Drug Wastage : Observational Study in Intensive Care Units in France

Study Overview
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Brief Summary
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Environmental awareness leads medical field to question its responsibility and possibilities for action. Drug residues can have a major environmental impact as per their bioaccumulation, toxicity and persistence characteristics, depending on where they are discarded. In France, drug residues should be disposed of by incineration, but in practice, this is not systematic. Moreover, data on drug wastage in Intensive Care Units (ICU) are rare. GAME-OVER observational study aims to evaluate drug wastage in ICU in France and to suggest ways to improve health care practices.

Detailed Description
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Observational study with data collection during a 24-hour business day. Data collected refer to healthcare team's practices and patients. Collection starts when day shift starts (at 7:00 am) and ends when night shift leaves (at 7:00 am the following day).

Official Title
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Drug Wastage : Observational Study in Intensive Care Units in France

Conditions
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Drug Use

Intervention / Treatment
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* Other: Quantification of IV drugs wastage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients hospitalized in intensive care units during the 24 hours of data collection. Exclusion Criteria: Patient's opposition to participate in the study or patient family opposition if the patient is not able to be informed.

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intravenous (IV) drugs<br>Patient and prepared/administrated/discarded IV drugs data will be collected during 24 hours. | Other: Quantification of IV drugs wastage<br>* Drugs are prescribed depending on physician discretion. Specific collection bins are provided to ICU. Healthcare teams discard syringes labelled with name and dilution which have been used to prepare drugs into these bins. After 24 hours of collection, bins are analyzed by investigators.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of overall wastage in milliliter (mL) of prepared and discarded IV drugs to overall volume in milliliter (mL) of prepared IV drugs. | Wastage is defined as any prepared and unused drug that remains in syringe or IV bag. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reason for discarding drug residues | A questionnaire will be fulfilled by healthcare teams with the following possible categories: 1/ prepared in advance and not used ; 2/ systematic change at fixed times ; 3/ prescription change ; 4/ change by anticipation of care ; 5/ drug no longer needed ; 6/ preparation error ; 7/ other reason. | 24 hours | 
| Drug residues discarding process | A questionnaire will be used to determine which discarding process are applied by nurses in their usual pratices. | 24 hours | 
| Use of enteral administration route | Use of enteral administration route versus per os and IV routes will be analyzed for paracetamol and proton pump inhibitor according to the accessibility of enteral route and the reason and the date of patient entry in ICU. | 24 hours | 
| Cost of overall IV drug wastage | Estimated cost of drug residues will be evaluated for each drug, according to the reason for discarding, by the following formula : volume of discarded IV drugs x theoretical price | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intravenous (IV) drug, Waste, Intensive Care Unit (ICU), Environmental sustainability, Drug wastage, Care Eco-design