The National Medicines Safety Agency (ANSM) is sounding the alarm. The out-of-stock epinephrine auto-injector pens are becoming too frequent.
Too much is too much for the Medicines Agency. This summer again, pharmacies ran out of adrenaline auto-injector pens. It was necessary to make an inventory of these devices to distribute them equitably throughout France. Because, if the demand is strong, the supply is far insufficient. For more than a year, the adrenaline-based specialties Anapen and Jext have regularly been out of stock. These drugs, considered essential by ANSM, urgently treat anaphylactic shock, especially linked to many allergies. They save the lives of hundreds of patients every year.
The Bioprojet Pharma and ALK laboratories, producers of the Anapen and Jext self-injection devices, are experiencing production difficulties. This explains the repeated supply tensions. The ANSM therefore asks the two companies to make production more reliable and, in the event of a breakdown, to import similar specialties produced abroad.
The phenomenon of drug outage is not recent. What the ANSM criticizes the two laboratories is its frequency. Since April 2012, Anapen and Jext auto-injector pens have regularly been out of supply. Transitional solutions were provided each time. In August 2012, a similar specialty intended for the Belgian market was made available to the French market. A transitional solution even became permanent in January 2012, with the marketing authorization for Jext. This solution for injection in a pre-filled syringe made it possible to complete the Anapen offer, until then the only adrenaline-based self-injection device available in France.
The phenomenon of supply disruption is not isolated: the summer of 2013 also saw a shortage of stock for the drug Levothyrox, which treats hyperthyroidism.
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