Abstract
The objective of this study is to collate and analyse adverse event reports associated with the use of complementary health products (CHP) submitted to the Health Sciences Authority (HSA) of Singapore for the period 2010–2016 to identify various trends and signals for pharmacovigilance purposes. A total of 147,215 adverse event reports suspected to be associated with pharmaceutical products and CHP were received by HSA between 2010 and 2016. Of these, 143,191 (97.3%) were associated with chemical drugs, 1,807 (1.2%) with vaccines, 1,324 (0.9%) with biological drugs (biologics), and 893 (0.6%) with CHP. The number of adverse event reports associated with Chinese Proprietary Medicine, other complementary medicine and health supplements are presented. Eight hundred and ninety three adverse event reports associated with CHP in the 7-year period have been successfully collated and analyzed. In agreement with other studies, adverse events related to the “skin and appendages disorders” were the most commonly reported. Most of the cases involved dermal allergies (e.g., rashes) associated with the use of glucosamine products and most of the adulterated products were associated with the illegal addition of undeclared drugs for pain relief. Dexamethasone, chlorpheniramine, and piroxicam were the most common adulterants detected. Reporting suspected adverse events is strongly encouraged even if the causality is not confirmed because any signs of clustering will allow rapid regulatory actions to be taken. The findings from this study help to create greater awareness on the health risks, albeit low, when consuming CHP and dispelling the common misconception that “natural” means “safe.” In particular, healthcare professionals and the general public should be aware of potential adulteration of CHP. The analysis of spontaneously reported adverse events is an important surveillance system in monitoring the safety of CHP and helps in the understanding of the risk associated with the use of such products. Greater collaboration and communication between healthcare professionals, regulators, patients, manufacturers, researchers, and the general public are important to ensure the quality and safety of CHP.
Highlights
In Singapore, health products are defined as any substance, preparation or device intended for use by humans, solely or principally for a health-related purpose
A total of 147,215 adverse event reports suspected to be associated with pharmaceutical products and complementary health products (CHP) were received by Health Sciences Authority (HSA) between 2010 and 2016
143,191 (97.3%) were associated with chemical drugs, 1,807 (1.2%) with vaccines, 1,324 (0.9%) with biological drugs, and 893 (0.6%) with CHP
Summary
In Singapore, health products are defined as any substance, preparation or device intended for use by humans, solely or principally for a health-related purpose. These include pharmaceutical products, complementary health products (CHP), medical devices, and cosmetic products (Figure 1). There have been some concerns about the safety of CHP, in particular adverse effects associated with them. World Health Organization (WHO) defines adverse drug reaction as a reaction which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of a disease, or for the modification of a physiological function [2]. An adverse event is “a medical occurrence temporally associated with the use of a medicinal product, but not necessarily causally related” [2]. For the purpose of this paper, the term “adverse event” will be used
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