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An educational intervention to improve adverse drug reactions reporting among Galician physicians

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN91140684
Enrollment
7498
Registered
2009-06-17
Start date
2007-10-01
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 Adverse drug reaction reporting

Interventions

We implemented a continuing medical education multifaceted intervention comprising of a visit and report form. The main didactic material used for this purpose was a four-part presentation. The first
in this last study four attitudes were identified: complacency, insecurity, diffidence and indifference. Then, emphasis was laid on the fact that only five minutes was required to complete the report

Sponsors

Spanish Ministry of Health (Spain)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All physicians working in the National Health System in Galicia (Spain)

Exclusion criteria

Exclusion criteria: 1. Not involved in clinical activities (e.g. analysis, administrative tasks, genetics, etc.) 2. Working in drug abuse rehabilitation centres 3. Working at the Regional Pharmacovigilance Centre or in any other unit that has a special programme for the reporting of adverse drug reactions

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

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026