LAUSR

Letter to the editor We respectfully take issue with the recent article published in the journal by Hughes and Weiss which offers a valuable and thoughtful documentation of various barriers and potential facilitators to reporting of adverse drug reactions (ADRs). While pharmacists generally expressed positive attitudes towards the reporting, they identified some key obstacles to ADR reporting, including lack of observed ADRs, lack of time to report as well as difficulty in determining the causative drug. We think it might be worthwhile to acquaint the authors and the readers of a recent study in our institution on the prevalence of ADRs in a primary care setting in Malaysia. We documented a total of 186 ADR cases between 2015 and 2018 with an average of 47 cases per annum or 4 cases per month. Antibiotics (penicillin, macrolide, sulfonamide, tetracycline, cephalosporin, chloramphenicol, and aminoglycoside) and analgesics (NSAID, acetaminophen, and opioid) were the leading causative drugs for ADRs. Cutaneous adverse drug reactions were most commonly reported. The causality of ADR performed by Naranjo scale showed that ADRs were possible in 71 (38.2%) cases, probable in 57 (30.6%) cases, and definite in 58 (31.2%) cases. 157 (84.4%) patients had completely recovered, and 24 (12.9%) were in the process of recovery during time of reporting, while 5 (2.7%) had an unknown outcome. In Malaysia, pharmacovigilance activities are regulated by the National Centre for Adverse Drug Reactions Monitoring, a division within the National Pharmaceutical Regulatory Agency (NPRA). Malaysia is practising a spontaneous voluntary reporting system for health professionals. Reporting by the pharmaceutical industry, by contrast, is mandatory in Malaysia, requires marketing authorisation holders to report any ADRs for their drug products. Since the founding of ADR reporting process in 1987, the number of ADR reports received by NPRA has increased attributable to an enhanced awareness of the importance of ADR reporting and an increased number of pharmacists working in government medical facilities. Nonetheless, underreporting of ADRs is still a major concern in Malaysia and many developed nations. Several studies have suggested that less than 10% of ADRs are effectively reported by healthcare providers to medicine regulatory authorities. This, coupled with the sparsity of contributions from community pharmacies and primary care in ADR detection and reporting, ADR detection and reporting, can have an unambiguously negative impact on clinical practice and public health. The study by Hughes and Weiss recommends the provision of further training, alerts, peer support, innovative technology approaches,