Development of a high-alert medicines list and pilot testing of error prevention strategies in Sri Lanka: a cross-sectional mixed methods study

High-alert medicines (HAM) cause preventable harm. This study aimed to develop a national HAM list and corresponding error prevention strategies (EPS) for hospital and community pharmacy settings in Sri Lanka. A mixed-methods cross-sectional observational study was conducted. Potential HAM were identified through an interviewer-administered questionnaire completed by 315 pharmacists from government (n=155) and private (n=160) sectors. Concurrently, a research pharmacist documented HAM-related problems and errors over three years. Additional HAM were identified by reviewing the Institute for Safe Medication Practices (ISMP) HAM list. A draft HAM list was refined and validated during five national stakeholder meetings convened by the Directorate of Healthcare Quality and Safety, Ministry of Health, Sri Lanka, involving 62 multidisciplinary stakeholders. These medicines were categorized using the A-PINCH (O) framework. EPS were developed through literature review and pilot-tested at a tertiary care hospital in Colombo. Key strategies included red-colour labelling, HAM stickers, separate storage, enhanced counselling, improved labelling, and patient information leaflets in Sinhala and Tamil for ten prioritised medicines. Feasibility was evaluated one year post-implementation using a questionnaire and three focus group discussions among hospital pharmacists (n=45). Quantitative data were analysed descriptively and qualitative data thematically. HAM identification differed by source: pharmacists (n=43), research pharmacist (n=40), ISMP list (n=80), and stakeholders (n=20). The validated list included 100 HAM for acute care settings, mainly injectable medicines, and 40 HAM for community settings, predominantly oral medicines. Awareness of the HAM list was 95.6% following implementation. Self-reported adherence to EPS, use of HAM labels and stickers, and availability of patient information leaflets were each 100%. Overall, 93.2% of pharmacists reported counselling patients on HAM requiring special instructions. Five themes emerged: usefulness, content adequacy, EPS implementation, operational barriers, and recommendations. National HAM lists for acute care and community settings were successfully developed. Pilot-tested EPS demonstrated high feasibility and acceptability, supporting national implementation and informing MOH policy through an official circular.