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Health: Drugs

Volume 706: debated on Wednesday 21 January 2009


Asked by

To ask Her Majesty's Government what steps they have taken to ensure patient safety when prescribing and dispensing immunosuppressant drugs for post-transplantation care. [HL590]

To ask Her Majesty's Government what communications they have received concerning prescribing and dispensing errors relating to immunosuppressant therapies. [HL591]

The National Patient Safety Agency (NPSA) reviews medication errors on an ongoing basis, and prioritises the production of guidance and recommendations based on the level of harm reported to its Reporting and Learning System, other national and international reporting systems and published literature.

The agency has also produced a series of design guides in the “Design for Patient Safety” series, which aim to improve the labelling and packaging of pharmaceutical products. These have been issued to pharmaceutical companies to assist them in producing products that minimise the risk of mis-selection and other patient safety incidents. These materials are also used by National Health Service medicines procurement groups to purchase products which are safer in use. A design guide on “The Dispensing Environment” which identifies ways that good design of the dispensing environment can help improve the accuracy of the dispensing process has also been produced by the NPSA.

The department, the Medicines and Healthcare Products Regulatory Agency (MHRA) and the NPSA have received communications from Astellas Pharma Ltd, a manufacturer of immunosuppressant medicines, about prescribing and dispensing errors relating to Advagraf and Prograf. The MHRA has, as part of an EU-wide action, agreed to send a “dear doctor/healthcare practitioner” letter to the relevant NHS staff, and made proposals for changes to the packaging for Advagraf to emphasise that it differs from Prograf. In addition, MHRA included the issue in its December edition of the Drug Safety Update, with a further article in the January 2009 edition. These should help to make prescribers, pharmacists and patients aware of the brand being prescribed, whatever the manufacturer, and the associated dose regimen. MHRA has also highlighted the issue to other information providers, including the British National Formulary and the National Prescribing Centre.