DOH issues guidance for HCW with Monkeypox and CDC updates Tecoviramat requirements

July 22, 2022

GNYHA continues to monitor updated guidance and other developments related to the monkeypox outbreak. The following includes updated health care worker guidance from the New York State Department of Health (DOH), changes to the monkeypox therapy protocol, and clarification about monkeypox-related waste disposal.

DOH Guidance for Health Care Workers with Monkeypox

DOH issued the attached reminder to health care facilities to encourage staff with signs and symptoms of monkeypox to not report for work. All persons who have been exposed to someone with confirmed monkeypox should isolate at home and contact their employer and primary care provider for guidance on testing and treatment. As the cases of monkeypox continue to rise–as of July 21, 2022, there were a total of 830 confirmed cases across New York State – DOH encourages providers to be alert for the signs and symptoms of monkeypox in patients and staff.

Updates to Tecoviramat IND Protocol

The Centers for Disease Control and Prevention (CDC) updated its investigational new drug (IND) protocol For Tecovirimat (TPOXX®) for Treatment of Human Non-Variola Orthopoxvirus Infections in Adults and Children, to make it easier for providers to prescribe TPOXX® for patients with monkeypox. The key changes are listed below:

  • Reduced follow-up visits and specifying that all can be telemedicine visits
  • Reduced number and length of case report forms – pharmacokinetic (PK) sampling is optional and no longer required
  • Serum samples not required, but serology testing is available at CDC if requested by treating clinicians
  • Clinical laboratory parameters no longer required
  • Lesion photos are now optional
  • An indication for use of tecovirimat as an alternative or complementary option to post-exposure prophylaxis vaccination has been added

The CDC IRB approval for the Expanded Access IND for Tecoviramat has been extended and will now expire on July 23, 2023.

For more information and the updated IND protocol, GNYHA encourages providers to review the CDC webpage.

Disposal of Medical Waste from Patients with Suspected or Confirmed Monkeypox

In response to member requests for clarification on disposal of Regulated Medical Waste from patients with suspected or confirmed monkeypox, GNYHA is pleased to receive confirmation from DOH that New York State is following CDC/US Department of Transport guidance that waste from a patient with suspected or confirmed monkeypox virus can be disposed of as Regulated Medical Waste, in the same way other waste from health care facilities is regularly managed-if the clinician has confirmed that the patient does not have epidemiological risk factors for Congo basin clade of Monkeypox Virus (e.g. history of travel to the Democratic Republic of the Congo, the Republic of Congo, the Central African Republic, Cameroon, or Gabon in the prior 21 days).

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