SPD2 – Early access programmes – ensuring safety and quality

Link to EAHP Statements
Section 1 – Introductory Statements and Governance: Statements – 1.1, 1.3, 1,4
Section 2 – Selection, Procurement and Distribution: Statements – 2.1, 2.6
Section 3 – Production and Compounding: Statements – 3.3, 3.4, 3.6
Section 5 – Patient Safety and Quality Assurance: Statements – 5.4, 5.9, 5.10

Abstract
This seminar will focus on the growing role of early access (also known as expanded access) and other ‘free of charge’ programmes, which allow patients to receive promising new treatments before they are officially approved. These programmes offer a crucial opportunity for patients in need, but they also present significant challenges for hospital pharmacists, who must ensure that these therapies are provided safely and in compliance with legal and regulatory standards.
Hospital pharmacists must manage early access requests while ensuring medication safety, quality, and conformity. In addition, they face challenges in managing prescribers’ expectations, particularly when medications are requested through online platforms offering push deliveries. These shipments often lack critical documentation, such as GMP and batch release certificates, which the pharmacist must secure in order to take responsibility for dispensing the therapy, adding to their workload.
This seminar will feature two speakers: a hospital pharmacist with practical experience in managing early access programmes and a treating physician with experience in clinical trials and early access. Together, they will discuss the operational and ethical challenges of these programs, emphasizing the importance of clear communication and structured processes to ensure safe, effective access to new treatments for patients.

Learning objectives
After the session, the participant should be able to:
– Identify challenges in managing early access programmes and “free of charge” treatments.
– Evaluate the impact of early access on patient safety and pharmacist workload.
– Develop strategies for collaboration between pharmacists and prescribers in early access programmes.

Educational need addressed
This seminar addresses the need for hospital pharmacists to manage early access programs while ensuring patient safety, medication quality, and regulatory compliance. It highlights challenges in coordinating with prescribers and securing necessary documentation. The session emphasizes the importance of clear communication and collaboration to ensure safe access to new treatments.

Keywords
Early access, expanded access, medication safety, patient-centred care, free of charge.