E-DRUG: Remote assessments of the quality systems of pharmaceutical distributors
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Dear E-druggers,
I would like to present a very recent publication in the Journal of
Pharmaceutical Policy Practice. This work results from the well-established
collaboration between QUAMED (https://www.quamed.org/) and the Institute of
Tropical Medicine in Antwerp. We explored pragmatic ways to assess the quality
systems of pharmaceutical distributors when travelling to the distributors'
site is limited or impossible, and we report on our exploratory results and
related recommendations.
The full paper is freely available at
https://joppp.biomedcentral.com/articles/10.1186/s40545-021-00323-w, while the
abstract is copy-pasted below:
Background -Adequate quality systems throughout pharmaceutical supply chains
are crucial to protect individuals and communities from substandard and
falsified medical products. Thus, pharmaceutical distributors are regularly
assessed by qualified experts. Since the COVID-19 pandemic has forced a
suspension of normal activities, remote assessments via videoconferencing may
represent a temporary alternative to on-site audits. We exploratorily evaluated
the feasibility of remote assessments of pharmaceutical distributors, located
in a low- or middle-income country hard-to reach during the COVID-19 pandemic.
Methods -We conducted pilot remote assessments of four conveniently selected
distributors. The expert was remotely connected via videoconference, and
supported by an in-country assessment facilitator (ICAF), who had received ad
hoc training and was present at the assessed facility. First, the remote expert
assessed the quality assurance (QA) activities and rated their compliance with
the standards of the World Health Organization Good Storage & Distribution
Practices (GSDP), as per routine practice. Second, s/he assessed the
completeness, clarity and accuracy of data collected remotely, first per
distributor, and then in aggregated form.
Results - Data completeness was assessed by the expert as excellent, while
clarity and accuracy were good. Overall data quality (a combination of
completeness, clarity and accuracy) was good, with no major differences across
QA activities, nor across distributors. Contextual limitations included poor
internet connection, language barriers, and distributors' lack of familiarity
with QA terminology.
Conclusions - Our findings are exploratory and cannot be extrapolated to other
contexts, nor to other types of audits. Nonetheless, this pilot experience
suggests that a well-planned remote assessment of pharmaceutical distributors,
conducted with the support of a well-trained onsite ICAF, can provide data of
acceptable quality, allowing to assess GSDP-compliance and to make temporary
decisions about licensing or purchasing. Purchasers and policy makers should
read the results of remote assessments in light of their intrinsic limitations.
At the moment, onsite assessments remain the gold standards, but this could
change in the longer term, with improved information technology and in light of
the need to avoid unnecessary travels. Furthermore, remote assessments could be
considered for routine pre-screening candidates for on-site assessments, and
for targeted follow-up of on-site assessment.
Raffaella Ravinetto
Medicines Research & Policy Support
Institute of Tropical Medicine
Antwerp, Belgium
Raffaella Ravinetto <rravinetto@itg.be>
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