Guidance on the transfer of information about medicines

27th July 2011

The Royal Pharmaceutical Society has produced new best practice guidance on keeping patients safe when they transfer between care providers – getting the medicines right.

The guidance, endorsed by the Academy of Medical Royal Colleges, the Royal College of GPs, the Royal College of Nursing and the Royal College of Physicians, contains:

• good practice principles for all healthcare professionals involved in the sending and receiving of information about medicines
• recommended core information about medicines that should move with the patient in order to ensure safe transfer
• suggestions for provider and commissioner organisations to help with the implementation of the good practice principles.

The guidance for both health care professionals and organisations can be downloaded from the links below. More information about the campaign is available on the Royal Pharmaceutical Society website http://www.rpharms.com/medicines-safety/getting-the-medicines-right.asp

Professional guidance
Organisational guidance

Thalidomide increases risk of arterial thrombosis

27th July 2011

The MHRA have highlighted the following in their July Drug Safety Update:

Patients treated with thalidomide have an increased risk of arterial thromboembolism, including myocardial infarction and cerebrovascular events, in addition to the established risk of venous thromboembolism. Healthcare professionals should consider venous and arterial thrombotic risk and administer antithrombotic prophylaxis for at least the first five months in patients commencing thalidomide.

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Paracetamol - new dosing guidelines for children

27th July 2011

New dosage instructions for paediatric oral liquid paracetamol will be on products entering the UK market by the end of 2011. The dosing for children has been revised and is based on narrower age bands with a single dosing option per band to ensure that children receive the optimum and safe dose for their age.

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Reports on addiction to prescribed and over-the-counter medicines published

27th July 2011

The MHRA July Drug Safety Update has highlighted the publication of two reports commissioned by the Department of Health on addiction to prescribed and over-the-counter medicine. They feature benzodiazepines and codeine containing medicines.  

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Risk of accidental overdose with IV paracetamol

27th July 2011

Letters have been sent out by the MHRA to healthcare professionals highlighting the risk of accidental overdose with confusion over the strength of paracetamol 10mg/mL intravenous infusion, particularly in children. There have been several fatalities worldwide where 10 times the dose has been given in error. Special care and attention should be given to prescribing and administering the dose. In addition the 100mL infusion bags (containing 1g paracetamol) should only be used in patients weighing >33kg.

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NICE End of Life consultation

7th July 2011

The draft National Institute for Health and Clinical Excellence (NICE) quality standard for end of life care is now available for consultation. The draft quality standard contains 20 statements for the care of adults (18 years and older) with advanced, progressive, or life-limiting conditions who are approaching the end of their life, and for adults who die suddenly or after a very brief illness, in settings where care is provided by health and social care staff. It also covers support for the families and carers of people in these groups.

The consultation period will end at 5pm on 22nd July 2011.

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Glycopyrronium oral suspension stability study

7th July 2011

A stability study for extemporaneously prepared glycopyrronium oral suspension 0.5mg/mL in a 1:1 mixture of Ora-Plus/Ora-Sweet or Ora-Plus/Ora-Sweet SF, for 90days at room temperature, has been published. 

Cober M et al. (2011) Stability of extemporaneously prepared glycopyrrolate oral suspensions. American Journal of Health-System Pharmacy. 68: 843-845.

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Tapentadol launched in the UK

7th July 2011

Tapentadol (Palexia, Grunenthal, 0870 3518960) has been launched in the UK for the treatment of adults with severe chronic pain, which can only be adequately managed with opioid analgesics. Tapentadol is a Schedule 2 controlled drug with two mechanisms of action, μ-opioid receptor agonism and noradrenaline reuptake inhibition (MOR-NRI).

It is available as 50mg and 75mg immediate-release tablets, costing £24.91 and £37.37 respectively for a box of 56 tablets, and 50mg, 100mg, 150mg, 200mg, 250mg modified-release tablets (Palexia SR) costing £24.91, £49.82, £74.73, £99.64 and £124.55 respectively for a box of 56 tablets.

For more information see the SPC below.

Following a resubmission, the Scottish Medicines Consortium (SMC) has accepted tapentadol modified-release (Palexia SR) for restricted use within NHS Scotland for the management of severe chronic pain in adults, which can be adequately managed only with opioid analgesics. Its use is restricted to patients in whom morphine sulphate modified-release has failed to provide adequate pain control or is not tolerated. The SMC has not yet received a submission for tapentadol immediate-release tablets and theses are therefore currently not recommended for use in NHS Scotland.

Palexia SPC
Palexia SR SPC
SMC advice

Thalidomide SPC updated

7th July 2011

The SPC for Thalidomide Celgene 50mg hard capsules has been updated as follows:

Section 4.4 includes further information regarding MI and VTE. Additions have also been made to the section regarding patients with renal and hepatic impairment.

Section 4.5 states that non-enzymatic hydrolysis suggests the potential for drug-drug interactions with thalidomide is low.

Section 4.8 includes hypersensitiviy, hearing impairment or deafness, renal failure, myocardial infarction and worsening of Parkinson's disease symptoms and pancytopenia to adverse reactions experienced in post marketing surveillance.

See below for link to SPC.

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