Second Survey Exposes Worsening Bicillin L-A Shortage Amid National Syphilis Crisis 

Contact: Elizabeth Finley, efinley@ncsddc.org, 919-749-7309

Washington, DC – The National Coalition of STD Directors (NCSD) has released the results of a new survey on the growing severity of the nationwide shortage of Bicillin L-A, the only treatment available for pregnant patients with syphilis and the preferred treatment for nearly all syphilis patients. Pfizer, the only U.S. manufacturer of Bicillin L-A, acknowledged the shortage in a letter to the FDA in June 2023 amid a dire outbreak of syphilis and congenital syphilis cases.

The Second Bicillin L-A Shortage Severity Survey updates an August survey of sexual health clinics – the first known survey measuring the severity of the shortage in sexual health clinics – and has been expanded to include questions for state and local health department STI leaders. The survey results update what is known about the impact of the shortage on patient care and clinic operations, as well as the implications for community level syphilis rates.

Among the key findings, the Second Bicillin L-A Shortage Severity Survey discovered instances where pregnant patients could not access Bicillin L-A when they needed it. The CDC’s recent Vital Signs report on congenital syphilis highlighted that the failure to provide timely treatment to pregnant patients is a significant driver of the congenital syphilis epidemic.  [FIND OUR BRIEF FOR POLICY MAKERS: NCSD RELEASES ITS SECOND SURVEY OF THE BICILLIN L-A SHORTAGE SEVERITY]

With responses from 151 clinics and 136 health departments representing 39 states, one territory, Washington, D.C. and communities served by Indian Health Services, the survey shows that the drug shortage is worsening, and that the shortage is likely to have implications for the nation’s explosive congenital syphilis outbreak.

Second Bicillin L-A Shortage Severity Survey

November 6, 2023 – November 9, 2023

Health departments and clinics urgently need more information, situation monitoring, and resources from CDC and HHS to manage the impact of the Bicillin L-A shortage on patients, clinics, and communities.

• Although the CDC has repeatedly said that they are not aware of pregnant patients who cannot get Bicillin L-A, health departments are hearing different information. Respondents in 13 different states and one Indian Health Services agency say they’ve received reports of a pregnant person in their jurisdiction who was unable to access Bicillin L-A. While most respondents said they were aware that treatment was ultimately provided, only 56% could say that treatment was provided within one week.
• Health departments are focused on solutions and named specific actions the federal government and Pfizer could take to support them:
  • According to 80% of responding jurisdictions, more communication from the federal government to different healthcare settings that consume and administer Bicillin L-A, like hospitals, would help manage the shortage.
  • Seventy percent of health departments want more updates from federal agencies and Pfizer on the shortage and how to access Bicillin L-A.
  • Sixty-seven percent need more funding for disease intervention specialists (DIS). Throughout the survey, respondents named ways DIS are mitigating the shortage, including coaching patients through a full course of doxycycline treatment when it can be used as alternative treatment. The need for DIS funding will become more acute as communities feel the impact of the June 2023 decision to rescind DIS funds, “we will lose 15 DIS who specifically follow up on syphilis in June of 2024.”
  • Other measures requested included a HAN message from CDC (44%), more funding for clinics (42%), and declaring a public health emergency (39%.)
• As syphilis rates continue to rise, 68% of health department respondents say the Bicillin L-A shortage itself will directly cause syphilis rates to increase in their jurisdiction.

Patients – including pregnant patients – are not getting the syphilis treatment they need when they need it because of the Bicillin L-A shortage.

Pregnant Patients

• In the past three months, health department respondents from 13 different states and one Indian Health Services agency say they’ve received reports of a pregnant person in their jurisdiction who was unable to access Bicillin L-A.
• While most health department respondents were able to confirm that pregnant patients who could not immediately get Bicillin L-A were eventually able to receive the treatment, only 56% could say that treatment was provided within one week and 31% said it took between 8 and 28 days to receive treatment.

Patients Who Are Not Pregnant

• In the past three months, 36% of clinics have had a patient who could not complete their full course of doxycycline treatment for syphilis.
• 11 clinics, which collectively serve 9,811 people per month have had to reduce or eliminate expedited partner therapy (EPT), a best practice for treating infections and preventing reinfections.

Healthcare providers’ access to Bicillin L-A has continued to get worse since NCSD conducted its first Bicillin L-A Shortage Severity Survey in August.

• In the previous three months, 46% of clinics have attempted to order Bicillin L-A, but the drug was not available, compared to 40% in the first survey conducted in August.
  • 55% of clinics that had orders completely unfilled had more than half of their orders unfilled, compared to only 38% of clinics reporting this challenge in the first survey.

• Partially filled orders and delayed orders continue to be a challenge for clinics:
  • Thirty-one percent of clinics have received partially filled orders in the past three months, compared to 33% of clinics reporting this challenge in our first survey.
  • Forty percent of clinics have had their Bicillin L-A orders delayed in the past three months, compared to 37% of clinics reporting this challenge in our first survey.

Sexual health clinics have stepped up to navigate the Bicillin L-A shortage without being provided additional resources, but the impact of the shortage is likely to get worse.

• Sixty-two percent of clinics are currently reserving doses for pregnant people and other patients who cannot use doxycycline, such as unhoused patients.
• Sixty-three percent of clinics have added follow-up appointment services for patients receiving doxycycline to help increase the likelihood of the patient completing treatment.
• All of clinics that responded to the survey plan to protect the availability of client services, even as their capacity is stretched, however one in 10 are already referring patients to other clinics for syphilis treatment and another 23% of clinics anticipate needing to divert patients before the shortage is resolved.
• Only 13% of clinic respondents believe Pfizer’s assurances that the Bicillin L-A shortage will be resolved in Q2 of 2024.

About the Survey

The Second Bicillin L-A Shortage Severity Survey was conducted November 6, 2023 – November 9, 2023. Responses were received from 136 state and local health departments and 151 sexual health clinics. The clinics that responded to the survey collectively serve nearly 70,000 patients each month and estimate providing syphilis screening or treatment to a minimum of 21,000 patients each month.

About the Bicillin L-A Shortage

Bicillin L-A is the only treatment available for pregnant people with syphilis and is an essential drug for preventing congenital syphilis; Bicillin L-A is also the first line of treatment for all syphilis patients. In June of 2023, Pfizer alerted the FDA to a shortage of Bicillin L-A and predicts the shortage continuing into Q2 of 2024. In response to the shortage, CDC has asked providers to prioritize treating pregnant patients with syphilis with Bicillin L-A and using doxycycline for other patients. While doxycycline is an effective drug for syphilis, patients can struggle to complete doxycycline treatment, leaving their syphilis untreated and risking continued community transmission.

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