Pharmacovigilance (PV) is defined as the science and activities related to detecting, assessing, understanding and preventing adverse effects and other medicine-related problems [1]. Its main goal is to minimise harm by medicines, ultimately protecting and promoting public health. Research has shown that adverse drug reactions (ADRs) are a frequent cause of (prolongation of) hospitalisation and they increase the risk of mortality [2,3,4].

Assessing the impact of PV at the population level on preventing harm is challenging and an area that is currently still insufficiently researched [5]. In daily practice, there are a variety of PV activities that all influence different steps in the PV pathways (Fig. 1). These pathways of PV activities are often intertwined and complementary. This makes the assessment of impact for the individual steps complicated. Another challenge is to take into account the unintended effects and other simultaneous events such as changes in clinical practice or secular trends in health outcomes.

Pathways of pharmacoviligance activities. A The generation of pharmacovigilance knowledge. B The dissemination and communication of this knowledge. ADR adverse drug reaction, PASS post-authorisation safety studies

Undoubtedly, PV has demonstrated its value in practice, but to measure its impact [6,7,8], more evidence is needed about the effectiveness and public health consequences of PV activities at the population level. This would also provide insights into enablers and barriers for generating positive health impacts, which could aid in further improving PV.

Of course, PV is continually evolving, and calls for improvement are ongoing. Bate and Stegmann argued in 2021 that if PV further develops to widely and routinely use innovative advances, ADRs will be better understood and therefore more predictable and preventable. To achieve this, a proactive approach is warranted from all PV stakeholders [9].

In my opinion, there is a gap with clinical practice. More interaction with daily clinical practice is needed. Pharmacovigilance does not make optimal use of clinical observations from healthcare professionals and patient experiences. Therefore, considerable knowledge on ADRs remains under the radar. Next to that, it is crucial to take into account the information needs of healthcare professionals (HCPs) and patients regarding ADRs to ensure that the knowledge generated by PV is useful and applicable in pharmacotherapy.

Furthermore, PV processes should be accelerated. The time required to generate and ensure the availability of important safety information must be reduced. An evaluation of signals over a period of 10 years from the Dutch spontaneous reporting system showed that most of the signals concerned drugs that had been on the market for 10 years or more (172 signals, 84.7%) [10]. With new drugs rapidly becoming available through fast-track development and registration, accelerated PV is necessary to ensure patient safety.

Last, but not least, PV needs to take on a more significant social role in ensuring trustworthy information. In the post-modern world, independent and widely trusted information on drug safety, especially for vaccines, as shown during the COVID-19 pandemic, is of utmost importance. Pharmacovigilance organisations must provide reliable information to support informed choices and counterbalance misleading and false information.

In this appeal to improve the impact of PV, I focus on two main areas in the pathways of the PV process: the generation of PV knowledge (A) and the dissemination and communication of this knowledge (B) (Fig. 1).