Assurance of aseptic preparation of medicines – Guidance to replace EL(97)52 in England

The guidance will support the NHS in England to continue providing critical medicines for patients. It strengthens accountability and responsibility for the preparation of ready-to-administer injectable medicines in unlicensed pharmacy aseptic units in the NHS, as recommended in Transforming NHS pharmacy aseptic services in England – A national report for the Department of Health and Social Care by Lord Carter of Coles.

These units produce life-saving specialist medicines, such as chemotherapy and parenteral nutrition, and prepare other injectable medicines, including antibiotics, in syringes or infusion bags for direct administration to patients.

The guidance defines the roles and responsibilities for:

  • NHS organisations performing aseptic preparation activities;
  • the NHS Specialist Pharmacy Service Quality Assurance service (SPS QA). in providing regulatory oversight and inspection of aseptic preparation activity;
  • NHS England, in commissioning the overarching governance and assurance process, providing oversight and ensuring the delivery of enforcement where necessary;

It also describes the relationships with the regulatory bodies, primarily the Medicines and Healthcare Products Regulatory Authority (MHRA), Care Quality Commission (CQC) and General Pharmaceutical Council (GPhC), and introduces a new digital, good manufacturing practice (GMP) based audit and compliance management system: the Interactive Quality Assurance of Aseptic Preparation Services (IQAAPS).

Medicines supply and shortage management

The Department of Health and Social Care (DHSC) works closely with NHS England and NHS Improvement (NHSE&I), the wider NHS, pharmaceutical companies and others in the supply chain to ensure continuity of supply of medicines to patients.

In order to support pharmacists, clinicians and other NHS professionals with managing the supply of medicines to their patients, the DHSC and NHSE&I have worked closely together to produce A Guide to Managing Medicines Supply and Shortages.

This guide details the national, regional and local management and escalation processes and communication routes for medicines supply issues in order to consolidate existing practice across industry, government and the NHS.

It has been developed to support NHS teams and professionals who have responsibility for reporting a medicine supply issue, as well as those who need to take action when a shortage arises to ensure that patient care is protected.

New Home Parenteral Nutrition framework contract will support hospitals to have several suppliers

The new Home Parenteral Nutrition (HPN) framework contract aims to give patients, their carers and clinicians assurance in the supply of HPN. We are supporting hospitals to use at least two different suppliers to provide HPN to them as part of a new framework contract with the NHS which comes into force on 1 April 2020 in England.

Given the recent disruption to production at Calea UK we want to ensure that hospitals are not reliant on only one manufacturer. We are working with all suppliers of HPN to examine longer-term solutions for the supply of HPN to NHS patients. As part of this work to improve the stability of the market we are supporting hospitals to select a number of suppliers to provide HPN for their patients. The new framework contract NHS England has just concluded will help hospitals to meet those challenges by providing an improved range of possible suppliers.
The new framework contract also contains tougher financial sanctions that could be imposed on any supplier that does not meet the required standards of the contract. If any issues do arise we will work with the supplier as well as hospitals and patients to resolve the issue as soon as possible and ensure continuity of supply, but the NHS is prepared to impose contractual sanctions.

While Calea UK, a large provider, will continue to provide HPN products, NHS hospitals will also be able to choose from Baxter, B. Braun, Lloyds Pharmacy Clinical Homecare, Alcura, Healthcare at Home and the Royal Liverpool and Broadgreen University Hospitals NHS Trust. These suppliers have been selected by reference to a range of relevant factors including available production capacity – but also according to quality, safety, finance and governance requirements. It is also a contractual requirement that all suppliers hold a licence with the Medicines and Healthcare products Regulatory Agency and meet their regulatory requirements.

We will closely monitor all suppliers to ensure that they are meeting the requirements of the new contract through regular contract review meetings.