Covid 19 has enormously impacted our health, economy, and way of life with all of the restrictions and guidelines we need to follow to prevent widespread infection. Many people became very sick around the world. Fortunately, we are past the worst of the pandemic, with almost everything returning to normal. Unfortunately, many people are still infected with Covid 19, with minor sicknesses and a small minority who become quite ill.
Various vaccines were developed and approved by the FDA for administration to the general public to build immunity to the Covid-19 virus. Not all individuals can receive a vaccine due to unrelated health issues. Some individuals do not want to receive a vaccine. Evusheld was developed as a pre-exposure prophylaxis for the prevention of coronavirus disease. Before being administered Evusheld, patients were asked to review and sign an Evusheld consent form.
In addition, the Covid-19 virus has evolved, and since Evusheld is targeted at the initial virus, it is no longer viewed as an effective treatment for Covid variants by the FDA as of Jan 26, 2023.
What Is Evusheld Consent Form?
The Evusheld consent form is used to capture patient information, act as a pre-screening tool and ensure that potential patients understand the medical information about Evusheld. The FDA Emergency Use Authorization fact sheet is provided to patients for their information. The consent form confirms that they have read this document or had the details explained to them.
The consent form also confirms that the patient accepts this medication’s known benefits and risks. Finally, the patient signs the consent form acknowledging they have read it and are consenting to treatment.
Why is Evusheld Consent Form Important?
The Evusheld consent form is important for the patient and the medical staff administering the medication.
- Patient contact information is captured
- Patients are screened to ensure they are eligible to receive Evusheld
- Patients are made aware of the current level of approval by the FDA
- They are made aware of the potential risks and benefits of the treatment
- Patients are provided medical information about Evusheld they can use to make decisions regarding their health care treatment
- Medical staff are protected to some degree by the patient taking responsibility and accountability for their health care treatment
Essential Elements of an Evusheld Consent Form
The following essential elements of an Evusheld consent form should contain the following information:
- Patient contact details – full name, date of birth, gender, full address, phone number, and email address
- Screening questions to identify patients who should not receive the treatment
- Someone who has had Covid recently, tested positive, has symptoms, has been recently exposed, or is receiving treatment for Covid must be assessed to determine if they are eligible for treatment with Evusheld.
- Confirmation, the patient has all of the details needed to make decisions about their healthcare options and treatment
- Have read the FDA Emergency Use Authorization Fact sheet for patients, caregivers, and parents
- They are aware of the current FDA approval status
- They have had an opportunity to ask questions about the known risks and benefits associated with treatment using Evusheld
- Understanding the treatment schedule
- Signature of the patient and date the consent form is signed
- Indication of who is signing the consent form
- Legal guardian
- Legal representative or
The information and details contained in this document are provided as an educational aid only.
It is not provided as medical advice for personal conditions or treatment. It does not replace a medical exam or the services medical professionals provide. Discuss treatment plans with your doctor, nurse practitioner, or pharmacist before taking any medication or over-the-counter drugs.
Only your medical doctor, nurse practitioner, or pharmacist can advise on what is safe and effective.
This document makes no representation or warranty regarding the accuracy, usefulness, reliability, timeliness, or completeness of any information contained or implied in the products.
The following questions are some of the frequently asked questions many of our readers have about the Evusheld consent form.
Anyone about to receive Evusheld treatment must sign the consent form, or their legal guardian or parent must sign on their behalf.
The Evusheld consent form is considered a legal document designed to ensure communication between the patient and healthcare provider. It protects both the patient and the provider. All questions must be answered truthfully, and the benefits/risks must be understood by the patient.
Some Evusheld consent forms may request a detailed health history, including information about opioid abuse or other addictions. Many consent forms may not request these details.
However, it is in the patient’s best interest to discuss their full health status, including addictions and other health issues such as high blood pressure, asthma, bronchitis, etc., with their healthcare provider. Your healthcare provider can assess your overall health to determine if it is safe to administer Evusheld to you, considering known side effects and associated risks.
There are no known negative identified issues associated with taking Evusheld during pregnancy or breastfeeding. However, since this treatment is new and being further investigated by the FDA and other medical institutions, pregnant patients and those who are breastfeeding should check the latest recommendations on this issue. Your healthcare team, including your family doctor, can provide the latest information available concerning this treatment.
The Covid-19 virus has evolved, and Evusheld is no longer viewed as an effective treatment for Covid variants by the FDA as of Jan 26, 2023. Note: Covid variants are statistically responsible for 90% of current infections in the United States. The action and decision by the FDA are aimed at limiting patient exposure to potential side effects of Evusheld, such as allergic reactions in a small number of patients.
Patients contemplating Evusheld as a treatment for the prevention of Covid should review the current status and recommendations from FDA.
The Evusheld consent form is intended to screen patients who could be better candidates for treatment with Evusheld and ensure they are informed about the risks and benefits. In particular, patients are encouraged to review the FDA Emergency Use Authorization Fact sheet for Evusheld.
They should also review all questions they may have regarding treatment, the benefits and risks, and the effectiveness of the treatment concerning the various variants of Covid-19.
Patients considering Evusheld or any other Covid treatment should always discuss their current health issues and treatment plans with their healthcare provider to avoid potential drug interactions and side effects.