Drug Wastage : Observational Study in the Operating Rooms of France

Drug Use Clinical Trial

— GAME-OvBLOC  

Official title:

Drug Wastage : Observational Study in the Operating Rooms of France

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05609864
• Other study ID #: 2023-CHITS-001
• Status: Completed
• Start date: April 6, 2023
• Est. completion date: July 20, 2023

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Environmental awareness is leading 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 the operating rooms by anesthesia department are rare. The GAME-OvBLOC observational study aim to evaluate drug wastage in the operating rooms by anesthesia department in France and to propose ways of improving health care practices.

Description:

Observational study with data collection over a 24-hour business day. Data collected refer to healthcare team's practices and patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3763
• Est. completion date: July 20, 2023
• Est. primary completion date: July 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients who will need an anesthesia act in operating room during a 24 hours period

Exclusion Criteria:

• Patient opposition to participate in the study or parents opposition if the patient is a child or patient family opposition if the patient is not capable of being informed

Related Conditions & MeSH terms

• Drug Use

Intervention

Other:
• Quantification of injectable drugs wastage
Drugs are prescribed at discretion of physicians. For each patient who have anesthesia in the operating room, all labelled syringes having contained drugs (name + dilution) are collected and analyzed.

Locations

Country	Name	City	State
France	CHU d'Amiens	Amiens	Somme
France	Clinique Victor Pauchet	Amiens	Somme
France	Centre Hospitalier de l'Agglomération Montargoise	Amilly	Loiret
France	CHU d'Angers	Angers	Maine-et-Loire
France	Hôpital privé Arras les Bonnettes	Arras	Pas-de-Calais
France	Centre Hospitalier Henri Mondor	Aurillac	Cantal
France	Hôpital Privé de la Chataigneraie	Beaumont	Val d'Oise
France	Hôpital NOVO - Site de Beaumont-sur-Oise	Beaumont-sur-Oise	Val d'Oise
France	CHU Jean Minjoz	Besançon	Doubs
France	Clinique Aguilera	Biarritz	Pyrénées-Atlantiques
France	CHU de Bordeaux - Groupe hospitalier Pellegrin	Bordeaux	Gironde
France	CHRU de Brest	Brest	Finistère
France	HIA Clermont Tonnerre	Brest	Finistère
France	Centre Hospitalier de Brive-la-Gaillarde	Brive-la-Gaillarde	Corrèze
France	Hôpital mère-enfant (HCL)	Bron	Rhône
France	CHU de Caen	Caen	Calvados
France	Centre Hospitalier de Cannes	Cannes	Alpes-Maritimes
France	Centre Hospitalier Intercommunal Castres-Mazamet	Castres	Tarn
France	Hôpital NOVO - Site de Pontoise	Cergy-Pontoise	Val d'Oise
France	Centre Hospitalier de Charleville-Mézières	Charleville-Mézières	Ardennes
France	HIA Percy Clamart	Clamart	Hauts-de-Seine
France	CHU de Clermont-Ferrand	Clermont-Ferrand	Puy-de-Dôme
France	Clinique de la Plaine Santé	Clermont-Ferrand	Puy-de-Dôme
France	Centre hospitalier Sud Francilien	Corbeil-Essonnes	Essonne
France	Clinique des Cèdres	Cornebarrieu	Haute-Garonne
France	Centre Hospitalier de Dax	Dax	Landes
France	CHU de Dijon	Dijon	Côte d'Or
France	CHU de Grenoble	Grenoble	Isère
France	Centre Hospitalier Départemental de Vendée	La Roche-sur-Yon	Vendée
France	Groupe Hospitalier Littoral Atlantique	La Rochelle	Charente-Maritime
France	Centre Hospitalier d'Arcachon	La Teste-de-Buch	Gironde
France	Hôpital Marie Lannelongue	Le Plessis-Robinson	Hauts-de-Seine
France	Centre Hospitalier Emile Roux	Le Puy-en-Velay	Haute-Loire
France	Centre Hospitalier de Lens	Lens	Pas-de-Calais
France	Centre Oscar Lambret	Lille	Nord
France	CHU de Lille - Hôpital Huriez	Lille	Nord
France	CHU de Lille - Hôpital Jeanne de Flandre	Lille	Nord
France	CHU de Lille - Hôpital Roger Salengro	Lille	Nord
France	CHU de Lille - Institut coeur poumon	Lille	Nord
France	CHU de Limoges	Limoges	Haute Vienne
France	Groupe Hospitalier Bretagne Sud	Lorient	Morbihan
France	Centre Léon Bérard	Lyon	Rhône
France	Clinique de la Sauvegarde	Lyon	Rhône
France	Hôpital Edouard Herriot	Lyon	Rhône
France	Hôpital La Timone (AP-HM)	Marseille	Bouches-du-Rhône
France	Hôpital Nord (AP-HM)	Marseille	Bouches-du-Rhône
France	CHU de Nîmes	Nîmes	Gard
France	Clinique de l'Archette	Olivet	Loiret
France	Groupe Hospitalier Diaconesses Croix Saint Simon	Paris
France	Hôpital Européen Georges Pompidou	Paris
France	Hôpital La Pitié-Salpêtrière	Paris
France	Hôpital Lariboisière (AP-HP)	Paris
France	Hôpital Saint Louis (AP-HP)	Paris
France	Hôpital Tenon (AP-HP)	Paris
France	Hôpital Trousseau (AP-HP)	Paris
France	Institut mutualiste Montsouris	Paris
France	Centre Hospitalier de Pau	Pau	Pyrénées-Atlantiques
France	CHU de Bordeaux, Groupe Sud	Pessac	Gironde
France	Clinique mutualiste de Pessac	Pessac	Gironde
France	Centre Hospitalier de Cornouailles	Quimper	Finistère
France	Clinique la Croix du Sud	Quint-Fonsegrives	Haute-Garonne
France	Institut Godinot	Reims	Marne
France	CHU de Rennes - Hôpital Sud	Rennes	Ille-et-Vilaine
France	CHU de Rennes - Pontchaillou	Rennes	Ille-et-Vilaine
France	Clinique mutualiste La Sagesse	Rennes	Ille-et-Vilaine
France	Centre Hospitalier Jacques Puel	Rodez	Aveyron
France	CHU de Rouen	Rouen	Seine-Maritime
France	CHU de la Réunion	Saint Denis	La Réunion
France	Clinique de l'Union	Saint-Jean	Haute-Garonne
France	CHU de Strasbourg - IHU	Strasbourg	Bas-Rhin
France	Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer	Toulon	Var
France	Sainte-Anne Military Teaching Hospital	Toulon	Var
France	CHU de Toulouse - Hôpital Rangueil	Toulouse	Haute-Garonne
France	Hôpital Nord Franche-Comté	Trévenans	Territoire De Belfort
France	Centre Hospitalier de Valence	Valence	Drôme
France	Institut de Cancérologie de Lorraine	Vandoeuvre les nancy	Meurthe-et-Moselle
France	Hôpital Robert Schuman-Groupe UNEOS	Vantoux	Vaucluse
France	Hôpital Paul Brousse (AP-HP)	Villejuif
France	Institut Gustave Roussy	Villejuif	Val-de-Marne
France	Centre Hospitalier Intercommunal de Villeneuve Saint Georges	Villeneuve-Saint-Georges	Val-de-Marne
Guadeloupe	CHU de Guadeloupe	Pointe-à-Pitre
Mayotte	Centre Hospitalier de Mayotte	Mamoudzou
Monaco	Centre Hospitalier Princesse Grace	Monaco

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer	Sainte-Anne Military Teaching Hospital

Countries where clinical trial is conducted

France,  Guadeloupe,  Mayotte,  Monaco, 

References & Publications (4)

Barbariol F, Deana C, Lucchese F, Cataldi G, Bassi F, Bove T, Vetrugno L, De Monte A. Evaluation of Drug Wastage in the Operating Rooms and Intensive Care Units of a Regional Health Service. Anesth Analg. 2021 May 1;132(5):1450-1456. doi: 10.1213/ANE.0000000000005457. — View Citation

Mankes RF. Propofol wastage in anesthesia. Anesth Analg. 2012 May;114(5):1091-2. doi: 10.1213/ANE.0b013e31824ea491. Epub 2012 Mar 13. — View Citation

McGain F, Muret J, Lawson C, Sherman JD. Environmental sustainability in anaesthesia and critical care. Br J Anaesth. 2020 Nov;125(5):680-692. doi: 10.1016/j.bja.2020.06.055. Epub 2020 Aug 12. — View Citation

Ramstrom H, Martini S, Borgendahl J, Agerstrand M, Larfars G, Ovesjo ML. Pharmaceuticals and Environment: a web-based decision support for considering environmental aspects of medicines in use. Eur J Clin Pharmacol. 2020 Aug;76(8):1151-1160. doi: 10.1007/s00228-020-02885-1. Epub 2020 May 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratio of overall wastage in milliliter (mL) of prepared and discarded injectable drugs, to overall volume in milliliter (mL) of prepared injectable drugs	Wastage is defined as : any prepared and unused drug that remains in syringe	24 hours
Secondary	Reason for discarding drug residues	The reason of waste full syringe will be noticed : 1/ prepared in advance and not used ; 2/ prescription change ; 3/ preparation error ; 4/ other reason	24 hours
Secondary	Describe drug wastage for each kind of surgery/anesthesia	Drug wastage according to type of surgery and anaesthesia	24 hours
Secondary	Drug residues discarding process	Questionnaire on nursing practices on the choice of waste disposal circuits according to drugs	24 hours
Secondary	Cost of overall injectable drugs wastage	Estimated cost of drug residues will be evaluated for each drug by the following formula : volume of discarded injectable drugs x theoretical price	24 hours
Secondary	Describe drug wastage for each age group	Drug wastage according to the following age groups : adult (=18 years old) and pediatrics (< 1 year old, 1-5 years old, = 6 years old)	24 hours
Secondary	Describe waste and environmental impact of used plastic syringes	Number and volume of used syringes, use of pre-filled syringes, refilling of syringes and multi-patient use.; Environmental impact is indirectly assessed by type of plastic used and the transport distance from the production site to France.	24 hours
Secondary	Use of alternative to injectable drugs	Alternatives : local anaesthesia and anaesthetic gases	24 hours

External Links

•   Direction générale de la santé. Pour Une Bonne Gestion Des Déchets Produits Par Les Établissements de Santé et Médico-Sociaux. Déchets Issus de Médicaments. Déchets Liquides. Ministère des Affaires sociales et de la Santé; 2016.