alexa 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
ISSN: 2329-6887

Journal of Pharmacovigilance
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9th 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
ScientificTracks Abstracts: J Pharmacovigil
DOI: 10.4172/2329-6887-C1-026
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.

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: [email protected]

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