For many companies, signal detection in drug safety pharmacovigilance ranks closely behind regulatory submissions and case management as a key activity because it helps to proactively monitor a product’s risks that come to light from tracking the data submitted to internal and external drug safety databases and platforms.
Yet despite the importance of signal detection in drug safety, many organizations still rely on manual approaches to perform and manage this vital activity. Tracking and documenting safety signals in a consistent manner, with appropriate signoff, make manual approaches risky and impractical given today’s trend toward heightened, proactive analysis of data from multiple sources and across multiple areas of the organization – product development, clinical trials, post-marketing surveillance, customer complaints and more.
Certain business drivers are adding fuel to the future trend for automated processes that ensure compliant, rapid and efficient signal management based on high-quality data.
Regulatory Driver #1: Mandatory Compliance with EudraVigilance
For Marketing Authorization Holders (MAHs) doing business in Europe, the highest urgency for many companies is meeting the looming European Medicines Agency (EMA) guidance on routine signal detection methods in the new, bigger and better EudraVigilance system with enhanced functionalities for reporting and analyzing suspected adverse reactions.
EMA has set the date of November 22, 2017, which is by when MAHs in Europe will be required to be validate, review and assess the signals EMA has discovered on their products, and then submit their findings back to EMA. This will involve ongoing periodic review and assessment of all the signals of a given product. All reporting will be done in EMA’s EVDAS (EudraVigilance data analysis system).
With EudraVigilance, there is a goal for greater standardization of signals. The significant change for companies will be to know specifically what EMA considers a signal, as one must belong to either the important medical events (IME) or the dedicated medical events (DME) lists, which are published twice a year by EMA. At that point, a company will apply their signal detection against these lists within EVDAS.
An associated challenge will be that companies will need to have a secondary stream of signal detection, handled within their own signal detection system, to handle the non-valid signals that don’t appear on IME and DME lists. While these would not be reported to EMA, the company will still have the legal requirement to consider these cases. This will require an additional burden on safety departments, and companies need to carefully weigh the risks of handing these without an automated system to assist them in their efforts.
Business Driver #2: Compliance with eRMR
Along with EudraVigilance, will be the new EMA requirement “eRMR Readiness” whereby both authorities and MAHs will need to download the electronic Reaction Monitoring Report (eRMR) from EVDAS for updates and then send it back to EMA.
Signal detection and management capabilities will also be needed. According to EMA, they anticipate that their new requirements may require an increase in resources, including meeting the new signal management requirements using EudraVigilance data and screening electronic reaction monitoring reports (eRMR).
For more information, see their web page on EudraVigilance Change Management, section on “What should marketing authorisation holders do to prepare for the change?”
Business Driver #3: Risk of Non-Conformance
A time for high stress for any MAH is at the point of a regulatory inspection or audit. It’s often at that point that a company will learn how well their systems and processes have helped to ensure their compliance.
Over a period of time, taking a look at what non-conformance reports (NCs) have been issued, for example by MHRA, you will likely find that well over one-third of them are often due to improper signal management procedures and controls.
As a point of reference to this claim, read the January 2016 article in FDA News, “Critical Findings in MHRA Inspections Increase for Second Straight Year,” which shows that “The most cited critical finding was a lack of reference safety information, followed by signal management failures, oversight and quality system failures and risk management system lapses.”
Questions to Consider
With a full view of the benefit-risk landscape of a given medicinal product at hand, life sciences companies can now better evaluate and make informed decisions that ultimately help ensure patient safety.
Given the summary highlights addressed in this blog, life science companies need to carefully weigh whether their current processes and approaches are sufficiently ready to ensure their compliance with signal detection and achieve that objective.
This blog is part 1 of a 2-part series on signal and risk management. Part 2 will focus on “Taking a Best Practices Approach to Signal Detection and Risk Management.
Learn about ArisGlobal’s LifeSphere® Signal and Risk Management, a next-generation risk management solution for your pharmacovigilance and regulatory compliance needs.