INNOVATIONS NABP Launches the - to Further Shield US Medical Supply Chain
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NEWSLET TER OF THE NATIONAL ASSOCIATION OF BOARDS OF PHARMACY® INNOVATIONS NABP Launches the to Further Shield US Medical Supply Chain F E B R U A R Y 2 017 VO L U M E 4 6 NUMBER 2
INNOVATIONS table of contents EXECUTIVE COMMITTEE 4 Legal Briefs Prescription Points 18 State Board News Virginia Passes Legislation Edward G. McGinley Philip P. Burgess Prohibited Related to DSCSA Chairperson Member, District 4 Hal Wand 9 Association News Board of Pharmacy Members 19 Professional Update Affairs Gary W. Dewhirst President Member, District 5 Gather at Interactive Forum CDC Brochure Offers to Discuss Common Pharmacists Tips for Jeanne D. Waggener Gay Dodson Challenges, Advance Their Addressing Opioid Abuse President-elect Member, District 6 Shared Mission and Overdose Susan Ksiazek Mark D. Johnston 12 NABP Cosponsors USP CPE Course to Help Licensees Treasurer Member, District 7 Meet Requirements of Timothy D. Fensky Chapter Richard B. Mazzoni Member, District 1 Member, District 8 Caroline D. Juran NABP Executive Member, District 2 Committee elections are held each year at the Jack W. “Jay” Association’s Annual Campbell Meeting. Member, District 3 Innovations (ISSN 2472-6850 – print; ISSN 2472-6958 – online) is published 10 times a year by the National Association of Boards of Pharmacy® (NABP®) to educate, to inform, and to communicate the objectives and programs of the Association and its 66 member boards of pharmacy. The opinions and views expressed in this publication do not necessarily 6 Feature News reflect the official views, opinions, or policies of NABP or any board NABP Launches the Verified-Accredited Device Integrity unless expressly so stated. The subscription rate is $70 per year. Program to Further Shield US Medical Supply Chain, Protect Public Health National Association of Boards of Pharmacy 1600 Feehanville Drive, Mount Prospect, IL 60056 • 847/391-4406 www.n a b p.p h a rm a cy • h e lp @ n a b p. p h a r m a c y Carmen A. Catizone Executive Director/Secretary Amy Suhajda Communications Manager ©2017 National Association of Boards of Pharmacy. All rights reserved. No part of this publication may be reproduced in any manner without the written permission of the executive director/ secretary of the National Association of Boards of Pharmacy. NABP Mission Statement NABP is the independent, international, and impartial association 15 113th Annual Meeting that assists its member boards and jurisdictions for the purpose of Prominent Political Journalist to Offer Perspective on Health protecting the public health. Care Regulation During Keynote Address February 2017 innovations |2
Association News Association News VIPPS-Accredited Pharmacies to Register, Use .Pharmacy Domain Names to Maintain Accreditation Status To further assist consumers in finding verification logos on authentic- ® safe online pharmacies and expand looking sites to trick unsuspecting the secure pharmacy community, consumers into thinking they are pharmacies accredited through visiting a legitimate online pharmacy. NABP’s Verified Internet Pharmacy With .pharmacy, the “seal of quality” accredited pharmacies are exempt Practice Sites® (VIPPS®) program will is built into the web address. from the .Pharmacy application fee and need to register and use a .pharmacy are automatically approved to register domain name through the .Pharmacy Top-Level Domain (TLD) Program. NABP believes .pharmacy domains for their accredited websites. However, the annual domain Beginning September 1, 2017, all VIPPS-accredited pharmacies must the .pharmacy name registration fee charged by registrars still applies. Registration fees register and use a .pharmacy domain name in order to maintain their verified TLD is the are approximately $1,050 per year and vary by registrar. accreditation status. way to turn the tide NABP began the process of consolidating NABP developed the VIPPS program in 1999 in response to concerns against sophisticated its Veterinary-Verified Internet Pharmacy Practice Sites® (Vet-VIPPS®) and from regulatory agencies regarding criminals who can e-Advertiser ApprovalCM programs the safety of internet pharmacy into the .Pharmacy TLD Program practices. For the last 17 years, easily duplicate in August 2016. VIPPS accreditation has been the gold standard for pharmacies with verification logos on All the websites that NABP operates an internet presence in the United have transitioned to a .pharmacy States. However, as online safety authentic-looking sites domain, including: and security challenges continue to evolve, NABP recognizes that its to trick unsuspecting • www.nabp.pharmacy internet programs, including VIPPS, must likewise evolve and progress to consumers. • www.awarerx.pharmacy • www.safe.pharmacy protect public health. NABP believes All VIPPS-accredited sites are • www.nabplaw.pharmacy the .pharmacy verified TLD is the way automatically eligible to register a to turn the tide against sophisticated domain name through the .Pharmacy The Association also transitioned to criminals who can easily duplicate TLD Program. In addition, VIPPS- .pharmacy email addresses. Newly Accredited VIPPS Facilities The following internet pharmacies were accredited through the NABP Verified Internet Pharmacy Practice Sites® (VIPPS®) program: Commcare Pharmacy FTL, LLC, Unicare Pharmacy, Inc, Vitalab Pharmacy, Inc, dba Commcare Specialty Pharmacy dba MedicoRx Specialty Pharmacy dba Vasco Rx Specialty Pharmacy www.commcarepharmacy.com www.medicorx.com www.vascorx.com A full listing of the accredited VIPPS pharmacy sites representing more than 12,000 pharmacies is available on the NABP website at www.nabp.pharmacy. www.nabp.pharmacy February 2017 innovations |3
Legal Briefs Prescription Points Prohibited B oards of pharmacy are incentive programs” to induce the legislatively delegated with purchase of pharmacy services, drugs, the authority to promulgate or devices from particular pharmacies rules/regulations using the or pharmacists. Specifically, incentive expertise of the board members to add was defined as “money, gifts, discounts, specificity to the practice act. Such rebates, refunds, customer loyalty rules/regulations provide necessary schemes, coupons, goods or rewards.” details to the law and give the board an The bylaws further stated: additional basis for enforcement in the interest of public protection. Because 15 (1) A registrant must not provide rules/regulations have the force of or distribute, or be a party to the law, they are promulgated following provision or distribution of, an specified administrative procedures incentive to a patient or patient’s that allow for notice, comment periods, representative for the purpose of and under some circumstances, inducing the patient or patient’s Attorney Dale J. Atkinson, JD, public hearings. Failure to adhere to representative to outside counsel for NABP, duly enacted statutes or promulgated (a) deliver a prescription to a is a partner in the law firm rules/regulations may subject the particular registrant or pharmacy of Atkinson & Atkinson. respondent to administrative or for dispensing of a drug or device criminal sanctions. specified in the prescription, or Professional standards and ethics are (b) obtain any other pharmacy areas ripe for the specificity of rules/ service from a particular regulations to which pharmacies and registrant or pharmacy. pharmacists must comply. One such area of potential regulation may include (2) Subsection (1) does not prevent a incentive programs offered to patients Failure to regarding where their prescriptions are registrant from filled. Award programs, bonus points, (a) providing free or discounted adhere to duly and other offers intended to incentivize parking to patients or patient’s enacted statutes or or induce patients to frequent pharmacies create interesting legal representatives, promulgated rules/ issues. Consider the following. (As this (b) providing free or discounted delivery services to patients or judicial ruling is from British Columbia, regulations may Canada, terms such as registrant patient’s representatives, or (rather than licensee), college (rather subject the respondent than board), and bylaw (rather than (c) accepting payment for drug or device by a credit or debit card rule/regulation) will be used throughout to administrative or this article. In addition, Schedule III that is linked to an incentive. drugs in British Columbia are drugs criminal sanctions. that may be sold by a pharmacist to (3) Subsection (1) does not apply in respect of a Schedule III drug or any person from the self-selection an unscheduled drug, unless the Professional Products Area of a drug has been prescribed by a licensed pharmacy.) practitioner. In 2013, the College of Pharmacists Such bylaws were unanimously of British Columbia (College) adopted by the College in September promulgated bylaws that prohibit 2013 and forwarded to the minister of pharmacies from making “customer health under administrative procedures. February 2017 innovations |4
The minister may declare the bylaws may promote increased prescriptions than is prudent or necessary or or a portion thereof to be disallowed. based upon awards. The College also convenient or because it is not Failure of the minister to timely address argued that incentive programs infringe accompanied by a qualification or a submitted bylaw will result in its on the counseling time on which patients an exception which some judges automatic adoption. The referenced rely and deserve. may think ought to be there. bylaws were adopted based upon the failure of the minister to timely act. The lower court held that there was Acting with a bona fide approach, no empirical evidence of harm and the College determined that incentive Shortly after their adoption, the bylaws that the bylaws were more broad than programs created a public health were challenged through a judicial filing necessary. As a result, it struck down concern and that there was some initiated by the operators of Safeway and the entire bylaws as unreasonable. anecdotal evidence to support this Thrifty Foods stores (collectively referred notion. Further, at least one additional to as Petitioners). The Petitioners The College appealed the decision, province had adopted such a alleged that the purpose of the bylaw arguing that the lower court erred on prohibition. Taking into consideration amendments was to prevent patients its interpretation and application of the the need for the preservation of from choosing a pharmacy based reasonableness standard of review. standards across the province along upon price and to reduce or eliminate In particular, the College argued that with the important public protection competition among pharmacies on the the lower court erroneously followed mission, the court found that the bylaws basis of price in violation of relevant a standard whereby such court did not fall outside the range of possible Canadian competition laws. The effectively required the introduction and acceptable outcomes. Thus, the Petitioners also argued that no research of empirical evidence of harm to the substance of the bylaws did conform or data supported the prohibition from public as a basis for substantiating to the relevant standard and were able a patient care perspective and that the reasonableness of the bylaws. to withstand the Petitioners’ challenge. evidence showed that customers want The College argued that the standard The Court of Appeals reversed the incentives for pharmacy services. In actually allows for preventative lower court and upheld the validity of fact, they argued, research actually approaches to regulating on behalf of the bylaws prohibiting pharmacy and concludes that incentive programs the public. pharmacist incentive programs. improve pharmacist-patient relationships After a lengthy review of the issue of Boards of pharmacy are delegated and encourage patient compliance what constitutes a record for review, with the authority to promulgate rules/ with medication regimens. A motion the Court of Appeals turned its regulations/bylaws. Distinguishing by the Petitioners to impose an interim attention to the standard of review. The between statutes, rules/regulations/ injunction prohibiting enforcement of the court agreed that the lower court erred bylaws and policies can be a difficult bylaws was denied by the lower court. by failing to consider the bylaws as task. Boards are encouraged to seek The lower court also rejected a whole when determining the range legal advice when exercising their arguments of the College as illogical of reasonableness as a legal basis authority. The legal basis for upholding and “outside the range of possible for upholding the bylaws. The court challenged bylaws may differ from acceptable outcomes.” recognized the necessary deference to jurisdiction to jurisdiction. In British the expertise of the College members Columbia, the standard will focus On the merits, the College argued when assessing duly promulgated on a reasonableness test under the that the bylaws were a necessary and bylaws. It asked whether the bylaws circumstances. The judiciary should reasonable means to protect consumers represented a reasonable response to defer to the expertise of the board who are primarily made up of a the concerns of the College and the when assessing the sustainability of vulnerable public and that inducements harm or threat of harm to be remedied. such bylaws. to obtain prescription drugs are As noted by the court: detrimental. In addition, incentive Sobeys West Inc v. College of programs promote an atmosphere A bylaw is not unreasonable Pharmacists of British Columbia, 2016 focusing on the incentives, rather than merely because particular judges BCCA 41 (Court of Appeal for British on the necessity of the medication, and might think that it goes further Columbia 2016) February 2017 innovations |5
Feature News NABP Launches the Verified-Accredited Device Integrity Program to Further Shield US Medical Supply Chain, Protect Public Health to take sensitive measurements of their blood sugar levels to monitor their insulin requirements. The burgeoning “gray market” of reselling test strips is placing at risk the health of patients with diabetes. Whether it involves sellers advertising “unused” test strips online, or device distributors diverting them from international channels and reselling them to domestic distributors, such products may be adulterated or counterfeit. Further, when diverted diagnostic OTC devices such as test strips are reintroduced to the legitimate supply chain, records of the products’ handling or storage conditions are nonexistent. More specifi cally, the term “gray market” refers to products that are traded or sold outside of the manufacturer’s authorized distribution channels. One example of gray market products includes products that have been diverted from a country where they are approved for use into another country where they are not approved. For instance, in 2015, Abbott Laboratories and its diabetes care units won a court order barring NABP has a long history of working to a prescription. As an extension of pharmacies and wholesalers with wholesale distribution facilities the Verified-Accredited Wholesale distributing diagnostic OTC medical devices from importing and selling to protect the integrity of the Distributors® (VAWD®) program, VDIP versions of Abbott’s FreeStyle ® medication distribution system and helps prevent diverted or substandard diabetes test strips in the US, which were only intended for international employing appropriate security and diagnostic OTC medical devices from distribution. Abbott argued that best practices. NABP expanded entering the United States medical these wholesalers diverted the foreign-market test strips to US these efforts in September 2016 and supply chain. pharmacies, which in turn sold launched the Verified-Accredited them to consumers and submitted Gray Market: Diverted and fraudulent claims to insurance Device Integrity Program™ (VDIP™), Counterfeit OTC Devices companies, Medicare, Medicaid, which accredits distributors of and other third-party payers while Diabetes medical supplies are an claiming to have sold domestic strips. diagnostic over-the-counter (OTC) example of diagnostic OTC medical devices. Over 10 million Americans Such gray market diagnostic OTC medical devices that may be measure their blood glucose daily, medical devices pose substantial delivered by a pharmacy pursuant relying on at-home diabetes tests health and safety risks to patients. February 2017 innovations |6
Several differences in the international receives support from Food and NABP updated the VAWD criteria in test strip packaging and instructional Drug Administration. Currently, 24 2015 to align with the Drug Supply inserts are capable of confusing US states recognize VAWD and three Chain Security Act. (See Innovations, consumers. For example, instruction states – Indiana, North Dakota, August 2016.) inserts are often in a different and Wyoming – require VAWD language, a US toll-free number to call as a component of licensure for Team of Experts for assistance is missing, and storage wholesale distributors. temperatures may be listed in Celsius In addition to NABP conducting an instead of Fahrenheit. Like VAWD, VDIP allows diagnostic extensive examination of a diagnostic OTC device distributors a means OTC device distributor’s licensure In addition, there are cases of to assure pharmacies that they are status, disciplinary history, record distributors advertising online or on receiving products from a legitimate keeping, product verification processes, signage posted by the side of the source. and policies and procedures, the road to buy unused test strips from Association’s surveyors perform on-site consumers. These strips, which are With the VAWD program as a basis, surveys as part of the accreditation now adulterated, are then ultimately NABP developed the VDIP criteria process. These surveyors represent resold to pharmacies that may be to assess diagnostic OTC device a wide range of experience, from unaware of the product’s history. distributors. The criteria includes the pharmacist to former regulatory following: specialist to former law enforcement. Further, the danger of counterfeit Further, NABP’s annual surveyor medical products infiltrating the • Diagnostic OTC medical devices are training keeps surveyors up-to-date legitimate supply chain through purchased from the manufacturer on new regulations and procedures. gray market channels is also a or a distributor who purchased the The trainings ensure that surveyors concern. For instance, counterfeit devices from the manufacturer. operate consistently with the applicable copies of the OneTouch ® Test standards of the accreditation program • Licensee complies with all Strip sold by Johnson & Johnson’s as well as relevant jurisdictions. applicable statutes in all applicable LifeScan unit appeared in US and jurisdictions. Canadian pharmacies in 2006. For more information about the Specifi cally, the fake test strips were • Facility where diagnostic OTC VDIP program, contact the found in at least 35 states and in medical devices are stored and Accreditation department at Canada, Greece, India, Pakistan, handled has adequate temperature vdip@nabp.pharmacy. the Philippines, Saudi Arabia, and and security conditions, and Turkey. An investigation revealed inventory controls for detecting that the counterfeit test strip kits theft, counterfeiting, and diversion. were manufactured in China, made their way through Canada, and • Personnel are qualified for supervising Further, the ended up on pharmacy shelves in the US. Johnson & Johnson learned and handling the products. danger of counterfeit • Records and inventories are of the counterfeit test strips after maintained and readily available for medical products patients complained of faulty results. While no injuries were reported, this inspection. infiltrating the case demonstrates the potential for diabetics to inject the wrong • Policies and procedures are established to ensure authenticity legitimate supply chain amount of insulin, causing injury and possible death due to inaccurate of purchase orders, and processes through gray market are in place for handling devices test readings. deemed unfit for human use. channels is also a Accreditation Criteria Help NABP continuously reviews and concern. Protect Supply Chain updates its accreditation criteria for all its programs and will continue this Established in 2004, the VAWD practice for VDIP. For example, in program helps protect the public 2012, NABP held a task force meeting health from counterfeit, adulterated, to review and revise the VAWD criteria and substandard drugs that enter with the protection of public health at the supply chain, and the initiative the forefront of the charge. In addition, February 2017 innovations |7
Association News NABPF Offering Six Grants to Board Members or Staff to Attend APhA Institute on Alcoholism and Drug Dependencies The NABP Foundation® (NABPF™) is offering six grants to assist qualified board of pharmacy members or staff with some of the costs associated with attending the American Pharmacists Association (APhA) Institute on Alcoholism and Drug Dependencies. Held in Salt Lake City, UT, on June 1-4, 2017, the APhA Institute sessions will offer attendees educational information on alcohol and drug dependency and how to effectively support pharmacists who are in recovery. Continuing the annual University of Utah School on Alcoholism and Other Drug Dependencies program, which was discontinued in 2014, the APhA Institute of Alcoholism and Drug Dependencies is a four-day educational the APhA Institute on Alcoholism and Drug Dependencies is conference designed to support those active in state-level available on the APhA website at www.pharmacist pharmacist recovery programs and other leaders in this area. .com/apha-institute-alcoholism-and-drug-dependencies. The conference sessions provide information and instruction to assist these individuals in providing programs to support To apply for a grant, qualified board of pharmacy members and pharmacists in recovery. staff should contact the NABP Executive Office at ExecOffice@ nabp.pharmacy by March 1, 2017. Grants will be assigned on a Attendees may earn continuing pharmacy education through first-come, first-served basis. participation in this program. More information about Current VPP Inspection Reports Help Boards of Pharmacy Assess Compliance To support the state boards of current inspection, having previously pharmacy in licensure decision been inspected through the program. making, NABP encourages Additionally, of approximately 536 pharmacies to maintain current pharmacies: inspection reports by participating ® in the Verified Pharmacy Program® • 254 pharmacies engage in only (VPP®) and proactively requesting nonsterile compounding; inspections from NABP based on • 54 pharmacies engage in only sterile Completed VPP inspection reports are their state requirements. Based on compounding (two of which are also easily accessible to the state boards of review of various state laws and registered as outsourcing facilities); pharmacy. Each report is uploaded to regulations, NABP recommends NABP e-Profile Connect. Additionally, that pharmacies engaged in sterile • 157 pharmacies engage in both state boards of pharmacy may compounding undergo an annual sterile and nonsterile compounding upload their own inspections directly inspection, and pharmacies engaged (four of which are also registered as to e-Profile Connect. Participating in nonsterile compounding or general outsourcing facilities); state boards can access this shared pharmacy practices undergo a biennial data from fellow boards, which can inspection. • 67 pharmacies are general retail assist them when making licensure or mail-order pharmacies with no At press time, at least 536 pharmacies decisions. compounding; and have applied to VPP and currently, or For more information about VPP, visit soon will, have verified data available • 4 pharmacies are nuclear the Programs section of the NABP for the boards to view. Of the 536 pharmacies. website. VPP pharmacies, more than 105 have chosen to reapply for a more February 2017 innovations |8
Association News Board of Pharmacy Members Gather at Interactive Forum to Discuss Common Challenges, Advance Their Shared Mission “Stand Up and Be Counted to Advance Attendees followed McGinley’s In the second session, “How to Our Shared Mission” was the theme suggestion and engaged in a rich, Beat a Rigged System,” panelists of NABP’s 2016 Interactive Member nuanced discussion on the first discussed the Multistate Inspection Forum, held November 30 to December session, “What Can We Learn From Blueprint created by the boards of 1, 2016, in Rosemont, IL. The biennial the 2016 Race?” This session provided pharmacy and NABP, as well as networking event gave 46 board of panelists an opportunity to share updates on state implementation of pharmacy members and other board differing perspectives on what serving United States Pharmacopeia Chapter representatives an opportunity to on a board of pharmacy entails. guidelines. Topics requested collaborate and discuss common c o n t i n u e d o n p a g e 10 challenges faced by the state boards. It also reinforced the partnership between the boards of pharmacy and NABP and the shared mission to protect the public health. The two-day meeting included five sessions focused on topics relevant to all board of pharmacy members. During each session, panelists – who were also attendees of the meeting – provided a brief overview of the topic to spark discussion among all attendees. Each day also included a shared topics session with subjects gleaned from a survey sent to attendees prior to the meeting. Panelists presenting on “What Can We Learn From the 2016 Race?” included (from left to right) Jenny Downing Yoakum, RPh, member, Texas State Board of Pharmacy; Donna Forum Overview: Day One Wall, PharmD, RPh, member, Indiana Board of Pharmacy; T. Morris Rabb, RPh, member, Louisiana Board of Pharmacy; Kevin Dang, PharmD, RPh, member, Arizona State Board Day one of the Interactive Member of Pharmacy; and session moderator Edward G. McGinley, MBA, RPh, DPh, chairperson, Forum kicked off with a networking NABP Executive Committee. lunch, followed by NABP Chairperson Edward G. McGinley, MBA, RPh, DPh, welcoming board members to the event. McGinley noted that it was the Association’s goal that the collaboration facilitated among meeting attendees would provide them with insight and knowledge to help them in their work. He also pointed out that the attendees represented varied levels of experience serving on boards of pharmacy – from less than two years to more than 20 years – and various types of pharmacy practice experience, including community, Panelists presenting on “How to Beat a Rigged System” included (from left to right) Bill hospital, chain, and independent Cover, RPh, NABP member relations and government affairs director; session moderator pharmacist; academic; and Gay Dodson, RPh, member, NABP Executive Committee; Linda Witzal, RPh, member, New public board members. McGinley Jersey State Board of Pharmacy; Jody Allen, RPh, member, Virginia Board of Pharmacy; and encouraged interaction, questions, Nicole Chopski, PharmD, RPh, member, Idaho State Board of Pharmacy. Pictured on the right and discussion among attendees for is shared discussion topics moderator Richard B. Mazzoni, RPh, member, NABP Executive the meeting to have significant impact. Committee. February 2017 innovations |9
Association News Interactive Forum continued from page 9 by members in their pre-meeting security measures in community for their participation in the day’s survey were then introduced during pharmacies, and physician discussions. the first of two shared topic discussion dispensing. sessions. Topics addressed Forum Overview: Day Two included factors that contribute to The first day of the forum ended with a group dinner, which provided Attendees continued lively medication errors, pharmacists’ work attendees with an additional discussions during day two of the conditions, medication assistance networking opportunity. NABP Interactive Forum, which began with in dying regulations/standards and President Hal Wand, MBA, RPh, the session “Crossing Party Lines – collaboration with other health care greeted and thanked attendees Trending Practices.” This session’s practitioners, implementation of Panelists presenting on “Crossing Party Lines – Trending Practices” included (from left to right) session moderator Mark D. Johnston, RPh, DPh, member, NABP Executive Committee; Michael Moné, BS, JD, RPh, member, State of Ohio Board of Pharmacy; Kate James, RPh, member, Oregon State Board of Pharmacy; Garrett Cavanaugh, RPh, member, Massachusetts Board of Registration in Pharmacy; Janet MacDonnell, BScPharm, member, New Brunswick College of Pharmacists; and William “Bill” Gerla, member, Saskatchewan College of Pharmacy Professionals. Panelists presenting on “The Ballots on Prescription Drug Abuse Have Been Counted – Who’s Winning?” included (from left to right) Kevin Robertson, PharmD, RPh, BCPS, member, Arkansas State Board of Pharmacy; session moderator Gary W. Dewhirst, RPh, DPh, member, NABP Executive Committee; Christian Tadrus, PharmD, RPh, member, Missouri Board of Pharmacy; Kevin Eidson, PharmD, member, Tennessee Board of Pharmacy; Cathy Hanna, RPh, member, Kentucky Board of Pharmacy; James Bialke, BA, MA, member, Minnesota Board of Pharmacy; and David Schoech, RPh, member, Kansas State Board of Pharmacy. February 2017 innovations | 10
Panelists presenting on “Politics Aside – Whose Role Is It Anyway?” included (from left to right) Justin Wilson, DPh, member, Oklahoma State Board of Pharmacy; Diane Halvorson, RPhTech, CPhT, member, North Dakota State Board of Pharmacy; Tejal Patel, RPh, member, Delaware State Board of Pharmacy; session moderator Philip P. Burgess, MBA, DPh, RPh, member, NABP Executive Committee; Robert Frankil, RPh, member, Pennsylvania State Board of Pharmacy; and Kerri Kilgore, RPh, member, Wyoming State Board of Pharmacy. Pictured on the right is shared discussion topics moderator Jack W. “Jay” Campbell IV, JD, RPh, member, NABP Executive Committee. topics included state and province providers’ agents, and electronic updates on expanded provider health records used in nursing roles, and the status of state and homes and assisted living facilities. provincial laws and regulations for medical marijuana. Both topics were Closing the meeting, NABP The final session introduced by US and Canadian President-elect Jeanne D. Waggener, board member panelists. RPh, DPh, thanked attendees for of the Interactive their participation, commending forum During the second session, “The attendees for their hard work and Member Forum, Ballots on Prescription Drug Abuse dedication to protecting the public Have Been Counted – Who’s health. ‘Politics Aside – Whose Winning?” attendees discussed current trends in opioid abuse and For information about future meetings, Role Is It Anyway?’ increasing patient access to naloxone visit the Meetings section on the NABP website at www.nabp examined the expanding and updates on state prescription monitoring programs. .pharmacy. role of pharmacy The final session of the Interactive technicians, mandates Member Forum, “Politics Aside – Whose Role Is It Anyway?” for board composition, examined the expanding role of pharmacy technicians, mandates and challenges in for board composition, and challenges in the legislative and the legislative and regulatory process. Attendees then shared their experience regulatory process. and insights during the second shared topics discussion session, which included issues such as unauthorized e-prescribing by February 2017 innovations | 11
Association News NABP Cosponsors USP CPE Course to Help Licensees Meet Requirements of Chapter Health care personnel who handle Pharmacists and pharmacy technicians Compounding Compendium. Details hazardous drug preparations and all may earn 6.5 hours (0.65 CEUs) of about Chapter can be found entities that store, prepare, transport, Accreditation Council for Pharmacy at www.usp.org/frequently-asked- or administer hazardous drugs are Education (ACPE)-accredited CPE credit questions/hazardous-drugs-handling- mandated to meet the requirements after finishing the knowledge-based healthcare-settings. of United States Pharmacopeia (USP) course, passing the post-session test, General Chapter Hazardous and completing the course evaluation. To More USP CPE Opportunities Drugs—Handling in Healthcare Settings participate in the course, find dates for Available on Compounding beginning July 1, 2018. To support board live class sessions, or to register for the efforts to help licensees in meeting these home study webcast, visit USP’s website Like USP Chapter , Chapters requirements, NABP is cosponsoring at www.usp.org under the Meetings and are enforceable a comprehensive continuing pharmacy & Courses section. Claims for ACPE- standards. NABP is cosponsoring education (CPE) course on the new accredited CPE credit must be submitted additional USP courses for ACPE- standards. The course, titled “General on NABP’s CPE submission website, accredited CPE credit, including the Chapter Hazardous Drugs— which can be accessed by visiting the courses “USP General Chapter Handling in Healthcare Settings,” will Meetings section of the NABP website at Pharmaceutical Compounding— be offered both in a classroom setting www.nabp.pharmacy within 60 days of Sterile Preparations” and “USP in Rockville, MD, and as an on-demand completing the CPE activity. Pharmaceutical Compounding— webinar that licensees can take at Nonsterile Preparations.” Visit their convenience. The course will General Chapter is available USP’s website at www.usp.org to learn provide an introduction to the Chapter, in both the First Supplement to USP more about and sign up for upcoming including practice areas affected; 39–National Formulary 34 and the USP USP courses. identify documentation requirements; and discuss facility and engineering NABP and the NABP Foundation® are accredited by the Accreditation Council for Pharmacy control requirements in detail. It will also Education (ACPE) as providers of continuing pharmacy education (CPE). ACPE Provider Number: 0205. Participants may earn ACPE-accredited CPE credit by completing a Statement of Continuing describe the roles and responsibilities of Pharmacy Education Participation online and submitting it electronically to NABP. Full attendance individuals handling hazardous drugs, as and completion of the program evaluation and learning assessment for each session are required well as personnel training and proper use to receive CPE credit and for the credit to be recorded in the CPE Monitor ® system. If you do not submit your CPE claim within 60 days of the date you completed the CPE activity, you will be unable to receive credit, as this is the of personal protective equipment. maximum amount of time allowed for providers to transmit CPE claims to ACPE for credit. Please submit your claim as soon as possible to ensure that you receive credit. NABP Surveyors Participate in Annual Training NABP surveyors met in Rosemont, IL, on December 12-13, 2016, for their annual training workshop. The surveyor workshop included compliance updates on accreditation programs and inspection processes, an overview of the Drug Supply Chain Security Act, a look at how outsourcers impact the Verified Pharmacy Program® and Verified-Accredited Wholesale Distributors® program, an overview of the Verified-Accredited Device Integrity Program™ and the Health Insurance Portability and Accountability Act, and an open forum with questions and answers. Surveyors who inspect sterile compounding facilities also completed a gown and garb exercise. February 2017 innovations | 12
Association News Task Force Addresses Pharmacist Integrated Communications Skills Examination Members of the Task Force on the Pharmacist Integrated Communications Skills Examination met on December 13-14, 2016, in Rosemont, IL, to review the present status of pharmacy competency assessment as it relates to pharmacists’ communications skills and to discuss the concept of a pharmacist integrated communications skills examination. Pictured from left to right are Rebecca Deschamps, RPh, Montana Board of Pharmacy; Roger Fitzpatrick, RPh, Utah Board of Pharmacy; Jim Bracewell, BBA, Georgia State Board of Pharmacy; Randy Forbes, JD, Kansas State Board of Pharmacy; Rebecca “Suzette” Tijerina, RPh, Texas State Board of Pharmacy; Richard A. Palombo, RPh, New Jersey State Board of Pharmacy; Daphne Bernard, PharmD, RPh, District of Columbia Board of Pharmacy; Michael Bertagnolli, MBA, RPh, FACHE, Montana Board of Pharmacy; Caroline Juran, RPh, DPh, Executive Committee liaison, NABP; Stuart Williams, JD, Minnesota Board of Pharmacy; Maria Mantione, PharmD, RPh, CGP, FAPhA, New York State Board of Pharmacy; Brenda McCrady, RPh, Arkansas State Board of Pharmacy; and John Marraffa, Jr, RPh, New York State Board of Pharmacy. CM Newly Accredited VAWD Facilities Newly Accredited DMEPOS Facility The following facilities were accredited through the The following facility was accredited through the NABP Verified-Accredited Wholesale Distributors® durable medical equipment, prosthetics, orthotics, and (VAWD®) program: supplies (DMEPOS) program: Cardinal Health 200, LLC, dba H. D. Smith, LLC Cardinal Health Flower Mound, TX The Medicine Shoppe Pharmacy #0588 Grand Prairie, TX Jacksonville, IL Sanofi-Aventis US, LLC Taylor, PA A full listing of nearly 450 accredited DMEPOS companies representing almost 28,500 facilities is A full listing of more than 580 accredited VAWD facilities is available on the NABP website at www.nabp available on the NABP website at www.nabp.pharmacy. .pharmacy. February 2017 innovations | 13
Schedule Scheduleof of Events Events Saturday, Saturday,May May20, 20,2017 2017 Tuesday, Tuesday, May May 23, 23, 2017 8:30 8:30--11:30 11:30am am 10 am- -55pm 10am pm Joint JointCPE CPE 7:30 am -- 4 7:30 am 4 pm pm Registration/Information Registration/InformationDesk DeskOpen Open Educational EducationalPoster PosterSession Session Registration/Information Registration/Information Desk Open Open 1:30 1:30- -3:30 3:30pm pm Noon Noon--3:15 3:15pm pm Pre-Meeting Pre-MeetingCPE CPE First FirstBusiness BusinessSession Session 7:30 7:30 -- 8:30 8:30 am am NABP NABP Breakfast Breakfast 44- -55pm pm 3:45 3:45--4:45 4:45pm pm From FromDistrict DistrictMeeting Meetingto toAnnual Annual Joint 8:30 8:30 -- 10 10 am am JointCPE CPE Meeting Meeting– –Learning LearningAbout AboutNABP NABP Executive Executive Officer Officer CPE CPE Session 66- -99pm Monday, 8:30 8:30 -- 10 10 am pm Monday,MayMay22, 22,2017 2017 am President’s President’sWelcome WelcomeReception Reception Compliance Compliance Officer Officer CPE Session Honoring 7:30 - 12:30 7:30 am - 12:30 pm am pm HonoringNABP NABPPresident President Hal Registration/Information Registration/InformationDesk Desk Open Open 10:30 am -- Noon 10:30 am Noon HalWand, Wand,MBA, MBA,RPh RPh Dinner Expanding Expanding on on Forum Forum Discussions – Dinnerwill willbe beserved. served. 7:30 7:30--99am am the the Magic Magic of of Networking Networking on Shared Dress: Dress:Business Businesscasual casual USP USPUpdate UpdateandandBreakfast Breakfast Topics Topics Breakfast Breakfastserved servedplated platedfrom from 7:30 7:30 -- 88 am am Sunday, Sunday,May May21, 21,2017 2017 Noon Noon -- 1:30 1:30 pm pm 9:15 9:15--10:15 10:15am am Lunch Lunch Break Break 7:30 - 4:30 7:30 am - 4:30 pm am pm Joint JointCPE CPE (On (On your your own) own) Registration/Information Registration/InformationDesk DeskOpen Open 10:30 am--Noon 10:30am Noon 1:30 1:30 -- 4:15 4:15 pm 7:30 7:30- -8:30 8:30am am Second pm SecondBusiness BusinessSession Session Final Final Business Business Session Session NABP NABPAWAR AWARxE x EFun FunRun/Walk Run/Walk 8:30 Noon Noon--12:30 12:30pm pm 66 -- 6:45 6:45 pm 8:30- -11:30 11:30am am pm Hospitality Informal InformalMember/Candidate Member/Candidate Awards Awards Dinner Dinner Reception Reception HospitalityBrunch Brunchand andEducational Educational Table Discussion Discussion TableTop TopDisplays Displays 77 -- 9 9 pm pm Free FreeAfternoon: Afternoon:No Noprogramming programming Annual Annual Awards Awards Dinner Dinner Dress: Dress: Semiformal Semiformal Note: Note:The The113 Annual thth 113 AnnualMeeting Meetingschedule scheduleisissubject subjectto tochange. change.The Thefinal finalschedule schedule will will be be posted posted online online at at www.NABPAnnualMeeting.pharmacy. www.NABPAnnualMeeting.pharmacy. NABP NABPandandthe theNABP NABPFoundation Foundation are areaccredited accreditedby bythe theAccreditation Accreditation Council Council for for Pharmacy Pharmacy Education Education (ACPE) (ACPE) asas providers providers of continuing continuingpharmacy pharmacyeducation education(CPE). (CPE).ACPE ACPEProvider ProviderNumber: Number:0205. 0205.Details Detailson onthe thecontinuing continuing pharmacy pharmacy education education sessions sessions and the theoverall overallconference conferencelearning learningobjectives objectiveswill willbe beprovided providedininfuture futureissues issuesof ofInnovations Innovations and and on on the the Annual Annual Meeting Meeting Information Information and andRegistration RegistrationWebsite. Website.Instructions Instructionsfor forclaiming claimingCPE CPEcredits, credits,including includingcontinuing continuinglegal legaleducation, education, will will also also be be provided provided in in future future annual annualmeeting meetingcommunications. communications. February February 2017 2017 innovations | February 2017 innovations | 14
113th Annual Meeting Prominent Political Journalist to Offer Perspective on Health Care Regulation During Keynote Address Howard Fineman, one of the nation’s has also appeared in The New York most prominent political journalists Times and The Washington Post, and correspondents, will provide and his 2008 best-selling book, attendees with an informative The Thirteen American Arguments: bipartisan perspective on health care Enduring Debates That Define regulation in his keynote speech, and Inspire Our Country, explored “Politics: From the Top and the complex topics such as national Inside,” during the NABP 113th Annual identity, free speech, and the political Meeting. Throughout his remarkable process. Fineman was the first international career, Fineman has journalist to thoroughly interview interviewed and written about President George W. Bush after the every major presidential candidate events of September 11, 2001, and since 1984 and proved himself to his Newsweek cover story “Bush and be one of the leading reporters God” was part of a series of articles in Washington, DC. As boards of that won the 2003 National Magazine pharmacy face ever-changing political Award for General Excellence. His landscapes, Fineman will share his many other awards and honors perspective on today’s complicated include a “Silver Gavel” from the issues and political decisions with American Bar Association and a approachability, humor, and candor “Page One” from the Headliners Club during his keynote address. of New York. Fineman is currently global editorial Originally from Pittsburgh, PA, director of the Huffington Post Fineman received his bachelor of arts degree from Colgate University, his Media Group, a position he has held since March 2011. He joined The master of journalism from Columbia Throughout Huffington Post in September 2010 University Graduate School of Journalism, and his juris doctor degree his remarkable and helped it become one of the world’s top news sites. In April 2012, from University of Louisville School international The Huffington Post became the first of Law. In 2006, Columbia University commercial news website to win a honored him with the Alumni Award. career, Fineman has Pulitzer Prize. Fineman also makes His journalism career began in regular appearances on MSNBC’s Louisville, KY, where he wrote for The interviewed and written Hardball with Chris Matthews, NBC’s Courier-Journal about topics such as Today Show, and ESPN Radio’s Tony the coal industry and state politics. about every major In 1978, he joined the newspaper’s Kornheiser Show, where he offers his keen views on current events. From Washington bureau. presidential candidate 1983 to 1995 he was a regular panelist Fineman will deliver the keynote since 1984 and proved on PBS’ Washington Week in Review, and he has also appeared on Fox address during the First Business Session of the NABP 113th Annual himself to be one of the News Sunday and The Daily Show with Jon Stewart. Meeting, on Sunday, May 21, 2017, leading reporters in at the Hyatt Regency Orlando on Before joining The Huffington Post, International Drive in Orlando, FL. Washington, DC. Fineman held several influential More information will be available on positions with Newsweek, including the Annual Meeting website at www senior editor and columnist, chief .NABPAnnualMeeting.pharmacy. political correspondent, and deputy Washington bureau chief. His work February 2017 innovations | 15
113th Annual Meeting Still Time to Request a Travel Grant Are you an active board of pharmacy member or administrative officer who is attending the Annual Meeting? NABP has travel grant opportunities available for qualified individuals to cover costs for needed expenses. Eligible individuals may receive up to $1,500 to cover the costs of travel, hotel rooms, meals, taxis, parking, and tips. The grant does not include Annual Meeting registration fees. • One grant will be awarded to a current board member or administrative officer of each active NABP member board of pharmacy, as designated by the board’s administrative officer. Online Registration • Active member boards of pharmacy must have a voting delegate in attendance at the Annual Meeting to vote during all applicable Available in February business sessions in order to receive reimbursement. at To obtain a grant application, board administrative officers may contact www.NABPAnnualMeeting.pharmacy the NABP Executive Office at ExecOffice@nabp.pharmacy. • Early Registration Rate – April 7 Important Deadlines • Early Hotel Reservation Rate – April 20 • Voting Delegate Submissions – April 21 NABP Seeks Proposals for Educational Poster Session NABP seeks proposals for the annual Educational Poster Session to take place on Sunday during the Annual Meeting. Proposed posters should reflect the overall theme of “Imagineering for the Protection of Public Health.” Those displaying posters have the opportunity to share information about their organization’s latest legislative issues, technology, policy development, and/or disciplinary cases as they relate to this year’s theme. To submit a poster concept for consideration, please send the proposed poster topic to NABP Professional Affairs staff via email at Prof-Affairs@nabp.pharmacy by Friday, March 3, 2017. Board of pharmacy members and staff as well as schools and colleges of pharmacy are invited to participate. Student presenters are welcome and must be accompanied by a licensed pharmacist. Poster Session presenters may be eligible to earn ACPE-accredited continuing pharmacy education credit. Details will be provided to individuals selected to present at the session. February 2017 innovations | 16
Association News Around the Association Executive Officer Changes of Pharmacy. Sullivan’s appointment will Law’s appointment will expire expire October 31, 2019. June 1, 2019. • Kimberly A. Leonard, RPh, has been appointed executive secretary of the • Dan Somsen, RPh, has been • Gregory Lippe has been reappointed New York State Board of Pharmacy, appointed a member of the South a public member of the California replacing Lawrence “Larry” H. Mokhiber, Dakota State Board of Pharmacy. State Board of Pharmacy. Lippe’s MS, RPh. Leonard began work at the Somsen’s appointment will expire appointment will expire June 1, 2020. Board of Pharmacy in 2012 as the October 30, 2019. • Albert Wong, PharmD, RPh, has pharmacy supervisor of practice and • Katy Wright, MBA, PharmD, RPh, been reappointed a member of the registration. Before working for the has been appointed a member of California State Board of Pharmacy. Board, she was a supervisor for the the Tennessee Board of Pharmacy. Wong’s appointment will expire New York State Department of Health, Wright’s appointment will expire July June 1, 2020. Medicaid Program, Bureau of Pharmacy 15, 2021. Policy and Operations. Prior to state • Carolyn Ma, PharmD, RPh, has service, she worked for more than 15 • K. Kumar Shah has been appointed been reappointed a member of the years as a community pharmacist. a public member of the Utah Board Hawaii State Board of Pharmacy. Ma’s Leonard graduated in 1989 from Albany of Pharmacy. Shah’s appointment will appointment will expire June 30, 2019. College of Pharmacy and Health expire June 30, 2020. Sciences. • Winifred A. Landis, RPh, has • Sam Kapourales, RPh, has been reappointed a member of the Board Member Appointments been appointed a member of the Indiana Board of Pharmacy. Landis’ West Virginia Board of Pharmacy. appointment will expire October • Jennifer L. Hardesty, PharmD, Kapourales’ appointment will expire 15, 2020. RPh, has been appointed a member June 30, 2021. of the Maryland Board of Pharmacy. • Donna S. Wall, PharmD, RPh, has Hardesty’s appointment will expire Board Member Reappointments been reappointed a member of the May 1, 2020. Indiana Board of Pharmacy. Wall’s • Lenora Newsome, PD, RPh, has appointment will expire August • Kevin Morgan, RPh, has been been reappointed a member of the 31, 2020. appointed a member of the Maryland Arkansas State Board of Pharmacy. Board of Pharmacy. Morgan’s Newsome’s appointment will expire • Richard M. Indovina, Jr, MBA, RPh, appointment will expire May 1, 2020. June 30, 2022. has been reappointed a member of the Louisiana Board of Pharmacy. • Ryan Harper, PharmD, RPh, has • Ryan Brooks has been reappointed Indovina’s appointment will expire been appointed a member of the a public member of the California June 30, 2022. Mississippi Board of Pharmacy. State Board of Pharmacy. Brooks’ Harper’s appointment will expire appointment will expire June 1, 2020. • James Stevenson, PharmD, RPh, June 30, 2021. FASHP, has been reappointed a • Victor Law, BPharm, RPh, has member of the Michigan Board of • Sabrina Beck, PharmD, RPh, has been been reappointed a member of the Pharmacy. Stevenson’s appointment appointed a member of the Nebraska California State Board of Pharmacy. will expire June 30, 2020. Department of Health and Human Services, Division of Public Health, Licensure Unit. Beck’s appointment will expire November 30, 2018. • Charlene Dunbar has been Next FPGEE Administration appointed a public member of the Nebraska Department of Health and to Be Held April 25, 2017 Human Services, Division of Public Information about registering for and Health, Licensure Unit. Dunbar’s scheduling the Foreign Pharmacy Graduate appointment will expire November Equivalency Examination® (FPGEE®) is available 30, 2021. to candidates in the Programs section of the • Robert Sullivan has been appointed a NABP website at www.nabp.pharmacy. public member of the Nevada State Board February 2017 innovations | 17
State Board News Virginia Passes Legislation New Hampshire Board Updates naloxone is available at www.youtube .com/watch?v=uGkBCcFJRHI. Related to DSCSA Rest Breaks for Pharmacists Rule The Board also suggests that the In response to the Drug Supply Chain The New Hampshire Joint Legislative availability of naloxone is discussed Security Act (DSCSA), also referred Committee on Administrative Rules with individuals who are chronically to as Title II of the Drug Quality and approved the revision of Pharmacy taking opioids. Security Act (DQSA), the Virginia Rule 704.01, which mandates that General Assembly passed House pharmacists take a 30-minute break Arizona Board Expands Role to Bill (HB) 528, which amends several if they are working more than an Provide Certificate of Free Sale sections of law regarding supply chain eight-hour shift. This rule requires requirements. The amendments to HB pharmacists to take a 30-minute rest and GMP Certificate 528 are summarized below. break in an effort to give pharmacists The Arizona State Board of Pharmacy a mental/physical break and thereby has expanded its role in providing the • Defines a “third-party logistics improve patient safety. Pharmacy Rule following certificates. provider” in 54.1-3401 to distinguish 704.01 took effect at the September them from wholesale distributors • The certificate of free sale New Hampshire Board of Pharmacy and requires in-state providers to be is evidence that goods, ie, meeting, when it was adopted by permitted by the Virginia Board of nutraceuticals, are legally sold or the full Board. The rule is posted on Pharmacy. distributed in the open market, freely the Board website at www.nh.gov/ • Requires every pharmacy, without restriction, and approved pharmacy. nonresident pharmacy, wholesale by the regulatory authorities in the country of origin (United States). distributor, and nonresident South Dakota Provides Update wholesale distributor to comply • The Good Manufacturing Practice with federal requirements for an on Naloxone Bill (GMP) certificate validates a system electronic, interoperable system to HB 1079 was passed by the 2016 in place to ensure that products identify, trace, and verify prescription South Dakota Legislature, signed by are consistently produced and drugs as they are distributed. the governor, and became effective on controlled according to quality July 1, 2016. SDCL 34-20A-105 states, standards and covering all aspects • Creates a new licensing category “A licensed health care professional of design, monitoring, and control for registering nonresident may, directly or by standing order, of manufacturing processes and manufacturers shipping into the prescribe an opioid antagonist to facilities to ensure that products do Commonwealth, in lieu of registering a person at risk of experiencing an not pose any risk to the consumer or them as nonresident wholesale opioid-related overdose, or prescribe public. This would include, but is not distributors. to a family member, friend, or other limited to, a positive GMP inspection • Specifies that bulk drug substances close third party person the health according to Title 21 Code of Federal used for compounding drugs care practitioner reasonably believes Regulations Parts 210-211. distributed by a supplier other than to be in a position to assist a person at a licensed wholesale distributor or Additional information may be found in risk of experiencing an opioid-related registered nonresident wholesale the Board’s October 2016 newsletter, overdose.” This allows pharmacies distributor must be provided by a available in the Boards of Pharmacy to develop collaborative practice supplier who is approved by the section of the NABP website. agreements (CPAs) with physicians to Board as well as the federal Food be able to write the order based upon and Drug Administration. the CPA or “protocol” as it is used in The Board’s October 2016 newsletter, SDCL 36-11-19.1. which is available in the Boards The South Dakota State Board of of Pharmacy section of the NABP Pharmacy notes that education will website, has more details on new laws need to be provided when dispensing. affecting the practice of pharmacy. A video that teaches how to administer Newsletters of state boards participating in the NABP State Newsletter Program are available in the Boards of Pharmacy section on the NABP website. Five years worth of issues are posted on each participating state’s page. February 2017 innovations | 18
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