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Vol 12 No. 1 Winter 2015

Winter 2015

Pharmacy Journal of New England

Pharmacists’ Care Process: Consistency is Critical Pharmacy Metrics VS Patient Safety IRA Rolloves for Lump-Sum Payouts Financial Forum

Law VS Ethics Rx and the Law Complete association and college winter updates

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Pharmacy Journal

Vol 12 No. 1 Pharmacy Journal of New England • Winter 2015

of New England Metrics Versus Patient Safety


Dear Readers,

Managing Editor

Over the last few months, several of the state pharmacy associations in New England have looked into how metrics are affecting pharmacists’ performances, and how all of that relates to patient safety.

Ellen Zoppo CPA

In the last several years, the pharmacist’s role has changed – the addition of immunizations, health checks such as blood pressure, and patient counseling have shifted the balance to more face-to- face conversations with the patients. However, the pressures to fill prescriptions, manage technicians and wade through the various third party payers, insurance issues and Medicaid quandaries remains at the same, if not increased, levels.

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

Design & Production Kathy Harvey-Ellis MPhA 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.

In the words of a Connecticut pharmacist, something has to give. In response, the CPA sent Pharmacy Journal of New England a letter to the Pharmacy Commission last November. That set in motion a Task Force from 35 Cold Spring Road, Suite 121 Rocky Hill, CT 06067-3167 the Commission that has been meeting with pharmacists. A survey is also in the design phases to be sent in this month to anyone who would like to add information to this process. Submitting Articles to the It is our hope that this will result in a collaborative effort among pharmacists, corporate Pharmacy Journal of New England™ The Pharmacy Journal of New England is the product management, and the Pharmacy Commission to enact positive changes to the workplace. ™

And last month, MPhA President Susan Holden took to the airwaves to give a face to this issue. Her on-air segment may be viewed by clicking here. This is an issue that affects every aspect of pharmacy, and we hope that you continue to advocate for your profession through support of initiatives that will assist in balancing these competing demands and ensuring pharmacist and patient safety.

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

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

Contents 02

16 19 21 29

David Johnson Executive Vice President Massachusetts Pharmacists Association

New England States Feature: Important Updates for Influenza Vaccination 2014-15 Pharmacy Marketing Group: Rx and the Law, Financial Forum From the Colleges Continuing Education for Pharmacists 1

New England States Connecticut

b. Collaborating with other pharmacy organizations both with other states around the country and within our state

President’s Message


a. Partner with research teams studying the effects of medical marijuana

This winter, the CPA is deep into devel-

oping a strategic plan with outcomes and new programs that sustain our mission to advance the practice and interest of pharmacy in the state of Connecticut. Some of the items currently in process include:

Diversify revenue streams


Karen Hoang CPA President

1. We are transitioning the chairs of our committees to train the next generation of leaders. a. Phil Hritcko and Jean Keating are taking the reins from Angelo Defazio and Rick Carbray after their many years of chairing the Legislative Committee, and Marissa Salvo is now chairing the Membership Committee. If you want to get involved but don’t know what you can do, a great way to start is by joining a committee. 2. The External Relations Committee is working on presenting pharmacists and the profession in a positive light. a. Educating public on the value of pharmacists with the social media posts, and some exciting projects are in the works.

Looking into Webinars for CE’s and other purposes

c. Developed a condensed Certified Pharmacy Tech course for experienced techs looking to get nationally certified 4.

Adding even more value for your Membership

a. Ellen’s famous ‘Friday Fast 5’ email to members on cutting-edge news b. Providing new and exciting topics for CE’s like Medical Marijuana and Veterinary pharmacy that was offered at the Midwinter Conference. I would like to thank everyone who braved the wintry conditions to attend the MidWinter and especially the dozen or so pharmacists who took advantage of our MidWinter membership special and joined the Association. Many important pieces will continue to unfold with the legislative agenda as well as our work with the Pharmacy Commission concerning pharmacy metrics and workplace conditions. -Karen Hoang

Current CPA President Karen Hoang (l) chats with former CPA President Lucrezia Finegan during the MidWinter Lunch.


Pharmacy Journal of New England • Winter 2015

CPA Mid-Winter Event a Success Despite a Frigid February CPA held its Annual MidWinter Conference on February 5th at the Aqua Turf Club. The CE Event featured 200 attendees, an exhibit hall, and seven live CE programs. Keynote Speaker Dan Hussar braved the unpopular winter weather, traveling from Philadelphia to present an engaging and informative New Drugs of 2014 morning session. In addition to Dr. Hussar, the Connecticut Pharmacists Association also invited several other pharmacists to speak on topics of interest including Veterinary prescriptions, Epilepsy, a BEERS update, Pain, and Update on Connecticut Law and Clinical Management of Outpatient Anticoagulation.

What’s a little snow compared to knowing you spent a frigid Thursday earning up to 8 CEs that you won’t have to worry about in August? (above)

The CPA Board of Directors would like to thank the sponsors and vendors who joined us at the Exhibit Hall for an extended lunch. Their continued support ensures that the CPA is able to produce affordable and high quality live CE programs. This year’s Gold Sponsor was McKesson, with AmerisourceBergen, Kinray, and the University of Saint Joseph School of Pharmacy as Silver Sponsors. A special thanks to Paula Kaspar of Professional Pharmacy Personnel who supplies the material folders for the event, and a thank you to the exhibitors: AmerisourceBergen, AstraZeneca, Cardinal Health, the Connecticut Pharmacists Foundation, David Lerner Associates Investments, H.D. Smith, Indivior Pharmaceuticals, Kinray, McKesson, Pharmacists Mutual, and Sigma Tau. Dan Hussar speaks on New Drugs as part of the morning program (above).

Thanks to our vendors and supporters for joining us at lunch (above, McKesson, and right, Invidior).


New England States


Governor Malloy Proposes Legislation Combating Substance Abuse and Opiod Overdose The Connecticut Pharmacists Association was pleased to hear Governor Dannel P. Malloy recently announce that he will propose legislation to combat substance abuse and opioid overdose in Connecticut. The legislation will help curb heroin and prescription opioid abuse through more streamlined prescription reporting, continuing education requirements for practitioners, and greater availability of the overdose reversing drug Naloxone in case of emergency. “I’ve been clear that, as a state, we need to be smarter about how we approach punishment with our drug laws. But we also need to be more diligent about preventing addiction in the first place. That’s why we’re proposing legislation that will ensure health care professionals check accurate, real-time data to help them make smart decisions and curb potential abuse,” Governor Malloy said. “Opioid abuse has historically been viewed as an isolated problem, but trends from across the nation demonstrate that it is affecting communities, both large and small. Connecticut is taking smart, preventative action to streamline processes and prevent potential addiction.” To combat addiction, Governor Malloy’s legislation will streamline the process to help practitioners identify potential abuse by alerting them if patients seeking certain prescriptions have recently received these medications from multiple other prescribers or pharmacists. The proposal requires all pharmacies in Connecticut to report the dispensing of prescriptions for all controlled substances immediately – rather than weekly – through the state’s prescription monitoring program (PMP), helping ensure that prescribers have accurate, real-time data for treatment decisions. It also requires any prescriber supplying more than a 72-hour supply of a controlled substance to review the patient’s record in the PMP, allowing emergency departments and others prescribing very short term prescriptions the expediency they need while working to prevent potential abuse for longerterm prescriptions.


Further, in cases of overdose or medical emergency, the legislation saves lives by making Naloxone – a drug that reverses overdoses – more widely available, allowing pharmacists, after being trained and certified through the Department of Consumer Protection, to prescribe it to Connecticut families, first responders, and the treatment community across the state. The legislation also requires more education on the issue for medical professionals as part of the existing process for them to renew their licenses. It also reconstitutes the Alcohol and Drug Policy Council, led by the Department of Mental Health and Addiction Services and the Department of Children and Families, to focus on addiction in Connecticut and inform the Governor and General Assembly on future policy changes and public awareness strategies necessary to combat addiction. Good Samaritan laws passed in 2012 have encouraged more people to call 911 in order to save the life of a friend or loved one who may be overdosing. Third-party prescription laws passed in 2014 now allow practitioners to prescribe Naloxone to anyone who can treat or prevent a drug overdose, such as family members or friends of suspected opioid abusers, a practice that has saved countless lives. Moreover, Connecticut State Police now universally carry Naloxone in their cruisers, a step which has saved 13 lives in the few short months since implementation in October 2014. ___________________________________________________

Save the Date!

Connecticut Pharmacists Foundation Annual Wine Tasting Saturday, May 17, 2015 Cassidy Hill Vineyard, Coventry, CT

To benefit scholarships and community outreach programs.

Pharmacy Journal of New England • Winter 2015

Massachusetts President’s Message

MPhA is looking forward to the spring and warmer weather! We are gearing up for our annual Spring Conference on Thursday, April 30 at the Four Points by Sheraton in Norwood. Our speakers’ topics will include overdose education and Naloxone rescue kits, the new compounding laws, bariatric surgery, and much more. Be sure and register soon. Susan Holden MPhA President

Save the date for the next New England Pharmacists Convention - fall will be here before you know it! Plan for September 24-25 at Gillette Stadium in Foxboro, MA – home of the world champion New England Patriots.

Legislative Update Earlier this year, the 2013-2014 legislative session closed with a flurry of activity that included the passage of An Act Regulating Pharmacy Audits and An Act Authorizing Certain Pharmacy Interns to Administer Immunizations. These passages speak to the growing influence of the pro-pharmacy grassroots lobby. For the 2015-16 legislative session, the Associations have teamed up to craft and promote three bills: SD1301 – An Act to Ensure Access to Medications, filed by Sen. James B. Eldridge. D-Acton. This legislation amends the “Any Willing Provider” law to allow community pharmacies to fill prescriptions for “specialty medications. ” Insurers and pharmacy benefit managers have been getting around the “Any Willing Provider Law” by designating a medication a “specialty medication” even when the drug requirements are minimal. This issue has similarly plagued hospital pharmacies. Patients, who normally receive their medications from the hospital’s pharmacy, have their discharge delayed while they wait for the delivery of a specialty drug from a specialty pharmacy. This legislation will close that loophole. This will also assist patients by allowing them to obtain all their medication from one pharmacy.

HD746 – An Act to Ensure Access to Generic Medications filed by Rep. Paul Heroux. D-Attleboro. This legislation requires insurers and pharmacy benefit managers (PBMs) to make generic drug price lists available to pharmacies. The bill also requires that the drug price list be updated every three business days to reflect the dramatic fluctuations in generic drug prices. Finally, the bill requires that insurers/PBMs respond to an appeal from a pharmacy within 7 business days. This legislation thus provides incentives to use generic medications, which are less expensive and keep health care costs down. These reasonable standards will ensure independent community pharmacies are treated fairly by the large PBMs. HD592 - An Act Recognizing Pharmacists as Healthcare Providers filed by Rep. Angelo Puppolo, D-Springfield. This legislation will formally recognize pharmacists as healthcare providers and will give them a mechanism to provide and bill for certain services to chronic disease patients when acting under the auspices of a signed Collaborative Drug Therapy Management (CDTM) agreement with a physician. The bill would also amend the current CDTM law to eliminate the list of disease states eligible for a CDTM agreement in a retail setting. The reason for this change is to allow a pharmacist and physician to team up on any disease that the physician requests. This section of law is also amended to allow pharmacists to administer medications ordered by a prescriber. In 19 other states pharmacists are administering monthly injections for schizophrenia patients at the pharmacy, a practice that has yielded high adherence rates. This practice is not permitted here in MA. Finally, similar to California’s new law, this bill would permit pharmacists to dispense nicotine replacement therapies and hormonal contraceptives by protocols established jointly by the Boards of Medicine and Pharmacy.

Working with the Colleges On February 24, we held our monthly MPhA Board meeting at Northeastern University, where we met pharmacy students at the Bouve College of Health Sciences involved with the campus’ APhA-ASP Chapter. This was a great way for members of both groups to meet, and for students –the future pharmacists—to learn more about MPhA and what we do. Thanks for your support, and I look forward to meeting you at an event soon. --Susan Holden 5

New England States


A New Research Network Forms in New England to Bring Better Patient Outcomes By Shefali Rao It’s a step towards collaboration in every possible way. The Massachusetts Pharmacists Association (MPhA) is teaming up with senior pharmacy faculty at Northeastern University and Pro-Cure Health Design (Pro-CureHD), a researcher development company, in addition to pharmacists, prescribers, university administrators, and other pharmacist associations in the New England states to bring a first-of-its-kind initiative to the region: its very own New England Pharmacy PracticeBased Research Network (NEP-PBRN). The new collaboration will include everything from crossdisciplinary grant-submission partnerships, to grant-writing and manuscript training workshops for health practitioners, to research collaborations involving community pharmacists, prescribers, patients, and pharmacy researchers and educators all in an attempt to increase the different groups’ connection and alliance. The goals? Enhanced pharmacist-prescriberpatient communication, reduced adverse medication events and inappropriate and unnecessary medications, improved medication adherence and efficacy, and powerful and effective research collaborations, all of which will lead to better health outcomes and a reduction in per-patient costs.

Behind it all The new network, which will also build solid relationships with both aspiring and seasoned researchers from other healthcare disciplines, was founded by three passionate individuals who are dedicated to strengthening pharmacy research in the region. It was an idea brought to the group by Dr. Nathaniel Rickles, PharmD, Ph.D., an associate professor in the School of Pharmacy at Northeastern University, that sparked the conversation among the three – Dr. Rickles, David Johnson, Executive Vice President of the MPhA, and Peaches Udoma, COO and Principal of Pro-CureHD. She tells us that her company’s interest in the project was the opportunity to help create a thriving network, which is one of the collaboration services the company offers in its Pro-CureConnections™ arm. Dr. Rickles tells us, “Pharmacists can play a critical role in filling the gaps of primary health care in improving patient outcomes. But they often do not have the infrastructure and support to perform in what we could call those “enhanced” roles. Through research, we can show the value of commu6

nity pharmacists as instrumental members of the healthcare team, and how increasing their resources can help maximize their impact on patient care,” he says. Johnson feels that the NEP-PBRN will benefit pharmacists “who want to continue, in a sense, their academic careers… to be involved in research, to put together their ideas and put them to work,” he says. It’ll be equally beneficial, he adds, to other healthcare researchers who can then enlist the help of pharmacists. “Research is stifled because right now, it can be a chore to enlist pharmacies in a research project. Creating a network like this makes researchers take a good look at community pharmacy with an eye toward new sustainable business and health care delivery models.” Udoma adds, “We all have a commitment to empower pharmacy researchers and other health-based researchers who are not in the limelight a lot of the time. The ideas are there. The talent is there. The brilliance is there. But the community may not be. And community and collaboration are necessary to strengthen the individual researcher and to make his/her research vision a reality.”

The value proposition While there are a few other pharmacy practice-based research networks in the U.S., there are certain things that set this one apart from the others. “The really big difference is the training piece,” says Dr. Rickles. “Another is the sustainability of the research infrastructure. This will help leverage the intellectual property of the region. New England is rich with progressive medical thought leaders and we just haven’t tapped into this connection yet,” he says. The other networks, he highlights, do not necessarily build paths for future collaboration.

Spreading the word Bringing the idea to conferences, submitting grants (the NEP-PBRN has already submitted two, since January), media exposure, offering training opportunities, and starting social media discussion groups is how the NEP-PBRN is spreading the word about the network. They’re on a mission and it’s one that they’re extremely excited about. “I hope it results in innovation for community pharmacy through some high quality research. It’s especially exciting for young pharmacy research-

Pharmacy Journal of New England • Winter 2015

ers,” says Johnson. In fact, the MPhA is rolling out grant and manuscript writing training programs for new and seasoned investigators from their headquarters in Woburn, MA, this June, in partnership with Pro-CureHD. “What we find in pharmacy researchers is that many of them tend to work alone, like other researchers,” says Udoma, “even though collaboration is the watchword of our age, when it comes to health-based research. And research just doesn’t get done that way. At least good research doesn’t. We know there’s strength in numbers and that’s why this community is so crucial. Researchers can often be stopped by thinking they don’t have something important to give, but they do,” says Udoma. “We can counter every single reason why they think they don’t with a reason why they do.” For more information about the NEP-PBRN, contact David Johnson at or Nate Rickles at Visit Pro-Cure Health Design at

2015 MPhA Spring Conference 2015 Spring Conference

Register now for MPhA’s 2015 Spring Conference

April 30, 2015

Join us at the Four Points by Sheraton in Norwood On Thursday, April 30, the Conference promises to be an informative day filled with topics such as bariatric surgery and weight loss drugs; overdose education and Naxlone kits; and much more. MPhA's Spring Conference Gives You:  Seven CE credits, which includes two 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: Bariatric Surgery and Weight Loss Drugs: What Pharmacists Should Know by Michael Malvesti, Pharm.D., Clinical Pharmacist at the VA Medical Center in West Roxbury When Kinetics Doesn’t Cut It: A Mini-Case Series for Pharmacists by Chuck Berds, Pharm.D., Clinical Pharmacist, VA Boston Healthcare, Jamaica Plain USP 795: New Restrictions and Regulations (Law CE) by Timothy Fensky, R.Ph., Director of Pharmacy Operations, Sullivan’s Pharmacy and Medical Supply, Massachusetts Board of Registration in Pharmacy Overdose Education and Naloxone Rescue Kits in Massachusetts by Alexander Y. Walley, MD, MSc, Boston University School of Medicine, Boston Medical Center

We look forward to seeing you at the Four Points! To register, visit or call us at (781) 933-1107. 7

New England States


New Hampshire New Hampshire Pharmacists are Recognized at Annual Holiday Party MCPHS University (Manchester Campus) at Manchester sponsored the Annual Holiday Reception on Wednesday, December 17, 2014 at the Manchester Country Club in Bedford, New Hampshire. The celebration was also supported by the NH Pharmacists Association (NHPA), the NH Society of Health-System Pharmacists (NHSHP) and the NH Independent Pharmacy Association (NHiPA).

Gold Certificate This year, the NH Board of Pharmacy recognized a New Hampshire pharmacist who has been licensed in the state for 50 continuous years. The ceremony included the presentation of a framed gold certificate. While the “Gold Certificate” itself has been around for well over 30 years, the presentation only became formal in the past 6 years. The gold certificate is a replica of the recipient’s license which is engraved with his/her name, as well as a signed citation from the Governor Maggie Hassan. The gold certificate of licensure was presented by Charles Fanaras, President, NH Board of Pharmacy to William Keefe, BSP, RPh. Bill’s interest in pharmacy began in 1952 when he went to work at Cate’s Rexall Pharmacy in Rochester, NH. After graduating from the Massachusetts College of Pharmacy -Boston in 1964, Bill continued his employment at Cate’s Drug as staff pharmacist. In 1967 he purchased Carney Drug, also in Rochester, and continued as the owner until 2005 when he sold the pharmacy and opened Carney Medical Supply. During his active practice years, Bill was a member and graduate of the Professional Compounding Centers of America.


Throughout his professional practice years, Bill became involved in pharmacy affairs on both the state and national levels. He was a founding member of the NH Consultant Pharmacists’ Association and the NH Durable Medical Equipment Association, serving as Vice-President for both organizations.

(Above, from L to R: William Keefe and Charles Fanaras)

As well as serving as an officer on the Executive Committee of the NHPA for 8 years, Bill was elected Association President in 1980. Additionally, in 1980-81, Bill was one of 8 pharmacists nationally selected to review and set a new mission and goals for (NARD) the National Association of Retail Druggists (NARD). As a community pharmacist, Bill authored and initiated a Drug Abuse / Awareness Educational Program in conjunction with his local police department and he made presentations at schools and adult groups throughout the state.

2014 New Hampshire Technician of the Year The NH Pharmacy Technician of the Year Award is co-sponsored by NHPA, NHSHP and NHiPA. This award is presented annually to a pharmacy technician licensed and practicing in New Hampshire who demonstrates excellence in his/her practice setting, is motivated to learn, exhibits a professional attitude and is dedicated to the profession of pharmacy. This year’s recipient is Meredith DeCross. Meredith has been a certified pharmacy technician for more than 5 years and continues to share her experiences and talents in both hospital and community pharmacy settings. Her supervisor describes her as “an outstanding pharmacy technician who always comes to work with a smile and a positive attitude.“ Meredith goes beyond what is asked of her by assisting with the teaching of pharmacy students and new technicians in the operations of the pharmacy department. Additionally, she mentors other technicians in all areas, from training them on proper sterile technique to troubleshooting the Pyxis machines.

Pharmacy Journal of New England • Winter 2015

2014 New Hampshire Pharmacist of the Year

2014 Distinguished Young Pharmacist Award

The NH Pharmacist of the Year award is co-sponsored by NHPA, NHSHP and NHiPA. 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 Distinguished Young Pharmacist Award is sponsored by Pharmacists Mutual Companies. This award is presented annually to a pharmacist licensed in New Hampshire who has practiced ten years or less, practices in a community, institutional, or consulting pharmacy and who has actively participated in national/state pharmacy associations and/or community service. This year’s recipient is Elizabeth Wade.

The recipient of the 2014 NH Pharmacist of the Year is Michael Viggiano. Michael has worked in a community practice setting for the past 38 years. Throughout his career as a pharmacist, he has held numerous roles with the NHPA serving as a member of the Board of Directors and past Treasurer. He has also served as consultant to the Association’s lobbyist relative to legislative issues facing pharmacists and pharmacy. During the past 2 years, Michael has worked on the establishment, and finally the launch, of the NH Prescription Drug Monitoring Program. His contribution to this project as the Pharmacist Technical Consultant has been most valuable. He has invested numerous hours in a project that will contribute to the saving of lives due to narcotic abuse and overuse. A 1976 graduate of the Massachusetts College of Pharmacy, he was also instrumental in the establishment of the NHPA Scholarship Foundation. He earned his MBA from Rivier University in 2010. (Below: Michael Viggiano with Lorriane Radick).

Elizabeth received her Pharm.D. degree from Northeastern University in 2008. Following graduation, she completed 2 years of postgraduate education at the Johns Hopkins Hospital in Maryland, first in pharmacy practice followed by a PGY2 in Medication Use Safety. She currently is the Medication Safety Officer at Concord Hospital. Elizabeth started working with the New Hampshire Society of Health System Pharmacists (NHSHP)’s Board of Directors, providing a unique focus on medication-use safety. On the national level, she has served as a delegate for ASHP’s House of Delegates and was appointed to ASHP’s Council on Pharmacy Practice.

Excellence in Innovation Award The Excellence in Innovation award is a national award coordinated by the National Alliance of State Pharmacy Associations, and sponsored by Upsher-Smith Laboratories, Inc. It honors a 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. This year’s recipient is Marge Kerns. Marge established the first pharmacist run Coumadin Clinic offered to the public sector in New Hampshire in 1998. She also developed one of the earliest inpatient dosing protocols for Warfarin. Marge has furthered the participation of pharmacists as vital members of the medical team. She recently imbedded a pharmacist into a physician’s office practice at the Laconia Clinic and plans to expand this model throughout the system. Her innovative work has undoubtedly changed the practice of pharmacy in this state. 9

New England States


2014 Cardinal Health Generation Rx Champions Award The Cardinal Health Generation Rx Champions Award recognizes a pharmacist who has demonstrated excellence in community-based prescription drug abuse prevention. The 2014 Cardinal Health Generation Rx Champions Award recipient is pharmacist Margaret Clifford who has served as the Chief Compliance Investigator for the NH board of pharmacy for 6 years. Peg has worked with organizations such as Allies in Substance Abuse Prevention, the Community Alliance for Teen Safety (CATS), and the Hollis/Brookline Rotary Club. She has participated in drug abuse panel discussions at area high schools and Rivier University in Nashua, talking about the dangers of prescription drug abuse. Peg has also worked as part of the Prescription Drug TakeBack Program at Anthem Blue Cross and Blue Shield, which allows people to responsibly dispose of unwanted prescription drugs. She also recently presented at the NH Drug Task Force continuing education pharmacy program.

This year’s recipient of the Bowl of Hygeia is Larry Routhier. A 1977 graduate of the Massachusetts College of Pharmacy, Larry then worked as a staff pharmacist in several independent pharmacies and then as staff pharmacist and pharmacy manager for several Osco Pharmacies in NH and MA. Larry has also served in those positions for CVS Pharmacies in both Belmont and Gilford, NH. Beginning in 2002, Larry has been serving as Director of Pharmacy Operations for the Lakes Region General Hospital and the Franklin Regional Hospital as well as at The Pharmacy Center at the Laconia Clinic. A resident of the town of Gilford, NH since 1986, Larry has served as: •

Chairman and member of the Board of Selectmen

Member of the Zoning Board of Adjustment

Member of the Drug and Alcohol Task Force

Member of the Conservation Commission

• Chairman of the Capital Improvement Projects Committee, and as a Police Commissioner

In addition, Peg has been one of the main supporters of the Prescription Drug Monitoring Program in NH, assisting the Advisory Committee with the drafting of the Rules for NH’s PDMP. Peg has served on the NH Board of Pharmacy for nine years, supporting efforts to combat the abuse and misuse of prescription drugs. Since 2007, she has been a member of the National Association of State Controlled Substance Authorities (NASCSA) and for the past 4 years has also served on its Executive Committee.

Bowl of Hygeia Award 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. 10

(Above, Lawrence Routhier with Cheryl Abel).

Lifetime Achievement Award The Lifetime Achievement Award is co-sponsored by the NHPA, NHSHP and NHiPA. The award is presented in recognition of exceptional commitment, loyalty and dedication to the practice of pharmacy in the State of New Hampshire. 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. The recipient of the 2014 Lifetime Achievement Award is Donald Messina.

Pharmacy Journal of New England • Winter 2015

Don launched his professional career by working at independent pharmacies in Boston and Westport, CT. In 1966, Don accepted employment with Eli Lilly and Company, and he worked for Lilly for 29 years as a Professional Service Representative. Following his retirement from Lilly, Don returned to community pharmacy practice until 2009. He took on an assignment as Instructor in several pharmacy technician programs. Don served as President of the NH Pharmacists Association in 1982, 86, 87, 1990, 91, 98 and 2005. For MCPHS, his alma mater, Don invested his time and personal skills on a number of advisory committees, including service as president of the MCPHS Alumni Association in 2003-2004, a member of the Alumni Council and since 1990, a member of the College Corporation. For his country, Don is a retired Commander for the U.S. Naval Reserve with 25 years of service; he is the founder and first Commanding Officer of the Naval Sea Cadet Division, Manchester, NH.

NHPA Presentation of Scholarships Each year the New Hampshire Pharmacists Association (NHPA) Scholarship Foundation provides student pharmacists of NH an opportunity to receive scholarship funds. The Scholarship Committee included the following members: Cheryl Abel, Lorraine Radick, Donald Messina, Joe Clement and Paul Boisseau. The committee places high value on students with the right balance of professionalism, initiative, leadership, insight, and decisiveness, as well as, need and scholastic ability. This year the foundation awarded three outstanding students. The recipients were honored at the New Hampshire Pharmacy Awards banquet in December. The first 2014 scholarship recipient is Andrew Brueckner. Andrew is currently in his last year of MCPHS UniversityWorcester/Manchester’s Accelerated PharmD. He is the president of the Rho Chi Honor Society and treasurer of the Phi Lambda Sigma Leadership Society. Andrew is also a member of NHPA and a student Board of Directors Member. The second recipient is Morgan Ratte, a 2016 PharmD Candidate, currently studying at University of Rhode Island’s College of Pharmacy. Morgan is a member of the University’s

Rho Chi Honor Society, Phi Lambda Sigma Pharmacy Leadership Society and America’s Senior Care Pharmacists. Morgan has also participated in the College’s mission trip to an orphanage in Jamaica where students of pharmacy provided education to caregivers on medication adherence and dosing. Morgan is leading the 2015 mission revisit trip. The third recipient is a University of Connecticut 2016 PharmD Candidate, Emily Seamans. Emily is a member of Lambda Kappa Sigma Professional Pharmacy Fraternity as well as the Honor Society, Alpha Lambda Delta. Emily serves as a student ambassador for the University’s incoming students, as well as a Student Mentor and Assistant Program Director for the Nutmeg Big Brother Big Sisters program. Emily has also served as a hospitality volunteer at David’s House, a home-away-from-home for families whose children are being treated at Dartmouth Hitchcock Medical Center.

Last Chance CE Program at SERESC NHPA held a “Last Chance” CE Program at SERES Conference Center in Bedford. Topics included drug diversion, pharmacy law update, monoclonal antibodies, and pediatric GERD. This year, four pharmacy students from MCPHS University (MHT campus) presented posters. Their topics included: “The Diagnosis, Treatment, and Prevention of Clostridium difficile Infection, “ presented by Megan Januzewski, PharmD Candidate. “Ebola 2014: The Virus That Scares Even the Experts” presented by Vanya Chan, PharmD Candidate. “Fundamentals of Chronic Wound Healing” presented by Travis Paige, PharmD Candidate. “Medication Safety and Disposal” presented by the Student Pharmacists Against Prescription Drug Abuse led by Michael Nardone, Christopher Rochon, and Meghan Farrell, PharmD candidates.

Spring CE Program at Attitash On Saturday, May 30, 2015 NHPA will sponsor its fifth annual CE program at the Grand Summit Hotel in Bartlett, New Hampshire. We will be offering two free dinner speaker programs both on Friday, May 29 and Saturday May 30, 2015. Please join us. 11

New England States



President’s Message On January 29th the Vermont Pharmacists Association (VPA) held its annual Pharmacy Day event at the statehouse in Montpelier, joined by a contingent from our student chapter at the Albany College of Pharmacy and Health Sciences (ACPHS), Colchester, Jim Godfrey, President VT campus. As pharmacy students are the future of the profession and of our association, this was a great opportunity to introduce them to the legislative process. Students had the chance to sit in on committee meetings, and our board members provided testimony to the Senate Health and Welfare Committee. The VPA is supporting H.97, proposed by Vermont Retail Druggists, which addresses PBM MAC pricing and calls for patient choice of pharmacy without differential BuySell_ad_5x7half_Layout 1 1/27/13 2:12 PM Page 3 copayments.

In December, Vermont Gov. Peter Shumlin announced plans for single-payer universal health care would be abandoned due to unacceptably large tax increases that would be required. Vermont will continue to strive to improve healthcare accessibility, and the VPA will continue to advocate for pharmacists’ role in our healthcare system. I am pleased to report the addition of Sandy Rosa to the Vermont Pharmacists Association board. Sandy also serves on the faculty of Albany College of Pharmacy and Health Sciences Colchester, VT campus and is past president of the Rhode Island Pharmacists Association. July 31st of this year marks the deadline for license renewal. The VPA will be offering 5 credits of live continuing education at our spring meeting, so watch for details on the Vermont Pharmacists Association website Jim Godfrey, RPh President

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

1. Confidentiality is CRITICAL to maintaining business value. The more people who know about a sale (employees, suppliers, customers), the less value it will ultimately have. Limit your conversations to trusted advisors, associates and family members. 2. Connect to the largest group of QUALIFIED BUYERS to create the highest price, by leveraging the highest level of interest in your business. Limiting your buyer pool (e.g. ONLY your wholesaler's customers), limits your ability to sell and sale price.

Your Local Specialist Jack Collins, R.Ph. Tel: 1-(203)-395-6243

3. DO NOT engage in conversations, information sharing or negotiations with ANY buyer without professional representation, particularly if contemplating a sale to a chain. Thirteen years of experience selling pharmacies has shown us time after time that direct engagement rarely—if ever—gets the independent owner the best price or the best deal.

Completely confidential!

1-(877)-360-0095 12

Pharmacy Journal of New England • Winter 2015

Maine Pharmacists Nutting and Chace Elected to Maine House of Representatives Congratulations to pharmacists Bob Nutting of Oakland, ME and Paul Chace of Durham, ME who were elected to Maine’s 127th Legislature! Bob Nutting, Speaker of the House in the 125th Legislature, was re-elected to represent Maine District 78. Paul Chace won his first political race to represent Maine District 46. Not since 2004 have two pharmacists simultaneously served in Maine’s legislature (Bob Nutting & Joe Bruno in the 121st). Representatives Nutting and Chace are in elite company as only 45 other pharmacists hold state level office in the entire nation. Both Nutting and Chace will bring to Augusta their entrepreneurial experience and a voice of reason on many issues including business and healthcare.

Paul Chase of Durham

Maine Pharmacy Association Spring Convention and Trade Show MPA will be hosting our annual Spring Convention and Trade Show, March 20-22nd at the Hilton Garden Inn, Freeport, Maine. Come join your colleagues for a weekend filled with a wide variety of CE programming, professional networking, and celebration of our profession. You can complete your yearly CE requirements in a single weekend, since all programming is completely ACPE accredited CE through the University of New England. Bob Nutting of Oakland

We will be hosting a Pharmacy Reception on Saturday night, March 21st from 5:00pm - 7:00pm. All are invited to attend.


New England States


Rhode Island Hello fellow RIPA members! We now have our new Council in place, having installed the new officers and Council members at our President’s Dinner, which was held at the New England Pharmacists Convention in October. Our Council has been hard at work serving you, our members, with new added benefits, continuing education (CE) and social activities, and of course, advocating for you, Rhode Island Pharmacists, and our profession in our state. With Spring around the corner, we are busy planning our Annual RIPF Kimberly McDonough Spring Seminar, which is coming up on May 6. This year’s Seminar is focused on “Pharmacist-led Interventions to Improve Quality of Care,” and includes 5 live CE credits. Also, as an added member benefit this year, all dues-paying members will receive a complimentary registration for the seminar! If you haven’t been to our Spring Seminar before, it’s a great opportunity to not only learn and get your live CE credits before June license renewals, but also a great chance to network with your fellow pharmacists. If you’re not a member, join by April 1st and register to take advantage of this great member benefit! Planning for our Annual Face of Pharmacy Day is underway as well. This year’s event will take place on Wednesday, April 1st, at the Rhode Island Statehouse Rotunda. Our legislative committee has been hard at work advocating for recognition for our pharmacists as part of the patient’s health care provider team. Key issues we’re trying to address for you include: • The ability of pharmacists to perform CLIA-waived tests for patients, such as glucose monitoring, A1c, cholesterol, etc. • The recognition of pharmacists as providers to increase patient access to the benefits of pharmacists’ services through proper payment models We’ve also been busy planning our upcoming social and fundraising events for the rest of the year. We had another RIPA Cheers with Peers in February, giving us a chance to network and have fun together while cheering on the URI Rhody Rams


basketball team. Our annual Golf Tournament is coming up on June 8th, which will benefit the Rhode Island Pharmacists Foundation, and support our scholarship fund. Our Women in Pharmacy paint night event last year was so successful that we are planning another Women in Pharmacy event for this year as well. Keep your eyes open for a PAC fundraiser as well, so we can continue to advocate on your behalf. Our association is nothing without its members. If you aren’t yet a member, please consider joining today. You’ll find that your membership provides a great value in advocacy, networking opportunities, CE, discounts, etc., as well as the pride of being part of the only pharmacist professional association in the state that represents all practice areas of pharmacy. All of our Council meetings are open to all membership, and we would love the opportunity to show you first-hand what we’re working on. If you are a member and we haven’t seen you in a while, please reach out – we’d love to see you. You can come to a Council meeting, or feel free to reach out to us by email (, or check out our upcoming events on our website ( If you’d like to get more involved but aren’t sure how, please email us – we can discuss the open opportunities with you. We looking forward to seeing you at an upcoming event soon!

RIPA Council of Administration, 2014-15


Save the Date May 29-31, 2015 New England Pharmacy Collaborative Weekend CE Program Also offering the APhA Diabetes Certificate Program! At Lake Morey Resort, Fairlee VT

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 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


Feature Pharmacists’ Patient Care Process: Consistency is Critical Recognizing the need for a consistent process in the delivery of patient care across the profession, the Joint Commission of Pharmacy Practitioners (JCPP)1 recently released the Pharmacists’ Patient Care Process. The process is applicable to any practice setting where pharmacists provide patient care and for any patient care service provided by pharmacists. This article describes the development of the Pharmacists’ Patient Care Process, what the process is, why it’s important, and initial implementation steps.

The Foundation JCPP’s vision statement for the pharmacy profession and strategic plan for reaching this vision were revised in July 2013 as part of a strategic planning retreat that included thought leaders from inside and outside the profession. The newly adopted vision, “Patients achieve optimal health and medication outcomes with pharmacists as essential and accountable providers within patient-centered, team-based health care,” reflects the need for pharmacists to be patient-centered and accountable for patient outcomes while working collaboratively with other members of the health care team. Key drivers to achieving the JCPP vision identified by pharmacy thought leaders include: 1) a widely-adopted and consistently delivered pharmacist patient care process, 2) quality measures to measure the value of pharmacists’ services, 3) robust health information technology to support patient care, and 4) payment for pharmacists’ services. The need for pharmacists to use a consistent approach to patient care delivery has always been important. However, with the increasing movement to outcomes-based payment models in the health care system, this need is becoming more urgent. Payment models are starting to emerge where health care professionals are paid for achieving desired outcomes for their patients (e.g., patients’ blood pressure at goal) instead of by the number of patient visits they complete. To 16

measure the outcomes of pharmacists’ services in a meaningful way, a consistent process of care must be used to deliver the services. That way an “apples to apples” comparison can be made for the collective value that pharmacists provide within the health care system. The Pharmacists’ Patient Care Process was developed by a group of national pharmacy organizations working under the direction of JCPP. The foundation for the process is embedded within the pharmaceutical care model developed by Hepler and Strand in the 1990s and was developed by examining a number of key source documents on pharmaceutical care and medication therapy management. These key documents were cataloged and compared to create a patient care process consistent with best practice models in pharmacy. The patient care process is articulated in a manner aligned with the patient care processes of other health care professionals while at the same time detailing the unique medication-related aspects of pharmacists’ training. The development process included organizational comment periods and testing with clinicians to create the document approved by JCPP on May 29, 2014.

Pharmacy Journal of New England • Winter 2015

What is the Pharmacists’ Patient Care Process? The Pharmacists’ Patient Care Process uses a patient-centered approach that depends first and foremost on the pharmacist having an established relationship with the patient. This relationship supports engagement and effective communication with the patient, family members, and caregivers throughout the process. The process also involves the pharmacist working with prescribers and other practitioners to optimize patient health and medication outcomes (see sidebar). The follow-up step signals that patient care process is repeated with each and every patient encounter, and the frequency of follow-up depends on the acuity of the patient and the nature of their care. The level of intensity for each step will vary with the service provided, but the process should not vary. The process is intended to be used in all patient care settings, and while one pharmacist might be responsible for all the steps in some settings, in other settings, there may be more than one pharmacist involved at different stages of the process.

Pharmacist Involvement National pharmacy associations are currently working to facilitate implementation of the process across the profession, including developing case examples for different practice settings. The Accreditation Council for Pharmacy Education (ACPE) has incorporated the Pharmacists’ Patient Care Process into the Draft Standards 2016 revision for the Doctor of Pharmacy curriculum. These Standards will be considered for final approval at the January 2015 ACPE Board meeting and will be distributed profession-wide shortly thereafter. With the ACPE Standards revision, schools and colleges of pharmacy will be working to incorporate the process into the curriculum. ACPE-accredited continuing education providers will also be encouraged to incorporate the process into continuing education programming for pharmacists. You can play an important role in the adoption of this process. Start by reviewing the process and thinking about how closely the patient care process used in your practice mirrors this process. Talk to other pharmacists in your practice to make them aware of the process and to discuss

how the practice as a whole can adopt a consistent process of care. Consider how pharmacy technicians can be incorporated into aspects of the process such as data collection to improve the efficiency of the process. Share the process with other health care practitioners you work with to make them aware of it. Practice using the process and reflect on how effectively the process facilitated patient care. Share your experiences with other pharmacists in your practice, your colleagues, and at professional meetings. Incorporate the process into the teaching materials for students you precept on IPPEs, APPEs, and internships. Make sure that students have the opportunity to practice using the process in their patient care encounters. Students will be asking about the process so if you are a preceptor, it’s important to be prepared. Finally, watch for additional resources to assist you in the implementation and assessment of the pharmacists’ patient care process. Pharmacists are often called upon to describe the value they bring to the health care system. A unified, consistent patient care process is critical to measuring pharmacists’ value and advancing the profession as a whole in the evolving health system.

1The Joint Commission of Pharmacy Practitioners (JCPP) includes the following organizations: Academy of Managed Care Pharmacy, Accreditation Council for Pharmacy Education, American Association of Colleges of Pharmacy, American College of Apothecaries, American College of Clinical Pharmacy, American Pharmacists Association, American Society of Consultant Pharmacists, American Society of Health-System Pharmacists, National Association of Boards of Pharmacy, National Alliance of State Pharmacy Associations, and the National Community Pharmacists Association.




Pharmacists’ Patient Care Process Using principles of evidence-based practice, pharmacists: A. Collect The pharmacist assures the collection of necessary subjective and objective information about the patient in order to understand the relevant medical/medication history and clinical status of the patient. Information may be gathered and verified from multiple sources, including existing patient records, the patient, and other health care professionals. This process includes collecting:

• Engages the patient through education, empowerment, and self-management. • Supports care continuity, including follow-up and transitions of care as appropriate. D. Implement

• A current medication list and medication use history for prescription and nonprescription medications, herbal products, and other dietary supplements.

The pharmacist implements the care plan in collaboration with other health care professionals and the patient or caregiver. During the process of implementing the care plan, the pharmacist:

• Relevant health data that may include medical history, health and wellness information, biometric test results, and physical assessment findings.

• Addresses medication- and health-related problems and engages in preventive care strategies, including vaccine administration.

• Patient lifestyle habits, preferences and beliefs, health and functional goals, and socioeconomic factors that affect access to medications and other aspects of care.

• Initiates, modifies, discontinues, or administers medication therapy as authorized.

B. Assess The pharmacist assesses the information collected and analyzes the clinical effects of the patient’s therapy in the context of the patient’s overall health goals in order to identify and prioritize problems and achieve optimal care. This process includes assessing: • Each medication for appropriateness, effectiveness, safety, and patient adherence. • Health and functional status, risk factors, health data, cultural factors, health literacy, and access to medications or other aspects of care. • Immunization status and the need for preventive care and other health care services, where appropriate. C. Plan The pharmacist develops an individualized patient-centered care plan in collaboration with other health care professionals and the patient or caregiver that is evidence-based and cost effective. This process includes establishing a care plan that: • Addresses medication-related problems and optimizes medication therapy.


• Sets goals of therapy for achieving clinical outcomes in the context of the patient’s overall health care goals and access to care.

• Provides education and self-management training to the patient or caregiver. • Contributes to coordination of care, including the referral or transition of the patient to another health care professional. • Schedules follow-up care as needed to achieve goals of therapy. E. Follow-up: Monitor and Evaluate The pharmacist monitors and evaluates the effectiveness of the care plan and modifies the plan in collaboration with other health care professionals and the patient or caregiver as needed. This process includes the continuous monitoring and evaluation of: • Medication appropriateness, effectiveness, and safety and patient adherence through available health data, biometric test results, and patient feedback. • Clinical endpoints that contribute to the patient’s overall health.

Outcomes of care including progress toward or the achievement of goals of therapy.

Pharmacy Marketing Group

Rx and the Law

Pharmacy Journal of New England • Winter 2015

Law VS Ethics

about the “reasonable person”. What would a reasonably prudent pharmacist have done in your situation? This is the measuring stick for situations where black and white laws don’t exist, which is most of the time. These situations make pharmacists nervous because there may not be one “right” answer. Most likely there will be a best answer. Many people wish that more laws were simple right or wrong choices, but the reality is that our society is too complicated for such laws. Changing one little factor in a scenario may drastically change your conclusion.

I recently attended a conference which had some very thought-provoking sessions. While the conference was billed

Look at this list of issues if you think that pharmacists aren’t faced with ethical decisions:

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.

as a pharmacy law conference, ethical issues kept percolating to the surface. What is the difference between law and ethics? Why should I care? What impact can ethics have on pharmacy practice? We should care because law and ethics work together to maintain our society. Law is a rule of conduct that is formally recognized by a society as binding and is enforced by that society. Ethics on the other hand is less structured and less formal. As a professional, pharmacists must use their professional skills for the benefit of their patients. Ethics involves the decision-making process required to treat patients. Many times the choices faced are not dealt with directly by laws. Some commentators view laws as the baseline for professional conduct. This must mean that there is some advanced mode of practice that exceeds the requirements of the law. For example, if a pharmacist is required to undergo an annual skills assessment, there would be nothing to prevent the assessment being done every six months if it was thought that it provided better care for the patient. It still complies with the requirement set by law. The cost/benefit analysis and the decision-making process that ensues to decide if every six months is warranted is where ethics comes into play. Some pharmacists don’t believe that ethical questions will affect them. They follow the law every day and that will suffice. However, there is a limitation on the effectiveness of the law. Law tends to be reactionary, not proactive. Law deals with yesterday’s problems, not tomorrow’s. Also, law is limited. There are not laws to address every single issue that comes up in today’s society. If there were, our code books would be enormous. This is why lawyers are always talking

- Should pharmacists be involved in the dispensing of Medical Marijuana? - Should pharmacies sell alcohol or tobacco products? - Should pharmacists take part in executions by lethal injection? - Should pharmacists have the right to refuse to dispense drugs based on their personal morals? - Should pharmacists dispense drugs for assisted suicide? Depending on your state, most of these activities are legal. If following the law is your only criteria, then there is little to debate here. But, ethical questions can arise because of a number of different reasons. It could be a conflict between the pharmacist’s moral values and the law. It could be competing laws that don’t coincide leaving the individual to try to reconcile the two different laws. They might also arise when there is no applicable law at all. Ethical questions might also arise when a patient’s needs cannot be met within the legal guidelines. Chances are that we are all going to be faced with these types of choices at some point in our professional lives. Take time to prepare before you are faced with an urgent decision. There are plenty of references available that explain the principles of ethics and the decision-making process. When you are better prepared, the challenges are easier to handle. The ostrich approach is not going to prepare you well. Pharmacists are required to study the applicable laws. They should also study ethics because law and ethics work hand in hand. Neither alone is sufficient for pharmacists’ practices in the 21st Century. 19

Financial Forum Pat Reding and Bo Schnurr may be reached at 800-288-6669 or

IRA Rollovers for Lump Sum Pension Payouts Give those Dollars the Opportunity for Further Tax-Deferred Growth A big payout leads to a big question. If you are taking a lump sum pension payout from your former employer, what is the next step for that money? It will be integral to your retirement; how can you make it work harder for you? Rolling it over might be the right thing to do. If you don’t have substantial retirement savings, that lump sum may be just what you need. The key is to plan to keep it growing. That money shouldn’t just sit there. Even tame inflation whittles away at the value of money over time. Most corporate pension payments aren’t inflation-indexed, so those monthly payments eventually purchase less and less. Lump sums are just as susceptible: if you receive $100,000 today, that $100,000 will buy 50% less by 2028 assuming consistent 3% inflation (and that is quite an optimistic assumption).1,2 Putting it in the bank might cause you some financial pain. If you just take your lump sum payout and deposit it, all that money will be considered taxable income by the IRS. (There are very few exceptions to that rule.) Moreover, you won’t get the whole amount that way: per IRS regulations, your employer must withhold 20% of it.2,3 Don’t you want to postpone paying taxes on those assets? By arranging a rollover of your lump sum distribution to a traditional IRA, you may defer tax on those dollars. You can even defer tax on a distribution already paid to you if you roll over the taxable amount to an IRA within 60 days after receipt of the payout.3 In doing so, you are keeping those assets in a tax-deferred account. They can be invested as you like, and that money will not be taxed until it is withdrawn. (You may only transfer 20

a lump sum distribution from a company pension plan into a traditional IRA – you may not transfer it to a Roth IRA.)4 If you are considering taking a lump sum payout, make sure you position that money for additional tax-deferred growth. Talk to a financial professional who can help you with the paperwork and get your IRA rollover going.

Citations. 1 - [9/1/12] 2 - [9/11] 3 - [1/4/13] 4 - manageretirement2.htm [1/21/13]

Pat Reding and Bo Schnurr may be reached at 800-288-6669 or 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.

Register Today! MPhA Spring Conference April 30, 2015 Four Points by Sheraton, Norwood, MA

From the Colleges

Pharmacy Journal of New England • Winter 2015

University of St. Joseph School of Pharmacy Message from the Dean Dear Colleagues: Greetings and Happy New Year! We have all traversed several milestones in the past year. Let us appreciate these wonderful journeys, and be hopeful about the many more to come. Thank you for your continuous support and well wishes. – Dean Joseph R. Ofosu

New Appointment: Andrea Leschak, Pharm.D., Assistant Professor, Department of On Dec. 2, 2014, the Hartford Business Journal honored Pharmacy Practice and Administration eight Connecticut health care professionals for their comDr. Leschak is a Pharm.D. graduate of Mercer University. As a mitment to helping others during the publication’s annual Health Care Heroes Awards at the Connecticut Convention testament to the diversity of opportunities for pharmacists, Dr. Leschak has experience in a number of different settings: Center in Hartford. These Awards identify outstanding leaders in the health care industry who are the epitome of a community pharmacy, working abroad as a contractor with “hero.” Winners were also recognized in a special issue of the the US Army, and as a consultant in long term care. With Hartford Business Journal on Dec. 8th. more than twenty years serving as a pharmacist, she is able to draw on a lifetime of experience, to present first-hand accounts of moments learned from both failures and successes, which helps her connect with her students. In Dr. Leschak’s own words: “They understand that I teach evidence based practices enhanced by insight I gained from years in the profession.”

“This year’s honorees are truly heroes in the health care industry, and phenomenal leaders in their respective fields,” said Joe Zwiebel, founding publisher of the Hartford Business Journal. “We are proud to have these eight fantastic individuals as part of our outstanding health care team in the State of Connecticut.” The Dean’s comment about winning the award was, “For me, I happen to accept it for the TEAM we have built here and OUR collective effort.”

University of Saint Joseph Honors “Preceptors of the Year” The University of Saint Joseph (USJ) School of Pharmacy hosted its annual Preceptor of the Year Award Ceremony on October 28, 2014 honoring Stephen R. Cofone, R.Ph. and Jacqueline M. Murphy, R.Ph. As experiential education professionals, pharmacist preceptors teach students practice-related skills necessary to provide quality pharmacist care. In addition to serving as teachers, pharmacist preceptors mentor student pharmacists, promoting personal and professional growth. Jacqueline Murphy, R.Ph., a 1978 graduate of the University of Connecticut School of Pharmacy, works as a community pharmacist at Hancock Pharmacy at Long Wharf in New Haven, CT. She holds advanced degrees from the Hartford Graduate Center and Fairfield University. Stephen R. Cofone, R.Ph. is a pharmacist at Lawrence & Memorial Hospital, a position he has held for 17 years. He is a graduate of the University of Rhode Island College of Pharmacy, and the 2013 recipient of their Preceptor of the Year Award. 21

From the Colleges


University of Connecticut School of Pharmacy School Designated as Evidence-Based Practice Center The UConn School of Pharmacy received a five-year designation as an Evidence-based Practice Center (EPC) from the Agency for Healthcare Research and Quality (AHRQ) to conduct research that assesses outcomes, comparative effectiveness and appropriateness of drugs, devices, and health care services. The systematic review research generated by these centers is used by the Centers for Medicaid and Medicare Services (CMS) in making health coverage and performance measure decisions that affects millions of patients nationwide. In addition, EPCs work with over 25 national medical, nursing, and pharmacy organizations to develop the evidence base for national guidelines for the care of patients that impacts care nationally. Co-directors C. Michael White and Craig Coleman anticipate that annual project funding will be in the $1 million dollar range and will consist of three projects per year. Projects under the Affordable Care Act could be as high as $3 to $5 million dollars annually. Other EPCs currently in the program include Brown, Vanderbilt, UNC, Oregon Health Sciences, Johns Hopkins, and USC, among others. UConn is the only university EPC that is not housed in a School of Medicine. The UConn EPC is part of the Health Outcomes, Policy, and Economics (HOPES) collaborative group. They, along with other faculty members and research fellows, use meta-analysis and economic models to look at the comparative effec-


tiveness of certain drugs or to assess the long-term economic benefits to the health care system of, for example, choosing one drug over another. Some members of the collaborative have specific research interests. White, for example, conducted studies in cardiothoracic surgery and the use of statins. Coleman, on the other hand, considers himself to be “disease-state agnostic.” He is intrigued by study design and current methodology including ‘network meta-analysis’ that allows researchers to compare like drugs head-to-head, rather than matching them against placebos. Coleman takes pride in the fact that the group has a reputation for delivering results on-time and within budget. He also appreciates the opportunities to work with fellows and students in small group settings. “I like that our students have the chance to be actively engaged in real research and are not only working on mock projects.” These projects can have long-term effects not only from a cost-savings standpoint, but also on patient health and safety. Link to C. Michael White discussing the EPC on Fox Connecticut:

Pharmacy Journal of New England • Winter 2015

Massachusetts College of Pharmacy and Health Sciences – Boston

their plans to complete: medical school, graduate programs in neuropharmacology, positions in rehabilitation/long-term care, and residencies in pharmacy practice, managed care, ambulatory care, infectious disease, cardiology, transplant, and psychiatry.

Dear Colleagues, On behalf of President Charles F. Monahan Jr. and Provost Douglas Pisano, I hope that 2015 finds you well. As usual our students have been very busy and I would like to share some of their achievements with you. Sincerely, Paul DiFrancesco EdD, MPA, RPh, Dean, School of Pharmacy Boston

Dean Paul DiFrancesco

MCPHS University School of Pharmacy Honors Program MCPHS-School of Pharmacy-Boston established an Honors Program in our Doctor of Pharmacy program to enhance students’ experience with advanced experiences in research and practice over the last three years of their PharmD curriculum. We are pleased to announce the graduation of our first class from the program. The upcoming graduates of the Pharm D Honors Program Class of 2015 are: Francis Cannata, Joseph Faulhaber, Michael Fiore, Janet Kim, Cassandra Letho, Stephanie Lewis, Jagoda Misniakiewicz, Shatha Mufti, Chandni Patel and Elizabeth Travis. These students have made significant contributions to their community and future profession , from publications (two published, three submitted, and several in progress), and nine poster presentations at national and regional meetings. Three students held presidential positions in the local chapters of major pharmacy organizations (Rho Chi Honors Society, APhA-ASP, and AMCP), and two students participated in the International Pharmaceutical Students’ Federation Student Exchange Program (Switzerland and Germany). The students were recognized for their initiative and work when all students were inducted into the Rho Chi Honors Society, 80% were inducted into the Phi Kappa Phi Honors Society, and 20% were inducted into the Sigma Xi Scientific Research Society. We look forward to witnessing all that these students will contribute to the future of health care as they pursue

School of Pharmacy Honors Program -Class of 2015

New Faculty members As our programs continue to grow, as does our highly experienced faculty. The following faculty members have joined us. Dr. Ted Eguale has joined the faculty as an Associate Professor of Social and Administrative Sciences. He received his MD from the Jimma University in Ethiopia and his M.S. and Ph.D. degrees in epidemiology, biostatistics and occupational health from McGill University in Montreal, Quebec. He also completed postdoctoral fellowships at McGill and Brigham and Women’s Hospital / Harvard Medical School. His area of expertise includes off-label prescribing, pharmacosurveillance, patient safety, electronic prescribing and medication safety. Dr. Hongwei Zhang has recently joined us as an Assistant Professor of Pharmaceutics in the Department of Pharmaceutical Sciences. Zhang received his B.S. in Pharmacy and PhD in Pharmaceutics from the Sichuan University in China. He then completed a postdoctoral research fellowship at University of Nebraska Medical Center, School of Pharmacy in the Center for Drug Delivery and Nanomedicine. He then continued his postdoctoral research at the Gene Therapy Center at the University of Massachusetts Medical Center in Worcester, MA 23

From the Colleges


Massachusetts College of Pharmacy and Health Sciences – Worcester/Manchester The faculty and staff are excited to welcome the class of 2017 to SOP-Worcester/Manchester. It is always wonderful to experience all the energy and enthusiasm that the new students bring. This energy helps reenergize the faculty and makes them excited to begin the educative process of a new generation of pharmacists. I hope that everyone has a successful beginning to the semester and a productive new year.

Evan R. Horton, Anna Morin, Helen C. Pervanas, S. Mimi Mukherjee, Paul Belliveau. A Novel Structured Format for Engaging Pharmacy Students in Bioethics Discussions. AJPE 2014;78 (9) Article 171

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

Poster Presentations

Grant Awards

Furgal E, Ko J, Lu J, Desmond A, Bartlett D, Juengel K, Evans P. Pharmacy student initiative to increase awareness of Medicare’s Limited Income NET Program. ASCP Annual Meeting, Orlando, FL. November 2014.

Colleen Massey, Paula Evans, and Donna Bartlett received a City of Boston Agency on Aging Title III grant for a project titled “Ask the Pharmacist” Medication Management and Safety. Funding period: Oct. 1, 2014-Sept. 30, 2015. $13,500. Chase Smith received a grant to attend the “National Library of Medicine Georgia Biomedical Informatics Course” hosted by the Georgia Regents University. (Dates: 9/14-9/20, 2014). The course reviewed the application of information science in biomedicine and health science and covered fundamental concepts and application areas of biomedical informatics.

Publications Karyn Sullivan, Ann Charrette, Colleen Massey, Donna Bartlett, Carrie Walker, Irena Bond, Paula Bylaska-Davies, Natalie Scheidt, Jeff Fong. Interprofessional education with a community fall prevention event. Journal of Interprofessional Care. Published online on October 14, 2014


Kara Bonaceto, Sheila Seed, Ann Charrette, Janna KucharskiHoward, Karyn Sullivan. Balance, Movement and Wellness (BMW) Center: a pilot project for interprofessional education on an advanced pharmacy practice experience. AACP Experiential Education Section Newsletter. Fall 2014;1(2):4-5.

Podium Presentations at ASHP Midyear Timothy Aungst, Aimon Miranda. “Integration of Mobile Technology into Pharmacy Practice: What does mHealth mean for Pharmacy?” ASHP 49th Midyear Clinical Meeting, Anaheim, CA. “Integrating Mobile Technology Into The Scientific Environment,”Mobile Applications Driving Data Efficiencies – Webinar, The Scientist

Jennifer Rodis, Timothy Dy Aungst. Perception and knowledge of medical apps between first, second, and third year student pharmacists. ASHP Midyear Clinical Meeting. Bryan Nguyen, Timothy Aungst. “Evaluating drug identifying mobile medical apps.” ASHP Midyear Clinical Meeting. Al-Najjar L, Morrill AM, Willett KC. Review of the Available Reversal Agents for Target Specific Oral Anticoagulants. ASHP Pharmacists Mid-Year Clinical Meeting. December 2014. Chen HY, Pervanas HC. Evaluation of student pharmacists participation in an interactive event to educate teens about substance abuse. American College of Clinical Pharmacy Annual Meeting. Austin, TX October 2014. Callahan CP, Spooner LR, Abel C, Durand C, Spooner L. Pharmacist-provided medication therapy management (MTM) pilot program at a unique setting for a medically complex and aging HIV positive population. American College of Clinical Pharmacy Annual Meeting. Austin, TX October 2014.

Pharmacy Journal of New England • Winter 2015

University of New England UNE Joins Greater Portland Health Study Collaborative

James Krebs and Kayla Stewart interviewed for Dr. Lisa Radio Hour

The University of New England has joined a collaborative of Greater Portland businesses and nonprofits that will receive a $50,000 grant to study the possibility of growing a health information business cluster in the Portland area.

James Krebs, Pharm.D., assistant dean of Experiential Education in UNE’s College of Pharmacy, and Kayla Stewart, Pharm.D., graduate of the UNE College of Pharmacy Class of 2014, were recently interviewed for the Dr. Lisa Radio Hour, a local radio show and podcast.

The study, called the “Health Informatics Assessment Project,” will examine what kind of educational programs and training are necessary to grow the health informatics industry. The field of health informatics involves keeping, processing, and analyzing medical records, helping medical professionals make more informed decisions about patients. UNE is one of several higher educational institutions in the collaborative, including Southern Maine Community College, St. Joseph’s College in Standish, University of Southern Maine, and Kaplan.

Nancy Moua elected Member-at-Large for American Pharmacists Association Academy of Student Pharmacists Nancy Moua, College of Pharmacy Class of 2017, was elected Member-at-Large for Region 1 of the American Pharmacists Association Academy of Student Pharmacists (APhA-ASP) at the recent Midyear Regional Meeting in Albany, New York. Moua will represent Maine, New Hampshire, Vermont, Massachusetts, Rhode Island, Connecticut and New York as a regional officer of APhA-ASP. As Member-at-Large, Moua will be responsible for responding to the needs of members within Region 1 to ensure adequate communication

Krebs and Stewart discussed the partnership between the University of New England and Apothecary By Design and how it leads to economic development and retention of young professionals in Maine. A recording of the interview is available at themainemag. com/radio.

UNE Student Society of Health-System Pharmacy and Visiting Nurses Association provide screenings and vaccinations to community members The UNE Student Society of Health-System Pharmacy partnered with the Visiting Nurses Association (VNA) to administer blood pressure screenings and flu vaccinations to the community at Sacred Heart Church in Portland, Maine on October 26th. Under the supervision of a licensed pharmacist, students provided medication reviews and discussed the Vials for Life initiative with patients. This free program, designed for seniors and individuals with serious medical conditions, provides pertinent medical information to emergency personnel who respond to and treat home emergencies. More than 40 patients were counseled at the event, and more than 200 have received services so far this semester in collaboration with the VNA.

between chapters in regards to membership, patient care, and APhA-ASP activities. “We’re all very proud of Nancy’s accomplishments. She’ll represent the College of Pharmacy and Region 1 with enthusiasm and dedication,” said Deborah Sturpe, Pharm.D., M.A., B.C.P.S., associate clinical professor in UNE’s College of Pharmacy.


From the Colleges


Awards and Honors Jessica Dizon and Andrew Sedano to Participate in 2015 National Association of Chain Drug Stores RxImpact Day Jessica Dizon, College of Pharmacy ’15, and Andres Sedano, College of Pharmacy ’17, have been selected to participate in the 2015 National Association of Chain Drug Stores (NACDS) RxImpact Day in Washington, DC. This event aims to train the next generation of pharmacy leaders and advocates. Dizon and Sedano will be advocating for two congressional bills: one that would increase access to Medication Therapy Management for Medicare beneficiaries, and another that would amend the Social Security Act to include pharmacists as providers, enabling patients to access and pay for pharmacist services. “The application process was very competitive, and only 60 students were selected for this opportunity nationwide,” said Kenneth McCall, B.S.Pharm, Pharm.D., Chair of UNE’s Department of Pharmacy. “We are very fortunate to have two outstanding pharmacy students from the University of New England participating in this event.

Edward Bilsky and Christian Teter present pharmacology information at Biddeford High School Edward Bilsky, Ph.D., professor of Pharmacology, vice president for Research and Scholarship, and Christian J. Teter, Pharm.D., BCPP, associate professor of Pharmacology, presented findings about the dangers of pharmaceutical drugs at a forum for high school students and their parents at Biddeford High School on November 12. During the presentation, Bilsky provided data and statistics about the rise of prescription drug sales and overdoses from 1999-2010. He explained the dangers of opiates, and advocated for exercising caution with any type of drug. Teter continued by discussing the adverse short and longterm effects that marijuana use can have for teenagers. He suggested that more research needs to be done to assess its medical benefits and risks for the adult population. 26

UNE College of Pharmacy Generation Rx students work to prevent prescription medication abuse Last week, College of Pharmacy students from UNE’s Generation Rx group traveled to the Biddeford campus to share information with students about the dangerous effects of combining medicines belonging to certain classifications of drugs. Generation Rx is an educational program facilitated by the American Pharmacists Association Academy of Student Pharmacists (APhA-ASP) to increase public awareness of prescription medication abuse. It encourages health care providers, community leaders, parents, teens and college students to actively work to prevent future abuse. According to Pharm.D. ’16 candidate Katherine Freudenberger, “We’re trying to bring awareness to the fact that even though you might be taking multiple prescriptions, it’s always a good idea to make sure you double check with your physician and pharmacist about possible interactions to improve patient safety.”

Karen Houseknecht to attend The National Institute of Diabetes and Digestive Kidney Diseases Principle Investigator Workshop Karen Houseknecht, Ph.D., professor of Pharmacology, attended The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Principle Investigator Workshop in Bethesda, MD on December 2-3, 2014. This workshop targets new principle investigators of R01 research grants, and includes discussions on grant strategy and funding opportunities with program officers of NIDDK. Houseknecht is the principle investigator of a four-year RO1 grant focusing on molecular mechanisms that cause adverse endocrine and metabolic side effects with atypical antipsychotic medications.

Pharmacy Journal of New England • Winter 2015

Edward Li to speak about biosimilars at two national pharmacy events in December Edward Li, Pharm.D., BCOP, associate professor in the Department of Pharmacy Practice at the UNE College of Pharmacy, was invited to share his expertise on biosimilars at two national meetings in December: On December 5, Li presented, “Biosimilar Regulation and Edward Li Development in the United States” at the American Society of Hematology Meeting & Exposition in San Francisco, California. From December 7- 8, , Li spoke on three topics at the American Society of Health-System Pharmacists Midyear Clinical Meeting in Anaheim, California: o “Introduction of Biosimilars to the United States Market: Are You Ready?” o “Biosimilars in the United States: Critical Updates for Pharmacists.” o “How Can We Ensure Efficacy, Safety, and Traceability of Biosimilars?” Biosimilars are officially approved copies, or “highly similar” versions, of biopharmaceutical products.

College of Pharmacy Leadership Society partners with The Opportunity Alliance to benefit children UNE’s College of Pharmacy Leadership Society, Phi Lambda Sigma (PLS), partnered again this year with The Opportunity Alliance to help fulfill the wish-list of many less-fortunate children. This year’s “Adopt-a-Child for the Holidays” gift drive touched the lives of children and teens either in foster care or homeless youth services, or whose families are in desperate financial situations including recently widowed parents, impoverished families trying to move or stay out of local shelters and special needs children with developmental disorders or mental health issues. Without this gift

drive, most of these children would not have anything for the holiday season. More than 100 children benefited from the generous help and donations of students, faculty and friends of UNE. Devon Sherwood, Pharm.D., BCPP, associate professor and clinical Psychopharmacology specialist, founded the program in 2011, and donations have increased each year through devoted efforts of student PLS members, also known as “Santa’s Elves”. College of Pharmacy Dean Gayle Brazeau gave special thanks to Sherwood for being a faculty advisor, PLS Adopt-A-Child Committee Co-Chairs Silpa Nunna and Katie Eastman, and all student members of the UNE PLS Chapter.

Ada and Donald Olins win Diatome Award for work in microscopy Ada Olins, Ph.D., and Donald Olins, Ph.D., both research professors in the Department of Pharmaceutical Sciences, were recently awarded third-place in the Annual Diatome Award for their poster “ELCS in Ice: Cryo-electron Microscopy of Nuclear Envelope-Limited Chromatin Sheets.” A total of 454 posters were entered into this year’s competition. Over the last 20 years, the Diatome Award, given at the Microscopy Society of America’s annual meeting, recognizes scientists who produce new, enlightening work in microscopy.

Ala and Donald Olins


From the Colleges


Kenneth McCall selected to receive American Pharmacists Association Immunization Champion Award Kenneth McCall, BSPharm, Pharm.D., associate professor for the Department of Pharmacy Practice, was selected as the National Winner recipient of the American Pharmacists Association (APhA) Immunization Champion Award in the category of Individual Practitioner. The APhA Immunization Champion Awards recognize individuals and organizations within the profession of pharmacy that have made extraordinary contributions towards improved vaccination rates within their communities. McCall was selected out of more than 80 nominees from across the nation. He will receive his award during a presentation at the APhA Annual Meeting on March 29, 2015, from 5:30–7 p.m. at the Hilton San Diego Bayfront-Indigo in San Diego, California.

UNE partnership with Apothecary by Design featured in MaineBiz The partnership between UNE’s College of Pharmacy and Apothecary by Design was featured in MaineBiz in January for its role in keeping knowledgeable, talented employees in Maine. The article discussed the difficulty faced by Maine businesses to recruit and maintain quality labor in the state. UNE was credited for contributing to Apothecary by Design’s continued growth by supplying four students who were later hired full-time, five part-time employees, and more than 50 interns. The partnership, which began in 2009, provides students with hands-on experience, while allowing the company to evaluate how those students perform in a professional pharmacy setting. This cooperation benefits students, businesses and the local economy by training and hiring the next generation of pharmacists. To read the full article, please visit the Mainebiz website.

Save the Date! September 24 & 25, 2015 The biggest New England Pharmacists Convention ever-in the middle of football season!

Gillette Stadium

Foxboro, MA

Home of the Champion New England Patriots More info to come soon! 28

Continuing Education for Pharmacists The Role of the USP in Setting Enforceable Quality Standards for Medicine By: Gordon R. Johnston, R.Ph., Section Chair (Generic Pharmaceutical Association) Barbara J. Ferguson (New Jersey Pharmaceutical Quality Control Association) N. Lee Rucker, M.S.P.H (AARP) Joseph G. Valentino, J.D. (Honorary Member) # 0106-0000-15-020-H04-P (1.5 CEUs)

Learning Objectives: At the conclusion of this lesson, successful participants should be able to: 1. Discuss the current status of USP standards and the deficiencies that exist in the USP and NF 2. Explain the challenges USP is facing in acquiring and maintaining sound public standards and some approaches taken to address these challenges 3. Describe how USP is moving towards more harmonized standards

Introduction For nearly two hundred years, the United States Pharmacopeial Convention (Convention or USP) has worked to set quality standards for drugs (medicines and their ingredients). Much has changed during that period, including the globalization of the pharmaceutical industry, ongoing availability of better drugs to promote health and treat disease, demands for access to good quality medicines, systems that deliver interchangeable multi-source products after periods of patent and market protection, advances in measurement and manufacturing science, and calls for regulatory and compendial harmonization. In these contexts, USP’s public standards continue to play an important role in assuring both practitioners and patients that the medicines they use are of good quality relative to their safety and efficacy. If anything, recent events such as the rise in counterfeit and substandard medicines and adulteration crises (diethylene glycol, melamine, heparin) have heightened concerns about the quality of drugs, and reinforced the importance of USP’s public standards as part of the safety net that protects practitioners and patients in the U.S. and elsewhere. USP’s standard-setting activities have a long and

distinguished history. At the first meeting of the Convention in 1820, the convening practitioners established recipes for the first Pharmacopeia of the United States of America (United States Pharmacopeia or USP). These recipes were used in the preparation of medicines to assure their consistency— process standards for articles of medicinal commerce. In the latter part of the 19th century, Charles Rice, Chair of the Committee of Revision (predecessor of the Council of Experts), transformed the United States Pharmacopeia from a book of recipes to a book of tests with procedures and acceptance criteria for medicines and their ingredients—product standards for articles of medicinal commerce. The National Formulary (NF), originally a repository for preparations deleted from the USP when such preparations were deemed less effective, later became a compendium of excipient product standards. NF was acquired by the Convention in the 1970s, and USPNF is published now as a combined text of documentary standards. In the early part of the 20th century, the Convention began offering reference materials to assist analysts in the conduct of monograph procedures. Today the procedures for all monographs in USP-NF are likely to (or should) have an allied reference material. USP’s drug standards are given special force by their longstanding recognition in U.S. law. In the 1906 Pure Food and Drug Act, Congress created a role for the Federal government to enforce (assess conformity to) Convention standards by naming USP as an official compendium of the United States. Congress strengthened this role in the 1938 Federal Food, Drug, and Cosmetic Act (FDCA) and made USP’s standards enforceable by the newly-created Food and Drug Administration (FDA) under the adulteration and misbranding provisions of the FDCA. NF was subsequently added as well as an official compendium of the United 29

Continuing Education for Pharmacists continued States. Today, the FDCA continues to mandate compliance with USP-NF standards, giving them broad impact across both the innovator and generic pharmaceutical industry. This legal status and the public-private partnership between the United States Federal government and USP created through these laws reflects a societal agreement recognizing the importance of public standards for both manufactured and compounded medicines. Many state laws also recognize USP’s standards, reaffirming this societal agreement. With this history in mind and looking towards the future, the Council of the Convention Section on Quality of Manufactured Medicines describes in this white paper ways that USP might be further transformed to better fulfill its historic and legal role of establishing quality standards for drugs and helping to address current challenges in assuring a safe global drug supply. A general thesis of this white paper is that the original societal agreement reflected in Federal and state laws tying the Convention and FDA together in the early part of the 20th century must evolve in today’s environment to allow continued availability of public standards to help assure the quality of drugs. At the same time, modern measurement science allows opportunity for change that can transform USP and pave the way both for global harmonization and rapid detection of adulterated medicines. The Overview section below discusses the current status of USP standards, and the deficiencies that exist today in the USP and NF. The next section explains the challenges USP faces in acquiring and maintaining sound public standards. It also describes the innovative approaches USP has taken to address these challenges, and how USP is working to facilitate movement towards more harmonized standards while advancing the measurement science behind its standards. The last two sections explore the current societal problems of adulteration and contamination and ways that USP identity standards can play a role.

Overview and Current Status of USP Standards Although the complexity of the discovery, development, registration, and utilization processes for a medicine can be staggering, the concepts behind these processes are straightforward. A medicine and its ingredients must 30

have specified quality and be produced under good manufacturing practices. Based on consistency in quality attributes over time (sometimes termed “equivalence”) relative to clinical study materials, practitioners and patients can expect predictable safety and efficacy outcomes when a medicine is administered. For new drugs, quality attributes are developed and maintained privately as part of the new drug application process and eventually, if a manufacturer is willing to provide this information to USP, can become public standards in USP. The private and public standards contain tests, procedures, and acceptance criteria that form the specification for the article, for both the medicine itself and its ingredients. Those in Congress and at USP framing the societal agreement embodied in the legislation of 1906 and 1938 may have expected a public standard for all medicines legally marketed in the U.S. While that expectation is currently expressed in USP’s Board of Trustees strategic plan for the 2005-2010 cycle, it has not been realized. The table below indicates the current status of USP in terms of monographs in four stages: 1) approved drug articles where no monograph exists, 2) articles with newly acquired monographs that are not official, 3) articles with official monographs that need updating, and 4) articles with official monographs reflecting the state of the industry.

Monograph Acquisition and Modernization 1. CHALLENGES TO DEVELOPING AND MAINTAINING PUBLIC STANDARDS A key reason for the lack of up-to-date monographs in USP lies in the fact that USP has no way to compel information and receipt of candidate materials to support a public monograph. Via the FDA Freedom of Information Act exemptions at 21 CFR Part 20, FDA is prohibited from giving USP the private regulatory specification—a prohibition generally termed trade secret or data protection. Manufacturers may resist voluntary donation of needed information and materials because of: 1) the need for some time after market access for controls in the private specifications to finalize, 2) the involved resource burden, and 3) a desire to protect trade secret information. Moreover, despite the fact that the societal agreement reflected in federal law does not distinguish between single-source and multi-source drugs, the innovator industry sometimes questions the need and rationale for a public monograph

Pharmacy Journal of New England • Winter 2015

The numbers indicate that about 44% of USP is deficient-either because of articles for which there are no monographs (34%) or because of monographs that need updating (10%).

prior to generic entry. USP has been slow to develop a monograph in the absence of donated information and material because of the difficulty in developing suitable analytical procedures and certain science and technical constraints. For example, without knowledge of synthetic and degradation routes for a drug substance (active pharmaceutical ingredient or API), USP has little understanding of which impurities exist within a drug product or its ingredients. Similarly, understanding of degradant impurities requires special studies that are, for the most part, beyond USP’s capability to conduct. Patent barriers may limit access to and availability of certain reference materials. 2.


a. Alternative Monograph Development Paths One way in which USP has attempted to respond to its monograph acquisition challenges is to develop alternative pathways for monograph development. These allow greater flexibility for manufacturers and may enhance the usefulness of monographs to manufacturers, regulators, and— ultimately—practitioners and patients/consumers. • The flexible monograph moves away from a “one size fits all” approach for the monograph’s specification to an approach that allows differences in the tests, procedures and acceptance criteria of the monograph depending on routes of synthesis, differences in formulation, or other factors. This approach facilitates voluntary donation of information from multi-source manufacturers of pharmaceutical ingredients and products and reduces the likelihood of “lock-out” specifications from any single manufacturer.

• The pending monograph encourages voluntary submission of information and material to support a Webbased public monograph in advance of a regulatory decision, coupled with rapid advance to official status in USP at the time of regulatory approval. This approach is particularly applicable to multi-source manufacturers. • A non-U.S. monograph allows USP to develop Webbased monographs for medicines and their ingredients that are marketed outside the United States. This approach is an effort to provide standards for manufacturers and the public interested in having a sound public monograph irrespective of (and at times in the absence of) strong regulatory systems. Thus, these monographs may be of special value to manufacturers, purchasers and regulatory authorities in developing countries who are seeking assurance of quality. The program is limited now to medicines and their ingredients intended to treat neglected infectious disease, and thus has a very targeted public health focus. • The performance based monograph (PBM) is a new idea to USP, although the approach has been widely used by other industries. Conceptually, the model is straightforward. A PBM might consist of tests and acceptance criteria, as presented now, but the procedures of the monograph would not be specified. Instead criteria for an acceptable procedure would be provided, and over time a list of acceptable procedures would be made available. The approach is based on the availability of a qualified reference material, and this reference material preferably would be certified. The reference material would be the drug substance itself or an “equivalent” material, or one or more impurities. Taken together, the general approach has many


Continuing Education for Pharmacists continued

positive advantages as well as features that merit special consideration. From a global standpoint, the approach might allow rapid advance towards compendial harmonization. Only the tests and acceptance criteria would need to be harmonized— the procedures themselves would be the responsibility of manufacturers and their corresponding regulatory agencies. Any acceptable procedure would be allowed for determining if a medicine or its ingredients were suitable for use. And these procedures could be public or private, depending on the interests of involved parties. The relationship between these repositories can be clearly understood based on modern metrological principles and careful collaborative studies. The PBM approach is still in the exploratory stage and there are many important questions to be answered, including those related to FDA’s need for a default or referee procedure in a monograph to readily determine non-compliance with USP standards. While all of these opportunities are of interest and have some value, those implemented to date have not had a substantial impact on the acquisition of new monographs or the updating of existing monographs. Comparisons of monograph backlogs at the beginning and close of the 2005-2010 cycle 32

indicate a rise in the backlog (i.e. the number of articles for which there is no up-to-date monograph). b. SPONSOR OUTREACH AND PRIORITIZATION EFFORTS USP has increased its efforts in recent years to educate manufacturers as to USP’s role and the value of public standards. In order to lessen the resources required from manufacturers to provide needed information, USP has assisted with monograph development—including providing easy-to-use templates for monograph submission and furnishing USP staff on-site at a manufacturer’s facilities to work on monographs. Although these efforts seem to have been well-received, as the table above indicates they have not had an appreciable effect in increasing the development of USP standards. Understanding that the effort needed to correct all of the deficiencies in USP is an immense challenge, USP has made efforts to prioritize its monograph acquisition and modernization activities so that it can conduct more targeted outreach to manufacturers. This includes working with industry to identify those monographs that are of greatest importance in terms of public health impact. Such prioritization activities

Pharmacy Journal of New England • Winter 2015

help USP to more effectively utilize its acquisition resources, and make it easier for manufacturers to understand and allocate the resources requested of them for development of high-priority monographs. USP has also worked to expand the recognition it gives to sponsors of monographs and reference standards, so that it can more publicly acknowledge the contribution that monograph sponsors make to the public health. It is too early to tell whether these efforts will prove fruitful in increasing the quantity of monograph submissions. 3. INTERNATIONAL COMPENDIA AND COMPENDIA MODERNIZATION In today’s global pharmaceutical market, the desire and need of industry for harmonized standards and requirements have become more pressing, and USP has recognized this. Harmonization of regulatory requirements has occurred in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) for countries and regions with advanced drug regulatory systems, and at the World Health Organization (WHO) for all countries. The primary mechanism for compendial harmonization has been the Pharmacopoeial Discussion Group (PDG), begun through Convention impetus in 1989, which continues to this date and operates in connection with ICH. PDG includes representation from organizations that elaborate the major compendia of the world—the European Pharmacopoeia (European Department for the Quality of Medicine and Health Care or EDQM), the Japanese Pharmacopoeia (Ministry of Health, Labor, and Welfare or MHLW), and USP, with WHO as an observer. WHO itself continues to elaborate The International Pharmacopoeia, which focuses on essential medicines. PDG does not work to harmonize monographs for medicines or their active ingredients; rather, PDG has concentrated on excipient monographs and allied general chapters (with 40 monographs and 26 general chapters concluded to date) and other non-excipient general chapters. PDG-harmonized documents may undergo a further evaluation in ICH to become guidances to assist in developing the private regulatory specification for the ICH regulatory agencies (FDA, Japan’s MHLW, and the authorities of the European Union, including the European Medicines Agency). Recently, PDG participants agreed to continue and expand their work. However, the PDG process, which requires the pharmacopoeias to retroactively revise varying and conflict-

ing standards to achieve harmonization, remains slow and laborious. Moreover, although a 2005 Convention resolution encouraged USP to broaden harmonization efforts outside of PDG, for the most part this has not occurred as a PDG activity, although all major pharmacopoeias hope for and at times realize opportunities to work together. USP has been particularly vigorous in these activities in this cycle, reflecting the intent of prior Convention resolutions. Another harmonization opportunity has arisen through a pilot currently being conducted by USP and EDQM, known as “prospective harmonization,” in which a manufacturer works with USP and EDQM simultaneously on the development of a monograph and accompanying reference standard. The advantage of this approach is that a monograph would at least be harmonized between the European Pharmacopoeia and USP from the outset, avoiding the difficult process of attempting to harmonize such standards after the fact. In addition, because manufacturers benefit from obtaining a harmonized monograph through a single process, they may be willing to provide the necessary information and materials for such monograph and reference standards at an earlier stage in the life of the product. Although, again, it is far too soon to tell whether this new approach will be successful in significantly accelerating the development of harmonized monographs. Early phases of the pilot have proceeded well. Harmonization with less-developed pharmacopoeias may also be advanced through USP’s “adopt/adapt” approach. Under this activity (started in the 1990s with plans to reinvigorate the general approach), USP permits pharmacopoeias in regions with limited resources to incorporate USP monographs and general chapters in their own pharmacopoeias as they see fit. While the primary purpose of this initiative is to help these countries develop better standards for use with their domestic manufacturers and raise the standard of quality in these regions, it may also result in de facto harmonization between USP and other pharmacopoeias. MODERN MEASUREMENT SCIENCE In recent years, USP’s standard development activities have been aided by its growing understanding and application of measurement science—termed “metrology.” Metrology is the science of measurement and embraces both legal and 33

Continuing Education for Pharmacists continued fundamental aspects. The societal agreement created by Congress between FDA and USP relies on metrology, which in this context helps assure that a material is fit for its intended use; i.e., that a medicine may be used suitably by practitioners and patients to maintain health and treat disease. Today, modern measurement science undergirds the tests, procedures, and acceptance criteria in USP’s standards. Metrology originally was driven by needs of commerce, and commerce still is the major motivation for legal aspects of metrology. Fundamental metrology is of more academic interest and involves the establishment and realization of measurement units (such as the International System of Units or SI), research into new measurement methods, the development of measurement standards, and the transfer of metrological traceability throughout a measurement system. A country’s national metrology institute—in the United States, the National Institute of Standards and Technology—typically has statutory responsibility for a nation’s measurement system, including the advancement and maintenance of the nation’s primary standards. The interface of legal metrology and fundamental metrology is often called “applied metrology,” which concerns the application of measurement science to manufacturing, ensuring the suitability of measurement instruments, their calibration, and quality control of measurements. The Convention’s official compendia, USP and NF, represent the application of applied metrology, which includes both legal and fundamental metrology. Through staff and Council of Experts’ activities, the Convention has worked to enhance metrological science in USP. In part, the way has been made easier by a general movement of national drug control laboratories (official medicines control laboratories) towards International Organization for Standardization (ISO) 17025 and other standards. These standards encourage traceability of results to enhance consistency and reliability of measurements. A specific example of the Convention’s use of applied metrology is release of a certified reference material as an official USP Reference Standard by the Council of Experts Reference Standard Committee. Such certified reference materials may result in a better understanding of repositories of reference materials at the global (global primary), regional (regional primary), national (national primary), and manufacturer (secondary, house, or working standards) levels and their respective 34

uses to assess the quality of drugs in global commerce. They also allow manufacturers, regulators, and others to compare results across different procedures—a critical task now with supplier-purchaser relationships in question—and also assess contributions of manufacturing and analytical variability to avoid “out of specification” results.

Determining ‘Quality’ Medicines: Concepts of Adulteration and Identity In some respects, issues of adulterated or substandard medicine —and the challenges USP faces in trying to address these through compendial standards—are far from new. Even in the earliest edition of the USP, the presence of a recipe to assure consistency in the quality of what we would now term a “compounded medicine” could not protect against the possibility of a medicine that might be deemed unacceptable or adulterated. Efforts to protect patients gained great force in Congressional decisions of the early 20th century as the Federal government sought ways to remove medicines from the market that were unsafe, ineffective, and/or of substandard quality. Congress relied on the terms “adulteration” and “misbranding” in the FDCA, and it is in these provisions that USP and NF are specifically recognized as official compendia of the United States as a means of assessing adulterated or misbranded products. In modern terms, USP’s standards speak to the identity of a medicine, as well as its strength, quality, and purity—terms now comprised, through harmonization, under the overarching term “quality.” Our understanding of identity insofar as it relates to a medicine, its ingredients, and its packaging is rapidly evolving based on the science of spectroscopy. The use of both identity testing and spectroscopy to help combat today’s problems of substandard and intentionally adulterated drugs is addressed below. 1. ADULTERATION Over the years, many countries around the world, including the United States have been challenged by economically motivated adulteration. Examples include melamine in pet food and infant formula, oversulfated chondroitin sulfate in heparin, and diethylene glycol in glycerin. Such instances involve the deliberate substitution of a less costly substance for a more expensive one, resulting in patient harm and even death.

Pharmacy Journal of New England • Winter 2015

USP’s role in helping to address these challenges stems from its legal recognition and the requirement under the FDCA that medicines meet the identity, strength, quality, and purity standards in USP relative to an established name, as discussed more fully below. Even a well manufactured medicine may at times fail these standards and must be removed from the marketplace or risk a claim of adulteration. The approach is used daily by manufacturers (first parties), and information about it is often publicly available at Safety/Recalls/default.htm. The public-private partnership established by Congressional and Convention forebears a century ago thus works still today—quietly and without notice—when a manufacturer tests a batch to assure it meets requirements in USP or withdraws a drug from the marketplace when it does not. The matter becomes more challenging when manufacturers themselves may unknowingly or, worse, intentionally adulterate a medicine or its ingredients. Work at FDA and in the Convention is advancing approaches that rely on identity standards to reduce the likelihood of economically motivated adulteration. Placement of limits on known adulterants in the Identification test of a USP monograph requires manufacturers of a medicine to test to assure absence of the adulterant prior to use of a material in manufacturing. The approach relies on knowledge of the adulterant and thus is limited to known examples. Unfortunately, there are many other materials that might be used to adulterate a medicine, either for economic or other motivations, which at this time remain unknown. 2. IDENTITY PROVISIONS IN THE FDCA Identity standards (and related tests and reference standards) play an important role in defining or characterizing what is meant by a “drug” as defined in USP. The identity component of a compendial standard is distinct from the array of specifications related to strength, quality, and purity. Identity may not legally vary from the USP specifications, although strength, quality, and purity can, if a medicine is appropriately labeled. The 1906 Pure Food and Drug Act first officially recognized the role of USP standards for strength, quality, or purity in terms of defining when a drug would be deemed to be adulterated. The 1938 FDCA built on the 1906 Act with Section 501(b), which contains the more extensive, two-part,

modern, USP-related provisions related to adulteration:501(b) - “If it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium. Such determination as to strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in such compendium, . . . .” FDCA 501(b). The first section (underlined) creates an implicit compendial role in establishing standards for identity (i.e., is it, or is it not, the drug addressed in the compendium?). The second section (italicized) includes the explicit compendial role for standards related to strength, quality and purity (i.e., whether the drug measures up in terms of various quality parameters). FDA regulations subsequently established an important and unambiguous role for compendial standards of identity, and reflect the interconnection between the naming and identity authority in FDCA [at 502(e)] and the compendial adulteration standards [at 501(b)]. Part 299 of the Code of Federal FDA regulations concerns official and established names. One subsection in particular addresses the role of compendial naming and identity requirements, as well as other compendial standards; it has remained unchanged in FDA regulations since Part 299 was first promulgated in 1975 (40 Fed. Reg. 14041, March 27, 1975). Under FDCA and in Part 299, a drug with a name recognized in USP must comply with compendial identity standards or be deemed adulterated, misbranded, or both. Such drugs may vary in terms of strength, quality, or purity, if truthfully labeled [per FDCA 501(b)], but they may not vary from the compendial identity specified for such a drug. As noted above, USP has worked with FDA to leverage this distinctive role of identity standards to address recent cases of intentional adulteration. These recent efforts reaffirm the value of the public-private partnership created in law and reinforce the ongoing importance of public standards in today’s environment. 3. THE ROLE OF SPECTROSCOPY Identity frequently relies on use of portions of the electromagnetic spectrum to “see” an article —just as humans recognize each other (relative to their estab 35

Continuing Education for Pharmacists continued lished names) by sight —which relies on the visible portion of the electromagnetic spectrum. For wellmanufactured medicines, USP has long allowed the use of infrared (IR) spectra as a means of establishing identity in the USP Identification test (General Chapter <197> Spectrophotometric Identification Tests). And spectral images (photographs) have long been used by practitioners to identify medicines, e.g., Physician Desk Reference (PDR) photographs. Modern analytical instrumentation offers the opportunity to use far larger portions of the electromagnetic spectrum and with modern informatics and hand-held devices can now bring identity tests to any site on the globe for screening purposes. Using near-IR instrumentation, China’s government has led the way in the use of mobile vans and personnel to utilize this technology to check for counterfeit and substandard medicines. USP has considered using Raman spectroscopy to assess identity in the field, and pharmaceutical manufacturers have built non-public spectral libraries to allow rapid identification of incoming materials. Results typically require confirmation via more in-depth laboratory studies—as with the eye, instrumentation recognizes what it has seen before. Consequently, identification of materials used to adulterate for economic or other purposes require additional study. But even here, understanding of likely adulterants would pave the way for spectral libraries using repositories of likely and potentially dangerous adulterants. For episodes of intentional adulteration, such as the production of fake medicines (counterfeits), rapid reporting systems might allow the detection of outbreaks of poor quality manufacturing, just as we now identify outbreaks of infectious disease. Thus, scientific advances in instrumentation and informatics, linked with repositories of spectral images of legally marketed medicines (and their ingredients and packaging), coupled with spectral images of undesirable materials and medicines, allow understanding of identity in ways that would have amazed Convention forbears 100 years ago. At the same time, the use of “sight” to establish the identity of a medicine and its ingredients would have been entirely comprehensible to them. USP intends to continue the exploration of spectral libraries

as a potentially important weapon in the ongoing global battle against adulterated and substandard medications.

Conclusion This white paper suggests several avenues that might be pursued to help resolve current deficiencies in the availability of public monographs and reference materials, promote compendial harmonization, advance the availability of good quality medicines, and detect and deter adulterated (counterfeit/substandard) medicines. The basic approach remains the concept of a public monograph containing product standards for all legally marketed medicines and their ingredients, allied with publicly available reference materials. The procedures of the monograph would be clearly linked to and supported by global, regional, national, and manufacturer reference materials for both the medicine (drug product) and its ingredients and their packaging. Availability of this material would allow comparisons across procedures and yield results, where feasible, traceable to SI units. Public reference materials would be a public repository of chemicals and mixtures of chemicals reflective of legally marketed medicines and their ingredients. The repository would also include likely adulterants. The materials of the repository would be associated with spectral images drawn from the electromagnetic spectrum to allow screening to assure identity and to detect and deter adulterants. Many aspects of the approach are transformational. Yet none are beyond current scientific capability, nor would the general approach require major changes in policy, with possibly the exception of adjustment in barriers to the availability of reference materials. While full expression of the concept might await stronger global institutions, the approach could be implemented now nationally or regionally. The USP Convention might be a major advocate for advancing the general approach, working on the assumption that the Convention itself supports public standards for medicines and their ingredients—in the 21st century as it did in the 19th and 20th centuries—and recognizes the value of such standards in assuring patients and practitioners of good quality medicines. Reprinted with permission. Copyright 2009, The United States Pharmacopeial Convention. All rights reserved.


Continuing Education Quiz The Role of the USP in Setting Enforceable Quality Standards for Medicine 1. What percentage correctly represents the USP Monograph status for articles with newly acquired monographs that are not official? a. 4% b. 10% c. 34% d. 52%

2. Which type of alternative monograph development pathway moves away from the “one size fits all” approach?

a. European Department for the Quality of Medicine and Health Care (EDQM)


An example of adulteration is:


Melamine in pet food

b. (WHO)

b. Oversulfated chondroitin sulfate in heparin

c. Pharmacopoeial Discussion Group (PDG) d. (FDA)


Diethylene glycol in glycerin


All of the above

Food and Drug Administration

6. Which year did the Pharmacopoeial Discussion group begin?

10. Which of the following can NOT legally vary from the USP specifications? a. Strength

a. 1980

b. Identity

b. 1989

c. Quality

Pending monograph

c. 2000

d. Purity


Flexible monograph

d. 2009


Non-U.S. monograph

a. graph

Performance based mono-


3. The pending monograph approach is particularly applicable to which of the following? a.

Single source manufacturers


Multi source manufacturers


Regulatory authorities

d. Purchasers

4. Which of the following would need to be harmonized under compendial harmonization? a. Tests b.

Acceptance criteria

c. Procedures d. A+B

7. In “prospective harmonization” USP works simultaneously with which of the following? a. European Department for the Quality of Medicine and Health Care (EDQM) b. (WHO)

5. Who has been the primary mechanism for compendial harmonization?

World Health Organization

c. Pharmacopoeial Discussion Group (PDG) d. (FDA)

Food and Drug Administration

8. Which of the following is true regarding “metrology?” a. It is not considered a science, but a measurement b. It was originally driven by the needs of commerce c.


World Health Organization

It embraces only legal aspects

d. It embraces only fundamental aspects

11. Part 299 of the Code of Federal FDA regulations concerns which of the following? a. Purity b.

Truthful labeling

c. Strength d.

Official and established names

12. Which type of spectroscopy has USP considered using to assess identity in the field? a.

Raman spectroscopy


Laser spectroscopy


Mass spectroscopy


Electron spectroscopy

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Winter 2015 (1.5 hours - 0.15 CEUs) ACPE Program No. # 0106-0000-15-020-H04-P (1.5 CEUs)

Expiration Date 2/28/2018 Type of Activity: Knowledge

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Dear Pharmacists, Attached below is the link for the Community Pharmacy Workplace survey that the CPA, in collaboration with the Pharmacy Commission, has asked the University of Connecticut School of Pharmacy to develop. As you may recall, the CPA sent a letter to the Pharmacy Commission last November outlining isues about working conditions and metrics after hearing from a variety of concerned members. The Commission established a sub-committee task force to investigate. This survey will be the vehicle for pharmacists to supply data and information to the Task Force in an anonymous way that the Task Force can use to make recommendations. Here is the URL for the survey: This survey is confidential, anonymous, and we encourage you to share it, forward it, and ensure all your pharmacist friends and colleagues have the opportunity to participate if they so wish. As discussed above, in order to maintain the unbiased nature of a survey, CPA is working with an independent investigator from UConn, Lauren Schlesselman, PharmD, who designed the survey. Thank you, Connecticut Pharmacists Association



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