Drug Safety and Risk Management: Staying Current with Health Canada
Nov 11, 2016
By Subhan Ahmed
An electronic, automated approach to drug safety and risk management is the way of the future, and Health Canada is one authority that has catapulted itself into a progressive, yet strict position to protect patients.
The agency has adopted a robust pharmacovigilance regulatory reporting system and has also laid out strict processes to better manage the reporting of serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSAR) during clinical trials, and spontaneous postmarketing adverse events.
The Health Canada requirements differ somewhat from those required by the US Food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS) for monitoring adverse events and medication errors. While the agency’s validations closely follow those required for the European Medicines Agency’s (EMA) Eudravigilance system, Health Canada has several additional rules that ensure that data being receive is high quality and can be easily aggregated for use in data dissemination and signal detection.
Health Canada grants a Notice of Compliance (NOC) and a drug identification number (DIN), which authorize the company to market their drug in Canada. While EMA and FDA support the messages of the ICH individual case safety reports (ICSRs) and periodic safety update reports (PSURs), Health Canada adds several other validation rules and data elements to its requirements.
These include messages such as CTICSRs, which are ICSR expedited reports from clinical trials, and DSURICSRs, which are non-expedited reports during interventional clinical trials. The agency also has separate guidance in support of expediting reporting for Canada’s Access to Medicines Regime (CAMR) and separately to expedite reporting for the Special Access Programme.
Health Canada also has its own way to assess records, checking a combination of data elements to determine if the record to be uploaded is a follow-up from the same source or a duplicate version from a new source of an existing case in the Canada Vigilance Adverse Reaction Online Database.
During the validation process for a marketing authorization holder to bring in new trading partners, the agency requests an extract of each company’s product dictionary, which is reconciled against the Health Canada’s product dictionary
Companies must also send their drug database, including approval details and dossier information, to Health Canada before they start reporting. This allows the agency to check against its drug safety system as to whether the reports being received are for valid drugs.
Since Health Canada’s system is set up with the rules on drug safety reporting pre-configured, it’s fairly easy for the agency to check whether the data that companies send meet requirements. However, companies that are sending reports manually or that have solutions that aren’t aligned with the agency’s requirements must make sure that what they send aligns with what is required of them.
For example, patient-reported spontaneous postmarketing adverse events often lack sufficient information to accurately identify the drug, dosage, or strength. Health Canada has therefore introduced several criteria that company need to include to match the event to the right product and assist with signal detection in drug safety. These criteria include active ingredient if the product name is unknown or strength of the formulation.
Without the processes in place to automate identification of the product and simplify coding, such as medical coding software, companies face a manual and time-consuming task.
In my next blog, I’ll explore the challenges and potential ramifications of manual reporting. To learn more about streamlining processes and aligning with Health Canada, contact me and my colleagues or read about the ARISg solution.