The quality of medication information in Australia: the need for more clinical expertise and accountability.

The current review of the Therapeutic Goods Administration is an opportunity to improve the system for updating product and consumer information on drugs harmaceutical product information (PI) and consumer medicines information (CMI) are mandatory for prescription products in Australia, and government regulations specify that CMI must be consistent with PI. 1 Health professionals and consumers should be able to assume that these sources are up-to-date and consistent with evidence-based best practice. However, this is not necessarily so, particularly for older medications. 2,3 There is a wide discrepancy between the high-quality information available for new medications (eg, through series such as NPS RADAR [National Prescribing Service Rational Assessment of Drugs and Research]) and some existing texts 2-4 that originate from pharmaceutical sponsors , who pay fees to the Therapeutic Goods Administration (TGA) for review and approval of their submitted material. Officially sanctioned information may appear different from different perspectives: all may seem to be in order when assessed from the top down, and shortcomings may become apparent only when specific end products or outcomes are evaluated. Two examples demonstrate this problem. Current CMI for glucocorti-coids fails to distinguish between the dosages for replacement and for anti-inflammatory and immunosuppressive effects, a potential health hazard for several thousand Australians with adrenal insuf-ficiency. 3 The CMI in question, presented without professional accountability, remains uncorrected 18 months after attention was drawn to it, 4 and is clearly inconsistent with the corresponding PI and advice in the Australian medicines handbook. 5 In a second example, review of the PI from four different sponsors for thyroid medications identified erroneous therapeutic recommendations and the omission of well established indications or important side effects, as well as inappropriate advice on dose adjustment. 2 Two years after publication of a detailed critique of the PI for these medications, 2 11 of 16 salient errors remain uncorrected. 6 When medical professionals point out necessary improvements to current PI or CMI, official responses tend to be self-affirming, legalistic and defensive, rather than receptive to evidence and the consensus of clinical expertise. For example, when it was pointed out that the instruction in CMI, " Do not take Cortate if you have an uncontrolled infection " , 5 was dangerous for those with adrenal insufficiency, the TGA responded with the unexpected sophistry that this advice meant only " before you commence taking Cortate " , rather than " before you take your continuing …