Evaluation of the Impact of the Presence of a Pharmacy Technician on the Quality and Cost of Drug Therapy

Hospitalization Clinical Trial

— OPTI-PP  

Official title:

Evaluation of the Impact of the Presence of a Pharmacy Technician on the Quality and Cost of Drug Therapy in the Hepato-Gastroenterology Department of the Nîmes University Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02614638
• Other study ID #: LOCAL/2015/GL-01
• Secondary ID: 2015-A01309-40
• Status: Completed
• Phase: N/A
• First received: November 19, 2015
• Last updated: January 31, 2017
• Start date: September 2016
• Est. completion date: December 16, 2016

Study information

• Verified date: January 2017
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of this study is to evaluate the impact of the presence of a pharmacy technician in a care unit (Hepato-Gastroenterology Department) on detected medication errors.

This is a before-after study consisting of three sequential phases:

Month 1: one month of observation of what is happening in the department Month 2: one month wash out period Month 3: active participation of a pharmacy technician in the department

Description:

The secondary objectives of this study are:

A- To assess the impact of the presence of a pharmacy technician on the ratio of the number of patients with at least one medication error / number of included patients hospitalized in the service.

B- To characterize detected medication errors.

C- To identify and evaluate the potential causes of medication errors.

D- To evaluate whether the presence of a pharmacy technician reduces nursing time spent on medication management.

E- To evaluate the economic impact of the presence of a pharmacy technician.

F- To evaluate the acceptability of the intervention by the nursing staff and pharmacy technicians using questionnaires.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: December 16, 2016
• Est. primary completion date: December 16, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The patient must be insured or beneficiary of a health insurance plan

• The patient is hospitalized in the Hepato-Gastroenterology Department of the Nîmes University Hospital

Exclusion Criteria:

• The patient is under judicial protection

• The patient, or his/her legal guardian, expresses opposition to participation in the study

• It is impossible to correctly inform the patient

Related Conditions & MeSH terms

• Hospitalization

Intervention

Other:
• One month of department-wide observation
A pharmacy technician will be present full time in the care unit from Monday to Friday between 8:30 and 17h for 1 month for observational purposes only. During this phase, the pharmacy technician observes the current practices of preparation and administration of medication by nurses. He / she will collect medication errors and other observational data.
• Pharm Tech participates in department
Following a 1 month wash-out period, a pharmacy technician will again be present full time (in practice, two technicians will relay each other) in the care unit from Monday to Friday between 8:30 and 17h for 1 month. He/she will actively take part in drug care activities in the department: management of product pathways, verification of injectable preparation, advice, etc. Medication errors and other observational data will be collected.

Locations

Country	Name	City	State
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The following ratio (relative units): Number of medication errors / number of medications administered and omitted from among all those listed on the prescription for admission	Primary Outcome Measure as given in protocol: Number of medication errors / number of medications administered and omitted from among all those listed on the prescription for admission (during month 1 versus during month 3).	5 days
Secondary	Number of patients with at least one medication error / total number of hospitalized patients included in the service		5 days
Secondary	For each medication error: the name of the drug		5 days
Secondary	For each medication error: the type of error	Errors are classifies as one of the following types: Omission; Drug; Dosage form; Expired or damaged drug; Dose; Concentration; Frequency of administration; Administration technique; Route of Administration; Rate of administration; Duration of administration; Administration Time; Patient; Drug interaction.	5 days
Secondary	For each medication error: the severity index		5 days
Secondary	For each medication error: when (which step) the error occurred during the drug pathway	The considered steps are: Writing the prescription Medical decision for the prescription Transcription Pharmaceutical analysis Deliverance Preparation / reconstitution Pillbox Administration Procurement Storage Compliance Therapeutic and clinical follow-up	5 days
Secondary	For each medication error: the evolution of the adverse drug event, if occurred		5 days
Secondary	For each medication error: the criticality of the error	Criticality is graded according to the following classes: C: no potential harm to the patient; D: treatment or increased monitoring without harm to the patient; (E to I): potential harm to the patient; 3E: treatment or surgery with temporary harm 3F: longer duration of hospitalization with temporary harm 3G: permanent harm 3H: involving a life-threatening harm 3I: death; Criticality is determined by the concordance of two, independent expert opinions; or, in case of discordance, the concordance of 2 out 3 expert opinions.	5 days
Secondary	The potential causes of medication errors		5 days
Secondary	The average number of interruptions per hour during preparation or administration of drug doses by nurses		5 days
Secondary	The number of patients for whom personal treatments were managed by the nursing staff on admission / number of patients who brought their personal treatments to the care unit		5 days
Secondary	The number of patients for whom personal treatments were returned by the nursing staff at hospital discharge / number of patients who brought their personal treatments to the care unit		5 days
Secondary	Nursing staff time dedicated to: the preparation of individual doses		5 days
Secondary	Nursing staff time dedicated to: ordering health products		5 days
Secondary	Nursing staff time dedicated to: stock management and exceptional orders		5 days
Secondary	Nursing staff time dedicated to: the delivery, receipt and storage of health products		5 days
Secondary	Nursing staff time dedicated to: cabinet inventories		5 days
Secondary	Nursing staff time dedicated to: the management of expired drugs		5 days
Secondary	The number of calls made to the central pharmacy		5 days
Secondary	Staff time dedicated to managing exceptional requests		5 days
Secondary	The number of drugs consumed		5 days
Secondary	The number of medical devices consumed		5 days
Secondary	The number of immobilized drugs		5 days
Secondary	The number of immobilized medical devices		5 days
Secondary	The cost of adverse drug events care		5 days
Secondary	Care staff satisfaction questionnaire		5 days
Secondary	Pharmacy technician satisfaction questionnaire		5 days