ADR that result in revision of patient information
|
| |
| Canada: Information Update - Label changes for controlled-release opioid pain medicines encourage more targeted prescribing and safer use |
| |
Health Canada is advising healthcare professionals and Canadians that it has implemented labelling changes for the class of drugs known as controlled-release opioid pain medicines, to enhance their safe and appropriate use. The changes provide standardized wording that more clearly outlines the risks and safety concerns associated with controlled-release opioids. The updated label also encourages more appropriate patient selection and monitoring.
While an effective pain treatment, opioid medications carry risks and can have serious negative health impacts, even at recommended doses. Their use can also lead to accidental overdose and death. The label changes seek to reduce these risks, which include addiction, misuse and abuse, while preserving access for those who need them most. There are currently 38 brand name and generic controlled-release opioid medicines in Canada and include, among others, controlled-release versions of morphine, oxycodone, and fentanyl. “Controlled release” medications are designed to be long acting, meaning they produce gradual, steady absorption of the drug in the body over an extended period of time, which allows patients to take them less often. The changes apply now to all classes of controlled and extended release non-generic opioids. Similar label changes will soon be implemented for generic opioids.
The approved use for all opioids in this class has been modified to remove use for “moderate” pain. The new label clarifies that these drugs are indicated for the management of pain severe enough to require daily, continuous, long-term opioid treatment that is opioid-responsive and for which alternative treatment options are not adequate. The changes preserve the ability for prescribers to choose appropriate treatment for their patients, but provide clearer guidance on the recommended patient population.
In addition, existing warnings and safety information have been made clearer, including health risks to children from accidental exposure and to newborns exposed during pregnancy. Warnings with respect to opioid addiction potential have also been strengthened and made clearer. As well, the changes standardize label information, and ensure information targeted to patients is easier to read and understand.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../41157a-eng.php
In Hong Kong, there are 24 registered pharmaceutical products which are controlled-release opioid pain medicines. 15 of them are in oral tablet forms and 9 of them are in transdermal patch forms. All of the products are prescription-only medicines. Related news has been released by the US FDA, and was posted on the Drug Office website on 11 September 2013. A letter to healthcare professional was also issued on the same day to draw their attention to the matter. As previously reported, the matter will be discussed in the meeting of the Registration Committee (the Committee) of the Pharmacy and Poisons Board. In view of Health Canada's announcement, the information will also be submitted to the Committee for consideration. The Department of Health will remain vigilant on any updates related to the products and regulatory actions taken by overseas health authorities.
Ends/ Tuesday, August 19, 2014
Issued at HKT 13:00
|
| |
|
