Audit is important part of drug safety and regulation

BMJ 2005; 331 doi: https://doi.org/10.1136/bmj.331.7514.456 (Published 18 August 2005) Cite this as: BMJ 2005;331:456
  1. Michael I Carter, consultant anaesthetist (Michael.Carter{at}ldh-tr.anglox.nhs.uk),
  2. Jane Murkin, patient safety manager
  1. Luton and Dunstable Hospital NHS Trust, Luton LU4 0DZ
  2. Luton and Dunstable Hospital NHS Trust, Luton LU4 0DZ

    EDITOR—Waller et al write about the responsibilities of the pharmaceutical companies and the regulating agencies such as the UK Medicines and Healthcare products Regulatory Agency to improve the safety of the drugs that are licensed for prescription.1 Although cyclo-oxygenase 2 inhibitors and selective serotonin reuptake inhibitors have been under the spotlight in recent months, other drugs may be of greater concern.

    In 2000 the National Institute for Health and Clinical Excellence (NICE) issued guidance on the use of proton pump inhibitors in treating dyspepsia.2 In January 2005 in our hospital, an audit of record of 50 deceased patients identified 20 who were taking these drugs. Twelve of the 50 patients had had Clostridium difficile isolated in recent months, and eight of them had been taking proton pump inhibitors. Forty three patients received one or more antibiotics, 29 received three or more (cephalosporins 27, co-amoxiclav 19, metronidazole 19, clarithromycin 14; five or fewer had received nine other antibiotics).

    Studies in Plymouth in 2003 and Montreal in 2004 indicated that using proton pump inhibitors, especially in the long term, compounded with other precipitators such as multiple antibiotic usage and nasogastric feeding, more than doubled the incidence of infection with C difficile.3 4

    As a profession, we have the responsibility to follow the advice of agencies such as NICE about prescribing and to audit the effects of our treatments on our patients. We are looking at deceased patients' records in blocks of 50 using some of the trigger tools recommended by the Institute for Healthcare Improvement.

    This audit has led to several improvements already and highlighted the rapidly increasing popularity of proton pump inhibitors for infirm elderly people, who are most at risk of C difficile infection. Although some of these patients with C difficile died as a result of the organism's effects, the new North American strain was not identified.


    • Competing interests None declared.


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