RESUMO

Substandard antibiotics are thought to be a major threat to public health in developing countries and a cause of antimicrobial resistance. However, assessing quality outside of a laboratory setting, using simple equipment, is challenging. The aim of this study was to validate the use of a portable Fourier transform infrared (FT-IR) spectrometer for the identification of substandard antibiotics. Results are presented for amoxicillin packages from Haiti, Ghana, Sierra Leone, Democratic Republic of Congo, India, Papua New Guinea, and Ethiopia collected over the course of 6 months in 2017, including two field trips with the FT-IR to Ghana and Sierra Leone. Canadian samples were used as a control. Regarding drug quality, of 290 individual capsules of amoxicillin analyzed, 13 were found to be substandard with total active pharmaceutical ingredients (API) lying outside the acceptable range of 90-110%. Of these 13, four were below 80% API. The FT-IR reliably identified these outliers and was found to yield results in good agreement with the established pharmacopeia liquid chromatography protocol. We conclude that the portable FT-IR may be suitable to intercept substandard antibiotics in developing countries where more sophisticated techniques are not readily available.

Assuntos

Antibacterianos/química , Antibacterianos/normas , Cromatografia Líquida , Sistemas Automatizados de Assistência Junto ao Leito , Controle de Qualidade , Espectroscopia de Infravermelho com Transformada de Fourier , Amoxicilina/química , Amoxicilina/normas , Canadá , Medicamentos Falsificados/química , Países em Desenvolvimento , Embalagem de Medicamentos , Gana , Haiti , Humanos , Índia , Garantia da Qualidade dos Cuidados de Saúde/métodos , Serra Leoa

RESUMO

BACKGROUND: Assessing the availability of health services during humanitarian emergencies is essential for understanding the capacities and weaknesses of disrupted health systems. To improve the consistency of health facilities assessments, the World Health Organization has proposed the use of the Health Resources Availability Mapping System (HeRAMS) developed in Darfur, Sudan as a standardized assessment tool for use in future acute and protracted crises. This study provides an evaluation of HeRAMS' comprehensiveness, and investigates the methods, quality and comprehensiveness of health facilities data and tools in Haiti, where HeRAMS was not used. METHODS AND FINDINGS: Tools and databases containing health facilities data in Haiti were collected using a snowball sampling technique, while HeRAMS was purposefully evaluated in Sudan. All collected tools were assessed for quality and comprehensiveness using a coding scheme based on the World Health Organization's health systems building blocks, the Global Health Cluster Suggested Set of Core Indicators and Benchmarks by Category, and the Sphere Humanitarian Charter and Minimum Standards in Humanitarian Response. Eight assessments and databases were located in Haiti, and covered a median of 3.5 of the 6 health system building blocks, 4.5 of the 14 Sphere standards, and 2 of the 9 Health Cluster indicators. None of the assessments covered all of the indicators in any of the assessment criteria and many lacked basic data, limiting the detail of analysis possible for calculating standardized benchmarks and indicators. In Sudan, HeRAMS collected data on 5 of the 6 health system building blocks, 13 of the 14 Sphere Standards, and collected data to allow the calculation of 7 of the 9 Health Cluster Core Indicators and Benchmarks. CONCLUSIONS: There is a need to agree upon essential health facilities data in disrupted health systems during humanitarian emergencies. Although the quality of the assessments in Haiti was generally poor, the large number of platforms and assessment tools deployed suggests that health facilities data can be collected even during acute emergencies. Further consensus is needed to establish essential criteria for data collection and to establish a core group of health systems assessment experts to be deployed during future emergencies.