Pharma R&D Today
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Why a reliable FAERS searching capability is essential for pharma companies
Posted on October 27th, 2017 by Sherry Winter in Pharmacovigilance
In the description of the FDA Adverse Event Reporting System (FAERS), the agency states that “voluntary and mandatory reporting plays an important role in the FDA’s post-market safety monitoring.” The FDA encourages lawyers, consumers, physicians and other healthcare professionals to make voluntary reports rather than relying solely on mandated pharmacovigilance activities for market authorization holders and healthcare institutions. The use of FAERS by all these groups has created an incredibly valuable source of real-world evidence about post-market drug safety.
The value of FAERS and other spontaneous adverse event reporting systems is that they support more rapid detection of signals and a true epidemiological approach to identifying adverse events that may be rare and difficult to detect in small numbers of patients. For example, they make it possible to detect low frequency adverse events, examine populations that are not typically tested in clinical trials, and visualize events that occur over long periods. They also add evidence of issues arising from drug–drug or drug–food interactions.
As with any data source, the volume of information can be daunting and can complicate the search for relevant information — unless of course a reliable research solution that enables pinpoint searching is available.
That is where the PharmaPendium FAERS Data functionality comes in. It enables specific searching of FAERS to not only find reports, but also to compare and visualize adverse events reported for a drug or group of drugs. It’s designed to quickly retrieve reports based on co-medications of interest, compare the adverse event profile across different drugs or sets of drugs and to create subsets of data for easy comparison across age groups, dates, gender and more. Since the results can be filtered by (for example) secondary suspect drug or type of adverse event, the FAERS Data queries enable users to hone in on the exact information they need.
Tasks that can be achieved include:
- Quick retrieval of reports based on co-medications of interest
- Easy comparison of the adverse effect profile across different drugs or sets of drugs
- Creation of subsets of data for comparison across age groups, gender and date
- Filtering of data by reporter occupation (i.e., physician, lawyer, consumer, etc.)
- Filtering of data by outcome (i.e., serious, non-serious)
This type of detailed searching can provide additional insights into drugs suspected in adverse events, including information on drugs reported as a primary suspect drug and as a secondary suspect drug. It means users can more easily identify co-morbidities or potential drug–drug interactions not evident during clinical trials, helping to mitigate risk for new drugs in development and to make drugs safer post-market.
All opinions shared in this post are the author’s own.
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