Idaho Healthcare Providers Encourages to Monitor Supply of Bicillin L-A®; FDA Announces Shortage

Concurrent with elevated rates in syphilis infections in parts of Idaho, the U.S. Food and Drug Administration has listed Penicillin G benzathine injectable suspension products (Bicillin L-A®) on their drug shortage webpage, noting limited supply due to increased demand. Penicillin G procaine has been discontinued by the manufacturer.

Idaho public health officials have not received notification of in-state shortages; however, providers in other areas of the United States are currently experiencing difficulty procuring enough Bicillin L-A® to meet needs.

A nationwide shortage could impact healthcare providers. Idaho public health officials and CDC strongly encourage the following priority actions during the shortage announced by FDA:

Take inventory:

• Monitor local supply of Bicillin L-A® and evaluate your use to forecast need.
• Continue to contact distributors to procure Bicillin L-A® as appropriate. Contact Pfizer (see “Dear Patient Letter” posted on the FDA website) if there is less than a 2-week supply, the distributor has no supply, and there is a risk that patients may not be treated.

Prioritize using Bicillin L-A® to treat pregnant patients with syphilis and babies with congenital syphilis as penicillin is the only recommended treatment for these populations.

• Choose doxycycline for non-pregnant patients to help preserve Bicillin L-A® supplies.
• Facilities should consider involving antimicrobial stewardship leaders to help institute systems-level approaches to limit the use of Bicillin L-A® and encourage the use of alternative effective antimicrobials for treatment of other infectious diseases.

Appropriately stage syphilis cases to ensure appropriate use of antimicrobials. Early syphilis (primary, secondary and early latent) only requires 2.4 million units of Bicillin L-A®.

See the CDC STI Treatment Guidelines. Healthcare providers should:

• Conduct a thorough physical exam to accurately stage syphilis. Primary lesions are often hidden inside the mouth, anus or vagina; signs of secondary syphilis may be found on the skin, mouth or anogenital area (i.e., mucus patches, condyloma lata). The rash of secondary syphilis can be subtle.
• Attempt to access historical syphilis serologic test results that can assist with staging a patient with latent syphilis as early latent, if there is evidence of new infection within the last year (i.e., new seroconversion or a sustained four-fold increase in RPR titer in an individual who has had syphilis in the past). Local public health epidemiologist may have access to some of these results and can assist.
• Review signs and symptoms and sexual partner history from the past 12 months to assist with determining the likelihood of syphilis acquisition within the last 12 months, which also only requires 2.4 million units of Bicillin L-A ® instead of 7.2 million units.
  • For questions about syphilis clinical management contact an Infectious Diseases specialist at Central District Health at 208-327-8625, or the Department of Health and Welfare (DHW) Epidemiology Section at 208-334-5939.
• Report syphilis infections to Central District Health or the DHW Epidemiology Section.

Healthcare providers should consider notifying Central District Health or the DHW Epidemiology Section of any local shortages of Bicillin L-A® so public health officials can continue to monitor this situation and provide situational awareness to CDC, FDA, and Pfizer

Resources:

CDC STI Treatment Guidelines: https://www.cdc.gov/std/treatment-guidelines/syphilis.htm

Idaho Public Health Districts: https://healthandwelfare.idaho.gov/health-wellness/community-health/public-health-districts

National Coalition of STD Directors Bicillin Forecasting Tool: https://www.ncsddc.org/resource/bicillin-forecasting-and-inventory/

Online National Network of STD Clinical Prevention Training Centers STD Clinical Consultation Network: https://www.stdccn.org/render/Public

Staging Syphilis from the National STD Curriculum: https://www.std.uw.edu/go/comprehensive-study/syphilis/core-concept/all#clinical-manifestations

Staging Syphilis from the New York City Department of Health and Mental Hygiene: http://bit.ly/SyphilisMonograph2019PTC

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