- Drug safety updates published for:
- Magnesium sulfate: risk of skeletal adverse effects in the neonate in pregnancy.
- Restriction on tofacitinib (Xeljanz▼) recommended in patients at high risk of pulmonary embolism while safety review is ongoing.
- Restrictions for alemtuzumab (Lemtrada) after serious cardiovascular and immune-mediated adverse reactions reported.
- Primary hyperparathyroidism guideline published.
- Inotersen recommended for hereditary transthyretin amyloidosis in final guidance.
- High-intensity focused ultrasound for glaucoma recommended for research only.
- Implant insertion for prominent ears recommended for research only.
- Withdrawal of marketing authorisations for fenspiride medicines announced.
- Supply problems reported.
- Pioneering Centre for Perioperative Care launched to improve patients’ lives.
- Guidance published on managing iron deficiency anaemia in adults.
- Revised competencies to support orthopaedic and trauma practitioners published.
- Overview of work done to achieve parity of esteem between mental and physical health published.
- NHS to invest £5 million to improve care for people with a learning disability.
- New measures to improve care for people with autism and learning disabilities announced.
- Early interventions needed to save lives of young adults with eating disorders, report finds.
- Research reveals hospitality workers suffer from work-related severe mental health issues.
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY
MAGNESIUM SULFATE: RISK OF SKELETAL ADVERSE EFFECTS IN THE NEONATE IN PREGNANCY
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a drug safety update regarding the maternal administration of magnesium sulfate, which when administered for longer than 5–7 days in pregnancy has been associated with skeletal adverse effects and hypocalcaemia and hypermagnesemia in neonates. The MHRA advises that, if the use of magnesium sulfate in pregnancy is prolonged or repeated, healthcare professionals should consider monitoring neonates for abnormal calcium and magnesium levels and skeletal adverse effects. Furthermore, healthcare professionals should report suspected adverse drug reactions to magnesium sulfate following exposure during pregnancy on a Yellow Card.
RESTRICTION ON TOFACITINIB RECOMMENDED IN PATIENTS AT HIGH RISK OF PULMONARY EMBOLISM WHILE SAFETY REVIEW IS ONGOING
Following observation in a clinical study of an increased risk of pulmonary embolism and overall mortality with tofacitinib (Xeljanz▼) 10 mg twice-daily in rheumatoid arthritis, a safety review has started and new contraindications introduced. While an in-depth review of these risks is ongoing, the 10 mg twice-daily dose of tofacitinib must not be prescribed in patients with one or more of the following risk factors for pulmonary embolism:
- Use of combined hormonal contraceptives or hormone replacement therapy
- Heart failure
- Previous venous thromboembolism, either deep venous thrombosis or pulmonary embolism
- Inherited coagulation disorder
- Patients undergoing major surgery.
Additionally, other risk factors for pulmonary embolism to be considered when prescribing tofacitinib 10 mg twice-daily are age, obesity (BMI>30 kg/m2), smoking, and immobilisation.
RESTRICTIONS FOR LEMTRADA AFTER SERIOUS CARDIOVASCULAR AND IMMUNE-MEDIATED ADVERSE REACTIONS REPORTED
While an urgent EU safety review evaluates reports of serious cardiovascular events and immune-mediated reactions, including autoimmune hepatitis, the use of alemtuzumab (Lemtrada) has been restricted and strengthened requirements have been introduced to monitor vital signs and liver function before and during treatment. Healthcare professionals are advised:
- alemtuzumab for multiple sclerosis should only be started in adults with either:
- relapsing-remitting multiple sclerosis that is highly active despite an adequate course of treatment with at least two other disease-modifying therapies
- highly active relapsing-remitting multiple sclerosis if all other disease-modifying therapies are contraindicated or otherwise unsuitable
- patients already on alemtuzumab for multiple sclerosis may continue treatment if it is beneficial and they have been informed of the additional monitoring requirements and new risks.
New monitoring requirements and precautions for use include:
- monitor vital signs, including blood pressure, before and periodically during alemtuzumab infusion – consider stopping the infusion and conducting additional monitoring, including electrocardiography (ECG), if any clinically significant changes in vital signs occur
- monitor liver function tests before and during treatment with alemtuzumab for multiple sclerosis
- consider discontinuing treatment in patients who develop hepatic injury or serious immune-mediated reactions
- evaluate immediately any patients who develop early manifestations of pathologic immune activation and consider a diagnosis of haemophagocytic lymphohistiocytosis.
Further advice to give to patients is also detailed in the MHRA drug safety update.
NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE
PRIMARY HYPERPARATHYROIDISM GUIDELINE PUBLISHED
NICE has published a guideline which covers the diagnosis, assessment and management of primary hyperparathyroidism. It aims to improve recognition and treatment of the condition, reduce long‑term complications and improve quality of life. This guideline includes recommendations on:
- diagnostic testing in primary care
- testing and assessment in secondary care
- referral for surgery and surgical management
- non-surgical management
- care before and during pregnancy
- information and support
INOTERSEN RECOMMENDED FOR HEREDITARY TRANSTHYRETIN AMYLOIDOSIS IN FINAL GUIDANCE
NICE has published final highly specialised technologies guidance which recommends inotersen (Tegsedi), within its marketing authorisation, as an option for treating stage 1 and stage 2 polyneuropathy in adults with hereditary transthyretin amyloidosis. It is recommended only if the company provides inotersen according to the commercial arrangement. According to NICE, clinical trial evidence shows that inotersen slows progression of the disease considerably, although its long-term benefits are uncertain. Some assumptions in the economic modelling are also uncertain, particularly around the utility values and the healthcare costs. NICE says, despite the uncertainties, inotersen is likely to provide important clinical benefits for people with hereditary transthyretin amyloidosis and value for money within the context of a highly specialised service.
HIGH-INTENSITY FOCUSED ULTRASOUND FOR GLAUCOMA RECOMMENDED FOR RESEARCH ONLY
NICE has published draft guidance which finds that the evidence on the safety and efficacy of high-intensity focused ultrasound for glaucoma is inadequate in quality and quantity. Therefore, NICE recommends this procedure should only be used in the context of research. Research should ideally take the form of randomised controlled trials comparing this procedure with standard therapies and should report safety events and long-term outcomes. NICE may update the guidance on publication of further evidence.
IMPLANT INSERTION FOR PROMINENT EARS RECOMMENDED FOR RESEARCH ONLY
NICE has produced draft recommendations on the procedure of implant insertion for prominent ears. NICE finds that the current evidence on the safety and efficacy of the procedure is inadequate in quality and quantity. Therefore, this procedure should only be used in the context of research. NICE recommends that further research should include comparisons of this procedure with current best therapy. Furthermore, the research should address issues of patient selection, such as age and type of ear shape, nature of ear implants used, long-term efficacy and safety outcomes, and patient reported outcomes using validated quality-of-life measures.
EUROPEAN MEDICINES AGENCY
WITHDRAWAL OF MARKETING AUTHORISATIONS FOR FENSPIRIDE MEDICINES ANNOUNCED
The European Medicine Agency’s safety committee (PRAC) has recommended that the marketing authorisations for fenspiride medicines be revoked, so the medicines can no longer be marketed in the EU. This follows a review that has confirmed that these cough medicines could cause heart rhythm problems. The PRAC considered all the available evidence in its review. This included cases of QT prolongation and torsades de pointes in patients using these medicines, results of laboratory studies, data from published literature and stakeholder input. Heart rhythm problems can be serious and occur suddenly, and it is not feasible to identify in advance the patients who may be at risk of these problems with fenspiride. In contrast, fenspiride medicines are used to treat non-serious cough. Therefore, the PRAC considered that these medicines should no longer be marketed. Healthcare professionals are advised that they should no longer prescribe fenspiride medicines and advise their patients to stop taking fenspiride medicines.
DOCTORS’ DISPENSING ASSOCIATION
SUPPLY PROBLEMS REPORTED
The Doctors’ Dispensing Association (DDA) has reported that the following medicines will be out of stock:
- Microgynon 30, 3×21 tablets (ethinylestradiol 30 mcg, levonorgestrel 150 mcg) from end of May to July 2019.
- Ovranette tablets from early June until August 2019.
- Diamorphine 5mg injection from 27 May to the week commencing 5 August 2019.
Furthermore, the DDA also reports that the intermittent supply issues for Sinement are expected to continue until early June with the following products:
- Sinemet 25mg/250mg 10×10 tablets.
- Sinemet 12.5mg/50mg 9×10 tablets.
- Sinemet CR 50mg/200mg 6×10 tablets.
- Sinemet plus 10mg/100mg 10×10 tablets.
However, Sinemet Plus 25mg/100mg 10×10 tablets and Sinemet Half CR 25mg/100mg 6×10 tablets should now be available.
ROYAL COLLEGE OF ANAESTHETISTS
PIONEERING CENTRE FOR PERIOPERATIVE CARE LAUNCHED TO IMPROVE PATIENTS’ LIVES
The Centre for Perioperative Care (CPOC) has been launched by the Royal College of Anaesthetists, as a cross-specialty, national centre dedicated to the promotion, advancement and development of perioperative care. CPOC will facilitate and encourage cross-organisational and new ways of working to enhance and improve the perioperative care of patients. The initial work of CPOC will build on the foundations of existing College perioperative care work streams alongside partner organisations including the Royal College of Surgeons of England, the Royal College of Physicians of England, they Royal College of Nursing, the Royal College of General Practitioners and the Association of Anaesthetists. The centre will also work closely with NHS England and the equivalent bodies responsible for healthcare policy in the other UK devolved nations. Work from the centre will be aligned with the Colleges’ global and sustainability strategies. Working with CPOC partners, the College will champion the ‘prehab to rehab’ model which is at the heart of perioperative care. Building on the national shift toward cohesive care systems outlined in NHS England’s Long Term Plan, CPOC will work to help professionals and hospitals to better prepare patients for their surgery, increase coordination between specialities and provide a cohesive aftercare programme to enhance recovery and improve quality of life following surgery.
ROYAL COLLEGE OF NURSING
GUIDANCE PUBLISHED ON MANAGING IRON DEFICIENCY ANAEMIA IN ADULTS
The Royal College of Nursing has produced guidance on iron deficiency anaemia in adults. The guidance has been developed by expert nurses from several specialties and is for the use of nurses, health care assistants, midwives, and health visitors from all specialties and backgrounds. Pharmacosmos UK Ltd and Vifor Pharma UK Ltd have provided funding, medical and scientific advice. It includes information on the management of iron deficiency, including; dietary iron, oral iron supplements, intravenous iron and practical administration; and blood transfusions.
REVISED COMPETENCIES TO SUPPORT ORTHOPAEDIC AND TRAUMA PRACTITIONERS PUBLISHED
The RCN has published revised competencies to support orthopaedic and trauma practitioners in an evidenced-based format to reflect their specific, specialist knowledge and skills. The competencies can be employed in various roles across acute, primary and community settings in the United Kingdom and the framework is inclusive for all practitioners working in the NHS, independent or voluntary sector. It also includes frameworks specific to musculoskeletal trauma but excludes major general trauma - this is covered in a separate document detailing competencies for the care of major trauma patients within major trauma centres and trauma units.
OVERVIEW OF WORK DONE TO ACHIEVE PARITY OF ESTEEM BETWEEN MENTAL AND PHYSICAL HEALTH PUBLISHED
The RCN has published an overview which covers the work the College is doing to address the mortality gap between people with serious mental illness and the rest of the population. It also includes details of the College’s collaborative approach to establishing parity of esteem between mental and physical health.
NHS TO INVEST £5 MILLION TO IMPROVE CARE FOR PEOPLE WITH A LEARNING DISABILITY
NHS England has announced that an additional £5 million will fund reviews to improve care for people with a learning disability and committed to renewed national action to tackle serious conditions (see OnMedica article).The programme which reviews the deaths of everyone with a learning disability is being expanded to speed up the spread of best practice; thousands more reviews will be carried out over the next 12 months. NHS England has also committed to national action to tackle the major killer conditions among people with a learning disability based on lessons learned from reviews. These include:
- Pneumonia – efforts will focus on increasing the uptake of the flu vaccine among people with a learning disability alongside other at-risk groups through a targeted awareness campaign.
- Respiratory – The NHS will commission an independent review into the deaths of people with a learning disability due to respiratory conditions to address inequalities amongst this patient group.
- Constipation – the NHS will launch a national campaign to promote awareness around the risk of constipation including how it can be prevented, recognised and treated to better support families, carers and staff who work with people with a learning disability.
- Sepsis and deterioration – Earlier this year NHS England took action to help ensure hospital staff spot and treat the killer blood condition within an hour to save thousands more lives.
- Cancer – the uptake of screening to ensure early diagnosis of cancer is a priority for the NHS with a focus on people with a learning disability in the national screening review. The NHS is prioritising making reasonable adjustments for screening including the roll out of easy read information.
DEPARTMENT OF HEALTH AND SOCIAL CARE
NEW MEASURES TO IMPROVE CARE FOR PEOPLE WITH AUTISM AND LEARNING DISABILITIES ANNOUNCED
The Department of Health and Social Care has announced that it will introduce new measures to improve care for people with autism and learning disabilities. The measures will include a new working group for learning disabilities and autism, and funding specialist advocates to review the care of patients in segregation or long-term seclusion.
ROYAL COLLEGE OF PSYCHIATRISTS
EARLY INTERVENTIONS NEEDED TO SAVE LIVES OF YOUNG ADULTS WITH EATING DISORDERS, REPORT FINDS
Investment in adult eating disorder services has failed to keep up with spending on care for children with conditions like anorexia and bulimia, creating an “unacceptable health inequality”, a report by the Royal College of Psychiatrists finds. Since 2016, around £135 million has been invested in children and young people’s eating disorder services, with around 70 community teams now deployed across the country. Access to treatment has improved. However, the College calls for parity between child and adult services in terms of access, waiting times and service provision. The report found:
- People can wait up to 41 months for treatment, with adults waiting on average 30% longer than under-18s
- Adults must also overcome hurdles before accessing services, such as their Body Mass Index (BMI) being more than 16 or if they are self-harming or misusing alcohol. This can cause major delays to their treatment
- Delays are putting lives at risk as people with an eating disorder are twice as likely to die than the general population. Risks of psychological illnesses – including suicidality – are also high from the early stages of an eating disorder.
However, the report found that a very different picture is emerging for young people. Latest NHS data shows 81% of under-18s received treatment within one week of an urgent referral, while 87% of non-urgent referrals were seen within four weeks. These percentages have steadily improved since investment and monitoring began in 2016. Early interventions have been shown to improve recovery rates.
ROYAL SOCIETY FOR PUBLIC HEALTH
RESEARCH REVEALS HOSPITALITY WORKERS SUFFER FROM WORK-RELATED SEVERE MENTAL HEALTH ISSUES
The Royal Society for Public Health (RSPH) has published new research which finds that mental health and wellbeing of hospitality workers is under significant strain. In the latest report, Service With(out) a Smile, 84% of hospitality workers reported increased stress which was believed to be a direct consequence of their job. 24% of respondents required medical or psychological help, and 45% said they would not recommend working in hospitality.
The report highlights a number of initiatives which have been introduced to address concerns around staff health and wellbeing, such as Hospitality Action, which set up an Employee Assistance Programme, and Me, Myself in Mind, which run classes on mental health awareness for the hospitality industry.