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德国精神药物药品说明书的正确性不足。

Insufficient correctness of package inserts for psychotropic drugs in Germany.

作者信息

Arning Adina, Seifert Roland

机构信息

Institute of Pharmacology, Hannover Medical School, Carl-Neuberg-Straße 1, 30625, Hannover, Germany.

出版信息

Naunyn Schmiedebergs Arch Pharmacol. 2025 Mar;398(3):2879-2895. doi: 10.1007/s00210-024-03430-y. Epub 2024 Sep 20.

DOI:10.1007/s00210-024-03430-y
PMID:39302419
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11919942/
Abstract

Package inserts often cause displeasure among patients as they are perceived as misleading and confusing. The aim of this study was to find out how comprehensible, complete, and truthful package inserts are formulated in Germany. 311 package inserts for antipsychotics (mGPCR antagonists) and antidepressants (NE/5-HT enhancers) from different manufacturers and dosages were analysed. The analysis criteria included the description of the effect, the warning of increased suicide risk, the explanation of interactions with co-medication, food and stimulants, as well as alcohol and the warning of impaired roadworthiness. In addition, the timeliness of the information regarding pregnancy and breastfeeding was checked and the symptoms mentioned under the topic of discontinuation symptoms and adverse drug reactions were compared. For most parameters, inconsistencies among various products, deficiencies and incorrect information were noted. This was particularly true for the items pregnancy and breastfeeding. Thus, package inserts for mGPCR antagonists and NE/5-HT enhancers need to be updated and standardised urgently. Such measures will reduce confusion among patients and increase drug adherence.

摘要

药品说明书常常让患者感到不满，因为它们被认为具有误导性且令人困惑。本研究的目的是了解德国的药品说明书在表述上的易懂性、完整性和真实性如何。对来自不同制造商和不同剂量的311份抗精神病药（mGPCR拮抗剂）和抗抑郁药（NE/5-HT增强剂）的药品说明书进行了分析。分析标准包括疗效描述、自杀风险增加的警示、与合并用药、食物、兴奋剂以及酒精相互作用的解释，以及对车辆驾驶能力受损的警示。此外，还检查了有关怀孕和母乳喂养信息的及时性，并比较了在停药症状和药物不良反应主题下提及的症状。对于大多数参数，注意到各种产品之间存在不一致、缺陷和错误信息。在怀孕和母乳喂养这两项内容上尤其如此。因此，mGPCR拮抗剂和NE/5-HT增强剂的药品说明书急需更新和标准化。此类措施将减少患者的困惑并提高药物依从性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3fb/11919942/7c900a7e550d/210_2024_3430_Fig12_HTML.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3fb/11919942/7c900a7e550d/210_2024_3430_Fig12_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3fb/11919942/56a4176bbcec/210_2024_3430_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3fb/11919942/a3d52aa2de63/210_2024_3430_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3fb/11919942/277851b9bc83/210_2024_3430_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3fb/11919942/fc1e8bf18e94/210_2024_3430_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3fb/11919942/b549cc19c0f6/210_2024_3430_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3fb/11919942/5c76a0470bff/210_2024_3430_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3fb/11919942/dd251094fc59/210_2024_3430_Fig7_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3fb/11919942/5039f0e6c722/210_2024_3430_Fig8_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3fb/11919942/f174db0ad47b/210_2024_3430_Fig9_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3fb/11919942/99690d838b41/210_2024_3430_Fig10_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3fb/11919942/4aba02e71944/210_2024_3430_Fig11_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3fb/11919942/7c900a7e550d/210_2024_3430_Fig12_HTML.jpg

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