Healthcare guidance body NICE has today (17 December) published the first in a new series of guidance that provides advice and guides good practice for those involved in handling, prescribing, commissioning and decision-making about medicines. The NICE good practice guide on the development and updating of local formulariesⁱ has been designed to help organisations develop and update local formularies that reflect local needs, reduce variation in prescribing, and allow rapid uptake of innovative medicines and treatments, in accordance with statutory requirements.

The NHS Constitution provides patients with the right that medicines that have been positively appraised by NICE should be made available, where appropriate, and therefore included within the formulary adopted by local healthcare providers and commissioners. The Constitution also states that medicines that have not yet been considered by or have not received a positive recommendation for use in the NHS by NICE should be considered by the local NHS using a robust assessment of the best available evidence. However, up until now there has been no standard process or advice for putting together a local formulary and this has led to variations across the country.

This was highlighted in a recent reportⁱⁱ into innovation in healthcare by the Department of Health which found that not all local formularies are including all of NICE's technology appraisals and in some cases are duplicating NICE assessments and challenging its recommendations, acting as a barrier to the uptake of NICE-approved medicines. The Department of Health has since introduced a NICE compliance regime for the funding direction attached to NICE technology appraisals, and has asked all NHS organisations to publish information which sets out which NICE technology appraisals are included in their local formularies by April 1 2013 at the very latest.

The aim of the NICE good practice guide is to support organisations in ensuring they have a local formulary that is fit for purpose and complies with statutory requirements. The following recommendations are among those highlighted in the guidance as key priorities for implementation:

• Include medicines with a positive NICE technology appraisal into the local formulary automatically, where clinically appropriate and relevant to the services provided by the organisation. This process should take place within 90 days.
• For medicines where there is a NICE technology appraisal, ensure there is no further duplication of the NICE evidence assessment, or challenge to an appraisal recommendation.
• Publish all relevant local formulary information online, in a clear, simple and transparent way, so that patients, the public and stakeholders can easily understand it.

Professor Mark Baker, Director of the Centre for Clinical Practice at NICE, said: “It is important that patients should have access to NICE-approved drugs where these are clinically appropriate. It is also important that the NHS embraces and allows the rapid uptake of innovative medicines and treatments. Both these imperatives have been enshrined in recent legislation - most notably the NHS Constitution for England. Together with changes to NHS commissioning arrangements, these changes to the regulatory framework have persuaded many local healthcare providers and commissioners of the need to review their local formulary structures and the processes that underpin them. This good practice guidance will support the development of local formularies that adhere to statutory requirements while reflecting local needs and reducing variation in prescribing.”

Dr Keith Ridge, Chief Pharmaceutical Officer, said: “This guidance is an important step in ensuring patients continue to have prompt access to the medicines they need. I would encourage local health systems to use this guidance to review their approach to formularies - ensuring they are patient focused, outcomes based and support optimised use of medicines."

Professor Alan Silman, Medical Director, Director of Research Strategy and Policy, Arthritis Research UK, and Chair of the Guidance Development Group, said: “A local health formulary is an important tool in educating and guiding prescribers. The guidance provided in this document allows formularies to continue to responding to local needs and circumstances but also ensure that NICE's decisions to approve an intervention and other appropriate inputs into formulary production are taken up in a timely and transparent manner.”

Leslie Galloway, Ethical Medicines Industry Group (EMIG) and Deputy Chair of the Guidance Development Group, said: “It has been a privilege to work with very talented experts from NICE, the NHS and academia to create this good practice guide. I believe it will enable those with existing or proposed new formularies to minimise duplication and deliver the consistency, transparency and engagement with stakeholders that will drive even greater support for the NHS.”

Helen Gordon, Chief Executive, Royal Pharmaceutical Society, said: “Local formularies are taking centre stage in the drive to improve patient outcomes and reduce variation in access to medicines. This guidance will spread best practice and support the clinical leadership that Chief Pharmacists have already shown by making formularies responsive to patient needs.”

Trevor Beswick, Chair, UK Medicines Information Executive and member of the Guidance Development Group, said: “The Guidance Development Group has produced some excellent guidance which, at a time of significant change for commissioners and providers, should prove very valuable in ensuring that local policies and procedures remain well focussed on meeting the needs of patients and optimising the use of new medicines. The guidance highlights the need for local decision making groups to collaborate and to avoid wastefully duplicating effort by making use of existing medicines information resources from relevant organisations.”

Ends

Notes for editors

References

1. Local formularies range in complexity from, at their most basic, simple lists of drugs to, at their most comprehensive, highly detailed summaries of evidence linked electronically to local care pathways and policies. In addition, the range of healthcare providers covered by a formulary also varies from a single secondary care trust to those spanning multiple commissioning organisations, extensive primary and secondary providers together with specialist tertiary services, community services and care homes.
2. Department of Health (2011). Innovation health and wealth - Accelerating adoption and diffusion in the NHS. December 2011

About the NICE good practice guidance

1. The NICE good practice guidance on developing and updating local formularies is available on the NICE website.

2. Further information about the Medicines and Prescribing Centre at NICE, including details of good practice guidance in development, is also available on the NICE website.

3. NICE has published an interim process statement setting out how we develop good practice guidance.

4. Further information about the DH's Innovation Health and Wealth action which includes details of the NICE compliance regime is available on the DH website.

About NICE

1. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health.

2. NICE produces guidance in three areas of health:

• public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
• health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
• clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

3. NICE produces standards for patient care:

• quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
• Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients
• Commissioning Outcomes Framework - NICE develops the potential indicators for the COF, the scheme starting in 2013, which will help measure the health outcomes and quality of care commissioned by Clinical Commissioning Groups.

4. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates high quality guidance and evidence-based information to help professionals deliver the best patient care through NHS Evidence.