Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 20 de 70
Filter
1.
ABCS health sci ; 47: e022202, 06 abr. 2022. tab
Article in English | LILACS | ID: biblio-1363542

ABSTRACT

INTRODUCTION: Tigecycline is an antimicrobial agent, approved for the treatment of complicated skin and soft tissue infections, hospital-acquired and community-acquired pneumonia, intra-abdominal infections and anaerobic or atypical infections. OBJECTIVE: To describe the use of tigecycline in a teaching hospital and to compare data from patients who had their prescriptions audited by the hospital infection committee with those who did not have audited prescriptions. METHODS: Retrospective observational cohort study conducted at a teaching hospital from April 2012 to March 2014 including patients who received tigecycline. Demographic variables, comorbidities, microbiological findings, prescribed antibiotics and technical opinions issued by the Hospital Infection Control Service were collected. RESULTS: 71 patients were included, aged between 13 and 92 years, 63.4% were male and 56.3% were non-white. Tigecycline was the first antimicrobial choice in 19.7% (14/71) of the cases, while the use associated with other antibiotics was observed in 66.2% (45/71) of the prescriptions. mainly with meropenem (28.9%). Empirical use was performed in 69.0% of cases, after culture and the antibiogram in 31.0% and off label use in 81.7%. The microorganisms frequently identified by the culture tests were Enterococcus faecalis (17.6%), Pseudomonas aeruginosa (14.7%) and Klebsiella penumoniae (11.8%). CONCLUSION: The study demonstrated that empirical and off label use is common in clinical practice and few prescriptions were guided by the results of the culture and the antibiogram, demonstrating the need for prescribers to evaluate the benefits/ risks of using this antibiotic, risk of resistance, adverse effects and drug interactions, in addition to cost.


INTRODUÇÃO: A tigeciclina é agente antimicrobiano, aprovada para o tratamento de infecções complicadas na pele e tecidos moles, pneumonia hospitalar e adquirida na comunidade, infecções intra-abdominal e infecções anaeróbias ou atípicas. OBJETIVO: Descrever o uso da tigeciclina em hospital de ensino e comparar dados de pacientes que tiveram suas prescrições auditadas pela comissão de infecção hospitalar com os que não tiveram prescrições auditadas. MÉTODOS: Estudo de coorte retrospectivo observacional realizado em hospital de ensino de abril de 2012 a março de 2014 incluindo pacientes que receberam tigeciclina. Foram coletadas variáveis ​​demográficas, comorbidades, achados microbiológicos, antibióticos prescritos e pareceres técnicos emitidos pelo Serviço de Controle de Infecção Hospitalar. RESULTADOS: Foram incluídos 71 pacientes, com idade entre 13 e 92 anos, 63,4% eram do sexo masculino e 56,3% eram não brancos. A tigeciclina foi primeira escolha antimicrobiana em 19,7% (14/71) dos casos, enquanto o uso associado a outros antibióticos foi observado em 66,2% (45/71) das prescrições. principalmente com meropenem (28,9%). O uso empírico foi realizado em 69,0% dos casos, após cultura e o antibiograma em 31,0% e o uso off label em 81,7%. Os microrganismos frequentemente identificados pelos testes de cultura foram Enterococcus faecalis (17,6%), Pseudomonas aeruginosa (14,7%) e Klebsiella penumoniae (11,8%). CONCLUSÃO: O estudo demonstrou que o uso empírico e off label é comum na prática clínica e poucas prescrições foram orientadas pelos resultados da cultura e do antibiograma, demonstrando necessidade de prescritores avaliarem os benefícios/riscos do uso desse antibiótico, risco de resistência, efeitos adversos e interações medicamentosas, além do custo.


Subject(s)
Humans , Male , Female , Tigecycline , Hospitals, University , Cross Infection , Off-Label Use , Anti-Infective Agents
2.
Rev. bras. ter. intensiva ; 33(2): 266-275, abr.-jun. 2021. tab, graf
Article in English, Portuguese | LILACS | ID: biblio-1289071

ABSTRACT

RESUMO Objetivo: Avaliar o uso de medicamentos off-label e sem licença em recém-nascidos prematuros hospitalizados em unidade de terapia intensiva neonatal. Métodos: Estudo de coorte não concorrente, incluindo prematuros admitidos em três unidades de terapia intensiva neonatais, nos anos de 2016 e 2017, acompanhados durante o período neonatal. O uso de medicamentos e o número foram registrados para todo o período e classificados segundo a Anatomical Therapeutic Chemical. Foram realizadas análises descritivas e bivariadas dos dados para avaliar associações entre o número de medicamentos utilizados (total, off-label e sem licença) e as variáveis explicativas de interesse. Resultados: Os 400 neonatos prematuros utilizaram 16.143 medicamentos, com 86 especialidades diferentes; 51,9% desses itens foram classificados como off-label e 23,5% como sem licença. Os mais prescritos foram gentamicina e ampicilina (17,5% e 15,5% dos off-label, respectivamente) e cafeína (75,5% dos não licenciados). O estudo demonstrou associações significativas do uso de medicamentos off-label com a menor idade gestacional, baixo peso ao nascer, menor escore de Apgar no quinto minuto, manobra de reanimação avançada em sala de parto e óbito. Com os medicamentos não licenciados, foram verificadas associações com a menor idade gestacional, baixo peso ao nascer e escore de Apgar no quinto minuto menor que 7. Conclusão: Os neonatos internados em unidades de terapia intensiva neonatais são muito expostos ao uso de medicamentos off-label e sem licença. Tornam-se necessários mais investimentos em estudos para alcançar maior segurança e qualidade da terapêutica medicamentosa empregada em neonatologia.


ABSTRACT Objective: To evaluate the use of off-label and unlicensed medications in preterm infants hospitalized in a neonatal intensive care unit. Methods: This nonconcurrent cohort study included preterm infants admitted to 3 neonatal intensive care units in 2016 and 2017 who were followed up during the neonatal period. The type and number of medications used were recorded for the entire period and classified based on the Anatomical Therapeutic Chemical. Descriptive and bivariate data analyses were performed to assess associations between the number of drugs used (total, off-label and unlicensed) and the explanatory variables of interest. Results: Four hundred preterm infants received 16,143 prescriptions for 86 different pharmaceuticals; 51.9% of these medications were classified as off-label and 23.5% as unlicensed. The most prescribed drugs were gentamicin and ampicillin (17.5% and 15.5% among off-label, respectively) and caffeine (75.5% among unlicensed). The results indicated significant associations between the use of off-label drugs and lower gestational age, low birth weight, lower 5-minute Apgar score, advanced resuscitation maneuver in the delivery room and death. The prescription of unlicensed drugs was associated with lower gestational age, low birth weight and 5-minute Apgar score below 7. Conclusion: Neonates admitted to neonatal intensive care units are highly exposed to off-label and unlicensed medications. Further studies are needed to achieve greater safety and quality of drug therapy used in neonatology.


Subject(s)
Humans , Infant, Newborn , Infant , Pharmaceutical Preparations , Intensive Care Units, Neonatal , Infant, Premature , Cohort Studies , Prescriptions , Off-Label Use
4.
Evid. actual. práct. ambul ; 24(3): e002106, 2021. tab
Article in Spanish | LILACS, BINACIS, UNISALUD | ID: biblio-1348697

ABSTRACT

A partir del caso de una paciente con trastorno por deseo sexual hipoactivo durante su climaterio y a través del resumen de los resultados de dos revisiones sistemáticas, los autores de este artículo revisan la evidencia sobre la suplementación con andrógenos para el tratamiento de esta condición clínica. Concluyen que su uso sería relativamente seguro a corto plazo, aunque su eficacia no alcanzaría la relevancia clínica y no contamos aún con mayor información sobre la seguridad en el largo plazo. Los autores destacan además que el abordaje de las pacientes con este problema de salud debería ser realizado en forma integral, incluyendo opciones terapéuticas no farmacológicas e informando sobre las incertidumbres todavía presentes. (AU)


Based on the case of a patient with hypoactive sexual desire disorder during her climacteric period and through the summary of the results of two systematic reviews, the authors of this article review the evidence supporting androgen supplementation for the treatment of this clinical condition. They conclude that its use would be relatively safe in the short term, although its efficacy would not reach clinical relevance and no further information on long-term safety is available. The authors also highlight that patients with this health problem should be approached comprehensively, including non-pharmacological therapeutic options and providing information on the uncertainties still present. (AU)


Subject(s)
Humans , Female , Middle Aged , Testosterone/therapeutic use , Climacteric , Sexual Dysfunctions, Psychological/drug therapy , Androgens/therapeutic use , Menopause , Off-Label Use , Systematic Reviews as Topic
5.
San Salvador; MINSAL; abr. 03, 2020. 53 p. ilus.
Non-conventional in Spanish | LILACS, BISSAL | ID: biblio-1341937

ABSTRACT

El presente documento describe los aspectos técnicos y logísticos necesarios a tener en cuenta para implementar la farmacovigilancia especial intrahospitalaria, sobre el uso de medicamentos off-label autorizados, según el "plan de acciones reguladoras para la implementación de opciones 8 terapéuticas y diagnósticas en situaciones de riesgo sanitario en El Salvador" para el manejo clínico de pacientes con enfermedad COVID-19; también, es una herramienta de apoyo para los profesionales de la salud que estarán en la primera línea de atención hospitalaria para la detección, identificación o sospecha de posibles reacciones adversas, interacciones medicamentosas u otros riesgos asociados al uso de estos, así mismo para la prevención de errores de medicación en el manejo de los pacientes y la notificación oportuna de dichos eventos


This document describes the technical and logistical aspects necessary to take into account to implement special intra-hospital pharmacovigilance, on the use of authorized off-label drugs, according to the "regulatory action plan for the implementation of therapeutic and diagnostic options in situations of health risk in El Salvador "for the clinical management of patients with COVID-19 disease; It is also a support tool for health professionals who will be in the first line of hospital care for the detection, identification or suspicion of possible adverse reactions, drug interactions or other risks associated with the use of these, as well as for prevention of medication errors in the management of patients and the timely notification of such events


Subject(s)
Patients , Pharmaceutical Preparations , Off-Label Use , Pharmacovigilance , COVID-19
6.
Rev. Hosp. Ital. B. Aires (2004) ; 40(1): 34-38, mar. 2020. tab
Article in Spanish | LILACS | ID: biblio-1102292

ABSTRACT

Las mujeres han sido tratadas por décadas con testosterona intentando aliviar una gran variedad de síntomas con riesgos y beneficios inciertos. En la mayoría de los países, la testosterona se prescribe "off-label", de modo que las mujeres están utilizando compuestos y dosis ideadas para tratamientos en hombres. En este sentido, varias sociedades médicas de distintos continentes adoptaron recientemente por consenso una toma de posición sobre los beneficios y potenciales riesgos de la terapia con testosterona en la mujer, explorar las áreas de incertidumbre e identificar prácticas de prescripción con potencial de causar daño. Las recomendaciones con respecto a los beneficios y riesgos de la terapia con testosterona se basan en los resultados de ensayos clínicos controlados con placebo de al menos 12 semanas de duración. A continuación se comentan las recomendaciones. (AU)


There are currently no clear established indications for testosterone replacement therapy for women. Nonetheless, clinicians have been treating women with testosterone to alleviate a variety of symptoms for decades with uncertainty regarding its benefits and risks. In most countries, testosterone therapy is prescribed off-label, which means that women are using testosterone formulations or compounds approved for men with a modified dose for women. Due to these issues, there was a need for a global Consensus Position Statement on testosterone therapy for women based on the available evidence from placebo randomized controlled trials (RCTs). This Position Statement was developed to inform health care professionals about the benefits and potential risks of testosterone therapy intended for women. The aim of the Consensus was to provide clear guidance as to which women might benefit from testosterone therapy; to identify symptoms, signs, and certain conditions for which the evidence does not support the prescription of testosterone; to explore areas of uncertainty, and to identify any prescribing practices that have the potential to cause harm. (AU)


Subject(s)
Humans , Female , Aged , Testosterone/therapeutic use , Postmenopause/drug effects , Appetite Depressants/adverse effects , Phenytoin/adverse effects , Placebos/administration & dosage , Psychotropic Drugs/adverse effects , Tamoxifen/adverse effects , Testosterone/administration & dosage , Testosterone/analysis , Testosterone/adverse effects , Testosterone/pharmacology , Cardiovascular Agents/adverse effects , Indomethacin/adverse effects , Gonadotropin-Releasing Hormone/adverse effects , Postmenopause/physiology , Controlled Clinical Trials as Topic , Cholinergic Antagonists/adverse effects , Contraceptives, Oral/adverse effects , Sexual Dysfunctions, Psychological/etiology , Sexual Dysfunctions, Psychological/therapy , Danazol/adverse effects , Consensus , Aromatase Inhibitors/adverse effects , Off-Label Use , Factor Xa Inhibitors/adverse effects , Amphetamines/adverse effects , Histamine Antagonists/adverse effects , Androgen Antagonists/adverse effects , Androgens/physiology , Ketoconazole/adverse effects , Narcotics/adverse effects
7.
Rev. colomb. cancerol ; 24(1): 3-10, ene.-mar. 2020. tab, graf
Article in Spanish | LILACS | ID: biblio-1115578

ABSTRACT

Resumen Objetivo: El uso de medicamentos en condiciones diferentes a las autorizadas es el uso de medicamentos en condiciones distintas a las incluidas en su ficha técnica. El objetivo del presente trabajo es analizar las solicitudes de medicamentos fuera de ficha técnica y sus resultados, realizadas por el Servicio de Oncología y Hematología en un hospital de segundo nivel. Materiales y métodos: Se realiza un estudio observacional retrospectivo de todas las peticiones de fármacos "off label" recibidas por el Servicio de Farmacia. Los medicamentos se clasifican según impacto económico, una clasificación propia según el tipo de fármaco y motivo de petición y según su grado de evidencia. Se analiza para cada solicitud los datos demográficos, de diagnóstico y de tratamiento de los pacientes. Se presenta un seguimiento de los efectos adversos, mediana de supervivencia libre de progresión y mediana de supervivencia global. Resultados: Se aprueban 85 solicitudes de tratamiento. La mayoría de los tratamientos son de alto impacto dirigidos principalmente a patologías raras y últimas opciones de tratamiento. Un 22% de las solicitudes presentan alto grado de evidencia. La media de supervivencia libre de progresión (SLP) es de 6,6 meses (IC 95% 5,2-8) y la supervivencia global (SG) es de 9,7 meses (IC95% 8,2-11,2). Un 18,7% de pacientes presentan toxicidad de grado 3-4 al recibir el tratamiento. Conclusiones: A pesar de la heterogeneidad de las patologías, y la baja evidencia, los resultados obtenidos en SLP y SG, junto a la escasa toxicidad obliga a seguir avanzando en la evaluación de este tipo de tratamientos.


Abstract Background and objective: the use of off-label drugs is the use of medications in conditions other than those included in its prescribing information. The objective of this paper is to analyze the off-label drugs applications and their results, performed by the Oncology and Hematology services in a second level hospital. Materials and methods: A retrospective observational study of all requests for "off label" drugs received by the Pharmacy Service is carried out. The drugs are classified according to economic impact, a classification according to the type of drug and the reason for the request and according to the degree of evidence. The demographic, diagnostic and treatment data of the patients are analyzed for each request. A follow-up of adverse effects, median progression-free survival and median overall survival is presented. Results: 85 treatment requests are approved. Most of the treatments are high impact, mainly aimed at rare pathologies and last treatment options. 22% of the requests have a high degree of evidence. Progression free survival (PFS) and overall survival (OS) are 6.6 (95% CI 5.2-8) and 9.7 months (95% CI 8.2-11.2). 18.7% of patients have grade 3-4 toxicity when receiving treatment. Conclusions: Despite the heterogeneity of the pathologies, and the low evidence, the results obtained in SLP and SG, together with the low toxicity, force us to continue advancing in the evaluation of this type of treatments.


Subject(s)
Humans , Off-Label Use , Medical Oncology , Therapeutics , Pharmaceutical Preparations , Toxicity , Hematology
9.
Rev. cienc. cuidad ; 17(1): 57-70, 2020.
Article in Spanish | LILACS, BDENF, COLNAL | ID: biblio-1051725

ABSTRACT

Identificar conocimientos y prácticas del personal de salud respecto al uso de medicamentos en vías y condiciones diferentes a las establecidas en la ficha técnica. Método: Estudio cuantitativo de tipo descriptivo y corte transversal en dos fases: la primera consistió en una revisión de la literatura en donde se incluyeron de forma inicial 82 artículos, de los cuales ocho fueron elegidos para la revisión; la segunda fase estuvo conformada por 31 participantes que trabajaban en Instituciones de Salud; fueron seleccionados de forma no probabilista secuencial, a quienes se les aplicó un cuestionario, para identificar conocimientos y prácticas desarrolladas, el cual fue evaluado por 3 profesores expertos en la temática; también se realizó una prueba piloto. Resultados: La revisión de la literatura fue referente para la construcción del instrumento. En la segunda fase el 87% de los participantes no conocían el concepto off label, el 65% fueron profesionales de la enfermería que describieron su experiencia como una práctica que no se podría considerar como off label por la falta de soporte científico. Los medicamentos antiinfecciosos, antifúngicos, analgésicos y electrolitos, fueron los grupos de mayor utilización. La principal modificación fue en el cambio de la vía de administración, seguido de la indicación y el 71% de las prácticas no fue descrita en los registros clínicos. Conclusiones: Existe limitada evidencia que soporte el uso de medicamentos en vías y condiciones no establecidos en la ficha técnica; no existe una definición clara y común, presentándose un desconocimiento en los profesionales de la salud.


Identify the knowledge and practices of the health personnel regarding the use of medicine different from the procedures and conditions established in the medical fact sheet. Method: Quantitative study of descriptive and cross-sectional type: the first consisted of a review of the literature where 82 articles were initially included, from which eight were selected for review; the second one was made by 31 participants who worked at healthcare institutions; these were selected by sequential sampling, and a questionnaire was used to identify the knowledge and practices developed, the questionnaire was evaluated by 3 expert professors; a pilot experiment was also made. Results: The review of the literature was a reference to build the instrument. On the second phase, 87% of the participants did not know the concept off label, and 65% were nursing professionals who described their experience as a practice that cannot be considered off label due to the lack of scientific support. The anti-infective, anti-fungal, analgesics and electrolytes were the most used drugs. The main adjustment was the administration procedure, followed by the indications, and 71% of the practices were not described in the case report form. Conclusions: There is limited evidence that supports the use of medicine different from the procedures and conditions that are not established in the medical fact sheet; there is no clear and common definition, implicating unknowingness of the healthcare professionals.


Identificar conhecimentos e práticas do pessoal de saúde respeito ao uso de medicamentos em vías e condições diferentes às estabelecidas na bula. Método: Estudo quantitativo, descritivo de corte transversal realizado em duas fases: a primeira, realizou-se uma revisão da literatura onde incluíram- se inicialmente 82 artigos, dos quais 8 elegeram-se para a revisão; a segunda fase, estudou 31 participantes trabalhadores do setor saúde selecionados de maneira não probabilística sequencial aplicando-se um questionário para estabelecer os conhecimentos e práticas desenvolvidas, avaliado previamente por 3 professores expertos na temática; também foi realizada uma prova piloto. Resultados: A revisão da literatura esteve relacionada com a construção do instrumento. Na segunda fase o 87% dos participantes não conhecia o conceito off label pela ausência de suporte científico. Os medicamentos antibacterianos, antifúngicos, analgésicos e eletrólitos foram os de maior utilização. A principal modificação foi a mudança na via de administração, seguido da indicação e o 71% das práticas não foram registradas no prontuário. Conclusões: Existe limitada evidencia que suporte o uso de medicamentos nas vias e condições não estabelecidas na bula; não existe definição clara e comum, presentando-se o desconhecimento nos profissionais da saúde.


Subject(s)
Drug Utilization , Pharmaceutical Preparations , Drug Therapy , Off-Label Use
10.
Ciênc. Saúde Colet ; 25(9): 3413-3419, Mar. 2020.
Article in English | ColecionaSUS, LILACS, ColecionaSUS, SES-SP | ID: biblio-1133142

ABSTRACT

Abstract When Covid-19 emerged in December last year, there was no vaccine nor was there specific effective treatment for this fast-spreading and life-threatening viral respiratory infection. Clinical trials were planned and are in progress to investigate whether drugs used for influenza, HIV and other viruses, and also anthelmintics (ivermectin, nitazoxanide, niclosamide), and antimalarials (chloroquine, hydroxychloroquine) showing antiviral activity in in vitro assays, are effective and safe for Covid-19. So far there is no convincing evidence that these antiviral and antiparasitic drugs are of any benefit for Covid-19. Notwithsanding the absence of evidence of clinical efficacy, these drugs are widely used outside of clinical trials (off label) for prophylaxis and treatment of this viral infection. The rationale behind the prescription of macrolide antibiotics (azithromycin) for Covid-19 is obscure as well. The widespread prescription and use of drugs of unproven efficacy and safety for Covid-19 is at odds with the rational use of medicines, a cornerstone principle of pharmacotherapy advanced by WHO in 1985. This irrational use of drugs is cause for concern because some of them are associated with serious heart disorders and deaths.


Resumo Quando a Covid-19 surgiu em dezembro do ano passado, não havia vacina nem tratamento eficaz específico para esta infecção respiratória viral de rápida disseminação e risco de vida. Ensaios clínicos foram planejados e estão em andamento para investigar se os medicamentos usados para influenza, HIV e outros vírus e também anti-helmínticos (ivermectina, nitazoxanida, niclosamida) e antimaláricos (cloroquina, hidroxicloroquina) mostrando atividade antiviral em ensaios in vitro são eficazes e seguros para Covid-19. Até o momento, não há evidências convincentes de que esses medicamentos antivirais e antiparasitários sejam benéficos para a Covid-19. Não obstante a ausência de evidência de eficácia clínica, esses medicamentos são amplamente utilizados fora dos ensaios clínicos (off label) para profilaxia e tratamento dessa infecção viral. A lógica por trás da prescrição de antibióticos macrolídeos (azitromicina) para a Covid-19 também é obscura. A ampla prescrição e uso de medicamentos de eficácia e segurança não comprovadas para a Covid-19 está em desacordo com o uso racional de medicamentos, um princípio fundamental da farmacoterapia promovido pela OMS em 1985. Esse uso irracional de medicamentos é motivo de preocupação, porque alguns deles estão associados a graves doenças cardíacas e mortes.


Subject(s)
Humans , Pneumonia, Viral/drug therapy , Coronavirus Infections/drug therapy , Off-Label Use , Antiviral Agents/administration & dosage , Antiviral Agents/adverse effects , Pneumonia, Viral/virology , Practice Patterns, Physicians'/standards , Coronavirus Infections , Coronavirus Infections/virology , Inappropriate Prescribing/statistics & numerical data , Pandemics
12.
Evid. actual. práct. ambul ; 23(2): e002057, 2020.
Article in Spanish | LILACS | ID: biblio-1103663

ABSTRACT

La pandemia de COVID-19 está generando información epidemiológica y clínica en una escala sin precedentes para una enfermedad de reciente aparición. Aunque ya se han iniciado numerosos ensayos clínicos de fármacos antiguos y nuevos como potenciales antivirales específicos, la mayor parte de la información publicada hasta ahora carece de los controles básicos para la evaluación de la eficacia de un medicamento. Los medios de comunicación amplifican estos resultados preliminares y suman presión a los médicos asistenciales y a los decisores de políticas públicas. Este artículo revisa las pruebas disponibles sobre los cuatro tratamientos antivirales específicos más prometedores: hidroxicloroquina, lopinavir/ritonavir, remdesvir e interferones alfa y beta. Se comprueba en todos ellos que no hay demostración suficiente de eficacia como para recomendar su uso fuera de una investigación experimental adecuadamente controlada. En el uso individual de un medicamento no hay forma de saber si está beneficiando o perjudicando al paciente. Es erróneo asumir que la eventual curación se debe al fármaco y un mal desenlace debe atribuirse a la enfermedad. Sólo la comparación entre grupos de pacientes asignados al tratamiento experimental o a un control adecuado permite conocer la eficacia y seguridad de las intervenciones. El desafío es conciliar la urgencia de actuar con la generación de nuevos conocimientos.Aunque no resulta sencillo organizar ensayos clínicos en este contexto, las instituciones pueden sumarse a los proyectos en marcha a nivel nacional e internacional. El uso de estos fármacos debe considerarse experimental, por lo que es necesario obtener el consentimiento informado del paciente. (AU)


The COVID-19 pandemic is generating epidemiological and clinical information on an unprecedented scale for a newly emerging disease. Although numerous clinical trials of old and new drugs as potential specific antivirals have already been started, most of the information published so far lacks basic controls for evaluating drug efficacy. The media amplify these preliminary results and add pressure to doctors and policymakers. This article reviews the available evidence for the four most promising specific antiviral treatments: hydroxychloroquine, lopinavir / ritonavir, remdesvir, and alpha and beta interferons. The findings show that none of them has sufficient demonstration of efficacy to recommend its use outside ofthe adequately controlled experimental study. In the individual use of a drug there is no way of knowing if it is benefiting orharming the patient. It is wrong to assume that the eventual cure is due to the drug and a poor outcome must be attributed to the disease. Only the comparison between groups of patients assigned to the experimental treatment or to an adequate control can establish the efficacy and safety of the interventions. The challenge is to reconcile the urgency to act with the generation of new knowledge. Although it is not easy to organize clinical trials in this context, the institutions can join theongoing projects at the national and international levels. The use of these drugs should be considered experimental, so it is necessary to obtain the informed consent of the patient. (AU)


Subject(s)
Humans , Antiviral Agents/pharmacology , Pneumonia, Viral/drug therapy , Interferons/pharmacology , Coronavirus Infections/drug therapy , Ritonavir/pharmacology , Lopinavir/pharmacology , Hydroxychloroquine/pharmacology , Antiviral Agents/adverse effects , Treatment Outcome , Azithromycin/pharmacology , Risk Assessment , Ritonavir/administration & dosage , Ritonavir/adverse effects , Evidence-Based Medicine/trends , Information Dissemination , Off-Label Use , Health Communication , Pandemics , Lopinavir/administration & dosage , Lopinavir/adverse effects , Hydroxychloroquine/administration & dosage , Hydroxychloroquine/adverse effects , Informed Consent
13.
Rev. bras. epidemiol ; 23: e200030, 2020. tab
Article in Portuguese | LILACS | ID: biblio-1101600

ABSTRACT

RESUMO: Objetivo: Estimar a prevalência de uso off-label de medicamentos segundo a idade em crianças de 0 a 12 anos no Brasil. Métodos: Estudo transversal de base populacional (Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos - PNAUM), incluindo 7.528 crianças de 0 a 12 anos de idade. Entrevistas individuais face a face foram utilizadas para coletar os dados nos domicílios. A classificação off-label segundo a idade foi realizada por meio de consulta ao compêndio eletrônico da Agência Nacional de Vigilância Sanitária (ANVISA). Características sociodemográficas, presença de doença crônica, uso de serviços de saúde e características do informante foram coletadas. Os dados foram expressos por frequências relativas e intervalos de confiança de 95% (IC95%). O teste do χ2 de Pearson foi usado para avaliar a significância estatística das diferenças entre os grupos, com um nível de significância de 5%. A principal medida de desfecho foi a prevalência de uso off-label segundo a idade. Resultados: A prevalência de uso off label por idade foi de 18,7% (IC95% 16,4 - 21,3). Crianças com menos de 2 anos apresentaram maior prevalência desse uso em relação às mais velhas. Os medicamentos com maior frequência de uso off-label segundo a idade foram amoxicilina, nimesulida e a combinação de fenilefrina com bronfeniramina. Conclusão: O uso off-label de medicamentos segundo a idade é comum na população pediátrica brasileira, especialmente nas crianças menores de 2 anos de idade.


Abstract: Objective: To estimate the prevalence of off-label drug use by age in children 12 years old and younger in Brazil. Method: Population-based cross-sectional study (National Survey on Access, Use and Promotion of Rational Use of Medicines - PNAUM), including 7,528 children aged 12 years or younger. Face-to-face interviews were used to collect the data in the domiciles. The age-related off-label classification was carried out using the electronic medication compendium of National Agency of Sanitary Surveillance (ANVISA). Sociodemographic characteristics, presence of chronic disease, use of health services and characteristics of the informant were collected. Data were expressed by relative frequencies and 95% confidence intervals. Pearson's chi-square test was used to evaluate the statistical significance of the differences between the groups, with a significance level of 5%. Main outcome measure was the prevalence of off-label use. Results: The prevalence of off-label use by age was 18.7% (95%CI 16.4 - 21.3). Children younger than 2 years old presented the highest prevalence of off-label use. The most frequently used off-label drugs by age were amoxicillin, nimesulide and the combination of phenylephrine and brompheniramine. Conclusion: The off-label use of drugs by age is common in the Brazilian pediatric population, especially among children under two years old.


Subject(s)
Humans , Male , Female , Infant , Child, Preschool , Child , Off-Label Use/statistics & numerical data , Socioeconomic Factors , Brazil , Cross-Sectional Studies , Age Factors , Sex Distribution , Age Distribution
14.
Einstein (Säo Paulo) ; 18: eAO4745, 2020. tab, graf
Article in English | LILACS | ID: biblio-1039746

ABSTRACT

ABSTRACT Objective To estimate the prevalence of and factors associated with the use of methylphenidate for cognitive enhancement among undergraduate students. Methods Simple random sample of students of the Universidade Federal de Minas Gerais (n=438), invited to answer an online questionnaire about the use of methylphenidate. Data collection occurred from September 2014 to January 2015. The sample was described by means of proportions, means and standard deviations. A multivariate analysis was performed using the Classification and Regression Tree algorithm to classify the cases of use of methylphenidate for cognitive enhancement in groups, based on the exposure variables. Results Out of 378 students included, 5.8% (n=22) reported using methylphenidate for cognitive enhancement; in that, 41% (9/22) in the 4 weeks prior to the survey. The housing situation was the variable most often associated with the use of methylphenidate for cognitive enhancement. Eleven students reported using methylphenidate for cognitive enhancement and other purposes 4 weeks prior to the survey, 27% of whom had no medical prescription to purchase it. Conclusion The use of methylphenidate for cognitive enhancement is frequent among Brazilian undergraduate students and should be considered a serious public health problem, especially due to risks of harm and adverse effects associated with its use.


RESUMO Objetivo Estimar a prevalência e os fatores associados ao uso de metilfenidato para neuroaprimoramento entre estudantes universitários. Métodos Amostra aleatória simples de discentes da Universidade Federal de Minas Gerais (n=438), convidados a responder um questionário online sobre o consumo de metilfenidato. A coleta ocorreu de setembro de 2014 a janeiro de 2015. A amostra foi descrita em termos de proporções, médias e desvio padrão. A análise multivariada foi realizada utilizando o algoritmo Classification and Regression Tree para classificação dos casos de uso do metilfenidato para neuroaprimoramento em grupos, com base nas variáveis de exposição. Resultados Dos 378 alunos incluídos, 5,8% (n=22) declararam ter feito uso de metilfenidato para neuroaprimoramento, sendo 41% (9/22) nas 4 semanas anteriores à pesquisa. A situação da moradia foi a variável mais associada ao uso de metilfenidato para neuroaprimoramento. Relataram o uso do metilfenidato para neuroaprimoramento e outros fins nas 4 semanas anteriores à pesquisa 11 estudantes, sendo que 27% não apresentaram prescrição médica para adquiri-lo. Conclusão O uso de metilfenidato para neuroaprimoramento ocorre no meio acadêmico brasileiro e deve ser considerado sério problema de saúde pública, principalmente diante dos riscos de danos e efeitos adversos associados ao seu uso.


Subject(s)
Humans , Male , Female , Adult , Young Adult , Students/statistics & numerical data , Universities/statistics & numerical data , Nootropic Agents/administration & dosage , Nootropic Agents/therapeutic use , Central Nervous System Stimulants/administration & dosage , Socioeconomic Factors , Students/psychology , Brazil/epidemiology , Decision Trees , Exercise/psychology , Residence Characteristics/statistics & numerical data , Prevalence , Cross-Sectional Studies , Surveys and Questionnaires , Risk Factors , Off-Label Use/statistics & numerical data , Methylphenidate/administration & dosage
16.
Cad. Ibero Am. Direito Sanit. (Impr.) ; 8(3): 27-47, jul.-set. 2019. tab
Article in Portuguese | ColecionaSUS, LILACS, ColecionaSUS, CONASS | ID: biblio-1022851

ABSTRACT

Objetivos: o registro sanitário garante minimamente a segurança nas indicações de bula. Com o julgamento do Recurso Extraordinário (RE) nº 657.718/2019, essa questão não está pacificada. O objetivo desse estudo é comparar as indicações aprovadas nas agências sanitárias americana, europeia e brasileira e analisar dados referentes à indicação de medicamentos imunoterápicos para o tratamento de câncer, em demandas judiciais contra a Secretaria de Estado da Saúde de São Paulo (SES/SP). Métodos: foi realizada uma pesquisa documental nas bulas de seis medicamentos imunoterápicos, disponíveis em julho de 2019 nos websites das agências sanitárias elegidas para o estudo, e comparada a indicação desses medicamentos em demandas judiciais no Estado de São Paulo, utilizando os dados de relatórios ou documentos escaneados disponíveis no sistema S-Codes. Resultados: todos os medicamentos têm registro sanitário para, ao menos, uma indicação em bula nas três agências sanitárias, porém, com diferenças nas indicações aprovadas, muitas delas sendo aprovações aceleradas (fast track). O tempo médio entre a aprovação na Food and Drug Administration (FDA) e na Agência de Vigilância Sanitária (Anvisa) foi de 464,5 ± 170,8 dias; e 278 (98%) das demandas judiciais ocorreram pós-registro na Anvisa. Há pouca informação disponível nos documentos escaneados, mas foi possível identificar situações envolvendo indicações de medicamentos, além de resultados de testes genéticos. Discussão e conclusão: a análise mostra que a FDA tende a ser menos rigorosa na aprovação de novas indicações, e que a maioria das demandas não se enquadraria nos critérios do RE nº 657.718/2019. Apesar do avanço, faz-se necessária a discussão do uso off-label desses medicamentos e sua especificidade. (AU).


Objectives: The drug approval minimally guarantees the safety in the label directions. With the judgment of Extraordinary Appeal No. 67718, this issue is not pacified. The aim of this study is to compare the indications approved by the American (FDA), European (EMA) and Brazilian (Anvisa) health agencies and to analyze data regarding the indication of immunotherapeutic drugs for cancer treatment, in lawsuits against the Secretary of State of Health of São Paulo (SES/SP). Methods: Documentary research was performed on the package leaflets of six immunotherapeutic drugs available in July 2019 on the websites of the health agencies eligible for the study, and comparing the indication of these drugs in lawsuits in the state of São Paulo, using data from reports. or scanned documents available on the S-Codes system. Results: All drugs are registered for at least one indication in the 3 health agencies, but with differences in the approved indications, many of them being conditional approvals (fast track). The average time between FDA and Anvisa approval was 464.5 ± 170.8 days, and 278 (98%) of the demands occurred post-registration with Anvisa. There is little information available in the scanned documents, but it was possible to identify situations involving indications as well as genetic test results. Discussion and Conclusion: analysis shows that the FDA tends to be less rigorous in approving new indications, and that most demands would not meet the criteria of RE 657718/2019. Despite the progress in discussions involving the judicialization of health, it is necessary to discuss the off-label use of these drugs and their specificity. (AU).


Objetivos: el registro sanitario garantiza mínimamente la seguridad de las instrucciones de etiquetado. Con la sentencia de Apelación Extraordinaria (RE) No. 657,718 / 2019, este asunto no se pacifica. El objetivo de este estudio es comparar las indicaciones aprobadas por las agencias de salud estadounidenses, europeas y brasileñas y analizar datos sobre la indicación de medicamentos de inmunoterapia para el tratamiento del cáncer, en demandas contra el Departamento de Salud del Estado de São Paulo (SES / SP). Métodos: se realizó una investigación documental en los prospectos de seis medicamentos inmunoterapéuticos, disponibles en julio de 2019, en los sitios web de las agencias de salud elegibles para el estudio. documentos escaneados disponibles en el sistema S-Codes. Resultados: todos los medicamentos tienen un historial médico para al menos una indicación de etiqueta en las tres agencias de salud, pero con diferencias en las indicaciones aprobadas, muchas de ellas son aprobaciones aceleradas. El tiempo promedio entre la aprobación de la Food and Drug Administration (FDA) y la Agencia de Vigilancia de la Salud (Anvisa) fue de 464.5 ± 170.8 días; y 278 (98%) de las demandas ocurrieron después de registrarse con Anvisa. Hay poca información disponible en los documentos escaneados, pero fue posible identificar situaciones que implican indicaciones de drogas, así como resultados de pruebas genéticas. Discusión y conclusión: el análisis muestra que la FDA tiende a ser menos rigurosa en la aprobación de nuevas indicaciones, y que la mayoría de las demandas no se ajustan a los criterios de RE 657.718/2019. A pesar del progreso, es necesario discutir el uso fuera de etiqueta de estos medicamentos y su especificidad. (AU).


Subject(s)
Off-Label Use , Health's Judicialization , Access to Essential Medicines and Health Technologies
17.
Yonsei Medical Journal ; : 277-284, 2019.
Article in English | WPRIM | ID: wpr-742534

ABSTRACT

PURPOSE: Label adherence for non-vitamin K antagonist oral anticoagulants (NOACs) has not been well evaluated in Asian patients with non-valvular atrial fibrillation (AF). The present study aimed to assess label adherence for NOACs in a Korean AF population and to determine risk factors of off-label prescriptions of NOACs. MATERIALS AND METHODS: In this COmparison study of Drugs for symptom control and complication prEvention of AF (CODE-AF) registry, patients with AF who were prescribed NOACs between June 2016 and May 2017 were included. Four NOAC doses were categorized as on- or off-label use according to Korea Food and Drug Regulations. RESULTS: We evaluated 3080 AF patients treated with NOACs (dabigatran 27.2%, rivaroxaban 23.9%, apixaban 36.9%, and edoxaban 12.0%). The mean age was 70.5±9.2 years; 56.0% were men; and the mean CHA₂DS₂-VASc score was 3.3±1.4. Only one-third of the patients (32.7%) was prescribed a standard dose of NOAC. More than one-third of the study population (n=1122, 36.4%) was prescribed an off-label reduced dose of NOAC. Compared to those with an on-label standard dosing, patients with an off-label reduced dose of NOAC were older (≥75 years), women, and had a lower body weight (≤60 kg), renal dysfunction (creatinine clearance ≤50 mL/min), previous stroke, previous bleeding, hypertension, concomitant dronedarone use, and anti-platelet use. CONCLUSION: In real-world practice, more than one-third of patients with NOAC prescriptions received an off-label reduced dose, which could result in an increased risk of stroke. Considering the high risk of stroke in these patients, on-label use of NOAC is recommended.


Subject(s)
Anticoagulants , Asian Continental Ancestry Group , Atrial Fibrillation , Body Weight , Cohort Studies , Drug and Narcotic Control , Drug Labeling , Female , Hemorrhage , Humans , Hypertension , Korea , Male , Off-Label Use , Prescriptions , Prospective Studies , Risk Factors , Rivaroxaban , Stroke
18.
Article in Korean | WPRIM | ID: wpr-766562

ABSTRACT

Over the last two decades, the systemic treatment of cancer has evolved from cytotoxic chemotherapy to targeted therapy and now immunotherapy. Next-generation sequencing (NGS) is entering clinical applications for cancer treatment through the help of more powerful computational analyses. The increasing number of targeted therapies approved by regulatory authorities (RAs) with or without biomarkers necessitates the screening of multiple biomarkers using NGS, which is now approved and reimbursed by Korean RAs for some types of malignancies. However, the clinical utility of NGS remains to be established as a prerequisite for its routine incorporation into clinical practice. Currently, the best scenario of NGS use in clinics is to enroll patients into clinical trials based on the detection of biomarkers, but this is only possible in the hospitals conducting the specific trial. The other scenario is the off-label use of a targeted drug, but this requires social consensus for future implementation. The clinical applications of NGS are expanding in terms of its platforms, from targeted sequencing to whole exome and RNA sequencing, and in terms of systemic therapy, from targeted therapy to immunotherapy. Research into tumor mutational burden and neoantigens is shedding new light on the clinical use of NGS in immunotherapy.


Subject(s)
Biomarkers , Consensus , Drug Therapy , Exome , Humans , Immunotherapy , Mass Screening , Off-Label Use , Sequence Analysis, RNA
19.
Prensa méd. argent ; 104(10): 493-499, dic 2018. tab
Article in Spanish | LILACS, BINACIS | ID: biblio-1046967

ABSTRACT

La profilaxis pre-exposición (PrEP) es una medida eficaz para la prevención de la transmisión del VIH. Con la implementación de la misma, algunos estudios señalan una reducción en la transmisión superior al 90%, cuando la adherencia es alta. Sin embargo, el uso de Emtricitabina/ Tenofovir alafenamida (FTC/TDF) en la Argentina aún no esta aprobado por las autoridades regulatorias. En profesionales de Argentina el conocimiento, aval y factores asociados con la prescripción de la PrEP no ha sido evaluada. Este es un estudio de corte transversal mediante una encuesta on line realizada en Agosto de 2017. La misma fue distrubuida entre profesionales de Argentina y valoró diferentes aspectos de la PrEP (conocimiento, aval e indicación de la misma). Los resultados obtenidos se expresaron en frecuencias y porcentajes. Para las asociaciones entre variables categóricas se realizó un análisis univariado (test de chi2 ) y de regresión logística binaria. Se consideró como significativo, un valor de p < 0.05. La encuesta fue realizada por 238 profesionales pertenecientes a 81 centros asistenciales. Los escenarios clínicos donde se observó mayor predisposición a la indicación de PrEP fueron: parejas discordantes (77%), trabajadores/as sexuales (61%), pacientes transgénero (32%), adictos a drogas intravenosas (31%), hombres que mantienen sexo con otros hombres (HSH) (23%). Los factores asociados con la prescripción de PrEP fueron: cargo asistencial de jefe de servicio (p<0.05), médicos especialistas en enfermedades infecciosas (p<0.05), atención de más de 200 pacientes seropositivos para el virus de la inmunodeficiencia humana (VIH) por año (p<0.009), prescripción previa de profilaxis post-exposición (p<0.008). Los autores concluyen señalando que, a pesar de no estar aprobado por los entes regulatorios, la PrEP ha sido prescripta off label por profesionales de Argentina. Entre ellos, aquellos que adoptaron la prescripción fueron los que mostraron mayor experiencia en la atención de pacientes VIH positivos, jefes/as de servicio y especialistas en infectología. Estos resultados podrían ser utilizados en un futuro para impulsar nuevas herramientas de prevención en la transmisión de VIH


Pre-exposure prophylaxis (PrEP) is an effective measure to prevent HIV transmission. If the adherence is high, transmission rates are reduced by more than 90%. In Argentina, FTC-TDF is not yet approved for PrEP by the local regulatory agency.  PrEP  awareness,  PrEP  adoption, and factors associated with adoption among argentine physicians had not been studied to date. We designed a cross-sectional online survey conducted in August 2017 among argentine physicians and valored differents items about PrEP, (knowledge, attitudes, and beliefs associated with adoption). Univariate analysis was performed; the associations between categorical variables were analyzed by means of the chi2  test. The level of significance was considered with p <0.05. A total of 238 surveys were received from 81 centers in Argentina. Clinical scenarios associated with the highest prescription were: serodiscordant couples 77%, sex workers 61%, transgender patients 32%, people who inject drugs 31%, and men who have sex with men (MSM) 23%. Factors associated with PrEP prescription between physicians were been chief of staff (p<0.05), been an infectious diseases specialist (p<0.05), assist more than 200 HIV seropositive patients per year (p<0.009) and having prescribed postexposure prophylaxis (PEP) (p<0.008). The authors concluded that in spite of not yet approved by the local regulatory agency, PrEP is been prescribed off- label by argentine physicians. Adopters were more likely to have experience providing HIV care, been chief of staff and ID specialist. These results could be used to plan future HIV prevention strategies in Argentina.


Subject(s)
Humans , Chi-Square Distribution , Cross-Sectional Studies , Surveys and Questionnaires/statistics & numerical data , HIV , Off-Label Use , Post-Exposure Prophylaxis
20.
Cad. Ibero Am. Direito Sanit. (Impr.) ; 7(2): 48-60, abr./jun. 2018.
Article in Portuguese | LILACS | ID: biblio-969872

ABSTRACT

Objetivo: Este artigo tem o objetivo analisar do ponto de vista sobre o tema do uso do medicamento off label no âmbito da Saúde Suplementar. Metodologia: foi realizado uma revisão da legislação pátria, consultando o inteiro teor das leis e normas que constituem o tema. Foram consultadas as bases de dados legislativos do Senado Federal, bem como a base legal da Agência Nacional de Vigilância Sanitária e a Agência Nacional de Saúde Suplementar. Resultados: há fartura de normas legais para a regulamentação da matéria, sendo que toda a política de tratamento deste tema está consubstanciada na base da pirâmide hierárquica de leis, ou seja, nas portarias e instruções normativas. Conclusão: A existência de previsão de cobertura da doença ou patologia no contrato, há liberdade de prescrição de medicamentos off label pelo médico assistente se aplica. (AU)


Objective: This article aims to analyze from the point of view on the subject of the use of the off label drug in the scope of Supplementary Health. Methods: a review of the national legislation has been carried out, consulting the entire content of the laws and norms that constitute the theme. The legislative databases of the Federal Senate were consulted, as well as the legal basis of the National Sanitary Surveillance Agency and the National Supplementary Health Agency. Results: There are plenty of legal norms for the regulation of the matter, and the whole treatment policy of this theme is based on the hierarchical pyramid of laws, that is, in ordinances and normative instructions. Conclusion: The existence of predicted coverage of the disease or pathology in the contract, there is freedom of prescription of off-label medications by the attending physician applies. (AU)


Objetivo: Este artículo tiene el objetivo de analizar desde el punto de vista sobre el tema del uso del medicamento off label en el ámbito de la Salud Suplementaria. Medotología: se realizó una revisión de la legislación patria, consultando el entero contenido de las leyes y normas que constituyen el tema. Se consultaron las bases de datos legislativos del Senado Federal, así como la base legal de la Agencia Nacional de Vigilancia Sanitaria y la Agencia Nacional de Salud Suplementaria. Resultados: hay abundancia de normas legales para la reglamentación de la materia, siendo que toda la política de tratamiento de este tema está consubstanciada en la base de la pirámide jerárquica de leyes, o sea, en las ordenanzas e instrucciones normativas. Conclusión: La existencia de previsión de cobertura de la enfermedad o patología en el contrato, hay libertad de prescripción de medicamentos fuera de etiqueta por el médico asistente se aplica. (AU)


Subject(s)
Humans , Pharmaceutical Preparations , Products Registration , Off-Label Use/legislation & jurisprudence , Legislation, Drug
SELECTION OF CITATIONS
SEARCH DETAIL