Descriptions of Reports Submitted via the Smartphone Application in Tanzania and Subsequent Outcomes
| Region | n | Report Type | Product | Product Type | Product Suspected to Be Substandard or Falsified | Product Suspected to Have Caused Adverse Reaction or Unexpected Lack of Efficacy | Reporting Reason | Testing Results | Conclusion | TMDA Action | Reported to WHO |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Mbeya | 6 | Medicine | Combiart | Antimalarial | Substandard |
No (n=5) Yes (n=1) | N/A | Passed Minilab by TLC but failed visual inspection - foreign marks on tablets and no manufacturing date on primary container | Falsified | Recall | Yes |
| Mbeya | 1 | Medical device | NeoVac | IV cannula | Falsified | Yes | Not functioning properly | Sterility failure | Substandard | Recall | Yes |
| Mbeya | 1 | Medical device | Kit Kath | IV cannula | Falsified | Yes | Not functioning properly | Sterility failure | Substandard | Recall | Yes |
| Dar es Salaam | 1 | Medical device | CareStart Malaria | Rapid diagnostic test | Substandard | Yes | Errored/no results; using up to 5 rapid diagnostic test per patient | N/A | Substandard | Recall | Yes |
| Dar es Salaam | 3 | Medicine | Diclofenac Injection | Analgesic | Substandard |
Yes (n=2) No (n=1) | N/A | N/A | Substandard | Recall | Yes |
| Arusha | 1 | Medicine | Adrenaline | Broncho-dilator/cardiac stimulant | Substandard | Yes | N/A | N/A | Unregistered | Recall | N/A |
| Tabora | 2 | Medicine | Metronidazole tablets |
Antibiotic/antibacterial/ antiprotozoal | Substandard |
Yes (n=1) No (n=1) | N/A | N/A | Unregistered | Recall | N/A |
| Mwanza | 1 | Medicine | Tranexamic acid tablets (Tranacad) | Antifibrinolytic | Substandard | Yes | N/A | Not tested due to no sample available | No conclusion | N/A | N/A |
| Mwanza | 1 | Medical device | Sterile umbilical cord clamp | Umbilical cord clamp | Substandard | Yes | N/A | Not tested due to no sample available | No conclusion | N/A | N/A |
| Mwanza | 1 | Medicine | Coram 10 | Antihypertensive | Substandard | Yes | N/A | N/A | Genuine | N/A | N/A |
| Arusha | 1 | Medicine | D5 infusion injectable solution | Hydrous dextrose | Substandard | Yes | Leakage of product | N/A | Genuine | N/A | N/A |
| Mtwara | 1 | Medicine | LARTEM | Antimalarial | Substandard | Yes | ADRs | N/A | Genuine | N/A | N/A |
Abbreviations: ADR, adverse drug reaction; N/A, not applicable; TLC, thin-layer chromatography; TMDA, Tanzanian Medicines and Medical Devices Authority; WHO, World Health Organization.