International Journal of Biomedical and Clinical Sciences
Articles Information
International Journal of Biomedical and Clinical Sciences, Vol.4, No.3, Sep. 2019, Pub. Date: Nov. 4, 2019
Enhancing Post-market Surveillance Through Laboratory Testing on Blue-green Algae Products in Malaysia
Pages: 88-96 Views: 1495 Downloads: 501
Authors
[01] Bujang Nur Baizura, National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health, Petaling Jaya, Malaysia.
[02] Shamsuddin Noor’ain, National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health, Petaling Jaya, Malaysia.
[03] Muhamad Muhammad Zhariff, National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health, Petaling Jaya, Malaysia.
[04] Zahari Siti Hajar, National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health, Petaling Jaya, Malaysia.
[05] Shahrir Mohamed Shahrizan, National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health, Petaling Jaya, Malaysia.
[06] Gunasagaran Vinomalar, National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health, Petaling Jaya, Malaysia.
[07] Mohamed Ali Norleen, National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health, Petaling Jaya, Malaysia.
[08] Khoo Yvonne Siew Khoon, National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health, Petaling Jaya, Malaysia.
[09] Ghafar Zakiah Abdul, National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health, Petaling Jaya, Malaysia.
Abstract
Algal blooms present naturally in marine and fresh water ecosystems are harvested as ingredients in health supplement products. Blue-green algal supplements (BGAS) such as Aphanizomenon flos-aquae, can be contaminated with highly potent toxins, most common being microcystin-LR (MC-LR). Recently, the Pharmacovigilance Section of NPRA has received adverse drug reaction (ADR) reports including liver and kidney toxicities suspected to be related to products containing Aphanizomenon flos-aquae in the local market. The objectives of this study were: (1) to develop and validate a MC-LR quantification test method and (2) to use quality control test results as a complement to managing product safety issues. During investigation on ADR reports concerning Aphanizomenon flos-aquae products, samples obtained through ADR reporting and market surveillance were used to develop and validate a test based on liquid chromatography-tandem mass spectrometry (LC-MS/MS) system. Testing results have been applied to supplement other investigational activities which together support follow-up regulatory actions on the ADR reports received by NPRA. This research report illustrates an example in which a test method developed in-house can serve to supplement other regulatory components in handling product safety issues.
Keywords
Microcystin-LR, Aphanizomenon flos-aquae, Test Method Development, Adverse Drug Reaction, Complementary and Alternative Medicinal Products
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