Out of Specification Advanced Therapy Medicinal Products

Anne Black, Regional QA Specialist Pharmacist and Chair of the Pan UK Pharmacy Working Group for Advanced Therapy Medicinal Products (ATMPs) based at The Newcastle upon Tyne Hospitals NHS Foundation Trust – has recently published an article as a first stop for professional medicine advice on the administration of Out of Specification (OOS) ATMPs. The publication focuses on the necessary processes to be undertaken to establish when it is appropriate to administer OOS ATMPs. It reviews the challenges to the NHS whilst also clarifying the regulatory perspective surrounding such OOS medicines for licensed, unlicensed and ATIMPs.

The guidance concentrates on the responsibilities involved in administration of OOS ATMPs, emphasising the need for other considerations such as the transfer of liability to the administering site and treating physician when an OOS ATMP is potentially going to be administered. Furthermore, the publication stresses the importance for the correct local governance to be in place prior to administration. The article expresses the necessity to consider time sensitive decisions in the supply chain and import procedures (if the ATMP is not manufactured in the EU). Patient related issues are also identified, such as patient benefit and the stability of the patient’s healthcare are also highlighted as factors to be considered before deciding to administer an OOS ATMP.

It is advised that clarification on reimbursement pathways is always obtained from commissioners or sponsors.   User friendly illustrations are provided demonstrating the recommended hospital process in the event of an OOS licensed ATMP, OOS ATIMP and OOS unlicensed ATMP being offered for use in a hospital.

The link to the full article can be found below: