Situations of Health Product Problems Reporting from ASEAN Post Marketing Alert System

Abstract

Background: The Division of Import and Export Inspection (DIEI) receives health product problem reports via the ASEAN Post Marketing Alert System (PMAS). These data reports are useful to surveillance and risk control of importing health products that are sold in Thailand. However, in the past, the reports were not compiled and analyzed systematically.

Objectives: This study aimed to collect quality and safety problems of health products that exchanged through the PMAS.

Methods: This research collected data from PMAS reports in fiscal year 2017 that included cosmetic products, health supplement products, and medicine and traditional medicine. These reports were from ASEAN member countries excepted report of Thailand which DIEI received from Health Product Vigilance Center. The data was analyzed by using descriptive statistics.

Results: The DIEI received health product reports through the PMAS at 35 reports which was alert by 291 items. Most alerts were cosmetic products 67.4% which it was safety problems including a use of prohibited substances in skin care products such as mercury 36.5% and hydroquinone/tretinoin 13.1%; generally prohibited preservatives in the products were isobutyl paraben and isopropyl paraben. Moreover, on medicinal product reports found that a major problem was a quality defect which causes originated pharmaceutical manufacturing process that did not meet requirements of Good Manufacturing Practice (GMP) at 78.0%, dissolution problem 8.0%, and dissolution/disintegration and content of active ingredient problems 4.0%. Besides, utmost problems of traditional medicines and health supplement products were pharmaceutical substances adulteration. The top three of adulterated substances were sibutramine 22.2%, dexamethasone 18.5%, and sildenafil 11.1%.

Conclusions: Reports from PMAS can be use a guideline to develop an effective system for monitoring and surveillance of health products by the DIEI and other health product regulators to protect consumers to get safety from health product using.