Goal

This project aims to review oral antibiotics in the AWaRe (Access, Watch, Reserve) system that are not included in the WHO Model List of Essential Medicines (EML) – a “Grey Group”. 

Lead

Shrey Mathur – City St George’s, University of London

What we did

Global data for Grey Group antibiotics were assessed for regulatory approvals (USA, UK, India, Tanzania, Nigeria, Thailand, and Egypt), inclusion in 80 Standard Treatment Guidelines (STGs) and 137 National Essential Medicines Lists (NEMLs), and sales data from 74 countries.

Key learnings

Key findings indicate that 58% of Grey Group antibiotics are oral Watch antibiotics. Only 3% are approved by all seven WHO-Listed Authorities (WLA), while 54% have no approvals. 58% of Grey Group antibiotics were not included in any of the 137 NEMLs. STGs listed 32% of Grey Group antibiotics. Overall, 40 Grey Group antibiotics were not included in any of the WLAs, STGs and NEMLS, of these 37.5% were Watch. Grey Group antibiotics accounted for 15.4% of all oral antibiotic sales in 2019, with 83.2% being oral Watch antibiotics. The study concludes that, given the high number of Watch Grey Group antibiotics lacking regulatory approval, countries may need to consider the availability of these antibiotics to help reach Access targets. 

Outputs

TBC

Funder

The Wellcome Trust