As the blossoms of spring usher in a season of renewal, it's not just our homes that could use a thorough cleaning – our safety data deserves a refreshing sweep too. In an enlightening conversation with Laura Hopper, President of Pharmacovigilance, we delved into the vital significance of upkeeping pristine safety data. Join us as we uncover the insights Laura generously shared on the essential spring cleaning that your safety data demands:
Every Spring, I get the urge to organize. It starts with drawers, then moves to closets and eventually to attics where I can spend hours filing all the family snapshots together, donating unworn clothes I forgot that I owned, boxing up loose mementos, and double checking my fire extinguishers and smoke alarm batteries. Because it’s never truly done, for me, organizing is a constant cycle getting me ever closer to my goal of streamlined organizational ease. I’ve been thinking though, what would that look like to apply the same concepts to a pharmacovigilance project? Is there value in spring cleaning your safety data?
4 Ways to Spring Clean Your Safety Database
Combining Similar Terms
One key to aggregating data for any periodic report is based on the consistency with which you use the MedDRA dictionary. Ask yourself these questions:
- Are all of the COVID-related diagnoses coded to the newest COVID preferred terms (PTs)? Or are some of the events still straggling under the old PTs and therefore pointing to a different System-Organ-Class (SOC)?
- Does one medic suggest coding preferences slightly different from another medic?
- When marrying the data for the annual report, will inconsistencies be created?
Applying spring cleaning techniques, think about reviewing or updating the coded terms list to verify consistency, or start a coding convention document to include decisions made regarding the expected coding of certain event terms. Once completed, including the coded event terms by SOC> in one aggregate report is much more concise when the coding has been consistently applied. With clinical trial data, this will create a huge efficiency when preparing an Analysis of Similar Events, too.
Find the Forgotten
A client requested that we enter into each case in the Safety database, a separate suspect product for each phase of their clinical trial program that was experienced by the subject (Single blinded dose, multi-dose phase, and the open-label extension). The thought was that each case should include all the prior treatments received by that subject, even those treatments received in separate clinical trials. This meant that one event could potentially have multiple entries for the same investigational product, listed in a slightly different way. It was easy to forget what this convention was doing to their downstream data until the listings revealed six events of cardiovascular accident occurring on the trial instead of the actual two! This happened because the listing generates the same event for each suspect product entered into the Safety database.
Expert Advice: Sometimes inconsistencies are created in the data when we continue to do what we've always done. The Spring Cleaning hint here would be to review the data using a new report, maybe categorize events by SOC instead of by case ID, and make a change to look at the data through a new lens.
Tie Up the Loose Ends
The most time-consuming task in an organization project is to finish all the little things that previously you meant to do, such as gathering up all the loose items and finally file them or cleaning up those pesky loose ends. In pharmacovigilance, this can look like finally updating the MedDRA dictionary version for older legacy data so that it is harmonized in the Clinical Study Report. Or moving the data stranded in multiple Safety databases to one comprehensive Safety database in order to improve efficiency with signal management and data review. There’s no easy way to accomplish this however your cleaning efforts every Spring will certainly keep those loose ends under control. Creating a single source of harmonized data saves time, saves money, and improves every aspect of a PV program.
Doublecheck for Safety
Equally as important as the batteries in a smoke alarm, confirming annually that your assumptions are actually being followed is key. (There's a reason they're called assumptions.)
- Are the proper versions currently being used by PV for Reference Safety Information, protocols for clinical trials, and the MedDRA version in the Safety database?
- Has the Safety Management Plan or other governing project document been reviewed to ensure that any small changes made throughout the year have been incorporated? Or are you using meeting minutes and Notes-to-File as the duct tape holding together your processes?
- Are there updates to the safety profile of the product that should be triggering training for the team?
- Has the applicable Regulatory Intelligence been reviewed recently to incorporate any country-specific modifications?
This can be a good opportunity to add a safety net to your program, such as purchasing Regulatory Intelligence to make that high-level review for yourself. Pharmacovigilance is fast-paced and doesn't typically provide breaks for catching up and double-checking assumptions. Building a quick pause into the process each Spring ensures that gaps are filled and future errors reduced.
Who is Responsible for Maintaining Clean Safety Data?
Ultimately, the sponsor or client is responsible for all activity within their program. Incorporating a Spring Cleaning step is a great way to ensure that your process is streamlined, efficient, built on regulatory requirements, and that your safety data is properly managed. Now that's audit and inspection readiness!
Elevating Pharmacovigilance through Data Vigilance
Pharmacovigilance is an ongoing journey, and the call for spring cleaning extends beyond mere seasonal changes. Much like the meticulous organization of our living spaces, the maintenance of safety data requires deliberate attention and strategic care. By applying the principles of spring cleaning—aggregating similar terms, finding forgotten data, tying up loose ends, and double-checking for safety—we not only enhance operational efficiency but also fortify the foundation of our safety databases.
Partner with ProPharma: Your Expert Ally in Safety Data Excellence
Ready to elevate your safety data to new heights? Don't navigate the spring cleaning process alone. Partner with ProPharma for expert assistance in meticulously cleaning and maintaining your safety database. Our dedicated team is here to ensure your data is not just cleaned but optimized for peak performance. Experience the difference – trust ProPharma for a safer, more streamlined future in pharmacovigilance. Contact us today and speak to a pharmacovigilance expert.
