Bogaert M
Heymans Instituut-Vakgroep Farmacologie Universiteit Gent.
Verh K Acad Geneeskd Belg. 1997;59(4):227-36.
The task of the authorities with regard to medications starts with formulating the appropriate rules concerning clinical studies, mainly for drugs that are not yet registered, and also includes registration and reimbursement. There is, however, an important task for the authorities with regard to post-marketing activities, e.g. pharmacovigilance and drug use studies, in order to define better the value of a product, with implications for the future fate and reimbursement of a product. The authorities have also an important role in providing information to those who prescribe, deliver or use medications. Also in order to improve prescribing, the prescriber should be aware of his/her prescribing pattern. Ever more emphasis is put upon the "rational use of drugs" (use only drugs for which validated studies exist, use them in an appropriate manner and with consideration for the financial aspects) and upon "Evidence-Based Medicine" and "Evidence-Based Pharmacotherapy". For rational prescribing and use of medications based on evidence, a long term policy is needed and Belgium has in this regard still much to do.
当局在药物方面的任务始于制定有关临床研究的适当规则,主要针对尚未注册的药物,还包括注册和报销。然而,当局在上市后活动方面也有一项重要任务,例如药物警戒和药物使用研究,以便更好地界定产品的价值,这对产品的未来命运和报销有影响。当局在向开药、配药或使用药物的人员提供信息方面也发挥着重要作用。同样为了改善开药情况,开处方者应了解自己的开药模式。人们越来越强调“合理用药”(仅使用有经过验证研究的药物,以适当方式并考虑财务方面使用它们)以及“循证医学”和“循证药物治疗”。为了基于证据合理开药和使用药物,需要一项长期政策,而比利时在这方面仍有很多工作要做。