The quality of anti-malarial medicines in Embu County, Kenya

Ndwigah, Stanley; Stergachis, Andy; Abuga, Kennedy O.; Mugo, Hannington; Kibwage, IO

doi:10.1186/s12936-018-2482-3

Cited by 9 publications

(8 citation statements)

References 12 publications

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“…5 6 They affect countries across the full spectrum of financial levels, from low-income countries (LICs) to high-income countries (HICs). [6][7][8][9][10][11][12][13][14] SF medicines exist in many different therapeutic classes, are sold with the explicit intent to deceive the end user of their origin, authenticity and efficacy 9 15-21 and can have wide ranging effects including failure of treatment, toxicity and antimicrobial resistance. 6 22 Arguably, the most morally reprehensible crime is the willing sale of falsified lifesaving treatments, such as antimalarial products, in areas where the disease is endemic, a practice that continues at great cost to human life.…”

Section: Introductionmentioning

confidence: 99%

A systematic review of substandard, falsified, unlicensed and unregistered medicine sampling studies: a focus on context, prevalence, and quality

McManus

Naughton

2020

BMJ Glob Health

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Substandard and falsified (SF) medicines are a global issue contributing to antimicrobial resistance and causing economic and humanitarian harm. To direct law enforcement efficiently, halt the spread of SF medicines and antimicrobial resistance, academics, NGOs and government organisations use medicine quality sampling studies to estimate the prevalence of the problem. A systematic review of medicine quality studies was conducted to estimate how the methodological quality of these studies and SF prevalence has changed between 2013 and 2018. We also aimed to critique medicine sampling study methodologies, and the systematic review process which generates prevalence estimates. Based on 33 studies, the overall estimated median (Q1–Q3) prevalence of SF medicines appears to have remained high at 25% (7.7%–34%) compared with 28.5% in 2013. Furthermore, the methodological quality of prevalence studies has improved over the last 25 years. Definitive conclusions regarding the prevalence of SF medicines cannot be drawn due to the variability in sample sizes, consistency of design methods, and a lack of information concerning contextual factors affecting medicine quality studies. We contend that studies which present cumulative average prevalence figures are useful in a broad sense but could be improved to create more reliable estimates. We propose that medicine quality studies record the context of the study environment to allow systematic reviewers to compare like with like. Although, the academic rigour of medicine quality studies is improving, medicine sampling study limitations still exist. These limitations inhibit the accurate estimation of SF medicine prevalence which is needed to support detailed policy changes.

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Section: Introductionmentioning

confidence: 99%

A systematic review of substandard, falsified, unlicensed and unregistered medicine sampling studies: a focus on context, prevalence, and quality

McManus

Naughton

2020

BMJ Glob Health

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“…Some research groups and international NGOs have tried, over the last two decades, to estimate their prevalence and highlight the problem in developing countries. [10][11][12][13][14][15][16][17][18][19][20] Examples include a study conducted in the late 1990s in Nigeria and Thailand, showing that 36% of the samples collected in Nigeria and 40% of samples collected in Thailand contained quantities of APIs outside pharmacopoeial limits. 21 The death of a patient from bacterial meningitis was associated with substandard ceftriaxone in Uganda in 2013.…”

Section: Introductionmentioning

confidence: 99%

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

Tabernero

Swamidoss

Mayxay

et al. 2022

Journal of Antimicrobial Chemotherapy

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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 18.3% (188/1025) of the samples had units outside the International Pharmacopoeia/United States Pharmacopoeia assay (percentage of label claim) specifications. Trimethoprim had a high number of samples [51.6% (64)] with units below the limit range, followed by ceftriaxone [42.9% (3)] and sulfamethoxazole [34.7% (43)]. Doxycycline, ofloxacin and ciprofloxacin had the highest number of samples with high API content: 43.7% (38), 14.7% (10) and 11.8% (2), respectively. Significant differences in %API were found between stated countries of manufacture and stated manufacturers. Conclusions With the global threat of antimicrobial resistance on 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.

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“…There are several quality assessments reports in Kenya that mainly focused on antimalarial drugs [ 13 , 14 ]. A recent study carried out in Embu County by Ndwigah and Co-workers [2018] [ 15 ] evaluated 39 samples of artemisinin based combination tablets and oral suspensions where all passed quality control tests.…”

Section: Introductionmentioning

confidence: 99%

Quality assessment of selected co-trimoxazole suspension brands marketed in Nairobi County, Kenya

et al. 2021

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Introduction Quality of medicines in both developed and developing countries is sometimes compromised due to infiltration of counterfeit, substandard or degraded medicines into the markets. It is a public health concern as poor quality medicines endanger public health where patients are exposed to chemical toxins and/or sub-therapeutic doses. This could lead to reduced treatment efficacy and promote development of drug resistance. Co-trimoxazole, a fixed dose combination of sulfamethoxazole and trimethoprim, is a broad spectrum for bacterial diseases and is also used as a prophylaxis for opportunistic infections in HIV infected individuals. This study evaluated quality of selected co-trimoxazole suspension brands marketed in Nairobi County, Kenya. Methods A total of 106 samples were collected, categorized into 15 brands and evaluated for active pharmaceutical ingredient content (API) and pH following United States Pharmacopeia. Assay for API was conducted using High Performance Liquid Chromatography. Results were compared with pharmacopeia references. Visual examination of labels and confirmation of retention status of the brands with Pharmacy and Poisons Board retention register was carried out. Results The samples were primarily of local origin (86.7%). On October 23, 2019, retention status of six of the fifteen brands documented were no longer listed in the Pharmacy and Poisons Board retention register. Of the 106 samples tested 70.6% and 86.8% were compliant with United States Pharmacopeia (USP) specifications for pH and API respectively while 84.0% adhered to packaging and labelling requirements. Conclusion This study has demonstrated that majority of co-trimoxazole suspensions tested were compliant with USP requirements. Additionally, it has provided evidence of poor quality co-trimoxazole medicines that could compromise treatment of infectious diseases in children. This emphasizes the need for regular quality assurance tests to ensure only quality medicines are in the market.

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The quality of anti-malarial medicines in Embu County, Kenya

Cited by 9 publications

References 12 publications

A systematic review of substandard, falsified, unlicensed and unregistered medicine sampling studies: a focus on context, prevalence, and quality

A systematic review of substandard, falsified, unlicensed and unregistered medicine sampling studies: a focus on context, prevalence, and quality

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

Quality assessment of selected co-trimoxazole suspension brands marketed in Nairobi County, Kenya

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