Limitations and strengths of spontaneous reports data

Goldman, Stephen A.

doi:10.1016/s0149-2918(98)80007-6

Cited by 196 publications

(142 citation statements)

References 15 publications

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“…Concerning the numerator, passive surveillance data may underestimate the incidence of adverse events, and thus the annual rate of TB in the RATIO registry might be toward the low end of the true incidence rate (16,17). The denominator of the incidence rate was estimated only.…”

Section: Discussionmentioning

confidence: 99%

Risk of tuberculosis is higher with anti–tumor necrosis factor monoclonal antibody therapy than with soluble tumor necrosis factor receptor therapy: The three‐year prospective french research axed on tolerance of biotherapies registry

Tubach

Salmon

Ravaud

et al. 2009

Arthritis & Rheumatism

583

366

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Objective. Tuberculosis (TB) is associated with anti-tumor necrosis factor (anti-TNF) monoclonal antibody (mAb) therapy, but whether this association is drug-specific remains a concern. Our objective was to describe cases of TB associated with anti-TNF mAb therapy, identify risk factors, and estimate the incidence.Methods. We conducted an incidence study and a case-control analysis to investigate the risk of newly diagnosed TB associated with the use of anti-TNF agents. As part of the French Research Axed on Tolerance of Biotherapies (RATIO) registry, for 3 years we collected cases of TB among French patients receiving anti-TNF mAb therapy for any indication; for each case, 2 patients treated with anti-TNF agents served as control subjects.Results. We collected 69 cases of TB in patients treated for rheumatoid arthritis (n ‫؍‬ 40), spondylarthritides (n ‫؍‬ 18), inflammatory colitis (n ‫؍‬ 9), psoriasis (n ‫؍‬ 1) and Behçet's disease (n ‫؍‬ 1) with infliximab (n ‫؍‬ 36), adalimumab (n ‫؍‬ 28), and etanercept (n ‫؍‬ 5). None of the patients had received correct chemoprophylactic treatment. The sex-and ageadjusted incidence rate of TB was 116.7 per 100,000 patient-years. The standardized incidence ratio (

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Section: Discussionmentioning

confidence: 99%

Risk of tuberculosis is higher with anti–tumor necrosis factor monoclonal antibody therapy than with soluble tumor necrosis factor receptor therapy: The three‐year prospective french research axed on tolerance of biotherapies registry

Tubach

Salmon

Ravaud

et al. 2009

Arthritis & Rheumatism

583

366

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“…A notificação espontânea também permite detetar eventos adversos raros e/ou de longo tempo de latência. [27][28][29] A taxa de notificação é um dos indicadores de desempenho da atividade das URF. Comparativamente aos resultados obtidos num estudo anterior verificou-se um aumento do número de notificações espontâneas por milhão de habitantes por ano recebidas pela UFC ao longo dos últimos 3 anos (máximo de 171 casos/milhão de habitantes/ano em 2013).…”

Section: Discussionunclassified

Farmacovigilância em Portugal: Atividade da Unidade Regional do Centro

et al. 2015

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Introduction:The aim of this study was to characterize the spontaneous reports of adverse events that were received by the Central Portugal Regional Pharmacovigilance Unit. Material and Methods: Spontaneous reports received between 01/2001 and 12/2013 were considered. The annual reporting ratios were estimated. The cases were characterized according to their seriousness, previous description, causality assessment, origin and professional group of the reporter, type of adverse event and pharmacotherapeutic groups of the suspected drugs most frequently reported. Results:The Pharmacovigilance Unit received 2408 reports that contained 5749 adverse events. In 2013, the reporting rate was estimated at 171 reports per million inhabitants. Fifty-five percent of the reports were assessed as serious. Ninety percent of the cases were assessed as being at least possibly related with the suspected drug. The suspected drugs most frequently reported were antiinfectives for systemic use (n = 809, 33%). The most frequently reported adverse events were "Skin and subcutaneous tissue disorders" (n = 1139, 20%). There were 154 (6.4%) reports resulting in life-threatening situations and/or death, and 88 (3.6%) containing at least one adverse event assessed as serious, unknown and certain or probable. Discussion: The present results are in line with those found in other studies, namely the seriousness and type of the adverse events and the pharmacotherapeutic groups of the most frequently reported suspected drugs. Conclusion:In the last years, the Central Portugal Regional Pharmacovigilance Unit has registered a growth in the reporting rate in general, as well as an increase in the reporting of unknown and serious adverse drug reactions.

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“…Postapproval, the Food and Drug Administration (FDA) utilizes the voluntary MedWatch reporting system (passive surveillance) to identify safety signals. However, only a small proportion of physicians submit MedWatch reports, and the interpretation of these data is hampered by a lack of denominator data (i.e., the total number of patients exposed to the medication of interest) (9). Postmarketing registries have been developed specifically to assess adverse events via incidence rates in a defined cohort of patients over the long term, and there are 2 completed postapproval registries (etanercept and celecoxib) that are particularly noteworthy regarding JIA management (10,11).…”

Section: Introductionmentioning

confidence: 99%

Novel Method to Collect Medication Adverse Events in Juvenile Arthritis: Results From the Childhood Arthritis and Rheumatology Research Alliance Enhanced Drug Safety Surveillance Project

Ringold

Hendrickson

Abramson

et al. 2015

Arthritis Care & Research

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Objective. Few data are available regarding the rates of serious adverse events (SAEs) and important medical events (IMEs) outside of product-based registries and clinical trials for juvenile idiopathic arthritis (JIA). The Enhanced Drug Safety Surveillance Project (EDSSP) was developed to pilot a novel system to collect SAEs/IMEs in children with JIA. This analysis reports the results from this 4-year (2008 -2012) EDSSP. Methods. Participating physicians were surveyed monthly to ascertain whether their JIA patients experienced an SAE or IME. Sites were surveyed every 6 months to determine the number of unique JIA patients seen at each site during that 6-month period. Reporting rates were calculated per 100 person-years and 95% confidence intervals (95% CIs) were calculated based on a Poisson distribution. Results. Thirty-seven Childhood Arthritis and Rheumatology Research Alliance sites with 115 physicians participated. The mean response rate to the monthly surveys was 65%. There were 147 total SAEs and 145 total IMEs. The largest proportion of SAEs and IMEs occurred in children with polyarticular JIA (39% and 37%, respectively). The majority of SAEs and IMEs were reported for patients receiving therapy with biologic agents (76% and 69%, respectively). The total event rate for SAEs and IMEs combined was 1.07 events per 100 person-years (95% CI 0.95-1.19). The rates for SAEs and IMEs were 0.54 per 100 person-years (95% CI 0.45-0.63) and 0.53 per 100 person-years (95% CI 0.49 -0.62), respectively. Conclusion. The EDSSP provided a simple tool for SAE/IME reporting within an established research network and resulted in a similar range of reported events as captured by a traditional product-based registry.

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Limitations and strengths of spontaneous reports data

Cited by 196 publications

References 15 publications

Risk of tuberculosis is higher with anti–tumor necrosis factor monoclonal antibody therapy than with soluble tumor necrosis factor receptor therapy: The three‐year prospective french research axed on tolerance of biotherapies registry

Risk of tuberculosis is higher with anti–tumor necrosis factor monoclonal antibody therapy than with soluble tumor necrosis factor receptor therapy: The three‐year prospective french research axed on tolerance of biotherapies registry

Farmacovigilância em Portugal: Atividade da Unidade Regional do Centro

Novel Method to Collect Medication Adverse Events in Juvenile Arthritis: Results From the Childhood Arthritis and Rheumatology Research Alliance Enhanced Drug Safety Surveillance Project

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