Healthy Skepticism Library item: 7586

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Publication type: news

Pollard R.
Out-of-date information puts thyroid medication users at risk
The Sydney Morning Herald 2007 Jan 15
http://www.smh.com.au/news/national/outofdate-information-puts-thyroid-medication-users-at-riskprofessor/2007/01/14/1168709616126.html

Full text:

PATIENTS are being put at risk by a flawed federal regulation system that allows product information on medications to become dangerously out of date.

A review of the information for thyroid medications – involving 780,000 prescriptions each year – found numerous unsafe, inadequate or omitted treatment recommendations.

Information for two anti-thyroid drugs, carbimazole and propylthiouracil, had not been updated significantly since 1985, although there had been important treatment advances since then.

Another drug, thyroxine, has product information that is out of step with current practice, particularly for commencement of treatment and in relation to pregnancy.

The review, conducted by Jim Stockigt, a professor of medicine at Monash University and The Alfred and Epworth hospitals in Melbourne, found that under current guidelines the manufacturer alone was responsible for managing the product information.

It was not possible to extrapolate his findings across the entire spectrum of available drugs, he told the Herald.

“You would find some discrepancies with other medications, but the thyroid medication is the most outstanding example I have found. Some of the information is so fundamentally wrong, it is clear it has never been across the desk of anyone expert in thyroid treatment.”

The poor quality of information meant patients could be using too much or not enough medication to control their condition, leaving them vulnerable to a recurrence of symptoms, or in the case of pregnant women have an impact on the baby, he said.

The revelations have led to calls for the drug regulator the Therapeutic Goods Administration to take a more active role in ensuring drug information is up-to-date with current practice. Professor Stockigt is deeply critical of the opposition of the TGA, describing it as having an “it can’t be done” mentality.

The information in the MIMS medication database and the Australian Prescriptions Product Guide was used as the benchmark for consumer products.

“Medical literature gets peer reviewed, the stuff in MIMS has been put together by the sponsor, and somebody at the TGA without specialist knowledge looks it over,” Professor Stockigt said.

His review, published in the Medical Journal of Australia today, should prompt an urgent revision of product information and the system used to manage it, he said.

In an accompanying editorial, the editor of Australian Prescriber, John Dowden, suggested a use-by date for product information. He also criticised a system that allowed the drug’s maker or sponsor to be solely responsible for keeping the information up to date.

The TGA was reviewing Professor Stockigt’s claims and was discussing the issue with the sponsors of the products, a spokeswoman said.