Case Studies
Standardising pharmacy approaches to handling ATMPs
The challenge
Advanced therapy medicinal products (ATMPs) have substantially different pathways through patient care compared to conventional treatments. These products may be manufactured for specific patients following harvest of a patient’s blood or bone marrow and may be only suitable for that particular patient (autologous). Other ATMPs are made on a larger scale, allowing many patients to be treated from the same manufacturing batch (allogeneic).
All ATMPs have specific storage, handling and dispensing instructions that must be followed to ensure that the quality and safety of products are maintained. Pharmacists are responsible for ensuring that the ordering, storage, reconstitution and dispensing of ATMPs are in line with their product specifications, patient clinical needs and protocols when the products are offered as part of a clinical trial.
The solution
The pan-UK Pharmacy Working Group (PWG) is acting as an expert and informed body to support the activities of the three ATTCs and, indeed, hospitals around the UK in the administration of ATMPs. The group consists of pharmacists from across the UK that specialise in the governance, clinical trials, prescribing, administration and monitoring of ATMPs and is an excellent example of collaboration across the NHS. The aims of the group are to promote good practice, identify and resolve pharmacy issues to maximise the effectiveness and development of services for hospitals to administer advanced therapies.
The results
The group has developed guidance and checklist documents in the implementation of ATMPs to provide consistency in governance, clinical and operational aspects for pharmacies across the country. The PWG is now formally a Specialised Pharmacy Service Network and is becoming an important partner to the NHS in the administration and commissioning of ATMPs and will continue to develop best practice and guidance for this class of medication[1].
Making further impact
As new hospitals begin to use ATMPs in the clinic, there are procedures and checklists are available to support clinical staff. Commercial ATMP developers also benefit due to the more consistent approach at different hospitals, making set up at different sites a smoother process
