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16 Health Outcomes of Interest for Surveillance Preparedness

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