Background: The AWaRe tool was set up by the World Health Organization (WHO) to promote the rational use of antimicrobials. Indeed, this tool classifies antibiotics into four groups: access, watch, reserve and not-recommended antibiotics. In The Democratic Republic of Congo, data on antibiotic dispensing (prescribing) by health professionals according to the AWaRe classification are scarce. In this research work, we aimed to explore antibiotic dispensing pattern from health professionals according to the WHO AWaRe classification to strengthen the national antimicrobial resistance plan. Methods: For this purpose, a survey was conducted from July to December 2022 in the district of Tshangu in Kinshasa. From randomly selected drugstores, drug-sellers were interviewed and randomly selected customers attending those drugstores were included in the study for medical prescriptions collection. The prescribed antibiotics were classified into the access, watch, reserve and not-recommended antibiotics group and by antibiotics number by prescription among pharmacies surveyed. Results: 400 medical prescriptions were collected from 80 drugstores and among which, 301 (75.25%) contained antibiotics. Out of 301 prescriptions, we noticed 164 (54.5%) containing one antibiotic, 117 (38.9%) containing two antibiotics, 15 (5%) containing three antibiotics and 5 (1.6%) containing four antibiotics. A total of 463 antibiotics were prescribed and distributed as 169 (36.5%) were from the access group, 200 (43.2%) from the watch group and 94 (20.3%) from not-recommended antibiotics group, respectively. This can explain the fact of emerging bacterial strains, as, according to the WHO recommendations, the access group should be prioritized because of its activity against a wide range of commonly encountered pathogens and its showing low resistance susceptibility compared to antibiotics from other groups. Based on the anatomical, therapeutic and chemical (ATC) classifications, we observed that third generation cephalosporins represented 34.33% of the prescribed antibiotics, followed by penicillins (17.17%), macrolides (7.63%), aminoglycosides (7.36%) and Imidazole (7.36%), thus accounting approximately for 74% of the classes of antibiotics prescribed. Additionally, among them, the most frequently prescribed antibiotics were Ceftriaxone (21.38%), Amoxicillin (11.01%), Gentamycin (5.61%), Amoxicillin-clavulanic acid (5.61%), Azithromycin (4.97%) and Metronidazole (4.75%), thus accounting for approximately 54% of all the prescribed antibiotics. Conclusion: These results highlight the importance of strict implementation of the national plan to combat antimicrobial resistance and the need to train health workers in the correct application of the WHO AWaRe classification.
Amoxicillin and Clavulanate potassium oral suspensions are one of antibiotics combination mainly available as dry powders for reconstitution. Made of a β-lactam molecule with a β-lactamase inhibitor, this combination existence can be justified by the potency of Clavulanate potassium which protects Amoxicillin against bacteria producing β-lactamases. Once reconstituted, suspension in single dose bag need to be taken by patient on daily basis following the medical prescription and the one in bottle to be taken according to the medical prescription and the remaining part (in the same container) kept refrigerated in order to get the optimal benefit from the drug. This study investigated the stability of Amoxicillin and Clavulanate potassium suspension both in bags (sachets) for single dose per daily-usage and in bottles for multiple dose usage. The last were reconstituted using distilled water and stored in refrigerator and the previous were instantly reconstituted before measurement. The stability evaluation was conducted on three brands (Six samples totally, two per brand including bottle and sachet for each brand) and for duration of seven days using a validated HPLC method. The evaluation was based on the measurement of pH values, color observation of reconstituted suspensions stored under refrigerator during 7 days and the active compounds concentrations determination. After analysis, no change was observed in pH values and a small change of color for multiple dose presentations stored in refrigerator. And the concentrations of suspensions evaluated in day 1 and day 7 showed over 90% up to seventh day under same storage conditions for both of the Amoxicillin and Clavulanate potassium pharmaceutical presentations. As the study aimed to assess the stability of the suspension in single-dose from bag presentation and in multiple-dose from suspension in bottle, we observed that the reconstituted suspension in distilled water of Amoxicillin + Clavulanate potassium stored in refrigerator is stable for seven days of use, independently from their pharmaceutical presentations either for oral suspensions (powders) in bottles or those in bags for single use after reconstitution.
A Cefixim Trihydrate method was developed and validated for determination of Cefixim in raw materials and tablets. This was to enable quantification of the compound using an available and less expensive analytical method for those forms. Henceforth, this study aimed to develop and validate a fast, simple and economical Ultraviolet-visible (UV/vis) spectrophotometric method for the quantitative estimation of Cefixim in pure state and in tablet forms. The predicted wavelength for maximal absorption to perform with this method was 286 nm with 0.1N HCl as solvent and blank. This gave useful results for the following steps. Linearity, precision, accuracy, specificity, robustness, limit of detection (LOD) and limit of quantification (LOQ) were evaluated for the method validation according to the International Conference on Harmonization (ICH) requirements. The developed method was used for the quantitative determination of Cefixim tablets marketed on the local market. The calibration data showed a better correlation (R 2 =1) over the range of concentrations used (2.5-15µg / ml) and the regression equation was Y=0.0511X. The limits of detection (LOD) and quantification (LOQ) determined were 0.275 µg/ml and 0.919 µg/ml, respectively. The accuracy study carried out at three concentration levels (80%, 100%, and 120%) gave respective recovery rate averages of 97.25%, 97.56% and 97.44% at which the relative standard deviations (RSD) were all less than 2%. The intra and inter-day precision, specificity and robustness were also satisfactory.
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