Safety could be at stake when PI is not updated
Letters to the MJA from the National Prescribing Service (NPS) and the Australian Medicines Handbook (AMH) say safety may be at stake when manufacturers fail to update PI on which electronic software systems base dosage advice.
They use the example of colchicine, with a new low-dose regimen being recommended by NPS RADAR and the AMH in 2010, while higher doses remain in the PI.
Professor Nicholas Buckley and Simone Rossi, from the AMH, acknowledged that amending PI was a costly and lengthy process.
The current system for maintaining it often broke down with out-of-patent, grandfathered and orphan drugs, they said.
In the case of colchicine, they had suggested to the TGA it could initiate PI change “in the public interest”.
MJA 2011; 195:517