Monkeypox Info & Guidance for Santa Cruz County Healthcare Providers

Report all Suspect Monkeypox Cases to Santa Cruz County Public Health.

All suspect monkeypox cases must be reported within 1 working day to Santa Cruz County Communicable Disease Control, preferably by email or fax. Please submit a Confidential Morbidity Report form by email to HSACD@santacruzcounty.us or by fax to (831) 454-5049. 24/7 reporting of suspect monkeypox by telephone is no longer required and is not the preferred method.

Diagnosis:

• Clinical recognition guidance: Clinical Recognition | Monkeypox | Poxvirus | CDC
• Please consider both epidemiological and clinical criteria when submitting specimens for testing.

For patients presenting with concern for monkeypox infection:

• Clinicians should implement appropriate infection prevention/control measures: Infection Control: Healthcare Settings | Monkeypox | Poxvirus | CDC
• Providers should counsel patient(s) on appropriate isolation and infection control measures. Please see isolation instructions here: Isolation and Prevention Practices for People with Monkeypox | Monkeypox | Poxvirus | CDC
• For additional guidance: Clinician FAQs | Monkeypox | Poxvirus | CDC
• Please provide patients with suspected monkeypox infection with a written work excuse.

Commercial Reference Labs. Monkeypox testing is now available through LabCorp, Quest, ARUP and other reference labs are rapidly developing capacity to test.

• For most Santa Cruz County Healthcare providers a commercial reference laboratory will be the best option for streamlined monkeypox testing and resulting.
• Please check with the reference lab regarding their lab-specific submission forms and requirements for specimen collection, labeling, and transport.
• There is no need to contact Santa Cruz County Public Health for approval to test at commercial laboratories, but providers must still report all suspect cases within 1 working day.

Santa Clara County Public Health Lab is still accepting specimens for monkeypox testing reserved for abnormal clusters of cases and severely ill individuals. For Public Health Lab specific submission forms and requirements for specimen collection please reference the Monkeypox PHL Testing Guidance.

JYNNEOS monkeypox vaccine continues to be in short supply. Santa Cruz County receives vaccine allotments from the state health department and continues to request as many doses as possible in the shortest timeframe available to address the critical shortage of local vaccine needed to stem the outbreak.

Eligibility. Until inventory levels are increased, please review and adhere to current CDPH eligibility guidance (updated 8/4/2022 to clarify limited 2nd dose eligibility) for 1st and 2nd doses of JYNNEOS vaccine, by prioritizing people that are contacts of confirmed or suspect cases of Monkey Pox, members of certain Occupational Groups, or those who are in Tier 1 or Tier 2 for eligibility.

Prioritizing 1st doses. Additionally, CDPH is asking that 1st doses are prioritized at this time and to defer 2nd doses for now except for those with moderate to severe immune compromise.

• CDC Monkeypox Vaccine Guidance: https://www.cdc.gov/poxvirus/monkeypox/clinicians/smallpox-vaccine.html
• CDPH Prioritizing inventory of JYNNEOS smallpox and monkeypox vaccine: https://www.cdph.ca.gov/Programs/CID/DCDC/Pages/Monkeypox-vaccine-doses.aspx
• CDPH Considerations for Expanded Monkeypox Post-Exposure Prophylaxis (PEP++): https://www.cdph.ca.gov/Programs/CID/DCDC/Pages/Considerations-for-Expanded-Monkeypox-Post-Exposure-Prophylaxis.aspx#msdynttrid=2qvszz9jxcc4f0b46gPkGI5DVrYbLp9UPinNHBuFIB4

CAIR. It is vital that providers enter all JYNNEOS doses in CAIR. CDPH is watching CAIR closely to determine the future allocation of MPX vaccine to Santa Cruz County.

• If you need support entering doses administered into CAIR – please reach out to immunizations@santacruzcounty.us.

Storage, Handling, Expiration and Administration. Please see Santa Cruz County Public Health JYNNEOS document which includes information on:

• Vaccine administration
• Storage and handling
• Reporting
• Additional resources

Pediatric Vaccination. JYNNEOS has an FDA indication for ages 18 years and up. An expanded access program (EA-IND) for pediatric JYNNEOS is in development. Meanwhile, if JYNNEOS is needed for a pediatric contact to a monkeypox case, CDC has made an S-IND (single patient) process available; please contact immunizations@santacruzcounty.us for facilitation as needed and please include the subject line: “Pediatric JYNNEOS Vaccine”.

If you are a provider in need of JYNNEOS vaccines or have any questions, please reach out immunizations@santacruzcounty.us.

Tecovirimat (TPOXX) has an FDA indication for treating smallpox and is available to treat cases of monkeypox via Expanded Access Investigational New Drug (EA-IND) protocol. Tecovirimat efficacy for treatment of monkeypox disease in humans is unknown and undergoing evaluation. For guidance on TPOXX use under the EA-IND, please see the CDC’s Monkeypox Healthcare Provider TPOXX page.

Many patients experience subjectively severe symptoms of monkeypox disease that do not meet current criteria for tecovirimat administration. Provider experience supports the use of supportive care and symptomatic treatment for what is in most cases a self-limited illness, including pain relievers, topical cortisone and benzocaine/lidocaine gels for painful proctitis.

Obtaining TPOXX: Required Paperwork and Patient Informed Consent
Prescribing tecovirimat requires the following regulatory paperwork and patient informed consent. Check for updated information on paperwork requirements on the CDC’s webpage: Information for Healthcare Providers on Obtaining and Using TPOXX for Treatment of Monkeypox. Get started by filling out form Form FDA 1572; CDC only requires one form per facility.

Review IND Protocol

• Tecovirimat IND Protocol

Submit Once (Initial Onboarding)

• Form FDA 1572 completed and sent to CDC by one provider per facility within 3 days of initiation.
  • CDC only needs one form per facility.

Prior to Treatment

• Obtain Informed Consent Prior to treatment patients have consented and provider has consent on file. Consent forms do NOT need to be returned to CDC.

During Treatment

• Patient Intake Form completed and sent to CDC within 3 days of Tecovirimat, TPOXX initiation.

After Treatment

• Clinical Outcome Form is completed and returned within 3 days of last patient follow up.
• Occurrence of Serious Adverse Events (SAEs) – if yes, reported by completing a MedWatch Form and returning to CDC via email (regaffairs@cdc.gov) within 72 hours of awareness or sooner if possible. A fillable-PDF MedWatch Form can also be downloaded from MedWatch Forms for FDA Safety Reporting | FDA

Choose one method to return the above information:

• Encrypted email: regaffairs@cdc.gov (personally identifiable information should not be emailed without encryption)
• Fax: 404-902-5921
• Secure Share File for lesion photos and large file sizes (please zip multiple files and use filenames with patient identifier, hospital name, and date https://centersfordiseasecontrol.sharefile.com/r-r3941801ebcbd4002b4dfe98e314ec697

For clinical questions regarding tecovirimat, please contact Santa Cruz County Communicable Disease: HSACD@santacruzcounty.us.

Santa Cruz clinicians seeking assistance to become a prescriber can email immunizations@santacruzcounty.us subject line: TPOXX Support Request.

Ordering TPOXX
To place an order for TPOXX, please fill out the linked TPOXX Resource Request Form and email it to immunizations@santacruzcounty.us. A member of our team will confirm receipt of your request and begin processing your order. Orders will be shipped directly to the address listed on your resource request form. Please note the above paperwork requirements that must be completed within three (3) days of TPOXX treatment initiation.