Department of Assessment and Control on Prescribing and Use of Medicines and Health-Related Products, Iran Food and Drug Administration, Ministry of Health and Medical Education, Tehran, Iran.
Department of Pediatrics, Iran University of Medical Sciences, Tehran, Iran.
Int J Health Policy Manag. 2018 Dec 1;7(12):1090-1096. doi: 10.15171/ijhpm.2018.91.
Medication errors are the second most common cause of adverse patient safety incidents and the single most common preventable cause of adverse events in medical practice. Given the high human fatalities and financial burden of medication errors for healthcare systems worldwide, reducing their occurrence is a global priority. Therefore, appropriate policies to reduce medication errors, using national data and valid statistics are required. The primary objective of this study was to provide a national 'characteristic profile' of medication error-associated adverse drug reactions (ADRs), which are also known as preventable ADRs (pADRs). A retrospective study of pADR reports submitted to the national pharmacovigilance center (PCV) within Iran's Food and Drug Administration was conducted over a 2-year period (2015-2017). Preventability Method (P-Method), which is a standardized tool developed and recommended by the World Health Organization (WHO), was used for preventability assessment. The results of the analyses revealed that while the number of pADRs increased from year one to two (601 to 630), their proportion out of all ADRs per year decreased (7.32% to 6.44%). The percentage of pADRs was higher in females (61.01%) and adults (83.27%), and the highest number of reports were received by nurses (71.57%). Having 'a documented hypersensitivity to an administered drug or drug class' was the most common preventable factor in both years (61.23% and 54.29% respectively), and 'anti-infectives used systemically' were the medication class which primarily contributed to both serious (53.29%) and non-serious pADRs (39.19%). The specific characteristics of medication errors associated with ADRs from this study, especially the preventable criteria which led to their occurrence, can help devise more specific preventative policies.
药物错误是导致不良患者安全事件的第二大常见原因，也是医疗实践中可预防的单一最常见不良事件的原因。鉴于药物错误对全球医疗保健系统造成的高人员死亡率和财务负担，减少其发生是当务之急。因此，需要利用国家数据和有效统计数据制定适当的政策来减少药物错误。本研究的主要目的是提供与药物错误相关的药物不良反应（ADR）的国家“特征概况”，这些 ADR 也称为可预防的 ADR（pADR）。对在伊朗食品和药物管理局国家药物警戒中心（PCV）提交的为期两年（2015-2017 年）的 pADR 报告进行了回顾性研究。采用世界卫生组织（WHO）开发并推荐的标准化工具——预防方法（P-Method）进行预防评估。分析结果表明，虽然 pADR 的数量从第一年增加到第二年（从 601 例增加到 630 例），但它们每年占所有 ADR 的比例却下降（从 7.32%降至 6.44%）。女性（61.01%）和成年人（83.27%）中 pADR 的比例更高，护士收到的报告最多（71.57%）。在这两年中，“对给予的药物或药物类别有记录的过敏反应”是最常见的预防因素（分别为 61.23%和 54.29%），“全身性使用的抗感染药物”是导致严重（53.29%）和非严重 pADR（39.19%）的主要药物类别。本研究中与 ADR 相关的药物错误的具体特征，特别是导致其发生的可预防标准，可帮助制定更具体的预防政策。
