Pharmacovigilance, also known as Adverse Drug Reactions (ADR) monitoring, is the process of constantly monitoring the undesirable effects medical drugs can have on the body post-licensing for use.
As pre-marketing clinical trials often fail to detect ADRs with low incidence rates or when they are caused by drug-drug interactions, its aim is to collect unbiased safety data about various broad aspects of medicinal product safety. For pharmacovigilance to take place, it is critical to receive the necessary information from patients and healthcare providers via Individual Case Safety Reports (ICSRs) and other sources such as medical literature.
Regulatory agencies such as the FDA and European Medicinal Agency’s pharmacovigilance guidelines require Pharma companies to provide a strict ‘signal detection’ process for identifying new adverse events. Depending on the severity of the ADR, these companies also need to quickly assess such signals and promptly notify the regulatory bodies.
For this purpose, Pharma companies require efficient solutions that can provide systematic and comprehensive approaches to monitoring adverse events in scientific literature where the information is far less structured than in ICSRs. Semantic technology can help automate this complex process, thus significantly improving the overall healthcare of the patients.
The existing process of monitoring and screening for reported ADR in scientific literature has always been time and effort-consuming but generally fails to meet its goal. The main challenges are:
The solution for scientific literature monitoring of adverse events that Ontotext can provide is based on semantic text analysis and knowledge graphs. It is highly configurable and flexible, going beyond the standard deep indexing of content.
The solution allows Pharma companies to automatically process any scientific literature data feed delivered in a standard format and loaded with an up-to-date subset of case reports abstracts from NCBI PubMed or other sources. The extracted data is complemented with structured ADR knowledge from a public Adverse Event Reporting system (such as FAERS from US FDA, EudraVigilance, VigiBase from WHO). The information in it is normalized to established medical and drug terminologies like MedDRA, SNOMED CT, MeSH, and more.
On top of being able to efficiently identify potential adverse events mentioned in scientific literature, Ontotext’s solution can also capture causal relations between key structured ICSR data elements such as patient profile (gender, age), drug information (drug name, active ingredients, structured dosage information, co-treatment drug, route of administration), etc.
With Ontotext’s scientific literature monitoring solution, using semantic text analysis, Pharma companies can scour vast amounts of textual data, such as medical records, and clinical notes, to identify potential ADR signals. This also supports compliance monitoring, adhering to both regulatory agencies and healthcare needs. Additionally, users gain an integrated drug safety signals detection process that helps them identify and validate ADR signals timely and efficiently.
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