Table 4.
Risk factors associated with substandard (n=11) and falsified (n=50) ACAs (n=677)
| Sample characteristics of ACAs | Total number of samples | Poor-quality samples | Crude ORs (95% CI) |
Likelihood- ratio p value | |
| Generic type | AM | 350 | 34 (9.7%) | 1 | 0.36 |
| DHA | 3 | 1 (33.3%) | 4.6 (0.4 to 52.6) | ||
| AS | 324 | 26 (8.0%) | 0.8 (0.5 to 1.4) | ||
| WHO prequalified/AQACT | Not prequalified | 379 | 35 (9.2%) | 1 | 0.82 |
| Prequalified | 298 | 26 (8.7%) | 0.9 (0.6 to 1.6) | ||
| AMFm | Non-AMFm medicines | 579 | 36 (6.2%) | 1 | <0.001 |
| AMFm medicines | 98 | 25 (25.5%) | 5.2 (2.9 to 9.1) | ||
| Region of stated country of manufacture | Asia | 471 | 33 (7.0%) | 1 | <0.001 |
| North America | 71 | 26 (36.6%) | 7.7 (4.2 to 14.0) | ||
| Not stated | 73 | 2 (2.7%) | 0.4 (0.1 to 1.6) | ||
| Expired at time of analysis | Not expired | 663 | 56 (8.4%) | 1 | <0.001 |
| Expired* | 14 | 5 (35.7%) | 6.0 (2.1 to 17.0) | ||
| Outlet type | Pharmacies | 519 | 51 (9.8%) | 1 | 0.14 |
| Medicine vendors | 75 | 5 (6.7%) | 0.7 (0.3 to 1.7) | ||
| Private clinics | 89 | 5 (5.6%) | 0.5 (0.2 to 1.4) | ||
*Of the five expired samples, one was a falsified tablet and four were substandard suspensions.
ACAs, artemisinin-containing antimalarials; AM, artemether; AMFm, Affordable Medicines Facility—malaria; AQACT, acceptable quality-artemisinin combination therapy; AS, artesunate; DHA, dihydroartemisinin; ORs, odds ratio.