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DTB Select: 5 | May 2015 NICE guidance on medicines optimisation ● Hormone replacement therapy and CVD ● MHRA advice on tiotropium ● Paracetamol and adverse effects ● Updated guidance on depression in children and young people ● Impact of HPV vaccination programmes ● NICE lowers threshold for diagnosing gestational diabetes ● Online learning module on corticosteroid adverse effects ● New quality standards on psychosis and schizophrenia
NICE guidance on medicines optimisation Helping people to maximise the potential benefit of their medicines, while minimising the risk of harm, is the focus of new guidance issued by the National Institute for Health and Care Excellence (NICE).1 The guideline provides “best practice advice on the care of all people who are using medicines and also those who are receiving suboptimal benefit from medicines”. It lists three key priorities for implementation: • identifying, and learning from, medicines-related patient safety incidents; • sharing information about the person and their medicines when transferring from one care setting to another; and • obtaining a current, accurate medication list that documents any discrepancies from the most recently held information. Further recommendations include: • giving consideration to a structured medication review with the aim of reaching an agreement with the individual over their treatment in order to optimise the effect of their medicines and minimise the number of medication related problems; • implementing self-management plans to empower people to be involved in managing their condition; • using patient decision aids to facilitate a shared decisionmaking approach; • using clinical decision support software to help health professionals manage a person’s condition; and • considering a multidisciplinary team approach and cross-organisational working to improve outcomes. The new guidance recognises medicines management as an important aspect of healthcare primarily led by pharmacy and medicinesmanagement teams, while noting that medicines optimisation “focuses on actions taken by all health and social care practitioners and requires greater patient engagement and professional collaboration across health and social care settings”. Comment: DTB has previously described some of the challenges associated with addressing multimorbidity, polypharmacy and improving the use of medicines. 2,3 Responsibility for implementing this new guidance across a health economy is likely to fall to medicines management teams who have to juggle many competing priorities. The NICE guidance provides a helpful focus on the need to develop a system-wide approach across health and social care to improve outcomes from the use of medicines. However, this may require greater focus on providing direct support to patients and prescribers and less emphasis on chasing marginal Drug Tariff price changes. 1. National Institute for Health and Care Excellence, 2015. Medicines optimisation: the safe and effective use of medicines to enable the best possible outcomes (NG5) [online]. Available: https://www.nice.org.uk/guidance/ng5 [Accessed 22 April 2015]. 2. Describing deprescribing. DTB 2014; 52: 25. 3. Optimising medicines management. DTB 2013; 51: 37.
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Hormone replacement therapy and CVD An updated Cochrane review has assessed the effects of hormone therapy on the prevention of cardiovascular disease (CVD) in postmenopausal women.1 In addition, it examined whether there was a difference in its use in primary or secondary prevention. The review included 19 randomised controlled trials (including six added at this update) that compared orally administered hormone therapy (oestrogen alone or combined with a progestogen) with placebo or no treatment in 40,410 postmenopausal women. Treatment duration varied from 7 months to 10.1 years; study quality was described as generally good. The authors found that hormone therapy conferred no protective effects for all-cause mortality, cardiovascular death, non-fatal myocardial infarction, angina, or revascularisation in both primary and secondary prevention. However, there was an increased risk of stroke in those in the hormone therapy arm for combined primary and secondary prevention (risk ratio [RR] 1.24, 95% CI 1.10 to 1.41). Compared with placebo, hormone therapy was associated with an increase in venous thromboembolic events (RR 1.92, 95% CI 1.36 to 2.69) and pulmonary emboli (RR 1.81, 95% CI 1.32 to 2.48). In postmenopausal women without prior cardiovascular disease, hormone therapy compared with placebo or no treatment did not reduce the risk of death from cardiovascular causes. However, hormone therapy was associated with an increased risk of stroke (RR 1.32, 95% CI 1.12 to 1.56; four studies, n=28,719), and an increased risk of venous thromboembolism (RR 1.92, 95% CI 1.24 to 2.99; six studies, n=33,477). In postmenopausal women with pre-existing cardiovascular disease, hormone therapy compared with placebo or no treatment did not reduce the risk of death from cardiovascular causes. Hormone therapy was associated with an increased risk of stroke (RR 1.09, 95% CI 0.89 to 1.33; five studies, n=5,172), and an increased risk of venous thromboembolism (RR 2.02, 95% CI 1.13 to 3.62; six studies, n=4,399). The authors also performed subgroup analyses according to when treatment was started. There was moderate-quality evidence suggesting that women who started hormone therapy less than 10 years after the menopause had lower mortality (RR 0.70, 95% CI 0.52 to 0.95) and coronary heart disease (composite of death from cardiovascular causes and non-fatal myocardial infarction; RR 0.52, 95% CI 0.29 to 0.96) compared with placebo or no treatment. However, high-quality evidence suggested that they were still at increased risk of venous thromboembolism (RR 1.74, 95% CI 1.11 to 2.73). In women who started treatment more than 10 years after the menopause there was high-quality evidence that it had little effect on death or coronary heart disease between groups but there was an increased risk of stroke (RR 1.21, 95% CI 1.06 to 1.38) and venous thromboembolism (RR 1.96, 95% CI 1.37 to 2.80). Comment: Current advice suggests that some women may find hormone replacement therapy useful to manage menopausal symptoms but that the risks and benefits of treatment must be considered for each woman, particularly in those older than 60 years who have increased baseline risk of serious adverse events.2,3 The Cochrane review provides updated data on the cardiovascular effects associated with hormone therapy compared with placebo or no treatment. However, the review did not differentiate between women taking oestrogen alone and those taking oestrogen and progestogen. Although subgroup analysis highlighted evidence of a differential effect depending on when hormone treatment was started, the authors acknowledge that the results might be subject to bias. Such findings are unlikely to change current advice on the use of hormone therapy.
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1. Boardman HM et al. Hormone therapy for preventing cardiovascular disease in post-menopausal women. Cochrane Database Syst Rev 2015; 3: CD002229. DOI:0.1002/14651858.CD002229.pub4 [Last assessed as up-to-date 25 February 2014]. 2. National Institute for Health and Care Excellence, 2015. Clinical Knowledge Summaries: menopause [online]. Available: http://cks.nice.org.uk/menopause [Accessed 22 April 2015]. 3. Medicines and Healthcare products Regulatory Agency. Hormone replacement therapy: updated advice. Drug Safety Update 2007; 1 (2): 2 [online]. Available: https://www.gov.uk/drug-safety-update/hormone-replacement-therapy-updatedadvice [Accessed 22 April 2015].
MHRA advice on tiotropium The Medicines and Healthcare products Regulatory Agency (MHRA) has warned prescribers to be mindful of the cardiovascular adverse effects of tiotropium delivered by the Respimat and HandiHaler devices when prescribing to patients with certain cardiac conditions, who were excluded from most clinical trials of the drug.1 Tiotropium is indicated as maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (COPD).2,3 In addition, the Respimat formulation is also indicated as an add-on maintenance bronchodilator treatment in adult patients with asthma who are currently treated with the maintenance combination of inhaled corticosteroids (≥800µg budesonide/day or equivalent) and long-acting beta2 agonists and who experienced one or more severe exacerbations in the previous year. 3 After previous studies suggested an increased risk of death with Respimat compared with placebo and HandiHaler, the MHRA advised that the Respimat device should be used with caution in people with known cardiac rhythm disorders.4 However, following the publication of a large randomised double-blind non-inferiority trial that compared the safety of both devices, the MHRA has updated its advice. 5 The TIOSPIR trial, which included 17,135 participants with COPD followed up for a mean of 2.3 years, found no significant difference in its primary outcome of time to death from any cause between tiotropium delivered by HandiHaler and either of two doses delivered by Respimat (5µg vs. HandiHaler: hazard ratio 0.96, 95% CI 0.84 to 1.09; 2.5µg vs. HandiHaler: hazard ratio 1.00, 95% CI 0.87 to 1.14). The incidences of different causes of death (including death due to cardiovascular events) and major cardiovascular adverse events were adjudged to be similar across the three groups. Of the deaths attributed to myocardial infarction 21 were in patients using the Respimat device and three in patients using the Handihaler (p-value not stated). In people with previous cardiac arrhythmia there was no significant difference in the risk of all-cause mortality between tiotropium Respimat 5µg and HandiHaler. The MHRA has extended the warning on tiotropium to include both formulations. It now advises that clinicians should take the risk of cardiovascular adverse effects into account for patients with conditions that may be affected by the anticholinergic action of tiotropium, including: • myocardial infarction in the last 6 months; • unstable or life-threatening cardiac arrhythmia; • cardiac arrhythmia requiring intervention or a change in drug therapy in the past year; and • hospitalisation for heart failure (New York Heart Association [NYHA] class III or IV) within the past year. People with these conditions (with the exception of cardiac arrhythmia) have been excluded from clinical trials of the drug. Prescribers should tell patients to report any worsening of cardiac symptoms after starting tiotropium, and should review the treatment of patients already taking tiotropium to ensure that it remains appropriate for them. Patients at high risk of cardiovascular events should be regularly reviewed and reminded not to exceed the once-daily dose. Comment: The latest MHRA advice applies to both formulations of tiotropium but does not mention other muscarinic receptor antagonists. However, the Summaries of Product Characteristics for the other longer-acting muscarinic receptor antagonists also include special
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warnings and precautions for people with cardiovascular disease. Aclidinium should be used with caution in patients with a myocardial infarction during the previous 6 months, unstable angina, newly diagnosed arrhythmia within the previous 3 months, or hospitalisation within the previous 12 months for heart failure (NYHA III and IV).6 Glycopyrronium should be used with caution in patients with unstable ischaemic heart disease, left ventricular failure, history of myocardial infarction, arrhythmia (excluding chronic stable atrial fibrillation), a history of long QT syndrome or whose QTc (Fridericia method) was prolonged.7 Umeclidinium should be used with caution in patients with severe cardiovascular disorders, particularly cardiac arrhythmias.8 Healthcare professionals need to be aware of this new advice and review the appropriateness of the use of tiotropium and other muscarinic receptor antagonists in patients with certain cardiac conditions. 1. Medicines and Healthcare products Regulatory Agency. Tiotropium delivered via Respimat compared with Handihaler: no significant difference in mortality in TIOSPIR trial. Drug Safety Update 2015; 8 (7): 1 [online]. Available: https://www. gov.uk/drug-safety-update/tiotropium-delivered-via-respimat-compared-withhandihaler-no-significant-difference-in-mortality-in-tiospir-trial [Accessed 22 April 2015]. 2. Spiriva 18microgram inhalation powder, hard capsule. Summary of product characteristics, UK. Boehringer Ingelheim International GmbH, January 2015. 3. Spiriva Respimat 2.5microgram, inhalation solution. Summary of product characteristics, UK. Boehringer Ingelheim International GmbH, December 2014. 4. Medicines and Healthcare products Regulatory Agency. Tiotropium. Drug Safety Update 2011; 4 (4): H2 [online]. Available: https://www.gov.uk/drug-safetyupdate/tiotropium [Accessed 22 April 2015]. 5. Wise RA et al. Tiotropium Respimat inhaler and the risk of death in COPD. N Engl J Med 2013; 369: 1491-501. 6. Eklira Genuair 322micrograms inhalation powder. Summary of product characteristics, EU. AstraZeneca AB, March 2015. 7. Seebri Breezhaler inhalation powder, hard capsules 44mcg. Summary of product characteristics, EU. Novartis Europharm Limited, June 2014. 8. Incruse 55micrograms inhalation powder, pre-dispensed. Summary of product characteristics, EU. Glaxo Group Limited, December 2014.
Paracetamol and adverse effects The authors of a review of the safety of paracetamol have suggested that adverse effects may be more prevalent than is widely believed.1 The review used data from eight observational cohort studies that investigated adverse effects in people (adults aged >18 years) taking oral paracetamol at a standard therapeutic dose (0.5–1g every 4–6 hours; maximum 4g/24 hours) compared with non-use. The authors excluded evidence from randomised controlled trials because of the short-term follow-up and the non-representative nature of trial populations. The main adverse effects included all-cause mortality, cardiovascular effects (incidence of myocardial infarction, cerebrovascular accidents and hypertension), gastrointestinal effects (incidence of bleeding) and renal effects (reductions in estimated glomerular filtration rate, increases in serum creatinine concentration and the need for renal replacement therapy). However, meta-analysis was only possible for a singular outcome (incidence of hypertension) because of the non-comparable nature of outcomes and different paracetamol dosage definitions reported by individual studies. One study found a dose response and a relative rate of mortality that ranged from 0.95 (95% CI 0.92 to 0.98) to 1.63 (95% CI 1.58 to 1.68). Four studies reporting cardiovascular effects found a dose response and one reported a risk ratio of all cardiovascular adverse effects that ranged from 0.91 (95% CI 0.67 to 1.24) to 1.68 (95% CI 1.10 to 2.57). One study reported a dose response for gastrointestinal effects with an increased relative rate that ranged from 1.11 (95% CI 1.04 to 1.18) to 1.49 (95% CI 1.34 to 1.66). Of four studies reporting renal effects, three reported a dose response including a decrease in estimated glomerular filtration rate of at least 30%. The reviewers acknowledged limitations associated with the data, including reliance on self-reported use in some studies and on prescribing data in others. Five of the studies involved healthy female nurses or male doctors, which limits the generalisability of the findings. They also highlighted the possibility of ‘channelling bias’ in some studies—the likelihood of larger effect
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sizes due to patients being prescribed paracetamol who were considered not suitable for NSAIDs, thus forming preselected groups who were at higher risk of adverse effects. In addition, the quality of evidence for all the outcomes studied was graded as low or very-low. Nevertheless, the authors concluded their article by suggesting “that a systematic review of paracetamol’s efficacy and tolerability in individual conditions is warranted”. Comment: Most of the data presented came from single studies, as the reviewers were only able to perform a meta-analysis for one outcome. Several of the studies did not adjust for concomitant NSAID use. Given the many limitations associated with the data, the evidence presented in this systematic literature review would not appear sufficient to warrant a change in clinical practice. In 2013 the Commission for Human Medicines reviewed the safety of paracetamol in the context of its use to treat pain associated with mild osteoarthritis.2 The Commission noted that there was insufficient evidence to conclude that paracetamol causes serious disorders of the heart and circulatory system (such as heart attack and high blood pressure), kidneys or gastrointestinal system.” 1. Roberts E et al. Paracetamol: not as safe as we thought? A systematic literature review of observational studies. Ann Rheum Dis [Epub ahead of print] 2 March 2015; DOI:10.1136/annrheumdis-2014-206914. 2. Commission on Human Medicines, 2013. Summary of the commission on human medicines meeting held on Thursday 20th & Friday 21st June 2013 [online]. Available: http://webarchive.nationalarchives.gov.uk/20140711163402/http://www.mhra.gov. uk/home/groups/l-cs-el/documents/committeedocument/con297576.pdf [Accessed 22 April 2015].
Updated guidance on depression in children and young people The National Institute for Health and Care Excellence (NICE) has published updated guidance relating to the management of depression in children and young people.1 The original guideline, published in 2005, was reviewed in 2013 as part of NICE’s routine evidence surveillance programme. New evidence was identified and the guidance amended to include new recommendations relating to the use of psychological therapy and the combination of psychological therapy and antidepressant treatment:2 • Offer children and young people with moderate to severe depression a specific psychological therapy (individual cognitive behavioural therapy, interpersonal therapy, family therapy, or psychodynamic psychotherapy) that runs for at least 3 months. • Discuss the choice of psychological therapies with children and young people and their family members or carers. Explain that there is no good-quality evidence that one type of psychological therapy is better than the others. • Consider combined therapy (fluoxetine and psychological therapy) for initial treatment of moderate to severe depression in young people (12–18 years), as an alternative to psychological therapy alone followed by combined therapy. It should be noted that in the UK fluoxetine is the only antidepressant with marketing authorisation for use in children and adolescents aged 8 years and above. It is indicated for moderate to severe major depressive episode, if depression is unresponsive to psychological therapy after four to six sessions. Fluoxetine should be offered to a child or young person with moderate to severe depression only in combination with a concurrent psychological therapy. 3 Comment: Healthcare professionals should take the updated NICE recommendations into account when managing children and young people with depression. The use of fluoxetine requires careful consideration and arrangements must be put in place to ensure that the child or young person is reviewed and monitored regularly. 1. National Institute for Health and Care Excellence, 2015. Depression in children and young people: identification and management in primary, community and
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secondary care (CG28) [online]. Available: http://www.nice.org.uk/guidance/ cg28 [Accessed 22 April 2015]. 2. National Institute for Health and Care Excellence, 2015. Addendum to clinical guideline 28, depression in children and young people [online]. Available: http://www.nice.org.uk/guidance/cg28/evidence/depression-in-children-andyoung-people-guideline-addendum2 [Accessed 22 April 2015]. 3. Prozac 20mg hard capsules, and 20mg per 5ml oral liquid. Summary of product characteristics, UK. Eli Lilly and Company Limited, October 2014.
Impact of HPV vaccination programmes The authors of a recently published systematic review have concluded that long-term population-level effects of human papillomavirus (HPV) vaccination programmes are promising.1 More than 50 countries have implemented vaccination programmes to reduce the incidence of cervical cancer. All HPV vaccination programmes target pre-adolescent girls and a few countries have included boys in their programme. The systematic review and meta-analysis assessed 20 time-trend studies analysing changes between the pre- and postvaccination periods in nine high-income countries. It covered 140 million person-years of follow-up and focused on three main outcomes: prevalence of HPV infection; frequency (prevalence or incidence) of anogenital wart diagnosis; and frequency of high-grade cervical lesions. The reviewers included studies that used the bivalent (HPV types 16 and 18) and quadrivalent vaccine (HPV types 6, 11, 16 and 18). The review found that, in countries with female vaccination coverage of at least 50%, HPV type 16 and 18 infections decreased significantly between the prevaccination and postvaccination periods by 68% (relative risk [RR] 0.32, 95% CI 0.19 to 0.52), and anogenital warts decreased significantly by 61% (RR 0.39, 95% CI 0.22 to 0.71) in girls aged 13–19 years old. Significant reductions were also recorded in HPV types 31, 33, and 45 in this age group of girls (RR 0.72, 95% CI 0.54 to 0.96), suggesting cross-protection. The incidence of anogenital warts was significantly reduced in males aged under 20 years and in women aged 20–39 years, which the review’s authors say suggests herd effects. In countries with female vaccination coverage below 50% there were significant reductions in HPV types 16 and 18 infection and in anogenital warts in girls younger than 20 years of age, but with no indication of cross-protection or herd effects. The review’s authors suggest that the lack of direct data on HPV-related cancers can be attributed to the long time-lag between infection and expression, but that their results are promising for the long-term populationlevel effects of HPV vaccination programmes. They do, however, note that there is a need for continued monitoring to identify any signals of potential waning efficacy or type-replacement. In the UK, the quadrivalent HPV vaccine is indicated for use in those aged 9 years and above for prevention of premalignant genital lesions (cervical, vulvar and vaginal), premalignant anal lesions, cervical cancers, anal cancers and genital warts.2 The current national HPV vaccination programme targets females aged 11–18 years. Females above the age of 18 years and males of any age are not covered by the national HPV vaccination programme. 3 However, the Joint Committee on Vaccination and Immunisation has set up a working group to advise on expanding the programme to include adolescent boys.4 Comment: Although causality cannot be assumed, the results of the meta-analysis are encouraging. The authors suggest that the benefits are associated with HPV vaccination programmes and that school-based vaccination programmes led to the sharpest decline in HPV-related outcomes. Efficacy data from national immunisation programmes that include males, such as that in Australia, may help to inform future UK policy. 1. Drolet M et al. Population-level impact and herd effects following human papillomavirus vaccination programmes: a systematic review and meta-analysis. Lancet Infect Dis [Epub ahead of print] 2 March 2015; DOI 10.1016/S14733099(14)71073-4. 2. Gardasil. Summary of product characteristics, EU. Sanofi Pasteur MSD SNC, October 2014.
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3. Public Health England, 2014. Human papillomavirus (HPV): the green book, chapter 18a [online]. Available: https://www.gov.uk/government/uploads/system/uploads/ attachment_data/file/317821/Green_Book_Chapter_18a.pdf [Accessed 22 April 2015]. 4. HPV sub-committee of the joint committee on vaccination and immunisation, 2014. Minute of the meeting held on Monday 20 January 2014 [online]. Available: https://app. box.com/s/600veu6zr6s3gjvx8mkt/1/2678951279/22846870601/1 [Accessed 22 April 2015].
NICE lowers threshold for diagnosing gestational diabetes The National Institute for Health and Care Excellence (NICE) has lowered the threshold for diagnosing gestational diabetes as part of its updated guidance on diabetes in pregnancy.1 Healthcare professionals are advised that women should be diagnosed with gestational diabetes if they have either: • a fasting plasma glucose level of ≥5.6mmol/L, or • a 2-hour plasma glucose level of ≥7.8mmol/L. While the 2-hour plasma glucose level remains unchanged, NICE previously considered a fasting plasma level of ≥7mmol/L to be indicative of gestational diabetes.2 It is thought that the revised threshold will help to address variations in the glucose levels currently used for diagnosing gestational diabetes. The updated guidance includes several other key priorities for implementation: • Pregnant women with any type of diabetes should be advised to maintain capillary plasma glucose levels below the following targets (as long as this doesn’t cause problematic hypoglycaemia): 5.3mmol/L for fasting and either 7.8mmol/L 1 hour after meals or 6.4mmol/L 2 hours after meals. • A pregnant woman with any type of diabetes who presents with hyperglycaemia or is unwell should urgently be tested for ketonaemia to exclude diabetic ketoacidosis. • Women with gestational diabetes whose blood glucose levels return to normal after giving birth should be offered a fasting plasma glucose test 6–13 weeks after the birth to exclude diabetes. If this test is not performed by 13 weeks and a fasting plasma glucose test is not possible, women can be offered a glycated haemoglobin (HbA1c) test instead. A 75g 2-hour oral glucose tolerance test should not routinely be offered. • Women who have a negative postnatal test for diabetes should be offered an annual HbA1c test. Comment: The revised threshold may lead to more women being diagnosed with gestational diabetes, with associated cost and resource implications. However, the potential benefits are substantial, including reduced complications during pregnancy and labour, and improved outcomes for women and babies. 1. National Institute for Health and Care Excellence, 2015. Diabetes in pregnancy: management of diabetes and its complications from preconception to the postnatal period (NG3) [online]. Available: https://www.nice.org.uk/guidance/ ng3 [Accessed 22 April 2015]. 2. National Collaborating Centre for Women’s and Children’s Health, 2008. Diabetes in pregnancy: management of diabetes and its complications from preconception to the postnatal period [online]. Available: http://www.nice.org. uk/resource/CG63/pdf/c/cg63-diabetes-in-pregnancy-full-guideline-reissuedjuly-2008?id=bibc43b2ffrpcurgafbncfrbcu [Accessed 22 April 2015].
Online learning module on corticosteroid adverse effects The Medicines and Healthcare products Regulatory Agency (MHRA) has launched an online learning module aimed at reducing adverse effects of corticosteroids.1 The interactive learning module is designed to identify the most important hazards of corticosteroids and to help doctors, nurses and pharmacists
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anticipate, minimise and manage the risks. The MHRA claims that it draws on proven techniques for enhancing online learning. The module guides the learner through a series of exercises, questions and case studies, and concludes with a multiple-choice assessment of the learner’s knowledge. On completing the module successfully, learners can download a certificate. The MHRA stresses that this module on its own does not offer sufficient training on how and when to use a corticosteroid, and that prescribers should use up-to-date authoritative guidelines for selecting the best treatment, taking into account clinical circumstances and the patient’s views. To access the learning module, users need to register and login to the MHRA’s site (http://learning.mhra.gov.uk/mhra/lr_login.jsp). Comment: The learning module includes 129 slides and has a total running time of about 2 hours. However, it is broken down into manageable sections that can be tackled separately and provides health professionals with the ability to look at areas of specific interest to them. The MHRA is inviting feedback that could guide improvements in the module. 1. Medicines and Healthcare products Regulatory Agency, 2015. Regulator launches learning module on steroids [online]. Available: https://www.gov.uk/government/ news/regulator-launches-learning-module-on-steroids [Accessed 22 April 2015].
New quality standards on psychosis and schizophrenia The importance of managing both the physical and mental health of people with psychosis and schizophrenia is highlighted in a quality standard published by the National Institute for Health and Care Excellence (NICE).1 The standards define eight high-priority areas for quality improvement for adults with psychosis or schizophrenia. These include starting treatment in early intervention in psychosis services within 2 weeks of referral for adults with a first episode of psychosis; use of cognitive behavioural therapy for psychosis; family intervention for family members of adults with psychosis or schizophrenia; use of clozapine for adults with schizophrenia that has not responded adequately to treatment with at least two antipsychotic drugs; supported employment programmes; and carer focused education and support programmes. According to NICE, the standards were developed to provide a prioritised set of ”specific, concise and measurable objectives” for the care of people with these disorders. Each standard is underpinned by existing guidance, which NICE details in its background information. Also discussed are the implications of each standard for service providers, health and social care practitioners, commissioners, as well as patients, service users and carers. Of particular note are the standards relating to comprehensive physical health assessments and the promotion of healthy eating, physical activity and smoking cessation programmes. A national audit of 5,608 patients with schizophrenia in England and Wales in 2014 showed that there was poor monitoring of, and intervention for, risk factors for diabetes and cardiovascular disease.2 Comment: These standards provide a welcome focus towards improving the management of people with psychosis or schizophrenia. The emphasis on physical health is of particular importance, given that people with these disorders have a life expectancy that is 15–20 years lower than that of the general population, and are more likely to be obese, have type 2 diabetes and smoke. 1. National Institute for Health and Care Excellence, 2015. Psychosis and schizophrenia in adults. NICE quality standard 80 [online]. Available: http:// www.nice.org.uk/guidance/qs80 [Accessed 22 April 2015]. 2. Royal College of Psychiatrists, 2014. Report of the second round of the national audit of schizophrenia (NAS2) 2014 [online]. Available: http://www.rcpsych. ac.uk/workinpsychiatry/qualityimprovement/nationalclinicalaudits/ schizophrenia/nationalschizophreniaaudit/reports.aspx [Accessed 22 April 2015].
DOI: 10.1136/dtb.2015.5.0324
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DTB Select: 5 | May 2015 NICE guidance on medicines optimisation ● Hormone replacement therapy and CVD ● MHRA advice on tiotropium ● Paracetamol and adverse effects ● Updated guidance on depression in children and young people ● Impact of HPV vaccination programmes ● NICE lowers threshold for diagnosing gestational diabetes ● Online learning module on corticosteroid adverse effects ● New quality standards on psychosis and schizophrenia
NICE guidance on medicines optimisation Helping people to maximise the potential benefit of their medicines, while minimising the risk of harm, is the focus of new guidance issued by the National Institute for Health and Care Excellence (NICE).1 The guideline provides “best practice advice on the care of all people who are using medicines and also those who are receiving suboptimal benefit from medicines”. It lists three key priorities for implementation: • identifying, and learning from, medicines-related patient safety incidents; • sharing information about the person and their medicines when transferring from one care setting to another; and • obtaining a current, accurate medication list that documents any discrepancies from the most recently held information. Further recommendations include: • giving consideration to a structured medication review with the aim of reaching an agreement with the individual over their treatment in order to optimise the effect of their medicines and minimise the number of medication related problems; • implementing self-management plans to empower people to be involved in managing their condition; • using patient decision aids to facilitate a shared decisionmaking approach; • using clinical decision support software to help health professionals manage a person’s condition; and • considering a multidisciplinary team approach and cross-organisational working to improve outcomes. The new guidance recognises medicines management as an important aspect of healthcare primarily led by pharmacy and medicinesmanagement teams, while noting that medicines optimisation “focuses on actions taken by all health and social care practitioners and requires greater patient engagement and professional collaboration across health and social care settings”. Comment: DTB has previously described some of the challenges associated with addressing multimorbidity, polypharmacy and improving the use of medicines. 2,3 Responsibility for implementing this new guidance across a health economy is likely to fall to medicines management teams who have to juggle many competing priorities. The NICE guidance provides a helpful focus on the need to develop a system-wide approach across health and social care to improve outcomes from the use of medicines. However, this may require greater focus on providing direct support to patients and prescribers and less emphasis on chasing marginal Drug Tariff price changes. 1. National Institute for Health and Care Excellence, 2015. Medicines optimisation: the safe and effective use of medicines to enable the best possible outcomes (NG5) [online]. Available: https://www.nice.org.uk/guidance/ng5 [Accessed 22 April 2015]. 2. Describing deprescribing. DTB 2014; 52: 25. 3. Optimising medicines management. DTB 2013; 51: 37.
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Hormone replacement therapy and CVD An updated Cochrane review has assessed the effects of hormone therapy on the prevention of cardiovascular disease (CVD) in postmenopausal women.1 In addition, it examined whether there was a difference in its use in primary or secondary prevention. The review included 19 randomised controlled trials (including six added at this update) that compared orally administered hormone therapy (oestrogen alone or combined with a progestogen) with placebo or no treatment in 40,410 postmenopausal women. Treatment duration varied from 7 months to 10.1 years; study quality was described as generally good. The authors found that hormone therapy conferred no protective effects for all-cause mortality, cardiovascular death, non-fatal myocardial infarction, angina, or revascularisation in both primary and secondary prevention. However, there was an increased risk of stroke in those in the hormone therapy arm for combined primary and secondary prevention (risk ratio [RR] 1.24, 95% CI 1.10 to 1.41). Compared with placebo, hormone therapy was associated with an increase in venous thromboembolic events (RR 1.92, 95% CI 1.36 to 2.69) and pulmonary emboli (RR 1.81, 95% CI 1.32 to 2.48). In postmenopausal women without prior cardiovascular disease, hormone therapy compared with placebo or no treatment did not reduce the risk of death from cardiovascular causes. However, hormone therapy was associated with an increased risk of stroke (RR 1.32, 95% CI 1.12 to 1.56; four studies, n=28,719), and an increased risk of venous thromboembolism (RR 1.92, 95% CI 1.24 to 2.99; six studies, n=33,477). In postmenopausal women with pre-existing cardiovascular disease, hormone therapy compared with placebo or no treatment did not reduce the risk of death from cardiovascular causes. Hormone therapy was associated with an increased risk of stroke (RR 1.09, 95% CI 0.89 to 1.33; five studies, n=5,172), and an increased risk of venous thromboembolism (RR 2.02, 95% CI 1.13 to 3.62; six studies, n=4,399). The authors also performed subgroup analyses according to when treatment was started. There was moderate-quality evidence suggesting that women who started hormone therapy less than 10 years after the menopause had lower mortality (RR 0.70, 95% CI 0.52 to 0.95) and coronary heart disease (composite of death from cardiovascular causes and non-fatal myocardial infarction; RR 0.52, 95% CI 0.29 to 0.96) compared with placebo or no treatment. However, high-quality evidence suggested that they were still at increased risk of venous thromboembolism (RR 1.74, 95% CI 1.11 to 2.73). In women who started treatment more than 10 years after the menopause there was high-quality evidence that it had little effect on death or coronary heart disease between groups but there was an increased risk of stroke (RR 1.21, 95% CI 1.06 to 1.38) and venous thromboembolism (RR 1.96, 95% CI 1.37 to 2.80). Comment: Current advice suggests that some women may find hormone replacement therapy useful to manage menopausal symptoms but that the risks and benefits of treatment must be considered for each woman, particularly in those older than 60 years who have increased baseline risk of serious adverse events.2,3 The Cochrane review provides updated data on the cardiovascular effects associated with hormone therapy compared with placebo or no treatment. However, the review did not differentiate between women taking oestrogen alone and those taking oestrogen and progestogen. Although subgroup analysis highlighted evidence of a differential effect depending on when hormone treatment was started, the authors acknowledge that the results might be subject to bias. Such findings are unlikely to change current advice on the use of hormone therapy.
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1. Boardman HM et al. Hormone therapy for preventing cardiovascular disease in post-menopausal women. Cochrane Database Syst Rev 2015; 3: CD002229. DOI:0.1002/14651858.CD002229.pub4 [Last assessed as up-to-date 25 February 2014]. 2. National Institute for Health and Care Excellence, 2015. Clinical Knowledge Summaries: menopause [online]. Available: http://cks.nice.org.uk/menopause [Accessed 22 April 2015]. 3. Medicines and Healthcare products Regulatory Agency. Hormone replacement therapy: updated advice. Drug Safety Update 2007; 1 (2): 2 [online]. Available: https://www.gov.uk/drug-safety-update/hormone-replacement-therapy-updatedadvice [Accessed 22 April 2015].
MHRA advice on tiotropium The Medicines and Healthcare products Regulatory Agency (MHRA) has warned prescribers to be mindful of the cardiovascular adverse effects of tiotropium delivered by the Respimat and HandiHaler devices when prescribing to patients with certain cardiac conditions, who were excluded from most clinical trials of the drug.1 Tiotropium is indicated as maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (COPD).2,3 In addition, the Respimat formulation is also indicated as an add-on maintenance bronchodilator treatment in adult patients with asthma who are currently treated with the maintenance combination of inhaled corticosteroids (≥800µg budesonide/day or equivalent) and long-acting beta2 agonists and who experienced one or more severe exacerbations in the previous year. 3 After previous studies suggested an increased risk of death with Respimat compared with placebo and HandiHaler, the MHRA advised that the Respimat device should be used with caution in people with known cardiac rhythm disorders.4 However, following the publication of a large randomised double-blind non-inferiority trial that compared the safety of both devices, the MHRA has updated its advice. 5 The TIOSPIR trial, which included 17,135 participants with COPD followed up for a mean of 2.3 years, found no significant difference in its primary outcome of time to death from any cause between tiotropium delivered by HandiHaler and either of two doses delivered by Respimat (5µg vs. HandiHaler: hazard ratio 0.96, 95% CI 0.84 to 1.09; 2.5µg vs. HandiHaler: hazard ratio 1.00, 95% CI 0.87 to 1.14). The incidences of different causes of death (including death due to cardiovascular events) and major cardiovascular adverse events were adjudged to be similar across the three groups. Of the deaths attributed to myocardial infarction 21 were in patients using the Respimat device and three in patients using the Handihaler (p-value not stated). In people with previous cardiac arrhythmia there was no significant difference in the risk of all-cause mortality between tiotropium Respimat 5µg and HandiHaler. The MHRA has extended the warning on tiotropium to include both formulations. It now advises that clinicians should take the risk of cardiovascular adverse effects into account for patients with conditions that may be affected by the anticholinergic action of tiotropium, including: • myocardial infarction in the last 6 months; • unstable or life-threatening cardiac arrhythmia; • cardiac arrhythmia requiring intervention or a change in drug therapy in the past year; and • hospitalisation for heart failure (New York Heart Association [NYHA] class III or IV) within the past year. People with these conditions (with the exception of cardiac arrhythmia) have been excluded from clinical trials of the drug. Prescribers should tell patients to report any worsening of cardiac symptoms after starting tiotropium, and should review the treatment of patients already taking tiotropium to ensure that it remains appropriate for them. Patients at high risk of cardiovascular events should be regularly reviewed and reminded not to exceed the once-daily dose. Comment: The latest MHRA advice applies to both formulations of tiotropium but does not mention other muscarinic receptor antagonists. However, the Summaries of Product Characteristics for the other longer-acting muscarinic receptor antagonists also include special
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warnings and precautions for people with cardiovascular disease. Aclidinium should be used with caution in patients with a myocardial infarction during the previous 6 months, unstable angina, newly diagnosed arrhythmia within the previous 3 months, or hospitalisation within the previous 12 months for heart failure (NYHA III and IV).6 Glycopyrronium should be used with caution in patients with unstable ischaemic heart disease, left ventricular failure, history of myocardial infarction, arrhythmia (excluding chronic stable atrial fibrillation), a history of long QT syndrome or whose QTc (Fridericia method) was prolonged.7 Umeclidinium should be used with caution in patients with severe cardiovascular disorders, particularly cardiac arrhythmias.8 Healthcare professionals need to be aware of this new advice and review the appropriateness of the use of tiotropium and other muscarinic receptor antagonists in patients with certain cardiac conditions. 1. Medicines and Healthcare products Regulatory Agency. Tiotropium delivered via Respimat compared with Handihaler: no significant difference in mortality in TIOSPIR trial. Drug Safety Update 2015; 8 (7): 1 [online]. Available: https://www. gov.uk/drug-safety-update/tiotropium-delivered-via-respimat-compared-withhandihaler-no-significant-difference-in-mortality-in-tiospir-trial [Accessed 22 April 2015]. 2. Spiriva 18microgram inhalation powder, hard capsule. Summary of product characteristics, UK. Boehringer Ingelheim International GmbH, January 2015. 3. Spiriva Respimat 2.5microgram, inhalation solution. Summary of product characteristics, UK. Boehringer Ingelheim International GmbH, December 2014. 4. Medicines and Healthcare products Regulatory Agency. Tiotropium. Drug Safety Update 2011; 4 (4): H2 [online]. Available: https://www.gov.uk/drug-safetyupdate/tiotropium [Accessed 22 April 2015]. 5. Wise RA et al. Tiotropium Respimat inhaler and the risk of death in COPD. N Engl J Med 2013; 369: 1491-501. 6. Eklira Genuair 322micrograms inhalation powder. Summary of product characteristics, EU. AstraZeneca AB, March 2015. 7. Seebri Breezhaler inhalation powder, hard capsules 44mcg. Summary of product characteristics, EU. Novartis Europharm Limited, June 2014. 8. Incruse 55micrograms inhalation powder, pre-dispensed. Summary of product characteristics, EU. Glaxo Group Limited, December 2014.
Paracetamol and adverse effects The authors of a review of the safety of paracetamol have suggested that adverse effects may be more prevalent than is widely believed.1 The review used data from eight observational cohort studies that investigated adverse effects in people (adults aged >18 years) taking oral paracetamol at a standard therapeutic dose (0.5–1g every 4–6 hours; maximum 4g/24 hours) compared with non-use. The authors excluded evidence from randomised controlled trials because of the short-term follow-up and the non-representative nature of trial populations. The main adverse effects included all-cause mortality, cardiovascular effects (incidence of myocardial infarction, cerebrovascular accidents and hypertension), gastrointestinal effects (incidence of bleeding) and renal effects (reductions in estimated glomerular filtration rate, increases in serum creatinine concentration and the need for renal replacement therapy). However, meta-analysis was only possible for a singular outcome (incidence of hypertension) because of the non-comparable nature of outcomes and different paracetamol dosage definitions reported by individual studies. One study found a dose response and a relative rate of mortality that ranged from 0.95 (95% CI 0.92 to 0.98) to 1.63 (95% CI 1.58 to 1.68). Four studies reporting cardiovascular effects found a dose response and one reported a risk ratio of all cardiovascular adverse effects that ranged from 0.91 (95% CI 0.67 to 1.24) to 1.68 (95% CI 1.10 to 2.57). One study reported a dose response for gastrointestinal effects with an increased relative rate that ranged from 1.11 (95% CI 1.04 to 1.18) to 1.49 (95% CI 1.34 to 1.66). Of four studies reporting renal effects, three reported a dose response including a decrease in estimated glomerular filtration rate of at least 30%. The reviewers acknowledged limitations associated with the data, including reliance on self-reported use in some studies and on prescribing data in others. Five of the studies involved healthy female nurses or male doctors, which limits the generalisability of the findings. They also highlighted the possibility of ‘channelling bias’ in some studies—the likelihood of larger effect
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sizes due to patients being prescribed paracetamol who were considered not suitable for NSAIDs, thus forming preselected groups who were at higher risk of adverse effects. In addition, the quality of evidence for all the outcomes studied was graded as low or very-low. Nevertheless, the authors concluded their article by suggesting “that a systematic review of paracetamol’s efficacy and tolerability in individual conditions is warranted”. Comment: Most of the data presented came from single studies, as the reviewers were only able to perform a meta-analysis for one outcome. Several of the studies did not adjust for concomitant NSAID use. Given the many limitations associated with the data, the evidence presented in this systematic literature review would not appear sufficient to warrant a change in clinical practice. In 2013 the Commission for Human Medicines reviewed the safety of paracetamol in the context of its use to treat pain associated with mild osteoarthritis.2 The Commission noted that there was insufficient evidence to conclude that paracetamol causes serious disorders of the heart and circulatory system (such as heart attack and high blood pressure), kidneys or gastrointestinal system.” 1. Roberts E et al. Paracetamol: not as safe as we thought? A systematic literature review of observational studies. Ann Rheum Dis [Epub ahead of print] 2 March 2015; DOI:10.1136/annrheumdis-2014-206914. 2. Commission on Human Medicines, 2013. Summary of the commission on human medicines meeting held on Thursday 20th & Friday 21st June 2013 [online]. Available: http://webarchive.nationalarchives.gov.uk/20140711163402/http://www.mhra.gov. uk/home/groups/l-cs-el/documents/committeedocument/con297576.pdf [Accessed 22 April 2015].
Updated guidance on depression in children and young people The National Institute for Health and Care Excellence (NICE) has published updated guidance relating to the management of depression in children and young people.1 The original guideline, published in 2005, was reviewed in 2013 as part of NICE’s routine evidence surveillance programme. New evidence was identified and the guidance amended to include new recommendations relating to the use of psychological therapy and the combination of psychological therapy and antidepressant treatment:2 • Offer children and young people with moderate to severe depression a specific psychological therapy (individual cognitive behavioural therapy, interpersonal therapy, family therapy, or psychodynamic psychotherapy) that runs for at least 3 months. • Discuss the choice of psychological therapies with children and young people and their family members or carers. Explain that there is no good-quality evidence that one type of psychological therapy is better than the others. • Consider combined therapy (fluoxetine and psychological therapy) for initial treatment of moderate to severe depression in young people (12–18 years), as an alternative to psychological therapy alone followed by combined therapy. It should be noted that in the UK fluoxetine is the only antidepressant with marketing authorisation for use in children and adolescents aged 8 years and above. It is indicated for moderate to severe major depressive episode, if depression is unresponsive to psychological therapy after four to six sessions. Fluoxetine should be offered to a child or young person with moderate to severe depression only in combination with a concurrent psychological therapy. 3 Comment: Healthcare professionals should take the updated NICE recommendations into account when managing children and young people with depression. The use of fluoxetine requires careful consideration and arrangements must be put in place to ensure that the child or young person is reviewed and monitored regularly. 1. National Institute for Health and Care Excellence, 2015. Depression in children and young people: identification and management in primary, community and
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secondary care (CG28) [online]. Available: http://www.nice.org.uk/guidance/ cg28 [Accessed 22 April 2015]. 2. National Institute for Health and Care Excellence, 2015. Addendum to clinical guideline 28, depression in children and young people [online]. Available: http://www.nice.org.uk/guidance/cg28/evidence/depression-in-children-andyoung-people-guideline-addendum2 [Accessed 22 April 2015]. 3. Prozac 20mg hard capsules, and 20mg per 5ml oral liquid. Summary of product characteristics, UK. Eli Lilly and Company Limited, October 2014.
Impact of HPV vaccination programmes The authors of a recently published systematic review have concluded that long-term population-level effects of human papillomavirus (HPV) vaccination programmes are promising.1 More than 50 countries have implemented vaccination programmes to reduce the incidence of cervical cancer. All HPV vaccination programmes target pre-adolescent girls and a few countries have included boys in their programme. The systematic review and meta-analysis assessed 20 time-trend studies analysing changes between the pre- and postvaccination periods in nine high-income countries. It covered 140 million person-years of follow-up and focused on three main outcomes: prevalence of HPV infection; frequency (prevalence or incidence) of anogenital wart diagnosis; and frequency of high-grade cervical lesions. The reviewers included studies that used the bivalent (HPV types 16 and 18) and quadrivalent vaccine (HPV types 6, 11, 16 and 18). The review found that, in countries with female vaccination coverage of at least 50%, HPV type 16 and 18 infections decreased significantly between the prevaccination and postvaccination periods by 68% (relative risk [RR] 0.32, 95% CI 0.19 to 0.52), and anogenital warts decreased significantly by 61% (RR 0.39, 95% CI 0.22 to 0.71) in girls aged 13–19 years old. Significant reductions were also recorded in HPV types 31, 33, and 45 in this age group of girls (RR 0.72, 95% CI 0.54 to 0.96), suggesting cross-protection. The incidence of anogenital warts was significantly reduced in males aged under 20 years and in women aged 20–39 years, which the review’s authors say suggests herd effects. In countries with female vaccination coverage below 50% there were significant reductions in HPV types 16 and 18 infection and in anogenital warts in girls younger than 20 years of age, but with no indication of cross-protection or herd effects. The review’s authors suggest that the lack of direct data on HPV-related cancers can be attributed to the long time-lag between infection and expression, but that their results are promising for the long-term populationlevel effects of HPV vaccination programmes. They do, however, note that there is a need for continued monitoring to identify any signals of potential waning efficacy or type-replacement. In the UK, the quadrivalent HPV vaccine is indicated for use in those aged 9 years and above for prevention of premalignant genital lesions (cervical, vulvar and vaginal), premalignant anal lesions, cervical cancers, anal cancers and genital warts.2 The current national HPV vaccination programme targets females aged 11–18 years. Females above the age of 18 years and males of any age are not covered by the national HPV vaccination programme. 3 However, the Joint Committee on Vaccination and Immunisation has set up a working group to advise on expanding the programme to include adolescent boys.4 Comment: Although causality cannot be assumed, the results of the meta-analysis are encouraging. The authors suggest that the benefits are associated with HPV vaccination programmes and that school-based vaccination programmes led to the sharpest decline in HPV-related outcomes. Efficacy data from national immunisation programmes that include males, such as that in Australia, may help to inform future UK policy. 1. Drolet M et al. Population-level impact and herd effects following human papillomavirus vaccination programmes: a systematic review and meta-analysis. Lancet Infect Dis [Epub ahead of print] 2 March 2015; DOI 10.1016/S14733099(14)71073-4. 2. Gardasil. Summary of product characteristics, EU. Sanofi Pasteur MSD SNC, October 2014.
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3. Public Health England, 2014. Human papillomavirus (HPV): the green book, chapter 18a [online]. Available: https://www.gov.uk/government/uploads/system/uploads/ attachment_data/file/317821/Green_Book_Chapter_18a.pdf [Accessed 22 April 2015]. 4. HPV sub-committee of the joint committee on vaccination and immunisation, 2014. Minute of the meeting held on Monday 20 January 2014 [online]. Available: https://app. box.com/s/600veu6zr6s3gjvx8mkt/1/2678951279/22846870601/1 [Accessed 22 April 2015].
NICE lowers threshold for diagnosing gestational diabetes The National Institute for Health and Care Excellence (NICE) has lowered the threshold for diagnosing gestational diabetes as part of its updated guidance on diabetes in pregnancy.1 Healthcare professionals are advised that women should be diagnosed with gestational diabetes if they have either: • a fasting plasma glucose level of ≥5.6mmol/L, or • a 2-hour plasma glucose level of ≥7.8mmol/L. While the 2-hour plasma glucose level remains unchanged, NICE previously considered a fasting plasma level of ≥7mmol/L to be indicative of gestational diabetes.2 It is thought that the revised threshold will help to address variations in the glucose levels currently used for diagnosing gestational diabetes. The updated guidance includes several other key priorities for implementation: • Pregnant women with any type of diabetes should be advised to maintain capillary plasma glucose levels below the following targets (as long as this doesn’t cause problematic hypoglycaemia): 5.3mmol/L for fasting and either 7.8mmol/L 1 hour after meals or 6.4mmol/L 2 hours after meals. • A pregnant woman with any type of diabetes who presents with hyperglycaemia or is unwell should urgently be tested for ketonaemia to exclude diabetic ketoacidosis. • Women with gestational diabetes whose blood glucose levels return to normal after giving birth should be offered a fasting plasma glucose test 6–13 weeks after the birth to exclude diabetes. If this test is not performed by 13 weeks and a fasting plasma glucose test is not possible, women can be offered a glycated haemoglobin (HbA1c) test instead. A 75g 2-hour oral glucose tolerance test should not routinely be offered. • Women who have a negative postnatal test for diabetes should be offered an annual HbA1c test. Comment: The revised threshold may lead to more women being diagnosed with gestational diabetes, with associated cost and resource implications. However, the potential benefits are substantial, including reduced complications during pregnancy and labour, and improved outcomes for women and babies. 1. National Institute for Health and Care Excellence, 2015. Diabetes in pregnancy: management of diabetes and its complications from preconception to the postnatal period (NG3) [online]. Available: https://www.nice.org.uk/guidance/ ng3 [Accessed 22 April 2015]. 2. National Collaborating Centre for Women’s and Children’s Health, 2008. Diabetes in pregnancy: management of diabetes and its complications from preconception to the postnatal period [online]. Available: http://www.nice.org. uk/resource/CG63/pdf/c/cg63-diabetes-in-pregnancy-full-guideline-reissuedjuly-2008?id=bibc43b2ffrpcurgafbncfrbcu [Accessed 22 April 2015].
Online learning module on corticosteroid adverse effects The Medicines and Healthcare products Regulatory Agency (MHRA) has launched an online learning module aimed at reducing adverse effects of corticosteroids.1 The interactive learning module is designed to identify the most important hazards of corticosteroids and to help doctors, nurses and pharmacists
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anticipate, minimise and manage the risks. The MHRA claims that it draws on proven techniques for enhancing online learning. The module guides the learner through a series of exercises, questions and case studies, and concludes with a multiple-choice assessment of the learner’s knowledge. On completing the module successfully, learners can download a certificate. The MHRA stresses that this module on its own does not offer sufficient training on how and when to use a corticosteroid, and that prescribers should use up-to-date authoritative guidelines for selecting the best treatment, taking into account clinical circumstances and the patient’s views. To access the learning module, users need to register and login to the MHRA’s site (http://learning.mhra.gov.uk/mhra/lr_login.jsp). Comment: The learning module includes 129 slides and has a total running time of about 2 hours. However, it is broken down into manageable sections that can be tackled separately and provides health professionals with the ability to look at areas of specific interest to them. The MHRA is inviting feedback that could guide improvements in the module. 1. Medicines and Healthcare products Regulatory Agency, 2015. Regulator launches learning module on steroids [online]. Available: https://www.gov.uk/government/ news/regulator-launches-learning-module-on-steroids [Accessed 22 April 2015].
New quality standards on psychosis and schizophrenia The importance of managing both the physical and mental health of people with psychosis and schizophrenia is highlighted in a quality standard published by the National Institute for Health and Care Excellence (NICE).1 The standards define eight high-priority areas for quality improvement for adults with psychosis or schizophrenia. These include starting treatment in early intervention in psychosis services within 2 weeks of referral for adults with a first episode of psychosis; use of cognitive behavioural therapy for psychosis; family intervention for family members of adults with psychosis or schizophrenia; use of clozapine for adults with schizophrenia that has not responded adequately to treatment with at least two antipsychotic drugs; supported employment programmes; and carer focused education and support programmes. According to NICE, the standards were developed to provide a prioritised set of ”specific, concise and measurable objectives” for the care of people with these disorders. Each standard is underpinned by existing guidance, which NICE details in its background information. Also discussed are the implications of each standard for service providers, health and social care practitioners, commissioners, as well as patients, service users and carers. Of particular note are the standards relating to comprehensive physical health assessments and the promotion of healthy eating, physical activity and smoking cessation programmes. A national audit of 5,608 patients with schizophrenia in England and Wales in 2014 showed that there was poor monitoring of, and intervention for, risk factors for diabetes and cardiovascular disease.2 Comment: These standards provide a welcome focus towards improving the management of people with psychosis or schizophrenia. The emphasis on physical health is of particular importance, given that people with these disorders have a life expectancy that is 15–20 years lower than that of the general population, and are more likely to be obese, have type 2 diabetes and smoke. 1. National Institute for Health and Care Excellence, 2015. Psychosis and schizophrenia in adults. NICE quality standard 80 [online]. Available: http:// www.nice.org.uk/guidance/qs80 [Accessed 22 April 2015]. 2. Royal College of Psychiatrists, 2014. Report of the second round of the national audit of schizophrenia (NAS2) 2014 [online]. Available: http://www.rcpsych. ac.uk/workinpsychiatry/qualityimprovement/nationalclinicalaudits/ schizophrenia/nationalschizophreniaaudit/reports.aspx [Accessed 22 April 2015].
DOI: 10.1136/dtb.2015.5.0324
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