Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

NICE Guidance - April 2016

The National Institute of Health and Care Excellence (NICE) have published new or updated guidance for the month of April 2016. This month there is one clinical guideline, one guideline and two technology appraisals that impact upon primary care.

The Depression in adults: recognition and management clinical guideline covers identification and management of depression in adults aged 18 years and older, in primary and secondary care. It aims to improve care for people with depression by promoting improved recognition and treatment. This guideline was updated to contain a link to the guidance on repetitive transcranial magnetic stimulation for depression

The Controlled drugs: safe use and management guideline covers systems and processes for using and managing controlled drugs safely in all NHS settings except care homes. It aims to improve working practices to comply with legislation and have robust governance arrangements. It also aims to reduce the safety risks associated with controlled drugs.

The Abiraterone technology appraisal reviews the place of this drug in treating metastatic hormone-relapsed prostate cancer before chemotherapy. Abiraterone in combination with prednisone or prednisolone is recommended, within its marketing authorisation, as an option in people who have no or mild symptoms after androgen deprivation therapy has failed, and before chemotherapy is indicated. This recommendation is made only when the manufacturing company rebates the drug cost of abiraterone from the 11th month until the end of treatment for people who remain on treatment for more than 10 months.

The Sacubitril / Valsartan technology appraisal reviews the place of this drug treating symptomatic chronic heart failure with reduced ejection fraction. Treatment is recommended as an option for people with New York Heart Association (NYHA) class II to IV symptoms and a left ventricular ejection fraction of 35% or less and who are already taking a stable dose of angiotensin‑converting enzyme (ACE) inhibitors or angiotensin II receptor‑blockers (ARBs).

Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.

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Drug Safety Update - April 2016

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for April 2016 (PDF).

This issue reminds clinicians that they should test for raised ketones in diabetic patients taking a sodium-glucose co-transporter 2 (SGLT2) inhibitor with ketoacidosis symptoms, even if plasma glucose levels are near-normal. It is further recommended that treatment with an SGLT2 is stopped when ketoacidosis is suspected or during acute episodes of serious illnesses.

Clinicians are also reminded that live attenuated vaccine use should be avoided those who are clinically immunosuppressed. Recent Yellow Card adverse reaction reports have been submitted regarding immunosuppressed patients who have received a live attenuated vaccine, some of which resulted in severe infection and death.

The product license for meprobamate will be cancelled by the end of 2016 and UK manufacturing has ceased. This was recommended by the European Medicines Agency in 2012. Any patient who is currently receiving a meprobamate-containing medicine should be reviewed with a view to switching them to an alternative treatment.

Clinicians are reminded that paraffin-based emollients are a fire hazard. A recent fatal incident reported to the NHS England National Reporting and Learning System.

Finally this month there is a summary of letters sent to healthcare professionals in March.

Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.

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FDA safety concerns over saxagliptin and alogliptin

The FDA has issued a safety alert regarding saxagliptin (Onglyza®) and alogliptin (Vipidia®). More information is available in the FDA safety announcement. The Summary of Products Characteristics for saxagliptin and alogliptin for the UK market already contain cautionary information about using these medicines in patients with heart failure.

A safety review found that type 2 diabetes medicines containing saxagliptin and alogliptin (including combinations containing metformin) may increase the risk of heart failure, particularly in patients who already have heart or kidney disease. The FDA alert advises that healthcare professionals should consider discontinuing medications containing saxagliptin and alogliptin in patients who develop heart failure and monitor their diabetes control.

The review included data from two large clinical trials (SAVOR and EXAMINE). In the saxagliptin trial, 3.5% of patients who received the drug were admitted to hospital for heart failure versus 2.8% of patients who received a placebo. In the alogliptin trial, 3.9% of alogliptin treated patients were admitted to hospital for heart failure versus 3.3% in the placebo group. The trials ran for different durations but these data indicate that for approximately 1 in every 150 patients treated with either of these drugs for around 2 years would be expected to be admitted to hospital with heart failure.

Patients taking these medicines should be advised contact a healthcare professional if they develop signs and symptoms of heart failure such as:

  • Unusual shortness of breath during daily activities
  • Trouble breathing when lying down
  • Tiredness, weakness, or fatigue
  • Weight gain with swelling in the ankles, feet, legs, or stomach

Action: Clinicians should be aware of this recent safety development. Patients who are prescribed these medicines should be monitored for signs of heart failure and these medicines stopped should signs develop.

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Corgard discontinued

The manufacturer of nadolol (Corgard®) has confirmed that this product has been discontinued. The product has been discontinued for commercial reasons.

Nadolol, a beta blocker, is licensed for use in hypertension, angina, arrhythmias, migraine prophylaxis and adjunctive treatment of thyrotoxicosis. Supply chain stock will be limited and there is no generic alternative. Treatment should not be stopped abruptly and therefore patients who are currently being prescribed nadolol should be identified, reviewed offered an appropriate alternative.

Action: Clinicians should be aware of this product being discontinued. It would be prudent to run clinical system searches to identify any patients who are currently prescribed this product to allow a review and an alternative to be arranged.

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SMC Update - April 2016

The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.

Alendronic acid effervescent tablets (Binosto®) have been accepted for restricted use in the treatment of postmenopausal osteoporosis. The restriction limits use to patients who are unable to swallow tablets where alendronic acid is the appropriate treatment choice.

Camellia sinensis (Catephen®) has been accepted for restricted use in the cutaneous treatment of external genital and perianal warts (condylomata acuminata) in immunocompetent patients from the age of 18 years. The restriction limits use to patients not suitable for podophyllotoxin or who have not responded to treatment with podophyllotoxin.

Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.

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