Drug Wastage : Observational Study in Intensive Care Units in France

Completed

• Conditions: Drug Use

• Registration Number: NCT05553054
• Lead Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2022-09-21
• Study First Submitted QC: 2022-09-21
• Study First Posted: 2022-09-23
• Study Start: 2022-11-08
• Primary Completion: 2023-03-15
• Study Completion: 2023-03-15
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-04
• Last Update Posted: 2025-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1066

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Drug residues discarding process	24 hours	A questionnaire will be used to determine which discarding process are applied by nurses in their usual pratices.
Reason for discarding drug residues	24 hours	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.
Use of enteral administration route	24 hours	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.
Cost of overall IV drug wastage	24 hours	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

Trial Locations

Locations (61)

Centre Hospitalier de Charleville-Mezieres; 🇫🇷 Charleville-Mézières, Ardennes, France

CHRU de Strasbourg; 🇫🇷 Strasbourg, Bas-Rhin, France

Hôpital Nord; 🇫🇷 Marseille, Bouches Du Rhône, France

Centre Hospitalier d'Aurillac; 🇫🇷 Aurillac, Cantal, France

Groupe Hospitalier Littoral Atlantique; 🇫🇷 La Rochelle, Charente-Maritime, France

CHU de Besançon; 🇫🇷 Besançon, Doubs, France

Centre Hospitalier de Montélimar; 🇫🇷 Montélimar, Drôme, France

Hôpital privé Claude Galien; 🇫🇷 Quincy-sous-Sénart, Essonne, France

HIA Clermont Tonnerre; 🇫🇷 Brest, Finistère, France

CHRU de Brest; 🇫🇷 Brest, Finistère, France

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