Advanced therapy medicinal products

• Published in: European journal of hospital pharmacy. Science and practice Vol. 31; no. 1; pp. 63 - 65
• Main Authors: Lozano-Blázquez, Ana, Makridaki, Despina, Plesan, Claudia Roxana, Kohl, Stephanie
• Format: Journal Article
• Language: English
• Published: England British Medical Journal Publishing Group 27.12.2023; BMJ Publishing Group LTD; BMJ Publishing Group
• Subjects: Best practice; Clinical medicine; Clinical trials; Collaboration; Continuing education; Curricula; Drug Industry; Drug stores; EAHP position paper; Education; EDUCATION, PHARMACY; Gene therapy; Good Manufacturing Practice; Hospitals; Information sharing; Medical errors; Medical personnel; Patient safety; Pharmaceutical industry; PHARMACEUTICAL PREPARATIONS; Pharmacists; Pharmacoeconomics; Pharmacovigilance; PHARMACY SERVICE, HOSPITAL; Professionals; PUBLIC HEALTH; R&D; Research & development; Tissue engineering; Workforce; Europe; PUBLIC HEALTH; Workforce; EDUCATION, PHARMACY; PHARMACY SERVICE, HOSPITAL; PHARMACEUTICAL PREPARATIONS
• ISSN: 2047-9956; 2047-9964
• DOI: 10.1136/ejhpharm-2022-003470

The European Commission (EC) noted this in its Pharmaceutical Strategy for Europe which also touches on ATMPs in the section covering enabling innovation and digital transformation.1 The European Medicines Agency (EMA) plays a central role in the authorisation of new therapies and included supporting the translation of ATMPs into patient treatments as one of the strategic goals and a core recommendation for human medicines in its Regulatory Science to 2025 Strategy.2 Within the European Union (EU), ATMPs are centrally regulated3 and cover biological medicinal products that can be classified as either gene therapy medicinal products (GTMPs), somatic cell therapy medicinal products (sCTMPs), tissue-engineered medicinal products (TEPs) or any combination of the three.4 They are often injectable and all healthcare professionals, including hospital pharmacists, need to understand how to handle ATMPs safely. The involvement of hospital pharmacists in their management has not only been proven to enhance patient safety but can also support earlier detection of adverse drug reactions and medication errors and thereby reduce high healthcare costs.11 Estimations show that ATMP development and in turn the application for marketing authorisation is growing. With research and development for these products increasing and more and more ATMP-based treatments becoming an integral part of clinical practice, the demand for training and educating healthcare professionals is also rising.15 To further assist its members, EAHP has set up a Special Interest Group focused on hospital pharmacists’ preparedness for in-vivo gene therapy medicinal products.16 One of the goals of this group is to develop best practices, support and guidance materials for hospital pharmacists and other healthcare professionals within the multidisciplinary team environment for the handling of in-vivo gene therapy medicinal products. [...]EAHP recommends the rapid development of European education and training materials in collaboration with scientific societies for healthcare professionals covering the entire ATMP spectrum.