A regional project to reduce adverse drug reactions due to medication errors in hospital

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/27997
• EU PAS number:
  EUPAS5160
• Study ID:
  27997
• Official title and acronym:
  A regional project to reduce adverse drug reactions due to medication errors in hospital
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  Background: 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.
• Study status:
  Finalised

Research institutions and networks

Institutions

Pharmacology Unit - Veneto Pharmacovigilance Centre (Pharmacol UNIVR), University Hospital Verona

Italy

Study timelines

Date when funding contract was signed

Planned: 01/01/2011

Actual: 01/01/2011

Study start date

Planned: 04/02/2013

Actual: 04/02/2013

Data analysis start date

Planned: 03/06/2013

Actual: 03/06/2013

Date of final study report

Planned: 30/06/2014

Actual: 30/11/2016

Sources of funding

Other

More details on funding

Italian Medicines Agency

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable