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NICE statement on neuropathic pain guidelines

22nd July 2010

The UK National Institute for Health and Clinical Excellence (NICE) has posted a statement on it's website with reference to the concerns on the recommendation of the use of pregabalin (taken directly from source):
"NICE is aware that there have been concerns about the associated costs that pregabalin may bring to the NHS as one of the first line treatment options for adults with neuropathic pain. NICE, in collaboration with the Health Technology Assessment group are reviewing the economic modeling. Until a further announcement is made, the guideline continues to represent best practice for the NHS."

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MHRA and FDA warnings against quinine for leg cramps

15th July 2010

The June issue of the MHRA drug safety update reminds health professionals about the risks of serious undesirable effects with the use of quinine. It states that quinine should not be a routine treatment for nocturnal leg cramps. It should only be considered when cramps cause regular disruption of sleep, when cramps are very painful or frequent, when other treatable causes of cramp have been ruled out and when non-pharmacological measures have not worked (e.g. passive stretching exercises). After an initial trial of 4 weeks, treatment should be stopped if there is no benefit.
In the US, the FDA has approved a risk management plan (REMS) to warn against the off-label use of quinine sulphate (Qualaquin) for night time leg cramps following continued reports of serious side effects. The FDA states that quinine should not be used for night time leg cramps and requires that patients be given a medication guide explaining what the drug is and is not approved for, as well as the potential side effects. In addition, the REMS requires that the manufacturer issue a Dear Health Care Provider letter warning of the risk of serious and life-threatening haematological reactions.
Further advice and information can be obtained from the links below.

MHRA Drug Safety update June
FDA alert for quinine

NPSA updated guidance for medical safety incidents

15th July 2010

The UK National Patient Safety Agency (NPSA) has issued updated guidance on the steps junior doctors should follow in the event of a medical safety incident. This supersedes the version first published in 2005.

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NPSA rapid response report on insulin safety

8th July 2010

The UK National Patient Safety Agency (NPSA) has issued a rapid response report aimed at reducing the number of wrong dose incidents involving insulin.
All organisations in the NHS and independent sector should ensure that (taken directly from source):
• All regular and single insulin (bolus) doses are measured and administered using an insulin syringe or commercial insulin pen device Intravenous syringes must never be used for insulin administration.
• The term 'units' is used in all contexts. Abbreviations, such as 'U' or 'IU', are never used.
• All clinical areas and community staff treating patients with insulin have adequate supplies of insulin syringes and subcutaneous needles, which staff can obtain at all times.
• An insulin syringe must always be used to measure and prepare insulin for an intravenous infusion. Insulin infusions are administered in 50mL intravenous syringes or larger infusion bags. Consideration should be given to the supply and use of ready to administer infusion products e.g. prefilled syringes of fast acting insulin 50units in 50mL sodium chloride 0.9%.
• A training programme should be put in place for all healthcare staff (including medical staff) expected to prescribe, prepare and administer insulin. An e-learning programme is available from: www.diabetes.nhs.uk/safe_use_of_insulin
• Policies and procedures for the preparation and administration of insulin and insulin infusions in clinical areas are reviewed to ensure compliance with the above.
Insulin safety forms part of the NPSA's 10 for 2010 improvement programme. The deadline for the above actions to be completed is 16 December 2010.

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GMC guidance for end of life care

8th July 2010

New guidance, "Treatment and care towards the end of life: good practice in decision making", from the UK General Medical Council (GMC) came into effect on 1st July 2010 and replaces the booklet "Withholding and withdrawing life-prolonging treatments" (2002) and expands on the guidance in "Consent, patients and doctors making decisions together".

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MHRA drug safety update: zoledronic acid

8th July 2010

The April issue of the MHRA drug safety update reminds health professionals about the use of intravenous zoledronic acid and adverse effects on renal function. Zoledronic acid is associated with reports of renal impairment and renal failure, especially in patients with pre-existing renal dysfunction or other risk factors. Renal function should be measured before each dose, and patients should be adequately hydrated before treatment. Renal function monitoring is recommended after use of zoledronic acid in at-risk patients and those with pre-existing renal impairment. Use in patients with severe renal impairment is generally not recommended, but may be considered for tumour-induced hypercalcaemia, if the benefits outweigh the risks.
For further information see the original article and the PCF monograph for zoledronic acid.

MHRA drug safety update April
PCF zoledronic acid monograph