With the advent of technology, we are cocksure to upgrade ourselves not only to fear that we would turn obsolete soon but also to accomplish the objective of organizational Good pharmacovigilance practices.
For any drug that sees light of the day, there are case studies that will be published, research and review articles that would be written by the researchers working to discover the yet unknown or to confirm the trial findings on a pivotal scale.
The existence of each of these literature of interest will ultimately be cycled to manage the regulatory reporting and document the literature screening activity, as an essential part of routine pharmacovigilance surveillance.
In recent past and even currently so, manual search is the preferred alternative, though insufficient to meet some fundamental regulatory norms such as:
- Who searched when and why the literature article was rejected or put on hold
- Duplicate search seems the rate limiting step till it is too late to witness that article has been reprocessed and case is created when a team of people is working on same drug product
- No audit trail to demonstrate (during audit/inspections) that the activity was carried out on a regular basis, usually weekly, unless prompted more frequently
- No drug-wise/client-wise /date-range wise segregation of articles to process ICSRs or save articles for later use in aggregate report writing
- Manual entry in database only to consume a lot of time resulting in loss of productivity
- No track history of articles (with documented remarks) disapproved in workflow to prevent their re-entry
All of the above listed limitations and many others are encountered in routine pharmacovigilance monitoring of scientific literature for medicinal products. As if this is not enough, ample time goes in literature management process rather than reviewing and classifying it to report to regulatory as per stipulated deadline.
Global database cannot be screened by a single physical eye and hence a team of resources is channelized to carry out the same effectively. If the task of scientific and medical literature for screening safety issues can be automated, it would improvise the overall screening process to assure expedited cases can be timely processed as ICSRs or archived for later reference.
If you want to perform Literature monitoring, of course in compliance to ‘Appendix 2 – Detailed guidance on the monitoring of scientific literature’ of Module VI on Good Pharmacovigilance Practices (GVP), here is the registration link to Webinar on ‘Impetus to literature surveillance in pharmacovigilance on wheels of automation’
All of the manual limitations listed here can be effectively overcome on governing the pharmacovigilance literature management through unprecedented technology support.