Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
An educational intervention to improve adverse drug reactions reporting: a cluster-randomised trial among Portuguese physicians and pharmacists
Acronym
Study hypothesis
1. An educative intervention enhances the rate of reporting 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 quantity and relevance could be more than one year
Ethics approval
In Portugal, educational interventions are not evaluated by ethical committees. In hospitals, it is the teaching committee that approves educational interventions. In communitarian pharmacies, we usually contact the pharmacist responsible by telephone.
Study design
Cluster-randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Under-reporting of adverse drug reactions
Intervention
We implemented a continuing medical education multifaceted intervention comprising of an outreach visit, reminder and report form. The main didactic material used for this purpose was a two-part presentation. The first part included definitions of pharmacosurveillance and adverse drug reaction, a number of international studies on morbidity and mortality, hospital admissions and the cost to health systems and patients, followed by the methods used in pharmacosurveillance and in spontaneous reporting systems in particular, explaining that underreporting constituted the system's principal limitation. The second part was designed to change the five attitudes identified by the previous case-control study as being associated with underreporting, and for this section we created animated pictures that depicted a physicians daily work. Lastly, emphasis was laid on the fact that only five minutes was required to complete the report form. The control group clusters did not receive the intervention but, like those in the intervention group, did receive the briefing and standard training given by Portugal's northern pharmacovigilance unit.
Intervention type
Other
Phase
Not Specified
Drug names
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 trial start date
16/03/2004
Overall trial end date
30/06/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All National Health System physicians working in the Northern Region of Portugal and all pharmacists working in the same geographical area.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
6,451 physicians and 1,433 pharmacists
Total final enrolment
1433
Participant exclusion criteria
Physicians not involved in any clinical activity (e.g. engaged in administrative tasks, analysis, etc.); working in substance abuse and rehabilitation centers; working at the regional pharmacosurveillance center or any department having a specific voluntary adverse drug reaction reporting program and physicians attached to specific hospitals (cancer, maternity, etc). Pharmacists working at the regional pharmacosurveillance center and attached to specific hospitals (cancer, maternity, etc).
Recruitment start date
16/03/2004
Recruitment end date
30/06/2005
Locations
Countries of recruitment
Portugal
Trial participating centre
Dto. Medicina Preventiva
Santiago
15783
Spain
Sponsor information
Organisation
Educational Development Program for Portugal (Programa de Desenvolvimento Educativo para Portugal) (PRODEP) (Portugal)
Sponsor details
Rua de Xabregas 52
Lisboa
1949-003
Portugal
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Educational Development Programme for Portugal (Programa de Desenvolvimento Educativo para Portugal) (PRODEP) (Portugal)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2008 results in: https://www.ncbi.nlm.nih.gov/pubmed/18366244 (added 11/07/2019)