1. Introduction and New Features January 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. 2

3. 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! 4

5. Adverse Reaction Tracking at Work RPMS CHOOSE 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) 5

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. 6

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 7

8. 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 9

10. 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. 10

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 11

12. 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 12

13. 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 13

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. 14

15. 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. 15

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. 16

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 17

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 18

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! 19

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. 20

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.http:www.ihs.gov/RPMS Click “Feedback” on the left hand side. Use the RPMS Application “Pharmacy-New Reactant/Symptom Request (PRSR). 21

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.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). 22

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 23

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. 24

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. 25

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. 26

27. 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. 28

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. 29

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. 30

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. 31

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. 32

33. 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 Text Building list of free text allergies...this may take a few minutes

34. 34 Allergy Tracking Update Apr 26, 2011 10:33:16 Page: 1 of 18 Allergy Tracking Free Text Entries Reactant # Active Entries 1 AC I/ARB 1 2 ACEI 3 3 ACTIFED 1 4 ADVERSE DRUG REACTION H202 1 5 AKE: ACI 1 6 ALBUTEROL 22 7 ALENDRONATE 7 8 ALL ANTIBIOTIC UNKNOWN 1 9 ALL DYES 1 10 ALL EYE DROPS 1 11 ALL NSAIDS 1 12 ALL TAPES 1 13 ALLERGIC TO DYE 1 14 AMITRIPTYLINE 24 15 AMLODIPINE 30 16 AMOXICILLIN 700 17 AMPICILLIN 110 + Select one or more entries AE Add/Edit Allergy File EE Mark entered in error DD Detailed Display UR Update to new reactant Select Item(s): Next Screen//

35. 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, 2011 Do 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 36

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. 37

38. Detailed Display 38

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 39

40. Detailed Display PATIENT: 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: DRUG DRUG INGREDIENT: ALBUTEROL VA DRUG CLASS: ANTIASTHMA/BRONCHODILATORS DATE/TIME: JUL 12, 2004@17:27:02 USER ENTERING: WOFFORD-FARRIS,JAMES CLIFTON III 40

41. Update to New Reactant Select Item(s): Next Screen// UR Select Entries from list: 1 You are about to update the selected patient's ALBUTEROL 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/IPRATROPIUM CHOOSE 1-2: 1 ALBUTEROL You selected ALBUTEROL Is this correct? Y//YES 41

42. Entered in Error Select Item(s): Quit// EE Select Entries from list: 1 You are about to mark the selected patient's ACEI allergy as entered in error. ARE YOU SURE? NO// Y (YES) 42

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. 43

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. 44

45. 45 Allergy Tracking Update Apr 26, 2011 10:41:45 Page: 1 of 18 Allergy Tracking Free Text Entries Reactant # Active Entries 1 AC I/ARB 1 2 ACEI 2 3 ACTIFED 1 4 ADVERSE DRUG REACTION H202 1 14 AMITRIPTYLINE 24 15 AMLODIPINE 30 16 AMOXICILLIN 700 17 AMPICILLIN 110 + Select one or more entries AE Add/Edit Allergy File EE Mark entered in error DD Detailed Display UR Update to new reactant Select Item(s): Next Screen// EE Select Entries from list: 2 You are about to mark ALL allergies with the selected reactant as entered in error. ARE YOU SURE? NO//YES

46. Allergy Tracking Update Apr 26, 2011 12:41:42 Page: 1 of 18 Allergy Tracking Free Text Entries Reactant # Active Entries 1 AC I/ARB 1 2 ACTIFED 1 3 ADVERSE DRUG REACTION H202 1 4 AKE: ACI 1 5 ALBUTEROL 21 6 ALENDRONATE 7 7 ALL ANTIBIOTIC UNKNOWN 1 17 ANESTHESIA MEDS 1 +Select one or more entries AE Add/Edit Allergy File EE Mark entered in error DD Detailed Display UR Update to new reactant Select Item(s): Next Screen// UR Select Entries from list: 5 You should use the detailed display option to review entries in this group before doing a mass update. CHANGES CANNOT BE UN- DONE! Press enter to continue: 46

47. You are about to update ALL allergies with the selected reactant to a new reactant. ARE YOU SURE? NO// YES Updating ALBUTEROL reactions For patient DEMO,PATIENT LEE 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/IPRATROPIUM CHOOSE 1-2: 1 ALBUTEROL You selected ALBUTEROL Is this correct? Y// ES Performing order checking...patient has no active orders. For patient DEMO,PATIENT KEITH Use reactant ALBUTEROL? Y// ES Performing order checking...patient has no active orders. 47

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 48

49. ENTERING A NEW 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 50

51. ART Allergy Entry Enter Causative Agent: IBUPROFEN Checking 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/PSEUDOEPHEDRINE CHOOSE 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 51

52. ART Allergy Entry No 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. DIARRHEA Enter from the list above : 11 Select SIGN/SYMPTOMS NAME: GI REACTION NATIONAL SIGN/SYMPTOM Select 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 52

53. ART Allergy Entry The following is the list of reported signs/symptoms for this reaction: Signs/Symptoms Date Observed -------------------------------------------------------------------- 1 GI REACTION Apr 04, 1973 Select Action (A)DD, (D)ELETE OR : 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 SUBSTANCE COMMENTS: No existing text Currently 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 DRUG IBUPROFEN SPOUSE NO PHARM HIST DRUG Reactions: GI REACTION(Source: SPOUSE) 53

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 54

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 55

56. Adverse Reaction Tracking in 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) 56

57. Allergy Entry - EHR Right click in a blank part of the adverse reaction component and select New Adverse Reaction. 57

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. 58

59. EHR Allergy Dialog Box 59 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.

60. 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. 61

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. 62

63. RPMS Could not find SPONGEBOB in any files. Before sending an email requesting the addition of a new reactant, please try entering the first 3 or 4 letters of the reactant to search for the desired entry. Would you like to send an email requesting SPONGEBOB be added as a causative agent? Send email? NO// YES You may now add any comments you may have to the message that is going to be sent with the request to add this reactant. You may want to add things like sign/symptoms, observed or historical, etc that may be useful to the reviewer. Enter RETURN to continue or '^' to exit: ==[ WRAP ]==[ INSERT ]============ ===========[ H=Help ]==== THIS PATIENT REPORTS A VIOLENT REACTION TO WATCING SPONGEBOB. ===== Message sent - NOTE: This reactant was NOT added for this patient. Enter another Causative Agent? YES// NO 63

64. EHR Click Yes to open the Enter Optional Comments dialog. 64

65. Entering Feedback Go to: http://www.ihs.gov/RPMS/index.cfm?module=fe edback&option=add&newquery=1 http://www.ihs.gov/RPMS/index.cfm?module=fe edback&option=add&newquery=1 Optionally, go to http://www.ihs.gov/RPMS and click Feedback in the left-hand menuhttp://www.ihs.gov/RPMS 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 65

66. 66

67. 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). 68

69. 69 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 YES ALLERGY HIST DRUG (METHYLPHENIDATE) Reactions: TACHYCARDIA Enter Causative Agent: MOTRIN M 05-16-1983 XXX-XX-3440 CI 142507 MOTRIN OK? Yes// (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: HISTORICAL ID BAND MARKED: CHART MARKED: SIGNS/SYMPTOMS: (May 19, 2010@10:45:20) MECHANISM: PHARMACOLOGIC VERIFIER: USER,YSTUDENT VERIFIED: MAY 19, 2010@13:37:26 Is the reaction information correct? Yes// N (No) Mark this reaction as 'Entered-in-Error'? YES COMMENTS: 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 70

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. 71

72. Inactivating reactions OBS/ REACTANT SOURCE VER. MECH. HIST TYPE -------- ------ ---- ------- ---- ---- WALNUTS PATIENT NO UNKNOWN HIST FOOD Reactions: HIVES(Source: PATIENT) Enter Causative Agent: WALN Checking existing PATIENT ALLERGIES (#120.8) file for matches... F 10-24-1933 XXX-XX-4127 WW 110211 WALNUTS WALNUTS OK? Yes// (Yes) PATIENT: DEMO,ALLERGY CONNIE CAUSATIVE AGENT: WALNUTS SOURCE OF INFORMATION: PATIENT ORIGINATOR: 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@09:59:49 SIGNS/SYMPTOMS: HIVES (Jan 29, 2010) SOURCE: PATIENT MECHANISM: UNKNOWN Is the reaction information correct? Yes// N (No) Mark this reaction as 'Entered-in-Error'? NO Inactivate this reaction? YES Select reason: ?? Choose from: NO LONGER ALLERGIC REACTION IS TOLERABLE Select reason: NO LONGER ALLERGIC Enter another Causative Agent? YES// NO 72

73. 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

74. 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. 75

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. 76

77. 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 ES Select reason: ?? Choose from: ALTERED MENTAL STATUS CAREGIVER DOES NOT KNOW LANGUAGE BARRIER OTHER PATIENT DOES NOT KNOW UNCONSCIOUS Select reason: UNCONSCIOUS Patient has been marked unasessable Press 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. 78

79. 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 80

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. 81

82. 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

83. 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 84

85. Verification Access option through multiple paths: Prescription processing Adverse Reaction Tracking (ART) verifier menu Electronic Health Record (EHR) via Notifications 85

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 key AND They are members of the GMRA VERIFY DRUG ALLERGY mailman group (or other group assigned to the bulletin) 86

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 87

88. Verification Via Rx Processing DEMO,PATIENT ALLEN 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 88

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: HISTORICAL ID BAND MARKED: CHART MARKED: SIGNS/SYMPTOMS: TACHYCARDIA (May 19, 2010@13:39:13) MECHANISM: ALLERGY Is the reaction information correct? Yes// (Yes) 89

90. Verification VIA RX Processing Currently you have verifier access. Would you like to verify this Causative Agent now? Yes// (Yes) CAUSATIVE AGENT: RITALIN TYPE: DRUG INGREDIENTS: METHYLPHENIDATE VA 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// NO This session you have CHOSEN: RITALIN Have the Chart(s) been marked for this CAUSATIVE AGENT? Y (Yes) 90

91. Verifier Menu 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 91

92. Verification Using ART Menu Select Adverse Reaction Tracking Verifier Menu Option: 2 Verify Patient Reaction Data Would you like to verify a single patient's data? NO// D Drug N Non-drug B Both Select type of AGENT to verify:(D/N/B): B OBS/ PATIENT ALLERGY HIST ADR TYPE ------- ------- ---- --- ---- 1. DEMO,ALLERGY CHARLES (104836) AMOXICILLIN HIST NO DRUG 2. DEMO,ALLERGY CHARLES (104836) WALNUTS HIST UNK FOOD 3. DEMO,ALLERGY CONNIE (110211) PENICILLIN OBS NO DRUG 12. DEMO,PATIENT GIRL (993300) AMOXICILLIN HIST NO DRUG 13. DEMO,PATIENT LYNN (111410) ACE INHIBITORS UNK DRUG 14. DEMO,PATIENT MADISON (100756) BASCTRIM HIST UNK DRUG 15. DEMO,PATIENT MADISON (100756) SULFA UNK DRUG TYPE '^' TO STOP OR Select a number between 1-15: 92

93. Verification in EHR 1.Double click on a notification to process 2.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. 93

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. 94

95. 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. 96

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. 97

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 98

99. Selected Reports of Interest 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 99

100. Selected Reports of Interest 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 100

101. Selected Reports of Interest 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 101

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. 102

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. 103

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 D PATIENT 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 C OUGH, 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 104

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, 2011 PATIENT 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: 105

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, 2011 PATIENT 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 106

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. 107

108. Cleaning up the Lists 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 108

109. Cleaning up the Lists 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. 109

110. 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! 111

112. What do we REALLY need to do now? 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! 112

113. What do we REALLY need to do now? 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! 113

114. What do we REALLY need to do now? 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. 114

115. What do we REALLY need to do now? 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. 115

116. What do we REALLY need to do now? 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. 116

117. What do we REALLY need to do now? 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! 117

118. What do we REALLY need to do now? 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. 118

119. Questions? 119