Pharmacovigilance in the Social Networks

Pharmacovigilance consists in a set of activities to identify, assess, understand and prevent adverse events or any other issue related to medicinal products.

Such activities have the final purpose to ensure a risk/benefit profile of drugs that is favourable for the population.

To this end, the MA holder, through the figure of the EUQPPV, must ensure a pharmacovigilance system complying with the requirements provided for by the national and European regulations, and by the (Good Pharmacovigilance Practices).

They should also ensure a sound and well-structured quality system supervising the activities that are carried out, implementing corrective actions intended to improve the pharmacovigilance system itself.

In recent years, digital channels have become a source of communication that is more and more important. Pharmaceutical companies tend to create their own profiles on social media like Instagram, Facebook, Twitter, in order to sponsor their trademark.

The topic of pharmacovigilance and social networks is related to this context, along with the need to monitor and ensure that the flow of ADR reports, coming from this social channels, is not stopped.

MA holders must in fact ensure that a section dedicated to privacy regarding the authorisation to process the data as well as a section clearly specifying how to report ADRs is included.

Moreover, they shall ensure the presence of dedicated corporate staff charged with the control of social networks and of any safety information reported, even in a chat, for instance.

These processes shall be managed according to standard operating procedures (SOP) describing the actions to be performed to ensure reports monitoring and management.

An adverse reaction is any medical unintended and harmful event in a patient receiving a medicinal product, not necessarily having a causal link to this treatment.

This medicine can be taken:

under the terms of the marketing authorisation
outside the terms of marketing authorisation , including overdose, off-label use, misuse, abuse and medication errors.
by professional exposure.

One of the main activities carried out by the pharmacovigilance unit, that is the centre of a drug safety monitoring, is therefore the collection and assessment of drug adverse reactions.

This starts a chain reaction of related activities, such as the identification of the signal, leading for instance to the update of Summary of Product Characteristics (SmPC), with the addition of new warnings.

The loss of this information would lead to an incomplete overview for the subsequent preparation of documents such as the PSUR (Periodic Safety Update Report).

It is therefore essential to ensure that all (valid and non valid) reports, from different sources (e-mails, telephone, corporate website, social networks, etc.) are transmitted to the MA holder and that the latter processes them as requested by the regulations in force and following the company in-hose standard procedures.

A report can be considered as valid if it complies with the following 4 requirements:

one or more identifiable reporters (defined as primary source)
a patient
one or more suspected substances/medicines
one or more suspected adverse reactions

How can reporting be encouraged?

Different projects and events have been promoted by European and national authorities to simplify and encourage adverse event reporting.

The Uppsala Monitoring Centre (UMC) cooperates with medicine regulatory authorities all over the world to encourage side effects reporting via a #MedSafetyWeek campaign.

Now at its 7th edition, that took place on 7 to 13 November 2022, this campaign aims at making patients and health professionals aware of the importance of reporting suspected undesirable effects of drugs. The Italian Medicine Agency has joined the campaign promoting this event.

The IMI WEB-RADR (recognising adverse reactions) project is also included in this end to improve pharmacovigilance through the new technologies and social media. Launched in 2014, the project provides for the development of mobile apps specific for each country to report drug adverse events and receive updated information and news.

In September 2018 the WEB-RADR 2 project was launched in order to improve the app, also including the MedDRA terms in the codification of the adverse events.

Written by: Martina Durighello on 09/03/2023

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