UPDATE: Shortage of Penicillin G Benzathine (Bicillin L-A)

 

     June 22, 2023

 

Dear Colleague,

Please note: The letter previously issued on June 21, 2023, has been updated to accurately reflect CDC’s guidance that presumptive treatment is not needed for persons who have had sexual contact with a person who receives a diagnosis of primary, secondary or early latent syphilis greater than 90 days before the diagnosis if serologic tests are negative. 

The FDA listed a shortage of Penicillin G benzathine injectable suspension products (Bicillin L-A®) on April 26, 2023.  Pfizer provided an availability update on June 12, 2023, with an expected recovery in the second quarter of 2024.   There are no emergency stockpiles of this medication, and product is being allocated with limited inventory released, resulting in the supply not meeting demand.  Providers should work with their supplier or Pfizer directly regarding product availability.

Virginia has observed increased incidence of syphilis among adults and congenital syphilis.  Reported cases of syphilis during the first four months of 2023 were 22% higher than during the same timeframe in 2022, and six cases of congenital syphilis have been reported so far this year.  The number of syphilis cases with ocular, otic or neurological manifestations has increased 118% from 2022 compared to the first four months of 2023.  Many syphilis diagnoses are occurring among persons who inject or otherwise use drugs.  Successful disease intervention efforts by health counselors in local health departments have also led to increased utilization of Bicillin L-A to treat patients infected with syphilis and their exposed partners.

Bicillin L-A is the only CDC-recommended treatment for some patients, including pregnant people infected with or exposed to syphilis, and babies with congenital syphilis.  Although Bicillin L-A remains the treatment of choice for patients with syphilis, CDC has recommended that healthcare providers prioritize the use of Bicillin L-A to treat pregnant people and babies with congenital syphilis.  If warranted due to the drug shortage, doxycycline is an alternative therapy for non-pregnant patients diagnosed with or exposed to syphilis; however, doxycycline is an FDA Pregnancy Category D medication, and is not recommended as an alternative treatment for pregnant individuals.  Pregnant individuals should be treated with the recommended penicillin regimen for their stage of infection.

VDH advises health care providers to consider the following recommendations, in order to conserve Bicillin L-A for use with patients for whom it is the sole recommended treatment against syphilis.

VDH Recommendations for Alternative Treatment Options

  • If a drug shortage of Bicillin L-A warrants alternative therapy, consider using doxycycline to treat syphilis for adult patients who are not pregnant or allergic to doxycycline. This will help ensure Bicillin L-A doses are available for use for the priority populations below:
    • Pregnant people and their sexual partners
    • Infants and neonates with congenital syphilis
    • People of reproductive age who can get pregnant and their sexual partners
    • Patients with doxycycline allergy
    • Patients who have already begun a course of treatment with either 1.2MU or 2.4MU doses of Bicillin L-A.
  • Educate patients receiving doxycycline on the importance of adherence
  • Consider alternatives to Bicillin L-A to treat other infectious diseases (such as streptococcal pharyngitis) when other treatment options are available
  • Should Bicillin L-A 2.4MU doses be unavailable, providers may consider administration of two (2) doses of 1.2MU per dose interval.
  • Use of other intramuscular formulations of penicillin, including Bicillin C-R, are not acceptable alternatives for the treatment of syphilis.

Below are the CDC-recommended courses of treatment using doxycycline for patients diagnosed with probable syphilis.

  • Early syphilis (primary, secondary, or early latent): Doxycycline 100mg by mouth twice daily for 14 days.
  • Late syphilis (late latent or unknown duration): Doxycycline 100mg by mouth twice daily for 28 days.

Additional CDC Recommendations

  • Thorough clinical and serologic follow-up of persons receiving doxycycline or another alternative therapy for syphilis is essential to ensure treatment is successful. Patients should be followed to ensure that a fourfold RPR titer decrease is achieved within six to 12 months of completing treatment.
  • Patients who are coinfected with HIV can be treated as described for patients who do not have HIV. However, consider additional follow-up to ensure adherence and successful fourfold RPR titer reduction.
  • Persons who have had sexual contact with a person who receives a diagnosis of primary, secondary, or early latent syphilis <90 days before the diagnosis should be treated presumptively for early syphilis, even if serologic test results are negative.
  • Persons who have had sexual contact with a person who receives a diagnosis of primary, secondary, or early latent syphilis >90 days before the diagnosis should be treated presumptively for early syphilis if serologic test results are not immediately available and the opportunity for follow-up is uncertain. If serologic tests are negative, no treatment is needed. If serologic tests are positive, treatment should be based on clinical and serologic evaluation and syphilis stage.
  • Clinicians with questions about syphilis clinical management may contact the National Network on STD Prevention Training Centers (NNPTC) STD Clinical Consultation Network.

Additional Resources and Reference Materials for Clinicians

Thank you for partnering with us for disease treatment and prevention as we strive to reduce syphilis and especially to reduce congenital syphilis in Virginians.

Sincerely,

Karen Shelton, MD

State Health Commissioner

Respiratory Illness Update

 

Respiratory Illness Update

October 21, 2022 

Dear Colleague,

Public health surveillance indicates Virginia may experience a challenging flu and respiratory disease season this fall and winter. Following are some related data along with steps you can take to help prevent and reduce illness among your patients. 

Respiratory Syncytial Virus

Emergency department (ED) and urgent care (UC) visits with diagnosed Respiratory Syncytial Virus (RSV) have quadrupled and have been rapidly increasing in Virginia’s syndromic surveillance system since early September.  

Figure 1: ED and urgent care visits that include RSV in the discharge diagnosis. Syndromic surveillance data limitations should be considered when interpreting these data.

Recommended Actions: Review diagnosis and treatment information for RSV. Palivizumab is a monoclonal antibody recommended by the American Academy of Pediatrics (AAP) for certain high-risk individuals. Ensure you are familiar with AAP’s RSV prophylaxis guidance. 

Influenza

ED and UC visits for influenza-like illness (ILI) are increasing. During the week ending October 15, 2022 the percent of ILI visits was higher than the same week during each of the past five years. This may signal an early start to the flu season and VDH will closely monitor outbreak and laboratory data to better understand this. Among 0-4 year olds, 14.1% of all ED and UC visits during October 9-15 were for ILI.

Virginia Immunization Information System data indicate that flu vaccination uptake between July 1 and October 16 of this year is lower, especially in pediatric populations, than the same time periods during the previous three years.

According to the CDC, racial and ethnic disparities in influenza-associated hospitalizations were consistently observed among Black, AI/AN, and Hispanic adults compared with White adults in the U.S., with hospitalization rates an average of 1.2 to 1.8 times those in White adults during the past 13 seasons. The reasons for these disparities are likely multifactorial, including lower influenza vaccination coverage.

Recommended Actions: 

  • Recommend flu vaccine to your patients.  Your strong flu vaccine recommendation is one of the most important factors in patients accepting the vaccine. 
    • For the 2022-2023 season, there are three flu vaccines that are preferentially recommended for people 65 years and older.  
    • Additional recommendations from ACIP for the 2022-2023 flu season were published August 26, 2022.  
  • Offer flu and COVID-19 vaccines at the same visit, if eligible and the timing coincides.  Getting both vaccines at the same visit increases the chance that a person will be up-to-date with their vaccinations.
  • Remind patients to stay home when they are sick and to practice good hand hygiene and respiratory etiquette.  
  • Monitor flu activity on the VDH website.  

Thank you for providing care to your patients and for your partnership with public health.

Sincerely,
Colin M. Greene, MD, MPH
Colonel, US Army, retired
State Health Commissioner

Additional Resources: