Future Regulatory Initiative for Opioids



Future Regulatory Initiative for Opioids


Posted: Monday May 15th, 2017

Article by: Pinky Mazumder

If you have been tuning in to recent Canadian news, you will have noticed various critiques and discussions around the use of opioids. In case you are not familiar, opioids are narcotic pain relieving medications and are commonly prescribed in North America for acute and chronic pain1. However, in addition to its therapeutic effects, opioids carry various side effects including increasing tolerance and the potential for dependence and overdose, which can be fatal2. In fact in the year of 2015, there were approximately 2000 deaths in relation to opioid use in Canada1. With such alarming rates of overdoses and deaths across the nation, the need for a change could not be overlooked.

To respond to the opioid crisis, on May 8th, 2017, the Canadian Medical Association Journal published a clinical practice guideline with suggested recommendations on prescribing opioids. The guideline is primarily directed to physicians and relevant policy makers, and includes 10 recommendations for prescribing opioids for cases of chronic pain (non-cancer related)1. For more information, please read the guideline by clicking on this link. In addition to such clinical changes, Health Canada has also released a proposed regulatory initiative for opioid drugs3.

For the Forward Regulatory Plan of 2017-2019, Health Canada proposed a regulatory initiative titled: Amendments to the Food and Drugs Regulations – Labelling and Risk Management Plans for Opioid Drugs. These amendments may bring additional regulatory requirements for opioid drugs such as affixed warning stickers and mandatory risk management plans3. Complete and detailed information on the Forward Regulatory Plan by Health Canada, can be found here. The proposed changes are expected to be released in Canada Gazette Part I in 2017, to allow for public comments and consultations on the matter3. A link to the Canada Gazette Part I: Notices and Proposed Regulations can be found here.


Thank you for reading the CAPRA Blog. If such information is relevant to you, your organization/company, or to someone you know, please feel free to share this blog post with the Share buttons provided. Tune in next time for information on regulatory changes/updates for the industry. However, for implementation of any mentioned regulatory information and other regulatory information, please refer to the information directly released from the appropriate regulatory authorities. CAPRA is not a regulatory authority, nor a regulatory affairs consultation service. Thank you.

References
1.http://www.cmaj.ca/content/189/18/E659

2.https://www.canada.ca/en/health-canada/services/substance-abuse/prescription-drug-abuse/opioids/about.html

3.http://www.hc-sc.gc.ca/ahc-asc/legislation/acts-reg-lois/frp-ppr/2016-2018/opioid-opiode-eng.php