PATIENT INFORMATION ON IMMUNOTHERAPY (Allergy Shots

PATIENT INFORMATION ON IMMUNOTHERAPY (Allergy Shots)

AND INFORMED CONSENT FOR TREATMENT- Dr. Michael Vaughn

1. Immunotherapy or “Allergy shots” have been proven beneficial for nasal allergies, asthma,

eczema and stinging insect allergy and may also decrease the incidence of sinus infections.

Allergy shots are typically offered only to allergic patients who have severe symptoms that affect

their quality of life. Most allergic patients do not need allergy shots for treatment of their

symptoms. However, if medications and environmental changes are not sufficient to minimize

symptoms, then allergy shots may be the only effective treatment option available. In persons

who require multiple medications to control their symptoms, allergy shots may also be a cost

saving option.

2. Immunotherapy works by gradually “turning off” allergy to plant pollens, molds, dust mites,

animal dander and insect venom. During the “build-up” process, the allergen is usually injected

two times each week in progressively stronger doses over a 6-month period until the top dose

“maintenance” vial is reached. After reaching the maintenance dose, the time between each

injection can then be increased with the goal of making the routine maintenance shot interval

twice per month. In our office, a 3-year course of allergy shots, given twice per month, typically

results in a complete loss of allergen sensitivity however; an occasional patient may not be

completely “cured” and require more than 3 years of treatment. Unfortunately, up to 50 % of

patients who suffer from Allergic Rhinitis (AR), caused by allergic antibodies (IgE), also suffer

with “Non-allergic Rhinitis” (NAR). NAR is caused by an unusual sensitivity to environmental

irritants such as: tobacco smoke, perfumes, strong chemical odors, diesel fumes, spicy food, dust

and many other irritants. Although the symptoms of NAR are similar to those of AR, NAR will

not improve on allergy shots and NAR symptoms may require medications for control.

3. To obtain the best results, a patient needs to receive maintenance shots twice per month.

Missing shots for more than one month may require a temporary dosage reduction, but missing

shots for more than 6 weeks will typically necessitate a full re-start. Annual skin testing is

recommended to judge the effectiveness of the shots since over time; skin testing reactions are

expected to disappear. The results from each annual skin test are used to modify the doses of

allergens contained in the shots (if necessary). The allergy shots are typically stopped when the

skin testing is negative for more than 1 year to the patient’s main allergy trigger(s).

4. Immunotherapy injections may be associated with various types of side effects. Side-

effects are usually more common in the most severely allergic patients and in those with asthma.

The most common side effect is swelling and inflammation (tenderness) at the injection site.

These “local” reactions almost always improve over time. Allergy shots may occasionally be

associated with more serious generalized “systemic” reactions (anaphylaxis). Signs or

symptoms of these reactions may consist of: itching away from the injection site, hives, body

tissue swelling (distant from the injection site), asthma (new onset coughing, wheezing or chest

tightness), abdominal pains, diarrhea, dizziness and even loss of consciousness. Although our

office is prepared to treat any serious shot reaction that may develop, if the allergic symptoms do

not respond quickly to our treatment, it may be necessary to transport you by EMS to the near-by

Baptist or Methodist Hospital Emergency rooms for further monitoring.

5) Data from large studies has revealed that most serious allergic reactions occurred

within 30 minutes after an injection. For this reason, all patients are required to remain on-

site for 30 minutes after their allergy shot. In May 2015, we looked at the medical records from

all allergy shots we administered in 2014. We found that about 1 out of every 95 patients who

received allergy shots developed a systemic allergic reaction (anaphylaxis).

These reactions usually occurred following a shot administration from the strong 3

or 4

vials.

While these reactions were typically mild and reversed quickly with treatment, severe allergic

reactions resulting in death have occurred following allergy shots. Because serious reactions can

develop hours after a shot, every person receiving allergy shots is required to carry an

epinephrine self-injector on the day of the injection (we will not administer an allergy shot to

anyone who is not carrying their Epipen). “Home” or self-administered allergy shots and

“allergy drops”, offered by some non-Allergist physicians, are typically formulated using much

lower concentrations of allergens than the “in-office” shots given by Allergists. As a result, these

experimental treatments are less effective for symptom control than “full dose” allergy shots and

will typically not cure allergic sensitivities. The FDA has only approved oral (sublingual)

immunotherapy for grass, ragweed and dust mites.

6. “RUSH” allergy shots are available at our office. This treatment option is offered as a

convenience to those who would otherwise have difficulty with the typical build-up schedule.

With RUSH, 7 build-up injections are given in a three-hour session. In our clinical experience,

“RUSH” treatment has been as safe as “conventional” treatment. In a 2004 medical record

review, we found that among 255 patients who had completed “RUSH” with the first 2 build-up

vials, only one allergic reaction occurred. RUSH is currently only available for the 2 weakest

allergen dilution vials. Although “RUSH” build-up can help reach the maintenance dose sooner,

RUSH offers no long-term advantage over our “conventional” slower injection protocol and is

simply a convenience option that reduces the number of office visits. We have found that when

certain medications (Antihistamines, Pepcid and Singulair) were given prior to allergen

injections, these “pre-meds” reduced the frequency (and possibly the severity) of shot-induced

allergic reactions and so we strongly recommend that all persons on allergy shots, even those

choosing the “conventional” build-up protocol, take pre-meds on the day of an allergy shot. For

patients with asthma, using an albuterol inhaler before every allergy shot is recommended.

7. Fees for services: Alamo Allergy and Asthma Associates charge a fee for mixing the bottles

of allergy extract (we purchase our allergens from ALK – Abello). In addition, there is usually a

shot administration fee each time an injection is given. (RUSH-allergy shots are typically billed

as “time in our office” and you are not charged for each individual shot). Your insurance may

require you to pay a co-pay each time you see us for medical care but there is no “office visit”

charge for an allergy shot. Allergy shots are not scheduled; they are given on a walk-in basis as

“first-come-first-served”. Although we are contracted with almost all insurance companies,

coverage for allergy shot treatment varies. You are responsible for understanding the limitations

of your plan. If your insurance benefits change during the process of receiving allergy shots, you

are also responsible for immediately providing us with this updated information. If you choose to

discontinue your allergy shots, there is no refund for any unused portion of the allergen mixture.

* I am requesting to receive Immunotherapy (allergy shots) under the supervision of

Alamo Asthma & Allergy Associates. I have read and understand the risks and benefits of

allergy shots and all questions have been answered to my satisfaction.

Patient Name _______________________________ Date ___________________

Patient Signature____________________________ (Form revised 06/2017)