Are best practice followed in manufacturer labels of medicines used in Sri Lankan state hospitals?

Abstract Background: Labelling of medicines can greatly impact the quality and safety of medicine use. Regulatory requirements of labelling must be met in a country.Aim: This study assessed the availability of vital information, and adherence to local regulatory guidelines as specified by the Guidelines on Labelling of Medicines (GLM) V1.0 of the National Medicines Regulatory Authority (NMRA), Sri Lanka in primary and secondary labels of medicines used in a selected state hospital. Methods: An observational, descriptive, cross-sectional study was conducted on a random sample of 300 medicine labels using an online random number generator and considering the annual estimation list for state hospitals as total population (1032 medicines). As procurement of medicines to state sector hospitals are done through a central unit, medicines used at the study hospital represented medicines used in all state sector hospitals in the country. A checklist was developed based on NMRA guidelines, selected medicine labels were obtained from the study hospital and were reviewed against the checklist. Results: Among 300 labels assessed, 171(57%) were orals, 108(36%) were injectables, and 21(7%) were external preparations or local applications. Almost 40% were substandard medicine labels which did not include at least one of the essential information required by the regulations, and the strength was not indicated in the primary display panel of 5.3% of medicines. Further, 5.0% of labels of different strengths of the same medicine or different medicines of same manufacturer looked alike. However, 89.6% complied with the recommended format of the generic name followed by its pharmaceutical form and strength, and 84.0% specified its pharmacopeial monograph. Conclusion: Although most labels contained basic medicines information, majority did not completely fulfil the regulatory requirements specified in GLM V1.0 which could challenge both quality and safety of medicine use. Divergence from the specified standards was observed throughout the study, which challenges the safe and quality use of medicines.