MEOPA Labeling: Identifying and Understanding Distinctive Elements for Safe Use

2023-12-12 11:18:15

Several distinctive elements to properly identify MEOPA and oxygen bottles.

The National Agency for the Safety of Medicines and Health Products (ANSM) announced the gradual deployment, since November 2023, of new labeling on MEOPA bottles [1] (cf. Boxed).

Box – About MEOPA: indications, specialties and framework of use

MEOPA is the acronym used to designate the equimolar mixture (mole/mole) composed of oxygen and nitrous oxide (50%/50%).

This medical gas is used:

  • in short-term analgesia for painful procedures:
    • in case of mild to moderate pain in adults and children over 1 month old,
    • in obstetrics, in a hospital environment exclusively, while waiting for epidural analgesia or in the event of refusal or impossibility to provide it;
  • sedation in dental care in infants, children and adolescents, anxious or disabled patients.

It is subject to compulsory medical prescription (list I).

The MEOPA specialties available in France are (December 2023):

MEOPA is a medicine reserved for professional use:

  • apart from doctors and dentists, only nurses and radiology technicians can administer it, on medical prescription and under the supervision of a doctor;
  • midwives can also prescribe and administer this medication, but only in a hospital setting;

Healthcare professionals must have completed specific training before using MEOPA.

New labeling for MEOPA bottles to avoid confusion with oxygen

The evolution of the labeling aims to prevent the risk of confusion between MEOPA bottles and oxygen bottles.

The ANSM has recorded mistaken administrations of MEOPA, instead of oxygen, which can, in the most serious cases, lead to respiratory distress by desaturation.

Harmonization of the DCI and other developments

The presentation of the international nonproprietary name (INN) on MEOPA bottles has been harmonized and is now presented as follows on the body of the bottle:

  • nitrous oxide/oxygen – 50 % / 50 %.

Other changes in labeling relate to (cf. Illustration) [2] :

  • the enlargement of the commercial name of each of the specialties in order to cover a larger surface area on the body of the bottle;
  • the color of the warhead: white and blue warhead (while it is only white for oxygen).

Illustration – Diagram “Be careful of the risk of confusion between oxygen and MEOPA bottles” [2]

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#labeling #deployed

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