A study on the adulterated traditional-herbal medicinal products in Malaysia / Suriana Hanim Ariffin @ Sukri

The adulteration issues of Traditional-Herbal Medicinal (THM) products have been
discussed quite lengthily in Malaysia due to its availability in the Malaysian market and
the ease of purchase by the public. There has been an increased in announcements and
in the news concerning the adulteration of THM products that have caused undesirable
side effects for the consumer. As a consequence, the Malaysian authorities have
established several relevant and important guidelines and have heightened strategic
enforcement agendas in the attempt to curb adulteration issues. Several laboratory�based studies have been undertaken, to investigate the presence of adulterants or heavy
metals in THM products. However, there are limited Malaysian data that have been
published on the characteristics and adverse effects associated with adulterated THM.
The aims of this study were to establish the current characteristics of adulterated THM
in the Malaysian market while assessing the magnitude of adverse reactions associated
with THM product in Malaysia. In order to evaluate the characteristics and trends of
adulterated THM products in Malaysia, a total of 59,440 THM products that were seized
in Malaysia by the Pharmacy Enforcement Division from the year 2008-2014 were
analysed. Of these 6, 452 were included in the final analyses after taking into
consideration inclusion and exclusion criteria for this study. More than 50% (N= 3, 549)
were international THM products. The most common adulterants reported were steroid,
phosphodiesterase inhibitors and monoamine reuptake inhibitor. In terms of the
evaluation of the extent of adverse reactions associated with THM products in Malaysia,
a total of 1, 102 reports of adverse reactions associated with THM were extracted from
the spontaneous adverse reports database. In total, 900 adverse reaction reports were
used in this study according to the inclusion and exclusion criteria. Hepatobiliary
disorders (N=155, 17.22%) is the most common adverse reaction reported associated
with the use of THM products in Malaysia. This was followed by blood & lymphatic
disorders (N=149, 16.56%) and gastrointestinal disorders (N=68, 7.56%). Proportional
Reporting Ratio and Reporting Odds Ratio medication safety signalling tools were used
in this study to generate adverse reaction signals. Adverse reaction signals were
generated for: 1) respiratory & thoracic disorders and THM products indicated for
cough and cold, 2) cardiac disorders for THM products indicated for slimming and 3)
reproductive and breast disorders for THM products indicated for women’s health. In
conclusion, this study highlights the trend of the adulterated THM products in Malaysia
and the most common adverse reactions associated with the use of THM products in
Malaysia. It is hope that the significance of results of this study could help the Malaysian
authorities to strategise optimally based on the utmost priority.