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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

Journal of pharmaceutical policy and practice, 2021-05, Vol.14 (1), p.43-43, Article 43 [Peer Reviewed Journal]

COPYRIGHT 2021 BioMed Central Ltd. ;2021. This work is licensed under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. ;The Author(s) 2021 ;ISSN: 2052-3211 ;EISSN: 2052-3211 ;DOI: 10.1186/s40545-021-00323-w ;PMID: 33971973

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  • Title:
    Assessments of the quality systems of pharmaceutical distributors: a remote approach to be applied in times of COVID-19 and beyond
  • Author: Bourasseau, Anthony ; Lavergne, Laurine ; Ravinetto, Raffaella
  • Subjects: Audits ; Communication ; Compliance ; Confidentiality ; Conflicts of interest ; Coronaviruses ; COVID-19 ; Developing countries ; distant assessment ; Drug wholesalers ; Epidemics ; Good Manufacturing Practice ; Information management ; information technology ; Inspections ; Logistics ; Medical equipment ; Onsite ; Pandemics ; pharmaceutical distributor ; Pharmaceuticals ; Quality control ; quality of medicines ; remote audit ; Suppliers ; supply chain ; Supply chains ; Travel restrictions ; Vendor relations ; videoconferencing ; World health
  • Is Part Of: Journal of pharmaceutical policy and practice, 2021-05, Vol.14 (1), p.43-43, Article 43
  • Description: 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. 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. 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. 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.
  • Publisher: England: BioMed Central Ltd
  • Language: English
  • Identifier: ISSN: 2052-3211
    EISSN: 2052-3211
    DOI: 10.1186/s40545-021-00323-w
    PMID: 33971973
  • Source: SpringerOpen
    Geneva Foundation Free Medical Journals at publisher websites
    AUTh Library subscriptions: ProQuest Central
    PubMed Central
    Coronavirus Research Database
    ROAD: Directory of Open Access Scholarly Resources
    DOAJ Directory of Open Access Journals
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