The Royal Marsden Hospital Manual of Clinical Nursing Procedures - Lisa Dougherty [521]
The addition of prescriptive authority to the nurse role has been a positive way of not only making a service more responsive for service users, but also has helped to meet increasing demands on health services (Bridge et al. 2005). Patients are satisfied with nurse prescribing (Latter et al. 2005). In 2005 it was estimated that there were 28,000 nurses who were able to prescribe from the limited formulary and 4000 extended prescribers (MHRA 2005). A national survey of 246 nurse prescribers concluded that nurse prescribing is largely successful in both practice and policy terms (Latter et al. 2005): this is discussed in more detail in Box 13.5. A range of competencies and skills are required to ensure quality and safe prescribing – the nurse prescriber:
Box 13.5 An evaluation of nurse prescribing (Latter et al. 2005)
Most nurse prescribers were confident in their prescribing practice.
Most felt extended prescribing had a positive impact on patient care and enabled them to make better use of their skills.
Most felt that the limited nurse formulary imposed unhelpful limitations on their practice.
Nurses were satisfied with the support received from their medical practitioner.
Patients were positive about their experience of nurse prescribing.
Doctors were positive about the development of nurse prescribers in their teams.
identifies main medical condition
explores patient’s presenting symptoms and their management
explores past medical history, current medication, including over-the-counter (OTC), allergies and family history
is able to initiate a physical examination
is able to request and interepret diagnostic tests.
The evidence is that nurses need greater consistency in the frequency with which they apply these skills (Latter 2008).
Unlicensed and ‘off-label’ medicines
Under European medicines legislation, a medicinal product placed on the market is required to have a marketing authorization (product licence) granted following demonstration of safety, quality and efficacy. However, member states can put in place arrangements to allow an authorized healthcare professional to gain access to an unlicensed medicine, that is, a medicine that doesn’t have a marketing authorization, to meet the special needs of individual patients. In the UK, this occurs via the arrangements for ‘specials’ manufactured in the UK and the notification scheme for products imported into the UK.
‘Specials’ can be supplied if there is an order for them, a registered doctor has requested the product and the product will be used for a patient under the care of that doctor and under that doctor’s supervision. A ‘special’ cannot be supplied if an equivalent licensed product is available which will meet the patient’s needs. If a ‘special’ is manufactured in the UK, the manufacturer must hold a manufacturer’s (special) licence issued by the MHRA. An unlicensed medicine may also be imported if the importer holds the appropriate wholesaler dealer license or wholesaler dealer import license issued by the MHRA. The importer will need to inform the MHRA on each occasion that they intend to import the product. ‘Off label’ refers to the use of a medicine outside the terms of its licence.
For herbal medicines, there are three possible regulatory routes by which they can reach the market in the UK: as an unlicensed herbal remedy, as a registered traditional herbal medicine (identified as the product container or packaging will include a nine-digit registration number starting with the letters THR (MHRA 2009) and as a licensed herbal medicine. Unlicensed herbal remedies