Bourasseau Anthony, Lavergne Laurine, Ravinetto Raffaella
, Paris, France.
QUAMED, Brussels, Belgium.
J Pharm Policy Pract. 2021 May 10;14(1):43. doi: 10.1186/s40545-021-00323-w.
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.
整个药品供应链中健全的质量体系对于保护个人和社区免受不合格及假冒医疗产品的侵害至关重要。因此，药品经销商会定期接受资质专家的评估。自新冠疫情迫使正常活动暂停以来，通过视频会议进行远程评估可能是现场审计的一种临时替代方式。我们探索性地评估了在新冠疫情期间位于低收入或中等收入国家且难以到达地区的药品经销商进行远程评估的可行性。
我们对四家方便选取的经销商进行了远程评估试点。专家通过视频会议进行远程连接，并由一名国内评估协调员（ICAF）提供支持，该协调员接受过临时培训且在被评估机构现场。首先，远程专家按照常规做法评估质量保证（QA）活动，并对其符合世界卫生组织良好储存与分销规范（GSDP）标准的情况进行评分。其次，专家先按经销商分别评估远程收集数据的完整性、清晰度和准确性，然后再评估汇总数据的这些方面。
专家评估数据完整性极佳，清晰度和准确性良好。总体数据质量（完整性、清晰度和准确性的综合）良好，在QA活动之间以及经销商之间均无重大差异。背景限制包括网络连接不佳、语言障碍以及经销商对QA术语不熟悉。
我们的研究结果具有探索性，不能外推至其他情况或其他类型的审计。尽管如此，这次试点经验表明，在训练有素的现场ICAF的支持下，对药品经销商进行精心规划的远程评估能够提供质量可接受的数据，从而能够评估GSDP合规情况并就许可或采购做出临时决策。采购方和政策制定者应根据远程评估结果的固有局限性来解读。目前，现场评估仍是金标准，但从长远来看，随着信息技术的改进以及避免不必要出行的需求，这种情况可能会改变。此外，远程评估可考虑用于现场评估候选人的常规预筛选以及现场评估的针对性跟进。
