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National Patient Safety Agency

Neonatal services urged to follow new gentamicin safety guidance

15 February 2010


New guidance, produced by the National Patient Safety Agency (NPSA) and NHS organisations across England and Wales, has been issued aimed at ensuring safer systems are in place to care for newborn babies needing treatment with gentamicin.


The publication of this Patient Safety Alert follows reports received by the NPSA of 507 patient safety incidents between April 2008 and March 2009 relating to the use of the intravenous antibiotic.


Gentamicin has a narrow therapeutic margin which means the effective dose has to be kept within a small range.  This also necessitates its administration within an accurate timing regimen as well as regular monitoring of the level of the medicine in the blood.


Side effects of gentamicin can include renal damage and hearing loss.  In order to reduce these risks it is important that the concentration of gentamicin in the blood is kept within the therapeutic range by giving the drug at the correct time and measuring the blood level.    


In 182 cases, the incident reported to the NPSA related to the administration of the medicine at the incorrect time.  In addition, in 124 incidents there had been a prescribing error and 86 incidents related to monitoring the blood level.


Ninety-six per cent of incidents (483) resulted in no or low harm while four per cent (23) were reported as resulting in moderate harm (please see Notes to Editors section for definitions of levels of harm).  However, as the incidence of hearing or renal damage may not be immediately apparent, these may not have been captured in the no/low harm reports.  


This latest Patient Safety Alert requires all NHS organisations to have a neonatal gentamicin protocol in place that clarifies dosage and blood level monitoring requirements.  It also requires clinicians to use a care bundle approach when prescribing and administering gentamicin.  A care bundle approach is when several evidence-based interventions are grouped together in a single protocol to increase patient safety and outcomes.


The elements of the care bundle were developed following a collaborative project between the NPSA and the Royal College of Paediatrics and Child Health (RCPCH).  These are:


  • following the 24-hour clock format when prescribing gentamicin and blocking out any unused time slots on the administration record at the time of prescribing.  This should assist with preventing administration at the wrong time.


  • ensuring those responsible for preparing and administering gentamicin are not interrupted.  They should wear disposable coloured aprons that will act as a signal to other staff that they are involved in the preparation or administration of a medicine.


  • adopting a double checking prompt during the preparation and administration of gentamicin.


  • administering the prescribed dose of gentamicin within one hour of the prescribed time.


Jenny Mooney, NPSA’s Child Health Lead, explained:  “Gentamicin is a highly effective antibiotic that is widely used for the treatment of neonatal infection. 


“Frontline services should adopt this latest Patient Safety Alert to ensure high standards of care are taken in the prescribing, administrating and monitoring of this drug.”


Professor Neena Modi, Vice President for Science and Research at the RCPCH who led this collaborative project, said:  “Newborn patient safety is an important issue.  This project was supported by a wide range of organisations and parent groups concerned with newborn wellbeing.  We are delighted that the successful outcome of this joint initiative by the RCPCH and NPSA is to be implemented by all NHS trusts.”


The alert and care bundle also have support from Bliss – a special care baby charity that provides vital support and care to premature and sick babies across the UK. 


Chief Executive, Andy Cole said:  “We welcome the recommendation of care bundles for the administration of the antibiotic gentamicin and are delighted that these crucial issues in neonatal care have been addressed by the NPSA.


“It is imperative that all drugs are given as safely as possible to sick babies to ensure that adverse reactions are minimised. It is important that parents are informed about the possible risks of any course of treatment for their baby and that they are able to discuss and properly assess the clinical options presented to them.  Ensuring the baby's best interest is paramount."




* Definitions of levels of harm:


No harm:  Impact prevented – any patient safety incident that had the potential to cause harm but was prevented, resulting in no harm to people receiving NHS-funded care.


Impact not prevented – any patient safety incident that ran to completion but no harm occurred to people receiving NHS-funded care.


Low: Any patient safety incident that required extra observation or minor treatmentand caused minimal harm, to one or more persons receiving NHS-funded care.


Moderate: Any patient safety incident that resulted in a moderate increase in treatmentand which caused significant but not permanent harm, to one or more persons receiving NHS-funded care.


Severe: Any patient safety incident that appears to have resulted in permanent harmto one or more persons receiving NHS-funded care.


Death: Any patient safety incident that directly resulted in the deathof one or more persons receiving NHS-funded care.



  1. Media enquiries to the NPSA Press Office:

Simon Morgan – 020 7927 9580 / simon.morgan@npsa.nhs.uk

Dominic Stevenson – 020 7927 9351 / dominic.stevenson@npsa.nhs.uk


Out of hours – 0788 411 5956


  1. The National Patient Safety Agency (NPSA) is an Arm’s Length Body of the Department of Health. It encompasses three divisions; the National Research Ethics Service, the National Reporting and Learning Service and the National Clinical Assessment Service. Each has its own sphere of expertise to improve patient outcomes. The NPSA’s vision is to lead and contribute to improved, safe patient care by informing, supporting and influencing healthcare individuals and organisations. For more information visit: www.nrls.npsa.nhs.uk.