{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,12]],"date-time":"2026-03-12T19:22:24Z","timestamp":1773343344107,"version":"3.50.1"},"reference-count":32,"publisher":"MDPI AG","issue":"3","license":[{"start":{"date-parts":[[2026,3,12]],"date-time":"2026-03-12T00:00:00Z","timestamp":1773273600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Antibiotics"],"abstract":"<jats:p>Background: Fixed-dose combination drugs (FDCs) are combinations of two or more active ingredients in a single dosage form. These formulations have proven effective in combating the development of resistance in diseases such as tuberculosis and malaria. Despite the benefits observed in the aforementioned cases, fixed-dose antibiotics combinations (FDACs) are increasingly raising questions about their rationality. This is the case for several FDACs listed in the AWaRe classification as not recommended, which unfortunately remain available on the pharmaceutical market, particularly in low- and middle-income countries like the Democratic Republic of Congo (DRC). Objectives: To identify the essential medicines available in pharmacies open to the public in the city of Kinshasa and to assess their inclusion in the DRC\u2019s National List of Essential Medicines (NLEM) and in the World Health Organization\u2019s (WHO) List of Essential Medicines (LEM). The rationality of the FDACs circulating in the city of Kinshasa were also evaluated based on the 2023 AWaRe classification. Methods: A cross-sectional and descriptive study was conducted between February and October 2025 in Kinshasa. For this purpose, fifty registered pharmacies open to the public were selected by systematic random sampling as the research sample. Data collection consisted of completing a data collection form after we had provided the pharmacies\u2019 owners with the necessary explanations regarding the importance of the study and guaranteed their anonymity. Results: The controlled FDACs encountered comprised 27 specialties across 15 different formulations. Out of 15 formulations, 12 (80%) were included on the WHO list of non-recommended antibiotics and were not included in the DRC\u2019s NLEM nor in the WHO\u2019s LEM. Some had been withdrawn from the market in their countries of manufacture. Of the 15 FDACs evaluated for their rationality and compliance, the injectable FDACs presented problems related to the relevance and completeness of information contained on their packaging. On their primary packaging, there was a significant difference in the expiration dates of the powder and sterile water for injection contained in the combination pack, ranging from 6 to 36 months. Furthermore, the secondary packaging lacked data related to the sterile water for injection contained in the combination pack. In addition, several medications contained the same therapeutic combination. For injectable FDAC, for example, the combination Ceftriaxone-Sulbactam was represented by eight medications. For oral FDACs, the combination Sulfamethoxazole-Trimethoprim was represented by seven medications. Globally, 100% of these drug combinations originated from India. Conclusions: Fifteen varieties of FDACs were available in Kinshasa, most of which (80%) were unsuitable. It is important that public health authorities address this situation and develop stricter guidelines for granting marketing authorizations, particularly for FDACs.<\/jats:p>","DOI":"10.3390\/antibiotics15030289","type":"journal-article","created":{"date-parts":[[2026,3,12]],"date-time":"2026-03-12T09:23:03Z","timestamp":1773307383000},"page":"289","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Critical Analysis of Fixed-Dose Antibiotic Combinations Sold in Kinshasa\u2014Democratic Republic of the Congo"],"prefix":"10.3390","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4047-6241","authenticated-orcid":false,"given":"Jocelyn Kakumba","family":"Mankulu","sequence":"first","affiliation":[{"name":"Laboratory of Drug Analysis, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa P.O. Box 212, Democratic Republic of the Congo"},{"name":"Laboratory of Pharmaceutical Organic and Analytical Chemistry, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa P.O. Box 212, Democratic Republic of the Congo"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-3533-7872","authenticated-orcid":false,"given":"Dadit Kitenge","family":"Ive","sequence":"additional","affiliation":[{"name":"Laboratory of Drug Analysis, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa P.O. Box 212, Democratic Republic of the Congo"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-4344-1619","authenticated-orcid":false,"given":"Freddy Mugisho","family":"Kasago","sequence":"additional","affiliation":[{"name":"Laboratory of Pharmaceutical Organic and Analytical Chemistry, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa P.O. Box 212, Democratic Republic of the Congo"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Exauc\u00e9 Mpuya","family":"Mpuya","sequence":"additional","affiliation":[{"name":"Laboratory of Drug Analysis, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa P.O. Box 212, Democratic Republic of the Congo"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bertin K.","family":"Mfuamba","sequence":"additional","affiliation":[{"name":"Laboratory of Drug Analysis, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa P.O. Box 212, Democratic Republic of the Congo"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-8099-8252","authenticated-orcid":false,"given":"Jean-Pierre","family":"Mufusama Koy Sita","sequence":"additional","affiliation":[{"name":"Laboratory of Drug Analysis, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa P.O. Box 212, Democratic Republic of the Congo"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1153-3294","authenticated-orcid":false,"given":"Patient","family":"Ciza Hamuli","sequence":"additional","affiliation":[{"name":"Laboratory of Drug Analysis, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa P.O. Box 212, Democratic Republic of the Congo"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8569-4659","authenticated-orcid":false,"given":"Tr\u00e9sor","family":"Kimbeni Malongo","sequence":"additional","affiliation":[{"name":"Laboratory of Drug Analysis, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa P.O. Box 212, Democratic Republic of the Congo"},{"name":"Laboratory of Pharmaceutical Organic and Analytical Chemistry, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa P.O. Box 212, Democratic Republic of the Congo"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6906-5329","authenticated-orcid":false,"given":"J\u00e9r\u00e9mie","family":"Mbinze Kindenge","sequence":"additional","affiliation":[{"name":"Laboratory of Drug Analysis, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa P.O. Box 212, Democratic Republic of the Congo"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5942-8365","authenticated-orcid":false,"given":"Jean-Marie","family":"Liesse Iyamba","sequence":"additional","affiliation":[{"name":"University Reference Center of Antimicrobial Resistance Surveillance (URC-AMRS), Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa P.O. Box 212, Democratic Republic of the Congo"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0400-803X","authenticated-orcid":false,"given":"Didi","family":"Mana Kialengila","sequence":"additional","affiliation":[{"name":"Laboratory of Drug Analysis, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa P.O. Box 212, Democratic Republic of the Congo"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2026,3,12]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","unstructured":"Kakumba, J.M., Kindenge, J.M., Kapepula, P.M., Iyamba, J.M.L., Mashi, M.L., Mulwahali, J.W., and Kialengila, D.M. (2023). Evaluation of Antibiotic Prescribing Pattern Using WHO Access, Watch and Reserve Classification in Kinshasa, DR C. 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