1. March 2010 Adverse Reaction Tracking

2. Describe the Adverse Reaction Tracking Package –Menu Options –Interaction between options Proper set up Identify common pharmacy issues in EHR Course Objectives

3. Adverse Reaction Tracking Package Setup The key to successful ADR screening in EHR Impacts all disciplines Providers Nurses Pharmacy Overview

4. Adverse Reaction Tracking (ART) Different menus for different types of users, less important with EHR, but need well defined workflow Site parameters make package easier to use with workflow at site Drug interactions will be interactive based on VA drug class in Outpatient Pharmacy v7.0 and Inpatient v5.0, and EHR Add users to mail groups so automatic bulletins will be sent appropriately

5. Set Up Users Clinical users –are the doctors, nurses, other clinicians and clerks entering the data into ART. Verifiers –designated users by the site who verify the correctness of the data in ART. Pharmacy and Therapeutics (P&T) Committee users –members of the hospital's P&T Committee and are assigned the P&T Committee Menu option. They review ADRs in the facility.

6. Security Keys GMRA-USER Needed to be able to enter allergies in EHR or RPMS, allows access to RPMS ART “User” menu GMRA-CLINIC Allows access to the RPMS ART “Clinician” menu, not needed for EHR GMRA-PT Allows access to the RPMS ART “P&T” menu

7. Security Keys GMRA ALLERGY VERIFY Needed to verify allergy/adverse reactions in RPMS or EHR GMRA SUPERVISOR Allows access to the RPMS ART full menu, and the authority to override the software’s security in order to edit data. GMRA-VERIFIER Appears to be an obsolete key from a previous software version

8. Mail Groups A Site Manager can enter users into different mailgroups that will receive a bulletin when: –A reaction needs verification (can separate out by drug, food, or other) –A reactions is marked as entered in error –P&T type data (FDA report) is entered –A chart/patient band needs to be marked for a reaction

9. Mailman Groups The mail groups are: GMRA VERIFY DRUG ALLERGY - A list of all verifiers who will need to be sent drug reaction information. GMRA VERIFY FOOD ALLERGY - A list of all verifiers who will need to be sent food reaction information. 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). GMRA P&T COMMITTEE FDA - A list of the members of the Pharmacy and Therapeutic (P&T) Committee. GMRA MARK CHART - A list of users who will need to mark a patient’s chart to record an allergy/adverse reaction.

10. Mailman Bulletins GMRA ENTERED IN ERROR –This bulletin is to be sent to both the verifiers and the chart marking groups so that the reaction can be corrected on the patient record. GMRA MARK CHART –This bulletin will alert the appropriate users to mark the patient chart for the patient and allergy/adverse reaction specified in the bulletin. GMRA P&T COMMITTEE FDA –This bulletin will be issued when an agent is both observed and a drug and has been signed off. GMRA SIGNS/SYMPTOMS UPDATE –This bulletin is to be set to the P&T committee if a reaction has had the Signs/Symptoms changed at anytime. GMRA VERIFY ALLERGY –This bulletin will indicate that an allergy/adverse reaction needs to be verified.

11. Sample Mailman Message Subj: ALLERGY/ADVERSE REACTION TO BE VERIFIED [#275013] 02/09/10@16:26 10 lines From: NIESEN,MARY ANN In 'ALLERGIES' basket. Page 1 Priority! ------------------------------------------------------------------------------- The following allergy/adverse reaction needs to be verified for the following patient: Patient: DEMO, PATIENT LIZA SSN: 00-29-45 Reaction: INFLUENZA VIRUS (SPLIT) VACCINE OBS/HIS: Historical Location: OUT PATIENT Signs/Symptoms Date Observed ------------------------------------------------------------ ANAPHYLAXIS Feb 09, 2010@16:21:08 Enter message action (in ALLERGIES basket): Ignore//

12. Sample Mailman Message Subj: REACTION ENTERED IN ERROR [#20942] 30 Sep 03 17 Lines From: POSTMASTER (DSD-RPMS) (Sender: STARR,JANICE) Page 1 ----------------------------------------------------------------------------------------- The following reaction has been ENTERED IN ERROR. Please ensure that the patient's Chart/ID Band are updated to reflect this change. Patient: LOPEZ,BYRON SCOTT SSN: 10-95-68 Reaction: CAPTOPRIL Location: 3EAST Originator: STARR,JANICE Entered in Error by: STARR,JANICE Entered in Error on: Sep 30, 2003@14:47:28 Comments: ENTERED IN ERROR Date: Sep 30, 2003@14:47:28 User: STARR,JANICE Title: Patient denies reaction, is taking Captopril with no problems. Select MESSAGE Action: IGNORE (in WASTE basket)// D Deleted !!

13. Setting up Mailman Groups May require Site Manager assistance Done via “Manage MailMan” menu which is usually part of the menus that only Site Mangers see. Bulletins and Groups are installed with the package –Need to assign people to the groups –Need to assign groups to the bulletins

14. Menu Options This is the main menu that has all options of the Adverse Reaction (ART) package Adverse Reaction Tracking (ART) 1.Enter/Edit Site Configurable Files... 2.Adverse Reaction Tracking User Menu... 3.Adverse Reaction Tracking Clinician Menu... 4.Adverse Reaction Tracking Verifier Menu... 5.P&T Committee Menu...

15. Enter/Edit Site Configurable Files 1.Edit Allergy File 2.Enter/Edit Signs/Symptoms Data 3.Enter/Edit Site Parameters 4.Sign/Symptoms List 5.Allergies File List

16. Enter/Edit Site Parameters Allows site configuration accross multiple divisions The site can configure the following: –The list of the ten most common signs/symptoms –The autoverification of data. –Whether originator of the data should provide comments. –Marking of a patient’s ID band or chart to indicate the presence of an allergy/adverse reaction. –FDA reporting data –Allows comments to be added to the reaction data that is entered in error

17. Associating Drugs with Correct VA Drug Class Match most common agents –should do this before starting or as soon as possible after Automatically assigns –once you have matched even one patient to the drug and VA class, the next one that you do will automatically attach the Class –If the VA Class has not been populated, then order checks in EHR and RPMS will fail.

18. Edit Allergy File Enter allergies (not patient specific) into the system. Software is distributed with a list of entries that is categorized as NATIONAL allergies. Can set autoverify ON for FOOD and OTHER allergies* Recommended that all DRUG allergies be verfied *Autoverify can cause odd results for some drug allergies!

19. Enter/Edit Signs/Symptoms Data Addition/editing of the site-specific allergy reactions. Allows the site to add any data as appropriate. The signs/symptoms list provided by ART may be inadequate or need revising.

20. Sign/Symptom List Prints a list of entries in the Sign/Symptoms file Select Enter/Edit Site Configurable Files Option: Sign/Symptoms List START WITH NAME: FIRST// DEVICE: RX01 RIGHT MARGIN: 80// SIGN/SYMPTOMS LIST FEB 2,1996 08:21 PAGE 1 NAME Nat'l/Local SYNONYM --------------------------------------------------------------------------- AGITATION National AGRANULOCYTOSIS National ALOPECIA National ANAPHYLAXIS National

21. Allergies File List Prints a captioned list of all entries in the GMR Allergies file START WITH NAME: FIRST// DEVICE: HOME RIGHT MARGIN: 80// GMR ALLERGIES LIST FEB 2,1996 08:21 PAGE 1 ------------------------------------------------------------------------------ NAME: ADHESIVE TAPE ALLERGY TYPE: OTHER NATIONAL ALLERGY: NATIONAL ALLERGY NAME: ALCOHOL ALLERGY TYPE: DRUG, FOOD NATIONAL ALLERGY: NATIONAL ALLERGY DRUG INGREDIENT: ALCOHOL NAME: ANIMAL HAIR ALLERGY TYPE: OTHER NATIONAL ALLERGY: NATIONAL ALLERGY

22. ART Verifier Menu This menu should be given to the verifiers of the Adverse Reaction Tracking package as designated by the site. The options on this menu will allow the user to edit/verify/print allergy/adverse reaction data. –Adverse Reaction Tracking Verifier Menu Enter/Edit Patient Reaction Data Verify Patient Reaction Data Reports Menu... Edit Chart and ID Band FDA Enter/Edit Menu... Online Reference Card

23. This menu should be assigned to all users of the Adverse Reaction Tracking package who are not verifiers or ADP coordinators. The options on this menu will allow the user to edit/display allergy/adverse reaction data. –Adverse Reaction Tracking User Menu Enter/Edit Patient Reaction Data Active Listing of Patient Reactions Edit Chart and ID Band List by Location of Unmarked ID Bands/Charts Patient Allergies Not Signed Off List by Location of Undocumented Allergies Print Patient Reaction Data ART User Menu

24. Patient Prescription Processing EA Enter/Edit Allergy/ADR Data –Enter/Edit or Remove a reaction from a patient Same option can be accessed when processing prescriptions via the “Complete Orders from OE/RR option in the Outpatient Pharmacy package

25. Adverse Reaction Tracking in EHR Providers can enter ADRs Multiple Ways –Site specific on actual entry points –Enter new reaction –Edit existing reaction –Cannot remove a reaction Only pharmacy an remove a reaction