Allergy Testing and Treatment Safety
Direct Allergy understands the concerns of physicians considering adding allergy testing and treatment to their practice. Allergy testing and immunotherapy have been around since 1911 and have benefited many patients since their discovery. Direct Allergy utilizes the Modified Quantitative Testing Protocol (MQT) which blends the skin-prick and intradermal testing (IDT) into a single, simple, safe testing method.1 Direct Allergy brings almost 40 years of clinical expertise and oversight the field of allergy testing and treatment.
A report from the Mayo Clinic on 79,593 immunotherapy injections over a 10-year period showed the incidence of adverse reactions to be less than two-tenths of 1 percent (0.137 percent). Most of the reactions were mild and responded to immediate medical treatment. There were no fatalities.2 More than 1 million injections were given without a fatality to 8,706 patients in allergy clinics at Roosevelt Hospital, New York City, between 1935 and 1955.3
Nevertheless, rare occurrences of fatal anaphylactic episodes related to immunotherapy continue to be reported and studied. A total of 35 deaths following immunotherapy administration were reported for the years 1985 through 1993. It has been estimated that during that period there were 52.3 million immunotherapy procedures, making the incidence of fatality less than one per million (0.6692 per million).4 Data recently compiled by the Allergen Products Manufacturers Association (APMA) estimated the incidence of fatalities to be about three per 190 million annual injections, or approximately one per 63 million injections.5 Another study evaluating 13 international fatalities related to immunotherapy between 1992 and 1996 identified an elevated risk for patients with active asthma and being switched to high doses.6 For perspective, it is useful to compare these statistics with the incidence of fatalities related to other kinds of injections. Studies of fatal anaphylaxis reactions to injected penicillin have ranged from 0.4 fatalities per million injections7 to 1 fatality per 7.5 million injections.8 Fatalities related to radiocontrast “dyes” used in intravascular radiologic studies in the early 1980s varied from 1 in 13,000 procedures9 to 1 in 75,000 procedures.10 A more recent study showed a substantial improvement to about 1 fatality in 169,000 procedures.11
Primary care physicians have been seeing allergy patients since medicine started and have been testing and treating them nearly as long. Currently about 15% of all allergy testing and treatment is done by primary care physicians. There is a predicted 4.5% decrease in allergists coming out of fellowships and an increase in patient demand of around 35%, so there will be a large clinical gap left unfilled if primary care physicians do not provide allergy testing and treatment services. Many of the antigen manufactures have a large number of clients who are primary care physicians and there are organized medical societies dedicated solely the training of primary care physicians in the field of allergy. The key to safety is training and oversight. Direct Allergy provides physician training through its chief medical officer and national nurse trainer. The nurses go through a comprehensive training protocol and are constantly being monitored and observed by the clinical faculty. Utilizing the MQT testing protocol combined with a vial safety test for each vial the potential for adverse reactions is greatly diminished. The nurses are highly trained to be aware of patients who may not be suitable candidates for testing and treatment. Direct Allergy clients always have access to clinical oversight should the need arise. We provide a partnership that helps you safely manage the allergy patients in your practice. Primary care often utilizes third-parties to provide ancillary services in their offices. Cardiac stress testing, imaging services, physical therapy, and cosmetic services are just a few. The protocol and clinical oversight provided by Direct Allergy falls in line with the safety profile of other ancillary services.
There are inherent risks in all aspects of medicine. Direct Allergy provides a safe and effective product to treat your allergy patients. You can rest assured you are in good hands with Direct Allergy.
1) Quantitative Skin Testing for Allergy : IDT and MQT, Marple and Mabry, August 2006
2) Valyaservi MA, Yocum MW, Gosselin VA, Hunt LW. Systemic reactions to immunotherapy at the Mayo Clinic. J Allergy Clin Immunol 1997; 99:S66.
3) Van Arsdel PP, Sherman WB. The risk of inducing constitutional reactions in allergic patients. J Allergy 1957; 28:251-261.
4) 10. Turkeltaub P. Deaths associated with allergenic extracts. FDA Medical Bulletin 24, May 1994.
5) 11. Data on file with the Allergen Products Manufacturers Association. April 1997 Communication.
6) 12. Kordash T, Miller J. Allergenic extracts used in immunotherapy fatalities. J Allergy Clin Immunol 1997; 99:S67.
7) 13. Orange RP, Donsky GJ. Anaphylaxis. In Middleton E, Reed CE, Ellis EF, editors. Allergy: principles and practice. St. Louis 1978, Mosby.
8) 14. Idsoe O, Gruthe T, Wilcox RR, et al. Nature and extent of penicillin side-reactions with particular references to fatalities from anaphylactic shock. Bull WHO 1968; 38:159.
9) 15. Shehadi WH. Death following intravascular administration
10) 16. Hartman GW, Hattery RR, Witten DM, Williamson B. Mortality during excretory urography: Mayo Clinic Experience. AJR 1982; 139:919-922.
11) 17.Katayama H, Yamaguchi K, Kozuka T, et al. Reactions to ionic and nonionic contrast media: A report from the Japanese Committee on the Safety of Contrast Media. Radiology 1990; 175:621-628