Vanessa’s Law regulations require hospitals to report serious adverse drug reactions (ADRs) and medical device incidents (MDIs) to Health Canada within thirty days of the event being documented within the hospital.
In British Columbia, this process is facilitated by BCPSLS, which receives, reviews, and forwards ADR and MDI reports to Health Canada on behalf of the health authorities.
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What is Vanessa's Law?
Vanessa’s Law is the Protecting Canadians from Unsafe Drugs Act, which received royal assent in 2014. Vanessa’s law introduces amendments to the Food and Drugs Act that give Health Canada more power to protect Canadians from unsafe products.
In addition to mandatory reporting of serious adverse drug reactions (ADRs) and medical device incidents (MDIs), Vanessa’s Law empowers Health Canada to order recalls, impose tougher penalties for unsafe products, and compel drug companies to review labels or do further testing on products.
Vanessa’s Law regulations are effective December 16, 2019.
Mandatory reporting is intended to improve the quality and increase the quantity of serious adverse drug reactions (ADRs) and medical device incidents (MDIs) reported to Health Canada in order to optimize detection of health product safety issues. Many ADRs and MDIs are only detected after market approval.
The more reports Health Canada receives, the more information it will have to identify issues and act quickly.
Health care professionals who report ADRs and MDIs may receive feedback and information from Health Canada about the safety of therapeutic products they prescribe or administer. In addition, BCPSLS Central Office may forward reporters any relevant information they’ve received about the drug or device.
What to report
A serious adverse drug reaction (ADR) is defined as a noxious, unintended response to a drug at any dose that required inpatient hospitalization or prolongation of existing hospitalization; caused congenital malformation; resulted in persistent or significant disability or incapacity; was life-threatening, or resulted in death; or led to other important medical event (use professional judgement). Example: Kidney damage from a diuretic (water pill) that required dialysis.
A medical device incident (MDI) is defined as an incident related to the failure of a medical device, deterioration in its effectiveness, or inadequacy in its labeling or directions that led to the death or serious deterioration in health of a patient, user, or other person OR could do so were it to recur. Example: An infusion pump stopped due to a malfunction but failed to give an alarm and the patient received an under-infusion of antibiotics, resulting in septic shock that prolonged the patient’s stay in hospital.
Who should report
Vanessa’s Law regulations mandate hospitals to report. Targeting hospitals is anticipated to capture serious adverse drug reactions (ADRs) and medical device incidents (MDIs) that occur in other settings, such as long-term care facilities, resulting in patient transfers to hospital and emergency room visits. Hospitals rely on health care professionals to report, including physicians and other prescribers, nurses, technicians, and pharmacists.
If you are the first person to discover an ADR or MDI, you are the one who should report it in PSLS. The person who discovers the ADR or MDI is best positioned to give the most accurate account of what happened. As the reporter, you may be contacted by BCPSLS Central Office for more information or to receive feedback about the drug or device involved.
While it’s only mandatory for hospitals to report serious ADRs and MDIs, all health care providers in all settings are encouraged to report all ADRs and medical device problems in PSLS.
Where to report
Report all adverse drug reactions (ADRs) and medical device incidents (MDIs) in PSLS.
ADR and MDI reporting in PSLS is designed to meet Health Canada’s requirements. When you report a serious ADR or MDI in PSLS, the Central Office team will ensure your report is reviewed, de-identified, and submitted to Health Canada within the 30-day deadline.
To report an ADR, select the ADR icon on the PSLS landing page.
To report an MDI, select the MDI icon OR select the report form that best reflects what happened to the patient (e.g. Fall, Medication, etc.) and choose “Yes” for the question “Was a device involved?” Then enter details about the equipment and how you suspect it contributed to the incident.
Can’t get to a computer? You can also report by phone at 1 877 789 PSLS (7757).
For more information
You will learn how to comply with Vanessa’s Law regulations; how to correctly identify the types of adverse drug reactions (ADRs) and medical device incidents (MDIs) mandated for reporting; how to correctly report ADRs and MDIs in PSLS; and where to find information and alerts about unsafe drugs and devices.
For further education and a look at the national approach to mandatory reporting, PowerPoint modules are available on the Health Canada website.
Contact BCPSLS Central Office at:
604 877 6422
1 877 789 PSLS (7757)