Johnston Atholl, Holt David W
Clinical Pharmacology, Barts and The London School of Medicine and Dentistry, Queen Mary, University of London, London, UK.
Br J Clin Pharmacol. 2014 Aug;78(2):218-43. doi: 10.1111/bcp.12298.
Poor-quality medicines present a serious public health problem, particularly in emerging economies and developing countries, and may have a significant impact on the national clinical and economic burden. Attention has largely focused on the increasing availability of deliberately falsified drugs, but substandard medicines are also reaching patients because of poor manufacturing and quality-control practices in the production of genuine drugs (either branded or generic). Substandard medicines are widespread and represent a threat to health because they can inadvertently lead to healthcare failures, such as antibiotic resistance and the spread of disease within a community, as well as death or additional illness in individuals. This article reviews the different aspects of substandard drug formulation that can occur (for example, pharmacological variability between drug batches or between generic and originator drugs, incorrect drug quantity and presence of impurities). The possible means of addressing substandard manufacturing practices are also discussed. A concerted effort is required on the part of governments, drug manufacturers, charities and healthcare providers to ensure that only drugs of acceptable quality reach the patient.
劣质药品是一个严重的公共卫生问题，在新兴经济体和发展中国家尤为突出，可能对国家的临床和经济负担产生重大影响。人们的注意力主要集中在故意伪造药品的日益增多上，但由于正品药品（品牌药或仿制药）生产过程中的生产工艺差和质量控制不善，不合格药品也流入了患者手中。不合格药品广泛存在，对健康构成威胁，因为它们可能无意中导致医疗失败，如抗生素耐药性和疾病在社区内传播，以及导致个人死亡或患病。本文回顾了不合格药品制剂可能出现的不同方面（例如，不同批次药品之间或仿制药与原研药之间的药理学差异、药品数量错误和杂质的存在）。还讨论了解决不合格生产工艺的可能方法。政府、药品制造商、慈善机构和医疗服务提供者需要共同努力，以确保只有质量合格的药品才能到达患者手中。
