Report a serious adverse drug reaction (for hospitals)

A. General information

Initial or follow-up: 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.

Documentation date: 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

First and last name: Enter the first and last name of a contact for the hospital.

Phone number and/or email: 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.

Hospital Information

Organization name: 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 hc.canada.vigilance.sc@canada.ca. 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.

Reason for seriousness: 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.

Sex: 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.

Age at the time of the serious ADR: Provide the patient’s age at the time of the reaction.

Height: Enter the patient’s height.

Weight: Enter the patient’s weight.

Known medical conditions and lifestyle factors: If available, provide information on the patient’s history and other known conditions.

Known allergies: Provide the allergies the patient is known to have experienced, whether to food, drugs, environmental components, etc.

C. Serious adverse drug reaction(s)

Did the person recover? Indicate the outcome of the serious ADR.

Reaction start date: Provide the date of onset of the serious ADR. Partial dates are acceptable

Reaction end date: Provide the end date of the serious ADR if applicable. Partial dates are acceptable. Do not provide this for reports involving death.

Description of the serious adverse drug reaction(s): 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.

Drug identification number (DIN): 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.

Identifying code for urgent public health need drugs (required if applicable): If the drug was imported as part of the access to drugs in exceptional circumstances, provide the code or number of the drug, if any, assigned in the country in which the drug was authorized for sale.

Brand name, common/proper name: Provide the brand name as per the product label if the DIN is not known. If the brand name cannot be provided, or is not specific (e.g. an active ingredient as brand name), please provide the proper name (active ingredients) and the manufacturer name.

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.

Product start date: Indicate the date on which the patient started using the product. If the exact date is not known, partial dates are acceptable.

Product end date: Indicate the date the patient stopped using the product, if applicable. Please only enter data in this field if it is known that the patient stopped taking the product. Partial dates are acceptable.

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.

Reporting to manufacturer: Indicate if the adverse reaction details were provided to the manufacturer. If so, please also provide the date on which the case was reported to the manufacturer and the reference number if known.

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)

Concomitant therapeutic products: List all known health products, other than the suspect product, the patient was taking at the same time (i.e. concomitantly) the reaction occurred. Information related to therapy details of these products is not required but encouraged. Do not include health products used to treat the reaction.

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