Pharmacy

(asked on 21st March 2019) - View Source

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the effect on aseptic compounding pharmacies operated by (a) NHS organisations and (b) non-NHS organisations of the UK leaving the EU without a deal.


Answered by
Caroline Dinenage Portrait
Caroline Dinenage
This question was answered on 28th March 2019

Hospital pharmacy aseptic services can be provided under either:

- a specific exemption for pharmacists within medicine legislation (derived from section 10 of the Medicines Act 1968); or

- a specials manufacturing licence from the Medicines and Healthcare products Regulatory Agency (MHRA).

Either approach requires services to meet the standards set by the MHRA within nationally recognised Good Manufacturing Practice. Licensed facilities are inspected by the MHRA and section 10 facilities are audited by regional quality assurance specialists under an Executive Letter, describing the arrangements for auditing unlicensed National Health Service aseptic units. The outcomes and risk ratings are reviewed through the NHS England Specialist Pharmacy Service.

Commercial aseptic pharmacies must hold a specials manufacturing licence from the MHRA to supply compounded aseptic products to the NHS. The MHRA has its own inspection team who visit and review licensed facilities including both NHS and commercial. The MHRA has regulatory enforcement powers to close, restrict or require improvement in these licensed facilities.

Capital spend to support individual pharmacy, aseptic or other NHS compounding services has historically been locally determined or has been part of wider whole hospital developments and, as such, there is no central repository of such spend.

NHS Improvement has, through the initial work of reviewing NHS-provided aseptic services, identified a range of challenges linked to such services, including workforce. The next stage of this work will focus on workforce provision within the wider strategic review. This work does not include non-NHS organisations. Health Education England is undertaking a review that, linked with the NHS Improvement strategic service review, will identify the pharmacy technical services workforce issues across all grades and workforce groups.

Aseptically compounded products are prepared from medicines that, in line with all medicines, are covered by the Department’s European Union exit planning process and products would all be included within the six-week additional stockpiling being managed through pharmaceutical suppliers.

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