Adverse Reaction Tracking (GMRA)

AdvancedMay 2012

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

OverviewParameters 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.

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

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.

Security KeysGMRA-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 EHRGMRA-PT• Allows access to the RPMS GMRA “P&T”

menu

Security KeysGMRA-ALLERGY VERIFY• Needed to verify allergy/adverse reactions in

RPMS or EHRGMRA-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

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

Mailman GroupsThe 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.

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

Sample Mailman MessageSubj: REACTION ENTERED IN ERROR [#20942] 30 Sep 03 17 LinesFrom: 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@14:47:28Comments: ENTERED IN ERRORDate: 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)//

Sample Mailman MessageSubj: Request to add new reactant [#14416] 05/02/12@08:45 20 linesFrom: ALLERGY PACKAGE In 'IN' basket. Page 1 *New*-----------------------------------------------------------------A request to add RELINZA as a new reactant was enteredby NIESEN,MARY ANN PHARM D for patient DEMO,ALLERGY CHARLES (5701)

User's contact information:Title : PHARMACISTOffice 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 theappropriate action. Be sure to try alternate spellings, etc beforerequesting new reactants. If this reactant does require review foraddition, please submit through the IHS RPMS Feedback page athttp://www.ihs.gov/RPMS using the RPMS Application 'Pharmacy-New Reactant/Symptom Request(PRSR)'

Sample Notifications

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

Menu Options

• This is the main menu that has all options of the Adverse Reaction (GMRA) package:

Adverse Reaction Tracking (GMRA)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 ...

Enter/Edit Site Configurable Files

1. Edit Allergy File2. Enter/Edit Signs/Symptoms Data3. Enter/Edit Site Parameters4. Sign/Symptoms List5. Allergies File List

Enter/Edit Site ParametersAllows site configuration across multiple divisionsThe 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

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.

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.

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.

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

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: OTHERNATIONAL ALLERGY: NATIONAL ALLERGY

NAME: ALCOHOL ALLERGY TYPE: DRUG, FOODNATIONAL ALLERGY: NATIONAL ALLERGYDRUG INGREDIENT: ALCOHOL

NAME: ANIMAL HAIR ALLERGY TYPE: OTHERNATIONAL ALLERGY: NATIONAL ALLERGY

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 1. Enter/Edit Patient Reaction Data2. Verify Patient Reaction Data3. Reports Menu ...4. Edit Chart and ID Band5. FDA Enter/Edit Menu ...6. Online Reference Card

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 Menu1. Enter/Edit Patient Reaction Data2. Active Listing of Patient Reactions3. Edit Chart and ID Band4. List by Location of Unmarked ID Bands/Charts5. Patient Allergies Not Signed Off6. List by Location of Undocumented Allergies7. Print Patient Reaction Data

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

EHR Parameters for GMRA

• In BEHART

AUT Automatic Signature of Adverse Reaction DataENT Enable Adverse Reaction Data EntryVER Allow Adverse Reaction Verification

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

EHR Order Checks

• BEHORDOCXPARENA and BEHORDOCXPAREDT and BEHORDOCXPARDAN– 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