Guidance on releasing information from adverse reaction and medical device incident reports to the public: Definitions and abbreviations 

Definitions

For the purpose of this procedure:

Adverse reaction (AR): a noxious and unintended response and includes "adverse drug reaction" as defined in the Food and Drug Regulations and "adverse reaction" as defined in the Natural Health Product Regulations.

"Adverse drug reaction" as defined in the Food and Drug Regulations means a noxious and unintended response to a drug, which occurs at doses normally used or tested for the diagnosis, treatment or prevention of a disease or the modification of an organic function.

"Adverse reaction" as defined in the Natural Health Products Regulations means a noxious and unintended response to a natural health product that occurs at any dose used or tested for the diagnosis, treatment or prevention of a disease or for modifying an organic function.

Domestic adverse reaction: an adverse reaction occurring in Canada.

Domestic medical device incident: an incident that occurred inside Canada involving a medical device marketed in Canada.

Foreign adverse reaction: an adverse reaction occurring outside Canada to a product that is marketed in Canada.

Foreign medical device incident: an incident that occurred outside Canada to a medical device marketed in Canada.

Health product: includes drugs, medical devices, natural health products, blood and blood components, cells, tissues and organs, and sperm and ova for the purpose of assisted human reproduction. Drugs include both prescription and non-prescription pharmaceuticals; biotechnology products, biologically derived products such as vaccines, serums and blood derived products; disinfectants; radiopharmaceuticals; and medical devices.

Line listing: a summary of a subset of the data from individual adverse reaction reports provided in a table format.

Market authorization holder (MAH): the legal entity that holds the Notice of Compliance, the Drug Identification Number (DIN), the medical device licence for class II, III and IV devices, the Natural Product Number (NPN), the Homeopathic Medicine Number (DIN-HM), the product licence number or that has received approval to initiate clinical/field trials in Canada. Market authorization holder can also be referred to as the sponsor or manufacturer.

Medical device incident (MDI): as described in section 59(1) of the Medical Devices Regulations, any incident involving a medical device that is sold in Canada when the incident occurs either within or outside Canada; relates to a failure of the device or a deterioration in its effectiveness, or any inadequacy in its labelling or in its directions for use (section 59 (1) (a)); and 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 if it were to recur (section 59 (1) (b)).

Medication incident: Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Medication incidents may be related to professional practice, drug products, procedures, and systems, and include prescribing, order communication, product labelling/packaging/nomenclature, compounding, dispensing, distribution, administration, education, monitoring, and use.

Serious adverse reaction: a noxious and unintended response to a marketed health product covered by this document that occurs at any dose and that requires in-patient hospitalization or prolongation of existing hospitalization, that causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death and includes "serious adverse drug reaction" as defined in the Food and Drug Regulations and "serious adverse reaction" as defined in the Natural Health Products Regulations.

"Serious adverse drug reaction" as defined in C.01.001(1) of the Food and Drug Regulations is a noxious and unintended response to a drug that occurs at any dose and that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death. For veterinary drugs, in the case of large animals this would include cases that required veterinary attention on-site.

"Serious adverse reaction" as defined in Section 1(1) of the Natural Health Products Regulations is a noxious and unintended response to a natural health product that occurs at any dose and that requires in-patient hospitalization or a prolongation of existing hospitalization that causes congenital malformation, that results in persistent or significant disability or incapacity that is life threatening or that results in death.

Spontaneous adverse reaction: an unsolicited communication by health care professional or consumer/animal owner to a company, regulatory authority or other organization (for example, World Health Organization, regional centres, Poison Control Centre) that describes 1 or more adverse reactions or medical device incidents in a patient who was given 1 or more medicinal products and that does not derive from a study or any organized data collection scheme.