NEISS-Cooperative Adverse Drug Event Surveillance (NEISS-CADES)

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

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. ADEs can look like Illnesses • 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

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

22. Fewer Fields on 2nd 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. 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 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) 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: • Self-harm / Suicide? • Intentional overdose? • Abuse / Recreational use? NO NO YES STOP! Do not fill out ADE Screen FINISH

27. Cases

28. Case 1: ED chart 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

29. Case 1: DX =“adverse effect” 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

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

31. Case 2: ED Chart 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

32. Case 2: DX= “drug reaction” and symptom = “rash” 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

33. Case 2: Second Screen Report 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”

34. Case 3: ED chart 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

35. Case 3: DX=“over anticoagulation” & symptom=“bleeding” 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

36. Case 3: Second Screen Report 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

37. Case 4: ED chart 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

38. Case 4: DX=“hypoglycemia” 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

39. Case 4: Second Screen Report 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

40. Case 5: ED chart 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

41. Case 5: Keywords “poisoning”, “ingestion” 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

42. Case 5: Second Screen Report 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

43. Case 6: ED chart 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

44. Case #6: Keyword “side effects” 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

45. Case 6: Second Screen Report 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

46. Case 7: ED chart 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

47. Case 7: Keyword “medication error” 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

48. Case 7: Second Screen Report CMT: Patient is drowsy and lightheaded. Accidentally took double dose of medications Reason: drowsy Drug1: Haldol Drug2: Depakote Dx: medication error Testing: CBC, UA Treat: None

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

50. Which ED chart corresponds to this case?