Drug info decades old

If you’re like me you rarely look at a drug’s formal product information, or PI. For detailed drug queries my computer software fails to answer I turn to sources other than the PI, such as the Therapeutic Advice Information Service (TAIS).
Nonetheless, I would have expected Product Information, supplied by the manufacturer and approved by the Therapeutic Goods Administration (TGA), to be accurate and up-to-date.
Unfortunately, according to two articles in this week’s MJA such assumptions are misguided. While the accuracy of information provided by the drug’s sponsor company is likely at its zenith at the time of registration, it may soon be outdated and should have a compulsory use-by date, says Australian Prescriber editor, Dr John Dowden.
With the pressure to approve drugs quickly, sometimes after phase II trials, new information will probably emerge soon after marketing, he says, quoting a US review of over 500 new drugs that found over 10% were subsequently withdrawn or acquired a ‘blackbox’ warning.
And while out-of-date PIs may not directly individual clinicians, Product Information is often the source people turn to when seeking detailed drug information as well as setting boundaries for advertising, consumer information (CMI) and forming the basis of MIMS.
In Australia, it is the sponsor’s responsibility to update product information, a costly exercise which may not take top priority especially in the case of old, less profitable drugs, says Dr Dowden.
And although previously government-funded, the TGA now relies on income from fees and charges from industry, resulting in a ‘risk management approach’ to regulation, he says.
Supporting this view, a prominent endocrinologist in the same issue of the MJA says PIs on thyroid medication are frequently ‘inadequate, inaccurate or outdated”, such as advice that thyroxine should always be commenced at a low dose.
Some PIs are around than 20 years old, says Professor Jim Stockigt, of Melbourne’s Monash University, yet financial disincentives currently deter pharmaceutical companies from updating them.
Surely we can come up with a better system than this.