RESUMO
Monitoring the quality of medicines plays a crucial role in an integrated medicines quality assurance system. In a publicly available medicines quality database (MQDB), the U.S. Pharmacopeial Convention (USP) reports results of data collected from medicines quality monitoring (MQM) activities spanning the period of 2003-2013 in 17 countries of Africa, Asia, and South America. The MQDB contains information on 15,063 samples collected and tested using Minilab® screening methods and/or pharmacopeial methods. Approximately 71% of the samples reported came from Asia, 23% from Africa, and 6% from South America. The samples collected and tested include mainly antibiotic, antimalarial, and antituberculosis medicines. A total of 848 samples, representing 5.6% of total samples, failed the quality test. The failure proportion per region was 11.5%, 10.4%, and 2.9% for South America, Africa, and Asia, respectively. Eighty-one counterfeit medicines were reported, 86.4% of which were found in Asia and 13.6% in Africa. Additional analysis of the data shows the distribution of poor-quality medicines per region and by therapeutic indication as well as possible trends of counterfeit medicines.
Assuntos
Antibacterianos/normas , Antimaláricos/normas , Antituberculosos/normas , Preparações Farmacêuticas/normas , África , Antimaláricos/química , Antituberculosos/química , Ásia , Medicamentos Falsificados , Bases de Dados Factuais , América do Sul , Fatores de TempoRESUMO
SETTING: The prevalence of substandard anti-tuberculosis drugs is unknown. To maximize the effectiveness of tuberculosis (TB) control efforts, simple, inexpensive drug quality screening methods are needed. DESIGN: Isoniazid (INH) and rifampin (RMP) single- and fixed-dose combination (FDC) formulations were collected from selected TB programs and pharmacies in Colombia, Estonia, India, Latvia, Russia and Vietnam. Samples were screened using a recently developed thin-layer chromatography (TLC) kit. All abnormal samples and a 40% random sample of normal formulations were further analyzed using confirmatory techniques. Samples outside of 85% to 115% of stated content, and/or containing compounds other than the stated drug, were defined as being substandard. RESULTS: Overall, 10% (4/40) of all samples, including 13% (4/30) RMP samples, contained <85% of stated content. More FDCs (5/24, 21%) than single-drug samples (2/16, 13%) were substandard. A comparison of TLC with the confirmatory analysis for RMP analysis showed a sensitivity of 100% (4/4), a specificity of 92% (24/26), a positive predictive value (PPV) of 67% (4/6), and a negative predictive value (NPV) of 100% (24/24). An analysis of INH showed a specificity of 90% (9/10). However, sensitivity, PPV, and NVP could not be determined. CONCLUSION: A substantial number of anti-tuberculosis drugs from several countries, in particular FDCs, were found to be substandard. Such drugs may contribute to the creation of drug-resistant TB. TLC is an effective, convenient, and inexpensive method for the detection of substandard drugs.
Assuntos
Antituberculosos/análise , Cromatografia em Camada Fina/métodos , Isoniazida/análise , Rifampina/análise , Tuberculose/tratamento farmacológico , Antituberculosos/normas , Ásia , Colômbia , Combinação de Medicamentos , Europa Oriental , Humanos , Isoniazida/normas , Valor Preditivo dos Testes , Controle de Qualidade , Padrões de Referência , Rifampina/normas , Sensibilidade e EspecificidadeRESUMO
Tratamiento de la TBC: Marco teórico, Grado de incumplimiento. Fármacos antituberculosos. Necesidades para implementar el plan de trabajo. Formación de grupos de trabajo. Programa extendido a Puestos Sanitarios B
Assuntos
Humanos , Tuberculose Pulmonar/tratamento farmacológico , Controle de Doenças Transmissíveis/organização & administração , Antituberculosos/normas , Tuberculose Pulmonar/prevenção & controle , Controle de Doenças Transmissíveis/métodos , Antituberculosos/administração & dosagem , Antituberculosos/efeitos adversos , Planos e Programas de Saúde , Resultado do TratamentoRESUMO
Tratamiento de la TBC: Marco teórico, Grado de incumplimiento. Fármacos antituberculosos. Necesidades para implementar el plan de trabajo. Formación de grupos de trabajo. Programa extendido a Puestos Sanitarios B