Abstracts from the 1st JoPPP Conference on Pharmaceutical Policy and Practice

Abstract

The aims of this study are to identify characteristics of seized, adulterated Traditional-Herbal Medicine (THM) products in Malaysia and to assess Adverse Reactions (ARs) signals associated with THM products. A total of 59, 440 THM products that were seized by the Malaysia Pharmacy Enforcement Division between 2008-2014 were analysed. Of these, 6, 452 THM products were included in the final analyses after taking into consideration the inclusion and exclusion criteria. To quantify the THM ARs signals, ARs reports for THM products were obtained from the National Pharmaceutical Regulatory Agency Adverse Drug Reaction Database. Proportional Reporting Ratio (PRR) and Reporting Odds Ratio (ROR) are safety signalling tools that were used to measure THM ARs signals. More than 50% (n=3, 549/6, 452) of the adulterated THM products originated from international countries where the highest was from Indonesia (45.68%, n=2, 947/3, 549). The most common adulterated THM product were claimed for pain and fever (53.64%, n=3, 461/6, 452), followed by sex stimulant (26.38%, n=1, 702/6, 452), and slimming (8.2%, n=529/6, 452). Steroids showed as the highest adulterant found in the adulterated THM products (47.78%, n=3, 083/ 6, 452), followed by phosphodiesterase inhibitor (25.77%, n=1, 663/6, 452), monoamine reuptake inhibitor (8.23%, n=531/6, 452), and nonsteroidal anti-inflammatory drugs (NSAIDS) (5.64%, n=364/6, 452). A total of 1, 102 ARs reports for THM products were extracted but only 900 AR reports were eligible to be analysed using PRR and ROR. Hepatobiliary disorders (n=155, 17.22%) was the most common ARs with the use of THM products in Malaysia, followed by blood and lymphatic disorders (N=149, 16.56%) and gastrointestinal disorders (n=68, 7.56%). AR signals were generated for: 1) respiratory & thoracic disorders and THM products that are claimed for cough and cold, 2) cardiac disorders for THM products that are claimed for slimming and 3) reproductive and breast disorders for THM products that are claimed for women's health. The results of this study highlight the trend of adulterated THM products seized in Malaysia and the ARs associated with the use of THM products. Strategic and systematic actions can be planned and implemented by the health authorities targeting the common adulterated THM products. A targeted awareness and educational programmes about THM products can be effectively undertaken for the public as well.