Future of pharmacovigilance

Report suspected side effects to medicines, vaccines, e-cigarettes, medical device incidents, defective or falsified (fake) products to the Medicines and Healthcare products Regulatory Agency.

The modern world is ruled by data

From wearables to self-driving cars, every product and service is in a race to collect more data and gain a competitive advantage by mastering the art of data processing in the shortest amount of time. The healthcare sector is no different. All patients leave a digital footprint at every stage of their interactions with healthcare professionals. With the advancing technology and the efficiencies of the data collection schemes, the adverse events patients experience are more likely to be reported for the AE collection schemes around the world. This data revolution not only has the potential to upend the entire diagnostic practices in the future but also has the potential to greatly improve patient safety.

The total number of ADR reports reported to the Eudravigilance portal has been steadily increasing over the last few years. In 2021, the increase was exponential (11). While the big numbers of AE reports might sound scary at first, they are the indicators of a healthy and robust safety infrastructure where the Pharma companies and regulators are more likely than ever to catch safety issues at an earlier stage.

electronic Patient Information (ePI)

There is a growing global trend toward elimination of paper-based product information, and adoption of a digital-first mix of paper and electronic version could be one of the solutions.

A digital solution would:

Address long-standing health literacy issues
Connect product information with digital health services
Offer Personalisation and visualisation of content by the user, beyond a pdf version of the PIL
Reduce the approx. 100 billion leaflets printed worldwide per year

Any solution

Must include the patient voice
Must not leave anyone behind - so a better (than current) paper-based solution must also address those without access to digital means

The transformation of science

This started with the digitisation practices that eliminated paper-based reporting systems. Digitalisation paved the way for automation of the AE collection and processing activities. The sector is now at the crossroads of automation and artificial intelligence (AI). The ultimate goal is the incorporation of AI technologies into all areas of the safety surveillance infrastructure. The field of artificial intelligence in pharmacovigilance, also referred as AIPV or PVAI, has become increasingly popular in the last 5 years. A study found that the number of unique citations returned by a simple search in MEDLINE for the words “Artificial Intelligence” and “Pharmacovigilance” has been exponentially growing since 2017 (1). This increasing popularity is driving a change in the PV industry, and it is creating a unique set of opportunities and challenges for the people who work in PV.

One notable example of the opportunities includes the potential of switching from volume-based work to more value-based work where the increasing use of the AI applications would reduce the administrative burden that currently exists on the initial part of the case receipt and processing activities. A survey of drug safety professionals conducted by a pharmaceutical company found that there is a keenness amongst the staff to shift the PV work into a more value-based model, which would allow more time for skills and competency development (3). This change could also result in the more widespread use of wearable devices during clinical trials which collect and analyse health data (12). For patients, this could have many advantages ranging from less frequent trips to trial sites to greater clinical trial access to novel therapeutics.

Regulatory authorities are also changing

The PVAI interventions should not be only applicable to pharmaceutical corporations. The regulatory authorities are facing a unique set of challenges which also demand innovative AI-based solutions. One notable example was the COVID-19 pandemic when the regulatory authorities around the world faced a sharp increase on the number of ICSRs being reported from the COVID-19 vaccines.

The French Agency for the Safety of Health Products (ANSM) deployed an AI model to facilitate the automatic coding of drug reaction reports (6). Many other regulatory authorities, including the UK’s Medicines and Healthcare products Regulatory authority (MHRA), deployed similar AI interventions to cope with the volume of AE reports (10). These examples from the regulatory bodies are showing us that the change is not limited to pharmaceutical companies and the safety infrastructure at any organisation can benefit from AI on a truly global scale.

Pharmacovigilance is evolving

The pharmaceutical industry is always changing, and the pharmacovigilance branch is no exception. All the changes mentioned above are transforming the once-siloed working patterns of pharmacovigilance into a new hybrid model where the safety professionals are being asked to train, approve, understand, and maintain the AI interventions at every stage in the safety system alongside the standardised and established safety work. Safety operations are becoming more integrated with technology, demanding a more diverse skill set from employees for a long time (5).

The PV environment is thriving for change, becoming one of the most innovative areas of the pharmaceutical business. It is an exciting time to be a part of this line of work where the future provides an impressive amount of development opportunities at every career stage.