QUALITY AND SAFETY OF COMPLEMENTARY HEALTH PRODUCTS: ADVERSE EVENT REPORTS AND SCREENING FOR ADULTERANTS

Abstract

The overall objectives of this work are to retrospectively analyse the adverse event reports due to complementary health products in the period 2010-2016 and to develop an analytical method to screen herbal products for adulterants. Out of 147215 adverse events, 893 (0.6%) were found to be associated with complementary health products. Majority of these reports were associated with products labelled to contain glucosamine and also products found to be adulterated with undeclared western drugs. A rapid and sensitive high resolution mass spectrometric method was developed and validated for the detection of 60 phosphodiesterase Type 5 enzyme inhibitors and their analogues. A novel tadalafil analogue, specifically N-cyclopentyl nortadalafil, was isolated and identified in a herbal health product claimed to enhance sexual performance. The work presented has provided useful information for health regulators, healthcare professionals and the general public, in the continuous efforts to improve the quality and ensure safety of complementary health products.