Staff View: Complementary and alternative medicine: Pharmacovigilance in Malaysia and predictors of serious adverse reactions

Complementary and alternative medicine: Pharmacovigilance in Malaysia and predictors of serious adverse reactions

What is known and objective Complementary and alternative medicine (CAM) is widely used worldwide for health maintenance, disease prevention and treatment. The objective of the study was to identify adverse drug reactions (ADR) associated with the use of CAM in Malaysia and factors which are associa...

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Main Authors:	Shaikh Abdul Rahman, Sameerah, Aziz, Zoriah
Format:	Article
Published:	Wiley 2020
Subjects:	RM Therapeutics. Pharmacology
Online Access:	http://eprints.um.edu.my/36955/
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spelling	my.um.eprints.369552023-11-29T07:14:07Z http://eprints.um.edu.my/36955/ Complementary and alternative medicine: Pharmacovigilance in Malaysia and predictors of serious adverse reactions Shaikh Abdul Rahman, Sameerah Aziz, Zoriah RM Therapeutics. Pharmacology What is known and objective Complementary and alternative medicine (CAM) is widely used worldwide for health maintenance, disease prevention and treatment. The objective of the study was to identify adverse drug reactions (ADR) associated with the use of CAM in Malaysia and factors which are associated with the more serious reactions. Methods All ADR associated with the use of CAM products (including health supplements) submitted to the Malaysian Centre for ADR Monitoring, National Pharmaceutical Regulatory Agency over a 15-year period were reviewed and analysed. Multivariate logistic regression analysis was performed to identify predictors of serious ADR. Results and discussion From a total of 74 997 reports in the database, 930 (1.2%) involved CAM products, and 242 (26%) were serious with 36 deaths. About a third of the reports involved used CAM products for health maintenance. Most (78.1%) of the ADR reports implicated unregistered products with 16.7% confirmed to contain adulterants which were mainly dexamethasone. Of the 930 reports, the ADR involved skin and appendages disorders (18.4%) followed by liver and biliary system disorders (13.7%). The odds of someone experiencing serious ADR increased if the CAM products were used for chronic illnesses (odds ratio OR] 1.99, confidence interval CI] 1.46-2.71), having concurrent diseases (OR 1.51, CI 1.04-2.19) and taking concurrent drugs (OR 1.44, CI 1.03-2.02). What is new and conclusions The prevalence of serious ADR associated with CAM products is high. Factors identified with serious ADR included ethnicity, CAM users with pre-existing diseases, use of CAM for chronic illnesses and concomitant use of CAM products with other drugs. The findings could be useful for planning strategies to institute measures to ensure safe use of CAM products. Wiley 2020-10 Article PeerReviewed Shaikh Abdul Rahman, Sameerah and Aziz, Zoriah (2020) Complementary and alternative medicine: Pharmacovigilance in Malaysia and predictors of serious adverse reactions. Journal of Clinical Pharmacy and Therapeutics, 45 (5). pp. 946-958. ISSN 0269-4727, DOI https://doi.org/10.1111/jcpt.13106 <https://doi.org/10.1111/jcpt.13106>. 10.1111/jcpt.13106
institution	Universiti Malaya
building	UM Library
collection	Institutional Repository
continent	Asia
country	Malaysia
content_provider	Universiti Malaya
content_source	UM Research Repository
url_provider	http://eprints.um.edu.my/
topic	RM Therapeutics. Pharmacology
spellingShingle	RM Therapeutics. Pharmacology Shaikh Abdul Rahman, Sameerah Aziz, Zoriah Complementary and alternative medicine: Pharmacovigilance in Malaysia and predictors of serious adverse reactions
description	What is known and objective Complementary and alternative medicine (CAM) is widely used worldwide for health maintenance, disease prevention and treatment. The objective of the study was to identify adverse drug reactions (ADR) associated with the use of CAM in Malaysia and factors which are associated with the more serious reactions. Methods All ADR associated with the use of CAM products (including health supplements) submitted to the Malaysian Centre for ADR Monitoring, National Pharmaceutical Regulatory Agency over a 15-year period were reviewed and analysed. Multivariate logistic regression analysis was performed to identify predictors of serious ADR. Results and discussion From a total of 74 997 reports in the database, 930 (1.2%) involved CAM products, and 242 (26%) were serious with 36 deaths. About a third of the reports involved used CAM products for health maintenance. Most (78.1%) of the ADR reports implicated unregistered products with 16.7% confirmed to contain adulterants which were mainly dexamethasone. Of the 930 reports, the ADR involved skin and appendages disorders (18.4%) followed by liver and biliary system disorders (13.7%). The odds of someone experiencing serious ADR increased if the CAM products were used for chronic illnesses (odds ratio OR] 1.99, confidence interval CI] 1.46-2.71), having concurrent diseases (OR 1.51, CI 1.04-2.19) and taking concurrent drugs (OR 1.44, CI 1.03-2.02). What is new and conclusions The prevalence of serious ADR associated with CAM products is high. Factors identified with serious ADR included ethnicity, CAM users with pre-existing diseases, use of CAM for chronic illnesses and concomitant use of CAM products with other drugs. The findings could be useful for planning strategies to institute measures to ensure safe use of CAM products.
format	Article
author	Shaikh Abdul Rahman, Sameerah Aziz, Zoriah
author_facet	Shaikh Abdul Rahman, Sameerah Aziz, Zoriah
author_sort	Shaikh Abdul Rahman, Sameerah
title	Complementary and alternative medicine: Pharmacovigilance in Malaysia and predictors of serious adverse reactions
title_short	Complementary and alternative medicine: Pharmacovigilance in Malaysia and predictors of serious adverse reactions
title_full	Complementary and alternative medicine: Pharmacovigilance in Malaysia and predictors of serious adverse reactions
title_fullStr	Complementary and alternative medicine: Pharmacovigilance in Malaysia and predictors of serious adverse reactions
title_full_unstemmed	Complementary and alternative medicine: Pharmacovigilance in Malaysia and predictors of serious adverse reactions
title_sort	complementary and alternative medicine: pharmacovigilance in malaysia and predictors of serious adverse reactions
publisher	Wiley
publishDate	2020
url	http://eprints.um.edu.my/36955/
_version_	1783945856126287872
score	13.211869

Complementary and alternative medicine: Pharmacovigilance in Malaysia and predictors of serious adverse reactions

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