The National Institute for Health and Care Excellence (NICE) have published new or updated guidance for the month of October 2019. This month there is one technology appraisal and five guidelines that impact upon primary care.
The Rivaroxaban for preventing atherothrombotic events in people with coronary or peripheral artery disease technology appraisal has been published. Rivaroxaban plus aspirin is recommended within its marketing authorisation, as an option for preventing atherothrombotic events in adults with coronary artery disease or symptomatic peripheral artery disease who are at high risk of ischaemic events. For people with coronary artery disease, high risk of ischaemic events is defined as:
- aged 65 or over, or
- atherosclerosis in at least 2 vascular territories (such as coronary, cerebrovascular, or peripheral arteries), or
- 2 or more of the following risk factors:
- current smoking
- diabetes
- kidney dysfunction with an estimated glomerular filtration rate (eGFR) of less than 60 ml/min (note that rivaroxaban is contraindicated if the eGFR is less than 15 ml/min)
- heart failure
- previous non-lacunar ischaemic stroke
The End of life care for adults: service delivery guideline has been published. It covers organising and delivering end of life care services, which provide care and support in the final weeks and months of life (or for some conditions, years), and the planning and preparation for this. It aims to ensure that people have access to the care that they want and need in all care settings. It also includes advice on services for carers.
The Diabetic foot problems guideline has been updated. It covers preventing and managing foot problems in children, young people and adults with diabetes. The update follows a review of the evidence for antimicrobial prescribing for diabetic foot infections.
The Gastro-oesophageal reflux disease and dyspepsia in adults guideline has been updated. It covers investigating and managing gastro-oesophageal reflux disease (GORD) and dyspepsia in people aged 18 and over. The update makes changes to recommendations on eradicating H pylori and updated footnotes in this guideline to reflect new restrictions and precautions for the use of fluoroquinolone antibiotics.
The Epilepsies: diagnosis and management guideline has been updated. It covers diagnosing, treating and managing epilepsy and seizures in children, young people and adults in primary and secondary care. The update amended footnotes to reflect a change in the law relating to pregabalin and gabapentin now being classed as controlled drugs.
The Familial hypercholesterolaemia: identification and management guideline has been updated. It covers identifying and managing familial hypercholesterolaemia (FH), a specific type of high cholesterol that runs in the family, in children, young people and adults. The update changed the first recommendation on case finding and diagnosis to be clearer about when to suspect familial hypercholesterolaemia.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for October 2019 (PDF).
This month clinicians are advised that ingenol mebutate gel (Picato®▼) has been associated with an increased incidence of skin tumours seen in some clinical studies. It is recommended that patients are 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.
Clinicians are also advised that consideration should be given to the most appropriate estimate of renal function when prescribing medicines in renal impairment. In most cases estimated Glomerular Filtration Rate (eGFR) is an appropriate. However, in the following situations the Cockcroft-Gault formula should be used to calculate creatinine clearance (CrCl).
- direct-acting oral anticoagulants (DOACs)
- patients taking nephrotoxic drugs (examples include vancomycin and amphotericin B)
- elderly patients (aged 75 years and older)
- patients at extremes of muscle mass (BMI <18 kg/m2 or >40 kg/m2)
- patients taking medicines that are largely renally excreted and have a narrow therapeutic index, such as digoxin and sotalol
Readers are advised of the alerts and letters issued about adrenaline auto-injectors in September and October 2019. In summary, Emerade® may fail to activate, advice has been given on how to manage this should the pens need to be used. EpiPen and Jext have had the expiry date extended by 4 months to support adequate supply of adrenaline auto-injectors in the UK.
The summary of letters to healthcare professionals this month includes letters sent in September 2019 about ingenol mebutate gel and adrenaline auto-injectors as mentioned above.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Glibenclamide (Amglidia®) has been rejected for use in the treatment of neonatal diabetes mellitus, for use in newborns, infants and children.
Triptorelin acetate (Decapeptyl®) has been accepted for us as adjuvant treatment in combination with tamoxifen or an aromatase inhibitor, of endocrine responsive early stage breast cancer in women at high risk of recurrence who are confirmed as premenopausal after completion of chemotherapy. For this indication, treatment initiation would normally be recommended by a specialist. This decision takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of triptorelin. This advice is contingent upon the continuing availability of the PAS in NHSScotland or a list price that is equivalent or lower.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
During September 2019 Clinical Knowledge Summaries were published or updated in the following areas.
The End of life care in children is new. The Hypercalcaemia topic has been significantly restructured in line with current evidence with new sections added covering prognosis and specialist assessment. The Leg ulcer - venous topic contains updated recommendations on managing an infected leg ulcer. The Retinal detachment topic has also been updated in line with current evidence and contains new sections on assessment and specialist management. The other topics have undergone reviews and minor restructures.
Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.