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Valproate use in pregnancy
Evidence shows that 1 in 10 babies (10%) exposed to valproate in pregnancy are born with a congenital malformation (birth defect) – for the general population, the risk is about 2–3%.

NICE recommend Brineura▼ (cerliponase alfa) for the treatment of neuronal ceroid lipofuscinosis type 2

The National Institute for Health and Care Excellence (NICE) have recommended that cerliponase alfa, brand name Brineura▼, as being suitable for patients with neuronal ceroid lipofuscinosis type 2.

This means that the medicine is available to patients by NHS England and Wales.

Neuronal ceroid lipofuscinosis type 2 (CLN2 disease), is an inherited condition in children that leads to progressive brain damage.

CLN2 disease is also known as Batten's disease.

NICE state: 'Cerliponase alfa is recommended as an option for treating neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency, only if the conditions in the managed access agreement are followed.

This recommendation is not intended to affect treatment with cerliponase alfa that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop. For children or young people, this decision should be made jointly by the clinician and the child or young person, or the child's or young person's parents or carers.

Managed access schemes are agreements between the manufacturer and the NHS, usually specifying a set of conditions under which reimbursement for the medicine will be made.

You can follow developments on Brineura by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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NICE consultation: Venous thromboembolic diseases: diagnosis, management and thrombophilia testing (2019)

The National Institute for Health and Care Excellence (NICE) have started a consultation on the diagnosis, management and thrombophilia testing in patients with venous thromboembolic diseases.

This guideline covers diagnosing and managing venous thromboembolic diseases in adults. It aims to support quick diagnosis and effective treatment for people who develop deep vein thrombosis (DVT) or pulmonary embolism (PE). It
also covers testing for conditions that can make a DVT or PE more likely, such as thrombophilia (a blood clotting disorder) and cancer.

Who is it for?
  • Adults (18 and over) with suspected or confirmed DVT or PE, their families and carers
  • Healthcare professionals in primary, secondary and tertiary care
  • Commissioners and providers of venous thromboembolism services
  • First-degree relatives of people with inherited thrombophilia or other venous thromboembolic diseases
This guideline will update NICE guideline CG144 (published June 2012, updated November 2015).

The draft guidance consultation period will run from 27 November 2019 to 24 December 2019 with an expected publication date of 30 March 2020.

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NICE guideline: Diverticular disease: diagnosis and management

The National Institute for Health and Care Excellence (NICE) have published a guideline on the diagnosis and management of diverticular disease.

Diverticular disease: the care you should expect
Diverticular disease affects the large intestine (bowel). As people get older, small bulges called ‘diverticula’ can develop in the lining of their intestine. These are very common and don’t usually cause any symptoms. But in a few people they can cause symptoms like abdominal pain, bloating and bleeding from the rectum (bottom). Rarely they can lead to complications like infections, abscesses or blockages in the intestine.

We want this guideline to make a difference to people with diverticular disease by making sure:
  • people get the right diagnosis straightaway and their symptoms are not mistaken for other bowel conditions
  • people get better advice on controlling their symptoms by making lifestyle changes
  • antibiotics are only offered when they’re really needed
  • people are referred quickly if they have complications that need urgent treatment.
The guideline covers:
  • Diverticulosis
  • Diverticular disease
  • Acute diverticulitis

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Kyprolis▼ (carfilzomib) - patient safety update

The Medicines and Healthcare products Regulatory Agency (MHRA) have advised of a new possible side effect for patients taking Amgen's multiple myeloma treatment carfilzomib, brand name Kyprolis▼.

The Agency advises that following reports of hepatitis B reactivation associated with carfilzomib; screening for hepatitis B before a patient starts treatment is recommended; as well as screening patients already under treatment with unknown hepatitis B virus serology.

This means that patients taking or about to take Kyprolis and who have previously suffered from hepatitis B should be screened for the condition. If a patients hepatitis B status be unknown they too should be screened for the virus.

You can follow developments on Kyprolis by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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NICE publish guidelines on the assessment and management of thyroid disease

The National Institute for Health and Care Excellence (NICE) have published their guideline on the assessment and management of thyroid disease.

The guideline makes a number of recommendations for patients with thyroid disorders covering:
1.1 Information for people with thyroid disease, their families and carers
1.2 Investigating suspected thyroid dysfunction or thyroid enlargement
1.3 Managing primary hypothyroidism
1.4 Follow-up and monitoring of primary hypothyroidism
1.5 Managing and monitoring subclinical hypothyroidism
1.6 Managing thyrotoxicosis
1.7 Follow-up and monitoring of hyperthyroidism
1.8 Managing and monitoring subclinical hyperthyroidism
1.9 Diagnosing, managing and monitoring thyroid enlargement with normal thyroid function

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NICE to recommend cannabidiol (Epidyolex▼) for treating Lennox-Gastaut syndrome

The National Institute for Health and Care Excellence (NICE) have stated that they are to recommend the use of GW Pharma's cannabidiol, brand name Epidyolex▼, a cannabis-based medicinal product, for severe treatment-resistant epilepsy.

The NICE decision came after considering feedback from consultation. NICE has prepared a Final Appraisal Document on cannabidiol for adjuvant treatment of seizures associated with Lennox-Gastaut syndrome.

This means that Epidyolex will be available for use by NHS England and Wales.

Recommendations - Lennox-Gastaut syndrome
Cannabidiol with clobazam is recommended as an option for treating seizures associated with Lennox-Gastaut syndrome in people aged 2 years and older, only if:
  • the frequency of drop seizures is checked every 6 months and cannabidiol is stopped if the frequency has not fallen by at least 30% compared with the 6 months before starting treatment
  • the company provides cannabidiol according to the commercial arrangement

This recommendation is not intended to affect treatment with cannabidiol, with clobazam, that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place before this guidance was published, until they and their NHS clinicians consider it appropriate to stop. For children and young people, this decision should be made jointly by the clinician and the child or young person, or the child or young person’s parents or carers.

For more information about Lennox-Gastaut syndrome see the epilepsy entry under conditions in Keep Me Informed.

You can follow developments on Epidyolex by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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NICE to recommend cannabidiol (Epidyolex▼) for treating Dravet syndrome

The National Institute for Health and Care Excellence (NICE) have stated that they are to recommend the use of GW Pharma's cannabidiol, brand name Epidyolex▼, a cannabis-based medicinal product, for severe treatment-resistant epilepsy.

The NICE decision came after considering feedback from consultation. NICE has prepared a Final Appraisal Document on cannabidiol for adjuvant treatment of seizures associated with Dravet Syndrome.

This means that Epidyolex will be available for use by NHS England and Wales.

Recommendations - Dravet syndrome
Cannabidiol with clobazam is recommended as an option for treating seizures associated with Dravet syndrome in people aged 2 years and older, only if:
  • the frequency of convulsive seizures is checked every 6 months and cannabidiol is stopped if the frequency has not fallen by at least 30% compared with the 6 months before starting treatment
  • the company provides cannabidiol according to the commercial arrangement
This recommendation is not intended to affect treatment with cannabidiol, with clobazam, that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place before this guidance was published, until they and their NHS clinicians consider it appropriate to stop. For children and young people, this decision should be made jointly by the clinician and the child or young person, or the child or young person’s parents or carers.

For more information about Dravet syndrome see the epilepsy entry under conditions in Keep Me Informed.

You can follow developments on Epidyolex by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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NICE publish a draft guidance update in the diagnosis, monitoring and management of chronic asthma

The National Institute for Health and Care Excellence (NICE) have published their latest update of guidance on the diagnosis, monitoring and management of chronic asthma.

The guideline covers diagnosing, monitoring and managing asthma in adults, young people and children. It aims to improve the accuracy of diagnosis, help people to control their asthma and reduce the risk of asthma attacks. It does not cover managing severe asthma or acute asthma attacks.

Who is it for?
  • People with suspected or diagnosed asthma, their families and carers
  • GPs and practice nurses
  • Healthcare professionals in secondary care and tertiary asthma services
  • Commissioners and providers
This guideline will update NICE guideline NG80 published in November 2017.

The consultation will end on 27th November 2019.

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NICE publish updated guidance on gastro-oesophageal reflux disease and dyspepsia

The National Institute for Health and Care Excellence (NICE) have updated their guidance on the investigation and management of gastro-oesophageal reflux disease and dyspepsia in adults.

NICE guidelines provide advice on the care and support that should be offered to people who use health and care services.

This information explains the advice about indigestion, heartburn and reflux in adults that is set out in NICE guideline 184.

This is an update of advice on indigestion that NICE produced in 2004.

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MHRA publish advice for skin lesions with Picato▼: patient safety update

The Medicines and Healthcare products Regulatory Agency (MHRA) have published a warning to patients taking Leo Laboratories' actinic keratosis treatment ingenol mebutate, brand name Picato▼. The advice is that an increased incidence of skin tumours has been seen in some clinical studies.

Patients should be advised to be vigilant for new skin lesions and to seek medical advice immediately should any occur. Use with caution in patients with a history of skin cancer.

Patients taking Picato and experience any new skin lesions should consult their doctor.

You can follow developments with Picato by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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MHRA publishes advice for patients taking Opdivo▼ (nivolumab): patient safety update

The Medicines and Healthcare products Regulatory Agency (MHRA) have published an alert for Bristol-Myers Squibb's cancer treatment nivolumab, brand name Opdivo▼, that there have been reports of cytomegalovirus (CMV) gastrointestinal infection or reactivation in patients taking Opdivo.

Patients on nivolumab who present with diarrhoea or other symptoms of colitis, and those who do not respond to steroid treatment for immune-related colitis, should be investigated to exclude other causes, including infections such as cytomegalovirus (CMV).

You can follow developments with Opdivo by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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NICE approve Xarelto▼ (rivaroxaban) for use in patients with coronary or peripheral artery disease

The National Institute for Health and Care Excellence (NICE) have recommended Bayer's anticoagulant treatment rivaroxaban, brand name Xarelto▼, for use in preventing atherothrombotic events in people with coronary or peripheral artery disease.

NICE state that rivaroxaban (Xarelto) with aspirin is available on the NHS. It is a possible treatment for preventing atherothrombotic events (such as stroke or heart attack) in adults who are at high risk because they have:
  • peripheral artery disease or
  • coronary artery disease and they:
    - are 65 or older, or
    - have atherosclerosis (fatty deposits) in at least 2 arteries, or
    - have at least 2 extra risk factors such as smoking, diabetes, certain types of kidney problem, heart failure, or they’ve had a type of stroke called a non-lacunar ischaemic stroke.
Rivaroxaban with aspirin may increase the risk of bleeding. So your risk of bleeding needs to be assessed before deciding whether to start treatment.

If you are not eligible for rivaroxaban but are already taking it, you should be able to continue until you and your doctor decide when best to stop.

You can follow developments with Xarelto by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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NICE recommendations: Rucaparib for maintenance treatment of relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer

The National Institute for Health and Care Excellence (NICE) have published draft guidance, recommending Clovis Oncology's cancer treatment, rucaparib, brand name Rubraca▼, as an option, through the Cancer Drugs Fund, for maintenance treatment of relapsed, platinum-sensitive high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to platinum-based chemotherapy.

The full recommendations are expected to be published in November 2019

You can follow developments with Rubraca by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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NICE draft guidance: Pentosan polysulfate sodium for treating bladder pain syndrome

The National Institute for Health and Care Excellence (NICE) have published draft guidance recommending use of Consilient Health's bladder pain treatment pentosan polysulfate sodium, brand name Elmiron, as an option for treating bladder pain syndrome with glomerulations or Hunner’s lesions in adults with urinary urgency and frequency, and moderate to severe pain, providing condition has not responded to an adequate trial of standard oral treatments.

The full guidance is expected to be published in November 2019.

You can follow developments with Elmiron by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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NICE guidance update: Diabetic foot problems: prevention and management

The National Institute for Health and Care Excellence (NICE) have published updated guidance on the prevention and management of diabetic foot problems.

The guideline covers preventing and managing foot problems in children, young people and adults with diabetes. It aims to reduce variation in practice, including antibiotic prescribing for diabetic foot infections.

In October 2019, NICE reviewed the evidence for antimicrobial prescribing for diabetic foot infections and updated the recommendations.

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NICE Guideline update: Epilepsies: diagnosis and management

The National Institute for Health and Care Excellence (NICE) have published updated guidelines on the diagnosis and management of epilepsies.

The update reflects the change to the status of the medicines, gabapentin and pregabalin.

The update states:
'Because of a risk of abuse and dependence, gabapentin and pregabalin are controlled under the Misuse of Drugs Act 1971 as class C substances and scheduled under the Misuse of Drugs Regulations 2001 as schedule 3 (as of 1 April 2019). Tables have been amended and a footnote has been added to this guideline to reflect this change.'

Some prescription medicines are controlled under the Misuse of Drugs legislation (and subsequent amendments). These medicines are called controlled medicines or controlled drugs.

Stricter legal controls apply to controlled medicines to prevent them:
  • being misused
  • being obtained illegally
  • causing harm
For example, these legal controls govern how controlled medicines can be:
  • stored
  • produced
  • supplied
  • prescribed
Controlled medicines are classified (by law) based on their benefit when used in medical treatment and their harm if misused.

Class C medicines represent those thought to have the least capacity for harm, and so the Act demands more lenient punishment.

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NICE publish guidelines for antimicrobial prescribing in cellulitis and erysipelas

The National Institute for Health and Care Excellence (NICE) have published a guideline on antimicrobial prescribing in the treatment of cellulitis and erysipelas.

Cellulitis is a skin infection, mostly of the hands, feet and legs, that's treated with antibiotics. It can be serious if it's not treated quickly.

Erysipelas is a superficial form of cellulitis typically caused by streptococci bacteria. Erysipelas causes a shiny, painful, red, raised patch on the skin. The edges have distinct borders and do not blend into the nearby normal skin. The patch feels warm and firm to the touch. It occurs most frequently on the legs and face. People often have a high fever, chills, and a general feeling of illness (malaise).

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NICE open consultation on updating ME guidelines

The National Institute for Health and Care Excellence (NICE) have started the consultation phase to update the guidelines for the diagnosis and management of myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome.

The update will be published in 2020 and will refresh the previous guidelines published in 2007.

Chronic fatigue syndrome (CFS) is a long-term illness with a wide range of symptoms. The most common symptom is extreme tiredness.

CFS is also known as ME, which stands for myalgic encephalomyelitis. Many people refer to the condition as CFS/ME.

CFS/ME can affect anyone, including children. It's more common in women, and tends to develop between your mid-20s and mid-40s.

NICE need evidence from the areas listed in the main article.

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NICE recommend cerliponase alfa (Brineura▼) for the treatment of ceroid lipofuscinosis type 2 (Batten's disease)

The National Institute for Health and Care Excellence (NICE) Highly Specialised Technology committee is supporting a positive recommendation for BioMarin's cerliponase alfa, brand name Brineura▼ for children with neuronal ceroid lipofuscinosis type 2 (CLN2) (also known as Batten's disease) – a very rare inherited condition affecting between one and six babies each year in the UK.

The decision results from a managed access agreement made with the manufacturer. Managed access schemes are agreements between the manufacturer and the NHS, usually specifying a set of conditions under which reimbursement for the medicine will be made.

Cerliponase alfa is an enzyme replacement therapy administered directly into the brain via a surgically implanted permanent access device.

The independent committee noted that although cerliponase alfa is not a cure for CLN2 disease, it is an important development for treating the condition, and that it has shown substantial short-term benefits in slowing the rate at which it progresses.

You can follow developments with Brineura by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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NICE recommend cemiplimab (Libtayo▼) for treatment of cutaneous squamous cell carcinoma

The National Institute for Health and Care Excellence (NICE) have recommended that Sanofi's skin cancer treatment cemiplimab, brand name Libtayo▼, be made available on the NHS for use within the Cancer Drugs Fund as an option for treating locally advanced or metastatic cutaneous squamous cell carcinoma in adults when curative surgery or curative radiotherapy is not appropriate. It is recommended only if the conditions in the managed access agreement are followed.

You can follow developments with Libtayo by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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NICE recommend dapagliflozin (Forxiga) for treatment of type 1 diabetes

The National Institute for Health and Care Excellence (NICE) have recommended AstraZeneca's type 1 diabetes treatment, dapagliflozin, (brand name Forxiga) with insulin as an option for treating type 1 diabetes.

The treatment is recommended for adults with a body mass index (BMI) of at least 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy, only if:
  • they are on insulin doses of more than 0.5 units/kg of body weight/day and
  • they have completed a structured education programme that is evidence based, quality assured, delivered by trained educators and includes information about diabetic ketoacidosis, such as:
  • how to recognise its risk factors, signs and symptoms
  • how and when to monitor blood ketone levels
  • what actions to take for elevated blood ketones, and
  • treatment is started and supervised by a consultant physician specialising in endocrinology and diabetes

You can follow developments with Forxiga by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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Hypertension in adults: diagnosis and management

NICE has published its updated guideline on the diagnosis and treatment of high blood pressure (hypertension) for public consultation.

In the biggest change to NICE’s previous guidance published in 2011, the level of a person’s cardiovascular disease risk at which treatment for high blood pressure can be started has been reduced.

The guideline recommends that blood pressure lowering drugs should be offered to people aged under 80 with a diagnosis of stage 1 hypertension who have a 10% or greater risk of developing cardiovascular disease within the next 10 years.

It is estimated that around 450,000 men and 270,000 women would fall into this category. However, it is likely that the impact of the new recommendations will in fact be lower as some estimates suggest half of people in this category are already receiving treatment.

The guideline also considered new studies suggesting people with blood pressure below the level at which high blood pressure is usually diagnosed (140/90mmHg) might also benefit from medication. It also looked at what the effect would be of lowering the blood pressure target for people on treatment. However, some of these studies, which formed a key part of the evidence reviewed in other recent international hypertension guidelines, were difficult to interpret because they included people who had other conditions that would also raise their cardiovascular disease risk, such as chronic kidney disease.

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EMA publishes new measures to avoid potentially fatal dosing errors with methotrexate for inflammatory diseases

The European Medicines Agency (EMA) has recommended new measures to prevent serious and potentially fatal errors with the dosing of methotrexate for treating inflammatory diseases such as rheumatoid arthritis, psoriasis and Crohn’s disease. The recommendations result from a review of reports that patients are using methotrexate incorrectly despite previous measures to prevent errors.

For inflammatory conditions, methotrexate must be used just once a week. Using methotrexate more frequently than intended can result in serious side effects. The review found that the error in dosing frequency can occur at any step from prescribing the medicine to the patient taking it.

The new measures to prevent errors include restricting who can prescribe these medicines, making warnings on the packaging more prominent and providing educational materials for patients and healthcare professionals. In addition, to help patients follow the once-weekly dosing, methotrexate tablets will be provided in blister packs and not in bottles (or tubes). The measures were agreed after consultation with patients and healthcare professionals.

Information for patients
  • If you are taking methotrexate for rheumatoid arthritis, psoriasis or Crohn’s disease, you must take it just once a week.
  • Take your methotrexate medicine on the same day every week.
  • Follow the instructions on the packaging of your methotrexate medicine.
  • You will receive a patient card with your methotrexate tablets (or oral liquid). Read it carefully because it tells you how to take your medicine.
  • Show your patient card to any new healthcare professional who treats you so that they know that you take your methotrexate medicine once a week.
  • See your doctor at once if you get a sore throat, fever, mouth ulcers, diarrhoea, vomiting, skin rashes, bleeding or unusual weakness. These can be signs of taking too much methotrexate.
  • Always attend your scheduled clinic visits and blood test appointments. They are important for making sure that your methotrexate medicine is working and that it is not causing any concern.
  • If you are not sure about how to take your methotrexate medicine or you have any questions about it, talk to your doctor or pharmacist.

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NICE recommend risankizumab (Skyrizi▼) for the treatment of moderate to severe plaque psoriasis

The National Institute for Health and Care Excellence (NICE) have recommended that AbbVie's psoriasis treatment risankizumab, brand name Skyrizi▼, be made available on the NHS as a possible treatment for plaque psoriasis in adults if:
  • the psoriasis is severe and affects quality of life and
  • the psoriasis has not improved with other treatments, for example, ciclosporin, methotrexate and phototherapy, or these can’t be taken
Treatment with risankizumab should be stopped after 16 weeks if the psoriasis does not improve enough.

You can follow developments with Skyrizi by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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NICE launch evidence review on Impetigo: antimicrobial prescribing guideline

The National Institute for Health and Care Excellence (NICE) have launched a consultation for an evidence review on Impetigo: antimicrobial prescribing guideline.

The consultation is open until 11 September 2019 at 5 p.m.

The guideline sets out an antimicrobial prescribing strategy for impetigo. It aims to optimise antibiotic use and reduce antibiotic resistance. The recommendations in this guideline are for the use of antiseptics and antibiotics to manage impetigo in adults, young people and children. It does not cover diagnosis.

Please note that the scope of this guideline is for adults, young people and children aged 72 hours and over. For treatment of children in the first 72 hours of life, please seek specialist advice.

Who is it for?
  • Adults, young people and children with impetigo, their parents and carers
  • Healthcare professionals
The guideline contains:
  • the draft recommendations
  • the rationales
  • summary of the evidence

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NICE to recommend blinatumomab (Blincyto▼) for the treatment of acute lymphoblastic leukaemia

The National Institute for Health and Care Excellence (NICE) have recommended Amgen's acute lymphoblastic leukaemia (ALL) treatment blinatumomab, brand name Blincyto▼, to be made available in England and Wales.

Blincyto has been approved in the EU for treating:
  • a blood cancer called B-precursor acute lymphoblastic leukaemia (ALL) in patients above 1 year of age when the cancer has come back (relapsed) or has not improved with previous treatment (refractory)
  • adults who have been treated for B-precursor ALL and have minimal residual disease (which means that they still have some detectable cancer cells in their body)
Blincyto is used in patients who are ‘Philadelphia-chromosome-negative’ which means that the patients’ cancer cells do not have an abnormal chromosome called the Philadelphia chromosome, and in patients who have the protein CD19 on their cancer cells (CD19-positive).

NICE have recommended blinatumomab as an option for treating Philadelphia chromosome-negative CD19-positive B-precursor acute lymphoblastic leukaemia in adults with minimal residual disease (MRD) of at least 0.1% if:
  • the disease is in first complete remission and
  • the company provides blinatumomab according to the commercial arrangement
Commercial arrangements are agreements between the manufacturer and the NHS, usually specifying a set of conditions under which reimbursement for the medicine will be made.

You can follow developments with Blincyto by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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NICE approve dacomitinib (Vizimpro▼) for the treatment of non-small cell lung cancer

The National Institute for Health and Care Excellence (NICE) have recommended Pfizer's medicine dacomitinib, brand name Vizimpro▼, as an option for untreated locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC) in adults.

This means that Vizimpro is available as a treatment option for patients in England and Wales.

You can follow developments with Vizimpro by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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NICE approve patisiran (Onpattro▼) for the treatment of hereditary transthyretin-mediated amyloidosis

The National Institute for Health and Care Excellence (NICE) have recommended Alnylam's medicine patisiran, brand name Onpattro▼ as an option for treating hereditary transthyretin amyloidosis in adults with stage 1 and stage 2 polyneuropathy.

Onpattro is used to treat nerve damage caused by hereditary transthyretin (hATTR) amyloidosis, a disease in which abnormal proteins called amyloids build up in tissues around the body including around the nerves.

This decision means that Onpattro is available as a treatment option for patients in England and Wales.

You can follow developments with Onpattro by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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NICE approve ribociclib (Kisqali▼) for the treatment of breast cancer

The National Institute for Health and Care Excellence (NICE) have approved Novartis' medicine ribociclib, brand name Kisqali▼, for use with another medicine, fulvestrant, for treating hormone receptor-positive, HER2-negative, advanced breast cancer.

This means that patients in England and Wales can be treated with the medicine.

Kisqali, with fulvestrant, is available through the Cancer Drugs Fund. It is a possible option for adults who have locally advanced or metastatic breast cancer that:
  • is hormone receptor-positive and human epidermal growth factor 2 (HER2)-negative and
  • has been treated with endocrine therapy previously and
  • if exemestane plus everolimus would be the most appropriate alternative to a cyclin-dependent kinase 4 and 6 inhibitor
More evidence on ribociclib is being collected, until December 2020. After this NICE will decide whether or not to recommend it for use on the NHS and update the guidance. It will be available through the Cancer Drugs Fund until then.

You can follow developments with Kisqali by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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Iclusig▼ (ponatinib) - patient safety update

Incyte Biosciences, the manufacturer of cancer treatment ponatinib, brand name Iclusig▼, have added new potential side effects of aneurysms and artery dissections with an unknown frequency.

An aneurysm is a bulge in a blood vessel caused by a weakness in the blood vessel wall, usually where it branches.

As blood passes through the weakened blood vessel, the blood pressure causes a small area to bulge outwards like a balloon.

Aneurysms can develop in any blood vessel in the body, but the 2 most common places are:
  • the artery that transports blood away from the heart to the rest of the body (the abdominal aorta)
  • the brain
Symptoms of a brain aneurysm include:
  • a sudden agonising headache – it's been described as a "thunderclap headache", similar to a sudden hit on the head, resulting in a blinding pain unlike anything experienced before
  • a stiff neck
  • sickness and vomiting
  • pain on looking at light
Symptoms of abdominal aneurysm include:
  • a pulsing sensation in the tummy (like a heartbeat)
  • tummy pain that doesn't go away
  • lower back pain that doesn't go away
Patients taking Iclusig and experiencing any of these symptoms should consult their doctor immediately.

You can follow developments with Iclusig by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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Amring launch glibenclamide formulation for treating neonatal diabetes

The European Medicines Agency (EMA) have approved Amring's glibenclamide, brand name Amglidia, for the treatment for neonatal diabetes.

Neonatal diabetes is a disease of early infancy due to genetic mutations which result in failure of insulin secretion.

The prevalence of neonatal diabetes is less than 0.02 per 10,000 individuals in the EU and should be considered as an extremely rare disorder of genetic origin which cannot be prevented.

Amglidia is a liquid formulation of glibenclamide.

You can follow developments with Amglidia by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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Tegsedi▼ gets approval for use in Scotland

The Scottish Medicines Consortium (SMC) have approved Akcea Therapeutic's medicine inotersen, brand name Tegsedi▼, for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR).

This means that Tegsedi will be available as an option for patients being treated under the NHS in Scotland.

You can follow developments with Tegsedi by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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Venclyxto▼ gets approval for use in Scotland

The Scottish Medicines Consortium (SMC) have approved AbbVie's medicine venetoclax, brand name Venclyxto▼, in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.

Progression-free survival was significantly longer in the venetoclax plus rituximab group compared with chemoimmunotherapy in a phase III study of patients with relapsed or refractory CLL.

This means that Venclyxto will be available as an option for patients being treated under the NHS in Scotland.

You can follow developments with Venclyxto by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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Glyxambi▼ gets approval for use in Scotland

The Scottish Medicines Consortium (SMC) have approved Boehringer Ingelheim's medicine containing empagliflozin and linagliptin, brand name Glyxambi▼, for the treatment of adults aged 18 years and older with type 2 diabetes mellitus:
  • to improve glycaemic control (blood sugar) when metformin and/or sulphonylurea and one of the components of Glyxambi do not provide adequate glycaemic control
  • When already being treated with the free combination of empagliflozin and linagliptin
In patients for whom this combination is appropriate, Glyxambi offers a single tablet at a lower cost per dose compared with the individual components.

You can follow developments with Glyxambi by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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Fycompa gets approval for use in Scotland

The Scottish Medicines Consortium (SMC) have approved Eisai's medicine containing perampanel, brand name Fycompa, for the adjunctive (in addition to other medicines) treatment of partial-onset seizures with or without secondarily generalised seizures in adult and adolescent patients from 12 years of age with epilepsy.

Fycompa is to be used as a second-line adjunctive treatment in patients with refractory partial onset epilepsy who are unable to swallow perampanel tablets. Treatment should be initiated only by physicians who have appropriate experience in the treatment of epilepsy.

The SMC has previously accepted perampanel tablets for restricted use as adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older.

The oral suspension provides an alternative formulation for patients who have difficulty swallowing tablets. Depending on the dose, it may be more expensive than the tablets but any overall net budget impact is likely to be small.

You can follow developments with Fycompa by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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Saxenda▼ (liraglutide) - patient safety update

Novo Nordisk, the manufacturers of weight loss treatment liraglutide, brand name Saxenda▼, have warned that following a drug safety update, that patients taking Saxenda who have type 2 diabetes mellitus, liraglutide must not be used as a substitute for insulin.

They report that diabetic ketoacidosis has been reported in insulin dependent patients after rapid discontinuation or dose reduction of insulin.

Diabetic ketoacidosis (DKA) is a serious problem that can occur in people with diabetes if their body starts to run out of insulin.

This causes harmful substances called ketones to build up in the body, which can be life-threatening if not spotted and treated quickly.

Signs of DKA include:
  • needing to pee more than usual
  • feeling very thirsty
  • being sick
  • tummy pain
  • breath that smells fruity (like pear drop sweets or nail varnish)
  • deep or fast breathing
  • feeling very tired or sleepy
  • confusion
  • passing out
DKA can also cause high blood sugar (hyperglycaemia) and a high level of ketones in your blood or urine, which you can check for using home-testing kits.

Symptoms usually develop over 24 hours, but can come on faster.

You can follow developments with Saxenda by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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Herceptin (trastuzumab) - patient safety update

Roche, the manufacturers of cancer treatment trastuzumab, brand name Herceptin, have added a new side effect for the medicine.

Tumour lysis syndrome (TLS) has been added as an adverse event of unknown frequency.

TLS is a condition that occurs when a large number of cancer cells die within a short period, releasing their contents in to the blood.

Diagnosis of TLS is achieved with blood tests and, possibly, and ECG.

Symptoms of TLS include:
  • abdominal pain and distension
  • urinary symptoms
    - dysuria (painful or difficult urination)
    - oliguria (small urine output)
    - haematuria (blood in the urine)
  • pain in the upper back, abdomen or side of the body
  • hypocalcaemia - symptoms of anorexia, vomiting, cramps, seizures, spasms, altered mental status, and tetany
  • hyperkalaemia -symptoms of weakness and paralysis
Patients taking Herceptin who experience any of these symptoms should consult their doctor.

You can follow developments with Herceptin by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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NICE approve cemiplimab (Libtayo▼) for the treatment of cutaneous squamous cell carcinoma

The National Institute for Health and Care Excellence (NICE) have recommend Sanofi's cancer treatment cemiplimab, brand name Libtayo▼, within the Cancer Drug Fund, as an option for locally advanced or metastatic cutaneous squamous cell carcinoma in adults when curative surgery or curative radiotherapy is not appropriate.

Treatment should be continued until disease progression or for up to 24 months.

This means that patients in England and Wales with squamous cell carcinoma will be able to receive Libtayo treatment if they meet the criteria and their doctor thinks it is appropriate. The medicine will be funded from the Cancer Drug Fund.

Squamous cell carcinoma starts in the cells lining the top of the epidermis and accounts for about 20% of skin cancers.

You can follow developments with Libtayo by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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NICE publish consultation information for rheumatoid arthritis

The National Institute for Health and Care Excellence (NICE) have started a consultation on Quality Standards for rheumatoid arthritis in patients aged over 16 years.

The consultation will provide the NICE committee with a basis for discussing and prioritising quality improvement areas for development into draft quality statements and measures for public consultation.

This quality standard will cover assessment, diagnosis and management of rheumatoid arthritis in over 16s. It will update and replace the existing NICE quality standard for rheumatoid arthritis in over 16s.

You can follow developments on rheumatoid arthritis by clicking on the Follow Condition button above.

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UK regulator approves Bavencio▼ (avelumab) used in combination with Inlyta (axitinib) in treating kidney cancer

The Medicines and Healthcare products Regulatory Agency (MHRA) have approved Merck-Pfizer's cancer treatment avelumab, brand name Bavencio▼, in combination with Pfizer's axitinib, brand name Inlyta, for first-line treatment of advanced renal (kidney) cancer. The treatment will be funded under the early access to medicines scheme (EAMS) and will be available for use by NHS England.

The aim of the Early Access to Medicines Scheme (EAMS) is to provide earlier availability of promising new unlicensed medicines to UK patients that have a high unmet clinical need.

The combination is not licensed in Europe for advanced renal cell cancer and is currently under review by European Medicines Agency.

You can follow developments with Bavencio and Inlyta by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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NICE start consultation process for colorectal (bowel) cancer

The National Institute for Health and Care Excellence (NICE) have started a consultation to update the guidance on the diagnosis and management of colorectal cancer.

This guideline covers managing colorectal (bowel) cancer in people aged 18 and over. It aims to improve quality of life and survival for adults with colorectal cancer through management of local disease and management of secondary tumours (metastatic disease).

Who is it for?
  • People with colorectal cancer, their families and carers
  • Health professionals working in secondary care
  • Cancer Alliances and cancer clinical networks
  • Commissioners of colorectal cancer preventative and treatment services (including Clinical Commissioning Groups and NHS England Specialised Commissioning)
This draft guideline contains:
  • the draft recommendations
  • recommendations for research
  • rationale and impact sections that explain why the committee made the recommendations and how they might affect practice and services
  • the guideline context

You can follow developments on colorectal cancer by clicking on the Follow Condition button above.

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NICE publish updated guidance for chronic obstructive pulmonary disease in over 16s

The National Institute for Health and Care Excellence (NICE) have published updated guidance on the diagnosis and management of chronic obstructive pulmonary disease in patients aged over 16.

The guideline covers diagnosing and managing chronic obstructive pulmonary disease or COPD (which includes emphysema and chronic bronchitis) in people aged 16 and older. It aims to help people with COPD to receive a diagnosis earlier so that they can benefit from treatments to reduce symptoms, improve quality of life and keep them healthy for longer.

Who is it for?
People with COPD and their families and carers
Healthcare professionals
Commissioners and providers

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NICE publish draft approval documents for the use of olaparib (Lynparza) in the treatment of ovarian, fallopian tube and peritoneal cancer

The National Institute for Health and Care Excellence (NICE) are to recommend use of AstraZeneca's cancer treatment olaparib, brand name Lynparza.

The approval is for use of Lynparza for maintenance treatment of ovarian, fallopian tube or peritoneal cancer in patients that have an inherited mutation of their BRCA genes. This means that patients in England will be able to be treated with Lynparza if they meet the conditions and their doctor thinks it appropriate.

BRCA1 and BRCA2 are human genes that produce tumour suppressor proteins. These proteins help repair damaged DNA and, therefore, play a role in ensuring the stability of each cell’s genetic material. Mutations can result in a greater likelihood of the cells becoming cancerous. 

Lynparza can be used if patients respond to another treatment called first-line platinum-based chemotherapy.

NICE state that there are currently no maintenance treatments for patients with these cancers and the approval of Lynparza is based on the results of clinical trials.

Lynparza is to be funded under the Cancer Drugs Fund for these conditions and will be available as an option for patients in England under the NHS.

NICE have agreed a price for the treatment with the manufacturers.

You can follow developments with Lynparza by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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NICE approve blinatumomab (Blincyto▼) in the treatment of acute lymphoblastic leukaemia

The National Institute for Health and Care Excellence (NICE) have approved Amgen's treatment for acute lymphoblastic leukaemia (ALL) blinatumomab, brand name Blincyto▼.

Blinatumomab is recommended as an option for treating a form of acute lymphoblastic leukaemia called Philadelphia-chromosome-negative, CD19‑positive B‑precursor ALL. The recommendation is specific for adults with minimal residual disease (MRD) of at least 0.1% and only if the disease is in first complete remission.

Minimal residual disease means that there is still some detectable cancer cells in the body

You can follow developments with Blincyto by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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New migraine treatment galcanezumab (Emgality▼) approved for use in EU

The European Medicines Agency (EMA) have approved Eli Lilly's migraine treatment, galcanezumab (brand name Emgality▼) for use in the EU.

Emgality was shown to be more effective than placebo at reducing the number of days of migraine, although the size of the effect is limited particularly for patients with chronic migraine.

The side effects seen with Emgality are considered manageable with most being mild or moderate in severity.

The European Medicines Agency therefore decided that Emgality’s benefits are greater than its risks and it can be authorised for use in the EU.

You can follow developments with Emgality by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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NICE publish updated quality standard for hypertension in pregnancy

The National Institute for Health and Care Excellence (NICE) have published their updated quality standard on hypertension in pregnancy.

This quality standard covers diagnosing and managing hypertension (high blood pressure) and pre-eclampsia during pregnancy, labour and birth. It also covers advice for women with hypertension who may become pregnant and postnatal care for women who have had hypertension or pre-eclampsia. It describes high-quality care in priority areas for improvement.

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NICE publish updated guidance for motor neurone disease

The National Institute for Health and Care Excellence (NICE) have published their updated guidance for motor neurone disease.

NICE guidelines provide advice on the care and support that should be offered to people who use health and care services.

This information explains the advice about motor neurone disease (MND) that is set out in NICE guideline NG42. It also covers advice on non‑invasive ventilation that NICE produced in 2010.

This guideline includes recommendations on:
  • recognition and referral
  • information and support at diagnosis
  • cognitive assessments
  • prognostic factors
  • organisation of care
  • planning for end of life
  • managing symptoms

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NICE publish draft quality standard update for lung cancer

The National Institute for Health and Care Excellence (NICE) have published the draft of their updated quality standard for lung cancer.

The quality standard covers diagnosing and managing lung cancer in adults. It describes high-quality care in priority areas for improvement and is now open for consultation.

The standard is for:
  • the public
  • commissioners
  • health service providers
  • health, public health and social care practitioners
Quality standard consultation
You can now comment on this draft quality standard.

Closing date for comments: Friday 23 August 2019 at 5pm

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New migraine treatment fremanezumab (Ajovy▼) approved for use in EU

The European Medicines Agency (EMA) have approved Teva's migraine treatment, fremanezumab (brand name Ajovy▼) for use in the EU.

The EMA stated that Ajovy can reduce the number of days patients have moderate to severe headaches and migraines. As most of the side effects are manageable and mild or moderate in severity, the European Medicines Agency decided that Ajovy’s benefits are greater than its risks and it can be authorised for use in the EU.

You can follow developments with Ajovy by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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Xarelto▼ (rivaroxaban) - patient safety update

The Medicines and Healthcare products Regulatory Agency (MHRA) have issued a reminder that Bayer's anti-coagulant medicine rivaroxaban, brand name Xarelto▼, 15 mg and 20 mg tablets should be taken with food. The MHRA has received a small number of reports of patients taking rivaroxaban 15 mg or 20 mg who experienced a thromboembolic event, which the reporter suspected was due to the patient taking the tablets on an empty stomach.

Thromboembolic events arise from the formation in a blood vessel of a clot (thrombus) that breaks loose and is carried by the blood stream to plug another vessel. The clot may plug a vessel in the lungs (pulmonary embolism), brain (stroke), gastrointestinal tract, kidneys, or leg.

The section of the patient leaflet for rivaroxaban 15 mg and 20 mg tablets that advises patients how to take their medicine has been revised to emphasise patients must take rivaroxaban with a meal and the tablets should be swallowed preferably with water.

You can follow developments with Xarelto by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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Adenuric (febuxostat) - patient safety update

The Medicines and Healthcare products Regulatory Agency (MHRA) have issued a warning for Menarini's gout treatment febuxostat, brand name Adenuric.

The Agency warn that an increased risk of cardiovascular death and all-cause mortality seen in a clinical trial in patients with a history of major cardiovascular disease.

The advice given is:

'Avoid treatment with febuxostat in patients with pre-existing major cardiovascular disease (for example, myocardial infarction, stroke, or unstable angina), unless no other therapy options are appropriate. Findings from a phase 4 clinical study (the CARES study) in patients with gout and a history of major cardiovascular disease show a higher risk for cardiovascular-related death and for all-cause mortality in patients assigned to febuxostat than in those assigned to allopurinol.'

You can follow developments on Adenuric by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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RoActemra (tocilizumab) - patient safety update

The Medicines and Healthcare products Regulatory Agency (MHRA) have issued a warning that there is a rare risk of serious liver injury including cases requiring transplantation in patients taking tocilizumab, brand name RoActemra.

RoActemra is used to treat rheumatoid arthritis, giant cell arteritis and juvenile idiopathic arthritis.

The advice to clinicians is that the levels of the enzymes (chemicals produced by the body that speed up reactions) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be measured before starting treatment with tocilizumab. These enzymes should be monitored every 4–8 weeks for the first 6 months of treatment followed by every 12 weeks thereafter. Serious liver injury has been reported on treatment with tocilizumab from 2 weeks to more than 5 years after initiation.

You can follow developments on RoActemra by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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Keep Me Informed - Patient safety updates added since April 2019

Since April 2019 Keep Me Informed have detailed over 30 patient safety warnings. Most of these relate to specific side effects that have been identified by manufacturers and resulted in amendments to the product information including the patient leaflet. Other safety information relates to interactions and contraindications (situations where a medicine should not be prescribed or prescribed with caution).

By notifying patients, carers and healthcare professionals of these side effects we hope to ensure that the information is targeted to people who have specific interest. This direct service is not available through any other source. In addition to the detailed changes made by the manufacturer we also aim to ensure that:
  • complex medical terms are explained in plain English
  • symptoms of side effects and interaction are described
An important situation we highlight is in the warnings to pregnant or breastfeeding women. Four of the warnings published are specifically about this topic.

For a list of the details please see the full article.

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MHRA - spotlight on the decline in the number of Yellow Card reports

The Medicines and Healthcare products Regulatory Agency (MHRA) have announced that the number of reports of adverse drug reactions from healthcare professionals has declined after increasing for the previous 8 years.

Between 2009 and 2017, the number of reports the MHRA received from UK healthcare professionals doubled. However, in 2018, there was a significant decrease in reports from some healthcare professional groups.

It is estimated that only 10% of serious reactions and between 2 and 4% of non-serious reactions are reported. Under-reporting coupled with a decline in reporting makes it especially important to report all suspicions of adverse drug reactions to the Yellow Card Scheme.

*The importance of ADR reporting cannot be overestimated. Research by the universities of Sheffield, Manchester and York concludes the following:
  • 66 million potentially clinically significant errors occur per year, 71% of these in primary care
  • Prescribing in primary care accounts for 33.9% of all potentially clinically significant errors
  • The estimated cost of avoidable ADRs are £98.5 million per year, consuming 181,626 bed-days, causing 712 deaths, and contributing to 1,708 deaths
  • Primary care ADRs leading to a hospital admission cost £83.7 million and causing 627 deaths
  • Secondary care ADRs leading to a longer hospital stay cost £14.8 million and caused 85 deaths and contributing to 1,081 deaths
[*Citation: Elliot RA, Camacho E, Campbell F, et al. Prevalence and economic burden of medication errors in the NHS England.]

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