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Terms modified by NICE Selected AbstractsLiquid-based cytology for cervical screeningCYTOPATHOLOGY, Issue 6 2000N. Payne England and Wales' new National Institute for Clinical Excellence (NICE) has completed the first of its appraisals and issued guidance on a diagnostic technique rather than a therapeutic intervention.1 It was directed to examine the use of liquid-based cytology (LBC) for cervical screening and took evidence from a wide variety of sources. LBC is a new method of preparing cervical samples for cytological examination. Unlike the conventional ,smear' preparation it involves making a suspension of cells from the sample and this is used to produce a thin layer of cells on a slide. [source] Saxagliptin: a new option for the management of type 2 diabetesFUTURE PRESCRIBER, Issue 3 2009MD Consultant Diabetologist, Marc Evans MRCP Incretin-based therapies for the treatment of diabetes mellitus (T2DM) present a new approach to disease management. Over recent years, several new drugs have entered the marketplace, and NICE have recently issued guidance on how best to incorporate these new drugs into treatment regimens. In this article, Marc Evans reviews saxagliptin, a dipeptidyl peptidase-IV (DPP-IV) inhibitor, and considers its potential clinical use. Copyright © 2009 John Wiley & Sons, Ltd. [source] Analysing risk attitudes to timeHEALTH ECONOMICS, Issue 6 2010Adam Oliver Abstract The assumption of risk neutrality over discounted life years underlies the standard QALY model of individual preferences over health outcomes, and is thus implicitly assumed by NICE and other health technology advisory bodies worldwide. The primary objective of this article is to report a study to test the assumption in a convenience sample of 30 respondents with use of the probability equivalence version of the standard gamble. The results indicate considerable risk aversion over life years, and therefore call into question the standard assumption of risk neutrality in practical cost-utility analyses (CUA). A secondary objective is to observe whether risk aversion can be reduced through the use of the lottery equivalents method, under the hypothesis that the gambling effect can be lessened with this instrument. In a separate convenience sample of 40 respondents, however, the observed level of risk aversion was at least that seen in the standard gamble. Further research is warranted to ascertain whether risk aversion over discounted life years is a generalisable concern. Copyright © 2009 John Wiley & Sons, Ltd. [source] Simulation of groundwater dynamics in the North China Plain by coupled hydrology and agricultural modelsHYDROLOGICAL PROCESSES, Issue 16 2006Tadanobu Nakayama Abstract We simulated the effects of irrigation on groundwater flow dynamics in the North China Plain by coupling the NIES Integrated Catchment-based Ecohydrology (NICE) model with DSSAT-wheat and DSSAT-maize, two agricultural models. This combined model (NICE-AGR) was applied to the Hai River catchment and the lower reach of the Yellow River (530 km wide by 840 km long) at a resolution of 5 km. It reproduced excellently the soil moisture, evapotranspiration and crop production of summer maize and winter wheat, correctly estimating crop water use. So, the spatial distribution of crop water use was reasonably estimated at daily steps in the simulation area. In particular, NICE-AGR reproduced groundwater levels better than the use of statistical water use data. This indicates that NICE-AGR does not need detailed statistical data on water use, making it very powerful for evaluating and estimating the water dynamics of catchments with little statistical data on seasonal water use. Furthermore, the simulation reproduced the spatial distribution of groundwater level in 1987 and 1988 in the Hebei Plain, showing a major reduction of groundwater level due mainly to overpumping for irrigation. Copyright © 2006 John Wiley & Sons, Ltd. [source] Pharmacy support staff involvement in, and attitudes towards, pharmacy-based services for drug misusersINTERNATIONAL JOURNAL OF PHARMACY PRACTICE, Issue 6 2009Jenny Scott Abstract Objective This study aimed to examine involvement of pharmacy support staff in delivering services to drug misusers; to quantify their participation in related training; and to examine relationships between attitudes, practice experience and training. Methods The setting was a random sample of 10% of UK community pharmacies (n = 1218) using a postal questionnaire with two reminders. Pharmacy managers were used as gate-keepers to access pharmacy support staff, which included dispensary technicians and medicines counter assistants. Key findings Six hundred and ninety (56.7%) pharmacies responded, and 1976 completed questionnaires were returned from 610 (50.1%) pharmacies. A further 80 (6.6%) opted out. Three-fifths of staff had no input into decisions about whether their pharmacy provided services for drug misusers. One-third working in pharmacies that provide services were uncertain or negative about whether their pharmacy should do so. Staff were more involved in needle exchange (91%) and decisions to sell needles (95%) than supervising consumption of therapies (64%) or handing out dispensed medicines to drug misusers (73%), suggesting managers perceive needle exchange and sales as appropriate roles. Three-quarters of those working in pharmacies that provide services had not received any training to do so. Those who had undertaken training and who worked in pharmacies that provided services had significantly more positive attitudes compared to those had not undertaken training but also worked in pharmacies that provided services, or those who had undertaken training but did not provide services. Conclusions Pharmacy support staff were involved extensively in drug-misuse services but the majority had not been trained to do so. Attitudes were more positive in those who were involved in service provision and had undertaken training. The findings suggest a need for more extensive training and for further exploration of the views of managers on appropriate roles, particularly the clinical versus supply nature of needle exchange. This is timely given the recent publication of guidelines by the National Institute of Health and Clinical Excellence (NICE) on needle exchange. [source] Metastatic spinal cord compression: a review of practice and careJOURNAL OF CLINICAL NURSING, Issue 13-14 2010Lynn Kilbride Aim and objectives., The aim of this review was to address: (1) How is spinal stability assessed? (2) What is the role of bracing/should braces be used? (3) When is it safe to mobilise the patient? (4) What position should the patient be nursed in? Background., Controversy surrounds the care for patients with metastatic spinal cord compression (MSCC). There is some evidence to indicate that care for patients with MSCC is based on individual clinician preference rather than evidence-based guidelines which has been shown to cause delays and discrepancies in patient treatment. Design., A structured literature review to synthesise the available evidence about the management of MSCC. Methods., The following databases were searched: Medline, EMBASE, Cochrane Systematic Reviews Database, SIGN (Scottish Intercollegiate Guidelines Network), NICE (National Institute for Clinical Excellence), AMED (Allied and Complementary Medicine), CINAHL (Cumulative Index to Nursing and Allied Health Literature) and BNI (British Nursing Index). Publications were selected from the past 10 years. The search yielded a total of 1057 hits, 755 abstracts were screened, and 73 articles were retrieved and examined. Thirty-five articles were included. Results., The findings identified a gap and evidence relating to spinal stability, bracing, patient mobilisation, and positioning is limited and may be inconclusive. It is important for patients with a poor prognosis that their preferences and quality of life are considered. Conclusion., Currently, the evidence base to underpin care is limited, and further research in this area is necessary for patients and healthcare professionals alike. Relevance to clinical practice., Patients who suffer from MSCC suffer numerous physical, psychological and social issues. Because of lack of consensus, the current guidelines to inform clinical decision-making of professional staff are of limited benefit. [source] Communication skills for behaviour change in dietetic consultationsJOURNAL OF HUMAN NUTRITION & DIETETICS, Issue 6 2009K. Whitehead Abstract Background:, Both the UK's National Health Service (NHS) and the National Institute of health and Clinical Excellence (NICE) have recommended increased training for health professionals in communication skills. There is evidence to suggest that communication skills are important in helping people to change health-related behaviour, which is a key role for dietitians. This study investigated the views of UK dietitians about their training needs and experience in relation to communication skills in dietetic practice. Methods:, In October 2007, a cross-sectional survey was mailed to all British Dietetic Association members (n = 6013). The survey gathered quantitative data and free-text comments to ascertain the level, type and effect of communication skills training received by dietitians at both the pre- and post-registration level. Results:, There were 1158 respondents; a response rate of 19.3%. Ninety-eight percent (n = 1117) rated communication skills as either very or extremely important in client consultations. Post-registration training had been undertaken by 73% (n = 904). Of these, over 90% of respondents perceived that post-registration training had led to improvements in their relationships with patients, their confidence in client interviews and their ability to cope with challenging clients. However, 248 (21.4%) felt time keeping in interviews had worsened. Lack of time for client interviews was also the most commonly identified barrier (19%, n = 216) to implementing the skills. Conclusions:, This study has explored an important and under-researched area. Respondents strongly endorsed the importance of good communication skills and the benefits of post-registration training in this area. Some felt that good communication was time consuming but others felt that time management had improved. Further research and training is required to support the implementation of these skills into dietetic practice. [source] Guidelines to Practice Gap in the Use of Glycoprotein IIb/IIIa Inhibitors: From ISAR-REACT to Overreact?JOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 2 2009G. VISWANATHAN M.R.C.P. Adjunctive use of glycoprotein IIb/IIIa inhibitors (GPI) is associated with favorable outcomes following percutaneous coronary intervention (PCI). Guidelines for use of GPI have been published by various national societies including National Institute of Clinical Excellence (NICE), United Kingdom. The latter has not been updated since publication. The impact of contemporary trials such as ISAR-REACT (which showed no benefit of abciximab and 600 mg of clopidogrel compared with 600 mg of clopidogrel alone, in elective patients) on adherence to NICE guidelines is unknown. Methods: We audited use of GPI against NICE guidelines following publication in May 2002. Data were collected from 1,685 patients between September and November in years 2002, 2003, 2004, and 2007. Results: In 2002 and 2003, only 10.2% and 11.8%, respectively, of patients were noncompliant to NICE guidelines. Over time, there was an increase in patients not given GPI despite meeting NICE criteria. After publication of ISAR-REACT, the comparative figures for noncompliance in 2004 and 2007 were 40.0% and 44.5%. A similar pattern was seen in patients with diabetes; in 2002 and 2003 noncompliance was 16.7% and 11.1%, respectively, and in 2004 and 2007 noncompliance was 38.0% and 44.7%, respectively. Qualitatively, similar findings were recorded in patients with NSTE-ACS. The overall noncompliance to NICE guidelines increased from 11.0% to 42.1% (P < 0.0001) after the ISAR-REACT study. Conclusions: We found a decline in compliance to NICE guidelines on GPI usage during PCI. This was likely influenced by contemporary trials demonstrating little or no benefit of GPI in patients undergoing elective PCI who are adequately pretreated with clopidogrel. Our findings suggest the need for a mechanism whereby regular updates to guidelines can be disseminated following new trial evidence. [source] Evidence based guidelines and current practice for physiotherapy management of knee osteoarthritisMUSCULOSKELETAL CARE, Issue 1 2009Nicola E. Walsh MSc MCSP Abstract Objectives:,To document physiotherapy provision for patients with knee osteoarthritis (OA) in relation to the United Kingdom (UK) recently published National Institute of health and Clinical Excellence (NICE) guidelines for osteoarthritis. Design:,Questionnaire survey of chartered physiotherapists. Method:,300 postal questionnaires were distributed to Physiotherapy Departments requesting information regarding source of referrals, treatment aims, preferred methods of treatment and service delivery. Results:,Responses were received from 83 physiotherapists (28 %), predominantly working in the UK National Health Service. Approximately equal numbers of referrals came from primary and secondary care. Aims of physiotherapy management were to; encourage self-management; increase strength and range of movement; reduce pain; and improve function. To achieve these, exercise was utilised by 100% of practitioners, often supplemented with electrotherapeutic modalities (66%), manual therapy (64%) and acupuncture (60%). The majority of patients received individual treatment for a total contact time of 1,2 hours, whilst most group interventions lasted 5,6 hours. Approximately half (54%) of respondents reported using outcome measures to determine treatment efficacy. Conclusions:,Although knee OA is usually managed in primary care, the similar number of referrals from primary and secondary care may suggest a deviation from evidence-based management guidelines. The guidelines' recommendations of exercise, patient education and self-management are observed by physiotherapists, but other modalities are often used despite poor or no research evidence supporting their efficacy. Whether any of these interventions are clinically beneficial is speculative as treatment outcomes were frequently under-evaluated. Copyright © 2008 John Wiley & Sons, Ltd. [source] Response to NICE: Guidelines for the treatment of antisocial personality disorderPERSONALITY AND MENTAL HEALTH, Issue 1 2010Donald W. Black No abstract is available for this article. [source] ABCD position statement on screening for gestational diabetes mellitusPRACTICAL DIABETES INTERNATIONAL (INCORPORATING CARDIABETES), Issue 4 2007FRCP Consultant Physician, S Robinson MD, Senior Lecturer Abstract Gestational diabetes mellitus is an increasingly common medical problem seen in pregnancy. A randomised clinical trial, published in 2005, showed improved perinatal morbidity and mortality in pregnancies of women with actively managed gestational diabetes. Prior to 2003 the evidence base for screening and treating all women with gestational diabetes was not strong enough for the National Institute for Clinical Excellence (NICE), in its 2003 antenatal guidelines, to recommend universal screening for gestational diabetes. As we await the review of these original 2003 NICE guidelines we offer a pragmatic approach for the detection of glucose intolerance in pregnancy. Copyright © 2007 John Wiley & Sons. [source] Combination treatment of insulin with oral hypoglycaemic agents in patients with type 2 diabetes mellitusPRACTICAL DIABETES INTERNATIONAL (INCORPORATING CARDIABETES), Issue 8 2004AN Dixon MRCP (UK) Clinical Research FellowArticle first published online: 7 DEC 200 Abstract The recently published guidelines from the National Institute for Clinical Excellence (NICE) on the management of blood glucose in type 2 diabetes and the NICE guidelines on the use of the long-acting insulin analogue, glargine, have brought to the fore the use of combination therapy of insulin with oral hypoglycaemic agents (OHAs). The NICE guidelines recommend that when a patient with type 2 diabetes is failing to achieve satisfactory glycaemic control with OHAs alone, insulin should be initiated in combination with OHAs. However, evidence for this approach is less than robust and combination treatment of OHAs with insulin remains a controversial area. This article presents the evidence for different insulin regimens in patients who have secondary failure to OHAs, including combination therapy with basal insulin. The evidence and potential drawbacks of such regimens are discussed. Copyright © 2004 John Wiley & Sons, Ltd. [source] 11th annual NICE conference: innovation and valuePRESCRIBER, Issue 1-2 2010Article first published online: 4 FEB 2010 NICE held their annual conference last month with the theme of innovation and value. We have highlighted a selection of the principal sessions. Copyright © 2010 Wiley Interface Ltd [source] Latest news and product developmentsPRESCRIBER, Issue 12 2008Article first published online: 14 JUL 200 Patients want to stop ,Z' drugs more than benzos A study from Lincolnshire has revealed that patients prescribed a ,Z' drug - zaleplon (Sonata), zolpidem or zopiclone - for insomnia are more likely to want to stop treatment than those prescribed a benzodiazepine (Br J Gen Pract 2008;58:417-22). The cross-sectional survey of 705 patients prescribed a hypnotic for insomnia found that more patients taking a Z drug wanted to stop (23 vs 12 per cent prescribed a benzodiazepine) and tried to stop treatment (52 vs 41 per cent). New NICE guidance NICE has published an updated clinical guideline for the management of type 2 diabetes, covering: the control of blood glucose with lifestyle modification, oral hypoglycaemic drugs and insulin; reducing blood pressure and lipids, antithrombotic therapy and estimating cardiovascular risk; and screening and treatment for long-term complications. There is also a new clinical guideline on cardiovascular risk assessment and the modification of blood lipids for the primary and secondary prevention of cardiovascular disease. New technology appraisals include the use of erythropoietin analogues for cancer-associated anaemia, and adalimumab (Humira) and etanercept (Enbrel) for ankylosing spondylitis; infliximab (Remicade) is not recommended. See New from NICE (pages 13-14) for further details. Prescriber consultant editor wins award Professor Tony Avery, professor of primary care at Nottingham University and consultant editor for Prescriber, has won the John Fry Award for his work in promoting the discipline of general practice through research and publishing as a practising GP. The citation acknowledges Professor Avery as ,quite simply one of the best researchers we have had in general practice,' describing his output of original work and research as impressive. The award commemorates the work of the late Dr John Fry, perhaps the most prominent GP of his generation involved in research. Antihypertensive dose ignores adherence Clinicians take no account of poor adherence when they increase the dose of antihypertensive therapy due to apparent lack of effect, US researchers say (Circulation 2008; published online May 27; doi 10.1161/CIRCULATIONAHA.107.724104). Their retrospective analysis included reimbursement records for 38 327 patients with hypertension who presented with elevated BP (140-200/>90mmHg) in one year (mean 1.8 events per patient). After adjusting for potential confounders, they found that antihypertensive medications were added or the dose of medication increased in about one-third of patients regardless of the degree of nonadherence in the previous year. LABAs improve COPD Inhaled long-acting beta2-agonists (LABAs) improve COPD and do not increase the risk of death, a new safety review has concluded (Chest 2008;133:1079-87). The meta-analysis of 27 RCTs in patients with moderate to severe stable COPD found that LABAs reduced exacerbations by 22 per cent, improved lung function, reduced use of rescue medication and improved quality of life. There was no effect on respiratory deaths, though a combination of a LABA with an inhaled steroid reduced the risk by two-thirds compared with LABA monotherapy. Tiotropium (Spiriva) was associated with a 50 per cent lower risk of exacerbations than LABAs. These findings follow the MHRA's review of LABAs in the treatment of asthma, which found no increase in mortality provided they are used with an inhaled steroid (Drug Safety Update 2008;1:9). Naproxen as effective in acute gouty arthritis Naproxen is as effective as prednisolone in the treatment of acute gouty arthritis, say researchers from The Netherlands (Lancet 2008;371:1854-60). Their study in 118 primary care patients showed that five days' treatment with naproxen 500mg twice daily or prednisolone 35mg daily reduced pain scores to a similar extent with a comparable incidence of adverse effects. Copyright © 2008 Wiley Interface Ltd [source] Latest news and product developmentsPRESCRIBER, Issue 9 2008Article first published online: 21 MAY 200 Dabigatran launched Dabigatran (Pradaxa), an orally active direct thrombin inhibitor, has been introduced for the prophylaxis of venous thromboembolism in patients undergoing elective total hip or knee replacement. Treatment is initiated within four hours of surgery and continued for 10 days after knee replacement and 28-35 days after hip replacement. Dabigatran has been shown to be as effective and well tolerated as enoxaparin (Clexane). The launch was widely publicised in the lay media; the charity Lifeblood claimed it could help prevent tens of thousands of deaths. NICE is preparing a technology appraisal of the new agent but it has not announced a publication date. Loop diuretics may increase bone loss Continuous use of a loop diuretic appears to double the rate of bone loss in men compared with nonusers, an observational study suggests (Ann Intern Med 2008;168: 735-40). Up to five years' follow-up of 3269 men aged over 65 revealed that the mean rate of bone loss in the hip among those who did not use a loop diuretic was 0.33 per cent compared with 0.78 per cent among users and 0.58 per cent in those who had intermittently used a loop diuretic. Use of these agents should be included as a risk factor for fractures, the authors suggest. Rosuvastatin not for heart failure patients? Prescribers should pause before using rosuvastatin (Crestor). in patients with heart failure and ischaemic heart disease, the National Prescribing Centre (NPC). says. Commenting on the CORONA trial (N Engl J Med 2008; published online 5 Nov 2007; 10.1056/NEJMoa 0706201)., which found no reduction in cardiovascular events or mortality in older patients with systolic heart failure despite a reduction in LDL-C, the NPC says GPs should still consider evidence-based statins such as simvastatin in this patient group. The reason for the outcome of CORONA is unclear but the NPC points out that not all statins affect mortality equally. Rimonabant CV benefits sustained Two-year follow-up of the RIO-Europe trial has shown that the benefits of rimonabant (Acomplia). on weight loss and cardiovascular risk factors are sustained with continuing treatment (Eur Heart J 2008; published online doi: 10.1093/ eurheartj/ehn076). In addition to a dietary deficit of 600kcal per day, rimonabant 20mg per day achieved greater mean weight loss (5.5 vs 1.2kg). and improvements in waist circumference, HDL-cholesterol, triglycerides, fasting glucose and insulin levels, insulin resistance, and metabolic syndrome prevalence compared with placebo. Many patients discontinued treatment (placebo 42 per cent, rimonabant 45 per cent). but, although psychiatric events were more common with rimonabant during the first year, there was little difference in patients remaining in the second year. Early glatiramer cuts MS progression risk Early treatment with glatiramer acetate (Copaxone). appears to reduce the risk of progression to multiple sclerosis (MS), according to a study presented at the 60th Annual Meeting of the American Academy of Neurology in Chicago. Interim analysis of the PreCISE trial showed that, in patients with a single episode and MRI suggestive of MS, glatiramer was associated with a lower incidence of progression to a second episode of MS compared with placebo (25 vs 43 per cent). The placebo arm of the trial has now been stopped. NRT before quitting Beginning nicotine replacement therapy (NRT) before stopping smoking may double the six-month success rate compared with beginning treatment on the scheduled quit day, a meta-analysis suggests (Addiction 2008;103: 557-63). The analysis of four trials involving 755 participants found that starting NRT two to four weeks before the agreed quit date was twice as likely as the conventional strategy to achieve abstinence after six weeks and six months. Copyright © 2008 Wiley Interface Ltd [source] Latest news and product developmentsPRESCRIBER, Issue 8 2008Article first published online: 12 MAY 200 Glargine preferred to lispro as type 2 add-on Basal insulin glargine (Lantus) and insulin lispro (Humalog) at mealtimes improved glycaemic control equally well in patients with type 2 diabetes poorly controlled by oral agents, but patient satisfaction was greater with basal insulin (Lancet 2008;371:1073-84). The 44-week APOLLO trial, funded by Sanofi Aventis, was a nonblinded randomised comparison of basal and prandial insulin regimens added to oral treatment in 418 patients. It found similar reductions in HbA1C (,1.7 vs ,1.9 per cent respectively). Fasting and nocturnal glucose levels were lower with insulin glargine and postprandial levels were lower with insulin lispro. The basal regimen was associated with fewer hypoglycaemic events (5.2 vs 24 per patient per year), less weight gain (3.01 vs 3.54kg) and greater improvement in patient satisfaction scores. Treating hypertension cuts mortality in over-80s Treating hypertension in the over-80s reduces all-cause mortality by 21 per cent, the HYVET study has shown (N Engl J Med online: 31 March 2008; doi: 10.1056/NEJMoa 0801369). Compared with placebo, treatment with indapamide alone or with perindopril for an average of 1.8 years also reduced the incidence of fatal stroke by 39 per cent, cardiovascular death by 23 per cent and heart failure by 64 per cent. The incidence of stroke was reduced by 30 per cent but this was of borderline statistical significance. Fewer serious adverse events were reported with treatment than with placebo. New work for NICE The DoH has announced the 18th work programme for NICE. Seven public health interventions include preventing skin cancer, smoking by children and excess weight gain during pregnancy. Public health guidance will include the provision of contraceptive services for socially disadvantaged young people. Two new clinical guidelines are sedation in young people and management of fractured neck of femur. New technology appraisals may include eight therapies for cancer, two new monoclonal antibodies for psoriasis and rheumatoid arthritis, an oral retinoid for severe chronic hand eczema and methylnaltrexone for opioid-induced bowel dysfunction. Combinations no better against CV disease Taking ezetimibe and simvastatin (Inegy) does not appear to slow the progression of atherosclerosis more than high-dose simvastatin alone, say researchers from The Netherlands (N Engl J Med 2008;358: 1431-43). In patients with hypercholesterolaemia, there was no difference in regression or progression of atherosclerosis after two years' treatment with simvastatin 80mg per day alone or combined with ezetimibe 10mg per day. Adverse event rates were similar. In patients with vascular disease or high-risk diabetes, there was no difference between the ACE inhibitor ramipril 10mg per day or the ARB telmisartan (Micardis) 80mg per day as monotherapy, or their combination, in the risk of a composite outcome of cardiovascular death, MI, stroke and admission for heart failure (N Engl J Med 2008;358:1547-59). Combined treatment was associated with higher risks of hypotensive symptoms, syncope and renal dysfunction. Twice-daily celecoxib increases CV risk Taking celecoxib (Celebrex) twice daily carries a higher risk of cardiovascular events than the same total dose taken once daily, a metaanalysis suggests (Circulation 2008; doi: 10.1161/ CIRCULATIONAHA.108. 764530). The analysis of six placebo-controlled trials involving a total of 7950 patients taking celecoxib for indications other than rheumatoid arthritis found that the combined risk of cardiovascular death, myocardial infarction, stroke, heart failure or thromboembolic event increased with dose over the range 400-800mg per day. The risk was significantly greater with 200mg twice daily (HR 1.8) than 400mg once daily (HR 1.1). Patients at greatest baseline risk were at disproportionately increased risk from celecoxib. Long-term etanercept effective in AS An open-label study suggests that etanercept (Enbrel) remains effective in the treatment of ankylosing spondylitis in the long term (Ann Rheum Dis 2008;67:346-52). Of 257 patients who completed six months' treatment with etanercept and who entered the nonblinded extension study, 126 completed a total of 168-192 weeks' treatment. The commonest adverse events were injection-site reactions (22 per cent), headache (20 per cent) and diarrhoea (17.5 per cent). The annual rate of serious infections was 0.02 per person. Response and partial remission rates after 192 weeks were similar to those reported after 96 weeks. Metformin reduces risk Metformin reduces the risk of developing diabetes in individuals at increased risk, a meta-analysis suggests (Am J Med 2008;121:149-57.e2). The study included 31 mostly small, randomised, controlled trials involving a total of 4570 participants and lasting at least eight weeks (8267 patient-years of treatment). Metformin was associated with reductions in body mass (,5.3 per cent), fasting glucose (,4.5 per cent) and insulin resistance (,22.6 per cent); lipid profiles also improved. The odds of developing diabetes were reduced by 40 per cent,an absolute risk reduction of 6 per cent over 1.8 years. MHRA clarifies cough and colds advice Press reports mistakenly suggested that the MHRA had banned some cough and cold remedies when it issued new guidance on treating young children, the MHRA says. The Agency's advice followed a review of over-thecounter cough and cold medicines for children by the Commission on Human Medicines. Children under two are at increased risk of adverse reactions and should no longer be treated with products containing antihistamine (chlorphenamine, brompheniramine, diphenhydramine), antitussives (dextromethorphan, pholcodine), expectorants (guaifenesin, ipecacuanha) and decongestants (phenylephrine, pseudoephedrine, ephedrine, oxymetazoline and xylometazoline). The MHRA said these products, which are classified as general sale medicines, should be removed from open shelves until available in new packaging that complies with the advice. They may still be supplied by a pharmacist for the treatment of older children. Coughs and colds should be treated with paracetamol or ibuprofen for fever, a simple glycerol, honey or lemon syrup for cough, and vapour rubs and inhalant decongestants for stuffy nose. Saline drops can be used to thin and clear nasal secretions in young babies. Parents are being urged not to use more than one product at a time to avoid inadvertently administering the same constituent drug twice. Perindopril brand switch Servier Laboratories is replacing its current formulations of perindopril (Coversyl, Coversyl Plus) with a new product that is not bioequivalent. The current Coversyl brand contains perindopril erbumine (also known as tert -butylamine). The new formulation contains perindopril arginine; it will be distinguished by new brand names (Coversyl Arginine, Coversyl Arginine Plus) and new packaging. Coversyl 2, 4 and 8mg tablets are equivalent to Coversyl Arginine 2.5, 5 and 10mg. Servier says the change is part of the simplification and harmonisation of global manufacturing; the arginine salt is already used in other countries and offers greater stability and a longer shelf-life. Both Coversyl and Coversyl Arginine will be in the supply chain for the next few weeks. Generic perindopril will continue to be the erbumine salt and prescriptions for generic perindopril are not affected. New from NICE Diabetes in pregnancy: management of diabetes and its complications from preconception to the postnatal period. Clinical Guidance No. 63, March 2008 This clinical guideline focuses on additional aspects of care for women with gestational diabetes (88 per cent of cases) or pre-existing diabetes (of which about 40 per cent is type 2 diabetes) and their babies. To date, insulin aspart (NovoRapid) is the only drug in the guideline specifically licensed for use in pregnancy and NICE advises obtaining informed consent to implement its recommendations for using other insulins and oral hypoglycaemic agents. As with other guidelines, NICE begins by stressing the importance of patient-centred care and involving women in decisions about their treatment. The guideline is divided into six sections, dealing with consecutive periods of pregnancy. Preconceptual planning should include empowering women to help them reduce risks, optimising glycaemic control (after retinal assessment) and increasing monitoring intensity, and providing information about the effects of pregnancy on diabetes. Metformin may be recommended as an adjunct or alternative to insulin, but other oral hypoglycaemic agents should be replaced with insulin, although glibenclamide is an option during pregnancy. Isophane insulin is the preferred long-acting insulin; lispro (Humalog) and aspart are considered safe to use. ACE inhibitors and angiotensin-II receptor blockers should be replaced with other antihypertensive agents and statins should be discontinued. Recommendations for screening and treatment of gestational diabetes build on previous guidance (CG62). Drug treatment will be needed by 10-20 per cent , this includes insulin (soluble, aspart or lispro) and/or metformin or glibenclamide, tailored to individual need. Antenatal care includes optimising glycaemic control. Insulin lispro or aspart should be considered in preference to soluble insulin. If glycaemic control cannot be achieved with insulin injections, an insulin pump may be indicated. The guideline includes a timetable for appointments and the care that should offered after each interval. Recommendations for intrapartum care, which supplement those in CG55, include frequent monitoring of blood glucose. Neonatal care includes recommendations for monitoring and screening the infant and the management of hypoglycaemia. Postnatal care (supplementing CG37) involves adjusting maternal treatment to avoid hypoglycaemia and recommendations for returning to community care. Metformin and glibenclamide are the only oral agents suitable for breastfeeding women. Women with gestational diabetes need advice about glycaemic control and planning for future pregnancies. Lifestyle advice and measurement of annual fasting plasma glucose should be offered. Inhaled corticosteroids for the treatment of chronic asthma in adults and in children aged 12 years and over. Technology Appraisal No. 138, March 2008 The latest technology appraisal of asthma treatments covers inhaled steroids for adults and children over 12 with chronic asthma. It makes only two recommendations. First, the cheapest appropriate option is recommended. Second, when a steroid and a long-acting beta2-agonist are indicated, the decision to prescribe a combined inhaler or separate devices should take into account therapeutic need and likely adherence. Combined inhalers are currently less expensive than separate devices, though they may not remain so. When a combined inhaler is chosen it should be the cheapest. NICE concludes that, at equivalent doses, there is little difference in the effectiveness or adverse event profile of the available steroids or the fixed-dose combinations. According to specialist advice, choosing the best device for an individual remains the overriding concern. Continuous positive airway pressure for the treatment of obstructive sleep apnoea/hypopnoea syndrome. Technology Appraisal No. 139, March 2008 NICE recommends continuous positive airway pressure (CPAP) for adults with moderate or severe obstructive sleep apnoea, and for those with a milder disorder if quality of life and functioning are impaired and alternative strategies such as lifestyle change have failed. Diagnosis and treatment is the responsibility of a specialist team. A CPAP device costs £250-£550 and lasts for seven years. Copyright © 2008 Wiley Interface Ltd [source] Latest news and product developmentsPRESCRIBER, Issue 7 2008Article first published online: 28 APR 200 Referrals from Boots The majority of people requesting Boots' erectile dysfunction or weight management programmes are referred to their GP(Pharm J 2008;280:297). The programmes are run under patient group directions and exclude people with elevated blood pressure, blood glucose or cholesterol. Over 80 per cent of customers screened for the erectile dysfunction programme in Manchester and two-thirds of those screened for the national obesity programme were referred. Vildagliptin: new DPP-4 inhibitor for diabetes Novartis has introduced the DPP-4 inhibitor vildagliptin for the treatment of type 2 diabetes. Two formulations are available: Galvus (vildagliptin 50mg) is licensed for use with metformin, a sulphonylurea or a thiazolidinedione when these agents do not achieve glycaemic control alone, and Eucreas (vildagliptin 50mg plus metformin 850 or 1000mg) is licensed for patients requiring combined therapy with vildagliptin and metformin. Inhibition of DPP-4 blocks the breakdown of the incretin hormones GIP and GLP-1, reducing fasting plasma glucose and postprandial hyperglycaemia. Vildagliptin is the second DPP-4 inhibitor to be introduced; the first was sitagliptin (Januvia), which has similar licensed indications. The third available drug acting on the incretin system is the incretinmimetic exenatide (Byetta); administered by injection, this is licensed for use with metformin and/or a sulphonylurea and is the only agent in this class to be approved for triple therapy. No comparative trials of these agents have been published. A month's treatment with twice-daily vildagliptin 50mg or either strength of vildagliptin plus metformin costs £31.76. Sitagliptin 100mg once daily costs £33.26. Sinusitis symptoms don't guide treatment The severity and duration of symptoms do not help to identify which patients with sinusitis will be helped by antibiotics, a new meta-analysis suggests (Lancet 2008;371: 908-14). The analysis of patient-level data from nine trials involving a total of 2547 adults showed that the number needed to treat (NNT) to cure one patient with rhinosinusitis was 15. Cure took longer to achieve in older patients and in those reporting symptoms for longer or with more severe symptoms. The authors comment that treatment is not justified given the risk of resistance and adverse effects and cost of antibiotics. Draft guidance from the National Institute for Health and Clinical Excellence (NICE) on the management of respiratory infections states that no antibiotic therapy or a delayed antibiotic prescribing strategy should be negotiated for patients with acute sinusitis. Taking cod liver oil leads to fewer NSAIDs Cod liver oil could help some patients with rheumatoid arthritis to reduce their NSAID consumption, according to a study from Dundee (Rheumatology online: 24 March 2008; doi: 10.1093/rheumatology/ ken024). A total of 97 patients were randomised to nine months' treatment with cod liver oil 10g per day or placebo. After 12 weeks, patients attempted to reduce or stop their use of NSAIDs. Significantly more of those taking cod liver oil achieved at least a 30 per cent reduction in NSAID use compared with placebo (39 vs 10 per cent). There were no differences in adverse effects or disease activity. Welsh prescriptions up The reduction in the prescription charge in Wales in 2004 was followed by an increase in prescribing of nonsedating antihistamines in wealthier areas, a study suggests (Health Policy online: 5 March 2008; doi:10.1016/j. healthpol.2008.01.006). In the two years preceding the cut, prescriptions for nonsedating antihistamines increased by about 7 per cent; in the two years after the cut, the increase was nearly 14 per cent. By contrast, there was no change in the rate of increase in the south-east of England (4,5 per cent in both periods). The increased growth in prescribing was statistically significant in the five least deprived but not in the five most deprived health boards in Wales. Aspirin linked with reduced asthma risk Low-dose aspirin is associated with a reduced risk of developing asthma, a new analysis of the Women's Health Study has shown (Thorax online: 13 March 2008; doi:10.1136/ thx.2007.091447). The analysis included 37 270 women with no asthma at baseline who were randomised to take placebo or aspirin 100mg every other day. After 10 years, 872 cases of asthma occurred in women taking aspirin and 963 with placebo, a 10 per cent reduction in risk. However, risk was not reduced in obese women. The mechanism by which aspirin may affect the risk of asthma is unknown. The latest evidence is consistent with findings published by the same investigators after analysis of two other large observational studies, the Physicians' Health Study and the Nurses Health Study. Anastrozole bone loss Long-term follow-up of the ATAC (Anastrozole, Tamoxifen, Alone or in Combination) trial has confirmed that adjuvant therapy with anastrozole (Arimidex) is associated with greater loss of bone mineral density (BMD) than tamoxifen in postmenopausal women with invasive primary breast cancer (J Clin Oncol 2008;26: 1051,7). After five years, median BMD was reduced by 6 and 7 per cent in the lumbar spine and hip with anastrozole compared with approximately 3 and 1 per cent respectively for tamoxifen, though no patients developed osteoporosis. Copyright © 2008 Wiley Interface Ltd [source] Latest news and product developmentsPRESCRIBER, Issue 6 2008Article first published online: 24 APR 200 Government responds to NICE report The Government has published its response to the Health Select Committee's report into NICE, broadly arguing that the Committee's recommendations are either already being dealt with or are not appropriate. The Committee recommended appraisals for all new drugs, shorter, rapid appraisals to coincide with their launch, and improved mechanisms for setting drug prices. The Government says its negotiations on the PPRS preclude a detailed response but suggests a rapid system may not be transparent or legally robust. It is exploring how high-cost drugs can be brought within the payment-by-results tariff. While defending NICE's reliance on QALYs, the Government accepts the need to explore how wider economic factors can be considered. As for the threshold cost per QALY by which NICE defines cost effectiveness, it says this is being validated scientifically and NICE will continue to determine the threshold. More topically, the Committee criticised the quality of clinical trial data available to NICE. The Government sees no need to compel pharmaceutical companies to disclose information and says NICE is already becoming more involved with research programmes. All clinical trials must be registered (confidentially) with the EU and the Government believes mandatory registration in the UK would be ineffective and illegal. Prescription charge up again from April The Government has raised the prescription charge by 25p to £7.10 per item with effect from 1 April. Prescription prepayment certificates will cost £27.85 for three months and £102.50 for 12 months. The increase, below the annual rate of inflation for the 10th successive year, will be levied on the 12 per cent of prescriptions that are liable for the charge: 5 per cent via prepayment certificates and 7 per cent from other prescriptions. The charge will generate £435 million in England in 2008/09; this excludes money from prescriptions written by dispensing doctors, which is retained by the PCT. Following criticism of the charge by the Health Select Committee, the Government says it has reviewed the charge and is now consulting on ,cost-neutral' options. MHRA safety update The MHRA warns of possible dose errors associated with Boots Medisure Domiciliary Dosage System in its latest issue of Drug Safety Update (2008;1:issue 8). One case has been reported in which incomplete sealing allowed tablets to mix between compartments. No other cases are known and the MHRA says no harm was reported but the risk is serious. The system should be carefully sealed and inspected visually and physically. The MHRA reaffirms its plans to reclassify all pseudoephedrine and ephedrine products to prescription-only status in 2009 if the new restrictions on sales do not reduce misuse. Other topics in this month's Update include revised indications for oral ketoconazole (Nizoral), restricting its use to selected conditions unresponsive to topical therapy; reformulation of the injectable antibiotic Tazocin (piperacillin plus tazobactum); the risk of peripheral neuropathy associated with pegylated interferon and telbivudine (Sebivo) in the treatment of hepatitis B; and serious adverse events associated with modafinil (Provigil). First oral anticoagulant since warfarin In January this year the EMEA issued a positive opinion to recommend marketing authorisation of the oral, fixed-dose, direct thrombin inhibitor dabigatran etexilate (Pradaxa) for the primary prevention of venous thromboembolism (VTE) in adult patients that have undergone elective knee or hip replacement surgery. Marketing authorisation for the EU (including the UK) is expected from the European Commission in the next few weeks, making dabigatran the first oral anticoagulant since warfarin was introduced in 1954. Dabigatran etexilate has been shown to be as safe and effective as enoxaparin (Clexane) with a similar adverse event profile in the noninferiority phase III RENOVATE (Lancet 2007;370: 949-56) and RE-MODEL (J Throm Haemost 2007;5:217885) trials, which investigated the efficacy and safety of dabigatran compared to enoxaparin in reducing the risk of VTE after total hip and knee surgery respectively. Dabigatran has the practical advantage over low-molecular-weight heparin of oral postoperative administration and no risk of heparin-induced thrombocytopenia and, unlike warfarin, does not require monitoring or dose titration. Risk scale predicts anticholinergic effects US investigators have developed a scale for predicting the risk of anticholinergic side-effects from older patients' medicines (Arch Intern Med 2008;168: 508-13). The scale assigns a score from 1 (low) to 3 (high) for the risk of anticholinergic effects such as dry mouth, constipation and dizziness associated with commonly prescribed medicines. Checking the scale retrospectively in older patients in residential care, a higher score was associated with a 30 per cent increased risk of side-effects after adjustment for age and number of medicines. When this was repeated prospectively in a primary-care cohort, the increased risk was 90 per cent. HRT cancer risk persists The latest analysis of the Women's Health Initiative (WHI) trial of HRT shows that the small increase in the risk of cancer persists for up to three years after stopping treatment (J Am Med Assoc 2008;299:1036-45). WHI was stopped after 5.6 years' follow-up when it became clear the risks of HRT outweighed its benefits. This follow-up after a further three years (mean 2.4) involved 15 730 women. The annual risk of cardiovascular events was similar for HRT (1.97 per cent) and placebo (1.91 per cent). Cancers were more common among women who had taken HRT (1.56 vs 1.26 per cent), in particular breast cancer (0.42 vs 0.33 per cent). All-cause mortality was higher, but not statistically significantly so, with HRT (1.20 vs 1.06 per cent). Tight glycaemic control may increase falls Maintaining HbA1C at or below 6 per cent with insulin is associated with an increased risk of falls, a US study suggests (Diabetes Care 2008;31:391-6). The Health, Aging and Composition study involved 446 older people with type 2 diabetes (mean age 74) followed up for approximately five years. The incidence of falls ranged from 22 to 30 per cent annually. Comparing subgroups with HbA1C of ,6 per cent and >8 per cent, an increased risk of falls was associated with insulin use (odds ratio 4.4) but not oral hypoglycaemic drugs. Copyright © 2008 Wiley Interface Ltd [source] Latest news and product developmentsPRESCRIBER, Issue 5 2008Article first published online: 3 APR 200 Newer antidepressants no better than placebo? A new meta-analysis suggests that newer antidepressants are no superior to placebo in most patients with depression , the exception being those with very severe depression, who can expect a small benefit. Writing in the online-only open access journal PLoS Medicine (5:e45.doi:10.1371/ journal.pmed.0050045), researchers from Hull and the US analysed published and unpublished trials submitted to the Food and Drug Administration in marketing applications for fluoxetine, paroxetine, venlafaxine (Efexor) and nefazodone (no longer available). Using the Hamilton Rating Scale for Depression (HRSD) score as an endpoint, meta-analysis of 35 trials involving 5133 patients and lasting six to eight weeks showed that mean HRSD score improved by 9.6 points with drug treatment and 7.8 with placebo. The authors say the difference of 1.8 was statistically significant but below the criterion for clinical significance (3.0) set by NICE in its clinical guideline on depression. A review of the study by the NHS Knowledge Service (www.nhs.uk) points out that it omits trials published after the drugs were licensed (1999) and those not sponsored by the pharmaceutical industry. It did not include any patients with severe depression and only one trial in patients with moderate depression. An earlier US study of data submitted to the FDA (N Eng J Med 2008;358:25260) showed that published trials of antidepressants were more likely to be positive (37/38) than unpublished ones (3/25). Further, FDA analysts concluded that 51 per cent of trials (published and unpublished) demonstrated positive findings compared with 94 per cent of those that were published. Audit reveals variations in hospital psoriasis care There are unacceptably large variations in the quality of care for patients with psoriasis in UK hospitals, a report by the British Association of Dermatologists and the Royal College of Physicians reveals. The audit of 100 hospital units found that 39 per cent restricted access to biological therapies because of cost, and over one-third of pharmacies could not supply ,specials' such as topical coal tar preparations. More positively, the units are adequately resourced to provide timely communication with GPs. RCGP responds to Public Accounts Committee The Royal College of General Practitioners has agreed with the Commons Public Accounts Committee that drug package labelling should include the cost of the medication. The suggestion was made by the Committee in its report Prescribing Costs in Primary Care. While recognising the importance of generic prescribing, the RCGP cautions against frequent medication switches because it may unsettle patients. ,Any changes must be carried out for sound clinical reasons with good communication between GPs and their patients,' it adds. Statins for patients with kidney disease? Statins reduce cardiovascular risk in people with chronic kidney disease, a new study suggests, but their effects on renal function remain unclear (BMJ 2008; published online doi: 10.1136/bmj. 39472.580984.AE). The meta-analysis of 50 trials involving a total of 30 144 patients found that statins reduced lipids and cardiovascular events regardless of the severity of kidney disease. However, all-cause mortality was unaffected and, although proteinuria improved slightly, there was no change in the rate of decline of glomerular filtration rate. An accompanying editorial (BMJ 2008; published online doi:10.1136/ bmj.39483.665139.80) suggests that the indications for statin therapy to reduce cardiovascular risk in patients with chronic kidney disease should be the same as for those with normal renal function. New NICE guidance New clinical guidelines from NICE (see New from NICE, pages 14,15) include the diagnosis and management of irritable bowel syndrome in adults in primary care, the care and management of osteoarthritis in adults, and the diagnosis and treatment of prostate cancer. In a public health guideline on smoking cessation services, NICE endorses the use of nicotine replacement patches for 12,17 year olds. Suspect additives in children's medicines The Food Commission (www.foodcomm.org.uk) has drawn attention to the presence in children's medicines of food additives it says are linked with hyperactivity. The Commission, a national nonprofit organisation campaigning for ,the right to safe, wholesome food', says that seven common additives (including tartrazine, sodium benzoate and Ponceau 4R) are associated with hyperactivity in susceptible children. Checking the SPCs, it found that 28 of 70 children's medicines , including formulations of paracetamol, ibuprofen, amoxicillin, erythromycin and codeine phosphate throat linctus , contain at least one suspect additive. Digoxin may increase mortality in AF patients An observational study has suggested that digoxin may increase deaths in patients with atrial fibrillation (Heart 2008;94:191,6). The study was a planned subgroup analysis of a trial evaluating anticoagulant therapy in 7329 patients with atrial fibrillation. Of these, 53 per cent were treated with digoxin. Mortality was significantly higher among digoxin users than nonusers (4.22 vs 2.66 per cent per year); myocardial infarction and other vascular deaths (but not stroke, systemic embolic episodes and major bleeding events) were significantly more frequent with digoxin. Poor communications cause readmission Elderly hospital patients are often discharged with inadequate information or arrangements for care, causing almost three-quarters to be readmitted within a week, say investigators from Nottingham (Qual Safety Health Care 2008;17:71,5). Retrospective review of records for 108 consecutive patients aged over 75 found that readmission was related to medication in 38 per cent and, of these, 61 per cent were considered avoidable. Almost two-thirds had no discharge letter or were readmitted before the letter was typed; two-thirds of discharge letters had incomplete documentation of medication changes. Copyright © 2008 Wiley Interface Ltd [source] Latest news and product developmentsPRESCRIBER, Issue 4 2008Article first published online: 20 MAR 200 Suicide warning for all antidepressants All antidepressants are to include a warning of the risk of suicide in their product information, the MHRA says. The requirement formerly applied only to SSRIs but, following a US review of safety data, the Agency says the risk is similar for all classes of antidepressants. Patients at increased risk include young people with psychiatric morbidity and those with a history of suicidal ideation. Patients are at increased risk of suicide until remission occurs, and clinical experience shows that the risk is increased during the early stages of recovery. Confusion over type 2 diabetes management Contradictory findings have been reported from two studies of intensive management of type 2 diabetes. The STENO-2 study (N Engl J Med 2008;358:580-91) found that tight control of blood glucose, blood pressure and lipids plus low-dose aspirin in 160 patients with type 2 diabetes and microalbuminuria significantly reduced all-cause mortality, cardiovascular events, cardiovascular death and microvascular complications by 40-60 per cent. The US National Heart, Blood and Lung Institute has announced the end of the intensive treatment arm of the ACCORD study (unpublished). This study was comparing intensive lowering of blood glucose below currently recommended levels (target HbA1C <6 per cent) with conventional management in adults with type 2 diabetes at especially high risk for heart attack and stroke. Although mortality was reduced in both arms compared with other populations, intensive treatment was associated with increased mortality equivalent to three deaths per 1000 patients per year over four years. Another antibiotics campaign The Government has launched another campaign to promote public awareness that antibiotics are not appropriate for viral infections causing coughs, colds and sore throats. Get Well Soon , Without Antibiotics is supported by a national advertising campaign and leaflets and posters encouraging the public to ask advice rather than demand a prescription. Details are available at www.dh.gov.uk. Episenta: once-daily sodium valproate Following a launch to specialists last year, a new once-daily modified-release formulation of sodium valproate is being promoted more widely to GPs. Episenta is licensed for the treatment of all forms of epilepsy and is formulated as modified-release capsules of 150mg and 300mg and sachets of modified-release granules of 500mg and 1000mg. The dose may be administered once or twice daily. Patients may be switched from enteric-coated tablets of valproate to the same dose given as Episenta. Episenta costs £5.70 or £10.90 for 100 × 150mg or 300mg capsules, and £18 or £35.50 for 100 × 500mg or 1000mg sachets. Latest NICE agenda The Department of Health has referred a new batch of topics for appraisal by NICE. Six of seven technology appraisals are for cancer drugs; the last is for dabigatran etexilate for venous thromboembolism. There will be four new clinical guidelines: autism spectrum disorders, hypertension in pregnancy, bed-wetting in children and severe mental illness with substance abuse. Two combined public health and clinical guidelines will address alcohol misuse. Varenicline vs NRT Varenicline (Champix) offers slightly greater smoking cessation rates than nicotine replacement therapy (NRT) in the long term and better symptom improvement, an international study has shown (Thorax 2008; published online:10.1136/ thx.2007.090647). A total of 746 smokers were randomised to treatment with varenicline 1mg twice daily for 12 weeks or transdermal NRT (21mg reducing to 7mg per day) for 10 weeks. Continuous abstinence rates for the last four weeks of treatment were 56 vs 43 per cent. The corresponding rates for one year were 26 and 20 per cent. Varenicline was associated with greater reductions in cravings, withdrawal symptoms and smoking satisfaction, but more nausea (37 vs 10 per cent). Adverse reactions class effect of statins The MHRA has identified several adverse effects that it says are class effects of the statins (Drug Safety Update 2008;1:Issue 7). Following a review of clinical trials and spontaneous reports, it is now apparent that any statin may be associated with sleep disturbance, depression, memory loss and sexual dysfunction; interstitial lung disease has been reported rarely. Product information is being updated to include the new information. Depression, including suicidal ideation, has also been associated with varenicline (Champix), the MHRA says; affected patients should stop treatment immediately. The combination of transdermal nicotine replacement therapy (NRT) and varenicline appears to be associated with a higher incidence of nausea, headache, vomiting, dizziness, dyspepsia and fatigue than NRT alone. The MHRA has also announced that, following the suspension of marketing authorisation for carisoprodol (Carisoma), it is considering a phased withdrawal of the closely-related meprobamate , the main active metabolite of carisoprodol. Following a successful pilot study, the public are being encouraged to report adverse reactions on yellow cards; the MHRA notes that health professionals provide more complete reports but patients include more information about quality of life. The scheme will be promoted via community pharmacies throughout the UK from February 2008. Cochrane: evidence on back pain interventions The latest release of Cochrane reviews includes three meta-analyses assessing interventions for back pain. Overall, NSAIDs were found to be effective as short-term treatment for acute or chronic back pain but the effect size was small. They were comparable with paracetamol but associated with more adverse effects; COX-2 selective NSAIDs were similarly effective, with slightly fewer adverse effects. There was no evidence that antidepressants reduced back pain but intensive individual patient education (lasting 2.5 hours) was effective for acute and subacute back pain and comparable with manipulation and physiotherapy; its effects on chronic pain were unclear. Copyright © 2008 Wiley Interface Ltd [source] Latest news and product developmentsPRESCRIBER, Issue 3 2008Article first published online: 26 FEB 200 Higher risk of CV events in aspirin resistance More than one in four patients may have aspirin resistance, a new metaanalysis shows, and they face a four-to sixfold increased risk of a major cardiovascular event or death compared with aspirin-sensitive patients taking low-dose aspirin (BMJ online: 17 Jan 2008; doi:10. 1136/bmj.39430.529549.BE). The analysis included 20 studies involving a total of 2930 patients with cardiovascular disease. Of these, 28 per cent were defined as having aspirin resistance (according to the various definitions in each study). Compared with aspirin-sensitive patients, the odds ratio of any cardiovascular event or acute coronary syndrome was about 4 and the odds ratio of death was 6. Aspirin-resistant patients did not benefit from other antiplatelet treatment. ADOPT: rosiglitazone fracture risk in women A new analysis of the ADOPT trial (N Engl J Med 2006;355: 2427-43) has found that the risk of fractures during treatment with rosiglitazone (Avandia) is approximately twice as high as with metformin or glibenclamide, but mainly in women (Diabetes Care online: 25 Jan 2008; doi: 10.2337/dc07-2270). The study found a significant difference in risk between the drugs only for women, with a cumulative incidence of 15.1 per cent with rosiglitazone, 7.3 per cent with metformin and 7.7 per cent with glibenclamide after five years. No risk factors were identified although the incidence of fractures was higher among postmenopausal than premenopausal women. New from NICE Infliximab for the treatment of adults with psoriasis. Technology Appraisal Guidance No. 134, Jan 2008 Infliximab (Remicade), a monoclonal antibody against TNF-alpha, should be an option for treating very severe plaque psoriasis in adults, NICE recommends. Using its fast-track single technology appraisal procedure, NICE concluded that infliximab should be considered when standard therapies,methotrexate or ciclosporin (Neoral), or PUVA , have failed or are unsuitable. The criteria for disease severity are defined by the Psoriasis Area Severity Index (PASI) score (,20) and the Dermatology Life Quality Index (DLQI) score (>18). Treatment response is also defined by these measures and infliximab should be continued for longer than 10 weeks only when predefined thresholds are met. Infliximab costs an average of £11 750 annually. In 2006, NICE recommended etanercept (Enbrel) and efalizumab (Raptiva) for patients with severe psoriasis (PASI ,10 and DLQI >10). Commons committee wants tougher targets Most GPs get full QOF points for medicines management even though there is inexplicably large variation in good prescribing practice between PCTs, the Public Accounts Select Committee points out in its latest report, Prescribing Costs in Primary Care. The Committee wants to see tougher QOF targets among several initiatives to reduce prescribing costs. Although most publicity centred on its endorsement of the National Audit Office claim that GPs could save £200 million by prescribing lower-cost drugs, the report contains some more far-reaching proposals. GPs should prescribe generic alternatives within a therapeutic category, so when a brand is not available generically, eg Lipitor, a different drug that is, eg simvastatin, should be used when clinically appropriate. Further, this form of substitution should be rewarded via QOF targets. There should be greater uniformity in the appearance, labelling and packaging of generic and branded equivalents. The Department of Health should consider raising awareness of the value of medicines by printing the cost on packaging, and to reduce the £100 million wasted annually in dumped medicines, it should investigate which drugs aren't used and why patients won't take them. Strategic health authorities should work with the National Prescribing Centre to develop more prescribing indicators with which to measure PCT performance and support PCTs to promulgate best practice. They should also collaborate on promoting joint primary-secondary care formularies and increase the consistency of prescribing, not only between hospital specialists and GPs but also between PCTs. To monitor the influence of the pharmaceutical industry, PCTs should keep a record of gifts and hospitality and publish a register. Questions to ask about mental health treatment The Department of Health has published a booklet designed to raise awareness of medicines management issues affecting people using mental health services and their carers, and professionals in the health and social services. Although one aim of Medicines Management: Everybody's Business is to empower people with mental health problems to ask about their medication, its formal style is better suited to staff who need to improve their person-centred approach to care. It covers what information people should expect and what questions to ask when drug treatment is being considered, what to expect at review and issues to consider when contemplating stopping treatment. Copies can be downloaded at www.dh.gov.uk. Consider statins for all patients with diabetes Treatment with a statin should be considered for all patients with diabetes unless their risk is low, say the authors of a new study (Lancet 2008;371:117-25). Their meta-analysis of 14 randomised trials involving 18 686 people with diabetes and an average follow-up of 4.3 years found that statins reduced vascular events and vascular mortality as much as in nondiabetic populations. The overall benefit was 42 fewer major events per 1000 people treated for five years. This was independent of a history of vascular disease or other baseline characteristics. No evidence for OTC cough medicines There is no evidence that over-the-counter cough medicines for adults and children are effective in relieving acute cough, a new Cochrane review has concluded (Cochrane Database of Systematic Reviews 2008, Issue 1). The review of 17 randomised trials involving 2876 adults and eight involving 616 children reported conflicting findings of uncertain clinical relevance. The trials were heterogeneous and of low quality. Copyright © 2008 Wiley Interface Ltd [source] Latest news and product developmentsPRESCRIBER, Issue 2 2008Article first published online: 11 FEB 200 NICE should evaluate all new medicines NICE should determine the cost effectiveness of all new medicines, the Health Select Committee has concluded in its second review of the Institute. The review, prompted by criticisms from patients, health professionals and the pharmaceutical industry, found that NICE is doing ,a vital job in difficult circumstances'. The Committee called for the costs to carers and society to be included in cost effectiveness estimates (this is currently prohibited) and for cost per QALY thresholds to be aligned with NHS affordability. NICE should publish brief appraisals at the time of a product launch , these could be used to negotiate prices. GPs responsible for unlicensed co-proxamol GPs who prescribe co-proxamol are now responsible for the consequences, the MHRA warns. The Agency agrees that the drug may be needed by ,a small group of patients who are likely to find it very difficult to change from co-proxamol or where alternatives appear not to be effective or suitable'. Following the withdrawal of product licences, stock that is currently in the supply chain may be dispensed but no new stock should be released by suppliers. The Drug Tariff price of co-proxamol has now increased from £2.79 to £20.36 per 100 tablets. Vitamin D deficiency on the increase Pregnant and breastfeeding women may need vitamin D supplements, the Department of Health has warned, and GPs are seeing increasing numbers of patients with vitamin D deficiency. Endogenous synthesis may be low in some ethnic groups and dark-skinned people, and north of Birmingham there is no light of the appropriate wavelength for the synthesis of vitamin D during the winter. The Department says free vitamin supplements are available for eligible patients through its Healthy Start Scheme (www.healthystart.nhs.uk) and may also be supplied at low cost by some PCTs. Innovation and good practice recognised Innovative practice and better outcomes for patients have been recognised through awards from the NHS Alliance and Improvement Foundation presented by the Secretary of State for Health, Rt Hon Alan Johnson, at the annual NHS Alliance conference held in Manchester. The Mountwood Surgery in Northwood, Middlesex, won the CHD QOF GP Practice Award sponsored by Schering Plough for their outstanding multidisciplinary approach to tackling CHD. In addition to having a highly organised in-house cardiology team, they have produced an interactive, patient-empowering booklet for CHD. Mountwood Surgery achieved blood pressure targets of 96.79 per cent in their CHD patients. North Tees PCT wins the CHD QOF PCO Award, also sponsored by Schering Plough, for their support and encouragement to GP practices to ,own' CHD care. They provide timely feedback of performance data using funnel plots and regular communication by the CHD LIT and Cardiac Network. Even though North Tees PCT has a high CHD prevalence, 4.2 per cent vs 3.6 per cent nationally, across the 27 practices 85 per cent of patients achieved cholesterol targets and 91 per cent reached the QOF blood pressure target. The St Benedict's Hospice Day Centre Project (for the Sunderland Teaching Primary Care Trust) won the Guy Rotherham Award for its excellent multidisciplinary team improvement of the palliative care provided. This team demonstrated a thorough understanding of the use of quality improvement methods to improve patient care, and carefully measured the individual improvements they made. Through the use of a referral ,decision tree', nonattenders were reduced by 300 per cent and average waiting times halved. The Extended Primary Care (EPC) Gynaecology Service (for the Practice Based Commissioning Consortium South Manchester Hub) was highly commended for its development of an effective and innovative service offering gynaecological treatment managed within a primary care setting, allowing patients improved access closer to home. The Salford Perinatal Mental Health Project was also highly commended for effectively challenging the high levels of maternal suicides. The awards were also supported by Prescriber, the British Cardiac Patients Association and the British Cardiac Society. Anastrozole superior to tamoxifen in long term A new analysis of the ATAC trial (Lancet Oncology 2008;9:45-53) shows that the advantages of the aromatase inhibitor anastrozole (Arimidex) over tamoxifen as adjuvant therapy for breast cancer persist for at least four years after the end of treatment. After primary treatment with surgery, chemotherapy or radiotherapy, postmenopausal women with localised invasive breast cancer were randomised to five years' treatment with anastrozole or tamoxifen. Among 5216 women who were hormone-receptor positive, anastrozole increased disease-free survival by 15 per cent after 100 months. Time to recurrence and distant recurrence were also increased, though overall survival was similar; the absolute difference in time to recurrence was greater at nine years (4.8 per cent) than at five years (2.8 per cent). Joint symptoms and fractures were more frequent with anastrozole during treatment but not thereafter. Use a steroid with a LABA , MHRA reminder The MHRA has reminded clinicians that patients treated with an inhaled long-acting beta-agonist (LABA) should also use an inhaled steroid. In the latest edition of Drug Safety Update (2008;1:No.6), the Agency reviews the implications of the SMART study (Chest 2006;129:15-26), which reported an increased risk of respiratory- and asthma-related deaths among patients using salmeterol (Serevent). This is contradicted by epidemiological data suggesting that asthma-related admissions have declined since LABAs were introduced. Randomised trials also do not support such a risk, probably because inhaled steroids are used more consistently in trial settings. The latest Update notes that product licences for carisoprodol (Carisoma) have been suspended due to concerns about the risk of abuse and psychomotor effects. It also includes a comprehensive summary of drug interactions with statins, a warning that methylene blue should not be prescribed for a patient taking a drug with serotonergic activity, and a reminder that only oral formulations of desmopressin are now licensed for primary nocturnal enuresis. This issue of Update is available at www.mhra.gov.uk. Copyright © 2008 Wiley Interface Ltd [source] Latest news and product developmentsPRESCRIBER, Issue 22 2007Article first published online: 28 DEC 200 Glitazones: benefits outweigh the risks Following a review of the safety of rosiglitazone and pioglitazone, the European Medicines Agency (EMEA) has concluded that their benefits outweigh their risks in the approved indications. The review was prompted by reports of an increased risk of fractures in women and, in patients taking rosiglitazone, ischaemic heart disease. The EMEA concluded that prescribing information for rosiglitazone should now include a warning that, in patients with ischaemic heart disease, it should only be used after careful evaluation of each patient's individual risk, and the combination of rosiglitazone and insulin should only be used in exceptional cases and under close supervision. No change was considered necessary to the prescribing information for pioglitazone. Modern dressings no better? A systematic review has found only weak evidence that modern dressings are better than saline gauze or paraffin gauze for healing acute and chronic wounds (Arch Dermatol 2007;143: 1297-304). The analysis, which included 99 studies, found that only hydrocolloids were demonstrably better than older dressings for healing chronic wounds, and alginates were superior to other modern dressings for debriding necrotic wounds. There was no evidence that modern dressings offered superior overall performance to the older alternatives. Hospital inflation twice primary care level The cost of drugs prescribed in secondary care but dispensed in the community increased by 6.4 per cent in 2006 - twice the rate of inflation in primary care - according to the latest statistics on hospital prescribing in England. The increase follows a reduction in costs in 2005 after the introduction of the new PPRS scheme. Data from The Information Centre (www.ic.nhs.uk) show that hospital medicines make up about 24 per cent of the NHS drugs budget. Secondary care has a consistently better record than primary care in prescribing lower-cost alternatives within therapeutic categories, eg simvastatin and pravastatin among the statins, omeprazole and lansoprazole among PPIs, and ACE inhibitors among drugs acting on the renin angiotensin system. The most expensive drug prescribed by hospital specialists and dispensed in the community is interferon beta. MHRA limits the use of fibrates The Medicines and Healthcare products Regulatory Agency (MHRA) has advised that fibrates should now be reserved for the treatment of isolated severe hypertriglyceridaemia. They should be considered for hypercholesterolaemia only when a statin or other treatment is contraindicated or not tolerated. In the latest Drug Safety Update, the MHRA says there is insufficient evidence of long-term benefits from fibrates, and first-line use is no longer justified because the evidence for the benefits of statins is robust. The MHRA also warns that some breastfeeding infants have increased susceptibility to the adverse effects of codeine taken by their mother, and that St John's wort may affect the hepatic metabolism of any anticonvulsant. Annual zoledronic acid infusion cuts mortality after hip fracture Once-yearly infusion of zoledronic acid (Aclasta) after hip fracture reduces deaths over a two-year period by 28 per cent compared with placebo, US investigators say (N Engl J Med 2007;357:1799-809). The HORIZON Recurrent Fracture Trial randomised 2127 men and women (mean age 75) within 90 days of surgery for hip fracture to zoledronic acid 5mg yearly or placebo. Mortality over 1.9 years of follow-up was 9.6 per cent with zoledronic acid and 13.3 per cent with placebo. Zoledronic acid also significantly reduced the rate of any new clinical fractures (by 35 per cent) and new clinical vertebral fractures(by 45 per cent),but the lower rate of hip fracture (2.0 vs 3.5 per cent with placebo) was not statistically significant. Rivastigmine patch for mild to moderate AD Rivastigmine (Exelon) is now available as a transdermal patch for the treatment of mild to moderate Alzheimer's disease. Applied once daily, the patch delivers 9.5mg per 24 hours and, says manufacturer Novartis, is associated with a lower incidence of nausea and vomiting than a comparable oral dose. The patch is available in two strengths: 4.6mg per 24hr is equivalent to oral doses of 3 or 6mg per day, and the 9.5mg per 24hr patch is equivalent to 9 or 12mg per day orally. The recommended dose of the patch is 9.5mg per day; both strengths cost £83.84 for 30 patches. Women more aspirin resistant than men? The cardioprotective effect of low-dose aspirin may be lower in women than men, say Canadian investigators (BMC Medicine 2007;5:29 doi: 10.1186/1741-70155-29). Their meta-analysis of 23 randomised trials involving a total of 113 494 participants found that aspirin significantly reduced the risk of nonfatal but not fatal myocardial infarction (MI). About one-quarter of the variation in its effects on nonfatal MI was accounted for by the sex mix of the trial population. Separating the results by sex showed the reduction in risk with aspirin use was statistically significant in men (relative risk, RR, 0.62) but not in women (RR 0.87). Look after physical health of mentally ill GPs and other primary care workers should take more responsibility for the physical health of their mentally ill patients, say advocacy groups. Mind and Body: Preventing and Improving Physical Health Problems in Patients With Schizophrenia points out that the mental health needs of patients with schizophrenia are met in secondary care, but their physical health needs should be met in primary care. In particular, the metabolic effects of antipsychotics may lead to obesity, diabetes and cardiovascular disease, and weight gain in particular is a frequent reason for nonadherence to treatment. The Mind and Body Manifesto was developed by SANE, The Mental Health Nurses Association, The National Obesity Forum and The Disability Rights Commission and sponsored by Bristol-Myers Squibb Pharmaceuticals Limited and Otsuka Pharmaceuticals (UK) Ltd. Copies are available from elizabeth.green@ ogilvyhealthworld.com. Health eCard costs Some costs quoted in our article on the Health eCard (The Health eCard: the way ahead for medical records?,5 October issue, pages 28-9) have been revised: the card and initial download will cost patients £39.50, and GPs will be entitled to charge patients £10 per annum for subsequent downloads. NICE appraisals of cytokine inhibitors in RA NICE has endorsed the use of the anti-TNF agents adalimumab (Humira), etanercept (Enbrel) and infliximab (Remicade), normally in conjunction with methotrexate, for the treatment of active RA when methotrexate and another DMARD have failed (also see New from NICE below). NICE has provisionally concluded, subject to consultation, that abatacept (Orencia) should not be recommended for the treatment of RA. Boots and BMJ launch health advice site www.askbootshealth.com is a new website providing information about health and medicines for the public produced by Boots using information provided by the BMJ Publishing Group. The website covers many of the topics already available from NHSDirect, with perhaps more information about available treatments. Diabetes care shows small improvement The third National Diabetes Audit in England and Wales has found that more people with diabetes were achieving the targets set by NICE for cholesterol levels, glycaemic control and blood pressure in 2005/06 - but younger patients were doing less well. Overall, the HbA1C target of ,7.5 per cent was achieved in 60 per cent of people with diabetes compared with 58 per cent in 2004/05. However, HbA1C was >9.5 per cent in 30 per cent of children and young people, of whom 9 per cent experienced at least one episode of ketoacidosis. More topics for NICE New topics referred to NICE include clinical guidelines on ovarian cancer, coeliac disease and stable angina, public health guidance on preventing cardiovascular disease, and technology appraisals on insulin detemir (Levemir) for type 1 diabetes, several treatments for cancer and hepatic and haematological disorders, and biological therapies for juvenile arthritis. New from NICE NICE appraisal on anti-TNFs for RA Since NICE published its first appraisal of agents acting against tumour necrosis factor-alpha (anti-TNFs) for the treatment of RA in 2002, the product licences for etanercept (Enbrel) and infliximab (Remicade) have changed and a new agent, adalimumab (Humira), has been introduced. The anti-TNFs act in different ways. Infliximab is a chimeric monoclonal antibody that binds to TNF-alpha, neutralising its activity. Etanercept, a recombinant human TNF-alpha receptor fusion protein, and adalimumab, a human-sequence antibody, both bind to TNF-alpha and block its interaction with cell surface receptors. Adalimumab also modulates some biological responses induced or regulated by TNF-alpha. These agents are recommended for adults with severe active RA (defined as a disease activity score - DAS28 - greater than 5.1) who have already tried two disease-modifying drugs, including methotrexate (if not contraindicated). Prior treatment should have been of at least six months' duration, including two months at the standard dose (unless limited by toxicity). Anti-TNFs should normally be prescribed with methotrexate; when this is not appropriate, etanercept and adalimumab may be prescribed as monotherapy. Treatment with an anti-TNF should be continued beyond six months only if there is an adequate response (defined as an improvement in DAS28 of at least 1.2). Data from the British Rheumatology Society Biologics register show that, after six months, 67 per cent of patients met NICE criteria for an adequate response; this declined to 55 per cent at 18 months. The basic annual cost of treatment is £9295 for adalimumab 40mg on alternate weeks or etanercept 25mg twice weekly; infliximab costs £3777 for a loading dose, then £7553-£8812 depending on dose. Assuming no progression of disability, the incremental costs per QALY (compared with sequential DMARDs) were £30 200 for adalimumab, £24 600 for etanercept and £39 400 for infliximab. There are no direct comparative trials of the anti-TNFs, and their clinical trial findings are not directly comparable. Unless other factors determine treatment choice, NICE therefore recommends the least expensive. If the first anti-TNF is withdrawn within six months due to an adverse event, a second may be tried. [source] Latest news and product developmentsPRESCRIBER, Issue 20 2007Article first published online: 26 NOV 200 GPs and pharmacists to work more closely Closer working between GPs and community and primary-care pharmacists ,could further improve prescribing quality and therapeutic outcomes for patients', according to a report by the London School of Pharmacy and Alliance Boots. The report suggests that the expansion of primary-care centres and the increasing complexity of care they offer mean that community pharmacists will increasingly need to take on some GP roles. It foresees an increase in shared premises and calls for closer interdisciplinary working between GPs, pharmacists and nurses. Variation in PCT commissioning of enhanced services from pharmacies has resulted in ,a fragmented system of postcode pharmaceutical care rationing'. Full read-write access to patients' records will be essential if the benefits of electronic prescribing are to be realised. How pharmacists can support commissioners The NHS Alliance and Primary Care Pharmacists' Association have published a guide for practice-based commissioners on making the most of primary-care pharmacists. Prescribing Support and Prescribing Advice for Practice Based Commissioners , A Guide for Commissioning Groups and GPs illustrates how pharmacists can support commissioners at all levels of medicines use. Copies are free to NHS Alliance members and cost £10 for others. Directory website aids diabetes management The National Diabetes Support Team is developing a website that brings together different datasets and tools for diabetes management. The Diabetes Data Directory (www.yhpho.org.uk/diabetesdatadirectory/introddd.asp) summarises what other online databases can provide and lists the tools that can be used to answer specific questions. The first edition is now online, providing direct links to the appropriate sites. Flu vaccine efficacy in older people challenged US reviewers have questioned the effectiveness of flu vaccine in older people (Lancet Infect Dis online: 24 September; doi: 10.1016/ S1473-3099(07)70236-0). They were unable to confirm a reduction in flu mortality since 1980, concluding that biased patient selection and nonspecific end-points such as all-cause mortality may have exaggerated the benefits of vaccination in clinical trials. The Department of Health is encouraging younger people in at-risk groups to be vaccinated against flu this winter; last year, 58 per cent of under-65s at risk were not vaccinated. OC cervical cancer risk probably overestimated Recent evidence that oral contraceptives may be associated with a small increase in the incidence of cervical cancer probably overestimates the risk, says the Clinical Effectiveness Unit of the Faculty of Family Planning and Reproductive Health Care (www.ffprhc.org.uk). A recent study in the BMJ reported a 12 per cent reduced overall risk of cancer associated with oral contraceptives but an increased risk of cervical cancer of 38 per 100 000 woman-years after at least eight years' use. The FFPRHC says this study was conducted before the UK cervical screening programme was established, and at a time when the average Inhaled insulin ,unlikely to be cost effective' Inhaled insulin (Exubera) is safe and effective but costs so much more than injected insulin that it is unlikely to be cost effective, according to a new Health Technology Assessment (2007;11:No.33.www.hta.nhsweb.nhs.uk). The review included nine trials (seven of Exubera), in which the only significant difference between inhaled and injected soluble insulin was in patient preference. However, most of the trials used syringes for insulin injection rather than pens. The extra cost of inhaled insulin is put at between £600 and £1000 per year. New topics for NICE The Secretary of State for Health has referred the novel antihypertensive aliskiren (Rasilez) for appraisal by NICE; aliskiren is the first direct renin inhibitor to be introduced. Other referrals to NICE include five clinical guidelines (multiple pregnancy, transient loss of consciousness, lower UTI in men, post-ITU rehabilitation and colorectal and anal cancer). Topics for technology appraisals include cetuximab (Erbitux) for colorectal and head and neck cancers. QOF statistics for 06/07 GPs in England averaged 96.3 per cent of the maximum points available for the clinical domain of the Quality and Outcomes Framework in 2006/07 compared with 97.1 per cent previously, official statistics show. Mean practice scores for most clinical areas were in the mid-90 per cent range, but highest for obesity (100 per cent) and lowest for depression (81 per cent), palliative care (90 per cent), mental health and epilepsy (<95 per cent). NICE consulting on type 2 diabetes guideline NICE is consulting on its draft clinical guideline for the management of type 2 diabetes. Comments should be submitted online by 22 November; publication is scheduled for April 2008. The drug of first choice for glycaemic control is metformin, which should be considered even for patients who are not overweight; a sulphonylurea is an alternative or adjunctive agent if glycaemic control is not achieved with metformin alone. If these regimens fail, a glitazone may be added. Exenatide (Byetta) is recommended only for obese patients for whom other oral treatments have failed. The guidance will update and replace clinical guidelines E, F, G and H, and technology appraisals 53, 60 and 63. Glitazones increase risk of HF but not CV death A new meta-analysis , this time of seven trials involving a total of 20 191 patients with type 2 diabetes or impaired glucose tolerance treated with a glitazone , has concluded that these agents are associated with an increased risk of heart failure but not cardiovascular death (Lancet 2007;370:1129,36). Compared with comparator drugs, glitazones were associated with an increased risk of congestive heart failure (2.3 vs 1.4 per cent; relative risk, RR, 1.72; number needed to harm over 30 months, 107). There was no heterogeneity between studies, showing that this is a class effect. However, the risk of cardiovascular death was not increased for either rosiglitazone (Avandia) or pioglitazone (Actos). Copyright © 2007 Wiley Interface Ltd [source] Latest news and product developmentsPRESCRIBER, Issue 17 2007Article first published online: 6 NOV 200 Drug information stilllacking for mentally ill Half of people with mental illness still have no say in the medication they are prescribed and one-third are not informed about side-effects, according to the latest report by the Healthcare Commission and the Commission for Social Care Inspection (www.health-carecommission.org.uk). The annual national review of adult mental health services found overall improvement among local intervention teams in 2005/06 compared with the preceding year, though all could improve further and the performance of 46 per cent were rated as only fair or weak. A survey of 7446 people with schizophrenia also showed that only 46 per cent had access to psychological treatments. More incentives for shift of care in Scotland Scotland has made good progress on shifting NHS care into the community but joined-up thinking, better information and incentives are needed to overcome barriers to better management of long-term conditions in adults, says Audit Scotland (www.audit-scotland.gov.uk). Reviewing progress on the 2005 strategy document Delivering for Health, Audit Scotland found good progress on asthma and diabetes services , partly due to the effects of the GMS contract. Better information about clinical activity, costs and effectiveness is needed to help redesign services. Patients with more than one long-term condition do not receive co-ordinated care and many want greater involvement in their care, the report concluded. Acorn, QOF and Guy Rotherham awards Entries are invited for the 2007 annual Acorn, QOF and Guy Rotherham Awards. The awards are run in association with the NHS Alliance, Improvement Foundation, British Cardiac Society, British Cardiac Patients Society and Prescriber. The CHD QOF Award, sponsored by Schering-Plough, recognises the achievement of an individual practice that gains maximum points in the CHD and heart failure QOF domains, and a second award is given to the primary care organisation (PCO) that achieves the best average scores across its practices. The entry form can be found at www.escriber.com. The closing date is 12 October. Entries are also invited for the Guy Rotherham Award from PCOs that can demonstrate they have delivered a high-impact change resulting in better outcomes and services for patients. For online entry go to www.improvementfoundation.org/guy rotherhamaward. Closing date is 5 October. Award winners will receive free entry for three to the NHS Alliance conference and the conference dinner. The winner of the Guy Rotherham Award will also receive £3000. NICE scores five out of six NICE acted unreasonably in relying solely on the Mini-Mental State Examination (MMSE) to define severity of Alzheimer's disease in its updated technology appraisals, with the effect of discriminating against people with learning or language difficulties, the High Court has ruled. The five other claims by Eisai that NICE acted unreasonably and irrationally were not upheld. This was the first court action against NICE in its eight-year history. It has now promised to publish revised appraisals on its website on 7 September and is consulting with Eisai, Shire Pharmaceuticals and the Alzheimer's Society on the best approach. PPRS reform follows Office of Fair Trading report The Government is to renegotiate the Pharmaceutical Price Regulation Scheme (PPRS) following the critical report by the Office of Fair Trading (OFT). In February, the OFT recommended renegotiation of the PPRS to reward innovation and obtain better value for patients. In particular, it called for a pricing scheme based on value for patients, ie effectiveness, rather than profit controls. The DoH, acknowledging the report's complexity, says it will take four principles into account in its negotiations during the forthcoming months: value for money, promoting innovation, assisting the uptake of new cost-effective medicines and promoting market stability. MHRA launches e-bulletin The MHRA (www.mhra.gov.uk) has next issue can be downloaded. The launched an electronic bulletin to August bulletin includes items on provide health professionals with antidepressants and suicide, updates about the safe use of medi-adverse effects of dopamine ago-cines. Users need to sign up to nists and information about smokreceive an e-mail alert when the ing cessation and isotretinoin. DURG call for abstracts The Drug Utilisation Research Group is calling for abstracts for its 19th annual meeting ,Target-driven medicine , is this the end of prescribing freedom?' to be held on 7 February 2008 at the Royal Society of Medicine, London. Abstracts are requested on any aspects of drug utilisation research. A bursary of £500 will be awarded for the best abstract received. The closing date for receipt of abstracts is 26 November. Further information about abstract submission is available at www.durg.org.uk. GP prescribing up by half Prescription volume and costs in England increased by approximately half over the decade to 2006, according to data published by the Information Centre for Health and Social Care (www.ic.nhs.uk). The number of items dispensed per year increased by 55 per cent and the cost by 60 per cent in real terms. The average number of items per head of population was 10.0 in 1996 and 14.8 in 2006; older people received 21.2 items per head in 1996 but 40.8 in 2006. MR morphines similar Modified-release preparations of morphine are equivalent in the treatment of severe pain, according to a new review by Bandolier (www.jr2.ox.ac.uk). The analysis of 54 randomised trials, which reviewed the release mechanisms and clinical data for four brands, showed these preparations provide effective analgesia for malignant and nonmalignant pain; about 4 per cent of patients were unable to tolerate the adverse effects of morphine. NSAIDs compared in OA Etoricoxib (Arcoxia) and naproxen are equally effective in the long-term treatment of osteoarthritis (Ann Rheum Dis 2007;66:945,51). Extension studies for two one-year trials showed that, after a total of 138 weeks, the two drugs had almost identical effects on pain and function assessments. All treatments were generally well tolerated, but serious cardiovascular effects were more common with etoricoxib and serious GI effects more common with naproxen. CPN nystatin allowed Community practitioner nurses (CPNs) may now prescribe oral nystatin (Nystan) to treat oral thrush in neonates, following a special amendment to the regulations limiting their prescribing to licensed indications. CPNs may now prescribe oral nystatin at the dose recommended in the BNF for Children provided they are sure of the diagnosis. In doing so, they accept clinical and medicolegal responsibility for their actions. There are no other exceptions to the prohibition of off-label prescribing. Copyright © 2007 Wiley Interface Ltd [source] Latest news and product developmentsPRESCRIBER, Issue 12 2007Article first published online: 4 OCT 200 NAO: GPs still not prescribing efficiently The National Audit Office (NAO) says NHS funds are being wasted through inefficient GP prescribing and patients not taking their medicines. The NAO's long-awaited report, Prescribing Costs in Primary Care (www.nao.org.uk), found large variations between PCTs in generic prescribing of statins, ACE inhibitors and angiotensin-II antagonists, and protonpump inhibitors; PCTs were also paying widely differing prices for these products. There was a five-fold variation in prescribing volume for clopidogrel between PCTs. These four drugs accounted for only 19 per cent of total spending but, if all practices matched the performance of the best 25 per cent, the NHS would save £200 million annually. PCTs should do more to rationalise prescribing and support their GPs, the NAO concludes. The NAO says that the cost of medicines dispensed for but not taken by patients lies somewhere in the range £100-£800 million annually. Strategies to reduce waste include public awareness campaigns and restricting supplies to four weeks (or two weeks for new medicines). Rosiglitazone may increase CV death risk A meta-analysis of 42 clinical trials has suggested that rosiglitazone is associated with increased risks of myocardial infarction (MI) and cardiovascular death (N Engl J Med 2007; published online 21 May: doi 10.1056/ NEJMoa072761). Like the COX-2 inhibitors, rosiglitazone was licensed without determining its possible effects on long-term cardiovascular outcomes, and interpretation of the latest findings is complicated by the multiple comparisons involved. For risk of MI, there was no significant difference between rosiglitazone and placebo (though this was of borderline statistical signifi-cance , p=0.07), metformin, sulphonylureas or insulin. Rosiglitazone was associated with a statistically significant 43 per cent increased risk compared with all comparators combined but the absolute increase in risk was very small (0.02 per cent). The trends were similar for risk of cardiovascular death, though rosiglitazone was associated with a 64 per cent increased risk compared with all comparators combined that was of borderline statistical significance (p=0.06). The authors acknowledge that their analysis pooled short-term studies that excluded patients at risk of heart disease and was not designed to determine cardiovascular outcomes, and they had no access to patientlevel data; as a result, there is uncertainty about their findings. Nevertheless, they say there is now an urgent need to clarify the risk associated with rosiglitazone. GlaxoSmithKline has rebutted the findings, stating that the cardiovascular risk profile of rosiglitazone is comparable with that of other oral antidiabetic drugs. The MHRA says warnings in the current SPCs for Avandia and Avandamet already reflect most of the data in the latest US review. The possible effects of rosiglitazone on cardiovascular events is currently being evaluated in the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of glycaemia in Diabetes (RECORD) study. Good management tool The Department of Health has published a disease management tool to enable PCTs to model local interventions that could reduce emergency admissions. The web-based ,voluntary good practice tool' will demonstrate how interventions in primary care and social care settings can improve the management of long-term conditions including cardiovascular disease, asthma and COPD, and dementia and depression. Counterfeit medicines The MHRA has issued an unprecedented three alerts about fake medicines in the legitimate supply chain, recalling all affected lot numbers. Three batches of Zyprexa 10mg tablets (olanzapine) were withdrawn after a company printing labels became suspicious and alerted Eli Lilly. Two of the batches, which contained 60 per cent of the stated active ingredient, had reached patients but no adverse events were reported. Two lots of parallel-imported Plavix 75mg tablets (clopidogrel) have been withdrawn after counterfeit packs were identified. The lots were in French original packaging but will have been overlabelled for the UK market. The counterfeits were mixed with genuine packs from Sanofi-Aventis. Fake Casodex 50mg tablets (bicalutamide) have been identified in a parallel import from France. The Royal Pharmaceutical Society reports that the fake contains 75 per cent of the stated dose of bicalutamide. Alcohol-free mometasone Schering-plough has introduced an alcohol-free formulation of mometasone furoate nasal spray (Nasonex) for hay fever. The company says that an alcohol vehicle causes nasal irritation and leaves an unpleasant aftertaste, adding that over 40 per cent of patients cite this as the main reason for stopping treatment, and over 50 per cent state a preference for an alcohol-free product. Aid to improve statin adherence Adherence to statin therapy can be improved if patients use a decision aid when they are offered treatment,US investigators say (Arch Intern Med 2007;167:1076-82). The decision aid estimated the individual's 10-year cardiovascular risk and the risk reduction from treatment, and summarised the disadvantages of statins.Patients with diabetes who used the aid knew more about their risk and were less indecisive about treatment than those who did not. The odds of having missed a dose over three months were three times higher for patients who had not used the aid. Online tool calculates switch savings A new online tool can help GPs estimate the savings achievable from switching patients to cheaper medicines. The Switch Saving Calculator, developed by the Prescribing Analysis & Support Team at the NHS Regional Drug and Therapeutics Centre in Newcastle, calculates potential savings based on past, current or projected use of the target drug. It can be applied to individual prescribers or scaled up to practice, commissioning group, PCT, health authority or even national level. Separate calculators are available for primary and secondary care. The current version calculates potential savings by switching from atorvastatin to simvastatin. The Newcastle team says other drugs will be added and they will update prices regularly. The calculator is at www.nyrdtc.nhs.uk:80/Services/presc_supp/ switch_saving_calculator/switch_saving_calculator.html. No improvement in drug information for patients leaving hospital The information given to patients discharged from hospital is not improving, according to the Healthcare Commission's annual patient survey (www.healthcare commission.org.uk). The 2006 survey found that the commonest reason patients were kept waiting for at least four hours to leave hospital was the delay in providing discharge medicines. Provision of written information increased from 62 per cent of patients in 2005 to 65 per cent in 2006. However, only 76 per cent said they had been told about their medicines in a way they could ,completely' understand (79 per cent in 2002). The proportion of patients reporting complete information about sideeffects also fell (from 40 per cent in 2005 to 37 per cent). Aspirin in preeclampsia A new meta-analysis has found that primary prevention with low-dose aspirin modestly but consistently reduces the risk of preeclampsia (Lancet 2007; published online 18 May). The study of 31 trials involving 32 217 women at low to moderate risk found that antiplatelet agents (mostly aspirin) reduced the risk of pre-eclampsia and preterm birth by 10 per cent without an increased risk of bleeding. The benefit was similar across subgroups. There were also nonsignificant reductions in the risk of small for age, stillborn and death before discharge. New from NICE NICE approves varenicline for NHS NICE has endorsed the use of varenicline (Champix) as an aid to smoking cessation within the NHS for England and Wales; it has already been approved for use in Scotland by the Scottish Medicines Consortium. Varenicline is a partial agonist at the ,4,2 nicotinic receptor. It alleviates craving and withdrawal symptoms, and reduces the rewarding and reinforcing effects of smoking. The commonest adverse effect is mild to moderate nausea, which improves with time.1 Varenicline is licensed for smoking cessation in adults; NICE says it should be offered as an option for smokers who say they want to quit as part of a programme of behavioural support. However, treatment should not be withheld if counselling and support are not available. NICE was critical of manufacturer Pfizer's economic arguments in favour of varenicline, which inappropriately included US data, assumed a single quit attempt and may have overestimated its efficacy. It nonetheless concluded that varenicline is more effective than nicotine replacement therapy (NRT) or bupropion (Zyban) in achieving continuous abstinence. NICE estimated that, compared with NRT, the odds of abstinence at one year with varenicline were 54 per cent greater. A Cochrane review1 concluded that abstinence was 66 per cent more likely with varenicline than with bupropion, and three times more likely than with placebo. There was also a benefit from offering smokers a wider choice of treatments. A 12-week course of varenicline costs £163.80; it is also licensed for an additional 12-week course and dose tapering may be considered for those at high risk of relapse. The final appraisal determination does not state which is the treatment of first choice for smoking cessation. NICE is currently preparing guidance on smoking cessation in pri-mary care, pharmacies and workplaces. Copyright © 2007 Wiley Interface Ltd [source] Latest news and product developmentsPRESCRIBER, Issue 9 2007Article first published online: 3 SEP 200 Clinical trials flatter anti-TNFs in RA The efficacy of anti-TNF agents in clinical trials is not matched by experience in daily practice in patients with rheumatoid arthritis, say Dutch investigators (Ann Rheum Dis online: 10 April 2007; doi:10.1136/ard.2007.072447). They compared outcomes from a systematic review of trials of etanercept (Enbrel), infliximab (Remicade) and adalimumab (Humira) and a national postmarketing surveillance scheme (DREAM). In 5 of 11 comparisons, the response rate in DREAM was significantly lower than that in RCTs. Responses among DREAM patients who met the inclusion criteria for clinical trials were significantly greater than among noneligible patients and comparable with those of patients participating in the trials. The authors conclude that patients in trials have more severe disease and therefore a response to treatment that is not matched in daily practice. Methadone prescriptions double in 10 years Methadone treatment for opiate addicts has more than doubled in the past 10 years, according to an audit of opiate substitution in England by the National Treatment Agency for Substance Misuse (www.nta.nhs.uk). The total number of methadone prescriptions increased from 970 900 in 1995 to over 1.8 million in 2004. The introduction of buprenorphine (Subutex) has not reduced methadone prescribing , 96 per cent of responding centres prescribed methadone and 88 per cent prescribed buprenorphine. Seventy-two per cent of centres prescribe benzodiazepines to opiate addicts, causing the NTA some concern. GPs were involved in prescribing management in about 60 per cent of centres. Next NICE guidelines The Department of Health has referred eight topics to NICE for the development of clinical guidelines: preventing venous thromboembolism, acute coronary syndromes, chest pain, social complications during pregnancy (eg drug misuse), benign prostatic hyperplasia, constipation in children, neonatal jaundice and metastatic disease of unknown primary origin. Errors with children , Every step of drug treatment for children, from prescribing to writing notes, is associated with a substantial level of error, say US investigators (Quality and Safety in Health Care 2007;16:116-26). Their systematic review of 31 studies reporting medication errors in paediatrics found that 3-37 per cent were associated with prescribing errors, 5-58 per cent with dispensing errors, 72-75 per cent with errors of administration, and 17-21 per cent with documentation errors. Suggestions for remedial strategies were not evidence based, the authors found. , and transplant patients Errors in medication are common among outpatients who have received liver, kidney or pancreas transplants, a second US study has found (Arch Surg 2007;142:278-83). Twelve months' follow-up of 93 patients revealed a total of 149 errors of drug treatment, with a frequency of 15 in 219 visits over a four-week period. One-third of errors were associated with adverse events including hospital admission and graft rejection. Patients were taking an average of 11 medicines; analysis showed that over half of errors originated with the patients and 13 per cent were associated with prescribing. Paracetamol pack benefit challenged A new study has challenged accepted wisdom that reducing the OTC pack size of paracetamol cut the suicide rate (PLoS Medicine 2007;4:e105). In 1998, pack sizes of paracetamol were limited to 16 in general sale outlets and 32 in pharmacies. Suicide rates subsequently decreased but, though widely assumed, a causal link has not been established. Researchers from London and the Office of National Statistics have now examined mortality trends from suicide associated with antidepressants, aspirin, compound paracetamol preparations and nondrug poisoning. They found that all fatal suicides declined at similar rates after the pack size reductions. While not excluding the possibility that restricting easy access to paracetamol may have helped, these data suggest that other factors were also important. CV risk with ibuprofen among aspirin users Ibuprofen, but not naproxen, is associated with a higher risk of cardiovascular events and heart failure than lumiracoxib (Prexige) in high-risk patients, according to a new analysis of the TARGET trial (Ann Rheum Dis online: 5 April 2007; doi:10.1136/ard.2006.066001). TARGET comprised two studies comparing naproxen or ibuprofen with lumiracoxib in a total of 18 325 patients with OA. This post-hoc analysis stratified patients by their cardiovascular risk; the primary end-point was a composite of cardiovascular mortality, nonfatal myocardial infarction and stroke at one year. Among those at high risk who were taking aspirin, ibuprofen was associated with an increased risk of the composite end-point compared with lumiracoxib (2.14 vs 0.25 per cent). The risk was similar for naproxen and lumiracoxib (1.58 vs 1.48 per cent). In high-risk patients not taking aspirin, the risk was similar for ibuprofen and lumiracoxib, but lower for naproxen than lumiracoxib. Congestive heart failure was more common in patients taking ibuprofen than lumiracoxib (1.28 vs 0.14 per cent); the risk was similar with naproxen and lumiracoxib. The authors emphasise that their findings should be considered hypothesis-generating. CVD guidelines criticised The second edition of the guidelines of the Joint British Societies on preventing cardiovascular disease have been harshly criticised for failing to meet international quality standards (Int J Clin Pract online doi: 10.1111/j.1742-1241.2007.01310.x). Kent GP Dr Rubin Minhas evaluated the guidelines against the criteria of the Appraisal of Guidelines and Research (AGREE) Collaboration. He identified areas of weakness including stakeholder involvement, rigour of development, applicability (by not considering cost) and editorial independence from the pharmaceutical industry. The guidelines should not be recommended for clinical practice, he concludes. OTC naproxen? The MHRA is consulting on switching naproxen 250mg to pharmacy-only status for the treatment of period pain in women aged 15-50. The change would offer an alternative to ibuprofen, currently the only other OTC medicine with this indication. Responses should be submitted by 23 May. The Agency is currently considering responses to its consultation on switching tranexamic acid to OTC status for heavy menstrual bleeding. Diabetes costs The total cost of prescribing for diabetes in England has doubled in only five years, official statistics show. The NHS Information Centre (www.ic.nhs.uk) report shows that spending in primary and secondary care in 2006 was £561 million, up 14 per cent on 2005. Growth was due to increased prescribing of oral hypoglycaemic agents (notably the glitazones , up by one-third over 2005) and the higher costs of insulins. Pharmacists may give flu jabs PCTs may consider using pharmacists to administer flu vaccines to some at-risk groups in the 2007/08 season, according to Department of Health plans. Flu vaccination payment for patients with diabetes, coronary heart disease, and stroke and TIA is provided under the Quality Outcomes Framework. The Department suggests that PCTs consider contracting a local enhanced service from pharmacists to reach other patients at increased risk, such as those with chronic liver disease, multiple sclerosis and related conditions, hereditary and degenerative disease of the CNS and carers. Copyright © 2007 Wiley Interface Ltd [source] Latest news and product developmentsPRESCRIBER, Issue 4 2007Article first published online: 3 APR 200 Low-dose aspirin may reduce asthma risk Low-dose aspirin may reduce the risk of new-onset asthma, according to a US analysis (Am J Respir Crit Care Med 2007;175:120-5). Prompted by speculation of such a link, the authors conducted a post-hoc analysis of the Physicians' Health Study, a placebo-controlled study of aspirin 325mg on alternate days involving 22 071 men aged 40-84. The risk of developing a new diagnosis of asthma during the five-year study was reduced by 22 per cent (p=0.045) among those taking aspirin. However, the number of cases was low: 113 among aspirin recipients and 145 with placebo. The clinical importance of this finding is therefore uncertain, though it received wide coverage in the lay media. Lifestyle changevsdrugs in type 2 diabetes Modifying lifestyle is at least as effective as drugs in delaying the onset of type 2 diabetes in people with impaired glucose tolerance, according to a study from Leicester (BMJ online. doi: 10.1136/bmj.39063.689375.55). The meta-analysis of 17 trials involving 8084 participants found that lifestyle change or orlistat approximately halved the risk of progressing to diabetes, whereas oral hypoglycaemic agents reduced the risk by 30 per cent. A Chinese herb, jiang tang bushen, reduced the risk by two-thirds. The analysis was conducted before the findings of major trials of rosiglitazone (Avandia) , DREAM and ADOPT , were published. Optician prescribing The diagnosis and treatment of disorders such as conjunctivitis by opticians is to be an enhanced service that PCTs can commission according to local need, a Department of Health review has concluded. The General Ophthalmic Services Review considered new arrangements to support PCTs provide ophthalmic services. Professional representatives proposed that the diagnosis and treatment of some eye conditions should be classed as ,additional services' that PCTs should be obliged to commission. While the Department agreed that opticians can play an important role, it found a lack of evidence of benefits and concluded that PCTs should be able to determine their level of services. A commissioning toolkit has been produced to help implement the review's findings. Warfarin stroke risk A four-fold increase in warfarin use has been linked with an increased incidence of intracerebral haemorrhage in a US study (Neurology 2007;68:116-21). Reviewing all first admissions for haemorrhagic stroke in the Cincinnati area, the study found that the proportion of cases associated with warfarin or heparin increased from 5 per cent in 1988 to 9 per cent in 1993/94 and 17 per cent in 1999. The annual incidence among patients aged 80 or older increased from 2.5 to 46 per 100 000 from 1988 to 1999. During the same period, warfarin distribution increased four-fold and there was no change in the incidence of thromboembolic strokes. Co-proxamol will go, MHRA reaffirms The MHRA has confirmed that it still intends to withdraw co-proxamol from the market despite protestations from MPs. The issue was raised by two MPs , one a member of the Health Select Committee , in a House of Commons debate. Both called for the withdrawal process to be abandoned, arguing that GPs should have the right to prescribe a drug for which there may be no alternative. The MHRA has restated its view that the risk from overdose with co-proxamol outweighs its benefits, adding: ,The avoidable death toll from co-proxamol overdose cannot be ignored. Sometimes regulation has to balance the needs of the individual against the benefits at a population level. In this case the removal of marketing authorisations with continued use possible in exceptional circumstances is the best balance that could be achieved. The public health gain is already becoming apparent.' Co-proxamol may still be prescribed as an unlicensed drug after its product licence is withdrawn at the end of this year. Guide to pharmacy services A guide to community pharmacy services has been published for patients, carers and members of patient organisations. Developed by the South East Local Pharmaceutical Committee Forum, Understanding and Making the Best Use of Community Pharmacy explains what pharmacies offer and the services available under the 2005 pharmacy contract. Copies can be downloaded from www.psnc.org.uk/resources. Little benefit from opioids for back pain There is little evidence that opioids relieve chronic back pain but the risk of abuse is high, according to a US analysis (Ann Intern Med 2007;146:116-27). The systematic review of trials of oral, topical and transdermal opioids in the treatment of chronic back pain found no trials lasting more than 16 weeks. There was no significant reduction in pain in placebo-controlled trials and limited, nonsignificant pain reductions in comparative trials. By contrast, estimates of prevalence of current substance misuse were as high as 43 per cent and that of ,aberrant medication-taking behaviours' ranged from 5 to 24 per cent. Dual antiplatelet therapy with drug-eluting stents Patients with drug-eluting stents should not stop dual antiplatelet therapy prematurely (Circulation 2007; published online 15 January; DOI: 10.1161/CIRCUL ATIONAHA.106.180944). Although 12 months' treatment with low-dose aspirin plus a thienopyri- dine, eg clopidogrel (Plavix) and ticlopidine, has been shown to reduce cardiac events after implanting a drug-eluting stent, it is not uncommon for the thienopyridine to be discontinued. Health professionals must do more to educate patients about their treatment and the risks associated with stopping. Scottish approval The SMC (www.scottishmedicines.org.uk) has approved varenicline (Champix) for use within NHS Scotland as part of a smoking cessation programme; it notes that the benefits of extending a course of treatment beyond the initial 12 weeks are modest. Controversially, the SMC has not approved omalizumab (Xolair) as add-on therapy for severe persistent allergic asthma on the grounds that an economic case had not been made. Asthma UK criticised the decision as unjust and inhumane. NICE is due to publish an appraisal of omalizumab later this year. No decline with anti- psychotics Treatment with anti- psychotics does not hasten cognitive decline in patients with Alzheimer's disease, say investigators from London (J Neurol Neurosurg Psychiatry 2007;78:25-9). Their prospective study of 224 patients found no difference in the rate of cognitive decline in those treated with antipsychotics (atypical or otherwise) for at least six months. Label translation online Health IT consultancy Rxinfo has developed a website offering translations of the most common types of labelling. The site (www.translabel.co.uk) offers translations into 13 Asian and European languages for 15 standard labelling phrases covering oral medicines and ENT formulations. A free application can be downloaded to allow direct-to-printer printing. Copyright © 2007 Wiley Interface Ltd [source] Latest news and product developmentsPRESCRIBER, Issue 2 2007Article first published online: 1 MAR 200 Venlafaxine: same suicide risk Venlafaxine (Efexor) is probably not associated with a higher risk of suicide than citalopram, fluoxetine or dosulepin, even when prescribed for patients at higher risk, according to an analysis of the UK General Practice Research Database (BMJ, doi:10.1136/bmj.39041.445104.BE. Published 12 December 2006). The retrospective cohort study found that venlafaxine was associated with a significantly higher risk of completed and attempted suicide in adults than the other antidepressants but, after adjusting for risk factors, the authors concluded that much, if not all, of the difference could be explained by confounding. Raised glucose with thiazides not clinically significant? A new analysis of the ALLHAT trial suggests that the small increase in blood glucose levels associated with long-term thiazide therapy is not associated with an increased risk of cardiovascular events (Arch Intern Med 2006;166:2191-201). The ALLHAT trial compared cardiovascular outcomes in over 18 000 patients with hypertension who were treated with chlortali- done (Hygroton), amlodipine and lisinopril. After two years, fasting blood glucose had increased in all groups (by 0.47, 0.31 and 0.19mmol per litre respectively); compared with chlortalidone, the odds of developing diabetes were 45 per cent lower with lisinopril and 27 per cent lower with amlodipine. However, there was no significant link between fasting blood glucose levels and cardiovascular events, end-stage renal disease or death; developing diabetes was associated with an increased risk of CHD overall but this was not statistically significant for chlortalidone in particular. Withdrawing alendronate after five years' treatment Discontinuing treatment of osteoporosis with alendronate after five years does not significantly increase fracture risk for many women, a US study has shown (J Am Med Assoc 2006;296:2927-38). In this five-year extension to the Fracture Intervention Trial, 1099 women who had taken alendronate for five years were randomised to continue treatment or switch to placebo for a further five years. In those taking placebo, bone mineral density decreased by 2.4 per cent at the hip and 3.7 per cent in the spine but remained above pre- treatment levels. Continuing with alendronate was associated with a lower risk of clinical vertebral fractures (2.4 vs 5.3 per cent) but no significant reduction in morphometric vertebral fractures (9.8 vs 11.3 per cent respectively). The cumulative risk of nonvertebral fractures was 19 per cent in each group. The authors conclude that women at very high risk of clinical vertebral fractures may benefit from continuing alendronate, but for many discontinuation does not appear to increase fracture risk. Instructions on labels Patients with low levels of literacy are at high risk of not understanding medicines labelling (Ann Intern Med 2006;145:887-94). In 395 English-speaking adults, 71 per cent correctly repeated simple label instructions, but only 35 per cent could demonstrate the correct number of tablets involved. Low literacy levels were associated with a twofold increased risk of misunderstanding labelling. Statins campaign The National Prescribing Centre (NPC) has launched a campaign to increase prescribing of low-cost statins. Resources available from its website at www.npc.co.uk/statins.htm are divided into four categories: policy and guidance, therapeutics, implementation resources and monitoring tools. Formats include documents and case studies, Powerpoint presentations and E-learning workshops. patients feeling rested on waking and daytime functioning. The Z-drugs were also believed to cause fewer adverse effects. GPs believe in ,Z' drugs A survey of GPs in Lincolnshire has revealed that their beliefs about nonbenzodiazepine hypnotics are inconsistent with NICE guidance and published evidence (Br J Gen Pract 2006; 56:964-7). Responders believed that zaleplon (Sonata), zopiclone and zolpidem were superior to benzodiazepines in increasing sleep time, patients feeling rested on waking and daytime functioning. The Z-drugs were also believed to cause fewer adverse effects. The authors note that, while benzodiazepine prescribing is declining, that of the Z-drugs is increasing, and they suggest this may be explained by misplaced beliefs about their relative effectiveness and safety. Pharmacy EHC guidance Pharmacists can supply emergency hormonal contraception (EHC) in advance but should consider when it is clinically appropriate to do so, according to revised guidance from the Royal Pharmaceutical Society. The move follows support for advance supply from the British Pregnancy Advisory Service and Marie Stopes International. Pharmacists are advised to decline repeated requests and recommend contraception instead, and to counsel users on using EHC safely and appropriately. More support from NICE NICE has developed two databases to support implementation of its recommendations. The shared learning database (www.nice.org.uk/ sharedlearning) includes experiences of implementing NICE guidance. The second, known as ERNIE (Evaluation and Review of NICE Implementation Evidence), includes data provided by NICE on uptake of its advice and external information (www.nice.org.uk/ernie). Mental health briefings The DoH (www.dh.gov.uk) has published several briefing documents to explain the main changes to mental health legislation, covering professional roles, criteria for detention and supervised community treatment (SCT). SCT applies to patients with a stable chronic mental disorder who have been discharged from hospital and who, but for their treatment, may pose a risk to themselves or others. Patients remain the responsibility of the mental health team. Copyright © 2007 Wiley Interface Ltd [source] NICE and warm: but is it necessary?ANAESTHESIA, Issue 6 2010A. Thwaites No abstract is available for this article. [source] | |||||||||||||||||||||||||||||||||||||