Quinzler Renate, Bertsche Thilo, Szecsenyi Joachim, Haefeli Walter E
Abteilung Innere Medizin VI, Klinische Pharmakologie und Pharmakoepidemiologie, Universitätsklinikum Heidelberg, Heidelberg, Germany.
Med Klin (Munich). 2008 Aug 15;103(8):569-74. doi: 10.1007/s00063-008-1092-1. Epub 2008 Sep 21.
In Germany, about one fourth of all tablets are split before ingestion. Since April 2007, by German law, pharmacists are legally obligated to substitute a prescribed drug for a generic drug, provided the patients' health insurance company has made corresponding contracts with pharmaceutical companies (discount contracts). However, generic drugs may differ substantially in their splitting properties. Until now it is unknown how generic substitutions due to discount contracts will influence the prescribing quality with regard to tablet splitting.
The prescription data of 425 ambulatory patients with polymedication insured at the Allgemeine Ortskrankenkasse (AOK) were analyzed and their drugs switched according to current discount contracts.
Altogether 24% of all tablets were split before ingestion. For 54% of these split tablets (182 of 335) existing discount contracts mandated generic substitution. In about 10% of the substitutions there was a chance of substituting a scored tablet for a dosage form not suitable for splitting (unscored tablet or capsule).
Therefore, current legislation should not only aim at reducing medication cost but also safeguard both effectiveness of the drugs and handling by the patients.
在德国,约四分之一的片剂在服用前会被掰开。自2007年4月起,根据德国法律,若患者的健康保险公司已与制药公司签订相应合同(折扣合同),药剂师有法律义务用仿制药替代处方药。然而,仿制药在掰开特性上可能存在显著差异。到目前为止,尚不清楚因折扣合同进行的仿制药替代会如何影响片剂掰开方面的处方质量。
分析了425名在Allgemeine Ortskrankenkasse(AOK)参保的多药联用门诊患者的处方数据,并根据当前折扣合同更换了他们的药物。
总计24%的片剂在服用前被掰开。在这些掰开的片剂中,54%(335片中的182片)现有折扣合同要求进行仿制药替代。在约10%的替代情况中,存在用有刻痕片剂替代不适合掰开的剂型(无刻痕片剂或胶囊)的可能性。
因此,现行立法不仅应旨在降低用药成本,还应保障药物的有效性和患者的使用便利性。