Report a serious adverse drug reaction (for hospitals)
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Purpose of collection: Health Canada requires this information to assess adverse reaction reports, monitor the safety of health products and enforce relevant legislation where applicable. Personal information may be used to analyze general trends, report to senior management and evaluate related programs and services. Trend and safety data in a de-identified format may be communicated by a variety of risk communication tools and/or responses to inquiries. A subset of de-identified Canada Vigilance adverse reaction reporting program data is made publicly available from the Canada Vigilance adverse reaction online database.
Other uses or disclosures: Personal information may be shared within Health Canada and with the Public Health Agency of Canada, the Canadian Medication Incident Reporting and Prevention System Program (managed in partnership with the Canadian Institute for Health Information, the Institute for Safe Medication Practices Canada, and the Canadian Patient Safety Institute), and international regulatory and health product monitoring authorities, for monitoring adverse reactions. In limited and specific situations, your personal information may be disclosed without your consent in accordance with subsection 8(2) of the Privacy Act.
For more information: This personal information collection is described in Info Source, available online at https://www.canada.ca/en/health-canada/corporate/about-health-canada/activities-responsibilities/access-information-privacy/info-source-federal-government-employee-information.html#a26. Refer to the personal information bank HC PPU 417.
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Reporting by hospitals is requiredSection C.01.020.1 of the Food and Drug Regulations and section 62 of the Medical Devices Regulations, require hospitals to report to Health Canada all serious adverse drug reactions (ADRs) and medical device incidents (MDIs) within 30 days of being documented within the hospital.
Who is regulated
This regulatory requirement only applies to hospitals.Hospital is defined as a facility that:
- is licensed, approved or designated as a hospital by a province or territory, in accordance with the laws of the province or territory, to provide care or treatment to persons suffering from any form of disease or illness; or
- is operated by the Government of Canada and provides health services to in-patients.
What to reportA serious ADR is a noxious and unintended response to a drug that occurs at any dose and that:
- requires in-patient hospitalization or prolongs existing hospitalization
- causes congenital malformation
- results in persistent or significant disability or incapacity, or
- is life-threatening or results in death.
A MDI means an incident related to a failure of a medical device or a deterioration in its effectiveness, or any inadequacy in its labelling or in its directions for use that has led to the death or a serious deterioration in the state of health of a patient, user, or other person, or could do so were it to recur.
What therapeutic products are within scopeThe mandatory reporting requirements for hospitals apply to the following therapeutic products:
- pharmaceuticals (prescription and non-prescription);
- biologic drugs (biotechnology products, DIN-assigned manufactured blood products, as well as vaccines, excluding those administered under a routine immunization program of a province or territory);
- radiopharmaceutical drugs;
- drugs for an urgent public health need;
- medical devices.
Additional information on the regulatory requirements related to mandatory reporting can be found in the guidance document intended for hospitals.
When in doubt, Health Canada encourages hospitals to report.
ContactFor additional information on the Canada Vigilance Program or about mandatory reporting of serious ADRs/MDIs:
- Call toll free 1-866-234-2345
- Email firstname.lastname@example.org
A. General information
: Indicate whether the report is the first one submitted for this specific adverse drug reaction (ADR) (i.e. initial) or a follow-up to a previously submitted report.
Health Canada reference number: If the report is identified as a follow-up, indicate the reference number provided by Health Canada after submitting an initial report.
Organization file number: Indicate the hospital’s identification number for the case. For follow-up reports, the file number should be the same as the number assigned to the initial report.
: Indicate the date when the hospital first documented this serious ADR.
Source of report: Indicate the profession of the hospital employee who first flagged this as a potential serious ADR.
Organization Contact Information
: Enter the first and last name of a contact for the hospital.
: Enter the telephone number and/or email address to contact in the case of follow-up.
Fax: Enter a facsimile number to contact in the case of follow-up.
: Enter the full name of the reporting hospital.
Health Canada institutional ID: Indicate the submitter’s unique hospital identifier as assigned by Health Canada. To obtain this identifier, please contact email@example.com. Address details do not need to be completed if this unique number is provided.
Address/City/Province-Territory/Postal code: Enter the hospital’s civic address.
: Select one or more criteria that best describes the serious ADR. Enter the date of death if known. Partial dates are acceptable.
B. Patient information
Patient ID: Provide a patient identifier in order to readily locate the case for follow-up purposes. This can be the patient’s initials or the record number. Please do not provide the full name of the patient.
: Enter the patient’s biological sex. Intersex is a term used for a variety of conditions in which a person is born with a reproductive anatomy that does not fit the typical definitions of female or male.
: Provide the patient’s age at the time of the reaction.
Height: Enter the patient’s height.
Weight: Enter the patient’s weight.
: If available, provide information on the patient’s history and other known conditions.
: Provide the allergies the patient is known to have experienced, whether to food, drugs, environmental components, etc.
C. Serious adverse drug reaction(s)
Indicate the outcome of the serious ADR.
: Provide the date of onset of the serious ADR. Partial dates are acceptable
: Provide the end date of the serious ADR if applicable. Partial dates are acceptable. Do not provide this for reports involving death.
: List the serious adverse drug reaction(s) that the patient experienced. Please try to avoid use of acronyms in this section.
D. Suspect product
Reporting of product-specific identifiers is important for traceability of an adverse reaction to a specific suspect product. The drug identification number (DIN) is a unique identifier for all drug products sold in Canada. If the DIN is unknown, biologic drugs including biosimilars can be uniquely identified by providing their brand name. Generic drugs can be uniquely identified by providing both the generic name and the manufacturer name. Please also include the lot number, if known.
: Provide the drug identification number of the product the patient took, if available. For drugs accessed under an urgent public health need, provide the identifying code or number for the country in which the product is marketed. If the DIN is provided, it is not necessary to provide manufacturer, product name, active ingredient(s), strength, or dosage form.
Manufacturer name: Indicate the manufacturer name of the suspect product.
Strength: Provide the amount of active ingredient per single dosage form of the drug. For example, if the patient took two tablets of a medication, please provide the strength of only one tablet. Strength is defined as the amount of an active ingredient that the product contains. If applicable, indicate other strength unit in Other field.
Dose: Indicate the amount of the product taken by the patient per the dosing regimen. Dose is normally expressed as a quantity. If applicable, indicate other dose unit in Other field.
Frequency: Indicate how often the dose was taken by the patient. Shorthand text, such as b.i.d., is acceptable in this field.
Dosage form: Indicate the dosage form of the product (e.g. tablet, powder, liquid).
Route of administration: Provide the means by which the drug entered the patient’s body. The top five most common routes of administration are at the top of the dropdown list. If applicable, indicate other route of administration in Other field.
Indication: Enter the therapeutic reason for use.
Lot no.: If known, indicate the lot number(s) of the suspect product.
Expiry date: If known, indicate the expiry date.
Action taken: Indicate what action was taken with the product.
Reaction stopped if dose was reduced or removed: Indicate if the adverse reaction stopped after the suspect product was discontinued or the dose was reduced.
Reaction returned with reintroduction: Indicate if the adverse reaction reappeared after the suspect product was reintroduced.
E. Concomitant therapeutic product(s)
F. Additional information
This section can be used to provide a narrative summary of the serious adverse drug reaction, additional information on the underlying diagnosis that is pertinent to the reaction, or information that did not fit in the structured fields that could help to determine why the reaction occurred. For serious cases involving death, this section can also be utilized to provide details on the official cause of death and autopsy results.
For more details, refer to the Guidance Document for hospitals at https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting/mandatory-hospital-reporting/drugs-devices.html