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1.
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
3.
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
4.
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
6.
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
10.
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
12.
JAMA Pediatr ; 173(1): 68-74, 2019 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-30452498

RESUMO

Importance: Many medicines prescribed to children have not been studied or formally approved for pediatric use. The Pediatric Research Equity Act of 2003 authorized the US Food and Drug Administration (FDA) to require pediatric clinical studies. Objective: To evaluate the characteristics, completion rate, and transparency of study design and results for mandatory pediatric postmarketing studies required under the Pediatric Research Equity Act. Design and Setting: A retrospective cohort study was conducted of pediatric postmarketing studies required for new drugs and new indications approved by the FDA between January 1, 2007, and December 31, 2014, with follow-up through December 1, 2017. Information on the status, design, and results of pediatric studies was obtained from publicly available FDA databases and ClinicalTrials.gov, direct communication with the FDA, and searches of MEDLINE, EMBASE, and Web of Science for peer-reviewed publications. Main Outcomes and Measures: Characteristics and transparency of pediatric studies, results reporting (in ClinicalTrials.gov, peer-reviewed literature, or FDA documents), and availability of pediatric information in drug labels. Rates and times to study completion were evaluated using Cox proportional hazards regression models. Results: Between 2007 and 2014, the FDA approved 114 new drugs and new indications for already approved drugs that were subject to Pediatric Research Equity Act requirements. These drugs were associated with 222 required pediatric postmarketing clinical studies. Overall, 75 pediatric studies (33.8%) were completed as of December 1, 2017. The rates of completion were significantly lower for efficacy studies (38 of 132 [28.8%]) compared with pharmacokinetic studies (19 of 34 [55.9%]; adjusted hazard ratio, 0.31; 95% CI, 0.12-0.82). Information on randomization, blinding, comparator, end point, and study size could not be identified for 74 studies (33.3%), and no reason for discontinuation was provided for 29 of the 42 discontinued studies (69.0%). Among the completed studies, the results were reported for 57 (76.0%). At the time of approval, 18 of 114 drug approvals (15.8%) had any pediatric efficacy, safety, or dosing information in their labels. After a median duration of follow-up of 6.8 years (interquartile range, 4.7-9.1 years), 47 of 114 of drug labels (41.2%) had any pediatric information. Conclusions and Relevance: Only 33.8% of mandatory pediatric postmarketing studies have been completed after a median follow-up of 6.8 years, and most drug labels do not include information important for pediatric use. To improve evidence-based prescribing of medicines to children, more timely completion of pediatric drug studies is needed.


Assuntos
Pesquisa Biomédica/legislação & jurisprudência , Aprovação de Drogas/estatística & dados numéricos , Pediatria/legislação & jurisprudência , Vigilância de Produtos Comercializados/estatística & dados numéricos , Projetos de Pesquisa/estatística & dados numéricos , Adolescente , Pesquisa Biomédica/normas , Pesquisa Biomédica/estatística & dados numéricos , Criança , Pré-Escolar , Rotulagem de Medicamentos/estatística & dados numéricos , Seguimentos , Humanos , Lactente , Recém-Nascido , Vigilância de Produtos Comercializados/normas , Modelos de Riscos Proporcionais , Projetos de Pesquisa/legislação & jurisprudência , Projetos de Pesquisa/normas , Estudos Retrospectivos , Fatores de Tempo , Estados Unidos , United States Food and Drug Administration
13.
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
15.
Drug Saf ; 42(5): 649-655, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30569267

RESUMO

INTRODUCTION AND OBJECTIVE: Adverse event reports from industry-sponsored programs, such as patient support programs, have contributed to a rise in the number of individual case safety reports in the US Food and Drug Administration Adverse Event Reporting System database. This study aimed to characterize individual case safety reports from industry-sponsored program and non-industry-sponsored program sources and compare their usefulness in safety signal detection. METHODS: Individual case safety reports of six drug and biological products were identified in the Food and Drug Administration Adverse Event Reporting System database between the date of Food and Drug Administration product approval and the first quarter of 2017. A random subset of industry-sponsored program and non-industry-sponsored program individual case safety reports were then compared to identify differences in reporters, outcomes, data completeness, and usefulness. The 'usefulness' of individual case safety reports was assessed by manually reviewing the availability of key information in the narrative (e.g., temporality, comorbidities). RESULTS: Compared with non-industry-sponsored program reports, more industry-sponsored program reports were associated with a serious outcome (51.4% vs. 58.8%, p = 0.02) and were reported by consumers (35.5% vs. 50.4%, p < 0.01). Industry-sponsored program reports tended to contain more data elements than non-industry-sponsored program reports (i.e., age, sex, indication for use), but completeness was variable across products. No significant difference in usefulness was identified between non-industry-sponsored program and industry-sponsored program individual case safety reports (30.6% vs. 28.5%, p = 0.42). Useful reports that contained at least one serious, unlabeled adverse event represented only 4% and 6.2% of the non-industry-sponsored program and industry-sponsored program report cohorts, respectively. CONCLUSIONS: Our study suggests that reports obtained from industry-sponsored programs in the Food and Drug Administration Adverse Event Reporting System database contain more data elements but are similar to non-industry-sponsored program reports with regard to 'usefulness' in signal detection.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/normas , Indústria Farmacêutica , Vigilância de Produtos Comercializados/normas , Antineoplásicos/efeitos adversos , Antineoplásicos/uso terapêutico , Produtos Biológicos/efeitos adversos , Produtos Biológicos/uso terapêutico , Fármacos Cardiovasculares/efeitos adversos , Fármacos Cardiovasculares/uso terapêutico , Fármacos Hematológicos/efeitos adversos , Fármacos Hematológicos/uso terapêutico , Humanos
16.
BMC Med Res Methodol ; 18(1): 175, 2018 12 22.
Artigo em Inglês | MEDLINE | ID: mdl-30577764

RESUMO

BACKGROUND: The purpose of this report is to evaluate the quality of data sources used to study cough and cold medication (CCM) safety in children via the Pediatric Cough and Cold Safety Surveillance System. METHODS: The System utilized the National Poison Data System (NPDS), FDA Adverse Event Reporting System (FAERS), English-language medical literature, manufacturer postmarket safety databases, and news/media reports to identify cases from January 2008 through September 2016. Each data source was evaluated by the proportion of detected cases determined to be eligible (met case criteria) and the proportion determined to be evaluable (able to determine causal relationship between adverse event and exposure). RESULTS: A total of 7184 unique cases were identified from 27,597 detected reports. Of these, 6447 (89.7%) were evaluable. The data source with the highest volume of detected cases was news/media; however, only 0.3% of those cases were eligible for panel review and only 0.2% (24 out of 13,450 cases) were evaluable. The data source with the highest proportion of eligible and evaluable cases was NPDS with 7691 detected cases, 6113 (79.5%) eligible cases, and 5587 (72.6%) evaluable cases. CONCLUSIONS: The data sources utilized to evaluate the safety profile of pediatric CCMs yielded variable detection and evaluation rates, but overall provided a comprehensive look at exposures that otherwise cannot be studied in clinical trials. While this study suggests that each source made a valuable contribution and that evaluable cases are generalizable, improvements are needed in case completeness and accuracy to enhance the quality of postmarket safety evaluations.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Resfriado Comum/tratamento farmacológico , Tosse/tratamento farmacológico , Armazenamento e Recuperação da Informação/estatística & dados numéricos , Vigilância de Produtos Comercializados/estatística & dados numéricos , Sistemas de Notificação de Reações Adversas a Medicamentos/normas , Criança , Pré-Escolar , Confiabilidade dos Dados , Feminino , Humanos , Lactente , Recém-Nascido , Armazenamento e Recuperação da Informação/normas , Masculino , Centros de Controle de Intoxicações/normas , Centros de Controle de Intoxicações/estatística & dados numéricos , Vigilância de Produtos Comercializados/métodos , Vigilância de Produtos Comercializados/normas
18.
Sante Publique ; 30(2): 225-232, 2018.
Artigo em Francês | MEDLINE | ID: mdl-30148310

RESUMO

BACKGROUND: Spontaneous reporting of adverse drug reactions remains the cornerstone of postmarketing drug safety surveillance (pharmacovigilance). However, the marked underreporting of adverse drug reactions constitutes a major limitation. The main objective of this study was to assess the use of this simplified reporting by general practitioners (GPs) in Western Normandy based on the number of ADRs reported and to assess its impact on the quality of these reports. METHOD: Simplified online pharmacovigilance reporting was proposed in June 2015 by the Caen Normandie regional pharmacovigilance center (CRPV) in conjunction with the Normandy Union régionale des médecins libéraux (URML Normandie) for GPs. This new tool is based on items to be completed by the GP. They were selected by members of CRPV in an attempt to combine good quality reporting and maximum simplicity. RESULTS: Between June 2014 and June 2016, 220 reports were made by 67 GPs. One year after introduction of this new tool, the monthly number of reports was multiplied by 4.8 and the number of reporting GPs was multiplied by two. The quality of reporting remained unchanged over the same period (p = 0.1). Simplified reporting allowed a decreased number of inaccurate reports (33% versus 36%, p = 0.04). CONCLUSION: Simplified online reporting is effective quantitatively (increased number of reports) but also qualitatively (quality unchanged). We must now try to develop this tool in other French regions and reassess it over time.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos , Clínicos Gerais/organização & administração , Farmacovigilância , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos/organização & administração , Sistemas de Notificação de Reações Adversas a Medicamentos/normas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Feminino , Humanos , Internet , Masculino , Pessoa de Meia-Idade , Sistemas On-Line , Vigilância de Produtos Comercializados/normas
20.
J Neurointerv Surg ; 10(Suppl 1): i35-i38, 2018 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30037952

RESUMO

BACKGROUND AND PURPOSE: The purpose of this study was to assess the initial post-market experience of the device and how it is compared with the Penumbra Pivotal trial used to support the 510k application. METHODS: A retrospective case review of 157 consecutive patients treated with the Penumbra system at seven international centers was performed. Primary endpoints were revascularization of the target vessel (TIMI score of 2 or 3), good functional outcome as defined by a modified Rankin scale (mRS) score of ≤2 and incidence of procedural serious adverse events. Results were compared with those of the Penumbra pivotal trial. RESULTS: A total of 157 vessels were treated. Mean baseline values at enrollment were: age 65 years, NIHSS score 16. After use of the Penumbra system, 87% of the treated vessels were revascularized to TIMI 2 (54%) or 3 (33%) as compared with 82% reported in the Pivotal trial. Nine procedural serious adverse events were reported in 157 patients (5.7%). All-cause mortality was 20% (32/157), and 41% had a mRS of ≤2 at 90-day follow-up as compared with only 25% in the Pivotal trial. Patients who were successfully revascularized by the Penumbra system had significantly better outcomes than those who were not. CONCLUSION: Initial post-market experience of the Penumbra system revealed that the revascularization rate and safety profile of the device are comparable to those reported in the Pivotal trial. However, the proportion of patients who had good functional outcome was higher than expected.


Assuntos
Isquemia Encefálica/cirurgia , Revascularização Cerebral/métodos , Transtornos Cerebrovasculares/cirurgia , Vigilância de Produtos Comercializados/normas , Acidente Vascular Cerebral/cirurgia , Dispositivos de Acesso Vascular/normas , Idoso , Idoso de 80 Anos ou mais , Isquemia Encefálica/diagnóstico por imagem , Revascularização Cerebral/instrumentação , Revascularização Cerebral/tendências , Transtornos Cerebrovasculares/diagnóstico por imagem , Europa (Continente)/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Vigilância de Produtos Comercializados/tendências , Estudos Retrospectivos , Acidente Vascular Cerebral/diagnóstico por imagem , Trombectomia/instrumentação , Trombectomia/métodos , Trombectomia/tendências , Estados Unidos/epidemiologia , Dispositivos de Acesso Vascular/tendências
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