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[e-drug] Remote assessments of the quality systems of pharmaceutical distributors

E-DRUG: Remote assessments of the quality systems of pharmaceutical distributors

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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