[Sentinel surveillance of risk of severe reactions associated with specific immunotherapy. A method for quality assurance of procedures with rare, but serious adverse effects].
BACKGROUND
Whether procedures are "out of control" or "in control" is a central concept in quality assurance. It is essential to stay "in control" concerning treatment. Often this is simple, when risk is known and can be discussed before treatment has been agreed upon. The situation becomes more difficult when a treatment with a well-known risk gets out of control due to an increase in side effects. This happened during 2003, when an increase in notified serious adverse events after specific allergy vaccination (SAV) was observed.


METHODS
A sentinel survey was established in five allergy clinics with experience in SAV. The numbers of monthly side effects and injections were reported, and the results were returned.


RESULTS
No serious reactions were observed, and therefore the maximal risk of a serious reaction was estimated. On the basis of a total of 7,538 injections, of which 44% were grass ALK 225 injections, the maximal risk was < 0.05% for all injections and < 0.1% for antigrass injections (97.5% CI).


CONCLUSIONS
Sentinel surveillance of SAV led to the re-establishment of an "in control" situation. At present the official system for notification of side effects, the Danish Medicines Agency, and the Danish Allergy Society are not able to respond fast enough and adequately enough to gain control of the situation, and we suggest that in all high-risk and high-volume procedures sentinel surveillance should be performed by the doctors close to the patients and in charge of the procedures instead of by a centralised surveillance entity.
Madsen
Flemming F
FF
Allergi- og Lungeklinik, Helsingør. fm@allergia.dk
Frølund
Lars
L
Christensen
Mogens
M
Frost
Andreas
A
Petersen
Ulrik Søes
US
D016907:Adverse Drug Reaction Reporting Systems; D000485:Allergens / Q000009:adverse effects*; D003718:Denmark; D003888:Desensitization, Immunologic / Q000009:adverse effects*; D006801:Humans; D006967:Hypersensitivity / Q000276:immunology / Q000628:therapy*; D007167:Immunotherapy / Q000009:adverse effects*; D011785:Quality Assurance, Health Care / Q000379:methods*; D018570:Risk Assessment / Q000379:methods*; D012307:Risk Factors; D014612:Vaccines / Q000008:administration & dosage / Q000009:adverse effects*
D000485:Allergens; D014612:Vaccines