The organizational structure and governing principles of the Food and Drug Administration's Mini‐Sentinel pilot program

Forrow, Susan; Campion, Daniel; Herrinton, Lisa J.; Nair, Vinit; Robb, Melissa A.; Wilson, Marcus D.; Platt, Richard

doi:10.1002/pds.2242

Cited by 52 publications

(49 citation statements)

References 2 publications

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“…The Mini-Sentinel program is a public health activity under the auspices of the FDA and is not under the purview of institutional review boards. 31,32 …”

Section: Additional Analysesmentioning

confidence: 99%

Comparative Risk for Angioedema Associated With the Use of Drugs That Target the Renin-Angiotensin-Aldosterone System

Toh¹,

Reichman²,

Houstoun³

et al. 2012

Arch Intern Med

187

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Background: Although certain drugs that target the renin-angiotensin-aldosterone system are linked to an increased risk for angioedema, data on their absolute and comparative risks are limited. We assessed the risk for angioedema associated with the use of angiotensinconverting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), and the direct renin inhibitor aliskiren.Methods: We conducted a retrospective, observational, inception cohort study of patients 18 years or older from 17 health plans participating in the Mini-Sentinel program who had initiated the use of an ACEI (n=1 845 138), an ARB (n=467 313), aliskiren (n=4867), or a ␤-blocker (n = 1 592 278) between January 1, 2001, and December 31, 2010. We calculated the cumulative incidence and incidence rate of angioedema during a maximal 365-day follow-up period. Using ␤-blockers as a reference and a propensity score approach, we estimated the hazard ratios of angioedema separately for ACEIs, ARBs, and aliskiren, adjusting for age, sex, history of allergic reactions, diabetes mellitus, heart failure, or ischemic heart disease, and the use of prescription nonsteroidal antiinflammatory drugs.Results: A total of 4511 angioedema events (3301 for ACEIs, 288 for ARBs, 7 for aliskiren, and 915 for ␤-blockers) were observed during the follow-up period. The cumulative incidences per 1000 persons were 1.79 (95% CI, 1.73-1.85) cases for ACEIs, 0.62 (95% CI, 0.55-0.69) cases for ARBs, 1.44 (95% CI, 0.58-2.96) cases for aliskiren, and 0.58 (95% CI, 0.54-0.61) cases for ␤-blockers. The incidence rates per 1000 person-years were 4.38 (95% CI, 4.24-4.54) cases for ACEIs, 1.66 (95% CI, 1.47-1.86) cases for ARBs, 4.67 (95% CI, 1.88-9.63) cases for aliskiren, and 1.67 (95% CI, 1.56-1.78) cases for ␤-blockers. Compared with the use of ␤-blockers, the adjusted hazard ratios were 3.04 (95% CI, 2.81-3.27) for ACEIs, 1.16 (95% CI, 1.00-1.34) for ARBs, and 2.85 (95% CI, 1.34-6.04) for aliskiren.Conclusions: Compared with ␤-blockers, ACEIs or aliskiren was associated with an approximately 3-fold higher risk for angioedema, although the number of exposed events for aliskiren was small. The risk for angioedema was lower with ARBs than with ACEIs or aliskiren.

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“…The Mini-Sentinel program is a public health activity under the auspices of the FDA and is not under the purview of institutional review boards. 31,32 …”

Section: Additional Analysesmentioning

confidence: 99%

Comparative Risk for Angioedema Associated With the Use of Drugs That Target the Renin-Angiotensin-Aldosterone System

Toh¹,

Reichman²,

Houstoun³

et al. 2012

Arch Intern Med

187

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“…For peripheral joint prostheses, the median number of postmarket changes per device was 7.5 (IQR, [3][4][5][6][7][8][9][10][11][12][13][14], or 0.9 changes (IQR, 0.4-1.9) per active device-year. For spinal implants/prostheses, the median number of postmarket changes per device was seven (IQR, 3-13), or 1.4 changes (IQR, 0.9-1.8) per active device-year.…”

Section: Postmarket Changes For Pma-approved Devicesmentioning

confidence: 99%

“…As a result, continued postmarket surveillance of high-risk orthopaedic devices is critical to ensure patient safety [5]. Although the quality of FDA-mandated postapproval studies has been questioned [19], efforts to build national and international orthopaedic device registries [15] and electronic health record-based monitoring systems [8,17] are underway. Programs such as these may enable continued manufacturer innovation through least burdensome premarket regulation, while still maintaining sufficient postmarket oversight to limit patient safety risks.…”

Section: Device Recalls and Market Withdrawalmentioning

confidence: 99%

How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval?

Samuel

Rathi

Grauer

et al. 2016

Clinical Orthopaedics &Amp; Related Research

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Background The FDA approves novel, high-risk medical devices through the premarket approval (PMA) process based on clinical evidence supporting device safety and effectiveness. Devices subsequently may undergo postmarket modifications that are approved via one of several PMA supplement review tracks, usually without additional supporting clinical data. While orthopaedic devices cleared via the less rigorous 510(k) pathway have been studied previously, devices cleared through the PMA pathway and those receiving postmarket PMA supplements warrant further investigation. Questions/purposes We asked: What are (1) the types of original orthopaedic devices receiving FDA PMA approval, (2) the number and rate of postmarket device changes approved per device, (3) the types of PMA supplement review tracks used, (4) the types of device changes approved via the various review tracks, and (5) the number of device recalls and market withdrawals that have occurred for these devices? Methods All original PMA-approved orthopaedic devices between January 1982 and December 2014 were identified in the publically available FDA PMA database. The number of postmarket device changes approved, the PMA supplement review track used, the types of postmarket changes, and any FDA recalls for each device were assessed. Results Seventy original orthopaedic devices were approved via the FDA PMA pathway between 1982 and

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“…The Sentinel program, 39 administered by the US Food and Drug Administration (FDA), and the CDC's Vaccine Safety Data Link (VSD) 40 utilize cooperative data-sharing models to perform surveillance for medical product safety and vaccine adverse effects, respectively. These programs have assembled consortia of hospital-associated research groups who work under fee-for-service contracts to perform studies of interest to CDC and FDA that use specific data extracted from EMRs and stored in a common format.…”

Section: Achieving Universal Emr Data Accessmentioning

confidence: 99%

A Conceptual Architecture for National Biosurveillance: Moving Beyond Situational Awareness to Enable Digital Detection of Emerging Threats

Velsko¹,

Bates²

2016

Health Security

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Despite numerous calls for improvement, the US biosurveillance enterprise remains a patchwork of uncoordinated systems that fail to take advantage of the rapid progress in information processing, communication, and analytics made in the past decade. By synthesizing components from the extensive biosurveillance literature, we propose a conceptual framework for a national biosurveillance architecture and provide suggestions for implementation. The framework differs from the current federal biosurveillance development pathway in that it is not focused on systems useful for "situational awareness" but is instead focused on the long-term goal of having true warning capabilities. Therefore, a guiding design objective is the ability to digitally detect emerging threats that span jurisdictional boundaries, because attempting to solve the most challenging biosurveillance problem first provides the strongest foundation to meet simpler surveillance objectives. Core components of the vision are: (1) a whole-of-government approach to support currently disparate federal surveillance efforts that have a common data need, including those for food safety, vaccine and medical product safety, and infectious disease surveillance; (2) an information architecture that enables secure national access to electronic health records, yet does not require that data be sent to a centralized location for surveillance analysis; (3) an inference architecture that leverages advances in "big data" analytics and learning inference engines-a significant departure from the statistical process control paradigm that underpins nearly all current syndromic surveillance systems; and (4) an organizational architecture with a governance model aimed at establishing national biosurveillance as a critical part of the US national infrastructure. Although it will take many years to implement, and a national campaign of education and debate to acquire public buy-in for such a comprehensive system, the potential benefits warrant increased consideration by the US government.

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The organizational structure and governing principles of the Food and Drug Administration's Mini‐Sentinel pilot program

Cited by 52 publications

References 2 publications

Comparative Risk for Angioedema Associated With the Use of Drugs That Target the Renin-Angiotensin-Aldosterone System

Comparative Risk for Angioedema Associated With the Use of Drugs That Target the Renin-Angiotensin-Aldosterone System

How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval?

A Conceptual Architecture for National Biosurveillance: Moving Beyond Situational Awareness to Enable Digital Detection of Emerging Threats

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