Clinical Audit on the Practice of Labelling Multi-Dose Drugs in Ward Settings at Balik Pulau Hospital

Abstract

Introduction:
Multi-dose drugs (MDDs) are pharmaceutical products containing more than one dose. Maintaining product integrity after first opening is a key quality concern. This audit aimed to ensure that all MDDs were labelled with both the open date and correct in-use shelf life (ISL).
Methods:
This criterion-based audit was conducted across all wards at Balik Pulau Hospital over two six-week cycles. Data were collected using a data collection form. The audit standard, set by consensus, was 100% compliance with open date and correct ISL labelling for MDDs. Staff nurses’ knowledge was assessed using a structured written test. Following identification of a shortfall in quality, targeted remedial measures were implemented before the re-audit.
Results:
Of the 78 MDDs identified during the pre-audit, 51.28% (n=40) were labelled with an open date, and only 2.56% (n=2) had the correct ISL. The assessment of staff nurses' knowledge on ISL of MDDs revealed that their knowledge level was below 50%. Re-audit findings following remedial actions—which included Continuous Nursing Education sessions, use of standard ISL reference list, and customized labels—demonstrated significant improvement. In the re-audit of 98 MDDs, open date labelling increased to 75.51% (n=74), and correct ISL recording rose to 51.02% (n=50). In addition, staff nurses' ISL knowledge improved significantly following the remedial measures (P < 0.001).
Conclusion:
The audit identified poor compliance in labelling MDDs with open date and correct ISL, posing potential risks to patient safety. Targeted remedial actions have significantly improved compliance and staff knowledge. Although full compliance was not achieved, routine monitoring of open date and the ISL of MDDs has become an essential practice during quarterly ward inspection. This practice is expected to reduce the risk of administering expired medications and enhance overall medication safety within the wards.