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

J ALLERGY CLIN IMMUNOL
VOLUME 120, NUMBER 3
Cox et al S63
as to whether to continue immunotherapy. If immunotherapy
is continued, a decision must then be made about
whether to continue an unchanged immunotherapy program
initiated by the previous physician or to prepare a
new immunotherapy program. D
Summary Statement 64: If a patient transfers from one
physician to another and continues on an immunotherapy
program without changes to either the schedule or allergen
immunotherapy extract, the risk of a systemic reaction is
not substantially increased. D
Summary Statement 65: A full, clear, and detailed
documentation of the patient’s schedule must accompany
a patient when he or she transfers responsibility for their
immunotherapy program from one physician to another.
In addition, a record of previous response to and compliance
with this program should be communicated to the
patient’s new physician. D
Summary Statement 66: An allergen immunotherapy
extract must be considered different from a clinical
standpoint if there is any change in the constituents of
the extract. These include changes in the lot, manufacturer,
allergen extract type (eg, aqueous, glycerinated,
standardized, and nonstandardized), and/or components
or relative amounts in the mixture. D
Summary Statement 67: There is an increased risk of a
systemic reaction in a patient who transfers from one
physician to another if the immunotherapy extract is
changed because of the significant variability in content
and potency of allergen extracts. The risk of a systemic
reaction with a different extracts might be greater with
nonstandardized extracts and with extracts that contain
mixtures of allergens. D
Summary Statement 68: Immunotherapy with a different
extract should be conducted cautiously. If there is
inadequate information to support continuing with the
previous immunotherapy program, re-evaluation might be
necessary, and a new schedule and allergen immunotherapy
extract might need to be prepared. D
Patients often transfer from one physician (previous
physician) to another (current physician) while receiving
allergen immunotherapy. When this occurs, a decision must
be made by the current physician about whether to continue
immunotherapy and, if so, what allergen immunotherapy
extract and schedule should be used: the one that the patient
brought from the previous physician (ie, an unchanged
immunotherapy program) or one to be prepared by the
current physician (ie, a new immunotherapy program).
If the patient transfers from one physician to another and
continues on the previous immunotherapy program without
changing either the schedule or allergen immunotherapy
extract, he or she is not at substantially increased risk
of having systemic reactions as long as there is a full, clear,
and detailed documentation of the patient’s previous
schedule and the contents of the allergen immunotherapy
extract (see Appendices 7, 8, 11, 12, and 14 for examples of
allergen immunotherapy prescription and administration
forms and documentation guidelines for allergen immunotherapy
forms). In addition, the patient’s previous response
to and compliance with this program must accompany the
patient who transfers responsibility for the immunotherapy
program from one physician to another. This should include
a record of any reactions to immunotherapy and how
they were managed, as well as the patient’s response to immunotherapy.
Under these circumstances, immunotherapy
can be continued with the allergen immunotherapy extract
that the patient was previously receiving if (1) the previous
physician is willing and able to continue to provide the
patient with a schedule and the allergen immunotherapy
extract, (2) the patient has shown significant improvement
on this immunotherapy program, and (3) the contents of
the allergen immunotherapy extract are appropriate for
the area in which the patient is now living.
An allergen immunotherapy extract must be considered
different from a clinical standpoint if there is any change in
the constituents of the allergen immunotherapy extract.
These include changes in the lot, manufacturer, vaccine
type (eg, aqueous, glycerinated, standardized, and nonstandardized),
and component allergens and their respective
concentrations in the allergen immunotherapy extract.
There is increased risk of a systemic reaction if the allergen
immunotherapy extract is changed and the patient’s dose is
not modified. This increased risk is due to the significant
variability in content and potency of extracts and the
variability in methods used by physicians to prepare the
patient’s maintenance concentrate and its dilutions. For
example, the strength of a given concentration of nonstandardized
extracts might vary significantly from vial to
vial. The risk of systemic reactions in such a situation
might be greater with nonstandardized extracts and allergen
immunotherapy extracts that contain mixtures of allergens.
Therefore if the allergen immunotherapy extract is to be
changed, the patient might need to be retested for specific
IgE to the appropriate allergens and started on an immunotherapy
schedule and immunotherapy extract formulation
that is appropriate. In this situation the starting dose
should be comparable with the initial dose that would be
used if the patient had not previously been receiving
immunotherapy. If the information that accompanies the
patient is thorough, the current physician can prepare an
allergen immunotherapy extract identical or almost identical
to that provided by the previous physician. In such a
case, all that might be required is a decrease in the dose
from the patient’s previous injection provided the interval
of time since the last injection has not been too long. For
lot changes from the same manufacturer, the physician can
consider decreasing the dose by 50% to 90%. For changes
in manufacturer and nonstandardized extracts, a greater
decrease in dose might be necessary.
SPECIAL CONSIDERATIONS IN
IMMUNOTHERAPY
Allergen immunotherapy in children
Summary Statement 69: Immunotherapy for children is
effective and often well tolerated. Therefore immunotherapy
should be considered (along with pharmacotherapy
and allergen avoidance) in the management of children