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• Respondents had good perception but poor solid/liquid medicine disposal practice. • Unused and expired solid & liquid medicines were disposed of in the environment. • Accidental ingestion, toxicity, environmental pollution are banes of poor disposal. • A retrieval system for unused/expired medicines should be established & regulated. Unused, damaged, and expired medicines (UEMs) pose disposal challenges globally, despite their importance. The environmental disposal of UEMs portends public health consequences, hence, this study in high-density (HDS) and low-density (LDS) urban households in Southwest Nigeria. The comparative, cross-sectional study utilised multi-stage sampling to enrol 404 females, experienced in use and medicines safekeeping. The response rate was 93%. Data were analysed by IBM-SPSS, version 20. Continuous and categorical variables were presented in tables as mean(±SD), proportions (%), respectively while χ2 and logistic regression statistics determined differences between LDS and HDS (P α > 0.05). 53.4% and 71.2% of respondents respectively had good knowledge and positive attitudes to safe disposal of UEMs. At least 31.5% of households don't stock medicines while antimalarial (57.3%), analgesics (52.7%) and antibiotics (49.7%) predominate in households and significantly different between LDS and HDS. 72.9% and 67.8%; 47.9% and 55.6% respondents in LDS and HDS, respectively, disposed of solid and liquid UEMs in storage bins, though 34.9% (LDS) and 16.7% (HDS) disposed of liquid UEMs in toilet/sink. There were significant differences in medicines abundance and disposal practices between LDS and HDS for solid and liquid medicines. 37.1% of respondents perceived consequences for the poor UEMs disposal, including accidental ingestion (76.6% vs 26.7%), land pollution (69.6% vs 36.7%), water pollution (72.4% vs 32.8%) and toxicity (58.3% vs 32.8%), respectively in LDS and HDS. Respondents' good knowledge and positive attitudes contrasted with poor UEMs disposal practices, which compromise public health. Legislation, compliance monitoring and enforcement are germane for incentive-driven UEMs recovery. [ABSTRACT FROM AUTHOR]

There are increasing reports of substandard antimalarial drugs, and these have been a severe under-recognised public health problem especially in developing countries. For this reason, 21 samples of different brands of artemisinin-based combination therapies (ACTs) comprising of artemether/lumefantrine and artesunate/amodiaquine oral drug formulations that are available on sale in different hospital pharmacies and patent medicine stores in Katsina State, Nigeria were evaluated for microbial and chemical qualities. Microbial limit test (MLT) and assay for the content of the active pharmaceutical ingredients (APIs) using standard high performance liquid chromatography (HPLC) procedures were carried out as described in the official monograph of the United States Pharmacopoeia (USP) and the International Pharmacopoeia (IP). The results obtained had indicated that all the ACTs oral drug preparations were free from microbial contamination except one sample of artesunate-amodiaquine showing viable total combined yeasts/moulds count (TYMC) of 1.0 x 10¹ colony forming units (CFU)/g. All the samples complied with the USP and IP criteria for the microbiological quality of non-sterile oral dosage forms. On the other hand, 10 (47.6%) out of the 21 samples met the specific chemical quality standards. Moreover, 8 (57.1%) and 3 (42.9%) of the artemether/lumefantrine and artesunate/amodiaquine had active ingredient outside the set pharmacopoeial limit and, therefore, were none compliant to the IP specifications for percentage content. The presence of substandard ACTs may lead to possible therapeutic failure from the use of such kind of formulations, facilitate the development and spread of drug-resistance. There is the need for effective government regulation and adequate enforcement on the production, distribution and sales of good quality medicines. [ABSTRACT FROM AUTHOR]

Despite the recommended methods of current good manufacturing practices (CGMP) and the efforts of the Government's regulations, there is still suspicion on the circulation of pharmaceutical products with questionable quality primarily in the developing countries. The circulation and use of substandard drugs pose a serious health risk to the patient, therapeutic failure of infectious disease, and the development and spread of antimicrobial resistance. Accordingly, a study on the pharmacopoeial quality was undertaken on oral drug preparations commonly prescribed in public hospitals in Katsina State, Nigeria. A total of 400 oral drug samples were evaluated for microbial and chemical quality using standard procedures as described in the official monograph of the British and United States pharmacopoeia. Microbial limit tests (MLT) was carried out on the sampled pharmaceutical products. Isolated microbial contaminants were identified via conventional microbiological protocols, PCR and 16S rRNAgene sequencing. On the other hand, the chemical quality was evaluated by assessing the presence and the percentage content of the stated active pharmaceutical ingredients using validated HPLC assay and titration methods. The results of the assessment of the microbial quality of the analyzed oral drug samples revealed that 174 comprising 43.5% of the samples had microbial contamination; of these, 82 (20.5%) failed to meet the acceptance criteria set for microbial quality of non-sterile oral dosage forms. The isolated microbial contaminants comprised of 175 (76.8%) bacterial isolates, and 53 (23.8%) fungal isolates. Phylogenetic analysis of the 16S rRNA gene sequences placed the isolates within the genus Bacillus, Enterobacter, and Pseudomonads and has shown a sequence similarity that ranged from 96 - 100% with other sequences of related bacteria strains from the NCBI data base. Similarly, the result of the chemical quality showed that 37.1% had active ingredient outside the set pharmacopoeial limit and therefore were none compliant to the BP, USP and IP specifications for percentage content. It is recommended that manufacturers of pharmaceutical products should strictly adhere to the current good manufacturing practices (CGMP) at any stage of production, as these may greatly affect the microbiologic and chemical quality of the finished pharmaceutical products. [ABSTRACT FROM AUTHOR]