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

Pharmacoepidemiol Drug Saf. 2013 Mar;22(3):329-33. doi: 10.1002/pds.3389. Epub 2012 Dec 26.

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.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Consensus
  • Contraindications
  • Cooperative Behavior
  • Drug Labeling* / standards
  • Drug Utilization
  • Europe
  • Guideline Adherence
  • Humans
  • International Cooperation
  • Patient Safety
  • Pharmacoepidemiology
  • Practice Guidelines as Topic
  • Practice Patterns, Physicians'* / standards
  • Psychotropic Drugs / adverse effects*
  • Risk Assessment
  • Risk Factors
  • United States

Substances

  • Psychotropic Drugs