Division of Practice Advancement and Clinical Education, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
Department of Global Public Health, United States Pharmacopeia, Rockville, Maryland, USA.
BMJ Open. 2023 Jun 8;13(6):e068923. doi: 10.1136/bmjopen-2022-068923.
To explore the impact of the Coronavirus disease 2019 (COVID-19) pandemic on the quality of medical products in Zimbabwe, including market risks for substandard and falsified products and impacts on quality assurance activities.
Qualitative study based on in-depth key informant interviews.
Health system stakeholders across the medical product supply chain in Zimbabwe.
36 key informants were interviewed between April and June 2021.
We found that the COVID-19 pandemic disrupted quality assurance and regulatory activities of medical products in Zimbabwe, resulted in observations of poor-quality personal protective equipment (PPE) and other COVID-19-related products and led to increased risks to quality. Risks to quality due to COVID-19-related disruptions included increased layers of agents in the supply chain and an influx of non-traditional suppliers. COVID-19-related movement restrictions reduced access to health facilities and thus may have increased the usage of the informal market where smuggled and unregistered medical products are sold with less oversight by the regulator. Most reports of poor-quality medical products were for PPE, such as masks and infrared thermometers, used for the COVID-19 response. Besides these reports, many participants stated that the quality of essential medicines in the formal sector, not related to COVID-19, had largely been maintained during the pandemic due to the regulator's stringent quality assurance process. Incentives for suppliers to maintain quality to retain large donor-funded contracts, and the need for local wholesalers and distributors to comply with quality-related aspects of distribution agreements with global manufacturers of brand-name medical products, mitigated threats to quality.
The COVID-19 pandemic presented opportunities and market risks for circulation of substandard and falsified medical products in Zimbabwe. There is a need for policymakers to invest in measures to safeguard the quality of medical products during emergencies and to build resiliency against future supply chain shocks.
探讨 2019 年冠状病毒病(COVID-19)大流行对津巴布韦医疗产品质量的影响,包括不合格和假冒产品的市场风险以及对质量保证活动的影响。
基于深入的关键知情人访谈的定性研究。
津巴布韦医疗产品供应链中的卫生系统利益相关者。
2021 年 4 月至 6 月期间对 36 名关键知情人进行了访谈。
我们发现,COVID-19 大流行扰乱了津巴布韦的医疗产品质量保证和监管活动,导致观察到个人防护设备(PPE)和其他 COVID-19 相关产品质量差,并增加了质量风险。由于 COVID-19 相关中断而导致的质量风险包括供应链中增加了代理商的层数,以及非传统供应商的涌入。COVID-19 相关的流动限制减少了对卫生设施的访问,因此可能增加了走私和未注册的医疗产品在非正式市场上的使用,而监管机构对这些产品的监督较少。大多数有关劣质医疗产品的报告是针对 PPE,例如用于 COVID-19 应对的口罩和红外温度计。除了这些报告外,许多参与者还表示,由于监管机构严格的质量保证程序,大流行期间正规部门(与 COVID-19 无关)的基本药物质量基本保持不变。供应商为了保留大型捐助者资助的合同而保持质量的激励措施,以及当地批发商和分销商遵守与名牌医疗产品全球制造商的分销协议中与质量相关的方面,减轻了对质量的威胁。
COVID-19 大流行给津巴布韦不合格和假冒医疗产品的流通带来了机遇和市场风险。政策制定者需要投资于在紧急情况下保障医疗产品质量的措施,并建立对未来供应链冲击的恢复力。