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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Hospitalization

Intervention / Treatment
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* Other: One month of department-wide observation
* Other: Pharm Tech participates in department


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1st observational period (before experimental intervention)<br>Patients in this arm are included during a first month of observation before the intervention is implemented. Intervention: One month of department-wide observation | Other: One month of department-wide observation<br>* 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.<br>|
| Experimental: 2nd obs. period (during experimental intervention)<br>Following a one-month wash-out period, patients in this arm are included during a second month of observation during which the intervention is implemented. Intervention: Pharm Tech participates in department | Other: Pharm Tech participates in department<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with at least one medication error / total number of hospitalized patients included in the service |  | 5 days | 
| For each medication error: the name of the drug |  | 5 days | 
| 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 | 
| For each medication error: the severity index |  | 5 days | 
| 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 | 
| For each medication error: the evolution of the adverse drug event, if occurred |  | 5 days | 
| 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 | 
| The potential causes of medication errors |  | 5 days | 
| The average number of interruptions per hour during preparation or administration of drug doses by nurses |  | 5 days | 
| 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 | 
| 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 | 
| Nursing staff time dedicated to: the preparation of individual doses |  | 5 days | 
| Nursing staff time dedicated to: ordering health products |  | 5 days | 
| Nursing staff time dedicated to: stock management and exceptional orders |  | 5 days | 
| Nursing staff time dedicated to: the delivery, receipt and storage of health products |  | 5 days | 
| Nursing staff time dedicated to: cabinet inventories |  | 5 days | 
| Nursing staff time dedicated to: the management of expired drugs |  | 5 days | 
| The number of calls made to the central pharmacy |  | 5 days | 
| Staff time dedicated to managing exceptional requests |  | 5 days | 
| The number of drugs consumed |  | 5 days | 
| The number of medical devices consumed |  | 5 days | 
| The number of immobilized drugs |  | 5 days | 
| The number of immobilized medical devices |  | 5 days | 
| The cost of adverse drug events care |  | 5 days | 
| Care staff satisfaction questionnaire |  | 5 days | 
| Pharmacy technician satisfaction questionnaire |  | 5 days |