Vidhya Hariraj,
Zoriah Aziz 
For correspondence:- Zoriah Aziz Email: zoriah@um.edu.my Tel:+60379674909
Accepted: 24 July 2018 Published: 31 August 2018
Citation: Hariraj V, Aziz Z. Direct patient reporting of adverse drug reactions: An analysis of spontaneous reports submitted to Malaysian pharmacovigilance centre. Trop J Pharm Res 2018; 17(8):1673-1679 doi: 10.4314/tjpr.v17i8.29
© 2018 The authors.
This is an Open Access article that uses a funding model which does not charge readers or their institutions for access and distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0) and the Budapest Open Access Initiative (http://www.budapestopenaccessinitiative.org/read), which permit unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited..
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
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