Introduction and New Features January 2012 Adverse Reaction Tracking (GMRA) 1.

Introduction and New FeaturesJanuary 2012

Adverse Reaction Tracking (GMRA)

1

2

Session Objectives• At the end of this session, participants should be able to:• Explain the need to create an integrated strategic plan when implementing

technology in different parts of the adverse reaction tracking process.• Examine potential sources of potential error in the adverse reaction

tracking process and with the use of current technology.• Evaluate the approach to training, implementation, and maintenance of

the adverse reaction tracking process to ensure patient medication safety.• Design a method of adverse reaction tracking clean up.• Justify the argument for patient safety-related improvements in the

process for tracking adverse reactions in many health-system pharmacy departments.

• Support at least two examples of improvements to patient care and medication safety resulting from the cleanup of adverse reaction data.

INTRODUCTION

3

4

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 Reactions, but not all Adverse Reactions are Allergies!

5

Adverse Reaction Tracking at Work

RPMSCHOOSE 1-2: 1 PENICILLIN VK

250MG TAB AM110 -112926 000 93-5194-10 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)

6

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.

7

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 or Certification requirements

PACKAGE SETUP

8

9

Adverse Reaction Tracking Package Setup

• The key to successful Adverse Reaction screening in EHR

• Impacts all disciplines:• Providers• Nurses• Pharmacy• ...and more

10

Adverse Reaction TrackingSet 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.

11

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

12

Security Keys

GMRA-USER• Needed to be able to enter reactions in EHR or

RPMS, allows access to RPMS ART “User” menuGMRA-CLINIC• Allows access to the RPMS ART “Clinician”

menu, not needed for EHRGMRA-PT• Allows access to the RPMS ART “P&T” menu

13

Security Keys

GMRA-ALLERGY VERIFY• Needed to verify allergy/adverse reactions in RPMS

or EHRGMRA-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

14

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 reaction is marked as entered in error.• P&T type data (FDA report) is entered.• A chart or patient band needs to be marked for a reaction.• The signs or symptoms of a particular reaction have been

updated.• A user has requested the addition of a new reactant.

15

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 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.

16

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.

17

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

18

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

19

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!

20

Associating Drugs with Correct VA Drug Class

• Ensure entries in the drug file are matched to the National Drug File (NDF):• Should do this before starting or as soon as

possible after.• Once you have matched a drug to the NDF, the

drug will have a VA Class code and ingredient(s).• Order checks in EHR and RPMS are dependent on

having a VA Drug Class and/or ingredients.

21

Edit Allergy File• Software is distributed with a list of entries categorized as

NATIONAL allergies:• Approximately 785 entries delivered with EHR patch 8.• Additional entries will be delivered with future patches as the VA

updates their file.• 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 http:www.ihs.gov/RPMS.• Click “Feedback” on the left hand side.• Use the RPMS Application “Pharmacy-New Reactant/Symptom

Request (PRSR).

http://www.ihs.gov/RPMS

22

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 http:www.ihs.gov/RPMS.2. Click on “Feedback” on the left hand side.3. Use the RPMS Application “Pharmacy-New

Reactant/Symptom Request (PRSR).


23

ART Configuration on EHR (BEH) Menu

• AUT: Automatic Signature of Adverse Reaction Data

• ENT: Enable Adverse Reaction Data Entry• VER: Allow Adverse Reaction Verification

24

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.

25

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.

26

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.

ALLERGY CLEANUP UTILITY

27

28

Why Perform Clean-up?

• Previously, users could enter reactions using a variety of files, or by using a “free text” entry not linked to any specific file.

• These entries may or may not have the correct information to order check.

• These entries do not have the needed information for data exchange and interoperability.

29

Clean Up Utility

• This utility does NOT automatically match any entry to a “better” entry, nor does it suggest better entries.

• It is simply a tool for identifying allergies that may be problematic and allows the user to take action on them.

30

Three Clean Up Options

• Free Text• These entries are not tied to any particular file.• Sites MUST clean these up as soon as possible.

• Ingredient• These entries are tied to the DRUG INGREDIENT file

(#50.416).• These will need clean up at some point, but are not as

urgent.• Drug Class

• These files are tied to the VA DRUG CLASS file (#50.605).• These also require clean up but are not as urgent.

31

Free Text Clean Up

• When the user selects a free-text reactant, a list of currently existing free-text entries is displayed in alphabetical order.

• This list may take a few minutes to generate, as all existing entries need to be evaluated to determine which are “free text.”

• The list shows the name of the reactant, and the number of entries for that reactant.

32

Free Text Clean Up

• When entering the utility, any users who are currently working in the utility are listed.

• If users are listed as working with the utility, the next user will not be allowed to update the list:• In other words, only one user can be updating

the list at any given time.

33

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

Select Enter/Edit Site Configurable Files Option: 6 Allergy clean up utility

Select one of the following:

1 Free Text 2 Ingredient 3 Drug Class

Select the list you wish to work with: 1 Free TextBuilding list of free text allergies...this may take

a few minutes

34

Allergy Tracking Update Apr 26, 2011 10:33:16 Page: 1 of 18Allergy Tracking Free Text Entries Reactant # Active Entries1 AC I/ARB 12 ACEI 33 ACTIFED 14 ADVERSE DRUG REACTION H202 15 AKE: ACI 16 ALBUTEROL 227 ALENDRONATE 78 ALL ANTIBIOTIC UNKNOWN 19 ALL DYES 110 ALL EYE DROPS 111 ALL NSAIDS 112 ALL TAPES 113 ALLERGIC TO DYE 114 AMITRIPTYLINE 2415 AMLODIPINE 3016 AMOXICILLIN 70017 AMPICILLIN 110+ Select one or more entriesAE Add/Edit Allergy File EE Mark entered in errorDD Detailed Display UR Update to new reactantSelect Item(s): Next Screen//

35

NOTE: If the list was built previously, the following alternative text is displayed:

Select the list you wish to work with: 1 Free Text

The free text list was last built on Apr 26, 2011Do you want to rebuild the list? NO// YES

36

Free Text Clean Up

Once in the list, select one of the following options:• DD: Detailed Display• EE: Mark entered in error• UR: Update to new reactant

37

Detailed Display

• This displays all of the entries for that particular reaction.

• It includes all the reactions tied to each patient with that reactant:• Can only act on the reaction you are currently

working on (look in the top right corner to see which reaction you are on)

• Shows as a string of text separated with the tilde (~)• Choose additional actions from this screen.

38

Detailed Display

39

Detailed Display

Can choose several options from here:• DD Allergy Detailed Display

• Shows a FileMan style listing of the reaction details for the selected patient

• UR Update to new reactant• Updates the selected patient’s reaction only

• EE Entered in Error• Marks the reaction as “entered-in-error” for the selected patient

only

• PR Add/Edit Patient Reaction• Allows the user to add additional reactions for the selected patient

40

Detailed DisplayPATIENT: DEMO,PATIENT MAE REACTANT: ALBUTEROL GMR ALLERGY: OTHER ALLERGY/ADVERSE REACTION ORIGINATION DATE/TIME: JUL 12, 2004@17:24 ORIGINATOR: WOFFORD-FARRIS,JAMES CLIFTON III OBSERVED/HISTORICAL: HISTORICAL ORIGINATOR SIGN OFF:

YES MECHANISM: UNKNOWN VERIFIED: YES VERIFICATION DATE/TIME: JUL 12, 2004@17:25:41 VERIFIER: WOFFORD-FARRIS,JAMES CLIFTON III ALLERGY TYPE: DRUGDRUG INGREDIENT: ALBUTEROLVA DRUG CLASS: ANTIASTHMA/BRONCHODILATORSDATE/TIME: JUL 12, 2004@17:27:02 USER ENTERING: WOFFORD-FARRIS,JAMES CLIFTON III

41

Update to New ReactantSelect Item(s): Next Screen// URSelect Entries from list: 1You are about to update the selected patient'sALBUTEROL allergy to a new reactant.

ARE YOU SURE? NO// YES

For patient DEMO,PATIENT MAE

Enter Causative Agent: ALBUTEROL

Checking GMR ALLERGIES (#120.82) file for matches...

Now checking the National Drug File - Generic Names (#50.6)

1 ALBUTEROL 2 ALBUTEROL/IPRATROPIUMCHOOSE 1-2: 1 ALBUTEROL

You selected ALBUTEROLIs this correct? Y//YES

42

Entered in ErrorSelect Item(s): Quit// EESelect Entries from list: 1

You are about to mark the selected patient'sACEI allergy as entered in error.

ARE YOU SURE? NO// Y (YES)

43

Add/Edit Patient Reaction

• This option can be used to add additional reactions for the patient.

• This option should be used to add NEW reactions only.

• If existing entries are marked as entered in error from within this option it will not update the utility's display until the list is rebuilt upon re-entry of this option:• This could cause confusion as the list will no longer be

accurate.

44

Batch Updating

• Entries can be “batch” updated from the main screen.

• This should be used with caution, especially for entries that have several patient entries tied to it.

• However, once the details have been reviewed for each patient, this can make the clean up go faster.

45

Allergy Tracking Update Apr 26, 2011 10:41:45 Page: 1 of 18Allergy Tracking Free Text Entries Reactant # Active Entries1 AC I/ARB 12 ACEI 23 ACTIFED 14 ADVERSE DRUG REACTION H202 1<...>14 AMITRIPTYLINE 2415 AMLODIPINE 3016 AMOXICILLIN 70017 AMPICILLIN 110+ Select one or more entriesAE Add/Edit Allergy File EE Mark entered in errorDD Detailed Display UR Update to new reactantSelect Item(s): Next Screen// EESelect Entries from list: 2

You are about to mark ALL allergies with the selected reactantas entered in error.

ARE YOU SURE? NO//YES

46

Allergy Tracking Update Apr 26, 2011 12:41:42 Page: 1 of 18Allergy Tracking Free Text Entries Reactant # Active Entries1 AC I/ARB 12 ACTIFED 13 ADVERSE DRUG REACTION H202 14 AKE: ACI 15 ALBUTEROL 216 ALENDRONATE 77 ALL ANTIBIOTIC UNKNOWN 1<...>17 ANESTHESIA MEDS 1+ Select one or more entriesAE Add/Edit Allergy File EE Mark entered in errorDD Detailed Display UR Update to new reactantSelect Item(s): Next Screen// URSelect Entries from list: 5

You should use the detailed display option to review entries inthis group before doing a mass update. CHANGES CANNOT BE UN-DONE!Press enter to continue:

47

You are about to update ALL allergies with the selected reactant to a new reactant.ARE YOU SURE? NO// YESUpdating ALBUTEROL reactionsFor patient DEMO,PATIENT LEEEnter Causative Agent: ALBUTEROLChecking GMR ALLERGIES (#120.82) file for matches...

Now checking the National Drug File - Generic Names (#50.6) 1 ALBUTEROL 2 ALBUTEROL/IPRATROPIUMCHOOSE 1-2: 1 ALBUTEROLYou selected ALBUTEROLIs this correct? Y// ESPerforming order checking...patient has no active orders.For patient DEMO,PATIENT KEITHUse reactant ALBUTEROL? Y// ESPerforming order checking...patient has no active orders.

48

Ingredient and Drug Class

• These options work the same as the free text utility.

• As with Free Text, use the “batch” options with extreme care.

• Though these are not critical to clean NOW, these will eventually need to be cleaned:• It is wise to start on this project as soon as the

free text are cleaned up, to avoid a time crunch later

ENTERING ANEW ADVERSE REACTION

49

50

Where can Reactions be Entered?

• In RPMS• Through the Adverse Reaction Tracking package• Through prescription processing functions of the

Pharmacy package (or through the inpatient pharmacy functions)

• Through Patient Care Component (PCC) data entry (ALG mnemonic)

• In EHR• Through the adverse reaction component

51

ART Allergy EntryEnter Causative Agent: IBUPROFENChecking existing PATIENT ALLERGIES (#120.8) file for matches...Now checking GMR ALLERGIES (#120.82) file for matches...

Now checking the National Drug File - Generic Names (#50.6) 1 IBUPROFEN 2 IBUPROFEN/PSEUDOEPHEDRINECHOOSE 1-2: 1 IBUPROFEN IBUPROFEN OK? Yes// (Yes)SOURCE: ? Only allow items designates as a source of information Answer with BEH ALLERGY VALUES NAME Do you want the entire BEH ALLERGY VALUES List? Y (Yes) Choose from: CHART REVIEW EXTERNAL SOURCE FAMILY FRIEND MEDICAL PROVIDER OTHER SOURCE PATIENT SPOUSE

52

ART Allergy EntryNo signs/symptoms have been specified. Please add some now.The following are the top ten most common signs/symptoms: 1. ANXIETY 7. HIVES 2. ITCHING 8. DYSPEPSIA 3. SWELLING (NON-SPECIFIC) 9. ANAPHYLAXIS 4. DROWSINESS 10. RASH 5. NAUSEA,VOMITING 11. OTHER SIGN/SYMPTOM 6. DIARRHEAEnter from the list above : 11Select SIGN/SYMPTOMS NAME: GI REACTION NATIONAL SIGN/SYMPTOMSelect SIGN/SYMPTOMS NAME:Date(Time Optional) of appearance of Sign/Symptom(s): 4-4-1973 (APR 04, 1973)Select source: ? Answer with BEH ALLERGY VALUES NAME Do you want the entire BEH ALLERGY VALUES List? Y (Yes) Choose from: CHART REVIEW EXTERNAL SOURCE FAMILY FRIEND MEDICAL PROVIDER OTHER SOURCE PATIENT SPOUSE

53

ART Allergy EntryThe following is the list of reported signs/symptoms for this reaction: Signs/Symptoms Date Observed-------------------------------------------------------------------- 1 GI REACTION Apr 04, 1973Select Action (A)DD, (D)ELETE OR <RET>:SNOMED EVENT: ?? Choose from: ALLERGY TO SUBSTANCE DRUG ALLERGY DRUG INTOLERANCE FOOD ALLERGY FOOD INTOLERANCE PROPENSITY TO ADVERSE REACTIONS PROPENSITY TO ADVERSE REACTIONS TO DRUG PROPENSITY TO ADVERSE REACTIONS TO FOOD PROPENSITY TO ADVERSE REACTIONS TO SUBSTANCECOMMENTS: No existing textCurrently you have verifier access.Would you like to verify this Causative Agent now? Yes// N (No) OBS/REACTANT SOURCE VER. MECH. HIST TYPE-------- ------ ---- ------- ---- ----BEN-GAY YES UNKNOWN HIST DRUGIBUPROFEN SPOUSE NO PHARM HIST DRUG Reactions: GI REACTION(Source: SPOUSE)

54

Prescription Processing

• Option is available from the patient information screen when processing prescriptions:• EA Enter/Edit Allergy/ADR Data:

• Enter/Edit or Remove a reaction from a patient

• Can be accessed anywhere prescriptions can be processed

• Once selected, displays the same entry interface as when using the ART Package

55

PCC Data Entry

• Using the ALG mnemonic• User must have GMRA-USER key• Mnemonic must be allowed

• Once the ALG mnemonic is invoked, displays the same entry interface as when using the ART package

56

Adverse Reaction Trackingin EHR

• Providers can enter Adverse Reactions (ADR) in the EHR using the right click menu on the Adverse Reaction component

• Enter a new reaction• Edit an existing reaction• Delete their own unsigned reaction• Mark a reaction “entered-in-error”• Mark a reaction as inactive, or reactivate a reaction• Document the inability to assess reactions• Document chart review functions (reviewed or no active

allergies)

57

Allergy Entry - EHR

Right click in a blank part of the adverse reaction component and select New Adverse Reaction.

58

Allergy Entry - EHR

Enter a few characters of the causative agent (watch for misspellings). For medications, choose from the National Drug File entries. For foods or other non-drug substances, choose from the VA Allergies file. The local drug file will not be selectable; drug ingredients and VA Drug class should only be used as a last resort.

59

EHR Allergy Dialog Box

Enter the required information. Nature of Reaction will be set by the causative agent chosen, and cannot be changed. Event Code, Source of Information, and Signs/Symptoms are required (use “Possible Reaction” if symptoms are not known). Date and time and source of the signs/symptoms are optional. Comments may be added as needed to provide additional information.

REQUESTING A NEW REACTANT

60

61

What if the reactant is not available?

• IHS is adding more than 700 entries to the allergy file with GMRA patches 1001 and 1002.

• Additional will be added as needed to keep current with the VA.

• However, IHS has created a feedback mechanism to request additional reactants beyond these.

62

Requesting a New Reactant

• In both RPMS and EHR, if the desired reactant is not found, the user will be offered the option to send a message to request the new reactant.

• Although the text states this is an email, it is really a mailman bulletin:• Therefore, it cannot be directed outside the

facility.• A package coordinator will need to check these

messages routinely and send information to the feedback mechanism.

63

RPMSCould not find SPONGEBOB in any files.

Before sending an email requesting the addition of a new reactant, pleasetry entering the first 3 or 4 letters of the reactant to search forthe desired entry.

Would you like to send an email requesting SPONGEBOBbe added as a causative agent?Send email? NO// YES

You may now add any comments you may have to the message thatis going to be sent with the request to add this reactant.You may want to add things like sign/symptoms, observed or historical, etcthat may be useful to the reviewer.

Enter RETURN to continue or '^' to exit:

==[ WRAP ]==[ INSERT ]============< >===========[ <PF1>H=Help ]====THIS PATIENT REPORTS A VIOLENT REACTION TO WATCING SPONGEBOB.

<=====T=====T======T======T======T======T======T======T======T>=====

Message sent - NOTE: This reactant was NOT added for this patient.

Enter another Causative Agent? YES// NO

64

EHRClick Yes to open the Enter Optional Comments dialog.

65

Entering Feedback

• Go to:http://www.ihs.gov/RPMS/index.cfm?module=feedback&option=add&newquery=1• Optionally, go to http://www.ihs.gov/RPMS and click

Feedback in the left-hand menu• Fill out the available form, using the RPMS

Application “Pharmacy – New Reactant/Symptom Request (PRSR)”

• These will be reviewed promptly, and will be added through patch updates on a regular basis as needed

http://www.ihs.gov/RPMS/index.cfm?module=feedback&option=add&newquery=1

http://www.ihs.gov/RPMS/index.cfm?module=feedback&option=add&newquery=1


ENTERED IN ERROR & INACTIVATING/REACTIVATING

67

68

Reactions Entered In Error

• Entered in Error may be used when the reaction entry was a mistake (wrong patient, wrong causative agent):• Wrong causative agent will require a new entry for the

correct agent• Entering comments is strongly recommended to allow

auditors, surveyors, and other providers to know what was done with the reaction and why.

• NOT for reactions that the patient no longer has (e.g. Ibuprofen caused stomach upset once but is now taken regularly, or patient has undergone de-sensitization therapy).

69

REACTANT VER. MECH. HIST TYPE-------- ---- ------- ---- ----MOTRIN YES PHARM HIST DRUG (IBUPROFEN) Reactions: PENICILLIN V POTASSIUM YES ALLERGY HIST DRUG (PENICILLIN) Reactions: APNEA, SWELLING-THROATRITALIN YES ALLERGY HIST DRUG (METHYLPHENIDATE) Reactions: TACHYCARDIAEnter Causative Agent: MOTRIN <A> M 05-16-1983 XXX-XX-3440 CI

142507 MOTRIN OK? Yes// <enter> (Yes) PATIENT: DEMO,PATIENT ALLEN CAUSATIVE AGENT: MOTRIN INGREDIENTS: IBUPROFEN VA DRUG CLASSES: NONSALICYLATE NSAIs,A ORIGINATOR: USER,YSTUDENT ORIGINATED: MAY 19, 2010@10:45:20 SIGN OFF: YES OBS/HIST: HISTORICALID BAND MARKED: CHART MARKED: SIGNS/SYMPTOMS: (May 19, 2010@10:45:20) MECHANISM: PHARMACOLOGIC VERIFIER: USER,YSTUDENT VERIFIED: MAY 19, 2010@13:37:26Is the reaction information correct? Yes// N (No)Mark this reaction as 'Entered-in-Error'? YESCOMMENTS: 1>WRONG PATIENT 2>EDIT Option: Enter another Causative Agent? YES// NO

70

Select Entered in Error from the right click menu to display the Confirm dialog

Click Yes to remove the adverse reaction

71

Inactivating reactions

• Used for situations where the patient has previously reported a reaction but is now able to tolerate the causative agent or is no longer allergic:• Retains a record of the reaction that is visible in

EHR but clearly marked as “inactive.”• Can be reactivated as needed.• Retains record of when and who inactivated and

reactivated the reaction.

72

Inactivating reactions OBS/REACTANT SOURCE VER. MECH. HIST TYPE-------- ------ ---- ------- ---- ----WALNUTS PATIENT NO UNKNOWN HIST FOOD Reactions: HIVES(Source: PATIENT)Enter Causative Agent: WALNChecking existing PATIENT ALLERGIES (#120.8) file for matches... <A> F 10-24-1933 XXX-XX-4127 WW 110211 WALNUTS WALNUTS OK? Yes// <enter> (Yes) PATIENT: DEMO,ALLERGY CONNIE CAUSATIVE AGENT: WALNUTS SOURCE OF INFORMATION: PATIENTORIGINATOR: NIESEN,MARY ANN ORIGINATED: Apr 27, 2011@09:58 SIGN OFF: YES OBS/HIST: HISTORICAL EVENT: FOOD INTOLERANCE CODE: 235719002 ID BAND MARKED: CHART MARKED: Apr 27, 2011@09:59:49SIGNS/SYMPTOMS: HIVES (Jan 29, 2010) SOURCE: PATIENT MECHANISM: UNKNOWNIs the reaction information correct? Yes// N (No)Mark this reaction as 'Entered-in-Error'? NOInactivate this reaction? YESSelect reason: ?? Choose from: NO LONGER ALLERGIC REACTION IS TOLERABLESelect reason: NO LONGER ALLERGICEnter another Causative Agent? YES// NO

Inactivating reactions

Select Inactivate Adverse Reaction on the right-click menu to open the Confirm dialog.Click Yes to open the Reason Prompt dialog.

73

UNABLE TO ASSESS

74

75

Unable to Assess

• Sometimes, the patient or proxy may not be able to relate their adverse reaction history.

• There is now a way to document that the attempt was made but could not be completed.

• It does NOT mean that NO reaction history is available, just that the user is unable to determine if the listed information is current and correct.

76

Unable to Assess

• This information will remain until some other action is performed on the adverse reactions:• Review• Add/Edit• Inactivate/Mark “entered-in-error”

• This information is retained for auditing purposes.• This may be marked several times:

• For example, once each nursing shift or when handing off care in an emergency room.

Select Adverse Reaction Tracking Clinician Menu Option: 7 Unable to assess allergies

Select PATIENT NAME: DEMO,ALLERGY CHARLES

OBS/REACTANT SOURCE VER. MECH. HIST TYPE-------- ------ ---- ------- ---- ----ASPIRIN FAMILY YES UNKNOWN HIST DRUG Reactions: ANAPHYLAXIS(Source: EXTERNAL SOURCE)BEE STINGS CHART REVIEW AUTO UNKNOWN HIST OTHER Reactions: HIVES(Source: CHART REVIEW)Do you want to mark this patient as being unable to assess for allergies?? NO//Y ESSelect reason: ??

Choose from: ALTERED MENTAL STATUS CAREGIVER DOES NOT KNOW LANGUAGE BARRIER OTHER PATIENT DOES NOT KNOW UNCONSCIOUS

Select reason: UNCONSCIOUSPatient has been marked unasessablePress RETURN to continue

77

78

Select Inability to Assess from the right-click menu to open the Reason Prompt dialog.

Select a reason, type a comment, and click OK to complete the action.

CHART REVIEW FUNCTIONS

79

80

Chart Review

• Allows for the documentation of a review of reported adverse reactions or “no active allergies” (once the initial entry of “No Known Allergies” has been completed).

• Assists providers in meeting Meaningful Use criteria as well as in documentation needed for many accrediting organizations.

• Documentation is per visit, per user:• For example, can be documented by both the nurse

and the physician for the same visit

81

Chart Review

• Can be accessed through the chart review component (see EHR patch 8 notes), OR

• Through the right-click menu in the adverse reactions component• “No active allergies” can only be chosen when there are

no active reactions documented• “Reviewed” can be chosen when reactions exist, but will

also be added when marking “no active”• An additional status of “Updated” will be stored when

reactions are added, deleted, or otherwise manipulated.

82

The chart review component is usually located in the header bar area. Clicking on the button gives the options of “Reviewed” or “No Active” as appropriate. The button caption changes as actions are marked or taken (for example, the user here selected “no active” which updated the button to show that the list was both reviewed and found to have no active reactions. The caption is shown with brackets until the actions are signed by the user, after which only the letters will show.The chart review options can also be accessed from the cover sheet components. The buttons on the chart review component will update as above. Again, the options available depend on whether the patient has active reactions

VERIFYING A REACTION

83

84

Verification of Reactions

• In this instance, “verifying” does not imply you have interviewed the patient and are convinced the allergy or reaction is real.

• It means you have checked the entry in the patient’s profile and it contains all required information (VA Class code, Ingredients, sign/symptom info, source, SNOMED Event code, etc.)

• If the allergy does not contain the correct information, the order checking will not work

85

Verification

Access option through multiple paths:• Prescription processing• Adverse Reaction Tracking (ART) verifier

menu• Electronic Health Record (EHR) via

Notifications

86

Finding Reactions Needing Verification

• May be found during prescription processing, the ART verification menu, or using the ART reports

• Users may receive notifications in RPMS and EHR if:• They hold the GMRA-ALLERGY VERIFY keyAND• They are members of the GMRA VERIFY DRUG

ALLERGY mailman group (or other group assigned to the bulletin)

87

Unverified reactions found in Rx processing

Allergies and adverse reactions are displayed at the bottom of the patient information screen; non-verified reactions are listed separately from verified reactions

88

Verification Via Rx Processing DEMO,PATIENT ALLEN <A> PID: 183-17-3440 (HRN: 142507) Ht(cm): _______ (______) DOB: MAY 16,1983 (27) Wt(kg): _______ (______) SEX: MALE

Eligibility: DIRECT ONLY Insurance Information:

Disabilities:

1333 WRIGHTS CREEK RD CARIBOU PHONE: 555-555-8591 MAINE 04736 Prescription Mail Delivery: Regular Mail

Allergies Verified: PENICILLIN V POTASSIUM, Non-Verified: RITALIN, + Enter ?? for more actions EA Enter/Edit Allergy/ADR Data PU Patient Record Update DD Detailed Allergy/ADR List EX Exit Patient List Select Action: Next Screen// EA

89

Verification VIA RX Processing REACTANT VER. MECH. HIST TYPE -------- ---- ------- ---- MOTRIN YES PHARM HIST DRUG (IBUPROFEN) Reactions: PENICILLIN V POTASSIUM YES ALLERGY HIST DRUG (PENICILLIN) Reactions: APNEA, SWELLING-THROAT RITALIN NO ALLERGY HIST DRUG (METHYLPHENIDATE) Reactions: TACHYCARDIA

Enter Causative Agent: RITALIN RITALIN OK? Yes// (Yes) PATIENT: DEMO,PATIENT ALLEN CAUSATIVE AGENT: RITALIN INGREDIENTS: METHYLPHENIDATE VA DRUG CLASSES: OPIOID ANALGESICS AMPHETAMINE LIKE STIM ORIGINATOR: USER,YSTUDENT ORIGINATED: MAY 19, 2010@13:39:13 SIGN OFF: YES OBS/HIST: HISTORICALID BAND MARKED: CHART MARKED: SIGNS/SYMPTOMS: TACHYCARDIA (May 19, 2010@13:39:13)

MECHANISM: ALLERGYIs the reaction information correct? Yes// <enter> (Yes)

90

Verification VIA RX ProcessingCurrently you have verifier access.Would you like to verify this Causative Agent now? Yes// <enter> (Yes)CAUSATIVE AGENT: RITALIN TYPE: DRUG INGREDIENTS: METHYLPHENIDATEVA DRUG CLASSES: CN101 - OPIOID ANALGESICS CN802 - AMPHETAMINE LIKE STIMULANTS OBS/HIST: HISTORICAL SIGNS/SYMPTOMS: TACHYCARDIA (May 19, 2010@13:39:13) MECHANISM: ALLERGY

Would you like to edit any of this data? N (No) PATIENT: DEMO,PATIENT ALLEN CAUSATIVE AGENT: RITALIN INGREDIENTS: METHYLPHENIDATE VA DRUG CLASSES: OPIOID ANALGESICS AMPHETAMINE LIKE STIM ORIGINATOR: USER,YSTUDENT ORIGINATED: MAY 19, 2010@13:39:13 SIGN OFF: YES OBS/HIST: HISTORICAL

ID BAND MARKED: CHART MARKED:

SIGNS/SYMPTOMS: TACHYCARDIA (May 19, 2010@13:39:13)Change status of this allergy/adverse reaction to verified? Y (Yes)Enter another Causative Agent? YES// NOThis session you have CHOSEN: RITALINHave the Chart(s) been marked for this CAUSATIVE AGENT? Y (Yes)

91

Verifier Menu

Adverse Reaction Tracking Verifier Menu1. Enter/Edit Patient Reaction Data2. Verify Patient Reaction Data3. Reports Menu ...4. Edit Chart and ID Band5. FDA Enter/Edit Menu ...6. Online Reference Card7. Reactivate Reaction/Allergy8. Unable to assess allergies

92

Verification Using ART MenuSelect Adverse Reaction Tracking Verifier Menu Option: 2 Verify Patient Reaction

DataWould you like to verify a single patient's data? NO// D Drug N Non-drug B BothSelect type of AGENT to verify:(D/N/B): B OBS/ PATIENT ALLERGY HIST ADR TYPE ------- ------- ---- --- ----

1. DEMO,ALLERGY CHARLES (104836) AMOXICILLIN HIST NO DRUG2. DEMO,ALLERGY CHARLES (104836) WALNUTS HIST UNK FOOD3. DEMO,ALLERGY CONNIE (110211) PENICILLIN OBS NO DRUG<...>12. DEMO,PATIENT GIRL (993300) AMOXICILLIN HIST NO DRUG13. DEMO,PATIENT LYNN (111410) ACE INHIBITORS UNK DRUG14. DEMO,PATIENT MADISON (100756) BASCTRIM HIST UNK DRUG15. DEMO,PATIENT MADISON (100756) SULFA UNK DRUGTYPE '^' TO STOP ORSelect a number between 1-15:

93

Verification in EHR

1. Double click on a notification to process2. Select a set of notifications to process and

click the “Process selected” button:• To select multiple notifications that are grouped

together, click the first in the list, press and hold the shift key, then click the last in the list.

• To select multiple notifications not grouped together, press and hold the control key, then click each notification to process.

94

Once the verification dialogue opens, click the button to the right of the causative agent (labeled with the primary VA Class Code) to see the details on the VA Class Codes and Drug Ingredients tied to that causative agent. Note that these cannot be edited in EHR. Click the “Current” button to see a list of the patient’s current active reactions, to ensure the new entry is not a duplicate.

REPORTS

95

96

ART Reports

• Extensive reports are available in the ART Package.

• The quality of the reports is directly related to the quality of the data put in.

• Some reports will have little value for sites not fully utilizing the package:• For example, if the site is not entering P&T

Committee data, those reports will not be useful.

97

ART Reports

• Each ART Menu includes reports.• The types of reports may vary from menu to

menu.• The USER menu does not have a separate

“reports” sub menu though some reports are listed.

• All other menus have a separate “reports” submenu.

98

Selected Reports of Interest

• Active Listing of Patient Reactions:• Provides a listing of the ACTIVE reactions for a single patient

• Patient Allergies Not Signed Off:• Provides a list of reactions that have not been signed

off/completed• List by Location of Undocumented Allergies:

• Provides a list of patient who do not have an allergy assessment (either “no known allergies” or a reaction documented)

• Print Patient Reaction Data:• Provides a list of reaction data for a single patient• User can choose to include active, inactive, and/or entered in

error

99


• List by Location Not Verified Reactions:• Provides a list of patients with reactions needing

verification, sorted by location• This report may be tasked

• List by Location and Date All Signed Reactions:• Provides a list of all signed/completed reactions over a

date range

• List Autoverified Reaction Data:• Provides a list of reactions that were auto-verified by

date range, location, and mechanism

100


• List of Fatal Reaction over a Date Range:• Provides a list of fatal reactions over a date range• If the date of death is recorded in Patient Registrations, the report

will include that date• Print Summary of Outcomes:

• Provides a summary report of patient outcomes over a date range• No patient list is included

• Frequency Distribution of Causative Agents:• Provides a list of reactants and the frequency over a date range

• Frequency Distribution of Drug Classes:• Provides a list of the VA Drug Class associated with a reactant and

the frequency over a date range

101


• Total Reported Reactions Over a Date Range:• Provides a number of reported reactions over a date range

• P&T Committee ADR Outcome Report:• Provides a list of reactions and summary of outcomes over

a date range• Only useful if the P&T data was entered

• P&T Committee ADR Report:• Provides a list of reactions, signs, mechanism, severity, and

comments over a date range• MUST be printed to a 132 column printer

102

Reports Outside ART

PLAL Reports:• Located in the PCC supervisor options.• Provide a way to search for potential reactions that are

listed on the problem list (includes INACTIVE problems!).• The reports may contain items that do not translate well

to entries in the ART package:• “seasonal allergies” or “environmental allergies”• Might have coding errors.

• Does NOT check to see if these are already in the ART package.

103

PLAL Reports

• List All Patients with Allergies or NKA on Problem List:• Provides a list of patients who have an allergy or NKA entered on

the Problem List.• Can be VERY large – print in sections and after regular hours.

• List Pts seen in N yrs with Problem List Allergies:• Essentially the same as the above but allows for restriction based

on when the patient was last seen.• List Patients with Allergies entered in a Date Range:

• Provides a list of patients who have had reactions entered onto the problem list over a date range.

• Can be useful to run after the initial clean up has been done to catch new entries.

104

List All Patients with Allergies or NKA on Problem List

DEMO INDIAN HOSPITAL PATIENTS WITH ALLERGIES OR DOCUMENTED NO KNOWN ALLERGIES ON PCC PROBLEM LIST PATIENTS WITH LAST NAMES BEGINNING WITH D through DPATIENT NAME CHART # DOB-------------------------------------------------------------------------------

DEMO,ANNA HUGHES 100547 Jul 07, 1954 DATE ADDED DX PROVIDER NARRATIVE ---------- -- ------------------ DEC 10, 2002 995.2 PCN-ANAPHYLAXIS, ASA-GI, HA, IODINE- ANAPHYLAXIS, ACE1 COUGH, CELEBREX APR 23, 2003 995.2 ADE: ROSIGLITAZONE-ITCH

DEMO,JUDY CAROL 100672 Jun 16, 1968 DATE ADDED DX PROVIDER NARRATIVE ---------- -- ------------------ AUG 28, 2001 799.9 NKDA

DEMO,BILLIE JO 100703 Jul 11, 1953 DATE ADDED DX PROVIDER NARRATIVE ---------- -- ------------------ JUL 15, 1996 995.2 ALLERGY: ASA

105

List Pts seen in N yrs with Problem List Allergies

DEMO INDIAN HOSPITAL PATIENTS WITH ALLERGIES OR DOCUMENTED NO KNOWN ALLERGIES ON PCC PROBLEM LIST PATIENTS SEEN BETWEEN VISIT DATES: MAY 11, 2008 TO MAY 11, 2011PATIENT NAME CHART # DOB-------------------------------------------------------------------------------

DEMO,ANDREA BERTALOTTO 100016 Nov 16, 1912 DATE ADDED DX PROVIDER NARRATIVE ---------- -- ------------------ MAY 28, 1996 995.2 ALLERGIES: PCN, ASA

DEMO,LUTHER JIM 100640 Jun 23, 1983 DATE ADDED DX PROVIDER NARRATIVE ---------- -- ------------------ AUG 24, 1997 799.9 NKDA

DEMO,CARRIE MARIE 100788 Jan 31, 1984 DATE ADDED DX PROVIDER NARRATIVE ---------- -- ------------------ FEB 27, 1996 995.2 ALLERGIES: PCN, ERYTHROMYCIN

Enter RETURN to continue or '^' to exit:

106

List Patients with Allergies entered in a Date Range

DEMO INDIAN HOSPITAL PATIENTS WITH ALLERGIES OR DOCUMENTED NO KNOWN ALLERGIES ON PCC PROBLEM LIST ALLERGIES ADDED TO THE PROBLEM: MAY 11, 2010 TO MAY 11, 2011PATIENT NAME CHART # DOB-------------------------------------------------------------------------------

PATIENT,CRSY 900024 Sep 01, 1953 DATE ADDED DX PROVIDER NARRATIVE ---------- -- ------------------ AUG 16, 2010 995.3 Allergy, Unspecified, Not Elsewhere Classified

PATIENT,CRSFB 900157 Apr 07, 1955 DATE ADDED DX PROVIDER NARRATIVE ---------- -- ------------------ AUG 16, 2010 995.3 Allergy, Unspecified, Not Elsewhere Classified

TEST,CATHY 3 1992 DATE ADDED DX PROVIDER NARRATIVE ---------- -- ------------------ JUL 26, 2010 V14.0 TEST ALLERGY JUL 26, 2010 693.1 test

107

Cleaning up the Lists

• Look at the problem list entry for the patient.• Review the note for the date the problem was

entered.• Look for other notes or data that provide

information on the reaction.• Review the adverse reactions package to see

if it was already documented there:• Ensure all information is included.

108


If needed, enter or edit the reaction in the ART package or adverse reaction module in EHR:• Ensure all available data is included.• Although sign/symptom data can be added in EHR,

deleting can only be done on non-verified reactions.• Include comments to show:

• Original date documented• Who documented• That it was moved from Problem List to ART• Any other information that may be useful in determining who

did what and why

109


Remove the reaction information from the Problem List, if appropriate:• Inactivated entries will still show on PLAL.• Consider waiting until the reaction has been verified:

• In this instance, it may be useful to have the verifier perform this step.

• Remember that problems are now “logically” deleted:• This means that the information is still discoverable for legal

and other purposes.• Will not show in EHR, Health Summaries, etc for normal

users.

NEXT STEPS

110

111

What do we REALLY need to do now?

Sites should run the Free Text Clean Up• Some reactions may NOT participate in order

checking if not cleaned up.• Failure to clean up reactions may lead to patient

harm.• May further impact data exchange/interoperability

which may lead inaccurate patient data being sent to other facilities.

• In other words, this is a PATIENT SAFETY issue!

112


• Sites have been encouraged since the launch of EHR to move reactions from the problem list to the ART package:• Use the reports in PLAL to find potential issues.• Enter the reactions into the ART package.• Remove the Problem List entries that should not be retained.• Goal is NOT an empty PLAL report, but a reasoned move of some

entries to the appropriate package• This should be done as soon as possible if not already done.• May need to run the reports again to check for new entries since

last cleaned up.• Reactions on the Problem List will NOT participate in Order Checks.• Again, this is a PATIENT SAFETY issue!

113


Sites should ensure the Drug file is up to date, complete and accurate, and matched to the National Drug file where possible:• Order checks rely not only on accurate information in ART,

but in the drug file as well.• Entries unable to be matched to the National Drug file

should have a VA class manually assigned:• This is a “last resort” type of option.• Matching provides additional information beyond the class code.• Unmatched drugs should be checked periodically (i.e. after

National Drug file updates) to see if they can now be matched.• You guessed it, this is also a PATIENT SAFETY issue!

114


Sites should run the Patient Allergies Not Signed Off report:• Some may be years old.• If possible, have the originator sign the reaction.• If not possible, a user with the GMRA-SUPERVISOR

key may simply verify these to complete them:• They will NOT be visible for verification to users without

the GMRA-SUPERVISOR key.

115


Sites should run the List by Location Not Verified Reactions report OR look in the verification utility:• Determine how many reactions require

verification.• Develop a plan to get the reactions verified.

116


Sites should run the List by Location of Undocumented Allergies report:• Meaningful Use requires all patients to have a

list of reactions or “No Known” documented.• This list can assist in identifying patients who

still require documentation.• This may best be done AFTER the Problem List

clean up has occurred, as this may reduce the list considerably.

117


Sites should run the Drug Class and Ingredients Clean Up:• Some reactions may NOT participate in order

checking if not cleaned up.• Failure to clean up reactions may lead to patient

harm.• May further impact data exchange/interoperability

which may lead inaccurate patient data being sent to other facilities.

• In other words, this is a PATIENT SAFETY issue!

118


Sites who have autoverification allowed should run the List Autoverified Reaction Data periodically:• This provides a sample of what the settings are

allowing to auto-verify.• Site may then wish to alter the auto-

verification settings.• It is strongly recommended that all drug

reactions be manually verified.

Questions?

119

Introduction and New Features January 2012 Adverse Reaction Tracking (GMRA) 1.

Documents

Transcript of Introduction and New Features January 2012 Adverse Reaction Tracking (GMRA) 1.