Compliance Towards the Malaysian Laws on Poisons and Sale of Drugs: a Retrospective Observational Study in The State of Sarawak

Abstract

Compliance with the laws and regulations on the sale and supply of medicine ensures that it is conducted safely and professionally. This study identified the compliance rate of community pharmacists and general practitioners in the state of Sarawak towards the Malaysian Laws on Poisons and Sale of Drugs and review the effect of the enforcement actions taken by the Sarawak Pharmacy Enforcement Branch. This was a retrospective observational study where the data were extracted retrospectively from the annual inspection reports on community pharmacists and general practitioners conducted by the Sarawak Pharmacy Enforcement Branch from 2016 to 2020. Data were extracted using a self-developed data collection tool by trained enforcement officers. Overall, 50 criteria were examined but 24 more criteria were also examined for community pharmacists. The compliance rate of community pharmacists has improved slightly from 58.6% in 2016 to 61.1% in 2020. In the meantime, the rate of compliance among general practitioners went from 35.9% in 2016 to 71.2% in 2020, which is a big jump. The recording provisions on the supply of substances containing codeine, dextromethorphan, ephedrine, and pseudoephedrine (12.3%-24.1%) and the prescription book (7.7%-27.6%) were the most common non-compliance recorded for all the 5 years among community pharmacists and general practitioners, respectively. Enforcement action (issuance of warning letters) was found to induce a major (79.5%) improvement in the compliance rate. Community pharmacists and general practitioners' compliance rate have improved throughout the years. The highest non-compliance rate was towards the recording provision on the supply of medicine. Constant assessment of the compliance rate, as well as the effectiveness of enforcement actions, must be done regularly.