Adverse Reaction Tracking (ART) Basics

1. Adverse Reaction Tracking (ART) Basics May 2012

2. Course Objectives Upon completion of this session the student will: • Understand the need for a comprehensive process for adverse reaction tracking • Understand the relationship between the National Drug File (PSN) and Adverse Reaction Tracking (GMRA) packages • Identify ways allergies are entered into the system • Be able to verify allergies in the GMRA package • Be able to mark allergies as entered in error

3. 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 normaluse. How does an ADR differ from a side effect or allergy? An allergy is an adverse drug reaction mediated by an immune response (e.g., rash, hives). A side effect is an expected and known effect of a drug that is not the intended therapeutic outcome. The term “side effect” tends to normalize the concept of injury from drugs. It has been recommended that this term should generally be avoided in favor of adverse drug reaction. All Allergies are Adverse Drug Reactions, but not all Adverse Drug Reactions are Allergies!

4. Adverse Reaction Processes • Covers entry of reaction to determination of clinical significance and potential for re-challenge, and removal of invalid or inactive entries • CANNOT be fully completed in the computer at this time • Often utilizes a multi-disciplinary approach • Often uses a sub-committee of the Pharmacy and Therapeutics committee

5. Allergy 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//

6. Allergy Tracking at Work--EHR

7. How does it work? • Each drug file entry has a VA Drug Class and ingredient(s) assigned through the matching process • Allergies are linked to VA Drug classes and ingredients where applicable • EHR performs order checks on both order entry and signature of orders • RPMS checks for patient reactions upon prescription processing • Interventions can be tracked and trended using the Adverse Reaction Tracking (GMRA) Package

8. National Drug File: VA Class Code • National Drug File (NDF) Developed by the VA • New drugs and changes are put in a master VA databank and changes are transmitted through periodic patches • Lag time for new drugs, and typically only contains items the VA uses • VA Drug Class Code is one element of NDF • Example: CV100 Cardiovascular Agents • VA Drug Class Code is a basic link for drugs throughout the RPMS system

9. VA Drug Class Report National Drug File • RPRT National Drug File Reports Menu ... • CLVA VA Drug Classification • Can include descriptions or not • Can print entire list or a subsection • Handy to have a complete copy available in the pharmacy with the descriptions included

10. Entry and Verification of allergies • Allergies are entered by a variety of people: Coders, Providers, Nurses • Pharmacists “verify” allergies • Verifying (in this context) 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 is matched to the VA Drug Class and ingredients and contains all required information • If the allergy does not have both a VA Drug Class code and ingredients the checking may not work • Some entries may have only a class code or only an ingredient. The VA has experienced problems with some of these not triggering order checks in some cases, but has not been able to pinpoint a cause.

11. Unsigned Reactions • Reactions might be left “unsigned” for a variety of reasons • Unsigned reactions will not cross to be verified in most cases • Can be found using the ART reports • Newer unsigned reactions can be referred back to the entering provider for signature or deletion • Older unsigned reactions may need to be fixed by having someone with the supervisor key “edit” or verify the entry • The “edit” does not seem to require any data be actually changed.

12. Unverified Reactions • Reactions require “verification” in RPMS • “Verifying” in EHR is possible but the user verifying should make sure to check the ingredient(s) and VA Drug Class code(s). • Can be accomplished via GMRA process for a single patient or for all unverified reactions • Can also be accomplished in prescription and order processing • Non-verified reactions are clearly labeled as such in the patient profile seen in outpatient and inpatient processing

13. Verification • Access option through multiple paths: • Prescription or order processing • GMRA verifier menu • EHR via notifications • Remember that “verification” in the computer is at this point just checking for all the needed information, and NOT necessarily for clinical relevance

14. Verification • Users may get RPMS MailMan bulletins or EHR notifications about reactions needing verification. • System must be set up properly for this to happen • If getting notifications, user may still go to RPMS to verify the reaction. Once verified (no matter by what method), the notification will go away.

15. Allergies Entered In Error • Some entries need to be “removed” • Reaction is entered on the wrong patient or for the wrong item • Some fields are not editable, and the reaction may need to be marked “Entered in Error” and re-entered to correct them • Entered in Error will remove the reaction from most views, although it can be seen in some reports • Comments should ALWAYS be used when marking a reaction “Entered in Error” so there is accountability • NOT used to remove an allergy if patient previously had a reaction but now is found to no longer have a reaction • The decision to remove the allergy will depend on business processes and may need to be discussed with the provider.

16. Inactivate/reactivate reactions • Can be done in RPMS or EHR • Generally used when the patient really did have a reaction, but does not experience the reaction any longer. • Most often things like GI Upset that has now been determined to be tolerable based on risk/benefit analysis • Could also be from de-sensitization therapy