Are consumers ready to take part in the Pharmacovigilance System?—a Portuguese preliminary study concerning ADR reporting

Matos, Cristiano; van Hunsel, Florence; Joaquim, João

Publication

Are consumers ready to take part in the Pharmacovigilance System?—a Portuguese preliminary study concerning ADR reporting

2015-07Journal article

dc.contributor.author	Matos, Cristiano
dc.contributor.author	van Hunsel, Florence
dc.contributor.author	Joaquim, João
dc.date.accessioned	2018-10-15T10:47:08Z
dc.date.available	2018-10-15T10:47:08Z
dc.date.issued	2015-07
dc.description.abstract	BACKGROUND: New pharmacovigilance legislation allows consumers to report adverse drug reactions (ADRs) directly to competent authorities in all European Union countries. Consumer 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 from consumers. Consumer reporting could be one opportunity to reduce underreporting. AIM: The aim of this study was to describe the attitudes and knowledge of the general public regarding spontaneous reporting and the reasons and opinions that can influence consumers' ADR underreporting. METHODS: A descriptive-correlational study was performed looking for consumers' attitudes and knowledge regarding spontaneous reporting. A 6-month survey was conducted from June to November 2013 in general adult consumers from a community pharmacy in Coimbra, Portugal, who used prescribed medicines or over-the-counter (OTC) drugs. Attitudes and opinions were surveyed by personal interview in a closed-answer questionnaire using a Likert scale. Questionnaires from healthcare professionals or incomplete ones were not considered. Data were analyzed using descriptive statistics, chi-square (χ(2)) tests, and Spearman's correlation coefficients. RESULTS: One thousand eighty-four questionnaires were collected (response rate of 81.1%) and 948 completed 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 one consumer had previously reported directly an ADR. Reporting ADRs indirectly through a healthcare professional (HCP) was preferred by 62.4%. The main reasons for consumers reporting spontaneous ADR would be the severity of reactions (81.1% agreed or strongly agreed) and worries about their situation (73.4% agreed or strongly agreed). Only weak and moderate correlations were found between studied statements.. CONCLUSIONS: Consumers are more likely to do spontaneous report about severe reactions or if they are worried about the symptoms. Tailored and proactive information on ADR reporting and educational interventions on consumers could increase the number of reports from consumers in Portugal.	pt_PT
dc.description.version	info:eu-repo/semantics/publishedVersion	pt_PT
dc.identifier.citation	Matos, C., van Hunsel, F. & Joaquim, J. Eur J Clin Pharmacol (2015) 71: 883. https://doi.org/10.1007/s00228-015-1867-2	pt_PT
dc.identifier.doi	10.1007/s00228-015-1867-2	pt_PT
dc.identifier.issn	1432-1041 (Online)
dc.identifier.uri	http://hdl.handle.net/10400.26/24271
dc.language.iso	eng	pt_PT
dc.peerreviewed	yes	pt_PT
dc.publisher	Springer-Verlag Berlin Heidelberg	pt_PT
dc.relation.publisherversion	https://link.springer.com/article/10.1007/s00228-015-1867-2	pt_PT
dc.rights.uri	http://creativecommons.org/licenses/by-nc-sa/4.0/	pt_PT
dc.subject	Pharmacovigilance	pt_PT
dc.subject	Direct consumer’s reporting	pt_PT
dc.subject	ADR reporting	pt_PT
dc.subject	Attitudes and knowledge	pt_PT
dc.subject	Farmacovigilância	pt_PT
dc.subject	Relato de reações adversas relacionadas com medicamentos	pt_PT
dc.subject	Atitudes e conhecimento	pt_PT
dc.title	Are consumers ready to take part in the Pharmacovigilance System?—a Portuguese preliminary study concerning ADR reporting	pt_PT
dc.type	journal article
dspace.entity.type	Publication
oaire.citation.endPage	890	pt_PT
oaire.citation.issue	7	pt_PT
oaire.citation.startPage	883	pt_PT
oaire.citation.title	European journal of clinical pharmacology	pt_PT
oaire.citation.volume	71	pt_PT
rcaap.rights	openAccess	pt_PT
rcaap.type	article	pt_PT