Table 2 Features of packaging and labeling for oral artemisinin-containing pharmaceutical products at pharmacies in Dar-es-Salaam, Tanzania
Feature | Frequency |
|---|---|
General features | |
Packaged and sold as a unit dose | 19 (100%) |
Package insert included | 19 (100%) |
Image of mosquito appears on package | 7 (37%) |
TFDA Package and labeling requirements | |
International non-proprietary name included | 19 (100%) |
Non-proprietary name is printed larger or bolder* | 0 |
Strength of active ingredient identified | 19 (100%) |
Name and address of registrant identified | 17 (89%) |
Name and address of manufacturer other than registrant identified | 7 (37%) |
Labeled "Keep out of reach of children" | 10 (53%) |
Lot or batch number | 19 (100%) |
Expiry date | 19 (100%) |
Date of manufacture | 18 (95%) |
TFDA Registration number | 6 (32%) |
TFDA Package insert requirements | |
Indication (uncomplicated malaria) | 19 (100%) |
Dosage regimen | 19 (100%) |
Contraindications | 12 (63%) |
Side effects | 19 (100%) |
Drug interactions | 11 (58%) |
Precautions and warnings | 18 (95%) |
Symptoms and treatment of overdose | 11 (58%) |
Presentation (e.g. "12 tablets of 100 mg each") | 19 (100%) |
Storage instructions | 13 (68%) |
Shelf life | 14 (74%) |
Name and address of manufacturer other than registrant identified | 6 (32%) |
Date of publication of package insert | 9 (47%) |
Appropriateness of recommended dose | |
Recommended total adult dose consistent with international standards** | 4 (21%) |
Recommended duration consistent with international standards*** | 5 (26%) |
Mentions that non-immune patients may require additional doses | 2 (13%) |
Gives dosages for children | 17 (89%) |
Specifically formulated for children | 4 (21%) |