Ensuring Supply Amid Shortages
In the Spanish pharmaceutical sector, one of the biggest challenges is the shortage of essential medicines, a situation that particularly affects patients with rare or chronic diseases.
Medicines under Special Situations (MSS) play a critical role in this context, as they are often the only available therapeutic option for these patients.
At MANA PHARMA, we work closely with Health Authorities to mitigate drug supply shortages in Spain.
As an authorized distributor, we are committed to ensuring the supply of MSS during stock shortages, collaborating with regulatory agencies and international laboratories to guarantee no patient goes without treatment.
In this article, we explain what MSS are, why they are key to addressing shortages, and how our work helps tackle this issue in Spain.
What Are Medicines under Special Situations (MSS)?
While MSS are often assumed to be highly specialized drugs with limited production, the reality is that they encompass a wide variety of medications. Shortages can occur due to poor planning, raw material scarcity, or supply chain failures.
The most commonly affected MSS include:
- Orphan drugs: For rare diseases (e.g., certain oncology or neurological treatments).
- Critical hospital medicines: Such as anesthetics, anticoagulants, or immunosuppressants.
- Advanced therapies: Biotechnological products with complex replacement logistics.
- Discontinued medicines: When a manufacturer stops production without immediate alternatives.
- Any medication facing supply disruptions that the Marketing Authorization Holder (MAH) cannot resolve.
The Drug Shortage Problem in Spain
Like other European countries, Spain faces recurring drug shortages, primarily due to global production disruptions, overreliance on imports, and distribution issues. These shortages have severe consequences, including:
– Delays in life-saving treatments.
– Use of less effective alternatives.
– Clinical deterioration or even mortality in extreme cases.
This underscores the urgent need to ensure a steady supply of these essential medicines.
MANA PHARMA: Specialists in MSS Supply During Shortages
At MANA PHARMA, we prioritize rapid and efficient solutions to MSS shortages in Spain. Our approach includes:
- Identification and Management of Critical Medicines
- Proactive monitoring of drugs at risk of shortage.
- Collaboration with the Spanish Medicines Agency (AEMPS) to expedite exceptional authorizations.
- Fast-Track Importation of MSS
- Leveraging a reliable supply chain to provide swift solutions.
- Securing emergency stock through trusted international partners.
- Partnerships with International Laboratories
- Working with European MAHs to access scarce medicines.
- Maintaining strategic reserve stocks for emergencies.
- Rapid-Response Logistics
- Direct hospital deliveries within 48 hours (or 12-24h for urgent cases, including weekends).
- Full cold-chain compliance and traceability for sensitive MSS.
Success Stories: How We’ve Resolved Shortage Crises
In 2021-2022, we covered 100% of national demand for a critical thrombolytic drug during a shortage. In 2023, we imported a Von Hippel-Lindau (VHL) disease treatment from Canada—a rare disease with high supply vulnerability.
Conclusion
All medicines are vulnerable to shortages, making MSS a crucial safety net. At MANA PHARMA, we tackle this challenge by specializing in agile, reliable solutions—ensuring patients receive uninterrupted treatment.
Our model, based on active monitoring, fast-track imports, and close collaboration with authorities and labs, is key to addressing one of Spain’s pressing healthcare issues.
We remain committed to innovation, ensuring that supply shortages never compromise patient health.
