Digitally monitoring adverse reactions: A new future for pharmacovigilance

Pharmacovigilance has evolved and advanced over the years. Pharmacovigilance teams in various organizations have a great responsibility of rapidly adapting to the evolving digital landscape.

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Glenmark’s current portfolio consists of 173 products authorized for distribution in the U.S. marketplace and 49 Abbreviated New Drug Application (ANDA)’s pending approval with the U.S. FDA. (File)

By Dr. Ritu Jaswal

In the last two years of the Covid-19 pandemic, medicines and vaccines, in particular, have caught the attention of people across the world and the general public has become increasingly aware of the usage, benefits and risks associated with drugs. In such a scenario, pharmacovigilance is becoming an important area of interest. The World Health Organization (WHO) defines pharmacovigilance as, “The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem.” Essentially, it refers to the process of mapping efficiency of the drug/vaccine, to track any risks and adverse events once it is released into the market.

Considering the speed of rapid drug development, newer drugs being introduced in the market at a faster rate (especially around Covid-19 treatments), and an increase in the rate of drug consumption, the role of pharmacovigilance has become even more critical, as it involves managing large amounts of data reports to analyse risks and benefits of a particular drug.

As more organizations develop drugs for multiple sets of disease and therapy areas, the central repository of drug safety reports for all products that they manufacture globally has grown tremendously. This database, called the pharmacovigilance safety database, now allows the field to evolve from a single-source passive process into a complex, holistic and dynamic ecosystem.

With this significant shift, technology has become crucial for ensuring compliance, safety and monitoring of this dynamic system of safety data sources. However, there have been fewer conversations about digital transformation in pharmacovigilance, which can be attributed to two key reasons – the field is highly niche and highly regulated. With growing emphasis on fast-tracking drug approvals by regulatory bodies, and the huge amount of data being generated daily, it is difficult to imagine that pharmacovigilance will only remain in the periphery of digital transformation. Automation and digitization will be a boon and norm for the sector and clinical research organizations, as it will help improve the output, quality and efficiency.

Technology redefining processes

Real-World Data (RWD) and Real-World Evidence (RWE) are being widely accepted to analyse prospective advantages or risks of a medical drug. RWD refers to patients’ health status or healthcare delivery data collected from multiple sources regularly. By studying and analysing the same data, clinical evidence regarding the usage, benefits and risks are derived. However, to guarantee privacy and security, the data must be categorised and stored in specified forms. This standardisation and synchronisation among multiple RWD sources might be accomplished through collaborative efforts within the healthcare sector to increase its utility.

Another important emergence is social media technology. Life science companies are realising this as an important platform as consumers from all around the world share their personal information and experiences online. However, this is in its nascent stage as social media technology needs more refining to suit pharmacovigilance efforts. An effective semi-automated strategy to social media monitoring may give early insights into specific adverse occurrences. There is a need to develop newer advance processes for social media data management to benefit pharmacovigilance studies. The sector also requires some clarity and transparency from the regulatory bodies on how effectively these platforms can be utilized as data sources.

Reporting Apps are another excellent tool for medication safety, since they provide easy access to reporting Adverse Drug Reactions (ADRs), an important one being MedSafety, which has been developed by Upsala in collaboration with the WHO. There have been several studies, which suggest that using a reporting app increases ADR reporting by patients.

The Indian Pharmacopoeia Commission’s National Coordination Centre for Pharmacovigilance Program has launched a mobile application named “ADR PvPI” to alleviate some of the challenges associated with ADR reporting and to standardise and improve this process. This is consistent with the current emphasis on pharmacovigilance that is influenced by patient-reported outcomes and real-world data.

However, any transformational journey is challenged by certain barriers. One major limitation of digital technology in the field of pharmacovigilance is data privacy. As per a GlobalData survey conducted last year, digital privacy and data security were found to be the top concerns of respondents when it came to digital transformation (Refer: Link). The Digital India Mission acknowledges issues related to cyber security and as a result, is working on the proposed Digital Information Security in Healthcare Act (DISHA), to provide confidentiality, security and standardization of health data.

Pharmacovigilance has evolved and advanced over the years. Pharmacovigilance teams in various organizations have a great responsibility of rapidly adapting to the evolving digital landscape. Making this shift seamless and quick will be possible and influenced by the collaborative efforts of the regulatory authorities and life science organizations to streamline the process of safe drug development and roll-out.

(The author is the Vice President, Pharmacovigilance Operations, Parexel. Views expressed are personal and do not reflect the official position or policy of

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