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Unlicensed medicines can be prescribed by doctors, dentists and nurse independent prescribers (DH 2009). ‘Off-label’ medicines can be prescribed by doctors, dentists, independent nurse prescribers, independent pharmacist prescribers and independent optometrist prescribers. The MHRA has published advice for prescribers on the use of unlicensed and off-label medicines due to the responsibility for prescribing such medicines being potentially greater than for licensed products (Box 13.6). Nurse independent prescribers can also mix medicines prior to administration and direct others to mix, for example for use within syringe pumps/drivers (DH 2009).

Box 13.6 MHRA advice for prescribers on the use of unlicensed and off-label medicines

Before prescribing an unlicensed medicine, be satisfied that an alternative, licensed medicine would not meet the patient’s needs.

Before prescribing a medicine off label, be satisfied that such use would better serve the patient’s needs than an appropriately licensed alternative.

Before prescribing an unlicensed medicine or using a medicine off-label:

– be satisfied that there is a sufficient evidence base and/or experience of using the medicine to show its safety and efficacy

– take responsibility for prescribing the medicine and for overseeing the patient’s care, including monitoring and follow-up

– record the medicine prescribed and, where common practice is not being followed, the reasons for prescribing this medicine; you may wish to record that you have discussed the issue with the patient.

The MHRA also advises that best practice suggests that:

you give patients, or those authorizing treatment on their behalf, sufficient information about the proposed treatment, including known serious or common adverse reactions, to enable them to make an informed decision

where current practice supports the use of a medicine outside the terms of its licence, it may not be necessary to draw attention to the licence when seeking consent. However, it is good practice to give as much information as patients or carers require or which they may see as relevant

you explain the reasons for prescribing a medicine off label or an unlicensed medicine where there is little evidence to support its use, or where such use of a medicine is innovative.

Finally, the MHRA advises that healthcare professionals have a responsibility to help monitor the safety of medicines in clinical use through submission of suspected adverse drug reactions to the MHRA and CHM via the Yellow Card Scheme (www.yellowcard.gov.uk). Such reporting is equally important for unlicensed medicines or those used off-label as for those that are licensed (MHRA 2009).

Dispensing

Dispensing is defined as ‘to label from stock and supply a clinically appropriate medicine to a patient/client/carer usually against a written prescription, for self administration or administration by another professional and to advise on safe and effective use’ (NMC 2008a, p.28). The majority of these activities in hospitals are undertaken by the pharmacy department. They can supply medicines as stock to a ward or for specific patients, either as inpatients or outpatients. Pharmacists are professionally accountable for all decisions to supply a medicine and offer advice. As part of this accountability, they must ensure that if any tasks are to be delegated, they are delegated to persons competent to perform them. Nurses may only dispense in exceptional circumstances (NMC 2008a).

A pharmaceutical assessment of a prescription, which is the point at which pharmacists apply their knowledge to establish the safety, quality, efficacy and perhaps cost-effective use of drug treatments specified by a prescriber, must be performed by a pharmacist and must be carried out on every prescription (RPSGB 2007a). Following this assessment, the assembly of the prescription can be delegated to a pharmacy technician or a pharmacy assistant. Once the prescription is assembled, it will be presented for accuracy