Publication
Are patients ready to take part in pharmacovigilance system : a Portuguese preliminary study concerning ADR reporting
| datacite.subject.fos | Ciências Médicas | pt_PT |
| dc.contributor.advisor | Hunsel, Florence Petra Anne Maria van, 1981- | |
| dc.contributor.advisor | Joaquim, João José Morais, 1969- | |
| dc.contributor.author | Matos, Cristiano Filipe Romão, 1989- | |
| dc.date.accessioned | 2016-12-22T11:49:17Z | |
| dc.date.available | 2016-12-22T11:49:17Z | |
| dc.date.issued | 2014 | |
| dc.description.abstract | Background: New Pharmacovigilance legislation allows patients to report adverse drug reactions (ADRs) directly to competent authorities in all European Union (EU) member states. Patient reporting is available in Portugal since July 2012. In 2013, the National Pharmacovigilance System (SNF) had received 3461 spontaneous ADR reports, of which only 1.4% (n=50) were reported by patients. Underreporting remains a reality in Portugal, although patient reporting could be one of the measures to reduce the rate of underreporting by healthcare professionals (HCP). Objectives: The aim of this study was to describe the attitudes and knowledge of the patients regarding spontaneous reporting and the reasons and opinions that can influence patients ADR underreporting. Methods: A descriptive-correlational study was performed looking for patients’ attitudes and knowledge regarding spontaneous reporting. A 6-months survey was conducted from June to November 2013 in general adult patients from a community pharmacy in Coimbra, Portugal, that used prescribed medicines or OTC-drugs. Attitudes and opinions were surveyed in a closedanswer questionnaire using a Likert scale. Incomplete questionnaires and answers from healthcare professionals were excluded from data analysis. The data were analyzed using descriptive statistics, χ2 tests and Spearman’s correlation coefficients. Results: A total of 1084 questionnaires were collected with a response rate of 81,1% and 948 completed questionnaires were selected for analysis. Of the respondents, 44.1% never heard about SNF. Younger people and those with a higher education were significantly more likely to be aware of SNF. Only 1 patient had previously reported an ADR directly to SNF. Reporting ADRs indirectly through an HCP was preferred by 62.4%. The main reasons for patients reporting spontaneous ADR would be the severity of the reaction (81,1% agreed or strongly agreed) and worries about their own situation (73,4% agreed or strongly agreed). Only weak and moderate correlations were found between studied statements. Conclusions: Patients are most likely to do a spontaneous report about a severe reaction or if they are worried about the symptoms. Tailored and proactive information on ADR reporting and educational interventions on patients could increase the number of reports from patients in Portugal. | pt_PT |
| dc.identifier.tid | 201508338 | |
| dc.identifier.uri | http://hdl.handle.net/10400.26/17035 | |
| dc.language.iso | eng | pt_PT |
| dc.rights.uri | http://creativecommons.org/licenses/by-nc-sa/4.0/ | pt_PT |
| dc.subject | Farmacovigilância | pt_PT |
| dc.subject | Pacientes | pt_PT |
| dc.subject | Sistemas de notificação de reações adversas a medicamentos | pt_PT |
| dc.title | Are patients ready to take part in pharmacovigilance system : a Portuguese preliminary study concerning ADR reporting | pt_PT |
| dc.type | master thesis | |
| dspace.entity.type | Publication | |
| rcaap.rights | openAccess | pt_PT |
| rcaap.type | masterThesis | pt_PT |
| thesis.degree.name | Mestrado em Farmácia, Especialização em Farmacoterapia Aplicada | pt_PT |