Improving adverse drug reaction reporting through workshops and telephone education in Portugal

ISRCTN	ISRCTN33698297
DOI	https://doi.org/10.1186/ISRCTN33698297
Secondary identifying numbers	N/A

Submission date: 10/03/2011
Registration date: 13/09/2011
Last edited: 13/09/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Teresa Herdeiro
Scientific

Unidade de Farmacovigilância do Norte
Faculdade de Medicina
Universidade do Porto
Porto
4200
Portugal

Email	teresaherdeiro@ua.pt

Study information

Study design	Cluster randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Screening
Scientific title	Improving adverse drug reaction reporting through workshops and telephone education in Portugal: a cluster randomised trial
Study objectives	1. An educative intervention enhances the reporting rate of adverse drug reaction 2. An educative intervention enhances the quality of reporting, in terms of its relevance to the pharmacosurveillance system 3. Duration of the effect in terms of quality and relevance could be more than one year
Ethics approval(s)	1. Northern Region Health Authority (ARS-Norte) approved on 12/03/2007 2. The ethical committees of hospitals for intervention group approved on 27/05/2007 and 21/01/2008
Health condition(s) or problem(s) studied	Under-reporting adverse drug reactions
Intervention	We implemented a continuing medical education multifaceted intervention comprising of telephone interviews and workshops. Telephone education consisted of a telephone conversation between the researcher and the physician conducted according to the established guidelines and supported by material sent to the participant, including one acknowledge letter, one adverse drug reaction (ADR) spontaneous notification form and one Northern Pharmacosurveillance Unit (UFN) presentation folder. The workshops consisted of a brief presentation including presentations of pharmacosurveillance and ADRs and its impact in the public health, description of the methods used in pharmacosurveillance and in spontaneous reporting system and the aptitudes and knowledges of physicians about ADR spontaneous reporting.
Intervention type	Other
Primary outcome measure	Rate of total notifications per month
Secondary outcome measures	Rate of serious, unexpected, high-causality and new-drug-related adverse drug reactions per month
Overall study start date	01/01/2007
Completion date	31/05/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	6, 579 physicians
Key inclusion criteria	All National Health System physicians working in the northern region of Portugal
Key exclusion criteria	1. Physicians not involved in any clinical activity (e.g. engaged in administrative tasks, analysis, etc.) 2. Working in substance abuse and rehabilitation centres 3. Working at the regional pharmacosurveillance centre or any department having a specific voluntary adverse drug reaction reporting program and physicians attached to specific hospitals (cancer, maternity, etc)
Date of first enrolment	01/01/2007
Date of final enrolment	31/05/2009

Locations

Countries of recruitment

Portugal

Study participating centre

Unidade de Farmacovigilância do Norte

Porto
4200
Portugal

Sponsor information

Northern Pharmacosurveillance Unit (Portugal)
Government

Unidade de Farmacovigilância do Norte
Faculdade de Medicina
Universidade do Porto
Porto
4200
Portugal

Email	ufn@med.up.pt
Website	http://ufn.med.up.pt/

Funders

Funder type

Government

Ministry of Science, Technology and Superior Education (Portugal)- Science and Technology Fund (Fundação para a Ciência e Tecnologia) (grant SFRH/BPD/35746/2007)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan