Department of Pharmacy Practice, Faculty of Pharmacy, Kuwait University, Kuwait City, Kuwait.
Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, LL57 2PZ, UK.
Eur J Clin Pharmacol. 2021 Feb;77(2):251-260. doi: 10.1007/s00228-020-03003-x. Epub 2020 Sep 29.
Medicines regulatory authorities advise that patient information leaflets (PILs) should provide specific advice on what actions to take if one or more doses are missed. We aimed to assess the content in this regard, of PILs and Summaries of Product Characteristics (SmPCs) of prescription only medicines (POMs) marketed in the UK.
PILs and SmPCs were accessed via the electronic Medicines Compendium. The following terms were used in the advanced search facility: miss(ed), omit(ted), adhere(d), delay(ed), forgot, forget, lapse. Identified documents were screened for instructions on missed doses which were categorised according to level of specificity, and cross-referenced to the National Patient Safety Agency (NPSA) grading of risk of harm from omitted and delayed medicines. Any supporting clinical or pharmacological evidence was identified from SmPCs.
Two thousand two hundred eighty-four documents were identified from 7248 PILs and SmPCs relating to 1501 POMs. Seven hundred eighty-three (52%) POMs had SmPCs or PILs with no instructions on missed doses; 487 POMs (32%) included non-specific advice (e.g. "take as soon as possible"); 138 (9%) provided specific instructions; and 93 (6%) referred patients to seek medical advice. SmPCs for only 13/138 (9%) of those which included specific instructions provided any supporting clinical or pharmacological evidence. Instructions were absent for several medicines where the NPSA assessed that dose omissions may result in significant risk of harm.
Advice on missed doses is generally inadequate. Pharmaceutical companies and regulatory authorities should produce clear and concise instructions on what patients should do if they miss doses, with supporting evidence where necessary.
药品监管机构建议，患者用药指南（PIL）应就漏服一剂或多剂药物时应采取的措施提供具体建议。我们旨在评估在这方面，英国市场上的处方药物（POM）的 PIL 和产品说明书（SmPC）的内容。
通过电子药品综合数据库访问 PIL 和 SmPC。在高级搜索功能中使用了以下术语：miss(ed)、omit(ted)、adhere(d)、delay(ed)、forgot、forget、lapse。筛选出关于漏服剂量的指示文件，并根据具体程度进行分类，并与国家患者安全局（NPSA）对漏服和延迟药物的危害风险分级进行交叉参考。从 SmPC 中确定任何支持临床或药理学证据。
从 7248 份 PIL 和 SmPC 中确定了 2284 份文件，涉及 1501 种 POM。783 种（52%）POM 的 SmPC 或 PIL 中没有关于漏服剂量的说明；487 种（32%）包括非特定建议（例如“尽快服用”）；138 种（9%）提供了具体说明；93 种（6%）建议患者寻求医疗建议。在包括具体说明的 138 种药物中，只有 13 种（9%）的 SmPC 提供了任何支持临床或药理学证据。对于一些 NPSA 评估漏服剂量可能导致严重危害风险的药物，没有提供剂量说明。
关于漏服剂量的建议通常是不充分的。制药公司和监管机构应就患者漏服剂量时应采取的措施制定明确和简明的说明，并在必要时提供支持证据。
