Dentolegal consultant, Martin Foster, explains the current advice and guidance from NICE and SDCEP on antibiotic prophylaxis against infective endocarditis.
Background of antibiotic prophylaxis for dental procedures
For many years it was accepted clinical practice, when carrying out dental procedures on patients who were considered to be at risk of developing infective endocarditis (IE), to administer preventive (prophylactic) antibiotics beforehand. The evidence base for doing this, however, was not clear.
The NICE guidance: Clinical Guideline 64 Prophylaxis Against Infective Endocarditis (CG64)
The guidance produced by the National Institute for Health and Care Excellence (NICE) in 2008 was based upon the best available published evidence at that time and a consensus of multidisciplinary, expert opinion.
1 The evidence demonstrated that there is no consistent association between a patient having an “interventional procedure” (dental or non-dental) and the development of IE. On this basis, the clinical effectiveness of antibiotic prophylaxis is not proven. The evidence also suggested that antibiotic prophylaxis against IE for dental procedures was not cost-effective.
Research was published in the years after the guidance was launched, which suggested that rates of IE had risen in recent years. In response to this, NICE reviewed the 2008 guidance. The conclusion reached by NICE in 2015, after considering the available evidence, was that the existing guidance was still appropriate and should remain the relevant standard in the management of patients at risk of endocarditis.
In line with the process for all NICE guidance documents, NICE will continue to monitor any future relevant evidence that might suggest a further review of the guidance would be justified, but at the present time the guidance remains as it was when first published. The sole modification made following the 2015 review was the insertion of the word “routinely” in 2016 in the following recommendation: “Antibiotic prophylaxis against infective endocarditis is not recommended
routinely for people undergoing dental procedures”. This updated wording was intended to improve the practical application of the guidance, which otherwise remained unchanged.
Until such a time as the recommendations in the NICE guidance change,
the current guidance published on the NICE website remains the recognised standard to which practitioners should refer.
Is the guidance obligatory?
Some dentists have a contractual obligation to observe the guidance of NICE when writing prescriptions (eg if working under the NHS GDS regulations in England). In other circumstances there may not be any such contractual requirement, however it would be advisable for any clinician who chooses not to follow the guidance to be able to justify any departure from this.
Patient awareness
There are patients with cardiac conditions who have come to expect that antibiotic cover will be provided when they receive dental treatment. With the existing NICE guidance, however, there is no justification for this being routinely provided, and clinicians need to ensure that clear communication with the patient about current guidance is provided along with reassurance and support.
Although there is no justification for the routine use of antibiotics for prophylaxis of IE in connection with dental procedures, it should be stressed that the early diagnosis and effective management of infection is of particular importance for patients who are at increased risk of IE. Any infection in this group of patients should be dealt with quickly and appropriately.
What can the dental team do?
Dentists (and other healthcare professionals) can help by offering people at risk of IE clear and consistent information about prevention, including:
• advice about the importance of maintaining good oral health, recognition of symptoms that may indicate IE and when to seek expert advice
• an explanation of why antibiotic prophylaxis is no longer recommended routinely for dental care.
Dental Protection is not, and does not purport to be, an arbiter of clinical opinion, but can certainly signpost members to relevant sources of guidance and information on appropriate clinical practice. It is clearly important for clinicians to understand the implications of the NICE guidance, and Dental Protection also appreciates that the practical implementation of this may pose a challenge for some practitioners and patients.
Implementation advice from SDCEP for dentists
Implementation advice was published in August 2018 by the Scottish Dental Clinical Effectiveness Programme (SDCEP) and this advice was endorsed by NICE.
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The implementation advice does not aim to replace the NICE guidance but is essentially a practical guide for putting the existing guidance into practice. It is generally acknowledged as a resource that has helpfully clarified many of the points which had the potential to create areas of uncertainty.
The SDCEP advice has separate sections on patients at risk of IE, definitions of invasive dental procedures and prescribing advice, along with advice on the routine and non-routine management of patients. It also has sections dealing with child patients and emergency appointments.
The SDCEP antibiotic prophylaxis implementation advice is available online.
Consent issues
The SDCEP publication acknowledges the central importance of consent when discussing treatment options with the patient, and echoes the stance of both NICE and the GDC in emphasising patient involvement in treatment discussions and shared decision making. In the Montgomery case, it was ruled that consent is considered to be valid if the patient has been presented with all of the information necessary for that patient to make a fully informed choice about his/her care, based upon the patient’s view of the material risks.
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What is a material risk?
According to the decision in the Montgomery case the test of “materiality” of a risk is whether in the circumstances of the particular case “a reasonable person in the patient’s position would be likely to attach significance to the risk, or the clinician is or should reasonably be aware that the particular patient would be likely to attach significance to it.”
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To prescribe or not?
The current NICE guidance clearly states that there is no indication for antibiotics to be prescribed routinely for patients who undergo dental treatment. The reason for this is that there is no clear evidence that routine prophylaxis is in any way effective.
Against this background there have been queries from members wondering how to respond to dental patients who are known to be at increased risk of developing IE but who do not have an existing infection, and feel that they should be given antibiotics to ‘protect’ them when consenting to treatment. This may be more likely if the patients have been told in the past – perhaps, over many years – that receiving dental treatment without antibiotic prophylaxis could be very dangerous.
Patients with an elevated risk of IE are likely to be in the care of a cardiologist and they may attach most significance to their cardiologist’s opinion.
If there is a disparity in opinions, it would be sensible to seek the patient’s permission to discuss the matter with their cardiologist, to ensure that any advice they have received was given in light of the latest guidance from NICE – which you are following. An agreed way forward can then be presented to the patient before any treatment is started.
The patient’s best interests
Prescribing antibiotics without clear reason exposes the patient to the avoidable risks of unnecessary medication. It also may create a risk of lessening the efficacy of the antibiotic when it is actually required.
A practitioner who chooses to treat a patient in a manner which is at variance with
current evidence-based recommendations for best practice (“guidance”) and the clear implementation advice which is available, would be well-advised to carefully consider his/her reasons for so doing and be prepared to justify the reason for departing from the guidance. Detailed records of the consent process must be made and kept.
View our Antibiotic Prophylaxis FAQs
Future updates
• Please
contact Dental Protection if you wish to discuss any dentolegal issues arising from the NICE guideline and SDCEP advice.
• When NICE has completed a review, subscribers to their update service will receive a notification.
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References
1. National Institute for Health and Case Excellence (NICE),
Prophylaxis against infective endocarditis: antimicrobial prophylaxis against infective endocarditis in adults and children undergoing interventional procedures. Clinical guideline [CG64].2008. Available from:
https://www.nice.org.uk/guidance/cg64.
2. Scottish Dental Clinical Effectiveness Programme (SDCEP),
Antibiotic Prophylaxis Against Infective Endocarditis Implementation Advice. 2018. Available from:
http://www.sdcep.org.uk/published-guidance/antibiotic-prophylaxis/.
3.
Montgomery v Lanarkshire Heath Board [2015] UKSC 11.