Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Drug Safety Update - June 2015

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for June 2015 (PDF).

SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin) have been linked with an increased risk of diabetic ketoacidosis (DKA) even when plasma glucose levels are near-normal. It is recommended that patients presenting with symptoms of acidosis are tested for raised ketones and that SGLT2 inhibitors are stopped if DKA is suspected.

A recent review of the safety of high dose ibuprofen (>2400mg per day) has identified cardiovascular risks similar to COX 2 inhibitors and diclofenac. It is recommended that high dose ibuprofen is avoided in people with cardiovascular diseases (including ischaemic heart disease, peripheral arterial disease, cerebrovascular disease, congestive heart failure and uncontrolled hypertension). Individuals with these conditions who are already taking high dose ibuprofen should be reviewed at their next routine appointment.

Clinicians are also advised to inform women of the risks of uterine perforation before inserting an intrauterine system (IUS) or intrauterine device (IUD). It is noted that perforation occurs in less than 1 in 1,000 women and that the symptoms include:

  • severe pelvic pain after insertion (worse than period cramps)
  • pain or heavy bleeding after insertion which continues for more than a few weeks
  • sudden changes in periods
  • pain during sex
  • not being able to feel the threads

It is advised that women are told to report any of the above symptoms and also advised how to check their threads and are told to return for a check-up if they cannot feel them.

Finally there are requests to complete a survey of medicines safety communications which examines user experience of regulatory safety communications, views on their effectiveness and the information channels users prefer. There is also a call for any evidence considered relevant to a possible association between the use of oral hormonal pregnancy tests, which were available until the late 1970s, and adverse effects on pregnancy or birth defects.

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

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NICE Guidance - June 2015

The National Institute of Health and Care Excellence (NICE) has published new guidance for the month of June 2015. This month there are four guidelines and one technology appraisal that impact upon primary care.

The Suspected cancer: recognition and referral guideline offers evidence-based advice on the recognition of and referral for suspected cancer in children, young people and adults. This guideline is an update to CG27 published in June 2005.

The Lower urinary tract symptoms in men: assessment and management guideline offers evidence-based advice on the effective management of lower urinary tract symptoms (LUTS) in men. A new recommendation on phosphodiesterase-5 inhibitors has been added to section on drug treatment advising that these agents are not used solely for the purpose of treating lower urinary tract symptoms in men, except as part of a randomised controlled trial.

The Anaemia management in people with chronic kidney disease guideline offers evidence-based advice on diagnosing and managing anaemia of chronic kidney disease. This guideline is an update to CG114 published in February 2011.

The Workplace Health guideline makes recommendations on improving the health and wellbeing of employees, with a particular focus on organisational culture and context, and the role of line managers.

The Apixaban technology appraisal recommends this treatment, within its marketing authorisation, as an option for treating and preventing recurrent deep vein thrombosis or pulmonary embolism.

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

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Hypnotics and cancer risk concerns

New research published in the journal Sleep Medicine has raised concerns of an association between the use of hypnotics and an increased risk of cancer, in particular lung cancer. This study has been published in the wider media (Daily Mail and Daily Express).

This study connected data from the Finnish Public Sector study with the Finnish Cancer Register and the Drug Prescription Register of Finland. 5,053 cases of cancer were matched with 24,388 controls. Sex, age, socio-economic status, employer, and geographical area were used for matching. Purchases of prescribed sleep medications were used as an indicator of use of these medications.

Compared to non-use of sleep medications the odds ratio was 1.18 (95% CI 1.01-1.39) for those who used more than 100 defined daily doses per year and 1.16 (95% CI 1.01-1.34) for those who had such medication for more than three years. In cancers of the respiratory system the odds ratio for >100 defined daily doses per year versus no use was further raised at 3.47 (95% CI 1.97-6.11).

There are several limitations to this study; the data are observational, purchase of a prescription is presumed to be equivalent to use and there appears to have been no corrections made for smoking status.

The authors conclude that, "sleep medications use was associated with increased cancer incidence of the respiratory system". However they also state that, "further studies are needed to examine potential carcinogenic mechanisms".

Action: Clinicians should be aware of this study. There are already good reasons to limit use of these medicines to severe cases and for short durations of treatment. This study may be an opportunity to reduce use in patients who are on long term treatment and who are concerned about their cancer risk.

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SMC Update - June 2015

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

Apremilast (Otezla®) has been accepted for use in the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA).

Apremilast (Otezla®) has been accepted for restricted use alone or in combination with disease modifying anti-rheumatic drugs (DMARDs), for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy. The restriction limits use to patients who have had an inadequate response with at least two prior DMARD therapies or who are intolerant to such therapies.

Levonorgesterel (Levosert®) has been accepted for use as a contraceptive or in heavy menstrual bleeding. It is noted that this product contains the same total amount of levonorgestrel with the same release profile as an existing levonorgestrel-containing IUS at a lower unit cost.

Linagliptin and metformin (Jentadueto®) has been accepted for restricted use in the treatment of adult patients with type 2 diabetes mellitus in combination with insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control when insulin and metformin alone do not provide adequate glycaemic control. The restriction limits use to patients where a combination of linagliptin and metformin is an appropriate choice of therapy and the fixed doses are considered appropriate.

Magnesium aspartate dehydrate (Magnaspartate®) has been accepted for the treatment and prevention of magnesium deficiency, as diagnosed by a doctor.

Ombitasvir / paritaprevir / ritonavir (Viekirax®) and dasabuvir (Exviera®) have been accepted for use with or without ribavirin for the treatment of genotype 1 chronic hepatitis C (CHC) in adults and in combination with ribavirin for the treatment of genotype 4 CHC in adults.

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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De-noltab to be discontinued

The manufacturer of tripotassium dicitratobismuthate (De-noltab®) has written to healthcare professionals advising that the product will be discontinued with effect from the end of December 2015.

No reason for the decision to discontinue this product is provided in the letter. It is recommended that appropriate alternatives are discussed with any patient who is currently taking this medication as a long term treatment.

Action: Clinicians should be aware of this product being discontinued. It may 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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