MHRA drug safety update: daratumumab - risk of reactivation of hepatitis B virus

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Medicines and Healthcare products Regulatory Agency

  • Drug safety updates:
    • Daratumumab (Darzalex▼): risk of reactivation of hepatitis B virus
    • Naltrexone/bupropion (Mysimba▼): risk of adverse reactions that could affect ability to drive
    • Carfilzomib (Kyprolis▼): reminder of risk of potentially fatal cardiac events.

National Institute for Health and Care Excellence

  • Risankizumab recommended for moderate to severe plaque psoriasis in final guidance.
  • Cannabidiol not recommended with clobazam for Dravet and Lennox-Gastaut syndromes in draft guidance.
  • Fever in under 5s: new recommendations for Kawasaki disease in draft guideline update.
  • Quality standards published:
    • Coexisting severe mental illness and substance misuse
    • Intrapartum care: existing medical conditions and obstetric complications (draft).

Scottish Intercollegiate Guidelines Network

  • Management of chronic pain guideline revised.
  • Management of suspected bacterial lower UTI draft guideline published.

NHS England

  • NHS funds emicizumab for severe haemophilia.
  • New tech to spot sepsis saves lives.
  • Progressive Neurological Conditions Toolkit launched.
  • RightCare Frailty Toolkit launched.

NHS Digital

  • Pilot to improve care for people with a learning disability.

Department of Health and Social Care

  • New service to deliver urgent medicines and medical products into UK announced.
  • Personalised health checks to be considered in new review.
  • PM calls for urgent action to improve vaccination uptake.

World Health Organisation

  • New measles surveillance data published.

Royal College of Nursing

  • Competency framework published for nurses providing care to people with breast cancer.

MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY

DARATUMUMAB (DARZALEX▼): RISK OF REACTIVATION OF HEPATITIS B VIRUS

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a drug safety update on daratumumab (Darzalex▼) due to reports of reactivation of hepatitis B virus, including several fatal cases worldwide. Healthcare professionals are advised to:

  • screen all patients for hepatitis B virus before initiation of daratumumab; patients with unknown serology who are already on treatment should also be screened
  • monitor patients with positive serology for clinical and laboratory signs of hepatitis B reactivation during treatment, and for at least six months following the end of daratumumab treatment
  • advise patients with positive serology to seek medical help immediately if they experience signs and symptoms suggestive of hepatitis B virus reactivation
  • stop treatment with daratumumab in patients with hepatitis B virus reactivation and institute appropriate treatment in consultation with experts in the treatment of hepatitis B virus infection; consult with experts before resuming daratumumab in patients with adequately controlled viral reactivationreport any suspected adverse drug reactions associated with daratumumab to theYellow Card Scheme.

NALTREXONE/BUPROPION (MYSIMBA▼): RISK OF ADVERSE REACTIONS THAT COULD AFFECT ABILITY TO DRIVE

The MHRA has published a drug safety update for naltrexone/bupropion (Mysimba▼) due to the risk of adverse reactions that could affect the ability to drive. An EU review of cumulative data has identified somnolence as a common risk with naltrexone/bupropion and loss of consciousness as a rare risk. Given these and other adverse reactions, a new warning has been added to the product information that naltrexone/bupropion may affect the ability to drive, operate machinery, or perform dangerous tasks. In a few cases, loss of consciousness occurred when the patient was driving, including a small number of cases worldwide associated with a road traffic accident. Therefore, healthcare professionals should advise patients of the following:

  • always check the leaflet that comes with the medicine for information on how the medicine may affect driving ability
  • it is against the law to drive if driving ability is impaired by any medicine
  • do not drive if experiencing side effects that may impair driving, such as difficulties with vision or concentration; feeling sleepy, dizzy, or faint; or seizures
  • do not drive, operate machinery, or perform dangerous activities while taking a medicine until the side effects are known (especially just after starting or changing the dose of the medicine)
  • talk to a doctor or pharmacist if there are concerns about side effects while taking a medicine; side effects can be reported to the Yellow Card Scheme.

CARFILZOMIB (KYPROLIS▼): REMINDER OF RISK OF POTENTIALLY FATAL CARDIAC EVENTS

The MHRA has published a drug safety update as a reminder of risk of cardiac events with carfilzomib (Kyprolis▼). Carfilzomib has been associated with new or worsening cardiac failure, decreased ejection fraction, pericarditis, atrial fibrillation, tachycardia, myocardial ischaemia, and myocardial infarction. Death due to cardiac arrest has occurred within a day of carfilzomib administration and fatal outcomes have also been reported following cardiac failure and myocardial infarction. The MHRA recently received a report from a coroner following death by cardiac arrest of a man given carfilzomib, cyclophosphamide, and dexamethasone in a clinical trial. The Pharmacovigilance Expert Advisory Committee of the Commission on Human Medicines considered the safety profile for carfilzomib and risks of cardiac reactions. The Committee advised that warnings about risks in the product information of carfilzomib are clear but emphasised the need for prescribers to be reminded of the risk. Healthcare professionals are advised to monitor patients for signs and symptoms of cardiac disorders before and during treatment with carfilzomib; stop carfilzomib if severe or life-threatening cardiac events occur (restarting treatment may be considered at a lower dose once the condition is controlled and the patient is functionally stable); and to report any suspected adverse drug reactions (ADR) associated with carfilzomib via the Yellow Card Scheme.

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NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE

RISANKIZUMAB RECOMMENDED FOR MODERATE TO SEVERE PLAQUE PSORIASIS

NICE has published evidence-based recommendations which recommend risankizumab (Skyrizi) for treating moderate to severe plaque psoriasis in adults, only if:

  • the disease is severe, as defined by a total Psoriasis Area and Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and
  • the disease has not responded to other systemic treatments, including ciclosporin, methotrexate and phototherapy, or these options are contraindicated or not tolerated and
  • the company provides the drug according to the commercial arrangement.

NICE recommends stopping risankizumab treatment at 16 weeks if the psoriasis has not responded adequately. An adequate response is defined as:

  • a 75% reduction in the PASI score (PASI 75) from when treatment started or
  • a 50% reduction in the PASI score (PASI 50) and a 5‑point reduction in DLQI from when treatment started.

Risankizumab is proposed as an alternative to other biological therapies already recommended by NICE for treating severe plaque psoriasis in adults. Evidence from clinical trials shows that risankizumab is more effective than adalimumab and ustekinumab. Indirect comparisons suggest that risankizumab is likely to provide similar health benefits compared with guselkumab, and better PASI response rates compared with many other biologicals.

CANNABIDIOL NOT RECOMMENDED WITH CLOBAZAM FOR DRAVET AND LENNOX-GASTAUT SYNDROMES

NICE’s draft guidance does not recommend cannabidiol (Epidyolex) with clobazam for treating Dravet and Lennox-Gastaut syndromes. The committee noted that the clinical trial evidence shows that cannabidiol with clobazam reduces the number of the main types of seizures associated with these conditions compared with usual care with anti-epileptic drugs, and heard from patients and their carers how important these benefits are for them. However, because the duration of the clinical trials was only 14 weeks, the longer-term effectiveness of cannabidiol with clobazam is uncertain. The committee also had concerns about the validity of the economic models provided by the company. For example, the committee was not convinced that the models adequately reflect the underlying conditions, nor did the company explore scenarios that allow for the effectiveness of cannabidiol to diminish over time, which is seen with other antiepileptic drugs. The committee concluded that the models may not capture all aspects of severe treatment-resistant epilepsy- only the effects on health-related quality of life of reducing the number of main types of seizure are modelled, and not the effects of reducing other types of seizures.

NICE has announced its intention to work with GW Pharma to address the issues highlighted by its independent appraisal committee in its evaluation of cannabidiol for treating 2 types of severe treatment-resistant epilepsy. Final guidance is expected to be published in November.

FEVER IN UNDER 5s: NEW RECOMMENDATIONS FOR KAWASAKI DISEASE IN DRAFT GUIDELINE UPDATE

NICE has published a draft guideline update which covers the assessment and early management of fever with no obvious cause in children aged under five. The draft guidance, which  aims to improve clinical assessment and help healthcare professionals diagnose serious illness among young children who present with fever in primary and secondary care, includes new recommendations regarding when to suspect Kawasaki disease. The draft recommendations say that clinicians should be aware of the possibility of Kawasaki disease in children with fever that has lasted five days or longer. Additional features of Kawasaki disease may include:

  • bilateral conjunctival injection without exudate
  • erythema and cracking of lips; strawberry tongue; or erythema of oral and pharyngeal mucosa
  • oedema and erythema in the hands and feet
  • polymorphous rash
  • cervical lymphadenopathy.

Parents or carers should be asked about the presence of these features since the onset of fever, because they may have resolved by the time of assessment. Clinicians should also be aware that children under one year may present with fewer clinical features of Kawasaki disease in addition to fever, but may be at higher risk of coronary artery abnormalities than older children.

Final guidance is expected to be published in November 2019 and will update NICE guideline CG160.

QUALITY STANDARD: COEXISTING SEVERE MENTAL ILLNESS AND SUBSTANCE MISUSE

NICE has published a quality standard which covers the assessment, management and care provided for people aged 14 and over who have coexisting severe mental illness and substance misuse. It describes high-quality care in priority areas for improvement, including:

  • Initial identification of coexisting substance misuse: people aged 14 and over with suspected or confirmed severe mental illness are asked about their use of alcohol and drugs.
  • Exclusion from services: people aged 14 and over are not excluded from mental health services because of coexisting substance misuse or from substance misuse services because of coexisting severe mental illness.
  • Care coordinators: people aged 14 and over with coexisting severe mental illness and substance misuse have a care coordinator working in mental health services when they are identified as needing treatment from secondary care mental health services.
  • Follow-up after any missed appointment.

DRAFT QUALITY STANDARD: INTRAPARTUM CARE - EXISTING MEDICAL CONDITIONS AND OBSTETRIC COMPLICATIONS

NICE has published a draft quality standard which covers care during labour and birth for women who need extra support because they have a medical condition or complications in their current or previous pregnancy. It also covers women who have had no antenatal care. It describes high-quality care in priority areas for improvement. The draft statements are:

  • Women with an existing medical condition develop their individualised intrapartum care plan with a multidisciplinary team that includes a member with expertise in manging the medical condition during pregnancy.   
  • Women with an existing medical condition are involved in reviewing their intrapartum care plan with the multidisciplinary team.
  • Pregnant women with heart disease have intrapartum risk regularly assessed.
  • Women who have had a previous caesarean section and are in labour know about the potential benefits and risks of different modes of birth.
  • Women in labour with sepsis or suspected sepsis have observations carried out by a multidisciplinary team at a frequency based on the level of clinical concern.

It does not cover hypertension in pregnancy, diabetes in pregnancy, or the organisation of care for pregnant women with complex social factors.

The final standard is expected to be published in February 2020.

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SCOTTISH INTERCOLLEGIATE GUIDELINES NETWORK

MANAGEMENT OF CHRONIC PAIN GUIDELINE REVISED

The Scottish Intercollegiate Guidelines Network (SIGN) has published a revised guideline on the management of chronic pain, which provides recommendations based on current evidence for best practice in the assessment and management, in non-specialist settings, of adults with chronic non-malignant pain, defined for the purposes of the guideline as pain that has been present for more than 12 weeks. Self-management, pharmacological, psychological, physical, complementary and dietary therapies are also covered in the guideline.

MANAGEMENT OF SUSPECTED BACTERIAL LOWER UTI - DRAFT GUIDELINE PUBLISHED

SIGN has published a draft guideline on the management of suspected bacterial lower urinary tract infection (UTI) in adult women, which includes recommendations on:

  • The diagnosis and management of
    • Lower UTIs in women aged under 65 years
    • Lower UTIs in women aged 65 years and above
    • Catheter-associated lower UTI in women
  • The provision of information.

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NHS ENGLAND

NHS FUNDS EMICIZUMAB FOR SEVERE HAEMOPHILIA

NHS England has announced it will fund treatment for thousands of people with severe haemophilia, which it says will dramatically cut their risk of life-threatening bleeds and reduce treatment time. Emicizumab (Hemlibra®) bolsters the blood by mimicking the action of the blood protein factor VIII to avoid uncontrolled bleeding, while cutting treatment times from multiple time-consuming infusions every week to a single injection given once-a-week or fortnight. The NHS in England has agreed to fund the drug for around 2,000 people in the country who live with the condition, which include many young children whose parents sometimes struggle to administer the current infusion several times a month.

NEW TECH TO SPOT SEPSIS SAVES LIVES

A new ‘alert and action’ technology has been introduced by NHS England, which uses algorithms to read patients’ vital signs and alert medics to worsening conditions that are a warning sign of sepsis (see OnMedica article). Three leading hospitals are using alerts to help identify the infection and tell doctors when patients with the serious condition are getting worse, ahead of the measures being rolled out across England as part of the NHS Long Term Plan. NHS leaders in Cambridge, Liverpool and Berkshire are now helping the rest of the health service to adopt tools to spot it, which NHS England says costs 37,000 lives a year and is notoriously difficult to identify. In Liverpool, the hospital’s digital system brings together lab results and patient observations into one place to help staff diagnose and treat suspected sepsis, saving up to 200 lives a year. In Cambridge, deaths from sepsis have fallen consistently over the last three years, with at least 64 lives saved in the past year thanks to the innovative alert and action feature. In Berkshire, since introducing a digital system, the trust has increased screening rates by 70% with nine in 10 patients now consistently screened for sepsis during admission as opposed to two in 10 beforehand, allowing doctors to spot more cases sooner.

PROGRESSIVE NEUROLOGICAL CONDITIONS TOOLKIT LAUNCHED

NHS England has announced the launch of the Progressive Neurological Conditions Toolkit, which aims to speed up diagnosis and provide better coordinated care for those living with brain and nerve conditions like Parkinson’s (see OnMedica article). The toolkit will see fast-tracked blood tests rolled out and consultant appointments over Skype for those who want them, as well as improved access to specialist physical and mental health care. NHS England says people will also be supported to better understand and manage their symptoms at home, and to take a more informed and active role in making decisions about the treatment they receive.

RIGHTCARE FRAILTY TOOLKIT LAUNCHED

NHS England has launched the NHS RightCare Frailty Toolkit, which has been developed in collaboration with NHS England’s National Clinical Director for Older People, Age UK, Getting It Right First Time and NICE. The toolkit supports systems to understand the priorities in frailty identification and care, and key actions to take. It provides opportunity to assess and benchmark current systems to find opportunities for improvement.

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NHS DIGITAL

PILOT TO IMPROVE CARE FOR PEOPLE WITH A LEARNING DISABILITY

NHS Digital has announced it is piloting a reasonable adjustment flag on patient records, which will let doctors, nurses and other health and care staff know that a patient has a learning disability and has specific needs that require adjustments to the services provided so patients get the best care (see OnMedica article). In the trial, staff will access the information through a patient’s record on the Summary Care Record application. In the longer term, it will be integrated with clinical systems so that staff will be able to see it on their own screens as soon as they search for the patient. The reasonable adjustment flag may include a patient’s need for a longer appointment or a quiet waiting area as well as how to communicate with them or who to involve in decisions about their health and care. The pilots in Gloucestershire and Devon involve various care settings including GP surgeries, hospitals and community services for learning disability. They will look at how care is impacted when that information is readily available to staff from the first point of contact onwards. The pilots will run to the end of September to test the technology behind the flag and gather feedback from staff, patients and carers. NHS Digital will then explore a potential expansion, including widening the geographical area, giving access to more care settings and trialling integration with clinical systems.

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DEPARTMENT OF HEALTH AND SOCIAL CARE

NEW SERVICE TO DELIVER URGENT MEDICINES AND MEDICAL PRODUCTS INTO UK ANNOUNCED

The Department of Health and Social Care (DHSC) has announced it is setting up an express freight service to deliver urgent medicines and medical products into the UK as part of Brexit preparations (see OnMedica article). The service is intended to deliver small parcels of medicines or medical products on a 24-hour basis, with additional provision to move larger pallet quantities on a two- to four-day basis. The service will be available to the whole of the UK. DHSC says that, while the majority of goods will be standard medicines and medical products, the express freight service will also be able to deliver temperature-controlled products if needed. The contract will run for 12 months, with a possible further 12-month extension.

PERSONALISED HEALTH CHECKS TO BE CONSIDERED IN NEW REVIEW

DHSC has announced an evidence-based review into the NHS Health Check service (see OnMedica article). The checks are currently offered to everyone aged between 40 and 74 to spot the early signs of major conditions that cause early death, including stroke, kidney disease, heart disease and type 2 diabetes. However, DHSC said the checks pay little attention to people’s individual risks or needs. Therefore, the review will explore how to improve the system, with a focus on offering personalised interventions based on factors such as age, where people live and DNA. The changes are part of a wider move away from blanket approaches to public health, to an approach that takes personal choices into account. The new health checks will draw on lessons learned from cancer, for example, which is the most advanced area of personalised medicine in terms of detection and treatment. The review will also explore:

  • a special check-up for people approaching retirement age to help prevent or delay future care needs
  • increasing the range of advice the checks can offer – for example, prevention of musculoskeletal problems or early action on hearing loss
  • ways to increase the uptake of health checks
  • the digitisation of health checks where appropriate.

PM CALLS FOR URGENT ACTION TO IMPROVE VACCINATION UPTAKE

In light of the UK losing its ‘measles-free’ status with the World Health Organisation, the prime minister (PM) has called for urgent action to boost the number of children and young people receiving routine vaccinations (see OnMedica article). Actions set out by the PM include:

  • NHS England writing to GPs urging them to promote ‘catch up’ vaccination programmes for MMR for 10-11-year-olds, as well as all those 5-25-year-olds who have not had two doses of the jab;
  • Strengthening the role of local immunisation coordinators – healthcare professionals that promote vaccines particularly with hard-to-reach families. This includes supporting areas with low uptake and tailoring specific local interventions to under-vaccinated communities;
  • Addressing parents’ concerns about vaccines by updating the advice on NHS.uk specifically to address misleading information about the dangers of vaccines, by giving people NHS-approved, evidence-based and trusted advice on vaccines including through a new website;
  • Calling a summit of social media companies to discuss how they can play their part in promoting accurate information about vaccination; and
  • DHSC – working with Public Health England and NHS England – delivering a comprehensive strategy to address the issue in the Autumn.

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WORLD HEALTH ORGANISATION

NEW MEASLES SURVEILLANCE DATA PUBLISHED

The World Health Organisation (WHO) has published new measles surveillance data, which provides preliminary data based on country reports submitted monthly to WHO. According to the latest figures measles outbreaks continue to spread rapidly around the world with millions of people globally at risk of the disease. In the first six months of 2019, reported measles cases are the highest they have been in any year since 2006. According to WHO, there have been almost three times as many cases reported to date in 2019 as there were at the same time last year. This follows successive yearly increases since 2016, indicating a concerning and continuing upsurge in the overall measles burden worldwide. According to WHO and UNICEF coverage data released in July 2019, 86% children have received the first dose of measles vaccine and 69% the second. This means that around 20 million children in 2018 received no measles vaccine through their routine vaccination programmes. Furthermore, 23 countries have yet to introduce the second measles vaccine dose into their national schedule.

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ROYAL COLLEGE OF NURSING

COMPETENCY FRAMEWORK PUBLISHED FOR NURSES PROVIDING CARE TO PEOPLE WITH BREAST CANCER

The Royal College of Nursing (RCN) has published a competency framework which defines the standards of care expected for a competent registered nurse providing general breast cancer care or specialist breast cancer care. The publication replaces the RCN’s (2007) Clinical Standards for Working in a Breast Specialty. The framework is designed to be used flexibly, acknowledging that not all competencies will be relevant in every circumstance.

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OnMedica is an independent, easy to access on-the-go website for doctors. It provides GPs and specialists with easy to digest and up-to-date, relevant educational content whilst enabling the freedom to share and collaborate in a safe-space to further personal development.
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