M&D Clinical Corner: Guide to Monkeypox

The Clinical Corner is a monthly feature that highlights a variety of important pharmacist topics that is written by Morris & Dickson’s staff pharmacist, Paula Belle (RPh).

This month’s Clinical Corner provides a Community Pharmacist’s Guide to Monkeypox. The topics we’ll cover in this article include the following.

• What is monkeypox?
• How does monkeypox spread?
• What are the symptoms of monkeypox?
• Testing for monkeypox
• Prevention and treatment options for monkeypox
• The role of the community pharmacist

What is monkeypox?

• Monkeypox is a rare disease caused by infection with the monkeypox virus.^[1]
• Monkeypox virus is part of the same family of viruses as variola virus, the virus that causes smallpox.^[1]
• Monkeypox symptoms are similar to smallpox symptoms, but milder, and monkeypox is rarely fatal.^[1]
• Monkeypox is not related to chickenpox.^[1]
• Through October 25, 2022 there have been 28,061 documented cases of monkeypox in the United States with 6 deaths.^[2]

How does monkeypox spread?

• Monkeypox can be spread from the time symptoms start until the rash has healed, all scabs have fallen off, and a fresh layer of skin has formed.^[3]
• Monkeypox can be transmitted in a few ways.^[4]
  • Close or intimate contact:^[4]
    • Direct contact with monkeypox rash, scabs, or body fluids from a person with monkeypox
    • Touching objects, fabrics (clothing, bedding, or towels), and surfaces that have been used by someone with monkeypox
    • Contact with respiratory secretions
  • Monkeypox can be spread by a pregnant woman to her fetus via the placenta.^[4]
  • It’s also possible for people to get monkeypox from infected animals, either by being scratched or bitten by the animal or by preparing or eating meat or using products from an infected animal.^[4]
  • Scientists are still researching:^[4]
    • If the virus can be spread when someone has no symptoms
    • How often the virus is spread via respiratory secretions
    • Whether the virus can be spread via semen, vaginal secretions, urine or feces

What are the symptoms of monkeypox?

• Monkeypox symptoms usually start within 3 weeks of exposure to the virus.^[3]
• People with monkeypox get a rash that will go through several stages, including scabs, before healing.^[3]
• The rash can initially look like pimples or blisters and may be painful or itchy.^[3]
• Other symptoms of monkeypox can include:^[3]
  • Fever
  • Chills
  • Swollen lymph nodes
  • Exhaustion
  • Muscle aches and backache
  • Headache
  • Respiratory symptoms like sore throat, nasal congestion, or cough
• Some may experience flu-like symptoms then a rash.^[3]
  • If someone has flu-like symptoms, they will usually develop a rash 1 to 4 days later.^[3]
  • Some get the rash prior to other symptoms.^[3]
  • Some experience only a rash.^[3]
  • The illness typically lasts 2 to 4 weeks.^[3]

Testing for monkeypox

• Currently, testing is only recommended for patients that have a rash consistent with monkeypox.^[5]
• Only a healthcare provider can order a monkeypox test.^[5]
• The healthcare provider may take a specimen and send it to a lab for testing or they may send patients to a lab for both specimen collection and testing.^[5]
• For information on testing options in your community contact your local health department.^[5]
• Look up local State Health Departments by going HERE.

Prevention and treatment of monkeypox

Vaccination

• When properly administered before an exposure, vaccines are effective at protecting people against monkeypox.^[6]
• People can be vaccinated after exposure to monkeypox virus to help prevent monkeypox disease or make it less severe (i.e., post-exposure prophylaxis).^[6]
• In the current outbreak, patients should be vaccinated if they have been identified as having been exposed to monkeypox.^[7]
• In addition, patients should be vaccinated if they may be exposed to monkeypox in the future.^[7]
• Getting vaccinated before patients are exposed to monkeypox provides the best chance to prevent disease. For best protection, 2 doses of JYNNEOS vaccine spaced 28 days apart are recommended.^[7]
• If the patient has already been exposed, getting vaccinated as soon as possible after exposure to someone with monkeypox (ideally within 4 days) may help prevent the disease, or make it less severe.^[7]
• Currently, CDC is not encouraging vaccination against monkeypox for the broader public.^[7]
• The monkeypox vaccines are free. Providers must give patients the vaccine regardless of their ability to pay the administration fee.^[7]
• The providers may bill a program or plan that covers the monkeypox vaccine administration fee (like private insurance or Medicare and Medicaid).^[7]
• Patients who need help deciding whether they should get vaccinated should talk to a healthcare provider or contact their local health department. These resources can help patients determine if they should get vaccinated.^[7]
  • State and Territorial Health Department websites can be found HERE.
  • The Monkeypox Vaccine Locator Tool can be found HERE.
• JYNNEOS and ACAM2000 are the two vaccines that may be used for the prevention of monkeypox disease.^[6]
• No data are currently available on the clinical efficacy or effectiveness of JYNNEOS or ACAM2000 vaccines in the current outbreak.^[6]
• Because there are limitations in knowledge about the effectiveness of these vaccines in the current outbreak, people who are vaccinated should continue to take steps to protect themselves from infection by avoiding close, skin-to-skin contact, including intimate contact, with someone who has monkeypox.^[6]
• JYNNEOS vaccine is approved for the prevention of monkeypox and smallpox disease.^[6]
  • It is the primary vaccine being used in the U.S. during this outbreak.^[8]
  • Globally and in the United States, supply of JYNNEOS vaccine is currently limited.^[9]
  • JYNNEOS should be prioritized for people who are at high risk for severe disease from monkeypox (including but not limited to people with HIV, pregnant, or other immunocompromising conditions) or serious adverse events with ACAM2000.^[9]
  • The standard regimen for JYNNEOS involves a subcutaneous route of administration with an injection volume of 0.5mL.^[6]
  • JYNNEOS should be administered as two injections (two-dose series).^[9]
    • The two doses should be given 28 days apart (range 24 to 35 days).​
    • If the second dose was not given during the recommended interval, it should be given as soon as possible.
    • Peak immunity is anticipated 14 days after the second dose.
  • People 18 years of age or older may receive JYNNEOS via intradermal administration (alternative regimen).^[9]
  • This alternative regimen involving intradermal (ID) administration with an injection volume of 0.1mL may be used under an Emergency Use Authorization (EUA).^[6]
• ACAM200 vaccine is FDA-approved for the prevention of smallpox disease, and is allowed under a CDC-held Expanded Access IND (EA-IND) for the prevention of monkeypox disease.^[9]
  • ACAM2000 is indicated in adults ages 18 years or older.^[9]
  • In the United States, there is a large supply of ACAM2000.^[6]
  • ACAM2000 vaccine has been shown to have more frequent side effects than JYNNEOS vaccine.^[10]
  • Side effects of ACAM2000 vaccine can include:^[10]
    • Redness and itching at the spot where the vaccine is given
    • Swollen glands, headache
    • Tiredness
    • Fever
    • Muscle aches
    • Skin rashes
  • ACAM2000 vaccine should not be administered to patients with:^[9]
    • Three or more cardiac risk factors (hypertension, diabetes, hypercholesterolemia, heart disease at age ≥50 years in a first-degree relative, or smoking)​​
    • Eye disease treated with topical steroids
    • Congenital or acquired immune deficiency disorders, including those taking immunosuppressive medications and people living with HIV (regardless of immune status)
    • Atopic dermatitis/eczema and persons with a history of atopic dermatitis/eczema or other acute or exfoliative skin conditions
    • Infants less than 12 months of age
    • Pregnancy and breastfeeding
    • History of a severe allergic reaction (e.g. anaphylaxis) after a previous dose of ACAM2000
  • ACAM2000 is administered percutaneously as a single dose, using a bifurcated needle.^[9] This is a single dose given by multiple pricks to the skin using a special needle.^[10]
  • Patients are considered vaccinated against monkeypox 28 days after getting the single vaccine dose.^[10]

Treatment

• There are no treatments specifically for monkeypox virus infections.^[11]
• Monkeypox and smallpox viruses are similar, which means that antiviral drugs developed to protect against smallpox may be used to treat monkeypox effectively.^[11]
• For most patients with intact immune systems, supportive care and pain control may be enough.^[12]
• Because prognosis depends on multiple factors, such as initial health status, concurrent illnesses, previous vaccination history, and comorbidities, supportive care and pain control may not be enough for some patients (for example, those with weakened immune systems).^[12]
• Treatment should be considered for use in people who have the following clinical manifestations:^[12]
  • People with severe disease (e.g., hemorrhagic disease, confluent lesions, sepsis, encephalitis, or other conditions requiring hospitalization)
  • Involvement of anatomic areas which might result in serious sequelae that include scarring or strictures.
  • People who may be at high risk of severe disease:
    • People who are immunocompromised
    • Pediatric populations, particularly patients younger than 8 years of age
    • People with a condition affecting skin integrity
    • Pregnant or breastfeeding women
  • Antivirals
    • Tecovirimat (also known as TPOXX or ST-246) is FDA-approved for the treatment of human smallpox disease caused by variola virus in adults and children.^[13]
      • TPOXX use for other orthopoxvirus infections, including monkeypox, is not approved by the FDA. Therefore, CDC holds a non-research expanded access Investigational New Drug (EA-IND) protocol that allows for the use of tecovirimat for primary or early empiric treatment of non-variola orthopoxvirus infections, including monkeypox, in adults and children of all ages.^[13]
      • Tecovirimat may be considered for treatment in people infected with monkeypox virus:^[13]
        • With severe disease
        • With involvement of anatomic areas which might result in serious sequelae that include scarring or strictures
        • Who are at high risk of severe disease such as:
          • Immunocompromised patients
          • Pediatric patients especially those under 8 years
          • Pregnant or breastfeeding patients
          • Patients with conditions that affect skin integrity
        • Tecovirimat is available as a pill or an injection.^[12]
        • For children, the capsule can be opened, and medicine mixed with semi-solid food or liquid.^[12]
        • See the guide for opening and mixing tecovirimat capsules with food for those who cannot swallow pills, especially infants and children, by going HERE.
        • TPOXX is available through the Strategic National Stockpile (SNS), and multiple state and territorial health departments are pre-positioning supplies of TPOXX within their jurisdictions.^[14]
        • Clinicians and care facilitypharmacists requesting TPOXX should contact their state/territorial health department.^[14]
        • For urgent clinical situations after hours, providers may contact the CDC Emergency Operations Center at 770-488-7100 for clinical consultation on patient cases.^[14]
      • Cidofovir (Vistide) is an antiviral medication that is approved by the FDA for the treatment of cytomegalovirus (CMV) retinitis in patients with Acquired Immunodeficiency Syndrome (AIDS).^[12]
        • Data is not available on the effectiveness of Cidofovir in treating human cases of monkeypox. However, it has shown to be effective against orthopoxviruses in in vitro and animal studies.^[12]
        • CDC holds an expanded access protocol that allows for the use of stockpiled Cidofovir for the treatment of orthopoxviruses (including monkeypox) in an outbreak.^[12]
        • It is unknown whether or not a person with severe monkeypox infection will benefit from treatment with cidofovir, although its use may be considered in such instances.^[12]
        • Serious renal toxicityor other adverse events have not been observed during treatment of cytomegalovirus infections with Brincidofovir as compared to treatment using Cidofovir.^[12]
      • Brincidofovir (CMX001 or Tembexa) is an antiviral medication that was approved by the FDA on June 4, 2021 for the treatment of human smallpox disease in adult and pediatric patients, including neonates.^[12]
        • Data is not available on the effectiveness of Brincidofovir in treating cases of monkeypox in people. However, it has shown to be effective against orthopoxviruses in in vitro and animal studies.^[12]
        • Brincidofovir is not currently available from the SNS.^[12]
      • Gamma Globulin
        • Vaccine Immune Globulin Intravenous (VIGIV) is licensed by FDA for the treatment of complications due to vaccinia vaccination including eczema vaccinatum, progressive vaccinia, severe generalized vaccinia, vaccinia infections in individuals who have skin conditions, and aberrant infections induced by vaccinia virus (except in cases of isolated keratitis).^[12]
          • CDC holds an expanded access protocol that allows the use of VIGIV for the treatment of orthopoxviruses (including monkeypox) in an outbreak.^[12]
          • Use of VIGIV has no proven benefit in the treatment of monkeypox and it is unknown whether a person with severe monkeypox infection will benefit from treatment with VIGIV. However, healthcare providers may consider its use in severe cases.^[12]
          • VIGIV can be considered for prophylactic use in an exposed person with severe immunodeficiency in T-cell function for which smallpox vaccination following exposure to monkeypox virus is contraindicated.^[12]

The role of the community pharmacist

Counseling

• Advise patients that if they are exposed to the monkeypox virus, symptoms may take up to 3 weeks to appear.^[3]
• A person with monkeypox can spread it to others from the time symptoms start until the rash has fully healed and a fresh layer of skin has formed.^[4]
• Monkeypox can spread to anyone through close, personal, often skin-to-skin contact, including:^[4]
  • Direct contact with monkeypox rash, scabs, or body fluids from a person with monkeypox
  • Touching objects, fabrics (clothing, bedding, or towels), and surfaces that have been used by someone with monkeypox
  • Contact with respiratory secretions
• Advise patients with a rash consistent with monkeypox to consult their healthcare provider or local health department for testing^[5]
• Patients who need help deciding whether they should get vaccinated, should talk to a healthcare provider, or contact their local health departments for assistance in determining vaccination needs and locations to receive vaccinations.^[7] You can access the State and Territorial Health Department websites HERE.
• Patients with symptoms of monkeypox should talk to their healthcare provider to determine the need for treatment, even if they don’t think they have had contact with someone who has monkeypox.^[11]
• Countermeasures that may be used to treat patients with monkeypox are only available from the Strategic National Stockpile.^[12]
• Most people with monkeypox recover fully within 2 to 4 weeks without the need for medical treatment.^[11]

Paula Belle (BS Pharmacy, RPh) has been the Clinical Programs Coordinator for Morris & Dickson since 2016. Prior to joining M&D, Paula held the positions of Clinical Pharmacist with Pharmacea Services and  PharmMD/Adhere Health, as well as Market Pharmacist, Store Pharmacy Manager and District Pharmacy Supervisor with Walgreens. She holds a BS in Pharmacy from the University of Louisiana at Monroe, as well as Immunization and MTM Certifications from the American Pharmacists Association (APhA).

Stay connected with Morris & Dickson by following us on Facebook, LinkedIn, Twitter, Instagram and YouTube.

Sources

1. Centers for Disease Control and Prevention. About Monkeypox | Monkeypox | Poxvirus | CDC. 2022 2022-09-07T05:14:15Z [cited 2022; Available from: https://www.cdc.gov/poxvirus/monkeypox/about/index.html.
2. Centers for Disease Control and Prevention. 2022 Outbreak Cases and Data | Monkeypox | Poxvirus | CDC. 2022 2022-09-02T12:08:50Z; Available from: https://www.cdc.gov/poxvirus/monkeypox/response/2022/index.html.
3. Centers for Disease Control and Prevention. Signs and Symptoms | Monkeypox | Poxvirus | CDC. 2022 2022-08-29T03:51:16Z [cited 2022; Available from: https://www.cdc.gov/poxvirus/monkeypox/symptoms/index.html.
4. Centers for Disease Control and Prevention. How It Spreads | Monkeypox | Poxvirus | CDC. 2022 2022-08-29T05:25:41Z [cited 2022; Available from: https://www.cdc.gov/poxvirus/monkeypox/if-sick/transmission.html.
5. Centers for Disease Control and Prevention. Monkeypox Testing Basics | Monkeypox | Poxvirus | CDC. 2022 2022-09-06T05:45:19Z [cited 2022; Available from: https://www.cdc.gov/poxvirus/monkeypox/testing/testing-basics.html.
6. Centers for Disease Control and Prevention. Monkeypox Vaccine Information for Healthcare Professionals | Monkeypox | Poxvirus | CDC. 2022 2022-08-30T06:56:32Z; Available from: https://www.cdc.gov/poxvirus/monkeypox/clinicians/vaccines/index.html.
7. Centers for Disease Control and Prevention. Monkeypox Vaccination Basics | Monkeypox | Poxvirus | CDC. 2022 2022-09-07T03:11:42Z [cited 2022; Available from: https://www.cdc.gov/poxvirus/monkeypox/vaccines/vaccine-basics.html.
8. Centers for Disease Control and Prevention. JYNNEOS Vaccine | Monkeypox | Poxvirus | CDC. 2022 2022-08-30T06:52:56Z [cited 2022; Available from: https://www.cdc.gov/poxvirus/monkeypox/vaccines/jynneos.html.
9. HHS Administration for Strategic Preparedness and Response (ASPR). ASPR/CDC Monkeypox Vaccination Operational Planning Guide Monkeypox Vaccination Program HHS Monkeypox Vaccination Program. 2022 [cited 2022; Available from: https://aspr.hhs.gov/monkeypox/OperationalGuidance/Pages/Vaccines.aspx.
10.  Centers for Disease Control and Prevention. ACAM2000 Vaccine | Monkeypox | Poxvirus | CDC. 2022 2022-08-31T07:16:40Z [cited 2022; Available from: https://www.cdc.gov/poxvirus/monkeypox/vaccines/acam2000.html.
11.  Centers for Disease Control and Prevention. Treatment | Monkeypox | Poxvirus | CDC. 2022 2022-09-09T09:22:37Z [cited 2022; Available from: https://www.cdc.gov/poxvirus/monkeypox/if-sick/treatment.html.
12.  Centers for Disease Control and Prevention. Treatment Information for Healthcare Professionals | Monkeypox | Poxvirus | CDC. 2022 2022-07-29T06:16:44Z [cited 2022; Available from: https://www.cdc.gov/poxvirus/monkeypox/clinicians/treatment.html#anchor_1655488137245.
13.  Centers for Disease Control and Prevention. Guidance for Tecovirimat Use Under Expanded Access Investigational New Drug Protocol during 2022 U.S. Monkeypox Cases | Monkeypox | Poxvirus | CDC. 2022 2022-08-15T08:36:32Z [cited 2022; Available from: https://www.cdc.gov/poxvirus/monkeypox/clinicians/Tecovirimat.html.
14.  Centers for Disease Control and Prevention. Information for Healthcare Providers on Obtaining and Using TPOXX (Tecovirimat) for Treatment of Monkeypox | Monkeypox | Poxvirus | CDC. 2022 2022-09-07T04:32:38Z [cited 2022; Available from: https://www.cdc.gov/poxvirus/monkeypox/clinicians/obtaining-tecovirimat.html.