Policy and regulatory interventions to address antibiotic shortages in low and middle-income countries

Overview

Shortages of quality-assured antibiotics are a significant challenge to health systems and are a threat to combatting antimicrobial resistance (AMR). Shortages occur when the supply of approved and marketed antibiotics identified as essential by the health system is considered to be insufficient to meet public health and patient needs.

National regulatory authorities (NRAs), particularly in high-income countries, are becoming increasingly involved in measures to anticipate and mitigate antibiotic shortages. WHO and the Global Antibiotic Research and Development Partnership (GARDP) have undertaken a review of regulatory and policy measures being undertaken by NRAs and other stakeholders, including ministries of health and procurement agencies, to address antibiotic shortages. A stepwise approach to addressing shortages, based on country contexts, is proposed.

The review has been conducted as part of SECURE, an initiative of GARDP and WHO to increase sustainable, equitable, appropriate access to quality-assured antibiotics (www.secureantibiotics.org).