| | | | | | | | | The European Pharmacopoeia Commission addresses the increased need for medical oxygen | | EDQM
| | TOxygen shortages have recently been reported in various parts of the world. At the 8th “COVID-19 Pharmacopoeial Alert” meeting held at the end of January 2021, several participants stressed the urgent need to boost supplies of oxygen and to explore other qualities of the gas in order to meet the demands associated with the rising number of COVID-19-related hospitalisations. This sub-group of the International Meeting of World Pharmacopoeias was established in early 2020 to facilitate a co-ordinated response of the pharmacopoeias to the current pandemic.
The global call for oxygen also prompted the World Health Organization to publish a revised version of its monograph on oxygen. The EDQM/European Pharmacopoeia (Ph. Eur.) is very much involved in this field at the European level. For almost a year now, the group of experts in charge of the elaboration and revision of monographs on medicinal gases has been closely monitoring the situation. The Ph. Eur. currently includes two monographs on oxygen, Oxygen and Oxygen (93 per cent). The first of these was drafted over 50 years ago and covers oxygen produced by cryogenic distillation, with an oxygen content specification of minimum 99.5 per cent. The second, Oxygen (93 per cent), was first published in the Ph. Eur. in 2010 and covers oxygen produced by a pressure swing adsorption (PSA) oxygen generator plant that removes the nitrogen from ambient air. At the time of publication, the plants available on the market utilised a single-stage adsorption process that did not remove any argon from the air being processed. Advances have since been made in the design of these generators and two-stage PSA plants capable of producing oxygen with a nominal content of 98.0 per cent are now available. The decision was therefore taken to elaborate a new monograph, Oxygen (98 per cent), in response to the COVID-19-related increase (potentially 10-fold) in the demand for oxygen worldwide. In view of the situation, the Ph. Eur. Commission launched an extraordinary public consultation on how best to include Oxygen (98 per cent) obtained via two-stage generators in the Ph. Eur. About 40 different interested parties, including gas producers and industry associations, National Pharmacopoeia Authorities (NPAs), hospitals, consultants, dispensing pharmacists, healthcare establishments and manufacturers of oxygen generators provided comments on this proposal. This ground-level feedback was an essential first step when deciding how best to proceed with the monograph on Oxygen (98 per cent). It was clear from the comments that co-operation between the national authorities, hospitals and gas producers was excellent during the COVID-19 crisis and that no major oxygen shortages had occurred in Europe yet. The utility of oxygen generators in this context appeared to be very limited. Although the urgent elaboration of a monograph on oxygen 98 per cent is no longer seen as absolutely necessary for Europe, the monograph itself is still considered useful to cover the needs of remote areas and other settings and to cater for the need in other parts of the world. To further explore the needs and to support the Ph. Eur. Commission in taking an informed decision on how best to proceed further, the EDQM/Ph. Eur. organised a regulators-only workshop (9 and 11 February 2021) attended by assessors and inspectors knowledgeable in this field. Thanks also to the great support provided by some NPAs in organising this workshop, the latter was a great success as it will now be possible to make concrete proposals on how best to set appropriate quality requirements for oxygen 98 per cent at the next session of the Ph. Eur. Commission scheduled for 23 and24 March 2021. |
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