The supply problems have been reduced this 2024 for the first time since the pandemic. The report data presented Tuesday by the Spanish Agency for Medicines and Health Products (AEMPS) reveal a 12.7% decrease in this number of incidents with respect to 2023. In the case of drugs that have no alternative, the most cases the most cases Serious, the problem has been reduced even more, 31%.
In 2024, difficulties were detected to access 1,159 medicines presentations (in shapes such as tablets, envelopes, syrups or capsules), of a total of 33,012 authorized, which represents 3.51%. In most cases, the incidents were resolved within less than three months. The vast majority (93.3%) were notified by the owners of authorization for drug marketing (CT) and six out of ten were medications with recipe, while 26.7% were hospital drugs.
The most affected drugs have been those indicated for the nervous system, followed by cardiovascular and anti -infectious. However, a notable improvement in the availability of the latter has been observed: problems with antibiotics and antivirals have been reduced by 39.7% (from 450 cases to 322), after the application of preventive measures such as those adopted during the crisis of pediatric amoxicillin in 2023.
One of the persistent problems is the shortage of Analog drugs of LPG-1, such as Ozempic, used for diabetes and, in some cases, for weight control. Three years after the supply crisis starts, the situation is still unresolved, so the available units continue to be distributed in a controlled manner. The AEMPS has insisted on the need to strictly respect the indications of these drugs in their prescription. However, it expects that throughout this 2025, the situation will be “similar” to these years.
In addition, the Pharmaceutical Novo Nordisk has announced that the marketing of several fast insulins will cease, which could generate new problems in the treatment of diabetes. Given this, a working group has been constituted to guarantee their priority availability.
Six out of ten were medications with recipe, while 26.7% were hospital drugs
Another severely affected medication has been the prolonged liberation methylphenidate, used in the treatment of ADHD. The shortage has been due to the increase in the global demand of one of its most used formats, concert, as well as the lack of effective solutions by another of the laboratories that sell it, the Janssen. Therefore, the AEMPS has contacted Liconsa, Atenza manufacturer, to request an increase in medications manufactured in its facilities. Also, the European drug agency (EMA) has reported a delay in the reopening of the HFR reactor, key in the production of medical radioisotopes.
The causes behind supply problems remain the same. The main one has been the limitation in the production capacity of laboratory plants (25.8%), followed by the increase in demand (25%) and the manufacturing problems not related to quality (20.5% ), As has happened in this period with radiopharmaceuticals.
To deal with these difficulties, the agency carried out 1,631 actions in 2024, almost 30% more than the previous year. It also increased exceptional marketing authorizations (525 in 2024 compared to 438 in 2023) and tripled the export stop orders to member and third states, from 209 in 2023 to 590 last year.
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