Drs. Turner & Bull: Diabetes Mellitus (DM) protocol.
Index: Introduction/Aims Ethos Identification & registration of patients Data recording Call/Recall letters Non-surgery attendees/defaulters Screening Diagnosis Monitoring: IFG Diabetes De Novo checks 2 month reviews Annual reviews Referral criteria Treatment philosophy: Diet Insulin or non-insulin dependent? Diet alone, or diet with OHA? Biguanide, Sulphonylurea or glitazone? Which biguanide? Which sulphonylurea? Which Glitazone? Diabetic formulary Glycaemic control Commencing insulin Education – Insulin specific Aspirin Statins MHRA guidance Audit Introduction/Aims:
Date: 2/3/05. Review date: 2/3/07.
The potential benefits of a diabetes surveillance programme include: Better glycaemic control. Prevention, delay and amelioration of complications. Fewer surgery visits for poorly controlled diabetes. Fewer hospital admissions. Studies have shown equitable results regarding disease surveillance/monitoring and glycaemic control in General Practice compared to secondary care; additional social benefits accrue to patients, compared to hospital care.
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Drs. Turner & Bull: Diabetes Mellitus (DM) protocol.
Date: 2/3/05. Review date: 2/3/07.
In addition, “structured care” has been shown to be superior to “opportunistic” surveillance in General Practice, and “mini-clinics” are thought to work better than “open” attendance, although this compromises patient access. This practice will therefore continue to see patients on the latter basis. By increasing patient's understanding of the pathophysiology of diabetes, monitoring of HbA1c and the interpretation of results, patients should take greater responsibility for their "treatment". All too often, diabetes care has been doctor-motivated, rather than patient-motivated, and it is hoped that by increasing “shared-care” with patients, this will result in greater motivation to accompany the greater responsibility devolved to them. Ethos: This Practice will endeavour to adopt Evidence Base Medicine (EBM) & apply this appropriately to its practice population with sensitivity at the individual patient level. Chronological age per se will not be considered a barrier to effective treatment. PNs (& GPs) will endeavour to communicate simply and accurately the benefits and risks of treatment. PNs (& GPs) will involve patients in a shared-decision approach to treatment.
Following the results of the UK Prospective Diabetes Study (UKPDS) results published September 1998, practice will be influenced in the following areas: Greater emphasis (and integration with other protocols) on blood pressure control (target ‹130/‹80mmHg), lipid management and aspirin & ACEI therapy. Tighter glycaemic control (target HbA1c (DCCT aligned) ‹7.0%) Re. retinopathy and cataract formation. More aggressive Rx regimes: Metformin always indicated: I.e. No “diet only” Wider dose regimes (≤3g/day) Unless C/I or refused Aspirin always indicated Unless C/I or refused Statins: Treat all patients with Simvastatin 40mg: Unless C/I (see MHRA guidance) or refused Irrespective of age or pre-treatment cholesterol level Higher doses if post-Rx cholesterol ≥5.0mmol/L Or lower doses if not tolerated ACEI (or AT2 blockers if ACEI ADR) always indicated Regardless of pre-Rx BP Unless C/I or refused Orlistat for those with BMI ≥30 Or BMI ≥28 if poor (HbA1c ≥7.0mmol/L) DM control. Unless C/I or refused
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Drs. Turner & Bull: Diabetes Mellitus (DM) protocol.
Date: 2/3/05. Review date: 2/3/07.
Identification and Registration of Patients: Diabetes has a point prevalence of 3% (of whom 2% are known). For a practice of ~3170 patients (2/3/05), this equates to a predicted 95 diabetics of whom 63 would be known. This practice can currently identify 72 patients with diabetes (2.27% prevalence; 114% of predicted) and 73 patients with Impaired Fasting Glycaemia. Patients suffering from diabetes may be identified by: Computer disease register (DM) De-novo diagnoses; screening and case finding External correspondence (e.g. optician; chiropodist) All known diabetics will be identified as such: Computer summary (Significant/Active) Diagnostic categories include: o Type 1 (i.e. IDDM) o Type 2 (i.e. NIDDM) Diet-only On OHAs (Oral Hypoglycaemic Agents) Insulin treated o Impaired Fasting Glucose (IFG) Note: The WHO approved terms “Type 1/ Type 2” will be used. Data Recording: “Diabetes Mellitus” (Read code C10) will be entered as a Significant/Active code dated the day of diagnosis, along with a sub-code for the type/sub-type as Significant/Past. New sub-codes will be added (Significant/Past) as the disease/management evolves over time. All diabetic assessments (De-novo, 2m, and Annual checks) should be recorded via the Diabetes template in Consultation Mode (CM), linked to the C10 Read code. Standard review intervals are: o 2m for after initiation or change of Rx. o 12m for annual review Review dates should be set on template after each review, either 2m or 12m (reverting to the 12m “anniversary”), as required. All medication should be listed on the repeat prescribing screen (and set for 28 days).
Read Code Read Code Read Code Read Code Read Code Read Code
C10E C10F 66A3 66A4 66A5 R10D0
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Drs. Turner & Bull: Diabetes Mellitus (DM) protocol.
Call/recall letters:
Date: 2/3/05. Review date: 2/3/07.
Call will be generated by the person discovering the diabetes. Recall will be generated from the EMIS diary. Patients will be handed a CDM recall letter (stapled to their repeat prescription if on medication, or posted if not) and an appointment made with the Phlebotomist & PN 1-2w later. The letter will also request the patient to provide a urine sample after the blood test, which should be handed into reception @ the same appointment. Non-surgery attendees/defaulters: Attempts shall be made to undertake diabetic surveillance/management of non-surgery attendees by the following means: CDM recall letter (x3). Each recall request is logged on the EMIS system. Flagging of computer (major alert message) for opportunistic approach to discuss appointment, should surgery be attended for other purposes, after 3 CDM recall letters. District Nurse to call on housebound and implement the protocol. GP to visit housebound if required (e.g. further assessment/complications). Screening: Screening will take place through the following channels: Opportunistic: Medicals and urinanalysis for other purposes/protocols & antenatal checks. Case finding: Patients presenting with symptoms potentially related to diabetes. Annual review of IFG patients (q.v.). Diagnosis: WHO diagnostic criteria for diabetes: Fasting ≥ 7mmol/L on two occasions, or once if symptomatic. RBS and classic diabetic symptoms ≥ 11.1mmol/L on two occasions (but better to subsequently check FBS). WHO diagnostic criteria for IFG (Impaired Fasting Glucose): FBS 6.1-6.9mmol/L on any occasion. WHO “normal” criteria: FBS ≤ 6.0mmol/L Notes: If Random Blood Sugar (RBS) (i.e. plasma glucose) ≥ 8.0 mmol/L or BM or glucometer reading (i.e. capillary blood glucose) ≥ 7mmol/L, check FBS. HbA1c or fructosamine levels have no role in the diagnosis of diabetes.
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Drs. Turner & Bull: Diabetes Mellitus (DM) protocol.
Date: 2/3/05. Review date: 2/3/07.
IFG: Although these patients are at greater risk of developing diabetes in the future, as IFG they do not develop retinopathy nor other micro-vascular complications. However, they are at increased risk of macro-vascular complications (e.g. MI). Therefore, management is broadly similar to generic diabetic measures (q.v), i.e: Adapting diet Reducing weight Increasing exercise Stopping smoking Aspirin Treating o Hypertension o Hyperlipidaemia o Obesity These patients will be reviewed annually by the PN with FBS & FLP results. (Note these blood tests are fasting whereas all “diabetic” blood samples are non-fasting). Data will be recorded on the IFG template. They will be managed as “at risk” patients for macro-vascular disease, and should be given both aspirin and statins (if the pre-treatment level ≥ 5.0 mmol/L)
Diabetes: Patients with diabetes will be monitored according to the following strategy: De-novo diagnosis (1) PN (30’) (2) PN (30’) (3) PN (30’) PN (15’) PN (30’) T=0 T=4/52 T=8/52 As required T=12n/12
Diabetes template
2 monthly review: Any change of management Annual Review: Standard for all diabetics De-novo diagnosis: Symptoms
Short history covering: Thirst, polydipsia or polyuria Weight loss Thrush Skin sepsis Erectile dysfunction Et al
Session 1
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Drs. Turner & Bull: Diabetes Mellitus (DM) protocol.
Date: 2/3/05. Review date: 2/3/07.
1
PMH
FH
SH
Diabetogenic Rx Poor Compliance? S/E or ADR to DM Rx Examination
Check no major DM-related diagnoses missing from computer summary: BP IHD PVD CVA/TIA IFG Thyroid disorder Hyperlipidaemia Check FH up to date Re: DM IHD<60 or IHD>60 CVA<60 or CVA>60 BP Enquiry and advice as necessary: Smoking status Alcohol (u/wk) Occupation (via A rather than template) Diet Exercise If on diabetogenic Rx, consult with GP: BFZ? Steroids? Reasons, if not good.
1
1
1
2+3
Document. ADRs should also be recorded in the patient’s computer summary (Significant/Past). Ht; Wt; BMI. Urinanalysis (protein) BP (sitting and standing); PR/rhythm. Injection sites (if on insulin). Bloods/tests HbA1c; U&E; Se. cholesterol. LFT (if on metformin>/=2g/day, or statin or glitazone) TFT Urine albumin/creatinine ratio (not if dipstick ≥ 2+ protein); MSU (if dipstick ≥ 1+ protein, or symptoms of UTI).
1
1
6
Drs. Turner & Bull: Diabetes Mellitus (DM) protocol.
Date: 2/3/05. Review date: 2/3/07.
1 1 1 1 1 1 1 2 2 2 2 2 2 3 3 3 3 3 As nec.
Patient education and advice (education template)
Podiatrist’s & Optician’s reports. Treatment with agreement of GP (q.v.)
Give PCT Diabetes PIL (blue folder) Patient’s agenda for Q&A Primary care monitoring and schedules Explanation Re. diabetes Diet; weight; exercise Smoking cessation; alcohol Prescription exemption if on OHA or insulin Glycaemic control: Appropriate indications for test strips/glucometer (HBGM) Acute illnesses Hypos Foot care Free annual eye-checks; glasses Vaccinations (flu’, pneumococcal, tetanus) Travel DVLC+ car insurance (notification if on OHA or insulin) Diabetes UK; local support groups (e.g. NDDG) Pre-conception; pregnancy Insulin treatment These should be routinely entered (PN) into the relevant templates. Check/encourage/chase these annually. 1/ Glycaemic control: Diet; all patients OHA; o Metformin always indicated: I.e. No “diet only” Wider dose regimes (≤3g/day) Unless C/I or refused o Gliclazide MR (2nd choice). o Pioglitazone 15-30mg/day; as required, according to NICE advice. Insulin; Schedule according to lifestyle/patient preference. 2/ Other: ACEI (or AT2 blockers if ACEI ADR) always indicated o Unless C/I or refused o Regardless of pre-Rx BP. BP control (if hypertensive): o Most important aspect of diabetes care! o Rx per BP protocol with target levels <130/<80 o Or <120/<70 if raised urinary albumin/creatinine ratio or frank proteinuria
2+
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Drs. Turner & Bull: Diabetes Mellitus (DM) protocol.
Date: 2/3/05. Review date: 2/3/07.
PN Referrals
GP Referrals
Lipid control: Treat aggressively with statins o Treat all patients with Simvastatin 40mg: o Unless C/I (see MHRA guidance) or refused o Irrespective of age or pre-treatment cholesterol level o Higher doses if post-Rx cholesterol ≥5.0mmol/L o Or lower doses if not tolerated Note MHRA guidance Re. statin interactions. Aspirin always indicated o Unless C/I or refused Statins: Treat all patients with Simvastatin 40mg: o Unless C/I or refused o Irrespective of age or pre-treatment cholesterol level o Higher doses if post-Rx cholesterol ≥5.0mmol/L o Or lower doses if not tolerated Orlistat for those with BMI ≥30 o Or BMI ≥28 if poor (HbA1c ≥7.0mmol/L) DM control. o Unless C/I or refused 3/ Counselling: Refer to Clinical Pharmacist for drug counselling: o Increases patient understanding of indications and risk reductions o Increased concordance o Reduced PN time invested in other aspects of patient education Podiatrist; baseline assessment/reinforcement of education, if not already arranged. Optician; baseline assessment/reinforcement of education, if not already arranged. Dietician; single educational session after 2/12, if required. GP: Complications; further assessment/advice needed Back to PN for 2m or 12m review Diabetic Liaison Sister (DLS) Diabetes, ophthalmic or vascular Specialist
1 1 2 3
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Drs. Turner & Bull: Diabetes Mellitus (DM) protocol.
2 month reviews: Symptoms SH
Date: 2/3/05. Review date: 2/3/07.
Poor Compliance? S/E or ADR to DM Rx Examination Bloods/tests Q+A Patient education and advice (education template) Podiatrist’s & Optician’s reports. Treatment with agreement of GP (q.v.)
Short history covering relevant symptoms Check regarding any relevant changes and advice as necessary: Smoking status Alcohol (u/wk) Diet Exercise Reasons, if not good.
Document. ADRs should also be recorded in the patient’s computer summary (Significant/Past). Wt; BMI. HbA1c @ 6w (min) Patient’s agenda. Patient education should be eclectic: Discuss according to need, and point patients to PILs available via www.patient.co.uk or PCT Diabetes “Blue Book”. Note: Only patients using insulin (whether Type I or II) or with “brittle” diabetes or frequent hypos should be using Home Blood Glucose Meters (HBGM): All other Type II diabetics should have the issues discussed and test strips deleted from Rpt Rx. Check/encourage these annually.
1/ Glycaemic control: Diet; all patients OHA; o Metformin always indicated: I.e. No “diet only” Wider dose regimes (≤3g/day) Unless C/I or refused o Gliclazide MR (2nd choice). o Pioglitazone 15-30mg/day; as required, according to NICE advice. Insulin; Schedule according to lifestyle/patient preference. 2/ Other: ACEI (or AT2 blockers if ACEI ADR) always indicated o Unless C/I or refused o Regardless of pre-Rx BP. BP control (if hypertensive): o Most important aspect of diabetes care! o Rx per BP protocol with target levels <130/<80 o Or <120/<70 if raised urinary albumin/creatinine ratio or frank proteinuria
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Drs. Turner & Bull: Diabetes Mellitus (DM) protocol.
Date: 2/3/05. Review date: 2/3/07.
Referrals
Lipid control: Treat aggressively with statins o Treat all patients with Simvastatin 40mg: o Unless C/I (see MHRA guidance) or refused o Irrespective of age or pre-treatment cholesterol level o Higher doses if post-Rx cholesterol ≥5.0mmol/L o Or lower doses if not tolerated Note MHRA guidance Re. statin interactions. Aspirin always indicated o Unless C/I or refused Statins: Treat all patients with Simvastatin 40mg: o Unless C/I or refused o Irrespective of age or pre-treatment cholesterol level o Higher doses if post-Rx cholesterol ≥5.0mmol/L o Or lower doses if not tolerated Orlistat for those with BMI ≥30 o Or BMI ≥28 if poor (HbA1c ≥7.0mmol/L) DM control. o Unless C/I or refused 3/ Counselling: Refer to Clinical Pharmacist for additional drug counseling, if required: o Increases patient understanding of indications and risk reductions o Increased concordance o Reduced PN time invested in other aspects of patient education Podiatrist: Assessment/reinforcement of education, if not already arranged. Optician: Assessment/reinforcement of education, if not already arranged. GP: Complications; further assessment/advice needed
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Drs. Turner & Bull: Diabetes Mellitus (DM) protocol.
Annual reviews: Symptoms
Date: 2/3/05. Review date: 2/3/07.
PMH FH SH
Diabetogenic Rx Poor Compliance? S/E or ADR to DM Rx Examination
Short history covering: Thirst, polydipsia or polyuria Weight loss Thrush Skin sepsis Erectile dysfunction Et al Check no new major DM-related diagnoses missing from computer summary Check FH up to date Check these every year. Enquiry and advice as necessary: Smoking status Alcohol (u/wk) Occupation? (via A rather than template) If on diabetogenic Rx, consult with GP: BFZ? Steroids? Reasons, if not good.
Document. ADRs should also be recorded in the patient’s computer summary (Significant/Past). Wt; BMI. Urinanalysis (protein) BP (sitting and standing); PR/rhythm. Injection sites (if on insulin). Bloods/tests HbA1c; U&E; Se. cholesterol. LFT (if on metformin>/=2g/day, or statin or glitazone) TFT Urine albumin/creatinine ratio (not if dipstick ≥ 2+ protein); MSU (if dipstick ≥ 1+ protein, or symptoms of UTI). Q+A Patient’s agenda. Patient Patient education should be eclectic: Discuss according to need, and point education patients to PILs available via www.patient.co.uk or PCT Diabetes “Blue Book”. and advice Note: Only patients using insulin (whether Type I or II), with “brittle” (education diabetes or frequent hypos should be using Home Blood Glucose Meters template) (HBGM): All other Type II diabetics should have the issues discussed and test strips deleted from Rpt Rx. Podiatrist’s These should be routinely entered (PN) into the relevant templates. & Optician’s Check/encourage/chase these annually. reports.
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Drs. Turner & Bull: Diabetes Mellitus (DM) protocol.
Treatment with agreement of GP (q.v.)
Date: 2/3/05. Review date: 2/3/07.
1/ Glycaemic control: Diet; all patients OHA; o Metformin always indicated: I.e. No “diet only” Wider dose regimes (≤3g/day) Unless C/I or refused o Gliclazide MR (2nd choice). o Pioglitazone 15-30mg/day; as required, according to NICE advice. Insulin; Schedule according to lifestyle/patient preference. 2/ Other: ACEI (or AT2 blockers if ACEI ADR) always indicated o Unless C/I or refused o Regardless of pre-Rx BP. BP control (if hypertensive): o Most important aspect of diabetes care! o Rx per BP protocol with target levels <130/<80 o Or <120/<70 if raised urinary albumin/creatinine ratio or frank proteinuria Lipid control: Treat aggressively with statins o Treat all patients with Simvastatin 40mg: o Unless C/I (see MHRA guidance) or refused o Irrespective of age or pre-treatment cholesterol level o Higher doses if post-Rx cholesterol ≥5.0mmol/L o Or lower doses if not tolerated Note MHRA guidance Re. statin interactions. Aspirin always indicated o Unless C/I or refused Statins: Treat all patients with Simvastatin 40mg: o Unless C/I or refused o Irrespective of age or pre-treatment cholesterol level o Higher doses if post-Rx cholesterol ≥5.0mmol/L o Or lower doses if not tolerated Orlistat for those with BMI ≥30 o Or BMI ≥28 if poor (HbA1c ≥7.0mmol/L) DM control. o Unless C/I or refused 3/ Counselling: Refer to Clinical Pharmacist for drug counselling: o Increases patient understanding of indications and risk reductions o Increased concordance o Reduced PN time invested in other aspects of patient education
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Drs. Turner & Bull: Diabetes Mellitus (DM) protocol.
Referrals Referral criteria:
Date: 2/3/05. Review date: 2/3/07.
Podiatrist: Assessment/reinforcement of education, if not already arranged. Optician: Assessment/reinforcement of education, if not already arranged. GP: Complications; further assessment/advice needed
PN---> GP (most treatment issues resolved via PN/GP discussion) Recent hypo/symptomatic. Poor control. When there are treatment related S/E. When the patient presents with symptoms not attributable to diabetes. When the nurse is worried about any aspect of patient care. GP---> P/N Poorly controlled diabetics now stabilized. For reinforcement of patient education where this is required. GP---> Consultant "Paediatric" diabetics (≤15 years). Pregnant diabetics, and for specialist pre-conceptual counselling if required. Diabetic complications. Ophthalmic - cataracts/retinopathy/glaucoma. Moderate-severe peripheral vascular disease. Renal failure - age dependent? Diabetic crises - acute ketoacidosis or hyperosmolar non-ketotic state. For advice/support with non-routine cases. Consultant---> GP All routine diabetics All non-routine diabetics (as considered suitable) with agreement of GP. Treatment philosophy: Diet. Diet forms the basic cornerstone of all diabetic treatment, whether insulin dependent or not, on OHA's or not (e.g. patient refusal of metformin). However, the 'diet' is not legalistic, but intended to be flexible within guidelines. Lack of rigidity requires extra patient education in order to achieve responsible eating and therefore good compliance. The dietary guidelines form the basis of a "general ideal" as proposed by Report 41: Dietary reference values for food energy & nutrients for the UK (D.O.H.), and comprises the following:
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Drs. Turner & Bull: Diabetes Mellitus (DM) protocol.
Date: 2/3/05. Review date: 2/3/07.
(a) Fats 30% CHO 55-60% Protein 10-15%
total calories
(b) Fats should, ideally, be further subdivided:- 10% polysaturates - 80% monosaturates - 10% polyunsaturates (c) Carbohydrates should be taken in complex form (e.g. starches), generally avoiding mono and di-saccharides. (d) The diet should be high fibre(> 30 g/day) and low salt (< 5g/day). All new patients, if thought necessary, should be referred to the dietitian initially for a “one-off” education session emphasizing the importance of diet and weight control. Insulin or Non-insulin dependant? Insulin requirement is broadly determined by two medical criteria, (and probably also influenced by social and psychological factors). (a) Ketosis. (b) Glycaemic control. Persistent mild to moderate ketosis would imply relative insulin insufficiency and, even assuming glycaemic control, would dictate exogenous insulin. Poor glycaemic control in the face of good dietary concordance and maximal OHA treatment, would also suggest the need for a glitazone or insulin, even if non-ketotic. Diet alone, or diet with OHA? Traditionally, requirement for OHA's is dictated by symptoms and/or glycaemic control, which in turn is influenced by diet and exercise; qualities and quantities. However, the UKPDS seems to indicate that starting all patients on low dose (or appropriate dose to achieve glycaemic control) improves patient outcomes. The philosophy is towards early Rx with metformin.
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Drs. Turner & Bull: Diabetes Mellitus (DM) protocol.
Biguanide, Sulphonylurea or glitazone?
Date: 2/3/05. Review date: 2/3/07.
Whichever type of OHA is used, they should augment the dietary effort, not replace it. Sulphonylureas (e.g. gliclazide MR) act by stimulating pancreatic insulin secretion (and are consequently only effective when some residual pancreatic islet cell activity is present). With longer term administration they have an extra-pancreatic effect, possibly by increasing peripheral insulin receptor numbers. Biguanides, of which Metformin is the only available example, exerts its effect by reducing gluconeogenesis and by increasing peripheral utilization of glucose. It, too, works only in the presence of endogenous insulin from residual functioning pancreatic islet cells. Traditionally, biguanides were used as a supplement to sulphonylureas where concerted dietary and drug management has failed to gain glycaemic control. The UKPDS has confirmed metformin’s safety and efficacy. They are useful as first line agents whether or not patients are obese (BMI > 25) and fail to reduce weight, except where there is evidence of liver or renal dysfunction (which precludes their use because of the risk of lactic acidosis) or an alcohol problem. Use in the elderly (> 75 years) should always be subject to confirmation of hepatorenal sufficiency (LFT/U&E). (Creatinine /=2g/day) Which Sulphonylurea? Gliclazide MR. Patients on long acting OHA's (eg Chlorpropamide and higher doses of glibendamide in the elderly) should be actively encouraged to transfer to gliclazide MR. However, where patients are currently well controlled on treatment, this should be continued unless problems occur (e.g. side-effect/loss of glycaemic control) in which case gliclazide MR should be substituted. Dosage: Initially 15 - 30mg om Maximum 135mg (up to 60mg as single dose) S/E - Rashes/other allergic phenomenon. Advantages: (a) Once daily dosage (bd maximum) (b) More potent than first generation sulphonylureas. (c) Less tendency to weight gain than other sulphonylureas. (d) Less prone to hypoglycaemia than other sulphonylureas (e) Hepatic metabolism and therefore safe in renal failure. (f) May have beneficial effects on platelet adhesiveness and aggregation. (g) Approx ≤ 0.7% HbA1c vs. standard gliclazide Which Glitazone? Pioglitazone or Rosiglitazone? Rosiglitazone: Indicated in combination with Metformin or a Sulphonyluria, but only in combination with Metformin in obese patients. Not indicated as a monotherapy. Dose: 4mg-8mg in single or twice daily dose with/without food. LFT monitoring is indicated. Baseline LFT, before commence Rx: If ALT >2.5x upper limit normal, do not use. Once Rx initiated, 2 monthly LFTs for first 12m, then 'periodically'. If ALT increases to 3x upper limit normal, urgent repeat. If still 3x, discontinue Rx.
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Drs. Turner & Bull: Diabetes Mellitus (DM) protocol.
Date: 2/3/05. Review date: 2/3/07.
Pioglitazone: Comparable indications/restrictions/monitoring. Once daily dose. However, this agent is cheaper, has fewer listed S/E and is always taken once daily. It is the agent of choice and on the Drug Formulary. Diabetic Formulary: Biguanides - Metformin 500mg 850mg Sulphonylurea – Gliclazide MR 30mg Glitazones – Pioglitazone 15mg and 30mg (Rosiglitazone 4mg and 8mg) Insulins - various Glycaemic control: Normal glycaemic control is 4 - 7 mmol/l. This level of control would imply glycosuria was either: Transient post-prandial Low renal glucose threshold However, blood glucose is no longer advocated for diabetic monitoring in Type II diabetes. Therefore, good control for diabetic patients should be HbA1c <7. Target blood glucose/HbA1c levels by age:Age <50 years 50-59 60-69 70+ HbA1c <7 <7 <7 <7 (- <10)
Failure to achieve glycaemic control with current management would necessitate stepwise increase in therapy, remembering to check reported compliance with both diet and medication. When maximal OHA treatment fails to alleviate symptoms and/or provide adequate glycaemic control, insulin will be necessary, usually maintaining the metformin. Note: Failure to achieve glycaemic control with insulin suggests non-compliance, and any patient requiring more than 100iu/day is non-compliant until proven otherwise!
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Drs. Turner & Bull: Diabetes Mellitus (DM) protocol.
Commencing insulin:
Date: 2/3/05. Review date: 2/3/07.
Diabetic patients requiring insulin should be treated individually and their insulin regime reflect their social and medical needs. Consequently, no repeat prescription protocol is feasible for Type I or Type II insulin treated patients. Education – Insulin specific: Need for insulin and mode of action. How to draw up insulin + injection technique Timing of injection(s) Injection sites and rotation schedule/complications. Regular meals/snacks Disposal of sharps. Home monitoring Adjusting dose according to tests results and needs. Storage of insulin. Factors affecting insulin requirement. Types of insulin used and length of action. Symptoms of hypoglycaemia. Factors likely to cause hypoglycaemia. Management of hypoglycaemia - emergency/longer term. What to do in terms of sickness - QDS BM - Insulin to suit blood glucose, not food intake. - Who/how to contact for advice. - Sick day rules. ID card PN contact No. Aspirin: Many experts argue that the 10yr CHD risk of diabetics equals that of a patient with an MI and should automatically qualify for aspirin under the secondary prevention rule. Therefore, aspirin 75mg should be advised for secondary prevention: All diabetic or IFG patients unless a C/I exists or patient refuses. Aspirin notes: Where a patient becomes intolerant of aspirin, try reducing to 37.5mg/day. If intolerance persists, continue aspirin 75mg/day and add cytoprotection (either H2RA, misoprostol or PPI). Where a patient is allergic (not just intolerant) to aspirin, dipyridamole MR 200mg bd should be substituted.
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Drs. Turner & Bull: Diabetes Mellitus (DM) protocol.
Statins:
Date: 2/3/05. Review date: 2/3/07.
Many experts argue that the 10yr CHD risk of diabetics equals that of a patient with an MI and should automatically qualify for statins regardless of age, type of diabetes or pre-Rx cholesterol level. Therefore, simvastatin 40mg (as Simvador) should be advised: All diabetics And regardless of age. Or IFG patients with total serum cholesterol (Tc, not Tc:HDL ratio) ≥ 5.0mmol/L, Treatment target for secondary prevention: Total serum cholesterol (Tc, not Tc:HDL ratio) < 5.0mmol/L, And ≥25% reduction. Simvastatin dose may be increased accordingly (or reduced if not tolerated @ 40mg/day). Note the MHRA guidance: Interacting Drug Potent CYP3A4 inhibitors: HIV protease inhibitors Azole antifungal agents Erythromycin Clarithromycin Telithromycin Ciclosporin Gemfibrozil Niacin (>1g/day) Verapamil Amiodarone Diltiazem Grapefruit juice
Prescribing Advice Avoid Statin
Do not exceed 10mg Simvastatin
Do not exceed 20mg Simvastatin Do not exceed 40mg Simvastatin Avoid when taking Simvastatin.
Note: Under nGMS, there is no age limit and absolute benefits increase with age. However, issues around intolerance, polypharmacy, interactions are likely to increase and QALY’s & years of life saved reduce. These issues need to be explored with the patient sensitively. There is no blanket solution: Either prescribe or consider using exclusion codes. Audit: Annual review of all relevant structure, process & outcome indicators. Richard Bull: 2/3/05.
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