Readers are invited to write in with their questions about decisions of the Pharmaceutical Benefits Advisory Committee (PBAC). Australian Prescriber publishes selected questions from readers, together with answers from the PBAC. Questions may address issues such as regulatory decisions, pharmaceutical benefits listings and withdrawals.
This exclusive arrangement helps Australian Prescriber readers understand how the contents of the Pharmaceutical Benefits Scheme (PBS, see www.pbs.gov.au) are determined.
Letters and responses are reviewed by the Editorial Executive Committee and may be edited before publication. It may not be possible to reply to all individual questions.
Question to the PBAC
I was very interested in 'Your questions to the PBAC: Adrenaline' (Aust Prescr 2005;28:90). In particular I wish to comment about the short expiry date of Epi Pens.
About six or seven years ago I contacted the distributor of the Epi Pen in Australia. I complained that sometimes I would purchase an Epi Pen for my son and often it only had seven or eight months left before it expired.
Their explanation was that it was actually transported from the USA and by the time it arrived here many months of its 12-month shelf-life were gone.
On hearing this I checked out an old Martindale (26th edition) and I read that adrenaline in solution was very stable for a number of years. I wrote to the manufacturer of Epi Pens in the USA with a photocopy of the extract out of Martindale but never received a reply.
Being a sceptic I just wonder whether it suits the manufacturer to overlook these details as obviously it would affect their sales substantially. Also I think it would be unlikely that a company would actively pursue ways of extending the expiry date!
At the time I was thinking about having the adrenaline stability checked out in an expired Epi Pen, but did not have time to pursue this further.
Perhaps if the Pharmaceutical Benefits Advisory Committee (PBAC) did it on a more authoritative basis one might receive a reply.
The Pharmaceutical Benefits Advisory Committee responds
The PBAC is aware of the short expiry date of Epi Pen. However, the sponsor, CSL Limited, has advised recently that the most recent data from the manufacturer's stability program do not support an extension of shelf-life.
CSL Limited is currently implementing a number of changes to the distribution process. These aim to improve the shelf-life in Australia of Epi Pen which is produced with a 20-month shelf-life by the US supplier, Dey Laboratories. The company advises that the following changes have been introduced to minimise the time lost between manufacture and patient in the distribution chain:
- Epi Pen will now be produced with Australian packaging by Dey Laboratories to save on repacking time in Australia
- CSL will work with wholesalers and pharmacies to minimise the time stock spends on shelves
- CSL will not release Epi Pen with a shelf-life of less than 13 months and in most cases it will be considerably more. Stock released since September 2005 will not expire for 17 months.
Letters explaining these changes were sent by CSL to doctors (general practitioners, immunologists, allergists, paediatricians and respiratory physicians), pharmacies and wholesalers.