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Health Outcomes Among Individuals Exposed to Medical Products

These assessments examine the occurrence of pre-specified health outcomes, or health events, among individuals exposed to particular medical products. Health outcomes can include the subsequent occurrence of new diagnoses, additional medical procedures, or use of other additional medical products (or combinations of these). The specifications of an assessment can vary widely based on the definition of exposures, comparators, outcomes, cohort inclusion and exclusion criteria, time periods, and analytic approaches. There are three subcategories of assessments:

  • Modular program based one-time assessments. These assessments provide rapid response by making use of adaptable standardized programs ("modular programs"). These assessments can provide stratified results by age group, sex, and calendar year.
  • Prospective Routine Observational Monitoring Program Tools (PROMPT) assessments. These assessments involve repeated evaluation of electronic, administrative and claims-based healthcare data as they accrue within the Mini-Sentinel Distributed Database. PROMPT assessments perform active surveillance of newly approved medical products in a prospective and semi-automated manner as experience with these products accumulates in near real time. A small number of study designs and analytical methods ("PROMPT tools") have been implemented that can be modified quickly to accommodate specific products, outcomes, populations, and time periods for evaluation. The emphasis is on detecting potential excess risk of adverse events associated medical products rather than formal assessment of causal relationships. This approach requires that signals be carefully followed up to understand the explanation for the finding.
  • Protocol based assessments.These assessments use customized study designs and protocols that allow 1) detailed specification of exposure groups and health events, 2) adjustment for a range of potential confounding factors, and 3) comparison of event rates between different medical products. These may be one-time assessments or may involve repeated evaluation of information as it accrues within the Mini-Sentinel Distributed Dataset. They may use a variety of study designs and statistical methods, including sequential methods.

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Results from Assessments of Diagnoses and Medical Procedures Search. Click on the title in each column header to sort based on that column; click twice to reverse the sort. By default, the list is sorted by date with newest postings first.
 TitleAssessment TypeStatusDate Posted
DetailsMetabolic Effects of Second Generation Antipsychotics in YouthProtocolComplete 7-31-2014
DetailsPROMPT: Mirabegron Surveillance Plan v2.0PROMPTIn progress 6-25-2014
DetailsProjected Timelines for CBER Protocol-Based Mini-Sentinel Medical Product AssessmentsProtocolOngoing 6-25-2014
DetailsImmunoglobulin & hemolysis 1Modular ProgramComplete 6-10-2014
DetailsImmunoglobulin & hemolysis 3Modular ProgramComplete 6-10-2014
DetailsAnti-D, dexamethasone, prednisone, romiplostim & hemolysis Modular ProgramComplete 6-10-2014
DetailsImmunoglobulin & hemolysis 2Modular ProgramComplete 6-10-2014
DetailsPneumococcal conjugate vaccines & Kawasaki’s diseaseModular ProgramComplete 5-29-2014
DetailsThromboembolic Events After Immunoglobulin Administration Protocol v2.0ProtocolIn progress 5-20-2014
DetailsInfluenza Vaccines and Febrile Seizures (PRISM)Protocol Complete 5-15-2014
DetailsGardasil Vaccination and Venous Thromboembolism Protocol v2.0 (PRISM)Protocol In progress 4-28-2014
DetailsInfluenza Vaccines and Pregnancy Outcomes Protocol (PRISM) v2.0ProtocolIn progress 3-31-2014
DetailsPROMPT: Rivaroxaban Surveillance Plan v2.0PROMPTIn progress 3-28-2014
DetailsA Protocol for Assessment of Dabigatran and Selected Safety OutcomesProtocolIn progress 3-26-2014
DetailsIntussusception Risk After Rotavirus Vaccination in U.S. Infants (PRISM)ProtocolComplete 2-06-2014
DetailsParenteral Iron and Anaphylactoid Reactions Protocol v2.0ProtocolIn progress 1-13-2014
DetailsQuinine sulfate, diltiazem & selected thrombotic eventsModular ProgramComplete 1-10-2014
DetailsAntiepileptic drugs (AEDs) & kidney stonesModular ProgramComplete 1-10-2014
DetailsAccessing the Freshest Feasible Data for Conducting Active Influenza Vaccine Safety Surveillance Protocol v3.0 (PRISM)ProtocolIn progress 1-09-2014
DetailsAnti-diabetes Drugs & Acute Myocardial Infarction Protocol v4.0ProtocolIn progress 1-08-2014
DetailsOxicam NSAIDs, modafinil/armodafinil, sulfamothoxazole & Severe Cutaneous Adverse Reaction (SCAR) eventsModular programComplete 6-07-2013
DetailsAngiotensin Receptor Blockers (ARBs), hydrochlorothiazide, atenolol, amlodipine use & celiac diseaseModular programComplete 6-07-2013
DetailsDabigatran, warfarin & GI bleed, intracerebral hemorrhageModular programComplete 5-03-2013
DetailsWarfarin & GI bleed, intracerebral hemorrhageModular programComplete 5-03-2013
DetailsPrevnar 13 Vaccine and Kawasaki Disease Protocol (PRISM)ProtocolProtocol in preparation 2-27-2013
DetailsInfluenza Vaccines and Birth Outcomes Protocol (PRISM)ProtocolIn progress 2-25-2013
DetailsDabigatran (Pradaxa), warfarin & GI bleed, intracerebral hemorrhageModular Program Complete 2-15-2013
DetailsNatalizumab, efalizumab, & progressive multifocal leukoencephalopathy (PML)Modular Program Complete 1-11-2013
DetailsDrugs that act on the renin-angiotensin-aldosterone system (angiotensin converting enzyme inhibitors, angiotensin receptor blockers, aliskiren) & angioedemaProtocol Complete 10-23-2012
DetailsSmoking cessation drugs & cardiovascular outcomesModular program Complete 1-17-2012
DetailsAngiotensin II receptor blockers & celiac diseaseModular program Complete 1-17-2012

 

Page Updated: 2014