The Centers for Disease Control and Prevention (CDC) is working to make it easier for U.S. healthcare providers to request TPOXX (also called tecovirimat), an antiviral drug that can be used under special circumstances to treat patients with monkeypox. CDC recently posted information clarifying the current TPOXX ordering process: Obtaining and Using TPOXX (Tecovirimat) | Monkeypox | Poxvirus | CDC.
The web posting clarifies that forms and other documentation required for obtaining TPOXX can be submitted after clinicians receive the drug and begin patient treatment. The prior requirements to photographically document lesions and to collect and ship specimens to CDC are now optional. Healthcare providers can begin administering TPOXX as soon as they obtain informed consent from the patient. Additional modifications are being worked out with the U.S. Food and Drug Administration (FDA) and will be announced soon.
TPOXX is approved by the FDA for the treatment of smallpox in adults and children but is not currently approved for monkeypox. Under an authority called Expanded Access Investigational New Drug (EA-IND) or compassionate use, TPOXX is authorized for physicians to use in treating patients with monkeypox. Supplies of TPOXX are maintained by the Strategic National Stockpile (SNS) in the Office of the Assistant Secretary for Preparedness and Response. The process to obtain medications from the SNS differs from the usual commercial means used by clinicians and healthcare care pharmacists to order other drugs.
Clinicians and healthcare facility pharmacists can request TPOXX preferably by contacting their state or territorial health department; however, they can also reach out directly to CDC by contacting its Emergency Operations Center (EOC, 770-488-7100; Poxvirus@cdc.gov). Clinicians and healthcare facilities are not required to be preregistered to order the drug. Once contacted, CDC staff can request shipment of the drug from the SNS, which will deliver the medication promptly. In some states, doses of TPOXX have been requested and are already pre-positioned for even faster access by clinicians.
As part of the EA-IND, certain documents need to be completed, including FDA Form 1572, an informed consent form, a patient intake form, an adverse event form, an outpatient case report form, and a post-TPOXX treatment form. CDC is committed to further reducing the burden of “red tape” for physicians while staying within the requirements of EA-IND regulations. To this end, CDC and FDA are working to further simplify the protocol with additional reductions in data collection and reporting requirements that will be made available soon.
Obtaining TPOXX through CDC’s EA-IND offers several benefits to clinicians and healthcare facilities. CDC’s protocol provides umbrella regulatory coverage, which means clinicians and healthcare facilities do not have to obtain their own INDs to administer TPOXX. Use of TPOXX under CDC’s EA-IND also provides liability protection for covered persons (e.g., healthcare providers prescribing, administering, or dispensing the drug) and compensation to patients if they are injured by the medication.
In addition, FDA permits participating sites or providers to obtain institutional review board (IRB) review through either a local IRB or a central IRB, including CDC’s central IRB. A waiver of the IRB requirements is not necessary if a particular site uses the CDC’s centralized IRB under the EA-IND protocol. For more detailed information, see FDA’s guidance titled Information Sheet Guidance For Sponsors, Clinical Investigators, and IRBs – Waiver of IRB Requirements for Drug and Biological Product Studies. Since CDC’s EA-IND protocol for TPOXX is solely for use as treatment that is not considered human subjects research, federal-wide assurance requirements do not apply |
