INDEX

    Reporting ADR’s and MDI’s in PSLS (Vanessa’s Law)

    Administration and Operational Issues, Environmental Injuries / Exposures, Toxicology

    Last Updated Nov 12, 2019
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    By BCPSLS, Julian Marsden, Kim Steger (BCPSLS); Thanh Vu (Health Canada); Caitlin Campbell (BCPSLS)

    Context

    • Effective December 16, 2019, hospitals in Canada are required to report serious adverse drug reactions (ADRs) and medical device incidents (MDIs) to Health Canada within 30 days of the incident being documented within the hospital (Vanessa’s Law).
    • Reporting ADRs and MDIs will improve protection of patient health and safety. Vanessa’s Law gives Health Canada greater power to recall unsafe drugs or devices, require label changes and package modifications, and require further testing of therapeutic products.
    • Many adverse reactions and incidents are only detected after market approval. The more reports Health Canada receives, the more information it will have to identify safety issues with drugs and devices and take appropriate action when a risk is identified.
    • Targeting hospitals is anticipated to also capture serious ADRs and MDIs that occur in other settings, such as long term care facilities, resulting in patient transfers to hospital and emergency department visits.
    • Even if the patient was not admitted as an inpatient after being treated in the emergency department, as long as the serious ADR or MDI was documented at the hospital, the hospital is responsible for reporting the incident to Health Canada.

    Process for Reporting

    • In BC, reporting ADRs and MDIs to Health Canada is facilitated by BC Patient Safety & Learning System (PSLS). You can report in PSLS on any health authority computer or by calling 1-877-789-PSLS (7757).
    • Each health authority has its own way of accessing PSLS (e.g. desktop shortcut; search “PSLS” on health authority intranet; link to “Report an event” on health authority intranet PSLS page).
    • To report an ADR, select the ADR icon on your health authority’s PSLS landing page.
    • To report an MDI, select the MDI icon or the most appropriate patient safety incident report form (e.g. fall, medication, etc.) and select “Yes” for the question “Was equipment involved in the event?” Enter details and how you suspect it contributed to the incident.
    • When you report a serious ADR or MDI in PSLS, the PSLS Central Office will ensure your report is reviewed, de-identified, and submitted to Health Canada within the 30-day deadline. You may receive feedback or information from Health Canada or PSLS Central Office about the drug or device.
    • Only serious ADR and MDI reports are required by Health Canada; however, all ADRs and medical device problems are helpful and welcome in PSLS.

              How to report in PSLS Cheat Sheet

    Definitions

    Serious ADR

    • 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).
    • Examples:
      • kidney damage from a diuretic that requires dialysis.
      • lung damage from a chemotherapy drug that requires long-term oxygen therapy.
      • allergic reaction to an antibiotic that is life-threatening.

    MDI

    • 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.
    • Examples:
      • an infusion pump malfunctioned but failed to give an alarm and that prolonged the patient’s stay in hospital.
      • an external defibrillator failed to deliver the programmed level of energy due to a malfunction. The patient was revived but there was a potential to cause serious harm were this to recur.

    Related Information

    OTHER RELEVANT INFORMATION

    1. Vanessa’s Law Information and Resources – BC Patient Safety & Learning System (BCPSLS) Central


    2. Protecting Canadian from Unsafe Drugs Act (Vanessa’s Law) – Government of Canada


    3. Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals – Government of Canada Guidance document


    4. 20-minute online learning module on: LearningHub (provincial) and iLearn (Interior Health).


    5. How to report in PSLS Cheat Sheet


    Relevant Resources

    RELEVANT CLINICAL RESOURCES

    View all Resources

    RELEVANT RESEARCH IN BC

    Preventing Adverse Drug Events

    RESOURCE AUTHOR(S)

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