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FDA to make companies provide education programmes for pain drugs

Aims to improve safety measures for extended-release and long-acting opioid medications

FDA opioid safety plan
Pharma companies in the US will have to provide doctors with an education programme for any extended-release (ER) and long-acting (LA) opioid medications they market in an effort to prevent drug abuse and misuse in patients.

The requirement is part of wider measures from the US Food and Drug Administration (FDA) to reduce risks and improve safe use of the pain drugs that include Pfizer's Avinza, Actavis' Kadian, Janssen's Nucynta ER and Duragesic and several products from Purdue Pharma, all of which can cause serious harm and even death if used improperly.

The extra training will be based on an FDA design and will inform healthcare professionals about the safe prescribing of ER/LA opioid medications so they can have a greater knowledge and awareness when having a conversation with a patient about the risks and appropriate use of a prescribed medicine.

Companies are expected to achieve goals established by the FDA for the percentage of prescribers of ER/ LA opioids who complete the training, and prescriber understanding will be audited and assessed. Courses will either be free or charged at a small fee.

Despite pharma firms being made to provide such training, prescribers are not required to take it under current US law.

Instead, the FDA said it “continues to support this approach, but absent the needed legislation, intends to exercise its authority to require mandatory elements for companies and voluntary elements for prescribers”.

In addition, the full risk evaluation and mitigation strategy (REMS) also includes an updated medication guide for each drug, provided to patients via pharmacists that explains how to safely use ER/LA opioid medicines.

“Misprescribing, misuse, and abuse of extended-release and long-acting opioids are a critical and growing public health challenge,” said FDA commissioner Dr Margaret Hamburg.

“The FDA's goal with this REMS approval is to ensure that healthcare professionals are educated on how to safely prescribe opioids and that patients know how to safely use these drugs.”

The FDA is also encouraging the safe storage of such medicines to prevent them being taken by someone other than the person they are prescribed for.

"Just because it's safe for the patient, doesn't mean it's safe for someone else," said Dr Sharon Hertz, deputy director of the FDA's division of anaesthesia, analgaesia and addiction products.

According to IMS Health, it is estimated that 22.9m prescriptions of the painkillers were dispensed in 2011. There were 15,597 deaths involving these medications in 2009, said the US Centers for Disease Control and Prevention.

11th July 2012

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