Background

NHS England established the Infusions and Special Medicines programme to implement the recommendations of Lord Carter of Coles’ 2020 review of aseptic medicines services ‘Transforming NHS Pharmacy Aseptic Services in England’. He made a specific recommendation to update the governance and visibility of the assurance and audit of unlicensed aseptic preparation.

Recommendations from the Review

The regulatory workstream of the Infusions and Special Medicines programme identified revision of the Department of Health’s Executive Letter 1997 (52) as an early priority as it no longer reflected the structures and accountabilities in the NHS. However, it is important to remember that the 1997 guidance was introduced following a number of deaths arising from the administration of contaminated injections.

The new guidance makes explicit not only the audit process, but the process for escalation of concerns and accountability for that. The aseptic preparation of medicines is widely recognised to be an area of high risk NHS work and the focus is assuring the quality of this work.

The new NHS England guidance ‘Assurance of aseptic preparation of medicines – Guidance to replace EL(97)52 in England’ was published in March 2023.

Roles and responsibilities

The guidance describes the inter-relationships with the regulatory bodies, primarily the Medicines and Healthcare products Regulatory Agency (MHRA), Care Quality Commission (CQC) and General Pharmaceutical Council (GPhC). It also defines the roles and responsibilities for the following groups in meeting the stated requirements.

NHS organisations

NHS organisations have responsibility for meeting quality standards, responding to audits and inspections, and reporting quality indicators when performing aseptic preparation activities.

NHS England SPS QA Service

The NHS England Specialist Pharmacy Service Quality Assurance service (SPS QA) have a role in providing regulatory oversight and inspection of aseptic preparation activity, and auditing services against quality standards.

NHS England

NHS England is responsible for commissioning the overarching governance and assurance process, providing oversight, and ensuring the delivery of enforcement where necessary.

Principles and process

The ability of NHS organisations to meet the necessary standards is predicated on universal implementation of a template for a digital, Good Manufacturing Practice (GMP) based audit and compliance management system termed iQAAPS (interactive Quality Assurance of Aseptic Preparation Services), which is being rolled out by SPS. This is supported by a web-based process which enables Chief Pharmacists to develop and improve their services.

Scope

The majority of the services operate under Section 10 exemption from the Medicines Act, but as detailed below, the scope of the guidance also encompasses a range of aseptic activities that sit outside Section 10 exemption and outside the scope of MHRA MS Authorisation. These include, for example, aseptic preparation / reconstitution of Investigational Medicinal Products (IMPs) and Advanced Therapy Medicinal Products (ATMPs) within NHS pharmacy aseptic facilities in England.

Key points

The guidance specifies the processes for the following activities:

• auditing
• monitoring
• assuring and reporting compliance of services and facilities with critical quality and patient safety parameters
• responding to serious concerns about non-compliance

It also specifies the process for escalation of unresolved concerns and signposts to other key guidance and standards applicable to NHS aseptic preparation services and activities.

A short video is available summarising key points from the Assurance of aseptic preparation of medicines.

Answers to Frequently Asked Questions

Any questions regarding the guidance can be posted via the ISMB Futures workspace. The page will be regularly updated with relevant responses.

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