New products for serious adverse drug reaction hospital reporting: Notice

February 15, 2023
Our file number: 23-101396-13

New products have been added to those that fall under the serious adverse drug reaction (ADR) reporting requirements for hospitals.

The additions are a result of new regulations that are now in effect for public and military health emergencies. Titled Sale of Drugs (Public or Canadian Armed Forces Health Emergencies), these regulations are set out in the Food and Drug Regulations. They are also known as 'block release regulations'.

This new regulatory framework makes available drugs that are not authorized for sale in Canada or not available through other emergency channels. Chief medical officers of health (public health officials) will be able to stockpile and use drugs obtained through these regulations for a public health emergency in Canada. Their use is anticipated to be a rare event.

Under the block release regulations, hospitals must report to Health Canada serious ADRs suspected from a drug obtained through these regulations for a public health emergency. Reporting must be done according to procedures already in place for mandatory reporting. These procedures are outlined in the following guidance document:

• Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals

Please note that we are updating this guidance document. The revised document will include information on the mandatory reporting of serious ADRs for drugs obtained through the block release regulations.

Public health officials will inform hospitals that a drug obtained through the block release regulations is being used for a public health emergency.

As drugs obtained through the block release regulations are not authorized for sale to the public, they do not have a drug identification number (DIN). Therefore, the serious adverse drug reaction report must include the drug's identifying name, code, number or mark. Please note that public health officials will also provide hospitals with either one of these 4 elements when informing that a block release drug is being used.

For more information, please contact the Bureau of Policy, Science and International Programs, Prescription Drugs Directorate by email at policy_bureau_enquiries@hc-sc.gc.ca.