Centre for Primary Care and Mental Health, Institute of Population Health Sciences, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, Yvonne Carter Building, 58 Turner Street, London, E1 2AB, UK.
Clinical Practice Research Datalink, Medicines and Healthcare Products Regulatory Agency, London, UK.
Drug Saf. 2021 Oct;44(10):1033-1040. doi: 10.1007/s40264-021-01093-9. Epub 2021 Jul 22.
The use of primary care databases has been integral in pharmacoepidemiological studies and pharmacovigilance. Primary care databases derive from electronic health records and offer a comprehensive description of aggregate patient data, from demography to medication history, and good sample sizes. Studies using these databases improve our understanding of prescribing characteristics and associated risk factors to facilitate better patient care, but there are limitations. We describe eight key scenarios where study data outcomes can be affected by absent prescriptions in UK primary care databases: (1) out-of-hours, urgent care and acute care prescriptions; (2) specialist-only prescriptions; (3) alternative community prescribing, such as pharmacy, family planning clinic or sexual health clinic medication prescriptions; (4) newly licensed medication prescriptions; (5) medications that do not require prescriptions; (6) hospital inpatient and outpatient prescriptions; (7) handwritten prescriptions; and (8) private pharmacy and private doctor prescriptions. The significance of each scenario is dependent on the type of medication under investigation, nature of the study and expected outcome measures. We recommend that all researchers using primary care databases be aware of the potential for missing prescribing data and be sensitive to how this can vary substantially between items, drug classes, patient groups and over time. Close liaison with practising primary care clinicians in the UK is often essential to ensure awareness of nuances in clinical practice.
在药物流行病学研究和药物警戒中，初级保健数据库的使用是不可或缺的。初级保健数据库源自电子健康记录，提供了综合的患者数据描述，包括人口统计学信息到用药史，以及良好的样本量。使用这些数据库的研究增进了我们对处方特征和相关风险因素的理解，有助于改善患者的护理，但也存在一些局限性。我们描述了英国初级保健数据库中八种可能影响研究数据结果的关键情况：（1）非工作时间、紧急护理和急性护理处方；（2）仅限专科医生开具的处方；（3）替代社区处方，如药房、计划生育诊所或性健康诊所的药物处方；（4）新批准药物的处方；（5）不需要处方的药物；（6）医院住院和门诊处方；（7）手写处方；以及（8）私人药房和私人医生处方。每种情况的重要性取决于所研究药物的类型、研究的性质和预期的结果测量。我们建议所有使用初级保健数据库的研究人员都要意识到处方数据缺失的可能性，并要意识到在不同项目、药物类别、患者群体和时间上，这种情况可能会有很大差异。与英国的执业初级保健临床医生保持密切联系通常对于确保了解临床实践中的细微差别至关重要。
