Mixing drugs together, where one is not a vehicle for the administration of the other, creates an unlicensed medicine.
Article date: November 2009
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.
Background: mixing of medicines in palliative care
In palliative care, it is usual to mix two or more medicines in a syringe driver before administration. In 2008, the MHRA realised that the legal position could potentially obstruct the provision of effective pain relief and symptom control to patients receiving palliative care. As a holding measure, we issued a statement that enforcement action would not be taken for breaches of medicines legislation by independent prescribers and nurses in palliative care who were engaged in mixing medicines, unless it would be in the public interest to do so.
To regularise the position permanently, we sought the Commission on Human Medicine’s (CHM) views on a public consultation proposing changes to legislation. CHM considered several options for change and provisionally favoured an amendment enabling non-medical prescribers to order “specially prepared” products for their individual patients, and to enable non-prescriber nurses or pharmacists to mix those medicines before administration. We began the consultation on this basis in December 2008.
In the meantime, a CHM Working Group was established to discuss the proposals and consider the results of the consultation; 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 that any legislative amendment which only addressed this area would not meet current clinical need.
Latest information on mixing of medicines in clinical practice
In May 2009, CHM considered a report from the Working Group. The Group recommended that:
- Doctors and dentists (who can already mix medicines) should be able to direct others to mix
- Non-medical prescribers should be able to mix medicines and direct others to mix
- Nurse and pharmacist independent prescribers should be allowed to prescribe unlicensed medicines for their patients
- The MHRA should approach the Home Office with CHM’s recommendations to make corresponding amendments to the Misuse of Drugs Regulations
- Guidance should be developed for those involved in the “mixing” of medicines
- Research should be commissioned to develop authoritative national advice on “mixing” of medicines
The MHRA plans to implement the necessary legislative amendments in November 2009.
The National Prescribing Centre will be producing a short good-practice guide to support practice in the mixing of medicines post-legislation. Further details will be available from www.npc.co.uk
Article citation: Drug Safety Update Nov 2009, vol 3 issue 4: 10.