Possible adverse drug events leading to hospital admission in a Brazilian teaching hospital

OBJECTIVES: Drug safety problems can lead to hospital admission. In Brazil, the prevalence of hospitalization due to adverse drug events is unknown. This study aims to estimate the prevalence of hospitalization due to adverse drug events and to identify the drugs, the adverse drug events, and the risk factors associated with hospital admissions. METHOD: A cross-sectional study was performed in the internal medicine ward of a teaching hospital in São Paulo State, Brazil, from August to December 2008. All patients aged ≥18 years with a length of stay ≥24 hours were interviewed about the drugs used prior to hospital admission and their symptoms/complaints/causes of hospitalization. RESULTS: In total, 248 patients were considered eligible. The prevalence of hospitalization due to potential adverse drug events in the ward was 46.4%. Overprescribed drugs and those indicated for prophylactic treatments were frequently associated with possible adverse drug events. Frequently reported symptoms were breathlessness (15.2%), fatigue (12.3%), and chest pain (9.0%). Polypharmacy was a risk factor for the occurrence of possible adverse drug events. CONCLUSION: Possible adverse drug events led to hospitalization in a high-complexity hospital, mainly in polymedicated patients. The clinical outcomes of adverse drug events are nonspecific, which delays treatment, hinders causality analysis, and contributes to the underreporting of cases

EDDA Study Designs Taxonomy (version 2.0)

The EDDA Study Designs Taxonomy (v2.0) was developed by the Evidence in Documents, Discovery, and Analytics (EDDA) Group: Tanja Bekhuis (Principal Scientist); Eugene Tseytlin (Systems Developer); Ashleigh Faith (Taxonomist); Faina Linkov (Epidemiologist). This work was made possible, in part, by the US National Library of Medicine, National Institutes of Health, grant no. R00LM010943. Foundational research is described in Bekhuis T, Demner Fushman D, Crowley RS. Comparative effectiveness research designs: an analysis of terms and coverage in Medical Subject Headings (MeSH) and Emtree. Journal of the Medical Library Association (JMLA). 2013 April;101(2):92-100. PMC3634392. Coverage of the terminology appearing in JMLA was extended with terms from MeSH, NCI Thesaurus (NCI), Emtree, the HTA Database Canadian Repository [international repository for health technology assessment], and Robert Sandieson's synonym ring for research synthesis. Collected terms were enriched with terms from the NCI Metathesaurus. Variants include synonyms for preferred terms, singular and plural forms, and American and British spellings. Definitions, if they exist, are mainly from MeSH, NCI, Emtree, and medical dictionaries. The EDDA Study Designs Taxonomy by Tanja Bekhuis and Eugene Tseytlin is licensed under a Creative Commons Attribution–NonCommercial–ShareAlike 4.0 International License

Thalidomide surveillance and pharmacovigilance in Brazil – an overview

Introduction:The thalidomide is probably the best-known teratogenic drug and still results in cases of severe physical deformities in children born in Brazil. Objective: To present the overall context of surveillance and pharmacovigilance of thalidomide in Brazil. Method: This article presents a narrative review of current literature concerning thalidomide regulation, policies, and pharmacovigilance in Brazil. Results: New cases of congenital abnormalities whose phenotype is compatible with thalidomide embryopathy were identified in the last ten years, while the approval of thalidomide for new indications was recently updated. The mechanisms of diagnosing thalidomide embryopathy are complex, remaining the challenge in distinguishing this condition from other congenital abnormalities. The increasing number of thalidomide users in Brazil is correlated with the occurrence of embryopathy and the real extension of the rationality of its use is largely unknown. Additionally, our pharmacovigilance and   surveillance systems are predominantly based on voluntary reports, issues that remains over the years. Conclusions: The policies have improved over the years to prevent the fetus from being exposed to thalidomide, and current regulation establishes rules for controlling its distribution, prescription, dispensation, and use. Brazilian surveillance system is manual and pharmacovigilance is supported by voluntary reports. The failure of the system to properly control the thalidomide use and its effects might lead to serious consequences to the community; therefore, this subject deserves constant attention.Título PT: Vigilância e farmacovigilância da talidomida no Brasil - uma visão geral Introdução: A talidomida é, provavelmente, a droga teratogênica mais conhecida e ainda resulta em graves deformidades físicas em crianças nascidas no Brasil. Objetivo: Apresentar o contexto geral de vigilância e farmacovigilância da talidomida no Brasil. Método: Este artigo apresenta uma revisão narrativa da literatura atual sobre regulação, políticas e  farmacovigilância da talidomida no Brasil. Resultados: Novos casos de anormalidades    congênitas cujo fenótipo é compatível com a embriopatia por talidomida foram identificados nos últimos dez anos, enquanto a aprovação da talidomida para novas indicações foi   recentemente atualizada. Os mecanismos de diagnóstico da embriopatia por talidomida são complexos, permanecendo o desafio de distinguir essa condição de outras anormalidades congênitas. O crescente número de usuários de talidomida no Brasil está correlacionado com a ocorrência de embriopatia e a real extensão da racionalidade de seu uso é amplamente desconhecida. Além disso, nossos sistemas de farmacovigilância e vigilância se baseiam predominantemente em notificações voluntárias, questões que permanecem ao longo dos anos. Conclusões: As políticas evoluiram ao longo dos anos para impedir que fetos fossem expostos à talidomida, e a regulamentação atual estabelece regras para controlar sua distribuição, prescrição, dispensação e uso. O sistema de vigilância brasileiro é manual e a farmacovigilância é apoiada por notificações voluntárias. A falha do sistema em controlar adequadamente o uso da talidomida e seus efeitos pode levar a sérias consequências para a comunidade, portanto, esse assunto merece atenção constante

Safety and effectiveness responses to etanercept for rheumatoid arthritis in Japan: a sub-analysis of a post-marketing surveillance study focusing on the duration of rheumatoid arthritis

The aim is to investigate the relationship of duration of rheumatoid arthritis (RA) with safety and effectiveness of etanercept (ETN) in Japan. Post-marketing surveillance data for 7,099 patients treated with ETN were analyzed. Baseline characteristics, treatment effectiveness, incidence of adverse events (AEs), and serious AEs (SAEs) in relation to duration of RA were studied. At baseline, patients with RA for longer duration were older, weighed less, had more comorbidities, allergies, and corticosteroid use, but smoked less and had less morning stiffness. By 2–5 years with RA, more than half of the patients had advanced to Steinbrocker radiographic stage III or IV. Methotrexate (MTX) was the most commonly used pre-treatment disease-modifying antirheumatic drug; however, concomitant MTX use and its dose were lower among patients with longer duration of RA. Remission rates (26.6%) were greatest among patients having RA for <2 years. Less AEs and SAEs were observed among patients with shorter duration of RA. These results suggest that RA treatment in Japan in the era pre-biologics may not have been adequate to control disease activity and prevent joint destruction. Patients with shorter duration of RA may have better physical status which allows the opportunity to treat more intensively putting a higher percentage of patients in remission and possibly decreasing exposure to SAEs

Informatic Tools and Approaches in Postmarketing Pharmacovigilance Used by FDA

The safety profile of newly approved drugs and therapeutic biologics is less well developed by pre-marketing clinical testing than is the efficacy profile. The full safety profile of an approved product is established during years of clinical use. For nearly 40 years, the FDA has relied on the voluntary reporting of adverse events by healthcare practitioners and patients to help establish the safety of marketed products. Epidemiologic studies, including case series, secular trends, case-control and cohort studies, are used to supplement the investigation of a safety signal. Ideally, active surveillance systems would supplement the identification and exploration of safety signals. The FDA has implemented a number of initiatives to help identify safety problems with drugs and continues to evaluate their efforts

Moduladores de la proteína CFTR en el tratamiento de la Fibrosis Quística

La Fibrosis Quística (FQ) es una enfermedad genética que afecta principalmente a los pulmones, páncreas, intestino, hígado, glándulas sudoríparas y órganos sexuales. Está causada por mutaciones en el gen que codifica la proteína CFTR, que causan defectos en el transporte de iones en la membrana de las células epiteliales. Según la Fundación Americana de Fibrosis Quística unas 70.000 personas en el mundo padecen esta enfermedad. Si bien existen líneas de tratamiento convencionales para la FQ, la necesidad de evitar su progresión a edades tempranas y los problemas secundarios a estos tratamientos convencionales, hacen necesario descubrir nuevas estrategias terapéuticas. El desarrollo de fármacos moduladores de la proteína CFTR representa una línea de tratamiento prometedora. El objetivo de este trabajo consiste en el estudio de la eficacia y seguridad de las nuevas terapias moduladoras de la CFTR en el tratamiento de la FQ. Se realizó una búsqueda bibliográfica en la base de datos PubMed utilizando las palabras clave: “tezacaftor/ivacaftor”, “elexacaftor/tezacaftor/ivacaftor”, “cystic fibrosis”, “efficacy”, “toxicity” y “clinical trials”. Definimos la eficacia en términos del cambio del porcentaje de FEV1 predicho, el cambio en la concentración de cloruro en sudor y la puntuación obtenida en la escala CFQ-R. Evaluamos la seguridad farmacológica en términos de efectos adversos. Tanto, Tezacaftor/Ivacaftor como, Elexacaftor/Tezacaftor/Ivacaftor demostraron ser altamente eficaces y el perfil de seguridad en ambas resultó satisfactorio. Se concluye que las terapias moduladoras de la proteína CFTR son una línea de tratamiento esperanzadora para la FQ

Falsificação de medicamentos no Brasil

OBJECTIVE: To identify the main counterfeit drugs seized by the Brazilian Federal Police and the states where seizures have been made. METHODS: A retrospective descriptive study on expert reports produced by criminal investigators of the Federal Police between January 2007 and September 2010, in relation to counterfeit drugs, was carried out. RESULTS: The drugs with greatest numbers of seizures were selective phosphodiesterase-5 inhibitors that are used for treating male erectile dysfunction (Cialis® and Viagra®, mean = 66% ), followed by anabolic steroids (Durateston® and Hemogenin®: 8.9% and 5.7%, respectively). The greatest proportions of the counterfeit drugs were seized in the states of Paraná, Santa Catarina (both Southeastern Brazil) and São Paulo (Southeastern), and the number of non-authentic drugs sent for investigation increased by more than 200% over the study period. There were increases in seizures of smuggled drugs found together with counterfeit drugs: 67% of the seizures included at least one smuggled drug. CONCLUSIONS: Counterfeiting of drugs is a severe public health problem. Identification of the classes of counterfeit drugs present in Brazil and the main Brazilian states with this problem may facilitate future preventive and suppressive actions by the Brazilian bodies responsible for such actions.OBJETIVO: Identificar los principales medicamentos falsificados incautados por la Policía Federal Brasileña y los estados donde hubo incautación. MÉTODOS: Estudio retrospectivo descriptivo de los laudos periciales elaborados por Peritos Criminales de la Policía Federal brasileña sobre medicamentos falsos entre enero de 2007 y septiembre de 2010. RESULTADOS: Los medicamentos con mayor número de incautaciones fueron los inhibidores selectivos de la fosfodiesterasa 5, utilizados para tratar la disfunción eréctil masculina (Ciallis® y Viagra®, en medio 66%), seguidos por esteroides anabolizantes (Durateston® y Hemogenin®, 8,9% y 5,7%, respectivamente). La mayor parte de los medicamentos falsos fue incautada en los estados Paraná, Sao Paulo y Santa Catarina, con incremento superior a 200% en el número de medicamentos inauténticos encaminados a la pericia en el período. Hubo aumento en las incautaciones de medicamentos contrabandeados arrecadados en conjunto con los falsos, 67% de las incautaciones incluyeron al menos un medicamento contrabandeado. CONCLUSIONES: La falsificación de medicamentos es un grave problema de salud pública. La identificación de las clases de medicamentos falsos en Brasil y los principales estados brasileños con esta problemática pueden facilitar acciones futuras de prevención y represión por los órganos brasileños responsables.OBJETIVO: Identificar os principais medicamentos falsificados apreendidos pela Polícia Federal brasileira e os estados em que houve a apreensão. MÉTODOS: Estudo retrospectivo descritivo dos laudos periciais elaborados por Peritos Criminais da Polícia Federal sobre medicamentos contrafeitos entre janeiro de 2007 e setembro de 2010. RESULTADOS: Os medicamentos com maior número de apreensões foram inibidores seletivos da fosfodiesterase 5, utilizados para tratar a disfunção erétil masculina (Cialis® e Viagra®, em média 66%), seguidos por esteróides anabolizantes (Durateston® e Hemogenin®, 8,9% e 5,7%, respectivamente). A maior parte dos medicamentos falsos foi apreendida nos estados do Paraná, São Paulo e Santa Catarina, com incremento superior a 200% no número de medicamentos inautênticos encaminhados à perícia no período. Houve aumento nas apreensões de medicamentos contrabandeados arrecadados em conjunto com os falsos; 67% das apreensões incluíram no mínimo um medicamento contrabandeado. CONCLUSÕES: A falsificação de medicamentos é um grave problema de saúde pública. A identificação das classes de medicamentos falsos no País e os principais estados brasileiros com essa problemática podem facilitar ações futuras de prevenção e repressão pelos órgãos brasileiros responsáveis

Procedimentos Operativos Normalizados para pesquisa de informação clínica sobre reações adversas no contexto da infeção VIH/SIDA

Information related to adverse effects of antiretroviral therapy can determine non-compliance and future therapeutic options. Evidence based practice includes a focalized clinical question to obtain the better information assessed by the parameters sensitivity and specificity. The main purpose of the work is the optimization of a systematic methodology of research clinical information about adverse effects of antiretroviral therapy, in MEDLINE database, with their identification in the literature and the construction of different search strategies to subsequent comparison of sensitivity and specificity values. A generic search strategy developed to find information related to drug iatrogenicity was considered as a reference to the development of search studied strategies. The results show the known adverse effects of antiretroviral agents that are mainly found in case reports. As the first work that approaches two different concepts simultaneously, adverse effects of antiretro-viral therapy and evidence based medicine approach to search literature, it shows and reinforces the real need for more available information to a better assessment of its quality.A informação relativa aos resultados negativos da terapêutica anti retrovírica assume particular importância como condicionante não só da adesão à terapêutica como das opções terapêuticas. A aplicação prática da Medicina Baseada na Evidência à pesquisa da informação compreende a formulação de uma questão focalizada para obtenção da melhor evidência, avaliada com o recurso às ferramentas estatísticas sensibilidade e especificidade. Com o presente trabalho, pretendeu-se otimizar uma metodologia de pesquisa de informação sobre reações adversas da terapêutica anti retrovírica, na MEDLINE, procedendo à sua identificação na literatura disponível e à construção de equações de pesquisa num nível crescente de complexidade, com base numa estratégia de pesquisa genérica desenvolvida para a busca de informação sobre iatrogenia medicamentosa, para posterior comparação dos valores de sensibilidade e especificidade calculados. Os resultados obtidos identificam as reações adversas características dos fármacos anti retrovíricos, encontrando-se essa informação, fundamentalmente, em casos clínicos descritos na literatura. A originalidade do trabalho comprova e realça a necessidade de uma maior disponibilidade de informação para uma avaliação mais criteriosa da sua qualidade.

Vaccine

We conducted a systematic review of the published literature to examine the impact of new vaccine introduction on countries' immunization and broader health systems. Six publication databases were searched using 104 vaccine and health system-related search terms. The search yielded 15,795 unique articles dating from December 31, 1911 to September 29, 2010. Based on review of the title and abstract, 654 (4%) of these articles were found to be potentially relevant and were referred for full review. After full review, 130 articles were found to be relevant and included in the analysis. These articles represented vaccines introduced to protect against 10 different diseases (hepatitis A, hepatitis B, Haemophilus influenzae type b disease, human papilloma virus infection, influenza, Japanese encephalitis, meningococcal meningitis, Streptococcus pneumoniae disease, rotavirus diarrhea and typhoid), in various formulations and combinations. Most reviewed articles (97 [75%]) reported experiences in high-income countries. New vaccine introduction was most efficient when the vaccine was introduced into an existing delivery platform and when introduced in combination with a vaccine already in the routine childhood immunization schedule (i.e., as a combination vaccine). New vaccine introduction did not impact coverage of vaccines already included in the routine childhood immunization schedule. The need for increased cold chain capacity was frequently reported. New vaccines facilitated the introduction and widespread use of auto-disable syringes into the immunization and the broader health systems. The importance of training and education for health care workers and social mobilization was frequently noted. There was evidence in high-income countries that new vaccine introduction was associated with reduced health-care costs. Future evaluations of new vaccine introductions should include the systematic and objective assessment of the impacts on a country's immunization system and broader health system, especially in lower-income countries.CC999999/Intramural CDC HHS/United States2015-11-23T00:00:00Z22940378PMC465543