Medicines in the Joint Formulary are classified into one of four colour categories that make up the BNSSG Traffic Light System (TLS) to facilitate prescribing choice and indicate recommended prescribing responsibility. Medicines within each chapter of the Joint Formulary appear in the colour of their category. Any new drug accepted by the Joint Formulary Group is assigned a TLS classification, however the BNSSG Joint Formulary Group will review the status of Red/Amber drugs upon request e.g. when more experience of use has been gained. Transferring a medicine from Red to Amber may require creation of a shared care protocol by clinicians.

The Traffic Light System

The Traffic Light System provides a framework for defining where clinical, and therefore prescribing responsibility should lie through categorisation of individual medicines.

Red – medicines for specialist use – responsibility for prescribing and monitoring remains with specialist team (currently this is largely within secondary care but there are specialist teams within community and primary care);

Amber – medicines that are appropriate for shared care – responsibility for prescribing may be transferred from the specialist team to primary care with the agreement of an individual GP;

Green – medicines that are appropriate for prescribing throughout the ICS within the competencies of the prescriber;

Blue – medicines that are appropriate for prescribing throughout the ICS within the competencies of the prescriber. Blue medicines are either alternative options or may be subject to specific formulary requirements - see below.

The prescriber should always ensure they have the competency and expertise to prescribe. In its guidelines on Responsibility for prescribing between Primary and Secondary/Tertiary Care, NHS England has advised that the legal responsibility for prescribing lies with the clinician who signs the prescription and it is the responsibility of the individual prescriber to prescribe within their own level of competence. Further information about Red, Amber and Blue medicines can be found below.

Red Category Medicines - for specialist use, responsibility for prescribing remains with specialist team on one or more of the following grounds:

only available in specialist setting: those medicines or appliances which are only available through hospital trusts, or require home care packages;
complexity of monitoring: there are special monitoring requirements which are considered too complex for primary care;
side effects - the side-effect profile necessitates rigorous supervision by the hospital specialist or, the full range of possible side-effects, particularly long-term effects needs to be established (e.g. cancer medicines);
new classes of medicine - where clinical experience is limited and/or evidence of benefit over existing preparations has not been established, so that:
their place in a pathway can be determined through experience of use;
shared-care arrangements allowing Amber categorisation have not yet been agreed;
special purchasing arrangements for the use of the drug have been made;
unlicensed medicines - i.e. unlicensed doses, off-label use for a specialist indication for new medicines; clinical trial & “named patient” medicines;
items e.g. dressings or appliances not listed in the current Drug Tariff.

N.B. Responsibility for monitoring a red medicine for specialist use lies with the specialist team prescribing the medicine).

Amber Category Medicines - are appropriate for shared care. Responsibility for prescribing may be transferred from the specialist team to primary care with the agreement of an individual GP.

There are four sub categories within Amber: Amber 3 months, Amber 1 month, Amber Specialist Initiated and Amber Specialist Recommended.

For Amber 3 and 1 month:

The patient needs to be stabilised and reviewed i.e. to monitor the patient’s response, adjust dosage and treat side-effects before asking the GP to take over clinical and prescribing responsibility. This generally occurs after 1 or 3 months prescribing by specialist team, with the duration determined by the shared care protocol. Transfer from specialist to primary care can be considered if:

the patient has undergone the appropriate stabilisation period for a medicine;
the GP has agreed to accept clinical and prescribing responsibility for the patient;
shared care guidance has been developed and shared with the GP before the transfer of clinical and prescribing responsibility.

N.B. Responsibility for monitoring Amber drugs is outlined within the shared care protocol.

For Amber Specialist Initiated:

Requires specialist initiation and continuation of prescribing until the patient is stabilised and reviewed i.e. to monitor the patient’s response, adjust dose and treat side-effects. The GP may then be asked to take over prescribing responsibility once the patient is reviewed and stabilised on a maintenance dose. As little or no monitoring is required once maintenance stage is reached no shared care protocol is required.

Expectation of Specialist Team and Primary Care for Amber Specialist Initiated:

Specialist Team:	Primary Care:
Initiates medicine and continues prescribing until patient is on a maintenance dose and has been reviewed.	Takes over prescribing responsibility once the patient is on a maintenance dose and has been reviewed by the Specialist Team.
Asks GP to take over prescribing responsibility, confirming that treatment is stabilised and details of dose.
Completes baseline and initial monitoring required to get patient to a maintenance dose including interpretation of results.	Completes ongoing monitoring once on a maintenance dose similar to monitoring an Amber Specialist Recommended, Blue or Green medicine: • Monitoring is minimal. • Monitoring as per Summary of Product Characteristics or specified on Formulary.
Communicates any future dose changes	Contacts / refers back to Specialist Team for advice and support if needed or issues arise.
Provides contact details and confirms referral pathway back to Specialist.
Provides advice and support to GP if issues arise with the medication e.g. dose adjustment / discontinuation, loss of disease control, side-effects, patient not satisfied with medication.

Monitoring is as per Summary of Product Characteristics or specified on the Formulary.

For Amber Specialist Recommended (formerly Amber No SCP):

The decision to initiate must be taken by the specialist team, however the first prescription may be written by the specialist or the GP may be asked to provide the first and ongoing prescriptions. No shared care protocol is required.

Blue Category Medicines - for prescribing throughout the ICS within the competencies of the prescriber. These are alternative options or may be subject to specific formulary requirements.

Blue medicines are either:

alternative choices to green medicines i.e. second/third line, or;
only for prescribing in specific circumstances or for specific indications which are clearly outlined in the Joint Formulary, or;
only for prescribing where prescribers have completed additional training to become competent in a clinical area, e.g. medicines for dementia. Please see individual medicines for further information.