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首页> 外文期刊>Pharmacoepidemiology and drug safety >Pharmacovigilance of over-the-counter products based in community pharmacy: methodological issues from pilot work conducted in Hampshire and Grampian, UK.
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Pharmacovigilance of over-the-counter products based in community pharmacy: methodological issues from pilot work conducted in Hampshire and Grampian, UK.

机译：基于社区药房的非处方产品的药物警戒：在英国汉普郡和格兰屏进行的试点工作中的方法学问题。

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PURPOSE: The incidence of serious adverse events from non-prescription medicines remains to be established. The aim of this initial pilot work, using an observational cohort design, was to determine the feasibility of conducting a pharmacovigilance study of a non-prescription medicine, based in community pharmacies. METHOD: Community pharmacists from Grampian, Scotland, and Hampshire, England, recruited user-purchasers of ibuprofen. Exposure data were collected from a series of self-completed questionnaires. Outcome data were any new symptoms, use of concomitant medication and subsequent health-care utilization. RESULTS: A total of 1021 eligible customers were recruited, 6.4% (466/7320) and 48.2% (555/1152) by the Hampshire and Grampian networks respectively. The cohorts differed with regard to age, smoking and socio-economic status, reason for purchase and recommendation, and duration of use. The two cohorts reported different use of concomitant medication (46.0 and 65.5%), asthma (7.2 and 10.5%), stomach/peptic ulcer (3.5 and 2.1%), a higher prevalence of gastrointestinal symptoms post-compared to pre-purchase (12.9 vs. 7.2%, p = 0.0006 and 8.8 vs. 5.8%, p = 0.034), ingestion of doses in excess of the licensed non-prescription dose by 5.1 and 3.9%, and discontinuation of treatment because the medicine upset them by 4.5 and 3.1%, respectively. Most participants did not seek medical advice for their symptoms. CONCLUSION: Greater vigilance is required for adverse events that may be attributable to non-prescription product use. Development of pharmacovigilance models using community pharmacies is one means of systematically collecting information regarding drug safety. Further work is needed to identify a method which maximizes patient recruitment whilst maintaining acceptable follow-up rates.
机译：目的：非处方药引起的严重不良事件的发生率尚待确定。这项初步试验工作的目的是使用观察性队列设计，以确定在社区药房进行非处方药的药物警戒研究的可行性。方法：来自苏格兰格兰屏和英格兰汉普郡的社区药剂师招募了布洛芬的用户购买者。暴露数据是从一系列自我完成的问卷中收集的。结果数据是任何新的症状，同时使用药物以及随后的医疗保健利用。结果：Hampshire和Grampian网络分别招募了1021名合格客户，分别为6.4％（466/7320）和48.2％（555/1152）。在年龄，吸烟和社会经济状况，购买和推荐理由以及使用时间方面，这些人群有所不同。这两个队列报告了不同的并用药物使用（46.0和65.5％），哮喘（7.2和10.5％），胃/消化性溃疡（3.5和2.1％），与购买后相比胃肠道症状的患病率更高（12.9）对比7.2％，p = 0.0006和8.8与5.8％，p = 0.034），超出许可的非处方剂量的摄入量分别为5.1和3.9％，并且由于药物使它们不适用于4.5和3.9而停止治疗分别为3.1％。大多数参与者并未就其症状寻求医疗建议。结论：对于可能归因于非处方药使用的不良事件，需要提高警惕。使用社区药房开发药物警戒模型是系统地收集有关药物安全性信息的一种方法。需要进一步的工作来确定一种在保持可接受的随访率的同时最大程度地招募患者的方法。

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