Quality and efficacy of two locally-manufactured generic albendazole (ABZ) products (Curex and Royal Drug) used for de-worming children in Nepal since 1999 were tested against the originator product (GSK). The study conducted disintegration and dissolution testing and a randomised controlled clinical trial comparing cure rates (CR) and egg reduction rates (ERR) for Ascaris lumbricoides, Trichuris trichiura and hookworm infections. Stool samples from 1277 children were examined before and 21 days after treatment. For A. lumbricoides GSK's (97.0%) and Royal Drug's (95.0 %) product provided significantly higher CR than Curex's (82.6%); however, all products provided ERR higher than 90%. For T. trichiura Curex's product showed significantly lower ERR (63.2%). For hookworm, GSK's product performed significantly better (CR 74.3%, ERR 87.1%) than Royal Drug's (CR 53.3%, ERR 80.8%) and Curex's (CR 50.7%, ERR 73.1%). Only GSK's product passed both disintegration and dissolution. Both generic products failed dissolution. Curex's product showed poor disintegration. Despite its lower efficacy the cheaper Curex's product achieved good results in controlling morbidity due to soil-transmitted helminth (STH) infections. This study shows that cost-effectiveness of drugs used in mass de-worming campaigns should not be inferred on the basis of one single quality testing parameter.
Objectives
The aim of the study was to find the compliance of selected pharmacy outlets with nine major provisions of Drugs Act, 1978 and Codes on Sales and Distribution of Drugs, 2014: registering pharmacy outlets, storing and dispensing registered medicines, separately keeping expired medicines, presence of authorized personnel while dispensing, presence of pharmacy registration certificate, renewing annually pharmacy registration certificate, keeping narcotic/psychotropic medicines, updating narcotic/psychotropic medicines record and having sign board of pharmacy outlet.
Methods
Cross‐sectional, observational study of pharmacy outlets was conducted using pretested, semistructured questionnaire and by direct observation in pharmacy outlets of two development regions of Nepal: Central Development Region and Western Development Region for above nine indicators of regulatory provisions. The preliminary data were analysed for descriptive statistics and Mann–Whitney test.
Key findings
Pharmacy outlets failed to comply with the regulatory provisions. Presence of authorized personnel in pharmacy outlets controlled non‐compliances partly only.
Conclusions
Stakeholders should come up with future stringent interventions for curbing such non‐compliances.
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