Guidance on releasing information from adverse reaction and medical device incident reports to the public: Standard summary formats for adverse reaction data

Standard summary formats for adverse reaction data

We will provide adverse reaction (AR) data from the Health Products and Food Branch (HPFB) adverse reaction reporting programs as line-listing summaries, either as paper copies or electronically, as PDF or Excel files. The format of the line listing may vary depending on the period searched, and the database used during that period.

Marketed Health Products Directorate, Canada Vigilance Program

A Canada Vigilance line listing of adverse reaction information includes standard information:

• Adverse Event Report (AER) number: report number assigned by Health Canada
• Adverse Event Report version number: report version number assigned by Health Canada where version 0 is the initial report received and subsequent version numbers refer to follow-up reports
• initial received date: date the Marketed Health Products Directorate (MHPD) received the initial report, version 0
• latest received date: date the MHPD received the last follow-up report
• report source: indicates the location through which the reporter sent the report
• Market Authorization Holder (MAH) number: MAH report number for reports received from a MAH or manufacturer
• source country: country from which the report originated
• type of report: spontaneous, study, solicited, published, registry
• reporter type: indicates who reported the adverse reaction and their relationship to the patient
• record type: indicates if the report is a duplicate or is linked to another report
• Link Adverse Event Report number: the identification number(s) of the related report(s)
• seriousness of report: defined as yes or no
• reason for seriousness of report: death, disability, congenital anomaly, life threatening, hospitalization, other medically important condition
• patient information: age, gender, height, weight
• report outcome: represents the outcome of the reported case as described by the reporter at the time of reporting and does not infer a causal relationship
  • report outcome is not based on a scientific evaluation by Health Canada
• product information: product description (name of product), product role (the characterization of the role of each product as provided by the original reporter: for example, suspect, concomitant), dosage form, route of administration, dosing and dosing frequency, therapy duration
• reaction information: Medical Dictionary for Regulatory Activities (MedDRA) preferred term (reaction term(s) selected to describe the reactions in the report, using internationally accepted adverse reaction terminology), MedDRA version (version of MedDRA terminology in use when information was extracted from the database)
• duration: the length of time the patient experienced the adverse reaction
• report criteria: report runtime (date information was extracted from the database), health product (product specified in search criteria), initial date of receipt (time period for which the database was searched according to initial date a report was received), total number of reports

Please note that the detail of the line listing is limited to the amount of information provided in each report. That is, if the reporter did not include the product dosing or frequency, then the boxes for these values would be empty.

Veterinary Drugs Directorate, Pharmacovigilance Program

A line listing of adverse reaction information includes standard information:

• report identification number
• date report was received by Veterinary Drugs Directorate (VDD)
• indication if the report is serious, defined as yes or no
• animal age
• animal gender
• production type/breed or species
• dosage form of the health product
• route of administration for each health product
• frequency of the dose for each health product, for example once daily, twice daily
• duration of use for each health product;
• reaction term(s) selected to describe the reactions in the report, using internationally accepted adverse reaction terminology (Veterinary Dictionary for Drug Related Affairs, or VeDDRA)
• outcome at time of report
  • report outcome represents the outcome of the reported case as described by the reporter at the time of reporting and does not infer a causal relationship
  • report outcome is not based on a scientific evaluation by Health Canada
• total number of reports (shown at the end of the line listing)
• date the information was extracted from the database
• time period for which the database was searched

Please note that the detail of the line listing is limited to the amount of information provided in each case report.