From pharmacovigilance to pharmacovigilance planning - The system building for safe medication

Hui Po Wang, Chun Li Wang, Wan Neng Yu, Shu Hui Hsu, Yu Wen Huang, Yu Ling Lin, Yen Lih Leu, Chin Yi Lee

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

The concept of pharmacovigilance planning (PVP) was initiated by the International Conference on Harmonization (ICH) in 2004 and followed by the publication of Topic ICH E2E Guideline. However, the implementation of PVP in societies like Taiwan where irrational medication or co-medication of conventional medicine with complementary/alternative medicine (CAM) is prevalent, became a challenge. This report aimed to (1) introduce the concept of PVP and the importance of evidence-based justification of medicinal products for risk prevention and minimization, (2) summarize the scientific evidence regarding the sites and mechanisms of drug-drug or drug-CAM interactions along the biological processing of xenobiotics and identify potential risks in relation to co-medication of conventional medicine with CAM by reviewing literatures, (3) employ public information to analyze potential risk underlying irrational medication of registered medicine, registered traditional Chinese medicine (TCM) and un-registered CAM in Taiwan, and (4) address the importance of conceptual change from individual product-oriented pharmacovigilance to a proactive system-based risk management of pharmacovigilance planning.

Original languageEnglish
Pages (from-to)377-386
Number of pages10
JournalJournal of Food and Drug Analysis
Volume15
Issue number4
Publication statusPublished - Dec 2007

Keywords

  • Co-medication
  • Complementary/alternativemedicine (CAM)
  • Conventional medicine
  • Medication risk
  • Nutraceuticals
  • Pharmacovigilance planning
  • Safe medication
  • Traditional Chinese medicine (TCM)
  • Xenobiotics

ASJC Scopus subject areas

  • Food Science
  • Pharmacology

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  • Cite this

    Wang, H. P., Wang, C. L., Yu, W. N., Hsu, S. H., Huang, Y. W., Lin, Y. L., Leu, Y. L., & Lee, C. Y. (2007). From pharmacovigilance to pharmacovigilance planning - The system building for safe medication. Journal of Food and Drug Analysis, 15(4), 377-386.