This document defines key terms related to adverse drug events and adverse drug reactions. It also outlines the steps for identifying, documenting, and reporting ADEs both within the VA system and to the FDA MedWatch program. Reporting serious ADEs helps identify new safety issues and ensures patient safety. The VA has national programs to facilitate ADE reporting and track outcomes.

1. Short Definitions
• Adverse Drug Event – Harm caused by the drug or
the use of a drug
• Adverse Drug Reaction – Harm directly caused by the
drug at normal doses
• Medication Error – Inappropriate use of a drug that
may or may not result in harm

2. Definitions of ADE & ADR
• Adverse Drug Event – harm caused by the use of a
drug
• Adverse Drug Reaction – a response to a drug which
is noxious & unintended & which occurs at doses
normally used for prophylaxis, diagnosis, or therapy
of disease or for the modification of physiologic
function

3. ADE ≠ Medication Error

4. Steps to Address and Identify ADEs
Ask about ADEs
Document in the progress note
Enter into the CPRS ART package

5. Purpose of FDA MedWatch
• Post marketing surveillance
• To identify new drug safety concerns not
evident in pre-marketing clinical trials

6. Items to Report to MedWatch
• Serious ADRs
• ADRs for any new molecular entities (NME)
within 3 years of release
• Any unexpected or previously unreported ADR

7. FDA MedWatch Program
Serious Reactions
• Death
• Life-threatening
• Hospitalizations – initial or prolonged
• Required intervention or prevent permanent
impairment/damage

8. FDA MedWatch Program
Serious Reactions
• Disability or permanent damage
• Medical/surgical intervention
• Congenital anomaly or birth defect
• Other serious (important medical events)

9. FDA MedWatch Program
• FDA Medwatch Form 3500 (Aug. 2005 version)
• www.fda.gov/medwatch/report/hcp.htm
– Hardcopy
– Electronic

10. National VHA ADE Reporting Program
• VHA facilities/VISNs submit ADE reports
to FDA & duplicates to VHA PBM Central
Office
• MedWatch forms undergo MedDRA
coding
• Reports are housed in VHA PBM ADE
Central Office Database

11. National VHA ADE Web-Based
Reporting Program
• Submit form to FDA electronically after P&T
decision of seriousness & significance
• Entry into VHA PBM ADE database
– MedDRA coding to classify/categorize ADE
reports
– Standard reports
– Available for searches & queries

12. National VHA ADE Reporting
Process
• Pharmacy will enter information at
vaww.vhaco.va.gov/aders/index.aspx
• Link will be established under the “Tools”
menu in CPRS
• Login with user ID & password
• 8-step process to report ADR to VA Central
Office Database

13. NCPS: Patient Safety Information
System
• A RCA must be performed for any reported
inpatient or outpatient serious ADE relating
to pharmaceutical care from a VA healthcare
provider
• Reported to Patient Safety Officer
• Entered in the Patient Safety Information
System

14. Manages System-Level Information
• Processes related to the ADE
– Ordering
– Dispensing
– Administering
– Documenting
• Identifying specific problems
– Removal of benzocaine from VA
– Safer administration of patient controlled analgesia

15. Adverse Drug Events in Pittsburgh
VAMC
• > 1500 reported events (2003-2004)
• 16% for off-label use
• Of these, 28% were reported by clinicians as serious
adverse events