Abstract
BackgroundThe use of substandard and degraded medicines is a major public health problem in developing countries such as Cambodia. A collaborative study was conducted to evaluate the quality of amoxicillin–clavulanic acid preparations under tropical conditions in a developing country.MethodsAmoxicillin-clavulanic acid tablets were obtained from outlets in Cambodia. Packaging condition, printed information, and other sources of information were examined. The samples were tested for quantity, content uniformity, and dissolution. Authenticity was verified with manufacturers and regulatory authorities.ResultsA total of 59 samples were collected from 48 medicine outlets. Most (93.2%) of the samples were of foreign origin. Using predetermined acceptance criteria, 12 samples (20.3%) were non-compliant. Eight (13.6%), 10 (16.9%), and 20 (33.9%) samples failed quantity, content uniformity, and dissolution tests, respectively. Samples that violated our observational acceptance criteria were significantly more likely to fail the quality tests (Fisher’s exact test, p < 0.05).ConclusionsImproper packaging and storage conditions may reduce the quality of amoxicillin–clavulanic acid preparations at community pharmacies. Strict quality control measures are urgently needed to maintain the quality of amoxicillin–clavulanic acid in tropical countries.
Highlights
The use of substandard and degraded medicines is a major public health problem in developing countries such as Cambodia
Selection of medication and study area Combination tablets of amoxicillin–clavulanic acid were selected from the essential medicine list of Cambodia in consultation with the country’s Ministry of Health (MoH)
A Cambodian registration number was found on 93.2% of the samples
Summary
The use of substandard and degraded medicines is a major public health problem in developing countries such as Cambodia. A collaborative study was conducted to evaluate the quality of amoxicillin–clavulanic acid preparations under tropical conditions in a developing country. Medicine plays an important role in maintaining health, preventing disease and saving lives. Ineffective medicines pose great risks to individuals and even threaten lives in emergencies [1,2]. Ineffectiveness takes several forms, such as medicines containing less than the stated dose of the active ingredient or containing unstated or harmful substance(s). Amoxicillin–clavulanic acid is available in a variety of doses: 250/125 mg (2:1), 500/125 mg (4:1), 875/125 mg (7:1), 1000/125 mg (8:1), and 2000/125 mg (16:1). 125 mg of clavulanic acid is sufficient to inhibit β-lactamase–producing organisms. Insufficient doses and inappropriate use of such potent antibiotics may lead to the development of resistance [15]
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