Compliance of Manufacturer Medicine Labels to the National Regulation in a State Hospital in Sri Lanka.

Abstract

Background: Nonstandard pharmaceutical or manufacturer labels may lead to medication errors. Therefore, label content and design are specified and monitored through regulatory frameworks. The aim of this study was to assess the availability of vital information in manufacturer labels of medicines used in a selected state hospital and adherence to the guidelines on labelling of medicines (GLM V1.0) of the National Medicines Regulatory Authority (NMRA), Sri Lanka.

Methods: Three hundred randomly selected medicine manufacturer labels were assessed using a checklist developed based on GLM V1.0.

Results: Of the 300 labels, 89.6% complied with the recommended format of the generic name followed by its pharmaceutical form and strength, and 84.0% specified their pharmacopeial monograph. Almost 40% were substandard, lacking at least one essential piece of information required by regulation. The strength of the medicine was not indicated in the principal display panel (PDP) of 5.3% of medicines. 5.0% of labels for various strengths of the same medicine or different medicines looked alike. Other observed flaws were missing necessary information and look-alike labels, reflecting a lack of quality control.

Conclusion: Divergence from specified standards demonstrates the need for a multifaceted approach by the NMRA to prevent ambiguous labels. Key calls to action for policymakers include better manufacturer guidance, stronger pre-submission assessments, rejecting non-standard labels, and introducing barcode readers.