Successful mass recall of losartan in SG hinges on timely intervention, coordination

Singapore has completed a mass medical recall of the tainted angiotensin II receptor blocker (ARB) losartan due to reported elevated levels of potentially carcinogenic nitrosamine impurities. Its success has been credited to timely intervention, cross-departmental coordination, effective communication, and judicious resource allocation, according to a recent study.

“The recall of the tainted losartan was a national healthcare crisis,” the researchers said.

“The crisis management plan underpins the framework of the Losartas Review Service (LRS). The early decision of institution leaders to form the crisis management task force was crucial in the successful formulation and coordinated implementation of the crisis management plan,” they added.

The Gonzalez-Herrero and Pratt Model was adapted to create the crisis management framework. The crisis management had three phases: (1) identification of impending crisis based on risk reports by local health authorities, (2) formation of a task force to develop turnaround strategies and measures, and (3) implementation and monitoring of the remedial measures.

The researchers retrieved data to plan and chart implementation 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.

LRS, an exigency scheme, was then established to speed up the replacement of the affected medication with another ARB or antihypertensive medication.

SingHealth Polyclinics successfully recalled 29,794 (92.1 percent) patients within 14 weeks of the Singapore Health Sciences Authority notification in March 2019. Doctors attended most of the patients (76.2 percent), while the LRS and pharmacy managed 16.5 percent and 7.3 percent, respectively. [Proc Singap Healthc 2022;doi:10.1177/20101058221129715]

To manage this medical crisis, the institution spent a total of SGD 2,824,760 or about SGD 95 for each affected patient.

“While the cost incurred was significant, prioritizing timely interventions to reduce the risk of our patients developing any potential adverse events was the institution’s priority,” the researchers said. “This is in keeping with SingHealth’s philosophy of care: Patients. At the heart of all we do.”

Crisis management

The alertness of institution leaders was a critical factor in the crisis management process, which led to the early formation of a multidisciplinary task force. At least nine in 10 patients received a medication replacement in this crisis.

The local healthcare system allowed patients to gain access to any healthcare provider without geographical restriction. While no official registry was implemented throughout the primary healthcare system, the Healthcare Information Department in the institution successfully generated a list of patients prescribed losartan at a previous polyclinic visit.

“The expeditious call to action has preserved the institution’s reputation and maintained the patients' trust,” the researchers said.

“This further highlights the importance of effective and timely crisis management, as adverse events can detrimentally erode the patient’s confidence in the healthcare system,” they added.

ARBs are used to treat hypertension and nephropathy.