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

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