MHRA medical device alert: use of barrier methods may affect performance of FreeStyle Libre flash glucose sensor

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National Institute for Health and Care Excellence

  • Tisagenlecleucel now recommended within CDF for adults with lymphoma in final draft guidance.
  • NICE has also recommended the following in final guidance:
    • UrgoStart for treating diabetic foot and leg ulcers.
    • Laparoscopic cerclage for cervical incompetence to prevent late miscarriage or preterm birth
    • Prostatic urethral temporary implant insertion for lower urinary tract symptoms caused by benign prostatic hyperplasia, for research purposes only
    • Electrically-stimulated intravesical chemotherapy for non-muscle-invasive bladder cancer, for research purposes only
  • Percutaneous insertion of a cerebral protection device to prevent cerebral embolism during TAVI recommended under special arrangements only (draft guidance).
  • Percutaneous venoplasty not recommended for chronic cerebrospinal venous insufficiency in multiple sclerosis (draft guidance).

Medicines and Healthcare products Regulatory Agency

  • The MHRA has issued the following alerts:
    • Use of barrier methods may affect performance of FreeStyle Libre flash glucose sensor.
    • Recall for certain batches of Eurotrol haemoglobin controls due to microbial contamination
    • Nellix Endovascular Aneurysm Sealing (EVAS) System: device recall and enhanced patient surveillance
    • Class 2 medicines recall: Macleods Pharma UK limited - Irbesartan 150mg film-coated tablets
    • Arjo Minstrel passive floor lift (portable hoist): risk of spreader bar detachment from lifts without a scale.
  • Positive EAMS scientific opinion for dupilumab for severe atopic dermatitis.

European Medicines Agency

  • Lartruvo not recommended for new patients with advanced soft tissue sarcoma.

Dispensing Doctors’ Association

  • Carbagen shortage alert issued.

NHS England

  • Updated flu vaccine ordering guidance published.

Academy of Medical Royal Colleges

  • ‘Artificial Intelligence in Healthcare’ report published.

Royal College of Nursing

  • Safeguarding children and young people: roles and competencies guidance published.

Department of Health and Social Care

  • Five-year action plan and 20-year vision for tackling antimicrobial resistance published.

NHS Digital

  • Digital outreach project brings healthcare technology to the homeless.

Public Health England

  • Local projects awarded funding from the HIV Innovation Fund.

NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE
  

TISAGENLECLEUCEL NOW RECOMMENDED WITHIN CDF FOR ADULTS WITH LYMPHOMA IN FINAL DRAFT GUIDANCE

NICE has published final draft guidance which recommends tisagenlecleucel (Kymriah) for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), within the Cancer Drugs Fund (CDF). It will be offered to people whose disease has not responded or those whose disease has relapsed after treatment with two or more courses of chemotherapy. NICE’s initial draft guidance did not recommend tisagenlecleucel as the therapy was not considered cost-effective. Further negotiations between NHS England and the treatment’s manufacturer Novartis led to a commercial agreement offering the therapy at a lower price. After considering the evidence, the committee concluded tisagenlecleucel for adults with large B-cell lymphoma, after two or more systemic therapies, can be offered through the CDF.

URGOSTART RECOMMENDED FOR TREATING DIABETIC FOOT AND LEG ULCERS

The National Institute for Health and Care Excellence (NICE) has published evidence-based recommendations which supports the case for adopting UrgoStart dressings to treat non-infected diabetic foot ulcers and venous leg ulcers in the NHS. The committee concluded that using UrgoStart improves the speed and rate of wound healing in people with diabetic foot ulcers compared with standard care, and should therefore be considered as an option after any modifiable factors such as infection have been treated. The innovative element of UrgoStart is that it contains a substance which inhibits the activity of enzymes within the wound, high levels of which are linked to slower wound healing. Cost modelling shows that, compared with standard care, using UrgoStart dressings to treat diabetic foot ulcers is associated with a cost saving of £342 per patient after one year. It also shows that UrgoStart is likely to be cost saving for treating venous leg ulcers, but NICE says the robustness of this conclusion is less certain from the evidence available. For both types of ulcers, potential cost savings mainly come from better healing with UrgoStart dressings. If 25% of people having treatment for diabetic foot ulcers use UrgoStart instead of a non-interactive dressing, the NHS may save up to £5.4 million each year.

LAPAROSCOPIC CERCLAGE RECOMMENDED FOR CERVICAL INCOMPETENCE TO PREVENT LATE MISCARRIAGE OR PRETERM BIRTH

NICE has published final guidance which recommends the use of laparoscopic cerclage for cervical incompetence to prevent late miscarriage or preterm birth. The procedure involves placing a stitch around the upper part of the cervix to keep it closed. NICE says that urrent evidence on the safety and efficacy of the procedure is adequate to support its use provided standard arrangements are in place for clinical governance, consent and audit. Patient selection should be done by a multidisciplinary team experienced in the management and prevention of preterm delivery.

PROSTATIC URETHRAL TEMPORARY IMPLANT INSERTION FOR LOWER URINARY TRACT SYMPTOMS CAUSED BY BENIGN PROSTATIC HYPERPLASIA RECOMMENDED FOR RESEARCH PURPOSES ONLY

NICE has published final guidance which recommends prostatic urethral temporary implant insertion for lower urinary tract symptoms caused by benign prostatic hyperplasia for research purposes only. The procedure involves inserting a wire device that creates new channels in the lining of the urethra, increasing the flow of urine. Current evidence on the safety and efficacy the procedure is limited in quantity and quality. Therefore, this procedure should only be used in the context of research. Further research, ideally in the form of randomised controlled trials, should report details of patient selection (including prostate size and the amount of median lobe enlargement), improvement in lower urinary tract symptoms in the short term and long term, re-intervention rates, and outcome measures of sexual function using established methods.

ELECTRICALLY-STIMULATED INTRAVESICAL CHEMOTHERAPY FOR NON-MUSCLE-INVASIVE BLADDER CANCER RECOMMENDED FOR RESEARCH PURPOSES ONLY

NICE has published final guidance which recommends electrically stimulated intravesical chemotherapy for non-muscle-invasive bladder cancer in adults for research purposes only. The procedure involves using a small electrical current to improve the effect of chemotherapy given directly into the bladder. Current evidence on the procedure shows there are no major safety concerns. However, evidence on efficacy is limited in quantity and quality. Therefore, this procedure should only be used in the context of research and further research should include randomised controlled trials compared with standard care, which should report details of patient selection.

PERCUTANEOUS INSERTION OF A CEREBRAL PROTECTION DEVICE TO PREVENT CEREBRAL EMBOLISM DURING TAVI RECOMMENDED UNDER SPECIAL ARRANGEMENTS ONLY

NICE has published draft guidance which recommends percutaneous insertion of a cerebral protection device to prevent cerebral embolism during transcatheter aortic valve implantation (TAVI), under special arrangements only. Among its draft recommendations, NICE says that the evidence on percutaneous insertion of a cerebral protection device to prevent cerebral embolism during TAVI raises no major safety concerns other than those associated with the TAVI procedure. However, the evidence on efficacy for preventing TAVI-related stroke is inconclusive. Clinicians wishing to do percutaneous insertion of a cerebral protection device to prevent cerebral embolism during TAVI should:

  • Inform the clinical governance leads in their NHS trusts.
  • Ensure that patients and their carers understand the procedure’s safety and efficacy, as well as any uncertainties about these.
  • Provide them with clear written information to support shared decision-making. In addition, the use of NICE’s information for the public is recommended.
  • Details of all patients should be entered into the UK TAVI registry.

This guidance is open for public consultation until 21 February 2019.

PERCUTANEOUS VENOPLASTY NOT RECOMMENDED FOR CHRONIC CEREBROSPINAL VENOUS INSUFFICIENCY IN MULTIPLE SCLEROSIS

NICE has published final guidance which does not recommend percutaneous venoplasty for chronic cerebrospinal venous insufficiency in multiple sclerosis. NICE says current evidence on the procedure shows that there are serious complications and that it provides no benefit.

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MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY

USE OF BARRIER METHODS MAY AFFECT PERFORMANCE OF FREESTYLE LIBRE FLASH GLUCOSE SENSOR

The MHRA has issued a medical device alert for FreeStyle Libre flash glucose sensor, as some users who are experiencing an immune response to the adhesive are applying creams, patches or sprays under their sensor to reduce skin reactions, which may affect device performance. Healthcare professionals are advised to:

  • Identify patients who have reported or may be experiencing skin reactions, which may include erythema, itching and blistering.
  • Consider if continued use of this device for patients with skin reactions is suitable.
  • Consider use of alternative glucose monitoring systems for these patients.
  • Report adverse incidents to the Yellow Card Scheme.

This is consistent with the guidance already provided in the manufacturer’s instructions for use, which state: “Some individuals may be sensitive to the adhesive that keeps the Sensor attached to the skin. If you notice significant skin irritation around or under your Sensor, remove the Sensor and stop using the FreeStyle Libre system. Contact your health care professional before continuing to use the FreeStyle Libre system.”

The manufacturer has confirmed that they have revised the formulation of the adhesive, which will be available to UK customers from April 2019.

The MHRA also says that the problem may not be unique to the Abbott FreeStyle Libre sensor adhesive and the same actions should be taken if patients experience similar symptoms with a different brand of continuous glucose monitoring system.

POSITIVE EAMS SCIENTIFIC OPINION RECOMMENDS DUPILUMAB FOR SEVERE ATOPIC DERMATITIS IN ADOLESCENTS

The MHRA has issued a positive Early access to medicines scheme (EAMS) scientific opinion for Dupilumab (Dupixent) in the treatment of adolescent patients between 12 and 18 years of age with severe atopic dermatitis who have responded inadequately to at least one systemic therapy or where the available systemic therapies are not recommended or are not tolerated. Dupilumab is an immunotherapy drug targeted to one aspect of the immune system that is involved in chronic skin inflammation of atopic dermatitis patients. Dupilumab works by attaching to the IL-4 receptor alpha subunit which sits primarily on the surface of cells of the immune system. This interferes with messages of two molecules, IL4 and IL13 that trigger the inflammation in the skin. Eczema patients have an overactive chronic inflammatory response and dupilumab works by dampening this down. The Public Assessment Report states that dupilumab results in meaningful improvement in the extent and severity of eczema as well as in the symptom of itch and in some patients the improvement may be marked.

RECALL FOR CERTAIN BATCHES OF EUROTROL HAEMOGLOBIN CONTROLS DUE TO MICROBIAL CONTAMINATION

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert for certain batches of Eurotrol haemoglobin controls due to microbial contamination, which may give readings below the values assigned to the product, leading to incorrect measurement results. . Healthcare professionals are advised to:

  • Identify affected lots, which are listed in the manufacturer’s Field Safety Notice (FSN)
  • Ensure all relevant members of staff receive the manufacturer’s FSN and that they understand the problem and actions to be taken.
  • Complete and return the acknowledgement form in the FSN.
  • Follow the manufacturer’s actions listed in the FSN until advised otherwise by the manufacturer.
  • Report adverse events involving these devices through the local incident reporting system and/or the national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales.

RECALL ISSUED FOR NELLIX ENDOVASCULAR ANEURYSM SEALING SYSTEM

The MHRA has issued a medical device alert for Nellix Endovascular Aneurysm Sealing (EVAS) System. Endologix has stopped selling the Nellix EVAS device and is recalling unused stock. The MHRA recommends enhanced patient surveillance due to a high risk of graft failure beyond two years after implantation. Healthcare professionals are advised to:

  • Immediately stop further implants of the device.
  • Identify if the centre has any device inventory that should be returned to Endologix following the instructions in the Field Safety Notice (dated 04 January 2019).
  • Identify all patients implanted with a Nellix device under surveillance at the centre.
  • Notify the nearest UK expert centre with the number of patients that currently remain under surveillance and discuss in advance the support this centre can provide if a patient requires re-intervention.
  • Continue to undertake lifelong follow-up of all patients according to normal clinical practice. Enhanced surveillance involving CT imaging should be repeated at least annually, unless the patient is considered unfit for secondary intervention. Arrange for early CT surveillance for all patients who have not received CT imaging within the last 12 months.
  • The most recent scans should be compared to immediate post-operative images to identify signs of device failure. This includes significant device migration, Type I endoleak and/or aneurysm sac expansion.
  • Discuss with the nearest UK expert centre all patients being considered for secondary intervention.
    • Patients that are suitable for surgical explant may be treated either locally or referred on to a larger volume centre if appropriate.
    • All patients in whom a Nellix-in-Nellix intervention is proposed as the optimum treatment should be treated at one of the named UK expert centres, according to the conditions set out in the protocol at appendix 1 of the MHRA medical device alert.

CLASS 2 MEDICINES RECALL: MACLEODS PHARMA UK LIMITED - IRBESARTAN 150MG FILM-COATED TABLETS

Macleods Pharma UK Limited is recalling specific batches Irbesartan 150mg Film-coated tablets from pharmacies as a precautionary measure due to possible contamination with N‑nitrosodiethylamine (NDEA). Healthcare Professionals and wholesalers are advised to:

  • Stop supplying the batches listed immediately. Quarantine all remaining stock and return it to their supplier using their supplier’s approved process.
  • If receiving queries about this issue from patients, to advise them to continue taking their medication as the health risk of discontinuing the medicine is higher than the potential risk presented by the contaminant. A treatment review is not necessary until the next routine appointment.

The MHRA does not anticipate any shortages of Irbesartan containing products. It is possible, however, that there may be some local supply issues, in which case patients should be advised to speak to their doctor to discuss alternative treatments. The MHRA continues to investigate the issue alongside the European Medicines Agency (EMA) and the European Directorate for the Quality of Medicines (EDQM).

RISK OF SPREADER BAR DETACHMENT WHEN USING THE ARJO MINSTREL PASSIVE FLOOR LIFT

The MHRA has issued a medical device alert for the Arjo Minstrel passive floor lift (portable hoist) due to the risk of the spreader bar becoming detached from the lift arm during patient transfer, with the potential for serious injuries to the patient. Healthcare professionals are advised to:

  • Check which version of the spreader bar the lifts have, using the manufacturer’s instructions in their Field Safety Notice (FSN).
  • If the device requires replacement, to stop using it immediately, quarantine it and contact Arjo UK. 
  •  If the device does not need replacement, to fill in and return the customer response form in the FSN to Arjo UK to confirm this.

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EUROPEAN MEDICINES AGENCY

LARTRUVO NOT RECOMMENDED FOR NEW PATIENTS WITH ADVANCED SOFT TISSUE SARCOMA

Following preliminary results from the ANNOUNCE study, the European Medicines Agency is recommending that no new patients should start treatment with Lartruvo (olaratumab) in combination with doxorubicin, as it was shown to be no more effective at prolonging the lives of patients with soft tissue cancer than doxorubicin alone. The EMA says that, based on the information available so far, there are no new safety concerns with the medicine, with side effects reported with the combination being similar to those with doxorubicin alone. Lartruvo was authorised in November 2016 to treat advanced soft tissue sarcoma, a condition for which there is a lack of suitable medicines. At time of its approval, data on the effects of Lartruvo were limited because of the small number of patients included in the main study which supported authorisation. The medicine was therefore granted a marketing authorisation on condition that the company provides additional data from the ANNOUNCE study in order to confirm the efficacy and safety of the medicine. Healthcare professionals will be informed in writing of the preliminary results of the study and the current treatment recommendations.

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DISPENSING DOCTORS’ ASSOCIATION

CARBAGEN SHORTAGE ALERT ISSUED

The Doctor’s Dispensing Association has reported that Mylan has informed the Department of Health and Social Care that 200mg and 400mg, and 200mg and 400mg modified-release Carbagen (carbamazepine) tablets will be unavailable until mid-late 2019. As such, patients currently taking Carbagen will need to be switched to an alternative brand during this time. Tegretol (carbamazepine) may be considered as an alternative during this time, and there is a clinical memo to assist clinicians in prioritising and switching patients.

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NHS ENGLAND

UPDATED FLU VACCINE ORDERING GUIDANCE PUBLISHED

NHS England has published advice on the recommended vaccines for the 2019/20 seasonal flu vaccination programme. Both of the vaccines that were recommended for the 2018/19 season will continue to be recommended for next year. Both vaccines are currently licensed and available to order for use in the UK:

  • the standard egg cultured quadrivalent inactivated vaccine (QIVe) will continue to be recommended for 18-64-year-olds in clinical at-risk groups and other eligible groups, including frontline health and social care workers.
  • the adjuvanted trivalent inactivated vaccine (aTIV) will continue to be recommended for individuals aged 65 years and over.

In addition, the cell grown quadrivalent vaccine (QIVc), Flucelvax® Tetra, is now licensed for use in the UK for patients aged nine years and upwards. The Joint Committee on Vaccination and Immunisation considers that QIVc is equally suitable to:

  • Quadrivalent inactivated vaccine (QIVe) for those aged 91-64 years in clinical at-risk groups and other eligible groups, including frontline health and social care workers. Both QIVe and QIVc are preferable to standard egg based inactivated trivalent vaccines (TIVe).
  • Adjuvanted trivalent vaccine (aTIV) for individuals aged 65 years and over, which is preferable to standard egg based inactivated trivalent and quadrivalent vaccines (TIVe/QIVe) on the grounds of both clinical and cost-effectiveness.

However, the high-dose trivalent vaccine (TIV-HD), which JCVI also advised as equally suitable for use in those aged 65 years and over, has now been licensed for use in the UK but has a significantly higher list price than the equally suitable vaccines. Therefore, this vaccine will not be commissioned by NHS England or reimbursed for use in the NHS Influenza vaccination programme in 2019/20.

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ACADEMY OF MEDICAL ROYAL COLLEGES

‘ARTIFICIAL INTELLIGENCE IN HEALTHCARE’ REPORT PUBLISHED


The Academy of Medical Royal Colleges has published a report which details the findings of a major enquiry into the likely impact of Artificial Intelligence (AI) in healthcare. The report includes the following recommendations:

  • Politicians and policymakers should refrain from thinking that AI is going to solve all the problems the health and care systems across the UK are facing.
  • Patient safety must remain paramount and AI must be developed in a regulated way in partnership between clinicians and computer scientists. However, regulation cannot be allowed to stifle innovation.
  • Clinicians can and must be part of the change that will accompany the development and use of AI. This will require changes in behaviour and attitude including rethinking many aspects of doctors’ education and careers.
  • For those who meet information handling and governance standards, data should be made more easily available across the private and public sectors. It should be certified for accuracy and quality.
  • Joined-up regulation is key to making sure that AI is introduced safely, as currently there is too much uncertainty about accountability, responsibility and the wider legal implications of the use of this technology.
  • External critical appraisal and transparency of tech companies is necessary for clinicians to be confident that the tools they are providing are safe to use.
  • Artificial intelligence should be used to reduce, not increase, health inequality – geographically, economically and socially.

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ROYAL COLLEGE OF NURSING

SAFEGUARDING CHILDREN AND YOUNG PEOPLE: ROLES AND COMPETENCIES GUIDANCE FOR HEALTHCARE STAFF PUBLISHED

The Royal College of Nursing had published guidance which provides a clear framework which identifies the competencies required for all healthcare staff to protect children and young people from harm, and help improve their wellbeing. Levels 1-3 relate to different occupational groups, while level 4 and 5 are related to specific roles. This version of the framework also includes specific detail for chief executives, chairs, board members including executives, non-executives and lay members.

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DEPARTMENT OF HEALTH AND SOCIAL CARE

FIVE-YEAR ACTION PLAN AND 20-YEAR VISION FOR TACKLING ANTIMICROBIAL RESISTANCE PUBLISHED

The government has published a 20-year vision and five-year national action plan for how the UK will contribute to containing and controlling AMR by 2040 (see OnMedica article). The plans include targets, such as:

  • cutting the number of drug-resistant infections by 10% (5,000 infections) by 2025
  • reducing the use of antibiotics in humans by 15%
  • preventing at least 15,000 patients from contracting infections as a result of their healthcare each year by 2024.

The plan focuses on making sure current antibiotics stay effective by reducing the number of resistant infections and supporting clinicians to prescribe appropriately. New technology will also be used to gather real-time patient data, helping clinicians understand when to use and preserve antibiotics in their treatment. The pharmaceutical industry will also be expected to take more responsibility for antibiotic resistance. NICE and NHS England will explore a new payment model that pays pharmaceutical companies based on how valuable their medicines are to the NHS, rather than on the quantity of antibiotics sold.

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NHS DIGITIAL

DIGITAL OUTREACH PROJECT BRINGS HEALTHCARE TECHNOLOGY TO THE HOMELESS

NHS Digital has reported that a digital healthcare outreach project has helped 122 homeless people in Hastings by using technology to improve how outreach workers respond to the healthcare needs of their clients. The team communicates with St John’s ambulance to get clinical opinions on injuries and symptoms. The project, which is a partnership between NHS Digital, NHS England, Good Things Foundation and The Seaview Project, has been using digital technology to record and triage health concerns of rough sleepers. Those who visit the wellbeing centre and other public spaces are also being encouraged to use the internet to access health information. The project is part of the NHS’s Widening Digital Participation Programme, which aims to make digital health services and information accessible to everyone – particularly the most excluded people in society.

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PUBLIC HEALTH ENGLAND

LOCAL PROJECTS AWARDED FUNDING FROM THE HIV INNOVATION FUND

Public Health England (PHE) has announced that this year’s initiatives for the HIV Innovation Fund will support the UK’s ambition to achieve zero new HIV transmissions by 2030. PHE announced 14 local pioneering projects have been awarded a share of the £600,000 fund available in 2018 to 2019. Projects that have been awarded funding include two charities collaborating to prevent HIV in women with female genital mutilation (FGM) in Berkshire; and The Grass is Always Grindr, a weekly drama series published on YouTube that focuses on how Londoners are affected by HIV.

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OnMedica

Editorial team, Wilmington Healthcare

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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