Immunotherapy Safety for the Primary Care ... - U.S. Coast Guard

S62 Cox et al
J ALLERGY CLIN IMMUNOL
SEPTEMBER 2007
The preferred location of allergen immunotherapy
administration is in the office of the physician who prepared
the patient’s allergen immunotherapy extract. The physician’s
office should have the expertise, personnel, and
procedures in place for the safe and effective administration
of immunotherapy. However, in many cases it might
be necessary to administer the allergen immunotherapy
extract in another physician’s office. Allergen immunotherapy
should be administered with the same care wherever
it is administered. A physician or qualified physician
extender to treat anaphylaxis should be in the immediate
vicinity when immunotherapy injections are administered.
Summary Statement 60: Patients at high risk of systemic
reactions, where possible, should receive immunotherapy
in the office of the physician who prepared the
patient’s allergen immunotherapy extract. D
Patients at high risk of systemic reactions (highly
sensitive, severe symptoms, comorbid conditions, and
history of recurrent systemic reactions), where possible,
should receive immunotherapy in the allergist/immunologist’s
office. 292 The allergist/immunologist who prepared
the patient’s allergen immunotherapy extract and
his or her support staff should have the experience and
procedures in place for the administration of allergen immunotherapy
to such patients. 184 The early signs of an allergic
reaction are more likely to be recognized and early
treatment initiated, which will decrease the possibility of a
serious outcome. Modifications might be frequently necessary
in the patient’s immunotherapy schedule, as well
as the patients total treatment program.
Other locations
Summary Statement 61: Regardless of the location,
allergen immunotherapy should be administered under the
supervision of an appropriately trained physician and
personnel. D
The physician and personnel administering immunotherapy
should be aware of the technical aspects of this
procedure and have available appropriately trained personnel,
resuscitative equipment/medicines, and storage
facilities for allergen immunotherapy extract. 292 The
health care professional and staff should be able to recognize
early signs and symptoms of anaphylaxis and administer
emergency medications as necessary.
The physician and staff should be aware of situations that
might place the patient at greater risk for systemic reactions
(eg, concomitant medications that can interfere with
emergency treatment, such as b-blockers, acute illness, or
allergy/asthma exacerbations at the time of allergen immunotherapy
extract injection or poorly controlled asthma).
Appropriate adjustment of dose should be made as
clinically indicated. The physician who prepared the
patient’s allergen immunotherapy extract should provide
adequately labeled allergen immunotherapy extract vials,
detailed directions regarding dosage schedule for build-up
and maintenance, and instructions on adjustments that
might be necessary under the following circumstances:
1. when providing patients with new vials;
2. during seasonal exposure to allergens that are in the
patient’s allergen vaccine, to which the patient is
very sensitive, or both;
3. if the patient has missed injections; and
4. when reactions occur to the allergen immunotherapy
extract.
Any systemic reaction to allergen immunotherapy
should be treated immediately, and the physician who
prepared the allergen immunotherapy extract should be
informed. This might require a return to the allergist/
immunologist’s office for treatment and re-evaluation.
Home administration. Summary Statement 62: In rare
and exceptional cases, when allergen immunotherapy
cannot be administered in a medical facility and withholding
this therapy would result in a serious detriment to
the patients’ health (eg, VIT for a patient living in a remote
area), very careful consideration of potential benefits and
risks of at-home administration of allergen immunotherapy
should be made on an individual patient basis. If this
approach is used, informed consent should be obtained
from the patient, and the person administering the injection
to the patient must be educated about how to administer
immunotherapy and recognize and treat anaphylaxis. D
Allergen immunotherapy should be administered in a
medical facility with trained staff and medical equipment
capable of recognizing and treating anaphylaxis. Under
rare circumstances, when the benefit of allergen immunotherapy
clearly outweighs the risk of withholding
immunotherapy (eg, patients with a history of venom
anaphylaxis living in a remote region), at-home administration
of allergen immunotherapy can be considered on
an individual basis. In this instance there should be a
discussion with the patient with very careful consideration
of the potential benefits and risks involved in home
administration and alternatives. Informed consent should
be obtained from the patient and appropriate family
members after this discussion. Under these circumstances,
another adult person should be fully trained to administer
the injection and to treat anaphylaxis if this should occur.
It should be noted, however, that the package insert
approved by the FDA that accompanies all allergen
extracts, including venom, implies that allergy injections
should be administered in a clinical setting under the
supervision of a physician. Intuitively, the risk from
administering allergenic extracts outside a clinical setting
would appear to be greater. Recognition and treatment of
anaphylaxis might be delayed or less effective than in a
clinical setting in which supports (personnel, medications,
supplies, and equipment) are more optimal for encouraging
prompt recognition and treatment of anaphylaxis
(Table V). Home administration should only be considered
in the rare circumstance when the benefit of immunotherapy
clearly outweighs the risks. Frequent or routine
prescription of home immunotherapy is not appropriate
under any circumstances.
Summary Statement 63: If a patient on immunotherapy
transfers from one physician to another, a decision must be
made by the physician to whom the patient has transferred