Position Statement on the Administration of Immunotherapy Outside of the Prescribing Allergist Facility

This statement was developed by the Drugs and Anaphylaxis Committee of the American College of Allergy, Asthma and Immunology. It was approved by the ACAAI Board of Regents on the recommendation of the Executive Committee on April 25, 1998.

This statement addresses some of the issues concerning the administration of immunotherapy outside of the prescribing allergist's office, in particular, the primary care physician's office. It has been a fairly common and acceptable practice for the allergist to arrange for immunotherapy to be administered by the primary care physician in instances where it may be inconvenient for the patient to travel to the allergist's office. Presumably, the decision to arrange for the immunotherapy to be administered outside of the allergist's office is made by the allergist on an individual basis weighing the risks versus benefits in each case. However, in recent years, managed care has evolved to play a more dominant role in health care decision making. Some managed care companies are insisting that the primary care physician administers immunotherapy.

The allergist may feel that the administration of immunotherapy outside of his/her office, especially in higher risk patients, presents an unacceptable medical risk for the patient. In addition, in some cases the primary care physicians may be uncomfortable with the technical aspect of immunotherapy and/or lack the appropriately trained personnel and resuscitative equipment. Facilities for proper storage of allergen extract must be available. By accepting the responsibility of allergen extract administration, the primary care physician is agreeing to provide knowledgeable and adequately supervised administration of allergen extract and treatment of emergencies. The decision for administration at the primary care physician's office should be acceptable to both the patient and the primary care physician.

Background
Fatalities from immunotherapy injections have been reported but are rare; one fatality per 63 million injections.(1) Risk factors associated with these fatalities include dose errors; seasonal exacerbation of allergic disease, especially symptomatic asthma; high degree of allergen sensitivity; injections from a new vial; and, beta-blocker use. The majority have occurred within 20 minutes of receiving the injection and led to the American Academy of Allergy, Asthma and Immunology's 1990 position statement concerning the waiting period after immunotherapy.(2) The twenty-minute waiting period should be extended in high-risk patients. Non-fatal systemic reactions from immunotherapy injections are more common and have been reported to occur at a rate of .05 to 3.2 per 100 injections (mean 0.5%).(3) These rates do not distinguish between the build-up or maintenance phase, but clinical experience suggests that there is greater risk of a systemic reaction during the build-up phase.

Patients who appear to be at greater risk for severe systemic reactions include:

  • Patients with currently symptomatic asthma.
  • Patients with high degree of allergen test activity.
  • Patients being treated with beta-blockers.
  • Patients suffering exacerbation of their allergic disease (especially asthma).(4)

Prior position statements have provided guidelines on appropriate personnel and resuscitative equipment to treat systemic reactions.(5) Recommended equipment includes:

  • Stethoscope and sphygmomanometer.
  • Tourniquet and large bore needles.
  • Aqueous epinephrine HCl, 1:1000.
  • Equipment to administer oxygen by mask.
  • Intravenous fluid set-up.
  • Oral airway.
  • Diphenhydramine or similar antihistamine.
  • Aminophylline for intravenous injection.
  • Corticosteroids for intravenous injection.
  • Vasopressor.

It has been recommended that allergen immunotherapy should be given in settings where emergency resuscitative equipment and trained personnel are immediately available to treat systemic reactions under the supervision of a physician (6) or licensed physician extender. The trained personnel should be familiar with the following procedures:

  • Adjustment of dose of allergen immunotherapy extract to minimize reactions.
  • Recognition and treatment of local and systemic reactions to immunotherapy injections.
  • Basic cardiopulmonary resuscitation.
  • Ongoing patient education in recognition and treatment of local and systemic reactions that occur outside the physician's office.

Position Regarding Administration of Allergen Immunotherapy in the Primary Care Physician's Office or Other Facility Outside the Prescribing Allergist's Office
The standard of care concerning the administration of immunotherapy should be the same regardless of where the immunotherapy is given and the specialty of the supervising physician. The decision of where the patient is to receive the immunotherapy should be made by the prescribing allergist after assessing the patient's risk profile. The allergist should determine that the patient is not at high risk for severe systemic reactions to immunotherapy injections and does not require the added expertise of a trained allergist in the supervision of the immunotherapy administration before allowing for the administration of the immunotherapy outside of his/her office.

It is the responsibility of the treating allergist to provide detailed instructions to the primary care physician or other facility concerning

  1. adjustment of allergen doses during the buildup phase as well as at maintenance,
  2. new vials,
  3. seasonal allergen peaks,
  4. missed injections, and
  5. follow-up to local and systemic reactions.

The allergen extract vials should be clearly labeled with contents, potency, expiration date, and patient's full name. It is desirable that the allergist provide a suggested protocol for treating local and systemic reactions along with a list of recommended resuscitative equipment. The primary care physician and the patient should be informed of the current guidelines concerning waiting period after immunotherapy injections. As many reactions occur when a patient receives, in error, injections from another patient's allergen vials, it would be advisable to attach a patient's photo to the allergen extract dosage instruction sheet. This would make misidentification less likely.

The medical instructions should include recommended qualifications for administering and supervising medical personnel. The primary care physician should ensure that the health care workers administering the immunotherapy injections are properly trained in the recognition and treatment of local and systemic reactions to allergen extracts as well as proper immunotherapy administration technique.

If patients fall into the high-risk category (see above), the allergist should consider treating them more cautiously and may need to supervise their immunotherapy regimen personally. The allergist has more experience and training in allergen immunotherapy than the primary care physician; thus is more likely to recognize signs and symptoms of a systemic reaction in the earliest stages and to initiate early treatment which may decrease the likelihood of a more serious outcome. In addition, the allergist's personnel are likely to have greater experience and training in the recognition and treatment of systemic reactions to immunotherapy injections and involve the physician at an earlier phase of reaction. They are also more likely to have greater knowledge of proper immunotherapy administration protocol and dose adjustment, which should in turn lead to less immunotherapy errors.

In summary, the standard of care for the supervision of allergen immunotherapy should be the same wherever it is administered and not be affected by the specialty of the supervising physician. The decision concerning the appropriate place for the allergen immunotherapy administration should be made by the allergist on an individual patient basis and not based on a corporate policy. If the immunotherapy is to be administered in the primary care physician's office, the patient and the primary care physician should be comfortable with this decision and recommended guidelines concerning waiting period, physician supervision, personnel qualifications and proper resuscitative equipment should be followed.

References

  1. American College of Allergy, Asthma and Immunology. Fact Sheet: Efficacy and Safety of Immunotherapy 1997.
  2. Executive Committee, American Academy of Allergy and Immunology. The waiting period after allergen skin testing and immunotherapy (position statement). J. Allergy Clin Immunol 1990;85:526-527.
  3. Stewart GE, Lockey RF. Systemic reactions from allergen immunotherapy. J. Allergy Clin Immunol 1992;90:567-578.
  4. Bukantz SC, Lockey RF. Adverse effects and fatalities associated with allergen immunotherapy. In Allergen Immunotherapy, Marcel Decker, Inc. 1991; 223-246.
  5. Executive Committee, American Academy of Allergy and Immunology. Personnel and equipment to treat systemic reactions caused by immunotherapy with allergenic extracts (Position Statement). J. Allergy and Clin Immunol 1986;77:271-273.
  6. American Academy of Allergy and Immunology Board of Directors. Guidelines to minimize the risk from systemic reactions caused by immunotherapy with allergenic extracts. (Position Statement). J. Allergy and Clin Immunol 1994;93:811-812.

For more medical information, please contact an allergist in your area.