Automation in Pharmacovigilance

Introduction

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