Journal of Pharmacovigilance

Introducing methodological procedures to improve detection and reporting of adverse drug reactions (ADRs) in oncological hospitals

Conference Series LLC Joint International Event on 7^th Pharmacovigilance & Pharmaceutical Industry

August 22-24, 2016 Vienna, Austria

Baldo Paolo, Francescon Sara, Polesel Jerry, Taborelli Martina and Fornasier Giulia

National Cancer Institute, Italy

Posters & Accepted Abstracts: J Pharmacovigil

Abstract:

Background: After the effective entry in force (2012) of the new European Pharmacovigilance Regulations (No 1235/2010 and 2010/84/EU), a substantial amount of projects and studies have been put in place by health organizations. In Italy, AIFA, the Medicines regulatory authority, has supported and funded a number of initiatives in hospitals, defined as �??Proactive Pharmacovigilance projects�?�, with the aim of sensitizing health personnel and patients in the recognition and active spontaneous reporting of adverse drug reactions. Study Design: In CRO Aviano Institute, an important oncology hospital, we conducted a prospective, 24-months observational study, the �??Target-VIG�?� trial, with following primary outcomes: (a) monitoring unexpected toxicity of most recent anticancer medicines, taken orally at home by out-patients, and (b) to evaluate the impact of a new standard operative procedure (SOP) used in our trial for the monitoring of patients, with the aim to reduce the phenomenon of ADRs under-reporting in pharmacovigilance, which is highly relevant in the oncology setting; (c) to improve compliance to anticancer drug therapy in the home setting. Materials & Methods: The SOP consisted in a system of colloquial, direct ambulatory visits, together with monthly telephone calls and interviews, conducted by a pharmacovigilance-trained clinical pharmacist; interviews aimed to work both as reminders, to facilitate compliance to therapy, and to detect toxicity or other drug-related problems experienced by patients during anticancer therapy. All colloquia and surveys were recorded in standardized-template forms, approved by local ethical committee, and in a database. Preliminary Results: Promising preliminary results showed a huge increment of the spontaneous individual reports of ADRs (>100% compared a 12-months�?? time period) by enrolled patients; the possibility to compare �?? based on single products SPCs (Summary of Product Characteristics) �?? expected and unexpected or unknown ADRs, if referred by patients; improvement in therapy compliance, confirmed by fulfillment of individual questionnaires. Importantly, we noticed that, after the very first period, the need expressed by most patients to voluntarily meet the clinical pharmacist in extra-programmed interviews and colloquia, in the aim to discuss about their own therapy and related problems, have represented for us the best witness about the positive impact and special important role of the clinical pharmacist in the care of patients with cancer.

Biography :

Email: pbaldo@cro.it