Investigating the Presence of Falsified and Poor-Quality Fixed-Dose Combination Artemether-Lumefantrine Pharmaceutical Dosage Forms in Kumasi, Ghana.

Artemether-lumefantrine (AL) is a highly effective and commonly used Artemisinin-based Combination Therapy (ACT) for treating uncomplicated malaria caused by Plasmodium falciparum, including drug-resistant strains. However, ineffective regulatory systems in resource-limited settings can lead to the infiltration of poor-quality and counterfeit antimalarial medicines into the pharmaceutical supply chain, causing treatment failures, prolonged illness, and disease progression. The objective of the study was to assess the quality of selected brands of fixed-dose combination (FDC) AL tablets and suspensions marketed in Kumasi, Ghana. A total of fourteen brands of FDC AL medicines, comprising eight tablets and six suspensions were purchased from various retail pharmacy outlets in Kumasi, Ghana. All samples were subjected to thorough visual inspection as a quick means of checking quality through meticulous observation of the packaging or dosage form. The quality parameters of the tablets were determined using uniformity of weight, hardness, friability, and disintegration tests. Suspensions were assessed based on pH and compared with the British Pharmacopeia (BP) standard. The samples were then analyzed for drug content (assay) using reverse-phase high-performance liquid chromatography (RP-HPLC). All the tablet samples conformed to BP specification limits for uniformity of weight (deviation of less than ± 5%), hardness (4.0-10 kg/mm2), friability (<1%), and disintegration time (<15 minutes). The active pharmaceutical ingredients' quantitative assay demonstrated that all the tablets met the BP specifications (90-110%). The results of the pH studies showed that out of the six brands of suspension investigated, five (83.3%) were compliant with the official specification for pH, while one (16.7%) failed the requirement. Unlike the tablet brands, drug content analysis of the six suspensions showed that two (33.3%) were substandard. The artemether and lumefantrine contents in these failed suspensions were variable (artemether: 81.31%-116.76%; lumefantrine: 80.35%-99.71%). The study results indicate that most of the tested products met the required quality standards, demonstrating satisfactory drug content and other quality specifications. The presence of substandard drugs underscores the necessity for robust pharmacovigilance and surveillance systems to eliminate counterfeit and substandard drugs from the Ghanaian market.

Development of the RP-HPLC Method for Simultaneous Determination and Quantification of Artemether and Lumefantrine in Fixed-Dose Combination Pharmaceutical Dosage Forms.

Developing countries face enormous challenges with substandard and falsified antimalarial drugs. One specific issue is the lack of a simple, cost-effective, and robust HPLC method to simultaneously determine and quantify the active pharmaceutical ingredients (APIs) in fixed-dose artemether-lumefantrine pharmaceutical dosage forms. The current study developed a novel, simple, sensitive, precise, accurate, and cost-effective RP-HPLC method for the simultaneous determination and quantification of artemether and lumefantrine in pharmaceutical dosage forms. The HPLC analysis was carried out on an Agilent 1260 Infinity Series HPLC system equipped with an ODS Intersil-C8 (150 × 4.6 mm) 5.0 µm column, by isocratic elution. The mobile phase composition consisted of acetonitrile and 0.05% orthophosphoric acid buffer of pH 3.5 in the ratio of 70 : 30 v/v. The analysis was performed at a 1 mL/min flow rate and a column temperature of 25°C. The total run time was 6 minutes. The detection was done with a variable wavelength detector (VWD) at an isosbestic point wavelength (λ) of 210 nm. The developed method was validated according to the ICH guidelines concerning system suitability, specificity, linearity, accuracy, precision, and robustness. The system suitability of the developed method revealed satisfactory theoretical plates and symmetry factors. The method proved to be specific, with no interference of mobile phase or excipients. The calibration plot exhibited linearity over the concentration range of 275-1925 µg/mL with R2 = 0.9992 for artemether and a range of 150-1050 µg/mL with R2 = 0.9985 for lumefantrine. The accuracy of the method, determined by the recovery study, was 99.79-100.16% for artemether and 99.04-99.50% for lumefantrine. The % RSD values for intraday precision were 0.175 and 0.203, while interday precision values were 0.340 and 0.554 for artemether and lumefantrine, respectively. The method demonstrated robustness when subjected to slight modifications in the flow rate, column temperature, and mobile phase composition. The developed analytical method proved satisfactory as per ICH guidelines and hence can be used for the determination and quantification of artemether and lumefantrine in bulk drug and pharmaceutical dosage forms.

Self-medication among pregnant women in Ghana: A systematic review and meta-analysis.

Background: Despite the associated health risks of self-medication during pregnancy, recent evidence suggests that the phenomena persist in most countries. However, self-medication during pregnancy in Ghana is poorly understood due to the lack of a comprehensive review study. Objectives: We sought to review existing literature on the prevalence of self-medication, drugs used in self-medication, diseases associated with self-medication, and why pregnant women in Ghana self-medicate. Methods: A comprehensive search was conducted in PubMed, Science Direct, African Journal Online (AJOL), Google Scholar, and the websites of Ghanaian universities to identify studies that were published until February 2022. We performed this review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). A random-effects meta-analysis was done in StatsDirect statistical software and OpenMeta [Analyst] to estimate the prevalence of self-medication during pregnancy and was reported in a forest plot. Simple charts and tables were used to summarize evidence on drugs used in self-medication, diseases associated with self-medication, and reasons for self-medication. Results: Six (6) studies met our inclusion criteria and the pooled prevalence of self-medication during pregnancy was 65.4% (95% CI = 58.2%-72.6%; I 2 = 88.32%; p < 0.001). Common drugs used for self-medication included analgesics (48.1%) and herbal drugs (45.9%). Headache and lower abdominal pain were the most common conditions for which pregnant women self-medicated. The main reasons for self-medication were the perceived unserious nature of diseases, previous experience with drugs, and easy access to over-the-counter drugs. Conclusions: Self-medication among pregnant women in Ghana is substantially high. Measures need to be implemented to reduce the high prevalence of self-medication during pregnancy to achieve sustainable development goals on maternal health in Ghana. A limitation of this study was the small number of included studies, which calls for more studies on self-medication during pregnancy in Ghana.

Bacterial Contaminants and Antibiogram of Ghana Paper Currency Notes in Circulation and Their Associated Health Risks in Asante-Mampong, Ghana.

Transmission of pathogens through currency notes has become very relevant in today's world due to COVID-19 pandemic. This study profiled microbial flora and their antibiotic activities from Ghana paper currency (GH¢) notes in circulation in Mampong Municipal of Ashanti Region, Ghana. The study employed a cross-sectional design to assess bacterial contaminants and their antibiotic activities from January to May 2019. A total of 70 GH¢ notes consisting of 15 each of GH¢1, GH¢2, and GH¢5; 10 each of GH¢10 and GH¢20; and 5 of GH¢50 were randomly sampled from persons at different shops, canteens, and commercial drivers. The surfaces of each GH¢ note were gently swabbed, and tenfold serial dilutions made were inoculated on plate count agar (PCA), MacConkey agar, mannitol salt agar, and deoxycholate citrate agar. The study used appropriate laboratory and biochemical tests for bacterial identification. SPSS-IBM version 16.0 was used to analyze the data. Of the 70 GH¢ notes studied, 97.1% were contaminated with one or more bacterial isolates. Mean counts on PCA ranged between 3.2 cfu/ml × 105 and 4.7 cfu/ml × 105 on GH¢ notes. Of 124 bacteria isolated, 34 (27.4%), 30 (24.2%), 22 (17.7%), 17 (13.7%), 13 (10.5%), and 8 (6.5%) were from GH¢1, GH¢2, GH¢10, GH¢5, GH¢20, and GH¢50, respectively (p < 0.05). Bacterial isolates were Escherichia coli (28.23%), Staphylococcus aureus (16.94%), coagulase-negative Staphylococcus (16.13%), Klebsiella species (11.29%), Salmonella species (9.68%), Shigella species (8.87%), Pseudomonas aeruginosa (5.65%), and Proteus species (3.23%). GH¢ notes had 25.81%, 20.16%, 19.35%, 17.74%, and 16.94% from meat shops, commercial drivers, canteens, grocery shops, and vegetable shops, respectively. All bacteria were 100% resistant to erythromycin, 87.5% to tetracycline, chloramphenicol, and cotrimoxazole, 75% to vancomycin, while 87.50% sensitive to amikacin. The GH¢ notes were heavily colonized with potential pathogens, which are resistant to most commonly used antibiotics and could pose a health threat to users during commercial transactions.

Microbial Contamination, an Increasing Threat to the Consumption of Fresh Fruits and Vegetables in Today's World.

Microbes are found all over the globe with some few exceptions, including sterilized surfaces. They include normal flora that is nonpathogenic, which contribute to the larger percentage, and pathogenic species which are few. Hence, the activities of humans cannot be completely separated from microbes. Thus, many pathogenic microbes have found their way into fresh fruits and vegetables which are a great source of a healthy diet for humans. The growing demand for fresh fruits and vegetables has necessitated larger production. The larger production of vegetables within the shortest possible time to meet the growing demand has placed them at a higher risk of contamination with the pathogenic microbes, making the safety of consumers uncertain. Study of sources of contamination and type of pathogenic etiological agents isolated from fresh fruits and vegetables includes Bacillus cereus, Campylobacter jejuni, Clostridium botulinum, E. coli O157: H7, Listeria monocytogenes, Salmonella spp., Shigella, Staphylococcus, and Vibrio cholera. Several measures have proven to be effective in controlling contamination of microbes and they include the establishment of surveillance systems to monitor the production chain and thoroughly washing vegetables with vinegar water. Saltwater and other washing techniques are effective but caution should be taken to make sure one does not use one cycle of water for washing all vegetables. The consumption of fresh fruits and vegetables is still encouraged by this review but significant measures must be taken to check the safety of these products before consumption.

Cytotoxic T Cell-Derived Granzyme B Is Increased in Severe Plasmodium Falciparum Malaria.

In Plasmodium falciparum malaria, CD8+ T cells play a double-edged role. Liver-stage specific CD8+ T cells can confer protection, as has been shown in several vaccine studies. Blood-stage specific CD8+ T cells, on the other hand, contribute to the development of cerebral malaria in murine models of malaria. The role of CD8+ T cells in humans during the blood-stage of P. falciparum remains unclear. As part of a cross-sectional malaria study in Ghana, granzyme B levels and CD8+ T cells phenotypes were compared in the peripheral blood of children with complicated malaria, uncomplicated malaria, afebrile but asymptomatically infected children and non-infected children. Granzyme B levels in the plasma were significantly higher in children with febrile malaria than in afebrile children. CD8+ T cells were the main T cell subset expressing granzyme B. The proportion of granzyme B+ CD8+ T cells was significantly higher in children with complicated malaria than in uncomplicated malaria, whereas the activation marker CD38 on CD8+ T cells showed similar expression levels. This suggests a pathogenic role of cytotoxic CD8+ T cells in the development of malaria complications in humans.

Author Correction: Differential expression pattern of co-inhibitory molecules on CD4+ T cells in uncomplicated versus complicated malaria.

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Differential expression pattern of co-inhibitory molecules on CD4+ T cells in uncomplicated versus complicated malaria.

The immune response of malaria patients is a main factor influencing the clinical severity of malaria. A tight regulation of the CD4+ T cell response or the induction of tolerance have been proposed to contribute to protection from severe or clinical disease. We therefore compared the CD4+ T cell phenotypes of Ghanaian children with complicated malaria, uncomplicated malaria, asymptomatic Plasmodium falciparum (Pf) infection or no infection. Using flow cytometric analysis and automated multivariate clustering, we characterized the expression of the co-inhibitory molecules CTLA-4, PD-1, Tim-3, and LAG-3 and other molecules implicated in regulatory function on CD4+ T cells. Children with complicated malaria had higher frequencies of CTLA-4+ or PD-1+ CD4+ T cells than children with uncomplicated malaria. Conversely, children with uncomplicated malaria showed a higher proportion of CD4+ T cells expressing CD39 and Granzyme B, compared to children with complicated malaria. In contrast, asymptomatically infected children expressed only low levels of co-inhibitory molecules. Thus, different CD4+ T cell phenotypes are associated with complicated versus uncomplicated malaria, suggesting a two-sided role of CD4+ T cells in malaria pathogenesis and protection. Deciphering the signals that shape the CD4+ T cell phenotype in malaria will be important for new treatment and immunization strategies.

Health care workers indicate ill preparedness for Ebola Virus Disease outbreak in Ashanti Region of Ghana.

BACKGROUND: The recent Ebola Virus Disease (EVD) epidemic that hit some countries in West Africa underscores the need to train front line high-risk health workers on disease prevention skills. Although Ghana did not record (and is yet to) any case, and several health workers have received numerous training schemes, there is no record of any study that assessed preparedness of healthcare workers (HCWS) regarding EVD and any emergency prone disease in Ghana. We therefore conducted a hospital based cross sectional study involving 101 HCWs from two facilities in Kumasi, Ghana to assess the level of preparedness of HCWs to respond to any possible EVD. METHODS: We administered a face-to-face questionnaire using an adapted WHO (2015) and CDC (2014) Checklist for Ebola Preparedness and assessed overall knowledge gaps, and preparedness of the Ghanaian HCWs in selected health facilities of the Ashanti Region of Ghana from October to December 2015. RESULTS: A total 92 (91.09%) HCWs indicated they were not adequately trained to handle an EVD suspected case. Only 25.74% (n = 26) considered their facilities sufficiently equipped to handle and manage EVD patients. When asked which disinfectant to use after attending to and caring for a suspected patient with EVD, only 8.91% (n = 9) could correctly identify the right disinfectant (χ2 = 28.52, p = 0.001). CONCLUSION: Our study demonstrates poor knowledge and ill preparedness and unwillingness of many HCWs to attend to EVD. Beyond knowledge acquisition, there is the need for more training from time to time to fully prepare HCWs to handle any possible EVD case.

Genotypic characterisation of human papillomavirus infections among persons living with HIV infection; a case-control study in Kumasi, Ghana.

OBJECTIVES: The objective of this study is to describe the burden of human papillomavirus (HPV) infection among women living with HIV and non-infected women in Ghana. METHODS: A case-control study was conducted involving 107 women living with HIV aged between 18 and 59 years (cases) and 100 non-HIV-infected apparently healthy women (controls) who were recruited from the Kumasi South Hospital, from July to December, 2014. Cervicovaginal swabs were taken from study participants to characterise 28 high- and low-risk HPV genotypes using a multiplex real-time PCR. RESULTS: The overall mean age for the participants was 40.10 ± 9.76 years. The prevalence of high-risk (hr)-HPV genotypes was significantly higher among the cases than the controls (77.4% vs. 41.6%, P < 0.0001). Overall, HPV 58 and 54 were the most predominant high-risk (18.8%) and low-risk (15.0%) genotypes detected. The two most common hr-HPV genotype isolates were 58 (18.8%) and 35 (15.9%) with 58 being the most prevalent among age group 35-44 years compared with hr-HPV 16, 18, 35 and 45, found predominantly among 18-34 age group. CONCLUSIONS: Significant variations exist in HPV genotypes among HIV-infected and uninfected women.