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Assessments of the quality systems of pharmaceutical distributors: a remote approach to be applied in times of COVID-19 and beyond #MMPMID33971973
Bourasseau A; Lavergne L; Ravinetto R
J Pharm Policy Pract 2021[May]; 14 (1): 43 PMID33971973show ga
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.
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J+Pharm+Policy+Pract 2021 ; 14 (1): 43
