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SPD2 – Handling EU shortages approach

Date:

12/03/2025 - 5:00 pm to 6:00 pm
13/03/2025 - 12:00 pm to 1:00 pm

Room:

Auditorium 15

Facilitator:

Thomas de Rijdt

Abstract:

Link to EAHP Statements
Section 1 – Introductory Statements and Governance: Statements 1.1, 1.2, 1.3, 1.5, 1.6
Section 2 – Selection, Procurement and Distribution: Statements 2.1, 2.2, 2.5
Section 5 – Patient Safety and Quality Assurance: Statements 5.9, 5.11

Abstract

Medication and medical device shortages have become part of our daily life and pose significant risks to patient care, arising from production issues, supply chain disruptions, economic factors, and regulatory challenges. The implementation of the Medical Device Regulation (MDR) and the limited number of notified bodies further exacerbate device shortages.
The European Union (EU) addresses these challenges through initiatives such as the EU Pharmaceutical Strategy, the Health Emergency Preparedness and Response Authority (HERA), and the Medicines Shortages Task Force, aiming to strengthen supply chains, enhance coordination, build strategic reserves, and promote solidarity between the member states.
In Belgium, the competent authority has established a dedicated working group and ad hoc task forces for critical shortages comprising all stakeholders such as hospital pharmacists, prescribers, patient associations, the Ministry of Healthcare, the reimbursement agency, and in close communication with the pharmaceutical industry. These task forces aim to collaboratively address and mitigate the impact of shortages in order to guarantee adequate therapy. Based on the outcome this methodology is seen as good practice.
Despite all these efforts, hospital pharmacists face increased workloads, including managing alternative therapies, communicating with healthcare providers, and ensuring continuous patient care. These shortages directly impact patients, potentially leading to suboptimal treatment outcomes, increased side effects, and decreased quality of care. Addressing these challenges requires ongoing collaboration between regulatory bodies, healthcare institutions, patient associations, and pharmaceutical companies to ensure the consistent availability of essential medications and medical devices.

Learning objectives
After the seminar, the participant should be able to:

  • To analyse the root cause and impact of medication and medical device shortages.
  • To evaluate the EU strategies for addressing shortages.
  • To implement best practices for managing critical shortages in a hospital pharmacy setting.

Educational need addressed
-Understanding and addressing the complexities of shortages.
-Knowledge of EU strategies to combat shortages.
-Enhancing collaborations and communication among healthcare stakeholders.

Keywords
Shortages, supply chain disruption, patient care impact, EU Commission, strategy.

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