Risk undermined in the bilateral pharmaceutical regulatory system in Taiwan

Abstract

The concept of Pharmacovigilance Planning and Risk Minimization Planning (PVP/RMP), initiated by the International Conference on Harmonization (ICH), addressed an important conceptual change from monitoring the safety of individual medicine to proactively conducting risk prevention for the minimization of medication error. However, the implementation of PVP/RMP is a challenge in societies like Taiwan where irrational medication and co-medication is prevalent. It is even more difficult in Taiwan where two regulatory bodies are governing pharmaceutical affairs, namely Taiwan Food and Drug Administration (TFDA) in charge of Western Medicine (WM) and the Department of Chinese Medicine and Pharmacy (DCMP) in charge of Traditional Chinese Medicine (TCM). There are thus dual-tract drug approval panels, two GMP controls and two independent adverse drug event reporting systems. This rendered irrational co-medication of WM and TCM undetectable and the standard tools for monitoring pharmacovigilance inapplicable. The bilateral regulatory system is conceptually unscientific in accordance with PVP/RMP and unethical from humanity point of view. The first part of this review delivers (1) social aspects of polypharmacy in Taiwan; (2) regulatory aspects of pharmaceutical administration; (3) risks undermined in the bilateral regulatory system and (4) pharmacoepidemiology in relation to the risk of polypharmacy. As evidence-based medicine (EBM) forms the fundamental risk-benefit assessment on medication, the second part of this review delivers (1) the scientific aspects of the beauty and the odds of biological system that governs host-xenobiotics interaction; (2) conceptual evolution from product management (pharmacovigilance) to risk management (PVP/RMP); (3) non-biased due process is essential for risk-benefit assessment on medicinal products and (4) the opinion of the authors on system building for safe medication.

Shenmai-Yin decreased the clearance of nifedipine in rats: The involvement of time-dependent inhibition of nifedipine oxidation

“…Herb-drug interactions that occur via the modulation of cytochrome P450 (CYP)-catalyzed drug oxidation are of increasing concern during the use of herbal remedies [ 1 , 2 ]. The calcium channel blocker, nifedipine, is currently used for the treatment of various cardiovascular disorders, including hypertension and angina.…”

Chinese Herbal Medicine as an Adjunctive Therapy Ameliorated the Incidence of Hypotension in Patients with End-Stage Renal Disease: A Nationwide Population-Based Cohort Study

“…In the past, due to concerns about aristolochic acid and heavy metal pollution in herbal medicines, the value of CHM for CKD patients was underestimated in Taiwan 27,28 . Today, the Ministry of Health and Welfare has banned the import of aristolochic acid-containing medicinal materials, requires TCM pharmaceutical companies to implement the Good Manufacturing Practice (GMP) system to check the quality of CHM products, and regularly checks the heavy metal content and impurities in such products 29 .…”

Juan Bi Tang, a traditional Chinese medicine, for alleviating pain related to arteriovenous fistula in maintenance hemodialysis patients: An interventional pilot study with brief review

“…CHMs in Taiwan are safe and high in quality due to strict controls, batch-by-batch inspection of Chinese medicinal materials, and preparation by stabilizing and strengthening the implementation of GMP pharmaceutical industry. [47,48] It is worth noting that concomitant use of a CHM prescription for activating blood and removing blood stasis with WM could engender serious herb-drug interactions leading to complications due to increases or decreases in the pharmacologic effect of either component. For instance, heparin, which is used in the dialytic extracorporeal circuit to prevent clotting, could increase bleeding risk if taken in combination with Rx.…”

“…CHMs in Taiwan are safe and high in quality due to strict controls, batch-by-batch inspection of Chinese medicinal materials, and preparation by stabilizing and strengthening the implementation of GMP pharmaceutical industry. [ 47 , 48 ]…”