# Presentation: 537887

## Overview

**Define ADE & ADR**
**Explain how to document an ADR in CPRS**
**Describe the reporting systems for ADEs **
**Discuss ADEs & off-label drug use**
**Describe how VHA uses ADE information at local, VISN, & national levels**

## 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**

## 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**

## ADE ≠ Medication Error

**ADE ≠ Medication Error**

## Steps to Address and Identify ADEs

**A****sk about ADEs**
**D****ocument in the progress note**
**E****nter into the CPRS ART package**

## Ask about ADEsDocumentEnter

**Review**
**Ask about past adverse reactions**
**Review past documentation of ADEs**
**Monitor**
**Ask about reactions to ****new**** & other medications, food or devices**

## AskDocument in Progress NoteEnter

**Describe ****timing**** of drug & reaction**
**include dechallenge & rechallenge response, if known**
**Differential diagnosis**** that reflects probability that the drug caused the event**
**Describe the ****action plan**

## AskDocumentEnter in CPRS/ART

**Enter all significant ADEs**
**Easily referenced**
**Easily visible to other providers**
**May trigger future drug allergy warning**

## When to Enter an ADE in CPRS/ART

**Goal:****	****Inform future use of a drug**
**Effect:****	****Generate alert**
**Types of ADEs to enter**
**ADRs, not errors**
**Always enter unexpected or serious ADRs**

## Importance of Documentation

**Protect ****patients**** from future problems through CPRS**
**Detect events of known & unknown frequency in ****post-marketing surveillance**** and for ****quality-improvement**** activities**

## How to Enter Reactions into CPRS/ART

**Choose drug (use search option)**
**What if reactant is not listed?**
**Incorrect spelling is usually the cause**
**Check observed or historical**
**Recent or new reactions are “observed”**
**“****Observed” does not require provider seeing this reaction**
**Only “observed” reactions are tracked**

## How to Enter Reactions into CPRS/ART

**Click on severity (if observed)**
**Choose type of reaction: allergy, pharmacological, unknown**
**Identify symptom (use pull-down menu)**
**Multiple symptoms can be entered**
**Add additional comments**

## Guide Future Therapy

**Description of manifestations to convey ****seriousness**
**Assessment of ****causation**
**Timing of reaction & drug**
**Competing/contributing factors**
**Dechallenge or rechallenge response**
**Dose**** (if dose-dependent)**
**Safe & problematic ranges**

## Information Counts

**Usual entry:**
**Ibuprofen renal failure**
**Informative entry:**
**Ibuprofen 400 mg TID**
**One week**
**Creatinine increased from 2 to 5 mg/dL with new 3+ edema **

## For Dose-Dependent Reactions

**Metoprolol 100mg BID**
**CHF and respiratory failure within 2 hours of the increased dose**
**Once in the setting of renal failure, fluid overload, and aspiration and once in the setting of aspiration alone**
**Metoprolol 25****-5****0mg BID was well tolerated**

## Make CPRS/ART Work

**Use it to ****alert**** future use**
**When you want future providers to think twice**
**Provide enough ****detail**** to guide future use **
**Save time**** by preventing a search through the chart**

**vaww.pbm.va.gov/vamedsafe**
**PowerPoint tutorial**
**Screen capture walk through of ADR entries with narration**

## 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 ProgramSerious Reactions

**Death**
**Life-threatening**
**Hospitalizations – initial or prolonged**
**Required intervention or prevent permanent impairment/damage**

## FDA MedWatch ProgramSerious 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**

## Definition: Off-Label Drug Use

**Use of a drug outside of indications approved by FDA**
**Disease/condition not indicated**
**Chronology (first-line therapy)**
**Dosing (above, below recommended doses)**
**Dosing regimen (monotherapy vs combination therapy)**
**Outside of intended population (age, gender)**

## How Common is Off-Label Drug Use?

**Knight Ridder: ~20% off-label**
**Off-label use especially high in:**
**Pediatrics**
**Oncology**
**Dermatology**

## Off-Label Prescribing:Why the Concern?

**May not have safety information for       off-label uses**
**Different patient populations**
**Drug-disease interactions**

## Off-Label Prescribing:Why the Concern?

**Rates of serious adverse events may be very different for off-label use**
**Types of adverse events may be different for off-label use**

## Off-Label Prescribing:Newer Drugs

**Lack post-marketing surveillance**
**Lack of clinical experience with untoward events**
**May not recognize new adverse events**

## 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**

## Off-Label Use: Media Attention

**November 2003: Knight Ridder report: **
**	****“****Prescription for Danger: Patients Injured and Killed as Doctors Prescribe Drugs for Unapproved Uses”**

## Off-Label Use: Media Attention

**May 1, 2005 *****San Francisco Chronicle*****: **
**	****“****HARD SELL: How Marketing Drives the Pharmaceutical Industry : A Patient's Right to Know”**
**	****Details stories of patients allegedly harmed by drugs used off-label, including highlighting a Veteran who died**

## Off-Label Use: Media Attention

**June 8, 2005- *****New York Times***** Syndicate:**
**	****“****FDA Moves to Warn Patients of Possible Drug Side Effects”**
**Details patient harms from off-label use where patients were not told the drug was being used off-label.**

## Off-Label Prescribing:PBM Guidance

**Use evidence based approach when possible**
**Balance evidence of benefit with risk**
**Proceed with caution where there is no evidence linking to health outcomes**
**Surrogate markers may not equate**

## Off-Label Prescribing Considerations

**Discuss with patient when drug is being used off-label (especially new drugs)**
**Be alert for unexpected adverse events**
**Report possible adverse events**
**Document indication for drug use in medical record**

## How is National VHA ADE Information Used?

**High-risk & problem-prone drug products**
**Newly approved agents**
**Agents with newly-identified safety information**

## How is ARTS Information Used?  Facility Level

**Pharmacist or ADR Coordinator/           P&T Committee**
**Evaluate/categorize type of ADR**
**Local Reports – customized per facility**
**Top agents associated with ADRs**
**Top ADRs**

## How is ARTS Information Used?  VISN Level

**VISN P&T Committee**
**Evaluates type of ADR **
**VISN Reports - Customized per VISN**
**Drug Allergy Performance Measure**
**New measure to monitor “no allergy assessment”**
**Encourages practitioners to assess patient for drug & food allergies**

## How is ARTS Information Used?  National Level

**Performance Measure for allergy assessment**
**Aggregate data to identify problem medications**
**Identify unknown or suspected signals for early warning & prevention**

## How Does FDA Use MedWatch Data?  

**Adverse Event Reporting System (AERS Database)**
**Premarketing – thousands of patients studied**
**Postmarketing – millions may be exposed**
**Postmarketing surveillance**
**ADE’s new or unrecognized **

## VANTS Call

**Dial-in Number 1-800-767-1750**
**Access Code 14945#**