Quality of selected drugs in Cambodgia, 1995
F. Gimenez (PSF & ReMeD), C. Bruneton (ReMeD), D.Y. Narong Rith (Ministery of Health, Cambodgia)
Parteners : Ministery of Health of the Kingdome of Cambodgia,
Pharmacists without boarders-PSF
French Ministery of Cooperation
French public and private quality contrôle laboratories
Scanning of three pharmaceutical sectors
- public sector : Central Medical Store
- private sector : 600 private pharmacies
- illicite sector
Selection of drugs to be studied
Most commonly used drugs were selected : amoxicilline, benzylpenicilline, chloramphenicol, cotrimoxazole, mebendazole, metronidazole, quinine, tetracycline
The collection of samples were arranged and revealed the maximum of information detailed on a special document.
n° of assessesment (n° : day/month/place), place and organisation
nomination and description of the product : generic name (DCI), commercial name, dose and dosage form, name and adress of the manufacture, batch number, expiry date, origine of the wrapping (bulk, box, blister...), quantity in stock, price...
ReMed 144 distributed and analysed samples in 6 private or public quality contrôle laboratories according to their availability and competence.
The anonymity of the manufacturers was respected since the analysis was identified by secret codes.
In sample analysis, the lab used it’s usual methods
Standards of consistency
A sample’s dose was considered inconsistent if :
- Dose was out of + 10% of the content indicated by the manufacturer
- and/or, the identification and the assay didn’t respond to the specifications stated in the pharmacoepia of référence.
This non-consistent results were regrouped into three classes according to the types of inconsistencies and/or the risk
- class A = under-dose,
with or without the presence of degradation products or impurities
- class B = substitution of the active ingredient by another active ingredient or by an inert product.
- class C = manufacturing défaut,
absence of mass uniformity, degradation time higher than normal, overdose.
This study, realized with limited financial means reflects the situation in termes of quality of drugs in a geographical area and a given time. Meanwhile, the number of analyzed samples is insufficient to be able to withdraw conclusion of a statistical value.
3 drugs were under-dosed assessed in the private sector bulk
cotrimoxazole was replaced by paracetamol
mebendazole was replaced by metronidazole (label present)
metronidazole was replaced by mebendazole (2 cases)
metronidazole replaced by chloramphenicol
quinine replace by a non-identified active ingredient
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