MHRA: class 2 medicines recall on some irbesartan tablets from Actavis Group PTC EHF

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National Institute for Health and Care Excellence

  • Perjeta now recommended for new breast cancer indication in final draft guidance.
  • Tecentriq in combination not recommended for lung cancer in draft guidance.
  • Antibiotic prescribing guidance for patients with suspected pneumonia published.
  • Draft guidance update on the diagnosis and management of hypertension in pregnancy published.
  • Quality standards published for:

     

    • Diagnosis and management of serious eye disorders
    • Recognising, assessing and responding to child abuse and neglect
    • The assessment and management of Lyme disease (draft)
    • Assessing and managing hearing loss in adults (draft)
    • Care and support of people growing older with a learning disability (draft)

Scottish Medicines Consortium

  • Medicines accepted for use within NHS Scotland:

     

    • Kymriah for acute lymphoblastic leukaemia in some paediatric and young adult patients
    • Xeljanz for moderate to severe active ulcerative colitis
    • Nplate for chronic immune (idiopathic) thrombocytopenic purpura in patients aged one year of more (restricted use)
    • Xarelto for the prevention of atherothrombotic event (restricted use)
    • Tafinlar in combination for stage III melanoma with a BRAF v600 mutation
    • Zebinix for partial-onset seizures in adolescents and children (restricted use)
  • Medicines not recommended:

     

    • Cabometyx for advanced renal cell carcinoma
    • Yescarta for relapsed or refractory diffuse large B cell lymphoma
    • Keytruda in combination for lung cancer
  • Four medicines not accepted due to lack of submission.

Medicines and Healthcare products Regulatory Agency

  • Class 2 medicines recall on some irbesartan tablets from Actavis Group PTC EHF.
  • Medical device alerts issued for:

     

    • Some implantable cardiac pacemakers: risk of syncope due to pause in pacing therapy
    • Ophthalmic implant Raindrop Near Vision Inlay: risk of corneal haze
    • Orthopaedic implant rHead Radial Head and Uni-Elbow: risk of early loosening

NHS Improvement

  • Patient safety alert issued for fracture fixation plates.

European Medicines Agency

  • New safety features for medicines sold in the EU detailed in the Falsified Medicines Directive (FDM).

Dispensing Doctors' Association

  • NHS England challenged on FMD funding.

NHS England

  • Rollout of lung cancer scanning trucks across the country announced.

NHS Digital

  • Figures show steep rise in hospital admissions for youths assaulted with sharp objects.

European Centre for Disease Prevention and Control

  • Epidemiological update published for yellow fever vaccination for those attending the Rio Carnival.

 

NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE

PERJETA NOW RECOMMENDED FOR NEW BREAST CANCER INDICATION IN FINAL DRAFT GUIDANCE

NICE has published final draft guidance which now recommends pertuzumab (Perjeta) with intravenous trastuzumab and chemotherapy for the adjuvant treatment of human epidermal growth factor receptor 2 (HER2)-positive early stage breast cancer in adults who have lymph-node-positive disease.

NICE says the evidence shows that adding pertuzumab to trastuzumab and chemotherapy after surgery increased the proportion of people whose disease didn’t spread. However, there is a lack of evidence on how long, if at all, adding pertuzumab might increase the overall length of time people live.

Following consultation on the draft guidance, Roche proposed an improved discount to the price of pertuzumab. They also submitted a revised economic model which included only people whose disease had spread to their lymph nodes (the previous draft guidance also included people who can’t have treatment with hormonal therapy), as well as using NICE committee’s preferred, more conservative estimates of how long treatment benefit with pertuzumab will last. The resulting cost-effectiveness estimate is below £20,000 per QALY gained.

Pertuzumab, given with trastuzumab and chemotherapy, is already recommended by NICE for treating early HER2-positive breast cancer before surgery (neo-adjuvant use). NICE also recommends it with trastuzumab and docetaxel for treating HER2-positive breast cancer that has either recurred in the breast following initial treatment or has spread from the breast to elsewhere in the body.

Final guidance is expected to be published in March.

TECENTRIQ IN COMBINATION NOT RECOMMENDED FOR LUNG CANCER IN DRAFT GUIDANCE

NICE has opened an appraisal consultation on draft guidance which does not recommend atezolizumab (Tecentriq) plus bevacizumab, carboplatin and paclitaxel, within its anticipated marketing authorisation, for untreated metastatic non-squamous non-small-cell lung cancer (NSCLC) or for previously treated (with targeted therapy) epidermal growth factor receptor (EGFR)-positive or anaplastic lymphoma kinase (ALK)-positive NSCLC in adults.

Evidence from an indirect comparison of studies suggests that people having atezolizumab plus bevacizumab, carboplatin and paclitaxel live longer than those having pemetrexed plus carboplatin or cisplatin with or without pemetrexed maintenance. This evidence also suggests that they live for longer before their condition worsens. But the company’s assumption about the proportion of people who have subsequent therapy is too high according to NICE. The draft guidance also states that the long-term survival estimates from the company’s model for people with EGFR-or ALK-positive NSCLC are not credible. Atezolizumab plus bevacizumab, carboplatin and paclitaxel meets NICE’s criteria to be considered a life-extending treatment at the end of life. But the most plausible cost-effectiveness estimates, compared with pemetrexed plus carboplatin or cisplatin with pemetrexed maintenance, are above what NICE normally considers acceptable for an end-of-life treatment. Also, it does not meet NICE’s criteria to be included in the Cancer Drugs Fund.

The closing date for comments is 4th March.

ANTIBIOTIC PRESCRIBING GUIDANCE FOR PATIENTS WITH SUSPECTED PNEUMONIA PUBLISHED

NICE and Public Health England have published draft antimicrobial prescribing guidance on hospital-acquired and community-acquired pneumonia. The new draft guidelines advise that antibiotics should be given to people with community- and hospital-acquired pneumonia within four hours of establishing a diagnosis. Oral antibiotics should be given first-line if the person can take oral medicines, and the severity of their condition does not require intravenous antibiotics. Choice of antibiotics should be reviewed once results from any microbiological testing are available. Although it is advised that shorter courses of antibiotics should be prescribed where appropriate to limit the risk of antimicrobial resistance, pneumonia can be a life-threatening infection and therefore, an effective course length is important. This new guidance provides detailed prescribing advice on hospital acquired infections that suggest treatment should be reviewed after five days and stopping the antibiotic if the person is clinically stable. Regarding community acquired infections, new recommendations say that antibiotics should be stopped after five days unless the person is not clinically stable. The closing date for comments is 11th March.

GUIDANCE DRAFT UPDATE: HYPERTENSION IN PREGNANCY - DIAGNOSIS AND MANAGEMENT

NICE has published a draft update for its guidance on the diagnosis and management of hypertension, including pre-eclampsia, during pregnancy, labour, birth and immediately after birth. The guidance includes advice for women with hypertension who wish to conceive and women who have had a pregnancy complicated by hypertension. It aims to improve care during pregnancy, labour and birth for women and their babies. NICE has reviewed the evidence on some aspects of the management of hypertension in pregnancy, postnatal treatment of hypertension, and advice and follow-up at discharge. The closing date for comments is 13th March.

QUALITY STANDARD: SERIOUS EYE DISORDERS

NICE has published a quality standard which covers the diagnosis and management of cataracts, glaucoma and age‑related macular degeneration (AMD) and the prevention of sight loss. The quality statements are as follows:

  • Adults with signs of possible glaucoma or related conditions on a routine sight test have additional tests before they are referred for a diagnosis. [2011, updated 2019]
  • Adults with cataracts are not refused surgery based on visual acuity alone. [new 2019]
  • Adults with late age‑related macular degeneration (wet active) start treatment within 14 days of referral to the macular service. [new 2019]
  • Adults with late age‑related macular degeneration (wet active) have monitoring for both eyes. [new 2019]
  • Adults with chronic open angle glaucoma or related conditions have reassessment at specific intervals. [2011, updated 2019]
  • Adults with serious eye disorders are given a certificate of vision impairment as soon as they are eligible. [new 2019]

The quality standard does not cover diabetic retinopathy. People aged 12 and over with type 1 or type 2 diabetes are eligible for the NHS diabetic eye screening (DES) programme.

QUALITY STANDARD: CHILD ABUSE AND NEGLECT

NICE has published a quality standard which covers recognising, assessing and responding to abuse and neglect of children and young people under 18. It covers physical, sexual and emotional abuse. The quality statements are as follows:

  • Children and young people who display marked changes in behaviour or emotional state are encouraged to talk about their wellbeing.
  • Children and young people who have experienced abuse or neglect receive support from a consistent group of practitioners.
  • Children and young people who have experienced abuse or neglect have their words accurately represented in notes summarising their conversations with practitioners.
  • Children and young people who have experienced abuse or neglect agree with practitioners how they will communicate with each other.
  • Children and young people who have experienced abuse or neglect are offered therapeutic interventions based on a detailed assessment of therapeutic needs.

The quality standard does not cover areas of national policy, such as legislative changes and statutory requirements.

DRAFT QUALITY STANDARD: LYME DISEASE

NICE has published a draft quality standard which covers the assessment and management of Lyme disease in people of all ages. The standard states that people presenting with erythema migrans, the characteristic skin rash associated with Lyme disease, can be diagnosed with the disease using clinical assessment alone, eliminating the need for blood tests. In addition, people with an initial negative enzyme-linked immunosorbent assay (ELISA) test result for Lyme disease who were tested within four weeks of onset of symptoms, and who continue to have symptoms should have a repeat ELISA test at four to six weeks after the first test. People with Lyme disease should also have access to antibiotic treatment, with the choice of antibiotic, dosage and duration determined by their symptoms and clinical presentation. This draft quality standard is out for consultation until 12th March.

DRAFT QUALITY STANDARD: HEARING LOSS (ADULT ONSET)

NICE has published a draft quality standard which covers assessing and managing hearing loss in adults (aged 18 and over). It includes people presenting with hearing loss for the first time in adulthood whether it started in adulthood or earlier. The draft quality statements are as follows:

  • Adults with earwax contributing to hearing loss or other symptoms, or preventing ear examination, have earwax removal in primary care or community ear care services.
  • Adults with sudden onset or rapid worsening of hearing loss are referred for immediate or urgent specialist medical care.
  • Adults presenting with hearing difficulties not caused by impacted earwax or acute infection are referred for an audiological assessment.
  • Adults presenting with hearing loss affecting their ability to communicate and hear are offered hearing aids.
  • Adults with hearing aids have a face-to-face follow-up audiology appointment six to 12 weeks after the hearing aids are fitted.

The closing date for comments is 12th March. 

DRAFT QUALITY STANDARD: CARE AND SUPPORT OF PEOPLE GROWING OLDER WITH A LEARNING DISABILITY

NICE has published a draft quality standard (QS), and is currently producing an easy-read version of the QS, on care and support of people growing older with a learning disability. The QS sets out five priority areas for improvement, including the importance of people with a learning disability being actively involved in care and needs assessments, and of them having a meeting with hospital staff to discuss reasonable adjustments before planned hospital admissions. Another QS, looking at the service model for people with a learning disability and behaviour that challenges, is also being developed - a draft, including an easy read version, is due to be published for consultation next week (Monday 18 February). A consultation on both runs until 11th March.

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SCOTTISH MEDICINES CONSORTIUM

KYMRIAH ACCEPTED FOR ACUTE LYMPHOBLASTIC LEUKAEMIA FOR SOME PAEDIATRIC AND YOUNG ADULTS 

Following a full submission considered under the ultra-orphan and end of life process, the Scottish Medicines Consortium (SMC) has accepted Kymriah (tisagenlecleucel), under a Patient Access Scheme, for the treatment of paediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse. Tisagenlecleucel was associated with an overall remission rate of 81% within three months of treatment in a single-arm, open-label, phase II study in paediatric and young adult patients with CD19+ relapsed or refractory B-cell ALL.

XELJANZ ACCEPTED FOR MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS

The SMC has accepted Xeljanz (tofacitinib), under a Patient Access Scheme, for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent. In phase III studies, tofacitinib was superior to placebo in achieving and sustaining remission in adult patients with moderately to severely active ulcerative colitis who had treatment failure with, or were intolerant to, a conventional or biologic medicine.

NPLATE ACCEPTED FOR CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIC PURPURA IN PATIENTS FROM THE AGE OF ONE YEAR (RESTRICTED USE)

Following an abbreviated submission, the SMC has accepted Nplate (romiplostim) for restricted use within NHS Scotland, for the treatment of chronic immune (idiopathic) thrombocytopenic purpura (ITP) in patients one year of age and older who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). It is restricted to patients with severe symptomatic ITP or patients with a high risk of bleeding. Romiplostim has previously been accepted for restricted use in adults with ITP. The licence has now been extended to use in children from the age of one year.

XARELTO ACCEPTED FOR CO-ADMINISTRATION IN THE PREVENTION OF ATHEROTHROMBOTIC EVENTS (RESTRICTED USE)

The SMC has accepted Xarelto (rivaroxaban) for restricted use within NHS Scotland to be co-administered with acetylsalicylic acid for the prevention of atherothrombotic events in adult patients with:

  • coronary artery disease, or
  • symptomatic peripheral artery disease and are
  • at high risk of ischaemic events.

It is restricted for use in patients with stable coronary artery disease that does not require dual antiplatelet therapy. The addition of rivaroxaban to low-dose aspirin (acetylsalicylic acid) reduced the incidence of a composite outcome that included stroke, cardiovascular death and myocardial infarction, mainly due to reductions in stroke and cardiovascular death. It also increased the incidence of major bleeding.

TAFINLAR ACCEPTED IN COMBINATION FOR STAGE III MELANOMA WITH A BRAF V600 MUTATION

The SMC has accepted Tafinlar (dabrafenib) for use within NHS Scotland, under a Patient Access Scheme, in combination with trametinib for the adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection. Relapse-free survival was significantly longer in the dabrafenib plus trametinib group compared with placebo in a phase III study of patients with completely resected, stage III melanoma with BRAF V600E or V600K mutations.

ZEBINIX ACCEPTED FOR PARTIAL-ONSET SEIZURES WITH OR WITHOUT SECONDARY GENERALISATION IN ADOLESCENTS AND CHILDREN (RESTRICTED USE)

The SMC has accepted Zebinix (eslicarbazepine acetate) for restricted use with NHS Scotland as an adjunctive therapy in adolescents and children aged above six years with partial-onset seizures with or without secondary generalisation. It is restricted to patients with highly refractory epilepsy who have been heavily pre-treated and remain uncontrolled with existing anti-epileptic drugs. The SMC has previously accepted eslicarbazepine acetate for restricted use as adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation.

CABOMETYX NOT RECOMMENDED FOR ADVANCED RENAL CELL CARCINOMA

Following a resubmission considered under the end of life process, the SMC has not recommend Cabometyx (cabozantinib) for use within NHS Scotland for the treatment of advanced renal cell carcinoma (RCC) in treatment-naïve adults with intermediate or poor risk. In a phase II study, in treatment-naïve adults with advanced RCC with intermediate or poor risk as defined by the International Metastatic RCC Database Consortium risk group categories, cabozantinib was superior to another tyrosine kinase inhibitor for progression free survival. However, the submitting company did not present a sufficiently robust economic analysis to gain acceptance by the SMC.

YESCARTA NOT RECOMMENDED FOR RELAPSED OR REFRACTORY DIFFUSE LARGE B CELL LYMPHOMA

Following a full submission assessed under the end of life and ultra-orphan process, the SMC has not recommend Yescarta® (axicabtagene ciloleucel) for use within NHS Scotland for the treatment of adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) and primary mediastinal large B cell lymphoma, after two or more lines of systemic therapy. Axicabtagene ciloleucel was associated with an objective response rate of 82% in a single-arm, open-label, phase I/II study in patients with refractory DLBCL. However, the submitting company’s justification of the treatment’s cost in relation to its health benefits was not sufficient and in addition the company did not present a sufficiently robust economic analysis to gain acceptance by the SMC. The submitting company has indicated their intention to make a resubmission.

KEYTRUDA NOT RECOMMENDED IN COMBINATION FOR LUNG CANCER

The SMC has not recommend Keytruda (pembrolizumab), for use within NHS Scotland, in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of metastatic non-squamous non-small cell lung carcinoma (NSCLC) in adults whose tumours have no EGFR or ALK positive mutations. The addition of pembrolizumab to pemetrexed and platinum chemotherapy significantly improved progression-free survival and overall survival of in patients with metastatic non-squamous NSCLC with no EGFR or ALK mutations, but the submitting company’s justification of the treatment’s cost in relation to its health benefits was not sufficient and in addition the company did not present a sufficiently robust economic analysis to gain acceptance by the SMC.

MEDICINES NOT RECOMMENDED DUE TO LACK OF SUBMISSION

The following medicines were not recommended due to a lack of submission from the holder of the marketing authorisation:

  • Cabometyx (cabozabtinib) for hepatocellular carcinoma in adults who have previously been treated with sorafenib.
  • Dexdor (dexmedetomidine) for sedation of non-intubated adult patients prior to and/or during diagnostic or surgical procedures requiring sedation, i.e. procedural/awake sedation.
  • Delstrigo (doravirine / lamivudine / tenofovir disoproxil) for adults infected with human immunodeficiency virus 1 without past or present evidence of resistance to the non-nucleoside reverse transcriptase inhibitor class, lamivudine, or tenofovir.
  • Pifeltro (doravirine) in combination with other antiretroviral medicinal products, for the treatment of adults infected with human immunodeficiency virus 1 without past or present evidence of resistance to the non-nucleoside reverse transcriptase inhibitor class.

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MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY

CLASS 2 MEDICINES RECALL ON SOME IRBESARTAN TABLETS FROM ACTAVIS GROUP

Actavis Group PTC EHF is recalling specific batches of Irbesartan 300mg Film-coated tablets, PL 30306/0108 and Irbesartan / Hydrochlorothiazide 300 / 25mg Film-coated Tablets, PL 30306/0267 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, 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.

MEDICAL DEVICE ALERT ISSUED FOR SOME IMPLANTABLE CARDIAC PACEMAKERS - RISK OF SYNCOPE DUE TO PAUSE IN PACING THERAPY

Medtronic issued a Field Safety Notice (FSN) on 17 January 2019 addressing the potential risk of loss of pacing therapy in a specific subset of dual chamber pacemakers. The problem is limited to these pacemakers when programmed to a dual chamber mode with atrial-sensing.

156,957 potentially affected devices were distributed worldwide from March 2017 to January 2019 inclusive, with around 7,400 sold in the UK. Devices distributed before March 2017 are not affected.

These pacemakers are at risk of experiencing a circuit error following an atrial sensed event, that may result in a device lock-up condition. During the lock-up condition, the pacemaker will not provide atrial or ventricular pacing, neither will it initiate a session with the programmer or CareLink remote monitor or respond to a magnet.

For most patients the chance of device circuit error is low, estimated by Medtronic to be around 2.8% per month. This, however, increases significantly for patients in atrial fibrillation, whose pacemaker is atrial sensing, due to the high number of atrial sensed events.

The pacemaker will resume normal pacing therapy as soon as an intrinsic ventricular event is detected. Therefore, patients with no ventricular escape rhythm are at greatest risk, as the cessation of pacing will be prolonged. Attention should also be paid to patients previously suspected to have experienced ventricular over-sensing, especially if this resulted in programming changes to ventricular sensing threshold.

As of the date of the FSN, there had been four non-UK events of clinically apparent pause in two patients ranging from 6 to 61 seconds. However, according to the analysis performed by Medtronic using CareLink data, for most patients the duration of the pacing pause would be clinically insignificant in the event of a circuit error, due to the detection of a ventricular sensed event.

A software fix mitigating the risk of circuit error is currently being developed by the manufacturer and is estimated to be released in the second half of 2019.

MEDICAL DEVICE ALERT ISSUED FOR OPHTHALMIC IMPLANT RAINDROP NEAR VISION INLAY DUE TO RISK OF CORNEAL HAZE

Patients implanted with ophthalmic implant Raindrop Near Vision Inlay, manufactured by ReVision Optics, Inc, have an increased risk of corneal haze. The USA’s Food and Drug Administration (FDA) issued a safety communication informing users that implantation of this device has led to an increased occurrence of corneal haze. The cited study shows that 75% of 150 enrolled patients developed corneal haze. In 42% of patients, the corneal haze has been present in the central region of the cornea. There is no specific guidance regarding frequency of follow-up from the manufacturer; the clinician should assess the risk of corneal haze in individual patients. The MHRA advises healthcare professionals (HCPs) to:

  • Not implant Raindrop Near Vision Inlays.
  • Identify all unused stock of Raindrop Near Vision Inlays and dispose of them.
  • Monitor patients who have the inlay implanted or have previously had the device explanted for the development of corneal haze. The frequency of follow up should be determined by individual patient risk assessment.
  • Report adverse events involving these devices through their local incident reporting system and/or their national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. HCPs should also report directly to manufacturers if their local or national systems do not.

MEDICAL DEVICE ALERT ISSUED FOR ORTHOPAEDIC IMPLANT RHEAD RADIAL HEAD AND UNI-ELBOW DUE TO RISK OF RISK OF EARLY LOOSENING

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert for Orthopaedic implant rHead Radial Head and Uni-Elbow. The manufacturer Stryker has informed the MHRA of post-operative loosening of the implant which may require revision surgery. Healthcare professional are advised to:

  • Not implant these devices
  • Identify and quarantine all affected devices
  • Identify and advise all patients implanted with affected devices to contact their orthopaedic surgeon if they develop symptoms such as pain, loss of function or instability.
  • Follow actions recommended in the manufacturer’s Field Safety Notice
  • Report all adverse events involving this device to Stryker and through the local incident reporting system and/or national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales.

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NHS IMPROVEMENT

PATIENT SAFETY ALERT ISSUED FOR FRACTURE FIXATION PLATES

NHS Improvement has issued a patient safety alert to reduce the risk of wrong selection of dynamic compression plates and reconstruction plates used for fixation of fractures. To reduce the risk of mis-selection, providers are asked to ensure that reconstruction plates are purchased as individually sterilised packs, stored separately and only fetched and taken out of sterile packaging when specifically required. Providers are also asked to identify all patients who had a plate fitted since 1 February 2018 for the treatment of shaft fractures and undertake a retrospective review of patient X-rays to ensure the correct plate was used.

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EUROPEAN MEDICINES AGENCY

NEW SAFETY FEATURES FOR MEDICINES SOLD IN THE EU DETAILED IN THE FALSIFIED MEDICINES DIRECTIVE

The European Medicines Agency has reported that the Falsified Medicines Directive (FMD), which came into force on 9 February 2019, will mean that most prescription medicines and some over-the-counter medicines for human use supplied in the European Union are required to have a unique identifier (a two-dimension barcode) and an anti-tampering device on their outer packaging. The anti-tampering device is a safety feature that shows whether the packaging has been opened or altered since it left the manufacturer, thereby ensuring that the content of the packaging is authentic. These mandatory safety features are a key measure of the FMD, which is part of the EU’s strategy to strengthen the security of the supply chain of medicines. The safety features are implemented through a delegated regulation that comes into application on 9 February 2019. It will apply in all EU/EEA Member States, except for Greece and Italy, who have until 2025 to update their already existing tracking systems. (See also OnMedica article)

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DISPENSING DOCTORS’ ASSOCIATION

NHS ENGLAND CHALLENGED ON FALSIFIED MEDICINES DIRECTIVE FUNDING

Both the Dispensing Doctors’ Association (DDA) and the British Medical Association have written to NHS England regarding the provision of equipment needed to implement the Falsified Medicines Directive (FMD) for the purpose of dispensing. In a letter from NHS England, it states that work has been progressing with system suppliers to provide an FMD solution – however, contrary to previous discussions, it states that dispensing doctors will need to make “their own provision for verification and decommissioning as part of dispensing”. The DDA advises that practices in England and Wales should not invest in FMD equipment at this point, but can show compliance with the FMD by registering with SecurMed and by familiarising practice staff with available FMD resources.

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NHS ENGLAND

ROLLOUT OF LUNG CANCER SCANNING TRUCKS ACROSS THE COUNTRY ANNOUNCED

Lung cancer scanning trucks that operate from supermarket car parks are being rolled out across the country in a drive to save lives by catching the condition early, NHS England has announced. Around £70 million will fund 10 projects that check those most at risk, inviting them for an MOT for their lungs and an on the spot chest scan that include mobile clinics. The targeted screening will help improve survival rates by going first to the some of the areas with the highest death rates from lung cancer. The roll out has the potential to reach around 600,000 people over four years, detecting approximately 3,400 cancers and saving hundreds of lives across the country. (See also OnMedica article)

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NHS DIGITAL

FIGURES SHOW STEEP RISE IN HOSPITAL ADMISSIONS FOR YOUTHS ASSAULTED WITH SHARP OBJECTS

NHS figures show that teenagers accounted for more than 1,000 admissions to hospital as a result of assaults with a knife or sharp object last year. Admissions for all injuries caused by an assault with knife or other sharp objects have gone up by almost a third since 2012-13, from 3,849 to 4,986 last year. However, admissions involving youngsters aged between 10 and 19 increased nearly twice as fast, with 656 hospital admissions in 2012-13 up to 1,012 last year – a rise of around 55%. Doctors have warned that high street sales of knives are helping to fuel the rise in stabbings and have called on retailers to do more to stem the tide of available weapons. The NHS warning about the rising human cost of knife crime comes as government confirms it is considering tougher laws for people carrying a weapon, and a series of high-profile incidents involving this type of attack.

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EUROPEAN CENTRE FOR DISEASE PREVENTION AND CONTROL

EPIDEMIOLOGICAL UPDATE PUBLISHED FOR YELLOW FEVER VACCINATION FOR THOSE ATTENDING RIO CARNIVAL 2019

The European Centre for Disease Prevention and Control (ECDC) has published an epidemiological update advising those travelling to Rio de Janeiro, Brazil for the Rio Carnival (1-9 March) should ensure that all their vaccinations are up to date in accordance with the national immunisation schedule in their country of residence, particularly two doses of measles-containing vaccine (usually MMR), rubella, diphtheria, tetanus and polio. In addition, vaccination against hepatitis A, meningococcal ACWY vaccine, typhoid and yellow fever should also be considered. According to the Brazilian Ministry of Health, there have been 12 confirmed and 116 suspected cases of yellow fever across the country since June 2018 as of 18 January 2019. Travellers to yellow fever risk areas, including the state of Rio de Janeiro, should consult their healthcare provider before the trip and receive the yellow fever vaccine at least 10 days before travelling (unless vaccination is contraindicated). They should also follow measures to avoid mosquito bites and be aware of yellow fever symptoms.

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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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