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1 Allergy and Lungclinic Helsingør.
Sct. Olai Gade 39 1, 3000 Helsingør, Denmark
2 Allergy and Lungclinic Hellerup, Bernstorffsvej 20,
2900 Hellerup, Denmark
3 Lung and Allergy Clinic Aabenraa, Madevej 11, 6200
Åbenrå, Denmark
4 Specialist Clinic Hellerup, Hans Edvard Teglersvej 9,
2920 Charlottenlund, Denmark
5 Roskilde Hospital, Department of Internal Medicine,
Roskilde, Roskilde Sygehus Køgevej 7-13, 4000 Roskilde,
Denmark |
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Abstract |
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Background and
Objective:
Subcutaneous
allergen-specific
immunotherapy (SCIT)
is an effective
treatment for
patients with
allergic asthma and
rhinitis. SCIT may
be performed in many
different ways and
good safety profiles
have been published.
Other studies,
however, have
reported high
frequencies of
severe adverse
events (SAEs) but
without identifying
the causes. After an
increase in SCIT-related
SAEs in Denmark
between 2003 and
2004, strict
performance
regulations were
imposed by the
authorities. Because
safety data from
national databases
were not available,
we implemented a
surveillance system
aimed at identifying
the causes of SAEs.
Methods: We
prospectively
registered the
number of injections
and SAEs during SCIT.
A slow up-dosing
regimen was used and
adherence to
international
standards was
optimized.
Results: No
SAEs were observed
with 28 992
injections. The
maximal risk per
injection was
calculated at <1.3
per 10 000
injections.
Discussion:
Our results confirm
the good safety
profile of SCIT. We
applied a sentinel
SCIT surveillance
system that may
offer a means of
guaranteeing safety
by providing online
feedback to all
participating
clinics when SAEs
occur in order to
explore their causes
by root course
analyses performed
by all participants.
Furthermore, such
quality assurance
documentation may
facilitate wider
acceptance of SCIT
by health care
administrators,
clinicians, and
patients.
Key words:
Safety. Risk
management. Allergen
immunotherapy. Risk.
Immunotherapies.
Allergen. Sentinel
surveillance
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