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An educational intervention to improve adverse drug reactions reporting: a cluster-randomised trial among Portuguese physicians and pharmacists

An educational intervention to improve adverse drug reactions reporting: a cluster-randomised trial among Portuguese physicians and pharmacists

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN45894687
Enrollment
7884
Registered
2006-06-15
Start date
2004-03-16
Completion date
Unknown
Last updated
2019-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Under-reporting of adverse drug reactions Not Applicable

Interventions

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 prese

Sponsors

Educational Development Program for Portugal (Programa de Desenvolvimento Educativo para Portugal) (PRODEP) (Portugal)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All National Health System physicians working in the Northern Region of Portugal and all pharmacists working in the same geographical area.

Exclusion criteria

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).

Design outcomes

Primary

MeasureTime frame
Rate of total notifications per month

Secondary

MeasureTime frame
Rate of serious, unexpected, high-causality, and new-drug-related adverse drug reactions per month

Countries

Portugal

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 6, 2026