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Shortage of benzathine benzylpenicillin (Bicillin L-A®)

South Australia,

Alert Status:
Active
Issued Date:
13 Dec 2023

There is a global shortage of Bicillin L-A® (benzathine benzylpenicillin pre-filled syringes of 600,000 units/ 1.17mL AND 1,200,000 units/ 2.3mL suspension for injection) due to a manufacturing issue and increases in consumer demand. The shortage is predicted to continue to 29 February 2024 (Bicillin L-A® 1,200,000 units) and 15 November 2024 (Bicillin L-A® 600,000 units). All efforts are being made to maintain supplies; however, conservation strategies are needed to ensure access for critical indications where no suitable alternative exists. See https://shorturl.at/lvE46 for further details of the shortage.

The Therapeutic Goods Administration (TGA) has approved an alternative of the 1,200,000-unit product (Brancaster Pharma brand from the UK) from ORSPEC Pharma under Section 19A (S19A) of the Therapeutic Goods Act 1989. It is expected the S19A-approved Brancaster Pharma product will be listed on the Pharmaceutical Benefits Scheme (PBS) from 1 January 2024: more information can be found on the  PBS website. The alternative product is equivalent in pharmacokinetics to Bicillin L-A® but is presented differently: it is a powder for reconstitution and has a higher volume for injection. See for details: https://shorturl.at/uEGV5

Doctors are recommended to:

  • Conserve the pre-filled syringe product of benzathine benzylpenicillin (Bicillin L‑A®) for the following priority indications and settings:
    • Treatment and secondary prophylaxis of acute rheumatic fever (ARF), and secondary prophylaxis of rheumatic heart disease (RHD), particularly for paediatric patients. Refer to www.sahealth.sa.gov.au/rhd for information on ARF/RHD for health professionals.
    • Treatment of other priority indications listed below, in rural and remote settings and in Aboriginal medical services and Aboriginal community-controlled health services.
  • Use the S19A-approved alternative benzathine benzylpenicillin product for the other priority indications for benzathine benzylpenicillin:
    • Treatment of syphilis in those with proven or suspected infection and their recent sexual contacts. Refer to the Australian STI Management Guidelines (https://sti.guidelines.org.au/) for stage-appropriate treatment. Note: doxycycline is not considered first-line treatment for syphilis.
    • Treatment of group A streptococcal infections (sore throats and skin sores) for people at high risk of ARF and post-streptococcal glomerulonephritis, where oral therapy is not acceptable or the likelihood of non-adherence is high.
  • Restrict ordering of Bicillin L‑A® for prescriber bag supplies, unless there is a reasonable expectation that a high number of patients with the priority indications listed above will be encountered. Order alternative antibiotics for prescriber bags (https://www.pbs.gov.au/browse/doctorsbag) where it is unlikely that a high number of patients with priority indications for Bicillin L‑A® will be encountered.
  • Consider referring patients requiring syphilis treatment to Adelaide Sexual Health Centre (7117 2800) if appropriate.
  • Contact CDCB if patients advise that they are unable to access BOTH Bicillin L‑A® AND the S19A-approved alternative ORSPEC Pharma benzathine benzylpenicillin products.