High Risk Medication - Norm



High Risk Drug

Educational Material and Consent Form

Patient name ________________________ Date of Birth________________________

Name of Medication ______________________________________________________

Name of provider conducting informed consent_________________________________

The facts in this form will help you learn more about the drug your doctor has recommended. Please read it carefully. You will be asked to sign the last page of this form and a copy of the consent will be given to you.

Your Health Problem

You have a specific health problem for which your doctor has prescribed a drug.

____________________ (name of drug) is a high risk drug. Your health and safety depend on:

• your cooperation with laboratory testing,

• following your doctor’s recommendations, and

• properly taking this drug.

If you agree to take this drug, you must be willing to have the needed laboratory tests to check your blood levels, and you must take the drug as directed by your doctor. Your doctor will examine you for Tuberculosis and perform a test to see if you have Tuberculosis. This test will be performed yearly while taking this medication.

Risks and Common Problems

It is important that you know the risks of taking this drug. Your doctor will talk about these with you. Some of the risks and common problems include, but are not limited to:

• Serious Infections: Please tell your doctor if you have any of the following signs of infection: fever, feeling very tired, have a cough, and have flu like symptoms, warm, red or painful skin.

• Liver Injury: Tell your doctor if you have jaundice (skin and eyes turning yellow), dark brown colored urine, pain on the right side of your stomach area, fever and extreme tiredness.

• Blood problems: Please tell your doctor if you have a fever that does not go away, bruise or bleed very easily or look very pale.

• Nervous System Disorders: Tell your doctor if you have changes in your vision, weakness in your arms and or legs, numbness or tingling in any part of your body or seizures.

• Allergic Reactions: Signs of an allergic reaction can include: hives (red, raised, itchy patches of skin), difficulty breathing, chest pain, high or low blood pressure, fever and chills

• High Risk Drugs that affect the immune system may increase the risk of certain cancers. Tell your health care provider if you have ever had any type of cancer.

• Actemra Only: Tears (perforation) of the stomach or intestines. Tell your health care provider right away if you have fever and stomach area pain that does not go away and a change in your bowel habits.

Other Choices

If you choose not to take this drug, your doctor will tell you about any other choices for treatment. How well any other treatment works will depend on your specific health problem. Some of the other choices:

________________________________________________________________________

________________________________________________________________________

How well any other treatment works will depend on your specific health problem.

More Facts

Monitoring

Regular blood tests will be required while you are taking this drug. Your doctor may change your dose after reviewing the results of these tests. It is very important that you keep all of your appointments for testing.

It is important to let your doctor or nurse know if you have had any changes in your medical history, surgeries or changes in medications.

Patient Agreement

By signing the final page of this form, you agree that you understand the following:

• You must have regular blood tests while taking the prescribed drug.

• Missed blood tests can result in problems with your medical condition.

• You must travel to the office for appointments and regular blood tests.

• You must tell the doctor or nurse about all of the drugs you are taking, including over-the-counter drugs and any herbal medicines.

• You must tell your doctor if you plan to take any vaccines. No live vaccines should be given while taking this medication.

• If you are pregnant or planning to become pregnant or breast feeding please inform you doctor before starting this medication.

Consent to Treatment

____Patient Initial The first two (2) pages of this form told you the risks, likely results, other choices, and problems that could happen with __________. If, after you have read and reviewed this form with your doctor, you do not believe that you really understand the risks, likely results, other choices, and possible problems of __________ , do not sign the form until all your questions have been answered.

Because of my special health problem, these extra risks have also been explained to me:

 none  list: ________________________________________________________________________

________________________________________________________________________

I have these allergies:  none  list: ________________________________________________________________________

________________________________________________________________________

I understand all the facts given to me in the first two (2) pages of this form. A copy of the patient medication guide for ___________ has been provided to me. I now give my consent to Dr. _____________ and his/her associates to prescribe __________ for me. I prove with my signature below that my doctor has discussed all of the facts in this form with me, that I have had the chance to ask questions, and that all of my questions have been answered.

___________________________________ __________________

Signature of Patient or Responsible Party Date and Time

___________________________________ ___________________

Witness Date and Time

Physician

I confirm with my signature that I have given the patient two (2) pages of educational material and have discussed with the above-named patient the risks, likely results, other choices, and possible problems of __________. The patient has had the chance to ask questions, all questions have been answered, and he or she has expressed understanding. Thus informed, the patient has asked that __________ be prescribed for him or her.

___________________________________ __________________

Physician Signature Date and Time

___________________________________ ___________________

Witness Date

** Please understand that our infusion suite has very limited space therefore there will be absolutely no visitors, family members or children allowed in the treatment room with you during your infusion. **

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