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Published on: August 30, 2018
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.
Abstract:
Poor-quality antimicrobial medicines continue to proliferate across supply chains, threatening patients' health and safety, especially in low- and middle-income regions. This article discusses consequences and risks of antimicrobial resistance and other ways in which antimicrobial medicines can be of poor quality and recommends regulatory and policy reforms to help maintain supply chain resilience and quality of antimicrobial medicines.
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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