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16 Health Outcomes of Interest for Surveillance Preparedness

Basic Details
Date Posted
Status
Complete
Health Outcome(s)
febrile seizure
Achilles tendon rupture (ATR)
ventricular arrhythmia
suicide
toxic epidermal necrolysis
severe acute liver injury (SALI)
Henoch Schönlein purpura (HSP)
attempted suicide
sudden cardiac death
erythema multiforme major
Guillain-Barré syndrome
hip fracture
idiopathic thrombocytopenic purpura
peripheral neuropathy
pulmonary hypertension
rhabdomyolysis
thrombocytopenia
valvulopathy
type 1 diabetes mellitus
Study Type
Literature Reviews
Description

This report 1) describes a review of the literature for algorithms used in administrative data environments to identify FDA-prioritized health outcomes that may be related to medical product and/or medical countermeasure exposure, and 2) recommends algorithms to identify these outcomes for use by Mini-Sentinel Prospective Routine Observational Monitoring Program Tools (PROMPT) in future surveillance activities.

Deliverable(s) (1)
16 Health Outcomes of Interest for Surveillance Preparedness
Workgroup Leader(s)

Sean Hennessy, PharmD, PhD; Center for Clinical Epidemiology and Biostatistics, and Center for Pharmacoepidemiology Research and Training, Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA

Workgroup Member(s)

Cristin Freeman, MPH, MBE and Charles E. Leonard, PharmD, MSCE; Center for Clinical Epidemiology and Biostatistics, and Center for Pharmacoepidemiology Research and Training, Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA

Patrick Archdeacon, MD; Office of Medical Policy, Center for Drug Evaluation and Research, FDA, Silver Spring, MD

Ryan Carnahan, PharmD, MS, BCPP and Elizabeth Chrischilles, MS, PhD; Department of Epidemiology, College of Public Health, The University of Iowa, Iowa City, IA