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

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

ADE ≠ Medication Error

Steps to Address and Identify ADEs

Ask about ADEs

Document in the progress note

Enter into the CPRS ART package

Purpose of FDA MedWatch

• Post marketing surveillance• To identify new drug safety concerns not

evident in pre-marketing clinical trials

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

FDA MedWatch ProgramSerious Reactions

• Death

• Life-threatening

• Hospitalizations – initial or prolonged

• Required intervention or prevent permanent impairment/damage

FDA MedWatch ProgramSerious Reactions

• Disability or permanent damage

• Medical/surgical intervention

• Congenital anomaly or birth defect

• Other serious (important medical events)

FDA MedWatch Program

• FDA Medwatch Form 3500 (Aug. 2005 version)

• www.fda.gov/medwatch/report/hcp.htm

– Hardcopy

– Electronic

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

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

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

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

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

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