Adverse drug reactions or adverse drug events refer to unwanted or harmful reactions experienced following the administration of a medicine or combination of medicines under normal conditions of use. A clinician or patient then suspects the reaction, such as rash or a headache, to be linked to the drug. The event is reported back to the manufacturer of the medicine for investigation and be subject to scrutiny by a regulatory agency, such as the U.S. Food and Drug Administration (FDA).
The practice of monitoring the effects of medical drugs after they have been licensed for use, especially in order to identify and evaluate previously unreported adverse reactions is referred to as pharmacovigilance, and monitoring is an activity incumbent upon drug manufacturers. The process is also designed to support public health programs by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.
To make this task easier, German pharmaceutical firm Bayer is experimenting with artificial intelligence. According to the website PharmaPhorum, Bayer has linked up with professional services firm Genpact for the development and has embarked upon a multi-year agreement for Pharmacovigilance Artificial Intelligence products.
Commenting on the partnership, Michael Levy, who acts as the global head of pharmacovigilance for pharmaceuticals and consumer health at Bayer, stated: “With Genpact, we have found a partner whose innovative capabilities in the area of applying advanced AI and machine learning technologies to pharmacovigilance provide us with an opportunity to further increase the efficiency of our pharmacovigilance operating model and case processing, while maintaining our high quality and compliance standards.”
