Insulin Prescribing Guidance - NHS Fife
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Insulin Prescribing Guidance Type 2 Diabetes This document aims to provide prescribing guidance to primary care practitioners with specialist knowledge and interest in diabetes management, on NHS Fife preferred insulin selection. NHS Fife Diabetes MCN Prescribing Subgroup Approved 6th April 2021 Approved by NHS Fife MSDTC 27th April 2021 NHS Fife acknowledges and agrees with the importance of regular and timely review of policy/procedure statements and aims to review policies within the timescales set out. Reviewed policies/procedures will have a review date set that is relevant to the content (advised by the author) but will be no longer than 3 years. If a policy/procedure is past its review date then the content will remain extant until such time as the policy/procedure review is complete and the new version published. Insulin Prescribing Guidance: Type 2 Diabetes Version: 04.0 Approved by Diabetes MCN Prescribing Group: 6th April 2021 NHS Fife Diabetes MCN Page: 1 of 13 Review due: April 2023
Contents Page Introduction 3 Important Notes to Health Care Practitioner Initiating 4 and Managing Patients on Insulin Initiation of Insulin in Type 2 Diabetes 5 Figure 1: Insulin Regimen Selection for Type 2 Diabetes 6 Figure 2: Once Daily Basal Insulin 7 Figure 3: Twice Daily Fixed Mix Insulin 8 Figur e 4: Basal Bolus 9 Figure 5: Intensification of Insulin Therapy 10 Appendix 1: Insulin Initiation Checklist 11 References 13 Insulin Prescribing Guidance: Type 2 Diabetes Version: 04.0 Approved by Diabetes MCN Prescribing Group: 6th April 2021 NHS Fife Diabetes MCN Page: 2 of 13 Review due: April 2023
Introduction This document was produced to provide a guide for primary care practitioners in cost effective and safe prescribing of insulin therapy in Type 2 Diabetes. This Guidance is not prescriptive or exhaustive and should be used in conjunction with clinical assessment and decision making. This document was developed through consultation with key stakeholders to provide quality improvement namely safe, effective, and efficient and person centred. It is intended to be a living document and will continue to evolve as NHS Fife develops its services in response to new initiatives, changes in prescribing availability and research and through lessons learnt from its implementation. The purpose of this document is to ensure: Safe and effective insulin initiation through appropriate insulin regimen initiation and adjusting. Support Fife Formulary adherence. Cost effective selection of insulin therapies for initiation in Type 2 Diabetes. Support primary care practitioners’ confidence and management of insulin therapy in Type 2 Diabetes. Insulin Prescribing Guidance: Type 2 Diabetes Version: 04.0 Approved by Diabetes MCN Prescribing Group: 6th April 2021 NHS Fife Diabetes MCN Page: 3 of 13 Review due: April 2023
Important Notes to Health Care Practitioner Initiating and Managing Patients on Insulin Primary Care Practitioners initiating and/or managing patients on insulin should be Independent Prescribers and have relevant training and/or experience in insulin initiation and management of insulin. Primary Care Practitioners should seek advice or refer patients to the Community Diabetes Specialist Nurse when they have reached their level of confidence and competence. Referral guidance and contact information can be accessed via Blink>Hub>Acute>Diabetes>Specialist Services>Community Diabetes Specialist Nurse Service https://app.joinblink.com/#/hub/ea71ee78-e29a-4849-b1ee-78e29a5849db All patients should be referred to the dietitian when initiated onto insulin and if changing insulin regimen. All patients commenced on insulin holding a driving licence must inform the DVLA. Please refer to the Driving and Vehicle Licensing Agency (DVLA) www.directgov.uk. and the Diabetes UK https://www.diabetes.org.uk/Guide-to-diabetes/Life-with- diabetes/Driving/ First line insulin selection should be initiated within the chosen insulin regimen unless it is not clinically indicated. Please refer to NHS Fife Formulary http://www.fifeadtc.scot.nhs.uk/formulary/6-endocrine.aspx and Figure 1, page 6. Insulin manufacturers may change insulins and/or devices periodically. Current availability should be checked prior to prescribing. Metformin should be continued unless not tolerated or contraindicated. Sulphonylureas may be continued with basal insulin but should be discontinued with other multiple insulin dose regimens. The licensing of other agents with insulin is continually evolving and should be checked by the prescriber. Continuation (or initiation) of other oral anti-diabetic agents or GLP-1 therapies with insulin should be referred to the Community Diabetes Specialist Nurse (CDSN) for consideration where practitioners feel this is out with their confidence and/or competence. Figures 2-5 provides guidance on insulin initiation and dose titration. However if a patient experiences an episode of hypoglycaemia that cannot be explained, or their blood glucose control is below their target range, the insulin impacting on that time of the day should be reduced by 2 units or 10%. Prescribing should be realistic and adjustment of treatment regime may be necessary in those at higher risk of adverse effects such as frail/elderly, residence in a nursing home, or chronic conditions (such as dementia, cancer, end-stage renal disease, severe chronic obstructive pulmonary disease or congestive heart failure). Remind patients to rotate injection sites within the same body region. Cutaneous amyloidosis at the injection site has been reported in patients using insulin and this may affect glycaemic control. For further advice, see MHRA Drug Safety Update September 2020 https://www.gov.uk/drug-safety-update/insulins-all-types-risk-of-cutaneous- amyloidosis-at-injection-site Insulin Prescribing Guidance: Type 2 Diabetes Version: 04.0 Approved by Diabetes MCN Prescribing Group: 6th April 2021 NHS Fife Diabetes MCN Page: 4 of 13 Review due: April 2023
Type 2 – Initiation of Insulin Diagnosis of Type 2 Decision to Choice of Initiation of Management Diabetes as per NHS initiate insulin regimen insulin and review Fife ‘Protocol for treatment General Practice’ Stage Diagnosis As per NHS Fife Diagnosis of Diabetes in Adults guidance Blink>Hub>Acute>Diabetes>Guidelines, Pathways, Protocols & SOPs Decision to Consider insulin initiation if patient failing to meet individual optimal glycaemic control despite initiate treatment intensification of non-insulin therapies. Decision should be made on the following factors: Patient on maximum tolerated dose oral or GLP-1 therapies. Symptoms of hyperglycaemia. High HbA1c over three months. Raised HbA1c consistently above individualised patient target over a prolonged period e.g. six months or more. Refer to NHS Fife Protocol for General Practice for target setting. (Blink>Hub>Acute>Diabetes>Guidelines, Pathways, Protocols & SOPs) Lifestyle factors. Choice of In line with NHS Fife Formulary, and based on individual need and preference, with Regimen consideration of: Patient understanding Lifestyle Vision Manual dexterity Patient’s ability to perform blood glucose monitoring Patient support mechanisms Initiation of Discussion at initiation should include (see also Appendix 1: Insulin Initiation Checklist): insulin Education including hypoglycaemia Choice of insulin regimen – suitability, appropriateness, mode of action Dose titration Injection sites and technique Glucose monitoring and HbA1c Driving guidance A dietetic consultation ideally before or close to the initiation of insulin is required to help minimise weight gain and optimise insulin use by appropriate carbohydrate management Review should be undertaken depending on clinical need, in consultation with nurse and Management and dietitian. review First medical review should be undertaken within 12 weeks of initiation. Second medical review should be undertaken within a minimum of 6 months – or on a needs basis. Structured review should include an assessment of: Clinical and lifestyle factors Symptoms- complications such as chronic complications, inter current illnesses, absence from work where applicable Advice on access to other services Unmet educational need, general wellbeing and emotional and psychological needs Agreed dietary modifications Patients should be encouraged to self manage, with support, and provision of the knowledge and skills to be an active partner in their care. Insulin Prescribing Guidance: Type 2 Diabetes Version: 04.0 Approved by Diabetes MCN Prescribing Group: 6th April 2021 NHS Fife Diabetes MCN Where possible, patients Page: 5should of 13 be Review seen by theApril due: same person at each review. 2023
Figure 1: Insulin Regimen Selection for Type 2 Diabetes st Once Daily (see figure 2) 1 Line: Intermediate acting Insulin in the morning (e.g. Humulin I; Insulatard) 1. Patient has good hypoglycaemia awareness and can interpret Blood Glucose (BG) results 2. Patient can respond to hypoglycaemia and manage appropriately. Consider once daily insulin in NB: Insulin can be given in the morning or twice daily to target rises in BG levels. additional to oral anti-diabetic agents or GLP-1 therapy to target fasting nd hyperglycaemia or when individual 2 line: Basal Analogue Insulins (e.g. Insulin Glargine (Abasaglar ; Lantus) glycaemic target not met. 1. Patients requiring insulin to be administered by community nursing team or timing of insulin administration a consideration (Note: Abasaglar is preferred formulary option but is not available in vials therefore Lantus vials should be prescribed). 2. Patient is elderly or with reduced hypoglycaemia awareness. 3. Patient is unable to BG monitor, interpret BG results and hypoglycaemia symptoms and respond Pre-mixed Pre-mixedInsulin with appropriate hypoglycaemia management. Patient failing Insulin (see figure 3) 4. Prolonged duration of action desirable. to meet (see Consider pre-mixed insulin to target individual fasting and post-prandial optimal hyperglycaemia when insulin st glycaemic intensification is required to meet a 1 Line: Pre-mixed Human Insulin (e.g. Humulin M3) control patient’s individual glycaemic target Patient must have a regular meal pattern and be able to plan their meals in advance to incorporate and the advantage of fewer insulin which should be administered 20 minutes prior to meals. despite injections is desirable. NB: Premixed insulin administered by community nursing staff should be Humulin M3 in vials. intensification NB: Patient must have a regular meal of non-insulin pattern. therapies. st 1 line: Intermediate acting Insulin in the morning (e.g. Humulin I; Insulatard) Basal Bolus (see figure 4) Patient should have good hypoglycaemia awareness. PLUS Soluble Human Insulin (e.g. Humulin S; Actrapid) Patient should have a regular meal pattern and be able to plan their meals in advance to incorporate Consider a basal bolus regimen to insulin which should be administered 20 minutes prior to a meal. nd target fasting and post-prandial 2 line (consider if patient is elderly or has reduced hypoglycaemia awareness; or a prolonged hyperglycaemia when insulin duration of action is required): intensification is required to meet a Basal analogue Insulin Once daily (e.g. Insulin Glargine (Abasaglar)) patient’s individual glycaemic target This should be administered once or twice daily at approximately the same time each day. and the advantage of flexible meal PLUS Soluble Human Insulin (e.g. Humulin S; Actrapid) patterns and flexible dose adjusting Patient should have a regular meal pattern and be able to plan their meals in advance to incorporate desirable. Patients should be able to insulin which should be administered 20 minutes prior to a meal. self administer. If the above insulin regimens are unsuitable, please refer to your Community Diabetes Specialist Nurse. For other insulins not on the formulary, please refer to your Community Diabetes Specialist Nurse. Insulin Prescribing Guidance: Type 2 Diabetes Version: 04.0 Approved by Diabetes MCN Prescribing Group: 6th April 2021 NHS Fife Diabetes MCN Page: 6 of 13 Review due: April 2023
Figure 2: Once Daily Basal Insulin Starting Dose: Initiate 8-10units once daily or 0.2units/kg Intermediate acting insulin should be given in the morning or Basal analogue insulin given morning or night to target fasting blood glucose (FBG) levels. Continue oral antidiabetic agents: Metformin and Sulphonylureas. Discontinue other oral antidiabetic agents and/or GLP-1 therapy (if no proven benefit of recent glycaemic reduction). Insulin Adjustment: Monitor fasting blood glucose (FBG) daily (and at additional times as appropriate) Increase insulin dose by 2 units every 3 days or If FBG >10mmol/L increase insulin by 4 units every 3 days or If patient on >40units insulin daily, increase insulin by 4 units or 10% every 3 days. Continue titrating until FBG within target 4-7mmol/L or within individual target range. If hypoglycaemia occurs consider reducing the insulin by 2 units or 10%. Repeat HbA1c every 3 months until individual target achieved (see Figure 5) If FBG within target range but HbA1c >target range: Monitor blood glucose readings before breakfast, lunch, evening meal and supper. Consider changing insulin regimen. Consider additional oral antidiabetic agents or GLP-1 therapy to target insulin resistance. Consider referral to Community Diabetes Specialist Nurse and/or dietitian. Insulin Regimen Change Consider changing to a twice daily insulin regimen to target prandial rises in blood glucose levels (see figure 3 for titration advice). Starting dose would be current total daily insulin dose divided by 2 minus 10%. Consider adding in meal time short acting insulin to target specific meals once/twice/three times daily (see figure 4 for titration advice). Starting dose of 4 units with meal. Insulin Prescribing Guidance: Type 2 Diabetes Version: 04.0 Approved by Diabetes MCN Prescribing Group: 6th April 2021 NHS Fife Diabetes MCN Page: 7 of 13 Review due: April 2023
Figure 3: Twice Daily Pre- Mixed Insulin Starting Dose: Initiate 6-10units or 0.1units/kg twice daily (Or see Insulin Regimen Change dose advice - Figure 2) Premixed human insulin should be taken 20 minutes prior to breakfast and evening meal. Continue Metformin. Continue GLP-1 therapy if proven benefit of glycaemic control. Discontinue sulfonylureas and pioglitazone. Monitor BG 2-4 times per day prior to breakfast, lunch, evening meal and supper/bed. Breakfast insulin Evening meal insulin Increase by 2 units or 10% every three days Increase by 2 units or 10% every three days until BG before lunch and evening meal is until BG before supper/bed and FBG is within within 4-7mmol/L or individual target. 4-7mmol/L or individual target. Repeat HBA1c every 3 months until individual target achieved (see Figure 5) If HBA1c remains above target: Continue to titrate insulin until BG within target 4-7mmol/L or individual target. If hypoglycaemia occurs, consider reducing the insulin controlling that time of the day by 2 units or 10%. Consider change in insulin regimen. Consider adding Gliptin or SGLT-2, GLP-1 therapy to target insulin resistance [Refer to Fife Formulary http://www.fifeadtc.scot.nhs.uk/formulary/6-endocrine.aspx]. Consider refer to Community Diabetes Specialist Nurse and/or dietitian. Insulin Regimen Change: Consider changing insulin regimen to three times daily mix or basal bolus as follows (see Figure 4) If twice daily mixed insulin does not attain target of both corresponding pre-meal BG readings to 4- 7mmols or individual target, consider switching to a three times daily mix. Refer to the Community Diabetes Specialist Nurse service for guidance. If twice daily mixed insulin does not permit target of both corresponding pre-meal BG readings to 4- 7mmol/L or individual target or the patient finds the regimen too restrictive, consider switching to basal bolus insulin regimen. Take the total insulin dose, minus 10%. Divide by 50% for basal dose, and the other 50% divided into the three bolus doses (see Figure 4 for titration advice). Insulin Prescribing Guidance: Type 2 Diabetes Version: 04.0 Approved by Diabetes MCN Prescribing Group: 6th April 2021 NHS Fife Diabetes MCN Page: 8 of 13 Review due: April 2023
Figure 4: Basal Bolus Starting Dose: Initiate 8-10 units or 0.2units/kg basal insulin. Initiate 4 units bolus insulin with meals (or see change of insulin regimen dose advice Figure 3). Basal Intermediate acting insulin should be given in the morning or basal long acting analogue given morning or night to target Fasting Blood Glucose (FBG) Levels. Soluble insulin should be given 20 minutes prior to meal/ rapid acting insulin should be given immediately before, during or up to 15minutes after the meal. Discontinue all oral antidiabetic agents and/or GLP-1 therapies if no proven benefit of glycaemic reduction except Metformin. Monitor blood glucose at least 4 times a day prior to breakfast, lunch, evening meal and supper/bed. Basal Insulin Breakfast Bolus Insulin Lunch Bolus Insulin Evening-meal Bolus Insulin Increase insulin dose by 2 Increase insulin dose by 2 Increase insulin dose by 2 Increase insulin dose by 2 units every 3 days or units every 3 days or units every 3 days or units every 3 days or Increase insulin by 4 units or Increase insulin by 4units or Increase insulin by 4units or Increase insulin by 4units or 10% every 3 days if FBG 10% if patient on >40units. 10% if patient on >40units. 10% if patient on >40units. >10mmol/L or if patient on Continue titrating until pre- Continue titrating until pre- Continue titrating until pre- >40units basal insulin. lunch BG within target evening meal BG within supper/bed BG within target Continue titrating until FBG 4-7mmol/L or within target 4-7mmols or within 5-8mmols or within within target 4-7mmol/L or individual target range. individual target range. individual target range. within individual target range. Ongoing Care (See Figure 5) Continue to titrate insulin and repeat HbA1c every 3 months until patient has reached individual BG and HBA1c target. If hypoglycaemia occurs, consider reducing the insulin controlling that time of the day by 2units or 10%. If patient failing to achieve individual targets, consider adding in Gliptin, SGLT-2 or GLP-1 therapy, to target HbA1c and reduce insulin requirement [see Fife Formulary http://www.fifeadtc.scot.nhs.uk/formulary/6-endocrine.aspx]. If patient failing to achieve individual targets, consider referral to the Community Diabetes Specialist Nurse and/or dietitian. Insulin Prescribing Guidance: Type 2 Diabetes Version: 04.0 Approved by Diabetes MCN Prescribing Group: 6th April 2021 NHS Fife Diabetes MCN Page: 9 of 13 Review due: April 2023
Figure 5: Intensification of Insulin Therapy Target Review Discuss Implement Review HbA1c current options for change Criteria management change Objectives achieved? NO YES Stage Criteria For target HbA1c: Target HbA1c not achieved. Target HbA1c but disabling hypoglycaemia. Lifestyle. Patient agreement to intensify their insulin management to achieve individual target. Review and current Review current factors to determine the most appropriate way that management treatment management can be intensified. This review should incorporate as a minimum the following: Informed decision making. Patient’s priorities. Lifestyle factors. Injection technique. Blood glucose profile. Symptoms of acute complications such as hypoglycaemia, chronic complications, inter current illnesses, absence from work where applicable. Current oral or insulin therapy and regimen. Psychological issues. Dietetic assessment/review and further intervention e.g. for appropriate carbohydrate management. Discuss options for change Consider referral to dietitian or Structured Patient Education or Community Diabetes Specialist Nurse Service. Consider intensifying the insulin regimen to a pre-mixed or multiple premixed injection regimen with meals or basal bolus regimen. Consider introduction of additional oral agents or GLP-1 therapy. Implement change Provide advice and support through agreed changes made to treatment. Review. Establish and evaluate from a clinical and patient perspective whether changes have achieved desired health outcomes. Patients should be encouraged to self manage, with support, and provision of the knowledge and skills to be an active partner in their care. Implement further treatment changes where and as appropriate. Insulin Prescribing Guidance: Type 2 Diabetes Version: 04.0 Approved by Diabetes MCN Prescribing Group: 6th April 2021 NHS Fife Diabetes MCN Page: 10 of 13 Review due: April 2023
Appendix 1 – Insulin Initiation Checklist INSULIN CHECKLIST Patient Details Medication changes STOP – START – Date/sign Date/sign Date/sign Blood Glucose Monitoring - Meter Type - Testing times Injecting - Storage - Preparation - Technique - Sites and rotation - Lypohypertrophy - Sharps disposal Adjusting Insulin - Self management/Titration sheet Driving - DVLA - Signed information letter and leaflets - Insurance Hypoglycaemia mild/moderate/severe Nocturnal Hypos Treatment and prevention Hyperglycaemia Sick Day Rules Complication Prevention Eye screening Foot screening Biochemistry/AC ratio BP Weight/BMI My Diabetes My Way referral Lifestyle Exercise Travel Sex Alcohol Diet Dietitan referral Additional comments: (Continue overleaf if required) Insulin Prescribing Guidance: Type 2 Diabetes Version: 04.0 Approved by Diabetes MCN Prescribing Group: 6th April 2021 NHS Fife Diabetes MCN Page: 11 of 13 Review due: April 2023
Appendix 1 – Insulin Initiation Checklist (continued) Written Information Provided. Driving/DVLA guidance Hypoglycaemia Travel Advice Travel Letter Diabetes and illness/sick day rule card Beating the Blues Insulin card/Passport Injection technique Insulin starter pack/ information Blood glucose diary Titration Advice My Diabetes My Way card Insulin Prescribing Guidance: Type 2 Diabetes Version: 04.0 Approved by Diabetes MCN Prescribing Group: 6th April 2021 NHS Fife Diabetes MCN Page: 12 of 13 Review due: April 2023
References Gale (2012) Newer Insulins in Type 2 Diabetes BMJ 345:e4611 Indian Health Service (2011) Standards of Care and Clinical Practice Recommendations: Type 2 Diabetes; Type 2 Diabetes and Insulin Algorithm. http://www.ihs.gov/MedicalPrograms/Diabetes/HomeDocs/Tools/Algorithms/DM_algorith m_Insulin_508c.pdf Kentucky Diabetes Network (2006) Algorithms for Glycaemic management of Type 2 Diabetes http://chfs.ky.gov/NR/rdonlyres/C3DF067A-CB05-4C16-8C71- 5DDAEA586421/0/AlgorithmTools62507.pdf Texas Diabetes Council (2010) Insulin Algorithm for Type 2 Diabetes Mellitus in Adults and Children www.tdctoolkit.org/algorithms_and_guidelines.asp Scottish Government Polypharmacy Model of Care Group (2018). Polypharmacy Guidance, Realistic Prescribing 3rd Edition. Scottish Government. www.therapeutics.scot.nhs.uk/Polypharmacy-Guidance-2018.pdf Insulin Prescribing Guidance: Type 2 Diabetes Version: 04.0 Approved by Diabetes MCN Prescribing Group: 6th April 2021 NHS Fife Diabetes MCN Page: 13 of 13 Review due: April 2023
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