Be-cause Health & QUAMED literature updates

·         Ref. Bourasseau, A., Lavergne, L. & Ravinetto, R. Assessments of the quality systems of pharmaceutical distributors: a remote approach to be applied in times of COVID-19 and beyond. J of Pharm Policy and Pract 2021; 1443

Dear Friend,

Today, I would like to present a very recent publication, which just appeared in the Journal of Pharmaceutical Policy Practice, and which 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 (as in COVID times, but also in case of conflicts and unstable political contexts); and we reported 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. Even if technical in nature, I think this work can be interesting for many of us, especially pharmacists and those involved in the pre-qualification of pharmaceutical suppliers.  

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 video conferencing 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 policymakers 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.

Have a nice reading,

Raffaella

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