MedWatch: The FDA Safety Information and Adverse Event Reporting Program

Craigle, Valeri

doi:10.3163/1536-5050.95.2.224

Cited by 67 publications

(42 citation statements)

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“…In order to assess patient safety improvement, a range of approaches have emerged world-wide, including the AHRQ patient safety indicators [17], the Utah/Missouri Adverse Event Classification [18], the Medicare and Medicaid systems [19,20], the Leapfrog Survey [21], and many others [22][23][24][25][26]. Although such approaches are potentially valuable contributions to patient safety improvement, governments do not require healthcare organisations to adopt them.…”

Section: Introductionmentioning

confidence: 99%

Application of the IHI Global Trigger Tool in measuring the adverse event rate in a Turkish healthcare setting

Kurutkan

Usta

Orhan

et al. 2015

International Journal of Risk &Amp; Safety in Medicine

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BACKGROUND: The goal of this study was to measure an adverse event rate and determine the potential usefulness of the Institute for Healthcare Improvement's Global Trigger Tool (GTT). Besides using the GTT to measure the adverse event rate, a comparison was also made with the internal Voluntary Reporting Notification System (VRNS) to identify and compare the strengths and weaknesses of the two approaches. METHOD: Retrospective data were collected from reported patient safety incidents covering a one-year period at Duzce University Hospital, Turkey. Using a range of selection criteria, a total of 219 patient records were selected and then reviewed by a trained GTT team, to investigate the positive triggers in the content of the patient records. RESULTS: It was determined that adverse events per 1000 patient days totalled 80.72. Adverse events per 100 admissions were 29.39, and the rate of admissions with adverse events was 16.67%. The comparison between the GTT and the VRNS showed that the GTT is 19 times more sensitive than the VRNS in the adverse event evaluation process. CONCLUSION: This is the first published study of the rate of adverse events in a Turkish healthcare setting using the GTT. It was found that the GTT was applicable in this setting, yielding more accurate measurement of the adverse event rate. However, the content of the GTT should be adjusted regarding the standards and documentations used in the Turkish healthcare system to be more useful.

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Section: Introductionmentioning

confidence: 99%

Application of the IHI Global Trigger Tool in measuring the adverse event rate in a Turkish healthcare setting

Kurutkan

Usta

Orhan

et al. 2015

International Journal of Risk &Amp; Safety in Medicine

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“…The latter group is required by law to submit the mandatory form immediately upon discovery of a product malfunction. Printable mail-in forms are available as an alternative to the online submission system [11]. …”

Section: Methodsmentioning

confidence: 99%

Alzheimer’s Disease and Intranasal Fluticasone Propionate in the FDA MedWatch Adverse Events Database

Lehrer

Rheinstein²

2018

Journal of Alzheimer's Disease Reports

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Background:Studies of Alzheimer’s disease suggest that neuroinflammation or deranged brain wound healing may be a cause of some cases. But a placebo controlled study showed no effect at all on Alzheimer’s disease of low dose oral prednisone after one year. Introducing the steroid directly into the hippocampus and rhinencephalon via the nose, as happens in hay fever subjects, could be more effective.Objective:In the present study, we analyzed FDA MedWatch data for intranasal fluticasone propionate (Flonase) to determine the frequency of Alzheimer’s disease as an adverse event reported after use of the medication.Methods:Machine-readable data from MedWatch, including adverse drug reaction reports from manufacturers, are part of a public database. We used the online tool eHealthMe to query the database.Results:By September 20, 2017, 35,221 people reported side effects to MedWatch after taking Flonase. Among them, 9 people (0.03%) had Dementia Alzheimer’s type. By October 3, 2017, 185,636 people reported side effects after taking Lipitor. Among them, 243 people (0.13%) had Dementia Alzheimer’s type. The lower incidence of Alzheimer’s dementia in the Flonase group compared to the Lipitor group was significant (p < 0.001, Fisher exact test, two tailed).Conclusion:Long term use of oral non-steroidal anti-inflammatory drugs (NSAIDs) is linked with reduced risk of developing Alzheimer’s disease. Data from MedWatch suggest that fluticasone propionate administered intranasally might have a similar preventive effect to ibuprofen. Perhaps combining ibuprofen and Flonase could be therapeutic. Further studies would be desirable.

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“…Suggested data sources included randomized controlled trials, observational studies (including pharmacoepidemiological studies performed on large databases), and information from regulatory agencies and other groups that collect postmarketing information and case reports on adverse events (e.g., the FDA's MedWatch program). 25 The KIs noted that reviewers should not rely solely on randomized trials since they are often underpowered to detect uncommon harms, too short to evaluate long-term harms, and often enroll "ideal" populations at low risk for harms. The KIs noted that case reports may identify potentially serious harms that are very uncommon; however, they also noted that it can be difficult to determine causality from such studies.…”

Section: Using Literature and Other Data Sources To Guide Prioritizatmentioning

confidence: 99%

Prioritization and Selection of Harms for Inclusion in Systematic Reviews

Chou¹,

Baker²,

Bañez³

et al. 2017

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None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.Persons using assistive technology may not be able to fully access information in this report. For assistance, contact EffectiveHealthCare@ahrq.hhs.gov PrefaceThe Agency for Healthcare Research and Quality (AHRQ), through its Evidence-based Practice Centers (EPCs), sponsors the development of evidence reports and technology assessments to assist public-and private-sector organizations in their efforts to improve the quality of health care in the United States. The reports and assessments provide organizations with comprehensive, science-based information on common, costly medical conditions and new health care technologies and strategies. The EPCs systematically review the relevant scientific literature on topics assigned to them by AHRQ and conduct additional analyses when appropriate prior to developing their reports and assessments.To improve the scientific rigor of these evidence reports, AHRQ supports empiric research by the EPCs to help understand or improve complex methodologic issues in systematic reviews. These methods research projects are intended to contribute to the research base in and be used to improve the science of systematic reviews. They are not intended to be guidance to the EPC program, although they may be considered by EPCs along with other scientific research when determining EPC program methods guidance.AHRQ expects that the EPC evidence reports and technology assessments will inform individual health plans, providers, and purchasers and the health care system as a whole by providing important information to help improve health care quality. The reports undergo peer review prior to their release as a final report.

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MedWatch: The FDA Safety Information and Adverse Event Reporting Program

Cited by 67 publications

References 0 publications

Application of the IHI Global Trigger Tool in measuring the adverse event rate in a Turkish healthcare setting

Application of the IHI Global Trigger Tool in measuring the adverse event rate in a Turkish healthcare setting

Alzheimer’s Disease and Intranasal Fluticasone Propionate in the FDA MedWatch Adverse Events Database

Prioritization and Selection of Harms for Inclusion in Systematic Reviews

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