While literature review is a core component of pharmacovigilance, the increasing number of data sources and regulatory requirements can make the process a daunting task. With more data sources available than ever before, and global regulations constantly shifting, pharmacovigilance teams are under stress to develop strategies that are both comprehensive and flexible.
Scientific literature is one of the most significant sources of information to monitor the safety profile and the risk-benefit balance of medicinal products, particularly in relation to detecting new or emerging safety signals or issues.
Monitoring this type of literature—and in particular, case reports– is the most accurate, efficient, and effective warning system for initial detection of new adverse reactions, rare events, or at-risk patients, because the corresponding case reports are detailed, assessed for quality by reviewers (mostly independent from commercial incentives), and open to any interested parties.
So, as you consider more efficient approaches for monitoring, searching, and distributing the results to the pharmacovigilance team, I would recommend the following:
1. Review SOPs
If you’re new to the library, get a copy of the pharmacovigilance SOP (standard operating procedures) from your quality assurance team. Review it carefully to see what role your team plays in the pharmacovigilance process. If the library is not part of the workflow for monitoring the literature, it likely should be. However, you also want to make sure that the library is not tasked with deliverables outside of your expertise. During a routine in-house audit my first year on the job, I learned that the library ‘owned’ the SOP for the drug safety reporting process. This ‘ownership’ made us ultimately responsible for the performance of the entire drug safety team. I felt strongly that this was the wrong chain of command, as the library team had no expertise in drug safety or adverse event reporting. Over the course of a 4-month collaboration with global drug safety, legal, and regulatory, we were able to revise the SOP and turn ownership over to the global drug safety team. We are now firmly ensconced in the work flow as the literature experts, but without overall responsibility for the process.
Carefully review the role of the library throughout the PV workflow to decide whether your team has the expertise to fulfill the requirements of the SOP. Remember that pharmacovigilance is a regulated process and all parties involved in the documented workflow are subject to FDA audit.
2. Align Information & Pharmacovigilance Departments
Although the library no longer owns the SOP, we continue to be an important element in the overall process. Our role is to collaborate with the PV scientists to create the safety queries and make sure that the resulting alerts are delivered to the appropriate people in the appropriate timespan.
Libraries must also work with pharmacovigilance colleagues to assist in creating search strategies. This includes choosing the most relevant publication databases, keywords, date ranges, and filters for your literature review.
Remember: They are the experts in drug safety. We are the experts in documents and creating robust searches. Work together to play on your strengths.
3. Work with your database providers to create a pharmacovigilance tool that meets your needs
Work with your database and tool providers to make sure what you want can be delivered. Do weekly check-ins with your data providers until the process you’re building is perfect.
When it comes to selecting a search and monitoring tool, I would recommend including your pharmacovigilance teams as you consider changes.
Here was a list of the qualifications we were both looking for within a tool:
- The ability to tag and highlight items
- Allow users to create shared libraries
- Enable content review
- Allow reviewers to sign off on an alert
- Create a paper trail for audit purposes
4. Build Out a Standard Search Core
Try to build out a standard search core that can be modified per product, so your basic searches are consistent and ready to be built out with drug names and other filters. This will save you and the rest of the team time when the search is due to be updated.
5. Do a Soft Launch
Do a soft launch before you convert the entire PV franchise. Recruit selected members of your PV team to ‘try out’ the new features and make yourself available for support. Point out how these new features will improve compliance with the SOP.
Remember that this may be a change from the old processes and you may meet with some resistance. Let patience and practicality prevail—if you’ve done your homework, it will be no time before the team recognizes the benefits of the new literature review system.