Session 5: Standards for aseptic units in the UK
6 October 2017Dr A. Beaney1, Dr J. Smith2 1 University of Sunderland, Newcastle upon Tyne, Royaume Uni
2 Cardiff, Pays de Galles
Aseptic units in the national health service (NHS) in the UK are either licensed and inspected by the regulatory authority (the Medicines and Healthcare products Regulatory Agency – MHRA) or, if unlicensed, operate under pharmacist supervision (known as Section 10 exemption from the UK Medicines Act). Unlicensed NHS aseptic units must comply with defined standards, known as the Quality Assurance of Aseptic Preparation Services. In late 2016, a new version (edition 5) of these standards was published by the Royal Pharmaceutical Society (RPS). The workshop leader edited these standards on behalf of the national Pharmaceutical Quality Assurance Committee and the RPS.
What will the workshop involve?
The workshop leaders will discuss the background to the standards for unlicensed aseptic units in the UK and how they relate to those for licensed units.
The workshop will explain:
- Why the standards are needed
- Key changes in the latest edition of the standards (and why these were introduced)
- How the standards are being implemented
- How the standards are being monitored across the UK to protect patient safety.
There will be an interactive discussion about differences in practices and in the regulatory frameworks between the UK and other countries.
To be in a stronger position to understand the current measures in place in the UK to assure the quality of aseptically -prepared unlicensed medicines, such as cytotoxics, parenteral nutrition, intravenous additives.
To compare and contrast these measures and legal frameworks with those in your own practice.