Information

First line

• Preferred treatment option, either within a treatment pathway or drug class.
• In some sections a first line option is not given. This is done to draw attention to cases where either pharmacotherapy is seen as second line to some other form of therapy or if the use of a drug from a different pharmacological class is seen as the first line treatment.

Second line

• Alternative treatment option generally used later down the treatment pathway or if the first-line drugs are inappropriate or ineffective.

Specialist use

• Treatments where specialist input is required for general use.
• A specialist is not exclusively a consultant, rather someone with recognised skills, for example a GP with a specialist interest, specialist nurse, or microbiology culture and sensitivity report.
• Examples of specialist input:
  • A specialist initiates treatment.
  • A specialist provides advice for a specific patient.
  • Appropriate prescribing is in accordance with specific guidelines developed either included or referenced in the formulary
• GMC prescribing guidance on responsibilities for contining care or treatment: www.gmc-uk.org/guidance/ethical_guidance

Secondary care only

• The prescribing responsibility for these medicines should normally remain with the consultant or specialist clinician. These drugs should not be initiated or prescribed in primary care
• It is recommended that the supply of secondary care drugs should be organised via the hospital pharmacy
• GP practice prescribing systems
  • It is important that GPs are informed of the supply and use of these drugs and that they are recorded in individual patient records on the GP prescribing system and added to the patient's medication list as a hospital drug
  • Ensure that the start date is recorded, the drug appears on the repeat list, and interactions/adverse effects are flagged up by the computer when other drugs are supplied
  • Systems should be in place to ensure no hospital drugs will be issued accidentally by a GP practice if a prescription is generated for the patient in error
  • Information from secondary care should be used to keep the records updated. For example where the drug is no longer required or changed. This will reduce the potential risks associated with inaccurate records
  • Please follow the advice here for adding medicines prescribed by outside sources to GP computer systems.
• GPs should contact their local Medicines Optimisation Pharmacist for advice and support on the use of secondary care drugs.

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:

• Where there is a difference in bioavailability between brands of the same medicine, particularly if the medicine has a narrow therapeutic index
• Where modified release preparations are not interchangeable
• Where products contain multiple ingredients and brand name prescribing aids identification
• Where there are important differences in formulation between brands of the same medicine
• Where administration devices (e.g. inhaler or self-injection) have different instructions for use and patient familiarity with one product is important
• Where the product is a biological rather than chemical entity.

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

Furosemide

• Tablets 20mg, 40mg, 500mg (£0.82 = 40mg daily)

To prescribe using the brand name

Slo-phyllin®

• Capsules 60, 125mg, 250mg (£4.34 = 250mg twice daily)

To prescribe using the brand name when there is a locally agreed formulary choice. The preferred brands will be listed below the generic name

Oxycodone CD

• Shortec® capsules 5mg, 10mg, 20mg (£48.00 = 30mg daily)

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:

• Recommended to be accepted for routine commissioning and incorporated into local joint formularies
• Not recommended for routine commissioning and that clinicians wishing to use the treatment in any patient should seek funding through the individual funding request panel
• Not recommended for routine commissioning but is considered suitable for trust-managed individual patient treatment for limited use, approved via Drugs and Therapeutics Committee (DTC) (or equivalent approval group).

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:

1. Make an application to their acute trust's DTC (or equivalent group) for approval of the treatment in each patient with a defined clinical need, detailing where commissioned (formulary) treatments are not suitable or have failed. Trusts' approval committees should consider each application per individual; clinicians should not seek approval for a cohort of patients. Where the request is not approved, the individual funding request panel remains a possible route.
2. If the DTC (or equivalent group) approves the treatment, the patient will be managed and treatment will be prescribed by the specialist for a minimum of six months to allow for assessment of individual clinical benefit to be balanced against adverse effects. All associated costs will also remain with the secondary care prescriber during this time.
3. The specialist will communicate with the GP explaining the reason for using the non-commissioned treatment, and inviting the GP to take on prescribing of the treatment once the initial period has elapsed (See trust-managed treatment primary care request form).
4. The specialist will inform the GP if the treatment does not show expected benefit and will discuss alternatives with the patient.