National alliance formed to respond the LCP review

30th August 2013

A new Leadership Alliance for the Care of the Dying has been formed by NHS England in response to the independent review of the Liverpool Care Pathway (LCP). It will be chaired by Dr Bee Wee, National Clinical Director for End of Life Care at NHS England, and many key organizations have already joined; Care Quality Commission, Department of Health, General Medical Council, Health Education England, NHS Improving Quality, Nursing and Midwifery Council and the National Institute for Health and Care Excellence.

The alliance will take forward the information from the LCP review and respond at a strategic and system-wide level to:

• support everyone involved in the care of people who are dying to respond to the findings of the review
• be the focal point for the system’s response to the findings and recommendations of the LCP review
• provide guidance on what needs to occur in place of the LCP
• consider how best health and social sector can address the recommendations in the review about the accountability and responsibility of individual clinicians, out of hours decisions, nutrition and hydration and communication with the patient and their relatives or carers
• map existing guidance, training and development, as a prelude to considering how these impact on the care of dying people and the circumstantial factors that might affect the adoption of good practice.

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Physiotherapists and podiatrists able to become independent prescribers

28th August 2013

New legislation has been introduced in the UK to allow physiotherapists and podiatrists to become independent prescribers following successful completion of their prescribing course.

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Nitrofurantoin reminder of precautions for use in renal impairment

22nd August 2013

The UK Medicines and Healthcare products Regulatory Agency (MHRA) is reminding health professionals that nitrofurantoin should not be used in patients with a renal creatinine clearance of <60mL/min, as treatment failure may occur due to insufficient drug being secreted into the urinary tract. The renal status of patients, particularly the elderly, should be checked before treatment.

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Alfentanil SPC updated

22nd August 2013

The UK SPC for alfentanil 500micgram/mL solution for injection has been updated to include information for use in paediatrics, following the outcome of an EU paediatric work-sharing procedure for alfentanil that was published earlier this year.

Alfentanil 500microgram/mL injection SPC

EU work-sharing procedure for alfentanil

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Oral morphine Cochrane review

20th August 2013

An updated version of the Cochrane review on oral morphine for cancer pain (CD003868.pub3), first published in 2003, is now available.

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Granisetron patches launched in UK

20th August 2013

Granisetron transdermal patches 3.1mg/24h (Sancuso; ProStrakan) have been launched in the UK. They are indicated for adults for the prevention of nausea and vomiting associated with moderately or highly emetogenic chemotherapy, for a planned duration of 3 to 5 consecutive days, where oral anti-emetic administration is complicated by factors making swallowing difficult. A single transdermal patch should be applied 24–48h before chemotherapy and removed a minimum of 24h after completion. The patch can be worn for up to 7 days depending on the duration of the chemotherapy regimen.

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Risperidone SPC updated

15th August 2013

The SPC for risperidone has been updated to include the warning of the risk of leukopenia, neutropenia and agranulocytosis which has been classified as occurring very rarely (<1/10,000 patients) following post-marketing surveillance. For more information see the SPC below.

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CQC annual report: safer management of controlled drugs

13th August 2013

The UK Care Quality Commission (CQC) has published their 2012 annual report on the safer management of controlled drugs.

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Driving under the influence of controlled drugs government consultation

8th August 2013

The UK department for transport has issued a consultation seeking views on proposals for threshold drug driving limits to be specified in the new regulations regarding the offence of driving with a controlled drug in the body. 

Views are sought on the government’s preferred policy option of making it an offence to drive if any of 16 controlled drugs are found in the blood over a specified limit. They propose a zero tolerance approach to the threshold limits that are given for 8 drugs most associated with illegal use; cannabis and cannabinol, cocaine, ketamine, benzoylecgonine, Lysergic Acid Diethylamide (LSD), MDMA (Ecstasy), methamphetamine, 6-monoacetylmorphine (6-MAM; Heroin/diamorphine). A road safety risk approach to the threshold limits is proposed for a further 8 drugs most associated with medical uses; clonazepam, diazepam, flunitrazepam, lorazepam, methadone, morphine, oxazepam and temazepam. A limit for amphetamine will be subject to a further consultation. Two other policy options are also considered.

This consultation follows the report ‘Driving under the influence of drugs’ from the expert panel on drug driving which was published in March 2013. The report states that there was not enough evidence to set threshold limits for other opioids e.g. codeine, dihydrocodeine, oxycodone, hydrocodone, tramadol. However recommendations regarding the role of the health professionals in informing patients about the risks of driving under the influence of drugs are made. 

The consultation which closes on 17 September 2013 and the full report from the expert panel which advised the department for transport can be downloaded below.

Drug driving consultation

Drug driving expert panel report 

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EMA restricts metoclopramide dose and duration of use

8th August 2013

The European Medicines Agency (EMA) has recommended changes to the dose and duration of use of metoclopramide in adults and children following a review. They recommend several changes to the authorized indications including restricting metoclopramide to short-term use (up to 5 days) with a maximum dose in adults of 10mg t.d.s. and significant restrictions for use in children. The full list of recommendations can be found from the link below.

There has been discussion on our bulletin board about the impact of this decision on palliative care patients including a posting of a statement from the EMA regarding use in palliative care situations.

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MHRA consultation on diclofenac as a Pharmacy medicine

8th August 2013

The UK Medicines and Healthcare products Regulatory Agency is consulting on the continued availability of diclofenac as a Pharmacy (P) medicine, as a result of the EU review on the cardiovascular risks of NSAIDs. The consultation closes on 28^th October 2013.

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Etamsylate tablets discontinued in UK

6th August 2013

Etamsylate 500mg tablets (Dicynene; Sanofi-Aventis) have been discontinued in the UK for commercial reasons, there is no alternative available.

Etamyslate 500mg tablets are available via IDIS 01932 824000 (Dicynone; a French product) as an unathorized UK product. They are considerably more expensive than the original UK tablets i.e. pack of 20 tablets = £23 approximately compared with the previous price of 100 tablets for £8.44.

The supply section of the on-line PCF Etamsylate monograph has been updated to reflect this.

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Oral ketoconazole contra-indicated for fungal infections

6th August 2013

The UK MHRA has stated that oral ketoconazole-containing products should no longer be prescribed for fungal infections as the risk of liver injury outweighs the benefits. This follows reported cases of hepatitis, cirrhosis and liver failure at the recommended daily dose of 200mg occurring sometimes less than 1month after starting treatment.

Topical ketoconazole formulations (creams, ointments, and shampoos) have very low systemic absorption and may continue to be used as currently approved.

The European Commission is considering suspending all licenses for oral ketoconazole, however, arrangements are being put in place to ensure patients with Cushing’s syndrome using oral ketoconazole off-label continue to have access to this product.

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FDA risk of rare but serious skin reactions with paracetamol (acetaminophen)

6th August 2013

The FDA has warned health professionals to be aware of the rare but serious risk of severe skin reactions, e.g. Stevens Johnson Syndrome, toxic epidermal necrolysis and acute generalised exanthematous pustulosis, with paracetamol (acetaminophen) following a review of the FDA adverse event reporting system database and medical literature. Warnings are to be added to the product labels of both prescription and over the counter drugs.

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