Format of the Joint Formulary and TLS classifications
The Joint Formulary is arranged in BNF order. It consists of a list of drugs recommended in each section and each drug is categorised to facilitate prescribing choice. There will be recommended choices, alternative choices and in some instances choices that are only formulary under specified indications.
- If a drug is not included within this website, then it is considered non-formulary
- Non-formulary drugs are still able to be prescribed but only when the formulary choices are not suitable.
- It is hoped that the formulary will cover 80-90% of prescribing, however it is recognised that there are occasions when it is clinically necessary for a non-formulary medicine to be prescribed. There are mechanisms within each organisation for the appropriate prescription of non-formulary mechanisms - Please refer to your individual organisation Pharmacy departments within secondary care, or Medicines Management Teams or Joint Formulary Pharmacist (See Contact Us Menu) for advice regarding the process of prescribing non-formulary medications.
Alongside a drug entry, there may be other prescribing points relevant to the drug, or relevant hyperlinks to other documents such as NICE Technology Appraisals, Local Guidelines. If the drug has a shared care protocol (SCP) associated to it, it will also have a hyperlink alongside it, which will take you directly to the BNSSG SCP.
Classification of drugs
The BNSSG Traffic Light Scheme (TLS) has been incorporated into the Joint Formulary, and there are now four colours that drugs are classified as. Drugs within the chapters appear in the colour that they have been classified within this system. Any new drug accepted by the Joint Formulary Group will be given a TLS classification at this time, however the BNSSG Joint Formulary Group will review the status of Red/amber drugs on request e.g. when more experience has been gained. Any requests from clinicians for transfer from Red to Amber category must be accompanied by a shared care protocol. The classification is advisory only but its existence should clarify expectations of prescribing responsibility.
New uses are sometimes found for older, established drugs that are outside the manufacturer’s original product licence e.g. metformin or finasteride for polycystic ovarian syndrome. Clinicians may prescribe a drug outside the terms of its product’s licence but will need to be aware of the quality of evidence to support its unlicensed or ‘off label’ use. Some older drugs are therefore listed in Red or Amber categories to highlight unlicensed indications, for which the prescriber will bear sole responsibility. Many paediatric preparations are unlicensed but are not listed specifically because their use in most situations will be familiar to prescribers.
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 drugs –
- Red for specialist use in secondary care or competent clinician only;
- Amber drugs are appropriate for shared care – responsibility for prescribing may be transferred from secondary to primary care with the agreement of an individual GP;
- Green drugs are appropriate for prescribing in primary and secondary care and within the competencies of the prescriber;
- Blue drugs are appropriate for prescribing in primary and secondary care and within the competencies of the prescriber, however they are either alternative choices (i.e. second/third line) or may only be prescribed in specific indications or circumstances.
The prescriber should always ensure they have the expertise to prescribe an agent before making the selection. In its guidelines on responsibility for prescribing between hospitals and general practitioners, the Department of Health has advised that legal responsibility for prescribing lies with the doctor who signs the prescription.
Red Category Drugs - for specialist use in secondary care or competent clinician only (including services to NHS patients in the private sector and hospices), on one or more of the following grounds:
- only available in hospital: those drugs or appliances which are only available through hospital trusts e.g. isotretinoin (Roaccutane), or require special home care packages
- complexity of monitoring: there are special monitoring requirements which are considered too complex for primary care (e.g. some immunosuppressants)
- 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 drugs)
- new classes of drug: where clinical experience is limited and/or evidence of benefit over existing preparations has not been established, so that:
- their place in therapy has not been determined
- shared-care arrangements allowing Amber categorisation have not yet been agreed
- specialist drugs: the drug needs to be used by a specialist to assess response to treatment and level of health gain pending full evaluation by authoritative bodies such as NICE
- CCG purchase: special purchasing arrangements for the use of the drug have been made
- unlicensed drugs: i.e. unlicensed doses, unlicensed indications for new drugs; clinical trial & “named patient” drugs
- items e.g. dressings or appliances not listed in current Drug Tariff.
Amber Category Drugs should be prescribed by a secondary care specialist or competent clinician to establish the patient on treatment, i.e. to monitor the patient’s response (efficacy, safety and appropriateness), adjust dosage and treat side effects, this is because these drugs are prescribed less frequently.
There are three sub categories within Amber: Amber 3 months, Amber 1 month and Amber (specialist recommendation, NO SCP)
For Amber 3 and 1 month:
The patient needs to be stabilised and reviewed before asking the GP to take over clinical and prescribing responsibility, this generally occurs after 3 months prescribing by secondary care. There is also a category amber 1 month, which means that prescribing responsibility remains with the specialist for only 1 month and then can be requested to be transferred. Transfer from secondary to primary care can be considered if:
- the patient is stabilised on the drug which is being used for the indication listed
- the GP has agreed to accept clinical and prescribing responsibility for the patient
- shared care guidance has been developed and sent to the GP before the transfer of clinical and prescribing responsibility.
For Amber (specialist recommendation, NO SCP):
The decision to initiate must be taken by a specialist, however the first prescription may be written by the specialist or the GP may be asked to provide the first and ongoing prescriptions.
Note: a prescriber can choose not to accept clinical responsibility because of lack of familiarity or competence in the use of a drug or if it is used outside agreed guidance. Prescribers may not refuse clinical responsibility on grounds of cost. Distance is not a reason for requiring transfer of care.