Academic Division of Child Health, University of Nottingham, Derbyshire Children's Hospital, Derby, UK.
BMJ Open. 2013 Aug 17;3(8):e002923. doi: 10.1136/bmjopen-2013-002923.
To explore the evidence available of poor-quality (counterfeit and substandard) medicines in the literature.
Systematic review.
Databases used were EMBASE, MEDLINE, PubMed and the International Pharmaceutical Abstracts, including articles published till January 2013.
Prevalence studies containing original data. WHO definitions (1992) used for counterfeit and substandard medicines.
Two reviewers independently scored study methodology against recommendations from the MEDQUARG Checklist. Studies were classified according to the World Bank classification of countries by income.
Data extracted: place of study; type of drugs sampled; sample size; percentage of substandard/counterfeit medicines; formulations included; origin of the drugs; chemical analysis and stated issues of counterfeit/substandard medicines.
44 prevalence studies were identified, 15 had good methodological quality. They were conducted in 25 different countries; the majority were in low-income countries (11) and/or lower middle-income countries (10). The median prevalence of substandard/counterfeit medicines was 28.5% (range 11-48%). Only two studies differentiated between substandard and counterfeit medicines. Prevalence data were limited to antimicrobial drugs (all 15 studies). 13 studies involved antimalarials, 6 antibiotics and 2 other medications. The majority of studies (93%) contained samples with inadequate amounts of active ingredients. The prevalence of substandard/counterfeit antimicrobials was significantly higher when purchased from unlicensed outlets (p<0.000; 95% CI 0.21 to 0.32). No individual data about the prevalence in upper middle-income countries and high-income countries were available.
Studies with strong methodology were few. The majority did not differentiate between substandard and counterfeit medicines. Most studies assessed only a single therapeutic class of antimicrobials.
The prevalence of poor-quality antimicrobial medicines is widespread throughout Africa and Asia in lower income countries and lower middle-income countries . The main problem identified was inadequate amounts of the active ingredients.
探索文献中劣质（假冒和伪劣）药品的现有证据。
系统评价。
使用的数据库包括 EMBASE、MEDLINE、PubMed 和国际药学文摘，包括截至 2013 年 1 月发表的文章。
包含原始数据的流行率研究。使用世界卫生组织（1992 年）对假冒和伪劣药品的定义。
两名评审员根据 MEDQUARG 清单的建议，独立对研究方法进行评分。根据世界银行按收入划分的国家分类，对研究进行分类。
提取的数据：研究地点；抽样药物类型；样本量；伪劣/假冒药品的百分比；包含的制剂；药物来源；化学分析和伪劣/假冒药品的问题陈述。
确定了 44 项流行率研究，其中 15 项具有良好的方法学质量。它们在 25 个不同国家进行；其中大多数在低收入国家（11 个）和/或中低收入国家（10 个）。伪劣/假冒药品的中位流行率为 28.5%（范围 11-48%）。只有两项研究区分了伪劣药品和假冒药品。流行率数据仅限于抗菌药物（15 项研究均涉及）。13 项研究涉及抗疟药，6 项涉及抗生素，2 项涉及其他药物。大多数研究（93%）的样本中有效成分含量不足。从无牌销售点购买的伪劣/假冒抗菌药物的流行率明显更高（p<0.000；95%CI 0.21 至 0.32）。没有关于中高收入国家和高收入国家的流行率的个别数据。
具有强大方法学的研究很少。大多数研究没有区分伪劣药品和假冒药品。大多数研究仅评估了单一治疗类别的抗菌药物。
劣质抗菌药物在非洲和亚洲的低收入国家和中低收入国家广泛存在。主要问题是有效成分含量不足。
