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Cyclizine injection from Martindale recalled

31st May 2012

Martindale Pharmaceuticals Ltd UK is recalling all remaining unexpired ampoules of cyclizine lactate injection 50mg/mL ampoules, which has been discontinued, as a precautionary measure. The recall is due to a Good Manufacturing Practice (GMP) concern at a third-party supplier and their own site. It is likely that very little stock remains but the company wishes to minimize any potential patient risk.Recipients are requested to return any remaining stock to their normal supplier for credit.

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Biotene Oralbalance gel supply problem

31st May 2012

There is a UK supply problem with Biotene Oralbalance saliva replacement gel (GSK), this is due to a manufacturing problem at one of the companies owned by GSK. The product is out of stock and currently there is no information on when this is likely to be resolved. An alternative similar product is BioXtra salivia replacement gel (RIS Products). The Biotene Oralbalance mouth moisturizing liquid has previously been discontinued.

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GMC postpones plans for unlicensed drug prescribing

30th May 2012

The UK General Medical Council (GMC) has postponed plans, which were put out for consultation last year, which would allow doctors to prescribe cheaper off-label or unlicensed alternatives to licensed medicines.

The Medicines and Healthcare products Regulatory Agency (MHRA) and the Association of the British Pharmaceutical Industry (ABPI) opposed the proposals. Legal advice, on the European Union (EU) directive on medicinal products for human use, confirmed that unlicensed medicines could be prescribed only where there was a special need, and that this could not be taken to encompass unlicensed medicines for patients with rare conditions if there were a licensed alternative or circumstances in which commissioning bodies did not support the funding of a licensed alternative. As a result, the GMC has agreed to revert to their existing guidance on prescribing unlicensed medicines, although they are still exploring the issue as the EU directive does not specifically address prescribing drugs outside the terms of their licence.

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NICE issues clinical guideline on prescribing opioids in palliative care

25th May 2012

The National Institute for Health and Clinical Excellence (NICE) has issued a clinical guideline (CG140) on the safe and effective prescribing of strong opioids for pain in palliative care of adults. The guideline is for first-line treatment with strong opioids for patients who have been assessed as requiring pain relief at the third level of the WHO pain ladder, and is primarily aimed at non-specialist healthcare professionals.

A costing report on the impact of implementing the guideline and a template for assessing local impact have also been issued. The report states that there are unlikely to be any significant costs in implementing this guidance as an increase in prescribing of strong opioids is not expected. In addition, the following potential savings and benefits are expected:

• Saving in prescribing costs for strong opioids

• Improved patient comfort

• Reduction in patient misinterpretations and misunderstanding in relation to opioids

• Consistent advice on the prescribing of strong opioids.

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Stimulant laxatives therapeutic review

24th May 2012

A therapeutic review on Stimulant laxatives and opioid-induced constipation has been published in the Journal of Pain and Symptom Management (JPSM):

Twycross R. et al (2012) Therapeutic Reviews: Stimulant laxatives and opioid-induced constipation. Journal of Pain and Symptom Management. 43: 306-313.

This is the 9th article in the series; previous ones include Octreotide (July 2010), Propofol (September 2010), Psychostimulants (November 2010), Thalidomide (January 2011), Ketamine (March 2011), Antipsychotics (May 2011), Loperamide (August 2011) and Anti-epileptics (November 2011). All are based on monographs featured in the Palliative Care Formulary.

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US shared REMS for TIRF website now available

22nd May 2012

The access website for the shared Risk Evaluation and Mitigation Strategy (REMS) program for prescribing, dispensing and distribution of all Transmucosal Immediate Release Fentanyl (TIRF) formulations in the US is now available (see our news item 20-02-2012).

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NHS Evidence update on depression

11th May 2012

NHS Evidence has issued a summary of selected new evidence relevant to the National Institute of Health and Clinical Excellence (NICE) clinical guideline 90 (published 2009) on the treatment and management of depression in adults. The update identifies new evidence that might reinforce or generate future change to the practice laid out in the NICE guideline.

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Study published on the impact of co-proxamol withdrawal

9th May 2012

A time series study on the impact of co-proxamol withdrawal on prescribing and deaths in the UK has been published. The study concludes that during the 6 years following the withdrawal of co-proxamol in the UK, there was a major reduction in poisoning deaths involving this drug, without apparent significant increase in deaths involving other analgesics.

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Die zweite Ausgabe des APM Newsletter ist fertig.

8th May 2012

The second issue of APM Newsletter for German-speaking users of is available.

Die zweite Ausgabe des APM Newsletter ist fertig. Über die aktuelle Ausgaben des Newsletters wird Sie das Bulletin Board informieren.

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