Background
The Chief Pharmacist has overall accountability for the safe use of all medicines within the Healthcare Organisation. As such, they are responsible for the governance and management of medicines; this includes authorised and investigational Advanced Therapy Medicinal Products (ATMPs and ATIMPs).
Cell and tissue based ATMPs require specialist handling and expertise which is not routinely available within hospital pharmacies. Agreements with local stem cell laboratories or other suitable third party blood and transfusion centres may be required to facilitate delivery of these specialist medicines. The suitability of these facilities must be established by the Chief Pharmacist.
Delivery Models
There are two broad scenarios by which appropriate services may be provided:
- Insourcing: Provision of the services by another department within the same legal organisation
- Outsourcing: Provision of the services across legal boundaries
In both cases, arrangements should be described in the ATMP policy describing local governance. Roles and responsibilities should be documented in a technical agreement and suitability of the service should be confirmed by audit and continuing oversight arrangements.
Template technical agreements for marketed ATMPs are available in Outsourcing the Receipt, Storage, Preparation and Onward Supply of Marketed Cryopreserved ATMPs – A Template Technical Agreement.
Template technical agreements for investigational ATIMPs are available in Outsourcing ATIMP Handling: A Template Technical Agreement.
Additional considerations for Outsourcing
Where medicines cross legal boundaries, there are a number of regulatory factors to consider. These factors and some example scenarios for ATIMPs are outlined in Outsourcing of Storage or Preparation of ATIMPs Across Legal Boundaries.
Performing Audits
The first document below has been designed to provide an audit & assessment tool for use by pharmacy departments to provide assurance on the storage and handling of cell based AT(I)MPs stored outside of pharmacy. It can be used when the cell storage facility is within the same hospital Trust/Health Board, or where this service is outsourced to a separate legal entity.
Instructions for Use
The audit must be carried out on behalf of the Chief Pharmacist, and performed by staff suitably familiar with the storage and handling of cell-based products (including aspects of Good Manufacturing Practise), independent of the department they are auditing. The audit tool below has been designed to provide a structure for an audit. Auditors should use the standards within the template to determine suitability of the provider, and where deficiencies are identified these should be ranked according to their severity (classifications of critical, major, or other are typically used).
On completion of the audit, the auditor must provide a report to the site who in turn must provide an action plan addressing all deficiencies identified. Once the actions have been agreed and no critical observations remain, the site would normally be considered as a suitable service provider.
Repeat audits may be required, these would typically be carried out every 1-2 years depending on the level of activity and the original audit findings (with more major findings indicating more frequent audits). ‘For-cause’ audits may be considered in the event of significant breaches from the required standards or the Technical Agreement.
Continual Monitoring and Oversight (Governance)
As part of the ongoing governance arrangements, the Chief Pharmacist should establish a programme of governance and oversight for service providers. The second tool below is provided as a guide which may be considered when developing such a programme. The guide directs the pharmacy team to review a random selection of product records to provide assurance that all requirements are in place for the handling of cell based ATMPs. A suggested frequency for this governance and oversight audit is 6 monthly.