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. 2024 Nov 4:15:20420986241293296.
doi: 10.1177/20420986241293296. eCollection 2024.

The evolution of the Pharmacovigilance department in the pharmaceutical industry: results of an Italian national survey

Lisa Stagi  1 , Ilenia Bocchi  2 , Daniela Bernardini  3 , Marika Ciappa  4 , Stefania Dellon  5 , Gian Nicola Castiglione  6 , Silvia Romano  7 , Eros Fabrizi  8 , Amanda Mattavelli  9 , Ilaria Grisoni  10 , Gabriella Finizia  11 , Stefano Bonato  12
Affiliations

The evolution of the Pharmacovigilance department in the pharmaceutical industry: results of an Italian national survey

Lisa Stagi et al. Ther Adv Drug Saf. .

Abstract

Background: Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine/vaccine-related problem. Since its inception in the 1960s, PV has undergone continuous evolution, progressing from a basic level mainly focused on the collection and analysis of cases in its earliest years to a complex system regulated by rigorous standards and laws with modern PV. In recent years, PV has faced the challenge of adapting to rapid scientific advancements, the complexity of the pharma industry, and the digital revolution. To better understand the current state and future developments of PV within pharma companies, the PV working group "Ernesto Montagna" of the Italian Society of Pharmaceutical Medicine (SIMeF ETS) conducted a national survey in Italy.

Objectives: The main objective of this survey was to explore the current state and future developments of PV within Pharmaceutical Companies in Italy.

Design: This study was designed as a national survey targeting members of the Italian Society of Pharmaceutical Medicine (SIMeF ETS).

Methods: The survey utilized computer-assisted web interview (CAWI) technology to collect data from SIMeF members across affiliate and corporate companies, aiming to explore expectations for PV. A simplified version of the questionnaire was also sent to members of the Clinical Research and Medical Affairs (RICMA) and Real-World Evidence working groups of SIMeF to gather input from RICMA professionals regarding the role of PV in pharma companies.

Results: The survey revealed that PV in pharma companies is undergoing a transformation, with the potential for greater strategic alignment with business objectives and stakeholder focus. However, there is still room for improvement, particularly in terms of perception within other company departments. It is evident that PV's evolution has only just begun.

Conclusion: A critical factor in the evolution of PV is the adoption of a holistic and comprehensive approach to activities and processes. Scientific associations such as SIMeF can play a valuable role in cultivating new skills and capabilities among PV professionals, assisting, and supporting this change.

Keywords: innovation; patient centricity; pharmacovigilance.

Plain language summary

The evolution of the Pharmacovigilance department in the pharmaceutical industry: results of an Italian national survey.

Background: Pharmacovigilance departments within the Pharmaceutical Companies have been structured several years ago, with the main objective to respond to the regulatory requirements and guarantee the correct and safe use of marketed products. The digitalization and the new approach to drug development drove to a rapid evolution of the healthcare environment. This change led the shift of Pharmacovigilance activities (initially mainly focused on the collection of the adverse events), to better ways to collect and use safety data, combined with the possibility to share them with decision makers, improving the engagement of patients and healthcare professionals. The Pharmacovigilance Working Group “Ernesto Montagna” of the Italian Society of Pharmaceutical Medicine (SIMeF ETS) carried out an online Italian national survey to have a better understanding of this new role of Pharmacovigilance in the new scenario and the perception of the Pharmacovigilance experts about this evolution. The digital world allows and makes easy sharing of information, including that related to the health status of patients and side effects of drugs. Healthcare/Pharmaceutical Companies are faced with both opportunities and challenges provided by such new ways of interaction among patients and healthcare professionals. It is precisely the emergence of new challenges in the scientific and technological fields and, not less important, the multiple and different operational and management skills required by Pharmacovigilance team members, that led us to reflect on which direction Pharmacovigilance is taking and what is expected for the near future.

Methods: The Pharmacovigilance Working Group “Ernesto Montagna” of SIMeF ETS distributed a questionnaire to the members of SIMeF addressing questions to the Pharmacovigilance dedicated associates. The questionnaire was composed of open and closed questions to explore the affiliate and corporate scenario. A simplified version of the questionnaire was also sent to the members of Clinical Research and Medical Affairs (RICMA) and Real Word Evidence (RWE) Working Groups of SIMeF ETS to collect the perspective by clinical research and medical affairs on the role of Pharmacovigilance in the Pharmaceutical Companies.

Results: The results show that the Pharmacovigilance departments in Pharmaceutical Companies are changing their positioning and have a greater attitude to be influential not only by executing the traditional compliance related tasks but also on more strategic and stakeholder-oriented activities. Despite this, there are still big areas of opportunities, and the change has just started.

Conclusion: In a scenario evolving very quickly, it is critical to manage Pharmacovigilance in a more holistic and comprehensive way, adding to the compliance related activities, a more customer-oriented perspective. Scientific Pharmaceutical Associations like SIMeF ETS itself could give a valuable contribution to the development of new skills and capabilities to Pharmacovigilance personnel, to help and support this change, in an ecosystem rapidly evolving under the pressure of new technology and regulations, a more patient oriented approach and a more complex drug development.

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Conflict of interest statement

The authors declare that there is no conflict of interest.

Figures

Figure 1.
Figure 1.
Location of responders (headquarter or an affiliate).
Figure 2.
Figure 2.
Reporting line of the PV department within the company. PV, Pharmacovigilance.
Figure 3.
Figure 3.
Perception of the PV role (reactive/proactive) according to the type of company (affiliate/corporate). PV, Pharmacovigilance.
Figure 4.
Figure 4.
How is the PV role perceived by the PV department itself? PV, Pharmacovigilance.
Figure 5.
Figure 5.
Evolution of the PV department in the last 5 years. PV, Pharmacovigilance.
Figure 6.
Figure 6.
Actions that can be put in place to improve PV perception in the company. PV, Pharmacovigilance.
Figure 7.
Figure 7.
Interaction between PV department and the other departments within the company. PV, Pharmacovigilance.
Figure 8.
Figure 8.
Perception of the PV department. PV, Pharmacovigilance.
Figure 9.
Figure 9.
Participation of the PV department in activities of external stakeholder engagement. PV, Pharmacovigilance.
Figure 10.
Figure 10.
Definition of PV in 2030. PV, Pharmacovigilance.
Figure 11.
Figure 11.
Keywords associated with PV. PV, Pharmacovigilance.
See this image and copyright information in PMC

References

    1. WHO PV definition, https://www.who.int/teams/regulation-prequalification/regulation-and-saf....
    1. For EU legislation please see for example: Directive 2010/84/EU; Directive 2012/26/EU; Regulation 1235/2010; Regulation 520/2012; European Medicines Agency (EMA) Good Pharmacovigilance Practices (GVP), https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisatio....
    1. For US legislation please see: Code of Federal Regulation (CFR) Title 21; Center for Drug Evaluation and Research (CDER) guidelines.
    1. Report of the CIOMS working group XI, 2022: Patient involvement in the development, regulation, and safe use of medicines.
    1. European Medicines Agency. Appendix 2 to the guideline on the evaluation of anticancer medicinal products in man. EMA/CHMP/292464/2014, https://www.ema.europa.eu/en/documents/other/appendix-2-guideline-evalua... (accessed 1 April 2016).

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