A random survey of the prevalence of falsified and substandard antibiotics in the Lao PDR.

Patricia Tabernero,Sengchanh Yeuchaixiong,Sivong Sengaloundeth,Isabel Swamidoss,Chindaphone Phonlavong,Mayfong Mayxay,Chanthala Vilayhong,Maniphone Khanthavong,Michael D Green,Chanvilay Sichanh,Paul N Newton

doi:10.1093/jac/dkz164

Abstract

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). 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. 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. 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.

Highlights

Access to good-quality medicines is a critical factor for the effective management and control of diseases globally and universal health coverage.[1]
The study methodology and results for antimalarials have been described,[37] and here we report the results on the quality of the antibiotics collected
All except one sample had all the units tested with %active pharmaceutical ingredients (APIs) between 75% and 125% of the content stated on the label

Summary

Introduction

Access to good-quality medicines is a critical factor for the effective management and control of diseases globally and universal health coverage.[1] The increased accessibility and inappropriate use of antimicrobials have led to enhanced selective pressure and development of resistant pathogens. Antimicrobial resistance threatens the effective prevention and treatment of infections in both the developed and developing world, and is growing at an alarming pace.[2,3,4,5]. Factors contributing to the development of antibiotic resistance include inappropriate use of antibiotics due to poor prescribing and patient adherence. Poor storage conditions may result in physicochemical changes causing degradation or altered dissolution of active ingredients. Subtherapeutic amounts of active pharmaceutical ingredients (APIs) and poor API

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Conclusion