The implementation of the Kerubin solution revolves around a central and crucial objective: to help the doctor intervene in time and to better manage the onset of adverse effects.
Hence the reason for the pursuit, right from the conception of the idea, of a direct channel with Pharmacovigilance (an institutionally responsible body for monitoring this phenomenon) with the aim of understanding its point of view and taking it into account in the design of the solution.
The feedback obtained was very positive and confirmed the interest on the part of Pharmacovigilance for an initiative such as Kerubin, which can make a strong contribution to monitoring activities.
Monitor drug safety
Pharmacovigilance is the set of activities aimed at identifying, evaluating, understanding and preventing adverse effects or any other issue related to the use of medicines, in order to ensure a favourable risk / benefit ratio for the population.
The main objective is to constantly monitor the drug during its use in clinical practice, with the aim of identifying the appearance of adverse reactions and verifying the therapeutic effects observed in the clinical trial, confirming them and / or identifying new ones.
With this in mind, monitoring the safety of a drug also means promoting its mindful use and ensuring its medical appropriateness.
The Italian Pharmacovigilance system is coordinated by the Italian Pharmaceutical Agency (AIFA) which, in carrying out drug surveillance activities, makes use of the Regional Pharmacovigilance Centres (CRFV).
In the Campania Region, with the implementation of Legislative Decree 95/2003, the Regional Relevance Centre for Pharmacovigilance and Pharmacoepidemiology (CRFV) was activated with resolution no. 2530 of 6 August 2003. The Centre, born out of the collaboration between the Department of Experimental Medicine - Pharmacology Section "L.Donatelli" of the Second University of Naples, the Pharmaceutical Sector and the Department of Health of the Campania Region carries out multiple tasks within the programs of the Regional Health Service.
The CRFV’s objectives of the Campania Region include:
- promotion of Pharmacovigilance activities throughout the region, involving all the managers of Pharmacovigilance of the Local Health Units, Hospitals and Scientific Research and Care Institutes;
- promotion of Pharmacovigilance activities in all healthcare professional categories;
- promotion of prescription appropriateness;
- conducting training and information programs in the fields of Pharmacovigilance, Pharmacoepidemiology, and Pharmaceutical Usage;
- conducting active pharmacovigilance and pharmacoepidemiology projects.