Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

NICE Guidance - February 2015

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

The Bladder cancer guideline offers evidence-based advice on the diagnosis and management of bladder cancer in adults.

The Diabetes in pregnancy guideline offers evidence-based advice on managing diabetes and its complications in women who are planning pregnancy and those who are already pregnant. It focuses on areas where additional or different care should be offered to women with diabetes and their newborn babies.

The Irritable bowel syndrome in adults clinical guideline is an update to the original guideline from 2008. It contains advice on the diagnosis and management of irritable bowel syndrome and details the circumstances when people need to be referred to a specialist. Recommendations for ovarian cancer screening as well as dietary and lifestyle advice and pharmacological therapy have been added to and updated.

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 - February 2015

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for February 2015. This month there are three updates pertinent to primary care.

The TIOSPIR clinical trial has been published and found no significant difference in mortality when tiotropium is delivered via Respimat or Handihaler device. This is reassuring however patients with certain cardiac conditions were excluded from the trial. As such it is still recommended to take into consideration the risk of cardiovascular side effects in patients with certain cardiovascular conditions including:

  • recent myocardial infarction < 6 months
  • any unstable or life threatening cardiac arrhythmia
  • cardiac arrhythmia requiring intervention or a change in drug therapy in the past year
  • hospitalisation of heart failure (NYHA Class III or IV) within the past year

Clinicians are also reminded that the new drugs and driving offence will be enforced from 2 March 2015 in England and Wales. It is recommended that clinicians talk to patients who are on medicines with potential to impair driving and discuss the patient leaflet advice.

Finally this month there is a summary of letters sent to healthcare professionals since November 2014, including the discontinuation of carbocisteine 125mg/5ml oral solution.

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

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SMC Update - February 2015

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

Colestilan (BindRen®) has been rejected for the treatment of hyperphosphataemia in adult patients with chronic kidney disease (CKD) stage 5 receiving haemodialysis or peritoneal dialysis. Comparative date with others similar agents did not demonstrate non-inferiority conclusively. The manufacturer did not present a sufficiently robust clinical and economic analysis to gain acceptance.

Umeclidinium / Vilanterol (Anoro®) has been accepted for use as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease. Two randomised controlled studies demonstrated improved lung function compared with an inhaled long-acting muscarinic antagonist and indirect comparisons demonstrated comparable efficacy with similar drug combinations.

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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Mucodyne Paediatric Liquid to be discontinued

The manufacturer of carbocisteine 125mg/5ml oral solution (Mucodyne® Paediatric) has written to healthcare professionals advising that this product has been discontinued due to manufacturing difficulties and will no longer be available from April 2015.

The 250mg/5ml solution remains available and may be an appropriate alternative if the required dose can be measured and delivered. An oral medicines syringe may be required. It should be noted however that the Summary of Product Characteristics advises that the product is not suitable for children and that the paediatric product should be used!

The normal daily dosage is 20 mg/kg bodyweight in divided doses. The previously recommended doses for the 125mg/5ml paediatric oral solution were:

  • Children 5 - 12 years: 10 ml three times daily
  • Children 2 - 5 years: 2.5 - 5 ml four times daily

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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Drug Safety Update - January 2015

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for January 2015. This month there are six updates.

There is new information and strengthened warnings related to safety of medicines containing valproate derivatives (sodium valproate, valproic acid and valproate semisodium), following completion of a Europe-wide review. It is noted that children exposed in utero to valproate are at a high risk of serious developmental disorders (in up to 30-40% of cases) and/or congenital malformations (in approximately 10% of cases). It is recommended that valproate should not be prescribed to female children, female adolescents, women of childbearing potential or pregnant women unless other treatments are ineffective or not tolerated. It is also recommended that treatment is started and supervised by a specialist and that all female patients are informed of and understand the risks.

Ustekinumab (Stelara®) has been associated with exfoliative dermatitis. Clinicians are advised to be alert for signs and symptoms of exfoliative dermatitis. If exfoliative dermatitis is suspected to have been caused by an adverse drug reaction to ustekinumab treatment must be stopped.

Mycophenolate has been linked with an increased risk of hypogammaglobulinaemia and bronchiectasis. Clinicians are advised to measure serum immunoglobulin levels if recurrent infections develop and to consider bronchiectasis or pulmonary fibrosis if patients develop persistent respiratory symptoms, such as cough and dyspnoea.

Oral diclofenac is now no longer available without prescription due to an increased risk of cardiovascular side effects.

Prescribing advice for aceclofenac (Preservex®) has been updated in line with diclofenac and COX-2 inhibitors. It is now contraindicated in people with vascular disease and heart disease. Patients with these conditions who are prescribed aceclofenac should be switched to a safer alternative as their next routine appointment.

Lastly readers are advised that the Yellow Card scheme has been extended to include devices, counterfeits and defective medicines. Previously there were separate reporting systems in place for such instances. The reporting systems have now been simplified.

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

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