Vanessa’s Law is the Protecting Canadians from Unsafe Drugs Act. The law strengthens the regulation of therapeutic products and improves the reporting of adverse reactions by healthcare institutions.
Vanessa’s Law at the MUHC – Reporting Severe Adverse Drug Reactions using 8888 O-Word Form
Vanessa’s Law was amended in 2019 to mandate that hospitals report all severe adverse drug reactions to Health Canada within 30 days of their documentation in the patient chart. Here is what makes an adverse drug reaction severe:
- requiring admission
- requiring prolongation of admission
- death
- disability or incapacity
- congenital malformation
To improve reporting, the Vanessa’s Law Task Force at the MUHC has designed a reporting tool for front-line workers. The new form is available through O-word on the Oacis application, form 8888. We will review these forms every two weeks only if they are finalized so we can send them to Health Canada by the 30-day requirement. Any member of the team can fill it and finalize it (including attendings, residents, pharmacists, nurses etc.) The idea is for it to be short and easy to fill so that we can improve voluntary reporting.
FAQ
Only if it meets the criteria for severity (above) and is not the result of a medical error (patient had known allergy and was given the medication).
Yes, but only if they meet the above criteria for severity. A hypoglycemic episode on the ward that does not prolong admission does not need to be reported to Health Canada.
Health Canada assesses for two triggers – either increase in frequency or severity of an adverse reaction to a medication, which then gets an investigation. This process can help with setting prescribing practice guidelines or improve drug labeling/indications. For example, age, weight, concomitant diseases or medications may end up being correlated to certain reactions and recommendations can be made around these for medications commonly used.
Most definitely! You will select the visit that you first found out about the severe adverse drug reaction when you are opening the O-word form.
For more detailed information on Vanessa’s Law and the requirements (in both English and French):