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Observational Study to Reduce Medication Errors

A Regional Project to Reduce Adverse Drug Reactions Due to Medication Errors in Hospital

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01734642
Acronym
OSME
Enrollment
8000
Registered
2012-11-27
Start date
2013-01-31
Completion date
2013-12-31
Last updated
2012-11-29

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

Conditions

Medication Errors

Keywords

Medication errors, patients hospitalized, ADRs, adverse events

Brief summary

A medication error is a failure in the treatment process that leads to, or has the potential to lead, to harm to the patient.1 Medication errors are a common unfortunate occurrence in hospital. They can occur in different phases of the therapeutic process (prescribing, distribution, administration and monitoring) and have significant impact on morbidity and mortality. Prescribing faults and prescription errors are major problem among medication errors .Prescription errors account for 70 % of medication errors that could potentially result in adverse drug effects.2 Overall it has been estimated prescription errors affect 7 % of medication orders, 2% of patient days and 50 % of hospital admissions.3,4 When harm arises from a medication error it is potentially preventable. The medication errors project was devised to analyze and limit through educational audit and other tools, as much as possible, damages due to the therapeutic process. The project will include 5 phases. Preliminary phase: organizational meetings. Phase I: Patient monitoring: a monitor in collaboration with health professionals of involved units will review all patient charts and will register all adverse drug reactions(ADRs). All ADRs will be introduced by the monitor in a database. Health professional will be invited to send the reports of observed ADRs. Evaluation of ADRs : a panel of experts will evaluate if the ADRs are due to medication errors or not. Phase II :educational audits directed to health professionals will be organized. Tools to reduce the medication errors will be proposed. Phase III: the same procedure of the first phase. Final phase (IV): analysis of data with publication of a scientific article.

Interventions

None listed

Sponsors

Ospedale S.Bortolo -Vicenza, Italy
CollaboratorUNKNOWN
Ospedale Mater Salutis-Legnago(Verona), Italy
CollaboratorUNKNOWN
Ospedale Fra Castoro- San Bonifacio (Verona), Italy
CollaboratorUNKNOWN
Azienda Ospedaliera Universitaria Integrata Verona
CollaboratorOTHER
Universita di Verona
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* all patients hospitalized in the involved units who gave their informed consent. Patients hospitalized during the week-end will be enrolled on the next monday.

Exclusion criteria

* all patients with evident mental and physical problems and all patients who did not give their informed consent.

Design outcomes

Primary

MeasureTime frame
Number of participants with adverse drug reactions due to medication errors occurring during hospitalizationwithin the first 3 months

Secondary

MeasureTime frame
Number of participants with preventable ADRs due to medication errors3 months

Other

MeasureTime frame
the impact of educational audit will be evaluatedduring the final phase

Countries

Italy

Contacts

Primary ContactLara Magro, Chemistry and pharm. technol.
lara.magro@univr.it0039 045/8027147
Backup ContactErmelinda Viola, Chemistry and pharm. technol.
ermelinda.viola@univr.it0039 045/8124904

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026