Stepping Up to Pandemic Challenges: Inspections Resume for Boards and NABP Accreditations
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Nov/Dec 2020 | Volume 49 | Number 10
Stepping Up to
Pandemic Challenges:
Inspections Resume for Boards
and NABP Accreditations
CONTENTS
06 04 09 Association News
09 2020-2021 Committee and Task
Force Members Appointed by
President Fensky
15 New Online Application Pulls
From Business e-Profiles to
Expedite NABP Accreditation
and Inspection Processes
16 Drug Utilization Reviews,
Impairment Related to
Cannabis Use Addressed in
NABP Model Act Updates
17 1 17th Annual Meeting
Submit Proposed CBL Amendments
by March 29
Interactive Forum
18 Interview With a Board Member
Virtual Interactive Executive
Neil B. Leikach, RPh, FACA
Officer Forum Engages,
Stimulates New Ideas
20 State Board News
New Process for Storing
01 I nterview With a Board Medications at Inpatient Hospice
Executive Officer Facilities in Massachusetts
Matt Martineau,
PharmD, RPh 2 1 Professional Affairs Update
Pharmacists May Administer
Childhood Vaccines During
02 P
olicy Perspectives COVID-19 Pandemic
Feature News Opioid Epidemic Worsens
Stepping Up to Pandemic During Pandemic: NABP Informs
Challenges: Inspections Resume for Legislators on Benefits of
Boards and NABP Accreditations Empowering Pharmacists and
Expanding Access to MAT
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
©2020 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
Matt Martineau, PharmD, RPh
Executive Director, Wyoming State Board of Pharmacy
How long have you served as after connecting with PMP InterConnect
executive director of the Wyoming and integrating some of Wyoming’s
State Board of Pharmacy? What community pharmacies.
was your role prior to working
with the Board? What actions were taken by the
I have served as executive director of the Board to address the issue?
Board since June 2019. Prior to being The Board worked with the Opioid
appointed executive director, I served as Addiction Task Force to update the
an inspector/compliance officer for the Wyoming Controlled Substances Act
Board, which I joined in September 2017. to allow us to connect and share PDMP
My career prior to joining the Board data with other states. We have also been
involved both community and institutional working closely with PMP Gateway, which
Wyoming State pharmacy. I have worked as a float and works in tandem with PMP InterConnect,
Board of Pharmacy staff pharmacist for two national chains as and our PDMP vendor to ensure that we
well as the pharmacist-in-charge for one have the capability to handle the increased
of them. Before working in community traffic to the WORx PDMP.
Number of Board
pharmacy, I was a staff/clinical pharmacist
Members
5 pharmacist for a critical access hospital. What other key issues has the
members and 4 Board been focusing on?
non-pharmacist What is one of the most significant In addition to rewriting the rules on
members (1 each: challenges or issues your Board CS prescriptions to comply with the
physician, dentist, addressed in the past year or so? electronic prescribing mandate and provide
or veterinarian,
The Wyoming State Legislature’s Opioid for exceptions, the Board has been working
public member, and
pharmacy technician) Addiction Task Force has worked on on updating the Wyoming Pharmacy Act
legislation to address the opioid epidemic Rules and Regulations, with a focus on
Number of in Wyoming. Statutory changes included United States Pharmacopeia Chapter
Compliance requiring practitioners to register with and expanding the pharmacy technician’s
Officers/Inspectors
the state’s prescription drug monitoring role to allow pharmacists greater flexibility
2
program (PDMP), the Wyoming in practicing at a higher standard.
Online Prescription Database (WORx);
Rules & Regulations search the database prior to prescribing What insights do you have for
Established by controlled substances (CS); and prescribe other states that may be facing
State Board of all CS electronically beginning January similar challenges?
Pharmacy
1, 2021. The Board has been working In our experience, it has been most
to enhance the WORx PDMP to keep effective to form task forces and break
Number of
up with this legislation. These efforts the work down into more manageable
Pharmacist Licensees
1,407 have included connecting with NABP topics. Our task forces include Board
PMP InterConnect® and integrating members and staff, stakeholders, and other
the WORx PDMP with community interested parties to make sure multiple
Number of pharmacy software systems, as well as with perspectives are represented. We have
Pharmacies institutions’ and practitioners’ electronic also found that frequent communication
141 health records. One of the challenges the with Board members ensures that we are
Board has faced is that the state statute working together. Having open lines of
did not allow information in the WORx communication with licensees also helps
Number of
Wholesale PDMP to be shared with entities outside increase transparency and understand each
Distributors of Wyoming. Another challenge has been other’s perspectives on compliance.
2 updating our hardware so that the WORx
PDMP can handle the increased traffic
NOV/DEC 2020 | 1
POLICY PERSPECTIVES
Opioid Epidemic Worsens During Pandemic: NABP Informs
Legislators on Benefits of Empowering Pharmacists and
Expanding Access to MAT
Boards of pharmacy and NABP have an five miles of a pharmacy. Pharmacists have
established mission of protecting public health unparalleled and underutilized expertise
and a documented history of combating as the health care industry’s medication
the opioid epidemic that has plagued the experts. As the opioid epidemic continues to
United States. Alarmingly, the coronavirus claim American lives, medical professionals,
disease 2019 pandemic has rocked our including pharmacists, should be leveraged
communities against the backdrop of this to expand access to lifesaving treatments like
ongoing public health crisis, exacerbating the MAT. Pharmacists are capable of supporting
epidemic and accelerating opioid overdoses the continuation of care, prescribing and
and deaths. Now more than ever, patients dispensing treatments like MAT, and
with opioid use disorder (OUD) need access offering medication management therapy
to medication-assisted treatment (MAT) to and counseling services.
support recovery. For this reason, the initiative Unfortunately, current federal law dictates
Sarah-Lloyd Stevenson, MPH of NABP President Timothy D. Fensky, RPh, that only certain qualified practitioners can
Faegre Drinker Biddle & Reath LLP
DPh, FACA, to combat the opioid epidemic, obtain a special waiver, called a “DATA 2000
as announced in May 2020, has become waiver” after the federal law that created it, or
even more important. Fensky recognizes the an “X waiver.” To obtain a waiver, qualified
important role that pharmacists play in their practitioners must notify Substance Abuse
communities, and that allowing them to and Mental Health Services Administration of
prescribe MAT would create new access to intent to treat patients with buprenorphine,
treatment for people in need. meet certain requirements, and then receive
An essential pillar of this presidential an “X-designation” from Drug Enforcement
initiative is ensuring that federal law does Administration (DEA). The law limits qualified
not unnecessarily hinder pharmacists from practitioners to physicians, nurse practitioners,
reaching and treating patients in need physician assistants, clinical nurse specialists,
of MAT. Despite the overwhelming consensus certified registered nurse anesthetists, and
that patients should have access to OUD certified nurse-midwives. For these providers,
Nisha K. Quasba, MPH treatment, an arbitrary and outdated federal the waiver process laid out in law requires
Faegre Drinker Biddle & Reath LLP law prohibits pharmacists – the providers additional training and burdensome steps that
who often have the most regular contact with ultimately limit patients’ access to care. For
their patients – from offering this treatment. providers like pharmacists, the current statute
Without fixing this federal law, pharmacists categorically prohibits them from using their
are unable to prescribe MAT despite the medication expertise to help treat patients in
steps boards of pharmacy may take. NABP need of MAT.
has thus endorsed and is actively advocating Since pharmacists already have a
for the enactment of S 2074 and HR 2482, dispensing role in the provision of MAT,
the Mainstreaming Addiction Treatment Act they could seamlessly expand their role to
(MAT Act) to empower pharmacists to play a prescribing MAT. In fact, pharmacists in
crucial role in providing access to MAT. almost every state are able to enter into
collaborative practice agreements with
Federal Restrictions Are Tying physicians to prescribe certain medications.
States’ and Providers’ Hands Further, despite the restrictive federal laws
Pharmacists are on the front lines of the that tie states’ hands, several states have
opioid epidemic and are often the most expanded scope of practice laws to allow
accessible provider to patients, with 90% pharmacists to prescribe controlled
of the American population living within substances such as buprenorphine.
2 | NOV/DEC 2020
POLICY PERSPECTIVES
Congress Should Enact the MAT Act
The MAT Act, introduced in 2019 by The Task Force on Medication-Assisted Treatment met
Representatives Paul Tonko (D-NY),
Antonio Delgado (D-NY), Ben Ray Luján virtually on November 17, 2020. Additional information
(D-NM), Ted Budd (R-NC), Elise Stefanik about this task force, including its charge and members,
(R-NY), and Mike Turner (R-OH) in
the US House of Representatives, and is available on page 10 of this newsletter.
Senators Maggie Hassan (D-NH) and Lisa
Murkowski (R-AK) in the US Senate, is a
common sense bill with bipartisan support
that would eliminate the redundant, but numbers are unlikely to have changed and Pensions. In March 2020, the House
outdated requirement that practitioners significantly since then) 80% of people in Energy and Commerce Committee held
apply for a separate waiver to offer MAT need of OUD treatment did not receive it. a hearing on “Combatting an Epidemic:
to their patients. This policy change These statistics and the bureaucratic Legislation to Help Patients with Substance
could reduce barriers to care and improve barriers that contribute to them demonstrate Use Disorders.” During this meeting, the
patients’ access to MAT through additional a significant threat to our nation’s public committee discussed the merits and potential
mid-level practitioner prescribers, health. During the opioid epidemic – and challenges of the MAT Act; however, the
including pharmacists. even more so during the current pandemic legislation has not yet advanced out of
Before introduction of the MAT Act, that has worsened the epidemic and further committee to the House floor.
Congress had traditionally taken slow, limited patients’ access to care – public health In 2021, Congress will enter its 117th
targeted steps to expand patients’ access to advocates should join forces to ensure that session, and the MAT Act will need to
MAT. The Comprehensive Addiction and unnecessary, unproven barriers to lifesaving be reintroduced. With the arrival of new
Recovery Act of 2016 raised the cap on the care are removed expeditiously. members of Congress and new congressional
number of patients that providers could treat Enactment of the MAT Act can achieve leaders, the bill could garner even more
with MAT and added nurse practitioners and three core goals: support upon reintroduction. For information
physician assistants as qualified providers. • The MAT Act removes an unnecessary on how to advocate for reform at the federal
The Substance Use-Disorder Prevention that federal restriction on states, enabling level, contact ExecOffice@nabp.pharmacy.
Promotes Opioid Recovery and Treatment state regulators and boards of pharmacy This article was written by Sarah-Lloyd
(SUPPORT) for Patients and Communities to determine the most appropriate care Stevenson, MPH, and Nisha K. Quasba, MPH,
Act of 2018 built on that expansion by delivery for their communities. with Faegre Drinker Biddle & Reath LLP. Please
further raising the cap and adding clinical • he MAT Act protects public health
T note, the opinions and views expressed by Faegre
nurse specialists, certified registered nurse by expanding access to MAT broadly, Drinker Biddle & Reath do not necessarily reflect
anesthetists, and certified nurse-midwives removing the burdensome and the official views, opinions, or policies of NABP
as qualified practitioners. These legislative bureaucratic waiver process that limits or any member board unless expressly stated.
changes required years of robust and sustained even currently eligible providers from
offering MAT.
advocacy efforts by providers, patients, and
families wishing to expand access to MAT. • he MAT Act paves the way for
T
More information about the initiative of
However, despite these attempts at pharmacists to offer lifesaving MAT
to their patients. NABP President Timothy D. Fensky, RPh,
expanding eligibility and access, the National DPh, FACA, to promote pharmacist-
Academies of Sciences, Engineering, and As of October 2020, the legislation had provided, medication-assisted
Medicine have estimated that fewer than been referred to the relevant committees treatment for patients diagnosed with
3% of eligible providers have gone through in both chambers of Congress. Those opioid use disorder is available at www
the necessary process to obtain a DATA committees are the House Energy and .nabp.pharmacy/about/presidential-
2000 waiver. Alarmingly, in 2017 (albeit Commerce Committee and the Senate initiative.
before enactment of the SUPPORT Act, Committee on Health, Education, Labor,
NOV/DEC 2020 | 3
INTERACTIVE FORUM
Virtual Interactive Executive Officer Forum Engages,
Stimulates New Ideas
Online Meeting Tools Helped Boards Network and Collaborate on Pertinent Issues
Pictured are attendees from the Forum interacting through the Zoom video feature.
Discussions Virtual, Still Robust using Zoom. Themed “Network, Exchange, by the boards. Executive officers, NABP
Icebreaker topics, a virtual café, and a bingo Innovate,” the virtual event offered attendees staff, and a Food and Drug Administration
game are just some of the unique ways in an opportunity to discuss common (FDA) representative served as panelists, and
which 38 board of pharmacy executive challenges faced by the boards, as well as members of the NABP Executive Committee
officers connected and collaborated with reinforce the partnership between the boards served as moderators. The panelist-led
fellow colleagues and peers during the of pharmacy and NABP and their shared sessions included topics on COVID-19 and
NABP Interactive Executive Officer Forum mission to protect the public health. preemption issues, virtual inspections, and
on Wednesday, September 30, 2020. With supply chain schemes, as well as an update
the coronavirus disease 2019 (COVID-19) Pandemic-Focused Sessions on the FDA memorandum of understanding
pandemic continuing to impact business Recognizing that the COVID-19 pandemic and NABP information sharing network.
travel and the health and safety of the public, has impacted all states on some level, several NABP staff also provided an update and
NABP moved the traditional in-person of the forum sessions focused on the related received member input on NABP programs
meeting to a completely virtual format regulatory challenges currently being faced and services, including NABP Passport
4 | NOV/DEC 2020
INTERACTIVE FORUM
Congratulations to the Bingo Winner!
Congratulations to Traci Collier, PharmD, RPh, administrator/chief drug inspector, South
Carolina Department of Labor, Licensing, and Regulation – Board of Pharmacy, for winning
the Network, Exchange, Innovate bingo game drawing. The bingo game invited attendees
to mark off topics discussed during the meeting by indicating the name or state of someone
who discussed the topics; completed cards were submitted to NABP for the drawing. Collier
received a $50 American Express gift card.
Thank You, Panelists!
NABP would like to extend special thanks to the following attendees for serving as
panelists and sharing their expertise to spark discussion on topics during the forum.
• ndrew Funk, PharmD, RPh, Executive Director,
A
Iowa Board of Pharmacy
• aroline D. Juran, BSPharm, DPh (Hon), NABP President-elect; Executive Director,
C
Virginia Board of Pharmacy
• ari Shanard-Koenders, RPh, Executive Director, South Dakota State
K
Board of Pharmacy
• rances “Gail” Bormel, JD, RPh, Acting Associate Director for Compounding, Office
F
of Compliance, Center for Drug Evaluation and Research, US Food and
Drug Administration
In addition, NABP thanks the following Executive Committee members for serving as
moderators for the sessions.
• icole L. Chopski, PharmD, BCGP, ANP, Member,
N
NABP Executive Committee
To help break the ice and practice navigating Zoom,
• Jeffrey J. Mesaros, PharmD, JD, RPh, Member, NABP Executive Committee attendees responded to a poll question asking
“What is your favorite aspect of Work From Home?”
• Lenora S. Newsome, PD, Member, NABP Executive Committee The most popular answer, with 37% of the vote, was
• Shane R. Wendel, PharmD, RPh, Member, NABP Executive Committee “No commute”; however, this was tied with those
indicating that they are still going into the office.
and the NABP Clearinghouse. In addition, pre- and post-pandemic drug supply schemes Future Meetings
attendees had a lively discussion on many of used the breakout room feature to allow On January 27, 2021, board of pharmacy
the shared discussion topics they submitted for discussion in smaller groups. Attendees members will have an opportunity to
prior to the meeting. were extremely active on the chat feature, connect virtually for the Interactive
exchanging additional pertinent information Member Forum. The meeting will continue
Interactive Features Keep and ideas, as well as asking questions to with the theme, “Network, Exchange,
Collaboration Alive spark further discussion during sessions. Innovate,” and offer similar virtual
To create an engaging experience that included Also, attendees were given an opportunity to opportunities for lively discussion and a
as many attendee voices as possible, the network via a virtual café lunch. Attendees unique networking setting. Invitations
forum utilized a variety of Zoom features. For chose from a list of lunch “tables,” each for the member forum were sent to the
example, attendees were given an opportunity focusing on a different topic, and the Zoom members selected by the executive officers
to annotate on the screen to prioritize the list breakout room feature was used to place them in October 2020.
of shared discussion topics and the session on at their virtual lunch tables.
NOV/DEC 2020 | 5
Stepping Up to
Pandemic Challenges:
Inspections Resume for Boards
and NABP Accreditations
6 | NOV/DEC 2020
How can we conduct facility inspections intended to safeguard guidance to maintain an appropriate level of review, and to ensure
medications and drug delivery, while ensuring that pandemic safety that products such as hand sanitizers and diagnostic tests were safe
precautions are in place? Can in-person surveys be conducted for consumers. By summer 2020, FDA began to resume prioritized
without endangering the lives of inspectors, facility staff, and domestic inspections utilizing a new risk assessment system. The
those with whom they come into contact? What role can virtual COVID-19 Advisory Rating system utilizes real-time data to
inspections play? In short, how do regulators balance two objectives qualitatively assess the number of COVID-19 cases in a local area
that share the goal of protecting the public health when one objective based on state and national data, which is then used to determine
can unintentionally risk the success of the other objective? when and where it was safest to conduct prioritized domestic
Boards of pharmacy are among the regulators who have faced inspections. The ratings created by the system were based on the
such questions during the coronavirus disease 2019 (COVID-19) Phase of the State (as defined by White House guidelines), and
pandemic. NABP accreditation services faced similar challenges to statistics measured at the county level to determine the current trend
carrying out surveys in support of applicants as well as inspections, and intensity of the pandemic in a given region.
both services that are vital to supporting the mission of the boards FDA has also been moving away from unannounced inspections
of pharmacy to protect the public health. Following a pause on during the pandemic. Although such inspections are often useful
such services to prevent the spread of the virus, NABP stepped up tools for providing a realistic look at how a facility operates day-to-
to pandemic challenges to restart such services with the addition of day, the safety of inspectors and facility staff requires preparation that
COVID-19 prevention measures into their processes. can only be made by pre-announcing visits.
Early Response to COVID-19 States Adapt Inspection Processes
Although COVID-19 was starting to make international headlines At the state level, many agencies also suspended their inspections
in late 2019, the disease quickly moved to the United States national during the spring of 2020. By press time, most states were allowing
spotlight in March 2020 when epidemiologists and other health at least some inspections or surveys to resume. For on-site visits,
experts observed the rapid spreading and severity of the disease across the state first lets NABP know that visits could resume. NABP then
the states. Individual lives and businesses were suddenly disrupted examines various trends, models, and data to ensure that COVID-19
by the state and community shelter-in-place orders that followed the rates are low enough to be safe for NABP inspectors and surveyors.
World Health Organization declaration of a global pandemic and A list of states where NABP inspections are taking place has been
President Donald J. Trump’s declaration of a national emergency. It maintained by NABP on the Coronavirus Updates section of its
quickly became clear that business as usual would need to change website. This list continues to be updated to account for states’
in response to the rapidly evolving pandemic, and this included rate of COVID-19 infections and responses to other public health
pharmacy and drug distributor businesses. developments tied to the pandemic.
For NABP’s part, the Association quickly responded to the pandemic in Several states also acted by modifying processes to continue
ways that affected all departments and staff (see the September 2020 issue pharmacy and distributor inspections during the pandemic. For
example, the North Dakota State Board of Pharmacy announced that
it would utilize a different process for inspections during the 2020-
Following a pause on such services to prevent the 2021 inspection cycle. With the adjusted process, compliance officers
and inspectors did not go into the field routinely (unless a specific
spread of the virus, NABP stepped up to pandemic
compliance issue was identified that needed to be investigated).
challenges to restart such services with the addition of Instead, compliance officers would reach out to facilities by phone to
COVID-19 prevention measures into their processes. finalize yearly inspections.
Mark J. Hardy, PharmD, RPh, executive director of the North
Dakota State Board of Pharmacy said, “Understanding the complex
of Innovations for further details). On March 19, NABP shared with its nature of the pandemic and the complications it was creating for
customers and its member boards of pharmacy that the Association would pharmacy locations, we felt like it was wise to move the inspection
suspend all facility inspections and accreditation surveys until further process to a different format this year. We were lucky enough to
notice. The announcement also stated that NABP would follow several already have implemented an online inspection process the year
guidelines before on-site visits would resume. These included all Centers prior. From that, we were able to adapt to an off-site process where
for Disease Control and Prevention (CDC) guidance, state guidelines the inspector would visit with the pharmacy over the phone or video
such as stay-at-home orders and mask mandates, as well as any board of conferencing to finalize the inspection.”
pharmacy or facility safety requirements. The Minnesota Board of Pharmacy announced that it would
Similar actions were taken by federal regulators at Food and make “every possible effort” to process applications for new licenses
Drug Administration (FDA). In March, FDA announced it would and registrations utilizing its usual procedure. However, the Board
postpone all domestic and foreign “routine surveillance facility conceded there could be delays. Licenses for in-state facilities are
inspections.” The agency continued to provide inspections that were not normally issued until after a facility has passed an inspection
deemed “mission critical,” for ensuring that applicable requirements conducted by a pharmacy surveyor. Early in the pandemic, surveyors
for safety were being met. During this time, FDA utilized tools such conducted opening inspections remotely, having the applicant submit
as remote assessments and import alerts to continue its oversight photographs and videos to supplement material submitted with the
responsibilities. The agency also adjusted certain processes and application. Since inspections are best done on site and in coordination
NOV/DEC 2020 | 7
TOTAL 2020 NABP INSPECTIONS
with the facility, the Board sought and received permission to have 163
the surveyors conduct on-site inspections. When on site at the facility,
pharmacy surveyors are required to wear masks and follow each
facility’s COVID-19 policies and procedures. Surveyors were also
Number of Inspections
allowed to contact representatives of the facilities to obtain information
in advance of the on-site visit, which would allow the on-site visit to be 114
SCHEDULED
shorter than usual.
“We learned as the pandemic evolved,” said Minnesota Board of
Pharmacy Executive Director Cody Wiberg, PharmD, MS, RPh. “We
DECLINED
talked to our surveyors first, and most of them wanted to go out into
65
the field.” Wiberg noted that, in fall 2020, the Board requested and
COMPLETED
received permission to begin having surveyors return to a more routine 54
ON HOLD
PENDING
schedule of on-site visits. The Board is carefully monitoring changes
in COVID-19 infection rates so that changes can be made, if needed.
26
(For example, if the current spike in COVID-19 continues, the Board
may have to once again cut back on in-person inspections.)
Iowa’s compliance officers were on hiatus from physical site inspections Inspection Status
for several months following guidance from the Iowa Department of
Public Health; the Iowa Board of Pharmacy resumed field inspections
and investigations in third quarter 2020. Several policies and procedures arrival. Additionally, a portion of inspections and surveys are now
were developed to ensure safety of compliance officers and facility staff, being handled remotely using conferencing software or, when a
including contacting each location prior to visiting to inquire about the facility lacks the ability to use such software, by telephone.
health of the facility staff and site safety precautions. On the day of each The virtual portions of these inspections and surveys typically take
visit, officers are required to check their temperature and to fill out a form about one to two hours, and focus on interviews with facility staff,
to screen for COVID-19 symptoms. To assist in contact tracing, the questions about policies and procedures, and other requirements
officers report back the time frame of their visit and provide the names of that do not require the physical presence of an inspector/surveyor.
anyone they had prolonged contact with. The virtual portion of the visit covers roughly 10-20% of the total
Executive officers of the boards of pharmacy had the opportunity inspection/survey.
to share some of their experiences related to inspections and surveys With these new processes in place, NABP inspections and
during the pandemic while attending the virtual NABP Interactive accreditation surveys have ramped up through the last quarter of
Executive Officer Forum on September 30, 2020. 2020. At press time, NABP has completed 257 inspections and
surveys since resuming them. At the time that on-site visits were
NABP Inspections and Surveys Resume, Safety restarted, there were 300 pending inspections/surveys that needed
Precautions Added to be completed. By early November, more than three-quarters were
NABP inspections and accreditation surveys resumed on July 31, completed. However, due to varying state restrictions, including
2020. As for many states, NABP’s processes had to be adapted to required quarantines for people traveling to or from a particular state,
balance safety for NABP inspectors/surveyors as well as facilities’ more than 27 facility visits remain on hold. At press time, NABP
staff and customers. Part of these changes included following CDC, was inspecting and surveying in 34 states. Many other states have
state, and facility guidelines, as NABP committed to back in March. been on NABP’s inspections/survey list over the past four months
To facilitate this commitment, NABP’s revised process includes but were removed due to an increase in COVID-19 infections. Once
contacting facilities in locations where inspections/surveys are the number of infections decreases and become more stable and safe,
NABP will resume inspections/survey in those states.
Pharmacy and distributor inspections and accreditation surveys
The virtual portions of these inspections and remain an essential part of how the boards of pharmacy ensure
that licensees are adequately satisfying regulatory or licensing
surveys typically take about one to two hours, and
requirements, as well as a key part of the NABP accreditation process.
focus on interviews with facility staff, questions As such, finding capacity to continue these inspections and surveys,
about policies and procedures, and other even as the pandemic continues, remains a high priority. As with so
requirements that do not require the physical many aspects of this global crisis, these decisions may have long-
presence of an inspector/surveyor. lasting repercussions on the health care landscape.
NABP continues to carefully monitor the pandemic and other
public health issues to maintain an essential balance in the interest
allowed to occur and working closely with applicants with a pending of public health. The Association remains committed to this shared
inspection or accreditation survey to ensure safety. This means that a mission with its member boards of pharmacy, and accreditation and
majority of NABP inspections and surveys are currently announced inspections staff are available to respond to questions and concerns
so that facility staff know when to expect the inspector’s or surveyor’s regarding inspections and surveys.
8 | NOV/DEC 2020ASSOCIATION NEWS
2020-2021 Committee and Task Force Members
Appointed by President Fensky
NABP provides guidance on current laws and rules addressing pharmacy • J illian Foster, MBA, PharmD, RPh,
topics of interest to the state boards of technician practice. FACHE, FASHP, Mississippi Board
pharmacy through the recommendations 2. Examine the language in The Model of Pharmacy
of commissioned, single-issue task forces. State Pharmacy Act and Model Rules • ichard Geaney, RPh, Massachusetts
R
When an issue arises that requires special of the National Association of Boards Board of Registration in Pharmacy
expertise or a commitment of time and of Pharmacy (Model Act) addressing • Debra B. Glass, RPh, Florida
funds, a task force is appointed to address a pharmacy technician practice and, if
• llison Hill, PharmD, RPh, District of
A
specific charge and to report its findings to necessary, recommend amendments Columbia Board of Pharmacy
the NABP Executive Committee. Task force that allow technicians to practice in
and committee reports are published on the the best interest of patient care.
• ori Henke, PharmD, RPh, Texas State
L
Board of Pharmacy
NABP website once approved. Chairperson of this task force was
NABP President Timothy D. Fensky, Andrew Funk, PharmD, RPh, Iowa Board • S ue Mears, RPh, Iowa Board
of Pharmacy
RPh, DPh, FACA, made the following of Pharmacy.
appointments for task forces and standing Individuals appointed to serve as • J oanne Trifone, RPh, Massachusetts
committees for 2020-2021. members included: Board of Registration in Pharmacy
• Allison Vordenbaumen Benz, MS, RPh, • yndi Vipperman, CPhT, Oregon
C
Task Forces Texas State Board of Pharmacy State Board of Pharmacy
The Task Force on Pharmacy Technician • obert Carpenter, RPh, Vermont Board
R
Practice Responsibilities was held virtually of Pharmacy Michael Blaire, RPh, of the Arizona State
on September 1, 2020. • J ohn Colaizzi, Jr, PharmD, RPh, CCP, Board of Pharmacy, and Anthony Gray,
The task force was charged with the New Jersey State Board of Pharmacy JD, of Kentucky, served as alternates. The
following objectives: Executive Committee liaison was Tejal J.
• aura Forbes, RPh, Virgin Islands Board
L
1. Evaluate the current environment of Pharmacy Patel, MBA, PharmD, RPh.
of pharmacy technician practice
responsibilities, including state
NOV/DEC 2020 | 9ASSOCIATION NEWS
The Task Force on Medication Reuse Forbes, JD, of the Kansas State Board of The Overview Task Force on
met virtually on October 29, 2020. The Pharmacy, served as alternates. The Executive Requirements for Technician
task force was established in response to Committee liaison was Fred M. Weaver, RPh. Education, Practice Responsibilities,
Resolution No. 116-4-20, passed at the 116th and Competence Assessment will be
NABP Annual Meeting. The Task Force on Medication- held virtually on December 1, 2020. The
The task force was charged with the Assisted Treatment met virtually on task force was established in response to
following objectives: November 17, 2020. The task force Resolution No. 115-4-19, passed at the
1. Review current state laws and was established in response to President 115th NABP Annual Meeting. This is the
regulations related to the reuse Fensky’s presidential initiative. second meeting of this task force, which
of medications. The task force was charged with the first met on September 11-12, 2019. The
2. Review existing NABP policy on following objectives: resolution states that the purpose of the task
the reuse of medications. 1. Review current federal and state force is to evaluate the current environment
3. Recommend the best mechanisms laws and regulations related to and make recommendations to NABP to
to enable the transfer of unused medication-assisted treatment. ensure a more active role in establishing
medications to persons in need of 2. Examine the language in the Model requirements for the education, practice
financial assistance to ensure access Act and, if necessary, recommend responsibilities, and competence assessment
to lifesaving therapies. amendments that allow pharmacists of pharmacy technicians.
Chairperson of this task force was to be key leaders in opioid safety and The task force was charged with the
Brenda McCrady, PD, Arkansas State patient care. following objectives:
Board of Pharmacy. Chairperson of this task force was 1. Review the reports of the Task Force
Individuals appointed to serve as Jeanne D. Waggener, RPh, DPh, of Texas. on Requirements for Pharmacy
members included: Individuals appointed to serve as Technician Education, Task Force on
• Mike Bertagnolli, MBA, RPh, FACHE, members included: Pharmacy Technician Competence
Montana Board of Pharmacy • James “Jim” Bracewell, Georgia Assessment, and Task Force on
• atie Busroe, RPh, Kentucky Board
K • uke Daniel, JD, Arkansas State Board
L Pharmacy Technician Practice
of Pharmacy of Pharmacy Responsibilities.
• Kim Caldwell, RPh, Texas • ebra Feinberg, JD, RPh, FASHP, New
D 2. Synthesize these task forces’
recommendations into one
• raci Collier, PharmD, RPh, South
T York State Board of Pharmacy
consolidated set of recommendations.
Carolina Department of Labor, • Robert Giacalone, JD, RPh, Ohio
Licensing, and Regulation – Board 3. Examine the language in the
• ichael J. Godek, RPh, Massachusetts
M
Model Act addressing all aspects of
of Pharmacy Board of Registration in Pharmacy
pharmacy technician regulation
• onna M. Horn, MS, RPh, DPh,
D
• Fiona Karbowicz, RPh, Oregon
CHC, Massachusetts and recommend amendments, if
• S am Lanctin, MBA, New Brunswick necessary, that support technician
• J ohn M. Marraffa, Jr, RPh, New York College of Pharmacists education, competence assessment
State Board of Pharmacy
• illiam T. “Bill” Lee, MPA, DPh,
W and practice, all in the best interest
• Dennis McAllister, RPh, FASHP, Arizona FASCP, Virginia Board of Pharmacy of patient care.
• Rich Palombo, RPh, DPh, New Jersey
• Karen M. Ryle, MS, RPh, Massachusetts Chairperson of this task force will be
• d Taglieri, MSM, RPh, NHA,
E
• aty Wright, MBA, PharmD, DPh,
K Malcolm J. Broussard, RPh, Louisiana Board
Massachusetts Board of Registration BCPS, Tennessee Board of Pharmacy of Pharmacy.
in Pharmacy Individuals appointed to serve as
• ynthia “Cindy” Warriner, RPh,
C Rhonda Toney, MBA, RPh, FASCP, of members include:
CDE, Virginia Maryland, and Cathy Winters, RPh, BCGP, • Cindy Fain, PD, Arkansas State Board
of the Wisconsin Pharmacy Examining of Pharmacy
• inda Witzal, RPh, New Jersey State
L
Board of Pharmacy Board, served as alternates. The Executive • J acqueline L. “Jackie” Hall, MBA,
Committee liaison was Nicole L. Chopski, RPh, Louisiana Board of Pharmacy
Mark Mikhael, PharmD, RPh, of the PharmD, BCGP, ANP. • ristina Jonas, PharmD, RPh, Idaho
K
Florida Board of Pharmacy, and Randy State Board of Pharmacy
10 | NOV/DEC 2020ASSOCIATION NEWS
• ranklin J. “Rocky” LaDien, RPh,
F
Wisconsin Pharmacy Examining Board
• J ulie Lanza, CPhT, Massachusetts Board
of Registration in Pharmacy
• dward G. McGinley, MBA, RPh,
E
DPh, New Jersey
• elen Pervanas, PharmD, RPh, New
H
Hampshire Board of Pharmacy
• J eenu Philip, RPh, Florida Board
of Pharmacy
• ari Shanard-Koenders, RPh,
K
South Dakota State Board of Pharmacy
• risten Snair, CPhT, Arizona State
K • evelop model regulations for pharmacy
D • J enny Downing Yoakum, RPh, Texas
Board of Pharmacy as assigned by the Executive Committee State Board of Pharmacy
• itch G. Sobel, MAS, RPh,
M or from resolutions adopted by the • ayle D. Ziegler, RPh, North Dakota
G
FASHP, CPGx, New Jersey State members of the Association, or from State Board of Pharmacy
Board of Pharmacy reports of the other committees of
• J ulienne Tran, PharmD, RPh, the Association.
Donna Montemayor, RPh, of the Texas
Massachusetts Board of Registration • ecommend to the Executive
R
State Board of Pharmacy, will serve as an
in Pharmacy Committee areas where model
alternate. The Executive Committee liaison
regulations are needed in pharmacy
Donald “Donnie” Lewis, RPh, of the is Reginald B. “Reggie” Dilliard, DPh.
for improving the protection of the
Texas State Board of Pharmacy, and Melissa public health.
Pollard, PharmD, RPh, of the Nebraska The Committee on Constitution and
Department of Health and Human Services, Steven W. Schierholt, Esq, State of Bylaws will convene virtually on April 5,
Division of Public Health, Licensure Unit, Ohio Board of Pharmacy, will serve as 2021. The charge of this committee, as
will serve as alternates. The Executive the committee chairperson. Committee defined by the NABP Constitution and
Committee liaison will be Bradley S. members include: Bylaws, is to review proposed amendments
Hamilton, RPh. • Alexandra Blasi, MBA, JD, Kansas State to the Constitution and Bylaws, suggest
Board of Pharmacy changes where appropriate, and issue
Standing Committees • S ebastian Hamilton, MBA, PharmD, a recommendation for each proposed
As authorized by the NABP Constitution RPh, Massachusetts Board of amendment.
and Bylaws, the Association’s standing Registration in Pharmacy Tamara McCants, PharmD, RPh,
committees annually perform specific • ony King, PharmD, RPh, Montana
T chairperson, District of Columbia Board
responsibilities that are essential to the Board of Pharmacy of Pharmacy, will be the committee
success of NABP’s programs. Once a • eborah C. “Debbie” Mack, PD,
D chairperson. Committee members include:
committee has explored its assigned issues, RPh, CHC, CCEP, Arkansas State • Paul Brand, PharmD, AE-C, Montana
the members submit recommendations Board of Pharmacy Board of Pharmacy
or resolutions to the NABP Executive
• avid Rochefort, RPh, New Hampshire
D • ichael Carroll, RPh, Vermont Board
M
Committee for consideration. Board of Pharmacy of Pharmacy
• im Tanzer, PharmD, RPh,
K • evin Dang, MBA, PharmD, RPh,
K
The Committee on Law Enforcement/ Arizona State Board of Pharmacy
Massachusetts Board of Registration
Legislation will be held virtually on January in Pharmacy • ark Smosna, RPh, Indiana
M
13, 2021. The committee is charged with the Board of Pharmacy
following tasks: • orri Walmsley, RPh, FAzPA, Arizona
L
State Board of Pharmacy
• Review and comment on existing David Bowyer, RPh, of the West Virginia
legislation and rules for the practice of • S hauna White, MS, PharmD, RPh, Board of Pharmacy, and Julie Spier, RPh, of
pharmacy, legal distribution of drugs, District of Columbia Board of Pharmacy
the Texas State Board of Pharmacy, will serve as
and related areas within pharmacy, • J . David Wuest, RPh, Nevada State alternates. The Executive Committee liaison is
including impaired pharmacists. Board of Pharmacy Kamlesh “Kam” Gandhi, PharmD, RPh.
NOV/DEC 2020 | 11ASSOCIATION NEWS
Redesigned NABP Website Offers Streamlined
Navigation, Engaging New Look
NABP launched its redesigned website on
October 28, 2020. The site features the
NABP logo and brand colors and links
to information about the Association’s
numerous accreditation and examination
programs, meetings, and resources.
Enhancements include:
• Drop-down menus for easier navigation
• n enhanced Member Services section
A
that provides boards of pharmacy
staff and members with easy access
to the valuable resources (NABP
State Boards of Pharmacy Member
Manual, task force reports, electronic
mailbag) and vital board services
(NABP Clearinghouse, data exchange
via NABP e-Profile Connect, and
inspection tools and services)
• n improved Boards of Pharmacy
A
section with current contact
information for each board and
easy access to state newsletters
• new Meetings section that allows users
A
to search for events by type
• nline forms that let users request
O
additional information about an NABP
program or sign up for e-newsletters.
Send Your Comments!
NABP welcomes comments
about its redesigned website,
www.nabp.pharmacy.
Feedback may be emailed
to the NABP Marketing
Department at Marketing@
nabp.pharmacy.
12 | NOV/DEC 2020ASSOCIATION NEWS
NABP Deploys e-Profile Improvements for Login, Security,
and Overall User Experience
This technology is
browser-friendly, and
designed to provide a
more uniform experience
for users, whether they are
using the standard web
interface, or the NABP
e-Profile mobile app.
access to a website or application only
after successfully presenting two or
more pieces of evidence to authenticate
a person’s identity. In addition to a
password, individuals who choose
to use the multifactor authorization
must input a code sent to them by text
message or email. When made available,
multifactor authorization will make it
much more difficult for bad actors to gain
unauthorized access to an account and
To make it easier for users to access to utilize accreditation and inspection improve data privacy.
needed services through NABP e-Profile, services would have needed two login In addition, user-facing technology
the Association has launched a series of accounts – one to access continuing was upgraded to meet modern industry
upgrades to the platform. This began in late pharmacy education and other pharmacist standards. This technology is browser-friendly,
September 2020, with the enhancements to services, and another to access the business and designed to provide a more uniform
the e-Profile login process. e-Profile for the pharmacy business. experience for users, whether they are using
Customers with multiple NABP As a part of the streamlined login the standard web interface, or the NABP
e-Profile accounts – an individual e-Profile process, NABP has made many technical e-Profile mobile app. Previously, the e-Profile
and a business e-Profile – will now notice upgrades to the e-Profile system. These app was limited to a few basic functions. With
a more streamlined user experience as upgrades include the capacity for improved these improvements, mobile app users now
these customers will now be able to access account security by adding a multifactor have access to all the same options available to
both accounts under one login. Prior to authorization – an electronic method those using a personal computer.
this upgrade, a pharmacist who wanted in which a computer user is granted Improving the customer experience with
NABP e-Profile will help keep licensee
data more secure. Incremental upgrades
As a part of the streamlined login process, NABP has to the e-Profile system will continue to be
made many technical upgrades to the e-Profile system. rolled out over time. NABP will provide
additional updates on these improvements
These upgrades include the capacity for account as they are implemented.
security by adding a multifactor authorization.
NOV/DEC 2020 | 13ASSOCIATION NEWS
PCOA Offered Online in 2021; School Registration Open Now
Due to the coronavirus disease 2019
pandemic’s impact on the schools and 2021 PCOA Testing Windows
colleges of pharmacy, the Pharmacy
Curriculum Outcomes Assessment® Testings School Registration Deadline
(PCOA®) will be offered with online
January 11-February 19, 2021 October 12, 2020
proctoring for academic year 2020-2021.
For online proctoring, schools select a date, March 29-May 21, 2021 January 4, 2021
(Monday through Friday) within one of the
five testing windows that may be used to June 14-June 25, 2021 March 15, 2021
administer the test. The test will be offered
over a three-day period. August 16-September 10, 2021 May 24, 2021
The PCOA is a comprehensive tool
November 8-December 10, 2021 August 16, 2021
developed by NABP to provide an
independent, objective, and external measure
of student performance in pharmacy suspend the requirement that professional through P4), an additional benefit includes
curricula. The blueprint of the assessment year three (P3) students complete the PCOA providing documentation of improvement
is a set of competency statements with for the current academic year. in individual performance after a curriculum
weightings that reflect the results of the Since the PCOA provides numerous has been modified or updated.
2015 United States Schools and Colleges benefits to schools and colleges of School registration for the second window
of Pharmacy Curricular Survey and the pharmacy, NABP continues to offer the is open until January 4, 2021.
Accreditation Council for Pharmacy Education assessment in an online proctored format. More information about the PCOA
(ACPE) Standards implemented in 2016. These benefits include providing data on can be accessed through the Examinations
As a result of many schools and colleges of students’ knowledge in specific content section under Programs on the NABP
pharmacy moving portions of their classes to areas and score reports with a comparison website at www.nabp.pharmacy.
online formats, and due to other pandemic- to national samples. For schools that choose
related challenges, ACPE has decided to to test all professional year students (P1
14 | NOV/DEC 2020ASSOCIATION NEWS
New Online Application Pulls From Business e-Profiles to
Expedite NABP Accreditation and Inspection Processes
A universal application enabling pharmacies
and other pharmacy-related businesses
to more easily apply for multiple NABP
accreditation and inspection programs is
now available. Launched in October 2020,
the application is available for all NABP
accreditation and inspection programs except
the .Pharmacy Verified Websites Program.
Previously, businesses were required to
complete separate applications for each
accreditation or inspection program to
which they were applying and for each
facility requiring NABP services. As a result,
businesses applying for multiple programs
and facilities often spent considerable
time reentering the same information into
each application. With the new universal
application, relevant information is pulled
from an applicant’s business e-Profile to Currently, the universal application is For more information about the
prepopulate data fields common to all available only to businesses applying for an universal application, read “New
accreditation and inspection applications, NABP accreditation or inspection program Streamlined Application for NABP
and then display questions relevant to the for the first time. Those in the second and Accreditation and Inspection Programs
programs to which the applicant is applying third year of their accreditation process Offers Benefits for Businesses, Boards”
appear. This makes the application process will be contacted by NABP’s Accreditation in the June/July 2020 issue of Innovations.
more efficient. The more complete and up staff regarding the next steps. Application
to date a business’ e-Profile is, the more renewals and reaccreditations are expected
seamless the application process is. to be available in 2021.
NABP Accreditations and Verifications
NABP awarded a total of 70 accreditations and verifications from June 1 to August 31, 2020. The breakdown by program is as follows:
• rug Distributor Accreditation (formerly
D • igital Pharmacy Accreditation
D • .Pharmacy Verified Websites: 58
known as Verified-Accredited Wholesale (formerly known as Verified Internet
Distributors®): 9 Pharmacy Practice Sites®): 3
1, 2, 3...
To see the names of businesses accredited and verified by NABP, visit the Programs section of the Association’s website at www.nabp.pharmacy.
NOV/DEC 2020 | 15ASSOCIATION NEWS
Drug Utilization Reviews, Impairment
Coming Soon!
Related to Cannabis Use Addressed in
2021 Survey of
NABP Model Act Updates
Pharmacy Law
With Updated
Design, New
Questions
Redesigned with a
2021 SURVEY OF PHARMACY LAW
fresh, modern look,
the 2021 edition
2021
SURVEY OF
of the Survey of
PHARMACY LAW
Pharmacy Law will
Including all 50 states, DC, Guam, and Puerto Rico
be available in late
ORGANIZATIONAL LAW | LICENSING LAW | DRUG LAW | CENSUS DATA
1 | NABP 2021 Survey of Pharmacy Law
December 2020. Published in a
The recently amended Model State Pharmacy The updated Model Act downloadable pdf format, the Survey
Act and Model Rules of the National Association of continues to be a valuable resource
Boards of Pharmacy (Model Act) is now available,
is available as a free for anyone looking for an overview of
and includes changes to definitions, an update download in the Members the laws and regulations that govern
to the Pharmacy Care Services Prospective Drug pharmacy practice in all 50 states
Utilization Review section, and information
section of the NABP and three jurisdictions: District of
about cannabis use among licensees. website. Columbia, Guam, and Puerto Rico.
The terms “good moral character” and The Survey consists of four
“gross immorality” were removed throughout chapters: a state-by-state overview
the Model Act. This change was instituted of organization law, licensing law,
to reflect similar revisions to the NABP Finally, footnotes were added instructing drug law, and census data. The
Constitution and Bylaws made in 2019. the boards to consider the issue of 2021 Survey includes three new
In addition, language was added to the impairment if a registrant or licensee tested questions addressing testing limits
Prescription Drug Order Processing section positive for substance misuse and/or abuse, for the North American Pharmacist
of the Model Act stating that pharmacists as well as to consider state and federal laws Licensure Examination® and
have a corresponding responsibility to ensure when evaluating a complaint related to a Multistate Pharmacy Jurisprudence
that a prescription for a controlled substance positive result on a cannabinoid drug test. Examination®, and criminal history
is properly prescribed and dispensed. This The changes to the Model Act were record check requirements for
adjustment was made pursuant to references incorporated as a result of the NABP pharmacy technicians.
to corresponding responsibility in state laws Executive Committee-approved Updates for the 2021 Survey were
and rules and federal regulations. Further recommendations made by the 2020 graciously provided by the state
supporting this purpose, a footnote was Committee on Law Enforcement/ boards of pharmacy.
added to clarify that such responsibility Legislation. Additional recommendations As in previous years, all final-year
should not impede patients from receiving made by the Task Force on Requirements pharmacy students receive the Survey
legitimately prescribed medications. for Pharmacy Technician Education and free of charge. In addition, board of
Amendments to the Pharmacy Care the Task Force on Pharmacy Technician pharmacy executive directors receive a
Services Prospective Drug Utilization Review Competence Assessment will be considered complimentary copy for their board.
section were also made. The amendments in 2021. The Survey will be available
note that prospective drug utilization reviews The updated Model Act is available as a for purchase through the NABP
may include information obtained from free download in the Members section of the e-Profile system.
reviewing data found in a state’s prescription NABP website. For more information, contact
monitoring program. help@nabp.pharmacy.
16 | NOV/DEC 2020You can also read
