PATIENT CONSENT FORM FOR COVID-19 TREATMENT PURPOSE OF INFORMED CONSENT (PAXLOVID)
As your medical provider has discussed with you, you have been diagnosed with COVID-19 (or SARS-CoV-2) or are at high risk after exposure to COVID-19. At the present time, there are few Food and Drug Administration (FDA) approved, or clinically proven therapies for treatment of COVID-19. As new clinical data emerges, local treatment guidelines have been developed and will be updated as new information becomes available. CDC guidelines reflect what is known about therapies that may work against the SARS-CoV-2 virus, have been used to treat other coronaviruses, or may theoretically target the underlying causes of virus-related severe lung conditions that make breathing difficult.
The FDA has granted Emergency Use Authorization (EUA) to permit investigational therapies in patients with confirmed or suspected COVID-19. Investigational therapies are not approved for any indication. They are authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. If checked below and signed, you consent to the use under this authorization.
TREATMENT
In order for you to be treated with the therapy by the pharmacy team, you must sign this form to show that you agree to the use of investigational or off-label treatments, and that you have been informed of the benefits and risks of taking such therapies as well as the benefits and risks of declining or refusing such use. You will be provided a patient informational handout regarding the specific antiviral before the therapy begins. You have the right to refuse to take this treatment(s) for any reason.
BACKGROUND
PAXLOVID is an investigational treatment of mild-to-moderate COVID-19 in adults and children[12 years of age and older weighing at least 88 pounds (40 kg)] with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.The FDA has issued an Emergency Use Authorization (EUA) to permit the use of this unapproved medication. Clinical trials are ongoing to study its safety and efficacy.
POSSIBLE BENEFITS
It is possible that the medication listed above may help to control your symptoms, slow or stop the growth of the virus, shorten the duration or lessen the severity of the illness in you. Possible benefits primarily include improvement in lung function (ability to breathe without assistance) and normalization of blood pressure. However, there is the possibility that this medication may be of NO direct medical benefit to you. Your condition may get worse.
POSSIBLE RISKS AND KNOWN SIDE EFFECTS
It is possible that the medication prescribed may not improve your symptoms and not shorten the duration nor severity of the illness. It is possible that the medication will unexpectedly interfere with your ability to improve, hasten damage to the lungs or other organs, and shorten your life.
List side effects/risks: dysgeusia (taste disorder), diarrhea, hypertension, myalgia (muscle pain)
Serious side effects: anaphylaxis
CERTIFICATION AND SIGNATURES
I have read this informed consent form and all of my questions have been answered to my satisfaction by my physician/pharmacy team. I understand that I have the right to refuse to take this medication(s) for any reason. If I choose not to take this medication(s), this decision will not otherwise affect my status as a patient. I voluntarily consent to take the antiviral medication as discussed with my physician and pharmacy team members as described in this consent form.
I also acknowledge that I've been provided with the electronic version of the FDA EUA information for Paxlovid.
CONSENT
The FDA has granted Emergency Use Authorization (EUA) to permit investigational therapies in patients with confirmed or suspected COVID-19. Investigational therapies are not approved for any indication. They are authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. If checked below and signed, you consent to the use under this authorization.
I have read and had explained to me the benefits versus risk of the above therapy. I am capable of making an informed decision and voluntarily grant consent, without coercion or duress to accept therapy.