Why Assuring the Quality of Antimicrobials Is a Global Imperative

Amy B Cadwallader1, Kavitha Nallathambi2, Carly Ching3

  • 1Director of regulatory and public policy development at US Pharmacopeia.

PubMed

Insights

Poor-quality antimicrobial medicines endanger global health, particularly in low-income nations. This article examines the risks of substandard antimicrobials and proposes regulatory reforms to enhance supply chain integrity and drug quality.

Area of Science:

  • Pharmaceutical Sciences
  • Global Health Security
  • Medicinal Chemistry

Background:

  • Substandard and falsified antimicrobial medicines are a significant global threat.
  • Poor-quality drugs compromise treatment efficacy and patient safety.
  • Low- and middle-income countries disproportionately affected by counterfeit medicines.

Purpose of the Study:

  • To discuss the multifaceted risks associated with poor-quality antimicrobial medicines.
  • To highlight the link between substandard antimicrobials and antimicrobial resistance.
  • To recommend policy and regulatory interventions for supply chain improvement.

Main Methods:

  • Literature review of antimicrobial drug quality issues.
  • Analysis of supply chain vulnerabilities.
  • Synthesis of regulatory and policy recommendations.

Main Results:

  • Poor-quality antimicrobials contribute to treatment failures and adverse events.
  • Substandard medicines exacerbate the crisis of antimicrobial resistance.
  • Existing supply chains lack robust mechanisms for quality assurance.

Conclusions:

  • Strengthening regulatory oversight is crucial for ensuring antimicrobial quality.
  • Policy reforms are needed to build resilient pharmaceutical supply chains.
  • International collaboration is essential to combat the proliferation of poor-quality medicines.

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