Critical Analysis of the Quality Assurance Procedures of Time- and Temperature-Sensitive Pharmaceutical Products in Selected Institutions in Sri Lanka

Abstract

Objective: This study critically assessed the quality assurance procedures for Time- and Temperature-Sensitive Pharmaceutical Products (TTSPPs) in selected institutions of Sri Lanka.

Design: A descriptive cross-sectional design was employed, involving direct observation and the use of a validated 99-item tool based on the guidelines of the World Health Organisation. Five domains and 18 subdomains were analysed, and scores were compared across institutional levels.

Setting: Medical Supplies Division (MSD) of the Ministry of Health, Regional Medical Supplies Divisions (RMSDs), and selected tertiary and secondary hospitals in the North-Western Province of Sri Lanka

Main Outcome Measures: The study covered five domains: general storage, indicators for temperature-controlled storage, transport, stock management, and general procedures/record-keeping.

Results: General storage performed best across institutions (mean score 77.6%), with the MSD showing the highest adherence. However, temperature-controlled storage practices were inconsistent, particularly in hospital wards, due to inadequate monitoring, insufficient equipment, and limited preventive maintenance. The transport of TTSPPs showed the poorest performance (31.1%), with minimal temperature monitoring and calibration procedures in place. Stock management practices were stronger at higher-level institutions, largely due to the support of the Medical Supplies Management Information System (MSMIS).

Conclusions: Overall, performance declined progressively from central to peripheral levels. Strengthening infrastructure, providing targeted in-service training, and instituting routine supervision using the assessment tool are recommended to enhance the reliability and sustainability of TTSPPs' quality assurance in Sri Lanka.