Journal of Pharmacovigilance

Under-reporting of adverse drug reactions: A problem that also involves medicines subject to additional monitoring; preliminary data from a single-centre experience on novel oral anticoagulants

9^th International Conference and Exhibition on Pharmacovigilance & Drug Safety

July 17-18, 2017 Munich, Germany

Anna Patrignani, Lucia Racca, Giorgia Palmieri, Nino Ciampani, Vincenzo Moretti and Antonio Mariani

Senigallia Hospital, Italy
ASUR Marche, Italy
Azienda Ospedali Riuniti di Ancona, Italy

Scientific Tracks Abstracts: J Pharmacovigil

Abstract:

Background: Spontaneous reporting system is most widely used by pharmacovigilance systems. Its �??voluntary nature�?� represents the main cause of adverse drug reactions (ADRs) under-reporting phenomena. Objective: To point out the issue of ADRs under-reporting from hospital doctors, above all of �??serious�?� ADRs and of adverse reactions caused by medicinal products subject to additional monitoring, such as novel oral anticoagulants (NOACs). Methods: We just analyzed serious ADR, defined as ones responsible for: death, life-threatening, hospitalization (initial or prolonged), disability (significant or permanent), and congenital anomaly. As a first step, we analyzed suspected adverse reactions alerts to NOACs submitted to the Area Vasta 2 (ASUR Marche) pharmacovigilance centre, from 16 June 2013 until 14 January 2017. Furthermore, we examined alerts coming from all over Italy and from the Marche region. In a second step, we just worked in Senigallia hospital; retrospectively, we identified some patients who experienced an ADR in that period of time and we submitted the alert. In a third step, from 15 January 2017 until 15 March 2017, we submitted suspected ADR alerts prospectively. Results: Phase 1: in 43 months, 1625 alerts have been submitted from all over Italy, 20 from the Marche region (one of them from the Senigallia Hospital). Phase 2: retrospectively, we collected eight suspected serious ADR, two of them resulting in death and three of them life-threatening. Phase 3: in just two months, prospectively, we observed seven serious ADR, two of them resulting in death and one of them life-threatening. Conclusions: Our study has shown that under-reporting phenomena are remarkable from hospital doctors and it also concerns medicinal products subject to additional monitoring and serious ADRs. In our opinion, the introduction of a system of �??rewards�?� for doctors who correctly report ADRs or a system of �??sanctions�?� for doctors who don�??t respect this important duty should be attempted.

Biography :

Anna Patrignani is a Cardiologist in a spoke model hospital in Marche region, Italy since 2009. She completed her Graduation with honors in 2002; attended the Erasmus Program in Strasbourg in 1999; completed her Residency in Cardiology at University of Pavia in 2006. She is a Fellow of Associazione Nazionale Medici Cardiologi Ospedalieri since 2010 and; Sub-investigator in the Garfield clinical trial (multi-centre, international registry of patients with atrial fibrillation).

Email: patrignani.anna@libero.it