Mpox (Monkeypox) Situational Awareness Materials

MPOX (MONKEYPOX) SITUATIONAL AWARENESS

Pamela Sardo, PharmD, B.S.

Pamela Sardo, PharmD, B.S., is a licensed pharmacist and Freelance Medical Writer at Sardo Solutions in Texas.

Topic Overview

Mpox, also known as monkeypox, is caused by the mpox virus, a member of the Orthopoxvirus genus. Cases of this viral disease have been reported in numerous countries around the world. Mpox generally causes less severe illness than smallpox. Diverse methods of transmission include close contact with an infected person or animal or exposure to material contaminated with the virus. A patient may present with fever, rash, and swollen lymph nodes, and complications are possible. Guidance from the Centers for Disease Control and Prevention and other health agencies is evolving. Therapeutic options for mpox may include the smallpox vaccine, cidofovir, tecovirimat, and vaccinia immune globulin (VIG), among others. Pharmacy team members are ideally positioned to engage in healthcare conversations involving mpox prevention and countermeasures.

Accreditation Statement:

RxCe.com LLC is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education.

Universal Activity Number (UAN): The ACPE Universal Activity Number assigned to this activity is 

Pharmacist 0669-0000-22-074-H01-P

Pharmacy Technician 0669-0000-22-075-H01-T

Credits: 1 hour of continuing education credit

Type of Activity: Knowledge

Media: Internet Fee Information: $4.99

Estimated time to complete activity: 1 hour, including Course Test and course evaluation

Release Date: December 10, 2022 Expiration Date: December 10, 2025

Target Audience: This educational activity is for pharmacists.

How to Earn Credit: From December 10, 2022, through December 10, 2025, participants must:

Read the “learning objectives” and “author and planning team disclosures;”

Study the section entitled “educational activity;” and

Complete the Course Test and Evaluation form. The Course Test will be graded automatically. Following successful completion of the Course Test with a score of 70% or higher, a statement of participation will be made available immediately. (No partial credit will be given.)

Learning Objectives: Upon completion of this educational activity, participants should be able to:

Understand the mpox virus, its etiology, and transmission

Recognize the signs and symptoms of the mpox virus

Specify treatment options for mpox

Use this information on mpox to answer patient or healthcare team questions

Disclosures

The following individuals were involved in the development of this activity: Pamela Sardo, PharmD, B.S., and Susan DePasquale, MSN, PMHNP-BC. There are no financial relationships relevant to this activity to report or disclose by any of the individuals involved in the development of this activity.

ⓒ RxCe.com LLC 2022: All rights reserved. No reproduction of all or part of any content herein is allowed without the prior, written permission of RxCe.com LLC.

Introduction

Human mpox, also known as monkeypox, is a rare disease caused by an infection with the mpox virus. The virus began as a zoonotic disease, meaning it was transmitted from animals to humans, but cases have emerged of human-to-human transmission, making mpox a disease of greater concern. A new mpox outbreak has begun to spread worldwide, making prevention measures critical. Once exposed to the mpox virus, a patient may present with the signs and symptoms of mpox. Treatment for the disease may be needed in more severe cases.

History of Mpox

The mpox virus is a double-stranded DNA that belongs to the Orthopoxvirus genus of the Poxviridae family.1 There are two clades (groups that share a common biological ancestor) of the mpox virus: the West African clade and the Central African Congo Basin clade. The Central African clade historically causes more severe illness, and it may be more transmissible.1,2

Mpox was first discovered in 1958 when monkeys being transported from Singapore to a Denmark laboratory developed a vesicular disease.3,4 The name mpox was applied because monkeys were the first animals identified with this disease; however, squirrels, rats, and other rodents are the largest animal groups that carry the virus.3

In 1970, in Africa, the first human case was diagnosed in a 9-month-old baby boy.4,5 It is unknown whether the boy contracted the virus by human- to-human or zoonotic means. The family reported that they had not been in contact with anyone symptomatic of the infection. They did eat monkeys as a delicacy at times, but there were no tests to determine whether the virus was transmitted from monkeys.5

In 2003, the first reported mpox cases outside of Africa were seen when an outbreak of 47 cases occurred in the USA following exposure to infected pet prairie dogs. The prairie dogs had been infected by animals imported from Ghana.4

The Current Mpox Outbreak

Unlike previous mpox outbreaks, believed to be caused by animal-to- human transmission, human-to-human transmission is responsible for the current outbreak.6 In May 2022, the U.S. Centers for Disease Control and Prevention (CDC), with state and local officials, activated an emergency response to identify, monitor, and investigate mpox. This response included a Health Alert Network (HAN) designed to develop public health and clinical recommendations, protocols, and medical guidance, and to facilitate the delivery of vaccine for post-exposure prophylaxis (PEP).2

In June 2022, the Council of State and Territorial Epidemiologists designated mpox as a nationally notifiable disease to report to health authorities. In August 2022, the U.S., declared mpox a public health emergency, shortly after the World Health Organization (WHO) named mpox a global health emergency.7

Between May 17 and October 6, 2022, 26,384 mpox cases were reported to the CDC by the 50 states, the District of Columbia, and Puerto Rico. Unexpectedly, 37% of all recent global cases, as of October 2022, were reported in the United States.8

On November 28, 2022, the WHO recommended renaming monkeypox. The new, proposed name is “mpox.”9 During the months-long deliberations on whether to change the name of this disease, the WHO applied its current “best practices” approach to naming diseases, something that was not in place in 1958 when the original name monkeypox was chosen.9 Under the best practices approach, new disease names are now given with the aim of eliminating unnecessary stigmas, and avoiding the use of names that may offend a cultural, social, national, regional, professional, or ethnic group. In

addition, names should not negatively impact trade, travel, tourism, or animal welfare. The WHO determined that the name monkeypox could be stigmatizing or offensive, and may negatively impact travel and trade, so the new name was selected. Both names will be used for the next year as “monkeypox” is phased out.9

Transmission of the Mpox Virus

Mpox can be transmitted by animal-to-human (zoonotic) transmission, human-to-human transmission, or from contact with a contaminated surface. Data shows that mpox is less transmissible and generally less severe compared to smallpox.1,10

Zoonotic transmission can occur from direct contact with the blood, bodily fluids, and cutaneous or mucosal lesions of infected animals. Eating inadequately cooked meat and other animal products of infected animals is a possible risk factor.1

Human-to-human transmission can result from close contact with respiratory secretions, skin lesions of an infected person, or recently contaminated objects. Transmission by respiratory droplets usually requires prolonged face-to-face contact. Spreading mpox through close skin-to-skin contact includes kissing and touching someone who has symptoms. Transmission can also occur through the placenta from mother to fetus or with contact during and after birth.1

Today, persons younger than 40 to 50 years of age may be more susceptible to mpox. This could be due to the fact that smallpox vaccinations ceased globally after the declaration by the WHO in 1980 that smallpox had been eradicated.1 The smallpox vaccinations administered in the decades prior to 1980 were credited with the prevention and control of mpox, as will be discussed at greater length below.1

Pregnant women are at a heightened risk of being infected with the mpox virus.11 Pregnant women generally have more vulnerable immune systems. In addition, women of reproductive age are usually younger, and therefore, it is likely they are in the age group that was not vaccinated for smallpox, as mentioned above.1,11 The fetus is also at greater risk because orthopox viral cells can overcome the barriers within the placenta.11

Signs and Symptoms of Mpox

The typical signs and symptoms of mpox are fever, rash, and swollen lymph nodes. The extent to which asymptomatic infection may occur is unknown.1 The infection can be divided into the invasion period and the skin eruption period.

The Invasion Period

The invasion period is characterized by fever, intense headache, lymphadenopathy (swelling of the lymph nodes), back pain, myalgia (muscle aches), and intense asthenia (lack of energy). Lymphadenopathy is a distinctive feature not seen with skin eruptions of chickenpox, measles, or smallpox. Other symptoms can include sore throat, nasal congestion, or cough.1,2,7

The Skin Eruption Period

The skin eruption usually begins within 1–3 days of the appearance of fever and tends to be more concentrated on the face and extremities (palms, soles of feet) rather than on the trunk. Oral mucous membranes, genitalia, conjunctiva, and the cornea can be affected.1

The rash evolves sequentially in stages:1

Macules- lesions with a flat base

Papules- slightly raised firm lesions

Vesicles- lesions filled with clear fluid

Pustules- lesions filled with yellowish fluid

Scabs- crusts that dry up and fall off

Mpox is usually a self-limiting disease with symptoms lasting from 2 to 4 weeks. The incubation period (interval from infection to onset of symptoms) is usually from 6 to 13 days but can range from 5 to 21 days.1,2

The rash can be confused with other conditions such as secondary syphilis, herpes, and varicella zoster. Some patients are co-infected with the mpox virus and other infections. Patients with a characteristic rash should receive diagnostic testing.2

Severe cases occur more commonly among children and are related to the extent of virus exposure, patient health status, and nature of complications. Underlying immune deficiencies may lead to worse outcomes. More severe complications of mpox can include secondary infections, bronchopneumonia, sepsis, encephalitis, and loss of vision.

People should contact their healthcare provider if they have a fever, chills, swollen lymph nodes, and a new, unexplained rash. People diagnosed with mpox should stay home and avoid close contact with others until the rash has fully resolved, the scabs have fallen off, and a fresh layer of intact skin has formed. The virus remains contagious while symptoms are present. For most people, infection with mpox is painful but not life-threatening.12

Potential Health Impact

Conditions leading to hospitalization include severe illness, the need to provide isolation, pain management, and treat secondary infections that may present.13 Mpox can cause mental health concerns of sadness, anger, frustration, depression, and anxiety. The result can impact the economy, social behavior, healthcare resources, and businesses involving animals.14

Pregnant women and their fetuses are at risk of greater, negative health outcomes from mpox.11 Data on pregnancy outcomes following an mpox infection are scarce, but reports include the potential for a miscarriage, preterm birth, and a congenital infection.11 Dashraath, et al. (2022) followed the pregnancy of four women in Africa who were infected with the mpox virus.11 One patient had mild disease symptoms and delivered her child at full term, with no clinical features of mpox infection. The other three women had moderate to severe maternal infections, which resulted in adverse obstetrical outcomes: two of the women had first-trimester miscarriages at 6 weeks’ gestation; the third woman had a second-trimester loss at 18 weeks’ gestation. One of the stillborn fetuses had a vesicular rash, hepatomegaly, and a high viral load.11

Groups possibly vulnerable to mental health and psychosocial consequences of mpox may include those exposed to the virus, family members, those vulnerable to psychological stresses, healthcare providers, or immunocompromised individuals. An August 2022 survey of gay and bisexual men reveals that half of the respondents reported changing their behavior and reducing sexual partners due to mpox.15

The mpox outbreak is slowing. This may be due to a combination of factors, including vaccination, behavior changes, and increases in infection- acquired immunity.16 Pharmacists are in an ideal position to deliver tailored, respectful support to diverse groups impacted by mpox.

Avoiding Transmission of the Mpox Virus

Preventing the spread of mpox requires a multifaceted approach. Limiting human exposure to possible host animals is the first step. Various animal species, such as squirrels, rats, non-human primates (monkeys, chimpanzees), and other species, are deemed susceptible to the mpox virus.1,9 Mpox patients should avoid contact with pets and other animals while infectious because of possible contagiousness and the risk of transmission.2

The most reliable way to prevent acquiring an infection from a surface is for individuals to wash their hands regularly with soap and water or use an alcohol-based hand sanitizer with at least 60% alcohol before eating or touching the eyes, nose, or mouth. Cleaning and disinfecting surfaces that a person with mpox may have touched can also help prevent the spread to others.17

Although mpox is less transmissible than smallpox, preventive measures are still warranted. Protecting at-risk groups, including healthcare workers, laboratory workers, and contacts of mpox patients, remains a priority. The CDC recommends that vaccines can achieve additional pre- exposure prophylaxis (PrEP).3,18 Pre-exposure prophylaxis is recommended for persons at high risk of infection, and post-exposure prophylaxis is recommended for recently exposed persons to prevent mpox infection or reduce its severity.18,19

In hospital settings, the CDC recommends isolation in negative-pressure rooms. Healthcare professionals must take adequate contact and droplet precautions. Use personal protective equipment, long sleeves, pants, and disposable gloves.2,3,20

Strategies for prevention include avoiding close, skin-to-skin contact with someone with a new, unexplained rash. Avoid close, skin-to-skin contact in large crowds where people are wearing minimal clothing, such as nightclubs, festivals, and saunas. Do not share cups, utensils, bedding, or towels with someone who is sick with the virus.12

Vaccination is recommended for those with a sex partner diagnosed with mpox in the past 14 days, or for persons who have multiple sex partners. Until more is known, individuals should continue using condoms after they recover and until more is known about the virus transmission.6,21

Approaches to Treatment

Most mpox patients have a relatively mild, self-limiting disease. Patients who are at risk of severe illness should be treated. This population includes patients who are immunocompromised, children (particularly those <8 years old), and persons with atopic dermatitis or other active exfoliative skin disorders. In addition, patients with severe symptoms may also require treatment. Pregnant or breastfeeding women and those with complications such as secondary bacterial skin infection, gastroenteritis with vomiting, diarrhea, or dehydration have a risk of increased severity. Mpox infections that involve the eyes, mouth, genitals, or anus may also result in a risk of severe disease.6,22

The CDC does not recommend mass treatment of entire communities to eliminate mpox. The CDC does recommend people at risk for occupational exposure receive vaccination against mpox. Vaccination may reduce symptoms but does not always prevent infection in a person exposed to mpox within the previous four days.6

Mpox can impact multiple systems, and co-infections are possible. Soap and water, povidone-iodine, silver sulfadiazine, and moist occlusive bandages are examples of supportive care that promote healing at lesion sites. Adequate hydration, nutrition, and protection of vulnerable anatomical sites such as the eyes and genitals are critical.23

Treatment for pain is recommended, but specific analgesics have not been specified. Antipyretics can be used for fever. Antiemetics can be considered to treat nausea as well. For ocular infection, topical application of trifluridine is used to resolve symptoms and to attempt to prevent possible ocular scarring. Topical or oral antibiotics are therapeutic options for bacterial infection or as prophylactic therapy. Bronchodilation, nebulizer, or suctioning is recommended if the respiratory tract is affected.23

Uncertainty remains whether optimal doses of expanded access investigational new drug (EA-IND) therapeutics for patients with mpox will be the same or different from doses for other indications.24 Pharmacists should consult the full prescribing information for each therapeutic for comprehensive information, and pharmacy technicians should use the approved prescribing information to find information on storage conditions, if necessary. Table 1 lists FDA-approved treatments and agents with an EA-IND protocol for mpox or treatments undergoing further research.24

Table 1: Mpox Approved and Investigational Agents 24-30

There are multiple mpox agents in the Strategic National Stockpile (SNS), including tecovirimat, brincidofovir, and vaccinia immune globulin.22 The CDC facilitates the availability of vaccine PEP to contacts with high-risk exposures (e.g., unprotected contact with a patient’s skin or mucous membranes, lesions, or body fluids).31

Post-exposure prophylaxis is not recommended for people with low or uncertain risk (e.g., health care providers entering a patient’s room without eye protection). Post-exposure prophylaxis is recommended for intermediate- and high-risk contacts.2,18 Regarding vaccines, Table 2 describes the distinctions between the smallpox vaccine and the smallpox and mpox vaccine.

Table 2: Smallpox vaccine and smallpox and mpox vaccine distinctions6

*SC -subcutaneous

^ID -intradermal

†PERC -percutaneous

§lower dose permitted only for adults under FDA emergency use authorization (EUA)

Brincidofovir and Cidofovir

Brincidofovir and cidofovir have demonstrated activity against poxviruses in in vitro and animal studies. Data is not available on the effectiveness of treating human cases of mpox. Their use may be considered, but the benefit is unknown.22 The CDC holds an expanded access protocol for both products that allows the use of stockpiled cidofovir for the treatment of orthopoxviruses (including mpox) in an outbreak. Brincidofovir may have a

better safety profile than cidofovir regarding renal toxicity or other adverse events.21 Brincidofovir has a boxed warning of increased mortality when used for a longer duration in a non-FDA-approved disease.25 Cidofovir has a boxed warning of renal impairment and neutropenia.26

Smallpox vaccine

The smallpox live vaccine is for immunization in people who are ≥18 years old and at high risk for smallpox infection. It is contraindicated in individuals with severe immunodeficiency. Select boxed warnings include myocarditis, encephalitis, and erythema multiforme major, among others. Additional warnings include ocular vaccinia, infants younger than 12 months, and pregnancy. Common adverse events include injection site reactions, malaise, fatigue, fever, and headache.27 It has been made available for the prevention of mpox under the EA-IND.24 The smallpox vaccine is not currently available to the general public.22

Smallpox and Mpox Vaccines

The FDA has licensed smallpox and mpox vaccines to prevent infection with smallpox and mpox viruses. Data from Africa suggests that the smallpox vaccine is at least 85% effective in preventing mpox. It may also decrease the virus severity.6,22,28

Anaphylactic reactions after dosing are possible. In smallpox vaccine- naïve healthy adults, the most common injection site reactions were pain, redness, swelling, induration, and itching. The most common systemic adverse reactions were muscle pain, headache, fatigue, nausea, and chills. Warnings include severe allergic reactions. Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished response to the vaccine. 6,22,28

Tecovirimat

Tecovirimat is an antiviral drug.11,32 It was approved for the treatment of smallpox disease under a regulation known as the “Animal Rule.”33 Studies are conducted on animals when studies on humans are not safe or ethical.33 Smallpox was eradicated in humans, so infecting humans to study the efficacy of tecovirimat is not feasible, and it would not be safe or ethical.33

Tecovirimat reduces the production and release of enveloped orthopoxvirus, in vitro, for six variola virus (smallpox) strains and seven mpox virus strains.11,32 Clinical trials on animals demonstrated that the drug is safe with only minor side effects.33

The injection formula is contraindicated in severe renal impairment. Clinicians should monitor for hypoglycemic symptoms. Both the capsules and injection may cause headaches.29,33

Vaccinia Immune Globulin (VIG)

The use of this immune globulin for mpox is under an EA-IND. The benefit of the immune globulin vaccine for mpox is currently undetermined; however, healthcare providers may consider its use in severe cases. VIG can be considered for prophylactic use in an exposed person with severe immunodeficiency in T-cell function for which smallpox vaccination following exposure to the mpox virus is contraindicated. A boxed warning indicates maltose in immune globulin products may give falsely high blood glucose levels in certain types of blood glucose testing systems. Additional warnings include renal dysfunction, thrombotic events, and infusion rate precautions. The most common adverse drug reactions are headaches and nausea.22,30

In October 2022, HHS Secretary Xavier Becerra amended the Public Readiness and Emergency Preparedness (PREP) Act to broaden the providers authorized to administer mpox vaccines. The expansion includes pharmacists, pharmacy technicians, dentists, nurses, podiatrists, and others under certain

conditions. This PREP Act declaration removes barriers for pharmacists to order and administer for patients in all states.34

What is Next?

Research is ongoing to address mpox. The National Institute of Allergy and Infectious Diseases (NIAID) is initiating two studies to explore whether tecovirimat is a safe and effective drug to treat mpox for 14 days.35,36

No next-generation vaccine is currently available, or close to FDA regulatory review, to treat mpox. International researchers remain hopeful. Scientists are investigating and publishing that multi-epitope vaccines, which are composed of a series of or overlapping peptides, may become future investigational candidates for clinical trials.37

Summary

Mpox is a rare disease caused by an infection with the mpox virus. The virus may be transmitted through human contact with animals or human-to- human contact. The current mpox outbreak has spread worldwide, making prevention measures critical. Once exposed to the mpox virus, a patient may present with the signs and symptoms of mpox, including fever, intense headache, lymphadenopathy, back pain, myalgia, a lack of energy, skin rash or eruptions, sore throat, nasal congestion, or cough. The skin eruptions tend to be more concentrated on the face and extremities (palms, soles of feet) rather than on the trunk. Oral mucous membranes, genitalia, conjunctiva, and the cornea can be affected as well.

Treatment for the disease may be needed in more severe cases. Pharmacy teams are well-positioned to support mpox patient care, whether severe or self-limiting. All healthcare providers should contact their local or state health department if they suspect a case of mpox.

Course Test

Strategies for the prevention of monkeypox include the following:

Avoid close skin-to-skin contact with someone presenting with a new unexplained rash

Avoid close skin-to-skin contact in small crowds where people are wearing heavy clothing

Avoid sharing cups, utensils, and towels but sharing bedding with someone who has the virus is OK

Healthcare workers caring for monkeypox patients should wear gloves but not eye protection

How does a person get monkeypox?

Direct contact

Respiratory droplets

Sexual contact

All of the above

Should an infected person stay away from pet animals?

No, monkeypox does not transmit to pet animals.

Yes, they should avoid contact with pet animals.

No, an infected person and pets should be quarantined together.

It depends, a person should only isolate if the pet animal is sick.

Which of the following statements is TRUE about monkeypox signs and symptoms?

Monkeypox is usually a severe disease with fever and symptoms lasting 60-90 days.

The infection can be divided into the invasion period and the fever and headache period.

The monkeypox skin eruption usually begins within 1–3 days of the appearance of fever.

The sequence of the skin eruption sequence is macules → vesicles

→ papules →scabs →pustules.

Treatment options for monkeypox include which of the following?

Wash the skin with soap and water, and do not cover it with any bandages so air can help scabs form.

Drink only 2 cups of water a day, supplement the diet with sugar, and protect vulnerable anatomical sites.

Treatment for pain is recommended but only with aspirin, acetaminophen, and hydrocodone.

Antipyretics can be used for fever, antiemetics for nausea, and topical trifluridine, if needed.

A second-year medical school fellow approaches the pharmacist because a pregnant patient is deemed appropriate to receive a vaccine for monkeypox. The fellow asks whether the smallpox vaccine (ACAM2000) or smallpox and monkeypox vaccines (Jynneos) has warnings about pregnancy. Which response is most accurate?

Explain that either the smallpox vaccine or a combination of smallpox and monkeypox vaccines is appropriate in pregnancy.

Smallpox and monkeypox vaccine labels describe no association with adverse outcomes in animal offspring.

The smallpox vaccine can be given in the second and third trimesters, but not the first trimester of pregnancy, due to headache risk.

Explain that both can be given to pregnant patients as long as not more frequently than every 11 years.

A customer, who is studying to become a pharmacy technician, approaches the pharmacy because they heard the end of a news report about mpox and want to know what mpox is. Which response is most accurate?

As of November 28, 2022, WHO has a new name for monkeypox. The new name is mpox.

Mpox is the term used to describe when a patient has a co-infection of measles and monkeypox.

As of January 1, 2018, the CDC identified mpox as a rash spreading from the hands to the chest.

Mpox is the term to describe the vaccine for veterinarians to use for canines with fever.

Which is correct regarding tecovirimat?

It is available as a capsule and as an injection.

It is indicated for smallpox in adults and pediatrics.

It is indicated for complications due to vaccinia.

Only a and b are correct

Which statement should be remembered about the spread of monkeypox?

Vaccination is recommended for those with a sex partner diagnosed with monkeypox in the past 14 weeks.

*Spreading monkeypox through close contact includes kissing and touching someone who has symptoms.

Researchers published data confirming that individuals are not required to continue using condoms after monkeypox.

People who are diagnosed with monkeypox can return to work or close contact with others after four days of a rash appearance.

Which sentence should the pharmacy team remember about monkeypox?

Brincidofovir tablet or solution is FDA approved for use in individuals with monkeypox.

Cidofovir infusion formulation is FDA approved for use in individuals with monkeypox.

Nonreplicating smallpox and monkeypox vaccines are FDA- approved for monkeypox.

Tecovirimat is FDA approved for use in individuals with monkeypox weighing under 10 kg.

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