Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Drug Safety Update - May 2015

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

Several treatments for hepatitis C infection, namely ledipasvir-sofosbuvir (Harvoni®), sofosbuvir (Sovaldi®) and daclatasvir (Daklinza®), have been found to interact with amiodarone and increase the risk of severe bradycardia and heart block. It is recommended that amiodarone only be used in conjunction with these treatments when other antiarrhythmics cannot be given and patients being started on amiodarone should be closely monitored for 48 hours.

Pomalidomide (Imnovid®), a treatment for adults with relapsed and refractory multiple myeloma, has been found to cause interstitial lung disease (ILD), cardiac failure and hepatotoxicity. It is recommended that patients receiving this treatment are monitored for the signs or symptoms of these conditions.

Finally this month there is a summary of letters sent to healthcare professionals in April 2015, including a reminder that ketoprofen gel is associated with photosensitivity reactions and of risk minimisation measures should be undertaken when skin is exposed to sunlight during treatment.

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

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SMC Update - May 2015

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

Budesonide (Budenofalk®) has been accepted for restricted use in the treatment of autoimmune hepatitis. The restriction limits use to non-cirrhotic patients who are intolerant of conventional oral corticosteroids (prednisolone) with severe corticosteroid-related side effects (actual or anticipated) such as psychosis, poorly controlled diabetes or osteoporosis.

Insulin degludec (Tresiba®) has been rejected for use in the treatment of diabetes mellitus in adults, adolescents and children from the age of 1 year. The manufacturer failed to make a submission and as a result this treatment cannot be recommended.

Linagliptin (Trajenta®) has been accepted for use in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults in combination with insulin with or without metformin, when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.

Liraglutide (Victoza®) has been accepted for use in the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with basal insulin when this, together with diet and exercise, does not provide adequate glycaemic control.

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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Drug Safety Update - April 2015

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

The maximum dose of hydroxyzine in an adult is restricted to 100mg due to an increased risk of QT interval prolongation and Torsade de Pointes. It is also recommended that hydroxyzine is not prescribed to people with a prolonged QT interval or who have risk factors for QT interval prolongation, for example those on other medicines that prolong QT interval, those with cardiovascular disease, family history of sudden cardiac death, significant electrolyte imbalance (low potassium or magnesium levels) or significant bradycardia. It is also advised to use the lowest effective dose for the shortest time possible.

Codeine is not recommended for use in children aged under 12 years old due to the risk of respiratory side effects. It is not recommended in those aged 12 to 18 years who have problems with breathing. The MHRA have received 26 Yellow Card reports of respiratory side-effects associated with the use of codeine in children up to 5 August 2014.

The European Medicines Agency is consulting on guidance to minimise the risk of medication error with high strength insulins. Until recently all insulins came in a standard strength of 100 units/mL. Several new insulin products have come to market recently; three high strength insulins which have concentrations greater than 100 units/mL (Tresiba®, Humalog®, Toujeo®), a fixed combination of insulin degludec and liraglutide (Xultophy®) and a biosimilar of insulin glargine (Abasaglar®). Extreme care should be taken when prescribing and dispensing these products to ensure that the patient is given the correct strength.

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

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Why A&E Campaign

It is 10 years since the first video was uploaded to YouTube. So it's nice to see that the Think! Why A&E campaign has uploaded a video encouraging patients to access the right NHS service for their symptoms.

Action: This may be a useful resource for general practices to link on their websites and perhaps use on practice television systems with due regard for the copyright. Practices wishing to use this resource should contact Colette Cassin at Blackpool CCG.

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SMC Update - April 2015

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

Aclidinium / Formoterol Inhaler (Duaklir Genuair®) has been accepted for use as maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease.

Levonorgestrel IUD (Jaydess®) has been accepted for use as contraception for up to 3 years.

Tacrolimus prolonged release tablets (Envarsus®) have been accepted for the prophylaxis of transplant rejection in adult kidney or liver allograft recipients and treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients. It is noted that this product has demonstrated non-inferiority to a tacrolimus immediate-release capsule and has a similar cost per equivalent dose.

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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