Storflor Janne Guldteig, Pettersen Linn Carina, Slørdal Lars, Spigset Olav
Avdeling for klinisk farmakologi, St. Olavs hospital, Norway.
Tidsskr Nor Laegeforen. 2013 May 7;133(9):955-9. doi: 10.4045/tidsskr.12.1272.
Package inserts should convey important information and promote correct, safe and effective use of medicines. The purpose of this study was to investigate possible differences in the information on package inserts between a selection of generic medicines on the substitution list of the Norwegian Medicines Agency.
We based our investigation on the 25 most commonly used drugs in Norway. Eight of these drugs were excluded since they were not listed or did not have generic equivalents on the substitution list. For the remaining 17 drugs we procured the package inserts for a total of 71 medicines and compared the texts. Differences which we judged to be a possible source of worry or confusion for the patient were included.
There was only one drug for which the package inserts for all the medicines were almost identical. For three other drugs there were consistently few differences. For the remaining 13 drugs (76%) there were cosiderable differences between the package inserts. There were generally fewest differences in the information on indications for use and most in the information on side effects. In many cases medical expressions without further explanation and unclear and vague words and expressions were used.
There are significant differences in the information in package inserts for generic medicines. This may lead to confusion, uncertainty and poorer patient compliance. The treating doctor should inform patients who are prescribed a generic medicine that the information on the package insert may vary, but that the medicines nevertheless have equal therapeutic value.
药品说明书应传达重要信息，并促进药物的正确、安全和有效使用。本研究的目的是调查挪威药品管理局替换清单上一系列仿制药的药品说明书信息可能存在的差异。
我们的调查基于挪威最常用的25种药物。其中8种药物被排除，因为它们未在替换清单上列出或没有仿制药等效品。对于其余17种药物，我们获取了总共71种药品的说明书并比较了文本。我们纳入了那些我们认为可能会让患者担忧或困惑的差异。
只有一种药物的所有药品说明书几乎完全相同。另外三种药物的差异始终很少。对于其余13种药物（76%），药品说明书之间存在相当大的差异。关于用法用量的信息差异通常最少，而关于副作用的信息差异最大。在许多情况下，使用了没有进一步解释的医学表述以及不清楚和模糊的词汇和表述。
仿制药的药品说明书信息存在显著差异。这可能导致困惑、不确定性以及患者依从性较差。主治医生应告知开了仿制药的患者，药品说明书上的信息可能会有所不同，但这些药物仍具有同等的治疗价值。
