1. NEISS-Cooperative Adverse Drug Event Surveillance (NEISS-CADES) Dan Budnitz, MD, MPH CDC Injury Center August 11, 2004 TM

2. Overview Early Results Updates − To simplify case identification − To speed reporting Example Cases Discussion

3. Early results are generating much interest!

4. To Date Pilot Study submitted to Annals of Emergency Medicine Food and Drug Administration (FDA) interest and support Over 8,000 ADE cases reported = about ½ million estimated cases *

5. Preliminary Findings Type of Case# Cases*National Estimate* Age >6563583,000 Age <2 years42456,000 Acetaminophen / NSAIDs 30941,000 Hypoglycemia from diabetes drugs** 20227,000 Bleeding from blood thinners ** 16922,000

6. Site Visits About 50% of cases not reported * –<50% cases of hypoglycemia from diabetes drugs (insulin) ** –<50% cases of bleeding from blood thinners (coumadin / warfarin) **

7. Site Visit Feedback About 50% of cases not reported * –<50% cases of hypoglycemia from diabetes drugs (insulin) ** –<50% cases of bleeding from blood thinners (coumadin / warfarin) ** Simplify case identification Streamline case reporting

8. Updates: To simplify case finding

9. A. Definition is on the computer:

10. Adverse Drug Events Include Side Effects Allergic Reactions Medication Errors Accidental Ingestions (children) Unintended Overdoses / High Levels of Medications (adults)

11. Do NOT Report Alcohol intoxication Using illegal drugs Drug abuse / “recreational” use Suicidal / Intentional Overdoses Drugs given during this ED visit

12. “Drugs” Include Prescription Medications OTC Medications Medicated Creams / Ointments Vaccinations / Immunizations Vitamins Herbals / Nutritional Supplements

13. Recall the “Three Tips” from the handbook? Now simplified

14. Medical conditions (hypoglycemia, GI bleed, dermatitis) Symptoms “linked to” drugs (nausea, abdominal pain, dizziness) Asymptomatic “errors” (child ingesting pills, high drug levels in adults) Poisonings / Toxicity / Overdoses ADEs can look like Illnesses

15. Examples Lower GI bleed and high PT/INR. Hyperprothrombinemia due to coumadin. Rash on the back after taking amoxicillin Abdominal pain, n&v 2° to antibiotics Infant got into meds in Grandma’s purse. Four pills missing. Ingestion.

16. The Three Tips Start with the Diagnosis/Assessment section Look for the Key Words that link a drug to an injury Look for Certain Symptoms which may be linked to drugs

17. #1 – Review the Diagnoses Diagnosis / Assessment Every Diagnosis Discharge Instructions Chief Complaint Other Sections Logbook

18. #2 - Look For Key Words Allergic reaction Adverse reaction Side-effect (s/e) Secondary to (2° to, due to, related to) Ingestion (poisoning) Toxicity (overdose, supra-therapeutic level)

19. #3 - Look for 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)

20. Updates: To ease reporting

21. Fewer “Unneeded” 2 nd Screens New “Illegal Drug” Code (#1939) − Cocaine / Crack − Heroin − Marijuana − PCP − Hallucinogens ADE second screen will NOT appear

22. Fewer Fields on 2 nd Screen FEWER Required Fields –Dosage, Route, and Duration - optional Fill these fields out only if the information is available –Reason, Diagnosis, Drug Name, Testing, and Treatments are still required NO more “Allergy” Questions

25. ADE Identification & Reporting on 1 page

26. 1. Look in Diagnosis Section of chart: Do diagnoses include key words? Allergic reaction Adverse reaction Side-effect (s/e) Secondary to (2° to, due to, related to) Ingestion (poisoning) Toxicity (overdose, supra-therapeutic level) 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: Self-harm / Suicide? 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

27. Cases

28. ED log:Pain CC:“sick stomach” HPI:59 yo F with sick stomach x3 weeks, decreased appetite, occasional chest pain, PMD increased digoxin PE:No acute distress, heart is regular… Lab:Dig = 5.7 Dx:1. Heart Failure 2. Adverse effect of Digoxin Case 1: ED chart

29. ED log:Pain CC:“sick stomach” HPI:59 yo F with sick stomach x3 weeks, decreased appetite, occasional chest pain, PMD increased digoxin PE:No acute distress, heart is regular… Lab:Dig = 5.7 Dx:1. Heart Failure 2. Adverse effect of Digoxin Case 1: DX = “adverse effect”

30. CMT:sick stomach x3 weeks, decreased appetite, occasional chest pain, PMD increased digoxin Reason:Pain Drug1:Digoxin Dx:1. Heart Failure 2. Adverse effect of Digoxin Testing:Dig = 5.7 Treat:none Case 1: Second Screen Report

31. ED log:Rash CC:skin rash and body aches HPI:Started taking clindamycin 6 days ago for tooth infection, now itchy, skin rashes, body aches PE:No acute distress, heart is regular… Orders: Pepcid 20 mg IV, benadryl 50 mg IV, solumedrol 125mg IV DX:possible drug reaction to clindamycin Instruction: d/c clindamycin Case 2: ED Chart

32. ED log:Rash CC:skin rash and body aches HPI:Started taking clindamycin 6 days ago for tooth infection, now itchy, skin rashes, body aches PE:No acute distress, heart is regular… Orders: Pepcid 20 mg IV, benadryl 50 mg IV, solumedrol 125mg IV DX:possible drug reaction to clindamycin Instruction: d/c clindamycin Case 2: DX= “drug reaction” and symptom = “rash”

33. CMT:Started taking clindamycin 6 days ago for tooth infection, now itchy, skin rashes, body aches Reason:skin rash and body aches Drug1:Clindamycin Dx:possible drug reaction to clindamycin Testing:None Treat:Pepcid 20 mg IV, benadryl 50 mg IV, solumedrol 125mg IV Other Information: discharge instructions state “d/c clindamycin” Case 2: Second Screen Report

34. ED log:nose bleed CC:cannot stop bleeding for lesion near nose HPI:Patient presents with bleeding below nares, unable to stop bleeding from lesion PE:No acute distress, heart is regular… Lab:INR=4.7, CBC Tx: Vit K 1mg Dx:1. arterial bleeding from lip 2. overanticoagulation from Coumadin Case 3: ED chart

35. ED log:epistaxis CC:cannot stop bleeding for lesion near nose HPI:Patient presents with bleeding below nares, unable to stop bleeding from lesion PE:No acute distress, heart is regular… Lab:INR=4.7, CBC Tx: Vit K 1mg Dx:1. arterial bleeding from lip 2. overanticoagulation from Coumadin Case 3: DX=“over anticoagulation” & symptom=“bleeding”

36. CMT:unable to stop bleeding for lesion below nares Reason:cannot stop bleeding Drug1:Coumadin Dx:1. overanticoagulation from Coumadin 2. arterial bleeding from lip Testing:INR=4.7, CBC Treat:Vit K 1 mg Case 3: Second Screen Report

37. ED log:syncope CC:passed out at store HPI:Was at grocery store when patient got dizzy and weak. Blood glucose is 30. NIDDM. Pt took regular meds and did not eat lunch. Takes glucophage for diabetes. PE:No acute distress, heart is regular… Lab:BS=30, CBC Tx: diet tray Dx:acute hypoglycemia Case 4: ED chart

38. ED log:syncope CC:passed out at store HPI:Was at grocery store when patient got dizzy and weak. Blood glucose is 30. NIDDM. Pt took regular meds and did not eat lunch. Takes glucophage for diabetes. PE:No acute distress, heart is regular… Lab:BS=30, CBC Tx: diet tray Dx:acute hypoglycemia Case 4: DX= “hypoglycemia”

39. CMT:Weak and dizzy at store, passed out. Took regular meds including glucophage for diabetes, forgot to eat lunch Reason:syncope Drug1:Glucophage Dx:acute hypoglycemia Testing:BS=30, CBC Treat:diet tray Case 4: Second Screen Report

40. ED log:poisoning CC:may have ingested grandma’s meds HPI:2 yo patient got into grandmother’s pills in a cup on top of TV, possibly took 1 lisinopril 10mg, and/or 1 lanoxin 0.125mg. PE:No acute distress, heart is regular… Lab:None Tx: activated charcoal Dx:ingestion Case 5: ED chart

41. ED log:poisoning CC:may have ingested grandma’s meds HPI:2 yo patient got into grandmother’s pills in a cup on top of TV, possibly took 1 lisinopril 10mg, and/or 1 lanoxin 0.125mg. PE:No acute distress, heart is regular… Lab:None Tx: activated charcoal Dx:ingestion Case 5: Keywords “poisoning”, “ingestion”

42. CMT:2yo patient got into grandma’s pills that were on top of TV. May have taken 1 Lisinopril 10mg and/or 1 Lanoxin 0.125mg Reason: poisoning Drug1:Lisinopril 10mg Drug2: Lanoxin 0.125mg Dx:ingestion Testing:None Treat:activated charcoal Case 5: Second Screen Report

43. ED log:fever CC:pt has fever and “cold” since getting shots HPI:Patient has fever and cold-like symptoms after receiving his immunizations four days ago. PE:Body temp=99F No acute distress, heart is regular… Lab:None Tx: None Dx:side effects of immunization shots Case 6: ED chart

44. ED log:fever CC:pt has fever and “cold” since getting shots HPI:Patient has fever and cold-like symptoms after receiving his immunizations four days ago. PE:Body temp=99F No acute distress, heart is regular… Lab:None Tx: None Dx:side effects of immunization shots Case #6: Keyword “side effects”

45. CMT:Patient has fever and cold-like symptoms after receiving immunizations four days ago. Reason: fever and cold symptoms Drug1:immunizations Dx:side effects of immunization Testing:None Treat:None Case 6: Second Screen Report

46. ED log:poisoning CC:feels drowsy, accidentally took double dose of medications HPI:Patient is noticeably drowsy and states that she feels lightheaded. Accidentally took double dose of Haldol and Depakote PE: No acute distress, heart is regular… Lab:CBC, UA Tx: None Dx:medication error Case 7: ED chart

47. ED log:poisoning CC:feels drowsy, accidentally took double dose of medications HPI:Patient is noticeably drowsy and states that she feels lightheaded. Accidentally took double dose of Haldol and Depakote PE: No acute distress, heart is regular… Lab:CBC, UA Tx: None Dx:medication error Case 7: Keyword “medication error”

48. CMT:Patient is drowsy and lightheaded. Accidentally took double dose of medications Reason: drowsy Drug1:HaldolDrug2: Depakote Dx:medication error Testing:CBC, UA Treat:None Case 7: Second Screen Report

49. CMT:45yo male patient had an OD on Oxycontin Reason: OD Drug1:Oxycontin Dx:OD Treat:None Other Information: Other Drugs: Case 8: Second Screen Report Help us with this case!

50. Which ED chart corresponds to this case?

51. ED log:overdose CC:overdose HPI:Patient is a 45yo Male with a history of drug abuse and depression. Patient takes Oxycontin for his “back pain”, but suspect medication misusage or abuse and addiction. Unsure if medication is prescribed or bought off street. Patient took three times a normal dose. Tx: None Dx: overdose Case #8a: ED chart

52. ED log:overdose CC:overdose HPI:Patient is a 45yo Male with documented chronic back pain. Patient is prescribed Oxycontin for his back pain. Patient took a second dose in order to ease severe back pain because he thought the “first dose was not helping”, subsequently experienced an overdose. PE: Patient appears to be oversedated, heart rate is rapid, but within normal limits. Tx: None Dx: overdose Case #8b: ED chart

53. CMT:45yo male patient had an OD on Oxycontin Reason: OD Drug1:Oxycontin Dx:OD Treat:None Other Information: Other Drugs: Case 8: Second Screen Report Help us with this case!

54. Is this abuse of a prescription drug or a real ADE? How you can help…..

55. Help Us By Documenting all pertinent information on: –Intent: Did the patient take the medication for therapeutic purposes? Did the patient take the medication to get high? –Dosage: How much did the patient take? –Drug: Always document which drug the patient took.

56. Questions? Contact your NEISS Representative or CDC directly: Dan Budnitz (CDC) DBudnitz@cdc.gov Tel: 770-488-1486 Fax: 770-488-4338 Kelly Weidenbach (CDC) KWeidenbach@cdc.gov Tel: 770-488-4230