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Medication Errors | Observational Study to Reduce Medication Errors

Medication Errors research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Medication Errors

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

PATIENT HOSPITALIZEDALL THE PATIENTS HOSPITALIZED IN THE INVOLVED UNITS WHO GAVE THEIR INFORMED CONSENT. PATIENTS HOSPITALIZED DURING THE WEEK-END WILL BE ENROLLED ON the next MONDAY

Study Status

Unknown status

Start Date: January 2013

Completed Date: December 2013

Phase: N/A

Type: Observational

Design:

Primary Outcome: Number of participants with adverse drug reactions due to medication errors occurring during hospitalization

Secondary Outcome: Number of participants with preventable ADRs due to medication errors

Study sponsors, principal investigator, and references

Principal Investigator: Giampaolo Velo, Medicine and Surgery

Lead Sponsor: Universita di Verona

Collaborator: Ospedale S.Bortolo -Vicenza, Italy

More information:https://clinicaltrials.gov/show/NCT01734642

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.

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