Adverse Drug Reporting Flashcards
Medical Device Incident
Failure, deterioration, mislabeling of a medical device that led to
- Death or Deterioration in patient health
- Or could do so if incident reoccurs
NHP and ADR
Very recently mandatory reporting has been applied to NHPs
Reporting Requirement of Vanessa’s Law
- Serious ADR
- Name of Product
- Drug Number / Code
- Age/Sex
- Serious ADR Description
Hospital is exempt from reporting if it does not have these 4 minimal essential information
Serious ADR
Unintended response from drug that led to
- Hospitalization or extended hospitalization
- Congenital malformation (Birth defect)
- Disability
- Death
- Important medical event
Post Market Surveillance Cycle
- Recognize the risks of a medication
- Report the ADR
- Collect all the ADR into a database
- Analyze all the ADR
- Communicate the safety information to people in Canada
Vanessa’s Law
- Mandatory reporting of ADR
- Stricter measure for people that do not comply
- Power to require information
- Power to issue a label change
- Power to recall
- Power to disclose information
Who is required to report ADR
- When must they report
Hospitals must report serious ADRs and MDIs to Health Canada
- Within 30 days of first documentation of reaction/incident
Definition of a Hospital
Facility licensed and approved as a hospital by Province
OR
Facility is operated by Federal government
Reporting Requirement of Vanessa’s Law
- MDI
Name or Identifier
MDI Description
Process of reporting serious ADRs
- Does the report involve a drug within the scope of federal regulations of mandatory reporting
- Is ADR considered serious
- Was ADR documented within hospital
- Is the facility a hospital
What Health Products do not require reporting
- Cannabis
- Blood products with no DIN
- Organs, Semen
- Drugs part of a clinical trial
