Rates of congenital syphilis (an infection passed from parents to infants during pregnancy or childbirth) have been rising rapidly in the United States over the past several years. At the same time, the country faces a critical shortage of the only antibiotic approved to treat syphilis in pregnant women. A new survey of health care providers by the National Coalition of STD Directors (NCSD) found that these shortages are actually delaying care for pregnant patients.
More than 3,700 babies will be born with syphilis in 2022, according to CDC data.More than 10 times the number of births in 2012. These infections can lead to miscarriage, stillbirth, premature birth, low birth weight, or death shortly after birth. Treatment during pregnancy can be beneficial for both parent and child, but the shortage of Bicillin-LA is making treatment very difficult.
drug shortage
Vicillin LA, also called penicillin G benzathine, is the preferred treatment for all patients with primary and secondary (P&S) syphilis. This is the only treatment approved for pregnant women. There was previously a shortage of the drug, first between 2005 and 2010, and again in 2017 as cases of congenital syphilis became more common. Pfizer is currently the only pharmaceutical company making this drug. Manufacturing delays were announced in June. The company said supply shortages will persist until 2024.
Meanwhile, the CDC suggests that clinicians prioritize administering Vicillin LA to pregnant women with syphilis and their babies with congenital syphilis. All other patients should receive doxycycline.
Poll
In late August, the National Coalition of STD Directors (NCSD) conducted a survey of more than 100 sexual health clinics to determine how drug shortages were impacting hospitals and patients. We found that in the three months prior to the survey, 40% of clinics attempted to order Bicillin LA but were told it was not available. Additionally, 28% of clinics said they had to purchase medications from a nearby clinic or refer patients elsewhere for treatment.
NCSD sent out another survey in early November and received responses from 151 clinics and 136 health departments. Respondents represented 39 states, one territory, the District of Columbia, and communities served by Indian Health Services. Results show drug shortages are worsening and are impacting patient care.
Respondents were asked about the three months prior to the survey. Results included:
- 46% of clinics attempted to order Bicillin LA but were unable to obtain the medication. (This is an increase from 40% in the first survey conducted in August.)
- 40% of clinics had delays with Bicillin LA orders (up from 37% in August).
- Currently, 62% of clinics are reserving doses for pregnant people and other patients who cannot use doxycycline.
- Ten percent of clinics are already referring patients to other clinics for syphilis treatment, and another 23 percent of clinics expect to have to divert patients before the shortage is resolved.
Respondents from 13 state health departments and one Indian Health Service said they had received reports of pregnant women unable to access Bicillin LA in their jurisdictions (all of these pregnant patients received treatment, but with delays of up to an hour). It takes 28 days to receive treatment.)
Only 13% of clinic respondents trust Pfizer's assurances that the Bicillin LA shortage will be resolved in the first half of 2024.
To control the increasing incidence of congenital syphilis and prevent infant illness and death, pregnant women must have access to screening and treatment. If this drug shortage does not end soon, the incidence of congenital syphilis is likely to worsen.