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Medicinal Oxygen: WHO International Pharmacopoeia PH.INT re-definition

A major milestone: Oxygen 93% is finally recognised as medically equivalent to Oxygen 99% / 99.5% 

Concerns that the draft revision of the WHO International Pharmacopoeia would restrict access to medical oxygen are resolved. Past uncertainties caused by separate international definitions of medicinal oxygen dependant on concentration are thus eliminated. Healthcare Authorities, Hospitals and Healthcare Professionals working to the PH.INT definition can now treat patients with both oxygen 93% and oxygen 99.5% regardless of source.

We are sharing the PH.INT Medicinal Oxygen on behalf of WHO International Pharmacopoeia, which defines and considers the following:

  • The Medicinal Oxygen monograph now incorporates both currently internationally recognized concentrations of oxygen. Both Oxygen 93% and Oxygen 99.5% are hereby deemed medically equivalent in terms of patient treatment. The stipulated quality requirements are identical.
  • In accordance with clinical guidelines, Medicinal Oxygen can be used either in undiluted form or as mixtures of Oxygen 93% and Oxygen 99.5%

This new definition comes as a result of in-depth consultation with globally recognized experts on the subject of patient treatment with Medicinal Oxygen. The WHO hereby drew on support from several key organizations including The Every Breath Counts Coalition https://stoppneumonia.org/, The World Federation of Societies of Anesthesiologists WFSAhttps://wfsahq.org/, ISO Technical Committee 121 (Anaesthetic and Respiratory Equipment)https://www.iso.org/committee/51984.html and the International Association of Manufacturers of Medical Gas Generators for Hospitals (MEDIGHAM) https://www.medigham.net/.

“The superior WHO definition of Medicinal Oxygen is a major milestone for PCI Gases as a recognized manufacturer of power-efficient onsite Oxygen Generation Plants (DOCS). PCI Gases appreciates being afforded the opportunity to contribute to this WHO driven advance, thus removing one of the major barriers to patient access to life-saving medicinal oxygen worldwide. The specific listing of VSA technology for the first time in an international pharmacopeia further broadens the possibilities for Healthcare Authorities and Hospitals to select the oxygen source most suitable for specific local requirements and situations.”

Finally, the experts at the WHO are to be congratulated for taking a leading role in reducing barriers to Medicinal Oxygen, especially in Low and Middle Income Countries LMICs. Their fact-based amendment of PH.INT is both groundbreakingly vital and farsighted. As a direct result, innumerable patients will benefit from increased access to Medicinal Oxygen, alleviating suffering and saving lives throughout the world.

 

 

Open letter source:  https://cdn.who.int/media/docs/default-source/essential-medicines/norms-and-standards/qas20-867-medicinal-oxygen.pdf?sfvrsn=ab60e2fe_5

Read more here: https://www.pcigases.com/latest-news/pci-gases-supports-international-efforts-to-remove-access-barriers-to-medicinal-oxygen/https://www.pcigases.com/latest-news/pharmacopoeia-description-of-the-drugs-new-oxygen-monograph/

For more information, contact the following person: 

–  Tim Boulton (Europe and Middle East): tboulton@pcigases.com

Posted August 31, 2022
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