WHO and the Global Antibiotic Research and Development Partnership (GARDP) have completed a review of regulatory and policy interventions by national regulatory authorities (NRAs) and other stakeholders to address antibiotic shortages in low- and middle-income countries. The report proposes a stepwise approach to addressing shortages, based on country contexts and informed by lessons learned from high-income countries' efforts to address shortages.
The first step in the approach is to strengthen the core functions of NRAs. Depending on the local context, subsequent measures start with policy implementation and structural changes to existing regulatory systems, such as for procurement from private sector channels or flexibility in labelling.
Where feasible, measures could then include regulatory changes, investment and enhanced multi-stakeholder decision-making, all to improve the availability and quality of supplies, such as through promoting high-quality local production and collaboration with manufacturers during shortages.
The most complex measures require significant systemic changes to increase the visibility of products on the market by forecasting or track-and-trace systems (with high logistical hurdles and extensive financial and human resources) or harmonizing regulatory strategies in a region.
Access to quality-assured antibiotics is critical for public health; however, shortages to these treatments are a recurring issue across the world. A 2022 survey of 29 European national pharmacist organizations revealed that 79% of respondents reported shortages of anti-infective agents, such as antibiotics, in the past year.
Shortages of quality-assured antibiotics are a significant challenge to health systems and make it harder to combat antimicrobial resistance (AMR). Shortages can also result in incomplete or inappropriate treatment , including overuse of broad-spectrum antibiotics and prolonged infections, which can exacerbate AMR. The risk is particularly high in Africa , where the burden of bacterial infections and the prevalence of AMR are highest.
Shortages occur when the supply of approved and marketed antibiotics essential for health systems is insufficient to meet public health and patient needs.
AMR occurs when bacteria, viruses, fungi and parasites no longer respond to medicines, making people sicker and increasing the risk of spread of infections that are difficult to treat, illness and deaths. AMR is an urgent global health and development threat. It is also a major economic challenge and could result in additional health care expenditures reaching US$ 412 billion annually, coupled with workforce participation and productivity losses of US$ 443 billion.
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.
