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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 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. Indeed, hospital pharmacists 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 Association of Hospital Pharmacists (EAHP) outlines the roles and responsibilities of hospital pharmacists in the handling of ATMPs, addresses their education 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 …
Collaborators Delegates of the 52nd EAHP General Assembly.
Contributors The position paper was approved and adopted by the delegates of the 52nd EAHP General Assembly in June 2022.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Provenance and peer review Commissioned; internally peer reviewed.