Consent for Administration of Immunotherapy (Allergy Injections)

Please read and be certain that you understand the following information prior to signing this consent for treatment.

Purpose

The purpose of immunotherapy (allergy injections) is to decrease your sensitivity to allergy-causing substances, so that exposure to the offending allergen (pollen, mold, mites, animal dander, stinging, insects, etc.) will result in fewer and less severe symptoms. This does not mean that immunotherapy is a substitution for avoidance of known allergens or for the use of allergy medications, but rather is a supplement to those treatment measures.

Allergy injections have been shown to lead to the formation of “blocking,” or protective, antibodies and a gradual decrease in allergic antibody levels. These changes may permit you to tolerate exposure to the allergen with fewer symptoms. You, in effect, become “immune” to the allergen. The amount of this immunization is different for each person and is, therefore, somewhat unpredictable.

Indications

For quality immunotherapy, there must be documented allergy to substances in the environment that cannot be avoided. Documentation of allergy can be either in the form of a positive skin test or a positive blood test (RAST/ELISA). In addition to demonstrable allergy on one of the above tests, problems such as hay fever or asthma should occur upon exposure to the suspected allergen, or you may have a history of a severe reaction to an insect sting. Due to the inherent risk of immunotherapy, avoidance measures and medical management should usually be attempted first.

Efficacy

Improvements in your symptoms will not be immediate. It usually requires 3 to 6 months before any relief of allergy symptoms is noted, and it may take 12 to 24 months for full benefits to be evident. About 85-90% of allergic patients on high-dose immunotherapy note significant improvement of their symptoms. This means that symptoms are reduced, although not always completely eliminated.

Procedure

Allergy injections are usually initiated at a very low dose. This dosage is gradually increased on a regular basis (1-2 times per week) until the therapeutic dose (often called the “maintenance” dose) is reached. The maintenance dose will differ from person to person. Injections typically are given once or twice per week while the dose is being increased.  The frequency interval reduces a chance of reaction and permits the maintenance dose to be reached within a reasonable amount of time.

Duration of Treatment

On average, it usually takes 6 months to reach a maintenance dose. The time may be longer if there are vaccine reactions or if the injections are not received on a regular basis. For this reason, it is important that the recommended schedule be followed. If you anticipate that regular injections cannot be maintained, immunotherapy should not be started. Immunotherapy may be discontinued at the discretion of the physician if the injections are frequently missed, as there is an increased risk of reactions under these circumstances. Most immunotherapy patients continue treatments for 3 to 5 years, after which the need for continuation is reassessed.

Adverse Reactions

Immunotherapy is associated with some widely recognized risks.  Risk is present because the substance to which you are known to be allergic is being injected into you. Some adverse reactions may be life-threatening and may require immediate medical attention. In order of increasing severity, the following brief descriptions explain the nature of these potential reactions.

Local Reactions - Local reactions are common and are usually restricted to a small area around the site of the injection. However, they may involve the entire upper body area, with varying degrees of redness, swelling, pain, and itching. These reactions are more likely to occur several hours after the injection. You should notify the nurse if your local reaction exceeds 1.5 inches (30mm) in diameter or lasts until the following day.

Generalized Reactions - Generalized reactions occur rarely, but are the most important because of the potential danger of progression to collapse and death if not treated. These reactions may include:

• UrticCalibri reactions (hives) including varying degrees of rash, swelling, and/or itching of more than one part of the body. There may be mild to moderate discomfort, primarily from the itching. This reaction may occur within minutes-to-hours after an injection.
• Angioedema is rare and is characterized by swelling of any part of the body, inside or out, such as the ears, tongue, lips, throat, intestine; hands, or feet, alone or in any combination. This may occasionally be accompanied by asthma and may progress to the most severe reaction, anaphylactic shock. In the absence of shock, the principal danger lies in suffocation due to swelling of the airways. Angioedema may occur within minutes after the injections and requires medical attention.
• Anaphylactic shock is the rarest complication, but is a serious event characterized by acute asthma, vascular collapse (low blood pressure), unconsciousness, and potentially death. This reaction usually occurs within minutes of the injections and is extremely rare.

The above reactions are unpredictable and may occur with the first injection or after a long series of injections, with no previous warning. All generalized reactions require immediate evaluation and medical intervention. If a localized or generalized reaction occurs, the treatment dosage will be adjusted for subsequent injections. Appropriate advice and management will always be given by our office staff at the time of any adverse reaction.

Observation Period Following Injection

All patients receiving immunotherapy injections must wait in the clinic area for 30 minutes following the first three injections, then as determined by physician/nurse. If you have a reaction, you may be advised to remain in the clinic longer for medical observation and treatment.  If a generalized reaction occurs after you have left the clinic area, you should immediately return to the clinic or go to the nearest medical facility. If you cannot wait the 30 minutes after your injection, you should not receive an immunotherapy injection. There are several allergy injection-related deaths each year in the United States. While most systemic reactions are not life threatening if treated promptly, the fact does stress the importance of remaining in the clinic for the suggested observation time.  If you do not remain in the clinic area for the designated time, the doctor may recommend discontinuation of immunotherapy.

Pregnancy

Females of child bearing potential: If you become pregnant while on immunotherapy, notify the office staff immediately, so that the physician can determine an appropriate dosage schedule for the injections during pregnancy. Immunotherapy doses will not be advanced during pregnancy, but may be maintained at a constant level as long as continuation of immunotherapy is approved in writing by your OB/GYN.

New Medication

Please notify the office staff if you start any new prescription medications, particularly medications for high blood pressure, migraine headaches, and glaucoma. “Beta-blocker” medications are contraindicated while on immunotherapy, and your injections will need to be discontinued while you are taking a Beta-blocker.

Allergy Injection Schedule

Patients need to take an anti-histamine at least 45 minutes-to-1 hour before allergy injection.

If you have any questions concerning anything in this Consent for Immunotherapy, please direct the questions to the nurses or to the physicians. If you wish to begin immunotherapy, please initial each of the first three pages of this document, then sign the Authorization of Treatment below, and return it to our front desk.

Consent for Administration of Immunotherapy (allergy injections) Authorization for Treatment

I have read the information in this consent form and understand it. The opportunity has been provided for me to ask questions regarding the potential risk of immunotherapy, and these questions have been answered to my satisfaction. I understand that precautions consistent with the best medical practice will be carried out to protect me from adverse reactions to immunotherapy (allergy injections) over an extended period of time and specified intervals. I further hereby give authorization and consent for treatment of any reactions that may occur as a result of an immunotherapy injection.

_________________________________________                         _____________________

Print Name of Immunotherapy Patient                                                          Date of Birth

_________________________________________                         _____________________

Patient Signature (or Legal Guardian)                                                           Date of Birth

_________________________________________                         _____________________

Witness                                                                                                          Date Signed

For Office Use Only:

I certify that I have counseled this patient and/or legal authorized legal guardian concerning the information in this Consent for Immunotherapy and that it appears to me that the signee understands understands the nature, risks, and benefits of the proposed treatment plan.

________________________________________                           ______________________

Physician Signature                                                                           Date