Innovations-Magazine-June-July-2022 - 13

Task Force Recommends NABP Provide Education,
Tools to Assist Boards in Ensuring Legal and Safe Prescription
Drug Importation
Members of the Task Force on State
Oversight of Drug Importation made several
recommendations for ways that NABP
can provide guidance to state and federal
governments and other policymakers on
the risks associated with prescription drug
importation and the necessary regulatory
oversight processes that may help to mitigate
those risks. The recommended actions
included monitoring legislation related to
prescription drug importation and proactively
communicating this information to the
boards, developing resources for boards to
use in educating legislators on this issue, and
increasing communication with Canadian
pharmacy regulators.
The task force meeting began with guest
presentations provided by representatives
from Colorado's Canadian drug importation
program and the New Mexico Board of
Pharmacy, who detailed their states' Section
804 Importation Programs (SIPs). Task force
members were able to ask questions, and
it soon became clear that these SIPs failed
to address some of the task force members'
biggest concerns. It was also noted that some
of the members' concerns could be alleviated
in future development of SIPs by ensuring
that state boards of pharmacy are consulted
in preliminary planning.
The task force's main concerns with
current SIPs were centered around supply
chain issues, with members noting that the
safest drug supply chain will always be the
shortest route from the manufacturer to
the patient. Members recognized that the
presented SIPs failed to consider the intricacies
of supply chain logistics and seemed focused
on acquiring foreign-sourced drugs rather
than what happens as medications continue
through the supply chain. These concerns were
further compounded by questionable oversight
of existing supply chain issues, such as those
related to active pharmaceutical ingredients
already sourced from foreign countries.
Task Force Charge
1. Evaluate the current regulatory
environment related to
prescription drug importation
and the challenges that states will
face with regulating importation.
2. Review NABP programs to
determine how they may
support states that implement
drug importation programs.
3. Develop educational tools
to assist states in the oversight
of drug importation.
Task force members also voiced concern
over which entities would have enforcement
responsibility over SIPs, particularly when
multiple agencies in different countries
were involved. Ultimately, the task force
agreed that NABP should communicate
with the National Association of Pharmacy
Regulatory Authorities, Health Canada,
and pharmacy regulators in the individual
Canadian provinces and foreign jurisdictions
to discuss importation issues, particularly
the regulation of their wholesale distributors
that will be selling prescription medications
to approved United States importers.
Additionally, NABP should discuss with
the Canadian regulators, state, and federal
agencies, as well as other foreign countries (if
and as they are approved) information about
NABP programs, such as the Supply Chain
Inspection, that could assist with regulatory
oversight by being utilized for nonresident
importers within the US.
Members also discussed miscellaneous but
important issues related to SIPs, including
the possibility of drug shortages, the possible
impact on the Canadian drug supply, and
whether the savings US patients might
see as a result of these programs would be
negligible. The task force members also
discussed the overarching issue of patient
safety, as the public's general knowledge
about drug importation may cause confusion
as well as how SIPs might interact with
the Drug Supply Chain Security Act.
The Task Force on State Oversight
of Drug Importation was established in
response to the 2021-2022 presidential
initiative of Caroline D. Juran,
BSPharm, DPh (Hon), which was to
increase efforts to support the boards of
pharmacy and to educate and protect
the public about state drug importation
plans. Task force members included:
* Andrew Funk, PharmD, RPh, chair;
* Paul Brand, PharmD, AE-C;
* Robert Carpenter, RPh;
* John Colaizzi, Jr, PharmD, RPh, CCP;
* Brenda McCrady, PD, RPh;
* Shanea McKinney, PharmD, RPh;
* Rich Palombo, RPh, DPh;
* Jeanne Waggener, RPh, DPh;
* Stuart Williams, JD;
* Linda Witzal, RPh; and
* Jeffrey R. Mesaros, PharmD, JD, RPh,
Executive Committee liaison.
Invited guests for the task force included:
* Cheranne McCracken, RPh, New
Mexico Board of Pharmacy;
* Lauren Reveley, MA, Colorado drug
importation program;
* Kelly Swartzendruber, PharmD,
CPPS, LSSBB, Colorado drug
importation program; and
* Caroline D. Juran, 2021-2022
NABP president.
The task force report was approved by the
Executive Committee during its December
2021 meeting and is available in the Reports
section at
JUNE/JULY 2022 | 11


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