Classification definitions



Prescribing responsibility should remain with the consultant or specialist clinician.Medicines with one or more of the following criteria should be categorised as RED. These are drugs that:

  1. are unlicensed medicines unsuitable for use in primary care  or are being used ‘off-label’ for an indication with no established evidence base;
  2. require long-term on-going specialist monitoring of efficacy or require long-term on-going specialist monitoring of toxicity (either because of difficulty in recognising side effects or high cost/availability of investigations to identify toxicity);
  3. are specifically designated as hospital only by nature of the product;
  4. are being used as part of a hospital based clinical trial;
  5. are not listed in the current BNF or BNFc;
  6. are part of a defined commissioning arrangement


Responsibility for prescribing may be transferred from secondary care/specialist services to primary care with agreement of an individual GP and when locally approved and agreed shared care arrangements have been established (e.g. approved shared care guidelines are available)Drugs that do not have written shared care guidelines may be prescribed in primary care at the GP’s discretion. The GP should be satisfied that he/she has all the information and support needed to prescribe and monitor the patient.

Medicines with the following criteria should be classified as AMBER:-

require specialist/Consultant assessment to enable patient selection and initiation of treatment, plus one or more of the following;

  1. require short or medium term specialist monitoring of efficacy;
  2. require short or medium term specialist monitoring of toxicity;
  3. are very rarely used, such that individual GPs are unlikely to see sufficient patients and acquire a working knowledge of the drug.


Green with Specialist Initiation

A medicine only to be initiated by the Clinician specified below, but where there is no requirement for additional monitoring for toxicity over and above the general requirements for all medicines i.e. monitoring of efficacy, annual review etc. The GP should be satisfied that he/she has all the information and support needed to continue to prescribe for the patient.

Health care professionals who can initiate GSI medicines are prescribers:

•Specialist working in a provider service


•Independent prescribers who undertake further training to demonstrate competence in an area of healthcare.

Primary care specialists work in a commissioned service.

Specialists are accountable, expert healthcare professionals who can be consulted because of their in-depth knowledge and skills in a particular specialist field. Their practise is underpinned by approved governance structures and regular demonstration of competency. They must take personal responsibility for their actions and omissions and fully recognise their personal accountability.

The person initiating prescribing should undertake any necessary pre-prescribing tests (bloods/ECGs/Xray etc) and initial monitoring.

Medicines with the following criteria should be classified as GREEN (specialist initiation):-

  1. requires a primary or secondary care clinician with specialist knowledge to enable patient selection;
  2. requires short or medium term specialist monitoring of efficacy;
  3. requires the dose to be titrated by the specialist service;
  4. is initiated following discussion with a specialist.


Drugs that have been classified as “black” are those drugs that commissioning organisations across the SWY APC boundaries  have agreed with local trusts and clinicians that they will not commission locally.Medicines with the following criteria should be classified as BLACK:

1.        there is a clear NHSE specialised commissioning group decision to not routinely fund usage of the drug.

2.        There is a CCG local decision not to routinely fund.

3.        There is a NICE recommendation that the drug should not be prescribed on the NHS for the condition specified

4.        A medicine for which the APC considers there is a poor evidence base or lack of cost effectiveness compared to alternative commissioned treatments


The drugs in this category have been reviewed and classified as GREEN by the NHS locally as being suitable for initiation, stabilisation and maintenance in a primary, secondary or tertiary care setting.

This list is not exhaustive. Please contact your medicines management team if you are unsure if you can prescribe a particular drug.



Black not yet classified (new classification)

The drugs and devices in this category have reached the market but have not yet been classified by the NHS locally.