Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Drug Safety Update - July 2018

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for July 2018 (PDF).

This issue advises of the risk of airway obstruction from aspiration of loose objects when using pressurised metered dose inhalers (pMDI). There have been 22 reports in the UK of accidental inhalation of the mouthpiece cover or objects that have become trapped in the inhaler since 1987 with a further 36 cases reported outside of the UK. It is suggested that patients using pMDI inhalers are advised to:

  • store the inhaler with the mouthpiece cover correctly in place
  • remove the mouthpiece fully before using the inhaler
  • shake the inhaler to remove loose objects that may not be visible before use
  • check the inside and outside of the mouthpiece are clear before inhaling a dose
  • not use damaged inhalers

Yellow Cards should be submitted to report adverse incidents during use of inhalers and are also invited in this issue for suspected adverse reactions associated with medicines taken during pregnancy experienced by women or the baby or child.

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 - June 2018

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for June 2018 (PDF).

This issue advises that there is an increased risk of neural tube defects in women who become pregnant while taking dolutegravir for the treatment of HIV. If pregnancy is confirmed in the first trimester their specialist should consider switching to an alternative treatment.

This issue also notifies readers of two emerging concerns regarding denosumab (Xgeva® ▼). Rebound hypercalcaemia have been reported up to 9 months after discontinuation of denosumab. Periodic monitoring of serum calcium is recommended. A pooled analysis has also shown an increased incidence of new primary malignancies in patients treated with denosumab compared to zoledronic acid. All suspected adverse reactions for denosumab should be reported, including any new primary malignancies.

Finally this month, the summary of letters to healthcare professionals includes a reminder of false readings seen with certain batches of Accu-Chek test strips, as reported last month.

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

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SMC Update - June 2018

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

Fluticasone / Formoterol (Flutiform k-haler®) has been accepted for use in the regular treatment of asthma where the use of a combination product is an appropriate treatment. This inhaler is a breath-actuated inhaler that is bioequivalent to Flutiform metered-dose inhaler (pMDI) and costs the same.

Eslicarbazepine (Zebinix®) has been rejected for use as monotherapy in the treatment of partial-onset seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy. The manufacturer failed to make a submission for this indication.

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 - May 2018

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for May 2018 (PDF).

This issue advises that Pregnancy Prevention Programme materials relating to the recent valproate medicines safety update are now available online.

This is also notifies readers of the risk of inhalation of capsules if placed in the mouthpiece of the Braltus® inhaler. It is recommended that patients are shown how to use the inhaler using a placebo device from the manufacturer. Patients should also be advised to store capsules in the screw-cap bottle provided (never in the inhaler) and to always check the mouthpiece is clear before inhaling.

The summary of letters to healthcare professionals includes information about the risk of mix-ups between Fiasp®▼ and Tresiba®. Fiasp are coloured yellow while Tresiba is light green; they are visually quite similar. Any patient concurrently using these two products should be advised to be extra vigilant in ensuring they are using the correct product. To strengthen the differentiation between the products, from June 2018 Fiasp® will be available coloured red and yellow.

Attention is also drawn to a recent field safety notice regarding faulty batches of Accu-Chek Aviva and Performa test strips. These batches have a higher risk of strip error messages and false high and low blood glucose results.

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 2018

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

Naltrexone / bupropion (Mysimba®) has been rejected for use as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (≥18 years) with an initial Body Mass Index (BMI) of:

  • ≥ 30 kg/m² (obese), or
  • ≥ 27 kg/m² to < 30 kg/m² (overweight) in the presence of one or more weight-related co-morbidities (e.g., type 2 diabetes, dyslipidaemia, or controlled hypertension)

The manufacturer failed to make a submission for this indication.

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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