Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 685
Filtrar
1.
Obesity (Silver Spring) ; 28(7): 1171-1172, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32374528

RESUMO

Obesity treatment is highly stigmatized, mainly because of the stigma of obesity itself. The frequent withdrawal of medications, lorcaserin being the last example, contributes to this stigma, but it is also probably a reflection of it, as data suggest that the threshold for a withdrawal is lower than with other classes of drugs. Safety should always be an absolute priority for every new medication, especially when used on a chronic basis; however, the safety scrutiny given to antiobesity medications is not given for other medications, such as postmenopausal hormone therapy and central nervous system drugs for psychiatric use. The withdrawal of medications for obesity can also impact future research in the area, so we need transparency and equality. Transparency in knowing exactly what reason led to a drug being discontinued and equality in long-term safety should be a concern with any medication prescribed for chronic diseases.


Assuntos
Fármacos Antiobesidade/efeitos adversos , Benzazepinas/efeitos adversos , Doença Crônica/tratamento farmacológico , Medicamentos sob Prescrição/uso terapêutico , Estigma Social , Fármacos Antiobesidade/uso terapêutico , Benzazepinas/uso terapêutico , Doença Crônica/epidemiologia , Humanos , Assistência de Longa Duração , Obesidade/tratamento farmacológico , Obesidade/epidemiologia , Obesidade/psicologia , Medicamentos sob Prescrição/classificação , Vigilância de Produtos Comercializados/normas , Retirada de Medicamento Baseada em Segurança , Estereotipagem , Estados Unidos/epidemiologia , United States Food and Drug Administration/normas
2.
PLoS One ; 15(2): e0228495, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32074113

RESUMO

Our objective was to quantify the impact on the use of zolpidem of the obligation implemented in France in 2017 to use secure prescription pads to prescribe it. We conducted a cohort study within the French SNDS healthcare database. Patients aged over 18 years of age were considered for inclusion. The number of prevalent users and incident episodes of zolpidem use were compared before the change in law (July 1, 2016 to January 1, 2017) and after (July 1, 2017 to January 1, 2018). A prevalent user was a patient who has been reimbursed for zolpidem at least once. An incident episode of zolpidem use was defined by a first administration of zolpidem without any prior administration within the previous six months. Regarding prevalence of zolpidem users, we observed a decrease from 2.79% (CI95%:2.75-2.83) to 1.48% (1.44-1.51), with a number of patients who stopped taking it after the change in law being approximately 4.3 times higher than the number of patients who started. We observed a negative association between the post-law change period (OR = 0.52 (0.51-0.53)) and the probability of receiving zolpidem, adjusting for sex, aging, low income and chronic disease. We observed a decrease from 183 treatment episodes per 100,000 insured months on average to 79 episodes per 100,000 insured months, with an incidence rate ratio (IRR) equal to 0.43 (0.38-0.49). The use of secure prescription pads seems to have reduced the exposure of the French population to zolpidem.


Assuntos
Implementação de Plano de Saúde , Padrões de Prática Médica/estatística & dados numéricos , Programas de Monitoramento de Prescrição de Medicamentos , Medidas de Segurança , Transtornos Relacionados ao Uso de Substâncias/prevenção & controle , Zolpidem/uso terapêutico , Adulto , Idoso , Estudos de Coortes , Confidencialidade/legislação & jurisprudência , Confidencialidade/normas , Bases de Dados Factuais , Registros Eletrônicos de Saúde/estatística & dados numéricos , Feminino , França/epidemiologia , Implementação de Plano de Saúde/legislação & jurisprudência , Implementação de Plano de Saúde/normas , Humanos , Hipnóticos e Sedativos/uso terapêutico , Masculino , Pessoa de Meia-Idade , Padrões de Prática Médica/legislação & jurisprudência , Padrões de Prática Médica/normas , Padrões de Prática Médica/tendências , Programas de Monitoramento de Prescrição de Medicamentos/legislação & jurisprudência , Programas de Monitoramento de Prescrição de Medicamentos/organização & administração , Programas de Monitoramento de Prescrição de Medicamentos/normas , Prescrições/normas , Prescrições/estatística & dados numéricos , Prevalência , Vigilância de Produtos Comercializados/métodos , Vigilância de Produtos Comercializados/normas , Medidas de Segurança/legislação & jurisprudência , Medidas de Segurança/normas , Transtornos Relacionados ao Uso de Substâncias/epidemiologia , Fatores de Tempo
3.
N Z Med J ; 133(1510): 83-87, 2020 02 21.
Artigo em Inglês | MEDLINE | ID: mdl-32078604

RESUMO

The purpose of this article is to offer evidence that vaccine safety is taken very seriously and various examples to support this premise are described. The article covers adverse event reporting following vaccination, the difference between events which occur after vaccination and events which are caused by vaccination, the comprehensive safety monitoring required when vaccines are first introduced, international vaccine withdrawals because of safety concerns and some vaccine changes in New Zealand where safety was an important consideration. Finally, recent developments in vaccine safety monitoring are outlined. It is hoped that this will be a useful resource for those involved in the complex issue of counteracting vaccine hesitancy.


Assuntos
Política de Saúde , Segurança do Paciente/normas , Vigilância de Produtos Comercializados/métodos , Vacinas/efeitos adversos , Humanos , Nova Zelândia , Vigilância de Produtos Comercializados/normas
7.
Curr Allergy Asthma Rep ; 19(9): 39, 2019 07 18.
Artigo em Inglês | MEDLINE | ID: mdl-31321555

RESUMO

PURPOSE OF REVIEW: This review aimed to introduce the regulations management and current situations of drug safety evaluation in China. RECENT FINDINGS: The nationwide implementation of good laboratory practice and good clinical practice guarantees the quality of pre-marketing drug safety evaluation. In recent years, post-marketing drug safety monitoring is changing from passive mode to the combination of active and passive monitoring. A national adverse drug reaction monitoring sentinel alliance has been created to actively identify, report, and evaluate adverse reactions, with more than 1.4 million cases reported in 2017. But the quality of the reports is not optimal, with few reports from drug manufacturers, low rate of severe reports, and trend of lag reporting. Drug safety evaluation in China is transitioning from passive monitoring to a combination mode. Drug pharmacovigilance is a powerful tool for active monitoring, but participation by drug manufacturers would be essential to an effective drug safety evaluation system.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/normas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Vigilância de Produtos Comercializados/métodos , Sistemas de Notificação de Reações Adversas a Medicamentos/história , Sistemas de Notificação de Reações Adversas a Medicamentos/legislação & jurisprudência , China , Regulamentação Governamental , História do Século XX , História do Século XXI , Humanos , Farmacovigilância , Vigilância de Produtos Comercializados/normas
8.
Pharmacoepidemiol Drug Saf ; 28(9): 1155-1165, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31318470

RESUMO

PURPOSE: Recent public health safety issues involving medical devices have led to a growing demand to improve the current passive-reactive postmarket surveillance (PMS) system. Various European Union (EU) national competent authorities have started to focus on strengthening the postmarket risk evaluation. As a consequence, the new EU medical device regulation was published; it includes the concept of a PMS Plan. METHODS: This publication reviewed Annex III Technical Documentation on PMS and Annex XIV Part B: Postmarket clinical follow-up from the new Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices. RESULTS: The results of the PMS activities will be described in the PMS plan and will be used to update other related documents. A modular approach to structure the contents of the PMS plan will help to consistently update other PMS information. It is our suggestion that the PMS plan should consist of a PMS plan Core and a PMS plan Supplement. The PMS plan Core document will describe the PMS system, and the PMS plan Supplement will outline the specific activities performed by the manufacturer for a particular medical device. CONCLUSIONS: The PMS plan may serve as a thorough tool for the benefit-risk evaluation of medical devices. If properly developed and implemented, it will function as a key player in the establishment of a new framework for proactive safety evaluation of medical devices.


Assuntos
Aprovação de Equipamentos/normas , Equipamentos e Provisões/normas , Vigilância de Produtos Comercializados/normas , Aprovação de Equipamentos/legislação & jurisprudência , Equipamentos e Provisões/efeitos adversos , União Europeia , Estudos de Viabilidade , Medição de Risco/legislação & jurisprudência , Medição de Risco/métodos , Medição de Risco/normas
9.
Clin Trials ; 16(5): 490-501, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31184490

RESUMO

BACKGROUND: The postmarket research goal is to assess "generalizability" or "external validity" to see if the early results of clinical trials with investigational devices are reproducible in everyday practice in the real world and the longer term. Registries have an important but ambivalent role in achieving this goal. METHODS: Although registries are common, in practice they follow the regulatory processes that appear designed primarily for pharmaceutical clinical trials and confirmatory studies. We review the literature to assess different definitions and the role of registries in the hierarchy of scientific evidence. We analyze common characteristics affecting registry design, implementation, and governance as well as safety reporting and off-label use while describing the experience of setting up an international, prospective registry for an endovascular device used to treat abdominal aortic aneurysms. RESULTS: Key areas in which to distinguish registries from trials are as follows: eligibility, setting (patients and institutions), device configurations and iterations, the use of design and quality "spaces," a focus on systematic quality checks (rather than source data monitoring), open-ended follow-up, flexibility in the definition of end points and sample sizes, data sharing, and publishing commitments. CONCLUSION: Both clinical trials and registries are essential and complementary research methods and the strengths and weaknesses of each need to be recognized. The specific characteristics of registry research deserve to be acknowledged and safeguarded in the regulations governing clinical investigations with medical devices.


Assuntos
Equipamentos e Provisões , Sistema de Registros/normas , Ensaios Clínicos como Assunto , Humanos , Vigilância de Produtos Comercializados/normas
10.
J Clin Epidemiol ; 112: 77-86, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-31108199

RESUMO

OBJECTIVE: Study designs involving self-controlled or exposure-matched samples are commonly used to monitor postmarket vaccine and drug safety, and they use a subset of the available larger cohort. This article overviews group sequential methods designed for observational data safety monitoring that use the whole exposed and unexposed cohorts by implementing regression adjustment or weighting to control confounding. METHODS: We summarize what is known about the performance of "whole cohort" methods in multisite health plan data networks such as the Sentinel System of the Food and Drug Administration, where outcomes are rare, individual-level patient data cannot be pooled across sites, site heterogeneity is large, and data are dynamically updated over time. RESULTS: Group sequential estimation and testing methods that use regression or weighting can flexibly handle electronic health care data's unpredictability, including an uncertain rate of new product uptake, variable composition of the population over time, and data changes due to dynamic administrative updates. Regression and weighting methods generally have higher power, faster signal detection, and fewer practical challenges compared with some design-based confounder adjustment methods. CONCLUSION: Group sequential regression adjustment and weighting approaches are feasible and underused in practice. They leverage more information than designs that involved sampling and increase power to detect rare adverse effects without increasing bias.


Assuntos
Monitoramento de Medicamentos , Vigilância de Produtos Comercializados , Sistemas de Notificação de Reações Adversas a Medicamentos , Bases de Dados de Produtos Farmacêuticos , Monitoramento de Medicamentos/métodos , Monitoramento de Medicamentos/normas , Monitoramento de Medicamentos/estatística & dados numéricos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Humanos , Vigilância de Produtos Comercializados/métodos , Vigilância de Produtos Comercializados/normas , Vigilância de Produtos Comercializados/estatística & dados numéricos
12.
Clin Pharmacol Ther ; 106(1): 103-115, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31025311

RESUMO

Real-world evidence provides important information about the effects of medicines in routine clinical practice. To engender trust that evidence generated for regulatory purposes is sufficiently valid, transparency in the reasoning that underlies study design decisions is critical. Building on existing guidance and frameworks, we developed the Structured Preapproval and Postapproval Comparative study design framework to generate valid and transparent real-world Evidence (SPACE) as a process for identifying design elements and minimal criteria for feasibility and validity concerns, and for documenting decisions. Starting with an articulated research question, we identify key components of the randomized controlled trial needed to maximize validity, and pragmatic choices are considered when required. A causal diagram is used to justify the variables identified for confounding control, and key decisions, assumptions, and evidence are captured in a structured way. In this way, SPACE may improve dialogue and build trust among healthcare providers, patients, regulators, and researchers.


Assuntos
Pesquisa Comparativa da Efetividade/métodos , Vigilância de Produtos Comercializados/métodos , Projetos de Pesquisa , Causalidade , Pesquisa Comparativa da Efetividade/normas , Fatores de Confusão Epidemiológicos , Tomada de Decisões , Humanos , Vigilância de Produtos Comercializados/normas , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Reprodutibilidade dos Testes
15.
PLoS One ; 14(1): e0210150, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30615647

RESUMO

Male condoms are important to prevent transmission of HIV (and other STIs) and unwanted pregnancies. Research was conducted to evaluate the quality of male condoms available in the Dominican Republic market based on preliminary concerns of suspect product. Based on international testing standards (ISO 4074 and ASTM D 3492-08), condoms were sampled across ten prominent brands within the market and evaluated for airburst pressure / volume, freedom from holes, visual defects, package seal integrity, packaging and marking, lubricant quantity, and dimensions. Five of the brands were found to have extensive quality problems, where holes were found in 5.7% to 17.5% of the condoms (depending on the brand). Between 5.1% and 30.5% of these condoms failed to meet the requirements for airburst properties, and violations in regulatory labeling where observed. Three additional brands were compliant for the other tests, but were found to have the same challenges with labeling violations as the previous five brands. Two brands were found to be fully compliant with all aspects of the evaluation. The level of defects observed in these samples would greatly increase the risk of HIV transmission (and other STIs) and unwanted pregnancies. When projected on the annual market of male condoms sold in the Dominican Republic (~26 million), potentially over 1 million condoms could be estimated to adversely impact the health risk of the end-user. These results prompted action by the Dominican Republic regulatory authorities to investigate and remove poor quality product from the market. This research study emphasizes the need for continued vigilance towards increased regulatory and market surveillance efforts to better protect public health interests.


Assuntos
Preservativos/normas , Anticoncepção/instrumentação , Vigilância de Produtos Comercializados/normas , Controle de Qualidade , Doenças Sexualmente Transmissíveis/prevenção & controle , República Dominicana , Humanos , Cooperação Internacional , Látex , Masculino , Doenças Sexualmente Transmissíveis/transmissão , Estados Unidos , United States Agency for International Development
17.
CNS Spectr ; 24(3): 279-280, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-30602400

RESUMO

Pharmacotherapy of multiple sclerosis (MS) is evolving rapidly. Despite impressive gains over the past 2 decades in the approval of multiple drugs for MS, lack of recruitment of minorities with MS in phase 3 clinical studies is a persistent concern and skews efficacy and disability data.


Assuntos
Afro-Americanos , Anticorpos Monoclonais Humanizados/efeitos adversos , Daclizumabe/efeitos adversos , Esclerose Múltipla/tratamento farmacológico , Vigilância de Produtos Comercializados/normas , Anticorpos Monoclonais Humanizados/uso terapêutico , Daclizumabe/uso terapêutico , Humanos , Vigilância de Produtos Comercializados/estatística & dados numéricos , Viés de Seleção , Estados Unidos , United States Food and Drug Administration/normas
19.
Drug Saf ; 42(3): 347-363, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30269245

RESUMO

Enormous progress has been made globally in the use of evidence derived from patients' clinical information as they access their routine medical care. The value of real-world data lies in their complementary nature compared with data from randomised controlled trials: less detailed information on drug efficacy but longer observational periods and larger, more heterogeneous study populations reflecting clinical practice because individuals are included who would not usually be recruited in trials. Real-world data can be collected in various types of electronic sources, such as electronic health records, claims databases and drug or disease registries. These data sources vary in nature from country to country, according to national healthcare system structures and national policies. In Italy, a growing number of healthcare databases have been used to evaluate post-marketing drug utilisation and safety in the last two decades. The aim of this narrative review is to describe the available Italian sources of real-world data and their contribution to generating post-marketing evidence on drug use and safety. We also discuss the strengths and limitations of the most commonly used Italian healthcare databases in addressing various research questions concerning drug utilisation, comparative effectiveness and safety studies, as well as health technology assessment and other areas.


Assuntos
Bases de Dados Factuais/tendências , Revisão de Uso de Medicamentos/organização & administração , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Registros Eletrônicos de Saúde/tendências , Programas Nacionais de Saúde/organização & administração , Vigilância de Produtos Comercializados/normas , Bases de Dados Factuais/normas , Registros Eletrônicos de Saúde/normas , Armazenamento e Recuperação da Informação , Itália , Vigilância de Produtos Comercializados/tendências
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA
...