STI Resources for Healthcare Providers

The Mark Cuban Cost Plus Drug Company (MCCPDC) is coordinating with the U.S. Food and Drug Administration (FDA) to temporarily import Lentocilin, a Portuguese-manufactured version of the form of penicillin known in the U.S. as Bicillin L-A. Lentocilin^©, (Benzathine Benzylpenicillin Tetrahydrate) Powder and diluent for suspension for injection 1,200,000 units, manufactured and marketed in Portugal by Laboratórios Atral S.A. Effective immediately, MCCPDC will distribute the following of Lentocilin^©, (Benzathine Benzylpenicillin Tetrahydrate) Powder and diluent for suspension for injection 1,200,000 units to address the shortage. Note: The volume of Lentocilin^© 1,200,000 units after reconstitution is around 4 mL compared to 2 mL for Bicillin L-A 1,200,000 units.

View more on this at: https://www.fda.gov/media/179787/download 

The CDC provided updated recommendations for the CDC Laboratory Recommendations for Syphilis Testing. Laboratories have a critical role in the public health response to the syphilis epidemic. The responsibility of the laboratory is to test specimens and report results in a timely manner, allowing clinicians to efficiently make clinical diagnoses for patient management. Public health reporting by laboratories also allows local health departments and CDC to conduct surveillance and monitor disease trends. This report details CDC’s new recommendations for syphilis testing, including laboratory-based tests, point-of-care (POC) tests, processing of samples, and reporting of test results to aid laboratorians and clinicians in the diagnosis of syphilis. Future revisions to these recommendations will be based on new research or technologic advancements for syphilis clinical laboratory science.

CDC Laboratory Recommendations for Syphilis Testing, 2024

The National Syphilis and Congenital Syphilis Syndemic Federal Trask Force has shared the Implementation of Point of Care Tests for Syphilis document to address the challenges in diagnosis and treatment of syphilis. This document emphasizes the often-asymptomatic nature of the infection and discusses the implementation of Point of Care (POC) tests to facilitate rapid diagnosis and treatment during the same visit. 

POC tests for syphilis differs from the traditional laboratory-based serologic testing primarily in specimen collection, time to result, need for confirmation, and sensitivity/specificity. While POC tests offers rapid results using whole blood from a fingerstick, it lacks the comprehensive assessment provided by laboratory-based tests, requiring confirmation and follow-up. It also underscores that laboratory-based testing remains the preferred option, particularly for individuals with a history of syphilis and low-risk individuals. Despite lower sensitivity and specificity, POC tests can be valuable, especially in settings with high incidence rates or where access to healthcare is limited.

Considerations for the Implementation of Point of Care (POC) Tests for Syphilis

Please be aware of the updated post here: https://www.cdc.gov/sti/php/from-the-director/2023-07-20-mena-bicillin.html regarding the bicillin shortage and additional bicillin supply from Pfizer. 
 
Update from Pfizer - June 10, 2024‎
On June 10, 2024, Pfizer shared an update on their 2.4 million Units/4 milliliter Bicillin L-A^® supply, noting that they currently have available supply. If there is sufficient supply of Bicillin L-A^® in your jurisdiction, please consider using Bicillin L-A^® for all appropriate patients, per CDC's standard guidance.

If you are experiencing Bicillin L-A^® supply issues, please notify DSTDP (stdshortages@cdc.gov) of any shortages and contact Pfizer Hospital US directly at the number or email below:

Pfizer Hospital US:
Phone: 844-646-4398
Hours: M-F 7 am - 5 pm CST
Email: PISupplyContinuity@Pfizer.com (For assistance with orders/supply information)

Note Bicillin^® L-A supply is improving, but it will not be fully available until later this year, per Pfizer's Availability Report.

E-mail for assistance with orders/supply information.

In January, Centers for Disease Control and Prevention (CDC) made aware that the U.S. Food and Drug Administration’s (FDA) announced the availability of Extencilline (benzathine benzylpenicillin injection, powder, for suspension) to address the ongoing shortages of Bicillin L-A^®. At that time, CDC directed all to the FDA’s distribution and administration information in a letter to healthcare providers (see the “Dear Healthcare Provider Letter”). The preparation and administration of Extencilline, as well as the contraindications for prescribing, differ from those for Bicillin-LA^®. CDC has provided a clinical information resource to more clearly delineate some of those differences and offer appropriate guidance. Please share this resource widely with your networks. 

Extencilline Information for Clinicians

The U.S. Department of Health & Human Services is offering the Stopping Syphilis: The HHS Summer Seminar Series, consisting of distinct webinars designed to share knowledge and tools to help reverse the syphilis and congenital syphilis epidemic in the United States. 

The series aims to highlight:

1. Latest developments and best practices
2. Tools for syphilis management
3. Insights directly from experts
4. Practical solutions for your communities

Register for this important initiative and help reverse the course of the syphilis epidemic in our communities. 

Stopping Syphilis: The HHS Summer Seminar Series

Webinar Schedule:

1. Correctional Facilities: Best Practices for Managing Syphilis
   Date: Wednesday, August 14, 2024
   Time: 11:00 AM-12:00 PM (CT)
   Register
   
   
2. Doxycycline for Syphilis: Alternative Treatments and Prevention
   Date: Wednesday, August 21, 2024
   Time: 11:00 AM-12:00 PM (CT)
   Register
   
   
3. Regional Insights: Syphilis Summit Findings by NACCHO and the Raven Collective
   Date: Tuesday, August 27, 2024
   Time: 11:00 AM-12:00 PM (CT)
   Register
   
   
4. Future Forward: Emerging Trends in the Syphilis Syndemic
   Date: Tuesday, September 17, 2024
   Time: 11:00 AM-12:00 PM (CT)
   Register

Originally held on 5/16/2024, this 1-hour Syphilis Update provides participants with training in the most recent advancements in epidemiology, diagnosis, and management of syphilis. This session focuses on general syphilis overview and basics.

COURSE OBJECTIVES

• Describe the changing epidemiologic trends of infection.
• List the stages of disease and describe clinical manifestations of each stage of syphilis.
• Discuss the clinical management of syphilis to include treatment, follow-up and partner management.
• Discuss screening recommendations.

(Free after you create a TRAIN account)

Access SD Syphilis Training Recording

To view all of the courses, visit https://courses.nnptc.org/upcoming_classes.html.  

Thank you for your continued diligence and partnership in the mission to reduce the rates of STIs in South Dakota.