Chronic heart failure: draft quality standard for consultation

28th January 2011

The UK National Institute for Health and Clinical Excellence (NICE) draft quality standard for chronic heart failure is now available for consultation. The document can be downloaded from the link below, further details on how to submit comments can be obtained from the website link. The closing date for comments is February 16^th 2011.

Chronic heart failure, draft quality standard
NICE website

Cardiovascular safety of NSAIDs: network meta-analysis

28th January 2011

The British Medical Journal has published a network meta-analysis of the available evidence for the cardiovascular safety of non-steroidal anti-inflammatory drugs.

Trelle S et al. (2011) Cardiovascular safety of non-steroidal anti-inflammatory drugs: network meta-analysis. British Medical Journal 342:7086.

BMJ article (full text, open access)

FDA limits the amount of acetaminophen (paracetamol) to 325mg per dosage unit for prescription products

18th January 2011

The US Food and Drug Admnistration (FDA) has asked manufacturers to reformulate prescription products containing acetaminophen (paracetamol) so that a single dosage unit contains a maximum of 325mg acetaminophen. This includes combination products of acetaminophen and opioids.

Additional boxed warnings highlighting the potential for sever liver injury and allergic reactions are also to be added to the product packaging.

Dosage recommendations will not be changed as a result of the lower amount of acetaminophen. The maximum daily dose of 4g/day is to remain in place.

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DH templates to monitor expenditure on end of life and specialist palliative care

18th January 2011

The UK Department of Health (DH) has issued templates to Strategic Health Authorities and PCT Directors of Finance to monitor how the additional money provided to help implement the End of Life Care Strategy has been invested in 2010/11, and expenditure on specialist palliative care in 2010/11.

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The commission on assisted dying: call for evidence

18th January 2011

The commission on assisted dying was launched in the UK on 30-11-2010 with a speech from the Chair, Lord Falconer. The aim of the commission is to:

• Investigate the circumstances under which it should be possible for people to be assisted to die
• Recommend what system, if any, should exist to allow people to be assisted to die
• Identify who should be entitled to be assisted to die
• Determine what safeguards should be put in place to ensure that vulnerable people are neither abused nor pressured to choose an assisted death
• Recommend what changes in the law, if any, should be introduced

There is a general public call for evidence on the commission on assisted dying website, with structured questions seeking opinions and a space for comments or personal experience. Submissions can be completed on-line or via a specific document that can be downloaded. The commission on assisted dying will run for 12months and will culminate in the publication of an independent report based on the evidence it has collected before the end of 2011.

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Diclofenac SPC updated

17th January 2011

The drug interaction section of the SPC for all Voltarol preparations (diclofenac, Novartis Pharmaceuticals) has been updated. Two new paragraphs have been inserted as follows:

Potent CYP2C9 inhibitors-caution is recommended when co-prescribing diclofenac with potent CYP2C9 inhibitors (such as sulfinpyrazone and voriconazole), which could result in a significant increase in peak plasma concentrations and exposure to diclofenac due to inhibition of diclofenac metabolism.

Phenytoin-when using phenytoin concomitantly with diclofenac, monitoring of phenytoin plasma concentrations is recommended due to an expected increase in exposure to phenytoin.

For further information, see the SPC which can be downloaded from the link below.

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Licensed warfarin oral suspension now available in UK

11th January 2011

A licensed warfarin sodium oral suspension 1mg/1mL is now available in the UK (Rosemont Pharmaceuticals, 0113 2441400) costing £55 plus VAT for 150mL.

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NPSA Rapid Response Report on loading doses

11th January 2011

The UK National Patient Safety Agency (NPSA) has issued a Rapid Response Report on preventing fatalities from medication loading doses, aimed at reducing the risk of incorrect use of loading doses or subsequent maintenance regimens that may lead to severe harm or death.

All organisations in the NHS and in the independent sector should ensure that (taken directly from source):

1. All medicines used by the organisation that are likely to cause harm if loading doses and subsequent maintenance doses are not prescribed and administered correctly are risk assessed and used to produce a list of critical medicines (which may contain speciality subsections). This must include warfarin, amiodarone, digoxin, phenytoin and any other medicines identified locally.

2. There is effective communication regarding loading dose and subsequent maintenance dose regimens when prescribing, dispensing or administering critical medicines. This should include handover of patients between healthcare organisations. Tools such as loading dose work sheets, loading dose prescription charts, handover and clinical protocols, and patient-held information should be considered.

3. Clinical checks are performed by medical, nursing and pharmacy staff (when available) so that loading and maintenance doses are correct. Appropriate information should be available to support these checks.

4. Healthcare professionals in the community know when to challenge abnormal doses of the identified critical medicines.

The deadline for action complete is 25^th November 2011.

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EMEA review of potential for interaction between alcohol and opioid modified-release mechanisms

11th January 2011

The European Medicines Agency has completed a review of the safety and effectiveness of modified-release oral opioid medicines when taken with alcohol. This was undertaken following reports of the risk of alcohol dissolving the modified release coating and releasing the whole dose in one go i.e. ‘dose dumping’.

They found that this risk is minor for the majority of modified release products and have concluded that the benefits of most of these medicines continue to outweigh their risks. However, the SPCs and PILs should be updated and warnings made consistent across the class that the concomitant use of alcohol with opioids may enhance the pharmacodynamic effect and should be avoided.

However, for modified-release medicines that contain a ‘polymethacrylate-triethylcitrate controlled release system’, the committee concluded that the marketing authorisations should be suspended until the companies that make these medicines have reformulated them so that they are more stable in alcohol. Currently the product that appears to be affected is Ethirfin (morphine sulphate, prolonged-release capsules, 20, 60, 120 and 200mg) previously available in Denmark.

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FDA approves denosumab for prevention of skeletal-related events in patients with metastatic cancer

11th January 2011

The US Food and Drug Administration (FDA) has approved denosumab (Xgeva) for the prevention of skeletal-related events in patients with metastatic cancer. Denosumab is a monoclonal antibody that targets the protein human RANKL involved in cancer-related bone destruction.

Currently in the UK, denosumab is licensed for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures and for the treatment of osteoporosis in postmenopausal women at increased risk of fractures.

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NPC e-learning resources for mixing of medicines

11th January 2011

The UK National Prescribing Centre (NPC) has produced an e-learning resource to support those involved in the mixing of medicines. This follows the Department of Health guidance points and NPC implementation resource that was published in last year (see our news item 2010-06-09). There are two workshops, one for prescribers and one for those mixing medicines, there is also a quiz and podcast.

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SMAC 4th edition receives a glowing review in JPSM

6th January 2011

A recent review of Symptom Management in Advanced Cancer (SMAC) 4^th edition in the Journal of Pain and Symptom Management (JPSM) states that the book is:

"...a great resource for all clinicians..."

"...a well-organized, concise and clinician-orientated text…"

"...a very user-friendly guide, especially for the busy clinician…"

"...a great addition to the libraries of all palliative medicine specialists."

It also positively highlights the additional new chapter on Last days which incorporates information on advance planning, artificial nutrition and hydration, cardiopulmonary resuscitation, withholding and withdrawing life-prolonging treatment, symptom relief, palliative sedation, diagnosing imminent death and dying at home.

The full review can be accessed on-line from the link below (registration required).

Lesage P and Zange A (2010) A clinician’s guide to symptom management: Symptom management in advanced cancer 4^th edition. Journal of Pain and Symptom Management. 40:626-627.

The book is published by www.palliativedrugs.com and edited by Robert Twycross, Andrew Wilcock and Claire Stark Toller. It can be purchased directly from the website for £40 and the proceeds are used to help keep www.palliativedrugs.com a free access resource.

JPSM review
Purchase SMAC 4th edition

Update: psychostimulants monograph

4th January 2011

The psychostimulants monograph has been fully updated and has been published in the Journal of Pain and Symptom Management (JPSM) as a therapeutic review. This version supersedes the PCF3 (first print, 2007) and the website version (dated June, 2008).

Howard P et al (2010) Therapeutic Reviews: Psychostimulants. Journal of Pain and Symptom Management. 40: 789-795.

This is the 3^rd therapeutic review in a series in the JPSM. Previous updated monographs include octreotide (July 2010) and propofol (September 2010). The updated octreotide monograph was the top article downloaded from the JPSM website in 2010.

Look out for more updated monographs in the therapeutic reviews section in the coming months, including thalidomide and ketamine.

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Itraconazole SPCs updated

4th January 2011

The SPCs for all Sporanox (itraconazole, Janssen-Cilag) formulations have been updated. Several changes have been made to sections 4.3–4.8. Changes of note include:

Section 4.3 – contraindications: addition of atorvastatin. Also, women of child-bearing potential should use contraceptive precautions.

Section 4.4 – special warnings: addition of the following wording

Itraconazole should not be used within 2 weeks after discontinuation of treatment with CYP 3A4 inducing agents (rifampicin, rifabutin, phenobarbital, phenytoin, carbamazepine, Hypericum perforatum (St. John's wort)). The use of itraconazole with these drugs may lead to subtherapeutic plasma levels of itraconazole and thus treatment failure.

The current SPCs for the oral preparations can be accessed from the links below. A history of the changes can also be obtained.

SPC Sporonox 10mg/mL oral solution
SPC Sporonox 100mg capsules