Centralized Coding in the Spotlight as Emphasis Turns to Risk Management
Sep 08, 2016
By Richard Jenkins
The ultimate purpose of any pharmacovigilance organization is to maximize patient safety by using its expertise to ensure company products are safe and effective. This obligation requires organizations to employ sophisticated signal detection methodologies that enable data from disparate sources to be quickly and efficiently analyzed.
Organizations also have a regulatory obligation to protect patient safety. For example, in 2015, the U.S. Food and Drug Administration released its Safety Assessment for IND Safety Reporting Guidance for Industry. The guidance emphasizes the importance of pulling data from literature, disease-specific registries, class information, historical data and other external databases in order to have a complete understanding of the safety profile of a product. Similar guidance has been published in Europe. The EMA guideline on good pharmacovigilance practices (GVP), Module IX – Signal management, states that the sources for identifying new signals are diverse and can potentially be derived from such sources as spontaneous Adverse Drug Reactions (ADRs), active surveillance systems, non-interventional studies, clinical trials, scientific literature, among other sources of information.
Without a coding tool, it would be impossible to pull all of these different sources of data together and prepare aggregate reports. A coding tool allows companies to make sense of the data, enhance signal detection and, ultimately, the safety of patients.
What’s more, regulators have their sights set firmly on risk management and signal detection, which has ramifications across their entire data collection and analysis process – even back to how they handle both clinical and post-marketing coding.
Watching for Adverse Event Signals
Recent history demonstrates why regulators are so sensitive to signal detection and risk management. In the U.S. alone, at least 35 drugs have been withdrawn from the market due to safety concerns. These include such notable drugs as Accutane, Baycol, Bextra, Cylert, Rezulin, and Vioxx. The question is whether or not these ‘drug disasters’ could have been prevented or minimized by having a more robust signal detection program in place, thus possibly enabling earlier detection of an emerging safety issue.
Today, companies are expected to have electronic signal detection tools and standard operating procedures (SOPs) in place, with standardized terminology – facilitated by MedDRA (Medical Dictionary for Regulatory Activities) and/or other medical terminology dictionaries – to enable timely identification of emerging safety signals. The end result is timely and accurate product-prescribing information which can minimize the occurrence of unanticipated Serious Adverse Reactions (SARs) / Suspected Unexpected Serious Adverse Reactions (SUSARs). Inspectors are looking for these tools and processes with an eye on signal detection, risk management, risk minimization, and risk assessment when they conduct an assessment.
It’s not enough to simply observe a product on the market. Rather, companies need to be connecting their clinical and post-marketing safety data through centralized and consistent coding in order to detect signals early on. That means collating and categorizing safety signals from the molecule stage and drawing on relevant information in medical literature – particularly as it relates to a class of drugs – as well as their own data from animal studies and beyond.
Regulators want to see a complete safety profile of the product, including clinical data, hence the move toward Periodic Benefit-Risk Evaluation Reports (PBRERs), which places emphasis on the cumulative knowledge of a product and its risk-benefit profile.
What Are Companies Doing?
Progress at companies has been mixed. Some still have separate clinical and post-market safety departments. While many companies have now combined these two functions, coding within clinical development is often still handled discretely. All too often, that results in disputes between the clinical and safety departments about the way coding is undertaken, which makes it difficult to provide a clear and quick response to regulators when they inquire about SAEs.
Having a common dictionary with centralized coding, enabled by a flexible cross-functional tool, enhances a company’s ability to pull all of this together quickly, conduct their analysis, and respond to regulators promptly and accurately.
Learn more about coding by downloading our in-depth white paper, Achieving Consistency in Clinical Coding for Periodic Reporting and Signal Detection.