Sinclair H K, Bond C M, Hannaford P C
Department of General Practice and Primary Care, University of Aberdeen, Scotland, UK.
Pharmacoepidemiol Drug Saf. 1999 Dec;8(7):479-91. doi: 10.1002/(SICI)1099-1557(199912)8:7<479::AID-PDS462>3.0.CO;2-B.
With the increasing range of potent medicines available for sale 'over-the-counter' (OTC) in community pharmacies, this feasibility study set out to develop and validate a method for the pharmacovigilance of OTC medicine, using ibuprofen as a model.
A trained network of community pharmacies (n=61) in Grampian, Scotland, tested different methods for recruiting people buying ibuprofen for their own use (pilot 1) and then used the 'best' method to test two methods of follow-up (pilot 2).
Recruitment rates-method 1 (pharmacy staff inserted the patient information sheet and recruitment questionnaire in the shop bag of eligible subjects): 18% (41/227) of questionnaires issued; method 2 (staff explained the study and asked eligible subjects to complete the questionnaire outwith the pharmacy): 31% (61/194); method 3 (staff explained the study and asked eligible subjects to complete the questionnaire in the pharmacy): 52% (100/192). A further 200 subjects were recruited in pilot 2. The majority of recruits (n=402) were female (75%), mean age 43 years (range 18-84 years), 73% drank alcohol, 72% were non-smokers, and 56% were in the two most affluent socio-economic categories. There was a strong association between the drug dose data collected prospectively and that collected retrospectively. The average response to postal follow-up was 80% (315/392) at 1 week and 79% (308/390) at 2 months.
The study has confirmed the support of pharmacy personnel in undertaking research and indicated the feasibility of a major pharmacovigilance project of OTC medicines.
随着社区药房中可“非处方”（OTC）销售的强效药物种类不断增加，本可行性研究旨在开发并验证一种以布洛芬为模型的非处方药药物警戒方法。
在苏格兰格兰扁地区，一个由61家经过培训的社区药房组成的网络，测试了招募购买自用布洛芬人群的不同方法（试点1），然后使用“最佳”方法测试了两种随访方法（试点2）。
招募率——方法1（药房工作人员将患者信息表和招募问卷放入符合条件受试者的购物袋中）：发放问卷的18%（41/227）；方法2（工作人员解释研究内容并要求符合条件的受试者在药房外完成问卷）：31%（61/194）；方法3（工作人员解释研究内容并要求符合条件的受试者在药房内完成问卷）：52%（100/192）。在试点2中又招募了200名受试者。大多数招募对象（n = 402）为女性（75%），平均年龄43岁（范围18 - 84岁），73%饮酒，72%不吸烟，56%属于两个最富裕的社会经济类别。前瞻性收集的药物剂量数据与回顾性收集的数据之间存在很强的关联。邮政随访的平均回复率在1周时为80%（315/392），在2个月时为79%（308/390）。
该研究证实了药房人员对开展研究的支持，并表明了一项非处方药重大药物警戒项目的可行性。
