Benzylpenicillin (BENPEN) shortage

Advice for health service providers

28 September 2011

The Therapeutic Goods Administration (TGA) has recently been advised by CSL Limited of a shortage of stock of the product BENPEN benzylpenicillin (as sodium) powder for injection. BENPEN is registered in 600 mg, 1.2 g and 3 g strengths (AUST R 10329, AUST R 10326 and AUST R 10327, respectively).

The reasons for the shortage are a delay in manufacture and delivery from an overseas manufacture facility. There are currently limited stocks of BENPEN held by CSL Limited in all strengths. Based on previous rates of usage, CSL advise that its stock of the 600 mg product will be exhausted within one week; the 1.2 g product within 2 weeks and the 3 g product within 6 weeks.

CSL has informed the TGA that adequate stocks of BENPEN benzylpenicillin powder for injection will be available from December 2011. The TGA is working with CSL Limited and other pharmaceutical supply companies to identify alternative benzylpenicillin products that could be supplied in Australia in the period until December 2011. The TGA expects to confirm whether there is available alternative supply by the end of this week.

The Australian Commission on Safety and Quality in Healthcare (ACSQHC) has developed specific advice for clinicians and health services about the options for alternative antibiotic therapy. That advice is available in the ACSQHC publication Clinical advice concerning the shortage of benzylpenicillin.

Both the TGA and the ACSQHS advise that there is no threat to public safety and currently available antibiotics (including other penicillin products) can adequately substitute for benzyl penicillin.

ACSQHC publication

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