Future of Pharmacovigilance

In the course of clinical trials, drugs are tested for their safety and efficacy on selected human beings only. When drugs are marketed, they are exposed to larger population, hence require close monitoring, which is termed as post-marketing surveillance or more precisely pharmacovigilance, which majorly depends on spontaneous reporting of adverse drug reaction (ADR).

The World Health Organization (WHO) defines an ADR as any drug effect, which is noxious, unintended and undesired and occur at normal therapeutic doses. Pharmacovigilance is defined by the World Health Organization (WHO) as ’the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem’.

The main objective of pharmacovigilance is to protect patients from preventable harm by identifying previously unrecognized adverse drug reactions, interpreting pre-disposing factors, contradicting safety signals, which do not act in accordance with the expected safety and efficacy of the drugs, and reckoning risk over benefits. In 2002, in excess of 65 nations have their own pharmacovigilance centers. WHO Collaborating Centre facilitates International Drug Monitoring, known as the Uppsala Monitoring centre (UMC) situated in Sweden, firmly associated with WHO since 1978. The main purpose of the Uppsala monitoring centre is to standardize signals detected and communicate among countries to expedite the identification of signals.

The global pharmacovigilance market size was valued at USD 6.33 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 11.5% from 2021 to 2028. We can observe a significant change in the pharmacovigilance system worldwide due to encroachments in technology, subsequently increasing availability of data to the companies as well as to the regulators.

The main objective of pharmacovigilance is to protect patients from preventable harm by identifying previously unrecognized adverse drug reactions, interpreting pre-disposing factors, contradicting safety signals, which do not act in accordance with the expected safety and efficacy of the drugs, and reckoning risk over benefits.

The biggest challenge pharmacovigilance companies are facing is an intense pressure to readily evaluate more data and to monitor approximate risks, and to report each signal detected globally. Commencement of digitalization in health care, augmented more prospects to access more, better data, and provide other approaches in pharmacovigilance, including both the detection and evaluation of ADRs.

The main data source for potential new safety issues is Individual Case Safety Reports (ICSR). By 2030, ICSR reporting will improve further. Industries and regulators are in process to revise the International Council on Harmonisation (ICH) guideline E2D on post-approval safety data management, which will open more prospects to elevate the collection, and management of ICSRs. The revised ICH comprehensively increases the global harmonized approach. 

Significant progress has been made through accessing and evaluating real-world data, such as Sentinel sites in the United States, the Observational Health Data Sciences and Informatics (OHDSI) network, and connecting the large-scale healthcare data from multi-stakeholders in the European Union. One of the prevalent challenges is to access and analyse real-world data to evaluate the on-market efficacy of any therapeutic product. In upcoming years, it is estimated that there will be planned monitoring of safety and efficacy of the medicines with an approximate real time decision-making approach by pharmaceutical companies as well as the regulators to enhance safe and effective use of not only medicines but also biological products and medical devices.

In recent years, worldwide regulatory agencies have worked immensely to engage with healthcare professionals and patients which leads to a historic change in adverse drug reaction reporting and this will further enhance if regulators and also healthcare professionals will meritoriously respond to patient needs and make sure that the information provided to them is effective to support safe and effective use of medicines.

The pharmacovigilance industry has witnessed rapid change globally. Technology advancement and artificial intelligence exponentially increased the data analysing process. It is estimated that, in the coming years more involvement of patients and healthcare professionals will embark on substantial growth of the pharmacovigilance industry worldwide.