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 Formulary Chapter 14: Immunological products and vaccines - Full Chapter
Notes:

 

This chapter does not contain details of vaccines that are otherwise listed in ‘Immunisation against infectious disease’ (the “Green Book”).  Please consult this reference for details of vaccines and related products. 
 Details...
14.01  Expand sub section  Active immunity
14.01  Expand sub section  Immunisation schedule
 note  See BNF
14.02  Expand sub section  Passive immunity
 note  See BNF
14.03  Expand sub section  Storage and use
 note  See BNF
14.04  Expand sub section  Vaccines and antisera to top
 link Link    MHRA Drug Safety Update April 2016: Live attenuated vaccines: avoid use in those who are clinically immunosuppressed
14.04  Expand sub section  Anthrax vaccine
14.04  Expand sub section  BCG vaccines
14.04  Expand sub section  Botulism antitoxin
Botulism antitoxin
View adult BNF View SPC online View childrens BNF 		Formulary
Red

unlicensed All patients should be tested for sensitivity (diluting the antitoxin if history of allergy).

 
Link  MHRA: Botulism: clinical and public health management
 
14.04  Expand sub section  Cholera vaccine
14.04  Expand sub section  Diphtheria vaccines to top
14.04  Expand sub section  Haemophilus influenzae type B vaccine
14.04  Expand sub section  Hepatitis A vaccine
14.04  Expand sub section  Hepatitis B vaccine
14.04  Expand sub section  Human papilloma virus vaccine
14.04  Expand sub section  Influenza vaccine to top
14.04  Expand sub section  Measles vaccine
 note  See MMR vaccine
14.04  Expand sub section  Measles, Mumps and Rubella (MMR) vaccine
14.04  Expand sub section  Meningococcal vaccines
 note  For meningococcal group C conjugate vaccine with haemophilus tybe B - see haemophilus type b vaccine.
14.04  Expand sub section  Mumps vaccine
 note  See diphtheria vaccines
14.04  Expand sub section  Pertussis vaccine to top
 note  See diphtheria vaccines
14.04  Expand sub section  Pneumococcal vaccines
14.04  Expand sub section  Poliomyelitis vaccines
 note  See diphtheria vaccines
14.04  Expand sub section  Rabies vaccine
14.04  Expand sub section  Rotavirus vaccine
14.04  Expand sub section  Rubella vaccine to top
 note  See MMR vaccine
14.04  Expand sub section  Smallpox vaccine
14.04  Expand sub section  Tetanus vaccines
 note  See diphtheria vaccines
14.04  Expand sub section  Tick-borne encephalitis vaccine
14.04  Expand sub section  Typhoid vaccines
14.04  Expand sub section  Varicella-zoster vaccine to top
14.04  Expand sub section  Yellow fever vaccine
14.05  Expand sub section  Immunoglobulins
 link Link    Immunoglobulin handbook (HPA)
14.05  Expand sub section  Normal immunoglobulin
Human normal immunoglobulin
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Red
NHS England

Therapeutic immunoglobulin is recommended to be available as a routinely commissioned treatment option for the indications within the criteria set out in the NHSE Clinical Commissioning Policy for the use of therapeutic immunoglobulin (Ig) England (2024).

 
Link  NHSE: Clinical Commissioning Policy for the use of therapeutic immunoglobulin (Ig) England (2024)
 
14.05  Expand sub section  Specific immunoglobulins
14.05  Expand sub section  Anti-D (Rho) immunoglobulin to top
14.05  Expand sub section  Interferons
INTERFERON GAMMA-1b (Immukin®)
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Red

Injection 200 microgram per 1 ml

Simultaneous administration of interferon gamma-1b with other heterologous serum protein preparations or immunological preparations (e.g. vaccines) should be avoided because of the risk for unexpected amplified immune response.

 
 
14.05.01  Expand sub section  Normal immunoglobulin
14.05.02  Expand sub section  Disease-specific immunoglobulins
14.05.03  Expand sub section  Anti-D (Rho) immunoglobulin
Anti-D (Rh0) Immunoglobulin (Rhophylac®)
View adult BNF View SPC online View childrens BNF 		Formulary
Red 		1500units/2mL pre-filled syringe

Available via Pathology Lab 
 
14.06  Expand sub section  International travel to top
 ....
Key
Restricted Drug Restricted Drug
Unlicensed Drug Unlicensed
click to search medicines.org.uk
 Link to adult BNF
click to search medicines.org.uk
 Link to children's BNF
click to search medicines.org.uk
 Link to SPCs
SMC
 Scottish Medicines Consortium
Cytotoxic Drug
 Cytotoxic Drug
CD
 Controlled Drug
High Cost Medicine
 High Cost Medicine
Cancer Drugs Fund
 Cancer Drugs Fund
NHSE
 NHS England
Homecare
 Homecare
ICB
 ICB
Green Low Carbon

Low carbon footprint
Amber Medium Carbon

Medium carbon footprint
Red High carbon footprint

High carbon footprint
Status Description

Green

 Green: Appropriate for initiation and ongoing prescribing in both primary and secondary care. Generally, little or no routine drug monitoring is required.  

Green Restricted

 Green (Restricted): Appropriate for initiation and ongoing prescribing in both primary and secondary care provided: Additional criteria specific to the medicine or device are met, or The medicine or device is used following the failure of other therapies as defined by the relevant LSCMMG pathway. Generally, little or no routine drug monitoring is required.   

Red

 Red medicines: Medicine is supplied by the hospital for the duration of the treatment course. Primary care initiation or continuation of treatment is not recommended unless exceptional circumstances such as specialist GP. Red medicines are those where primary care prescribing is not recommended. These treatments should be initiated by specialists only and prescribing retained within secondary care. They require specialist knowledge, intensive monitoring, specific dose adjustments or further evaluation in use. If however, a primary care prescriber has particular specialist knowledge or experience of prescribing a particular drug for a particular patient it would not always be appropriate for them to expect to transfer that prescribing responsibility back to secondary care. There should be a specific reason and a specific risk agreement, protocol and service set up to support this. Primary care prescribers may prescribe RED medicines in exceptional circumstances to patients to ensure continuity of supply while arrangements are made to obtain ongoing supplies from secondary care.  

Amber 0

 Amber level 0: Suitable for prescribing in primary care following recommendation or initiation by a specialist. Little or no specific monitoring required. Patient may need a regular review, but this would not exceed that required for other medicines routinely prescribed in primary care. Brief prescribing document or information sheet may be required. Primary care prescribers must be familiar with the drug to take on prescribing responsibility or must get the required information. When recommending or handing over care, specialists should ask primary care prescribers to take over prescribing responsibility, and should give enough information about the indication, dose, monitoring requirements, use outside product licence and any necessary dose adjustments to allow them to confidently prescribe.  

Amber 1

 Amber level 1 (with shared care): Suitable for prescribing in primary care following recommendation or initiation by a specialist. Minimal monitoring required. Patient may need a regular review, but this would not exceed that required for other medicines routinely prescribed in primary care. Full prior agreement about patient’s on-going care must be reached under the shared care agreement. Primary care prescribers are advised not to take on prescribing of these medicines unless they have been adequately informed by letter of their responsibilities with regards monitoring, side effects and interactions and are happy to take on the prescribing responsibility. A copy of locally approved shared care guidelines should accompany this letter which outlines these responsibilities. Primary care prescribers should then tell secondary care of their intentions as soon as possible by letter so that arrangements can be made for the transfer of care.  

Amber 2

 Amber level 2 (with shared care and enhanced service): Initiated by specialist and transferred to primary care following a successful initiation period. Significant monitoring required on an on-going basis. Full prior agreement about patient’s on-going care must be reached under the shared care agreement. Suitable for enhanced service. These medicines are considered suitable for GP prescribing following specialist initiation of therapy, as per shared care document which will be sent out with the request to prescribe, with on-going communication between the primary care prescriber and specialist. Amber Level 2 medicines require significant monitoring for which an enhanced service may be suitable. (Subject to local commissioning agreements).  

Do Not Prescribe

 Do not prescribe: NOT recommended for use by the NHS in Lancashire and South Cumbria. Includes medicines that NICE has not recommended for use and terminated technology appraisals, unless there is a local need.  

Grey

 Grey medicines: Medicines which have not yet been reviewed or are under the review process. GPs and specialists are recommended not to prescribe these drugs. This category includes drugs where funding has not yet been agreed.   

Multiple

 Refer to local guidance.  

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