Leroy B, Uhart M, Lajoinie A, Maire P, Ducher M, Bourguignon L
Service pharmaceutique, hôpital Antoine-Charial, groupement hospitalier de gériatrie, hospices civils de Lyon, 40, avenue de la Table-de-Pierre, 69340 Francheville, France.
Ann Pharm Fr. 2012 Nov;70(6):348-52. doi: 10.1016/j.pharma.2012.06.001. Epub 2012 Jul 25.
Visits from pharmaceutical representatives are controlled in France by regulations, but also by a Charter of good practice. The goal of this study was to measure compliance to the conditions of this charter by participating pharmaceutical companies.
An assessment grid was drafted to determine compliance to interdictions and obligations concerning the information provided during visits from pharmaceutical representatives.
We studied 20 visits from pharmaceutical representatives. All of the documents and obligatory information were only provided in 5% of cases. During 80% of these meetings, the pharmaceutical representatives made a comparison with competitor's drugs, which was associated with negative remarks in 44% of cases. The pharmaceutical representatives promoted cases of use outside those, which had received marketing approval in 35%. Gifts or samples were offered at the end of these meetings in 20% of cases. Prohibited practices were observed in a total of 85% of cases.
This study shows that meetings are respected by pharmaceutical representatives in terms of regulations related to donations. In opposite, there is a very low compliance concerning the proper use of the drug, whether to provide official documentation, to give information respectful of other pharmaceutical companies or to promote the proper use.
Our results suggest that, at present hospital visits by pharmaceutical representatives do not respect the commitments made by the pharmaceutical industry, and do not make it possible to ensure that honest information is provided to favor the proper use of drugs.
在法国,医药代表的拜访受到法规以及一份良好行为准则的管控。本研究的目的是衡量参与研究的制药公司对该准则条件的遵守情况。
起草了一份评估表,以确定对医药代表拜访期间所提供信息的禁令和义务的遵守情况。
我们研究了20次医药代表的拜访。所有文件和必备信息仅在5%的案例中提供。在这些会面的80%中,医药代表对竞争对手的药物进行了比较,其中44%的案例伴有负面评价。医药代表在35%的案例中推广了未获上市批准的用药案例。在20%的案例中,这些会面结束时提供了礼品或样品。总共85%的案例中观察到了被禁止的行为。
本研究表明,医药代表在与捐赠相关的法规方面遵守了会面规定。相反,在药物的合理使用方面,无论是提供官方文件、提供尊重其他制药公司的信息还是推广合理使用,遵守程度都非常低。
我们的结果表明,目前医药代表的医院拜访并未遵守制药行业做出的承诺,也无法确保提供诚实的信息以促进药物的合理使用。