Suleman Sultan, Hasen Gemmechu, Melaku Tsegaye, Belew Sileshi, Thitiri Johnstone, Shangala Jimmy, Obiero Christina W, Ngari Moses, Berkley James A
Clinical Research Department, KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya
Institute of Health, School of Pharmacy, Jimma University, Jimma, Oromia, Ethiopia.
BMJ Open. 2025 Jan 6;15(1):e090849. doi: 10.1136/bmjopen-2024-090849.
Medicine quality can be influenced by environmental factors. In low- and middle-income countries (LMICs) with tropical climates, storage facilities of medicines in healthcare settings and homes may be suboptimal. However, knowledge of the effects of temperature and other climatic and environmental factors on the quality of medicines is limited. A better understanding of the effects of climates may assist in the development of control strategies to help reduce factors contributing to poor-quality medicines. Therefore, this systematic review aims to synthesise data from published studies describing the effects of storage conditions on the quality of antibiotic medicines commonly used in LMICs.
We will search literature from databases, including the PubMed, Web of Science, Scopus and Google Scholar, and grey literature between 1987 and 2022. Experimental studies that evaluate the influence of temperature, humidity and sunlight on the quality of antibiotics applicable to Africa and South Asia will be included. Experimental studies that assess naturally occurring and simulated storage conditions and medicines prepared from powder with water and stored in hospitals or at home to be used across several doses will be also included. The key search terms related to the tropical climate, quality and commonly used antibiotics, such as temperature, storage condition, humidity, sunlight and moisture; quality, assay, purity, dissolution, disintegration, hardness, friability, weight variation, weight uniformity, degradation, impurities and stability; and amoxicillin, ceftriaxone, azithromycin, ciprofloxacin, doxycycline, metronidazole, trimethoprim-sulfamethoxazole, erythromycin, ampicillin and gentamicin, respectively, will be connected using the appropriate Boolean operators (OR, AND). The search terms will be used in correspondence with Medical Subject Heading terms by keyword arrangement. The available evidence for the poor quality of commonly used antibiotics is summarised by the type of diagnosis, type of drug and region. Meta-analysis using random effects will be performed using RevMan software to determine the pooled effects of environmental exposures. The degree of heterogeneity will be evaluated by the inverse of variance (I). Forest plots will be used to present the meta-analysis data.
Ethical approval is not required as the study is a systematic review. This review will be disseminated through open-access peer-reviewed publication.
CRD42023432848.
药品质量会受到环境因素的影响。在热带气候的低收入和中等收入国家(LMICs),医疗机构和家庭中的药品储存设施可能并不理想。然而,关于温度及其他气候和环境因素对药品质量影响的了解有限。更好地理解气候影响可能有助于制定控制策略,以减少导致药品质量不佳的因素。因此,本系统评价旨在综合已发表研究的数据,描述储存条件对LMICs常用抗生素药品质量的影响。
我们将检索1987年至2022年间来自数据库(包括PubMed、科学网、Scopus和谷歌学术)的文献以及灰色文献。将纳入评估温度、湿度和阳光对适用于非洲和南亚的抗生素质量影响的实验研究。还将纳入评估自然发生和模拟储存条件以及用水从粉末制备并储存在医院或家中以供多次剂量使用的药品的实验研究。与热带气候、质量和常用抗生素相关的关键检索词,如温度、储存条件、湿度、阳光和水分;质量、含量测定、纯度、溶出度、崩解度、硬度、脆碎度、重量差异、重量均匀度、降解、杂质和稳定性;以及阿莫西林、头孢曲松、阿奇霉素、环丙沙星、多西环素、甲硝唑、甲氧苄啶-磺胺甲恶唑、红霉素、氨苄西林和庆大霉素,将分别使用适当的布尔运算符(OR、AND)进行连接。检索词将通过关键词排列与医学主题词对应使用。常用抗生素质量不佳的现有证据按诊断类型(此处原文有误,推测应为研究类型)、药物类型和地区进行总结。将使用RevMan软件进行随机效应荟萃分析,以确定环境暴露的合并效应。异质性程度将通过方差倒数(I)进行评估。森林图将用于呈现荟萃分析数据。
由于本研究是一项系统评价,无需伦理批准。本评价将通过开放获取的同行评审出版物进行传播。
PROSPERO注册号:CRD42023432848。