The European drug regulator has decided not to qualify as “serious event” the current shortage of antibiotics on the continent, according to a source familiar with the matter.
The statement of “serious event” would allow the European Medicines Agency (EMA) to coordinate measures on a pan-European scale and increase the reporting obligations of manufacturers.
Some widely used antibiotics, such as amoxicillin – used to treat bacterial infections and often prescribed for ear and chest infections in children – have been in short supply since October.
According to the EMA, in almost all European countries there is a shortage.
A meeting of the EMA Executive Steering Group on Medicines Shortages and Safety took place early on Thursday, where the issue was discussed.
The EMA did not immediately respond to Reuters’ request for comment.
On Wednesday, a consortium of patient and consumer groups wrote to the EMA saying that not enough was being done to tackle shortages, and that the use of alternative antibiotics was reducing the supply of these other medicines. They also recommended the EMA to declare the situation “serious event”.
Source: Reuters
Source: Gestion
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