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ASHP urges HHS to issue PREP Act statement, allowing pharmacists to administer monkeypox vaccines

August 6, 2022 by admin

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 U.S. Department of Health and Human Services (HHS) to issue a Public Readiness and Emergency Preparedness (PREP) Act statement to enable pharmacists to order and administer monkeypox vaccines in a letter addressed to HHS Secretary Xavier Becerra.

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

According to the letter, written by Tom Kraus, MHS, JD, vice president of government relations at ASHP, there are more than 6,600 reported cases of monkeypox in the United States, and the number is rising rapidly. Kraus claims that a PREP Act statement, allowing pharmacists to order and administer the vaccine, would ensure timely access to vaccination and prevent viral infection in vulnerable populations.

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

The CDC recommends giving the monkeypox vaccine within 4 days of the exposure date for the best chance of preventing the onset of the disease and within 14 days of reducing 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 currently 2 vaccines, but neither is available from pharmacies yet.

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

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

“COVID-19 really emphasized the role of pharmacists in public health. As we know, the pharmacists and pharmacy technicians and interns have been at the forefront of vaccination efforts ever since,” Ganio said. “So we know from the COVID-19 experience that pharmacists are in a place where we can provide that accessibility for patients. utilize.”

In the letter, Kraus suggested that proactive authorization allowing pharmacists to order and administer monkeypox vaccines would allow pharmacists to expand access as vaccine stocks grow and prevent delays in vaccination for individuals exposed to the virus.

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

In addition, the PREP Act statement would improve access by unifying access to vaccines regardless of state.

“Currently, it’s a state-to-state patchwork of which vaccines pharmacists can administer,” Ganio noted in the interview with Pharmacy times. “So a declaration of the PREP Act and an amendment clarifying what pharmacists can administer would really streamline and unify that access nationwide, and it could probably include techs and pharmacy students, really increasing the workforce of available vaccinators.”

The ASHP letter also called on 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 the conditions under which pharmacists should administer monkeypox vaccines to our patients,” concluded Kraus.

Reference

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

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