Preliminary report: Review of adverse drug reactions (ADRs) reporting in the Malaysian elderly

Abstract

Elderly has a high risk of ADRs due to multifactorial factors. The occurrence of the ADRs can be patient-related or drug-related such as polypharmacy, impaired organ function and pharmacokinetic changes. This study aimed to review the medications and system organ function associated with ADRs in the Malaysian elderly population. Observational data were collected retrospectively from the Malaysian Adverse Drug Reactions Advisory Committee (MADRAC) database from January to December 2015. A total of 6,862 ADRs case were reported in year 2015, and 23% consisted of elderly patient (n=1328) with mean age of 68±7 years. Most of the elderly were Malays (45.5%), followed by Chinese (35.3%) and Indians 11.3%. The drug classes frequently implicated were antihypertensive agents (n=389), followed by anti-infectives (n=195) and lipid-lowering agents (n=147). The most common ADRs reported based on System Organ Class (SOC) were skin and appendages disorders (n=407), followed by body as whole (n=217) and central nervous system (CNS) (n=209). Using the Naranjo's algorithm to determine the causality of event, of the total 1,328 ADRs cases, it was found that 249 were definite, 635 were probable, and 444 were possible. This study showed that cardiovascular drugs and anti-infective agents were the drugs highly associated with the occurrence of ADRs which commonly affected CNS, respiratory and skin disorders. The highest ADRs reported in the Malaysian elderly population were skin appendages and body as whole.