Rapid Drug Desensitization High Intensity Allergy Care

1. Rapid Drug DesensitizationHigh Intensity Allergy Care NESA 1 April, 2011 David Sloane, MD Assistant Director, BWH Drug Desensitization Program

2. “Doc, it hurt’s when I do this…”

3. Desensitization • Establishes a TEMPORARY Clinical Tolerance to a medication • Tolerance wanes after approximately 24-48 hours off of medication. • Allows for safe delivery of an important medication in a patient with a known allergy to that medication • Transient results mean that each time the patient needs a course of the medication he/she must be desensitized • Imperative that doses be given ON TIME DURING and AFTER the process or patient may require repeat desensitization

4. Definition Rapid (hours to days) induction of a temporary state of tolerance to a medication to which a patient has had a severe adverse reaction.

5. What is rapid desensitization ? • High risk procedure: requires the introduction of a potentially lethal medication to a highly sensitized patient. • Performed in critically ill patients: survival depends on administration of a medication to which a patient has a previous history of a severe adverse reaction. • No alternative medications are available or the alternatives have less demonstrated therapeutic value .

6. What is Rapid Desensitization? • It is the induction of a temporary state. • It is done by administering progressively greater sub-threshold doses of the medication causing the adverse reaction. • Once desensitization is complete, the state of tolerance can be maintained (only) by continuous administration of the medication.

8. Drug Adverse Reaction: Urticaria/Angioedema

9. Drug Adverse Reaction: Upper Respiratory Tract Obstruction

10. Who are the patients?(People allergic to X who need X) • Patients with infections who need an antibiotic to which they are hypersensitive • Example = A CF patient allergic to cetazidime • Patients with NSAID Allergy in need of NSAID treatment • Examples = Aspirin Exacerbated Respiratory Disease; Coronary Artery Disease • Patients with chemotherapy hypersensitivity • Example = A patient with ovarian CA allergic to carboplatin; a patient with B cell lymphoma hypersensitive to rituximab

11. What are the drug allergies? • Anaphylaxis • Rashes • Urticaria, Flushing • Asthma • Back Pain, Chest Pain • Hypertension

12. (Data from 413 paper on initial reactions)

13. How do patients get into the program? • Have a reaction • Referral to Allergy • History • Exam • ? Skin Testing • Placed on schedule

14. How is it actually done?A Team Approach is Essential • Superb Nursing is the sine qua non of success. • Patients must be “on board” and obey the three rules of desensitization. • Education is a categorical imperative • MDs must be available in case of difficulty. • Peerless communication among all team members (patient, nurse, coordinator, MD) is critical • IV is most common route these days, but we have also done IP

15. A Typical Desensitization Protocol

16. Standard Premeds and PRN Meds • Premeds: • Diphenhydramine 25mg IV • Rantidine 50mg IV, Famotidine 20 mg IV • Montelukast 10mg PO • ASA 325 mg PO • PRNs: • Ativan 0.5-1mg IV • Epinephrine 0.3mg IM • Diphenhydramine 25-50mg IV • Ranitidine 50mg IV, Famotidine 20mg IV • Solumedrol 40mg IV • Montelukast 10 mg PO • ASA 325-650 mg PO

17. Nursing Considerations • 1:1 staffing for the duration of the procedure – appropriate resource designated by the nurse manager or designee • Length of 1:1 monitoring is determined by the Allergy Team • Usually patients can return to their normal level of care after the procedure • Prior to the procedure have a POLICY • Gather equipment • Review order set with Allergist and Pharmacy if ANY questions • Prior to procedure 2 RNs will: • Review the orders • Validate doses • Validate IV bag concentrations • Validate IV infusion rate calculations as each bag is hung • Second RN will initial the bedside flow sheet in the IV section at the time of the check • Eventually there will be ability to scan two RN barcodes • USE EXTREME CAUTION at the time of the bag change to assure correct solution is being hung – utilize second RN check

18. What Else Do You Need?Bedside Equipment • Oral Airway • Bag- Mask (ambu) • Oxygen • Suction and tonsil tip • DASH Monitor with Oxygen sat probe • Blood pressure cuff and stethescope • Peak Flow Meter • Allergic Reaction Medication Box from pharmacy

19. Peak Flow Meter • Single patient use • Review CCL • Careful instructions to the patient • Pre procedure • Post procedure

20. Allergic Reaction Medication Box • Epi-pen • Epi-pen Jr • Albuterol • Duoneb • Diphenhydramine • Hydrocortisone Each med is ordered by the Allergy Fellow/ The box is stocked and sent by the pharmacy which REMAINS locked until needed and may stay in the patient’s room. When the desensitization is complete – Call the pharmacy to return the box to the pharmacy. (Does not fit in the pharmacy bin) If a medication is used stamp and fill out the charge slip

22. Epi-pen Place patient SUPINE • IM administration • Grasp with black tip down • Remove Gray safety release • Jab firmly into outer thigh until it clicks • COUNT to 10 (injection complete - injection window shows red) • Remove and massage area for 10 seconds www.epipen.com

23. Monitoring • Pre medication may be needed • IV with NS at KVO • Second IV is desirable but generally not required • Vital Signs • HR, BP, RR, O2 Sat, and Temp at regular intervals and with any symptoms • Observe for signs of hypersensitivity reaction

24. Where is Rapid Drug Desensitization Performed? • In the past all desensitizations were done in the ICU. • Could cause delay in treatment as patients waited for ICU bed • Patients were transferred away from their pods to the ICU – but were stable • Transfer process into and out of ICU around the desensitization caused further delays

25. Criteria for Intermediate Care • Governed by the Allergy Team previous knowledge of the patient reactions • Patients must have had one successful (stable) desensitization in the ICU before being transitioned to intermediate or outpatient desensitization to the same medication. • This will be documented by the Allergy Team • Only patients stratified to LOW RISK category (during ICU desensitization) will be desensitized in Intermediate Care, i.e., an outpatient desensitization unit.

26. §Low risk May occur at any time of day Low Risk FEV1 > 1.5 L No cardiac history Mild allergic reaction (i.e. pruritus, rash, flushing, etc…) §High risk desensitizations (as determined by Allergist) must be started during the hours of 7 am-3 pm in the ICU: HIGH RISK FEV1 < 1.5 L Cardiac disease with beta blockade Severe allergic reaction (i.e. near fatal anaphylaxis, chest pain, throat tightening, shortness of breath, decreased O2 saturation, syncope, changes in blood pressure, etc ) Risk Categories

27. Does it work?

28. What are the problems? • Desensitization is no guarantee • Approximately 33-40% of patients have some reaction during the first few desensitizations • Generally milder than the initial reaction • Modification of the protocol may compensate • Lemma 1: the protocol is not static! • Lemma 2: the whole Rapid Drug Desensitization project is more than an algorithm – it is a approach to a specialized type of patient care.

29. Hypersensitivity Reaction • Skin • Itching, rash, urticaria, angioedema • Respiratory • Lip or tongue swelling, hoarseness, difficult swallowing, chest tightness, SOB, stridor, increased respiratory effort, wheezing, cyanosis • Cardiovascular • Chest pain, hypotension, hypertension, tachycardia • GI • Abdominal pain, nausea, vomiting, diarrhea

30. If a reaction occurs • Be prepared – Meds at the bedside • Stridor or Refractory hypotension – Call a Code, immediately administer emergency medications as ordered • Contact Allergy Fellow • May be instructed to continue the protocol at a slower rate • Lab is drawn for Tryptase to document the reaction – Page Lab or HO

31. Management of Reactions • Stop infusion • Treat patients with • Diphenhydramine for pruritus, rash • Supplemental oxygen for desaturation • Albuterol nebulizer for shortness of breath • IM epinephrine for throat tightness, hypotension • Corticosteroids for symptoms persisting > 5 min • Restart infusion at the step where the breakthrough reaction occurred • For subsequent desensitizations, an intermediate step may be added prior to the step where the previous breakthrough reaction occurred, or pre-medications may be adjusted

32. To date, we have had no deaths

33. Documentation • Flow Sheet • Event Note • Post desensitization Assessment and Plan • Assessment component is completed by the RN • Communication for Medication Desensitization form • Completed by the MD – in the chart before procedure begins • Medication Hypersensitivity Reaction form • Completed by the MD • Review blank

34. “Really, now, is this for everyone?!” • Driven by patient need • Is alternative (“second line”) treatment inferior? • Permitted by caregiver expertise and comfort