DH - Changes to medicines legislation to enable Mixing of Medicines prior to administration in Clinical Practice - 6 Jan

Source

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.

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 for medicines resulting from the mixing of medicines, so a PGD cannot be used for this purpose - other than dissolving or dispersing the product in, or diluting or mixing it with, some other substance used as a vehicle for the purpose of administering it.

The MHRA has also approached the Home Office and the Advisory Council for the Misuse of Drugs (ACMD) with the Commission on Human Medicine’s recommendations that corresponding amendments for controlled drugs are made to the Misuse of Drugs Regulations.  Meantime, existing good practice arrangements should contiunue on mixing before administration which includes a controlled drug.

Department of Health
December 2009

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