Division of Practice Advancement and Clinical Education, UNC Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, North Carolina.
Department of Maternal and Child Health, UNC Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina.
Am J Trop Med Hyg. 2022 Jul 13;107(1):14-20. doi: 10.4269/ajtmh.21-1133.
Substandard and falsified medicines are harmful to patients, causing prolonged illness, side effects, and preventable deaths. Moreover, they have an impact on the health system and society more broadly by leading to additional care, higher disease burden, productivity losses and loss of trust in health care. Models that estimate the health and economic impacts of substandard and falsified medicines can be useful for regulators to contextualize the problem and to make an economic case for solutions. Yet these models have not been systematically catalogued to date. We reviewed existing models that estimate the health and economic impact of substandard and falsified medicines to describe the varying modeling approaches and gaps in knowledge. We compared model characteristics, data sources, assumptions, and limitations. Seven models were identified. The models assessed the impact of antimalarial (n = 5) or antibiotic (n = 2) quality at a national (n = 4), regional (n = 2), or global (n = 1) level. Most models conducted uncertainty analysis and provided ranges around potential outcomes. We found that models are lacking for other medicines, few countries' data have been analyzed, and capturing population heterogeneity remains a challenge. Providing the best estimates of the impact of substandard and falsified medicines on a level that is actionable for decision-makers is important. To enable this, research on the impact of substandard and falsified medicines should be expanded to more medicine types and classes and tailored to more countries that are affected, with greater specificity.
劣药和假药对患者有害，导致病情延长、副作用和可预防的死亡。此外，它们通过导致额外的护理、更高的疾病负担、生产力损失和对医疗保健的信任丧失，对更广泛的卫生系统和社会产生影响。用于估计劣药和假药对健康和经济影响的模型可以帮助监管机构了解问题的背景，并为解决方案提供经济依据。然而，迄今为止，这些模型尚未被系统地编目。我们回顾了现有的用于估计劣药和假药对健康和经济影响的模型，以描述不同的建模方法和知识差距。我们比较了模型特征、数据源、假设和局限性。确定了七个模型。这些模型评估了国家（n=5）、地区（n=2）或全球（n=1）层面上抗疟药（n=5）或抗生素（n=2）质量的影响。大多数模型进行了不确定性分析，并提供了潜在结果的范围。我们发现，其他药物的模型缺乏，很少有国家的数据进行了分析，并且捕捉人口异质性仍然是一个挑战。提供劣药和假药对决策者可操作层面的影响的最佳估计非常重要。为此，应该扩大对劣药和假药影响的研究，涵盖更多的药物类型和类别，并针对更多受影响的国家进行定制，以提高针对性。
