Pharmaceutical 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 texts2-4 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 glucocorticoids 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 insufficiency.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 medication”.7 A response in the general press from NPS leadership denied any need to differentiate glucocorticoid replacement from other indications.8

What are the systemic weaknesses of Australia’s system of preparing, reviewing and updating PI and CMI?

• Australian pharmaceutical sponsors may lack the clinical resources and perspective to offer PI that reflects evidence-based best practice.

• The major publisher of PI and CMI, MIMS Australia, is restricted to publishing the TGA-approved texts.9

• PI and CMI are currently presented without professional accountability, a prerequisite for effective review.

How can these difficulties be addressed? Some recommend a defined “use by” date for PI.10 However, regular review would not necessarily address clinical concerns, and the cost might be prohibitive.

What else can be done?

• Regulatory authorities must abandon the now familiar response to any critique, “PI is the responsibility of the drug sponsor”, which can be used by these authorities to deny responsibility for deficiencies in that information.

• Sponsors need stronger clinical support, whether through the TGA or other means, in presenting therapeutic advice.

• Those who publish and disseminate PI and CMI, such as MIMS Australia, should be able to review, and should be accountable for, those texts. MIMS names a distinguished senior honorary editorial panel,6 who could have a valuable role in endorsing published PI or suggesting necessary revisions.

Abundant clinical expertise is available in Australia, often concentrated and coordinated in the clinical and scientific specialty societies, that could be brought together under the auspices of the Royal Australasian College of Physicians. Consensus advice from a specialty society, rather than individuals, would diminish the potential influence of commercial interests or pressure groups.

The key to effective updating and improvement of Australian pharmaceutical information is more fluent incorporation of clinical input, as occurs for adverse drug events. A notification process, initiated by vigilant professionals and consumers, should make it possible to eliminate incorrect, misleading, ambiguous or obsolete PI and CMI. The alternative is a progressively widening gap between industry and the consumers and professionals who use or prescribe medications. Both groups have the right to expect reliable, officially sanctioned pharmaceutical information. A revision of structures within the TGA is currently in progress.11 It would be a further setback if this opportunity to incorporate expert professional advice in the preparation and improvement of PI and CMI were overlooked.