EAHP position paper
Advanced therapy medicinal products Ana Lozano-Blázquez, 1 Despina Makridaki, 2 Claudia Roxana Plesan, 3 Stephanie Kohl , 4 delegates of the 52nd EAHP General Assembly
1 Pharmacy Department, Hospital Universitario Central de Asturias, Oviedo, Spain 2 Pharmacy Services, "Sismanoglio- Amalia Fleming", General Hospital of Attica, Athens, Greece 3 Pharmacy, Oncology Center Drobeta Turnu Severin, Drobeta-Turnu Severin, Romania 4 Policy & Advocacy, European Association of Hospital Pharmacists, Brussels, Belgium Correspondence to Stephanie Kohl, Policy & Advocacy, European Association of Hospital Pharmacists, Brussels 1200, Belgium; Stephanie.Kohl@ eahp. eu Published Online First 17 March 2023
EAHP POSITION PAPER ON ADVANCED THERAPY MEDICINAL PRODUCTS Making a difference by revolutionising patient care! The use of advanced therapy medicinal products (ATMPs) to treat disease and injury is growing. 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 thera- pies 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 regulated 3 and cover biological medic- inal 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 inject- able and all healthcare professionals, including hospital pharmacists, need to understand how to handle ATMPs safely. Indeed, hospital pharma- cists not only encounter ATMPs during clinical trials but also during regular clinical practice and may be called on to reconstitute them. This position paper of the European Associa- tion of Hospital Pharmacists (EAHP) outlines the roles and responsibilities of hospital pharmacists in the handling of ATMPs, addresses their educa- tion and training in relation to these products and provides insights on the assessment of ATMPs and pharmacoeconomics. EAHP states that the management of ATMPs, as licensed medications, is the responsibility of the hospital pharmacist. EAHP urges competent authorities across Europe to utilise the best practices and outcomes gathered by the Special Interest Group focused on hospital pharmacists’ preparedness for 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. EAHP calls on pharmacy schools and professional bodies offering continuing education to integrate training of pharmacists on ATMPs into their curricula and training programmes.
EAHP recognises the importance of further promoting the information sharing and communication on ATMPs to patients and patient organisations. EAHP reminds national competent authorities to recognise the invaluable role of hospital pharmacists in regard to the assessment of ATMPs and pharmacoeconomics. THE ROLE AND RESPONSIBILITIES OF THE HOSPITAL PHARMACIST IN ATMP HANDLING ATMPs are innovative and complex medicines used to treat a variety of human health issues. Areas of application include, but are not limited to, cancers, neurodegenerative diseases, inherited diseases and autoimmune diseases. 5 In particular, patients suffering from severe, rare or chronic diseases might benefit in the future from the growing use of ATMPs. Hospital pharmacists are responsible for ensuring the safe and effective use of medicines. This expertise of the pharmacy workforce should be a central component to adequate delivery of ATMPs within hospitals. 6 Their participation is not only invaluable in clinical trials for ATMPs where they are responsible for the correct receipt, storage, distribution and control of the clinical trial drug, but also for routine clinical practice. For holistic management and to guarantee the quality and safety of treatments with ATMPs, increased interaction and collaboration between different healthcare professionals is essential. 7 ATMPs are medicines and so by definition, they fall under the responsibility of the hospital pharmacist. Within the multidisciplinary treatment team, the hospital pharmacist must therefore be involved in their logistics (including process and order manage- ment), contract management, compounding/ production in the hospital, 8 reconstitution, quality control, medication management, pharmacovig- ilance and clinical follow-up. 9 Where applicable, hospital pharmacists should also be involved in reimbursement negotiations. EAHP states that the management of ATMPs, as licensed medications, is the responsibility of the hospital pharmacist. Concerning the pharmacovigilance of ATMPs, hospital pharmacists need to be directly involved in adverse drug reaction reporting using information systems. Due to their training, hospital pharmacists are uniquely positioned to be able to impact medi- cation safety at the individual patient level. Their medication management abilities allow them to analyse the performance of medication processes and to lead redesign efforts to mitigate drug-related outcomes that may cause harm. 10 These clinical
To cite: Lozano-Blázquez A, Makridaki D, Plesan CR, et al . Eur J Hosp Pharm 2024; 31 :63–65. © European Association of Hospital Pharmacists 2024. No commercial re-use. See rights and permissions. Published by BMJ.
Lozano-Blázquez A, et al . Eur J Hosp Pharm 2024; 31 :63–65. doi:10.1136/ejhpharm-2022-003470
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