Table 5. Univariate and multivariate analyses of associations of substandard, degraded and falsified samples with key risk factors (significant associations presented); N = 2824.
| Variable | Total samples | Poor quality samples | Crude odds ratios (95% CI) | Adjusted odds ratios (95% CI) | |
|---|---|---|---|---|---|
| The following are significant risk factors for poor quality (substandard, degraded and falsified) ACAs b | |||||
| Generic type | AM | 1701 | 80 (4.7%) | 1 | 1 |
| DHA | 501 | 72 (14.4%) | 3.4 (2.4,4.9) | 2.4 (1.6,3.4) | |
| AS | 622 | 43 (6.9%) | 1.5 (1.0,2.2) | 1.4 (0.9,2.2) | |
| WHO prequalified/ QAACT | not prequalified | 2047 | 190 (9.3%) | 1 | 1 |
| Prequalified | 777 | 5 (0.6%) | 0.06 (0.02,0.15) | 0.08 (0.02,0.3) | |
| AMFm | non AMFm drugs | 2072 | 191 (9.3%) | 1 | 1 |
| AMFm drugs | 752 | 4 (0.5%) | 0.05 (0.02,0.13) | 0.24 (0.1,0.8) | |
| Region of stated country of manufacture | Asia | 1940 | 159 (8.2%) | 1 | 1 |
| Africa | 546 | 30 (5.5%) | 0.7 (0.4,1.0) | 2.1 (1.3,3.2) | |
| Europe | 141 | 1 (0.7%) | 0.08 (0.01,0.6) | 0.04 (0.06,0.4) | |
| North America/unknown | 197 | 5 (2.6%) | 0.3 (0.1,0.7) | 12.5 (2.7,56.9) | |
| Expired at time of analysis | not expired | 2537 | 132 (5.2%) | 1 | 1 |
| expired a | 275 | 59 (21.5%) | 5.0 (3.6,6.9) | 6.4 (4.4,9.3) | |
| The following are significant risk factors specifically for falsified ACAs c | |||||
| Outlet type | Pharmacies | 1438 | 5 (0.4%) | 1 | 1 |
| PMVs | 1332 | 24 (1.8%) | 4.2 (2.0,12.0) | 3.9 (1.5,10.1) | |
| public health facilities | 54 | 0 | 1 | 1 | |
| Generic type | AM | 1701 | 8 (0.5%) | 1 | 1 |
| DHA | 501 | 18 (3.6%) | 7.8 (3.4,18.3) | 5.9 (1.9,18.1) | |
| AS | 622 | 3 (0.5%) | 1.0 (0.3,4.1) | 0.9 (0.2,3.5) | |
| Region of stated country of manufacture | Asia | 1940 | 7 (0.4%) | 1 | 1 |
| Africa | 546 | 17 (3.1%) | 8.9 (3.5,22.4) | 5.0 (1.9,13.2) | |
| Europe | 141 | 0 | 1 | 1 | |
| North America/unknown | 197 | 5 (2.5%) | 7.2 (2.4,21.1) | 27.9 (5.2,149.4) | |
ACAs = artemisinin-containing antimalarials; AM = artemether; AMFm = Affordable Medicines Facility—malaria; AS = artesunate;
CI = confidence interval; DHA = dihydroartemisinin; LR = likelihood-ratio; PMVs = patent medicine vendors; QAACT = quality-assured
artemisinin combination therapy; WHO = World Health Organisation.
aof these 59 expired samples 58% were suspensions that were substandard, while only 8% were tablets that were degraded.
badjusted for generic type, WHO prequalification, AMFm status, manufacture region, expired at time of analysis.
cadjusted for outlet type, provider health related qualification, generic type, AMFm status, manufacture region.