Allergy Clinic Policy & Procedures

Allergy Immunotherapy – Administration of Extracts Under Protocols from Allergists Not Privileged at the Northwestern University Health Service

Purpose:

Allergy immunotherapy is used to alter the immunologic response in allergic patients. The extracts used are individually prepared solutions supplied by allergists not privileged at the Northwestern University Health Service (NUHS). It is the intent of NUHS to provide to patients the service of administrating these extracts under protocols written and provided by outside allergists.

Policy:

  • Patients requesting administration of immunotherapy extracts will complete a consent and request form titled “Request and Consent for Administration of Allergy Immunotherapy (PDF)”.
  • Allergists not privileged at NUHS will complete a referral agreement indicating they have reviewed NUHS procedures for administering extracts and protocols for treating reactions and agree that they are acceptable for care of their patient. They further agree to be available to NUHS nurses for questions related to patient care and dosage adjustment.
  • Referring Allergists will provide:
    • Allergen Extract for injection
    • Detailed protocols for dosing and dose adjustments including schedules for: escalation and maintenance dosing, the use of new vials, during seasonal exposures, if the constituents of the allergen immunotherapy extract have changed, missed doses, and when reactions occur,
  • Protocols from referring Allergists will be reviewed and approved by the NUHS Consulting Allergist to insure that the protocol is consistent with current standards of care and consistent with the current capabilities of NUHS. If the protocol does not meet these criteria, the patient will be given an appropriate referral, either to the original Allergist or to an Allergist in the community.
  • The referring Allergist is responsible for the management of the individual immunotherapy and modification of dosing schedules. NUHS will periodically send updated treatment history back to the referring Allergist if outlined per the protocol provided by the referring Allergist.
  • Administration of immunotherapy extract will be performed by a licensed NUHS RN. The patient will not see a NUHS provider as part of routine immunotherapy injection visits.
  • RN encounter notes will be reviewed as indicated by the NUHS consulting allergist.
  • Allergen immunotherapy will not be administered unless an NUHS attending physician is present and readily accessible in the office.
  • Treatment of reactions will be done under NUHS protocol.
  • NUHS will provide the service of storing allergen extracts for patients between injections as described in the following procedures. NUHS is not liable for the compromise in the integrity of the medication due to handling before NUHS receives the medication or for loss or compromise of integrity due to power outage, storage equipment failure, or catastrophic event.
  • Consents and referral agreements expire at the end of each academic year (August 31st).

NUHS expects the referring Allergist to reevaluate the patient at least annually.

Procedures:

Allergy Clinic Visit

The patient is seen by an RN who is privileged to administer immunotherapy extract. The patient must have:

  1. Referral agreement signed by the referring Allergist.
  2. “Request and Consent for Administration of Allergy Immunotherapy ” signed by the patient.
  3. Protocols for dosing and dose adjustment form from the referring Allergist and approved by the NUHS consulting Allergist.
  4. Allergen extract from the referring Allergist.

Storage of Extract

  • The extract is to be stored in containers clearly indicating the patients name and labeled to identify the contents of the vial.
  • The extract is to be stored, refrigerated and kept between 3°C and 6°C (37.4°F and 42.8°F).
  • If the extract is exposed to heat or frozen, NUHS will contact the referring Allergist for instructions and document the contact and instructions.

Administration of Extract

  • A NUHS attending physician must be present in the office and readily available during the entire allergy injection and observation period before extract can be administered.
  • Injections are given subcutaneously using a 1-mLsyringe with a 26 or 27 gauge half-inch non-removable needle.
  • Injections should be given in the posterior portion of the middle third of the upper arm at the junction of the deltoid and triceps muscles.
  • The syringe should be aspirated to check for blood return in the syringe before injecting. If blood is present, the solution should not be injected and the syringe removed and discarded in an appropriate container.
  • The patient must remain and be observed for 30 minutes after an injection. (The onset of most anaphylactic reactions occur within 30 minutes following injection.)

Dosage and Dose Adjustment

Dose changes are indicated:

  1. during escalation and maintenance dosing,
  2. the use of new vials,
  3. during seasonal exposures,
  4. if the constituents of the allergen immunotherapy extract have changed,
  5. missed doses, and
  6. if reactions have occurred. Detailed dose and dose adjustment for the above mentioned scenarios are per the schedule provided by the referring Allergist.

Any questions or clarifications should be made to the referring Allergist.

Contraindications

  • Injections should be postponed if the patient is ill, febrile, has symptomatic asthma, or has sunburn or irritation at the injection site.
  • Injections should not be given to patients taking beta-blockers or monoamine oxidase inhibitors (MAOI’s).
  • Caution advised- appropriately revised dosage schedules must be obtained from the referring Allergist in order to continue injections during pregnancy.

Documentation

Every visit is to be charted in the NUHS EMR documenting the following information:

  • Current health status (document recent illnesses); include statement attesting to whether patient’s asthma is stable or not (e.g. albuterol usage in week prior to injection, nocturnal symptoms, hospitalizations or ER visits, compliance with medications).
  • Temperature (if clinically appropriate).
  • Record if patient felt any reaction occurred with most previous injection (local swelling, local itching, wheezing, hives, delayed reaction, systemic, large local, etc.)
  • Current Medications and Allergies.
  • Patient’s Baseline Peak Flow listed for reference (if patient is asthmatic).
  • Pre-injection Peak Flow if clinical concern for possible asthma symptoms or exacerbation (e.g. if Albuterol use in the last week, recent asthma flare, or recent illness).
  • Post-injection Peak Flow (if systemic reaction symptoms occur)
  • Missed or late dose
  • Protocol reference for next dose
  • Injection information (extract, concentration, volume , location of injection)
  • Documentation that patient was observed for 30 minutes or that patient left early
  • Inspection and description of injection site after 30 minutes (e.g. negative, inflammation, swelling, wheal and flare size in mm of longest diameter, etc.)
  • Reaction, if any, dueto injection (local or systemic)
  • Post injection treatment (e.g. ice, topical steroid, oral antihistamines, resuscitation, etc.)

The treatment record provided by the referring Allergist is to be completed for each visit and kept in a separate Allergy Clinic chart. Any time the treatment record is sent to the referring Allergist, a note should be placed in the EMR and a copy of the treatment record sent should be scanned into the EMR.

Treatment of Local Reactions by the RN

  • Usually no treatment is required for local reactions other than application of an ice pack and adjustment of future doses .
  • For Local reactions greater than 2 inches, topical steroids may be applied.
  • For local itching, redness and large swelling, an oral antihistamine such as diphenhydrmaine 50mg may be given.

Immediate Treatment of Systemic Reactions by the RN

  • If a systemic reaction is suspected, assess airway, breathing, and circulation. A physician should be summoned urgently.
  • The RN can administer a dose of 0.3 mL epinephrine 1:1000 intramuscularly into the Deltoid near the injection site.
  • Physician management of systemic reactions is per the protocol “Physician Management of Anaphylaxis and Systemic Reactions”.

8/11/09 – ja revision 4