United States Pharmacopoeia Convention
USP appreciates the opportunity to comment on the DG’s report on Antimicrobial Resistance and notes the significant progress underway. We highlight that medicines quality should be an integral part of AMR stewardship and National Action Plans (NAPs).
Poor-quality medicines contribute to treatment failure and directly drive pathogen resistance to life-saving treatments such as antibiotics and antimalarials. When patients receive sub-therapeutic doses from medicines it has the same effect as not taking the medicine as prescribed. Treatment adherence as a strategy of AMR stewardship will be undermined in settings with substandard medicines.
Published and ongoing laboratory research suggests that degraded and substandard medicines for tuberculosis and malaria fuel drug resistance and spread and could render current treatments ineffective.
Poor-quality antimicrobial medicines are found throughout the world, disproportionately in LMICs with under-resourced regulatory systems. On average, 12.4% of antibiotics and 19.1% of antimalarials are substandard or falsified in low resource settings. Co-endemics of infectious diseases and substandard medicines threaten health security globally.
Unlike other factors driving AMR, there are known solutions to assuring medicines quality.
• We commend WHO for increasing antimicrobial drug quality surveillance under the Global Surveillance and Monitoring System.
• Coordination between WHO’s AMR and Essential Medicines programs would facilitate information-sharing about how substandard medicines may contribute to drug resistance.
• The WHO “Prevent, Detect, Respond” framework for substandard and falsified (SF) medicines offer national regulatory authorities guidance in integrating medicine quality into NAPs, building regulatory capacity to deter SF presence in the market while generating evidence through surveillance and research.
We commit to collaborating with WHO and Member States to ensure antimicrobial drug quality.