Quality of phenobarbital solid-dosage forms in the urban community of Nouakchott (Mauritania).
OBJECTIVE
Epilepsy is a major public-health problem in Africa. The quality of available drugs is a limiting factor for an adequate management. The aim of this study was to describe the proportion of poor-quality phenobarbital (PB) solid-dosage forms and evaluate the factors associated with its quality in Nouakchott (Mauritania).


METHODS
A cross-sectional study was carried out within pharmacies, hospitals, and on the parallel market in March 2003. PB samples were bought by a native person and then assayed by a liquid chromatography method. A package was considered to be of good quality if the active-substance average content was between 85 and 115% of the stated content printed on the packet.


RESULTS
Forty-five pharmaceutical stores were visited, enabling us to collect 146 samples of PB. Three brand names were available in Nouakchott. They originated from France, Morocco, Senegal, and Egypt. Results: A prevalence of 13.7%[95% confidence interval (CI), 8.8-20.0] of poor-quality PB was found. All samples from Morocco were underdosed. The generic active content was satisfactory, but saccharose, an excipient with a potential side effects, was identified. Two factors associated with the good quality of PB have been put forward: tablets manufactured in France and loose packaging as generics conditioned in such a way were of good quality.


CONCLUSIONS
This study shows that the quality of antiepileptic drugs in Africa is still worrying. The setting up of medicine quality control in Mauritania is legitimate. Considering the good quality of generic PB and its lower cost, this type of medicine should be promoted in this region.
Laroche
Marie-Laure
ML
Institute of Neuroepidemiology and Tropical Neurology (EA 3174), Faculty of Medicine, Limoges, France.
Traore
Hamidou
H
Merle
Louis
L
Gaulier
Jean-Michel
JM
Viana
Marylene
M
Preux
Pierre-Marie
PM
D000927:Anticonvulsants / Q000008:administration & dosage / Q000592:standards* / Q000627:therapeutic use; D002626:Chemistry, Pharmaceutical / Q000592:standards; D003431:Cross-Cultural Comparison; D003430:Cross-Sectional Studies; D016527:Drug Costs; D004345:Drug Industry / Q000592:standards; D016568:Drugs, Generic / Q000191:economics / Q000592:standards; D004827:Epilepsy / Q000188:drug therapy*; D006801:Humans; D008435:Mauritania; D010593:Pharmaceutical Services / Q000592:standards; D010594:Pharmacies / Q000592:standards; D010634:Phenobarbital / Q000008:administration & dosage / Q000592:standards* / Q000627:therapeutic use; D011786:Quality Control; D019984:Quality Indicators, Health Care / Q000706:statistics & numerical data; D013607:Tablets / Q000191:economics / Q000592:standards*; D014505:Urban Population / Q000706:statistics & numerical data
D000927:Anticonvulsants; D016568:Drugs, Generic; D013607:Tablets; D010634:Phenobarbital