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Oramorph oral solution 10mg/5ml recall

27th November 2008

The remaining stock of several batches of Oramorph oral solution 10mg/5ml have been recalled due to several complaints regarding deviation in taste and some non-serious adverse events.
The affected batch numbers are: 833206A, 833207A, 833208A, 833209A, 833210A, 833214A, 833215A, 833216A, 833217A, 832873B.
All unused stock of the above batches should be quarantined and returned for credit via the original supplier. Please contact Boehringer Ingelheim Ltd. for returns and credit enquiries (01344 741191) or for medical information (01344 741286).
Full details of the recall can be obtained from the MHRA website link below.

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NICE announces measures on end of life medicines

27th November 2008

The National Institute for Health and Clinical Excellence (NICE) has announced proposals regarding recommendations on the use of end of life medicines for rare illnesses. The proposed changes to its technology appraisal process will mean that NICE will be able to provide its independent advisory bodies with additional information on the use of medicines that can extend life in some patients with rarer terminal illnesses. The proposals will be subject to a consultation, which closes on the 10th December 2008.

Press release
NICE consultation

Consultation on the Manual for Cancer Services 2008: Draft Children's Measures

27th November 2008

The UK Department of Health (DH) has released a consultation document on the new children's cancer measures to be added to the revised Manual for Cancer Services 2008 (due to be published later this year). The closing date for the consultation is 30 January 2009. A copy of the document and a response proforma can be downloaded from the DH website link below.

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National Audit Office report: End of life care

26th November 2008

The UK National Audit Office has published a report examining the current provision of end of life care. The report highlights areas for improvement and the issues that will need to be addressed in the implementation of the Department of Health's End of Life Care Strategy (see news items 2008-11-10 and 2008-08-04).

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NICE guidance on metastatic spinal cord compression

26th November 2008

The UK National Institute for Health and Clinical Excellence (NICE) has published guidance on metastatic spinal cord compression in adults. The guidance covers adults who have, or are at risk of developing, metastatic spinal cord compression. A summary and commentary of the guidance has been published in the British Medical Journal (BMJ).

NICE guidance
BMJ summary (full text requires athens registration)
BMJ commentary (full text requires athens registration)

NCEPOD report on systemic anti-cancer therapy

26th November 2008

The National Confidential Enquiry into Patient Outcome and Death (NCEPOD) has released the report, Systemic anti-cancer therapy: For Better, for Worse? The report highlights the process of care of patients who died within 30 days of receiving systemic anti-cancer therapy and takes a critical look at areas where the care of patients might have been improved. A copy can be obtained via the link below.

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FDA alert for skin reactions with phenytoin

25th November 2008

The US Food and Drug Administration (FDA) is investigating new preliminary data regarding a potential increased risk of serious skin reactions including Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) from phenytoin therapy in Asian patients positive for a particular human leukocyte antigen (HLA) allele, HLA-B*1502. Because fosphenytoin is a prodrug and is converted to phenytoin after administration, any concern regarding this association is also applicable to fosphenytoin. The FDA and MHRA have previously issued advice regarding this allele and an increased risk of SJS/TEN with carbamazepine. As with carbamazepine, the risk for serious skin reactions with phenytoin appears to be greatest in the first few months of therapy. Prescribers are advised to consider avoiding phenytoin and fosphenytoin as alternatives for carbamazepine in patients who test positive for HLA-B*1502.

FDA alert for phenytoin
FDA alert for carbamazepine
MHRA report on carbamazepine

Formoterol turbohaler updated SPC

25th November 2008

The UK SPC for formoterol 6 and 12 inhalation powder (Oxis turbohaler) has been updated with the following information:
Product contains lactose, which contains small amounts of milk proteins; these may cause allergic reactions.

Oxis turbohaler SPC

EMEA suspension of fentanyl iontophoretic transdermal system

25th November 2008

The European Medicines Agency (EMEA) has recommended the suspension of the marketing authorisation of Ionsys (fentanyl iontophoretic transdermal system) because of a defect with the delivery system that could lead to patients being overdosed. All batches were recalled in the EU in September 2008 as a precautionary measure (see news item 2008-09-30), however the company has been unable to resolve the problems and prevent this defect occurring. The EMEA has therefore concluded that the benefits of Ionsys no longer outweigh its risks and has recommended the suspension of the marketing authorisation until the company can robustly demonstrate the quality of the product.

EMEA press release

Consultation document on palliative care bill for Scotland

25th November 2008

A consultation document on a bill which calls for access to needs-based, high-quality palliative care for everyone in Scotland has been published. It aims to place a statutory duty on health boards in Scotland to provide palliative care to those who need it. Responses must be submitted by 28 February 2009.

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MHRA warn defibrillators may fail

25th November 2008

The UK Medicines and Healthcare products Regulatory Agency (MHRA) have issued a warning about Medtronic Physio-Control LIFEPAK CR Plus automatic external defibrillators (AED). If you have these available in your unit, please read the information from the link below about concerns that the defibrillator could fail to turn on and work due to a faulty internal cable.

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SIGN 106 Control of pain in adults with cancer published

14th November 2008

The Scottish Intercollegiate Network (SIGN) has published guideline 106: Control of pain in adults with cancer, on-line and in print. The full guide, quick reference guide and British Medical Journal (BMJ) summary can be downloaded from the links below. The guidelines have also been added to our document library under the topic of Pain (general).

SIGN 106 full guide
SIGN 106 quick reference guide
BMJ article (full text requires athens registration)

CRD summary of oxygen for relief of dyspnoea

14th November 2008

The NHS Centre for Reviews and Dissemination (CRD) has commented on the systematic review and meta-analysis of oxygen for the relief of dyspnoea in mildly or non-hypoxaemic patients with cancer, published in the British Journal of Cancer in January, and added it to their Database of Abstracts of Reviews of Effects (DARE). The review of five small studies found no symptomatic benefit from oxygen therapy in patients with refractory dyspnoea. The CRD summary states that these findings are likely to be reliable, but should be interpreted with some degree of caution given the possibility of language and publication bias. The database entry and original full text paper can be accessed from the links below.

DARE entry
BJC article

DH consultation on End of Life Care Quality Markers

10th November 2008

The UK Department of Health (DH) has launched a consultation on Quality Markers for End of Life Care, as promised in the End of Life Care Strategy published in July (see our news 04/08/08). The document is aimed at commissioners, performance managers and providers of end of life care services, from the NHS, voluntary and independent sectors. The consultation period closes on 6th February 2009.

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Dexamethasone 500microgram tablets discontinued in UK

4th November 2008

Organon (01223 432700) has discontinued manufacturing dexamethasone 500microgram tablets in the UK for commercial reasons. Supplies are expected to be exhausted by the end of 2008, but a small emergency stock of the tablets will be reserved. Dexamethasone 2mg tablets will remain available. Dexamethasone oral solution 2mg/5ml (Dexsol, Rosemont 0113 2441999) is an alternative product for dexamethasone doses less than 2mg.

Dexsol SPC

Lidocaine 5% plaster revised SPC

4th November 2008

The UK SPC for lidocaine 5% medicated plaster (Versatis, Grunenthal Ltd 0870 351 8960) has been revised. The main changes are summarised below. Section 4.1: Indications updated - Versatis is indicated for the symptomatic relief of neuropathic pain associated with previous herpes zoster infection. Section 4.2: Clarification and further advice on application and duration of use of the plaster.
Section 4.3: Addition of - The plaster must not be applied to inflamed or injured skin, such as active herpes zoster lesions, atopic dermatitis or wounds.
Section 4.4: Updates to warnings including addition of information on lidocaine metabolites and information on long term use.

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Ketoconazole tablets updated SPC

4th November 2008

The UK SPC for ketoconazole tablets (Nizoral, Janssen-Cilag 0800 7318450) has been updated as follows.
Update to section 4.8 - Undesirable effects: addition of photosensitivity as an adverse effect.

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IASP Global Year Against Cancer Pain

4th November 2008

The International Association for the Study of Pain (IASP) has launched the 2008-2009 Global Year Against Cancer Pain to focus attention on the pain and suffering faced by people with cancer and seek to raise awareness, grow support and improve treatment.
Throughout the year, there will be various programs and events designed to highlight the issues associated with cancer pain.
Further information, including fact sheets on cancer pain topics are available from the IASP website link below.

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