Literature DB >> 23280570

Different indications, warnings and precautions, and contraindications for the same drug--an international comparison of prescribing information for commonly used psychiatric drugs.

Barbara Pfistermeister1, Christian Schenk, Johannes Kornhuber, Thomas Bürkle, Martin F Fromm, Renke Maas.   

Abstract

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.
Copyright © 2012 John Wiley & Sons, Ltd.

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Year:  2012        PMID: 23280570     DOI: 10.1002/pds.3389

Source DB:  PubMed          Journal:  Pharmacoepidemiol Drug Saf        ISSN: 1053-8569            Impact factor:   2.890


  7 in total

1.  Sources of information used by regulatory agencies on the generation of drug safety alerts.

Authors:  Carlos Alves; Ana Filipa Macedo; Francisco Batel Marques
Journal:  Eur J Clin Pharmacol       Date:  2013-07-27       Impact factor: 2.953

2.  Clinical relevance of information in the Summaries of Product Characteristics for dose adjustment in renal impairment.

Authors:  Teresa M Salgado; Blanca Arguello; Fernando Martinez-Martinez; Shalom I Benrimoj; Fernando Fernandez-Llimos
Journal:  Eur J Clin Pharmacol       Date:  2013-07-25       Impact factor: 2.953

3.  Characteristics and drug use patterns of older antidepressant initiators in Germany.

Authors:  Kathrin Jobski; Niklas Schmedt; Bianca Kollhorst; Jutta Krappweis; Tania Schink; Edeltraut Garbe
Journal:  Eur J Clin Pharmacol       Date:  2016-10-18       Impact factor: 2.953

4.  Assessing the information in the Summaries of Product Characteristics for the use of medicines in pregnancy and lactation.

Authors:  Blanca Arguello; Teresa M Salgado; Fernando Fernandez-Llimos
Journal:  Br J Clin Pharmacol       Date:  2015-03       Impact factor: 4.335

5.  Inconsistencies and Ambiguities in Liver-Disease-Related Contraindications-A Systematic Analysis of SmPCs/PI of Major Drug Markets.

Authors:  Laura Weisbach; Anna K Schuster; Michael Hartmann; Martin F Fromm; Renke Maas; Katrin Farker
Journal:  J Clin Med       Date:  2022-03-30       Impact factor: 4.241

6.  Evaluation of Current Regulation and Guidelines of Pharmacogenomic Drug Labels: Opportunities for Improvements.

Authors:  Rawan Shekhani; Linda Steinacher; Jesse J Swen; Magnus Ingelman-Sundberg
Journal:  Clin Pharmacol Ther       Date:  2019-12-17       Impact factor: 6.875

7.  International Coherence of Pediatric Drug Labeling for Drug Safety: Comparison of Approved Labels in Korea and the United States.

Authors:  Yun-Kyoung Song; Nayoung Han; Gilbert J Burckart; Jung Mi Oh
Journal:  Clin Pharmacol Ther       Date:  2019-11-10       Impact factor: 6.875

  7 in total

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