Mandatory hospital reporting – How to report serious adverse drug reactions and medical device incidents
(Animated video, in a hospital.)
(A female physician is wearing a white lab coat with a stethoscope around her neck. She's in an office in a hospital.)
Are you a healthcare professional who works in a hospital? If so there are new federal regulations that could affect your work.
(We see the exterior of the hospital building. The next screen shows symbols representing medications, syringes, a heart monitor, prescription and other medications and medical devices typically found in a hospital.)
The new regulations require all hospitals in Canada to report all serious adverse drug reactions and medical device incidents to Health Canada.
(A woman appears. She takes a pill from a bottle and ingests it. After taking the pill, she holds her stomach in pain.)
A serious adverse drug reaction, or ADR, is an unintended response to a drug that causes a serious health issue, hospitalization or death.
(Images of drugs appear as the narrator lists them.)
Drugs may include: pharmaceutical drugs, biologics, and radiopharmaceutical drugs
(The female physician reappears on camera.)
A medical device incident, or MDI, is a problem with a medical device that causes a serious health issue, hospitalization or death. Problems can be related to the effectiveness of the device or how it's labelled.
(Images of medical devices appear as the narrator lists them.)
Medical devices can be adhesive bandages, hospital beds or more complex devices, such as MRIs, implants and pacemakers.
(We see a hand-held tablet computer screen. Images of medical devices and drugs are now on the screen.)
Mandatory reports from hospitals must be submitted to Health Canada within 30 calendar days of the serious ADR or MDI being documented within the hospital.
Hospitals will develop internal policies and procedures for reporting. Check with your administration to learn about any new requirements for your specific hospital.
Reports should be as detailed as possible.
(A giant screen showing icons of medical devices and drugs, each representing a report, is watched by a group of medical professionals. Three of the icons turn red, signalling a danger.)
More comprehensive reports will help to identify potential safety issues with a drug or device.
(The scene changes to a hospital room. A patient is in bed, and a medical professional and a family member stand by.)
Together we can improve patient safety while still ensuring access to safe and effective drugs and medical devices.
(We return to the female physician's office. She is facing the camera and holding a clipboard.)
Every report counts. Together they tell a story.
(Text on screen.)
Find out more about how to report a drug or device incident at: Canada.ca/drug-device-reporting
(A message from the government of Canada.)
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