Lalani Mirza, Matafwali Scott Kaba, Ndiaye Aminata Dior, Webster Jayne, Clarke Sian E, Kaur Harparkash
Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London, United Kingdom.
Department of Clinical Research, London School of Hygiene and Tropical Medicine, London, United Kingdom.
PLOS Glob Public Health. 2023 Jul 12;3(7):e0002004. doi: 10.1371/journal.pgph.0002004. eCollection 2023.
Poor-quality medicines pose a significant challenge for health systems in low- to middle-income countries (LMICs),with recent deaths in multiple countries following ingestion of substandard cough syrups emphasising the need for quality-assurance of medicines in our increasingly interconnected global markets. Research also suggests that the source (country of manufacture) and type of medicine (generic/brand) are perceived to be associated with medicine quality. This study explores perceptions of medicines quality among national stakeholders of a medicines quality assurance system (MQAS) in sub-Saharan Africa. Through semi-structured interviews (n = 29) with managers from organisations responsible for the MQAS, public-sector doctors and nurses, and regulated private-sector pharmacists in three urban centres in Senegal in 2013. A thematic approach to analysis was undertaken with themes organised under three main categories, the source of drugs, the type of medicine, and medicines storage. A key emerging theme was the perception of the inferior quality of generic medicines, especially those produced in Asia and Africa, as they were lower in cost and thus believed to be less effective in alleviating symptoms than their brand versions. Medicines in Senegal's less regulated (informal) street markets were also thought to be of poor-quality as they were not subjected to national regulatory processes or stored appropriately, resulting in exposure to direct sunlight and high temperatures. In contrast, the interviewees expressed confidence in medicines quality within the regulated sectors (public and private retail pharmacies) attributed to stringent national medicines regulation, secure medicines supply chains and adequate technical capacity to survey and analyse for medicines quality. Also, the views expressed typically described a medicine's quality in terms of its effectiveness in alleviating the symptoms of ill health (efficacy of a medicine).These perceptions may have implications for developing national medicines policy, the procurement and supply of affordable medicines and consumers' decision-making when purchasing medicines. Indeed, a proclivity for supplying and purchasing more expensive brand medicines may act as a barrier to accessing essential medicines.
劣质药品给低收入和中等收入国家(LMICs)的卫生系统带来了重大挑战,最近多个国家因摄入不合格止咳糖浆导致死亡,这凸显了在日益相互关联的全球市场中确保药品质量的必要性。研究还表明,药品的来源(生产国)和类型(仿制药/品牌药)被认为与药品质量有关。本研究探讨了撒哈拉以南非洲药品质量保证系统(MQAS)的国家利益相关者对药品质量的看法。2013年,通过对塞内加尔三个城市中心负责MQAS的组织管理人员、公共部门医生和护士以及受监管的私营部门药剂师进行半结构化访谈(n = 29)。采用主题分析法进行分析,主题分为三大类:药品来源、药品类型和药品储存。一个关键的新出现主题是对仿制药质量较差的看法,尤其是那些在亚洲和非洲生产的仿制药,因为它们成本较低,因此被认为在缓解症状方面不如品牌药有效。塞内加尔监管较少(非正式)的街头市场上的药品也被认为质量较差,因为它们没有经过国家监管程序,也没有妥善储存,导致暴露在直射阳光下和高温下。相比之下,受访者对受监管部门(公共和私人零售药店)的药品质量表示信心,这归因于严格的国家药品监管、安全的药品供应链以及足够的技术能力来调查和分析药品质量。此外,所表达的观点通常根据药品缓解健康问题症状的有效性(药品疗效)来描述药品质量。这些看法可能会对制定国家药品政策、采购和供应负担得起的药品以及消费者购买药品时的决策产生影响。事实上,倾向于供应和购买更昂贵的品牌药可能会成为获取基本药物的障碍。