Adverse Reaction Tracking (GMRA)

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

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.

3. introduction

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 RPMS Electronic Health Record (EHR) 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//

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

8. Package Setup

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” 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

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

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 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.

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).

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: • Accessed through http:www.ihs.gov/RPMS. • Click on “Feedback” on the left hand side. • 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.

27. Allergy Cleanup utility

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

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. 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

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 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

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

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)

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 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:

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.

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

49. Entering Anew adverse reaction

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