Active Surveillance for Adverse Drug Events

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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
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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

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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

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What is an Adverse Drug Event?
Events are outcomes

• Allergic Reactions
• Side-Effects
• Medication Poisonings
• Overdose causing injury
• Exposure leading to intervention

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What is a Drug?
Drugs include

• Prescription medications
• Over-the-counter medications
• Topical medications
• Vaccinations Vitamins
• Supplements Herbals

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What is NOT an ADE?
ADEs do NOT include

• Illegal (street) drugs
• Self-harm
• Abuse
• Reactions to drugs given during the current ED
  visit

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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

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Identifying and Reporting Adverse Drug Events
START
STOP Do not fill out ADE Screen

• 1. Look in Diagnosis Section of chart
• 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
• Or suspicious symptoms?
• Angioedema (face/lip/throat swelling)
• Anaphylaxis (severe allergy)
• Rash (urticaria, dermatitis)
• Bleeding (GI Bleed, hematemesis, epistaxis,
• hypocoaguability, high INR/PT)
• Hypoglycemia (low blood sugar)

NO
2. Is a Drug involved? Drugs include
prescription meds, over-the-counter meds,
vaccines, vitamins, dietary supplements.
YES

• 4. Fill out ADE Screen
• Record ED chart DIAGNOSIS
• word for word
• 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)

YES

• 3. Is there evidence of
• Suicide attempt?
• Intentional overdose?
• Abuse / Recreational use?

NO
YES
NO
STOP Do not fill out ADE Screen
FINISH
Questions? Contact your CPSC supervisor or Dan
Budnitz, 770-488-1486, dbudnitz_at_cdc.gov
8/04
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Information Flow
CPSC
NEISS Coder
CDC
FDA
Patient Chart
MedDRA Coding Drug Validation
Patient Identifiers Removed
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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

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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?