The Future of Public Health Protection in Our Hands - Artificial Intelligence Applied to Medication Data - NABP
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February 2021 | Volume 50 | Number 2 The Future of Public Health Protection in Our Hands Artificial Intelligence Applied to Medication Data
CONTENTS
04 08 01 Interview With a
Board Executive Officer
Cody Wiberg, PharmD, MS, RPh
02 olicy Perspectives
P
New Year, New Government:
Renewed Focus on Illegal
Online Drug Sales
07 Association News
07 PMP InterConnect Is the
Solution to Provider Challenges
11 NABP Receives BBB Torch
Award for Marketplace Ethics
1 2 NABP President Fensky
Promotes MAT Initiative
via Association Resources,
Virtual Events
14 Interview With a Board Member
Todd Barrett, RPh
16 State Board News
Oregon Adopts New Statewide Drug
Therapy Management Protocols
17 Professional Affairs Update
Feature News Feature News Final Insanitary Conditions at
The Future of Public Health Regulators Prepare for Compounding Facilities Guidance
Protection in Our Hands – Pharmacist Involvement in Released by FDA
Artificial Intelligence Applied to COVID-19 Vaccine Rollout
Medication Data
NABP Executive Committee
(ISSN 2472-6850 — print; ISSN 2472-6958 — Amy Sanchez Jack W. “Jay” Fred M. Weaver
online) is published 10 times a year by the National Communications Manager Campbell IV Member, District 4
Association of Boards of Pharmacy® (NABP®) Chairperson
©2021 National Association of Boards of Pharmacy. Shane R. Wendel
to educate, to inform, and to communicate the
All rights reserved. No part of this publication may Timothy D. Fensky Member, District 5
objectives and programs of the Association and its
be reproduced in any manner without the written President
65 member boards of pharmacy. Lenora S. Newsome
permission of the executive director/secretary of the
Caroline D. Juran 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 Reginald B. “Reggie” Member, District 7
NABP is the independent, international, and
unless expressly so stated. The subscription rate is Dilliard
impartial association that assists its member boards Kamlesh “Kam”
$70 per year. Treasurer
and jurisdictions for the purpose of protecting the Gandhi
National Association of Boards of Pharmacy public health. Bradley S. Hamilton Member, District 8
1600 Feehanville Drive, Mount Prospect, IL 60056 Member, District 1
847/391-4406 | www.nabp.pharmacy Tejal J. Patel NABP Executive
help@nabp.pharmacy Member, District 2 Committee elections
are held each year
Lemrey “Al” Carter Jeffrey J. Mesaros at the Association’s
Executive Director/Secretary Member, District 3 Annual Meeting.
2 | APRIL 2020
INTERVIEW WITH A BOARD EXECUTIVE OFFICER
Cody Wiberg, PharmD, MS, RPh
Executive Director, Minnesota Board of Pharmacy
How long have you served as period. The Board issued a separate civil unrest
executive director? FAQs document, which granted blanket
I have been executive director of the Board since variances to rules or exercised enforcement
September 21, 2005. Between January 1999 and discretion. We published a document on the
September 21, 2005, I was pharmacy program Board’s website, in five different languages,
manager for the Minnesota Department of with advice for patients on how to obtain
Human Services. Basically, my team and I served prescriptions if their pharmacy was closed.
as the internal pharmacy benefits manager We also worked with chain and independent
for Minnesota’s publicly funded programs, pharmacies to get temporary pharmacies open
including Medicaid and some state-funded at the sites of the pharmacies that had been
programs. I also worked with the Minnesota damaged the worst.
Legislature, providing technical assistance on During its 2020 session, the Minnesota
pharmacy-related issues. Legislature enacted legislation, signed into
Minnesota law by Governor Tim Walz, that required
Board of Pharmacy What is one significant issue your the Board to work with another agency,
Board addressed in the past year? MNsure, to develop the Minnesota Insulin
The coronavirus disease 2019 (COVID-19). Safety Net Program. The program, which has
Number of Board
been operating since July 1, 2020, requires
Members
6 pharmacist What actions were taken by the manufacturers to provide insulin to Minnesotans
members and 3 Board to address the issue? who meet certain eligibility criteria and who are
public members The Board issued a COVID-19 frequently asked having difficulty affording insulin.
questions (FAQs) document in mid-March and The legislature also passed a law requiring
has updated it several times since then. Through the Board to work with a vendor to establish
Number of
Compliance the FAQs document, our Board has effectively a prescription drug repository program,
Officers/Inspectors either granted blanket variances to rules or which became operational at the end of 2020.
7 exercised enforcement discretion by allowing The vendor established a central repository
licensees to do things not otherwise permitted and is working to establish local repositories
by the statutes. For example, under Minnesota around the state. Long-term care facilities,
Rules & Regulations Statutes, pharmacists and pharmacy technicians manufacturers, wholesalers, pharmacies, and
Established by cannot complete any portion of the dispensing members of the public (with certain restrictions)
Board of Pharmacy process from home. But in order to minimize are able to donate drugs to the repositories. Once
contact between pharmacy employees and the deemed safe by a pharmacist, the drugs are
public, the Board is allowing pharmacists and dispensed to patients who would not otherwise
Number of pharmacy technicians to perform data entry, be able to afford the drugs.
Pharmacist Licensees certification of data entry, profile reviews, and
9,033 prospective drug utilization reviews from home. What insights do you have for states?
Board staff also worked with the Minnesota The key to dealing with pandemics or with
Department of Health to provide legal clarity to man-made or natural disasters is to have a plan
Number of licensees so that pharmacists could be involved in place. For COVID-19, I began preparing
Pharmacies in COVID-19 testing. for the worst at least a month before the
2,142 World Health Organization officially declared
What other key issues has the a pandemic, and Governor Walz declared a
Board been focusing on? peacetime emergency. Consequently, we were
Number of We also handled some repercussions of the civil able to give guidance to licensees shortly after
Wholesale
unrest that occurred after the death of George the pandemic and emergency were declared.
Distributors
261 (resident) Floyd. At the height of the civil unrest, over I believe that boards need to be flexible when
200 pharmacies in Minnesota were temporarily dealing with such disasters and must be willing
closed as a precaution. Over 20 pharmacies to relax enforcement of statutes and rules –
were either destroyed or damaged to the extent but must do so in a way that minimizes any
that they had to remain closed for an extended additional risks to patients.
FEBRUARY 2021 | 1
POLICY PERSPECTIVES
New Year, New Government: Renewed Focus
on Illegal Online Drug Sales
Last month, the 117th Congress convened
and President Joseph R. Biden began his
term as president and, as such, we can expect
many new policy changes at the federal level.
As discussed in January’s issue of Innovations,
there are some issues that have garnered
interest across the political spectrum and
thus may be ripe for consideration. One of
those issues, which is of great interest to the
practice of pharmacy given its public health
and patient safety implications, is reforming
a telecommunications law – Section 230
Matthew J. Rubin Sarah-Lloyd Stevenson, MPH
of the Communications Decency Act Faegre Drinker Biddle & Reath LLP Faegre Drinker Biddle & Reath LLP
(47 USC §230) – that currently provides
liability immunity to online platforms resources for health information and services. legitimate providers on the internet.
that knowingly facilitate illegal or obscene For example, in 2017, approximately 30% Two programs, NABP Digital Pharmacy
content, including the sale of prescription of respondents to a national survey said they Accreditation and the .Pharmacy Verified
drugs and illicit narcotics through illegal would order medicine online. In 2020, that Websites Program, help consumers determine
online pharmacies. number climbed to nearly 75%. which pharmacy websites are licensed and
This growing interest in seeking out safe. Digital Pharmacy Accreditation has
The Dangers of Illegal medications online has also impacted the been recognizing legitimate websites offering
Online Pharmacies national response to the opioid epidemic, pharmacy services for more than 20 years
NABP and its member boards of pharmacy a major public health issue that NABP by ensuring that pharmacies with an online
are committed to protecting public health leadership – including President Timothy presence are licensed, operating in compliance
and ensuring the appropriate, safe practice of D. Fensky – is prioritizing. With the with pharmacy laws and practice standards,
pharmacy, whether through brick-and-mortar available data indicating a spike in opioid- and undergoing on-site inspections. The
storefronts or via the internet. Unfortunately, related overdose deaths, the confluence of .Pharmacy Program was launched in 2014
criminals are actively leveraging the internet the COVID-19 pandemic and this historic to address new online business models for
to target unsuspecting consumers, peddling public health emergency has significantly prescription dispensing and other pharmacy-
substandard, falsified, and otherwise counterfeit strained resources. The internet remains related services. A .pharmacy verification
drugs, and posing a significant risk to those a constant source of synthetic opioids instills confidence in patients’ choices and
who may rely upon these medications for and illicit narcotics, like fentanyl. With helps ensure access to care. If a pharmacy or
acute, chronic, or life-threatening conditions. local shutdown orders in place and social business offering pharmacy-related services
Alarmingly, last year NABP found that of the isolation setting in, individuals suffering has not been vetted through one or both
nearly 22,400 surveyed “pharmacy” websites, from substance use disorders have turned of NABP’s programs, it may be a rogue
95% were illegal. Despite this statistic, a recent to unsafe and illegal websites at alarming website offering medicines without a valid
survey conducted by the Alliance for Safe rates. The Centers for Disease Control and prescription, operating out of compliance
Online Pharmacies (ASOP Global) found that Prevention found that four in 10 Americans with pharmacy laws and practice standards,
seven in 10 Americans erroneously believe that if are suffering from mental health or substance and/or selling counterfeit or misbranded
an online pharmacy website appears high up in abuse issues due to the pandemic. Thirteen prescription drugs.
search engine results, it is likely to be legitimate. percent cited an initiation or increase
This misguided trust in online platforms in substance misuse and abuse, and an Section 230 and Federal
and “internet pharmacies” that are additional 31% cited anxiety or depression. Liability Protections
incorrectly assumed to be legitimate has One in 10 noted suicidal ideations. Despite the grave concerns associated
only been exacerbated by the proliferation with accessing illegal online pharmacies,
of misinformation and criminality during NABP’s .Pharmacy Program a seemingly obscure and concise section
the coronavirus disease 2019 (COVID-19) NABP has led efforts to curtail illegal online of a decades-old telecommunications law
pandemic, as more patients turn to online pharmacies and help patients identify indirectly helps protect these bad actors from
2 | FEBRUARY 2021
POLICY PERSPECTIVES
further scrutiny, particularly those platforms
that facilitate the distribution of harmful Notable Section 230 reform bills introduced in 2020:
content. Passed in 1996, Section 230 of the • Protecting Americans from Dangerous Algorithms Act; Representatives Tom
Communications Decency Act provides Malinowski (D-NJ) and Anna Eshoo (D-CA)
immunity for online publishers of third- • See Something Say Something Online Act; Senators Joe Manchin (D-WV) and
party content published on such platforms. John Cornyn (R-TX)
Specifically, the law states that “No provider • latform Accountability and Consumer Transparency Act; Senators John Thune
P
or user of an interactive computer service shall (R-SD) and Brian Schatz (D-HI)
be treated as the publisher or speaker of any
• nline Freedom and Viewpoint Diversity Act; Senators Roger Wicker (R-MS)
O
information provided by another information and Lindsey Graham (R-SC), chairmen of Senate Commerce and Senate
content provider.” Some policy experts refer Judiciary Committees
to these components of Section 230 as “the 26
words that created the internet.”
In practice, this provides civil liability
protection to online platforms that republish reining in the current policy, they have not yet Section 230, Rogue Online
or host unlawful material, including illegal agreed on how to do it. Pharmacies, and 2021
online drug sales. There are targeted exceptions Last year, several pieces of legislation were The first 100 days of the new administration
to the law, including a “good Samaritan” introduced on Capitol Hill – partisan and will be a defining time during which the
provision that allows the deletion of obscene bipartisan proposals in both chambers of president and members of Congress will
content removed in good faith and liability Congress. While no legislation advanced prioritize any number of specific policy
exclusions when copyright or sex trafficking in 2020, two powerful congressional reforms. Given the extensive attention
laws are infringed. However, unlawful content committees with jurisdiction over these Section 230 and illegal online activity
still prevails on the internet, notwithstanding issues – the Senate Committee on the received across Washington, DC, in 2020,
illicit drug sales. In recent years, NABP and Judiciary and the Senate Committee on this topic will certainly remain a policy of
other public health stakeholders like ASOP Commerce, Science, and Transportation – interest in the 117th Congress, and there is
Global have argued that Congress should take used the final weeks of the 116th Congress no shortage of proposed policy solutions
up Section 230 reform and mandate that – at to hear testimony from the executives of to be considered. NABP will closely follow
minimum – interactive computer service major technology platforms like Twitter, this debate as relevant policymakers on both
providers proactively address the pervasive Facebook, and Google on the real-world sides of the aisle and across government look
public health and patient safety threats that are practice of Section 230 immunity. Further, for opportunities to rein in these liability
caused by illegal online pharmacies. the Trump Administration’s Department of protections or propose other policies that
Justice released a comprehensive legislative could protect the public health by holding
Section 230 Policy Changes framework to reform the law, while the illegal online pharmacies accountable.
Proposed in 2020 Federal Communications Commission chief This article was written by Matthew J. Rubin
In 2020, policymakers on both sides of the aisle argued that the federal government has the and Sarah-Lloyd Stevenson, MPH, with Faegre
issued proposals to reform Section 230 and regulatory authority to reinterpret Section Drinker Biddle & Reath LLP. Please note, the
address violative content online. Unsurprisingly, 230 through rulemaking without action from opinions and views expressed by Faegre Drinker
a lot of the interest in the issue was fueled Congress. Supreme Court Associate Justice Biddle & Reath do not necessarily reflect the
by potential foreign interference in the 2020 Clarence Thomas also spoke of “paring back official views, opinions, or policies of NABP or
presidential election via the internet, causing the sweeping immunity” of Section 230 in a any member board unless expressly noted.
both candidates and many members of Congress statement issued pursuant to MalwareBytes,
to speak in favor of reform. While the existing Inc. v. Enigma Software Group USA, LLC.
statute has long been lauded as an important An outright repeal of the law may be too
policy protecting free speech and the ability blunt a solution, according to the technology
for the internet to grow and modernize, the industry as well as leaders in Congress
issue of internet reform has become a political who are championing several competing
hot topic as allegations of censorship and free legislative proposals to make targeted
speech infringement emerged leading into last changes to the liability protections. Of
November’s election. These activities rekindled note, the bills noted above were introduced
the Section 230 debate, creating a potential in the 116th Congress and may be up for
opportunity for true reform. However, while consideration or debate in the 117th.
decision makers in both political parties support
FEBRUARY 2021 | 3
The Future of
Public Health
Protection in
Our Hands
Artificial Intelligence
Applied to Medication Data
4 | FEBRUARY 2021
I’m sorry Dave, I’m afraid I can’t do that.
For decades, the cool and ominous voice of HAL 9000 in 2001: A Space Odyssey and other tropes of
science fiction have been the first things that come to mind when people hear the phrase artificial
intelligence (AI). Yet, as we push into the third decade of the 21st century, many professions,
including pharmacy, are experiencing gradual but steady transformations driven by applications
of AI in the real world. So far, AI has helped pharmacists respond to issues such as drug shortages,
drug recalls, the opioid epidemic, and even the coronavirus disease 2019 (COVID-19) pandemic. As
the technology improves, it seems inevitable that the pharmacy profession’s perception of AI will
continue moving beyond the realm of science fiction and into the day-to-day lives of pharmacists
and pharmacy regulators.
AI’s Strength Is in Mass Data Analysis personnel to investigate and confirm the root cause of any suspicious
As discussed during a continuing education session at the 115 th
activity and/or behavior.
NABP Annual Meeting in 2019, AI is already becoming a part of our Without AI, an audit of only 5% of CS administrations normally
daily lives. For example, smartphone technology with voice assistants takes several hours, according to a June 2020 article in Pharmacy
or cars with advanced driver-assistance technology, including parking Times. AI-backed software systems can perform a complete audit of
assistance or adaptive cruise control, are already using AI. Currently, all CS administrations in less time than it takes for staff to perform a
AI technology utilizes three key features: neural networks that manual audit of just 5% of CS administrations.
mimic some of the human brain’s ability to analyze, natural language Similarly, current AI technology can help with supply chain
processing that allows machines to understand and generate human management. This is particularly useful when manufacturers
language, and the use of sensors that allow machines to see through and dispensers need to respond to drug shortages and recalls.
object detection and pattern recognition. By analyzing large amounts of current medication and their
So far, the most successful applications of these features in health applications, AI can actually predict how medications can be
care involve analysis of massive amounts of data to discover trends combined in new ways to create effective treatments. This can
and flag anomalies. This is perhaps most evident in the way some expand the options available to pharmacists and other health care
hospitals are now using AI to monitor and respond to diversion of providers for offering medication therapy for specific conditions.
controlled substances (CS) by health care providers. By automating the task using AI-powered technology, researchers
Studies indicate that hospital-based health care workers struggle may be able to discover new treatments more quickly.
with substance use disorder (SUD) at rates that are similar to that Drug recalls have also presented significant hurdles for health care
of the general population. For example, a 2014 study in the Western providers and patients in recent years. For example, in April 2020,
Journal of Emergency Medicine found that 10-14% of emergency Food and Drug Administration issued a recall for all ranitidine
physicians were affected by an SUD. A report published by Protenus products after discovering levels of N-Nitrosodimethylamine, a
in 2018 found that 18.7 million dosage units of medication were lost probable human carcinogen, increased in potency over time. While
due to misuse and other diversion by health care employees. This has there are a number of alternative medications for ranitidine that
become such an important issue for health care providers that some patients can use to treat acid reflux, the large-scale nature of the recall
pharmacy schools are directly teaching their students about it. For illustrates the challenge health care providers and patients can face
example, the University of Michigan College of Pharmacy provides when common medications are no longer available.
seminars, community work, and course content to teach students AI may help to manage recalls by pinpointing exactly when
about medication management and how they should handle drug and where a drug was contaminated within the supply chain.
diversion incidents. This allows teams to correct the issue more efficiently than using a
Because AI can analyze massive data sets in short amounts of manual research-based process. AI also allows visibility down to each
time, the technology can flag abnormalities in the management individual item. In other words, AI can track every vial and syringe
of commonly abused medications, making it easier for hospital in a shipment from the manufacturer all the way to the patient.
FEBRUARY 2021 | 5
This means that when a recall is issued, affected medications can In another article, published in the HealthManagement.org journal,
be identified and removed from the supply chain more efficiently, Pearl noted the importance of separating the truth of AI technology
resulting in a smaller impact on patient care. in health care from the hype. “AI might someday radically transform
diagnostic medicine to the point it can identify cancer at the single-
Skepticism and Misgivings Remain cell level. Exciting projections like these have led many entrepreneurs
As AI in health care becomes more prominent, the technology and futurists to declare that machines will someday take over
has become a more frequent subject of presentations and trade complex diagnoses entirely. Today, however, the most commonly used
show discussions often held by technology companies eager to sell computer applications do not feature deep learning as with AI.” Pearl
their latest inventions to health care providers, which continue to argues that most of these technologies, while lifesaving, are not “true”
represent a large portion of the nation’s economy. Unfortunately, AI, and that they contribute to misunderstanding and even fear of
many of these innovations have so far failed to cause lasting these tools.
and widespread improvement in areas such as public health and One common misgiving about AI-driven technology is that it will
patient safety, as explained by Robert Pearl, MD, in a February be used to replace and override professional diagnosis and treatment
2020 Forbes article. decisions made by human health care providers. In the health care
“Tech companies too often set out to create AI innovations they industry, however, this has not been the case. Instead, AI systems
can sell, rather than trying to understand the problems doctors and are employed as new tools that can ultimately improve the ability of
patients need solved. At many traditional med-tech conferences and health care providers to give patients the best possible information in
trade shows, for example, talks and sales pitches focus squarely on a timely manner.
the technology while routinely overlooking the human fears and “AI is already transforming health care but will become increasingly
frustrations that AI can address,” Pearl wrote in the article. valuable as investments in systems that can capture and manage data
are made and clinical informatics entities work more collaboratively to
address current data shortfalls,” said Doug Zurawski, PharmD, during
an interview with Drug Topics. Zurawski is senior vice president
of clinical strategy at Kit Check, Inc, maker of radio frequency
identification/AI technology for hospital pharmacies to help with
medication management – a technology that is vital to applications
related to tracking and analyzing inventory. “It is incumbent upon us,
in this industry and in this field, to take the lead and learn more, invest
in systems that support AI and machine learning, and prepare for the
future with access to artificial intelligence.”
Use of AI applications
The Future
in pharmacy practice AI-based technology is giving pharmacists and other health care
providers more opportunities to take an active role in patient care.
This is important as value-based care models continue to be an
and the drug supply increasingly vital part of health care. Pharmacists are highly trained in
patient care, and yet, they too often must act as de facto supply chain
experts to keep hospitals stocked with the medications they need.
chain will likely With AI, pharmacists can direct more of their energy to patient care.
Use of AI applications in pharmacy practice and the drug supply
chain will likely continue to grow, perhaps bringing with them
continue to grow, new regulatory questions. For example, how may pharmacists’
scope expand if more time can be devoted to patient care, or if
perhaps bringing more diagnostic tools are available across health care teams? Can
diversion tools give boards of pharmacy the ability to further support
pharmacists and technicians in need of recovery networks to maintain
with them new their licenses and safe practice? Can using AI to analyze mass
amounts of data make recall and drug supply management more
efficient, possibly alleviating some concerns with pharmacy working
regulatory questions. conditions by freeing up time for other tasks?
As AI technologies continue to emerge and develop, there have also
been discussions about adequate guardrails to ensure good decision
making and to protect patient privacy and health. Such discussions
are vital to the continuing use of this technology as the technology
must be ethical and effective, while also adhering to all existing laws
and regulations for patient privacy and data security.
6 | FEBRUARY 2021
ASSOCIATION NEWS
PMP InterConnect Is the Solution to Provider Challenges;
GAO Report Examines Effectiveness of PDMPs
PMP InterConnect, due to the system
enabling states to have complete control over
how their data is shared. PMP InterConnect
creates a network between state PDMPs and
is well established with over 4.67 billion
transactions in the last 12 months. All major
pharmacy chains and the military health
system are connected.
PMP InterConnect also provides the
backbone for PMP Gateway – a third-
party service that works in tandem with
PMP InterConnect to facilitate a seamless
integration of state PDMP data into the
workflow of health care providers’ electronic
health information systems, including
hospitals, hospital systems, and pharmacies.
PMP Gateway allows a patient’s prescription
history to be viewed in one location,
reducing provider assessment time. In fact,
supporting data is available, which shows
As the nation’s only national network of states, that PDMPs are useful in preventing that in some states, after PMP Gateway
prescription drug monitoring programs drug misuse and potentially dangerous drug integration, prescriber engagement with
(PDMPs), NABP PMP InterConnect® prescribing. However, the physicians and PDMP data has increased tenfold.
facilitates over 1 billion patient encounters pharmacists from the 10 states interviewed While the GAO report aptly recognizes
per year, connecting over 100,000 facilities also identified issues accessing PDMP the importance of PDMPs, interstate
and 800,000 health care providers. NABP data, citing difficulty tapping into patient connectivity, and clinical integration, it
is committed to growing this network to prescription histories across state lines does not tell the full story of the innovation
ensure that as many providers are connected and clunky systems that require clicking that is already being implemented through
as possible. within several computer applications before PMP InterConnect and other tools such
PDMPs have been identified by the federal reaching the PDMP. as PMP Gateway. The solution for PDMP
government as key tools to help ensure the connectivity across state lines already exists;
safe and appropriate prescribing of opioids PMP InterConnect Is the Solution improvements to clinical integration are
and other controlled substances (CS), and PDMPs originated as standalone systems in currently under way and already working
Congress continues to make bolstering and each state and territory in the country and, for a number of large hospital systems
improving PDMPs a priority. In fact, the therefore, were not originally connected state- and pharmacies. NABP looks forward to
Substance Use-Disorder Prevention that by-state or clinically integrated into electronic working with Congress and the Biden
Promotes Opioid Recovery and Treatment health records and other existing clinical Administration to bring this critical data to
for Patients and Communities Act of systems. The infrastructure to solve both of even more providers.
2017 includes a provision for the United those issues now exists and has, in fact, been
States Government Accountability Office updated in many states – it is just a matter of
(GAO) to study the operation of PDMPs. implementing and continually improving it. The full GAO report may be accessed
In response, GAO released a report, PMP InterConnect has linked state at www.gao.gov/assets/710/709907.pdf.
“Prescription Drug Monitoring Programs: PDMPs since 2011, and today, 52 of 54 More information about the success
Views on Usefulness and Challenges of PDMPs across the country are connected of PDMPs using PMP InterConnect
Programs,” that examines how effectively to the information-sharing hub, sharing for exchanging data is available at
health care providers have used PDMPs. PDMP data with one another. Even with https://pdmpworks.org/data-sharing-
In the report, GAO found, in interviews the complexities of state laws that protect and-integration
with physicians and PDMP directors in 10 sensitive data, data sharing is possible via
FEBRUARY 2021 | 7
FEATURE NEWS
Regulators Prepare for Pharmacist
Involvement in COVID-19 Vaccine Rollout
Governments, private companies, and billion in funding awards divided among six a pandemic-related vaccination campaign.
nonprofit enterprises around the globe different vaccine manufacturers. In addition, But since the late 1990s, the laws have
pushed for the swift development of a the National Institutes of Health established gradually changed and pharmacists have
vaccine to help impede the spread of the the Accelerating COVID-19 Therapeutic been able to increase their scope of practice
coronavirus disease 2019 (COVID-19), Interventions and Vaccines partnership to to include administering vaccinations. For
a virus that has claimed the lives of more bring together various federal agencies, the a number of years, all US states as well as
than 2 million people, including more private sector, and philanthropic stakeholders the District of Columbia and Puerto Rico
than 400,000 people in the United States. in order to facilitate vaccine development. have allowed registered pharmacists to give
In the US, part of this push came through US Food and Drug Administration (FDA) flu vaccines to adults. While state laws
the federal Operation Warp Speed (OWS) issued regulatory guidance to maximize have and do vary widely beyond that one
initiative, which included a general goal of safety despite the accelerated development generality, the trend in recent years has been
accelerating the development, production, timeline. Concurrent with vaccine toward greater empowerment of pharmacists
and administration of various COVID-19 development, stakeholders, including to provide immunizations, as states have
vaccines, therapeutics, and diagnostics. government regulators from the federal steadily reduced age restrictions, increased
Though the statistics are daunting, hope level to the boards of pharmacy, laid the the number of allowed vaccine types, and
seems on the horizon with the approval of groundwork for vaccine distribution expanded autonomy. Almost all jurisdictions
two vaccines in December – one developed and administration – a process in which allow trained and supervised pharmacy
by Pfizer Inc and BioNTech SE and one pharmacists will play a prominent role. interns to administer vaccines as well, and a
developed by Moderna. few states, including Idaho, Rhode Island,
To advance this agenda, in October 2020, Expanding Scope of Practice and Utah, have even passed legislation
the US Department of Health and Human Twenty-five years ago, pharmacists may allowing qualified pharmacy technicians to
Services (HHS) announced more than $10 not have been considered a crucial part of administer vaccines to patients.
8 | FEBRUARY 2021FEATURE NEWS
With this expanded scope of practice,
pharmacists are now viewed as an important
part of influenza immunization campaigns. Pharmacies’ easy accessibility and pharmacists’
According to the National Association of
Chain Drug Stores, pharmacists gave flu
increasingly important role in providing influenza
shots to nearly one-third of adults who vaccines were two factors HHS cited in using its
received the vaccine in the 2018-2019 season emergency powers last August to increase pharmacists’
(about 38 million). A 2017 study examining
the potential impact of retail pharmacies on
scope of practice on a national scale, authorizing
influenza vaccine administration projected state-licensed pharmacists to independently order and
that, overall, the time to achieve 80% administer vaccines to children ages three through 18,
vaccination coverage nationally was reduced
by up to seven weeks when retail pharmacist
subject to certain requirements.
vaccination capacity was included in
calculations, increasing national capacity to
25 million doses per week. to children ages three and up, as previously partnering with “large chain pharmacies
Pharmacies’ easy accessibility and mentioned. The following month, HHS and networks that represent independent
pharmacists’ increasingly important role in issued guidance authorizing state-licensed pharmacies and regional chains.” HHS
providing influenza vaccines were two factors pharmacists to independently order stated that the COVID-19 vaccine would
HHS cited in using its emergency powers and administer COVID-19 vaccines be administered at the partner pharmacy
last August to increase pharmacists’ scope for patients ages three and older, again locations at no cost to patients.
of practice on a national scale, authorizing subject to certain requirements; supervised
state-licensed pharmacists to independently pharmacy interns were again included as Board of Pharmacy Actions
order and administer vaccines to children authorized to administer the vaccines. And The boards of pharmacy addressed
ages three through 18, subject to certain in October, HHS issued guidance adding many pandemic-related issues in 2020,
requirements. The action was one of several “qualified pharmacy technicians” to the from carrying out state of emergency actions
pharmacist scope of practice expansions “covered persons” under the PREP Act, (such as enabling out-of-state licensees
HHS announced in 2020, explicitly allowing them to administer childhood to provide in-state services), dealing with
preempting state laws while the COVID-19 and COVID-19 vaccines and COVID-19 unexpected issues (such as establishing hand gel
public health emergency remains in effect. testing, again under the supervision of a compounding guidelines), addressing licensure
HHS took the actions under the auspices licensed pharmacist and subject to certain renewal issues impacted by shutdowns (such
of the Public Readiness and Emergency conditions. The guidance noted that to be as allowing a grace period for immunizing
Preparedness Act (PREP Act), which “qualified,” pharmacy technicians must be pharmacists to renew their CPR certification),
authorizes the HHS secretary “to issue a licensed and/or registered in accordance and managing day-to-day business during
Declaration to provide liability immunity with state requirements or, if they work shutdowns and stay-at-home orders.
to certain individuals and entities . . . in a state without licensure or registration Nonetheless, many states have also addressed
against any claim of loss caused by . . . the requirements, they must have a certified the vaccine rollout as well as the federal
manufacture, distribution, administration, or pharmacy technician certification from either preemption regarding vaccine administration.
use of medical countermeasures . . . ” Earlier the Pharmacy Technician Certification Board Several boards of pharmacy, including
in 2020, HHS had used these powers to or the National Healthcareer Association. those in Iowa, Texas, and Washington,
designate licensed pharmacists as “qualified The Trump Administration had taken have used their websites to prominently
persons” under the PREP Act and gave them additional measures to prepare for a provide their licensees with information
the authorization to independently order COVID-19 vaccine rollout. In October, on registering to become COVID-19
and administer COVID-19 tests, whether HHS and the US Department of Defense vaccine providers. Nevada is offering
or not the state in which a pharmacist was announced agreements with CVS and vaccine training for pharmacists to better
licensed would ordinarily permit him or Walgreens pharmacy chains to provide help in the distribution of a COVID-19
her to do so. In August, citing the public and administer COVID-19 vaccines to vaccine. Arkansas and Kansas, among
health threat posed by pandemic-caused residents of long-term care facilities (LTCFs) others, have used their websites to advise
drops in childhood immunization rates, the nationwide, at no cost to those facilities; their licensees about the federal actions
HHS secretary amended the declaration LTCFs had a two-week sign-up window affecting pharmacists and outlining
to authorize licensed pharmacists to order for opting into the program. In November, the requirements pharmacists must
and administer (and qualified, supervised HHS announced an allocation program meet to order and administer vaccines.
pharmacy interns to administer) vaccines in which the federal government would be Other boards, including those in North
FEBRUARY 2021 | 9FEATURE NEWS
NABP Emergency Passport Program Extended in Response to Vaccination Efforts
Federal and state programs have placed pharmacists and
other pharmacy personnel on the front lines of delivering
covered countermeasures of the coronavirus disease 2019
(COVID-19) pandemic. These measures have evolved
throughout the pandemic, and pharmacists, pharmacy
technicians, and pharmacy interns will continue to play a
critical role in the COVID-19 response, including with the
national vaccination effort.
In response, NABP has extended the operation of the
Emergency Passport Program for pharmacists, pharmacy
technicians, and pharmacy interns, which was set to expire on
December 31, 2020. Passport holders for states continuing
participation after December 31, 2020, continue to be active.
New NABP Passport applications for participating states are Emergency Passport Program to practice in a state in which
currently being accepted. Applicants cannot have any current you do not hold a license or registration. Since the program’s
or prior board actions or discipline, with the exception of a launch, NABP has issued nearly 55,000 passports.
minor continuing education infraction. Participation in the NABP Emergency Passport Program is
NABP Passport was created in early 2020 to provide critical available to any individual or member board of pharmacy at
licensure and disciplinary screening to assist member boards no cost. Currently, more than 15 states utilize or are preparing
of pharmacy in safely and efficiently granting temporary to utilize NABP Passport.
emergency licensure to pharmacists, pharmacy technicians, If your board has not previously participated in the
and pharmacist interns in response to COVID-19. Authority program, please contact the NABP Member Relations and
to practice on a temporary or emergency basis is granted Government Affairs department at governmentaffairs@nabp
exclusively by the states and in accordance with state emergency .pharmacy. More information about the NABP Passport is
orders or as otherwise determined by that state’s board of available at https://nabp.pharmacy/coronavirus-updates/passport.
pharmacy. NABP does not grant authority through the
Carolina, Ohio, and Virginia, issued who follow the federal guidelines would States have also taken vaccine-related
documents walking their licensees through not be penalized. Ohio advised licensees action in addition to the board of pharmacy.
the differences between preexisting that federal actions had created “two In Montana, for example, the state’s
state laws and the preemptive federal processes for the administration of FDA- governor issued a directive suspending
requirements and noting that pharmacists authorized or FDA-licensed COVID-19 those parts of the public health laws that
vaccines by Ohio pharmacists and would have conflicted with the HHS
pharmacy interns, one authorized by preemption. The Minnesota Legislature
section 4729.41 of the Revised Code passed a law authorizing pharmacists to
. . . and a temporary process established administer a COVID-19 vaccine when it
States and the federal by HHS in response to the COVID-19 became available. Meanwhile, in September,
government continue pandemic . . . Pharmacists and pharmacy the California State Assembly passed a bill
to plan for a widespread interns must comply [fully] with either allowing pharmacists to independently
the federal or state process . . .” The initiate and administer vaccines in a manner
distribution of a COVID-19 Massachusetts Board of Registration similar to the HHS directive.
vaccine that could help end in Pharmacy issued a temporary policy States and the federal government
the pandemic. designed to align state requirements with continue to plan for a widespread
the HHS August amendment addressing distribution of a COVID-19 vaccine that
childhood vaccines. could help end the pandemic.
10 | FEBRUARY 2021ASSOCIATION NEWS
NABP Receives BBB Torch Award for Marketplace Ethics
NABP received its mission to protect the public health.
the Better Business Through its programs and services, NABP
Bureau (BBB) aims to establish trust in the marketplace “It is gratifying to be
of Chicago and while supporting public health and ensuring recognized for the work
Northern Illinois’s patient safety.
Torch Award for “It is gratifying to be recognized for that we consider to be
Marketplace Ethics the work that we consider to be ‘the ‘the right thing to do.’”
on December 10, right thing to do,’” remarked NABP
— Lemrey “Al” Carter, PharmD, MS, RPh,
2020. The Torch Award is the most Executive Director/Secretary Lemrey “Al”
NABP Executive Director/Secretary
prestigious BBB award presented to Carter, PharmD, MS, RPh. Displaying
exceptional organizations for their values of cooperation and innovation
dedication to integrity and ethical not only translates to protecting public
business practices. The year 2020 health but also permeates the culture at
marked the first year this award was NABP. “We pride ourselves on being a supports local outreach efforts through
granted to an organization in BBB’s great place to work,” said Carter. NABP fundraising and volunteer opportunities
new category for associations. employees thrive in the professional, team- with organizations such as Feed My
NABP’s core practices demonstrate its oriented environment that consistently Starving Children, Make-A-Wish Illinois,
belief in high ethical standards, which demonstrates the values of respect, Maryville Academy, and Mercy Home for
is central to the BBB’s principles. The dedication, and innovation. Boys and Girls in Chicago.
Association stands out as a leader in the In addition, NABP takes pride in its
pharmacy community while exercising commitment to community and actively
FEBRUARY 2021 | 11ASSOCIATION NEWS
NABP President Fensky Promotes MAT Initiative
via Association Resources, Virtual Events
eligible for Accreditation Council for Pharmacy dozen meetings with legislators and staff from
Education-accredited continuing pharmacy US Congressional offices, including Senators
education credit. More information is available Maggie Hassan (D-NH), Lisa Murkowski
in the Resources section of the NABP website (R-AK), and Representative Paul Tonko (D-
under Educational Programs. NY). Meetings were also held with staff from
The NABP Task Force on Medication- the Senate Committee on Health, Education,
Assisted Treatment met virtually in Labor, and Pensions and the House Committee
November 2020. The task force was charged on Energy and Commerce.
with the following objectives: The meetings supported Fensky’s initiative to
• Reviewing current federal and state laws improve patient access to MAT by encouraging
and regulations related to MAT the passage of the bill, which calls for the
• xamining the language in the
E elimination of the requirement that practitioners
Model State Pharmacy Act and Model apply for a separate waiver through Drug
Rules of the National Association of Enforcement Administration to offer MAT.
NABP President Timothy D. Fensky, RPh, Boards of Pharmacy and, if necessary, If passed, the bill could reduce barriers to care
DPh, FACA, has worked diligently to promote recommending amendments that allow and improve access to MAT through additional
his presidential initiative of expanding pharmacists to be key leaders in opioid practitioners, including pharmacists.
pharmacist-provided medication-assisted safety and patient care.
treatment (MAT) for patients diagnosed with Additional information about the task force
opioid use disorder (OUD). Since he first will be provided in future communications.
announced his initiative at the 116th Annual NABP Video Highlights
Meeting, Fensky has worked closely with Spreading the Word Pharmacists’ Role in
NABP staff, member boards of pharmacy, via Virtual Events Increasing Access to MAT
legislators, and other stakeholders to further In addition to promoting pharmacist- The important role that
this important objective during his term and provided MAT for OUD patients via NABP pharmacists can play in improving
beyond. Working within the current reality of resources, Fensky shared information about patient access to medication-assisted
“all virtual, all the time,” Fensky used videos, the initiative at other industry-related and treatment (MAT) is the subject
webinars, virtual meetings, and NABP’s website governmental events. of a new video as part of NABP
to disseminate his message. In August 2020, he served as a panelist for President Fensky’s MAT initiative.
the webinar “Addressing Access and Utilization Fensky educates viewers about
NABP Initiative Efforts of Opioid Overdose Reversal Medications,” the value and efficacy of MAT for
Last year, NABP added a Presidential Initiative which was hosted by the Collaborative for treatment of opioid use disorder
page to its website (www.nabp.pharmacy/ Effective Prescription Opioid Policies and (OUD). In addition, the video
about/presidential-initiative) that describes the Mothers Against Prescription Drug Abuse. Key explains the barriers that limit
initiative; the steps Fensky, NABP, and member discussion points for the webinar were reducing patient access to treatment, provides
boards will utilize to advance the initiative; overdose deaths through increased naloxone information on what the boards of
links to MAT resources, articles, and blogs; and access and utilization, and understanding pharmacy and NABP are doing to
a video featuring Fensky discussing MAT. COVID-19 implications on overdose reversal. eliminate these barriers, and advises
Also, in October 2020, NABP held a live Fensky and NABP Executive Director/ on what pharmacists can do in their
educational webinar titled “Medication-Assisted Secretary Lemrey “Al” Carter, PharmD, MS, daily practice to support patients
Treatment: Overcoming Barriers to Improve RPh, participated in several virtual Hill days in suffering from OUD.
Access for Patients.” Presenters addressed September 2020 to discuss the Mainstreaming The video may be accessed on
patients’ struggles with addiction and recovery, as Addiction Treatment Act (S 2074) with the Presidential Initiative page of
well as the steps that states are taking to increase committee and legislative staff. Over the the NABP website and on NABP’s
MAT access. Fensky also provided an overview course of two days, they discussed how the YouTube channel.
of his initiative. This webinar was recorded act would benefit patients struggling with
and is now available as a home study webinar OUD. The discussions included more than a
12 | FEBRUARY 2021117TH ANNUAL MEETING
Enhancing Networks and Expanding
Access to Protect Public Health
117th NABP Annual Meeting | Virtual | May 13-14, 2021
Join Your Colleagues for:
NABP Annual Business Sessions Virtual networking opportunities
Keynote: Kris Paronto, inspiring hero of Educational Poster Session
the 2012 Benghazi attack (Contact Prof-Affairs@nabp.pharmacy for details.)
Continuing pharmacy education (CPE) sessions,
including pre-meeting CPE on May 12
Registration available in March at
www.NABPAnnualMeeting.pharmacy
FEBRUARY 2021 | 13INTERVIEW WITH A BOARD MEMBER
Todd Barrett, RPh
Secretary, Mississippi Board of Pharmacy
When were you appointed to the practices of pharmacy benefits managers that
Board of Pharmacy? What type of might potentially violate the law.
member are you?
I was first licensed as a pharmacist in 1988 Has the Board encountered any
in Mississippi and currently hold licenses in challenges to developing and/or
Arkansas, Mississippi, and Tennessee. I began implementing these new policies,
practicing pharmacy as a consultant pharmacist legislation, or regulations?
with a long-term care (LTC) pharmacy chain Yes. Our state legislature passed legislation
with facilities in these states. Most of my practice in 2017 creating the Occupational
experience has been in LTC pharmacy and Licensing Review Commission, which
specialty pharmacy, with a short stint exploring provides oversight for new regulations that
sales with Eli Lilly & Co. I was appointed to occupational boards write. Regulations
the Mississippi Board of Pharmacy in 2013 and passed by occupational boards require review
Mississippi began serving on the Board in July 2013. I was and approval from the Commission. With
fortunate to serve as president of the Board from recent elections, new representation, and the
Board of Pharmacy
July 2017 to June 2018. coronavirus disease 2019, the Commission’s
ability to meet has been impacted and
Number of Board What steps should a Board member review of some of the regulations passed
Members take to be successful? by the Board has not taken place. No new
7 pharmacist members A good understanding of the charge for regulations are put into place until they are
the board (ie, to protect the public) should passed by this Commission.
always be in the forefront of every action
Number of Compliance or initiative of the board. A comprehensive What advice would you give to a
Officers/Inspectors grasp of every practice setting is not possible, new board member?
5
but a general concept of the challenges in Develop your relationships with more
delivering patient care within a practice experienced board members and continue to
helps prevent introductions of unnecessary develop relationships with your professional
Rules & Regulations regulatory burdens. Networking with your network. There will be times when you will
Established by
Board of Pharmacy,
board members and with those in other want perspective on practice specialty areas
approved by states helps one gain perspective. and issues that fall outside of your own
Mississippi experience. You can solicit perspective from
Occupational Licensing What are some recent policies, your colleagues, even while maintaining the
Review Commission legislation, or regulations your level of confidentiality that is required of
Board has implemented or is board members.
Number of currently working on?
Pharmacist The Board has responded to the opioid Have you served as a member of any
Licensees crisis in Mississippi by requiring pharmacists NABP task forces or committees, or
6,357 to become better educated on drugs of attended NABP or district meetings?
abuse. Additional continuing education I attend district meetings whenever possible
Number of requirements for pharmacists related to and have had the opportunity to attend some
Pharmacies opioids were implemented in 2019. Other of the NABP Annual Meetings as well. I also
1,462 regulations that are being explored or participated on the Task Force on Medication
developed address physician dispensing, Synchronization in 2014. Meetings with
telepharmacy, and drug facility licensing board members from other states allowed
Number of
Wholesale rules and regulations. me to better understand how NABP
Distributors Additionally, the Pharmacy Benefit Prompt supports each state’s board of pharmacy with
45 Pay Act of 2020 will require the Board to model regulations and how states can offer
manage complaints from permitted facilities consistency in regulatory measures.
and licensed pharmacists regarding certain
14 | FEBRUARY 2021AROUND THE ASSOCIATION
Board Member Appointments • J eff “Troy” Menard, RPh, has been Board Member Reappointments
• Tammy Lindemuth has been appointed appointed a member of the Louisiana • Lana Bell, RPh, has been reappointed
a public member of the Alaska Board of Board of Pharmacy. Menard’s a member of the Alaska Board of
Pharmacy. Lindemuth’s appointment will appointment will expire June 30, 2025. Pharmacy. Bell’s appointment will expire
expire March 1, 2021. • endra Metz, PharmD, RPh, has been
K March 1, 2022.
• Sharon Long has been appointed a appointed a member of the Minnesota • ichard Holt, MBA, PharmD, RPh, has
R
public member of the Alaska Board Board of Pharmacy. Metz’s appointment been reappointed a member of the Alaska
of Pharmacy. Long’s appointment will will expire January 1, 2024. Board of Pharmacy. Holt’s appointment
expire March 1, 2022. • Richard Tomasso has been appointed a will expire March 1, 2024.
• J ustin Ruffridge, PharmD, RPh, public member of the Nevada State Board • arl W. Aron, RPh, has been
C
has been appointed a member of the of Pharmacy. Tomasso’s appointment will reappointed a member of the Louisiana
Alaska Board of Pharmacy. Ruffridge’s expire October 31, 2022. Board of Pharmacy. Aron’s appointment
appointment will expire March 1, 2024. • ichael K. Bedenbaugh, MS, MBA,
M will expire June 30, 2026.
• Nick Goodman has been appointed a PharmD, RPh, has been appointed • Jacqueline L. Hall, PD, RPh, has been
public member of the Arizona State Board a member of the South Carolina reappointed a member of the Louisiana
of Pharmacy. Goodman’s appointment Department of Labor, Licensing, and Board of Pharmacy. Hall’s appointment
will expire January 20, 2025. Regulation – Board of Pharmacy. will expire June 30, 2026.
Bedenbaugh’s appointment will expire
• Cedar Ann Lahann, PharmD, RPh, has • Marty R. McKay, RPh, has been
been appointed a member of the Arizona June 30, 2026. reappointed a member of the
State Board of Pharmacy. Lahann’s • Archie L. McKnight, RPh, has been Louisiana Board of Pharmacy. McKay’s
appointment will expire January 20, 2025. appointed a member of the South appointment will expire June 30, 2026.
Carolina Department of Labor,
• heodore G. Tong, PharmD, FAPhA,
T • onnie Bagwell, RPh, has been
R
RPh, has been appointed a member of the Licensing, and Regulation – Board of reappointed a member of the Mississippi
Arizona State Board of Pharmacy. Tong’s Pharmacy. McKnight’s appointment will Board of Pharmacy. Bagwell’s
appointment will expire January 15, 2024. expire June 30, 2025. appointment will expire June 30, 2025.
NABP Accreditations and Verifications
NABP awarded a total of 77 accreditations and verifications from September 1 to October 31, 2020. The breakdown
by program is as follows:
Drug Distributor Digital Pharmacy Accreditation: .Pharmacy Verified
Accreditation: 3 Websites:
56 18
formerly known as Verified-Accredited formerly known as Verified Internet
Wholesale Distributors® Pharmacy Practice Sites®
To see the names of businesses accredited and verified by NABP, visit the Association’s website at www.nabp.pharmacy/programs.
FEBRUARY 2021 | 15You can also read
