Crisis management in the community mass recall of angiotensin II receptor blocker losartan due to nitrosamine impurities

Abstract

Introduction Angiotensin II Receptor Blockers (ARB) are widely utilized in the treatment of hypertension and nephropathy. In March 2019, a mass recall of selected brands of an ARB, losartan due to reported elevated levels of potentially carcinogenic nitrosamine impurities was implemented in a Singapore primary care institution. Objective To describe the crisis management of the mass losartan recall in a public primary healthcare institution in Singapore. Methods The crisis management framework was adapted from the Gonzalez-Herrero and Pratt model. This crisis was managed over three phases: identification of impending crisis based on risk reports by local health authorities, formation of a task force to develop turnaround strategies and measures, implementation and monitoring of the remedial measures. Data to plan and chart implementation was retrieved from the institution databases, including the Electronic Health Intelligence System for patient medical and prescription records, Outpatient Administrative System for reimbursement of medications and other expenditures incurred. An exigency scheme, Losartas® Review Service (LRS), was established to expedite the replacement of the affected medication with another ARB or another anti-hypertensive medication. Results SingHealth Polyclinics completed the recall of 29,794 (92.1%) patients within 14 weeks. The majority of the patients (76.2%) were attended to by doctors, while 16.5% and 7.3% were managed using the LRS and pharmacy respectively. The institution incurred a cost of SGD2,824,760 (estimated SGD95 per patient) to manage the crisis. Conclusion The successful implementation of a mass medication recall hinged on timely intervention, cross-departmental coordination, effective communication and judicious resource allocation.