Direct Allergy Safety Standards
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 (MQT) Protocol, which blends skin-prick and intradermal testing (IDT) into a single, simple, safe testing method.Direct Allergy brings almost 40 years of clinical expertise and oversight to 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.More than 1 million injections were given without a fatality to 8,706 patients in allergy clinics at Roosevelt Hospital in New York City between 1935 and 1955.
Rare occurrences of fatal anaphylactic episodes related to immunotherapy are 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 1 per million (0.6692 per million). Data recently compiled by the Allergen Products Manufacturers Association (APMA) estimated the incidence of fatalities to be about 3 per 190 million annual injections, or approximately 1 per 63 million injections.
Another study evaluating 13 international fatalities related to immunotherapy between 1992 and 1996 identified an elevated risk for patients with active asthma who are being switched to high doses. 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 injections to 1 fatality per 7.5 million injections. Fatalities related to radiocontrast “dyes” used in intravascular radiologic studies in the early 1980s varied from 1 in 13,000 procedures to 1 in 75,000 procedures. A more recent study showed a substantial improvement to about 1 fatality in 169,000 procedures.
Primary care physicians have been seeing allergy patients since medicine started and have been testing and treating them nearly as long. Currently, primary care physicians do about 15 percent of all allergy testing and treatment. There is a predicted 4.5 percent decrease in allergists coming out of fellowships and an increase in patient demand of around 30 percent, 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 manufacturers have a large number of clients who are primary care physicians, and they’ve organized medical societies dedicated solely to 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 comprehensive training protocol and are constantly being monitored and observed by the clinical faculty. Utilizing the MQT testing protocol, combined with a 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.
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.