16 Health Outcomes of Interest for Surveillance Preparedness

Project Title 16 Health Outcomes of Interest for Surveillance Preparedness
Date Posted
Tuesday, July 1, 2014
Status
Complete
Deliverables
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.

Health Outcome
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
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 Members

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