Quality assurance

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Chapter: Hospital pharmacy : Quality assurance

National Health Service (NHS) regional quality control (QC) laboratories were first established in 1966 following health memorandum HM(65)22. This dealt with the QC of purchased drugs and dressings, giving guidance to NHS regions on setting up regional QC services.


Quality assurance

 

National Health Service (NHS) regional quality control (QC) laboratories were first established in 1966 following health memorandum HM(65)22. This dealt with the QC of purchased drugs and dressings, giving guidance to NHS regions on setting up regional QC services. The aim was to ensure that the quality of the products procured through the regional purchasing system met a satisfactory standard. In the early 1970s the work of the laboratories was significantly extended following HSC(IS)128 Application of the Medicines Act to Health Authorities, which applied the principles of the Medicines Act to all pharmaceutical manufacturing operations undertaken by health authorities. The circular required quality assurance (QA) and QC arrangements to be in place for all such activities and resulted in provision of QC laboratory facilities for each NHS manufacturing unit, located in most major pharmacy departments. It also resulted in them being subjected to regular inspection by the Medicines Inspectorate.

 

In 1984, health circular HC(84)3 introduced a policy of costing hospital pharmaceutical manufacturing operations and required the NHS to engage in manufacture only if there was no satisfactory commercial source or if it was significantly more economical to do so. This, along with the increasing commercial availability of hospital requirements, resulted in the rationalisa-tion of both manufacturing and QC laboratory facilities through the remain-der of the 1980s and the 1990s. Some NHS regions took the view that QA and QC services should be provided centrally at regional level, in order to make the best and most cost-effective use of the specialist staff and laboratory resources; this resulted in regional QC services based within one or two large laboratories on hospital sites within their region.

 

Throughout the 1990s and early 2000s there was a very large increase in the number of pharmacy aseptic units preparing injections and other products, as well as an increase in the preparation of clinical trial materials. NHS executive letters EL(96)95 and EL(97)52 introduced requirements for regular internal and external quality audit of pharmacy aseptic preparation activities to ensure these services achieved appropriately high standards. The require-ments established the role of the regional QA specialist in performing these external audits. These aseptic services, along with the remaining NHS manufacturing units, continue to require specialist QA and QC facilities, as well as pharmacists and other QA staff with substantial skills and knowledge in QA, good pharmaceutical manufacturing practice, QC, audit, pharma-ceutical sciences and technology, formulation and stability.

 

In the early 2000s the Department of Health established the NHS Hospital Medicines Manufacturing and Preparative Services Implementation Board, which oversaw the review of hospital pharmacy manufacturing and associ-ated QA services, and then managed a modernisation programme from 2004 to 2006. The programme included considerable capital investment in facilities for these services. A risk management programme involving product rational-isation followed, including implementation of autoidentification (bar coding) systems, and the launch of a national database (called Pro-File) of NHS-manufactured items.

 

Following publication of the NHS next-stage review High Quality Care for All and the government’s White Paper Pharmacy in England: Building on Strengths, Delivering the Future in 2008, a new national strategy for NHS pharmaceutical services was developed and issued by the NHS Pharmaceutical Quality Assurance Committee. This gave details of the important roles that NHS pharmaceutical QA services now play as part of the pharmacy team in assuring the quality of medicines in the NHS from procurement or prepara-tion/manufacture through to their final point of use by patients.

 

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