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Patient Reporting of Adverse Drug Reactions (ADRs): Survey of Public Awareness and Predictors of Confidence to Report

Hariraj V, Aziz Z

Ther Innov Regul Sci, 2018 11;52(6):757-763.
PMID: 29714567 DOI: 10.1177/2168479017745025

BACKGROUND: Many countries incorporate direct patient reporting of adverse drug reactions (ADRs) into their pharmacovigilance systems as patients provide a different insight into drug safety compared to health care professionals. This study aimed to examine public awareness about ADR reporting in Malaysia and patients' confidence in reporting ADRs.
METHODS: Using a cross-sectional design and convenient sampling, data were collected in public areas within Kuala Lumpur, Malaysia, via face-to-face interview with a structured questionnaire. Multivariate logistic regression analysis was used to identify the significant predictors of patients' confidence in ADR reporting.
RESULTS: Out of 860 consented respondents achieving a response rate of 73.5%, only 69 (8%) were aware of the Malaysian ADR monitoring system. The majority (60%) of the respondents indicated they had the confidence to report ADRs. Multivariate logistic regression analysis revealed that ease in completing the ADR reporting form was the strongest variable predictive of confidence to report ADRs (odds ratio [OR], 18.45; 95% confidence interval [CI], 10.55-32.25). Increased confidence in ADR reporting was also associated with education level. Respondents with a higher education level were more likely to be confident to report ADRs compared to those with primary or no formal education (OR, 2.49; 95% CI, 0.77-8.1).
CONCLUSIONS: Lack of awareness of the ADR monitoring system is still prevalent among Malaysian patients. The ease of completing the ADR form and education level are predictive of patient confidence to report ADRs. These factors should be considered in designing public promotional activities to encourage patient contributions to pharmacovigilance.
Carbamazepine-Induced Severe Cutaneous Adverse Drug Reactions: A 21-Year Comparison Between Children and Adults in Malaysia

Hariraj V, Wo WK, Lee SC, Ramli A

J Clin Pharmacol, 2023 Oct;63(10):1126-1132.
PMID: 37291071 DOI: 10.1002/jcph.2289

Severe cutaneous adverse drug reactions (SCARs) are a life-threatening condition. We aimed to identify all carbamazepine-induced SCARs voluntarily reported to the Malaysian pharmacovigilance database and to compare between children and adults. Adverse drug reaction reports for carbamazepine were extracted from 2000 to 2020, and divided into 2 groups, that is, children (aged 0-17 years) and adults (aged 18 years and above). Age, sex, race, and carbamazepine dose were analyzed using multiple logistic regression. Of 1102 carbamazepine adverse drug reaction reports, 416 reports were SCARs (99 children, 317 adults). Stevens-Johnson syndrome and toxic epidermal necrolysis were the main SCAR types for both age groups. Median time-to-onset for any type of SCAR was 13 days, regardless of age. In children, Malay individuals were 3.6 times more likely to report SCARs (95% confidence interval, 1.356-9.546; P = .010) compared to the Chinese population. In adults, carbamazepine-induced SCARs were reported as 3.6 times higher in those with a daily dose of 200 mg or less as compared to a daily dose of 400 mg or more. (95% confidence interval, 2.257-5.758; P
Self-medication practices among adult population attending community pharmacies in Malaysia: an exploratory study

Hassali MA, Shafie AA, Al-Qazaz H, Tambyappa J, Palaian S, Hariraj V

Int J Clin Pharm, 2011 Oct;33(5):794-9.
PMID: 21811832 DOI: 10.1007/s11096-011-9539-5

OBJECTIVE: To assess the prevalence of self-medication among adults in an urban setting and to identify any factors contributing to self-medication in relation to consumer characteristics.
SETTING: The study was carried out in Kuala Lumpur, the capital of Malaysia.
METHODS: A cross-sectional study using a self administered questionnaire including adults above 21 years old as an exit survey was conducted in Kuala Lumpur.
MAIN OUTCOME MEASURES: Number of medications taken in a day by participants, source of medication for the treatment of minor illnesses among participants, common illnesses chosen for self-medication by participants, and the sources of information of participants.
RESULTS: Of 314 participants, 62.7% had taken at least one medication in the past week without prescription and 62.7% believed that over the counter medicines were just as effective as those prescribed by doctors. 69.4% would seek a healthcare professional's advice before purchasing any medication and 86.9% would consult a pharmacist prior to buying medication from the pharmacy. Only 86% checked the expiry dates on medications and 54.5% reported keeping leftover medication.
CONCLUSIONS: Self-medication practice is prevalent in Kuala Lumpur but some practice might be harmful. Education on appropriate use of self-medication need to be emphasized in order to ensure quality use of medicines.
Allopurinol-Induced Severe Cutaneous Adverse Drug Reactions: An Analysis of Spontaneous Reports in Malaysia (2000-2018)

Lee SC, Wo WK, Yeoh HS, Mohamed Ali N, Hariraj V

Ther Innov Regul Sci, 2021 05;55(3):514-522.
PMID: 33393015 DOI: 10.1007/s43441-020-00245-w

INTRODUCTION: Allopurinol-induced severe cutaneous adverse drug reactions (SCARs) are potentially debilitating and life-threatening reactions, which can cause a financial burden to the healthcare system.
OBJECTIVES: We aimed to identify risk factors for allopurinol-induced SCARs and to assess their impact on fatality.
METHODS: Adverse drug reaction (ADR) reports with allopurinol as suspected drug were extracted from the Malaysian pharmacovigilance database from year 2000 to 2018. Multiple logistic regression analysis was used to identify significant predictors of allopurinol-induced SCARs. We further analysed the association between covariates and SCARs-related fatality in a separate model. Level of significance was set at p value