This document is serves as Valley Health Systems (VHS) informed consent for telehealth services.

Telehealth is offered to improve access to services at Valley Health. Telehealth is the delivery of healthcare services when the healthcare provider and patient are not in the same physical location through the use of technology. Electronically transmitted information may be used for screening, diagnosis, therapy, follow-up, and/or patient education and may include both patient medical records, as well as medical images. The results of telehealth cannot be guaranteed or assured.

All aspects of Valley Health’s informed consent for treatment apply to these services.

Please note:

• You are not required to use telehealth and have the right to request other service options or referrals or withdraw this consent at any time without affecting your right to future care or treatment at Valley Health.
• Telehealth may not be appropriate, or the best choice of services for a variety of reasons
• You have the right to request documentation regarding all transmitted medical information

All systems will incorporate network and software security protocol to protect the confidentiality of patient identification, including measures to safeguard the data and ensure its integrity against intentional or unintentional corruption. Telehealth services are conducted and documented in a confidential manner according to applicable laws in similar ways as in-person services.  There are, however, additional risks including:

• Sessions could be disrupted, delayed, or communications distorted due to technical failures.
• Telehealth involves alternative forms of communication that may reduce visual and auditory cues and increase the likelihood of misunderstanding one another.
• Your provider may determine that telehealth is not an appropriate treatment option
• In rare cases security protocols could fail and your confidential information could be accessed by unauthorized persons.

Valley Health Systems works to reduce these risks by only using secure videoconferencing software.  Should there be technical problems with video conferencing, the most reliable backup plan is contact by phone.

If your health care costs may be paid or partly paid by Medicare, Medicaid, or a health insurance plan, Valley Health will disclose to the payer such treatment information as it is necessary for payment. If you are under the age of 18, your parents or guardians may receive health care information about you from Medicaid or the insurance company or the plan under which you are covered. The circumstances under which we are required or authorized to share your health information with persons outside the VH workforce are outlined in the NOPP.  I understand that it is my responsibility to provide Valley Health Systems with my insurance/medical card information and that this information will be used in order to bill for Telehealth services rendered. The Telehealth visit is the patient responsibility, and payment in full is expected upon receiving billing statements.

AUTHORIZATION TO PAY BENEFITS TO PHYSICIAN: I authorize payment directly to Valley Health.
AUTHORIZATION TO RELEASE MEDICAL INFORMATION: I authorize Valley Health to release any information acquired in the course of Telehealth services in order to facilitate care or payment.

The person giving consent (patient or parent/guardian) has capacity to consent for medical treatment.

I have read and understand the above information and all my questions have been answered.  I hereby give informed consent to use telehealth in my care. This form is valid for one year from date of signature and must be updated annually or if any information changes.

Complete Informed Consent Form for Telehealth Services

• This document is to serve as an addendum to the Valley Health Systems (VHS) behavioral health informed consent form and does not replace it.  All aspects of informed consent for treatment in that document apply to telemental health (TMH) treatment.  TMH refers to psychotherapy/counseling sessions that occur via phone or video conferencing using a variety of technologies.  TMH is offered to improve access to psychotherapy/counseling services to Valley Health patients when significant barriers of travel to another clinic exist.  However, the results of TMH cannot be guaranteed or assured.  You are not required to use TMH and have the right to request other service options or referrals or withdraw this consent at any time without affecting your right to future care or treatment at Valley Health.  TMH services may not be appropriate, or the best choice of service for reasons including, but not limited to: heightened risk of harm to oneself or others, active psychosis, active intoxication on drugs or alcohol, difficulty with communications technology, significant communication service disruptions, or need for more intensive mental health services.  In these cases, your therapy provider will help you establish referrals to other appropriate services.

TMH services are conducted and documented in a confidential manner according to applicable laws in similar ways as in-person services.  There are, however, additional risks including:

• Sessions could be disrupted, delayed, or communications distorted due to technical failures.
• TMH involves alternative forms of communication that may reduce visual and auditory cues and increase the likelihood of misunderstanding one another.
• Your therapy provider may determine that TMH is not an appropriate treatment option or stop TMH treatment at any time if your condition worsens, does not improve over time or if TMH presents barriers to good care.
• In rare cases security protocols could fail and your confidential information could be accessed by unauthorized persons.

Valley Health Systems works to reduce these risks by only using secure videoconferencing software.  Should there be technical problems with video conferencing, the most reliable backup plan is contact by phone.  You will be able to utilize an office phone at the Valley Health clinic from which you receive TMH services.  If there are also outages with the phone lines, you may have to be rescheduled either later that day, if schedules permit, or for a different day.

As there are inherent risks to mental illness and its treatment, the following are recommended in times of medical emergency or extreme emotional distress.

• Contact 911 and/or proceed to the nearest emergency room. I, my partner, Medical Power of Attorney, next of kin, or closest associate will inform the emergency personnel of any medications that I am taking, of all outpatient treatments that I am engaged in, as well as any history of unsafe behaviors, as this information is critical in managing psychiatric emergencies.
• If I believe I am experiencing extreme psychological distress and am contemplating suicide or homicide, I will call 911, and/or present to the nearest emergency room, or inpatient facility such as River Park Hospital in Huntington, Charleston Area Medical Center in Charleston, or Highland Hospital in Charleston. I understand that the Valley Health System office locations are not equipped to handle psychiatric safety emergencies, as these require a higher level of care. I have also been provided with crisis phone numbers by my therapy provider to call in times of crisis.
• If I need to speak to a Valley Health provider after hours I may call the office and be transferred to an answering service. The answering service will contact the provider on call. This provider will have access to my health records and will work to resolve my need. The provider on call may recommend that I seek additional services by following up with my physician or in emergency situations, recommend I seek emergency medical care.  I understand that this provider will NOT be a behavioral health specialist, and while addressing any urgent emergencies, they may defer any treatment decisions to my regular mental health provider on the next business day.

If your health care costs may be paid or partly paid by Medicare, Medicaid, or a health insurance plan, Valley Health will disclose to the payer such treatment information as it is necessary for payment. If you are under the age of 18, your parents or guardians may receive health care information about you from Medicaid or the insurance company or the plan under which you are covered. The circumstances under which we are required or authorized to share your health information with persons outside the VH workforce are outlined in the NOPP.  I understand that it is my responsibility to provide Valley Health Systems with my insurance/medical card information and that this information will be used in order to bill for Telehealth services rendered. The Telehealth visit is the patient responsibility, and payment in full is expected upon receiving billing statements.

AUTHORIZATION TO PAY BENEFITS TO PHYSICIAN: I authorize payment directly to Valley Health.
AUTHORIZATION TO RELEASE MEDICAL INFORMATION: I authorize Valley Health to release any information acquired in the course of Telehealth services in order to facilitate care or payment.

The person giving consent (patient or parent/guardian) has capacity to consent for medical treatment.

I have read and understand the above information and all my questions have been answered.  I hereby give informed consent to use Telemental Health in my care. This form is valid for one year from date of signature and must be updated annually or if any information changes.

Complete Informed Consent Form for Telemental Health Services

This document serves as the Valley Health Systems (VHS) informed consent for teledental services.

Teledentistry is offered to improve access to services at Valley Health. Teledentistry is the delivery of dental services when the healthcare provider and patient are not in the same physical location through the use of technology. Electronically transmitted information may be used for emergency and/or patient education and may include both patient dental records, as well as dental images (not including X-rays). The results of teledentistry cannot be guaranteed or assured.

All aspects of Valley Health’s informed consent for treatment apply to these services.

Please note:

• You are not required to use teledentistry and have the right to request other service options or referrals or withdraw this consent at any time without affecting your right to future care or treatment at Valley Health.
• Teledentistry may not be appropriate, or the best choice of services for a variety of reasons
• You have the right to request documentation regarding all transmitted dental information

All systems will incorporate network and software security protocols to protect the confidentiality of patient identification, including measures to safeguard the data and ensure its integrity against intentional or unintentional corruption. Teledentistry services are conducted and documented in a confidential manner according to applicable laws in similar ways as in-person services.  There are, however, additional risks including:

• Sessions could be disrupted, delayed, or communications distorted due to technical failures.
• Teledentistry involves alternative forms of communication that may reduce visual and auditory cues and increase the likelihood of misunderstanding one another.
• Your provider may determine that teledentistry is not an appropriate treatment option
• In rare cases security protocols could fail and your confidential information could be accessed by unauthorized persons.

Valley Health Systems works to reduce these risks by only using secure videoconferencing software.  Should there be technical problems with video conferencing, the most reliable backup plan is contact by phone.

If your health care costs may be paid or partly paid by Medicaid, or a health insurance plan, Valley Health will disclose to the payer such treatment information as it is necessary for payment. If you are under the age of 18, your parents or guardians may receive health care information about you from Medicaid or the insurance company or the plan under which you are covered. The circumstances under which we are required or authorized to share your health information with persons outside the VH workforce are outlined in the NOPP.  I understand that it is my responsibility to provide Valley Health Systems with my insurance/medical card information and that this information will be used in order to bill for Teledentistry services rendered. The Telehealth visit is the patient responsibility, and payment in full is expected upon receiving billing statements. This includes sliding fee patients.

AUTHORIZATION TO PAY BENEFITS TO DENTIST: I authorize payment directly to Valley Health.

AUTHORIZATION TO RELEASE DENTAL INFORMATION: I authorize Valley Health to release any information acquired in the course of Teledentistry services in order to facilitate care or payment.

The person giving consent (patient or parent/guardian) has capacity to consent for medical treatment.

I have read and understand the above information and all my questions have been answered.  I hereby give informed consent to use teledentistry in my care. This form is valid for one year from date of signature and must be updated annually or if any information changes.

Complete Informed Consent for Teledentistry Services

What is the most important information I should know about molnupiravir?
Molnupiravir may cause serious side effects, including:

• Molnupiravir may cause harm to your unborn baby. It is not known if molnupiravir will harm your baby if you take molnupiravir during pregnancy.
  • Molnupiravir is not recommended for use in pregnancy.
  • Molnupiravir has not been studied in pregnancy. Molnupiravir was studied in pregnant animals only. When molnupiravir was given to pregnant animals, molnupiravir caused harm to their unborn babies.
  • You and your healthcare provider may decide that you should take molnupiravir during pregnancy if there are no other COVID-19 treatment options authorized by the FDA that are accessible or clinically appropriate for you.
  • If you and your healthcare provider decide that you should take molnupiravir during pregnancy, you and your healthcare provider should discuss the known and potential benefits and the potential risks of taking molnupiravir during pregnancy.

For individuals who are able to become pregnant:

• You should use a reliable method of birth control (contraception) consistently and correctly during treatment with molnupiravir and for 4 days after the last dose of molnupiravir. Talk to your healthcare provider about reliable birth control methods.
• Before starting treatment with molnupiravir your healthcare provider may do a pregnancy test to see if you are pregnant before starting treatment with molnupiravir.
• Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with molnupiravir.

Pregnancy Surveillance Program:

• There is a pregnancy surveillance program for individuals who take molnupiravir during pregnancy. The purpose of this program is to collect information about the health of you and your baby. Talk to your healthcare provider about how to take part in this program.
• If you take molnupiravir during pregnancy and you agree to participate in the pregnancy surveillance program and allow your healthcare provider to share your information with Merck Sharp & Dohme, then your healthcare provider will report your use of molnupiravir during pregnancy to Merck Sharp & Dohme Corp. by calling 1-877-888-4231 or pregnancyreporting.msd.com.

For individuals who are sexually active with partners who are able to become pregnant:

• It is not known if molnupiravir can affect sperm. While the risk is regarded as low, animal studies to fully assess the potential for molnupiravir to affect the babies of males treated with molnupiravir have not been completed. A reliable method of birth control (contraception) should be used consistently and correctly during treatment with molnupiravir and for at least 3 months after the last dose. The risk to sperm beyond 3 months is not known. Studies to understand the risk to sperm beyond 3 months are ongoing. Talk to your healthcare provider about reliable birth control methods. Talk to your healthcare provider if you have questions or concerns about how molnupiravir may affect sperm.

You are being given this fact sheet because your healthcare provider believes it is necessary to provide you with molnupiravir for the treatment of adults with mild-to-moderate coronavirus disease 2019 (COVID-19) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 including hospitalization or death, and for whom other COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate.

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to make molnupiravir available during the COVID-19 pandemic (for more details about an EUA please see “What is an Emergency Use Authorization?” at the end of this document). Molnupiravir is not an FDA-approved medicine in the United States. Read this Fact Sheet for information about molnupiravir. Talk to your healthcare provider about your options if you have any questions. It is your choice to take molnupiravir.

What is COVID-19?

COVID-19 is caused by a virus called a coronavirus. You can get COVID-19 through close contact with another person who has the virus.

COVID-19 illnesses have ranged from very mild-to-severe, including illness resulting in death. While information so far suggests that most COVID-19 illness is mild, serious illness can happen and may cause some of your other medical conditions to become worse. Older people and people of all ages with severe, long lasting (chronic) medical conditions like heart disease, lung disease and diabetes, for example seem to be at higher risk of being hospitalized for COVID-19.

What is molnupiravir?

Molnupiravir is an investigational medicine used to treat mild-to-moderate COVID-19 in adults:

• with positive results of direct SARS-CoV-2 viral testing, and
• who are at high risk for progressing to severe COVID-19 including hospitalization or death, and for whom other COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate.

The FDA has authorized the emergency use of molnupiravir for the treatment of mild-tomoderate COVID-19 in adults under an EUA. For more information on EUA, see the “What is an Emergency Use Authorization (EUA)?” section at the end of this Fact Sheet.

Molnupiravir is not authorized:

• for use in people less than 18 years of age.
• for prevention of COVID-19.
• for people needing hospitalization for COVID-19.
• for use for longer than 5 consecutive days.

What should I tell my healthcare provider before I take molnupiravir?

Tell your healthcare provider if you:

• Have any allergies
• Are breastfeeding or plan to breastfeed
• Have any serious illnesses
• Are taking any medicines (prescription, over-the-counter, vitamins, or herbal products).

How do I take molnupiravir?

• Take molnupiravir exactly as your healthcare provider tells you to take it.
• Take 4 capsules of molnupiravir every 12 hours (for example, at 8 am and at 8 pm)
• Take molnupiravir for 5 days. It is important that you complete the full 5 days of treatment with molnupiravir. Do not stop taking molnupiravir before you complete the full 5 days of treatment, even if you feel better.
• Take molnupiravir with or without food.
• You should stay in isolation for as long as your healthcare provider tells you to. Talk to your healthcare provider if you are not sure about how to properly isolate while you have COVID-19.
• Swallow molnupiravir capsules whole. Do not open, break, or crush the capsules. If you cannot swallow capsules whole, tell your healthcare provider.
• What to do if you miss a dose:
  • If it has been less than 10 hours since the missed dose, take it as soon as you remember.
  • If it has been more than 10 hours since the missed dose, skip the missed dose and take your dose at the next scheduled time.
• Do not double the dose of molnupiravir to make up for a missed dose.

What are the important possible side effects of molnupiravir?
Possible side effects of molnupiravir are:

• See, “What is the most important information I should know about molnupiravir?”
• diarrhea
• nausea
• dizziness

These are not all the possible side effects of molnupiravir. Not many people have taken molnupiravir. Serious and unexpected side effects may happen. This medicine is still being studied, so it is possible that all of the risks are not known at this time.

What other treatment choices are there?

Like molnupiravir, FDA may allow for the emergency use of other medicines to treat people with COVID-19. Go to https://www.fda.gov/emergency-preparedness-and-response/mcm-legalregulatory-and-policy-framework/emergency-use-authorization for more information.

It is your choice to be treated or not to be treated with molnupiravir. Should you decide not to take it, it will not change your standard medical care.

What if I am breastfeeding?

Breastfeeding is not recommended during treatment with molnupiravir and for 4 days after the last dose of molnupiravir. If you are breastfeeding or plan to breastfeed, talk to your healthcare provider about your options and specific situation before taking molnupiravir.

How do I report side effects with molnupiravir?

Contact your healthcare provider if you have any side effects that bother you or do not go away.

Report side effects to FDA MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088 (1- 800-332-1088).

How should I store molnupiravir?

• Store molnupiravir capsules at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep molnupiravir and all medicines out of the reach of children and pets.

How can I learn more about COVID-19?

• Ask your healthcare provider.
• Visit www.cdc.gov/COVID19
• Contact your local or state public health department
• Call Merck Sharp & Dohme at 1-800-672-6372 (toll free in the U.S.)
• Visit www.molnupiravir.com

What Is an Emergency Use Authorization (EUA)?

The United States FDA has made molnupiravir available under an emergency access mechanism called an Emergency Use Authorization (EUA) The EUA is supported by a Secretary of Health and Human Service (HHS) declaration that circumstances exist to justify emergency use of drugs and biological products during the COVID-19 pandemic. Molnupiravir for the treatment of mild-to-moderate COVID-19 in adults with positive results of direct SARS-CoV-2 viral testing, who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by FDA are not accessible or clinically appropriate, has not undergone the same type of review as an FDA-approved product. In issuing an EUA under the COVID-19 public health emergency, the FDA has determined, among other things, that based on the total amount of scientific evidence available including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that the product may be effective for diagnosing, treating, or preventing COVID-19, or a serious or life-threatening disease or condition caused by COVID19; that the known and potential benefits of the product, when used to diagnose, treat, or prevent such disease or condition, outweigh the known and potential risks of such product; and that there are no adequate, approved, and available alternatives.

All of these criteria must be met to allow for the product to be used in the treatment of patients during the COVID-19 pandemic. The EUA for molnupiravir is in effect for the duration of the COVID-19 declaration justifying emergency use of molnupiravir, unless terminated or revoked (after which molnupiravir may no longer be used under the EUA).

Complete EUA Consent Form For Molnupiravir

You are being given this Fact Sheet because your healthcare provider believes it is necessary to provide you with PAXLOVID for the treatment of mild-to-moderate coronavirus disease (COVID-19) caused by the SARS-CoV-2 virus. This Fact Sheet contains information to help you understand the risks and benefits of taking the PAXLOVID you have received or may receive.

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to make PAXLOVID available during the COVID-19 pandemic (for more details about an EUA please see “What is an Emergency Use Authorization?” at the end of this document). PAXLOVID is not an FDA-approved medicine in the United States. Read this Fact Sheet for information about PAXLOVID. Talk to your healthcare provider about your options or if you have any questions. It is your choice to take PAXLOVID.

What is COVID-19?

COVID-19 is caused by a virus called a coronavirus. You can get COVID-19 through close contact with another person who has the virus.

COVID-19 illnesses have ranged from very mild-to-severe, including illness resulting in death. While information so far suggests that most COVID-19 illness is mild, serious illness can happen and may cause some of your other medical conditions to become worse. Older people and people of all ages with severe, long lasting (chronic) medical conditions like heart disease, lung disease, and diabetes, for example seem to be at higher risk of being hospitalized for COVID-19.

What is PAXLOVID?

PAXLOVID is an investigational medicine used to treat 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. PAXLOVID is investigational because it is still being studied. There is limited information about the safety and effectiveness of using PAXLOVID to treat people with mild-to-moderate COVID-19.

The FDA has authorized the emergency use of PAXLOVID for the treatment of mild-tomoderate COVID-19 in adults and children [12 years of age and older weighing at least 88 pounds (40 kg)] with a positive test for the virus that causes COVID-19, and who are at high risk for progression to severe COVID-19, including hospitalization or death, under an EUA.

What should I tell my healthcare provider before I take PAXLOVID?

Tell your healthcare provider if you:

• Have any allergies
• Have liver or kidney disease
• Are pregnant or plan to become pregnant
• Are breastfeeding a child
• Have any serious illnesses

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Some medicines may interact with PAXLOVID and may cause serious side effects. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.

You can ask your healthcare provider or pharmacist for a list of medicines that interact with PAXLOVID. Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take PAXLOVID with other medicines.

Tell your healthcare provider if you are taking combined hormonal contraceptive. PAXLOVID may affect how your birth control pills work. Females who are able to become pregnant should use another effective alternative form of contraception or an additional barrier method of contraception. Talk to your healthcare provider if you have any questions about contraceptive methods that might be right for you.

How do I take PAXLOVID?

• PAXLOVID consists of 2 medicines: nirmatrelvir and ritonavir.
  • Take 2 pink tablets of nirmatrelvir with 1 white tablet of ritonavir by mouth 2 times each day (in the morning and in the evening) for 5 days. For each dose, take all 3 tablets at the same time.
  • If you have kidney disease, talk to your healthcare provider. You may need a different dose.
• Swallow the tablets whole. Do not chew, break, or crush the tablets.
• Take PAXLOVID with or without food.
• Do not stop taking PAXLOVID without talking to your healthcare provider, even if you feel better.
• If you miss a dose of PAXLOVID within 8 hours of the time it is usually taken, take it as soon as you remember. If you miss a dose by more than 8 hours, skip the missed dose and take the next dose at your regular time. Do not take 2 doses of PAXLOVID at the same time.
• If you take too much PAXLOVID, call your healthcare provider or go to the nearest hospital emergency room right away.
• If you are taking a ritonavir- or cobicistat-containing medicine to treat hepatitis C or Human Immunodeficiency Virus (HIV), you should continue to take your medicine as prescribed by your healthcare provider.

Talk to your healthcare provider if you do not feel better or if you feel worse after 5 days.

Who should generally not take PAXLOVID?

Do not take PAXLOVID if:

• You are allergic to nirmatrelvir, ritonavir, or any of the ingredients in PAXLOVID.
• You are taking any of the following medicines:
  • Alfuzosin
  • Pethidine, piroxicam, propoxyphene
  • Ranolazine
  • Amiodarone, dronedarone, flecainide, propafenone, quinidine
  • Colchicine
  • Lurasidone, pimozide, clozapine
  • Dihydroergotamine, ergotamine, methylergonovine
  • Lovastatin, simvastatin
  • Sildenafil (Revatio®) for pulmonary arterial hypertension (PAH)
  • Triazolam, oral midazolam
  • Apalutamide
  • Carbamazepine, phenobarbital, phenytoin
  • Rifampin
  • St. John’s Wort (hypericum perforatum)

Taking PAXLOVID with these medicines may cause serious or life-threatening side effects or affect how PAXLOVID works.

These are not the only medicines that may cause serious side effects if taken with PAXLOVID. PAXLOVID may increase or decrease the levels of multiple other medicines. It is very important to tell your healthcare provider about all of the medicines you are taking because additional laboratory tests or changes in the dose of your other medicines may be necessary while you are taking PAXLOVID. Your healthcare provider may also tell you about specific symptoms to watch out for that may indicate that you need to stop or decrease the dose of some of your other medicines.

What are the important possible side effects of PAXLOVID?

Possible side effects of PAXLOVID are:

• Liver Problems. Tell your healthcare provider right away if you have any of these signs and symptoms of liver problems: loss of appetite, yellowing of your skin and the whites of eyes (jaundice), dark-colored urine, pale colored stools and itchy skin, stomach area (abdominal) pain.
• Resistance to HIV Medicines. If you have untreated HIV infection, PAXLOVID may lead to some HIV medicines not working as well in the future.
• Other possible side effects include:
  • altered sense of taste
  • diarrhea
  • high blood pressure
  • muscle aches

These are not all the possible side effects of PAXLOVID. Not many people have taken PAXLOVID. Serious and unexpected side effects may happen. PAXLOVID is still being studied, so it is possible that all of the risks are not known at this time.

What other treatment choices are there?

Like PAXLOVID, FDA may allow for the emergency use of other medicines to treat people with COVID-19. Go to https://www.fda.gov/emergency-preparedness-andresponse/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization for information on the emergency use of other medicines that are authorized by FDA to treat people with COVID-19. Your healthcare provider may talk with you about clinical trials for which you may be eligible.

It is your choice to be treated or not to be treated with PAXLOVID. Should you decide not to receive it or for your child not to receive it, it will not change your standard medical care.

What if I am pregnant or breastfeeding?

There is no experience treating pregnant women or breastfeeding mothers with PAXLOVID. For a mother and unborn baby, the benefit of taking PAXLOVID may be greater than the risk from the treatment. If you are pregnant, discuss your options and specific situation with your healthcare provider.

It is recommended that you use effective barrier contraception or do not have sexual activity while taking PAXLOVID.

If you are breastfeeding, discuss your options and specific situation with your healthcare provider.

How do I report side effects with PAXLOVID?

Contact your healthcare provider if you have any side effects that bother you or do not go away.

eport side effects to FDA MedWatch at www.fda.gov/medwatch or call 1-800-FDA1088 or you can report side effects to Pfizer Inc. at the contact information provided below.

How should I store PAXLOVID?

Store PAXLOVID tablets at room temperature, between 68○F to 77○F (20○C to 25○C).

How can I learn more about COVID-19?

• Ask your healthcare provider.
• Visit https://www.cdc.gov/COVID19.
• Contact your local or state public health department.

What is an Emergency Use Authorization (EUA)?

The United States FDA has made PAXLOVID available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by a Secretary of Health and Human Service (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic.

PAXLOVID for the 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, has not undergone the same type of review as an FDA-approved product. In issuing an EUA under the COVID-19 public health emergency, the FDA has determined, among other things, that based on the total amount of scientific evidence available including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that the product may be effective for diagnosing, treating, or preventing COVID-19, or a serious or life-threatening disease or condition caused by COVID-19; that the known and potential benefits of the product, when used to diagnose, treat, or prevent such disease or condition, outweigh the known and potential risks of such product; and that there are no adequate, approved, and available alternatives.

All of these criteria must be met to allow for the product to be used in the treatment of patients during the COVID-19 pandemic. The EUA for PAXLOVID is in effect for the duration of the COVID-19 declaration justifying emergency use of this product, unless terminated or revoked (after which the products may no longer be used under the EUA).

Additional Information

For general questions, visit the website or call the telephone number provided below.

www.pfizermedinfo.com or call 1-800-438-1985 for more information.

Complete EUA Consent Form For Paxlovid