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The South & West Devon Formulary is arranged in BNF order and consists of a list of treatment recommendations in each section, with supporting clinical guidance where appropriate.
The prescriber should always ensure they have the expertise to prescribe an agent before making a selection.
Drug entries are colour coded to guide selection as described below.
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Formulary choice drugs, unless specifically stated otherwise, are shown with the usual dose range in adults without significantly altered drug handling (such as renal impairment).
Using approved (generic) names is generally encouraged for prescribing in both primary and secondary care, this aims to improve cost-effectiveness.
There are some circumstances in which continuity of the same brand is important for patient safety and brand-name prescribing preferred. These include:
However, to help with cost pressures across the NHS and specifically for primary care prescribing some locally agreed preferred brands are specified in the formulary.
In some instances these will not be the brand provided in secondary care. Within secondary care the brands supplied are determined by nationally agreed pharmacy purchasing contracts.
The format of the formulary aims to define when to prescribe using the generic or brand name, for example:
To prescribe using the generic name
To prescribe using the brand name
To prescribe using the brand name when there is a locally agreed formulary choice. The preferred brands will be listed below the generic name
A licensed medicine has been assessed for efficacy, safety, and quality; has been manufactured to appropriate quality standards; and when placed on the market is accompanied by appropriate product information and labelling. The Medicines and Healthcare Products Regulatory Agency (MHRA) govern this process. Prescribers should usually prescribe licensed medicines in accordance with the terms of their licence.
On an individual patient basis for medical reasons, it is sometimes necessary when there is no suitable alternative, to prescribe unlicensed medicines or medicines which are used outside the terms of their product licence (off-label). Prescription of unlicensed or off-label medicines should wherever possible be supported by evidence and a body of expert opinion. Unlicensed and off-label medicines are more commonly used in some areas of medicine such as paediatrics, psychiatry and palliative care.
The responsibility that falls on healthcare professionals when prescribing an unlicensed or off-label medicine may be greater than when prescribing a licensed medicine within the terms of its licence. Prescribers should pay particular attention to the risks associated with such preparations which may include: adverse reactions, product quality, discrepant product information or labelling regarding indications, information in a foreign language for unlicensed imports, and potential confusion for patients or carers when the Patient Information Leaflet (PIL) is inconsistent with a medicine's off-label use.
Prescribers are required to give patients (or their parents or carers) sufficient information about medicines to allow them to make an informed decision before proposed treatment is prescribed.
Prescribers are advised to contact the NEW Devon CCG Medicines Optimisation Pharmacists or NHS South Devon and Torbay CCG Medicines Optimisation Pharmacists as appropriate if further information is required when prescribing such medication.
The GMC provides guidance regarding prescribing of unlicensed and "off-label" medication; accessed here.
The website Medicines for Children ( accessed here) produces leaflets that are written specifically for parents and carers regarding medicines that may be prescribed for children by healthcare professionals that are used off label or have no UK license.
Plymouth Hospitals NHS Trust Policy for the Procurement, Prescribing, Supply and Administration of Unlicensed Medicines can be accessed here (PHNT internal link only).
Biological medicines or "biosimilars" are medicines that are made, or derived from, a biological source. They are complex, with inherent variability in their structure.
A biosimilar is a biological medicine which is highly similar to another biological medicine already licensed for use (the reference product). It will have been shown not to have any clinically meaningful differences from the originator biological medicine in terms of quality, safety and efficacy.
Biosimilars cannot be considered generic equivalents of the originator biological medicine because the two products are not identical. However, they will have met regulatory requirements in terms of comparative quality, safety and efficacy.
Where NICE has already recommended an originator biological medicine, the same guidance will normally apply to any biosimilar subsequently produced. The development of biological medicines and biosimilars has the potential to increases choice for patients and clinicians, promote commercial competition and enhance value propositions for individual medicines.
The decision to prescribe an originator biological medicine or a biosimilar product rests with the responsible clinician in consultation with the patient. NICE states that, where more than one treatment is suitable, the least expensive agent should be chosen (taking into account administration costs, dosage and price per dose). Therefore if the medicine is considered appropriate and a biosimilar product exists then the biosimilar should be considered as the first option.
MHRA guidelines state that biological medicines and biosimilars must be prescribed by brand name to support on-going pharmacovigilance of the individual products. When dispensing a prescribed biological medicine, a biosimilar version should not be automatically substituted for the originator by the pharmacist.
The use of biosimilars is supported by NHS England. The appropriate use of biosimilars may release cost efficiencies, which could support the treatment of more patients and the uptake of new and innovative medicines.
Prices given are for 28 days treatment unless stated otherwise and are taken from the Drug Tariff, BNF and MIMS in operation during the development of that chapter.
It should be remembered that drug prices are subject to change. The prices of a large number of commonly prescribed generic drugs are included under Category M of the Drug Tariff. The prices of these drugs can fluctuate and may not always seem logical.
Applications for new drugs to be added to the Devon joint formularies are decided by the Devon wide Clinical Policy Committee (CPC). Treatments that are submitted to the CPC for consideration are subject to a robust review process by the clinical effectiveness team. All relevant evidence is evaluated and presented to the committee for consideration. Local specialists are invited to participate in the process, providing comments and/or attending the meeting where a commissioning recommendation is made. Treatments are considered from the viewpoint of clinical benefit and value for money to the health community as a whole; a proportion of treatments are not accepted for routine commissioning and therefore not adopted into the local joint formularies.
However, specialists will, from time to time, encounter individual patients for whom such non-commissioned treatments are the only option. Currently the route to gain approval for use of such treatments is through the Individual Funding Request Panel. It is acknowledged that the procedures associated with this can be disproportionate in situations of relatively straightforward treatments that would typically be used to treat conditions routinely managed in primary care, and for which there are no particular drug-specific monitoring requirements.
An alternative means has been developed, for individual patients, whereby specialists may seek approval for treatments that have been rejected for routine commissioning in NEW Devon and South Devon & Torbay CCGs. The aim is to prevent inappropriate requests for primary care initiation of non-commissioned treatments, or continuation where the drug concerned is clearly of a specialist nature; and to stop inappropriate requests for routine use made in an attempt to circumvent formulary rejections.
In December 2014 a letter was sent to local clinicians describing the intention to manage this (See Management of non-routinely commissioned drugs).
As part of its consideration process, the CPC it will determine if a proposed treatment is:
Commissioning policies published following a CPC decision will make it clear which of the above criteria apply, detailed under the exceptionality criteria for treatment. The Devon joint formularies contain details of local commissioning decisions together with links to policies, and information relating to the trust managed individual patient treatment process where applicable.
The process applies only to treatments that have been considered by the Clinical Policy Committee; it should not be used for treatments that have not been subject to consideration by the CPC. This process is subject to a trial period of twelve months; during this period, trusts should record details of applications received in order to monitor levels of activity.
Where a specialist identifies the clinical need to use a non-commissioned treatment in an individual patient, they should: