Direct patient reporting of adverse drug reactions: An analysis of spontaneous reports submitted to Malaysian pharmacovigilance centre
Document Type
Article
Publication Date
1-1-2018
Abstract
Purpose: To evaluate patient adverse drug reaction (ADR) reports in terms of categories by System Organ Class (SOC), suspected products and seriousness. Methods: The national database was retrospectively searched from 2008 to 2015. ADR reports by patients were included but vaccine-related reports and reports by healthcare professionals were excluded. Eligible reports were analysed descriptively and Chi-square test was used to evaluate the association of various categorical variables with serious ADRs. Results: Of the total of 75,391 reports screened in the National ADR database for the study period, only 81 (0.11 %) were reports from patients, of which 32 (40 %) reports involved serious ADRs. The majority of reports was associated with unregistered products or unapproved cosmetics. Half of the reports involved traditional products while cosmetic products constituted another 10 % of the reports. The three main SOCs involved were skin and appendages disorders (26 %), body as a whole (25 %), and central and peripheral nervous system disorders (9 %). A total of 23 out of 47 products tested were adulterated with prescription drugs while 4 cosmetic products exceeded the permitted limit for hydroquinone or mercury. Two factors found to be significantly associated with serious ADRs were product registration status and presence of adulteration. Conclusion: The findings indicate that patient reporting of suspected ADRs has the potential to add valuable information to pharmacovigilance.
Keywords
Adulterants, Patient reporting, Complementary and alternative medicines, Cosmetics, Pharmacovigilance
Publication Title
Tropical Journal of Pharmaceutical Research
Divisions
fac_med
Funders
University Malaya, Kuala Lumpur study grant (No. PG125-2014A)
Volume
17
Issue
8
Publisher
Pharmacotherapy Group, University of Benin, Benin City