| Formulary Chapter 14: Immunological products and vaccines - Full Chapter
|
| Notes: |
Please refer to the Public Health England Green Book on vaccines for the most up to date information on the recommended preparations and use.
The following vaccinations should not be prescribed on the NHS exclusively for the purposes of travel:
• hepatitis B
• Japanese encephalitis
• meningitis ACWY
• yellow fever
• tick-borne encephalitis
• rabies
• BCG. |
|
| Details... |
| 14.01 |
Active immunity |
|
|
| 14.01 |
Immunisation schedule |
|
|
| 14.02 |
Passive immunity |
|
|
| 14.03 |
Storage and use |
|
|
| 14.04 |
Vaccines and antisera |
|
|
Japanese Encephalitis Vaccine (Ixiaro®)
|
Formulary
|
|
|
|
Tuberculin Purified Protein Derivative
|
Formulary
|
|
|
|
|
|
| 14.04 |
Anthrax vaccine |
|
|
| 14.04 |
BCG vaccines |
|
|
BCG vaccine
(Bacillus calmette-guerin vaccine)
|
Formulary
|
(BCG Vaccine, Dried/Tub/BCG) 1ml multidose vials containing freeze dried powder for preparing intradermal injections
|
|
|
| 14.04 |
Botulism antitoxin |
|
|
Botulism antitoxin
|
Formulary
|
1 vial of Botulism antitoxin trivalent (equine) A B& E 5000 units injection
|
|
|
| 14.04 |
Cholera vaccine |
|
|
| 14.04 |
COVID-19 vaccine |
|
|
COVID-19 vaccines
|
Formulary
|
- Comirnaty® Original / Omicron BA.4-5
- Comirnaty® 10 Concentrate for children
- Comirnaty® 3 (THREE) Concentrate
- VidPrevtyn Beta®
- Spikevax® Original/Omicron BA.4-5
|
 MHRA Drug Safety Updates: COVID-19 Vaccines
SPS COVID-19 vaccine resources
|
| 14.04 |
Diphtheria vaccines |
|
|
Absorbed Diptheria Low Dose, Tetanus, and Poliomyelitis vaccine
|
Formulary
|
|
|
|
Absorbed Diptheria Low Dose, Tetanus, Pertussis and Poliomyelitis vaccine
|
Formulary
|
|
|
|
Absorbed Diptheria, Tetanus, Pertussis and Poliomyelitis vaccine
|
Formulary
|
|
|
|
| 14.04 |
Haemophilus influenzae type B vaccine |
|
|
Haemophilus influenzae type B
|
Formulary
|
|
|
|
Haemophilus Influenzae type b & Meningococcal Group C Conjugate vaccine
|
Formulary
|
|
|
|
| 14.04 |
Hepatitis A vaccine |
|
|
Hepatitis A vaccine
|
Formulary
|
|
|
|
Hepatitis A vaccine with Hepatitis B vaccine (Twinrix®)
|
Formulary
|
|
|
|
| 14.04 |
Hepatitis B vaccine |
|
|
Hepatitis B vaccine
|
Formulary
|
|
|
|
| 14.04 |
Human papilloma virus vaccine |
|
|
Human papilloma virus (HPV) vaccine
|
Formulary
|
|
|
|
| 14.04 |
Influenza vaccine |
|
|
Influenza vaccine
|
Formulary
|
|
|
|
| 14.04 |
Measles vaccine |
|
|
| 14.04 |
Measles, Mumps and Rubella (MMR) vaccine |
|
|
Measles, Mumps and Rubella Vaccine, Live (MMR)
|
Formulary
|
|
|
|
| 14.04 |
Meningococcal vaccines |
|
|
| 14.04 |
Mumps vaccine |
|
|
| 14.04 |
Pertussis vaccine |
|
|
| 14.04 |
Pneumococcal vaccines |
|
|
Pneumococcal polysaccharide conjugate vaccine
|
Formulary
|
|
|
|
| 14.04 |
Poliomyelitis vaccines |
|
|
Poliomyelitis Vaccine Inactivated (Salk)
(Inactivated poliomyelitis vaccine (IPV))
|
Formulary
|
|
|
|
Poliomyelitis Vaccine Live (oral)
|
Formulary
|
|
|
|
| 14.04 |
Rabies vaccine |
|
|
Rabies vaccine
|
Formulary
|
|
|
|
| 14.04 |
Rotavirus vaccine |
|
|
Rotavirus vaccine (Rotarix®)
|
Formulary
|
|
|
|
| 14.04 |
Rubella vaccine |
|
|
| 14.04 |
Smallpox vaccine |
|
|
| 14.04 |
Tetanus vaccines |
|
|
Tetanus vaccine
|
Formulary
|
|
|
|
| 14.04 |
Tick-borne encephalitis vaccine |
|
|
Tick-borne encephalitis vaccine
|
Formulary
|
|
|
|
| 14.04 |
Typhoid vaccines |
|
|
Typhoid vaccine
|
Formulary
|
|
|
|
| 14.04 |
Varicella-zoster vaccine |
|
|
Varicella Zoster vaccine (Zostavax®)
|
Formulary
|
|
|
|
Varicella-zoster vaccine
|
Formulary
|
|
|
|
| 14.04 |
Yellow fever vaccine |
|
|
Yellow fever vaccine (Live)
|
Formulary
|
Only available from designated Yellow Fever Vaccination Centres.
|
MHRA Drug Safety Update (April 2019): Yellow fever vaccine (Stamaril) and fatal adverse reactions: extreme caution needed in people who may be immunosuppressed and those 60 years and older
MHRA Drug Safety Update (Nov 2019): Yellow fever vaccine: stronger precautions in people with weakened immunity and in those aged 60 years or older
MHRA Drug Safety Update (Nov 2021): Yellow fever vaccine (Stamaril): new pre-vaccination checklist
|
| 14.05 |
Immunoglobulins |
|
|
 |
Please see https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/216671/dh_131107.pdf for information regarding Immunoglobulin which is commissioned by NHS England in line with Department of Health Clinical Guidelines for Immunoglobulin Use
Clinical Commissioning Policy: Human normal immunoglobulin for treatment of scleromyxedema (adults) [2271]. Please note that only the following providers are commissioned to provide this service within Yorkshire and Humber: Newcastle Hospitals NHS Foundation Trust, and South Tees Hospitals NHS Foundation Trust |
|
| 14.05 |
Normal immunoglobulin |
|
|
| 14.05 |
Specific immunoglobulins |
|
|
| 14.05 |
Anti-D (Rho) immunoglobulin |
|
|
| 14.05 |
Interferons |
|
|
| 14.05.01 |
Normal immunoglobulin |
|
|
Normal Immunoglobulin (Cuvitru®)
|
Formulary
|
|
|
|
Normal Immunoglobulin (Flebogamma®DIF)
|
Formulary
|
|
|
|
Normal Immunoglobulin (Gammanorm®)
|
Formulary
|
- 16.5% - 1g, 1.65g, 2g, 3.3g, 4g & 8g
|
|
|
Normal Immunoglobulin (Gammunex®)
|
Formulary
|
|
|
|
Normal Immunoglobulin (Intratect®)
|
Formulary
|
- 5% - 1g, 2.5g, 5g & 10g
- 10% - 1g, 5g, 10g & 20g
|
|
|
Normal Immunoglobulin (Iqymune®)
|
Formulary
|
|
|
|
Normal Immunoglobulin (Kiovig®)
|
Formulary
|
- 10% - 1g, 2.5g, 5g, 10g, 20g & 30g
|
|
|
Normal Immunoglobulin (Octagam®)
|
Formulary
|
- 5% - 5g & 10g
- 10% - 2g, 5g, 10g & 20g
|
|
|
Normal Immunoglobulin (Privigen®)
|
Formulary
|
- 10% - 2.5g, 5g, 10g & 20g
|
|
|
Normal Immunoglobulin (Subcuvia®)
|
Formulary
|
|
|
|
Normal immunoglobulin for Intramuscular use
|
Formulary
|
|
|
|
| 14.05.02 |
Disease-specific immunoglobulins |
|
|
Hepatitis B immunoglobulin (HBIG)
|
Formulary
|
- 200 international units - for infant use
|
|
|
Hepatitis B immunoglobulin (Hepatect CP®)
|
Formulary
|
|
|
|
Tetanus immunoglobulin
|
Formulary
|
|
|
|
Varicella-Zoster immunoglobulin (VZIG)
|
Formulary
|
|
|
|
| 14.05.03 |
Anti-D (Rho) immunoglobulin |
|
|
Anti-D (Rh0) Immunoglobulin (Rhophylac®)
|
Formulary
|
- Approved for the prevention of RhoD sensitisation in
women in line NICE.
- Approved for use by haematologists in appropriate patients with immune thrombo-cytopenia. The 1,500 and 5,000 unit vials (WinRho) are much more expensive than the other formulations and should only be used on advice from haematologists. It is the only formulation licensed for use in immune thrombocytopaenia.
|
|
|
Anti-D (Rh0) Immunoglobulin (WinRho SDF®)
|
Formulary
|
- Approved for the prevention of RhoD sensitisation in
women in line NICE.
- Approved for use by haematologists in appropriate patients with immune thrombo-cytopenia. The 1,500 and 5,000 unit vials (WinRho) are much more expensive than the other formulations and should only be used on advice from haematologists. It is the only formulation licensed for use in immune thrombocytopaenia.
|
|
|
| 14.06 |
International travel |
|
|
| |
The use of travel vaccines in primary care is not recommended in line with NHS England Guidance on items which should not routinely be prescribed in primary care |
|
| .... |
Key |
 |
Restricted Drug |
 |
Unlicensed |
|
|
Link to adult BNF
|
|
|
Link to children's BNF
|
|
|
Link to SPCs
|
|
Cytotoxic Drug |
|
Controlled Drug |
|
|
High Cost Medicine |
|
NHS England |
|
Homecare |
|
ICB |
|
Low carbon footprint |
|
Medium carbon footprint |
|
High carbon footprint |
|
| Status |
Description |
|
Drugs for hospital use only. The responsibility for initiation and monitoring treatment should rest with an appropriate hospital clinician and the drug should be supplied through the hospital throughout the duration of treatment. In some very exceptional circumstances (e.g. due to distance from the hospital, storage, supply or mobility/transport problems) it may be appropriate for the GP to be asked to prescribe a Red drug. This should be negotiated on an individual patient basis and should only be done with the GP’s prior informed agreement where the roles of the GP and hospital services are clearly defined and agreed. The GP should not feel under pressure to prescribe in these circumstances. For all RED drugs automatically added to the formulary in response to a positive NICE TA: Prescribers need to ensure that local Trust new drug governance procedures and pharmacy processes are followed before any prescribing. |
|
Drugs initiated by hospital specialist, but where continuing treatment by GPs may be appropriate under a shared care arrangement. These medicines are considered suitable for primary care prescribing following specialist initiation of therapy and stabilisation, with ongoing communication between the primary care prescriber and specialist as set out in the associated shared care guideline (SCG). Shared care should be initiated by the specialist, which includes consultant, suitably trained specialist non-medical prescriber or GPwER within a secondary, tertiary, or primary care clinic.
The specialist should send the primary care prescriber a copy of the NENC Clinical Effectiveness and Governance (CEG) Subcommittee approved SCG to sign. The primary care prescriber should sign the SCG or indicate reasons why they are unable to accept the agreement and return a copy back to the specialist, as soon as possible.
SCGs are available or are being developed for most of the drugs listed as AMBER. |
|
Drugs normally recommended or initiated by a hospital specialist who is a prescriber, a GP with an extended role [GPwER], or a specialist within primary care which can be safely maintained in primary care and monitored in primary care. In some cases, a further restriction for use may be defined. The primary care prescriber must be familiar with the drug to take on prescribing responsibility or must obtain the required information from the specialist. Therefore, provision of additional information, or an information leaflet, may be appropriate in some cases to facilitate continuing treatment by primary care prescriber or provide information re stopping criteria.
These are considered suitable for primary care prescribing following specialist assessment and recommendation of therapy, with ongoing communication between the primary care prescriber and specialist, if necessary.
In some case these drugs require specialist initiation and short to medium term monitoring of efficacy or toxicity until the patient’s dose is stable. Following specialist review the patient may be transferred to primary care for ongoing prescribing. Ongoing prescribing by primary care can include, if required, additional dose titrations and assessment of efficacy, with ongoing communication between the primary care prescriber and specialist, if necessary.
If the drug requires urgent initiation, it is expected that the specialist undertakes the initial prescribing responsibility for an appropriate period of time, usually a minimum of 28 days. A GREEN+ drug can only be recommended to primary care for initiation if does not need to be initiated within 28 days. |
|
Medicines suitable for initiation, ongoing prescribing and discontinuation in all care settings, subject to appropriate communication between those responsible. |
|
UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review. |
|
Drugs that have been considered by the NENC Clinical Effectiveness and Governance (CEG) Subcommittee (or other approved body) and are not approved for prescribing within the North East and North Cumbria ICS. These may also include all medicines with a “not NHS” or “DLCV” classification in the BNF, those agents as included within the NICE “Do not do” list, and those agents included with the NHS England: Items which should not routinely be prescribed in primary care. |
|
|
|
