Enhancing Patient Care and the Scope of Practice for Pharmacists, Student Pharmacists Through Immunizations During the Monkeypox Outbreak

A microscopic war started about 3 years ago against an unknown virus. It was soon discovered that this unknown virus was named SARS-CoV-2, and originated in Wuhan, China.¹

The entire health care field including pharmacists and student pharmacists have been fighting on the frontline to combat this newly discovered virus by providing numerous services, including rapid point-of-care testing for SARS-CoV-2, recommendations for treatments, consultations for medications, and vaccinations to their communities during the infectious disease outbreak.

With all the services that pharmacists provide, the patient cases of SARS-CoV-2 progressively began to decline; however, in the meantime, a new virus has slowly escalated. According to the Centers for Disease Control and Prevention (CDC), more than 80,000 Monkeypox (Mpox) cases have occurred globally.²

In the United States alone, more than 29,000 cases and 14 deaths have been reported.² The number of Mpox cases is expected to rise, requiring continued testing, vaccinations, and medication services provided by members of the health care field, including pharmacists.

Mpox is a double-stranded DNA viral infection that is part of the Orthopoxvirus genus and Poxviridae family, both of which are also shared by the smallpox virus.^3,4 This virus was first discovered when 2 outbreaks occurred in 1958 in a research laboratory with monkeys in Africa.

While this incident has given the virus its name, the exact origins remain unknown. It was not until 1970, when the first human Mpox infection was reported in a 9-month-old boy in the Democratic Republic of the Congo.

Prior to the worldwide outbreak in 2022, Mpox infections remained primarily in Central and West Africa. Mpox is classified into 2 variants based on its place of origin: West African (WA) or Central African/Congo Basin (CB).⁵

In August 2022, the classification of these variants was updated into Clade I and Clade II respectively, with Clade II being split into additional subclades (IIa and IIb). Clade IIb is identified to be the prominent variant in the 2022 outbreak. It is more virulent and transmissible in humans, but it is less lethal (fatality rate is 3% to 6 %).^5,6

Mpox infection transmission occurs when a person is in close and direct contact with an infected person’s skin rash, bodily secretions, used and unsanitary belongings including clothes, bedding, utensils, and sexual devices.⁷ Transmission can also occur through intimate activity, such as hugging, kissing, or having sexual intercourse with an infected person.

Zoonotic transmission may occur when a person is bitten, has been scratched by an infected animal, or consumes their meat.⁴ The infection will start at the point of inoculation before reaching the lymph node, spreading to nearby tissues and finally the skin.

Signs and symptoms of Mpox will present within 3 weeks of exposure. Most will present with a painful, blister-like rash typically around the genitals but may also occur around the face, chest, hands, or feet.^8,9

Other signs include swollen lymph nodes, fever, fatigue, muscle ache, or respiratory symptoms that present as a cough or sore throat. Mpox is self-limiting with a recovery period of 2 to 4 weeks;⁴ however, until the rash resolves and new skin forms, the virus remains capable of spreading. Those with an active infection are recommended to isolate, avoid intimate activity, avoid sharing personal household items, and sanitize their hands as well as any objects and surfaces after handling them.

To slow down the transmission rate of the Mpox virus, the California Department of Public Health (CDPH) has approved the use of 2 vaccines: Jynneos and ACAM2000. Jynneos is produced by Bavarian Nordic, and is derived from the Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) strain, an attenuated strain that cannot replicate.¹⁰

Jynneos is a 2-dose series, and was initially given 0.5 mL subcutaneously; however, due to limited availability amidst the recent outbreak, the CDPH approved an alternative dose of 0.1mL intradermally to extend the supply.^11,12 In which case, subcutaneous administration is reserved for individuals who are less than 18 years old, of African, Hispanic, or Asian descent, or have a history of keloid scars.

ACAM2000 is produced by Emergent, and derived from plaque purification of live, replicable smallpox vaccinia.¹³ It is administered as a single 0.0025 mL dose percutaneously using a bifurcated needle after which a blister will form at the site of vaccination and scab before falling off on its own.

The availability of 2 different vaccines increases the means to protect at-risk populations from the ongoing Mpox outbreak. Each vaccine has their own indicated populations and requirements for administration. It is important for pharmacists to equip themselves with the necessary training to deliver this care to their respective communities.

In response to advocacy efforts by several pharmacy organizations and the services the pharmacists provided for the SARS-CoV-2 pandemic, the Department of Health and Human Services (DHHS) announced that pharmacists, as well as pharmacy interns and technicians, are among the health care providers now authorized to administer vaccines and therapeutics against smallpox, Mpox, and other orthopoxviruses in a declared emergency.^14,15 DHHS used its authority under the Public Readiness and Emergency Preparedness (PREP) Act to improve access to vaccines and treatments necessary to address the Mpox outbreak nationally.¹⁵

To help combat the Mpox, a local independent pharmacy in Sacramento, Pucci’s Pharmacy, started to provide Mpox vaccines for the public around the middle of July 2022. As the supply of the Jynneos vaccine was limited, they strictly followed guidelines set forth by Sacramento County Public Health (SCPH) in collaboration with the California Department of Public Health and the CDC to give vaccinations to the populations who are at highest risk of Mpox.

Per the SCPH protocol, the population that was eligible for Mpox vaccination included anyone living with HIV, any man or trans person who has sex with men, transgender individuals, anyone who is a sex worker, or anyone who diagnosed with bacterial sexually transmitted infection.¹⁶ Besides ensuring this high-risk population was protected from Mpox, priority was also given to health care providers who were exposed to the virus or were in close contact with patients who might have Mpox.

People were aware of the importance of the Mpox vaccine, but they lacked the knowledge for understanding disease prevention. Pharmacists and student pharmacists worked together to develop protocols for creating counseling sessions to provide factual, evidenced-based information about Mpox transmission, prevention, the vaccinations available, adverse effects and how to treat them, to answer questions related to the disease and the vaccinations, to dispel myths and rumors regarding the disease and the vaccinations, and streamlined the vaccination process to get as many patients vaccinated as rapidly as possible.

Upon patients’ request, a 1-1 private patient consultation was provided to ensure patients were receiving appropriate information for disease prevention and vaccine information. Many patients were immunocompromised, on multiple chronic medications, and they were concerned about contraindications of the vaccines.

In general, compared to ACAM2000, Jynneos is safe and could be widely used for patients with HIV, those who are taking immunosuppressive medications, and those with dermatological conditions. Contraindications for the vaccine included patients who have anaphylaxis to gentamicin, ciprofloxacin, chicken, or egg protein.¹⁷ According to the FDA, the Jynneos vaccine is only approved for Mpox prevention, not disease treatment.¹⁸

When patients showed up with symptoms of Mpox infection, it was critical for pharmacists and student pharmacists to evaluate their symptoms, the appearance of any bumps, pimples, blisters, or rash spots, and refer them to a provider or the county public health nurse to be considered for treatment with tecovirimat (Tpoxx). Patients with symptoms were requested to provide contact information for their close personal contacts so the pharmacists could provide these persons with priority vaccinations because those without symptoms might benefit most from Jynneos post-exposure prophylaxis effect.

Early medical intervention is preferred because patients are more likely to have a higher cure rate during earlier stages rather than late stages. Although Jynneos is a newer vaccine and it has not been widely used, patients’ perspective to administration has been open and positive.

The demand for patient-care services from pharmacists for Mpox increased overnight. The clinical practice of administering Jynneos intradermally can be challenging because intradermal vaccine administration was a new skill for most pharmacists; however, pharmacists and student pharmacists immediately took action to adapt to the new protocol to step up and protect the community against this outbreak. Pharmacists and student pharmacists became the center of responding to the Mpox outbreak by providing immunizations to their communities.

Faculty from California Northstate University College of Pharmacy (CNU-COP) trained their student pharmacists on the proper techniques for administration of intradermal vaccines and provided educational sessions for students to learn about Mpox and the vaccine to prepare them for multiple Mpox vaccine events. Student pharmacists at CNU-COP, along with their professor and IPPE Director of Experiential Education, Dr. Jennifer Courtney, collaborated with Dr. Clint Hopkins from Pucci’s Pharmacy, to administer Jynneos at several outreach events to the LGBTIA+ community and other high-risk individuals in Sacramento.

Pucci’s Pharmacy was one of the first pharmacies in the nation to administer the Jynneos vaccine. To date, Pucci’s Pharmacy, in collaboration with CNU-COP’s student pharmacists, have administered more than 6100 vaccines to high-risk Californians out of a total of about 10,000 vaccines overall given in Sacramento County alone.

During the COVID-19 pandemic, followed by the Mpox outbreak, both pharmacists and student pharmacists have played an essential role in educating the public regarding vaccine safety and efficacy, and addressing vaccine hesitancy. Pharmacists are one of the most accessible health care professionals and serve as the first point of contact with patients for vaccinations, therefore it is very important for them to educate the public on the importance of all vaccinations.

With each new skill and expanded responsibilities during these outbreaks, pharmacists and student pharmacists not only acted as frontline workers, but also as a significant part of the health care system by promoting public health. In addition, the increased demand for patient care allowed pharmacists and student pharmacists to be more involved in community outreach. To this day, pharmacists continue to promote public health, reduce health care disparities, and guard their community, as well as advocate for the advancement of the pharmacy profession.

Acknowledgement

We would like to thank Dr. Hopkins, and Pucci’s Pharmacy, for including us in this endeavor. It is an honor to collaborate with them and serve our community.

References

1. Center for Disease Control and Prevention. COVID-19 and Your Health. Centers for Disease Control and Prevention.Published February 11, 2020. Accessed December 7, 2022. https://www.cdc.gov/coronavirus/2019-ncov/your-health/about-covid-19/basics-covid-19.html#:~:text=COVID%2D19%20
2. Center for Disease Control and Prevention. 2022 United States Monkeypox Response and Recommendations | Monkeypox | Poxvirus | CDC. www.cdc.gov.Published May 26, 2022. Accessed December 7, 2022. Published May 26, 2022. Accessed December 7, 2022. https://www.cdc.gov/poxvirus/monkeypox/response/2022/index.html
3. Center for Disease Control and Prevention. About Monkeypox. Centers for Disease Control and Prevention. Published July 22, 2022. Accessed October 3, 2022. https://www.cdc.gov/poxvirus/monkeypox/about/index.html
4. World Health Organization. Monkeypox. World Health Organization. Published May 19, 2022. Accessed October 3, 2022. https://www.who.int/news-room/fact-sheets/detail/monkeypox
5. Alakunle E, Moens U, Nchinda G, Okeke MI. Monkeypox Virus in Nigeria: Infection Biology, Epidemiology, and Evolution. Viruses. 2020;12(11):1257. Published 2020 Nov 5. doi:10.3390/v12111257
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7. Centers for Disease Control and Prevention. How it spreads. Centers for Disease Control and Prevention. Retrieved December 8, 2022. https://www.cdc.gov/poxvirus/monkeypox/if-sick/transmission.html
8. Moore MJ, Rathish B, Zahra F. Monkeypox. In: StatPearls. Treasure Island (FL): StatPearls Publishing; July 16, 2022. Accessed October 3, 2022.
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10. Center for Biologics Evaluation and Research. Jynneos. U.S. Food and Drug Administration.Published April 2022. Accessed October 7, 2022. https://www.fda.gov/vaccines-blood-biologics/jynneos
11. Aragon TJ. Interim guidance: Intradermal administration of JYNNEOS smallpox and monkeypox vaccine recommended to extend scarce supplies. California Department of Public Health.Published August 15, 2022. Accessed October 7, 2022. https://www.cdph.ca.gov/Programs/CID/DCDC/Pages/Intradermal-administration-of-JYNNEOS-smallpox-and-monkeypox-vaccine-recommended-to-extend-scarce-supplies.aspx
12. Center for Biologics Evaluation and Research. Fact sheet for healthcare providers administering vaccines. U.S. Food and Drug Administration. Accessed December 8, 2022. https://www.fda.gov/media/160774/download
13. Center for Biologics Evaluation and Research. Medication guide smallpox vaccine, live ACAM2000 - Food and drug ... U.S. Food and Drug Administration. Published December 2019. Accessed October 7, 2022.https://www.fda.gov/media/75800/download
14. Shapovalova, V. (2022). Monkeypox virus–new challenges of modernity: experimental organizational and legal, clinical and pharmacological studies. SSP Modern Pharmacy and Medicine, 2(3), 1-15.
15. Assistant Secretary for Public Affairs (ASPA). HHS amends PREP Act declaration increasing workforce authorized to administer monkeypox vaccines. US Department of Health and Human Services. Published October 3, 2022. Accessed December 8, 2022. https://www.hhs.gov/about/news/2022/10/03/hhs-amends-prep-act-declaration-increasing-workforce-authorized-to-administer-monkeypox-vaccines.html
16. Monkeypox Info: Pucci's pharmacy. Mysite. (n.d.).Retrieved December 7, 2022. Accessed December 8, 2022. https://www.puccirx.com/monkeypox-info
17. CDC. JYNNEOS vaccine. Centers for Disease Control and Prevention.Published November 10, 2022. Accessed December 8, 2022. https://www.cdc.gov/poxvirus/monkeypox/interim-considerations/jynneos-vaccine.html
18. FDA mpox response. U.S. Food and Drug Administration.Accessed December 8, 2022. https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/fda-mpox-response