Readiness Checklist

TPOXX (Tecovirimat) Operational Planning Guide — Information for Providing Therapeutics for Persons with Mpox

The following checklists are to facilitate jurisdiction readiness.

Determine which locations will receive TPOXX contingency/pre-positioned supply, ensuring access for re-distribution throughout the jurisdiction and consideration of initial need, as applicable.
Plan to receive at central locations for drug management and local redistribution, as applicable, within the jurisdiction.
Review CDC, FDA, and manufacturer materials regarding product configuration, shipping, storage, dosing, dosing intervals, and adverse event profiles.

Employ inventory management practices, including accurately reporting on-hand product inventory to inform tracking, near-expiry and redistribution.
Ensure plan is in place to report TPOXX inventory and utilization data weekly or as directed by HHS.
For each patient receiving treatment, submit data to the CDC as outlined by the EA-IND protocol.

Ensure providers are informed about availability of oral TPOXX treatment for mpox through STOMP trial and are encouraged to inform patients (see TPOXX and distribution sections above).
Ensure providers are informed that requests for stockpiled oral TPOXX for mpox treatment should be for patients who decline or are ineligible for voluntary participation in STOMP.
Ensure providers are informed about availability of pre-positioned oral TPOXX and processes for requesting through state health department. If no local pre-positioned oral TPOXX is available through the state, ensure providers are informed about process for requesting oral TPOXX through CDC.

Providers can request TPOXX from CDC by calling the CDC EOC or poxvirus@cdc.gov. (Note: The email box is monitored from 9 a.m. – 4 p.m. U.S. Eastern time on non-holiday weekdays. For urgent issues, contacting the on-call clinician via the EOC is preferred.)

Reinforce providers are required to use stockpiled TPOXX in accordance with the expanded access IND protocol that include:

obtaining informed consent before prescribing/dispending TPOXX.
completing and submitting the required EA-IND forms within the specified timeframe for each form as described on CDC’s website.

Disseminate training and communication materials to healthcare providers (e.g., fact sheets, online videos).
Ensure providers or other on-location staff are equipped and trained to respond to possible severe allergic reactions.
Maintain unused doses at appropriate temperatures to maximize shelf life (room temperature for capsules and refrigerated for IV).

Report aggregate TPOXX inventory and utilization counts through HPOP on a weekly basis or as directed by HHS
Ensure electronic systems are prepared to report and track TPOXX utilization and inventory.
Leverage Tiberius dashboards to help plan for an appropriate network of providers that ensures access by all. Use Tiberius to perform the distribution and thresholds

Create a communication plan to inform recipients of the risks and benefits of TPOXX.
Create a communication plan to inform providers of the required EA-IND filing needed for each patient to administer TPOXX to that patient.
Develop education and training materials for proper utilization of TPOXX.
Understand existing data on knowledge, attitudes, and perceptions regarding treatment in terms of need, provider types, and locations where treatment availability would be preferred. Share these data with local jurisdictions and partners to help shape messages.
Develop communications products for providers and the public that align with federal messaging and ensure communication materials are culturally and linguistically appropriate and consider feedback from stakeholders and community leaders.
Engage and educate partners and trusted messengers (e.g., healthcare professionals, community leaders) and at-risk communities as soon as possible regarding the availability of TPOXX and indications for use.