ADVERSE REACTION TRACKING

1. ADVERSE REACTION TRACKING

2. ADVERSE REACTION TRACKING(ART) • Tracks and reports patient allergy and adverse reaction data • Menus for different types of users • Site parameters can be based on how your facility plans to use the package • Drug interactions are interactive - based on VA drug class in Outpatient Pharmacy v7.0 and Inpatient v5.0 • Mail groups and bulletins based on site parameters

3. FOUR MAJOR COMPONENTS • Data Entry Options • Enter/Edit Patient Reaction Data allows the clinical users (i.e., doctors, nurses, other clinicians and clerks) to enter data into ART • Verify Patient Reaction Data allows the verifiers designated by ART to verify the correctness of data entered by the clinical users(Verification cannot be done in EHR)

4. FOUR MAJOR COMPONENTS (Cont) • Reporting options Report the patient causative agent data to the user via a print option. Also, this data is made available to other software applications via a data extract utility. • Enter/Edit Site Configurable Files Allows the various site configurable files to be modified to allow ART to better meet the needs of an individual site.

5. FOUR MAJOR COMPONENTS (Cont) • Adverse Drug Reaction (ADR) options • allows for the evaluation of a suspected ADR by a qualified individual (e.g., clinical pharmacist, clinical pharmacologist) other than the attending physician • generates the reports needed by the FDA

6. ART MENUS • Adverse Reaction Tracking [GMRAMGR] • Adverse Reaction Tracking User Menu [GMRA USER MENU] 3) Adverse Reaction Tracking Clinician Menu [GMRA CLINICIAN MENU] 4) Adverse Reaction Tracking Verifier Menu [GMRA VERIFIER MENU] 5) P&T Committee Menu [GMRA P&T MENU]

7. Enter/Edit Site CONFIGURABLE FILES MENU 1) Edit Allergy File 2) Enter/Edit Signs/Symptoms Data 3) Enter/Edit Site Parameters 4) Sign/Symptoms List 5) Allergies File List Site can tailor ART to meet its needs. Get P&T consensus.

8. ENTERING SITE PARAMETERS • Entering site parameters for a site that allows auto-verfication of FOOD or OTHER allergies • BUT requires verification of DRUG allergies

9. MAIL GROUPS Automatic mail bulletins sent to specific users: 1) GMRA MARK CHART - A list of users who will need to mark a patient’s chart to record an allergy/adverse reaction 2) GMRA VERIFY DRUG ALLERGY - A list of all verifiers who will need to be sent drug reaction information 3) GMRA VERIFY FOOD ALLERGY - A list of all verifiers who will need to be sent food reaction information 4) GMRA VERIFY OTHER ALLERGY - A list of all verifiers who will need to be sent other types of reaction information (i.e., not drug or food) 5) GMRA P&T COMMITTEE FDA - A list of the members of the Pharmacy and Therapeutic (P&T) Committee

10. Preparing data base for v5/7APCD patch 7 • Provided new options for ART Software • Permits data entry clerks to enter data directly into the ART package • All information entered by clerks must include the following information: REACTANT – SYMPTOM(S) – DATE OF REACTION • Pharmacists must finish (verify) the information • Print a list of the VA Drug classes from the National Drug File menu – CLVA VA Drug Classification