Purpose of a local formulary

The NHS Constitution for England, produced by the Department of Health (2009, revised 2012) provides patients with the right that medicines (and treatments) that have been considered by NICE through the technology appraisal process and given a positive assessment should be made available to patients, where appropriate, and therefore be included in the formulary adopted by the local healthcare providers and commissioners. The Constitution states:

'You have the right to drugs and treatments that have been recommended by NICE for use in the NHS, if your doctor says they are clinically appropriate for you.'

In addition, the Constitution provides a second right for patients. Medicines (and treatments) that have not yet been considered by, or have not received a positive recommendation for use in the NHS through, a NICE technology appraisal process should be considered by the local NHS using a robust assessment of the best available evidence. The Constitution states:

'You have the right to expect local decisions on funding of other drugs and treatments to be made rationally following a proper consideration of the evidence. If the local NHS decides not to fund a drug or treatment you and your doctor feel would be right for you, they will explain that decision to you.'

At the time of publishing, proposals to strengthen the NHS Constitution are set out for public consultation.

After publication of the original NHS Constitution, a set of key documents were produced to support rational local decision-making. Defining guiding principles for processes supporting local decision making about medicines (2009), produced by the National Prescribing Centre and Department Of Health and the accompanying Supporting rational local decision-making about medicines (and treatments) (2009), produced by the National Prescribing Centre underpin the good practice recommendations for developing and updating local formularies.

Statutory responsibility

Directions issued by the Secretary of State for Health (2010) make it a statutory obligation for commissioners to make funding available within 3 months for medicines that have been recommended by a NICE technology appraisal, unless they are directed otherwise by the Secretary of State for Health.

Innovation health and wealth

The Department of Health's report Innovation Health and Wealth, Accelerating Adoption and Diffusion in the NHS (2011, updated 2012) sets out the aspiration for the Government to support the NHS to embrace innovation to meet the current and future healthcare challenges. In particular, the NHS should ensure that local systems and processes for accessing medicines support innovation where appropriate. The report states:

'Formulary processes should proactively consider the impact of new NICE technology appraisals, and all NICE technology appraisal recommendations should – where clinically appropriate – be automatically incorporated into local formularies. This process should take place within 90 days to support compliance with the three month funding direction and the NHS constitution ensuring that these medicines are available for clinicians to prescribe, should they choose to, in a way that supports safe and clinically appropriate practice.'

In this report, the Department of Health introduced a NICE compliance regime for the funding direction attached to NICE technology appraisals to ensure rapid and consistent implementation throughout the NHS. The compliance regime aims to 'reduce variation and assure patients of their access to the clinically and cost-effective technologies and medicines their doctors believe they need'.

In a letter from the NHS Chief Executive, Innovation, Health and Wealth publication of NHS formularies (2012), the Department of Health has stated that all NHS organisations should publish information which sets out which NICE technology appraisals are included in their local formularies by 1 April 2013 at the very latest. The Chief Executive stated that 'It will be important that the publications are online, and are clear, simple and transparent, so that patients, the public and stakeholders can easily understand them'. From 1 April 2013, this will become a standard term and condition in NHS contracts.

The Chief Pharmaceutical Officer has also written to all chief pharmacists and prescribing leads, encouraging them to take action for reviewing local formulary processes to begin implementation of Innovation Health and Wealth.

Mandate to NHS England

The Department of Health has published A mandate from the Government to the NHS Commissioning Board: April 2013 to March 2015 (2012). This includes objectives that reinforce the NHS Constitution and patient's access to medicines and treatments recommended by NICE:

• …'to make significant progress in ensuring people have access to the right treatment when they need it, including drugs and treatments recommended by NICE'

• …'to uphold these rights and commitments [NHS Constitution], and where possible to improve the levels of performance in access to care."

NICE Good Practice Guidance - Developing and updating local formularies

NICE have produced guidance to provide good practice recommendations for the systems and processes needed to ensure NHS organisations develop and update local formularies effectively and in accordance with statutory requirements. This guidance is for people involved in handling, prescribing and commissioning medicines within the NHS, to support the development of local formularies that reflect local needs, reduce variation in prescribing, and allow rapid uptake of innovative medicines and treatments.  This guidance can be found online at http://publications.nice.org.uk/developing-and-updating-local-formularies-gpg1

General Medical Council  (GMC) guide to prescribing unlicensed (including off-label) medicines

This guidance is available here: http://www.gmc-uk.org/guidance/28349.asp