Patricia Tabernero1,2, Isabel Swamidoss3, Mayfong Mayxay1,4,5, Maniphone Khanthavong6, Chindaphone Phonlavong7, Chanthala Vilayhong1, Sengchanh Yeuchaixiong1, Chanvilay Sichanh1,8, Sivong Sengaloundeth9, Michael D Green3, Paul N Newton1,8,4,10,11. 1. Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU), Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao PDR. 2. Public Health Unit, Faculty of Medicine, University of Alcalá, Alcalá de Henares, Spain. 3. U.S. Centers for Disease Control and Prevention (CDC), Division of Parasitic Diseases and Malaria, Atlanta, GA, USA. 4. Centre for Tropical Medicine & Global Health, Nuffield Research Building, Churchill Hospital, University of Oxford, Oxford, UK. 5. Institute of Research and Education Development, University of Health Sciences, Vientiane, Lao PDR. 6. Centre of Malariology, Parasitology and Entomology (CMPE), Vientiane, Lao PDR. 7. Bureau of Food and Drug Inspection (BFDI), Ministry of Health, Government of the Lao PDR, Vientiane, Lao PDR. 8. WorldWide Antimalarial Resistance Network (WWARN), Oxford, UK. 9. Food and Drug Department (FDD), Ministry of Health, Government of the Lao PDR, Vientiane, Lao PDR. 10. Infectious Diseases Data Observatory, Nuffield Research Building, Churchill Hospital, University of Oxford, Oxford, UK. 11. Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine (LSHTM), London, UK.
Abstract
OBJECTIVES: In 2012, a stratified random survey, using mystery shoppers, was conducted to investigate the availability and quality of antibiotics sold to patients in the private sector in five southern provinces of the Lao People's Democratic Republic (Laos). METHODS: A total of 147 outlets were sampled in 10 districts. The active pharmaceutical ingredient (API) content measurements for 909 samples, including nine APIs (amoxicillin, ampicillin, ceftriaxone, ciprofloxacin, doxycycline, ofloxacin, sulfamethoxazole, tetracycline and trimethoprim), were determined using HPLC. RESULTS: All the analysed samples contained the stated API and we found no evidence for falsification. All except one sample had all the units tested with %API values between 75% and 125% of the content stated on the label. However, we identified the presence of substandard antibiotics: 19.6% (201/1025) of samples had their units outside the 90%-110% content of the label claim and 60.2% (617/1025) of the samples had units outside of the International Pharmacopoeia uniformity of content limit range. Amoxicillin had a high number of samples [67.1% (151)] with units above the limit range, followed by ciprofloxacin [58.8% (10)] and ofloxacin [57.4% (39)]. Ceftriaxone, trimethoprim and sulfamethoxazole had the highest number of samples with low API content: 57.1% (4), 51.6% (64) and 34.7% (43), respectively. Significant differences in %API were found between stated countries of manufacture and stated manufacturers. CONCLUSIONS: With the global threat of antimicrobial resistance to patient outcomes, greater understanding of the role of poor-quality antibiotics is needed. Substandard antibiotics will have reduced therapeutic efficacy, impacting public health and control of bacterial infections.
OBJECTIVES: In 2012, a stratified random survey, using mystery shoppers, was conducted to investigate the availability and quality of antibiotics sold to patients in the private sector in five southern provinces of the Lao People's Democratic Republic (Laos). METHODS: A total of 147 outlets were sampled in 10 districts. The active pharmaceutical ingredient (API) content measurements for 909 samples, including nine APIs (amoxicillin, ampicillin, ceftriaxone, ciprofloxacin, doxycycline, ofloxacin, sulfamethoxazole, tetracycline and trimethoprim), were determined using HPLC. RESULTS: All the analysed samples contained the stated API and we found no evidence for falsification. All except one sample had all the units tested with %API values between 75% and 125% of the content stated on the label. However, we identified the presence of substandard antibiotics: 19.6% (201/1025) of samples had their units outside the 90%-110% content of the label claim and 60.2% (617/1025) of the samples had units outside of the International Pharmacopoeia uniformity of content limit range. Amoxicillin had a high number of samples [67.1% (151)] with units above the limit range, followed by ciprofloxacin [58.8% (10)] and ofloxacin [57.4% (39)]. Ceftriaxone, trimethoprim and sulfamethoxazole had the highest number of samples with low API content: 57.1% (4), 51.6% (64) and 34.7% (43), respectively. Significant differences in %API were found between stated countries of manufacture and stated manufacturers. CONCLUSIONS: With the global threat of antimicrobial resistance to patient outcomes, greater understanding of the role of poor-quality antibiotics is needed. Substandard antibiotics will have reduced therapeutic efficacy, impacting public health and control of bacterial infections.
This article has been retracted and republished. Please see: Editor's Note https://doi.org/10.1093/jac/dkab458; and replacement articlehttps://doi.org/10.1093/jac/dkab435
Authors: Maria Regina Torloni; Mercedes Bonet; Ana Pilar Betrán; Carolina C Ribeiro-do-Valle; Mariana Widmer Journal: PLoS One Date: 2020-07-10 Impact factor: 3.240
Authors: Vilada Chansamouth; Mayfong Mayxay; David Ab Dance; Tamalee Roberts; Rattanaxay Phetsouvanh; Bouakham Vannachone; Manivanh Vongsouvath; Viengmon Davong; Phout Inthavong; Syseng Khounsy; Bounxou Keohavong; Valy Keoluangkhot; Khamla Choumlivong; Nicholas Pj Day; Paul Turner; Elizabeth A Ashley; H Rogier van Doorn; Paul N Newton Journal: BMJ Glob Health Date: 2021-11