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FDA criticises drug leaflets

The US Food and Drug Administration (FDA) has released data showing that the printed consumer medication information

The US Food and Drug Administration (FDA) has released data showing that the printed consumer medication information (CMI) leaflets voluntarily provided with new prescriptions by retail pharmacies are frequently inadequate and has suggested that it may pursue other measures to get the necessary information to consumers.

"The current voluntary system has failed to provide consumers with the quality information they need in order to use medicines effectively and safely," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. "We need to work with pharmacy operators, drug manufacturers, healthcare professionals, and consumers to come up with a sensible, comprehensive and more effective solution."

Currently, the FDA does not regulate CMI leaflets, although it does supply guidance to the companies that write them.

The FDA noted that in 1996, Congress set the goal that 95 per cent of all new prescriptions would be accompanied by useful CMI by 2006.  The new FDA-funded study, Expert and Consumer Evaluation of Consumer Medication Information, found that 94 per cent of new prescriptions are now accompanied by printed CMI, but that the material "does not consistently provide easy-to-read, understandable information about the use and risks of medications."

The study found that only about 75 per cent of the information met the minimum criteria for usefulness, meaning that it included scientifically accurate, unbiased information in an understandable and legible format.

The study also determined that there are only a few CMI publishers in the US, but that, even so, there is "considerable variability" in the amount of information provided and the way that it is formulated. "With an essentially voluntary effort, such variability might be expected," the study states.

"Because the Congressional goals have not been met, the FDA intends to seek public comment on initiatives that can be used to meet the goals," Woodcock said. 

The FDA's Risk Communication Advisory Committee will hold a public meeting to discuss the study's findings and "possible next steps" on February, 26-27 in Washington, DC.

31st December 2008

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