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Oxycodone import consultation and diamorphine supply

22nd January 2010

A consultation exercise from the UK Home Office is underway which examines four options around the importation of oxycodone.
In February 2008 the Home Office made changes to allow the importation of oxycodone from outside the European Economic Area (EEA). These changes were considered to have led to a number of undesirable consequences, including threatening the economic viability of Macfarlan Smith Limited (MSL), the sole producer of diamorphine, whom are reliant on sales of oxycodone.
The decision to allow these imports of oxycodone was therefore rescinded in February 2009, based on a number of factors, including that the Department of Health considered it essential that the supply of diamorphine was maintained for the NHS.
The Government's current preference is to restrict imports of oxycodone from outside the EEA and preserve the supply of diamorphine to the NHS. The consultation document can be downloaded from the link below and closes on 15th February 2010.
We are currently running a survey to see if you view diamorphine as an essential opioid. If you are a UK practitioner, we would be grateful if you would spend a few moments giving us your opinion. Please access the survey from our homepage.

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Changes to medicines legislation to enable mixing of medicines prior to administration

7th January 2010

The Medicines and Healthcare products Regulatory Agency (MHRA) has now put in place changes to medicines regulations to enable mixing of medicines prior to administration in clinical practice, effective from 21 December 2009 (see previous news item 2009-11-05).
These changes enable:
• Doctors and dentists, who can already mix medicines themselves, to direct others to mix
• Nurse and pharmacist independent prescribers to mix medicines themselves and to direct others to mix
• Supplementary prescribers to mix medicines themselves and to direct others to mix, but only where that preparation forms part of the clinical management plan for an individual patient
• Nurse and pharmacist independent prescribers to prescribe unlicensed medicines for their patients, on the same basis as doctors and dentists (and supplementary prescribers if part of a clinical management plan).
The legal changes also define mixing as "the combination of two or more medicinal products together for the purposes of administering them to meet the needs of a particular patient".
These changes apply not only to palliative care, but to all clinical areas where the mixing of medicines prior to administration is accepted practice and supported by the employer's policies for the delivery of healthcare.
No changes are intended to the existing legal requirements for Patient Group Directions (PGD) for medicines resulting from the mixing of medicines, so a PGD cannot be used for this purpose.
The MHRA has also approached the Home Office and the Advisory Council for the Misuse of Drugs (ACMD) that corresponding amendments for controlled drugs are made to the Misuse of Drugs Regulations. In the meantime, existing good practice arrangements on mixing before administration which includes a controlled drug should continue.

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MHRA ondansetron IV drug alert

5th January 2010

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 4 drug alert for ondansetron IV injection (Teva UK, all supplied in the Pliva livery). The SPC and PIL are missing certain information. To avoid stock shortages, existing stock is not being recalled. The SPC missing information relates to warnings about rare ECG changes with use and a statement about the unlikely need for dose changes due to drug interactions. The PIL missing information is about what to do in overdose. Full information can be found in the drug alert below.

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