Unger Marcus M, Reese Jens P, Oertel Wolfgang H, Eggert Karla M
Department of Neurology, Philipps Universitat Marburg, and Competence Network Parkinson Syndrome, Marburg, Germany.
Eur Neurol. 2008;60(3):122-6. doi: 10.1159/000144081. Epub 2008 Jul 14.
BACKGROUND/AIMS: In 1998, the European Medicines Agency suspended the approval for tolcapone in Parkinson's disease (PD) with motor complications due to the drug's implication in fulminant liver failure and the consequent death of 3 patients. Clinical data obtained by ongoing use of tolcapone in other countries proved that adequate safety can be achieved if liver enzymes are strictly monitored. In 2005, tolcapone was relaunched in the European Union under the prerequisite of biweekly liver enzyme monitoring. The objective of this study was to evaluate the compliance with mandatory drug safety monitoring under real-life conditions.
Twenty-one Parkinson's disease patients receiving tolcapone were analyzed with regard to their compliance in performing and reporting the required laboratory tests.
Tolcapone was effective and well tolerated. Yet, less than 25% of the patients regularly performed and reported the required laboratory tests and the compliance declined when comparing the first and second half-years of therapy.
Our data shed light on the incongruity between requirements of postmarketing drug surveillance and every-day reality. The depicted noncompliance is most likely a general problem in postmarketing drug surveillance with an impact for physicians, manufacturers and legal authorities. Practical, legal and ethical aspects will be discussed.
背景/目的：1998年，欧洲药品管理局暂停了托卡朋用于治疗伴有运动并发症的帕金森病（PD）的批准，原因是该药物与暴发性肝衰竭有关，并有3名患者因此死亡。其他国家持续使用托卡朋获得的临床数据证明，如果严格监测肝酶，可实现足够的安全性。2005年，托卡朋在欧盟重新上市，前提是每两周监测一次肝酶。本研究的目的是评估在实际生活条件下对强制性药物安全监测的依从性。
分析了21例接受托卡朋治疗的帕金森病患者在进行和报告所需实验室检查方面的依从性。
托卡朋有效且耐受性良好。然而，定期进行并报告所需实验室检查的患者不到25%，并且在比较治疗的前半年和后半年时，依从性有所下降。
我们的数据揭示了上市后药物监测要求与日常实际情况之间的不一致。所描述的不依从很可能是上市后药物监测中的一个普遍问题，对医生、制造商和法律当局都有影响。将讨论实际、法律和伦理方面的问题。
