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Sunderland Repository records the research produced by the University of Sunderland including practice-based research and theses.

FMEA: a new approach to manage high risk medicines

Donovan, Gemma, Wake, Nicola and Williamson, Steve (2009) FMEA: a new approach to manage high risk medicines. The British Journal of Clinical Pharmacy, 1. pp. 329-332.

Item Type: Article


Reducing harm from high risk medicines, including injectable medicines and cytotoxic chemotherapy, is a key priority for the NHS (see background box). At Northumbria Healthcare NHS Foundation Trust, pharmacy and nursing staff are familiar with handling and managing traditional cytotoxic chemotherapy drugs and many safeguards have been put into place. However, the recent introduction of
a number of new, biologically targeted anticancer therapies, in particular the monoclonal antibodies, has posed new safety challenges.

The NHS Pharmaceutical Quality Assurance Committee recommends that the manipulation of monoclonal antibody
preparations should be individually risk assessed, and those with high risk should be manipulated in pharmacy aseptic facilities. In cancer services it is normal for nursing staff who are trained in chemotherapy to administer these drugs under written protocols, with close monitoring. However, the demand for the administration of these drugs outside of cancer services raises new safety considerations. For example, where
prescribing volume is low, nurses may not be trained or may not have the resources for the high level of monitoring that these treatments require.

This article describes a pilot project to highlight the risks associated with the use of rituximab (Mabthera; Roche) and thus identify areas for improvement. Although use of this drug is well established in the Trust, its use is increasing as it gains approval for different indications.

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Depositing User: Gemma Donovan


Item ID: 5809
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Catalogue record

Date Deposited: 09 Nov 2015 13:55
Last Modified: 18 Dec 2019 15:38


Author: Gemma Donovan
Author: Nicola Wake
Author: Steve Williamson

University Divisions

Faculty of Health Sciences and Wellbeing
Faculty of Health Sciences and Wellbeing > School of Pharmacy and Pharmaceutical Sciences


Sciences > Pharmacy and Pharmacology

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