Hospitalization Clinical Trial
— OPTI-PPOfficial 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
Verified date | January 2017 |
Source | Centre Hospitalier Universitaire de Nimes |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
Country | Name | City | State |
---|---|---|---|
France | CHRU de Nîmes - Hôpital Universitaire Carémeau | Nîmes Cedex 09 |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nimes |
France,
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 |
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