Pharmacist FAQs
Frequently Asked Questions for Pharmacists on Monkeypox
THURSDAY, OCTOBER 6, 2022
US DHHS ISSUES PREP ACT DECLARATION AUTHORIZING PHARMACISTS TO ADMINISTER MONKEYPOX VACCINE AND THERAPEUTICS. On October 3, 2022, the United States Department of Health and Human Services issues a declaration under the Public Readiness and Emergency Preparedness (PREP) Act to expand the pool of qualified health professional authorized to administer monkeypox vaccines and therapeutics. The authorization includes pharmacists, pharmacy technicians, and pharmacy interns.
A summary of the new declaration is found here: https://aspr.hhs.gov/newsroom/Pages/PREP-Act-monkeypoxx-3Oct2022.aspx. An FAQ document is found here: https://aspr.hhs.gov/legal/PREPact/Pages/PREP-Act-FAQs-Monkeypox.aspx. The full declaration is found here: https://www.federalregister.gov/documents/2022/10/03/2022-21412/notice-of-amendment-to-the-january-1-2016-republished-declaration-under-the-public-readiness-and
The declaration states the training requirements that apply to pharmacist, pharmacy technicians, and pharmacy interns who exercise authority under this declaration:
(i) The vaccine or therapeutic must be authorized, approved, or licensed by the FDA;
(ii) Vaccination must be ordered and administered according to CDC's/ACIP's smallpox (variola virus), monkeypox virus, or other orthopoxvirus vaccine recommendation(s);
(iii) The healthcare professionals and students must have documentation of completion of the CDC-provided or -recommended training for the countermeasure and any additional training required in the FDA licensing, approval, authorization. In the absence of training requirements or recommendations from the CDC, other training(s) may be substituted if:
(1) it is approved or accredited training from a national or state recognized accrediting body or association, the FDA, or equivalent organization for the administration route of the medical countermeasure,
(2) it includes hands-on instruction for the administration route as appropriate for the countermeasure, supervised by someone that administers within their normal scope of practice,
(3) it includes clinical evaluations of indications or contraindications of smallpox (variola virus), monkeypox virus, or other orthopoxvirus countermeasures, and
(4) it includes the recognition and treatment of emergency reactions to smallpox (variola virus), monkeypox virus, or other orthopoxvirus countermeasures;
If applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering smallpox (variola virus), monkeypox virus, or other orthopoxvirus vaccines or therapeutics; *NOTE* AT PRESENT THERE ARE NO ADDITIONAL NORTH CAROLINA-SPECIFIC TRAINING REQUIREMENTS.
(iv) The healthcare professionals and students must have documentation of an observation period by a currently practicing healthcare professional experienced in the appropriate route of intradermal, subcutaneous, or intramuscular injections, dermal/percutaneous scarification, intranasal or oral administration and for whom the appropriate route of intradermal, subcutaneous, or intramuscular injections, dermal/percutaneous scarification, intranasal or oral administration is in their ordinary scope of practice, who confirms competency of the healthcare provider or student in preparation and administration of the smallpox (variola virus), monkeypox virus, or other orthopoxvirus vaccines or therapeutics to be administered and, if applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering smallpox (variola virus), monkeypox virus, or other orthopoxvirus vaccines or therapeutics;
(v) The healthcare professionals and students must have a current certificate in basic cardiopulmonary resuscitation;
(vi) The healthcare professionals and students must comply with recordkeeping and reporting requirements of the jurisdiction in which they administer vaccines or therapeutics, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine; and
(viii) *NOTE* THE JUMP FROM “VI” TO “VIII” IS A TYPOGRAPHICAL ERROR IN THE DHHS DECLARATION. The healthcare professionals and students comply with any applicable requirements (or conditions of use) as set forth in the CDC provider agreement and any other federal requirements that apply to the administration of smallpox (variola virus), monkeypox virus, or other orthopoxvirus vaccines or therapeutics.
PROTOCOL-BASED ADMINISTRATION OF MONKEYPOX VACCINE The PREP Act declaration authorizes qualified pharmacists who “hold a license or certification permitting the person to prescribe, dispense, or administer vaccines” and who meet the training requirements noted above to administer monkeypox vaccines. Under North Carolina law, immunizing pharmacists hold a license and certification to administer vaccines according to protocol. North Carolina law governing protocol-ordered vaccines administered by immunizing pharmacists does not include monkeypox vaccines. The PREP Act declaration, however, makes clear that “[t]o the extent that any State law that would otherwise prohibit a ‘qualified person’ from prescribing, dispensing, or administering Covered Countermeasures, such law is preempted.” Accordingly, Board staff concludes that qualified pharmacy personnel (i.e., those meeting the training requirements above) may administer monkeypox ordered according to protocol. Pharmacies and immunizing pharmacists may consult with the supervising physician who oversees their immunization protocol and, as appropriate, add monkeypox to their protocol-authorized immunizations.
*OCTOBER 11, 2022 UPDATE* North Carolina Medicaid has posted monkeypox vaccine billing guidelines: https://medicaid.ncdhhs.gov/blog/2022/10/07/monkeypox-vaccine-jynneostm-hcpcs-code-90611-billing-guidelines.
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FRIDAY, SEPTEMBER 9, 2022
NORTH CAROLINA DEPARTMENT OF HEALTH AND HUMAN SERVICES ISSUES INFORMATION FOR PHARMACISTS REGARDING ACCESS TO TPOXX FOR TREATMENT OF MONKEYPOX. In response to inquiries from practitioners in North Carolina, NCDHHS has issued the following information for pharmacists concerning TPOXX access.
At this time, there are no FDA-approved treatments for monkeypox infection. TPOXX (tecovirimat), an oral antiviral FDA-approved for the treatment of human smallpox disease, can be considered for treatment of monkeypox. CDC currently holds a non-research expanded access Investigational New Drug (EA-IND) protocol that allows for the use of TPOXX for primary or early empiric treatment of non-variola orthopoxvirus infections, including monkeypox, in adults and children of all ages. Treatment Information for Healthcare Professionals | Monkeypox | Poxvirus | CDC.
Prescribing physicians are responsible for completing the necessary paperwork associated with the EA-IND protocol. This includes obtaining signed, informed consent from the patient prior to initiating treatment. Detailed information about the EA-IND protocol can be found here.
Pharmacies dispensing TPOXX should ensure that signed, informed consent has been obtained by the prescriber prior to dispensing.
Physicians, Advanced Practice Registered Nurses and Physicians Assistants with active licensure in good standing with their respective governing bodies can prescribe and dispense TPOXX for treatment of monkeypox in accordance with the EA-IND, from their office, if the following conditions are met:
- There is absolutely no charge to the patient for the drug or act of dispensing, including seeking reimbursement of dispensing fees through 3rd party payors.
- Products are labeled in accordance with State and Federal dispensing laws.
TPOXX is only available through the Strategic National Stockpile. While distribution directly from the Strategic National Stockpile is currently limited, there are more than 900 courses of TPOXX pre-positioned at provider locations across the state. Providers in need of TPOXX, can place a request using this NC DHHS Monkeypox Medical Countermeasures Request Form. Requests are evaluated based on need and approved requests are currently being filled via transfer of pre-positioned product until direct distribution improves.
For questions regarding TPOXX, please contact PHPR.SNS@DHHS.NC.GOV.
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