, including a long-term prospective observational study (product exposure registry) of patients treated with Myalept, a study to assess for the immunogenicity (antibody formation) of Myalept, and an assessment and analysis of spontaneous reports of potential serious risks related to the use of Myalept. Eight additional studies are being requested as post-marketing commitments.

In clinical trials, the most common side effects observed in patients treated with Myalept were low blood sugar (hypoglycemia), headache, decreased weight, and abdominal pain. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm387060.htm

5

U.S. News

continued

Doctors urge FDA to Reverse Approval of Zohydro, Controversial New Pain Drug The new drug Zohydro – an opioid painkiller like morphine and oxycodone – has been critiqued by some doctors and addiction experts for being too potent.

A coalition of addiction experts, physicians and others is urging U.S. health officials to reverse course and block the launch of a powerful painkiller called Zohydro, expected to hit the market next month.

The opioid drug, manufactured by Zogenix Inc, contains a potent amount of an active ingredient that could be lethal to new patients and children and is not safer than other current pain drugs, the groups told the Food and Drug Administration.

“Someone unaccustomed to taking opioids could suffer a fatal overdose from just two capsules. A single capsule could be fatal if swallowed by a child,” they wrote in a petition to FDA Commissioner Margaret Hamburg, dated Wednesday.

In December, attorneys general from 28 states also urged the FDA to reconsider its approval of the drug.

Zogenix, in a statement, said it was confident in the FDA’s approval of the drug, which will be “subject to stricter prescribing and dispensing rules.” The company has said it plans to start selling the drug in early March.

The latest petition comes as the United States grapples with an epidemic of prescription drug abuse, especially involving powerful opioid pain medications. Opioids are a class of drugs that includes morphine, codeine and oxycodone as well as hydrocodone.

Nearly 5 million people in the United States ages 12 and older abuse pain drugs, outpacing sedatives, stimulants and other abused medications, according to a 2012 U.S. government survey.

The FDA, which has launched its own efforts aimed at curbing abuse of pain-killing medications, approved Zohydro last year despite earlier concerns from a panel of FDA outside advisers worried about addiction risks.

The FDA advisers echoed the concerns of public health experts, law enforcement and others, who pointed to the drug’s delivery system and say they are worried about the potential for Zohydro to be crushed or injected.

6

Zohydro can contain as much as 10 times the amount of the narcotic hydrocodone as other painkillers such as AbbVie Inc’s Vicodin or UCB Inc’s Lortab, advocates said in their petition.

“Zohydro is not safer,” they wrote.

Both Vicodin and Lortab also contain the pain-killing ingredient acetaminophen. Zohydro does not.

FDA officials have said they are working to balance public health worries about opioid addiction with access to the drugs for patients seeking pain relief. The FDA has said Zohydro’s benefits outweigh its risks.

FDA spokeswoman Morgan Liscinsky said the agency would review the group’s letter.

The petition was signed by 42 supporters, including representatives of advocacy groups such as Public Citizen as well as physicians and community addiction treatment providers.

In October the FDA recommended tighter restrictions on products that contain hydrocodone, and on Thursday the Drug Enforcement Administration proposed a rule that would reclassify hydrocodone-containing products.

Until now, Vicodin and other products that contain less than 15 milligrams of hydrocodone have been classified as Schedule III controlled substances. The DEA proposes reclassifying them more restrictively, as Schedule II products, in line with opioids such as morphine and oxycodone.

Reclassifying the products would make them harder to obtain, both by addicts and by legitimate pain patients.

Physicians are not allowed to call in a prescription for a Schedule II product to a pharmacy. Instead, patients must present a written prescription.

Last year an advisory committee to the FDA voted in favor of rescheduling the products. In December the Department of Health and Human Services sent the recommendation to the DEA. Shares of San Diego-based Zogenix closed down about 2.6 percent at $4.56 on the Nasdaq. http://www.nydailynews.com/life-style/health/docs-urge-fda-halt-launch-controversial-pain-drug-article-1.1706470#ixzz2uv8aWUjk

Pharmacy Journal of New England • Spring 2014

Your seat is ready.

Highlighted below are some of the newer task groups or areas needing expertise Share this list with your colleagues outside of NCPDP and encourage them to consider joining a task group that will provide value to their organizations.

If you are a participant in the NCPDP Collaborative Workspace already, to join a task group, just check the task group on your NCPDP Collaborative Workspace profile. If you have not yet joined the NCPDP Collaborative Workspace, please contact staff below for instructions.

New Task Groups: • The WG2 Application of BUS Clarification Task Group will identify the rationale used to determine the billing unit from past QUIC forms/products reviewed and the causes that lead to product reviews to capture/document the rationale and the process followed. Contact Patsy McElroy at pmcelroy@ ncpdp.org to join.

• The WG2 UDI Definition Task Group will define the UDI as it applies to all applicable NCPDP standards and review the definitions of existing product identifiers used in the NCPDP standards for accuracy. Contact Patsy McElroy at pmcelroy@ ncpdp.org to join.

• The WG7 Formulary Management Survey Task Group will develop and conduct a survey to understand the current scope, process and challenges for both the manufacturers and payer/processors in formulary management and validation. Contact Kittye Krempin at kkrempin@ncpdp.org to join.

• The WG11 Specialty Requirements for ePrescribing Task Group was formed to collaborate with WG10 Specialty and Compounding Pharmacy Services Task Group (see below). In the specialty pharmacy realm, there is often additional information needed before a prescription can be dispensed. This information is provided by the prescriber (or someone in the prescriber’s office). This information includes additional patient demographic and clinical information, order-specific clinical information and instructions related to delivery of the medication (i.e. to the patient or the clinic, nursing services required).

This information would be added to the appropriate SCRIPT Standard and/or Specialized Standard transactions, depending on analysis. Calls have been scheduled on the NCPDP Events Calendar or in the Conference Call Information document found on the task group on the NCPDP Collaborative.

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New England States Connecticut

President’s Message Dear CPA Members: I want to take this opportunity to update you on many of the activities that our Board of Directors is working on for 2014.

For those of you who are members of CPA I want to express my sincere appreciation for your commitment to our association and for standing alongside your fellow Phil Hritcko, President pharmacists to promote, support, and defend your profession. Those of you who are not members of CPA I would like to encourage you to consider membership because our individual organization’s success will not occur without you supporting, valuing and playing a role in advancing our successes. In the words of Helen Keller, “Alone we can do so little; together we can do so much.” There is a perception by some that CPA is too small and has no power to affect change. The reality is that everyone can do something and that collectively it can make a difference as embodied by a quote attributed to Margaret Mead “Never doubt that a small group of thoughtful, committed citizens can change the world. Indeed, it is the only thing that ever has.”

So let me discuss some initiatives that our State Association is working on at this time: 1 | Update Strategic Plan for 2014-2017 • Planning the future direction of our Association (Book Race for Relevance - 5 Radical Changes for Associations by Harrison Coerver & Mary Byers) • Review of Governance model – how do we best represent our membership – diversification of our member services – diversification of revenue sources • How do we increase our perceived value by our members • Increase participation by our members based upon their availabilities and life style

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2 | Membership Initiatives (What does membership mean to you?)

• Networking (mentoring program) opportunities to build relationships and develop leadership skills • Focus groups/Surveys • Virtual Open House 3 | Technology upgrades (communications with membership) • Receive breaking news through E-blasts & E-newsletters as well as online access to the quarterly journal “Pharmacy Journal of NE” • The Fast Five: CPA is now updating Members on a weekly basis on a variety of state and federal issues. The email is designed to deliver critical news immediately, instead of waiting for the monthly newsletter. Please also note that the CPA’s newly revised website has a “News and Notes” section where items of interest are posted on a regular basis.

• Job opportunities postings to give you a competitive edge – endorsements by CPA can make a difference • Virtual meetings through technology 4 | Legislative Session Strategies – CPA is on hand lobbying and representing our profession in the State of CT 5|A udit – As discussed by our Treasurer in his report to help secure our organization financials 6|C E programs throughout the year But what else does CPA need to offer to our members and how can we better represent pharmacists in the State of CT? That’s where we need your help! Please consider becoming an active member of your State Association and help to shape the future of the profession of pharmacy in the State of CT. It’s in everyone’s best interest as pharmacists to be part of the solution for the many issues and challenges facing our profession. Please feel free to discuss how you can be a part of our association by speaking with our CPA staff and BOD members attending today’s conference. We would welcome the opportunity to discuss your involvement with our organization.

Pharmacy Journal of New England • Spring 2014

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New England States

Massachusetts President’s Message 2014 is shaping up to be a busy year for the Massachusetts Pharmacists Association. As president, I am excited about the events, advocacy, and activities that the Massachusetts Pharmacists Association has planned for the next several months.

MPhA’s 2014 Spring Conference will be held Thursday, April 17 at the Four Points by Sheraton in Norwood, and we hope you will be able to join us. This promises to be an exciting day, filled with topics ranging from a pipeline preview to the pharmacist’s role in cardiovascular health to the implications of medical marijuana for pharmacists.

MPhA is excited to welcome David Sencabaugh, RPh and Executive Director of the Board of Pharmacy, to lead a Law CE at the Conference entitled “The Board of Pharmacy: What You Should Know.” Attendance at the Spring Conference provides you with 7 CEs including two law CEs. Though 2014 is still young, MPhA is already looking ahead to autumn and planning the 10th annual New England Pharmacists Convention, scheduled for October 23 & 24, 2014 at the MGM Grand at Foxwoods Resort.

Mark your calendars, and look for more information coming soon.

Advocacy Regarding legislative advocacy, much of our efforts have been centered on pending bills that would recognize pharmacists as healthcare providers, allow pharmacy interns to administer immunizations, and regulate pharmacy audits. Sponsored by MPhA, our sister associations and our schools of pharmacy, the Face of Pharmacy legislative day, held on March 18 was be an important forum for legislators to learn about their constituents’ views on this legislation.

We have seen solid progress on the Pharmacy Intern immunization bill, S.995. The bill has widespread support and could be brought to a vote this spring. Ongoing negotiations with the Financial Services Committee, bolstered by a grassroots effort of store owners, have us cautiously optimistic that the pharmacy audit bill, 10

continued S.483, will come out of that committee with a favorable recommendation and in time to bring it to a vote this session.

The progress of our legislative agenda has been impacted by lingering effects of the New England Compounding Center issue. Our work over the past twelve months has been to engage legislators to ensure that legislation filed in the wake of this tragedy addresses public safety without undue burdens on pharmacists. The House and Senate passed two different versions of a bill in the fall, H.3672 and S.1907, and a conference committee has been attempting to reconcile the versions since then. Until an oversight bill is signed into law, consideration of provider status for pharmacists is unlikely. However, we will seek every opportunity to see this goal realized.

Positive momentum is growing on these issues. Please contact your legislator and express your support for pharmacy bills. To find contact information for your state senator or representative, please go to: http://www. wheredoivotema.com/bal/MyElectionInfo.aspx.

Contact David Johnson, MPhA’s Exec. V.P. at djohnson@ masspharmacists.org if you have questions or need assistance.

Activities MPhA has been busy with other activities as well.

We continue to maintain a close relationship with Massachusetts’ pharmacy schools, and recently visited Northeastern students to educate them about the Face of Pharmacy. For the first time, the MPhA Foundation will award four deserving students with $1,000 scholarships.

We always welcome members to increase their level of involvement and attend our Board of Directors meetings at the MPhA office in Woburn. The next meeting date is May 27. Please register online at www.masspharmacists. org ahead of time if you would like to attend.

This update represents just a sample of the plans we have in the works for 2014. Additional networking meetings for pharmacists, a new blog with pharmacist guest writers, advocacy for a new advance in the profession...what are you looking for in MPhA? Please let me know: james. gagnon@umassmed.edu. The association will be only as productive as we all make it, and the Board and Staff eagerly await your input.

Pharmacy Journal of New England • Spring 2014

2014 MPhA Spring Conference 2014 Spring Conference

Register now for MPhA’s 2014 Spring Conference

April 17, 2014

Join us at the Four Points by Sheraton in Norwood On Thursday, April 17, the Conference promises to be an informative day filled with topics such as the pharmacist's role in the management of epilepsy, medical marijuana, and much more.

MPhA's Spring Conference Gives You:  Five CE credits, plus two additional law CE credits  A chance to network with fellow pharmacists  The opportunity to learn about timely topics that will have a real impact on your profession Your admission also includes lunch, continental breakfast, and time in the exhibit hall.

Featuring: Pipeline Preview 2014 by Maria M. Lowe, Pharm.D. Health Data & Drug Information Clinical Specialist, patientslikeme The Pharmacist's Role in Improving Cardiovascular Health

by William L. Baker, Pharm D., BCPS (AQ Cardiology), Assistant Professor of Pharmacy & Medicine University of Connecticut Schools of Pharmacy & Medicine, Farmington, CT The Pharmacist's Role in the Management of Epilepsy

by William J. House, MD, R.Ph., MBA, Head-Epilepsy Section, Bay State Health Medical Marijuana in Massachusetts: Implications for Patients and Pharmacists (Law CE)

by Todd Brown, BS, RPh, MHP, Vice Chair, Department of Pharmacy Practice Northeastern University Bouve College of Health Sciences, School of Pharmacy The Board of Pharmacy: What you should know (Law CE)

by David Sencabaugh, RPh, Executive Director, Massachusetts Board of Registration in Pharmacy

We look forward to seeing you at the Four Points! To register, visit our website.

Call us at (781) 933-1107 with any questions.

Massachusetts Pharmacists Association

781.933.1107

www.masspharmacists.org

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New England States

New Hampshire Welcome New NHPA Board Directors: Christopher Lopez, PharmD, CDE Christopher Lopez is a two time graduate of the University of Connecticut School of Pharmacy, where he most recently received his PharmD. He has worked in various capacities including as a diabetes educator, a community pharmacist, and an inpatient clinical pharmacist on a Neuro ICU. For a number of years, Chris worked in the Veterans Administration system as a Clinical Pharmacy Specialist, but recently took a new job at Dartmouth-Hitchcock Medical Center working the Accountable Care Support Team. His professional interests include Ambulatory Care Pharmacy practice, diabetes education and collaborative practice.

Chris currently lives in Grantham New Hampshire with his 6 year old son, Caleb, were they enjoy camping, baseball, skiing, skating, and many other outdoor activities.

Amanda Morrill, PharmD, BCPS Amanda obtained her Doctor of Pharmacy degree from the University of Rhode Island. After completing a PGY-1 Pharmacy Residency at Elliot Hospital in Manchester, NH, Amanda practiced as an inpatient pharmacist at Lahey Health and Medical Center in Burlington, MA. In July, Amanda accepted a position as an Assistant Professor in the in the Department of Pharmacy Practice at MCPHS University in Manchester, NH. Her practice interests include anticoagulation, geriatrics, and chronic medication management. Amanda lives in Hudson with her husband, Heath, and their cat, Ivan. In her spare time Amanda enjoys running, baking and watching football.

Amanda has taken a leadership role with NHPA as Chairperson for the Continuing Education Committee for 2014.

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Legislative Update: Representative William Hatch introduced a bill (HB 1219) on behalf of the NH Pharmacists Association. This bill is relative to the work schedules of pharmacists and would mandate that all pharmacists working longer than 6 consecutive hours per work day shall be required to take a 30 minute lunch/rest break. In New Hampshire, many pharmacists in the community/retail setting work 12 to 14-hour shifts with no breaks. Testimony in support of this bill will be provided by NHPA members to the Executive Departments and Administration Committee chaired by Representative Lucy Weber in the near future.

Another bill that will be watched closely is HB 1344 relative to the disposal of sharps waste by retail establishments.

This bill would mandate any pharmacy or other retail establishment that sells sharps to the public shall accept and dispose of sharps waste. This bill was heard in the House Environment and Agriculture Committee. Both the Independents and the NH Coalition of Chain Drug Stores testified in opposition to HB 1344.

NHPA is continuing discussions on an ongoing basis with the Board of Pharmacy on Collaborative Practices and Provider Status in the ambulatory care setting, and will continue to fight to improve working conditions for pharmacists in the Granite State.

Lastly, NHPA has representation at all Prescription Monitoring Advisory Council board meetings. In the Spring PJNE edition, we will provide an update on the legislative hearings and outcomes during this legislative session and timeline for the implementation of the Prescription Drug Monitoring Program.

New Hampshire Pharmacists are recognized at Annual Holiday Party The Massachusetts College of Pharmacy and Health Sciences University Manchester sponsored the Annual Holiday Reception on Wednesday, December 18, 2013 at the Manchester Country Club. The celebration was sponsored with support from the NHPA, the NH Society of Health-System Pharmacists (NHSHP) and the NH Independent Pharmacy Association (NHiPA).

Pharmacy Journal of New England • Spring 2014

2013 Awards’ Presentations Gold Certificate – Anthony D’Alessio, RPh

2013 Lifetime Achievement Award – Robert Dion, RPh

Recently, the NH Board of Pharmacy recognized one New Hampshire Pharmacist who has 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, although the presentation only became formal in the past 5 years. The gold certificate is an engraved replica of the recipient’s licenses and accompanied by signed citation from the Honorable Governor Maggie Hassan. The gold certificates of licensure were presented by Charles Fanaras, President, NH Board of Pharmacy to the recipient.

This year’s recipient is Anthony D’Alessio.

The Lifetime Achievement Award, new for 2013, 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 in recognition of exceptional commitment, loyalty and dedication to the practice of pharmacy in the State of New Hampshire.

Recipients of this award have distinguished themselves through a lifetime of exemplary service in the field of pharmacy. Recipients must be licensed and practicing in New Hampshire or formerly licensed and practicing in New Hampshire for 20+ years. The recipient must have demonstrated a career-long performance record of substantive, measurable impact and/or benefit to his/ her practice setting and/or the practice of pharmacy in the state of New Hampshire.

From left to right: Robert Dion, Ajay Gupta, Lorraine Radick, Cheryl Abel and Kerri Johnson. Absent from photo are Vahrij Manoukjan and Heather Radwan.

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New England States Bob was drafted into the Army at age 21 and served in the Korean War until age 24. Upon his return from the war, he went to college on the GI bill.

Bob chose the career of pharmacy while walking aimlessly down Main Street in Burlington, VT after discharge from the army. He walked into a drugstore where the “druggist” was making a hot fudge sundae. He decided then and there that he wanted to be a pharmacist! He spoke with that pharmacist who turned out to be a “big shot” at Massachusetts College of Pharmacy. He made some calls and got Bob into MCP. Bob took the bus to Boston shortly thereafter, not knowing anyone and enrolled in classes. He found a place to live right near the campus (about the size of a small bathroom) and quickly found a job at a restaurant nearby in Mission Hill as a dishwasher. Bob said that during his first year, he lived in a small square between Huntington and Landsdown Streets, and never needed to go beyond his square.

Bob graduated from MCP in 1957 at age of 27.

He married right away and began his first job as a pharmacist at Exeter Hospital.

A few years later, Bob started working at St. Joseph’s Hospital in 1959. He was the one and only pharmacist and the pharmacy was located in a “dungeon” in the basement of the building. He worked day shift and was on call at all times after that. There was also a nun, Sister Carrier, who worked as a nurse and doubled as a pharmacist at night. He recalls it being “crazy and fun”.

There was no state board or DEA involvement.

At this time, Bob also met monthly with a group of other pharmacists in the state to create rules and regulations.

St. Joseph’s evolved through the years from one single pharmacist to a director of pharmacy – Bob – (which he says he got by default as he was the first one there!), an assistant director, a team of pharmacists, technicians, secretaries, and the IV department. The pharmacy was eventually brought out of the basement, and he was able to see the light of day.

14

continued While working as a pharmacist and later as the director at St. Joe’s, Bob always had a part time job.

He would work 8:30-5pm at St. Joes, run home for dinner then work 6-10pm a few nights a week and on Sundays. He worked at various times at Nashua Pharmacy, Liggett Rexall and Rice’s Pharmacy.

Bob first “attempted” to retire from St. Joe’s in 1989 after 30 years. This “attempt” failed miserably as he totally missed what he loved most. He was subsequently hired at Southern NH Medical Center by his friend Bob Theriault. He started working 6 hour shifts which transitioned into evening and then day shifts. Bob always set an example for others as he was interested in learning new things and improving patient care every day. He ultimately retired in August of 2013 and the team misses him like crazy.

2013 New Hampshire Pharmacist of the Year – Lorraine Radick, MS, RPh 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 2013 New Hampshire Pharmacist of the Year is Lorraine Radick. Lorraine has worked fulltime for Rite Aid Pharmacy for the past 10 years.

Despite retiring this year, she continues to work per-diem for the company. Throughout her career as a pharmacist, Lorraine has always pursued the expansion and advancement of pharmacy practice.

To help achieve this goal, she has served on the NHPA Board of Directors for over 7 years. During this time, she has held many committee chair and leadership positions including: Vice-President for 2 years, President for 3 years and is currently serving as Immediate Past President.

Pharmacy Journal of New England • Spring 2014

Lorraine is being recognized for the impact she has made on pharmacy practice in the state of NH. She was an integral part in the passing of Senate Bill 93 which expanded the immunizing capacity of pharmacists to include the shingles and pneumococcal vaccines in addition to influenza. She spent many hours of her personal time testifying before house and senate committees to ensure that the senators and representatives understood the bill and realized the potential for pharmacists to improve immunization rates in the state. Her understanding of vaccine storage and billing aided in talks with the NH Medical Society to come to agreement regarding the language and scope of this bill. The passage of Senate Bill 93 did indeed expand the scope of practice for all pharmacists in the Granite State, and Lorraine was a vital part of this process. Currently, she continues to serve on NHPA’s legislative committee for clinical initiatives, and is diligently employed in the fight for improved working conditions for pharmacists.

grandfather to a local food bank to help wash dishes after meals. In her teenage years, she was active in her church community, and she has participated in spring break alternative mission trips as well as outreach initiatives for the poor as a college student.

Now as a pharmacist, she continues to serve the community at multiple levels.

In addition, Lorraine has been actively involved in community outreach programs including blood pressure and diabetes awareness clinics. She recently partnered with AARP and NHPA to provide immunizations at a senior health fair in celebration of American Pharmacists Month.

Cheryl has also provided medication safety presentations to many adolescent groups in the community. She has worked with a local middle and junior high school to educate their students about over-the-counter medication safety and literacy. She has also spoken with kindergarten and preschool aged children about appropriate use of medicine and the importance of communication with an adult before taking medicine.

2013 Bowl of Hygeia Award – Cheryl Abel, PharmD 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.

Community service is, and always has been, an integral part of life for the 2013 Bowl of Hygeia recipient. As a child Cheryl accompanied her

Cheryl works as an Assistant Professor of Pharmacy Practice at MCPHS University’s Manchester Campus. During her career as a pharmacist, she has served as a DREAM Program Guest Speaker for the Henry Moore School in Candia as well as a guest speaker for the UNH Health Science Career Information Night. In addition, she serves on the NHPA Board of Directors and chairs the group’s community service committee. She also is the faculty advisor for the Student Chapter of the American Pharmacists Association. Her leadership of these two groups has allowed other pharmacists and pharmacy students to engage in community service activities.

Currently, Cheryl is a leader for a Girl Scout Brownie Troop in her hometown of Bow, NH. Not only has she been able to serve as their troop leader in the traditional sense but she also takes every opportunity to educate them about medication safety and overall wellness. She has provided a medication safety presentation to the troop as well as an activity about hygiene and the prevention of the transmission of the flu.

Cheryl is a MCPHS University School of Pharmacy graduate who has revealed herself as a selfless and dedicated individual to her family and community.

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New England States 2013 Excellence in Innovation Award – Jay Gupta MScIM, RPh The Excellence in Innovation award is a national award coordinated by the National Alliance of State Pharmacy Associations, and generously sponsored by Upsher-Smith Laboratories, Inc. to recognize and honor a qualified pharmacist who has demonstrated significant innovation in their respective practice, method or service directly or indirectly resulting in improved patient care and/or advancement of the profession of pharmacy.

The recipient receiving this award is Jay Gupta.

Jay has worked as a Rite Aid pharmacist in NH since 2002, and has been awarded Rite Aid’s “My Favorite Pharmacist” award annually since 2005 as a result of positive patient feedback. He is passionate about providing excellent customer service and topnotch pharmaceutical care. Recently, he alerted an elderly patient of a severe drug interaction that her physician chose to ignore. Due to the counseling this patient received, she was able to recognize the signs of toxicity early and seek help which ultimately saved her life. In a statement published in Rite Aid’s newsletter, the patient’s family thanked this pharmacist for his “professionalism, thoroughness, kindness, and exceptional knowledge” that made such a difference for their family.

Jay is being recognized for what he does outside of the pharmacy to improve patient care. Jay views patients’ health and wellness as a personal passion.

He strives to share tools for healthy eating, stress reduction and gentle, yet effective, therapeutic exercises with the community. This year’s recipient began practicing yoga as a child, and has traveled from the Himalayas to the southernmost part of India to explore the depths of yoga and other natural cure practices. He has created a DVD called “Subtle Yoga for Rejuvenation” to share his knowledge. All proceeds from the sale of this DVD are donated to furthering the science of yoga.

16

continued

Jay has been teaching yoga for over 15 years. In 2006, he co-founded Yoga Caps, an all-volunteer, non-profit organization that has made yoga more available and affordable. This group has partnered with New Hampshire hospitals and community organizations to provide evidencedbased therapeutic yoga experiences for patients with chronic physical and mental health conditions. Yoga Caps’ goal is to help people manage and reverse chronic diseases with therapeutic lifestyle change.

On his days off from the pharmacy, this community pharmacist volunteers his time teaching several weekly “Thriving with Yoga” sessions for patients at area hospitals, a mental health center, a local YMCA and a senior center.

Due to space constraints the other two award recipients Vahrij Manoukian, ScD, RPh (2013 Cardinal Health Generation Rx Champions Award) and Heather Radwan (2013 Pharmacy Technician of the Year) will be highlighted in the next PJNE spring edition.

Lastly, NH Pharmacists Association would like to recognize and thank this year’s NH Pharmacy Awards Committee – Paul Boisseau, George Bowersox, Joe Clement, Maryann Cooper, Dave Lacoste, Don Messina, Paula Troie, Kristine Willett, and Gary Wingate.

2014 NH Pharmacists Association Executive Board Members: Congratulations and best wishes for success to the 2014 NHPA executive board members below: Jay Calabro, President Lorraine Radick, Immediate Past-President Cheryl Durand, Vice-President Joel Brown, Treasurer Lindsey Laliberte, Secretary

Pharmacy Journal of New England • Spring 2014

Upcoming 2014 Continuing Education Conferences: Spring CE Program at Attitash Mountain Resort

On May 31, 2014 NHPA will sponsor its fourth annual CE program at the Grand Summit Hotel in Bartlett, New Hampshire. We will be offering two free dinner speaker programs one on Friday, May 30, and the other on Saturday, May 31, 2014.

Please join us for an educational and fun filled weekend!

Remember, save the dates for all of our upcoming CE programs in 2014 which are as follows: Saturday, May 31, 2014 Attitash Grand Summit Hotel, Bartlett, NH September 7, 2014 SERESC, Bedford, NH

In Memorium: Carl H. Keough Carl H. Keough, 78 passed away on December 13, 2013 after a sudden illness. He is survived by his wife of 43 years, Penny (Normandin) Keough, and his sons and daughters. He was born in Keene.

Carl graduated from Massachusetts College of Pharmacy in 1957 and served as a community pharmacists for 52 years. Carl owned pharmacies in Anterim and North Woodstock during his early years. He retired in 2010 after a long career with Hannaford.

Carl was an outdoorsman and sports enthusiast and enjoyed life to the fullest between his two New Hampshire homes.

December 7, 2014 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”.

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2013 Recipients of the “Bowl of Hygeia” Award

Charles D. Sands III Alabama

Martie Lamont Alaska

Kathryn Labbe Arizona

Karrol Fowlkes Arkansas*

Vicki Fowlkes Arkansas*

Helen K Park California

Ronald Kennedy Colorado

Gregory L Hancock Connecticut

David W. Dryden Delaware

Judith Martin Riffee Florida

William Lee Prather Georgia

Selma Yamamoto Hawaii

Mark Johnston Idaho

Garry Moreland Illinois

Patrick Cashen Indiana

Bernard Cremers Iowa

Leland Hanson Kansas

J Leon Claywell Kentucky

Douglas Boudreaux Louisiana

Paul Chace Maine

Angelo C. Voxakis Maryland

John R Reynolds Massachusetts

Nancy J W Lewis Michigan

Harvey Buchholz Minnesota

Clarence DuBose Mississippi

Kenneth W. Schafermeyer Missouri

Carla Cobb Montana

Scott E Mambourg Nevada

Cheryl A Abel New Hampshire

Eileen Fishman New Jersey

Phil Griego New Mexico

James R. Schiffer New York

Jean Douglas North Carolina

Laurel Haroldson North Dakota

Kenneth S. Alexander Ohio

Eric Winegardner Oklahoma

Wayne Kradjan Oregon

Edward Bechtel Pennsylvania

Daniel Mahiques-Nieves Puerto Rico

Linda A Carver Rhode Island

Linda Reid South Carolina

Ann M Cruse South Dakota

Kenneth Smith Tennessee

Leticia Van de Putte Texas

Dominic DeRose Utah

The “Bowl of Hygeia”

Leo H Ross Virginia

Janet Kusler Washington

Russell Jensen Wisconsin

Timothy Seeley Wyoming

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

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Feature

By Nhi N. Tran Pharm.D. Candidate, 2014 University of Connecticut

St. John’s Wort in Depression: Implications for Practice Approximately 20 percent of American adults suffer from mental disorders, with depression afflicting about eight million annually.1 Unfortunately, depression’s subjective nature renders scientific tests ineffective when establishing clinical diagnoses. Practitioners must rely on individuals’ reported symptoms instead, since depression varies from patient to patient. The prevalence and heterogeneity of psychiatric illnesses highlights the importance of appropriate treatment, especially since no cure exists. Depressive disorders remain one of the most underdiagnosed and undertreated health conditions in this country.2

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Societal stigma, personal beliefs, and dissatisfaction with conventional therapy drive individuals to seek herbal supplements as “easier” alternatives. Herbal sales increased by over seven percent from 2007 to 2009, according to HerbalGram, the American Botanical Council’s quarterly journal.3 Top-selling herbals include St. John’s wort (SJW), which patients use to treat symptoms of depression. Accessibility, low cost, and purported health claims encourage patients to self-medicate, rather than seek professional advice. People inaccurately believe that something “natural” is also “safe,” thereby overlooking potential risks.

Pharmacy Journal of New England • Spring 2014

Pharmacists, hailed as the most accessible healthcare professionals, maintain a unique position at the forefront of care in the community.

Working with other practitioners to thoroughly understand patients’ medical history will help evaluate the potential for adverse drug events. Pharmacists can also assist in pinpointing key drug-drug, drugfood, and drug-lab interactions, as well as recognizing when to avoid SJW use. This manuscript will describe the history of SJW, characterize self-medication behaviors, and highlight pharmacists’ role in counseling patients about SJW’s risks and benefits.

Background and Evidence for SJW Named after St. John the Baptist, St. John’s wort (Hypericum perforatum) is a perennial shrub of yellow flowers belonging to the Hypericaceae family.

With 9 genera and 560 species, this plant grows in several geographic areas, including East Asia, the Canary Islands, Australia, and North America.4 Hypericum originates from the Greek word, hyperikon. Root words, “hyper” (meaning “over”) and “eikon” (meaning “apparition”), refer to SJW’s supposed ability to ward off demons.5 The first known reference of SJW’s medicinal uses dates back to Euryphon, a Greek physician in 288 BC. People have since used this botanical to treat numerous health conditions: Nicholas Culpeper, a famous herbalist in 1650, exploited SJW’s wound-healing properties, while Eclectic medicine practitioners in the 19th century concocted oily herbal preparations for ulcers, diarrhea, hysteria, and depression.6

The historical use inevitably contributes to society’s perception of SJW as an innocuous substance.

However, unlike conventional antidepressants, SJW’s mechanism of action and source of its moodenhancing effects are poorly characterized. Hypericum extracts contain at least seven compounds, including naphthodianthrons (i.e., hypericins), flavonoids (i.e., quercetin), biflavonoids (i.e., biapigenin), xanthons, and phloroglucinol derivatives (i.e., hyperforin), which may contribute to its pharmacologic activity.7 Hypericum extracts have also demonstrated antidepressant effects in standard animal models, but the matter remains disputed. However, the total extract seems more effective than isolated substances at affecting mood.7 Interactions between different components may therefore contribute to SJW’s overall effect, rather than the actions of just one constituent.

A Cochrane review pooled data from 29 trials, which contained samples of 30 to 388 patients and compared SJW to placebo or standard antidepressants.7 Evidence suggested that hypericum extracts have superiority over placebo, along with similar effectiveness and fewer side effects versus antidepressants, for mild to moderately severe depression.

Nonetheless, studies from Germanspeaking countries, where SJW boasts a long tradition of use, revealed more favorable results; whereas, SJW in studies from other countries seemed less effective. Differences could have stemmed from including patients with different types of depression, but German-speaking countries may have also reported overoptimistic findings.

Conversely, evidence for severe major depression was still insufficient to draw conclusions.7

Challenges Facing Patients with Depression Forty-one percent of those with depression use alternative medicine, versus only 28 percent of the general population.8 These “natural” drugs’ low cost and widespread availability contribute to their overall appeal.

However, drug interactions and consequences of poly-pharmacy constitute major concerns, particularly in elderly patients, 30 percent of whom already take at least three medications chronically.9 Patients’ autonomy and ease of access to medical resources are important considerations when evaluating their decisions to use SJW. Amidst societal stigma, patients with mental illnesses forgo prescription antidepressants to pursue alternatives.

The misguided communal belief that the mentally-ill are irresponsible, incompetent, and dangerous initiates feelings of shame, guilt, isolation, and hopelessness.1 Reluctance to accept public ridicule may consequently impede patients from seeking medical help, an otherwise critical element in controlling their complex illness.

Patients with depression may also buy SJW to circumvent interactions with doctors or pharmacists, but only 30 percent share this information with physicians.8 Deeming these exchanges as not “sufficiently important, [they believe] physicians would not understand [their reasons] for… taking complementary and alternative medications.”8 Patients may not just fear criticism, but also underestimate the seriousness of their condition and view professional help as unnecessary.

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Feature

continued

Along with antidepressant therapy’s common side effects, including GI upset, insomnia, and sexual dysfunction, Black Box Warnings could cause unease. In 2005, the FDA urged manufacturers to change antidepressant labeling to warn of suicidality in children and adolescents. Two years later, the FDA warned of increased suicidal behavior in 18 to 24 year-olds during initial treatment.10 These new precautions likely deterred patients from prescription medications and pushed them toward supplements, which themselves display questionable efficacy. Moreover, this sparked an unwillingness to “prescribe antidepressants to this age group [and] parents’… reluctance to accept this treatment for children.”11 Under-treatment of depression, a potential consequence of refusing to prescribe and take prescription medications, could lead to unfavorable results.

Combined with the increased risk of disruptive behavior, depression also represents a major societal burden, causing “employers to lose over $23 billion each year due to decreased productivity and absenteeism.”1 More importantly, conventional antidepressants typically require six- to eight-week treatment trials for adequate symptomatic improvement.1 Due to this delayed activity, people falsely deem antidepressants as ineffective, resorting to herbals for more “immediate” results. Those with this negative attitude may also view medical treatment for depression as a sign of weakness or an inability to combat emotional issues.12 Personal barriers overall lead to unnecessary treatment delays.

Rules and Regulations for Herbals Enacted in 1994, the Dietary Supplement Health and Education Act (DSHEA) demands no prior FDA approval of herbals or “food supplements” before their release into the market. Manufacturers need not undergo standardization, disclose information about their products’ safety and purported benefits, or participate in post-market reporting either. Therefore, the FDA only discovers up to one percent of adverse events.7 Loopholes in herbal supplement regulations compromise patients’ safety, thus underlining the need for patient education and pharmacists’ guidance to ensure safe utilization.

Questions surrounding SJW and other herbals pose risks to consumers, especially since “it is often not clear what doses are optimal to balance efficacy and safety. Preparation of products vary from manufacturer to manufacturer, and from batch to batch within one manufacturer.”6 SJW’s

22

many alternative names, including balsana, corancillo, and Lord God’s wonder plant,6 may baffle consumers further.

The LA Times conducted spot checks of ten SJW retail brands, including Pure Source and Sundown Herbals, by using an industry testing standard called the “hypericinmeasuring method.” To their dismay, percent of labeled claim varied from 140 to 20 percent.13 Potency also depended on parts of the plant used (i.e., flowers, stems, or leaves), the extraction process, and solvents. SJW products’ unreliable purity increases patients’ risks for adverse and/or inadequate therapeutic outcomes. Lack of standardization inevitably deceives patients, since SJW’s labeling rarely reflects the bottles’ actual ingredients.

While other countries may embrace SJW as an effective treatment option, certain risks are worth noting. In addition to metals and other toxic ingredients in foreign preparations, SJW products have minimal guarantee of consistency under DSHEA. Patients should thus seek brands that exhibit consistent results and contain USP seals or GMP designations (i.e., NOW, A. Vogel, etc.), which ensure that products have satisfied disintegration, dissolution, purity, strength, packaging, labeling, and weight variation standards. Products should also display scientific names, amount of active ingredients, manufacturer names, expiration dates, lot numbers, appropriate warnings, and side effects. Similar to traditional antidepressants, SJW demonstrates a delayed time to effect. Symptomatic improvement occurs in at least 3 to 4 weeks, contrary to beliefs that herbals produce quicker results. Abruptly discontinuing SJW after chronic use could also result in withdrawal or rebound symptoms.6 Most importantly, pharmacists should advise patients to monitor for any changes or side events after starting new supplements.

Pharmacists’ Course of Action Given SJW’s popularity, especially in today’s era of autonomy and self-help, patients will likely have questions about its role in depression. Not only should pharmacists proactively increase their knowledge through online resources, including the Natural Medicines Comprehensive Database, but they should also effectively counsel patients about widely-used herbals. Remaining empathetic and cognizant of depression’s negative connotations will ensure that pharmacists remain trusted healthcare professionals.

Vulnerable to society’s critical eye, patients with depression

Pharmacy Journal of New England • Spring 2014

desperately seek SJW to handle their debilitating disorder, without thoroughly recognizing risks. Thus, pharmacists have professional obligations to inquire about supplement use, assess SJW’s appropriateness, and recognize situations needing physician referrals.

The Patient Interview Pharmacists should quickly perform initial patient assessments before offering treatment recommendations.

If individuals are low-risk and otherwise healthy, take few medications, but are likely to self-medicate, then pharmacists should just note SJW’s low toxicities when counseling. On the contrary, if patients are elderly, highrisk, and take medications for various comorbidities, then physician referrals become possible options. Given depression’s complexity, physician consults can help to exclude other medical causes, distinguish acute crises from chronic illnesses, establish clear diagnoses, and determine possible causes of depression. Hypothyroidism, for example, may present like depression, and symptoms can manifest in different forms, including seasonal affective disorder, dysthymia, and bipolar depression. If pharmacists suspect that prescription medications are triggering such symptoms, then they should notify physicians and recommend modifications to therapy. Furthermore, patients with transient mood disturbances should first consider lifestyle changes and stress management before herbals. After carefully assessing patients’ history, pharmacists can customize treatment and offer advice about pharmacologic or non-pharmacologic options.

When approached with inquiries, pharmacists should explore patients’ reasons for choosing supplements.

Some may wish to start SJW for the first time, based on positive accounts from family or friends. With convenient information access, patients will have already researched SJW’s long-standing history of use and versatility in treating headaches, nausea, diarrhea, ulcers, muscle aches, and minor skin injuries. Designated as an approved herb by the German Commission E and named Germany’s most commonly prescribed antidepressant,14 SJW seems harmless. However, pharmacists should warn patients about the limited scientific evidence and discourage long-term use, since research studies have included relatively small patient populations and lasted up to twelve weeks. Patients should also acknowledge SJW’s variable therapeutic responses, with some experiencing no benefit.

For minor ailments, like headaches or nausea, pharmacists should offer advice about non-drug measures or direct patients to OTC products with more targeted activity.

Anyone considering SJW should always consult health practitioners for professional judgment about regulatory issues and safety/efficacy data.

Due to safety concerns, certain patients should avoid SJW. Reductions in protease inhibitor or non-nucleoside reverse transcriptase inhibitor drug concentrations may occur when combined with this herbal. Due to impending therapeutic failure, HIV/AIDS patients should avoid concurrent use.15 Similarly, SJW could significantly reduce immunosuppressant levels, particularly cyclosporine, so pharmacists should warn transplant recipients about organ rejection.15 Patients with suicidal ideation receiving chemotherapy also should not take this supplement, due to possible treatment failure and reduced effectiveness.

Increased difficulty with inducing relaxation and anesthesia may discourage SJW use before surgery as well. Case report data of human exposure to SJW during pregnancy is still insufficient to determine safety in those pregnant or lactating.15 Based on aforementioned interactions, pharmacists should defer certain patients from SJW.

Not Just Drug-Drug Interactions A 2012 systematic literature review in the International Journal of Clinical Practice described SJW as among the “top five herbs…documented to have the most interactions with individual medications [warfarin, insulin, aspirin, digoxin, and ticlopidine].”16 As a CYP3A4 inducer, SJW may interact with numerous medications, including SSRI’s and oral contraceptives, leading to sub-therapeutic levels and inadequate treatment. CYP1A2, CYP2C9 and P-glycoprotein induction could occur to a lesser extent.8 Hyperforin, one component of SJW, may inhibit serotonin, dopamine, norepinephrine, glutamate, and GABA uptake.6 As monotherapy, SJW is usually well-tolerated, but its broad mechanism of action could increase toxicity or augment current therapy.

Lesser known is SJW’s potential to interact with food and laboratory tests. Its weak MAOI activity could justify a warning to avoid tyramine-containing foods, due to possibilities of hypertensive crisis.17 Moreover, hypericum extracts may stimulate cortisol dose-dependently, thereby increasing blood pressure and heart rate.18 In vitro studies have also shown that SJW and hyperforin induce

23

Feature

continued

genes for facilitated glucose transporters and glycolysis, leading to increased glucose metabolism and potential hypoglycemia.19 By reducing effects of warfarin, SJW could also cause a statistically significant decrease in INR, even in stabilized patients. Additionally, significant increases in LDL and total cholesterol may occur with concomitant statin use.6

Conclusion Considering society’s desire for immediate results, patients often express distaste with traditional antidepressant therapy.

However, pharmacists should advise those contemplating SJW use to remain cautious. Depression, as a chronic disease, has no “quick fix.” Antidepressants need weeks to work, as does SJW. Furthermore, pharmacists should inform patients about the need for additional research.

While SJW is suitable “for short-term use in mild-tomoderate depression, placebo-controlled studies [have not demonstrated] acute efficacy in more severe depression… or long-term maintenance.”6 When assessing SJW’s suitability in individual situations, pharmacists should ask about current regimens, propose changes in sub-optimal doses, and recommend supplemental non-pharmacologic measures, including exercise or psychotherapy. Despite minimal side effects and safety as monotherapy, SJW can still interfere with established regimens. Pharmacists should urge medically-complex patients to consult physicians before adding on or switching to SJW. By encouraging realistic treatment expectations, suggesting alternatives, and collaborating with other disciplines, pharmacists can help patients reach therapeutic goals.

Stigmatized by depression’s negative societal connotations and conventional treatment’s inconveniences, individuals with depression feel tempted to use natural products.

Despite its widespread historical use, SJW remains an enigma with its questionable mechanism of action and unclear role in depression management. With depression being as complex as its treatment, pharmacists have major roles in adequately assessing those seeking self-treatment.

Not only are these patients vulnerable to risks of herbals, but they are also susceptible to suboptimal therapy.

References: 1. Information about Mental Illness and the Brain – NIH Curriculum Supplement Series [Internet]. Colorado: BSCS; 2007 [cited 2012 Mar 22]. Available from: http://www.ncbi.nlm.nih.gov/books/NBK20369/.

2. Depression Is Underdiagnosed and Untreated. Medical Wellness Archives [Internet]. 2006 [cited 2013 Mar 9]; 1(1):[about 1 p.]. Available from: http://www.medicalwellnessassociation.com/articles/depression.htm.

3. Johnston J. Herbal supplements are hot sellers: Pharmacists can teach clients about interactions. Drug Topics, Voice of the Pharmacist [Internet]. 2009 Sep [cited 2012 Mar 22]; 153(9):[about 1 p.]. Available from: http://drugtopics.modernmedicine.com/drugtopics/Modern+Medicine+Now/Herbal-supplements-are-hot-sellers/ ArticleStandard/Article/detail/624212.

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4. St. John’s wort (plant) – Britannica Online Encyclopedia [Internet]. Chicago (IL): Encyclopӕdia Britannica. c2012 – [cited 2012 Mar 22]. Available from: http://www. britannica.com/EBchecked/topic/517439/Saint-Johns-wort.

5. Klemow KM, Bartlow A, Crawford J, Kocher N, Shah J, Ritsick M. Medical Attributes of St. John’s Wort (Hypericum perforatum) In: Benzie IFF, Wachtel-Galor S, editors. Herbal Medicine: Biomolecular and Clinical Aspects. 2nd edition. Boca Raton (FL): CRC Press; 2011. Chapter 11. Available from: http://www.ncbi.nlm.nih. gov/books/NBK92750/.

6. Natural Standard – St. John’s wort [Internet]. Somerville (MA): Natural Standard. c2012 – [cited 2012 Mar 22]. Available from: http://www.naturalstandard.com/databases/herbssupplements/stjohnswort.asp.

7. Linde K, Berner MM, Kriston L. St John’s wort for major depression (Review). The Cochrane Collaboration [Internet]. 2009 [cited 2013 Dec 14]; Issue 4:[about 100 p.].

Available from: http://onlinelibrary.wiley.com.

8. Vasiliadis HM, Tempier R. Reporting on the prevalence of drug and alternative health product use for mental health reasons: results from a national population survey. Journal of Population Therapeutics and Clinical Pharmacology [Internet]. 2011 [cited 2012 Mar 22];18(1):[about 11 p.]. Available from: http://www.ncbi.nlm.nih.gov/ pubmed/21317442.

9. Bruno JJ and Ellis JJ. Herbal Use Among US Elderly: 2002 National Health Interview Survey. The Annals of Pharmacotherapy [Internet]. 2005 Apr [cited 2012 Apr 8]; 39(4):[about 6 p.]. Available from: http://www.theannals.com/content/39/4/643.full.pdf+html.

10. U.S. Food and Drug Administration [Internet]. Silver Spring (MD) FDA Proposes New Warnings About Suicidal Thinking, Behavior in Young Adults Who Take Antidepressant Medications; c2007 May 2 [updated 2009 Jun 18; cited 2012 Mar 22]. FDA News Release; [about 2 screens]. Available from: http://www.fda.gov/ NewsEvents/Newsroom/PressAnnouncements/2007/ucm108905.htm.

11. Singh T, Prakash A, Rais T, Kumari N. Decreased Use of Antidepressants in Youth After US Food and Drug Administration Black Box Warning. Psychiatry [Internet]. 2009 [cited 2012 Mar 22];6(60):[about 5 p.]. Available from: http://www. ncbi.nlm.nih.gov/pmc/articles/PMC2790401/?tool=pubmed.

12. Castaldelli-Maia JM, Scomparini LB, Andrade AG, Bhugra D, De Toledo Ferraz Alves TC, D’Elia G. Perceptions of and attitudes toward antidepressants: stigma attached to their use--a review. The Journal of Nervous and Mental Disease [Internet]. 2011 Nov [cited 2012 Mar 22];199(11):[about 6 p.]. Available from: http:// www.ncbi.nlm.nih.gov/pubmed/22048139.

13. Monmany T. Labels’ Potency Claims Often Inaccurate, Analysis Finds. The LA Times. 1998 Aug 31. Available from: http://articles.latimes.com/1998/aug/31/news/ mn-18279.

14. Lawvere S, Mahoney MC. St. John’s Wort. AAFP [Internet]. 2005 Dec 1 [cited 2012 Apr 20];72(11):[about 5 p.]. Available from: http://www.aafp.org/ afp/2005/1201/p2249.html.

15. Ulbricht C, Barrette E-P, Basch E, Boon H, Conquer J, et al. A Thorough Analysis of the Safety Profile of St. John’s Wort by the Natural Standard Research Collaboration. Natural Medicine Journal [Internet]. 2010 [cited 2013 Mar 9];2(2):[about 11 p.]. Available from: http://naturalmedicinejournal.net/pdf/ NMJ_FEB10_INT.pdf.

16. Tsai HH, Lin HW, Simon Pickard A, Tsai HY, Mahady GB. Evaluation of Documented Drug Interactions and Contraindications Associated With Herbs and Dietary Supplements. International Journal of Clinical Practice [Internet]. 2012 [cited 2013 Mar 9];66(11):[about 20 p.]. Available from: http://www.medscape.com/viewarticle/773337_1.

17. ST. JOHN’S WORT Monograph: Natural Medicines Comprehensive Database [Internet]. Stockton (Ca): Natural Medicines Comprehensive Database. c2013 – [cited 2013 Mar 9]. Available from: http://naturaldatabase.therapeuticresearch.com/ nd/Search.aspx?cs=&s=ND&pt=100&id=329&fs=ND&searchid=34150622.

18. Schüle C, Baghai T, Ferrera A, Laakmann G. Neuroendocrine effects of Hypericum extract WS 5570 in 12 healthy male volunteers. Pharmacopsychiatry [Internet]. 2001 [cited 14 Dec 2013];349(1):[about 6 p.]. Available from: http://www.ncbi.nlm.nih.gov/pubmed/11518061.

19. Krusekopf S and Roots I. St. John’s wort and its constituent hyperforin concordantly regulate expression of genes encoding enzymes involved in basic cellular pathways. Pharmacogenetic Genomics [Internet]. 2005 [cited 14 Dec 2013];15(11):[about 12 p.]. Available from: http://ovidsp.tx.ovid.com.

In addition to recognizing faculty members at the University of Connecticut School of Pharmacy for helping me with this publication, I would also like to express my most sincere thanks and appreciation to Dr. Gerald Gianutsos.

Student Showcase

By Kathleen Adams, PharmD Candidate, University of Connecticut

The Little Blue Pill’s Not So Little Impact on Pharmacy Pfizer’s New Approach In early May of 2013, Pfizer Inc. announced that it will begin selling Viagra, a popular erectile dysfunction medication, directly to patients on its website. Men will still need a prescription, but they will no longer have to visit a pharmacist for dispensing. Medications will arrive through the mail from CVS, the pharmacy responsible for filling the orders on Viagra.com.i Pfizer’s shift to the Internet is in response to counterfeit sales of Viagra online, as it is the most counterfeited drug in the United States.ii The Verified Internet Pharmacy Practice Sites (VIPPS) accreditation program indicates which online prescription retailers are compliant with National Association of Boards of Pharmacy (NABP) criteria along with state and federal laws. An online pharmacy that holds the VIPPS seal meets nationally endorsed standards of practice, demonstrates compliance with regards to privacy and security, and provides consultation between patients and pharmacists. iii A January 2013 study, by the National Association of Boards of Pharmacy, found that fewer than 3% of the 10,275 online pharmacies examined were legitimate and held the VIPPS seal.iv Both embarrassment and price drive men to purchase Viagra online, which in most instances is counterfeit and hazardous to the patient’s health.v Most online pharmacies operate from remote countries and are inaccessible to international inspection and research.vi

Pfizer’s new approach is intended to allow patients avoid potential embarrassment in the pharmacy while decreasing the incidence of counterfeit purchases from illegitimate online pharmacies.vii Pfizer hopes that by eliminating the embarrassment factor of treatment and making Viagra mail order, it will decrease counterfeit purchases and increase brand-name sales.

Unfortunately, if it is price rather than embarrassment that drives men to seek Viagra from the Internet, this will do little to combat online pharmacies that are selling counterfeit Viagra without a prescription for pennies.

Viagra runs about $25 a pill, isn’t covered by many insurance companies, and will be protected under patent until 2020.viii John Norton, Director of Public Relations for the National Community Pharmacists Association, cites research that shows only 2% of patients will choose Pfizer’s mail service if there are no financial incentives.ix If price is the driving factor for online purchases, then Pfizer’s approach does nothing more than eliminate the pharmacist from the interprofessional healthcare equation.

The Risks to Patients While the Viagra.com website states that CVS will handle “all aspects of your order,” including data security, prescription verification, insurance processing, credit card processing, and shipment, nowhere does it assure the patient that the Viagra prescription will be checked against 25

Student Showcase

continued

other medications for potential interactions.x Instead, the Viagra.com website encourages patients to discuss their medications with their doctors to determine if Viagra is an appropriate medication. Individuals age 65-69 years old take on average 14 prescriptions per year and physicians do not have access to a comprehensive list of these medications. xi The expectation that a patient will be able to recite his or her entire prescription regimen to a doctor each and every visit is inconceivable.

A 2007 study shows that the median doctor’s visit lasts 15.7 minutes.xii As a result, the physician may not have the opportunity to address all the important aspects of their patient’s medications.xiii When patients fill their prescriptions at a pharmacy, they are afforded a crucial opportunity to be counseled, ask questions, and have their medications checked for drug interactions. While Viagra is a relatively well-tolerated medication, it does have interactions with other drugs, which could be missed by the doctor.xiv By eliminating the pharmacist from the equation through this mail order process, the safeguard system put in place to double-check the physician and promote patient adherence is compromised.

Patients may see multiple physicians or have changes made to their medication regimen after hospital discharge. These multiple avenues to obtain prescriptions may do more harm than good. 39% of patients have an unintended medication discrepancy at hospital admission that has the ability to cause harm.xv Therefore, a system that relies solely on electronic methods, such as Pfizer’s new online approach, is missing a huge piece of the puzzle. When pharmacists have the ability to work face-to-face with their patients, they have the opportunity to address discrepancies in health records and perform medication reconciliation on their patient’s treatment regimen. However, for a proper medication reconciliation to take place, claims data must be present, health records must be present, and the patient must be present.xvi It is essential that the community pharmacist stays involved and maintains positive relationships with patients to enable optimal treatment outcomes.

In addition, many patients with erectile dysfunction have concurrent chronic conditions. For example, diabetes patients that experience erectile dysfunction are at an increased risk for cardiovascular disease.xvii Persons with chronic illnesses commonly develop sexual dysfunction, which can lead to stress and a reduced quality of life.xviii It is essential that both the physician and the pharmacist 26

address and understand these comorbidities and are able to see the big picture when it comes to the patient’s current health and health history. Pharmacists are responsible for medication coordination, which can only be successfully implemented if there is full access to a patient’s treatment plan. Pushing part of a medication regimen online eliminates medications from the pharmacist’s eyes and hinders a comprehensive pharmacist-patient interaction.

As pharmacists tailor counseling to each individual, it is essential that they are fully informed about all aspects of each patient’s health.

The Risks to Pharmacists and Healthcare Les Funtledyer, a health care strategist at Poliwogg, believes that if Pfizer’s strategy is successful, then other companies will hop on the bandwagon of selling medications online.xvx If Viagra moves to an online product, other commonly counterfeited medications, such as antibiotics, cardiovascular medications, painkillers, and medications for the treatment of allergies, Alzheimer’s, AIDs, cancer, and mental illness, may follow in its footsteps.xx While ensuring patient safety should be of first priority, if other pharmaceutical companies follow Pfizer’s move online, it could result in obstacles for the pharmacy profession and healthcare overall.

Improper medication use adds an unnecessary $290 billion a year to national health care costs. It is essential to keep the pharmacist in the equation to promote adherence and improve medication outcomes.xxi Reducing patient counseling could increase the money spent as a result of nonadherence. In addition, sidestepping the pharmacist by eliminating the role of counseling alters the profession from a clinical practitioner to a monotonous machine.

The profession is undermined and its service to patients is compromised when industries and consumers see pharmacies as unnecessary, or potentially embarrassing modes of medication delivery.

An Interprofessional Solution Erectile dysfunction reduces a person’s quality of life and causes emotional distress. However, many men who suffer from it do not seek medical treatment.xxii Dr. David Dershewitz of Newark’s University Hospital, says erectile dysfunction is common, but most men are too embarrassed to talk about it with their doctors.xxiii Up to 20 million men suffer erectile dysfunction, but only 5-25% of them see a doctor for treatment.xxiv

Pharmacy Journal of New England • Spring 2014

Instead of working around the pharmacist, both the pharmacist and physician must be proactive in identifying patient populations at risk for erectile dysfunction, and tactfully ask patients about their sexual health. Impotence can be caused by medications such as antidepressants, blood pressure medications, cardiac disease medications, and psychiatric medications. Pharmacists should inform their patients if their medications cause sexual dysfunction as a side effect, and open the door to the patient for more discussion. In addition, pharmacists can promote healthy lifestyle changes that can help prevent or reverse the onset of erectile dysfunction such as smoking cessation, limiting alcohol, and exercise.

iv. Pfizer to let bashful buyers get Viagra online. USA Today. http://www.usatoday. com/story/money/ business/2013/05/06/pfizer-Viagra-online/2138155/. Published May 6, 2013. Accessed June 3, 2013.

Many men who are put on treatment for erectile dysfunction do not properly discontinue their medication once sexual stimulation has been restored, or they choose to stop the medication without notifying their physician because of suboptimal treatment outcomes.xxv 1 in 5 patients stop “successful” erectile dysfunction treatment due to the adverse effects of the medication. It is the pharmacist’s job to properly educate the patients on what they are likely to expect with their medication.xxvi As a result, it is important for patients to feel comfortable talking to health care professionals about their conditions.

If pharmacists are able to promote their knowledge and understanding to their patients, they will be seen as a source of useful information and will be more likely to receive inquiries, and be in a better position to assist in preventing medication issues.

x. Viagra (sildenafil citrate) Tablets. https://www.cvs.com/Viagra/?DCSext.

SourceSiteVGA =Google&DCSext.KeywordVGA=Viagra.com. Published May 2013.

Accessed June 3, 2013.

It is the job of both the physician and pharmacist to educate patients about the dangers of counterfeit medications and the risks of using online pharmacies.

All health care professionals, especially in low-income populations, need to verse themselves in cost-saving opportunities and nonpharmacological treatments and make their patients aware of these options. The challenge to every pharmacist as part of the healthcare team, and we owe our patients no less, is to make ourselves an accessible and approachable resource for our patients.

References: i. Pfizer to let bashful buyers get Viagra online. USA Today. http://www.usatoday .com/story/ money/business/2013/05/06/pfizer-Viagra-online/2138155/. Published May 6, 2013. Accessed June 3, 2013. ii. Pfizer to let bashful buyers get Viagra online. USA Today. http://www.usatoday. com/story/money/ business/2013/05/06/pfizer-Viagra-online/2138155/. Published May 6, 2013. Accessed June 3, 2013. iii. VIPPS. National Assocation of Boards of Pharmacy. http://www.nabp.net/programs/accreditation/ vipps/. Accessed June 6, 2013.

v. Hensley, Scott. Pfizer Goes Direct With Online Viagra Sales to Men. http://www. npr.org/ blogs/health/2013/05/06/181577694/pfizer-goes-direct-with-Viagra-salesto-men. Published May 06, 2013. Accessed June 3, 2013. vi. Orizio G - J Med Internet Res (2011) Quality of online pharmacies and websites selling prescription drugs a systematic review.pdf vii. Hensley, Scott. Pfizer Goes Direct With Online Viagra Sales to Men. http://www. npr.org/blogs/health/2013/05/06/181577694/pfizer-goes-direct-with-Viagra-salesto-men. Published May 06, 2013. Accessed June 3, 2013. viii. Hensley, Scott. Pfizer Goes Direct With Online Viagra Sales to Men. http://www. npr.org/blogs/ health/2013/05/06/181577694/pfizer-goes-direct-with-Viagra-salesto-men. Published May 06, 2013. Accessed June 3, 2013. ix. Pfizer launches website for purchasing Viagra safely. American Pharmacists Assocation. http://www.pharmacist.com/pfizer-launches-website-purchasingViagra-safely-0. Published June 01, 2013. Accessed June 3, 2013.

xi. ASCP Fact Sheet. https://www.ascp.com/articles/about-ascp/ascp-fact-sheet.

Accessed June 3, 2013. xii. Tai-seale M, Mcguire TG, Zhang W. Time allocation in primary care office visits.

Health Serv Res. 2007;42(5):1871-94. xiii. Tai-seale M, Mcguire TG, Zhang W. Time allocation in primary care office visits.

Health Serv Res. 2007;42(5):1871-94. xiv. Fazio L, Brock G. Erectile dysfunction: management update. CMAJ. 2004;170(9):1429-37. xv. Cornish PL, Knowles SR, Marchesano R, et al. Unintended medication discrepancies at the time of hospital admission. Arch Intern Med. 2005;165:424-429. xvi. Pitman SK, Farley TM, Catney CM, Weetman DB. Integrating pharmacy students into medication reconciliation through a volunteer program. Am J Health Syst Pharm. 2013;70(12):1012-3. xvii. Yamada T, Hara K, Umematsu H, Suzuki R, Kadowaki T. Erectile dysfunction and cardiovascular events in diabetic men: a meta-analysis of observational studies.

PLoS ONE. 2012;7(9):e43673. xviii. Barsky JL, Friedman MA, Rosen RC. Sexual dysfunction and chronic illness: the role of flexibility in coping. J Sex Marital Ther. 2006;32(3):235-53. xix. Pfizer to let bashful buyers get Viagra online. USA Today. http://www.usatoday .com/story/money/business/2013/05/06/pfizer-Viagra-online/2138155/. Published May 6, 2013. Accessed June 3, 2013. xx. Haiken, Melanie. 7 Scariest Counterfeit Drugs. MSN. http://healthyliving.msn. com/ health-wellness/7-scariest-counterfeit-drugs?pageart=2. Accessed June 3, 2013. xxi. Pfizer launches website for purchasing Viagra safely. American Pharmacists Assocation. http://www.pharmacist.com/pfizer-launches-website-purchasingViagra-safely-0. Published June 01, 2013. Accessed June 3, 2013. xxii. Sadovsky R, Brock GB, Gutkin SW, Sorsaburu S. Toward a new ‘EPOCH’: optimising treatment outcomes with phosphodiesterase type 5 inhibitors for erectile dysfunction. Int J Clin Pract. 2009;63(8):1214-30. xxiii. Pfizer to Let Bashful Buyers Get Viagra Online. USA Today. http://www. usatoday .com/story/money/business/2013/05/06/pfizer-Viagra-online/2138155/.

Published May 6, 2013. Accessed June 3, 2013. xxiv. Sexual Function and Infertility – Erectile Dysfunction (ED). Columbia University Medical Center. http://columbiaurology.org/specialties/sexual_function_and_ infertility/erectile-dysfunction.html. Accessed June 3, 2013. xxv. Sadovsky R, Brock GB, Gutkin SW, Sorsaburu S. Toward a new ‘EPOCH’: optimising treatment outcomes with phosphodiesterase type 5 inhibitors for erectile dysfunction. Int J Clin Pract. 2009;63(8):1214-30. xxvi. Sadovsky R, Brock GB, Gutkin SW, Sorsaburu S. Toward a new ‘EPOCH’: optimising treatment outcomes with phosphodiesterase type 5 inhibitors for erectile dysfunction. Int J Clin Pract. 2009;63(8):1214-30.

27

Pharmacy Marketing Group

Rx and the Law By: Don R. McGuire Jr., R.Ph, JD 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.

The Drug Quality and Security Act Most pharmacists are aware that the Drug Quality and Security Act (DQSA) was signed into law by President Obama on November 27, 2013. Most are also aware that the law provides additional regulatory oversight over the compounding of sterile products. This comes from the Compounding Quality Act (CQA) portion of the DQSA. However, many pharmacists are unaware of the other provision in the DQSA, the Drug Supply Chain Security Act (DSCSA). This portion will increase the ability to track and trace products from manufacturers downstream to the ultimate users.

The CQA creates a new entity in the drug distribution model; the Outsourcing Facility. An Outsourcing Facility compounds sterile products and elects to register as an Outsourcing Facility under the act. A facility that compounds only non-sterile preparations cannot register as an Outsourcing Facility. An Outsourcing Facility is not required to be a licensed pharmacy. In addition, the Outsourcing Facility may or may not obtain prescriptions for identified individual patients. Registration and abiding by the provisions of the CQA allow the products compounded by the Outsourcing Facility to be exempt from the requirements of the New Drug Application process. Section 503A of the Food, Drug and Cosmetic Act contains another avenue for exemption when there is an identified individual patient who is the recipient of the compounded item, whether it is sterile or non-sterile.

The CQA provides a broad definition of compounding.

Compounding includes the combining, admixing, mixing, diluting, pooling, reconstituting, or otherwise altering a drug or bulk drug substance to create a drug. The inclusion of the words diluting and reconstituting show the intent to cover everything sterile that is compounded, no matter how simple the action. Note that the inclusion of admixing shows that IV admixture programs are considered compounding.

Outsourcing Facilities will have to register with the FDA annually. The list of registrants will be public information.

Outsourcing Facilities will also have to file with the FDA 28

reports of their activities twice per year. The contents of these reports will not be public information. Outsourcing Facilities will be subject to FDA inspection on a risk-based schedule.

The CQA will also require the implementation or completion of some lists of products/components in order for Outsourcing Facilities to be able to comply with the section. An Outsourcing Facility cannot compound a product if it is on a list of drugs that have been withdrawn or removed from the market for reasons of safety or effectiveness. Also, an Outsourcing Facility cannot compound a product that is on the Demonstrable Difficulties for Compounding list. In addition, bulk substances without an USP/NF monograph must not be used unless they are on an approved list of bulk substances. None of these lists are currently complete, but the FDA will be convening a Pharmacy Compounding Advisory Committee to help compile these lists.

The second part of the DQSA is the Drug Supply Chain Security Act. This provision will impact many more pharmacies than does the CQA. This act creates a drug product history, starting with the manufacturer that must be passed on with the product as is it sold or distributed down the supply chain. This encompasses wholesalers, third party logistics providers, trading partners, repackagers, and dispensers. The drug product history is not required to be provided by the dispenser to the prescribed patient. But the dispenser is required to have policies and procedures in place to quarantine suspect or illegitimate products, return them as necessary and notify any patients who may have received them from the dispenser.

Another provision of the act will require that a product identifier be affixed to the packaging of prescription drugs. This identifier will need to be readable by both humans and machines. The act also specifically outlines the content of the drug histories. Implementation of the different requirements of the act varies according to the type of entity involved, but many items will need to be implemented no later than July 1, 2015.

The DQSA has been covered in the media primarily as a compounding law, but the tracking and tracing requirements will apply to all participants in the drug distribution chain. So it behooves all pharmacists to review the act and determine which provisions impact their practice and when that impact will occur. Š 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.

Pharmacy Journal of New England • Spring 2014

Financial Forum This series, Financial Forum, is presented by PRISM Wealth Advisors, LLC and your State Pharmacy Association through Pharmacy Marketing Group, Inc., a company dedicated to providing quality products and services to the pharmacy community.

How impatience hurts retirement savings Keep calm & carry on – it may be good for your portfolio Why do so many retirement savers underperform the market? From 1993-2012, the S&P 500 achieved a (compound) annual return of 8.2%. Across the same period, the average investor in U.S. stock accounts got only a 4.3% return. What accounts for the difference?1,2 One big factor is impatience. It is expressed in emotional investment decisions. Too many people trade themselves into mediocrity – they react to the headlines of the moment, buy high and sell low. Dalbar, the noted investing research firm, estimates this accounts for 2.0% of the above-mentioned 3.9% difference. (It attributes another 1.3% of the gap to operating costs and the remaining 0.6% to portfolio turnover within accounts)2 Impatience encourages market timing. Some investors consider “buy and hold” passé, but it has certainly worked well since 2009. How did market timing work in comparison? Citing Investment Company Institute calculations of equity account asset inflows and outflows from January 2007 to August 2012, U.S. News & World Report notes that it didn’t work very well. During that stretch, investors either sold market declines or bought after market ascents 57.4% of the time. In addition, while the total return of the S&P 500 (i.e., including dividends) was -0.13% in this time frame, equity account investors lost 35.8% (adjusted for dividends).3 Most of us don’t “buy and hold” for very long.

Dalbar’s latest report notes that the average equity account investor owned his or her shares for 3.3 years during 1993-2012. Investors in balanced accounts (a mix of stocks and bonds), held on a bit longer, an average of about 4.5 years. They didn’t come out any better – the report notes that while the Barclays Aggregate Bond Index

notched a 6.3% annual return over the 20-year period studied, the average balanced account investor’s annual return was only 2.3% .2 What’s the takeaway here for retirement savers? This amounts to a decent argument for dollar cost averaging – the slow and steady investment method by which you buy shares over time, a little at a time. When the market sinks, you are buying more shares as they have become cheaper – meaning you will own more (quality) shares when they regain value.

It also shows you the value of thinking long-term.

When you save for retirement, you are saving with a time horizon in mind. A distant horizon. Consistent saving from a (relatively) early age and the power of compounding can potentially have much greater effect on the outcome of your retirement savings effort than investment selection.

Keep your eyes on your long-term retirement planning objectives, not the short-term volatility highlighted in the headlines of the moment.

Pat Reding and Bo Schnurr may be reached at 800-288-6669 or pbh@berthelrep.com.

Registered Representative of and securities and investment advisory services offered through Berthel Fisher & Company Financial Services, Inc. Member FINRA/SIPC. PRISM Wealth Advisors LLC is independent of Berthel Fisher & Company Financial Services Inc. This material was prepared by MarketingLibrary.Net Inc., and does not necessarily represent the views of the presenting party, nor their affiliates. All information is believed to be from reliable sources; however we make no representation as to its completeness or accuracy. Please note - investing involves risk, and past performance is no guarantee of future results. The publisher is not engaged in rendering legal, accounting or other professional services. If assistance is needed, the reader is advised to engage the services of a competent professional. This information should not be construed as investment, tax or legal advice and may not be relied on for the purpose of avoiding any Federal tax penalty. This is neither a solicitation nor recommendation to purchase or sell any investment or insurance product or service, and should not be relied upon as such. All indices are unmanaged and are not illustrative of any particular investment

Citations: 1 | finance.yahoo.com/news/p-fund-tops-p-500-142700129.html [5/3/13] 2 | marketwatch.com/story/7-reasons-why-retirement-savers-fail-2013-06-26 [6/26/13] 3 | money.usnews.com/money/blogs/the-smarter-mutual-fund-investor/2012/11/05/herd-behavior-hurts-fund-investors [11/5/12]

29

From the Colleges University of Connecticut School of Pharmacy UConn School of Pharmacy Announces Appointment of New Dean The UConn School of Pharmacy recently announced the appointment of Dr. James Halpert as dean of the School of Pharmacy, following a nationwide search.

Dr. Halpert comes to UConn from the University of California San Diego’s Skaggs School of Pharmacy and Pharmaceutical Sciences where he serves as professor and associate dean for scientific affairs. Prior to joining UCSD, Dr. Halpert was professor and chair of the Department of Pharmacology and Toxicology at the University of Texas Medical Branch, where he also served as director of the National Institute of Environmental Health Sciences Center in Environmental Toxicology, and interim director of the Sealy Center for Environmental Health and Medicine. He also held the Mary Gibbs Jones Distinguished Chair in Environmental Toxicology. Prior to joining the University of Texas, Dr. Halpert served for fifteen years on the faculty at the University of Arizona.

Dr. Halpert earned his Ph.D. in biochemistry from Uppsala University, Sweden in 1977, his M.S. in Toxicology from the Karolinska Institute, Stockholm, Sweden in 1978 and his B.A. in Scandinavian Languages from the University of California at Los Angeles in 1971.

In addition to his university leadership positions, Dr. Halpert served as editor of Drug Metabolism and Disposition, the primary scientific journal in his field of research, president and secretary-treasurer of The American Society for Pharmacology and Experimental Therapeutics, chair of the NIH Pharmacology Study Section, and as a member of the National Institute of Environmental General Medical Sciences Biomedical Research and Research Training Review Committee.

Dr. Halpert’s research for the past 35 years has focused on the structure and function of cytochromes P450 of the 2B and 3A subfamilies. This work has been funded continuously by the National Institutes of Health since 1985. He is a fellow of the American Association for the Advancement of Science. In 2010, Dr. Halpert was the recipient of the Bernard B. Brodie Award from the American Society for Pharmacology and Experimental Therapeutics.

UConn Provost Mun Choi stated “This is truly an exciting period in UConn’s history, and we recognize the important role of the School of Pharmacy in conducting breakthrough research and implementing innovative training programs. We are excited that Dr. Halpert will lead the university’s School of Pharmacy as dean, and look forward to the school’s continued success and next level of accomplishment. We wish to express our appreciation to Dean Greg Weidemann, Ms. Cindy Bastek, and the members of the search committee for their thoughtful work throughout the search process.”

The CPA congratulates the Men’s and Women’s UConn Huskies for their Double NCAA Win!

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Pharmacy Journal of New England • Spring 2014

University of Saint Joseph School of Pharmacy Message from the Dean Dear Colleagues: As we approach the graduation of our inaugural class, I want to express my sincere appreciation and that of the entire School of Pharmacy Community and University of Saint Joseph. We can note with pride and pleasure the impact that our students, faculty, and staff are having in and around the community. They demonstrate excellence in scholarship and practice skills. The students continue to be fully engaged academically, in national pharmacy organizations, and other community activities. To date, our student body has logged over 5000 hours of community service.

Through your commitment, advice and support we have come this far. And with your unstinting positive engagement we will go further.

We say Thank You – Our success is also your success.

Best, Dr. Josef Ofosu Dean, University of Saint Joseph School of Pharmacy

Dr. Ivan Edafiogho gets Tenure at University of Saint Joseph Dr. Ivan Edafiogho’s application for tenure at University of Saint Joseph was approved by President Pamela Trotman Reid, and the Board of Trustees to take effect from July 1, 2014. Dr. Ivan Edafiogho is Professor and Chair of Department of Pharmaceutical Sciences at the School of Pharmacy in Hartford, Connecticut. He teaches Pharmaceutical Calculations; co-teaches Herbal Products and Dietary Supplements, Immunology, and Research Elective in Medicinal Chemistry. He is well accomplished in research in synthesis of enaminone anticonvulsants, and published over 50 peer-reviewed articles. He Co-Inventor of four United States Patents.”

Publications The following two manuscripts were published in January by Dora E. Wiskirchen, PharmD, BCPS, Assistant Professor of Pharmacy Practice: Wiskirchen DE, Nordmann P, Crandon JL, Nicolau DP. Efficacy of Humanized Carbapenem and Ceftazidime Regimens against Enterobacteriaceae Producing the OXA-48 Carbapenemase in a Murine Infection Model. Antimicrob Agents Chemother 2014;58(3):1678-83.

Wiskirchen DE, Nordmann P, Crandon JL, Nicolau DP. In vivo Efficacy of Human Simulated Regimens of Carbapenems and Comparator Agents against NDM-1 Producing Enterobacteriaceae. Antimicrob Agents Chemother 2014:58(3):1671-7.

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From the Colleges

continued

Massachusetts College of PharmacyWorcester/Manchester School of Pharmacy Dear Colleagues, We are pleased to welcome over 300 new students to the Worcester and Manchester campuses and to welcome back the second year students who just finished their IPPE rotations. Both campuses are full of positive energy and excitement to begin the new academic year. The faculty continues to be actively engaged with all the students on and off campus while working diligently on making the most of their Scholarly opportunities. I hope that all of you enjoy a productive and healthy new year.

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

Promotions & New Hires New hires include one faculty member in the Department of Pharmaceutical Sciences and four faculty members in the Department of Pharmacy Practice.

Dr. Aimee Dietle is an Assistant Professor of Pharmacy Practice on the Worcester Campus. She is a University of Connecticut Doctor of Pharmacy graduate and completed a PGY1 Community Pharmacy residency at Holyoke Health Center in Holyoke, MA. Her practice site is an Ambulatory Care setting at Holyoke Health Center. She has specific interests in Medication Therapy Management, Diabetes, and Cultural Competency.

Dr. Amy LaMothe is an Assistant Professor of Pharmacy Practice on the Worcester Campus. She is a MCPHS University-Worcester Doctor of Pharmacy graduate and completed a PGY1 Pharmacy Practice residency at Baystate Medical Center in Springfield, MA. Her practice site is an Ambulatory Care setting at Baystate Medical Center. She has specific interests in Heart Failure, Hypertension, and Pediatrics.

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Dr. Matthew Metcalf is an Assistant Professor of Medicinal Chemistry on the Worcester campus. After obtaining his Doctor of Pharmacy degree from the University of Maryland in 2002, he went on to pursue a Doctor of Philosophy degree from the same academic institution and finished in 2007. From 2007 to 2013, he was a Post-Doctoral Associate at the University of Minnesota College of Pharmacy. Dr. Metcalf is filling in for Dr. Chase Smith, who is on Military Leave. He will be teaching medicinal chemistry as well as a spring 2014 elective course.

Dr. Amanda Morrill is an Assistant Professor of Pharmacy Practice on the Manchester Campus. She is a University of Rhode Island Doctor of Pharmacy graduate and completed a PGY1 Pharmacy Practice residency at Elliot Hospital in Manchester, NH. She was most recently a staff pharmacist at the Lahey Hospital & Medical Center in Burlington, MA. Her practice site is an Ambulatory Care setting at the Veteran’s Administration Medical Center (Manchester, NH). She has specific interests in Anticoagulation, Hypertension, and Geriatrics.

Dr. Jennifer Towle is an Assistant Professor of Pharmacy Practice on the Manchester Campus. She is a MCPHS University-Manchester Doctor of Pharmacy graduate and completed a PGY1 Pharmacy Practice residency at Elliot Hospital in Manchester, NH. Her practice site is an Ambulatory Care setting in the Family Health Center at Concord Hospital (Concord, NH). She has specific interests in Medication Safety, Transitions in Care, and Ocular Disorders.

Pharmacy Journal of New England • Spring 2014

Publications

Poster Presentations

Assiri A, Al-majzoub O, Kanaan AO, Donovan JL, Silva M. Mixed treatment comparison meta-analysis of aspirin, warfarin, and new anticoagulants for stroke prevention in patients with nonvalvular atrial fibrillation.

Clinical Therapeutics. 2013;35(7):967-984.e2.

Abdulghani A, Zeineldin R. Releasing content of lipid drug delivery vehicles by immune-related molecules. The Second Cancer Nanotechnology Gordon Conference. July 2013. West Dover, VT.

Kearney KR. Impact of a service-learning course on firstyear pharmacy students’ learning outcomes. American Journal of Pharmacy Education. 2013; 77(2):Article 34.

Sitole M, Silva M, Spooner L, Comee MK, Malloy M. Telaprevir versus boceprevir in chronic hepatitis C: a metaanalysis of data from phase II and III trials. Clinical Therapeutics. 2013;35(2):190-197.

Szkiladz A, Carey K, Ackerbauer K, Heelon M, Friderici J, Kopcza K. Impact of pharmacy student and residentled discharge counseling on heart failure patients.

Journal of Pharmacy Practice. Epub 2013 Jun 24.

Singh A, Happel C, Manna SK, Acquaah-Mensah G, et al. Transcription factor NRF2 regulates miR-1 and miR-206 to drive tumorigenesis. The Journal of Clinical Investigation. 2013;123(7):2921-2934.

Carey K, Horton E, Attwood R, Cross J. Pharmacy Boot Camp: A longitudinal experience to improve pharmacy resident teaching skills. American Association of Colleges of Pharmacy (AACP) Annual Meeting. July 2013.

Chicago, IL. Coppenrath V, Morin A, Jarvis C, Cooper M, Belliveau P. Perceptions of a hybrid team-taught elective advanced pharmacy practice experience in academic pharmacy. AACP Annual Meeting. July 2013. Chicago, IL. Friel C, Bond I, Lahoz MR. Teaching health information literacy to middle school students. A community outreach project. 3rd Annual Community Engagement and Research Symposium, UMass Medical School, Worcester, MA. November 8, 2013.

Youkhanna J, Syoufjy J, Rhorer M, Oladeinde O, Zeineldin R. Towards nanotechnology-based solutions for a particular disease: Ovarian cancer as an example.

Nanotechnology Reviews. 2013; 2(4):473-484.

Ward C, Carey K, Cross J, Horton E, LaMothe A. Interventions and clinical effects on glycated hemoglobin and LDL values for high risk patients attending a pharmacotherapy clinic in an underserved community.

2013 American Society of Health-System Pharmacists Midyear Clinical.

Paper Presentations

Podium Presentations

Papers were presented by faculty members at the American Association of Colleges of Pharmacy (AACP) Annual Meeting on July 2013, Chicago, IL: Aungst TD. Evaluating mobile medical apps for utilization by pharmacy students.

Kearney K (Speaker), Coppenrath V (Moderator).

Lessons from Madonna: reinventing yourself in pharmacy practice – alternative pathways to faculty development.

Lahoz MR. Improving the health information literacy of older adults: A faculty-librarian collaboration to offer a community outreach APPE rotation.

Lahoz MR (Presenter), Evans P, Bond I. Enhancing the health information literacy skills of older adults.

American Public Health Association 141st Annual Meeting & Expo, Boston, MA. November 6, 2013.

Grant Awards Massey C, Evans P, Bartlett, D. Enhancing the health information literacy skills of older adults. American Public Health Association 141st Annual Meeting & Expo, Boston, MA. November 6, 2013.

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From the Colleges

continued

Massachusetts College of Pharmacy and Health Sciences – Boston Dear Colleagues, I hope that the New Year finds you well. I bring you greetings from President Charles F. Monahan and Provost Dr. Douglas Pisano.

The students enrolled in the School of Pharmacy Boston continue to excel in their academic success. I am happy to inform you that the PharmD class of 2013 as a group, scored higher than the national average on their NAPLEX exam. Our students are very committed and will serve our profession well. I would also like to acknowledge our faculty for making this possible and for their many other recent accomplishments which I have listed below.

Sincerely, Paul DiFrancesco, EdD Acting Dean

interact with fellows who are working at other companies.

This gives them an important industry network as well as information about the differences in the corporate cultures at other companies. The Biopharmaceutical Industry is always searching for better ways to increase their efficiency and lessons learned in one area of the industry may be applicable to other areas.

Recently the programs from Worcester/Manchester and Boston have been unified into one combined leadership structure to allow a more effective and effective administration between the three MCPHS campuses.

MCPHS University at ASHP Midyear MCPHS University Boston was well represented at the ASHP Midyear Clinical Meeting in Orlando, Florida that took place December 7-12, 2013. Boston faculty and students presented a total of 68 poster presentations.

PharmD Industry Fellowship Program Last year, MCPHS University started a post graduate PharmD Industry Fellowship Program out of the Worcester campus serving one of the local growing Biotech companies. The program components include multiple rotations spent at the company site and scholarly activities at the University. The objective of the twoyear program is to allow PharmD graduates to explore the various disciplines for possible employment within the Biopharmaceutical Industry and to continue their educational activities. The post-graduate Industry PharmD Fellowship Program at MCPHS is the largest program in New England and one of the top programs in the country.

Some of the benefits of the program, in addition to the ones previously mentioned, is the ability of the Fellows to

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Pictured in front of one poster are (L to R); Michael Carvalho, Professor and Chair of the Department of Pharmacy Practice; Mary Amato, Associate Professor, Caroline Zeind, Associate Provost for Academic Affairs, and Jennifer Goldman-Levine, Professor.

Pharmacy Journal of New England • Spring 2014

From the Massachusetts General Hospital Program are pictured (L to R): Trisha LaPointe, Barbara Irby, Abrar Thabit, Christopher Lyman, Danielle Evans, Yana Bukovskaya, Yvonne LeBlanc, and Yin Wong.

New England Regional Residency/ Fellowship Showcase The MCPHS University ASHP Student Chapter-Boston along with chapter advisor, Trisha LaPointe, hosted the annual New England Regional Residency/Fellowship Showcase on November 7, 2013. The showcase was a huge success this year with over 230 pharmacy students from all over the Northeast attending; 43 residency programs and 10 fellowship programs participated.

Other News

Kara Bonaceto, PharmD and Cathy Simonian, PharmD provided a CE program for Cape Cod Healthcare at Falmouth Hospital on November 7, 2013. Kara delivered “Delirium and the Elderly: The Pharmacist’s Role in Prevention and Management” and Cathy presented “Pre-Advanced Pharmacy Practice Experience Core Competencies”. The program was attended by 30 pharmacists practicing in the Community and Hospital settings.

Lisa Padgett, PharmD and Rita Morelli, PharmD, both earned their Board Certification in Ambulatory Care Pharmacy. In addition, Rita received an MTM certificate with a focus on patients with Diabetes.

Kara Bonaceto, PharmD and Cathy Simonian, PharmD, provided a CE program for Cape Cod Healthcare at Falmouth Hospital on November 7, 2013. Kara delivered “Delirium and the Elderly: The Pharmacist’s Role in Prevention and Management” and Cathy presented “Pre-Advanced Pharmacy Practice Experience Core Competencies”. The program was attended by 30 pharmacists practicing in the Community and Hospital settings.

Lisa Padgett, PharmD and Rita Morelli, PharmD, both earned their Board Certification in Ambulatory Care Pharmacy. In addition, Rita received an MTM certificate with a focus on patients with Diabetes.

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From the Colleges

continued

URI College of Pharmacy Tom and Cathy Ryan Donate $15 million to University of Rhode Island to Establish Neuroscience Research Institute URI College of Pharmacy alumnus has lengthy record of giving to alma mater With the largest private donation in its history, the University of Rhode Island will establish a neuroscience research institute named for the parents of Thomas M. Ryan, a 1975 College of Pharmacy graduate of the University and former chairman, president and CEO of CVS Caremark. Tom and his wife Cathy have donated $15 million to establish the George & Anne Ryan Institute for Neuroscience at the University of Rhode Island.

“The Ryan Institute will elevate the visibility of the groundbreaking research taking place here in Rhode Island and position URI as a leader in neuroscience research and the treatment of neurodegenerative and neurological diseases,” said URI President David M. Dooley. “We are tremendously grateful to Tom and Cathy Ryan and the Ryan family for their foresight and continued generosity.

They have created an enduring legacy and made a truly transformational gift.”

“When I retired from CVS two years ago,” said Ryan, “we had conversations about what the family foundation would focus on and we decided to focus on education and health care. I had some discussions with President Dooley because, although I had given back to the University, I wanted to give to something that was more transformational, more lasting, really a future gift.”

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The Ryan Institute will focus its research, teaching, and outreach on neurodegenerative diseases and disorders, like Alzheimer’s, Parkinson’s and ALS. It will draw on the expertise of more than 30 scientists from across the University who have been studying brain disorders and diseases from multiple perspectives and disciplines.

The faculty – from pharmacy, engineering, psychology, chemistry, communicative disorders and more – participate in the University’s Interdisciplinary Neuroscience Program, established in 2011 to conduct innovative neuroscience research and offer master’s and doctoral degrees.

The Ryan Institute will be a magnet to attract people and engage them in solving some of the most pressing health care challenges we face in society – neurodegenerative diseases. This gift enables the University to attract leading researchers and train new generations of scientists to work on these problems. The Institute will collaborate with other state, regional and national entities to develop and deliver treatments for central nervous system disorders.

The University has unique research strengths in pharmacology/drug discovery, neuroengineering, and neuropsychology. To maximize statewide efforts in neuroscience, the Ryan Institute will stimulate cooperation among other institutions in Rhode Island, including the well-established neuroscience program at Brown University, the basic research programs of the Brown Institute for Brain Science, the newly formed Norman Prince Neurosciences Institute at Rhode Island Hospital that focuses on clinical neuroscience, and the U.S. Department of Veterans Affairs.

With more than 600 types of neurological disorders, the World Health Organization estimates that one in three Americans will suffer from a neurological disorder in their lifetime. Alzheimer’s disease alone cost the United States as much as $200 billion per year in direct and indirect health care expenses.

Pharmacy Journal of New England • Spring 2014

“When you look at what’s happening around the world with ALS, autism, epilepsy, Parkinson’s and Alzheimer’s, it’s truly an epidemic,” said Ryan. “As the population ages, not only in the U.S., but globally, it’s going to get worse.

“On a personal level, my dad retired at a young age, was extremely healthy, rock-solid, kind of bigger than life guy – and he had a stroke and then subsequent Alzheimer’s. I saw what it did to him, what it did to my mother, and our family.

The economic costs are one thing, but the personal, emotional costs are another. It steals memories. It saddles caregivers. I saw my mom’s health go down. I had colleagues at CVS pass away from ALS. So it hit close to home for us and – once we did the due diligence and saw what was going on at URI – it was a natural fit.“ “In addition to helping ease the suffering of millions of people around the globe, the George & Anne Ryan Institute for Neuroscience will contribute significantly to economic development in Rhode Island by creating a vibrant environment for the expansion of basic biomedical research and clinical practice in neuroscience,” Governor Lincoln D. Chafee said.

Seeking new treatments and therapies for disorders of the nervous system are also among the top priorities of federal funding agencies.

“Neuroscience is one of the last scientific frontiers where fundamental discoveries can still be made,” said Nasser Zawia, a professor of pharmacology and toxicology, director of the University’s Interdisciplinary Neuroscience Program and dean of the Graduate School. “This investment could not have come at a more opportune time.

Over the last decade or so there have been major advances in our understanding of the brain that have allowed for innovative therapeutic solutions and treatments not possible with our previous limited knowledge.”

This year, a national strategy to address these disorders was under discussion in Congress, the White House Office of Science and Technology Policy named its first coordinator of neuroscience research, the Obama administration unveiled a $100 million brain mapping initiative, and the Society for Neuroscience described the coming years as “a period of breakthrough discovery in brain science,” in which the field is “poised to make revolutionary advances.”

“A gift of this magnitude is truly historic for URI both in size and potential impact,” said Michael Smith, president of the URI Foundation. “This level of investment is truly transformational in nature in that it has the ability to make a significant impact, and to elevate and distinguish the important work being done in this area. This gift also makes an important statement about the Ryans’ faith in URI and its leadership, and about the affinity our alumni have for their alma mater. We are truly grateful.”

Ryan noted that, “If we do it right and we work together and we increase research dollars, get more faculty, more money in the state, find some cures, some breakthroughs, the economic development will follow. But, we’re not doing this for economic development, we’re doing this to try to solve a major problem in this country. And if we do that and do it better than anybody else, we will become the center of excellence, and I think that’s the ultimate goal.

“It’s just the right thing to do, and we think it’s going to make a difference; not only for URI, but for the state, and ultimately – for society.”

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Continuing Education for Pharmacists Treating Head Lice – Primer for the Community Pharmacist By: Maria A. Summa, PharmD, BCPS Associate Professor, University of Saint Joseph School of Pharmacy 0106-0000-14-005-H04-P (1 CEU Hour)

Learning Objectives: 1| Describe the clinical presentation of head lice infestation.

2| Identify the stages of the louse life cycle including factors affecting egg viability.

3| Apply patient specific information and knowledge of mechanism of action/resistance to recommend optimal head lice treatments.

4| Provide counseling to patients on head lice therapies to promote their safe and optimal use.

5| Describe effective environmental control strategies to reduce transmission of head lice.

Description of the Condition: Infestations with head lice (pediculus humanis capitis) occur in all countries of the world within all socioeconomic classes. In the United States, children aged 3-12 years and their household contacts and caretakers are most commonly affected, with infections occurring in an estimated 6-12 million patients annually. Although infection rates are not significantly affected by hair length, cleanliness, or frequency of grooming, infections are more common in girls, likely due to higher predilection for head-to-head contact. Head lice are not known to transmit disease to humans and infestations are not a sign of poor hygiene or related to the cleanliness of one’s home or school environment, however infestations are a noteworthy cause of excess days lost from school and work.1

Biology and Life Cycle: Human head lice are ectoparasites, meaning that they live on the body of their host. Head lice are normally found on the scalp but may also been discovered in the eyebrows of an infested individual. The adult head louse is generally caramel to greyish white in appearance and is about 1-3 mm in length – close to the size of a sesame seed. Lice have six front legs but do not have wings or back legs, accordingly they are unable to fly or jump and move only by crawling. At the end of each leg is a sharp claw that is adapted for feeding and clinging to hair.

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Lice are obligatory blood-feeders, requiring their host’s blood approximately five times each day. Lice feed by piercing the skin with their claws, injecting saliva, and sucking blood.2 The louse life cycle (from egg to egg) occurs entirely on the human head and is approximately 1 month in duration. Once mature, females lay 6-10 eggs (nits) per day. Eggs are laid within 1cm of the scalp with a gluelike substance that cements the egg casing to a single hair shaft. Viable eggs possess an eye spot which reflects a developed nervous system.3 Eggs can be most easily visualized at the base of the hairline, behind the ears, or at the crown of the head. Viable eggs that have been deposited within 1cm of the scalp hatch within 8-10 days, depending on the ambient temperature. Once hatched, the louse goes through three nymph stages over the next 9-12 days before maturing to the point where mating is possible and new adult females can begin laying eggs. Empty egg casings turn white and are easier to visualize against darker hair. These empty casings may remain attached to the hair shaft long after successful treatment for live lice infestations, unless removed manually.1

Clinical Presentation: Intense scalp pruritus is a common complaint in those who present with head lice, and some patients describe a tickling sensation in the hair. Lice feed by injecting saliva into the host’s head and sucking blood often during the day. Their saliva has vasodilatory and anticoagulant properties and can induce a delayed hypersensitivity reaction in a previously uninfected host. Scalp itching can occur within 2-6 weeks after the first exposure and sooner in previously sensitized hosts. While head lice are not known to transmit disease, scratching can lead to secondary bacterial infections and lymph node enlargement of the upper posterior neck.4 Long-standing infestations have been rarely associated with iron deficiency anemia.5 Sleeping difficulties have also been reported in untreated patients.6

Pharmacy Journal of New England • Spring 2014

Transmission: Transmission of head lice requires close head-to-head contact since lice move only by crawling. It has been estimated that at least 30 seconds of head-to-head contact are required for lice to move from one head to another, although lice do not appear to voluntarily leave their host’s head unless it is over-crowded.7 Indirect spread (from combs, hats, carpets and bed linens), or fomite transmission of head lice, is much less common, although theoretically possible since adult lice can live for about a day away from their blood supply.

Diagnosis: The American Academy of Pediatrics recommends finding at least one live louse on the head as criteria for an active head lice infestation.8 Live lice can be challenging to locate, but visualization can be improved by using a magnifying lens under a bright light and combing sections of the hair with a fine-toothed comb.9 Finding eggs (nits) alone is not enough to diagnose a current infestation as eggs may remain cemented to the hair shaft long after successful treatment. When live lice are found, household contacts of the affected individual should be examined for evidence of active infestation. Treatment should occur when live lice are found on the head.

Pharmacologic Treatment Options: Pharmacologic treatments for head lice presently include agents that are neurotoxic to the louse or those that impair louse respiration. Optimal treatment options are those that kill both adult lice (pediculocidal) and viable eggs (ovicidal), have low prevalence of resistance, and are safe to the host. Most available lice treatments are pediculocidal but less reliably ovicidal, thus requiring repeat treatment synchronized on the lice life cycle, for complete eradication of newly hatched nymphs. Clinical evidence for resistance to insecticide-based lice treatments (permethrin, pyrethrins, malathion, and lindane) continues to accumulate worldwide which has prompted research into new treatment strategies.10-12 In the United States, FDA-approved pharmacologic options to treat active lice infestation include benzyl alcohol, ivermectin, lindane, malathion, permethrin, pyrethrins/piperonyl butoxide, and spinosad [Table 1].

Pyrethrins (0.33%) plus piperonyl butoxide (4%); Permethrin (1%) Permethrin and pyrethrins are the two non-prescription pediculocides available in the United States. Pyrethrins are naturally occurring extracts of the chrysanthemum, while permethrin is synthetic. Piperonyl butoxide extends the action of pyrethrins by preventing the louse from catabolizing the insecticide. Both permethrin and pyrethrins are neurotoxic to the louse, lowering the action potential at voltage-gated sodium channels, which results in paralysis through hyperstimulation of the nervous system and the inability to feed.13,14 Since their introduction onto the market decades ago, efficacy rates for permethrin and pyrethrins have waned significantly. In 2001, investigators reported a 79.5% cure rate at Day 14 after treatment with 1% permethrin cream in 39 subjects.15 By 2007, 50% cure rates at Day 14 were reported after the same therapy in 10 subjects.16 Exact mechanisms by which lice achieve resistance to the pyrethroids are a subject of continued debate. It is prudent to assume that treatment failures are due to resistance if live lice are persistent after two appropriately administered applications of permethrin or pyrethrins.12 Keeping local resistance patterns in mind, permethrin 1% cream is a first-line drug of choice for pediculosis affecting patients aged 2 months and older owing to its low mammalian toxicity and ease of access. The product should be applied to towel-dried hair that has just been shampooed with a non-silicone-based shampoo, left on for 10 minutes, and then rinsed off with water. Patients should be counseled to use enough of the product to saturate the hair and to avoid re-washing the hair for 48 hours as permethrin can have residual effects on nymphs that emerge during this time period. As many commercial shampoos contain silicone-based additives, the post-application effect of permethrin may be decreased. The manufacturer advises a repeat application at Day 7 to eradicate any newly hatched lice but newer recommendations suggest that routine re-treatment at Day 9 is optimal.8 The concomitant use of a lice comb after each treatment application is also recommended.

Permethrin has an established record of safety but may cause local skin irritation in some patients.

Pyrethrins (0.33%) with piperonyl butoxide (4%) is available in shampoo or mousse formulations and is indicated for use in patients aged 2 years or older.

Pyrethrins have a low human toxicity profile when used according to dosage recommendations but labels 39

Continuing Education for Pharmacists continued warn against their use in patients with allergies to chrysanthemums or serious reactions to ragweed.

Pyrethrins are applied to dry hair, in an amount to sufficiently saturate the hair, left on for 10 minutes, and then rinsed. The concomitant use of a lice comb is also recommended. Unlike permethrin, pyrethrins have no known residual effect on emerging nymphs after the hair is rinsed. Newly laid eggs do not contain an intact nervous system and are not affected by the neurotoxic mode of action. A second treatment is required to kill nymphs that emerge from the 20-30% of eggs that remain viable after the first treatment application. As with permethrin, re-treatment at Day 9 is optimal.

Malathion (0.5%) Malathion is an organophosphate-based insecticide that binds irreversibly to acetylcholinesterase and causes respiratory failure in the louse. After being twice removed from the US market for poor sales secondary to prolonged application time, odor, and flammability, a reformulated 0.5% malathion lotion was introduced in 1999, providing an option for the treatment of head lice with suspected resistance to pyrethroids. Unlike preparations available in other countries, the US version of malathion lotion (OvideÂŽ) is formulated in a vehicle of 78% isopropyl alcohol, terpineol, dipentene, and pine needle oil. The vehicle itself is thought to have pediculocidal effects.

This, in addition to malathion’s lack of continuous use, may explain why head lice seem to have developed less resistance to malathion in the US when compared to countries like the UK where resistance is widespread.12 In the US, reported malathion efficacy rates for OvideŽ remain high, ranging from 98-100% effective at Day 14.17,18 Malathion is indicated for use in patients aged 6 years and older, although the American Academy of Pediatrics recommends that malathion may be used in patients as young as 2 years of age as long as safe use can be assured.8 The product should be applied to dry hair for 8-12 hours, typically overnight where the hair is allowed to air dry. As the vehicle is highly flammable, patients/parents should be counseled not to use hair dryers, curling irons

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or flat irons, or smoke near the hair while it is wet. After the recommended application time, the hair should be shampooed. Malathion does have ovicidal activity and one application is generally sufficient for most infestations. A second application is recommended in 7-9 days only if live lice are visualized. Reduced malathion application times and novel malathion formulations have been proposed, but to date the only FDA-approved version of malathion is the 0.5% lotion labeled for the prolonged application time.17,18 Adverse drug reactions include stinging and scalp irritation.19 Lindane (1%) Lindane is an organochloride that was first introduced in the 1950s and became the most widely used pediculocide in the US before the arrival of the pyrethroids. Lindane acts on the gamma-aminobutyric acid-gated chloride channel and causes louse death through central nervous system overstimulation. Worldwide resistance to lindane has been reported and the drug has very low ovicidal activity, with 30-50% of eggs remaining viable after use. Efficacy rates for 3 hours of exposure to one percent lindane shampoo ranged between 17-61% in the 1980s.20 Lindane is lipophilic, and thereby has the potential to accumulate in mammalian adipose tissues, the human placenta, and breast milk. Lindane use been associated with CNS toxicity in humans, ranging from dizziness to seizures. Deaths associated with lindane use, due to inappropriate topical administration or oral ingestion, have also been reported. For these reasons, lindane should only be used with extreme caution in otherwise healthy adults whose head lice infestations have failed to respond to first-line treatments or when firstline treatments are not tolerated.21 Lindane should be avoided in children and adults weighing less than 50kg, older adults, patients with HIV infection or those that take medications known to lower the seizure threshold.

Lindane is classified as pregnancy category C but its use in pregnant women is questionable given the potential for serious adverse effects to the developing fetus and the availability of safer products.22

Pharmacy Journal of New England • Spring 2014

Concerns about drinking water contamination and effects on wildlife led to a 2002 ban on lindane use in California.23 In 2009, the Michigan House of Representatives passed restrictions on the use of lindane.24 Elsewhere in the US, lindane remains available by prescription as a 1% shampoo. Dispensing is limited to a quantity of 60ml to reduce the potential for patients to apply more than necessary or to re-apply. Lindane is also available as a 1% lotion, but that product is indicated for scabies. Medication guides must be dispensed with each new prescription. Patients should be counseled to apply lindane shampoo to dry hair without adding water. After working thoroughly through the hair, the product should be left on for only 4 minutes, and then all of the lather should be rinsed away. The patient should avoid unnecessary contact with other body surfaces. Post-application itching is common, but re-application is not indicated.

Benzyl alcohol (5%) In 2009, 5% benzyl alcohol lotion, in a mineral oil vehicle, was approved for the treatment of head lice in patients aged 6 months and older. In pre-marketing trials describing its use versus placebo in 255 patients, two benzyl alcohol treatments applied weekly for two weeks eliminated all live lice in approximately 75% of subjects fourteen days after the second application. While benzyl alcohol has no ovicidal activity, exposed lice lose the ability to close their respiratory spiracles. The mineral oil vehicle then obstructs louse airways and causes suffocation.

Resistance to the drug has not yet been reported, nor is resistance expected to develop due to the unique mechanism of action.25 Patients should be counseled to apply the product to dry hair for 10 minutes then rinse.

Since benzyl alcohol is not ovicidal, the treatment must be repeated 7 days later, although consideration to retreating in 9 days is likely optimal as with other non-ovicidal therapies.8 Each treatment should be used in conjunction with lice comb. Prescribers should be made aware that dosing is dependent on hair length and the prescription should allow for a sufficient quantity of the product for the two required applications. Accordingly, the cost of therapy can become excessive for those with longer hair [Table 1]. The most common adverse drug reactions include eye irritation and contact dermatitis. Benzyl alcohol 5% lotion may be used in pregnant and lactating women.

Spinosad (0.9%) Spinosad topical suspension was approved for the treatment of head lice infestations in patients 4 years and older in 2011. Spinosad is a naturally occurring insecticide identified in soil with activity against a wide range of pests.

Spinosad interferes with nicotinic acetylcholine receptors and gamma-aminobutyric acid-gated ion channels in lice and nit embryos, producing neuronal hyperstimulation and death by eventual paralysis.26,27 Although spinosad is not immediately fatal to lice eggs without a developed nervous system, it has been postulated that the drug is ovicidal at all stages because it penetrates eggs without being metabolized, thus being available for effect when nervous system development has occurred.28 The efficacy of spinosad 0.9% suspension was compared to permethrin 1% crème rinse in two superiority trials representative of almost 950 subjects found in nearly 400 households. Households were randomly assigned to either pharmacologic treatment option and followed for eradication of head lice 14 days after one or two treatments. A subset of spinosad-assigned patients was further assigned to perform wet combing after the treatment application, but this data was not included in the efficacy analyses. All permethrin-assigned subjects followed package labeling, which recommends wet combing. In both studies, the percent of patients assigned to spinosad without combing who were lice-free 14 days after the last treatment was significantly higher than those assigned to permethrin with combing (84.6% vs 44.9% and 86.7% vs 42.9%, respectively). Seventy-five percent of those treated with spinosad required only 1 treatment application for a cure, compared with 37% in the permethrin group.29 These data suggest that one application of spinosad is sufficient for most patients.

As spinosad is pediculocidal and ovicidal in all stages, nit combing is not required, although it may still be recommended for aesthetic reasons or to decrease diagnostic confusion.

In the two trials that compared spinosad and permethrin, no serious adverse events were reported for either group. Spinosad was associated with less application-site erythema. The most commonly reported adverse effects are eye and scalp irritation. Spinosad 0.9% should be applied to dry hair for 10 minutes then rinsed. A repeat treatment course is indicated in 7 days if live lice are present. At this time there are no published reports of spinosad-resistant lice. Cost may be a barrier to treatment for cash-paying patients. Insurance plans may not cover it or may require prior authorization.

41

Continuing Education for Pharmacists continued Ivermectin (0.5%) Oral ivermectin has been long used to treat parasitic infections including scabies, onchocerciasis, and strongyloidiasis. The drug has been used off-label for head lice not eradicated by topical pediculocides in doses of 200-400mcg/kg as one or two doses on Day 1 and 8-10, although concerns of systemic toxicity in young children exist.8,30 Ivermectin interferes with the glutamate-gated or gamma-aminobutyric acid-gated chloride channels causing an influx of chloride ions across neuronal pathways leading to paralysis and eventual death of the louse. Topical ivermectin lotion, in a formulation including shea butter and olive oil to improve emollience, was approved in February 2012 for head lice in those aged 6 months and older. Pooled data from two randomized trials encompassing patients from 289 households (765 patients) showed that a single application of topical ivermectin was superior to placebo in eradicating head lice. The youngest child in the household was considered the index patient and household members found with three or more live lice were also enrolled. Both the active and placebo lotion were applied once to dry hair, left on for 10 minutes, and then rinsed with water. Lice combing was not allowed in either trial. At Day 14, 79% of ivermectin-treated patients were lice-free compared to 22% of those receiving a placebo application. There were no significant differences in the incidence or severity of adverse effects between groups. The most common adverse effects in ivermectin-treated patients included conjunctivitis, ocular hyperemia, and scalp irritation.31 While ivermectin is not directly ovicidal, in vitro data suggest that topical ivermectin is toxic to emerging louse nymphs by affecting their ability to feed after hatching, and this may explain the drug’s high eradication rate after a single application.32 Emerging resistance to oral ivermectin has been seen in onchoceriasis-endemic countries, but to date, head lice resistance to topical ivermectin has not been reported.33 As with spinosad, cost may reduce access to this product for cash-paying patients. Insurance plans may not cover it or may require prior authorization.

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Non-Pharmacologic Treatment Options: Non-pharmacologic treatment options purported for use in head lice infestation include essential oils, suffocationbased occlusive agents, desiccants, and manual removal (e.g., nit-picking).

Essential oils and occlusive agents Suffocation-based occlusive agents that have been described in head lice infestation include CetaphilÂŽ skin cleanser, mayonnaise, and petrolatum. Petrolatum and mayonnaise have not been evaluated in clinical trials for efficacy in head lice infestation. Additionally, petrolatum can be challenging to remove from the hair and mayonnaise can serve as a medium for bacterial growth if not removed appropriately from the scalp.

CetaphilÂŽ skin cleanser was evaluated for efficacy in 133 patients with difficult to treat head lice. Subjects applied the lotion to the scalp, combed it out after two minutes, dried the remaining product into the hair with a handheld hair dryer, and then shampooed the lotion out after a minimum of 8 hours. Eradication rates of 95% were reported, although the trial has been criticized for its lack of blinding, randomization, or control group.34 The essential oils melaleuca (tea tree oil) plus lavender oil and coconut oil plus anise oil have been studied for their utility in head lice infestations. Coconut plus anise oil spray was found to be more effective than permethrin 0.43% alcoholic lotion for head lice infestation based on a randomized trial in 100 patients aged 2-49 years, but it has not been studied against the more commonly used 1% concentration of permethrin.35 In a trial out of Australia, 98% of subjects randomized to three applications of 10% tea tree oil plus 1% lavender oil (Days 0, 7, and 14) were lice-free at 1-day after the final treatment compared to 33% in those treated with two applications of pyrethrins and piperonyl butoxide mousse (Day 0 and 7), and 100% of subjects randomized to three applications of a benzyl-alcohol based therapy (Day 0, 7, and 14). Lice combing was not done in any of the groups. Based on the louse life cycle, retreatment with the pyrethrin-based comparator

Pharmacy Journal of New England • Spring 2014

at Day 9 and adjunctive lice combing, may have altered efficacy rates in that treatment arm. Adverse events reported for the melaleuca (tea tree oil) plus lavender oil arm included stinging of the eyes and neck and erythema of the skin.36 Both lavender oil and tea tree oil have been associated with negative pharmacologic effects with repeated exposures.37 The safety and efficacy of melaleuca (tea tree oil) plus lavender oil or coconut oil plus anise oil have not been evaluated by the Food and Drug Administration, nor are herbal products regulated in the same way as prescription products. Patients should be made aware of the potential for variability in the constitution of available products which may affect their efficacy.

Desiccation Desiccation has been purported as a means of killing lice and their eggs. Lice are believed susceptible to this method because of their small size and flattened shape. Hot air, applied for a single, 30-minute treatment using a custombuilt hair dryer (AirAllé™, formally called LouseBuster) killed 95% of adult lice and eggs in a study involving 56 subjects. Operators require special training on its use and commercially-available blow dryers are not considering an appropriate substitute.38 Manual Nit Removal Data evaluating manual nit removal as an alternative to pediculocidal therapies are limited and inconsistent. Lice combs, combs with fine teeth (0.2-0.3mm apart) to trap lice and eggs, are however, a recommended adjunct to most pharmacologic pediculocidal therapies, particularly for removing those eggs within 1cm of the scalp [Table 1].

Manual nit removal can also be considered an alternative for children that are not candidates for pediculocidal therapy based on age. Nit removal is tedious and timeconsuming. The National Pediculosis Association has several informative videos that may be useful in assisting parents and caregivers to follow proper manual nit removal techniques.39 Acetic acid-containing products, which have been purported to ease with nit removal, are readily available to consumers but their efficacy has not been systematically evaluated in clinical trials.8

Environmental Controls and Policies: Indirect spread, or fomite transmission of head lice, is theoretically possible, but believed to be much less common than direct head-to-head contact. Cleaning items that have been that have been in contact with the head of an infested individual in the 24-48 hours preceding diagnosis, such as pillowcases, hair care items, and headgear, is a reasonable environmental control measure.

Stray lice and nits can be eradicated by washing or soaking these items in water above 130ºF or drying them at a similar temperature for a period of 5-10 minutes.

Items that cannot be washed or dried may be vacuumed or bagged for a period of 2 weeks, although it is rare that an adult louse, nymph, or egg would continue to be viable after such a long period away from the warmth and blood supply of the human head. Fumigant sprays or other chemical environmental decontamination methods are not recommended.8 While school-aged children should be taught not to share personal care items, clothing, or hats, neither excluding children from school during a confirmed lice outbreak or routine school-wide screening are effective as preventative measures. Additionally, since nits may remain on the hair long after successful treatment of the active infestation, “no-nit” policies are discouraged by the American Academy of Pediatrics and the National Association of School Nurses. In the school setting, after appropriate treatment with a pediculocide, parents and caregivers may consider removing nits, particularly those within 1cm of the scalp, to decrease diagnostic confusion and for aesthetic reasons.8

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Continuing Education for Pharmacists continued Initiating Treatment:

Key Points:

Unless resistance has been demonstrated in the community, permethrin (1%) or pyrethrins (0.33%) plus piperonyl butoxide (4%) are used first-line for active head lice infestations. Permethrin is the treatment of choice for those as young as 2 months of age, while pyrethrins may be used in those two years of age and older. Repeat application at Day 9 and use of a lice comb after each treatment is recommended. If resistance to first-line agents has been demonstrated, benzyl alcohol can be used in patients six months of age and older, while malathion can be considered for those ages six years and older.

Benzyl alcohol requires two applications and use of a lice comb. A repeat application of malathion on days 7-9 is recommended only if live lice are seen. Topical spinosad and ivermectin represent the most recent additions to the arsenal against head lice, and can be recommended as second-line agents in patients aged 4 years or older and aged 6 months and older, respectively. Both are indicated for one-dose treatment, although a repeat application of spinosad may be applied if live lice are present at Day 7.

Extensive nit combing is less likely to be required with spinosad due its ovicidal qualities and ivermectin given its nymphicidal mechanism of action. Preferred treatments for patients who are pregnant include permethrin, benzyl alchohol, and spinosad.

No one pediculocide is 100% effective in all situations.

Neurotoxic insecticides, particularly permethrin, pyrethrins, and lindane have a higher prevalence of resistance. Permethrin and pyrethrins are still considered first-line unless local resistance patterns preclude their use, in which case malathion can be considered as a second-line agent in patients aged 6 years and older. If patients are deterred by malathion’s long application time, other second-line options include benzyl alcohol (ages 6 months and up), spinosad (ages 4 and up), or topical ivermectin (ages 6 months and up). Cost of therapy and local coverage determinations may further guide the choice of therapy for particular patients. Removal of viable eggs or repeat pediculocide application timed on the lice life cycle as indicated for non-ovicidal therapies is important to prevent reinfestation. Fomite transmission is a theoretical concern but extraordinary environmental cleaning measures are not indicated given the reduced louse lifespan away from its blood supply. It is prudent to wash pillowcases and objects that have directly touched the hair of an infested individual in the 24-48 hours preceding diagnosis. “No-nit� policies for return to school should be discouraged as only adult lice are transmitted between close contacts.

Save the Dates 10th Annual New England Pharmacists Convention October 23 & 24, 2014 at the MGM Grand Hotel, Foxwoods Casino in Connecticut

44

Pharmacy Journal of New England • Spring 2014

References:

21. Nolan K, Kamrath J, Levitt J. Lindane toxicity: a comprehensive review of the literature. Pediatr Dermatol 2012; 29: 141-146.

1. Centers for Disease Control and Prevention. Parasites - Lice - Head lice: Resources for health professionals. 2013. http://www.cdc.gov/parasites/lice/ head/index.html. Accessed February 9, 2014.

22. Product information. Lindane lotion. Morton Grove, IL: Morton Grove Pharmaceuticals Inc., September 2009.

2. Habif, Thomas P. “Infestations and Bites.” Clinical Dermatology: A Color Guide to Diagnosis and Therapy. [Edinburgh]: Mosby, 2010. pp. 590-94.

23. Humphreys EH, Janssen S, Heil A et al. Outcomes of the California ban on pharmaceutical lindane: clinical and ecological impacts. Environ Health Perspect 2008; 116: 297-302.

3. Lebwohl M, Clark L, Levitt J. Therapy for head lice based on life cycle, resistance, and safety considerations. Pediatrics 2007; 119(5): 965-974.

4. Tebruegge M, Pantazidou A, Curtis N. What’s bugging you? An update on the treatment of head lice infestation. Arch Dis Child Edu Pract Ed. 2011; 96(1): 2-8.

5. Guss DA, Keonig M, Castillo EM. Severe iron deficiency anemia and lice infestation. J Emerg Med. 2011; 41(4): 362-4.

6. Mumcuoglu KY, Klaus S, Kafka D, et al. Clinical observations related to head lice infestation. Journal of the American Academy of Dermatology. 1991; 25: 248251.

7. Burgess IF. Treatment of head lice. Maternal and Child Health 1996; June: 142-6.

8. Frankowski BL, Bocchini JA. Head lice. Pediatrics 2010; 126(2): 392-403.

9. Jahnke C, Bauer E, Henngge UR, Feidmeier H. Accuracy of diagnosis of pediculosis capitis: visual inspection versus wet combing. Arch Dermatol 2009; 145(3): 341-348.

10. Burgess IF. Current treatments for pediculosis capitis. Curr Opin Infect Dis 2009; 22: 131-136.

11. Downs AMR, Stafford KA, Harvey I, Coles GC. Evidence for doubleresistance to permethrin and malathion in head lice. Br J Dermatol 1999; 141: 508-11.

12. Durand R, Bouvresse S, Berdjane Z, Izri A, Chosidow O, Clark JM. Insecticide resistance in head lice: clinical, parasitological, and genetic aspects. Clin Microbiol Infect 2012; 18: 338-344.

13. Product information. RID® (piperonyl butoxide/pyrethrum extract). Morristown, NJ: Bayer Healthcare, LLC, January 2011.

14. Product information. NIX® (permethrin). Langhorne, PA: Insight Pharmaceuticals Corp., June 2009.

15. Hipolito RB, Mallorca FG, Zuniga-Macaraig ZO, Apolinario PC, WheelerSherman J. Head lice infestation: single drug versus combination therapy with one percent permethrin and trimethoprim/sulfamethoxazole. Pediatrics 2001; 107: E30 16. Meinking TL, Vicaria M, Eyerdam DH, Villar ME, Reyna S, Suarez G. A randomized, investigator-blinded, time-ranging study of the comparative efficacy of 0.5% malathion gel versus Ovide® lotion (0.5% malathion) or Nix® Creme Rinse (1% permethrin) used as labeled, for the treatment of head lice. Pediatr Dermatol 2007; 24: 405–411 17. Meinking TL, Vicaria M, Eyerdam DH et al. Efficacy of a reduced application time of Ovide® lotion (0.5% malathion) compared to Nix® Crème Rinse (1% permethrin) for the treatment of head lice. Pediatr Dermatol 2004; 21: 670-674.

18. Meinking, TL, Vicaria M, Eyerdam DH, Villar ME, Reyna S and Suarez G. A randomized, investigator-blinded, time-ranging study of the comparative efficacy of 0.5% malathion gel versus Ovide® lotion (0.5% malathion) or Nix® Crème Rinse (1% permethrin) used a labeled for the treatment of head lice. Pediatr Dermatol 2007; 24: 405-411.

19. Product information. Ovide (malathion). Hawthorne, NY. Taro Pharmaceuticals, November 2011.

20. Meinking TL, Serrano L, Hard B et al. Comparative in vitro pediculicidal efficacy of treatments in a resistant head lice population in the United States. Arch Dermatol 2002; 138: 220–224

24. Michigan Legislature – House Bill 4402. 2009. Available at: http://www.legislature.mi.gov/(S(meqooe45tyu1ymj22jt1bw2t))/mileg.aspx?page=getObject&objec tName=2009-HB-4402. Accessed February 9, 2014.

25. Meinking TL, Villar ME, Vicaria M et al. The clinical trials supporting benzyl alcohol lotion 5% (Ulesfia™): a safe and effective topical treatment for head lice (pediculosis humanis capitis). Ped Dermatol 2010; 27: 19-24.

26. McCormack PL. Spinosad: in peduculosis capitis. Am J Clin Dermatol 2011; 12: 349-353.

27. Cole SW, Lundquist LM. Spinosad for treatment of head lice infestation. Ann Pharmacother 2011; 45: 954-959.

28. Villegas SC. Spinosad for the treatment of head lice infestations. Drugs Today 2012; 48:595-599.

29. Stough D, Shellabarger S, Quiring J, Gabrielsen, AA. Efficacy and safety of spinosad and permethrin crème rinses for pediculosis capitis (head lice). Pediatrics 2009; 124: e389-e395.

30. Chosidow O, Giraudeau B, Cottrell J et al. Oral ivermectin versus malathion lotion for difficult-to-treat head lice. N Eng J Med 2010; 362: 896-905.

31. Parisher DM, Meinking TL, Bell M, Ryan W. Topical 0.5% ivermectin for the treatment of head lice. N Eng J Med 2012; 367: 1687-1693.

32. Strycharz JP, Berge NM, Alves AM, Clark JM. Ivermectin acts as a posteclosion nymphicide by reducing blood feeding of human head lice that hatched from treated eggs. J Med Entomol 2011; 48: 1174-82.

33. Osei-Atweneboana MY, Awadzi K, Attah SK, Boakye DA, Gyapong JP, Pritchard RK. Phenotypic evidence of emerging ivermectin resistance in Onchocerca volvulus. PLoS Negl Trop Dis 2011; 5: e998.

34. Pearlman DL. A simple treatment for head lice: dry-on, suffocation-based pediculocide. Pediatrics 2004; 114: e275-e279.

35. Burgess IF, Brunton ER, Burgess NA, et al. Clinical trial showing superiority of a coconut and anise spray over permethrin 0.43% lotion for head louse infestation. Eur J Pediatr. 2010; 169: 55-62.

36. Barker SC, Altman PM. A randomised, assessor blind, parallel group comparative efficacy trial of three products for the treatment of head lice in children - melaleuca oil and lavender oil, pyrethrins and piperonyl butoxide, and a “suffocation” product. BMC Dermatology 2010; 10: 6.

37. Henley DV, Lipson N, Korach KS, Bloch CA. Prepubertal gynecomastia linked to lavender and tea tree oils. N Eng J Med 2007; 356: 479-485.

38. Rush SE, Rock AN, Jones SL, Malenke JR, Clayton DH. Efficacy of the LouseBuster, a new medical device for treating head lice (anoplura: pediculidae).

J Med Entomol 2011;48:67-72.

39. National Pediculosis Association. NPA Video Theater – How to use the LiceMeister. 2014. http://www.headlice.org/video/index.php. Accessed February 9, 2014 40. Gunning K, Pippitt K, Kiraly B, Sayler M. Pediculosis and scabies – a treatment update. Am Fam Physician 2012; 86: 535-541.

41. Thomson Reuters Micromedex (Healthcare Series). Red Book Online.http:// www.thomsonhc.com. Accessed February 9, 2014

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Continuing Education for Pharmacists continued

FDA-approved Lice Treatment Options 40

46

Product

Availability (unit size)

Mechanism Ovicidal* Indications

Directions

Benzyl alcohol (Ulesfia®)

RX 5% lotion (227g)

Impairs respiration

No

≥ 6 months old

Apply to dry hair for 10 minutes then rinse; repeat treatment course 7 days later

Ivermectin (Sklice®)

RX 0.5% lotion (117g)

Neurotoxic

Possibly

≥ 6 months old

Apply to dry hair and scalp for 10 minutes, then rinse

Lindane Generic available

RX 1% lotion or shampoo (60ml)

Neurotoxic

No

Adults > 50kg

Apply to dry hair for 4 minutes, then rinse – do NOT repeat

Malathion (Ovide®) RX Generic available 0.5% lotion (60ml)

Neurotoxic

Partially

≥ 6 months old

Apply to dry hair for 8-12 hours, then shampoo; repeat treatment course 7-9 days if live lice present

Permethrin (Nix®) Generic available

OTC 1% lotion (various sizes)

Neurotoxic

No

≥ 2 months old

Apply to shampooed, toweldried hair for 10 minutes, then rinse; repeat treatment course 7-9 days later

Pyrethrins/pipero- OTC nyl butoxide (Rid®) 0.3%/4% Generic available shampoo or mousse (various sizes)

Neurotoxic

No

≥ 2 years old

Apply to dry hair for 10 minutes, then rinse; repeat treatment course 7-9 days later

Spinosad (Natroba®)

Neurotoxic

Yes

≥ 4 years old

Apply to dry hair for 10 minutes, then rinse; repeat treatment course in 7 days if live lice present

RX 0.9% suspension (120ml)

Pharmacy Journal of New England • Spring 2014

Product

ADRs

Benzyl alcohol (Ulesfia®)

Eye irritation and contact dermatitis

Cost per application41

Pregnancy Category

Comments

$63 - $378

B

•N umber

of bottles required per application depends on hair length (represents 2 applications) - Up to 4 inches (ear length) – 2 bottles - Up to 8 inches (chin length) – 3bottles - Up to 16 inches (shoulder length) – 6 bottles - Up to 22 inches (past shoulders) – 8 bottles - Over 24 inches – 12 bottles

• Nit

combing required

Ivermectin (Sklice®)

Eye and local $310 skin irritation

C

• Extensive

Lindane Generic available

CNS toxicity

C

• Not recommended as pediculocide by AAP • Use banned in CA; restricted in MI • Systemically absorbed •U se only when all other agents are contraindicated

$133

nit combing less likely to be necessary

or ineffective

Malathion (Ovide®) Generic available

Stinging and scalp irritation

$188

B

• Second line pediculocide by AAP •M ay use in children as young as 24

Permethrin (Nix®) Generic available

Local skin irritation

$25

B

• First line pediculocide by AAP •A void pre-treatment with conditioner-containing

months as long as safe use can be assured •P rolonged application time, odor, and flammability may impede use •V ehicle is highly flammable; do not use any heat source near hair while it is wet

shampoos combing required

•N it

Pyrethrins/ Local skin piperonyl butoxide irritation (Rid®) Generic available

$25

Spinosad (Natroba®)

$280

Local skin irritation

C

• Nit combing required •R are cases of allergic

ragweed allergies)

B

• Extensive

reactions (chrysanthemum/

nit combing less likely to be necessary

* For pediculicides that are partially ovicidal/non-ovicidal, routine retreatment is recommended. For those that are more strongly ovicidal, retreatment is recommended only if live (crawling) lice are still present after a treatment course. Retreatment should occur after all eggs have hatched but before new eggs are laid.

Table 1 adapted from reference 40

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Continuing Education Quiz Treating Head Lice – Primer for the Community Pharmacist 1. Clinical presentation of those infested with head lice commonly includes which symptom? a. Iron deficiency anemia b. Intense scalp pruritus c. Inguinal adenopathy d. Burrows on the hands 2. Viable lice eggs are more likely those that are: a. F ound more than 1cm away from the scalp b. Missing an eye spot c. White in color d. Visualized behind the ears or at the crown of the head 3. A parent of an 18-month old enters the pharmacy after the child was sent home from day care for the finding of three live lice on the head. The child is otherwise healthy, up-to-date on vaccinations, and is taking no medications. Neither the child, nor family members have been treated previously for head lice. Which is the treatment of choice? a. Permethrin 1% – apply today with lice combing and reapply on Day 9 b. Pyrethrins 0.3% with piperonyl butoxide 4% – apply today with lice combing and reapply on Day 9 c. Malathion 0.5% – apply tonight and reapply in 7-9 days if live lice are present d. Spinosad 0.9% – apply today and reapply in 7 days if live lice are present

4. The parent agrees to begin treatment as recommended and asks what measures should be taken in the home to prevent reinfestation. Which describes the best management? a. P ediculocide spray to the patient’s bed linens b. Treat all household members empirically c. Wash items in contact with the child’s head in the last 2 days d. Discard all plush toys 5. A parent presents with an Ovide® prescription for her child to be applied to the scalp for the treatment of head lice infestation. Which is the most important counseling point to provide to the parent? a. R epeat application at Day 9 and use a lice comb after each treatment b. C ommonly reported adverse effects are eye and scalp irritation c. L eave the product on for 4 minutes and then rinse all the lather away d. D o not use sources of heat or smoke near the hair while it is wet 6. Which head lice treatment is ovicidal? a. Pyrethrins plus piperonyl butoxide b. Spinosad c. Benzyl alcohol d. Lindane

7. R esistance to which head lice treatment is unlikely to develop based on its mechanism of action? a. Benzyl alcohol b. Malathion c. Spinosad d. Ivermectin 8. Which is a preferred head lice treatment for pregnant patients? a. Ivermectin b. Pyrethrins plus piperonyl butoxide c. Lindane d. Permethrins 9. Prudent measures to prevent transmission of head lice in school-based settings include all EXCEPT: a. Avoid direct head-to-head contact b. D o not share personal care items, clothing, or hats c. Sequester

children found with nits at home d. P rovide information about transmission prevention to families of all children 10. Head lice treatments that routinely require two treatments for optimal efficacy include all EXCEPT: a. Benzyl alcohol b. Permethrins c. Ivermectin d. Pyrethrins plus piperonyl butoxide

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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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