Pharmaceutical and biopharma companies are required by regulatory compulsions to implement a pharmacovigilance/drug safety surveillance programme and monitor the safety profiles of their marketed products during the complete product lifecycle.
Companies have increasingly started focusing on the reorganisation of drug safety and risk management programs to facilitate proactive identification and prediction of safety signals and benefit-risk evaluation for marketed medicines, along with amalgamating data sets across all the stakeholders (pharmaceutical companies, regulatory authorities, patients and healthcare providers) to empower complete transparency, sharing and partnership.
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Numerous safety databases available in the market like Oracle Argus, ARIS-G etc. are used by the industry to process and report adverse events (AEs) to local regulatory authorities.
Usually, thousands of AEs are processed manually every month by ICSR (Individual case safety report) case processing teams at pharmaceutical companies or their outsourcing partners that are involved in case intake, triage, booking, data entry, quality review and medical review of individual case safety reports in the safety database. Some of these cases are reported to regulatory authorities on an expedited basis by submission teams.
Need for transformation to smart case processing
With the evolving regulatory environment and increased regulatory scrutiny, increasing disease complexity and number of drugs getting approved, growing awareness with patients and providers about reporting of adverse events, social media connectivity resulting in a huge influx of data and source documents with multiple templates or formats, there is increasing need for pharmaceutical companies to deploy and maintain more complex PV systems and manage safety surveillance activities more meticulously and proficiently than ever.
It's a need of the hour to revisit the traditional manual methods of case processing due to both the reduced supply of safety talent vis-à-vis demand and pressures on the companies to reduce the costs of manual case processing due to the increasing number of adverse events getting reported year on year.
As per the report published by Deloitte, pharmaceutical companies are allocating 40-85 % of PV budgets on case processing, and case volumes are increasing at a rate of 10-15 per cent per year.
As mentioned in the report, reducing the cost of case processing was the primary goal for 90% of respondents and survey respondents expected automation to deliver the cost savings of 30% per ICSR.
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Automating case processing: technologies and benefits
Automation strategy implementation roadmap would start typically with process mapping and assessment to drive improvements in process, making end-to-end case processing leaner and superior and eradicating repetitive steps in current processes.
Artificial Intelligence technologies starting with basic automation through RPA (robotic process automation) to cognitive automation with NLP (natural language processing) and finally taking to ML (machine learning) can be applied in the transformation of pharmacovigilance case processing to make it smarter at every stage with lesser human intervention.
Even though there are current cloud-based platforms like Oracle Argus, ARIS-G etc. automating case processing and reporting activities, the process still requires a lot of manual work in case intake and data entry.
The rules-based, recurring and generalised nature of these processes marks them an ideal fit for automation by using RPA/AI technologies through identification of patterns in unstructured data.
The whole process, from case receipt to reporting, can be automated, thereby reducing manual intervention to certain tasks like handling exceptions, quality control and medical review.
Strategies of standardisation and automation of PV processes designed with combined skillsets of pharmacovigilance domain experts, data scientists and IT engineers have the capability to enhance the case process efficiency by 20-30% ultimately contributing to significant cost reduction, reducing manual errors thus improving the quality deliverables to >99% and ensuring 100% regulatory compliance due to the improved turnaround time.
Adoption of these novel technologies thus can bring a new level of speed and intelligence to the pharmacovigilance process and can be achieved through clear vision and well-defined strategies and plans of implementation with mileposts to track the progress at each step and metrics to track the effectiveness and benefits.
Companies that understand the significance of integrating these novel disruptive technologies and harnessing them would essentially transform the drug safety landscape and would be more effective in managing the growing case volumes with better quality and ultimately complying with the regulatory obligations related to safety surveillance of their products.
(Dr. Pramod Dhembare, Founder and Managing Partner, Fidelity Health Services)
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