1. Active Surveillance for Adverse Drug Events Dan Budnitz, MD, MPH National Center for Injury Prevention & Control November 9, 2004 Collaborative Effort of Centers for Disease Control and Prevention Food and Drug Administration Consumer Produce Safety Commission TM

2. 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

3. 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

4. What is an Adverse Drug “Event”? “Events” are outcomes: Allergic Reactions Side-Effects Medication Poisonings -Overdose causing injury -Exposure leading to intervention

5. What is a “Drug”? “Drugs” include: Prescription medications Over-the-counter medications Topical medications Vaccinations & Vitamins Supplements & Herbals

6. 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

7. 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

8. 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) 2. Is a Drug involved? Drugs include: prescription meds, over-the-counter meds, vaccines, vitamins, & dietary supplements. Identifying and Reporting Adverse Drug Events YES NO 3. Is there evidence of: Suicide attempt? Intentional overdose? Abuse / Recreational use? 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 NO STOP Do not fill out ADE Screen STOP Do not fill out ADE Screen START FINISH Questions? Contact your CPSC supervisor or Dan Budnitz, 770-488-1486, dbudnitz@cdc.gov 8/04

9. Information Flow CDCFDA CPSC MedDRA Coding & Drug Validation Patient Chart NEISS Coder* *Patient Identifiers Removed

10. 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

11. Implications for Other Systems NHAMCS: Poisoning or ADE? CaseEventICD 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”?