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[41]
guided proton pump inhibitor prescribing . Although patients can be started on a medication before the
return of genotyping results, this is not an ideal model, and may result in patients being lost to follow up
with increases in economic burden for patients and healthcare system due to the costs of treatment for
adverse drug reactions, treatment failures and even the cost of the wasted initially filled medication.
PROVIDING OVERSIGHT FOR IMPLEMENTATION PROGRAM
The multidisciplinary implementation team
Several academic and non-academic institutions have spearheaded pharmacogenetic implementation
efforts, documenting site-specific implementation experiences and lessons learned. These implementation
efforts were summarized in other review papers [26,42] . Many of the implementation services were
pharmacist-led [43-45] . Pharmacists play many key roles in the implementation of pharmacogenetics such as
reviewing medication use and safety policies, developing educational strategies for other providers and
patients, reviewing and analyzing evidence, managing the pharmacogenetic database, and implementing
[43]
overall leadership . Physicians are also critical to the development and success of the implementation.
Understanding their interest within a practice site and how they perceive pharmacogenetics in their
clinical workflow is important for successful integration. Structured or semi-structured surveys
administered at the pre-implementation stage may help implementing clinicians glean understanding of the
institutional landscape, stakeholders’ goals, and clinicians’ interest and their perspectives about the use of
[46]
pharmacogenetics . Physician-champions should be identified and in the planning process for the targeted
clinical group and/or specialty. Their clinical expertise is vital especially when making protocol decisions
on pharmacogenetic-guided therapeutic recommendations and their associated alternative therapies or
dosing. Like pharmacists, physicians should be included in the oversight committee that is established early
on to oversee the activities from the planning phase through implementation of clinical pharmacogenetics
and post-implementation evaluation. Already established Pharmacy and Therapeutics (P&T) Committees
can serve this purpose as well. Additionally, experts from genetics, clinical laboratory, informatics and
information technology, administration, institutional leadership and patient advocacy should be included
in this committee.
RELEVANT RESOURCES FOR PHARMACOGENETIC IMPLEMENTATION
Clinical Pharmacogenetics Implementation Consortium
The CPIC is an international consortium of volunteers and dedicated members who are interested in
facilitating the use of pharmacogenetic information for patient care. It was created in 2009 as a shared
project between the international pharmacogenetics database and website, PharmGKB (www.pharmgkb.
org) and the NIH. The purpose of CPIC is to provide freely available, peer-reviewed, evidence-based
clinical pharmacogenetic practice guidelines. As of 2019, CPIC has a growing membership of 350 members
from 245 institutions in 33 countries with observers from the U.S. FDA and NIH. Members meet monthly
on general membership calls and through the informatics, dissemination, and other workgroup meetings.
CPIC guidelines are indexed in PubMed and published on the CPIC website (https://cpicpgx.org/
guidelines/) as well as annotated on the PharmGKB website (www.pharmgkb.org). As of August 2020,
there are 24 published guidelines with 2 more in progress. Their goal is to update the guidelines on a
biennial schedule. So far, they cover 19 genes and 46 medications across several therapeutic areas including
infectious diseases, cardiology, psychiatry, neurology, and oncology. CPIC also compiles a list of contacts
for PGx implementers across the U.S. (https://cpicpgx.org/implementation/) and other countries, which is
a great resource of contacts for experts and clinicians in the field.
United States Food and Drug Administration
Through their oversight of drug product labeling, the FDA also maintains a table of pharmacogenomic
biomarkers (https://www.fda.gov/drugs/science-and-research-drugs/table-pharmacogenomic-biomarkers-