CLEARINGHOUSE DATA SHARING - OFFERS NUMEROUS BENEFITS, PROTECTS PUBLIC HEALTH - NABP
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August 2021 | Volume 50 | Number 7 CLEARINGHOUSE OFFERS NUMEROUS DATA SHARING BENEFITS, PROTECTS PUBLIC HEALTH
CONTENTS 06 09 01 Letter From the Chairperson 02 Policy Perspectives The Future of Telehealth and the Ryan Haight Act Post-Pandemic 04 I nterview With a Board Inspector Krystal Brashears Stefanyk, CISCI 05 Association News 05 NABP Educates Consumers on Dangers of Rogue Online Pharmacies 08 Association Seeks Item Writers for NABP Examinations 15 Interview With a Board Member Julie Lanza, CPhT, CSPT 16 State Board News alifornia Board Develops Sample C Collaborative Practice Agreement for Providing MAT 17 Professional Affairs Update FDA Warns of Biological Products Being Offered to Patients Outside the Scope of an Approved BLA Feature News Association News Disciplinary Data Sharing Through NABP Inspectors Identify NABP Clearinghouse Offers Dangerous Scheme Involving Numerous Board Benefits, Over-the-Counter Insulin Products Protects Public Health NABP Executive Committee (ISSN 2472-6850 — print; ISSN 2472-6958 — Amy Sanchez Timothy D. Fensky Fred M. Weaver online) is published 10 times a year by the National Publications and Editorial Manager Chairperson Member, District 4 Association of Boards of Pharmacy® (NABP®) ©2021 National Association of Boards of Pharmacy. Caroline D. Juran Shane R. Wendel to educate, to inform, and to communicate the All rights reserved. No part of this publication may President Member, District 5 objectives and programs of the Association and its be reproduced in any manner without the written 65 member boards of pharmacy. Reginald B. “Reggie” Deborah C. Mack permission of the executive director/secretary of the Dilliard Member, District 6 The opinions and views expressed in this National Association of Boards of Pharmacy. President-elect publication do not necessarily reflect the official Nicole L. Chopski NABP Mission Statement views, opinions, or policies of NABP or any board Lenora S. Newsome Member, District 7 NABP is the independent, international, and unless expressly so stated. The subscription rate is Treasurer impartial association that assists its member boards Kamlesh “Kam” $70 per year. Bradley S. Hamilton Gandhi and jurisdictions for the purpose of protecting the National Association of Boards of Pharmacy public health. Member, District 1 Member, District 8 1600 Feehanville Drive, Mount Prospect, IL 60056 Tejal J. Patel 847/391-4406 | www.nabp.pharmacy Member, District 2 NABP Executive help@nabp.pharmacy Committee elections Jeffrey J. Mesaros are held each year Lemrey “Al” Carter Member, District 3 at the Association’s Executive Director/Secretary Annual Meeting. 2 | APRIL 2020
LETTER FROM THE CHAIRPERSON Fellow Members, We pharmacy regulators know all too well safety at risk. We strongly encourage boards to that if there’s a will, criminals can find a way. keep up with timely reporting of disciplinary Rapid advances in technology, social media actions to the NABP Clearinghouse as a sites, and the long-standing effects of the means to further combat these risks. With COVID-19 pandemic have made it easier many licensees holding licenses in multiple for bad actors to take advantage of vulnerable states, keeping the Clearinghouse updated in a consumers and threaten public health. In this timely manner is vital to determining whether issue, we delve into some of these continued a current or prospective licensee is eligible to threats, including a recent scheme involving safely practice pharmacy or operate a licensed diverted nonprescription insulin products that facility. I wish to personally thank those board was encountered by NABP surveyors during a of pharmacy staff members who dedicated routine visit to a pharmacy. their time to sharing their experiences using The online pharmacy landscape also the Clearinghouse and the benefits it has continues to threaten patient safety, with rogue offered them. For more information on their websites and social media accounts marketing experiences, see page 6. Timothy D. Fensky, fake, substandard, and counterfeit prescription Please know that NABP is aware of the RPh, DPh, FACA medications. As such, NABP educates patients many resource challenges our member NABP Chairperson about the risks of buying medication online boards face in their day-to-day business. Feel and, through its accreditation and verification free to reach out to NABP staff with any programs, provides patients with tools to help challenges you may be facing in reporting to them easily identify safe online pharmacies and the Clearinghouse as we likely have solutions pharmacy-related businesses. that can help. As part of this initiative, we are pleased to The NABP Interactive Forums are another announce the launch of the newest consumer great resource for connecting with fellow campaign, which focuses on the dangers of members and NABP staff about challenges buying medication from unlicensed internet you may be experiencing in your pursuit of pharmacies and social media sites. This year, public health protection. Make sure to save the campaign places a family’s devastating the dates for the three upcoming forums loss at the forefront with the story of Ed and taking place in person this fall/winter in Mary Ternan, who lost their son Charlie to Northbrook, IL. Dates for these events are a fake prescription pill purchased through available in the Meetings section of the NABP social media in 2020. We are honored and website. Invitations for the forums will be grateful to have partnered with Ed and Mary, sent to the executive officers soon. I’m looking who are founders of the nonprofit charity forward to these in-person discussions and Song for Charlie. Throughout the campaign, working on solutions with all of you. we encourage all boards to actively participate in connecting with consumers Sincerely, about these dangers. There are social media posts, images, video links, and more available in a social media kit that you can all access. More information about the campaign is available on page 5. This issue also focuses on one of the largest Timothy D. Fensky, RPh, DPh, FACA responsibilities that boards of pharmacy have NABP Chairperson in public health protection – licensure. It is up to us, the boards of pharmacy, to screen for licensees who have failed to uphold state and federal rules and regulations and put patients’ AUGUST 2021 | 1
POLICY PERSPECTIVES The Future of Telehealth and the of telemedicine over the last decade – especially in the last year – the “practice Ryan Haight Act Post-Pandemic of telemedicine” as implemented by DEA under the Ryan Haight Act is narrow and outdated, requiring the patient to be A year into the pandemic, the coronavirus Office of National Drug Control Policy, have physically located in a state-licensed hospital disease 2019 (COVID-19) has radically also been contemplating updates to the law or clinic, or in the presence of another DEA- changed our health care system – from the that enables providers to remotely prescribe licensed practitioner, to be prescribed CS. pace at which new drugs come to market controlled substances (CS) using telehealth. An additional exemption available to to the way patients access health care and DEA under the law is for the practice of medications. Arguably one of the most Telehealth Involving Controlled telemedicine performed by a practitioner dramatic shifts has been the major increase Substances: the Ryan Haight Act who has obtained a special registration from in telehealth usage and the expansion of At present, prescribers of CS operate under the DEA administrator. The original Ryan health care services that can be provided strict federal and state requirements for how Haight Act suggested DEA would eventually using the internet. According to a Centers and under what circumstances they can issue issue regulations effectuating this provision. for Disease Control and Prevention analysis, prescriptions to new and existing patients. Congress reiterated the need for DEA to the number of telehealth visits increased Federal requirements for CS are outlined allow for the practice of telemedicine as by 50% during the first quarter of 2020, in the 1970 Controlled Substances Act part of the SUPPORT for Patients and compared with the same period in 2019. (CSA), which granted Drug Enforcement Communities Act in 2018. Yet, to date, And, generally, telehealth has been well Administration (DEA) the authority to DEA has not acted. Thus, even before the received. In addition, a study recently establish regulations promulgating CSA pandemic, DEA had – and continues to published by the COVID-19 Healthcare requirements pertaining to the production, have – the legal authority to allow expanded Coalition found that of over 2,000 patients prescribing, and distribution of CS, and telemedicine prescribing of CS. who participated in at least one telehealth to enforce violations. In 2008, Congress visit during the pandemic, the majority also added several new provisions to the Ryan Haight Flexibility During found the experience overwhelmingly CSA in passing the Ryan Haight Online the COVID-19 Pandemic positive, with 79% responding that they Pharmacy Consumer Protection Act. The During the COVID-19 pandemic, DEA has were satisfied with their telehealth visit and act was named in remembrance of Ryan exercised its authority to waive the in-person 73% expecting to continue using virtual Haight who, at 18 years old, died of an visit prescriber requirement under another health care services beyond the pandemic. overdose of a combination of painkillers exception for PHEs. Starting in March Just over half of those patients (51%) were that had been prescribed to him online by 2020, DEA authorized providers to issue prescribed a medication during their virtual a doctor who had never met him in person prescriptions for CS regardless of the location visit and almost all (92%) found the process and did not conduct an adequate medical of the patient and without first conducting of obtaining their prescription easy. evaluation. The painkillers were delivered an in-person examination, provided that Whether those telehealth services will by an online pharmacy that was aware all of the following conditions are met: continue to be a readily available option of the physician’s dangerous prescribing • the prescription is issued for a for many patients largely depends on what habits. As the name suggests, the act was legitimate medical purpose by a actions Congress and government agencies designed to impose legal requirements for practitioner acting in the usual course take as we transition into a post-pandemic dispensing CS through the internet, including of their professional practice; world. Many of the laws and regulations by way of “rogue” online pharmacies. • t he telemedicine communication enacted in response to the COVID-19 is conducted using an audiovisual, pandemic were provisional and set to expire DEA Authority to Implement real-time, two-way interactive with the conclusion of the federal public ‘Practice of Telemedicine’ communication system; and health emergency (PHE). While the PHE Exemptions • t he practitioner is acting in accordance is not expected to end this calendar year, Recognizing that there is value in allowing with applicable federal and state laws. Congress has already started to explore licensed practitioners to prescribe CS which laws and regulations to make using the internet, the Ryan Haight Act Thus, in essence, the pandemic has forced permanent. Much of the federal attention outlined several circumstances that would DEA to embrace telehealth technology and has been on telehealth reimbursement for qualify for a “practice of telemedicine” the new channels to health care access that certain services through federal programs exemption, thereby allowing practitioners have exponentially evolved and expanded like Medicare. However, both members of to prescribe CS without an initial in-person since the Ryan Haight Act was first passed in Congress and federal agencies, such as the visit. However, given the rapid evolution 2008. What remains to be seen is whether 2 | AUGUST 2021
POLICY PERSPECTIVES Libby Baney, JD Jillian K. Brady, MS Megan S. Herber, MPH Faegre Drinker Biddle & Reath LLP Faegre Drinker Biddle & Reath LLP Faegre Drinker Biddle & Reath LLP the use of these services over the last year extent of providers’ adoption of telehealth Forecasting the Future of has also introduced weaknesses that are to prescribe CS during the pandemic Telehealth for Controlled now being exploited in what was previously is still largely unknown. A preliminary Substances a completely “closed system” for the study conducted by RTI International has Over the coming months, as Americans manufacture, distribution, prescribing, and shown that while substance use disorder see the light at the end of the pandemic dispensing of CS, and whether any negative (SUD) providers embraced the adoption tunnel, and the state and federal landscape consequences are overshadowed by increased of telehealth for outpatient services (97%) continues to evolve, policymakers in access to services. and group counseling (77%) during the Congress, across federal agencies, and in Advocates for a DEA-established COVID-19 pandemic, far fewer used it to statehouses will determine the future of telehealth provider special registry system prescribe buprenorphine (17%) and other health care and whether Americans will contend that allowing telemedicine providers medications (16%). be allowed to continue to access care and to continue to prescribe CS without a prior prescriptions virtually. While CS must be in-person medical evaluation is critical Do Not Forget State Laws handled with care and only accessed when to patients’ access to care, especially for Adding complexity, providers need to also clinically appropriate, much can be done to addiction treatment and child and adolescent comply with state law requirements. Pre- update federal rules to ensure that they are mental health care. Some public health pandemic, state laws varied as to whether not overly restrictive and limiting access to experts argue that DEA and state legislatures they allowed, prohibited, or were silent on legitimate care. should embrace permanent changes to the remote prescribing of CS without a prior This article was written by Libby Baney, the Ryan Haight Act, but only for select in-person medical evaluation. Further, some JD; Jillian K. Brady, MS; and Megan S. medications. In a report conducted by the states have prohibited online prescribing Herber, MPH, with Faegre Drinker Biddle George Washington University Regulatory of CS even if there has been a prior in- & Reath LLP. Please note, the opinions and Studies Center, researchers argue that person consult. During the pandemic, states views expressed by Faegre Drinker Biddle & DEA and the Substance Abuse and Mental embraced the expanded use of telehealth Reath do not necessarily reflect the official Health Services Administration should and many are already moving to make views, opinions, or policies of NABP or any execute their legal authority to extend the temporary provisions permanent. For member board unless expressly stated. flexibilities after the PHE by waiving the example, in July 2020, New Hampshire in-person visit requirement for providers passed a law eliminating the requirement for issuing buprenorphine prescriptions to an in-person exam prior to a virtual visit for treat opioid addiction. They contend that providers treating patients with SUD. And in easing restrictions will allow patients in rural January 2021, Florida lawmakers in both the communities who lack access to nearby state’s House and Senate introduced bills that opioid treatment centers to receive care would permanently allow the prescription of and improve compliance. Real-world data CS via telemedicine. demonstrating the effectiveness of DEA’s pandemic policy changes will take years. Unlike with other telehealth services, the AUGUST 2021 | 3
INTERVIEW WITH A BOARD INSPECTOR Krystal Brashears Stefanyk, CISCI Director of Inspections, North Carolina Board of Pharmacy How long have you been serving In North Carolina, do inspectors also as an inspector for the Board? conduct investigations for other What was your role prior to health regulatory boards? working for the Board? We work in conjunction with other regulatory I was an inspector for nine years and associate boards if it is related to pharmacy and director of investigations and inspections whatever professional practice a regulatory for three years. I have been director of board is investigating. For example, if an inspections for the past three years. Prior investigation involves a dispensing physician to joining the Board, I was in college, or nurse practitioner who was dispensing, obtaining a degree in criminal justice and we work those cases with the Medical Board also working as a pharmacy technician. or Board of Nursing, respectively. Those investigations are pretty straightforward, and What tools or skills are a must-have we are there to look at the dispensing side. North Carolina in a pharmacy inspector’s toolkit? We also work a lot of cases with Drug Board of Pharmacy One of the most important skills to have is Enforcement Administration (DEA). Those logical thinking. The best class I ever took cases can be pretty complicated. I have in college, which has helped me every day in worked an investigation involving a large Number of Board my career, had nothing to do with criminal volume of diversion, where over 100,000 Members 5 pharmacist members justice or pharmacy. It was a deductive logic dosage units were taken out of a pharmacy. and 1 public member class. That class taught me to look at several A pharmacist and three technicians – who different components at the same time and were working independently of each other separate what was important from what was – were diverting for their own uses. That Number of not important to get a complete picture of was a very interesting case because it took Compliance a situation. To me, that describes pharmacy many different twists and turns. I worked Officers/Inspectors 13 inspections and investigations perfectly. As with several agencies, local law enforcement, an inspector, you must be able to look at the North Carolina State Bureau of everything that is going on in a pharmacy in Investigation, and DEA. Rules & Regulations a very detailed manner and put those details Established by together for a complete picture of how the What advice would you give Board of Pharmacy pharmacy is operating. to a new board inspector? Ninety percent of the time our job is to What are some common issues that educate and teach our pharmacists and you have witnessed and addressed pharmacy staff how to get into compliance. Number of Pharmacist Licensees as an inspector with the Board? The advice that I give to new inspectors 17,009 We have been focusing on compounding is to take the time to learn the rules and over the last several years. A lot of common regulations and the meaning behind those issues that we see on the compounding rules and regulations, so they can be ready side are lack of documentation, a need for to educate our pharmacists and pharmacy Number of staff training, and gaps in knowledge of staff. There is a time and place to do what Pharmacies the standards of compounding. On the we need to do if there is a disciplinary 3,466 (in-state) retail pharmacy side, which is a majority matter that needs to be addressed of our pharmacies, we also see a lack of immediately, but for the most part, 90% Number of Wholesale documentation. In addition, we see a lot of of our job is educating and teaching. Distributors pharmacies that are overwhelmed and filling Wholesale drug a lot of prescriptions. This can lead to issues distributors are not such as cluttered shelves and disorganization. regulated by the Board. 4 | AUGUST 2021
ASSOCIATION NEWS NABP Educates Consumers on Dangers of Rogue Online Pharmacies Educating consumers about the dangers of Websites Program or have earned NABP’s buying medicine from unlicensed pharmacies Digital Pharmacy Accreditation will display online and through social media sites is the as “Verified,” and the campaign urges You Can Help Share the focus of NABP’s 2021 consumer awareness consumers to use these resources when buying Buy Safely Message campaign. NABP has found that patients medication online. Sites that appear to be out continue to buy medicine online because they of compliance with NABP patient safety and Boards of pharmacy think it is easy, cost-effective, and safe, and are pharmacy practice standards, or applicable interested in sharing the unaware of the dangers of rogue websites and law, will display as “Not Recommended.” message about safe ways social media accounts selling fake, substandard, This year’s campaign includes television and to buy medications online are encouraged to use the and counterfeit prescription medications online. radio public service announcements (PSAs) sample social media posts, These unlicensed sites often sell unapproved or that feature Ed and Mary Ternan (pictured images, video links, and fake medications that may contain toxic fillers above), founders of the nonprofit charity Song sample articles included in such as drywall, rat poison, sawdust, or deadly for Charlie (www.songforcharlie.org), who share the social media kit that amounts of fentanyl. The various elements of how they lost their son to a fake prescription NABP provided to all board the campaign seek to educate patients on these pill purchased through social media in 2020. executive officers. The kit dangers, and provide safe alternatives. The television and radio PSAs are being sent is available on the NABP to broadcast stations around the country, are website at https://safe Campaign Overview available on NABP’s YouTube channel, and will .pharmacy/resources. Throughout the campaign, NABP urges be used in various digital advertising campaigns patients to visit its consumer website at throughout the year. Also, in August 2021, Ed www.safe.pharmacy to use its free search Ternan and NABP President Caroline D. Juran, tool to check whether the online pharmacy BSPharm, DPh (Hon), will be interviewed by they are using is safe. Sites that have been several local and national television and radio verified through NABP’s .Pharmacy Verified stations during a satellite media tour. AUGUST 2021 | 5
Disciplinary Data Sharing Through NABP Clearinghouse Offers Numerous Board Benefits, Protects Public Health W hen pharmacists face disciplinary action, they are required to disclose that information to the boards of pharmacy in jurisdictions where they are licensed. However, some licensees neglect to do so in a timely manner. For this reason, it is possible for licensees who have faced serious repercussions for professional misconduct to continue to operate in other states without those states knowing. This has long been an issue with licensed professions managed at the state level. In pharmacy, NABP helps by providing its member boards with access to alerts created by the NABP Clearinghouse, a national database of disciplinary information and other important licensee records submitted by the Association’s member boards. These records serve as a vital resource in helping boards make the best-informed decisions about licensure for all applicable licensees. However, to be most effective, these records must be submitted by the boards in a timely manner. NABP Clearinghouse Review pharmacies, pharmacists, pharmacy technicians, and interns. NABP As of summer 2021, there are more than 91,000 has estimated that about 1% of the country’s pharmacist population records currently in the NABP Clearinghouse. has at least one record in the database. When a new record is These records are submitted by member boards submitted by one state against a licensee who is registered in other of pharmacy on all actions taken against all states, the other states receive an alert that contains the report and license holders, including wholesale distributors, any other available information about the action. The receiving states 6 | AUGUST 2021
or jurisdictions may then determine if any action needs to be taken 0 ACTIONS TAKEN by their board as well. Making member boards aware of disciplinary actions taken against licensees who may be registered in multiple states is vital to protecting the public health. The reports generated by the NABP Clearinghouse can also be used for tracking less critical but still important licensee data. Notably, this includes whether licensees are current on their continuing pharmacy education (CPE) requirements. While Boards of pharmacy now have the option to CPE compliance is rarely a disciplinary issue, licensee continuing report “zero” when they have no disciplinary education status is still something that some states and individual actions to submit on individuals or boards prefer to track and record, when appropriate. organizations. Contact clearinghouse@nabp The NABP Clearinghouse also plays a vital role in license .pharmacy for more information. verification, which is required by some NABP services such as the Electronic Licensure Transfer Program® (e-LTPTM). When verifying a license through the e-LTP process, NABP manually checks the database for any disciplinary records. As with disciplinary alerts, these details regarding the reported action, we find that most states are checks help boards make well-informed licensure decisions. willing to cooperate in providing additional information.” “The biggest advantage of using the Clearinghouse is getting Ellen Mitchell, recently retired investigation support coordinator a clear disciplinary history of North Carolina licensees or permit for the Idaho State Board of Pharmacy, had similar advice for other holders who are located in other states,” said Cindy Parham, boards. “The most critical thing for states to do is to report on a CISCI, an enforcement specialist with the North Carolina Board regular basis,” she said. “We have been reporting consistently for of Pharmacy. “Reports give us a clear picture of disciplinary history about 17 years. NABP staff was key in helping us to understand the during facility applications with the state. This also helps us to weed importance of reporting and how we support our sister boards by out the bad actors before they become licensed or permitted.” doing so. While older information can be helpful, it is much more helpful to see the actions as they happen.” Timely Reporting Is Vital NABP has long considered its Clearinghouse NABP Can Help With Reporting database to be extremely important to the shared There are some burdens that may make submitting mission of the Association and its member boards timely reports to the Clearinghouse more difficult. of pharmacy in protecting the public health, Among these, NABP recognizes that the federal particularly in situations that involve dangerous misconduct and/ requirement for state boards of pharmacy to submit or severe disciplinary actions. In fact, because timely reporting is disciplinary records to the National Practitioner Data Bank (NPDB) essential to maintaining the integrity and value of the database, may take priority over submitting these records to NABP. In these cases, NABP’s Constitution and Bylaws require member boards to report boards may also be concerned that their staff may need to duplicate work their disciplinary actions to the Clearinghouse as part of their by submitting disciplinary reports multiple times. NABP has taken steps membership to the Association. to help boards of pharmacy in these circumstances. Unfortunately, reporting is sometimes delayed in some states. Specifically, NABP and 34 state boards of pharmacy have entered When other priorities take precedence, such as the coronavirus disease into agreements that allow the Association to be their reporting 2019 pandemic, it may seem less important to devote resources to agent to NPDB. This can reduce the amount of board time and staff submitting disciplinary reports. However, the boards of pharmacy may needed and make it easier to keep reports for both databases up to want to keep in mind how vital this data can be for other states. date. More information about using NABP as an NPDB reporting Compliance Analyst David Meryman, PTR, and Enforcement agent is provided in the Members section of the NABP website under Program Manager Robert Rivera, PTR, of the Texas State Board of Clearinghouse. Pharmacy make regular use of the reports received by the NABP However, even if boards choose not to utilize NABP as a reporting Clearinghouse. “My advice to anyone who would be using these agent to NPDB, there are other ways that the Association can make records is to review the reports routinely and not let too much time reporting easier for its member boards. NABP wants the boards of elapse before acknowledging incoming reports,” Meryman stated. pharmacy to take full advantage of the NABP Clearinghouse and works Meryman also noted, “I would encourage participation from states that directly with them to help identify the best reporting methods. In many may not think they have the resources or manpower. In Texas, we have cases, automated reporting to NABP is possible. NABP Clearinghouse found that the process is not too involved. We receive the notification and staff can also assist boards to determine the best and most efficient option decide what we need to do. We usually do not need to expend a lot of staff that works with their current processes and resources. resources at our agency to process the incoming notifications.” In addition, the NABP Clearinghouse services and access are Rivera added, “It is surprising how often we get a notification regularly improved. Upgrades are planned for the coming year, and we never heard about, even years after the action. We are getting a more information will be shared through the appropriate channels. chance to take a look at information that we might not have known NABP thanks its member boards for all they do to keep their about had the licensee not reported it. If we determine we need more numbers updated regularly. AUGUST 2021 | 7
ASSOCIATION NEWS Association Seeks Item Writers for NABP Examinations • c ompound, dispense, or administer drugs, or manage delivery systems; and • evelop or manage practice or d medication-use systems to ensure safety and quality. The MPJE combines federal and state- specific questions that test an individual’s knowledge in pharmacy jurisprudence and includes the following areas: • pharmacy practice; • licensure, registration, certification, and operational requirements; and • general regulatory process. Writers for the MPJE are typically assigned by the participating jurisdiction; however, in some cases, individuals may be selected to participate independently of board of pharmacy affiliation. The FPGEE content areas cover curricula of accredited United States pharmacy programs, including: • basic biomedical sciences; NABP is seeking volunteers to apply to serve as designated examination program. Item • pharmaceutical sciences; item writers for the Association’s examination writers will then engage in the development • s ocial, behavioral, and administrative programs. Item writers develop test questions of new test items that will be considered for pharmacy sciences; and for NABP programs, including the North inclusion in NABP licensure, certification, • clinical sciences. American Pharmacist Licensure Examination® and assessment examination programs. The PCOA is suitable for students in all four (NAPLEX®), the Multistate Pharmacy Some item writing workshops may be professional years. The assessment follows a Jurisprudence Examination® (MPJE®), the held virtually and others will be at NABP’s blueprint that is representative of curricula of Foreign Pharmacy Graduate Equivalency Headquarters in Mount Prospect, IL. Please accredited US pharmacy programs, including: Examination® (FPGEE®), and the Pharmacy check the Meetings section of the NABP • basic biomedical sciences; Curriculum Outcomes Assessment® (PCOA®). website for updates. • pharmaceutical sciences; Item Writer Selection Process Overview of Exams • s ocial, behavioral, and administrative The opportunity to participate as an item The NAPLEX focuses on content pharmacy sciences; and writer is currently available to pharmacists relating to the knowledge, judgment, • clinical sciences. in all areas of practice and to faculty from and skills that an entry-level pharmacist schools and colleges of pharmacy. Item writers is expected to demonstrate. There are six How to Apply will be selected based on the specific needs of competency areas for the examination: Interested individuals should complete the programs. Those who are selected will be the online NABP Item Writer Volunteer • o btain, interpret, or access data, asked to participate in an item development medical, or patient information; Interest Form located on the Meetings workshop and training. Attendees will receive page of the NABP website and upload a detailed instructions and training materials • identify drug characteristics; current résumé or curriculum vitae. describing the item development process • develop or manage treatment plans; and content-related requirements for their • perform calculations; 8 | AUGUST 2021
ASSOCIATION NEWS NABP Inspectors Identify Dangerous Scheme Involving Over-the-Counter Insulin Products With decades of experience providing an important treatment option for diabetes Scheme Exploits Insulin Laws accreditations and inspections on a national patients who lack or have inadequate To make nonprescription insulin more level, NABP inspectors and surveyors have insurance to help with the high cost of accessible to patients, one of the top a unique perspective when it comes to drug prescription treatment options. Although manufacturers of insulin began working with safety issues and trends. That perspective these insulins are not displayed in the community pharmacy chains. The drug’s recently allowed NABP staff to observe several OTC section of retail pharmacies, upon retail price for patients is often below the schemes related to nonprescription insulin request, they can be sold to patients. In wholesale price of other insulin products sold that may pose a serious health risk to patients. this situation, the pharmacist is a frontline to pharmacies. A label on this insulin states, Recently, unscrupulous distributors resource for these patients. “ONLY FOR RETAIL SALE BY [CHAIN posing as patients have purchased a brand DRUGSTORE] AND ITS AFFILIATES.” of over-the-counter (OTC) insulin made for NABP became aware of a scheme and sold exclusively at retail pharmacies of a involving insulin purchased by a facility it large national pharmacy chain. The insulin is was inspecting that was collected from several collected in large quantities, then resold into chain drugstore pharmacies over a single the wholesale market. Wholesalers have then weekend. This scheme was carried out by purchased this diverted insulin and resold it to an organized group that sold the purchased retail pharmacies and, in some cases, to other insulin to a wholesale distributor, which wholesalers. This deliberate scheme to subvert then sold it to a mail-order pharmacy. Upon the supply of insulin is exposing patients further investigation, NABP discovered that to the high risk of receiving an adulterated this is the typical pathway in which diverted drug in the form of subpotent insulin due to insulin is resold into the marketplace. unknown storage conditions. The risk to patients with this type of While the specific pharmacies and According to NABP’s 2021 Survey of corrupt distribution is very high, as they are wholesalers involved in these schemes cannot Pharmacy Law, only 15 states require a receiving and injecting potentially adulterated become accredited by NABP until they license for wholesale distribution of OTC insulin that is very likely subpotent due to take corrective action and have ceased these drugs, including nonprescription insulin. improper storage. activities, patients may still be at risk from Notably, these insulin products are not To combat the nationwide threat posed by non-accredited facilities. subject to the traceability requirements this scheme, Georgia has enacted a law that that are part of the Federal Drug Supply criminalizes the resale of nonprescription Review of Insulin Regulation Chain Security Act of 2013 (Title II of the insulin that was first obtained through an and Proper Handling Drug Quality and Security Act), which was OTC sale. Insulin sold in this manner is Diabetes medications, including insulin, enacted to protect the integrity of drugs deemed adulterated under the law. usually require a prescription. However, some from adulteration and counterfeiting by NABP encourages the boards of pharmacy older forms of insulin can be purchased OTC. implementing requirements for traceability, to be aware of and to watch for variations In fact, they remain the only injectable human among other protections. of this scheme. Pharmacies and wholesalers drugs that can be sold without a prescription Insulins are complex biological products should maintain awareness and verify the under federal law. These drugs were on the that are sensitive to temperature variations. source of insulin products before purchasing. market without a prescription prior to the As a result, manufacturers recommend that Pharmacies that turn a blind eye to the enactment of certain provisions of the Federal insulin be stored in refrigerated conditions purchase and sale of insulin that is clearly Food, Drug, and Cosmetic Act, which (36o-46o F). At these temperatures, insulin labeled as being exclusively for sale by a chain created prescription-only status drugs, and are maintains its potency through the labeled pharmacy cannot claim ignorance of the grandfathered in to retain OTC status. As a expiration date. Once opened, insulin will source of the diverted insulin. result, these forms of insulin are not subject continue to be effective for up to 28 days In the interest of the shared mission to the same state and federal supply chain at room temperature (59o-86o F). Insulin of NABP and the boards of pharmacy to regulations as prescription insulins. can degrade and lose efficacy when exposed protect the public health, the Association will Diabetes advocacy groups, including the to extreme temperatures, either freezing continue to monitor these issues and trends American Diabetes Association, support temperatures or high heat. and report on any relevant updates. availability of nonprescription insulin as AUGUST 2021 | 9
ASSOCIATION NEWS Task Force Offers Recommendations for Improving Pharmacy Technician Regulations and Policies The Overview Task Force on Pharmacy Assessment, task force members discussed the Requirements for Pharmacy Technician Technician Education, Practice Responsibilities, career progression and time frame for each Education, task force members questioned and Competence Assessment was the fifth task level of pharmacy technician practice – from whether it was feasible to encourage state force established in response to Resolution applying as a candidate to becoming certified boards of pharmacy to license or register 115-4-19, which was approved by the NABP to earning an advanced certification. Members ancillary personnel, including cashiers, clerks, membership at the Association’s 115th Annual agreed that it is crucial to require technicians and delivery drivers. After extensive discussion, Meeting in May 2019. The task force met in to complete an accredited education and members agreed that NABP should not December 2020 and members reviewed the training program in order to increase encourage boards to register ancillary personnel recommendations of the previous task forces in standardization across the country. Members or add a definition for such personnel to the order to synthesize and consolidate them and also agreed with the previous task forces’ Model Act. However, members did agree that review the NABP Model State Pharmacy Act conclusions that the training component must NABP should continue to encourage state and Model Rules of the National Association of be site-specific. In addition, they recognized boards of pharmacy to license all certified Boards of Pharmacy (Model Act) to determine that the current certification examinations pharmacy technician candidates and certified whether any updates are warranted. (See the measure knowledge, but not necessarily pharmacy technicians and to maintain the bottom of page 11 for the official charge.) competence, and they noted that it is difficult definitions of both terms, as revised by the In reviewing the recommendations of the to measure the competence of a certified previous task forces and 2020 Committee on Task Force on Requirements for Pharmacy pharmacy technician candidate. Law Enforcement/Legislation report. Technician Education and the Task Force Upon further review of the Task force members also discussed and on Pharmacy Technician Competence recommendations of the Task Force on agreed with the addition to the Model Act Task Forces Convened in Response to Resolution 115-4-19 2019 Task Forces Overview Task Force on Requirements for Pharmacy Technician Education, Task Force on Requirements for Task Force on Pharmacy Technician Practice Responsibilities, and Pharmacy Technician Education Competence Assessment Competence Assessment 2020 Task Forces Overview Task Force on Task Force on Pharmacy Technician Pharmacy Technician Education, Practice Responsibilities Practice Responsibilities, and Competence Assessment In 2020, NABP held two task force meetings related to pharmacy technician practice and education. Both task forces were established in response to Resolution 115-4-19, which was approved by the membership at the Association’s 115th Annual Meeting. This 2019 resolution was also the impetus for three other pharmacy technician task forces held in 2019. 10 | AUGUST 2021
ASSOCIATION NEWS regarding a definition of and licensing process • ABP should encourage state N Task force members included: for “advanced level certified pharmacy boards of pharmacy to recognize, as technician.” However, the 2021 Committee a best practice, pharmacy technician • Malcolm Broussard, RPh (chair) on Law Enforcement/Legislation agreed that education that includes a didactic • Cindy Fain, PD curriculum from an accredited a new pharmacy technician category may provider and experiential training for • Jacqueline L. “Jackie” Hall, MBA, RPh be burdensome to boards of pharmacy and • Kristina Jonas, PharmD, RPh all levels of pharmacy technicians. ultimately decided not to add the definition to the Model Act. • ABP should encourage state boards N • Franklin J. “Rocky” LaDien, RPh Regarding existing technician certification of pharmacy to license all certified • Julie Lanza, CPhT, CSPT examinations, the task force agreed that it pharmacy technician candidates and • Edward G. McGinley, MBA, RPh, DPh certified pharmacy technicians. The was not necessary for NABP to perform Association should not, however, • Helen Pervanas, PharmD, RPh a gap analysis on the examinations or to • Jeenu Philip, RPh encourage boards to register other develop an additional examination. Members agreed, however, that NABP should perform ancillary personnel, such as cashiers, • Kari Shanard-Koenders, MSJ, RPh clerks, or delivery drivers. • Kristen Snair, CPhT a gap analysis of accreditation standards for pharmacy technician education programs, • ABP should perform a gap analysis of N • itchell G. “Mitch” Sobel, M accreditation standards for pharmacy MAS, RPh, FASHP, CPGx with the goal of recommending accreditation technician educational programs. standards that encompass future growth of • Julienne Tran, PharmD, RPh • ABP should retain and/or amend N pharmacist and pharmacy technician scopes of Model Act language pertaining to • radley S. Hamilton, BSPharm, B practice, as recommended by the Task Force RPh, Executive Committee liaison “certified pharmacy technician” on Requirements for Pharmacy Technician and “certified pharmacy technician Education. candidate” and include a definition The task force report was approved by the Lastly, the task force discussed remote practice for “advanced level certified pharmacy Executive Committee during its February and shared services – particularly related to technician,” but, as noted previously, 2021 virtual meeting and is available in the the coronavirus disease 2019 (COVID-19) was subsequently removed. Reports section at www.nabp.pharmacy. pandemic – and agreed that relevant Model • ABP should review Model Act N Act language that restricts or prohibits these language that prohibits remote practice types of practices should be reviewed. and consider removing or qualifying After careful review and deliberation, other provisions that have been the task force submitted the recently amended or waived due to the following recommendations: COVID-19 pandemic. Task Force Charge The task force was charged with the following objectives: 1 Review the reports of the Task Force on Requirements for Pharmacy Technician Education, the Task Force on Pharmacy Technician Competence Assessment, and the Task Force on Pharmacy Technician Practice Responsibilities. 2 Synthesize these task forces’ recommendations into one consolidated set of recommendations. 3 Examine the language in the Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy addressing all aspects of pharmacy technician regulation and recommend amendments, if necessary, that support technician education, competence assessment and practice, all in the best interest of patient care. AUGUST 2021 | 11
Sharing Sharing Solutions, Solutions, Advancing Regulation Advancing Regulation NABP Interactive Executive Officer Forum | September 28-29, 2021 | Northbrook, IL INTERACTIVE EXECUTIVE OFFICER Executive officers, join your colleagues in person on September 28-29, 2021, to network, gain new insights, and discover solutions to shared challenges facing the boards of pharmacy. FORUM No registration fees. Travel, hotel, and meals paid by NABP. September 28-29, 2021 NABP Headquarters The Interactive Executive Officer Forum will take place at the Hilton Chicago/Northbrook in Northbrook, IL. Executive officers will be sent invitations in August 2021. For questions, contact meetings@nabp.pharmacy. Mount Prospect, IL
ASSOCIATION NEWS Task Force on Medication-Assisted Treatment Recommends Adding MAT Definition to NABP Model Act During the Task Force on Medication- who are going through withdrawal to Lastly, task force members discussed the Assisted Treatment virtual meeting held seek treatment. The task force determined likelihood of pharmacists being added to in November 2020, members reviewed that the pharmacist’s role should involve the list of Drug Addiction Treatment Act of current federal and state laws and regulations initiation of short-term MAT therapy, 2000 (DATA 2000)-waived practitioners, as related to medication-assisted treatment including counseling on the medication and well as the likelihood that the Mainstreaming (MAT) and examined relevant language the need for further care, thus providing a Addiction Treatment Act (MAT Act) of in the Model State Pharmacy Act and “bridge” to long-term care. 2019, which would eliminate the DATA Model Rules of the National Association 2000 waiver requirement, would be passed. of Boards of Pharmacy (Model Act). The task force was informed that NABP is The task force meeting began with supportive of the MAT Act and is working guests sharing their experiences with the to educate federal legislators and regulators current trends that they are witnessing about the importance of the act in treating in various parts of the country regarding OUD patients. opioid use disorder (OUD) treatment, After careful review and deliberation, including progress in addiction treatment, the task force recommended that NABP the increase in OUD patients due to the In addition, task force members discussed amend the Model Act by adding a definition coronavirus disease 2019 pandemic, the how to best implement pharmacist-initiated of MAT that includes a footnote to clarify lack of available and/or willing providers, MAT in light of current state and federal that MOUD is the new term used by how some patients feel stigmatized because restrictions, as many states do not allow SAMHSA, and by adding an emergency- of their disorder, and the redundant shift pharmacists to obtain a state controlled use prescribing and dispensing provision to the use of methadone from the use of substance (CS) license. Task force members to Section 6. Pharmacist Care Services that buprenorphine in some areas. acknowledged that many states currently allows a pharmacist to prescribe and dispense Task force members also discussed the allow pharmacists to prescribe MOUD MAT on an emergency-use basis for patients term “medication-assisted treatment” and through the use of collaborative practice with OUD. The language specifies that how it compares to “medications for opioid agreements with practitioners who are when initiating MAT, pharmacists must use use disorder” (MOUD), the current term licensed to prescribe CS at the state and professional judgment to assess the clinical used by the Substance Abuse and Mental federal levels. Members agreed, however, appropriateness of the request and the length Health Services Administration (SAMHSA). that access to treatment would be greatly of treatment needed until the patient obtains While there was extensive discussion expanded if pharmacists had independent treatment by an authorized practitioner. regarding which term should be used to best authority at the state level to initiate The task force also recommended that further the presidential initiative of former MOUD for patients suffering from opioid NABP encourage state boards of pharmacy to NABP President Timothy D. Fensky, RPh, withdrawal, rather than having to enter into promulgate regulations that allow pharmacists DPh, FACA, task force members agreed collaborative practice agreements. to obtain CS licenses in order to prescribe that both terms should be referenced in the Model Act. They also agreed that the barriers to OUD treatment are more at issue than the term that is used. Regarding patient outcomes, task force Task Force Charge members and guests engaged in a robust 1 Review current state laws and regulations related to discussion as to whether counseling was medication-assisted treatment. necessary for OUD patients. After some conversation, all agreed that psychological 2 Examine the language in the Model State Pharmacy Act counseling should not be an eligibility and Model Rules of the National Association of Boards of requirement of MAT for OUD patients Pharmacy and, if necessary, recommend amendments seeking immediate treatment. Discussion that allow pharmacists to be key leaders in opioid safety also ensued regarding whether pharmacies and patient care. are an appropriate setting for patients AUGUST 2021 | 13
ASSOCIATION NEWS CS at the state level and obtain a federal CS • Debra Feinberg, JD, RPh, FASHP Invited guests for the task force included mid-level practitioner registration from Drug • Robert Giacalone, JD, RPh James J. Gasper, PharmD, BCPP, College of Enforcement Administration. Psychiatric and Neurologic Pharmacists; Jake • Michael J. Godek, RPh The Task Force on Medication-Assisted Nichols, PharmD, Professional Recovery Treatment was established pursuant to • Fiona Karbowicz, RPh Associates; and Erica Schlesinger, PharmD, former NABP President Fensky’s initiative, • Samuel Lanctin, MBA Tennessee Department of Mental Health and which is to promote pharmacist-provided • illiam T. “Bill” Lee, W Substance Abuse Services. MAT for patients diagnosed with OUD. MPA, DPh, FASCP The task force report was approved by the Task force members included: • Karen M. Ryle, MS, RPh Executive Committee during its February • 2021 virtual meeting and is available in the • Jeanne D. Waggener, RPh, DPh (chair) Katy Wright, MBA, Reports section at www.nabp.pharmacy. PharmD, DPh, BCPS • James “Jim” Bracewell • Luke Daniel, JD • icole L. Chopski, PharmD, BCGP, N ANP, Executive Committee liaison AROUND THE ASSOCIATION Board Member Appointments Services, Division of Public Health, • nthony D. Peterangelo, PharmD, A • oung Chang, MBA, RPh, has been Y Licensure Unit. Borcher’s appointment RPh, has been appointed a member of appointed a member of the Georgia will expire November 30, 2021. the Wisconsin Pharmacy Examining State Board of Pharmacy. Chang’s • odd M. Larimer, RP, has been T Board. Peterangelo’s appointment appointment will expire July 1, 2022. appointed a member of the Nebraska will expire July 1, 2023. • harles E. Page, RPh, has been C Department of Health and Human • Michael Walsh has been appointed appointed a member of the Georgia State Services, Division of Public Health, a public member of the Wisconsin Board of Pharmacy. Page’s appointment Licensure Unit. Larimer’s appointment Pharmacy Examining Board. Walsh’s will expire October 31, 2025. will expire November 30, 2024. appointment will expire July 1, 2024. • Christina Solis has been appointed • harles T. Tomlinson, PharmD, C • Shana Weiss has been appointed a member of the Guam Board of RP, has been appointed a member a public member of the Wisconsin Examiners for Pharmacy. Solis’ of the Nebraska Department of Pharmacy Examining Board. Weiss’ appointment will expire May 12, 2023. Health and Human Services, Division appointment will expire July 1, 2023. of Public Health, Licensure Unit. • rik Maki, PharmD, RPh, has been E Tomlinson’s appointment will appointed a member of the Iowa Board Board Member Reappointments of Pharmacy. Maki’s appointment expire November 30, 2025. • J . Andrew “Andy” Bowman, will expire April 30, 2024. • ischelle Johnson Corbin has been M PharmD, RPh, has been reappointed appointed a public member of the North a member of the North Carolina • hristopher Harlow, PharmD, C Board of Pharmacy. Bowman’s RPh, BCGP, has been appointed a Carolina Board of Pharmacy. Corbin’s appointment will expire June 1, 2025. appointment will expire May 1, 2026. member of the Kentucky Board of Pharmacy. Harlow’s appointment • allace Nelson, RPh, has been W • achael DeBarmore, RPh, has been R will expire January 1, 2024. appointed a member of the North reappointed a member of the Oregon Carolina Board of Pharmacy. Nelson’s State Board of Pharmacy. DeBarmore’s • J onathan Van Lahr, RPh, has been appointment will expire June 30, 2024. appointed a member of the Kentucky appointment will expire April 30, 2025. Board of Pharmacy. Van Lahr’s • ileen Ortega, RPh, has been appointed E • Cyndi Vipperman, CPhT, has appointment will expire January 1, 2024. a member of the Puerto Rico Board been reappointed a member of the Pharmacy. Ortega’s appointment Oregon State Board of Pharmacy. • J effrey Nikolaisen, RPh, has been Vipperman’s appointment will appointed a member of the Montana will expire November 23, 2024. expire February 16, 2024. Board of Pharmacy. Nikolaisen’s • iffany O’Hagan, MBA, PharmD, T appointment will expire July 1, 2025. RPh, has been appointed a member of • eri Ferreira, RPh, has been T the Wisconsin Pharmacy Examining reappointed a member of the Washington • evin C. Borcher, PharmD, RP, has K Board. O’Hagan’s appointment State Pharmacy Quality Assurance been appointed a member of the Nebraska will expire July 1, 2024. Commission. Ferreira’s appointment Department of Health and Human will expire January 28, 2024. 14 | AUGUST 2021
INTERVIEW WITH A BOARD MEMBER Julie Lanza, CPhT, CSPT Member, Massachusetts Board of Registration in Pharmacy When were you appointed to the great job developing and approving policies Board and as what type of member? and guidelines to assist the pharmacy I am a pharmacy technician who was appointed community while new regulations to the Massachusetts Board in December 2017. are waiting for promulgation. In 2019, I was elected secretary, and I am currently president for 2021. What advice would you give to a new board member? What steps should a board member Get involved and enjoy every moment. The take to be successful in their role? opportunity to serve on a board is an honor The most important thing a board member and a privilege. That said, every regulation, should do is listen to their fellow board every meeting, every discussion is an members. There is a wide range of specialty opportunity to learn something and become areas within the world of pharmacy, and we more well-rounded. It is okay to ask questions. Massachusetts Board of cannot be an expert in every area. Being able I was nervous and did not know what to expect Registration in Pharmacy to listen to other board members who have the when I was first appointed, but I quickly expertise and knowledge in an area unfamiliar learned that everyone on the Board was on the to you may help you make informed decisions. same team and working toward the same goal. Number of Board As a hospital-based pharmacy technician, In my three years on the Board, I have had the Members I have been able to expand my knowledge honor of serving with some amazing members 8 pharmacist members 2 public members in a host of areas simply by listening and of the pharmacy community. 1 pharmacy technician learning from other board members. 1 physician Have you served as a member of any 1 nurse What are some recent policies, NABP task forces or committees, or legislation, or regulations your attended NABP or district meetings? Number of Board has implemented? In January 2020, I attended the NABP Compliance Recently, the Board has approved a policy Interactive Member Forum and participated Officers/Inspectors 1 compliance officer allowing vaccine administration by qualified in the panel discussion Compounding by the and 12 inspectors pharmacy technicians. As a technician, this Numbers – Unlocking the Data of the MOU. was very exciting and another step in the right Additionally, I participated virtually in Rules & Regulations direction toward technicians in advanced roles. December 2020 in the Overview Task Force Established by This past year, I believe it has become more on Requirements for Pharmacy Technician Board of Registration evident that pharmacy technicians in advanced Education, Practice Responsibilities, and in Pharmacy roles have a positive overall impact on the Competence Assessment. Both experiences practice of pharmacy. They allow pharmacists were wonderful, but very different. The virtual Number of to have more patient-facing time and for the meeting was very informative, and I was able to Pharmacist Licensees implementation of more clinical services. Being hear other thoughts and opinions on the topics 13,936 involved with NABP gave me the opportunity presented. The benefits of the in-person meeting to connect with board members from other were gaining knowledge, but then also talking to states that already allowed this regulation. others about it. Comparing thoughts, ideas, and Number of Being able to ask questions and learn from processes with colleagues from other states in real Pharmacies 1,124 (includes home them allowed me to bring back to the Board time was beneficial for me to be able to bring infusion, mail-order information that was important for the back what I learned to the Board. I was able to pharmacies, and development and implementation of this policy. connect with multiple people at the in-person nuclear pharmacies) meeting whom I have since been able to contact Has the Board encountered any for their opinions on my quest for technician Number of challenges to developing new advancement. I feel as though any involvement Wholesale Distributors policies or regulations? with NABP is beneficial, and what I was able to 37 Implementation of any new regulation or take away from those experiences was far greater legislation takes time. My Board does a than what I expected. AUGUST 2021 | 15
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