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 Al.bronstein@rmpdc.org 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

Poison Center SPI at Work

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: Web-Based Application

131 NPDS Clinical Effects

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 Ages)

HI (25)

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

Situational Awareness Example: Two St. Louis Emergency Departments Closed

Anomaly 103126

Summary

NPDS and Poison Centers – 24/7 national infrastructure

– 26+ years of data

– Data collection by health care professionals

Available in Real Time

Statistics

Customizable AE tracking

Public Health asset

Enhances public health response

– Situational Awareness

– Surveillance

– Resilience