Status: Finalised First registered on: 15/11/2013
Last updated on: 12/02/2019
1. Study identification
EU PAS Register NumberEUPAS5160
Official titleA regional project to reduce adverse drug reactions due to medication errors in hospital
Study title acronym
Study typeObservational study
Brief description of the studyBackground: Medication errors are one of the most common types of medical error. A medication error is a failure in the treatment process that leads to, or has the potential to lead to, harm to the patient. Prescription errors account for 70% of medication errors that could potentially result in adverse drug effects. Objectives: A study has been projected to evaluate the incidence of adverse drug reactions (ADRs) due to medication errors in hospitalized patients before and after educational audits. Methods: All patients, aged ≥18 years, hospitalized in seven unit (three internal medicine and four geriatric) of the University Hospital of Verona during 3 months period (February- April 2013) were included in this study. The project was articled in 3 phases. In the first one, three monitors registered all ADRs occurred during hospital stay. Two panel of experts (6 physicians, 2 pharmacists and 2 pharmacologists) established, evaluating the available clinic information (e.g. clinical sheet) of all patients and according the Schumock and Thornton algorithm, if the ADRs were due to medication errors or not, in the case of error they identified the cause. At first the two panel worked separately, at a later stage a data condivision has been done to have shared data. In the second phase, educational audits directed to health care practitioners have been organized, and tools (e.g., check-list) to reduce the medication errors have been proposed. The third phase, that is similar to the first one and takes account of tools, is in progress. Preliminary Results: Preliminary data of the first phase showed that 1474 have been enrolled in the seven units involved; the analysis has been done for 1009 patients (68%) (median age: 76 years old with DS ± 15,2; female: 51%) who gave their informed consent. Three monitors registered 180 ADRs occurred in 1009 hospitalized patients, two panel evaluated 55 ADRs (30% of 180) as avoidable. Further results will be published as available.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsPharmacol UNIVR
Department/Research groupPharmacology Unit - Veneto Pharmacovigilance Centre
Organisation/affiliationUniversity Hospital Verona
Website/Homepagewww.sfm.univr.it
Details of (Primary) lead investigator
Title Professor
Last name Ugo
First name Moretti
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Italy
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/01/201101/01/2011
Start date of data collection04/02/201304/02/2013
Start date of data analysis03/06/201303/06/2013
Date of interim report, if expected
Date of final study report30/06/201430/11/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyItalian Medicines Agency100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Velo
First name Giampaolo
Address line 1Pharmacology Unit
Address line 2Policlinico GB Rossi 
Address line 3P.le L.A. Scuro 10 
CityVerona 
Postcode37134 
CountryItaly
Phone number (incl. country code)390458127450 
Alternative phone number390458127451 
Fax number (incl. country code)390458124876 
Email address giampaolo.velo@univr.it
Public Enquiries
Title Professor 
Last name Velo 
First name Giampaolo 
Address line 1Pharmacology Unit 
Address line 2Policlinico GB Rossi 
Address line 3P.le L.A. Scuro 10 
CityVerona 
Postcode37134 
CountryItaly 
Phone number (incl. country code)390458027450 
Alternative phone number390458127450 
Fax number (incl. country code)390458124876 
Email address giampaolo.velo@univr.it 
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