Adverse Reaction Tracking (GMRA) Advanced

1. Adverse Reaction Tracking (GMRA) Advanced May 2012

2. Course Objectives • Describe the Adverse Reaction Tracking Package • Menu Options • Interaction between options • Describe proper set up of the package and EHR • Identify common pharmacy issues in EHR

3. Overview Parameters and Set Up • GMRA Package and EHR Parameter Setup • The key to successful Adverse Reaction Tracking in RPMS and EHR • Impacts all disciplines • Providers • Nurses • Pharmacy • etc.

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 and ingredients 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 GMRA or EHR. • Verifiers • designated users by the site who verify the correctness of the data in GMRA or EHR. • Pharmacy and Therapeutics (P&T) Committee users • members of the facility's P&T Committee or other group who review adverse reactions in the facility.

6. Security Keys GMRA-USER • Needed to be able to enter allergies in EHR or RPMS, allows access to RPMS GMRA “User” menu GMRA-CLINIC • Allows access to the RPMS GMRA “Clinician” menu, not needed for EHR GMRA-PT • Allows access to the RPMS GMRA “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 GMRA full menu, and the authority to override the software’s security in order to edit data. GMRA-VERIFIER • An obsolete key from a previous software version

8. Mail Groups A Site Manager can enter users into different mail groups that will receive a bulletin/notification when: • A reaction needs verification (can separate out by drug, food, or other) • A reaction 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. • GMRA REQUEST NEW REACTANT – a list of persons designated by the site to review local requests for new reactant or sign/symptoms, and forward needed entries on to the National team. By default, this will be set up to use the GMRA VERIFY DRUG ALLERGY group but this can be changed if needed.

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. • GMRA REQUEST NEW REACTANT • This is NOT visible in the Bulletin edit menu

11. 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)//

12. Sample Mailman Message Subj: Request to add new reactant [#14416] 05/02/12@08:45 20 lines From: ALLERGY PACKAGE In 'IN' basket. Page 1 *New* ----------------------------------------------------------------- A request to add RELINZA as a new reactant was entered by NIESEN,MARY ANN PHARM D for patient DEMO,ALLERGY CHARLES (5701) User's contact information: Title : PHARMACIST Office Phone : Digital Pager: The user added the following comment: THIS PT HAS A RASH FROM RELINZA Please verify with the user the intended reactant and then take the appropriate action. Be sure to try alternate spellings, etc before requesting new reactants. If this reactant does require review for addition, please submit through the IHS RPMS Feedback page at http://www.ihs.gov/RPMS using the RPMS Application 'Pharmacy-New Reactant/ Symptom Request(PRSR)'

13. Sample Notifications

14. 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

15. Menu Options • This is the main menu that has all options of the Adverse Reaction (GMRA) package: Adverse Reaction Tracking (GMRA) • Enter/Edit Site Configurable Files ... • Adverse Reaction Tracking User Menu ... • Adverse Reaction Tracking Clinician Menu ... • Adverse Reaction Tracking Verifier Menu ... • P&T Committee Menu ...

16. Enter/Edit Site Configurable Files • Edit Allergy File • Enter/Edit Signs/Symptoms Data • Enter/Edit Site Parameters • Sign/Symptoms List • Allergies File List

17. Enter/Edit Site Parameters Allows site configuration across multiple divisions The site can configure the following: • The list of the ten most common signs/symptoms • The auto-verification of data • Force the originator of the data to provide comments • Marking of a patient’s ID band or chart to indicate the presence of an allergy/adverse reaction • Force entry of FDA reporting data • Allow comments to be added to the reaction data that is entered in error

18. Associating Drugs with Correct VA Drug Class • Should be taken care of by the matching process in the drug file • Extensive localizations within the GMRA package have been problematic and are no longer allowed • ART automatically assigns the allergy entry a VA Drug Class, Ingredients, or both (in most cases) • Most entries for drugs should be marked from one of the National Drug files (generic name or VA Product) • Other entries may have none (e.g. for some non-drug items), one, or both • If the VA Class and/or ingredients have not been populated, then order checks in EHR and RPMS will fail.

19. Edit Allergy File • NO LONGER ALLOWED • Local entries should have been inactivated with recent GMRA patches, if loaded at your site • Current patch is GMRA 1004 • Software is distributed with a list of entries that is categorized as NATIONAL allergies • Additional National entries are coming • Can set autoverify options* • Recommended that all DRUG allergies be verified *NOT RECOMMENDED! Autoverify can cause odd results for some drug allergies.

20. Enter/Edit Sign/Symptoms Data • NO LONGER ALLOWED • A large number of additional signs and symptoms will be released soon • New entries have synonyms to allow providers to more easily find what they need, but will not be visible in EHR until EHR patch 11.

21. 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// <ENTER> DEVICE: RX01 <ENTER> RIGHT MARGIN: 80// <ENTER> SIGN/SYMPTOMS LIST FEB 2,1996 08:21 PAGE 1 NAME Nat'l/Local SYNONYM --------------------------------------------------------------------------- AGITATION National AGRANULOCYTOSIS National ALOPECIA National ANAPHYLAXIS National

22. Allergies File List • Prints a captioned list of all entries in the GMR Allergies file START WITH NAME: FIRST// <ENTER> DEVICE:HOME <ENTER> RIGHT MARGIN: 80// <ENTER> 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

23. GMRA Verifier Menu • This menu should be given to the verifiers of the Adverse Reaction Tracking package as designated by the site. This is controlled by the GMRA ALLERGY VERIFY key. • 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

24. GMRA User Menu • This menu should be assigned to all users of the Adverse Reaction Tracking package who are not verifiers or ADP coordinators. This is controlled by the GMRA-USER key. • 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

25. Adverse Reaction Tracking in EHR • Providers can enter and edit reactions in the EHR • Users can only edit certain parts of reactions • Reaction reverts to “non-verified” if edited • Exception is if the documenting user is a verifier • Can also mark a reaction as entered in error or inactive, reactivate an inactive reaction, or mark a patient as “unassessible” • Can delete their own unsigned reactions • This is rare, as reactions are now automatically signed in most cases

26. EHR Parameters for GMRA • In BEHART AUT Automatic Signature of Adverse Reaction Data ENT Enable Adverse Reaction Data Entry VER Allow Adverse Reaction Verification

27. EHR Parameters for GMRA, cont. • AUT controls whether user has to manually enter signature or applied automatically when clicking on the signature button • Strongly recommended to set to “Yes” • ENT controls whether ANYONE can enter reactions in EHR • Usually only set to “no” when there are problems that are being fixed, i.e. rarely • VER allows the GMRA-Allergy Verify key to be assigned to users

28. EHR Order Checks • BEHORDOCXPARENA and BEHORDOCXPAREDT and BEHORDOCXPARDAN • ENA turns order checks on and off • EDT sets whether the order check can be turned off by the user • DAN sets the danger level and whether the provider has to enter an override reason