Under current legislation, except in very restricted circumstances, mixing drugs together, where one is not a vehicle for the administration of the other, creates an unlicensed medicine. The person undertaking this preparation, unless an exemption applies, must hold a manufacturer’s licence (MLX356).
In palliative care, it is usual to mix two or more medicines in a syringe driver prior to administration. In 2008, the Agency realised that the legal position could potentially obstruct the provision of effective pain relief and symptom control to patients receiving palliative care. To regularise the position, the Agency sought the Commission on Human Medicine's (CHM) views on a public consultation proposing changes to legislation.
The CHM provisionally favoured an amendment enabling non-medical prescribers to order 'specially prepared' products for their individual patients and to enable non-prescriber nurses/pharmacists to mix those medicines before administration. The Agency began the consultation on this basis in December 2008.
CHM working group
In the meantime, a CHM working group was established to discuss the proposals and consider the results of the consultation in detail. External experts were invited to offer views and advice. It became clear to the Working Group that 'mixing' was not restricted to palliative care and any legislative amendment which only addressed this area would not meet current clinical need.
The Working Group reported to the CHM in May 2009. The CHM fully endorsed the report’s recommendations and guiding principles. An executive summary of the report can be accessed below.
Report of the CHM Working Group on ‘Mixing’ Of Medicines
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