Literature monitoring


Literature data monitoring is a resource-intensive process that requires an employee of a drug manufacturing company to have the appropriate qualifications and technical capabilities to provide him with access to a sufficient amount of electronic resources, including paid databases.

The implementation of regular monitoring of the safety of medicines (MP) is one of the requirements of the Good Pharmacovigilance Practices (GVP) for marketing authorization holders. Search and study of information on adverse drug reactions (ARs) by manufacturers of pharmaceutical products makes it possible to constantly update the AR database, identify changes in the benefit-risk ratio when using drugs, and conduct a qualitative assessment of the safety profile.

The rules of good pharmacovigilance practice of the Eurasian Economic Union establish certain requirements for the organization of pharmacovigilance by marketing authorization holders (MAH), in particular, they provide for regular monitoring of information on the safety of medicines (MP). The main sources of information about changes in the safety profile of medicinal products are patients/consumers of medicinal products, medical and pharmaceutical workers, reports of registration and post-registration clinical trials, as well as literature reviews and information databases.

«Searching for information about the NR of a drug in the medical scientific literature, on the websites of regulatory agencies, in specialized electronic scientific databases and on pharmacovigilance information resources allows DRU to conduct effective monitoring of NR, timely identify changes in the benefit-risk ratio and conduct a qualitative assessment of the drug safety profile — GVP.

In addition to the service, our company considered this issue as a study, we analyzed various sources, identified the most suitable for monitoring from the point of view of regulatory authorities and real practice, formulated algorithms and singled out the most important.
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