The pharmacovigilance session, after the intervention of Dr. Cagnato who spoke about the Risk Management Plan and that of Dr. Diana who spoke about Real Evidence, saw an interesting double interview, moderated by Veronica Franchina of GIDMcrc and A.O. Papardo, Messina, to Laura Patrucco of Sofar and EUPATI expert patient and Francesco Pappalardo of the Romagna AUSL, who respectively represented the patient’s and the pharmaceutical company’s point of view. The topic of the interview was the all-round educational material, from the information present to its dissemination.

Franchina: For the pharmacovigilance responsible, how important is it to receive clear and updated material from pharmaceutical companies?

Pappalardo: receiving educational material from the pharmaceutical company is of fundamental importance, because this allows the pharmacovigilance responsible to always be updated on what are important safety information, on the events on which the risk must be minimized and consequently on the information that the pharmacovigilance manager or healthcare professional must then pass on to the patient. Specifically, the receipt of the educational material by the pharmacovigilance responsible makes him aware of what are important information and the use of some classes of drugs that are particularly delicate such as retinoids, such as Isotretinoin, which has high teratogenic effect; to be informed about the risks associated with the use of Valproate in women of childbearing age as it causes delayed effects in both body, psychological and psychic development; or even to be updated and informed on what are the pregnancy prevention programs in patients who take Valproate.

Franchina: For the patient, how important is it to be able to receive clear and updated material from pharmaceutical companies?

Pappalardo: It is necessary to make a premise on the interlocutors involved in the health supply chain, as pharmacovigilance has an impact, as regards clinical studies and above all the patient’s daily life: there has been an evolution in the concept of health, especially in this last period with Covid, and in addition to this there has also been an evolution in the role of the patient who started from being a person in need of care to become a patient who wants to get information, to know more about your pathology, up to the path of the EUPATI expert patient, therefore an expert patient, who in some way has certified himself, studying and acquiring skills, up to the 4.0 Patient, who is the trained and aware patient. This awareness is also of fundamental importance for the authorities involved in collecting clinical safety data, as these expert patients are increasingly participating in phase 4 of clinical studies, which in some way are also the most important for the patient because, in addition to efficacy, safety is investigated.

The importance of receiving educational material, but above all correct information becomes a must, precisely because the patient needs to be informed, to also eliminate the risk of fake news. We need to somehow create a single supply chain between all these interlocutors, from the drafting of educational material to dissemination.

Preventive pharmacovigilance is also of great importance: so far the company has always dealt with pharmacovigilance, but in a way linked to the safety of its drug, lately, thanks to the evolution of the patient, we are starting to talk about pharmacovigilance linked to patient health. Preventive pharmacovigilance is that which, when prescribing therapy to the patient, must inform about what are already known adverse effects, because in this way the patient has a greater ability to intercept those side effects and is urged to report, because also a single data collected through a single patient enrich the database for patient protection.

It is important to talk about tools, which exist and are adequate, but what should be encouraged is the use of these, through a greater culture on how to use them, both for the health of the drug and for the health of the patient.

Franchina: do you think the methods available are effective?

Pappalardo: I would say yes, the new technologies have benefited the dissemination of educational material both to healthcare professionals and to patients. A novelty is the fact of being able to use the educational material on computer support, such as the QR code which gives the possibility to scan and be sent directly to the pharmaceutical company website where important information on the safety of drugs can be found, to the possibility of being able to download the material on their devices and we know how much smartphones and tablets are part of our daily life today. So yes, digital has allowed wider and more widespread dissemination of information material.

Patrucco: on the patient side, the best dissemination is given by the empowerment of all these interlocutors who intervene in the health supply chain.

According to the guidelines of the EMA and the GVP, the collection of safety data is a must for health and is necessary precisely to achieve the goal of pharmacovigilance. It must be said that providing tools that allow us to intercept this security data from real life, therefore through the patient’s voice, allows us to enrich the real-world data database, which is a very precious asset, as it contains the data of the patient and somehow transforms the acts into evidence. It must be said that the tools also include the competent authority, which y has taken note of this need for patients who, through associations, have made themselves heard about the need to be pulled on board in this signaling and traceability circuit of safety data.

On the institutional sites, including that of AIFA, we find respectable educational materials; we also find the possibility of making spontaneous reports or, for example, we also have videos on YouTube, which perhaps fewer people know about their existence.

Patient involvement should help a little more to shift attention from what the document, the reporting of the adverse event or side effect is to something that is more patient-oriented and this can happen, for example, by creating greater awareness, greater culture precisely on the importance of not only having the tool but also of sharing it with associations. […]. There is also the sporadic patient who therefore does not have the habit of intercepting adverse events or simply does not have the awareness of how important this action is. Dissemination as an educational material must somehow help to harmonize the collection of data not only from patients who have chronic or oncological conditions but also from sporadic patients because even a single safety data is precious: many single data are somehow a whole.

Pharmacovigilance must also be a kind of interactive communication: we think of the electronic health record, for example, for patients who have medical devices, such as breast implants, how do they know what the effects are? Or, if they react, how should they go about reporting it? Here we use the collection of safety data through electronic tools such as the electronic health record.

Sooner or later it will also be necessary to talk about Digital Vigilance because it will also protect the security of patient data collected in terms of privacy, all the more so now that we are getting closer and closer to the topic of digital therapies. When there is a cooperation between all these interlocutors, I think it is easier to achieve the goal.

Franchina: Could the tools be improved?

Pappalardo: new technologies and digital tools can be valid tools to improve dissemination methods, on the other hand, it is also advisable to improve the identification and traceability of educational material which is very often distributed in the same way as promotional material, not giving due weight on the part of the health worker and consequently the information it contains is not transmitted to the final user who is the patient.

Patrucco: pharmacovigilance has different tools: drug registers, digital archives, the hubs that help to collect adverse events … There is a tendency on the part of companies to collect these patient prime data: it is precisely this awareness of the role of the patient who has evolved, he has become much more informed, much more experienced. In companies that have an interest in protecting not only the treatment anymore but also the patient who has to do the treatment, they have equipped themselves with patient safety councils, which are co-projects that take place precisely with patient associations, which are the spokespersons of the need, even in the drafting of what may be the most appropriate language to reach the recipient, because the tools must also be designed for the recipients, therefore also the usability of the language must be taken care of.

Having informed patients, the famous patient hired, gives the possibility of having a patient more compliant in intercepting the adverse effect: by making the patient responsible proactively and not only as a simple user of the drug it will be even easier for him to follow you in the adherence to supervision.

We must also think of those citizens who do not yet need to have information on a drug because they are still citizens, but who could be potential patients: it is also important to create a culture of progressive advertising, that advertising that reaches the community directly and not only on patient request. A beginning can also be given by the figure of the pharmacist who must be made responsible for the importance of giving information and empowering the patient by informing him of side effects.

Franchina: is the HCP willing to be able to report events concerning the risk to be minimized?

Pappalardo: The reception of the educational material is part of the health professional, generally he gives knowledge on what is important information on the safety of the drug and on the events of which the risk must be minimized. He is aware of having to transfer this information and transmit it to the patient and finally, if these should occur, he must report the various suspected adverse events that have occurred.

The receipt of the educational material by the health professional generates in him greater involvement in what is the reporting activity of these AEs. In recent years, however, the covid 19 pandemic has stolen time from all these health care activities, such as the training of the healthcare professional and the patient and not least the reporting of adverse events, consequently it is necessary to regain possession of these times and spaces. to ensure that the educational material is understood, the information is passed on to the patient and the AEs are reported.

Franchina: for the patient, once he has received the educational material, does he reassure him or alarm him because he discovers fears that he otherwise would never have evaluated?

Patrucco: already talking about drug supervision with a patient who does not have technical skills certainly generates many doubts. He needs to receive answers and this is where the need arises to create therapeutic alliance paths between the companies that provide drug safety information and patient associations. The therapeutic alliance can already be that between doctor and patient because when the patient reads a package leaflet, he cannot filter what he reads, as the leaflets are designed more for the protection of the data, not for the protection of the reader of that data, so it is important that these leaflets are rethought in a more user-friendly way and even more important is the figure of the doctor who reassures the patient and who does not leave him alone at the mercy of the package leaflet: he must establish a relationship of trust through constructive dialogue.

It is also important to think about gender pharmacovigilance because the AEs that happen to men are different from those that can happen to women and also in the drafting of protocols, involving an expert patient can also help to find an adequate therapy for women who still today they tend to be excluded from clinical studies and therefore also the safety data are somehow deficient. So we interact with associations, expert patients, companies and competent authorities.