Healthy Skepticism Library item: 12039

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Poisoning advice 'out of the dark ages'
Sydney Morning Herald 2007 Nov 18
http://www.smh.com.au/news/national/poisoning-advice-out-of-the-dark-ages/2007/11/18/1195321595279.html

Full text:

A guidebook relied on by Australian doctors to help medicate patients contains inaccurate, outdated and potentially dangerous information that could be life-threatening, a report has warned.

A review published in the Medical Journal of Australia has heavily criticised the trans-Tasman drug regulator for allowing omissions and inaccuracies in the MIMS annual, the drug information and treatment bible used by GPS and specialists.

Sydney emergency specialist Dr James Mallows reviewed the guidebook’s advice for 25 different types of poisoning and concluded that there were multiple omissions, inaccuracies and advice to use treatments now considered “out of the dark ages”.

“For the 25 drugs examined, 14 monographs contained inaccurate information, one contained a recommendation for ineffective treatment and 14 omitted specific treatment or antidotes,” said Dr Mallows, from Nepean Hospital.

“Many of these errors could delay or even prevent patients receiving currently accepted and effective therapies for life-threatening poisonings if MIMS were used as the primary resource.”

The product information in the guide is provided by drug companies and signed off by the Therapeutic Goods Administration (TGA). Under current guidelines, the manufacturer is responsible for keeping this official information up to date, but changes cost $4000 and are not enforced.

This latest review, which compared MIMS advice with “gold standard” consensus advice gathered from five sources, is one of several published recently to find fault with the process.

One report released in January also raised serious concerns and called for a prompt review. “Based on this and other reports, the TGA-approved product information monographs contain inaccurate, inadequate, out-of-date or potentially dangerous information relating to poisoning management advice, paediatric drug dosages, drug interactions, breastfeeding mothers and various thyroid medications,” Dr Mallows wrote.

“It is time for the TGA to take up its role as regulator and insist on updated and accurate monographs from pharmaceutical companies.”

But the drug regulator defended the product guidelines, saying they were “not intended to act as a textbook of medicine or general management of patients”.

“[It] is intended to contain sufficient information to allow a health professional, in average circumstances, to use the specified medicine safely and to refer to other sources of information and expertise should they be required,” TGA national manager David Graham wrote in the same journal.

He encouraged doctors to alert the TGA or drug companies to any errors and eluded to plans to rearrange the drug information in the future to make it clearer to understand.