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The World Health Organization (WHO), in collaboration with the Global Antibiotic Research and Development Partnership (GARDP), recently released a report titled Policy and Regulatory Interventions to Address Antibiotic Shortages in Low- and Middle-Income Countries. The report is based on a review of measures undertaken by National Regulatory Authorities (NRA) in high-income countries (HIC), upper-middle-income countries, and low- and middle-income countries (LMIC) to address the critical issue of antibiotic shortages.
GARDP is an organisation focused on developing new treatments to combat drug-resistant infections while ensuring their responsible use and sustainable access. This study was conducted under SECURE, an initiative of GARDP and WHO aimed at ensuring sustainable and equitable access to quality-assured antibiotics. SECURE also works to enhance the capacity of LMICs to anticipate and prevent antibiotic shortages.
WHO defines antibiotic shortages as a scenario in which “the supply of approved and marketed medicines, health products and vaccines identified as essential by the health system is insufficient to meet public health and patient needs”. This is distinct from stock-outs, defined as the “complete absence of the medicine, health product or vaccine at the point of service delivery to the patient”.
Antibiotic shortages contribute to antimicrobial resistance (AMR) in several ways, according to the report. AMR occurs when bacteria and other microbes no longer respond to medicines, resulting in increased illness and a higher risk of infection spread. AMR is an urgent global health and development threat.
A shortage of antibiotics can delay or interrupt ongoing treatment, allowing bacteria more time to adapt and develop resistance. It can also lead to the use of substandard or falsified antibiotics that may not work effectively, causing treatment failure and promoting resistance.
Additionally, shortages often necessitate the use of broader-spectrum antibiotics, which can exert unnecessary selective pressure and reduce their long-term effectiveness, further exacerbating resistance. Addressing antibiotic shortages is thus vital to combating AMR effectively.
The report categories shortages in antibiotics at three levels ─ global, national and subnational and identifies measures to tackle them. Globally, shortages are due to weak supply chains and the limited number of manufacturers.
Nationally, access issues arise as a result of high prices that neither healthcare systems nor patients can afford. Furthermore, many countries lack monitoring systems capable of predicting demand for manufacturers in advance. At the subnational level, stock-outs often result due to inefficient distribution of stock, poor infrastructure and transport networks.
In an international workshop on AMR organised by the Delhi-based think tank Centre for Science and Environment in April 2024, national AMR focal points from African and Asian nations, along with global experts recognised that access to antibiotics is a big concern in LMICs.
Most antibiotics developed over the last several years got introduced only in few out of many rich countries. This was largely due to the high cost of marketing and making them available but low expected returns either due to volumes, price or both.
Furthermore, the northern richer countries are experiencing stockouts as antibiotics are withdrawn from their markets due to a lack of profitability. It could also be that antibiotics could be prior registered but not introduced in several countries due to commercial interests or regulatory burden. Inaccessibility could also be due to supply chain hurdles, procurement constraints, or affordability concerns.
The report noted that the problem of antibiotic shortages has not received enough attention, particularly in LMICs. For instance, most LMIC NRAs lack an official mandate to address shortages. Additionally, antibiotic shortages are often masked by frequent stock-outs and circulation of substandard or falsified medicines. There is need for stringent enforcement mechanisms so that these unregulated products are removed from the market, the paper stated.
The report further explored whether the approach taken by HIC NRAs can be used in LMIC NRAs and other authorities to manage antibiotic shortages. Based on a comprehensive review of ongoing activities to address antibiotic shortages, it outlined five categories of measures that can be adopted:
Enhance flexibility for acute shortages: A flexible approach from countries is essential in managing acute shortages of critical medicines. This can include allowing temporary imports, extending the expiry dates safely and waiving specific testing requirements.
Strengthen sourcing: It focuses on anticipating shortages by strengthening procurement and manufacture of products. Measures such as multiple suppliers, encouraging local production, and maintaining buffer stocks have been highlighted.
Increase visibility: This includes information-sharing on potential future and existing shortages. It’s important to understand how medicines move within the country and where shortages might happen.
Institutionalize collaboration: This means setting up systems to handle future shortages better by creating emergency plans and building strong working relationships.
Strengthen foundation: It is pivotal to strengthen the core functions of the NRA which include improving regulatory approval processes, ensuring quality control and effective enforcement.
These recommendations provide a roadmap for countries to strengthen their health infrastructure and protect against future crises. When implemented holistically, these can help prevent shortages and prepare a country to act rapidly when necessary.
The report also stressed that ensuring access to essential antibiotics is a critical step in safeguarding healthcare systems worldwide.