Vanessa’s LawProtecting Canadians from Unsafe Drugs Act

Serious Adverse Drug Reaction and Medical Device Incident

Reporting

Outline

• Protecting Canadians from Unsafe Drugs Act (also known as Vanessa’s Law)

• Mandatory Reporting o Who is required to report?o What is a serious adverse drug reaction?o What is a medical device incident?

• Patients as Partners in Safety

• How Patients Can Submit Reports to Health Canada

• How Health Canada Shares Information with the Public

• Key Points to Remember

Protecting Canadians from Unsafe Drugs Act(Vanessa's Law)

The Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) introduces the requirement for mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals.

The Law improves Health Canada's ability to:• collect safety information;• take appropriate action (such as a label change or a product recall) when a serious

health risk is identified; and• increase transparency (by sharing more information).

Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/legislation-guidelines/protecting-canadians-unsafe-drugs-act-vanessa-law-amendments-food-drugs-act.html

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IDENTIFYsafety issues

ASSESS harm versus benefit

SHARElearning, including warnings

Reports help to:

IMPROVEpatient and product safety

What Are the Benefits of Reporting?

Who Is Required to Report?

The requirement for mandatory reporting applies to all hospitals.

• The requirement applies to outpatient clinics if they are legally part of the hospital.

• Health care institutions that are not defined as hospitals, such as private clinics or long-term care facilities (e.g., nursing homes), continue to be encouraged to report on a voluntary basis.

Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting/mandatory-hospital-reporting/drugs-devices/guidance.html

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Tips for Recognizing Harm from a Drug or Device• Harm from a drug or from a medical device can be mistaken for a symptom of a disease.

• Awareness and conversation with health care providers are key components in identifying a serious adverse drug reaction or medical device incident.

• Consider a serious adverse drug reaction or medical device incident if there is: § a new health problem or unexpected change in health§ a sudden need for treatments, procedures or surgeries

§ a sudden need for a rescue drug or antidote (e.g., naloxone, epinephrine, glucagon) § a sudden need to change treatment (e.g., stop a drug or device)

• A serious adverse drug reaction or medical device incident can occur shortly after beginning treatment or much later

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Patients as Partners in Safety• Patients and families ask questions and monitor their

treatments.• The 5 Questions to Ask about your Medications is

a helpful resource.

• Patients and families can also report.

• If you suspect that harm has been caused by a drug or device, you may talk to your health care provider about submitting a report.

• You may also submit reports directly to Health Canada

Source: https://www.ismp-canada.org/medrec/5questions.htm

How Patients Can Submit Reports to Health Canada

The Report an Adverse Reaction or Medical Device Problem web page provides access to more information and forms.

Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html

Patients Can Contact Health CanadaThe Canada Vigilance Program collects and assesses reports of harm involving health products marketed in Canada.

Voluntary Reporting for Health Products

• Online form: https://hpr-rps.hres.ca/static/content/form-formule.php

• Telephone: 1-866-234-2345 (toll-free)

• Fax or Mail: Download, print and complete the Side Effect Reporting Form (please read the instructions before completing the form)

○ Fax: 1-866-678-6789 (toll-free)○ Mail: Canada Vigilance Office (using the postage paid label)

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Medical Devices Online Database

Medical Device Incident Database

• Searchable database with information from reports since 1980

Reports can be searched and the following data is returned:

Source: https://hpr-rps.hres.ca/mdi_landing.php

• incident ID• receipt date• device name• device type

• company name• hazard severity• description• code types assigned

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Reporting Helps Prevent Harm from Happening Again

Maryann Murray's daughter Martha died of an adverse drug reaction at age 22.

Source: https://www.patientsafetyinstitute.ca/en/toolsResources/Member-Videos-and-Stories/Pages/Patient-Safety-Stories---Martha%27s-Story.aspx

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