ASHP Urges HHS to Issue PREP Act Declaration Enabling Pharmacists to Administer Monkeypox Vaccines

The move would help ensure timely access to vaccination following the declaration of monkeypox as a public health emergency.

The American Society of Health System Pharmacists (ASHP) urged the US Department of Health and Human Services (HHS) to issue a Public Readiness and Emergency Preparedness (PREP) Act declaration to allow pharmacists to order and administer monkeypox vaccines in a letter addressed to HHS Secretary Xavier Becerra.

The letter came in response to the HHS declaration of monkeypox as a public health emergency on August 4th, following a July 23rd announcement from the World Health Organization (WHO) declaring a global health emergency.

According to the letter, authored by Tom Kraus, MHS, JD, vice president of government relations at ASHP, there are over 6600 reported monkeypox cases in the United States, and the numbers are quickly rising. Kraus asserts that a PREP Act declaration allowing pharmacists to order and administer the vaccine would ensure timely access to vaccination and prevent virus infection in vulnerable populations.

“Pharmacists are well positioned to administer monkeypox vaccines for pre- and post-exposure prophylaxis of health care workers, patients, their close contacts, and populations at risk for severe disease from monkeypox virus (such as people with HIV or other immunocompromising conditions),” Kraus writes in the letter.

The CDC recommends the vaccine for monkeypox be given within 4 days from the date of exposure for the best chance to prevent onset of the disease and within 14 days to reduce symptoms of the disease.

In an interview with Pharmacy Times, Michael Ganio, PharmD, MS, BCPS, FASHP, senior director of pharmacy practice and quality at ASHP, explained that there are 2 current vaccines, but neither are available at pharmacies yet.

Referring to the Jynneos vaccine, fully approved for monkeypox, he said, “Currently, it's only available through the Strategic National Stockpile and it's being distributed to state and local territory health departments. From there, the state and territory health departments may work with a pharmacy or a health system or hospital to distribute the vaccine and help aid in immunization efforts.”

Ganio also discussed the role of pharmacists as a source of timely access to vaccines on a national scale, as demonstrated throughout the COVID-19 pandemic. This role could be key if pharmacists are authorized to administer vaccines for monkeypox.

“COVID-19 really put an emphasis on the role of pharmacists in public health. As we know, the pharmacist workforce and pharmacy technicians and interns have been at the forefront of vaccination efforts ever since,” Ganio said. “So, we know through the COVID-19 experience that pharmacists are in a place that we can leverage that patient accessibility.”

In the letter, Kraus suggested that proactive authorization allowing pharmacists to order and administer monkeypox vaccines would ensure that pharmacists are able to expand access as vaccine supplies increase and prevent delays in vaccination for individuals exposed to the virus.

“When patients access care from a pharmacist, directing the patient to another provider for vaccine administration would unnecessarily delay administration,” he wrote.

Additionally, the PREP Act declaration would improve access by making vaccine access uniform regardless of state.

“Currently, it's a patchwork from state to state of what vaccines pharmacists can administer,” Ganio noted in the interview with Pharmacy Times. “So, a PREP Act declaration and an amendment clarifying what pharmacists can administer would really streamline that access and make it uniform nationwide, and it could likely include technicians and pharmacy students, which really expands the workforce of available vaccinators.”

The ASHP letter also called for the HHS to proactively coordinate with payers, including Medicare and Medicaid, to ensure adequate reimbursement is available to support access to these services when provided by pharmacists.

“We welcome the opportunity to work with you to identify conditions under which pharmacists should administer monkeypox vaccines to our patients,” concluded Kraus.

Reference

American Society of Health-System Pharmacists Letter to HHS Secretary Xavier Becerra. ASHP; August 4, 2022. Accessed August 5, 2022. https://www.ashp.org/-/media/assets/advocacy-issues/docs/HHS-Letter-Monkeypox.pdf