Compliance to current national medicines law for proper storage and dispensing of medicines at community pharmacies in Bhutan

Abstract

Introduction: Compliance of community pharmacies with the national medicines law for proper storage and dispensing of medicines is crucial for ensuring the quality and safety of medicines. Community pharmacies in Bhutan are of two types: retail pharmacies and wholesale pharmacies. Objective: This study was aimed to assess the compliance of community pharmacies with the Medicines Act of the Kingdom of Bhutan 2003 and Bhutan Medicines Rules and Regulation 2012. Methods: This is a retrospective cross-sectional study from the inspection reports of community pharmacies inspected from January 2015 to December 2017. Descriptive statistics in frequency and percentage was used to report the results. Results: The overall compliance level for the regulatory provisions under critical and minor categories was 90.4% followed by 86.74% for major category. Around 32.99% of community pharmacies were found without standard operating procedures for storing and dispensing of medicines while 100% of community pharmacies had technical authorization from the Drug Regulatory Authority. Conclusion: Although the compliance level of community pharmacies in Bhutan for storing and dispensing of medicines was found to be above 80%, there are several areas that need to be corrected to ensure full compliance. This study will serve as a baseline for policymakers, managers, and researchers in developing designs for future interventions.