They are nowhere to be found pancreatic enzymesaccording to the alarm raised by Fedez, who underwent pancreatic cancer surgery in March 2022. The drug, which replaces the functions of a removed or reduced organ, is necessary for patients to assimilate food, but there will be significant shortages from the autumn of 2023. Deficiencies that they could last until the end of 2025highlights an information note fromItalian Medicines Agencyaimed at healthcare workers.
“Due to production issues/high demand the pancrelipase-based medicines Creon* 10,000, Creon* 25,000 and Creonipe* 35,000 – explains AIFA in the note dated 25 October 2023, with the owner/sales licensee Viatris Italia Srl – are currently distributed on a quota basis; this situation will presumably continue until 12/31/2025. The shortage is not due to safety or quality issues and has already been communicated to the regulatory authority in accordance with current legislation”.
AIFA therefore invites healthcare professionals to prescribe these drugs “only for authorized indications, to inform patients already under treatment also in order to avoid hoarding phenomena and to prescribe Creon 10,000 and 25,000 and Creonipe 35,000 only if strictly necessary, in the minimum effective dose, and if for the indication in question there are no valid therapeutic alternatives or if, for patients under treatment, it is not possible to switch to other medicines. This is to ensure that the available packs, as they are limited , are used for indications for which the medicinal product is not substitutable”. In the meantime, reports of patients seeking the drug have multiplied. “I'm receiving lots of emails. It would seem that the issue is bigger than it seemed at the beginning and that it no longer exists in northern Italy”, says Fedez in his Instagram stories tagging the Ministry of Health.
Ministry of Health
The Ministry of Health also responded to Fedez: “Regarding the lack of pancreatic enzymes, it is specified that the issue specifically concerns the drug Creon. This is a known situation independent of the regulatory activities of Aifa, which has already time provided to patients and healthcare workers with adequate information, including operational information”, he explains in a note.
“To date, the only manufacturing company (Viatris Italia Srl) has communicated the impossibility of satisfying demand due to excess demand – continues the ministry – However, as already communicated by Aifa through the procedures ordinarily used in the event of a shortage of drugs, the Agency allows healthcare facilities to import similar drugs authorized abroad, in the event that the facilities themselves encounter discontinuities in the supply, at the level of the distribution networks to which they have access – he underlines – Furthermore, pharmacies that do not should they find the product in the usual distribution channels, they can place a direct order with the owner via the appropriate Customer Service”. The Ministry of Health “follows the issue, as well as all those relating to cases of drug shortages, with great attention and implements all relevant activities aimed at guaranteeing therapeutic continuity for patients”.
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