The Pan-European Pancreatic Enzyme Shortage
The supply challenges affecting Nutrizym are part of a wider, multi-faceted issue impacting the availability of all pancreatic enzyme replacement therapy (PERT) medicines across the UK and parts of Europe. These life-saving treatments are crucial for individuals with pancreatic exocrine insufficiency (PEI) due to conditions like cystic fibrosis, pancreatic cancer, or pancreatitis. The reasons behind the supply chain disruption for PERT are interconnected, with problems affecting the largest manufacturer, Creon (Viatris), having a significant knock-on effect on smaller market competitors like Nutrizym (Zentiva).
Primary Culprits Behind the Nutrizym Scarcity
While Zentiva, the manufacturer of Nutrizym 22 capsules, reported their own specific manufacturing issue, the overarching problem is far more complex. The chain of events leading to the shortage is as follows:
- Creon's Manufacturing Limitations: Viatris, the manufacturer of the market-leading Creon, experienced significant manufacturing capacity constraints and issues with raw ingredient availability. As Creon commands a vast market share, its reduced availability created a massive shortfall in the overall PERT supply.
- Knock-On Demand for Nutrizym: With Creon in limited supply until at least 2026, patients began to switch to alternative brands, including Nutrizym. This sudden, unprecedented spike in demand quickly overwhelmed Zentiva's production capabilities, leading to intermittent shortages of Nutrizym 22 as well.
- Ingredient Supply Issues: The active pharmaceutical ingredients for PERT are derived from animal products, primarily pig pancreas. According to Essential Pharma, another PERT manufacturer, there were struggles sourcing a sufficient quantity of quality pancreas from pigs, highlighting a potential raw material bottleneck affecting the entire industry.
- Compounding Factors: The situation was further exacerbated by the discontinuation of another PERT product, Pancrease HL, by its manufacturer in late 2023. This led to more patients migrating to Creon and Nutrizym, further straining an already fragile supply chain.
Managing Your Pancreatic Enzyme Supply
For patients affected by the shortage, proactive management is critical to ensure continued access to therapy. Here is a list of recommended actions:
- Order Prescriptions Early: Request your prescription from your GP or pharmacy two weeks in advance of needing it. This gives your pharmacy additional time to source the medication.
- Request Single-Item Prescriptions: Ask your GP to prescribe your PERT as a single item. This allows you to try different pharmacies if your usual one is out of stock.
- Contact Your Pharmacist: Discuss the issue with your pharmacist. They can provide information on delivery dates and manage back-orders. They may also be able to facilitate access to unlicensed, imported versions if UK stock is unavailable.
- Do Not Ration Your Dose: It is crucial not to ration your medication. Patients must maintain their full prescribed dose to prevent malabsorption, weight loss, and other serious complications.
- Utilize Helpline Services: Manufacturers like Creon (Viatris) have established helplines to provide information on stock availability for pharmacies.
Navigating the Shortage: Alternative PERT Products
When Nutrizym is unavailable, several licensed and unlicensed alternatives might be considered in consultation with a healthcare professional.
| Feature | Nutrizym 22 | Creon (UK licensed) | Pancrex V | Unlicensed Imports (e.g., Pangrol, Zenpep) |
|---|---|---|---|---|
| Manufacturer | Zentiva | Viatris | Essential Pharma | Various (e.g., Alium, Durbin, Mawdsleys) |
| Availability | Intermittently limited (interim supply issues) | Limited until 2026 | Intermittently available; unable to support uplift in demand | Lead times vary; sourced when licensed alternatives are unavailable |
| Formulation | Gastro-resistant capsules | Gastro-resistant capsules/granules | Capsules and powder | Gastro-resistant capsules (brands vary) |
| Priority Use | For patients unable to tolerate Creon | Standard PERT; lower doses reserved for infants/swallowing issues | For specific cases like enteral feeding tubes | As directed by Serious Shortage Protocol where no UK licensed stock is available |
| Key Issue | Increased demand due to Creon shortage, plus a manufacturing issue | Limited raw ingredients and manufacturing capacity | Unable to meet increased demand due to market share and ingredient issues | Requires specific ordering process and longer wait times |
The Path Forward
While the shortage of Nutrizym has seen its own temporary resolution at times, its underlying fragility remains due to the sustained, significant limitations with Creon. The supply chain for PERT products relies on a complex system of sourcing raw materials and manufacturing that proved unable to handle the disruption of one major player and the discontinuation of another. Authorities continue to issue guidance and protocols to manage the crisis, but until the main manufacturer, Viatris, fully resolves its production issues, intermittent supply problems across the entire PERT market, including Nutrizym, may continue. Patients and healthcare providers must remain vigilant, following the official guidance provided by regulatory and health service bodies.
Conclusion
In summary, the Nutrizym shortage was not a standalone issue but a consequence of a larger, systemic problem within the pancreatic enzyme replacement therapy market. The discontinuation of one brand and significant manufacturing constraints affecting the market leader, Creon, led to an overwhelming surge in demand for Nutrizym. While Zentiva increased its production, it was not enough to fully cover the deficit. Patients should work closely with their healthcare providers and pharmacists to explore alternatives, utilize support channels, and follow all official guidance to ensure continued access to this vital medication until the wider supply chain stabilizes in 2026.
Pancreatic Cancer UK offers further information and support for patients.
