Per WHO definition, Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem. All medicines and vaccines undergo rigorous testing for safety and efficacy through clinical trials before they are authorized for use.
It is a process of data acquisition (entry), data analysis and giving benefit risk communication. Here we will list out activities that are targets for automation in pharmacovigilance.
In Data Acquisition (entry)
Adverse event and serious adverse event collected and reported in safety database system.
It is mostly transactional (exchange of data)
In Data Analysis
Internal data and external data surveillance occur by medical assessment and medical adjudication.
It is mostly analytical and cognitive (intellectual)
In Benefits Communication
Risk management plan worked as aggregate reporting on the basis of health hazard evaluation and corporate safety review.
Risk management review evaluation is analytical and cognitive.
Aggregate reporting is mostly transactional.
Aggregate reporting is also done by external and internal data surveillance
Medical adjudication studies 7-15 days reporting also form aggregate reporting.
Pharmacovigilance Automation Path
In starting period manual operations occur in pharmacovigilance after the Facilitation of database with workflow lead to automation.
Automation is done by robotic process automation by the enhancement of natural language process and natural language generation.
Nowadays intelligent automation taking the part lead to expansion of pharmacovigilance transaction focused with automation and intellectual theory/practices.
Software Automation Prioritization
Comprehensive review of all process in form of number 1-5
Constructing a process to distinct out the cases creating the list of cases by using automation.
Evaluation of the cases based on relevant criteria such as time, adverse event, seriousness, number of population and complete scoring matrix.
Use the scoring 1-5 prioritize the category of cases specific prioritization is to identify best relevant cases.
Author: Meghana Byru, Pharm.D
Clinosol Student ID :- O48/0222