Clinical trial NCT01734642: Observational Study to Reduce Medication Errors
Official title: A Regional Project to Reduce Adverse Drug Reactions Due to Medication Errors in Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Medication Errors
Keywords: Medication errors, patients hospitalized, ADRs, adverse events
Lead sponsor: Universita di Verona
Sponsor class: OTHER
Collaborators: name: Ospedale S.Bortolo -Vicenza, Italy
name: Ospedale Mater Salutis-Legnago(Verona), Italy
name: Ospedale Fra Castoro- San Bonifacio (Verona), Italy
name: Azienda Ospedaliera Universitaria Integrata Verona
First posted: 2012-11-27
Enrollment: 8000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients from 18 to 65 and over 65 years old hospitalized in the involved departments during the study period.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with adverse drug reactions due to medication errors occurring during hospitalization
timeFrame: within the first 3 months
Secondary outcomes:
measure: Number of participants with preventable ADRs due to medication errors
timeFrame: 3 months
Other outcomes:
measure: the impact of educational audit will be evaluated
timeFrame: during the final phase
Locations:
city: Legnago
country: Italy
facility: Mater Salutis Hospital
state: Verona
city: San Bonifacio
country: Italy
facility: Fracastoro Hospital
state: Verona
city: Verona
country: Italy
facility: University Hospital of Verona (AOUI), Verona, Italy
city: Vicenza
country: Italy
facility: San Bortolo Hospital
Study officials:
affiliation: The University of Verona, Verona , Italy
name: Giampaolo Velo, Medicine and Surgery
role: STUDY_DIRECTOR
References:
citation: 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.
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.
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. doi: 10.1136/jamia.1999.00660313.
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.