A Prospective Multicentric Development and Validation Study of a Patient-Reported Experience Measures (PREMS) Tool to Assess Medication Administration Safety in Indian Hospitals

Abstract Background Medication errors remain a leading cause of preventable harm worldwide. Existing safety assessments rely mainly on audits and staff reports, which often overlook patients’ perspectives. Patient-Reported Experience Measures (PREMs) offer a structured way to capture patients’ views on medication administration safety. However, no PREM tool has been developed in India. Objective To develop, validate, and apply a patient-centred PREM tool for assessing medication administration safety in Indian hospitals. Methods This prospective, multicentre study was conducted across 16 hospitals (September 2023–April 2024). Tool development followed standard questionnaire design processes, including expert focus groups, face/content validation, and piloting. The final 15-item checklist used binary (yes/no) responses. Reliability was assessed using Kuder-Richardson Formula 20 (KR-20). A total of 614 adult inpatients (>24 h stay) completed the questionnaire. Results Content validity indices showed excellent agreement (S-CVI/Ave = 0.96). Internal consistency was acceptable for an early-phase validation study (KR-20 = 0.66). High adherence was reported for safety practices such as identity verification (95.0%) and allergy history documentation (94.8%). Areas for improvement included cost communication (68.6%) and disclosure of side effects (67.4%). Missed or skipped doses were reported by 17.3% (95% CI, 14.5%–20.5%) of patients. Conclusion This is the first multicenter effort in India to developed and early-phase validated a PREMs tool for medication administration safety. The tool demonstrated feasibility and patient acceptability, while highlighting key safety gaps. Future work will focus on psychometric refinement and wider application, including integration into national quality assurance frameworks.