Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) Dietetic Management Protocol

Transcription

1 Nutrition and Dietetic Service Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) Dietetic Management Protocol Authors Hilary Mathieson, Renal Dietitian Paul McKeveney, Consultant Nephrologist Directorate responsible for Acute this Document Date of Implementation December 2014 Date Uploaded: 19 th January 2015 Review Date: 1 st January 2017 Clinical Guideline ID: CG0099 October 2014

2 CONTENTS PAGE 1.0 Introduction Aims of the Guidance Objectives of the Guidance Scope Competency Responsibilities of the Consultant Nephrologist Responsibilities of the Renal Dietitian Process for initiating or adjusting binder/vitamin D therapy 6 Appendix 1 Criteria for competence 7 Appendix 2 Supervised practice record 8 Appendix 3 Nutrition and Dietetic Service - letter 10 Appendix 4 Algorithm for phosphate binders 11 Appendix 5 Binder choice 12 Appendix 6 Algorithm for active vitamin D therapy 13 Appendix 7 Algorithm for vitamin D therapy 14 INTRODUCTION 2

3 THIS GUIDANCE MUST BE READ IN CONJUNCTION WITH THE RENAL ASSOCIATION GUIDELINES Patients with chronic kidney disease frequently develop an imbalance in calcium and phosphate blood levels. Evidence increasingly links inadequate serum phosphate control to higher morbidity and mortality in patients with Chronic Kidney Disease stage 5. Consistent control of the markers of bone metabolism and disease within published targets is a strong predictor of survival in dialysis patients and is now a key therapeutic goal in the treatment of CKD. Key elements to achieving acceptable blood levels in dialysis patients include the dietary restriction of phosphate, together with the use of phosphate binders to limit its absorption. The Renal Dietitian plays a key role in this process, assessing dietary phosphate intake and adherence to recommended medication. They assess tolerance of the various phosphate binders to the patient and identify problems with their use, as well as highlighting changes in calcium and phosphate levels that may require intervention to avoid significant symptoms and side effects. Responsibility for prescribing medication for renal patients lies with the General Practitioners on advice from Renal medical staff. This document outlines the specific criteria permitting appropriately skilled and competent Renal Dietitians to initiate and modify treatment with phosphate binders and vitamin D therapy for dialysis patients. 1.1 Aims of the Guidance Provide systematic guidelines allowing specified Renal Dietitians to contact GP s directly to suggest changes to phosphate binder and vitamin D therapy. To rationalise and expedite changes to phosphate binder medication prescription after the assessment of dietary phosphate intake and compliance with current binders by the Renal Dietitians, improving the efficiency of management of Mineral Bone Disease in dialysis patients. To achieve cost-effective control of calcium and phosphate blood levels. To improve the timeliness of the patient receiving the suggested change in treatment. To improve the patient experience. 1.2 Objectives of the Guidance 3

4 To maintain patients blood levels within the biochemical standards recommended by the Renal Association. To encourage patient adherence to phosphate dietary restrictions and bone medication. To provide an agreed hierarchy for the use of phosphate binders. To provide a framework for the timely monitoring of patients blood biochemistry: - Routine results to be reviewed monthly - Any change in medication to be actioned prior to the next month's bone biochemistry assessment. 1.3 Scope This protocol applies to Renal Dietitians employed in the SHSCT, who have been deemed competent by the Lead Bone Management Nephrologist. This protocol applies to Adult patients with end-stage renal failure requiring phosphate binders and/or vitamin D therapy who are receiving dialysis. Advice from the Consultant Nephrologist should be sought for those patients where: Phosphate remains above target despite maximum tolerated binder therapy Calcium level is > 2.55 mmol/l or < 2.10 mmol/l Agree to adhere to more than maximum binder therapy indicated in this protocol Require initiation of calcimimetic therapy or where a change in calcimimetic therapy is required PTH remains > 500 pg/ml or more than 300pg/ml and rising Are post para-thyroidectomy until Calcium levels ave stabilised Are pregnant or under 16 years. 2.0 Competency Renal Dietitians who have been qualified at least 5 years, with > 2 years experience working with dialysis patients, Band 6 or above and have completed competency based training in the use of the protocol and satisfactory supervised practice (Appendices 1 & 2). Evidence of competence and supervised practice should be held within the dietetic department/renal unit along with the individual Dietitians supervision notes. It is the responsibility of the Dietitian to ensure that they are competent and to inform their line manager of any further training needs. The Consultant Nephrologist will continue to assess competency during the 3 monthly MBD joint meetings. 4

5 If none of the Renal Dietitians specified to use this protocol are available; responsibility for the management of CKD-MBD reverts to the Renal medical team. 3.0 Responsibilities of the Consultant Nephrologist The Lead Bone Management Nephrologist will: Ensure the Dietitians working within this protocol have completed supervised practices which deem them competent in following this protocol. In combination with the Renal Dietitians, will ensure the bone protocol remains up to date and evidence based. The protocol will be reviewed yearly. Supervise the practice of Dietitians following this protocol by continuing bone management meetings every 3 months with the Dietitian. 4.0 Responsibilities of the Renal Dietitian The Renal Dietitian will: Work within the scope of this protocol. Ensure practice/knowledge is up to date by providing evidence of continued professional development. Provide regular updates to the professional manager as part of the supervision procedure. Actively engage in supervised practice with the Consultant Nephrologist. Monitor and evaluate this protocol, to include: improved timescales for patient receiving prescription charges (currently can take up to 8 weeks) biochemistry results patient satisfaction 5

6 5.0 Process for initiating or adjusting binder/vitamin D therapy. Review of biochemistry, dietetic assessment (see dietetic care pathway) Follow appropriate algorithm depending on assessment - Appendices 4-7 Agree treatment plan with patient Complete GP letter using standard letter for suggested treatment (Appendix 3) Document suggested medication changes on emed (Dietitian and clinical meeting note) (Following SHSCT dietetic record keeping guidance) Issue letter to patient who will take to GP or post to GP (depending on patient preference) who will issue script Update medication list on emed Check patient has received script, can tolerate new medication and is taking as directed (within 1 week, not more than 2 weeks) 6 Review bone biochemistry/changes at monthly bloods/bone management meeting

7 Appendix 1 CRITERIA FOR COMPETENCE End Competence: To be competent in suggesting to the patients GP, appropriate type and dose of phosphate binding medication and vitamin D therapy for maintenance haemodialysis patients. Name of Renal Dietitian Name of Supervisor /s :... :.... Competency Assessment 5 years post registration experience 2 years dialysis renal experience Band 6 or above Demonstrates a knowledge of: CKD-MBD Interpretation of calcium, phosphate and PTH blood results Other medications which can effect Ca, PO4 and PTH levels Scope of this protocol Binders included in this protocol, including contraindications, maximum doses, side effects, Calcium content and potential drug interactions The role of Vitamin D Incident reporting process Date Supervisor signature Date competency assessment completed: / /. Signature of Supervisor.. Designation.. Copies of completed competency and supervised practice forms to be kept in the Nutrition and Dietetic Dept, as part of the individual Dietitians supervision notes 7

8 Appendix 2 SUPERVISED PRACTICE RECORD - Clinical assessment - Consultant Nephrologist The candidate is to review and present suggested changes to the Consultant Nephrologist for dialysis patients, as part of assessment, following monthly bloods/preparation for bone management meetings. The patient s biochemistry is to be evaluated and the treatment plans recommended by the Dietitian are to be discussed and reflection encouraged. Name of Renal Dietitian: Date Summary of patient biochemistry and medication Changes suggested by Dietitian Comments from Nephrologist Competent Yes/No 8

9 Date Summary of patient biochemistry and medication Changes suggested by Dietitian Comments from Nephrologist Competent Yes/No Date sufficient satisfactory supervised practices completed: / /. Signature of Supervisor.. Designation.. Copies of completed competency and supervised practice forms to be kept in the Nutrition and Dietetic Dept. as part of the individual dietitians supervisi 9

10 Appendix 3 Nutrition and Dietetic Service This letter is sent from a non-prescriber Name: Address: This copy for General Practitioner Write Clearly and use ballpoint Hospital: Clinic: DOB: H&C number: Dear Dr: This patient was seen on. A suggested change in treatment is shown below Diagnosis /Problems Treatment given to. Treatment to be discontinued SUGGESTED NEW TREATMENT Dose and frequency (Approved Units) Route Length of course Bone biochemistry will be monitored at Haemodialysis Unit For information only - no GP prescribing required drug below provided by hospital New treatment administered on Haemodialysis unit Dose and Frequency Route Length of course This letter is sent from a non-prescriber. Please consider suggested treatment before issuing a prescription Suggested GP follow up / investigations Signature Name in Capitals Registered Dietitian Review arranged: Yes No Date: / / Clinical letter to follow Yes No Contact phone no: 10

11 Algorithm for phosphate binders Appendix 4 Check bone biochemistry Po4 1.1 mmol/l Po mmol. Po4 1.5 mmol/l Assess dietary intake and review need for binders Review monthly bloods Nutritional Assessment Check bone medication prescription and compliance Calculate average Po4 over 3 months Aver PO4 < 0.9 mmol/l Stop binders Aver PO mmol/l Reduce binders by half Calcium < 2.0 mmol/l Calcium mmol/l Look at calcium trend, vascular history, Dca. Seek advice from Consultant Po4 intake < 1000 mg per or nonadherence with diet or requires /change binders Suggest binder (see guidance on pg 12 ) Advise re: Diet and/or timing of binders based on PO4 dietary load Calcium >2.6 mmol/l Reduce Dca and Seek advice from Consultant Po4 intake high or nonadherence to recommended bone medication Advise re: low po4 diet +/- distribution of binders. Review monthly bloods Review monthly bloods October 2014

12 Appendix 5 Binder choice: 1st line binders Calcium Acetate Maximum dose Exclusions: Inclusions Renacet 950mg 7 tablets per CV disease Calcium > 2.55mmol/ Patient prefers to swallow Renacet 475mg 14 tablets per Phosex 1g 6 tablets per CV disease Calcium > 2.55mmol/ Patient prefers to swallow Phoslo 667mg 9 tablets per CV disease Patient prefers to swallow Osvaren 435mg calcium acetate + 235mg MgCO 3 October tablets per Calcium > 2.55mmol/ Mg > 2 mmol/l Check Mg levels 3 monthly and stop if Mg > 2 mmol/l Calcium > 2.55mmol/ 2 nd line binders Calcium Carbonate. Maximum elemental calcium load 1500mg Maximum dose Exclusions: Inclusions Adcal 600mg 3 times per CV disease Diabetes History of high Ca PO 4 average > 2.0mmol/L PTH <150 3 rd line binders Non calcium based binders Maximum dose Exclusions: Inclusions Renvela 800mg Sevelamer 15 tablets per carbonate Renvela sachets 2.4g Sevelamer carbonate Renagel 800mg Sevelamer hydrochloride Fosrenol 500 mg, 750 mg, 1000mg Lanthanum Fosrenol Sachet 750mg, 1000mg sachet Alucaps 475 mg Aluminium hydroxide 3 sachets per 15 tablets per 4500mg per 4 sachets per Bowel obstruction Bowel perforation GI disorders Dysphagia Bowel obstruction Bowel perforation GI disorders Bowel obstruction Bowel perforation Dysphagia GI disorders Inflammatory bowel disease, bowel obstruction Acute peptic ulcer Dysphagia Inflammatory bowel disease, bowel obstruction Acute peptic ulcer 6 per check Al level 3 monthly, stop if Al level is > 20 µg/l; Only on advice from Consultant Patient prefers to swallow Patient prefers to chew tablet Calcium >2.55 mmol/l Patient prefers to swallow Able to take larger number of tablets Eating habit - grazes Calcium >2.55 mmol/l Patient finds swallowing tablets difficult Dissolved in 60mls water Calcium >2.55 mmol/l Patient prefers to swallow Able to take larger number of tablets Eating habit - grazes Calcium >2.55 mmol/l Patient prefers to chew Prefers to take less tablets Eats only 3 times per Patient finds chewing tablets difficult. Spread on food Calcium >2.55 mmol/l PO4 poorly controlled despite adherence to Sevelamer

13 Algorithm for Active vitamin D therapy Appendix 6 Check monthly bloods consider trend in PTH PTH checked 3 monthly or monthly for PTH > 500 or on calcimimetics. PTH < 130 pg/ml PTH pg/ml and stable PTH >300, or 130 and rising PTH > 500pg/ml On Calcitriol Po4 1.7 mmol Po4 >1.7 mmol Discuss with consultant No Calcitriol Weekly dose < 750ng Weekly dose > 750ng Repeat PTH in 3 months Ca < 2.1 mmol/l Ca mmol/l Ca mmol/l Ca >2.5 mmol/l Discuss with consultant at 3/12 meeting Stop Calcitriol Repeat PTH in 3 months Reduce weekly Calcitriol dose by ½ Commence on Calcitriol 250 ng daily; Discuss with consultant if Ca <1.9 (consider higher Dca) Commence on Calcitriol 250 ng daily or Calcitriol dose by 1/3 Reduce Dca to next lowest available Commence on Calcitriol 250 ng 3/7 or Calcitriol dose by 1/3 Reduce Dca to next lowest available and discuss with consultant Repeat PTH in 3 months October 2014

14 Algorithm for Vitamin D therapy Appendix 7 Check Vitamin D status Vitamin D < 70 nmol/l Vitamin D nmol/l Vitamin D > 145 nmol/l Vitamin D <35 nmol/l Vitamin D 35 to 69 nmol/l No action required Seek advice from consultant for reduction in Colecalciferol Start 80,000 units each HD x 3, then 40,000 units colecalciferol weekly Start 20,000 units colecalciferol weekly (if vitamin D <50 load 80,000 units each HD x 3 initially) Re check vitamin D in 6 months October 2014