Observational Study to Reduce Medication Errors

Medication Errors Clinical Trial

— OSME  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01734642
• Other study ID #: 31025
• Status: Not yet recruiting
• Phase: N/A
• First received: November 21, 2012
• Last updated: November 28, 2012
• Start date: January 2013
• Est. completion date: December 2013

Study information

• Verified date: November 2012
• Source: Universita di Verona
• Contact: Lara Magro, Chemistry and pharm. technol.
• Phone: 0039 045/8027147
• Email: lara.magro[@]univr.it
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency(AIFA)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 8000
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Medication Errors

Locations

Country	Name	City	State
Italy	Mater Salutis Hospital	Legnago	Verona
Italy	Fracastoro Hospital	San Bonifacio	Verona
Italy	University Hospital of Verona (AOUI), Verona, Italy	Verona
Italy	San Bortolo Hospital	Vicenza

Sponsors (5)

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

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Aronson JK. Medication errors: definitions and classification. Br J Clin Pharmacol. 2009 Jun;67(6):599-604. doi: 10.1111/j.1365-2125.2009.03415.x. — View Citation

Bates DW, Teich JM, Lee J, Seger D, Kuperman GJ, Ma'Luf N, Boyle D, Leape L. The impact of computerized physician order entry on medication error prevention. J Am Med Inform Assoc. 1999 Jul-Aug;6(4):313-21. — View Citation

Lewis PJ, Dornan T, Taylor D, Tully MP, Wass V, Ashcroft DM. Prevalence, incidence and nature of prescribing errors in hospital inpatients: a systematic review. Drug Saf. 2009;32(5):379-89. doi: 10.2165/00002018-200932050-00002. Review. — View Citation

Velo GP, Minuz P. Medication errors: prescribing faults and prescription errors. Br J Clin Pharmacol. 2009 Jun;67(6):624-8. doi: 10.1111/j.1365-2125.2009.03425.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	the impact of educational audit will be evaluated		during the final phase	Yes
Primary	Number of participants with adverse drug reactions due to medication errors occurring during hospitalization		within the first 3 months	Yes
Secondary	Number of participants with preventable ADRs due to medication errors		3 months	Yes