Best Practice Advocacy Centre, Dunedin, New Zealand.
Drug Saf. 2012 Sep 1;35(9):733-43. doi: 10.1007/BF03261970.
Examination of clinical data routinely recorded in general practice provides significant opportunities for identifying and quantifying medicine-related adverse events not captured by spontaneous adverse reaction reporting systems. Robust pharmacovigilance methods for detecting and monitoring adverse events due to treatment with new and existing medicines are required to estimate the true extent of adverse events experienced by primary care patients.
The aim of the study was to examine evidence of adverse events contained in general practice electronic records and to study observed events related to selective serotonin reuptake inhibitors (SSRIs) as an example of drug-specific pharmaceutical surveillance achievable with these data.
Electronic clinical records for a cohort of 338 931 patients consulting from 2002 to 2007 were extracted from the patient management systems of 30 primary care clinics in New Zealand. Medical warnings files, prescription records and free text consultation notes were used to identify physician-recorded treatment cautions, including adverse events and medicines they were associated with. A structured chronological analysis of prescriptions, consultation notes and adverse events relating to patients prescribed the SSRI citalopram was undertaken, and included investigating reasons for switching treatment to another SSRI (fluoxetine or paroxetine) as a method for detecting evidence of drug safety signals. We compared the number of adverse events identified for patients at one practice with the number spontaneously reported to New Zealand's Centre for Adverse Reactions Monitoring (CARM).
During the 6-year study period, 173 478 patients received 4 811 561 prescriptions. There were 37 397 allergies, adverse events and other warnings recorded for 24 994 patients (7.4%); adverse events relating to 65 different types of drug were reported. Medicines most frequently implicated in adverse event reports were antibacterials, analgesics, antihypertensive medicines, lipid-modifying agents and skin preparations. Citalopram was prescribed for 5612 patients, and 701 adverse events relating to citalopram were identified in the electronic health records of 473 (8.4%) patients. A total of 713 (12.7%) patients changed treatment from citalopram to another SSRI, and 164 reasons for the switch were identified: suspected adverse drug effects for 129 (78.7%), lack of effect for 29 (17.7%) and patient preference for 6 (3.7%). The most common adverse events preceding the switch were anxiety, nausea and headaches. Of the 725 adverse events and medical warnings recorded at one practice, 21 (2.9%) were spontaneously reported to the CARM.
Routinely recorded general practice data provide a wealth of opportunities for monitoring drug safety signals and for other patient safety issues. Medical warning records and consultation notes contain a wealth of information on adverse events but structured search methodologies are often required to identify these.
对常规记录在全科医疗中的临床数据进行检查，为识别和量化自发不良反应报告系统未捕获的与药物相关的不良事件提供了重要机会。为了估计初级保健患者实际经历的不良事件的真实程度，需要稳健的药物警戒方法来检测和监测新的和现有的药物治疗引起的不良事件。
本研究旨在检查全科医疗电子记录中包含的不良事件证据，并以选择性 5-羟色胺再摄取抑制剂（SSRIs）的观察到的事件为例，研究使用这些数据实现的特定药物的药物警戒。
从新西兰 30 家初级保健诊所的患者管理系统中提取了 338931 名患者 2002 年至 2007 年就诊的电子临床记录。使用医疗警告文件、处方记录和自由文本咨询记录来识别医生记录的治疗警告，包括与药物相关的不良事件和药物。对开处西酞普兰的患者的处方、咨询记录和不良事件进行了结构化的时间顺序分析，并包括了因药物安全信号而将治疗方案切换到另一种 SSRI（氟西汀或帕罗西汀）的原因调查。我们比较了一家诊所识别的患者不良事件数量与向新西兰不良反应监测中心（CARM）自发报告的数量。
在 6 年的研究期间，有 173478 名患者接受了 4811561 次处方。为 24994 名（7.4%）患者记录了 37397 例过敏、不良事件和其他警告；报告了 65 种不同类型药物的不良事件。药物不良事件报告中最常涉及的药物是抗菌药物、镇痛药、抗高血压药物、调脂药和皮肤制剂。西酞普兰共处方给 5612 名患者，在 473 名（8.4%）患者的电子健康记录中发现了 701 例与西酞普兰相关的不良事件。共有 713 名（12.7%）患者将治疗方案从西酞普兰改为另一种 SSRI，确定了 164 个换药原因：怀疑药物不良反应 129 例（78.7%）、无效果 29 例（17.7%）和患者偏好 6 例（3.7%）。换药前最常见的不良事件是焦虑、恶心和头痛。在一家诊所记录的 725 例不良事件和医疗警告中，有 21 例（2.9%）自发向 CARM 报告。
常规记录的全科医疗数据为监测药物安全信号和其他患者安全问题提供了丰富的机会。医疗警告记录和咨询记录包含大量不良事件信息，但通常需要结构化的搜索方法来识别这些信息。
