School of Medicine, Trinity College, Dublin, Ireland.
Pharmacoepidemiol Drug Saf. 2011 Sep;20(9):979-86. doi: 10.1002/pds.2199. Epub 2011 Jul 19.
To examine the impact of safety warnings issued between 2005 and 2007 by the Irish Medicines Board (IMB) on the rate of prescribing of clopidogrel, co-amoxiclav, celecoxib and haloperidol by primary care physicians in the General Medical Services (GMS) scheme across Ireland.
This study was performed using the Irish Health Service Executive-Primary Care Reimbursement Services national prescribing database. Rate of prescribing per 1000 GMS population was calculated for each of the 12 months before and after the IMB warnings were issued to physicians. A segmented regression analysis was used to examine the change in level and trend in prescribing rates before and after the IMB warnings. Regression coefficients are presented with SEs. Significance at p < 0.05 was assumed. SPSS 16 and SAS were used for statistical analysis.
Prescribing of clopidogrel continued to rise in both genders following the warning. This increase was slightly higher in male patients. The prescribing of co-amoxiclav showed seasonal variation with significant autocorrelation. The rate of prescribing of celecoxib declined approximately 4 months prior to the IMB warning. A significant decrease in the level and trend of the rate of prescribing of celecoxib was observed with evident discontinuity. The IMB warning had no significant effect on the level of trend in the prescribing of haloperidol, suggesting no discontinuity.
Results indicate that the IMB safety warnings had inconsistent effects on the rate of prescribing of drugs considered.
研究 2005 年至 2007 年期间爱尔兰药品管理局（IMB）发布的安全警示对爱尔兰全科医生在通用医疗服务（GMS）计划中氯吡格雷、复方阿莫西林克拉维酸钾、塞来昔布和氟哌啶醇开方率的影响。
本研究使用了爱尔兰卫生服务执行局-初级保健报销服务国家处方数据库。在向医生发布 IMB 警告之前和之后的 12 个月中，计算了每种药物的每 1000 名 GMS 人群的开方率。使用分段回归分析检查 IMB 警告前后开方率的水平和趋势变化。给出了回归系数及其 SE。假设 p 值<0.05 具有统计学意义。使用 SPSS 16 和 SAS 进行统计分析。
氯吡格雷在警告发布后继续在两性中上升。男性患者的上升幅度略高。复方阿莫西林克拉维酸钾的开方具有季节性变化，具有显著的自相关。塞来昔布的开方率在 IMB 警告前约 4 个月开始下降。在 IMB 警告前，观察到塞来昔布开方率的水平和趋势显著下降，存在明显的不连续。IMB 警告对氟哌啶醇的开方率水平和趋势没有显著影响，表明没有不连续性。
结果表明，IMB 安全警示对所考虑药物的开方率产生了不一致的影响。
