Narsai K, Leufkens H G M, Mantel-Teeuwisse A K
Division of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, the Netherlands.
J Pharm Policy Pract. 2021 Apr 1;14(1):33. doi: 10.1186/s40545-021-00314-x.
Sub-Saharan Africa is going through an epidemiological transition, including an impressive increase in non-communicable diseases. The introduction of medicines has not kept pace with the needs in developing countries. The objectives of this study were to (i) examine the correlation between the number of medicine approvals and disease burden and (ii) compare approval timelines of medicines with disease burden in South Africa in the period 2012-2017.
The dataset was compiled from publicly available data on medicines registered in South Africa between 2012 and 2017. A correlation analysis was conducted to determine the level of alignment between the number and nature of medicines registered, as determined by the WHO ATC Classification and the Lancet Global Burden of Disease data. Median registration timelines were determined to assess whether medicines for diseases of higher burden were registered faster.
A total of 3059 registered medicines were included in the study, including 2779 generic medicines, 267 new chemical entities and 13 vaccines. There was a high level of alignment between the number of medicines registered to treat diseases with higher disease burden levels more effectively, except for lower respiratory tract infections and HIV/AIDS which showed less medicines registered as compared to expectations based on disease burden, respectively. HIV/AIDS showed a lower level of correlation with a much higher disease burden compared to number of medicines registered, but simultaneously also a much shorter median registration timeline (32 months) compared to the other disease areas.
There was generally a high level of alignment between disease burden and number of medicines authorised, except for HIV/AIDS and lower respiratory tract infections. Regulatory authorities should continue to consider burden of disease data to ensure that public health needs are met.
撒哈拉以南非洲正在经历流行病学转变，包括非传染性疾病显著增加。在发展中国家，药品的引进未能跟上需求。本研究的目的是：（i）研究药品批准数量与疾病负担之间的相关性；（ii）比较2012 - 2017年南非药品批准时间线与疾病负担情况。
数据集来自2012年至2017年在南非注册药品的公开数据。进行相关性分析，以确定根据世界卫生组织解剖学治疗学化学分类法确定的注册药品数量和性质与《柳叶刀》全球疾病负担数据之间的匹配程度。确定注册时间中位数，以评估高负担疾病药品的注册速度是否更快。
该研究共纳入3,059种注册药品，包括2,779种仿制药、267种新化学实体和13种疫苗。在更有效地治疗高疾病负担水平疾病的注册药品数量之间存在高度匹配，但下呼吸道感染和艾滋病毒/艾滋病除外，与基于疾病负担的预期相比，这两种疾病注册的药品较少。与注册药品数量相比，艾滋病毒/艾滋病的相关性较低，但疾病负担却高得多，不过与其他疾病领域相比，其注册时间中位数也短得多（32个月）。
除艾滋病毒/艾滋病和下呼吸道感染外，疾病负担与批准药品数量之间总体上高度匹配。监管机构应继续考虑疾病负担数据，以确保满足公共卫生需求。
