Fernandez-Llimos Fernando, Vazquez Gomez Isabel
Department of Social Pharmacy, Faculty of Pharmacy, University of Lisbon, Lisbon, 1649-003, Portugal.
Pharm World Sci. 2007 Dec;29(6):683-7. doi: 10.1007/s11096-007-9129-8. Epub 2007 Apr 27.
To assess the medical information provided by manufacturers in response to a specific request, and to compare the responses between generic and brand-name companies.
Community pharmacy in Spain.
A systematic request for product monographs was made between 1999 and 2002 to manufacturers registering new medicines in Spain. A standardised letter was sent to the medical affairs departments. If there was no reply after 3 months, a second standardised letter was sent requesting the monograph. Blood derivatives, intravenous medicines, and radiological contrast agents were excluded.
The delay that occurred in receiving information and the type of material sent in response to the request was compared between the two types of companies.
About of 833 medicines from 185 manufacturers were registered during the time period studied. After applying exclusion criteria, 805 medicines, including 419 (52.0%) generic and 386 (48.0%) brand-name products, were analyzed. No replies were received for 242 (30.0%) requests 183 (43.7%) generics and 59 (15.3%) brand-names; P < 0.005). We received 369 (65.5% of 533) replies after the first request: 140 of 236 (59.3%) generics and 229 of 327 (70.0%) brand-names (P = 0.009). The average response delay was 9.7 days [CI95%: 8.65-10.68]. There was a statistically significant difference between generic and brand-name companies after the first request (P = 0.001), but not after the second request (P = 0.312).
Brand-name manufacturers reply more often, more quickly, and with better quality information than generic manufacturers.
评估制造商针对特定请求提供的医学信息，并比较仿制药公司和品牌药公司的回复情况。
西班牙的社区药房。
在1999年至2002年期间，向在西班牙注册新药的制造商系统地索要产品说明书。向医学事务部门发送了一封标准化信函。如果3个月后没有收到回复，则发送第二封标准化信函索要说明书。血液衍生物、静脉用药和放射造影剂被排除在外。
比较两类公司在接收信息方面出现的延迟以及针对请求所发送材料的类型。
在研究期间，185家制造商的约833种药品进行了注册。应用排除标准后，分析了805种药品，其中包括419种（52.0%）仿制药和386种（48.0%）品牌药。242项（30.0%）请求未收到回复，其中183项（43.7%）为仿制药，59项（15.3%）为品牌药；P<0.005）。首次请求后收到369份（533份中的65.5%）回复：236份仿制药中的140份（59.3%）和327份品牌药中的229份（70.0%）（P = 0.009）。平均回复延迟为9.7天[CI95%：8.65-10.68]。首次请求后，仿制药公司和品牌药公司之间存在统计学显著差异（P = 0.001），但第二次请求后没有差异（P = 0.312）。
与仿制药制造商相比，品牌药制造商回复更频繁、更迅速，且提供的信息质量更高。
