Kovacs Stephanie, Hawes Stephen E, Maley Stephen N, Mosites Emily, Wong Ling, Stergachis Andy
Department of Epidemiology, University of Washington, Seattle, Washington, United States of America.
The Bill and Melinda Gates Foundation, Seattle, Washington, United States of America.
PLoS One. 2014 Mar 26;9(3):e90601. doi: 10.1371/journal.pone.0090601. eCollection 2014.
Falsified and substandard drugs are a global health problem, particularly in low- and middle-income countries (LMIC) that have weak pharmacovigilance and drug regulatory systems. Poor quality medicines have important health consequences, including the potential for treatment failure, development of antimicrobial resistance, and serious adverse drug reactions, increasing healthcare costs and undermining the public's confidence in healthcare systems. This article presents a review of the methods employed for the analysis of pharmaceutical formulations. Technologies for detecting substandard and falsified drugs were identified primarily through literature reviews. Key-informant interviews with experts augmented our methods when warranted. In order to aid comparisons, technologies were assigned a suitability score for use in LMIC ranging from 0-8. Scores measured the need for electricity, need for sample preparation, need for reagents, portability, level of training required, and speed of analysis. Technologies with higher scores were deemed the most feasible in LMICs. We categorized technologies that cost $10,000 USD or less as low cost, $10,000-100,000 USD as medium cost and those greater than $100,000 USD as high cost technologies (all prices are 2013 USD). This search strategy yielded information on 42 unique technologies. Five technologies were deemed both low cost and had feasibility scores between 6-8, and an additional four technologies had medium cost and high feasibility. Twelve technologies were deemed portable and therefore could be used in the field. Many technologies can aid in the detection of substandard and falsified drugs that vary from the simplest of checklists for packaging to the most complex mass spectrometry analyses. Although there is no single technology that can serve all the requirements of detecting falsified and substandard drugs, there is an opportunity to bifurcate the technologies into specific niches to address specific sections within the workflow process of detecting products.
假药和劣药是一个全球性的健康问题，在药物警戒和药品监管体系薄弱的低收入和中等收入国家（LMIC）尤为突出。质量不佳的药品会产生严重的健康后果，包括治疗失败、产生抗微生物药物耐药性以及严重的药物不良反应，增加医疗成本并损害公众对医疗体系的信心。本文综述了用于药物制剂分析的方法。主要通过文献综述确定了检测劣药和假药的技术。必要时，通过与专家进行关键信息访谈对我们的方法进行补充。为便于比较，为适用于低收入和中等收入国家的技术赋予了0至8的适用性评分。评分衡量了对电力的需求、样品制备的需求、试剂的需求、便携性、所需的培训水平以及分析速度。得分较高的技术被认为在低收入和中等收入国家最可行。我们将成本在10,000美元及以下的技术归类为低成本技术，成本在10,000至100,000美元之间的为中等成本技术，成本高于100,000美元的为高成本技术（所有价格均为2013年美元）。这种检索策略产生了关于42种独特技术的信息。有五种技术被认为成本低且可行性评分在6至8之间，另外四种技术成本中等且可行性高。有十二种技术被认为具有便携性，因此可在现场使用。许多技术可有助于检测劣药和假药，从最简单的包装检查清单到最复杂的质谱分析各不相同。尽管没有一种技术能满足检测假药和劣药的所有要求，但有机会将这些技术分为特定的细分领域，以解决检测产品工作流程中的特定环节。
