Document Sample
					                         DERBYSHIRE PRIMARY CARE FORMULARY

Prepared October 2008

Relevant Derbyshire guidelines:

6.1      Drugs used in diabetes

6.1.1    Insulins

         Short-acting           - Soluble insulin (Actrapid, Humulin S, Insuman Rapid)

         Intermediate-acting    - Isophane insulin [NPH] (Insulatard, Humulin I, Insuman Basal)

         Mixtures               - Biphasic isophane insulin
                                  (Mixtard 30, Humulin M3, Insuman Comb 15, 25 and 50)

         Short-acting           - Insulin aspart, insulin lispro

         Long-acting            - Insulin glargine, insulin detemir

         Mixtures               - Novomix 30, Humalog Mix25, Mix50

      1. Analogue insulins are not for routine use as they are not cost-effective options.
      2. Insulin aspart/lispro is approved for use in the small group of type 1 diabetics who want to
         achieve tight glycaemic control and are unable to do so with conventional insulins.
      3. For type 2 diabetes, short-acting insulin analogues have not been shown in a meta-
         analysis to improve HbA1c, hypoglycaemia, or quality of life, compared with conventional
         human insulin.
      4. Insulin glargine is covered by NICE guidance. It is not recommended for routine use in
         patients with type 2 diabetes who require insulin.
      5. A Cochrane review found that in type 1 diabetes, compared to intermediate-acting
         conventional insulin, long-acting insulin analogues have a clinically unremarkable effect on
         overall diabetes control. A beneficial effect was only seen on nocturnal glucose levels and
         they may therefore be appropriate for those who suffer from nocturnal hypoglycaemia.
         Cochrane advise a cautious approach to their use in view of their potential mitogenic
      6. A similar Cochrane review compared theses insulins in type 2 diabetes. Metabolic control,
         measured by HbA1c, and adverse effects did not differ in a clinical relevant way between
         treatment groups. Cochrane advise that until long-term efficacy and safety data are
         available, a cautious approach should be taken to therapy with insulin glargine or detemir.

6.1.2    Oral antidiabetic drugs

         Metformin tabs 500mg, 850mg, Metformin SR tabs 500mg, 750mg

         Gliclazide tabs 80mg

         Pioglitazone tabs 15, 30, 45mg
        1. Metformin is the first-line oral hypoglycaemic for all people with type 2 diabetes (unless
        contraindicated). Titrate the dose slowly – initially 500mg with breakfast for at least one
        week, then add 500mg with evening meal for one week, then add lunchtime dose if
        necessary. Usual maximum of 2g daily in divided doses but licensed up to 3g daily.
        2. Metformin SR is included for those patients who are intolerant of standard release
        metformin, even after slow dose titration. Try metformin SR before switching to an
        alternative hypoglycaemic agent.
        3. The risk of lactic acidosis with metformin, especially until creatinine clearance is below
        30ml/min, is very minimal. NICE advises to review the dose of metformin if the serum
        creatinine exceeds 130 micromol/litre or the estimated glomerular filtration rate (eGFR)
        is below 45 ml/minute/1.73-m2, and to stop the metformin if the serum creatinine
        exceeds 150 micromol/litre or the eGFR is below 30 ml/minute/1.73-m .
        4. Gliclazide is the first-line option if metformin cannot be used and the first-line option for
        add-on therapy to metformin.
        5. Pioglitazone is the choice should a glitazone be indicated (see NICE guidance).
        Glitazones as a class increase the risk of oedema, heart failure, and fractures.
        Rosiglitazone also increases the risk of cardiovascular events and is not recommended.
        6. Sitagliptin and vildagliptin are BROWN drugs (lack of data on safety and effectiveness).
        7. Exenatide is a RED drug (requires specialist assessment on patient selection, initiation
        and ongoing treatment).

6.1.4   Treatment of hypoglycaemia
        Refer to diabetes guideline

6.1.5   Treatment of diabetic nephropathy and neuropathy
        Refer to neuropathy guideline

6.1.6   Diagnostic and monitoring agents for diabetes mellitus

        1. Blood glucose self-monitoring is only useful as part of a management plan and when
        the patient knows what to do with the results.
        2. Self-monitoring of blood glucose in patients not using insulin is not essential, may not be
        desirable and may do harm. Patients currently prescribed testing strips should be
        considered for review.

   SMBG is only useful when a patient can use the results they measure, either to adjust treatment or as
   feedback of the results of changes made.
   For example, SMBG should be available in the following situations:
   (a) for people with type 1 diabetes;
   (b) for people with type 2 diabetes using insulin;
   (c) for people with type 2 diabetes not using insulin who
          i.   are having symptoms of hypoglycaemia;
         ii.   are making major lifestyle changes likely to impact upon glycaemic control;
        iii.   need to ensure safety during activities such as driving whilst on drugs potentially causing
   (d) for women who are pregnant;
   (e) for people with diabetes when they have intercurrent illness such as when admitted into hospital
       (BGM may be performed by health care professionals in this situation);
   (f) for people in whom there is a concern about a possible diagnosis of type 1 diabetes at diagnosis,
       or in whom it is suspected insulin therapy may be required (e.g. steroid-induced diabetes);
       glycaemic control should be measured by other means such as by HbA1c measurement every 3
       months (2-6 months).

   SMBG should not be routinely available to people with type 2 diabetes who do not use insulin
   (adjustments of oral hypoglycaemic medication can be done based on HbA1c results).
6.2.1   Thyroid Hormones

        Levothyroxine (thyroxine)    tabs 25, 50, 100 microgram

   1. As levothyroxine (thyroxine) has a long half life (about 7 days), full effects may not be
      seen for several weeks, and dosage adjustments should be made at 2-3 monthly
      intervals. Repeating thyroid function tests with a view to adjustment of replacement
      dosage any more frequently is inappropriate.
   2. In the elderly, and in patients with significant ischaemic heart disease or long-standing
      profound hypothyroidism, thyroid hormones should be commenced at a low dose and
      increased very cautiously, since angina and arrhythmias can be precipitated on starting
      treatment. If the patient is very unstable, contact an endocrinologist for advice.
   3. The effects of oral anticoagulants may be potentiated when thyroid hormones are
   4. If pregnancy is being considered, a target TSH of the bottom end of the normal range, 0.4
      to 2.0, is recommended. Please refer to the endocrine antenatal service if further advice
   5. If levothyroxine is prescribed in secondary care for thyroid malignancy, then advice from
      the thyroid cancer MDT should be followed.
   6. Liothyronine and Armour thyroid are not recommended for use outside of specialist
      initiation for very specific indications.
   7. Remember that a normal TSH may be found in patients with secondary hypothyroidism
      from pituitary disease – if clinically suspicious ask for FT4 as well

6.2.2   Antithyroid Drugs

        Carbimazole 5mg, 20mg tabs

        1. See BNF for CSM warning of neutropenia and agranulocytosis, patients should report
           signs and symptoms suggestive of infection, especially sore throat. Mention this when
           doing thyroid function tests.
        2. Hyperthyroid patients should be referred.
        3. Hyperthyroid patients are generally more sensitive to oral anticoagulants; increased
           dosage may be necessary as the hyperthroidism becomes controlled. Frequent
           review of INR is therefore recommended.
        4. Specialist review of women on thyroid medication is recommended as early as
           possible in pregnancy.

6.3     Corticosteroids
6.3.1   Replacement Therapy

        Fludrocortisone tabs 100 microgram

6.3.2   Glucocorticoid therapy

        Prednisolone tabs 1mg, 5mg, 25mg,
        2.5mg ec, 5mg ec, soluble tabs 5mg                 Use plain tablets where possible

        Dexamethasone tabs 2mg

        Hydrocortisone tabs 10mg, 20mg

        1. Corticosteroids should preferably be taken in the morning after breakfast.
        2. Steroid warning cards should be carried by those on long term treatment, both
           replacement and therapeutic. Patients on replacement therapy should be fully
           educated about the need to increase dosage during intercurrent illness. Abrupt
             withdrawal of steroids following long term therapy (> 3 weeks) should be avoided.
             See CSM warning in BNF.
        3.   See BNF for information on initiating corticosteroids and equivalent doses.
        4.   For acute asthma attack in adults, the British Asthma Guideline (BAG) recommends:
             2x25mg tabs daily for 5+ days.
        5.   For acute asthma attack in children, BAG recommends: <2 years (in the hospital
             setting): 10mg daily for up to 3 days, 2-5 years: 20mg daily – up to 3 days is usually
             sufficient, >5 years: 30mg-40mg daily - up to 3 days is usually sufficient (teenagers
             may not need soluble tablets).
        6.   Patients who are given systemic corticosteroids for purposes other than replacement
             and who have not had chickenpox should be regarded as being at risk of severe
             chickenpox. See BNF for further information.

6.4     Sex Hormones

6.4.1   Female Sex Hormones Oestrogens and HRT

                Oestrogen only
                Note - unopposed oestrogens must not be prescribed to women with a uterus, add
                a progestogen for 10-12 days per cycle

                Elleste solo tabs 1mg, 2mg

                Premarin 0.625 mg, 1.25mg tabs        alternative oral preparation

                Evorel patches                        1 patch to be applied twice a week
                25, 50, 75, 100 microgram             Second line preparation

                FemSeven patches 50, 75,             1 patch to be applied once a week
                100 microgram                        Second line preparation

                Oestrogen with progestogen combination products

                Elleste Duet tabs 1, 2mg

                Femoston tabs 1/10, 2/10, 2/20               alternative oral preparation for
                                                             progesterone sensitive patients

                Prempak-C 0.625, 1.25 tabs                   alternative oral preparation

                Evorel Sequi patches                         Note - second line preparation

                Continuous combined therapy

                Kliovance 1/0.5 tabs                         low dose

                Kliofem 2/1 tabs

                Femoston Conti tabs                          alternative oral preparation for
                                                               progesterone sensitive patients

                Premique tablets                             alternative oral preparation for
                (0.3/1.5 low dose; 0.625/5)                 progesterone sensitive patients

               Evorel Conti patches                           second line preparation
        1. The above products have been chosen on the basis of cost-effectiveness. The choice
           of HRT for an individual depends on an overall balance of indication, risk and
        2. For short-term use (e.g. 2-3 years maximum) for the relief of menopausal symptoms,
           the benefits are considered to outweigh the risks for most women. For long-term use
           the risks are likely to outweigh benefits. HRT is not recommended for prevention of
           CHD, osteoporosis, or other conditions. See BNF for latest CSM advice on HRT. Progestogens

                Norethisterone tabs 5mg

6.4.2   Male Sex Hormones and Antagonists

                Testosterone preparations for androgen deficiency follow consultant advice

                Finasteride tabs 5mg

        1. Alpha blockers remain the drug of first choice for the medical management of benign
           prostatic hypertrophy (BPH). See section 7.4.1.
        2. Choice of testosterone preparation should be based on cost-effectiveness and patient
        3. Intrinsa (testosterone patch) for women with hypoactive sexual desire disorder is not
           included due to lack of data showing clinical benefit. It is designated as BROWN.

6.4.3   Anabolic Steroids

        No drug is recommended for this section.

6.5     Hypothalamic and pituitary hormones and anti-oestrogens.

6.5.1   Hypothalamic and anterior pituitary hormones and anti-oestrogens

        Drugs in this section are for specialist use only

        See the PCT infertility policy

6.5.2   Posterior pituitary hormones and antagonists

        To be initiated after specialist advice

        Desmopressin nasal spray 10 microgram/metered spray.

        Desmopressin tabs 100, 200 microgram

        1. Desmopressin tablets are expensive and should be reserved for those patients who
           have problems with nasal preparations. The exception is primary nocturnal enuresis
           where only tablets are licensed
        2. See BNF for CSM warning regarding hyponatraemic convulsions.
6.6     Drugs affecting bone metabolism

6.6.1   Calcitonin and parathyroid hormone

        No drug is recommended for this section.

6.6.2   Bisphosphonates and other drugs affecting bone metabolism

               Adcal D3 tabs (chewable, lemon or tutti-frutti)
               (calcium 600mg + Vit. D3 400 units)

               Calcichew D3 Forte tabs (chewable, lemon)

               Calfovit D3 sachet
               (calcium 1200mg + Vit. D3 800 units)          Useful if unable to chew tablets

               Alendronic acid once-weekly tabs 70mg         Follow NICE guidance

               Risedronate 5mg tabs, 35mg once-weekly Follow NICE guidance, 2nd-line only

               Strontium ranelate 2g sachet                  Follow NICE guidance, 2nd-line only

               1. Ibandronate 150mg (monthly bisphosphonate) is not included and has been
                  designated a BROWN drug (lack of data on safety and effectiveness).

6.7     Other endocrine drugs

6.7.1   Bromocriptine and other dopaminergic drugs
        Seek specialist advice

6.7.2   Drugs affecting gonadotrophins
        Seek specialist advice

 1. Leuprorelin has been designated a BROWN drug (lack of data on effectiveness and cost-

6.7.3   Metyrapone and trilostane
        Seek specialist advice

6.7.4   Somatomedins
        Seek specialist advice