Shortages of pancreatic enzymes continue to affect patients in Italy, with the situation drawing attention from both government officials and public figures. The issue was first brought to light by singer Fedez and has since been the subject of discussions in the Senate and the Ministry of Health.
The shortage, which began in autumn 2023, has led to significant difficulties in the distribution of pancreatic enzymes, crucial for patients with compromised pancreas to assimilate food. The Italian Medicines Agency (AIFA) issued an information note last October, citing production problems and high demand as the cause of the shortages.
In response to the scarcity of the drug, AIFA has advised healthcare professionals to prescribe the medication only for authorized indications and to inform patients already undergoing treatment to avoid hoarding. Additionally, the agency recommended prescribing the drug only if strictly necessary and in the minimum effective dose.
Despite the ongoing shortage, undersecretary Marcello Gemmato announced that AIFA allows healthcare facilities to import similar medicines authorized abroad, and encouraged pharmacies to order directly from the manufacturing company if they cannot find the drug from usual suppliers. Gemmato emphasized that the Ministry of Health and AIFA have been working to manage the supply of the drug in the area to ensure therapeutic continuity for patients.
Viatris, the company responsible for marketing and distributing the pancreatic enzymes in Italy, acknowledged the difficulties in supplying the drug, attributing the shortage to high demand globally, rather than issues of quality, safety, or effectiveness.
The company also confirmed that the supply difficulties could continue until the end of 2025. With no immediate resolution in sight, patients and healthcare professionals are forced to navigate the challenging situation. The Italian government, regulatory agencies, and pharmaceutical companies are all working to mitigate the impact of the shortages and ensure the availability of essential medication for patients in need.