Complementary and alternative medicine: Pharmacovigilance in Malaysia and predictors of serious adverse reactions / Sameerah Shaikh Abdul Rahman
In Malaysia, Complementary and Alternative Medicine (CAM) products are readily available and increasingly used. Associated with their use were reports of serious adverse effects. The Centre for Adverse Drug Reaction (ADR) Monitoring, National Pharmaceutical Regulatory Agency (NPRA) through its sp...
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| Format: | Thesis |
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2019
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| Online Access: | http://studentsrepo.um.edu.my/11458/ http://studentsrepo.um.edu.my/11458/4/sameerah.pdf |
| Summary: | In Malaysia, Complementary and Alternative Medicine (CAM) products are readily
available and increasingly used. Associated with their use were reports of serious
adverse effects. The Centre for Adverse Drug Reaction (ADR) Monitoring, National
Pharmaceutical Regulatory Agency (NPRA) through its spontaneous reporting system
has received many reports of serious adverse events associated with the use of CAM
products. Yet, we know little about factors associated with serious adverse reactions.
The study aimed to describe the pattern of spontaneously reported adverse reactions
associated with CAM products and identify risk factors associated with serious
reactions. We reviewed and analysed all adverse reactions associated with CAM
products (including health supplements) submitted to the NPRA between 2000 and
2014. Data analysed and described included patient demography, characteristics and
descriptions of adverse reactions, suspected CAM products, severity and outcome of
adverse effects. Adverse reactions were considered serious if the reactions led to death,
hospitalisation or prolongation of hospitalisation, that were life-threatening, or that
caused significant disability.
From 74,997 of all reports received by the Centre, 930 (1.2%) involved CAM
products. Out of these, 242 (26%) were serious with 36 deaths. Most (78.1%) of the
reports implicated unregistered products with 16.7% confirmed to contain adulterants
which were mainly dexamethasone. Most of the adverse reaction reports involved
Malay users (59.9%), followed by Chinese (32.3%) and they were all mostly adults
between the ages of 19-60 (65.2%). Those who experienced adverse effects took CAM
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products mainly for health maintenance and weight loss (61.2%) while the rest used
CAM for chronic conditions such as diabetes mellitus, hypertension, stroke, and cancer.
The top two most reported adverse events were related to skin and appendages disorders
(18.4%) followed by liver and biliary system disorders (13.7%). Binary logistic
regression analysis revealed that serious adverse effects were associated with the
variables ethnicity, concurrent disease, concurrent drugs taken and use of CAM for a
chronic illness. The odds of experiencing serious adverse effects increased if the
respondents used CAM products for chronic illnesses compared to those who used
CAM for health maintenance [odds ratio (OR) 1.99, 95% confidence interval (CI) 1.46-
2.71], having concurrent disease [OR 1.53, CI 1.05-2.19] and taking concurrent drugs
[OR 1.44, CI 1.03-2.02]. Compared to Malay, being of Indian race was associated with
decreased odds of experiencing serious adverse effects [OR 0.09, CI 0.01–0.63].
Meanwhile the odds of having serious adverse effects among the race categorised as
‘others’ increased about 2.7 folds compared to Malay [OR 2.64, CI 1.36–5.13]. The
findings of this study provide important information on adverse reactions associated
with CAM and may help healthcare professionals and the public take necessary
measures to ensure its safe use as some products can be life-threatening. |
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