Introduction

The North East and North Cumbria ICS Formulary provides details of medicines approved for use in NHS organisations across the North East and North Cumbria ICS.

The formulary, associated decision-making and governance are managed by the Northern Treatment Advisory Group (NTAG) on behalf of the North East and North Cumbria ICS.

The range of medicines included in this formulary is intended to encourage safe, effective and economical prescribing. Having a common range of medicines available for use across the North East and North Cumbria ICS should help ensure seamless prescribing for patients between general practice and hospital trusts, facilitating continuity of treatment and minimising supply problems. It should also help those healthcare professionals that work for more than one organisation in the local healthcare economy. 

Where appropriate the formulary gives information as to which drugs are regarded as being the first choice and alternatives. It is not intended to be a comprehensive prescribing guide or to replace the BNF or BNF for children. 

An up to date version of the formulary may also be located on individual trusts' intranet sites, providing links to locally adapted electronic versions of the BNF, local policies and guidelines and additional information. 

1. Notes on using the formulary

Medicines in the formulary are listed in chapters and subsections that generally correspond with those in the BNF. Where possible drug names have been formatted as links to SPC, BNF and BNFC monographs. This is to enable users to easily refer to the BNF for information on doses, side effects, cautions, contraindications and drug interactions. Note: Where preparations (e.g. brands/strengths/formulations/sizes) are specifically mentioned in the entry these are the only ones approved for use.

Please note when searching the selected entry will be in red text to ensure it can be located easily amongst the chapter page.

Recommended International Non-proprietary Names (INNs) are used throughout the text, but proprietary names are used for some combination and modified release products, where brand name prescribing is recommended. 

NHS North East and North Cumbria Integrated Care Board (NENC ICB) - Position statement on the prescribing of branded generic medication

The cheapest available solid dosage form should be used when there are no bioavailablity issues.    

Products listed in the formulary are flagged to indicate if they are hospital only products, suitable for shared care, are unlicensed or have been approved for an unlicensed indication. Hospital doctors should not ask GPs to prescribe hospital only medicines (‘Red’ drugs) unless there is a very exceptional reason and agreement with the GP. 

When prescribing unlicensed medicines it is important that prescribers are aware that they are taking on additional responsibilities regarding the patient’s safety. Further information and guidance can be obtained from individual Trust unlicensed medicines policies.

2. NICE approved treatments 

All NICE Technology Appraisals are automatically endorsed by the North East and North Cumbria ICB Medicines Subcommittee. Relevant medicines are incorporated into the formulary and are available for clinicians to prescribe within 90 days of publication by NICE. 

3. Requests for products to be included in the formulary

Requests for products to be added to the formulary have to be approved by the North East and North Cumbria ICB Medicines Subcommittee. 

Requests normally have to be made by a consultant, general practitioner or other appropriate senior healthcare professional (e.g. optician, dentist, nurse, podiatrist, dietician or pharmacist) and wherever possible the request should be submitted electronically in Microsoft Word format by email. 

Consideration for formulary approval takes into consideration cost, clinical effectiveness and side effects/risk profile.

A formulary application is therefore expected to be completed, and approved, before any product is used in a manner for which there has not been previous approval. This includes new products, new  indications for existing products and new modes of delivery. It also applies to  use in a “trial” situation that has not been covered under separate, formal clinical trial approval processes.

Individual organisations have separate mechanisms for dealing with requests that fall under exceptionality or  compassionate use status.                  

4. Use of Non-Formulary Medicines

GPs and other prescribers in primary care are strongly encouraged to prescribe medicines that are included in the formulary. 

Prescribing of some medicines that are not included in the formulary is actively discouraged. Please see the County Durham and Tees Valley DO NOT PRESCRIBE and GREY LIST for details.

The formulary is intended to be followed closely in hospitals.  Consequently the hospital pharmacies may not stock medicines that are not included in the formulary. However it is recognised there are some circumstances where it will be necessary to use a non-formulary medicine and individual trusts have their own procedures for dealing with this. However, the following principles apply:

i) Initiating therapy with a Non-Formulary Medicine

In cases where it is considered that there is no formulary medicine appropriate for treating an individual hospital patient, the consultant responsible for the patient’s care should contact a senior pharmacist at the hospital where the patient is being treated.  The request will then need to be dealt with in accordance with the hospital trust’s non-formulary request procedure, which may include completion of a non-formulary request form. 

In exceptional circumstances only, if a hospital doctor wishes a patient’s GP to prescribe a non-formulary drug, then he/she should explain to the GP that the desired treatment is not in the formulary and give the reason(s) why it is being requested instead of a formulary medicine, e.g. if the patient has failed to tolerate or respond to possible formulary alternatives.

ii) Patients admitted to hospital on Non-Formulary medicines

The process for dealing with this issue varies between organisations, as it is largely dependent on how patients’ own medicines are handled. Prescribers should familiarise themselves with systems in their own organisation and act accordingly. 

In the absence of a system for routinely using patients’ own medicines during hospital stay, consideration should be given to changing to a formulary medicine where this is practicable and not likely to be detrimental to the individual patient’s care. Where it is not practicable to change the patient’s medication, a pharmacist should be contacted so that appropriate arrangements for continuing the treatment can be made. 

When therapy with a non-formulary drug is continued on admission, medication brought into hospital by the patient may be used, provided that it is clearly labelled and appears to be of good quality, in accordance with the hospital trust’s policy.

iii) Cancer Drugs Fund (CDF)and Early Access to Medicines Schemes (EAMS)

Schemes such as Cancer Drugs Fund (CDF) and Early Access to Medicines Schemes (EAMS), are not included on the formulary due to the temporary nature of the funding. Once drugs are NICE approved they will be added to the formulary. Patients may be able to access non-formulary drugs that have been approved in line with these additional funding mechanisms

5. Unlicensed Medicines and Use of Medicines for Unlicensed Indications 

This formulary contains a number of unlicensed medicines, and medicines that have been approved for unlicensed or ‘off-label’ indications. Their inclusion has been agreed after careful consideration of their benefits versus any known or perceived risks associated with their use by the North East and North Cumbria Medicines Subcommittee or by predecessor decision-making bodies. Many unlicensed medicines are formulations of well -established drugs that are included the BNF, whereas others are products that are less well known, but considered to be of benefit in the treatment of patients with conditions where licensed medicines cannot be used or fail to produce an adequate response. 

Unlicensed medicines included in the Formulary are marked using the suffix ^u and those that are considered unsuitable for prescribing by GPs (even if treatment has been started and stabilised by a hospital clinician) are classified as ‘RED’, or hospital only, medicines. 

When prescribing an unlicensed or a licensed product ‘off-label’ for an unlicensed indication it is important prescribers are aware that it is not only they who take on additional responsibilities regarding the patient’s safety and welfare, but the burden is shared with others involved in supply and administration. 

Further information and guidance can be obtained from the GMC website