+390677209020 | +39 0267380552 info@direnzo.biz | sedemilano@direnzo.biz


Pharmacovigilance: What is it? What is it used for?

Pharmacovigilance is a set of activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem, in order to ensure a positive benefit/risk relation for the population.

What does this mean? It means to put in play a series of actions to control that the medicinal products marketed by companies and prescribed by health professionals comply with the information approved by national and European competent authorities. In particular, pharmacovigilance considers adverse reactions that can occur following the intake or administration of a medicinal product.

The product information submitted to obtain the registration of a medicinal product includes, in fact, not only the drug therapeutic indications, but also any possible reactions that can be experienced following its use, already detected during the clinical trials carried out on the drug before its marketing. Both the Summary of Product Characteristics and the Patient Information Leaflet list these possible undesirable effects, but – since studies on drugs are carried out on a limited number of subjects, generally lower than the number of potential users – continuous monitoring is necessary, in order to keep such list continuously updated.

How is such monitoring performed?

Through the reporting of suspected adverse reactions that are considered as related to the use of a certain medicine. These reports can be sent either by patients, who can report suspected reactions to their physician, or by health professionals, that can upload them in the National Pharmacovigilance Network, a database collecting and managing the reports also at European level.

Health professionals are already able to relate the reactions reported by patients to the information present in the product information; to this aim, it is also important that patients read the information leaflet, drafted in a simple and exhaustive way, informing them about the risks and benefits of the treatment, and the adherence to the therapy.

Then, it is the M A holder’s task to investigate the suspected adverse reaction, first confirming or excluding a cause-effect relation between the use of the drug and the onset of the undesirable effect, then going into depth on any relation found.

Drug overdose, abuse or misuse are also considered as adverse affects. For this, the patient leaflet always recommends to bring the product carton to inform the doctor on the product taken: this information is, however, often missing in the reports from first aid hospital departments.

The goal of this suspected adverse reaction reporting system still remains to improve drug safety. In fact, in case the evaluation of the holder’s pharmacovigilance responsible person establishes an actual cause-effect relation between the drug and the new reaction, its onset will be further monitored in the future, and it could also lead to new warnings or contraindications and, in most serious cases, to the exclusion of the use in a specific population of patients, and even the product revocation. The so called risk/benefit profile of the drug is reviewed by the authorities and the product information is updated in order to protect users’ health.

By its continuous monitoring of drugs’ effects, pharmacovigilance ensures that information available to patients and health professionals is always updated and that patients’ safety is always a top priority of regulatory agencies.

Written by: Maria Pia Felici

Foto di Michal Jarmoluk da Pixabay