Michael Ganio, PharmD, MS, BCPS, FASHP, senior director of pharmacy practice and quality at ASHP, discussed the declaration of monkeypox as a public health emergency
In an interview with Pharmacy Times, Michael Ganio, PharmD, MS, BCPS, FASHP, senior director of pharmacy practice and quality at ASHP, discussed the declaration of monkeypox as a public health emergency, as well as pharmacists’ roles in educating patients. Although pharmacists are not currently able to administer vaccines for monkeypox, that authorization could come soon, as well.
Aislinn Antrim: Hi, I'm Aislinn Antrim with Pharmacy Times and I'm here with Dr. Michael Gonio, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists, to discuss the new designation of monkeypox as a public health emergency and what pharmacists’ roles are in this. And so, with this new declaration of this as a public health emergency, how should pharmacists counsel patients who are worried about monkeypox?
Michael Ganio, PharmD, MS, BCPS, FASHP: Well, first the pharmacists need to be aware of the symptoms and the patients that are at risk for monkeypox, so reviewing the materials on the CDC website is always a good idea. And what I expect to come from the public health emergency declaration is probably expanded access to vaccines and therapeutics.
Aislinn Antrim: Definitely. How is monkeypox transmitted and are there particular settings or environments where people are most at risk?
Michael Ganio, PharmD, MS, BCPS, FASHP: Well, currently, the outbreak seems to be among gay men or men who have sex with men, transmitted through close to skin contact. That's not necessarily sexual contact, but it is currently being spread through sexual activity. But we have to be careful that we don't classify it that way because it can be transmitted just through skin-to-skin contact. Simple contact like a handshake doesn't seem to be a significant risk, but there is a case report of a nurse who contracted monkeypox by changing bed linens from an infected patient. So, if there is an oozing or open wound, that may lead to transmission. So, we have to be really careful, again, about how we characterize it because people may think, “Well, I'm not at risk,” or not realize what the risk factors are. So, while it's currently in a specific community, it has spread beyond that community, and it definitely has the potential to spread further.
Aislinn Antrim: Absolutely. What are common symptoms that pharmacists and patients should be aware of?
Michael Ganio, PharmD, MS, BCPS, FASHP: Well, there's the pustules that form—they’re the telltale sign, and those pustules will eventually scab over. But while they're there and they're oozing, that's when the patients are most able to spread the virus. Some of those pustules can be very painful, so a lot of patients, especially those who are admitted to the hospital right now, are admitted for pain treatment, not necessarily because of any sort of issue with the disease. Fortunately, the case fatality rate for this current outbreak is very low in non-endemic countries. There have been 2 deaths currently in Spain, 1 in India, 1 in Brazil, and so far none in the United States. So as far as mortality is concerned, we're hopefully in a good place. But as far as the morbidity, you know, it's it can last between 2 to 4 weeks. So that may mean some isolation, obviously, being very careful about who you're in contact with. And then, of course, that acute serious pain that can land someone in the hospital.
Aislinn Antrim: Definitely. There are a lot of common misconceptions kind of going around [about monkeypox]. How would you recommend that pharmacists counsel patients to clarify these misconceptions?
Michael Ganio, PharmD, MS, BCPS, FASHP: Yeah, as I mentioned, it currently has a little bit of a stigma among the gay community and men who have sex with men. And it's very important that pharmacists understand that that is not in and of itself a primary risk factor. That just happens to be a community where it's spreading. And much like HIV when it was first an HIV outbreak, it was among gay men, but eventually it spread so that all populations had been affected by HIV. And again, especially because this is non-sexual contact, it can spread within a household. And that means that we could be looking at of course, the whole family. Men, women, and children can be affected, and with school starting, this is going to be important to keep an eye on to make sure that children aren't going to school and potentially spreading it there.
Aislinn Antrim: Absolutely. And are there any vaccines available for this? And are these vaccines available at pharmacies?
Michael Ganio, PharmD, MS, BCPS, FASHP: There are 2 current vaccines. Neither are available at pharmacies yet. One is actually fully approved for monkey pox [and] the other is a smallpox vaccine. It also carries with it several side effects. So, the primary vaccine that we're looking for here is called Jynneos, and it is approved for monkeypox. It's administered subcutaneously and the current FDA approval is for 2 subcutaneous doses, 4 weeks apart, and it is not available in pharmacies. 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. So as that vaccine becomes more available, we may see pharmacies and pharmacists, student pharmacists, and pharmacist interns become part of the providers who are administering these vaccines.
The other vaccine that I mentioned is called ACAM2000 and it is not highly recommended at this time. It's a unique injection technique; it actually uses a bifurcated needle. So, you think of like a little fork or prong, and it's 15 quick jabs into the skin after dipping it into the vaccine. It has higher incidence of myocarditis with it and it's actually a live, replicating vaccine, where Jynneos is not a fully viable virus. The ACAM vaccine actually contains a live virus that can replicate. So, anyone who's been immunized has to be very conscious around those who are immunocompromised because they can actually spread a case of the virus via infection to those patients. So, we're really trying not to use the ACAM2000, even though that is widely available. It's really just not recommended because of the side effects and those other risk factors.
Aislinn Antrim: And what is the current treatment landscape for monkeypox?
Michael Ganio, PharmD, MS, BCPS, FASHP: There's one primary treatment that's recommended. It's called TPOXX. That's the brand name, the generic name is tecovirimat. And currently it's available only through the CDC and it's available under an expanded access program through what's called an investigational new drug study. So, this is off-label use. Tecovirimat is only approved for treatment of smallpox. So, because it's being distributed through this strategic national stockpile by the CDC, it's only available through this expanded access program because it's off label. Now when we're in a fully approved drug that's available on the market, we do off-label treatments all the time. However, since these are government entities they’re following their approval processes very strictly. And that means that the only way to currently access the medication is through this expanded access program. Well, what we hope to see now that a public health emergency has been declared is that the FDA will now issue an EUA. So, the emergency use authorization would allow more widespread distribution of the drug, easier access, less paperwork. So, if the FDA does choose to issue the EUA for tecovirimat for the indication of monkeypox, then we would eliminate some of that paperwork and some of the enrollment process.
Aislinn Antrim: Wonderful. And how can pharmacists educate patients about monkeypox without contributing to existing stigma, as you mentioned, specifically among the gay community, since that misconception is going around.
Michael Ganio, PharmD, MS, BCPS, FASHP: For pharmacists to be able to educate, they need to fully understand the virus themselves, and that means reviewing resources. There are excellent resources in the Centers for Disease Control website, the FDA has some information on the treatments. And if you're looking for a central spot to find these resources, ASHP has launched a monkeypox resource center. And from that page, you can find a link to all of these resources. It's a one-stop shop. And as new resources and new news and information becomes available, we'll continue to update that page.
Aislinn Antrim: Wonderful. How has the COVID-19 pandemic helped us learn how to better prepare for health emergencies like this one? And are there any lessons learned from COVID-19 that pharmacists should keep in mind now?
Michael Ganio, PharmD, MS, BCPS, FASHP: Well, COVID-19 really put an emphasis on the role of pharmacists in public health. You know, as we know, the pharmacist workforce and pharmacy technicians and interns have been at the forefront of vaccination efforts ever since. You know, these first vaccination clinics, these mass clinics were set up by the state and local health departments and by hospitals and health systems. But over time, all of that shifted to the community pharmacies and the workforce, [and] they've really stepped up and improved the accessibility to these vaccines. So, we know through the COVID-19 experience that pharmacists are in a place that we can leverage that patient accessibility. We're also trusted medication experts, so when it comes to understanding COVID-19 treatments, whether it's monoclonal antibodies, we saw many examples of pharmacist prescribing and administering some of the monoclonal antibodies for COVID-19. Or now pharmacists have the ability to prescribe Paxlovid under certain conditions. Pharmacists are part of this public health infrastructure, and we need to continue to leverage them.
So, what I think we'll see with the monkeypox public health emergency is over time, as vaccine supplies increase, we may see a PREP Act declaration similar to what we saw for COVID-19, that would allow pharmacists nationwide to administer monkeypox vaccines. Currently, it's a patchwork from state to state of what vaccines pharmacists can administer. 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 other thing, again, would be the therapeutics. So, as the cases are more easily done, diagnosis and treatments become more widely available. Pharmacists will play a role in in helping to have patients understand those medications, how to take them, as we always do with everything. And then one other thing is still sort of growing, but we learned we were a little slow with COVID-19 getting the infrastructure for testing up and running. And so hopefully with monkeypox, we get a little bit more streamlined testing, whether it's through more widespread labs or eventually pharmacies, who were doing tests where they could send it off to have a PCR test done. At some point, we'll likely see point of care tests for monkey pox and that will streamline that diagnosis straight into treatment. And I think pharmacists will be a part of that too, moving forward.
Aislinn Antrim Absolutely. Is there anything you want to add or anything that I didn't think to ask about?
Michael Ganio, PharmD, MS, BCPS, FASHP: Sure. We actually, probably as we speak, we're finalizing a letter to HHS Secretary Xavier Becerra, asking for the PREP Act to for a direct declaration of monkeypox under the PREP Act, and then an issuance of an amendment that would allow this uniform immunization across the country for pharmacists, pharmacy students, and pharmacy interns. So that if the Public Health Department in a state or territory decides to ask a local hospital or pharmacy to help with immunization efforts, they're covered under the PREP Act and granted that authority. So, we hope to see a response to that soon. And we'll see, as a public health emergency was just declared, I think more of this type of information will be available in the coming weeks.
Aislinn Antrim: Definitely. And we will definitely be following all of this closely. Thank you so much for talking with me about this.
Michael Ganio, PharmD, MS, BCPS, FASHP: My pleasure. Thank you