WHO-GARDP Report on Antibiotic Shortages

Recently the World Health Organization (WHO) and the Global Antibiotic Research and Development Partnership (GARDP) released a report titled ‘Policy and Regulatory Interventions to Address Antibiotic Shortages in Low- and Middle-Income Countries.

• The report examines global, national, and subnational measures to address antibiotic shortages, with a focus on low- and middle-income countries (LMICs).
• This study was conducted under the SECURE initiative, which aims to ensure equitable and sustainable access to quality-assured antibiotics. 

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About 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”. 
• Stock-Outs: Complete absence of antibiotics at the point of service delivery.

Factors Contributing to Antibiotic Shortages

• Global Level:
  • Weak supply chains and limited manufacturers.
• National Level:
  • High prices, making antibiotics inaccessible for patients and healthcare systems.
  • Lack of predictive demand-monitoring systems for manufacturers.
• Subnational Level:
  • Stock-outs caused by poor infrastructure, inefficient distribution, and weak transport networks.

Challenges Specific to LMICs

• In LMICs, most National Regulatory Authorities (NRAs) lack mandates to address shortages.
• Antibiotics are often unavailable due to high marketing costs, low profitability, or regulatory barriers.
• Circulation of substandard or falsified antibiotics further complicates access.

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Global Disparities in Access

• New antibiotics are often introduced only in wealthy countries due to commercial interests, leaving LMICs underserved.
• Stock-outs are becoming more frequent even in richer countries as antibiotics are withdrawn from markets due to lack of profitability.

Implications of Antibiotic Shortages

• Antimicrobial Resistance (AMR):
  • Delayed or interrupted treatments allow bacteria to adapt and develop resistance.
  • Use of substandard or falsified antibiotics due to shortages promotes treatment failures and resistance.
  • Increased reliance on broad-spectrum antibiotics exacerbates resistance by applying unnecessary selective pressure.

Broader Implications

• Healthcare Systems: Antibiotic shortages jeopardize the effectiveness of healthcare systems and increase vulnerability to AMR.
• Global Equity: Strengthening LMIC capacities to anticipate and manage shortages is crucial for achieving equitable access.
• Urgency: Addressing shortages is essential for safeguarding public health and reducing the economic and social burden of AMR.

Recommendations for Addressing Antibiotic Shortages

The report identifies five key strategies:

1. Enhance Flexibility for Acute Shortages:
   • Allow temporary imports and safely extend expiry dates during shortages.
2. Strengthen Sourcing:
   • Encourage multiple suppliers, local production, and maintain buffer stocks to anticipate shortages.
3. Increase Visibility:
   • Share information about potential and existing shortages and map the movement of antibiotics within a country.
4. Institutionalize Collaboration:
   • Develop emergency plans and build collaborative frameworks to handle future shortages.
5. Strengthen Foundational Systems:
   • Improve core regulatory functions such as quality control, enforcement, and approval processes.

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Conclusion

The WHO-GARDP report underscores the critical need for integrated, proactive measures to manage antibiotic shortages. By adopting a combination of the recommended strategies, countries can build resilient healthcare systems capable of combating AMR and ensuring sustainable access to life-saving antibiotics.