1. At the time of publication of the NICE Guidelines (April 2018), doxycycline did not have a UK marketing authorisation for this indication in children under 12 years and is contraindicated. The use of doxycycline for children aged 9 years and above in infections where doxycycline is considered first-line in adult practice is accepted specialist practice. The prescriber should follow relevant professional guidance, taking full responsibility for the decision. They should take into account the degree of certainty regarding the diagnosis (ie risks of doxycycline use are reasonable where the diagnosis is secure, but may not be where the diagnosis is possible but unlikely).  Informed consent should be obtained and documented. See the General Medical Council's Prescribing guidance: prescribing unlicensed medicines for further information.  The move of the age ceiling down from 12 to 9 years was justified in the NICE guidance and the text is replicated here.  ‘The committee acknowledged that infectious disease specialists currently treat Lyme disease in children aged 9 and above with doxycycline, although it is not licensed in the UK for children under 12, and it is contraindicated in this age group because of side-effects, such as teeth staining.  Based on their experience and knowledge, feedback from stakeholders, and the evidence for adults, the committee agreed that doxycycline is the most effective treatment for Lyme disease and that the risk of dental problems in children is low when it is used for short-term treatment (28 days or less). Therefore, doxycycline can be used as the initial treatment for Lyme disease in children aged 9 and above. The committee agreed on doxycycline doses based on their knowledge and experience of current practice both in the UK and the US’.
  2. The NICE committee recommended 21 days doxycycline for erythema migrans (EM), while NHS Highland infection specialists are recommending 14 to 21 days.  The NICE committee did not find any evidence that a 21 day course of doxycycline was superior to 14 days.  The committee wished to avoid the ambiguity of a treatment range and to standardise treatment duration across antibiotic classes.   The impact of increasing the duration was felt to be low due to the low number of people with EM.  NHS Highland infection specialists feel that the randomised double blind placebo controlled trial of 10 days oral doxycycline versus 20 days for EM (Wormser et al 2003) which demonstrated no benefit for the longer course, provides sufficient evidence that 14 days are adequate for adults.  In addition, as Lyme disease is more prevalent in Scotland than in England, primary care physicians in Scotland are more experienced in its treatment and standardisation across antibiotic classes is less of a priority. NHS Highland infection specialists feel that the frequency of side effects with doxycycline (43% of patients in above study) means that a third week of antibiotics does have a negative impact.  It is recognised that some patients with EM may be concerned about chronic effects, and for these patients, the longer course in line with NICE is likely preferable.
  3. Do not use azithromycin to treat people with cardiac abnormalities associated with Lyme disease because of its effect on QT interval.
  4. At the time of publication of the NICE Guidelines (April 2018), azithromycin did not have a UK marketing authorisation for this indication in children under 12 years. The prescriber should follow relevant professional guidance, taking full responsibility for the decision. Informed consent should be obtained and documented. See the General Medical Council's Prescribing guidance: prescribing unlicensed medicines for further information.

Author(s): Antimicrobial Management Team.

Approved By: TAM Subgroup of ADTC

Reviewer name(s): Area Antimicrobial Pharmacist.

Document Id: AMT143