Resource and Patient Management Systems (RPMS) Adverse Reaction Tracking (GMRA) Introduction and Set Up 2011

Session Objectives At the end of this session, participants should be able to: Understand how the Adverse Reaction Tracking package works Discuss the importance of utilizing the Adverse Reaction Tracking package for documenting patient reactions Identify the menu options available in the Adverse Reaction Tracking package Examine the available options for customizing the Adverse Reaction Tracking package

What is an Adverse Reaction? What is an adverse drug reaction (ADR)? An adverse drug reaction is a “response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiologic function.” Note that there is a causal link between a drug and an adverse drug reaction. In sum, an adverse drug reaction is harm directly caused by the drug at normal doses, during normal use. How does an ADR differ from a side effect or allergy? An allergy is an adverse drug reaction mediated by an immune response (e.g., rash, hives). A side effect is an expected and known effect of a drug that is not the intended therapeutic outcome. The term “side effect” tends to normalize the concept of injury from drugs. It has been recommended that this term should generally be avoided in favor of adverse drug reaction. All Allergies are Adverse Drug Reactions, but not all Adverse Drug Reactions are Allergies!

Adverse Reaction Tracking at Work RPMS CHOOSE 1-2: 1 PENICILLIN VK 250MG TAB AM TEST PHARMACY Now doing order checks. Please wait... A Drug-Allergy Reaction exists for this medication and/or class! Drug: PENICILLIN VK 250MG TAB Ingredients: PENICILLIN, Do you want to Intervene? Y// Electronic Health Record (EHR)

How does it work? Each drug matched to the National Drug file has a Veterans Affairs (VA) Drug Class and Ingredients –If the drug cannot be matched to the National Drug File, a VA Drug Class can be manually assigned Adverse reactions are linked to VA Drug classes and ingredients RPMS checks for patient reactions upon prescription processing RPMS also checks for Drug-Drug and Drug-Food interactions Interventions can be tracked and trended using the Adverse Reaction Tracking (ART) Program

Why use Adverse Reaction Tracking? Order checking in EHR and RPMS Tracking and trending adverse reactions and outcomes Reporting Adverse Reactions to manufacturers and the Food and Drug Administration (FDA) Information data exchange (interoperability) Meaningful Use/Certification requirements

Adverse Reaction Tracking Package Setup The key to successful Adverse Reaction screening in EHR Impacts all disciplines Providers Nurses Pharmacy...and more

Adverse Reaction Tracking Set Up 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/or ingredients. Add users to mail groups so automatic bulletins will be sent appropriately.

ART Menus Main ART menu: 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 File 2 Enter/Edit Signs/Symptoms Data 3 Enter/Edit Site Parameters 4 Sign/Symptoms List 5 Allergies File List 6 Allergy clean up utility

Adverse Reaction Tracking User Menu 1 Enter/Edit Patient Reaction Data 2 Active Listing of Patient Reactions 3 Edit Chart and ID Band 4 List by Location of Unmarked ID Bands/Charts 5 Patient Allergies Not Signed Off 6 List by Location of Undocumented Allergies 7 Print Patient Reaction Data 8 Online Reference Card

Adverse Reaction Tracking Clinician Menu 1 Enter/Edit Patient Reaction Data 2 FDA Enter/Edit Menu... 3 Reports Menu... 4 Edit Chart and ID Band 5 Online Reference Card 6 Reactivate Reaction/Allergy 7 Unable to assess allergies

Adverse Reaction Tracking Verifier Menu 1 Enter/Edit Patient Reaction Data 2 Verify Patient Reaction Data 3 Reports Menu... 4 Edit Chart and ID Band 5 FDA Enter/Edit Menu... 6 Online Reference Card 7 Reactivate Reaction/Allergy 8 Unable to assess allergies

Pharmacy and Therapeutics (P&T) Committee Menu 1 Enter/Edit P&T Committee Data 2 Enter/Edit FDA Report Data 3 Reports Menu...

Set Up Users Clinical Users –The doctors, nurses, other clinicians, and clerks entering the data into ART Verifiers –Users designated by the site who verify the correctness of the data in ART P&T Committee users –Members of the hospital's P&T Committee or other committee that reviews ADRs in the facility

Security Keys GMRA-USER Needed to be able to enter reactions 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

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 An obsolete key from a previous software version, no longer used

Mailman Groups A Site Manager can enter users into different mail groups 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 The signs/symptoms of a particular reaction have been updated A user has requested the addition of a new reactant

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 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 users who will be notified of a new reactant request

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.

Sample Mailman Message Subj: ALLERGY/ADVERSE REACTION TO BE VERIFIED [#275013] 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: Reaction: INFLUENZA VIRUS (SPLIT) VACCINE OBS/HIS: Historical Location: OUT PATIENT Signs/Symptoms Date Observed ANAPHYLAXIS Feb 09, Enter message action (in ALLERGIES basket): Ignore//

Sample Mailman Message Subj: REACTION ENTERED IN ERROR [#20942] 30 Sep Lines From: POSTMASTER (DSD-RPMS) (Sender: STARR,JANICE) Page 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: Reaction: CAPTOPRIL Location: 3EAST Originator: STARR,JANICE Entered in Error by: STARR,JANICE Entered in Error on: Sep 30, Comments: ENTERED IN ERROR Date: Sep 30, User: STARR,JANICE Title: Patient denies reaction, is taking Captopril with no problems. Select MESSAGE Action: IGNORE//

Sample Mailman Message Subj: Request to add new reactant [#4895] 18 lines From: ALLERGY PACKAGE In 'IN' basket. Page A request to add SEABASS as a new reactant was entered User's contact information: Title : PHARMACIST Office Phone : Digital Pager: The user added the following comment: This patient has throat swelling from seabass. 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 using the RPMS Application ‘Pharmacy-New Reactant/Symptom Request (PRSR)’ Please note, an allergy to SEABASS was NOT entered for this patient! Enter message action (in IN basket): Delete//

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

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 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

Select Enter/Edit Site Configurable Files Option: 3 Enter/Edit Site Parameters Select GMR ALLERGY SITE PARAMETERS NAME: ? Answer with GMR ALLERGY SITE PARAMETERS NAME: HOSPITAL You may enter a new GMR ALLERGY SITE PARAMETERS, if you wish Answer must be 3-30 characters in length. Select GMR ALLERGY SITE PARAMETERS NAME: HOSPITAL NAME: HOSPITAL// (No editing) Select DIVISION: DEMO INDIAN HOSPITAL// ? Answer with DIVISION: DEMO INDIAN HOSPITAL You may enter a new DIVISION, if you wish Answer with INSTITUTION NAME, or STATUS, or STATION NUMBER, or OFFICIAL VA NAME, or CURRENT LOCATION, or CODING SYSTEM/ID PAIR, or NPI, or STATUS, or NAME (CHANGED FROM), or CODING SYSTEM Do you want the entire INSTITUTION List? N (No) Select DIVISION: DEMO INDIAN HOSPITAL// The following are the ten most common signs/symptoms: 1. ANXIETY 6. DIARRHEA 2. ITCHING 7. HIVES 3. SWELLING (NON-SPECIFIC) 8. DYSPEPSIA 4. DROWSINESS 9. ANAPHYLAXIS 5. NAUSEA,VOMITING 10. RASH Enter the number of the sign/symptom that you would like to edit:

AUTOVERIFY FOOD/DRUG/OTHER: NO AUTOVERIFY// AUTOVERIFY OBSERVED/HISTORICAL: NO AUTOVERIFY// AUTOVERIFY LOGICAL OPERATOR: AND// REQUIRE ORIGINATOR COMMENTS: NO// MARK ID BAND FLAG: NO// METHOD OF NOTIFICATION: BULLETIN// ALERT ID BAND/CHART MARK: NO// SEND CHART MARK BULLETIN FOR NEW ADMISSIONS: FDA DATA REQUIRED: NO// ENABLE COMMENTS FIELD FOR REACTIONS THAT ARE ENTERED IN ERROR: YES // REPORTER NAME: PHARMACIST,PHARMACIST ADDRESS: DEMO INDIAN MEDICAL CENTER 100 S. MAIN CITY: ANYTOWN STATE: OKLAHOMA ZIP: PHONE: OCCUPATION: PHARMACY Do you want to edit Reporter Information shown above? No// (No)

Autoverification issues Can set autoverify ON for FOOD and OTHER reactions* Can set Autoverify for Historical reactions Recommended that all DRUG reactions be manually verified Recommended that all OBSERVED reactions be manually verified *Autoverify can cause odd results for some drug allergies!

Associating Drugs with Correct VA Drug Class Ensure entries in the drug file are matched to the National Drug File –Should do this before starting or as soon as possible after Automatically assigns –Once you have linked a reaction to the drug ingredients and VA class, all previous and future reactions will have the same information –Order checks in EHR and RPMS are dependant on having a VA Drug Class and/or ingredients

Edit Allergy File Software is distributed with a list of entries categorized as NATIONAL allergies: –Approximately 785 entries delivered with EHR patch 8 –Additional 16,000+ entries will be delivered with the next GMRA patch Due to data standardization and interoperability concerns, the allergy file can no longer be edited at the local site. Users may request new reactants be added through the RPMS Feedback page: –Accessed through –Click on “Feedback” on the left hand side –Use the RPMS Application “Pharmacy-New Reactant/Symptom Request (PRSR)

Enter/Edit Signs/Symptoms Data Due to data standardization and interoperability concerns, this file is no longer editable at the local site. Users may request new Signs/Symptoms be added through the RPMS Feedback page: 1.Accessed through 2.Click on “Feedback” on the left hand side 3.Use the RPMS Application “Pharmacy-New Reactant/Symptom Request (PRSR)

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: HOME RIGHT MARGIN: 80// SIGN/SYMPTOMS LIST FEB 2, :21 PAGE 1 NAME Nat'l/Local SYNONYM AGITATIONNational AGRANULOCYTOSISNational ALOPECIANational ANAPHYLAXISNational

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, :21 PAGE 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

ART Configuration on EHR (BEH) Menu AUT: Automatic Signature of Adverse Reaction Data ENT: Enable Adverse Reaction Data Entry VER: Allow Adverse Reaction Verification

Automatic Signature of Adverse Reaction Data Allows for the automatic application of the user’s signature without them having to actually enter it. Prevents “unsigned” reactions. Strongly recommended to set to “yes” at the system level.

Enable Adverse Reaction Data Entry Allows users to document reactions in the EHR Should be turned on for any user who may need to document reactions

Allow Adverse Reaction Verification Allows assignment of the GMRA- ALLERGY VERIFY key. Use with caution, and assign only to those users who are tasked with the technical verification of adverse reaction data.

Questions?