What kind of role does communication with patients play in the pharmaceutical field? How much and what should consumers know? What effects can inaccurate communication have on users?
It was discussed at the fourth edition of the European Pharmacovigilance Congress, held online on 26th and 27th November where we were sponsors.
Giovanni Furlan, Safety Risk Lead Director at Pfizer, spoke more precisely of the paradoxical effects of communication. Here’s what he brought out.
The risk of adverse reactions is a fundamental thing to communicate to anyone who uses the drug in order to reduce the risk associated with it, but from the patient’s point of view is it really so useful? Several patient studies showed that after reading the Package Information Leaflet, they were shocked about the adverse reactions and their severity, with the result that some of them even stopped taking the drug or altered their doses.
Not to be underestimated in particular is the nocebo effect, a psychobiological phenomenon according to which our perception is altered following the conditioning of previous events or hostility regarding a product. The occurrence of this effect can contribute to the manifestation of adverse reactions as a patient with negative emotions about a drug is led to pay more attention to the effects of its intake, generally reporting more symptoms after taking it.
An example of this is the case of Finasteride, presented to subjects with prostatic hyperplasia and no sexual dysfunction, as a drug that can rarely cause erectile dysfunction, decreased libido, ejaculation problems: 43.6%, at one year of follow-up, reported sexual dysfunction.
Another example is the double-blind study in which patients with angina were given aspirin, sulfinpyrazone, both drugs or placebo. Patients informed of the risk of gastrointestinal irritation reported increased gastrointestinal symptoms and were six times more likely to withdraw from the study due to these.
The nocebo effect accounts for at least 40% of adverse events in clinical studies, as well as non-specific symptoms. The latter which can be symptoms of normal daily life, such as back pain, fatigue, headache, joint pain, sleep disturbances, etc. are often erroneously attributed to the drug. However, they must be inherent in the labelling of the drug, with the counterproductive effect, however, for which a patient is less willing to undergo such treatment.
A further problem is that numerical data of adverse reactions are not reported: it has been shown that patients who do not know the real incidence figures have a tendency to overestimate the frequency of adverse events compared to patients who receive information in numeric format if adverse events are symptoms of daily life; consequently, those who are not aware of the facts in numbers are less likely to take the drug.
One proposal – continues Furlan – could be to include precise figures in the labelling of the drug, using more direct infographics, so as not to influence the public.
In conclusion, it can be said that although communication is fundamental, the way in which it is done is even more important and the time has come to explore new ways of informing to avoid misunderstandings and unfounded conditioning.