Sinclair H K, Bond C M, Hannaford P C
Department of General Practice and Primary Care, University of Aberdeen, Scotland.
Drug Saf. 2001;24(12):929-38. doi: 10.2165/00002018-200124120-00006.
Despite the wider availability of medicines to the general public, little is known about their safety when supplied without prescription. Pilot work has already tested 4 methods of recruiting users of ibuprofen purchased from community pharmacies. This paper describes the piloting of a fifth method (a shortened questionnaire), long term follow-up rates of all methods, consistency of reporting of ibuprofen use, and issues relating to possible comparison groups in pharmacovigilance studies.
A shortened version of a previously tested recruitment questionnaire was used. Eligible study participants were all users, aged over 17 years, purchasing ibuprofen from a research network of community pharmacies (n = 61) in Grampian, Scotland. Postal questionnaires were sent at I week and 2, 6 and 12 months irrespective of the method of recruitment. The follow-up questionnaires collected information about ibuprofen and other drug usage, symptoms and associated health service utilisation.
The shortened form recruited 67% of people issued with a questionnaire. The overall 12-month follow-up rate was 67%, although there were important differences in the rates by method of recruitment. There was reasonable consistency in the reporting of use or non-use of ibuprofen at different follow-up times. In the 12 months after the index purchase, 17% of participants never used any ibuprofen (non-users) and 28% used it for more than 8 weeks in total (long term users). At 12 months, long term users were significantly more likely than short term users (< or =8 weeks total use) or non-users to have experienced dizziness, skin rash, itchy skin and wheeziness in the previous week.
Our pilot work has confirmed the feasibility of recruiting, and following-up over prolonged periods, users of nonprescription medicines. Evidence of long term use of ibuprofen confirms the need for pharmacovigilance studies of this drug, although further work is required to identify a suitable comparison group in order to inform the interpretation of such investigations.
尽管药品对普通大众的可及性有所提高，但对于非处方供应药品的安全性却知之甚少。前期试点工作已对从社区药房购买布洛芬的使用者的4种招募方法进行了测试。本文描述了第五种方法（一份简短问卷）的试点情况、所有方法的长期随访率、布洛芬使用报告的一致性以及药物警戒研究中与可能的对照组相关的问题。
使用了先前测试过的招募问卷的简短版本。符合条件的研究参与者为所有年龄在17岁以上、从苏格兰格兰扁地区社区药房研究网络（n = 61）购买布洛芬的使用者。无论招募方法如何，均在第1周以及第2、6和12个月发送邮政问卷。随访问卷收集了有关布洛芬和其他药物使用情况、症状以及相关医疗服务利用情况的信息。
简短问卷形式招募到了67%发放问卷的人群。总体12个月随访率为67%，尽管不同招募方法的随访率存在重要差异。在不同随访时间，布洛芬使用或未使用情况的报告具有合理的一致性。在首次购买后的12个月内，17%的参与者从未使用过任何布洛芬（非使用者），28%的参与者总共使用超过8周（长期使用者）。在12个月时，长期使用者比短期使用者（总共使用≤8周）或非使用者在过去一周出现头晕、皮疹、皮肤瘙痒和喘息的可能性显著更高。
我们的试点工作证实了招募非处方药品使用者并进行长期随访的可行性。布洛芬长期使用的证据证实了对此类药物进行药物警戒研究的必要性，尽管还需要进一步开展工作以确定合适的对照组，以便为这类调查结果的解读提供依据。
