Maintaining a Manual Approach to Drug Safety and Risk Management Puts Companies at Greater Risk of Scrutiny
Nov 11, 2016
By Subhan Ahmed
Pharmaceutical companies face extraordinary demands when it comes to drug safety and risk management. They must adhere to all regulations surrounding adverse event reporting and streamline their risk evaluation and mitigation strategies.
Perhaps the single biggest challenge for companies is meeting timelines, especially when so many are held back by manual, time-consuming processes. Those challenges intensify when handling spontaneous postmarketing adverse events.
If they lack the technology to automate this process, they have to manually identify how many serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSAR) they have to submit. Then once the authority has acknowledged receipt of those reports, the company must maintain a copy of the paper report and manually check and upload those receipts into their safety database. If the authority has any questions, they will have to recheck the information, make corrections and go through the same manual process again.
On top of those challenges, add on the issue of meeting timelines. Health Canada requires that a non-fatal or life-threatening Adverse Drug Reaction (ADR) be reported within 15 days of the company becoming aware of the information. Where the ADR is fatal or life-threatening, companies must report within seven days, and ideally immediately.
More Time, Better Quality
Handling reports manually gives companies very little time to assess, review and verify each case. A manual process makes it difficult for companies to validate the data they are capturing, and they may miss some of the key information that authorities expect them to capture, or they may not report the information that is received or recorded.
On the other hand, a robust pharmacovigilance regulatory reporting system that includes adverse reaction management software not only provides more time for the important assessment and review activities, but automates sending the cases and receipt of acknowledgements. Additionally, a drug safety system can identify whether cases have been reported and alert pharmacovigilance departments if they are overdue.
Data quality is imperative in an age where regulators are laser-focused on safety. With a drug safety system that aligns with regulatory authorities’ requirements, companies will be able to demonstrate that compliance checks have been done, will be better placed to ensure the quality of their data and will be able to respond quickly to any potential audits and inspections.
As the authority automates processes to ensure reduced processing, seamless integration and data interchange, they are also keeping an eye on the quality and compliance of the data. The shift now is toward verification of the data quality, honest assessment, and open reporting. To ensure the data submitted is clean and timely, authorities are subjecting companies to greater scrutiny, more queries and observations, and an increased number of audits and inspections. The best advice is to ensure a compliant and efficient safety system is in place.
If companies are not reporting sufficiently, the authorities might want to check how they are capturing information or determine whether they are missing information or potentially not reporting it honestly or adequately.
Undoubtedly, having a validated safety reporting solution vastly reduces the chance of an audit and inspection. Insufficient data or reports that don’t adhere to guidelines result in significantly more audits.
Learn more about ARISg and ARISj and why companies and regulatory authorities, including Health Canada, adopt these pharmacovigilance systems for global safety case reporting.