Digital Adverse Response Monitoring: A New Future for Pharmacovigilance

By Dr. Ritu Jaswal

In the last two years of the Kovid-19 epidemic, drugs and vaccines, in particular, have attracted the attention of people all over the world and the general public has become increasingly aware of the use, benefits and risks of drugs. In such a scenario, pharmacovigilance is becoming an important area of ‚Äč‚Äčinterest. The World Health Organization (WHO) defines pharmacovigilance as “the science and activity of identifying, evaluating, understanding, and preventing adverse effects or other drug / vaccine problems.” Basically, it refers to the process of mapping the effectiveness of a drug / vaccine, to track any risks and adverse events after it is released on the market.

The role of pharmacovigilance has become even more important considering the rapid pace of drug development, rapid introduction of new drugs on the market (especially in the vicinity of Covid-19 treatment) and increasing drug consumption rates, as it provides a wealth of data to analyze the risks and benefits of a particular drug. Involved in managing reports.

As more companies develop drugs for multiple sets of diseases and therapies, the central repository of drug safety reports for the products they manufacture worldwide has grown exponentially. Known as the Pharmacovigilance Safety Database, this database now allows the field to evolve from a single-source passive process to a complex, holistic and dynamic ecosystem.

With these significant changes, technology has become critical to ensuring compliance, security and monitoring of this dynamic system of security information sources. However, there has been little talk of digital transformation in pharmacovigilance, which can be attributed to two main reasons – the field is highly niche and highly regulated. With regulatory agencies increasingly emphasizing approvals for fast-tracking drugs, and huge amounts of data being generated every day, it is hard to imagine that pharmacovigilance would remain in the realm of digital conversion only. The automation and digitization sector and clinical research will be a blessing in disguise for organizations, as it will help improve output, quality and efficiency.

The process of redefining technology

Real-world data (RWD) and real-world evidence (RWE) are being widely used to analyze the potential benefits or risks of a medical drug. RWD refers to patients’ health status or healthcare delivery data that is regularly collected from multiple sources. By studying and analyzing the same data, clinical evidence regarding its use, benefits and risks is obtained. However, to ensure privacy and security, data must be categorized and stored in specific forms. This standardization and synchronization between multiple RWD sources can be accomplished through collaborative efforts to increase its utility within the healthcare sector.

Another important emergence is social media technology. Life science companies are seeing this as an important platform for consumers around the world to share their personal information and experiences online. However, it is still in its infancy because pharmacovigilance efforts require further refinement of social media technology. An effective semi-automated strategy for monitoring social media can provide an initial insight into certain adverse events. To facilitate pharmacovigilance studies, new advance mechanisms for social media data management need to be developed. The sector also needs some clarity and clarity from regulators on how these platforms can be effectively used as data sources.

Reporting applications are another excellent tool for drug safety, as they provide easy access to report adverse drug responses (ADRs), an important one being MedSafety, developed by Upsala in collaboration with WHO. There have been several studies that suggest that using the reporting app increases patients’ ADR reporting.

The National Coordinating Center of the Pharmacovigilance Program of the Pharmacopoeia Commission of India has launched a mobile application called “ADR PvPI” to address some of the challenges related to ADR reporting and to standardize and improve this process. This is consistent with the current emphasis on pharmacovigilance which is influenced by patient reported results and real-world data.

However, any transformational journey is challenged by certain obstacles. One of the major limitations of digital technology in the field of pharmacovigilance is data privacy. According to a GlobalData survey conducted last year, digital privacy and data security have been identified as the top concerns of respondents when it comes to digital transformation (refer to: link). The Digital India Mission acknowledges cyber security issues and, consequently, is working on a proposed Healthcare Act (DISHA) to provide privacy, security and standardization of health information.

Pharmacovigilance has evolved and improved over the years. Pharmacovigilance teams from various organizations have a great responsibility to adapt quickly to the evolving digital landscape. This transition will be smooth and rapid, and will be influenced by the collaborative efforts of regulatory authorities and life sciences organizations to develop safe drugs and streamline the roll-out process.

(ME Author Vice President, Pharmacovigilance Operations, Parexel. Opinions expressed are personal and not reflective Official position or policy of

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