Formulary Group Decisions January 2010
Re-classification of advice
Sibutramine update 21st January 2010: The European Medicines Agency (EMA) has completed a review of the obesity medicine sibutramine (Reductil®) and has found that the cardiovascular risks of sibutramine outweigh its benefits. The EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended suspension of the marketing authorisation for this medicine across the European Union.
In view of the new prescribing advice, sibutramine has been removed from the Grampian Joint Formulary.
Further information is available on the
EMA website.
Advice for healthcare professionals and patients
- Doctors should not issue any new prescriptions for sibutramine and should review the treatment of those who are currently taking this medicine
- Pharmacists should not dispense any prescriptions for sibutramine and should advise patients to make an appointment to see their doctor at the next convenient time
- Patients who are currently being treated with sibutramine should be advised to schedule an appointment at the next convenient time with their doctor to discuss alternative measures to lose weight, including use of diet and exercise regimes. Patients may stop treatment before their appointment if they wish.
A Direct Healthcare Professional Communication and a series of questions and answers is available for download below.
Direct Healthcare Professional Communication (68Kb)
Questions and answers (15Kb)
Direct Healthcare Professional Communication (68Kb)
Questions and answers (15Kb)Budesonide/formoterol turbohaler (Symbicort® SMART®)
Corticosteroids BNF 3.2
Corticosteroids BNF 3.2
Symbicort® SMART® - maintenance and reliever therapy was reclassified to allow treatment to be initiated in primary or secondary care. The wording from the full BTS/SIGN guideline was approved for inclusion in the GJF webpage - 'In selected adult patients at step 3 who are poorly controlled or in selected adult patients at step 2 (above BDP 400mcg/day who are poorly controlled), the use of budesonide/formoterol in a single inhaler as rescue medication instead of a short-acting beta-2 agonist, in addition to its regular use as controller therapy has been shown to be an effective treatment regimen. When this management option is introduced, the total regular dose of daily inhaled corticosteroids should not be decreased. The regular maintenance dose of inhaled steroids may be budesonide 200mcg twice daily or budesonide 400mcg twice daily. Patients taking rescue budesonide/formoterol once a day or more should have their treatment reviewed. Careful education of patients about specific issues around this management strategy is required.'
Approved for use in NHS Grampian
Rituximab concentrate for intravenous infusion (MabThera®)
Rituximab and alemtuzumab BNF 8.2.3
Rituximab and alemtuzumab BNF 8.2.3
Rituximab concentrate for intravenous infusion (MabThera®) was approved for inclusion in the GJF for restricted use for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia (CLL) in combination with chemotherapy.
Rituximab in combination with fludarabine and cyclophosphamide resulted in significantly longer progression-free survival than fludarabine and cyclophosphamide alone. The patient population in the pivotal clinical study had an Eastern Cooperative Oncology Group Performance Status of 0 or 1 and was a younger population than that generally seen in clinical practice. Evidence in patients over 70 years of age is limited [SMC 591/09]. Available for restricted use under specialist supervision and recommended for hospital use only. Use is restricted to use by specialists in haematology and haemato-oncology.
Rituximab in combination with fludarabine and cyclophosphamide resulted in significantly longer progression-free survival than fludarabine and cyclophosphamide alone. The patient population in the pivotal clinical study had an Eastern Cooperative Oncology Group Performance Status of 0 or 1 and was a younger population than that generally seen in clinical practice. Evidence in patients over 70 years of age is limited [
SMC 591/09]. Available for restricted use under specialist supervision and recommended for hospital use only. Use is restricted to use by specialists in haematology and haemato-oncology.Plerixafor, 20mg/mL solution for injection (Mozobil®)
Drugs used to mobilise stem cells BNF 9.1.7
Plerixafor, 20mg/mL solution for injection (Mozobil®)
was approved for inclusion in the GJF for restricted use in combination with G-CSF to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma whose cells mobilise poorly.
Significantly more patients treated with plerixafor than with placebo achieved their target collection of CD 34+ cells required for autologous stem cell transplantation with subsequent sustained engraftment [SMC 594/09]. Available for restricted use under specialist supervision and licensed for hospital use only. It should be initiated and supervised by a physician experienced in oncology and/or haematology.
was approved for inclusion in the GJF for restricted use in combination with G-CSF to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma whose cells mobilise poorly.
Significantly more patients treated with plerixafor than with placebo achieved their target collection of CD 34+ cells required for autologous stem cell transplantation with subsequent sustained engraftment [
SMC 594/09]. Available for restricted use under specialist supervision and licensed for hospital use only. It should be initiated and supervised by a physician experienced in oncology and/or haematology.Tocilizumab 20mg/mL concentrate for solution for infusion
(RoActemra®)
Drugs that suppress the rheumatic disease process BNF 10.1.3
(RoActemra®)
Drugs that suppress the rheumatic disease process BNF 10.1.3
Tocilizumab 20mg/mL concentrate for solution for infusion (RoActemra®)
was approved for inclusion in the GJF for restricted use in combination with methotrexate, for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs or tumour necrosis factor antagonists [
SMC 593/09]. Available for restricted use under specialist supervision and recommended for hospital use only. It is restricted to use in combination therapy only, should be initiated by healthcare professionals experienced in the diagnosis and treatment of RA and used in accordance with the British Society of Rheumatology guidelines for prescribing TNF-alpha blockers in adults. Patients treated with RoActemra® should be given the Patient Alert Card.
was approved for inclusion in the GJF for restricted use in combination with methotrexate, for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs or tumour necrosis factor antagonists [
SMC 593/09]. Available for restricted use under specialist supervision and recommended for hospital use only. It is restricted to use in combination therapy only, should be initiated by healthcare professionals experienced in the diagnosis and treatment of RA and used in accordance with the British Society of Rheumatology guidelines for prescribing TNF-alpha blockers in adults. Patients treated with RoActemra® should be given the Patient Alert Card.Approved by SMC, not requested by local clinicians - not approved for use in NHS Grampian
Esomeprazole injection (Nexium I.V.®)
Proton pump inhibitors BNF 1.3.5
Proton pump inhibitors BNF 1.3.5
Esomeprazole injection (Nexium I.V.®) is accepted for use within NHS Scotland for prevention of rebleeding following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers.
In patients with high-risk peptic ulcer bleeding, high-dose intravenous esomeprazole significantly reduced recurrent bleeding at 72 hours compared to placebo.
Overleaf is the detailed advice on this product.
Approved by SMC, not requested by local clinicians - Not recommended for use in NHS Grampian for this indication.
In patients with high-risk peptic ulcer bleeding, high-dose intravenous esomeprazole significantly reduced recurrent bleeding at 72 hours compared to placebo.
Overleaf is the detailed advice on this product.
Approved by SMC, not requested by local clinicians - Not recommended for use in NHS Grampian for this indication.
Fentanyl nasal spray (Instanyl®)
Opioid analgesics BNF 4.7.2
Opioid analgesics BNF 4.7.2
Fentanyl nasal spray (Instanyl®)
is accepted for restricted use within NHS Scotland for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain.
In an open-label comparative study intranasal fentanyl was superior to another fentanyl formulation used in the treament of breakthrough pain in terms of time to onset of pain relief, although more episodes using the intranasal formulation required a second dose.
Use of fentanyl nasal spray should be restricted to patients who are unsuitable for other short-acting oral opioids (e.g. oral morphine) as an alternative to other buccal and sublingual fentanyl preparations. It should be noted that the doses of fentanyl nasal spray are significantly lower than doses of fentanyl given by other routes of administration for this indication. Approved by SMC, not requested by local clinicians - Not recommended for use in NHS Grampian for this indication.
is accepted for restricted use within NHS Scotland for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain.
In an open-label comparative study intranasal fentanyl was superior to another fentanyl formulation used in the treament of breakthrough pain in terms of time to onset of pain relief, although more episodes using the intranasal formulation required a second dose.
Use of fentanyl nasal spray should be restricted to patients who are unsuitable for other short-acting oral opioids (e.g. oral morphine) as an alternative to other buccal and sublingual fentanyl preparations. It should be noted that the doses of fentanyl nasal spray are significantly lower than doses of fentanyl given by other routes of administration for this indication. Approved by SMC, not requested by local clinicians - Not recommended for use in NHS Grampian for this indication.
Filgrastim injection (Ratiograstim®)
Drugs used in neutropenia BNF 9.1.6
Drugs used in neutropenia BNF 9.1.6
Filgrastim injection (Ratiograstim®)
is accepted for use within NHS Scotland for:
is accepted for use within NHS Scotland for:- Reduction in the duration of neutropenia and the incidence of febrile neutropenia (FN) in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
- Reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia.
- Mobilisation of peripheral blood progenitor cells (PBPC).
- As long term administration, to increase neutrophil counts and to reduce the incidence and duration of infection-related events in children or adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 0.5 x 109/L, and a history of severe or recurrent infections.
- For the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Filgrastim (Ratiograstim®)
is a biosimilar product and has demonstrated equivalency in terms of efficacy and safety to a reference granulocyte colony stimulating factor (filgrastim (Neupogen®).
The British National Formulary advises that it is good practice to prescribe biological medicinal products by brand name. Approved by SMC, not requested by local clinicians - Not recommended for use in NHS Grampian for this indication.
is a biosimilar product and has demonstrated equivalency in terms of efficacy and safety to a reference granulocyte colony stimulating factor (filgrastim (Neupogen®).
The British National Formulary advises that it is good practice to prescribe biological medicinal products by brand name. Approved by SMC, not requested by local clinicians - Not recommended for use in NHS Grampian for this indication.
Not approved for use in NHS Grampian
Aliskiren tablets (Rasilez®)
Renin inhibitors BNF 2.5.5.3
Renin inhibitors BNF 2.5.5.3
Aliskiren tablets (Rasilez®)
is not recommended for use within NHS Scotland for the treatment of essential hypertension. Aliskiren has shown comparable efficacy to other antihypertensive agents in terms of blood pressure reduction, though its effects on mortality and long-term morbidity are currently unknown.
The manufacturer did not present a sufficiently robust clinical or economic analysis to gain acceptance by SMC for the position sought [SMC 462/08].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
is not recommended for use within NHS Scotland for the treatment of essential hypertension. Aliskiren has shown comparable efficacy to other antihypertensive agents in terms of blood pressure reduction, though its effects on mortality and long-term morbidity are currently unknown.
The manufacturer did not present a sufficiently robust clinical or economic analysis to gain acceptance by SMC for the position sought [
SMC 462/08].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Droperidol 2.5 mg/mL injection (Xomolix®)
Drugs used in nausea and vertigo, phenothiazines and related drugs BNF 4.6
Drugs used in nausea and vertigo, phenothiazines and related drugs BNF 4.6
Droperidol 2.5 mg/mL injection (Xomolix®)
was not approved for inclusion in the Grampian Joint Formulary for the prevention and treatment of postoperative nausea and vomiting, including prevention of nausea and vomiting caused by opioid analgesics in postoperative patient-controlled analgesia. Cost-effective alternative available, not recommended for use in NHS Grampian.
Not recommended for use in NHSG - will not be included in Grampian Joint Formulary for this indication.
was not approved for inclusion in the Grampian Joint Formulary for the prevention and treatment of postoperative nausea and vomiting, including prevention of nausea and vomiting caused by opioid analgesics in postoperative patient-controlled analgesia. Cost-effective alternative available, not recommended for use in NHS Grampian.
Not recommended for use in NHSG - will not be included in Grampian Joint Formulary for this indication.
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