National Poison Data System (NPDS): Pediatric Drug Safety Monitoring
Alvin C. Bronstein MD, FACMT Toxicosurveillance Director, AAPCC NPDS Steering Committee Chair American Association of Poison Control Centers Alexandria, VA
Medical Director Rocky Mountain Poison Center [email protected] Associate Professor University of Colorado Health Sciences Center Denver Health and Hospitals Denver, CO
13 September 2010 Pediatric Safety Surveillance Workshop Silver Spring, MD
American Association of Poison Control Centers
History of US Poison Centers
1940-50’s
– 800-1400 home poisoning fatalities a year
– 33% < 4 years of age
1953
– First US poison center
1958
– AAPCC founded
1970
– Poison Prevention Packaging Act
1978
– ~ 800 Poison Centers
1983
– Toxic Exposure Surveillance System
1988
– National Certification Requirements
2002
– National toll-free access 1-800-222-1222
2006
– NPDS goes online
2008
– 61 centers 24/7 service
2009
– 60 centers 24/7 service
60 Centers Upload Data to NPDS in Real-Time Median Time to Upload: 24 minutes
All 50 States, Puerto Rico, US Virgin Islands, 3 Pacific Jurisdictions
Open 24/7
National toll-free line
Who calls the poison center?
– Public
– Health care professionals
– Health departments
Data collected by health care professionals (RN, RPh, PharmD)
– Specialists in Poison Information (SPIs)
– Poison Information Providers (PIPs)
– Medical and clinical toxicologists
All centers collect standardized data set (stable since 1985)
Quality edits built into system
Centers and Data Collection
National Poison Database System (NPDS)
Over 4 M cases /year divided between exposures and information calls
SPIs code each substance contemporaneously to either
– A Hierarchical Generic Codes (947) or
– A Product specific code (360,000)
Bronstein AC, Spyker DA, Cantilena LR, Green JL, Rumack BH, Giffin SL. 2008 Annual Report of the American Association of
Poison Control Centers‘ National Poison Data System (NPDS). Clinical Toxicology, 47: 911 - 1084.
Available ONLINE at AAPCC.ORG
Year Exposures Information Calls
2006 2.4 M 1.5 M
2007 2.6 M 1.6 M
2008 2.6 M 1.7 M
2009 2.5 M 1.7 M
NPDS Adverse Events: 2009
Adverse Event All Ages Pediatrics:
0 - < 19 yrs
N % N %
Drug 44,460 1.79 9,004* 0.36
Other (eg: dermatitis associated with
jewelry, appropriate or
recommended use of a cleaning
product or cosmetic)
12,284 0.50 2,757 0.11
Food 5,718 0.23 1,882 0.08
Total 62,462 2.52 13,645 0.55
*40% of Pediatric Drug AEs treated in HCF
NPDS Adverse Drug Events: 2009 Pediatric Age Group (Exact Age) Managed in Health Care Facility: 2009
HI (10) HI (10)
NPDS Pediatric Age Categories
Track ages by
– Exact age (Days, Months, Years), or
– Age Ranges < 5 yrs 6-12 yrs Teen Unknown child (<19 yrs)
In 2009 there were 9004 Pediatric AEs to Drugs – 8815 (97.9%) had exact ages in NPDS
NPDS Product Data
Manufacturer
Dose
Route
Form
Schedule
OTC vs. Rx
Lot number (some products; readily added)
Devices (some products; readily added)
NPDS Data Field Summary
Global Case ID
State/Zip
Concomitant Exposures
Age, Gender, Weight
Exposure Site
Management site
Level of Care
– Treated/evaluated and released
– Admitted to critical care unit
– Admitted to non-critical care unit
– Admitted to psychiatric care facility
– Patient lost to follow-up/left AMA
Dosing cup errors
Fatalities
– All reviewed by independent multidisciplinary team
– Coroners/Medical Examiners reports reviewed when possible
Patient Data Available Only at Center Level
Name of caller
Address/Zip Code
Telephone number MD Specialty – tracked in notes
Health and Birth History
Drug Indication
NPDS Surveillance Methods AR Surveillance Using Case-Based Definitions
Call Volume
– Number of calls per time period of interest
– Threshold: historical baseline average + (N) SDs
Clinical Effects (signs and symptoms)
– Symptoms during 24-hour period
– Threshold: historical baseline average + (N) SDs
Cased-based definitions
– Case definition based on clinical effects
– Occurrence of specific chemicals, toxins, or products
Time Series
NPDS Outbreak Tracking
Previous Responses
– Contaminated Water
– Melamine in dog food
– Diethylene glycol in toothpaste
– E. Coli in spinach
– Salmonella in peanut butter
– Recalls
Improperly labeled Sindoor
Supplement with high concentrations of selenium
Rapid ability to trace back cases