Potential for injury compensation claims prompts TGA review of fentanyl patches

Date: Oct 02, 2013

The Age is currently looking into a review the Therapeutic Goods Administration (TGA) is conducting on fentanyl patches, which could lead to the possibility of injury compensation for those who have been affected.

The group is focussing on the packaging rules surrounding the painkiller patches. The TGA review was spurred by two reports of children coming into contact with the product and suffering adverse health consequences.

The TGA review is along the lines of a previous inquiry into the product, conducted by the US Food and Drug Administration, that led to changes in the way pharmaceutical companies can market fentanyl patches. In the US, companies must clearly print the name and strength in durable ink, so as to make the patches more visible.

This, the regulator said, will make it easier to spot in case the patch falls off, where it could come into contact with children. The FDA stated that several children had been killed over the years because of exposure to the patches.

"These types of events are tragic; you never want this to happen. We are looking for ways that we can help prevent this from happening in the future," said Douglas Throckmorton, deputy director of FDA's Center for Drug Evaluation and Research.

"This reinforces the need to talk to patients and their families to make sure that these patches are stored, used and disposed of carefully."
But the two recent cases of children being harmed by the patches has encouraged the TGA to make sure no deaths – such as those seen in the US – can occur.

Australian compensation lawyers prepare for changes

The review could mean changes in the way drug makers can market fentanyl patches in Australia. Although there is widespread evidence that intentional misuse of the product is a pressing concern, the TGA says its primary focus will be to address accidental injuries and deaths.

The Age spoke to Steve Hambleton, president of the Australian Medical Association, who stated that any changes to how the patch looks or is packaged would be welcomed in the medical community. With the proper markings, he said, the drug is still effective for dealing with intense pain.

One company that produces fentanyl patches in Australia has already been in contact with the TGA to say that it will "work collaboratively" with the administration to solve any issues that arise.

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