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CKS topic review: palliative cancer care pain

30th April 2009

This topic review from Clinical Knowledge Summaries (CKS; formerly PRODIGY) covers the assessment and management of adults with cancer who are in pain.

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MHRA reminder: effects of MRI on implantable drug pumps

28th April 2009

The UK Medicines and Healthcare products Regulatory Agency (MHRA) issued a recent reminder about the effects of MRI scanning in patients with Medtronic Synchromed implantable drug pumps. These implantable pumps, which are often used to provide baclofen or morpine infusions, have been reported not to behave as expected when exposed to the magnetic field of an MRI scan.
The pump rotor is known to stop temporarily by MRI scanning, thus suspending the drug infusion, but should resume once the patient is removed from the MRI field. However, a medical device alert in December 2008 highlighted a risk of delay of the drug infusion restarting, following incident reports, and a delay in the logging of motor stall events.
Healthcare professionals should ensure departmental procedures are in place for MRI scanning of patients with implantable Medtronic Synchromed drug pumps and where discussion with pump management staff has not been possible, consider alternative imaging techniques or more regular observations of the patient to confirm the pump has restarted.
Full details of the effect of magnetic field on the pumps, the problem and action to be taken can be found in the MHRA medical device alert below.

MHRA drug safety update
MHRA medical device alert December 2008

MHRA safety advice: off-label use or unlicensed medicines

28th April 2009

The UK Medicines and Healthcare products Regulatory Agency (MHRA) recent drug safety update advises prescribers of their responsibilities and best practice when prescribing off-label or unlicensed medicines.

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MHRA safety advice: antipsychotics in elderly people with dementia

28th April 2009

The UK Medicines and Healthcare products Regulatory Agency (MHRA) issued a recent drug safety update reminding health professionals there is an increased risk of stroke and small increased risk of death when antipsychotics (typical or atypical) are used in elderly patients with dementia.
It also discusses the balance of risks and benefits of the use of risperidone to treat behavioural disturbances in dementia and its licensed indication for short term use for persistant aggression in alzheimers type dementia (black triangle status).

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MHRA safety advice: antiepileptics and adverse effects on bone

28th April 2009

The UK Medicines and Healthcare products Regulatory Agency (MHRA) recent drug safety update advises on the adverse effects of long term use of antiepileptics on bone.

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FDA allows interim production and distribution of unapproved morphine sulfate oral solution 20 mg/mL

21st April 2009

The US Food and Drug Administration (FDA) have agreed to allow the continued production and distribution of morphine sulfate oral solution 20mg/mL, currently an unapproved product, on an interim basis.
This announcement follows the FDA statement on 30th March 2009 warning manufacturers to stop the production and distribution of certain unapproved prescription opioids (see below) as part of the initiative against illegally marketed unapproved drugs. According to the FDA "Doctors and patients are often unaware that not all drugs on the market are backed by FDA approval. It is a high priority for the FDA to remove these products from the market because they may be unsafe, ineffective, inappropriately labelled, or of poor quality".
For the majority of drugs on the list, other approved formulations are available, however, there is not an approved formulation of high concentrate morphine sulfate oral solution 20mg/mL.
In light of concerns raised by patients and health professionals in the palliative care community, the FDA will now allow companies that are currently manufacturing and distributing unapproved morphine sulfate oral solution 20mg/ml to continue to do so on an interim basis until an FDA approved version of this product or another acceptable alternative therapy becomes available.
The FDA statement of the 30th March 2009 still stands for the other products listed which include unapproved formulations of immediate release morphine sulfate, hydromorphone and oxycodone tablets.

FDA announcement on morphine sulfate oral solution 20mg/ml
FDA statement 30th March
FDA question and answers on unapproved opioids

NLH annual evidence update on acupuncture

21st April 2009

The National Library of Health (NLH) complementary and alternative medicine library has produced an annual update on the evidence for acupuncture.

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RCP guidelines on botulinum toxin for spasticity

14th April 2009

The UK Royal College of Physicians (RCP) has published guidelines on the management of spasticity in adults with botulinum toxin. They can be downloaded from the RCP website link below.

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RCP guidelines on treating anaphylaxis

14th April 2009

The UK Royal College of Physicians (RCP) has published guidelines on the treatment of anaphylaxis. A copy of the guidelines can be obtained by contacting the RCP communications officer on 020 7935 1174 x354, e-mail zoe.horwich@rcplondon.ac.uk.

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Thalidomide updated SPC

14th April 2009

The UK SPC for thalidomide pharmion 50mg hard capsules (Celgene 08448 010045) has been updated as follows:
Section 4.2 peripheral neuropathy guidelines have been amended.

Thalidomide Pharmion SPC

Lenalidomide updated SPC

14th April 2009

The UK SPC for Lenalidomide (Revlimid, Celegene 08448 010045) has been updated as follows:
Section 4.2 has been updated with new dosing guidelines for patients with impaired renal function.

Lenalidomide (Revlimid) SPC

GMC consultation on end of life treatment and care

7th April 2009

The UK General Medical Council (GMC) is consulting on new draft guidance, "End of life treatment and care: Good practice in decision-making". This updates and builds on the existing guidance "Withholding and withdrawing life-prolonging treatments" but also provides advice on end of life care more generally, including issues such as advance care planning, palliative care, bereavement issues and discussions about organ donation.
The consultation runs until 13 July 2009.

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NebuChamber (inhalation aid) recalled in UK

7th April 2009

All NebuChambers, an inhalation aid intended to be used with Pulmicort pressurised metered dose inhaler (AstraZeneca 01582 836836), have been recalled in the UK.
NebuChamber contains a one-way valve and it is essential that the mouthpiece is attached to the spacer in the correct direction. The product is normally manufactured to achieve this. AstraZeneca has received reports that the mouthpiece can sometimes be attached in the incorrect direction which is clinically significant.
AstraZeneca is requesting healthcare professionals contact known patients who have received a NebuChamber device and arrange for a device other than NebuChamber to be provided or switch the patient to an alternative medication. If an alternative device or treatment is not available or suitable, healthcare professionals are asked to emphasise the importance of correct assembly i.e. the frosted end of the mouthpiece must be attached to the spacer.

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MHRA drug alert: heparin sodium

7th April 2009

A very low level (0.6%) of over sulphated chondroitin sulphate (OSCS) has recently been identified in the active raw material used in the manufacture of 31 batches of CP Pharmaceuticals and Wockhardt UK heparin sodium injections distributed in the UK. This was identified using a more sensitive test method than was previously available. Wockhardt UK have provided details of affected presentations and batch numbers. Batches are in both CP (branded Monoparin and Multiparin) and Wockhardt (unbranded) livery.
Due to a potential out-of-stock situation which would have adverse clinical consequences, these products are NOT being recalled.
There is no evidence that this very low level of OSCS is associated with the anaphylactoid reactions reported following use of heparin with OSCS levels of 17 to 21% after i.v. administration, which were observed outside of the UK during 2007/8. Nonetheless healthcare professionals are advised to exercise particular caution when using the affected batches. Current evidence suggests that the risk of adverse reactions (ADRs) may be reduced by s.c. administration. Patients should be carefully monitored for signs of anaphylactoid or hypotensive reactions both during and after treatment, and standard therapies (ie vasopressor treatment and steroids) should be available as a precaution. Any suspected ADRs observed should be reported to the MHRA and Wockhardt UK in the usual way. As an extra precaution, it is suggested that batch details are recorded routinely in the patient's notes when using any heparin product.

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New National Clinical Guideline Centre

1st April 2009

A new National Clinical Guideline Centre (NCGC), formed from the merger of four National Collaborating Centres (NCCs) has been officially launched today in the UK.
Funded by the National Institute for Health and Clinical Excellence (NICE) and hosted by the Royal College of Physicians (RCP), the NCGC will replace the NCCs for acute conditions (based at the Royal College of Surgeons), chronic conditions (based at the RCP), nursing and supportive care (based at the Royal College of Nursing), and primary care (based at the Royal College of General Practitioners). All four established Royal Colleges will contribute to the governance of the new centre.

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NLH annual evidence update on pain

1st April 2009

The UK National Library of Health (NLH) supportive and palliative care specialist library has produced an annual evidence update on the following aspects of pain in supportive and palliative care:
. cannabinoids for pain management
. pain management in dementia
. pain and cancer survivorship

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MHRA consultation on reclassification of domperidone 10mg tablets

1st April 2009

The UK Medicines and Healthcare products Regulatory Agency (MHRA) is consulting on the reclassification of domperidone 10mg tablets (Motilium 10) from POM to P for the additional indication of nausea and vomiting of less than 48 hours duration. Domperidone can already be sold to the public for the relief of postprandial symptoms of excessive fullness, nausea, epigastric bloating and belching accompanied by epigastric discomfort and heartburn. Comments should be submitted to the MHRA by 7th May 2009.

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