Shortage of curares in France during the COVID-19 crisis. What were the findings?
In February 2020, the Sars-COV2 pandemic was falling on Europe and France. This pandemic led to a large number of people being admitted to intensive care with the need for long sedation. This sedation was induced by the administration of a narcotic, propofol and a curare. Very quickly, given the number of people being cared for, tensions in supply chain were observed and led to shortages or even breaks in some establishments. Very quickly, the Lille CHRU pharmacy set up a whole arsenal of procedures to avoid any breaks. One of these procedures consisted of restarting the operation of a batch curare compounding unit. This was done, but what can we learn from it today? It was necessary to:
1) Settle with the French drug agency, the regulatory problem that prohibited us from copying an existing formulation on the market.
2) Restarting the production machines and/or manual production, i.e. setting up a requalification of the machines and staff trained in these techniques.
3) To also set up a risk analysis in order to prove our capacity to produce in complete safety.
4) Find the API. For this, we had to go to the international markets to find pharmaceutical grade API which were bought by the French state at a high price.
5) Train the staff, the youngest, to manufacture an injectable form from powders.
6) Find the primary containers allowing the packaging adapted to the clinical use in order to modify as little as possible the habits of the resuscitation services.
In conclusion, some hospitals have started to recover specialized pharmaceutical technologies. But for France to be independent in the future for its care, it is essential that a few hospitals reappropriate production from API, train specialists, maintain the machines and human skills in non-crisis periods. Finally, the state must acquire a chemical library of basic products to enable trained hospitals to react quickly.
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Use of isolators as part of the future technology in the hospital pharmacies in Denmark ?
We expect that the isolator technology will become more and more widespread in the Danish hospital pharmacies over the next years
Isolator technology can be used in various types of production at hospital pharmacies in Denmark.
Large scale aseptic production
In order to meet the new requirements in the coming “New Annex 1”, it can be advantageous to invest in isolator technology, especially for large scale aseptic production. This technology will reduce costs for upgrading of the existing facility as well as reduce the ongoing costs for hygiene monitoring, clean room clothing, etc. For this type of production, the production line will consist of several modules of isolators.
Small scale aseptic production
This can be both batch production from API and reconstitution. For reconstitution where a longer shelf life than 24 hours is wanted, it is advantageous to use isolator technology. At the same time it will increase the quality and reduce the costs.
Can be used for reconstitution of GMO products. The isolator tent must be discarded after use for protection of the environment as well as a safer work environment. This type of isolator has been used in Denmark for the preparation of Luxturna and Zolgensma. For these products the isolator was approved by the Danish Working Environment Authority
The single-use insulator can also be used for the preparation of non-sterile drugs containing toxic API. A disadvantage of using the single-use isolator is the cost of the tent of 2,700 euro per tent
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Preparations and formulations for phage therapy
Rapid spread of antibiotic resistance is a serious threat to human healthcare for the upcoming years. Phage therapy consists in delivering viruses able to infect and kill bacteria, namely bacteriophages. They have a synergistic anti-biofilm activity with antibiotics and thus represent a promising and complementary therapeutic approach to treat infections due to multidrug-resistant bacteria. Moreover, phage therapy is a highly personalized strategy because of the specific activity of each phage.
In Lyon, the PHAGEinLYON consortium is developing phage therapy, especially in bone and joint infections. Each phage treatment requires an extemporaneous preparation performed by the hospital pharmacy. In this context, we wish to share our pharmaceutical experience.
First, the medical context of phage therapy in Lyon will be explained, as well as how hospital governance and healthcare authorities support this medical approach given the current status of phages in France.
Then, several formulations already prepared in our hospital (depending of the route of administration, i.e: intraarticular, intravenous, hydrogel application onto bone during surgery) will be presented with their intended.
Finally, quality controls and risk analysis performed for all preparations will be detailed.
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