同一药物的不同适应证、警示和注意事项及禁忌证——常用精神科药物说明书的国际比较。
Different indications, warnings and precautions, and contraindications for the same drug--an international comparison of prescribing information for commonly used psychiatric drugs.
机构信息
Institute of Experimental and Clinical Pharmacology and Toxicology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
出版信息
Pharmacoepidemiol Drug Saf. 2013 Mar;22(3):329-33. doi: 10.1002/pds.3389. Epub 2012 Dec 26.
PURPOSE
We aim to derive an internationally applicable data set to improve prescription safety of psychiatric drugs.
METHODS
We performed an in-depth analysis of the concordance of prescribing information of 10 key psychiatric drugs across four major drug markets with regard to indications, warnings and precautions, and contraindications.
RESULTS
The individual prescribing information covered on average 71.4 ± 30.3% of all named indications, 59.5 ± 17.1% of all potential warnings and precautions and 70.1 ± 24.4% of all applicable contraindications.
CONCLUSION
This substantial variation in key prescribing information across countries highlights the need for a better international cooperation and standardization of prescribing information.
目的
我们旨在制定一套适用于国际的数据集，以提高精神药物处方的安全性。
方法
我们深入分析了四大主要药物市场上 10 种关键精神药物的说明书，比较了适应证、警告和注意事项以及禁忌证的一致性。
结果
平均而言，每种药物的说明书涵盖了所有适应证的 71.4±30.3%、所有潜在警告和注意事项的 59.5±17.1%以及所有适用禁忌证的 70.1±24.4%。
结论
不同国家之间关键说明书信息存在显著差异，这凸显出需要更好的国际合作和说明书信息标准化。
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