Download Surveillance of Adverse Drug Events in the Outpatient Setting: An

Active Surveillance for
Adverse Drug Events
Collaborative Effort of
Centers for Disease Control and Prevention
Food and Drug Administration
Consumer Produce Safety Commission
Dan Budnitz, MD, MPH
National Center for Injury Prevention & Control
November 9, 2004
TM
Why is Active ADE Surveillance
Important?
• ADEs may cause 100,000 deaths
• Undercounting of ADEs with current
reporting systems
• Limited data collected in outpatient setting
Objectives of NEISS-CADES
Quantify and describe injuries from the use
of drugs that are treated in EDs:
•
•
•
•
Burden of ADE problem nationally
Magnitude of known drug reactions
Mechanism (overdose, allergy…)
Signal detection / Special
investigations
What is an Adverse Drug “Event”?
“Events” are outcomes:
•
Allergic Reactions
•
Side-Effects
•
Medication Poisonings
-
Overdose causing injury
-
Exposure leading to
intervention
What is a “Drug”?
“Drugs” include:
•
Prescription medications
•
Over-the-counter medications
•
Topical medications
•
Vaccinations & Vitamins
•
Supplements & Herbals
What is NOT an ADE?
ADEs do NOT include:
x Illegal (street) drugs
x Self-harm
x Abuse
x Reactions to drugs given during
the current ED visit
ADEs: Summary Definition
Someone comes to the ED because:
•
Allergic Reaction to a drug
•
Side-Effect of a drug
•
Taking a drug in the Wrong Way
•
Taking the Wrong Drug
 No evidence of self-harm or drug abuse
Identifying and Reporting Adverse Drug Events
START
STOP
1. Look in Diagnosis Section of chart:
Do not fill out
ADE Screen
Do diagnoses include key words?
•
•
•
•
•
•
•
Allergic reaction
Adverse effect
Side-effect (s/e)
Secondary to (2° to, due to, related to)
Ingestion (poisoning)
Toxicity (overdose, supra-therapeutic level)
Medication error
NO
2. Is a Drug involved?
YES
Drugs include: prescription meds,
over-the-counter meds, vaccines,
vitamins, & dietary supplements.
4. Fill out ADE Screen:
Or suspicious symptoms?
•
•
•
•
Angioedema (face/lip/throat swelling)
Anaphylaxis (severe allergy)
Rash (urticaria, dermatitis)
Bleeding (GI Bleed, hematemesis, epistaxis,
hypocoaguability, high INR/PT)
YES
• Record ED chart DIAGNOSIS
word for word
3. Is there evidence of:
•
•
•
Suicide attempt?
Intentional overdose?
Abuse / Recreational use?
• Hypoglycemia (low blood sugar)
YES
NO
STOP
Do not fill out
ADE Screen
NO
• Record drug name(s)
• If available, record dose, route,
frequency, and duration
• Record reason for visit, testing,
and treatments
• Record any other information
(e.g., discharge instructions or
medication error information)
FINISH
Questions? Contact your CPSC supervisor or Dan Budnitz, 770-488-1486, [email protected]
8/04
Information Flow
NEISS
Coder*
CPSC
CDC
Patient
Chart
FDA
MedDRA Coding
& Drug
Validation
*Patient Identifiers Removed
Limitations
Case Identification
• Only ADEs treated in EDs
• Only includes clinician-diagnosed and
documented events
• Sensitivity of coder case identification
needs improvement
Causality Assessment
• Limited to abstracted ED data
Implications for Other Systems
NHAMCS: Poisoning or ADE?
Case
Event
ICD code
A
92 yo with general ill feeling – gets a
little drowsy, DX= digoxin toxicity
E-code = poisoning
N-code = poisoning
B
86 yo with weakness and labored
breathing, DX= digoxin toxicity
E-code = Adverse
Drug Effect
N-code = poisoning
How does a patient have an adverse effect of a
drug “properly administered” if the patient also
has a diagnosis of “poisoning”?