Pharmacy Institutional Readiness for Marketed CAR-T Therapy: Guidance for Chief Pharmacists V4 (updated January 2020)

CAR-T Therapies are newly authorised products within Europe and currently undergoing review via the NICE Technology Appraisals process. They are classed as Advanced Therapy Medicinal Products (ATMPs) and, as such, require governance and management by Chief Pharmacists. They present risks which Chief Pharmacists should ensure are minimised. The greatest risks are around tracking and traceability as CAR-T is an individualised therapy with disastrous consequences if not administered to the patient it was intended for. Whilst collaboration with expert cellular product handling colleagues will be key operationally, it may present challenges for Pharmacy to embed this new working relationship. Additionally, CAR-T therapies are associated with toxicities which must be well understood and managed in a timely fashion.
It is advised that the following areas require Pharmacy input prior to an organisation implementing CAR-T Therapy. It is recognised that Pharmacy does not currently have the expertise to handle the products and that, routinely, Pharmacy may not come directly into product contact. However, where Pharmacy is not directly performing the procedures agreed, then roles should be clearly documented in an overarching technical agreement with reference made to approved SOPs.

Links

Attachments