EAHP position paper pharmacy skills are universally applicable and play a crucial role for ATMPs. Also, the digitalisation of healthcare must be further exploited. Pharmacovigilance systems interfaced with electronic health records support monitoring the performance of medicines and help identify medication errors and adverse drug reactions. 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 medica- tion errors and thereby reduce high healthcare costs. 11 Estimations show that ATMP development and in turn the application for marketing authorisation is growing. By 2025, it is predicted that 10 to 20 cell and gene therapy products could be approved each year. 12 The authorisation of ATMPs is carried out by the EMA, however, there should not be any additional requirements imposed by the marketing authori- sation holder on hospital pharmacists that are handling these products, especially for situations where existing national or international standards are already in place. Procedures for handling gene medicines in hospital pharmacies are similar to those already in place for handling hazardous substances, such as cytotoxic agents. 13 The handling includes activities such as ordering, proper storage, preparation, dispensing, administra- tion, cleaning, waste management and transportation. To ensure that all health systems can cope with the increase in ATMP use, best practices should be shared among hospital pharmacists across Europe. When handling biohazards, it is paramount that technical requirements, storage and infrastructure, e.g. separated cleanroom areas, hoods, special safety gowns and techniques, are provided. Having adequately trained staff is a prerequisite. Suffi- cient funding is essential to ensure appropriate staffing levels and optimal conditions for the handling of ATMPs in hospital pharmacies. EAHP’s Special Interest Group focused on hospital pharmacists’ preparedness for in-vivo gene therapy medicinal products is one of the front runners in this area. 14 EAHP urges competent authorities across Europe to use the best practices and outcomes gathered by the Special Interest Group focused on hospital pharmacists’ preparedness for in-vivo gene therapy medicinal products . The Special Interest Group is looking at the requirements for the handling, preparation and administration of gene therapy products throughout Europe in order to provide guidance and training materials to hospital pharmacists. EDUCATION AND TRAINING CONCERNING ATMPS One of the target areas of ATMPs is to address significant and growing unmet healthcare needs. With research and develop- ment 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. However, not only the creation of training materials for GTMPs is important but also efforts should be made to generate educa- tional information for sCTMPs and TEPs. Consequently, 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 also acknowledges that specific training for the handling of certain ATMPs approved in Europe might be necessary due to
the shared responsibility of the pharmaceutical industry and the healthcare professionals handling these products. The require- ments for this training should, however, be approved by the EMA. This training should only extend to novel and essential processes and not to already established hospital pharmacy prac- tices and procedures. In addition to the creation of materials, the training of hospital pharmacists and other healthcare personnel handling ATMPs needs to be strengthened. Competencies aimed at ATMPs should include theoretical and practical skills in virotherapy, biohazard management, genetically modified organism (GMO) legislation, molecular and cell biology (such as cell imaging or flow cytom- etry), as well as their application to gene therapy, cell therapy, and tissue engineering. These new competencies require further training in good manufacturing practices (GMP) for ATMPs and translational research related to hospital pharmacy challenges. 17 EAHP calls on pharmacy schools and professional bodies offering continuing education to integrate training of pharma- cists on ATMPs into their curricula and training programmes . For instance, for the development of programmes specifically focused on gene therapies, issues to consider include the best practices identified by EAHP’s Special Interest Group focused on hospital pharmacists’ preparedness for in-vivo gene therapy medicinal products. 14 Holistic development and management of AMTPs do not only involve healthcare professionals but also patients, their carers, families and representatives. 18 Together with regulators, health- care professional organisations need to ensure that patients and their representatives become more aware of and involved in ATMPs. EAHP recognises the importance of further promoting the information sharing and communication on ATMPs to patients and patient organisations . ASSESSMENT OF ATMPS AND PHARMACOECONOMICS It is important to acknowledge that hospital pharmacists play a key role in the provision of sustainable and quality healthcare. They ensure the timely selection of the most appropriate medic- inal product for the right patient under the highest quality stan- dards. 19 The hospital pharmacists’ pharmacoeconomic expertise and their involvement in health technology assessments are even more crucial for ATMPs due to their exceptional costs. 20 Assess- ments of ATMPs should follow the same principles as those of the medication formulary system in which decisions are based on clinical, ethical, legal, social, quality-of-life, safety and phar- macoeconomic factors that result in optimal patient care and include the active and direct involvement of physicians and other healthcare practitioners, such as pharmacists. 21 EAHP reminds national competent authorities to recognise the invaluable role of hospital pharmacists in regard to the assessment of ATMPs and pharmacoeconomics . 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. Patient consent for publication Not applicable. Ethics approval Not applicable. Provenance and peer review Commissioned; internally peer reviewed. ORCID iD Stephanie Kohl http://orcid.org/0000-0003-0324-7976
Lozano-Blázquez A, et al . Eur J Hosp Pharm 2024; 31 :63–65. doi:10.1136/ejhpharm-2022-003470
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