Amy-Jo Hooley Specialist Clinical Pharmacist

Transcription

1 Gut Decontamination Title of Guideline (must include the word Guideline (not protocol, policy, procedure etc) Contact Name and Job Title (author) Directorate & Speciality Guideline for the Safe Administration of and Dosing of Gut Decontamination Amy-Jo Hooley Specialist Clinical Pharmacist Family Health Gastroenterology Date of submission October 2016 Date on which guideline must be October 2019 reviewed (one to five ) Explicit definition of patient group All children under 18 of age within to which it applies (e.g. inclusion Nottingham Children s Hospital, who are believed to and exclusion criteria, diagnosis) have bacterial overgrowth, and are under the care of the gastroenterology team. Abstract The guideline discusses the assessment and management of children with bacterial overgrowth of the gut. Key Words Paediatrics; Children; Bacterial overgrowth, gut decontamination Statement of the evidence base of the guideline has the guideline been peer reviewed by colleagues? 1a meta analysis of randomised controlled trials 2a at least one well-designed controlled study without randomisation 4 2b at least one other type of well-designed quasi-experimental study 3 well designed non-experimental descriptive studies (ie comparative / correlation and case studies) 4 expert committee reports or opinions and / or clinical experiences of respected authorities 5 recommended best practise based on the clinical experience of the guideline developer Consultation Process Paediatric Gastroenterology Multidisciplinary Team, Policies and Procedures Group Target audience Clinicians and healthcare professionals caring for children and young people treated for Bacterial Overgrowth of the gut whom require gut decontamination at Nottingham University Hospitals NHS Trust This guideline has been registered with the trust. However, clinical guidelines are guidelines only. The interpretation and application of clinical guidelines will remain the responsibility of the individual clinician. If in doubt contact a senior colleague or expert. Caution is advised when using guidelines after the review date. Amy-Jo Hooley Page 1 of 8 October 2016

2 Document Control Document Amendment Record Version Issue Date Lead Author Description 1 Dec 2013 Amy-Jo Hooley Original guideline 2 Oct 2016 Amy-Jo Hooley Dose revision for nystatin General Notes: Version 2: Nystatin dose updated as per new guidance in BNF-C Statement of Compliance with Child Health Guidelines SOP This guideline refers to activities of only one specific team and consultation has taken place with relevant members of that team. Therefore this version has not been circulated for wider review. Martin Hewitt Clinical Guideline Lead Amy-Jo Hooley Page 2 of 8 October 2016

3 Policy for the Safe Administration of and Dosing of Gut Decontamination in Nottingham Childrens Hospital Background Information Many children with a short bowel are at risk of bacterial overgrowth. Short bowel syndrome arises when a large segment of the bowel is lost, usually as a result of surgery. Bowel resection can become necessary in conditions such as necrotising enterocolitis, long segment Hirschsprungs, gastroschisis, and also as a result of post operative complications. A short bowel can be categorised by one of the following three descriptions. (1) : - Jejunum-colon - Jejunum-ileum - Jejunostomy Short bowel may or may not include the presence of an ileo-caecal valve. It is well documented that children without an ileo-caecal valve are at greater risk of bacterial overgrowth. Bacterial overgrowth occurs when D-lactic acidosis arises in patients with a preserved colon and short bowel. Colonic bacteria degrade surplus fermentable carbohydrate to form D-lactate which is absorbed but not easily metabolised. (2) 1. Policy Statement This policy outlines the safe administration of gut decontamination with reference to all the possible treatment options available. 2. Aim / Rationale 2.1 To ensure that there is a clear, safe mechanism for the prescribing, dispensing, and dosing of gut decontamination. 3. Guidance for Prescribing 3.1 A checklist is included as appendix 1 to ensure that the key elements of this policy are followed. All elements of this checklist must be addressed/considered before treatment can begin. 3.2 The patient should first be assessed by a paediatric gastroenterology consultant before the decision to initiate treatment. ONLY a consultant clinician may initiate treatment. 3.3 Assessment should include the following diagnostic tests/procedures if clinically appropriate: - A hydrogen breath test - Folate and B12 levels 3.4 The intention to use gut decontamination should, be documented in the medical notes, stating the starting regimen, intended length of treatment, and starting doses. Amy-Jo Hooley Page 3 of 8 October 2016

4 3.5 The gastroenterology pharmacist must be informed of any new patients that are being commenced on a gut decontamination protocol. If they are not available, the ward pharmacist should be contacted instead. Gut decontamination cannot be initiated overnight or at a weekend as special products cannot be made outside of normal working hours. 3.6 The gut decontamination regimen should be clearly prescribed on the antibiotic section of the drug chart, and the start date, stop date, and indication should all be completed as per Trust policy. 3.7 Children will initially start on a standard gut decontamination regimen as per dosing Table 4.1. If they are deemed clinically to not tolerate this regimen, or they are not getting adequate clinical results then, at the discretion of a consultant gastroenterologist they may be started on amphotericin or colistin as per table 4.2. If adequate control is still not gained then, as a last resort, rifaximin may be used as per dosing Table The rationale for gut decontamination utilises the fact that the broad spectrum antibiotics should give a localised antibiotic effect, preventing the excessive growth of gut flora. The aminoglycosides, gentamicin and tobramycin (which are not absorbed enterally) are bactericidal and active against some gram positive, and many gram (4) negative bacteria. They are used in conjunction with miconazole and metronidazole as none of them provides sufficient anaerobe or fungal cover. Metronidazole is an antimicrobial drug with high activity against anaerobic bacteria and protozoa, and although absorbed systemically this should have good localised effect within the gut as well. Amphotericin is a polyene antifungal, and micafungin is an echinocandin antifungal. Neither are absorbed systemically when given via the oral route. (4) 3.9 Rifaximin is a semi synthetic rifamycin based non-systemic antibiotic, with a low gastro intestinal absorption and a good antibacterial activity. The antibacterial action covers gram positive and gram negative organisms, and both aerobes and anaerobes. Its antimicrobial action is based on its property to bind the beta subunit of bacterial DNA dependent RNA polymerase inhibiting bacterial RNA synthesis. Rifaximin helps to restore gut microflora imbalance, becoming an important therapeutic agent in several organic and functional gastrointestinal diseases. This antibiotic has the advantages of low microbial resistance, few systemic adverse events and being safe in all patient populations including young children. (3) Amy-Jo Hooley Page 4 of 8 October 2016

5 4. Patient Doses / Regimens Table 4.1 Regime Weeks Drug Dosing Frequency Age Dose (times daily) Gentamicin All Metronidazole All Tobramycin Miconazole 1 month Over mg/kg (max 80mg) 7.5mg/kg (max 400mg) 20mg 40mg 80mg Comments 10mg in 1ml solution available from special-order manufacturers, usually with one month expiry. Gentamicin levels should be carried out after the first week of treatment. 200mg in 5ml suspension is commercially available. Consider metronidazole 200mg tablets if need sorbitol free (tablets can be halved or quatered) 40mg in 1ml solution available from special-order manufacturers usually with a 1 month expiry. Consider tobramycin levels Neonate 1ml 2-4 Daktarin 1 month 2 2.5ml ml 2 5ml ml 4 oral gel. (Could use nystatin 2ml QDS under 2, and 4ml QDS over 2 as an alternative if child can tolerate sugar.) Amy-Jo Hooley Page 5 of 8 October 2016

6 Dosing regimens alternate every 2 weeks, as per the table above. However frequency can be changed to either monthly or 2 monthly prescriptions, according to the patients response. Amphotericin / Colistin are only used as per table 4.2 in special circumstances, and it generally replaces the miconazole in table 4.1. Table 4.2 Drug Amphotericin Colistin Dosing Age Dose 1 month 5 100mg mg Over 12 1 month Over mg 750,000 units 1.5 million units 3 million units Frequency (times daily) 4 4 Comments A licensed oral formulation is no longer available in the UK. A 100mg in 1ml liquid is available from import companies but it is very expensive. 1.5 million unit tablets (scored and crushable) are currently unavailable. Can use 1 million unit injection orally which is reconstituted in 2mls water for injection. Amy-Jo Hooley Page 6 of 8 October 2016

7 Table 4.3 Rifaximin generally gets used alone and patients receive 2 weeks on rifaximinn, then 2 weeks with nothing. Occasionally it has been used in combination with other gut decontamination agents, but routinely it should be used a sole agent. Drug Dosing Age Dose Rifaximin mg mg Over mg Frequency (times daily) 3 Comments Available as 2% granular suspension or as 200mg tablets. Advice would be to use suspension under 6 of age then to switch to tablets. 5. Monitoring of Patients on Gut Decontamination Regimens 5.1 All patients should undergo regular clinic review at a minimum of 6 monthly intervals. 5.2 All patients/parents should provide an up to date weight every 3 months to allow appropriate dosing to be maintained for the child. 5.3 A clinical review should be carried out annually to assess the appropriateness of the regimen, and where clinically possible repeat breath tests, and D-Lactate levels should be obtained. 5.4 In certain cases, if severe bacterial overgrowth is suspected, children should be prescribed a short course of oral ciprofloxacin (7 days), after discussion with a consultant microbiologist. 5.5 Systemic absorption of gentamicin or tobramycin is rare. If severe inflammation of the gut is suspected, then it is advisable to obtain a blood sample to confirm that absorption of the drug has not occurred. Providing the drug level is less than 1mg/L no further action should be required. If the drug level is greater than 1mg/L then the patient should be told to stop gut decontamination until a clinic review has been arranged. Amy-Jo Hooley Page 7 of 8 October 2016

8 References 1. Guidelines for the management of patients with a short bowel. J.Nightingale, JM. Woodward. Accesed via 4 th Aug YokoyamaK, Ogura Y, Kawabata M, et al. Hyperammonaemia in a Patient with Short Bowel Syndrome and Chronic Renal Failure. Nephron 1996; 72: Ojetti V, Lauritano EC, Barbaro F et al. Rifaximin pharmacology and clinical implications. Expert Opinion on Drug Metabolism and Toxicology. 5/6( ), (June 2009) 4. BNF for Children Edition. Published by BMJ Group, London 2012 Amy-Jo Hooley Page 8 of 8 October 2016