The National Institute for Health and Clinical Excellence (NICE) has published the first in a new series of guidances for people involved in handling, prescribing, commissioning and decision-making about medicines.
NICE’s new good practice guidance on the development and updating of local formularies 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, in accordance with statutory requirements, it says.
The Institute points out that NHS Constitution gives patients the right that medicines which have been positively appraised by NICE should be made available, where appropriate, and should therefore be included within the formulary adopted by local healthcare providers and commissioners.
The Constitution also states that medicines that have not yet been considered by NICE, or have not received a positive recommendation for use in the NHS from the Institute, should be considered by the local NHS, “using a robust assessment of the best available evidence.”
However, it adds, up to now there has been no standard process or advice for putting together a local formulary and this has led to variations across the country. The Department of Health reported recently that not all local formularies are including all NICE’s technology appraisals and, in some cases, they are duplicating its assessments and challenging its recommendations. This acts as a barrier to the uptake of NICE-approved medicines, it said.
The Department 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, says the Institute. Among its recommended key priorities for implementation are:
– 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; and
– 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.
“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,” said Professor Mark Baker, director of the Centre for Clinical Practice at NICE.
“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,” Prof Baker added.
The Chief Pharmaceutical Officer for England, Dr Keith Ridge, described the new guidance as “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,” said Dr Ridge.
And Ethical Medicines Industry Group (EMIG) chairman Leslie Galloway, who served as deputy chair of the guidance development group, said he believed the new guide “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.”
