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 Formulary Chapter 8: Malignant disease and immunosuppression - Full Chapter
Notes:
1. Please refer to Appendix 11 of the BHT Medicines Policy for full details of policies and procedures for the prescribing, preparation and administration of chemotherapy (including intrathecal chemotherapy)

2. Use chemotherapy in accordance with NHSE National dose banding tables. For latest version see here.
 Details...
08.02.01  Expand sub section  Antiproliferative immunosuppressants
Azathioprine 15mg/5mL, 50mg/5mL
(suspension)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted

unlicensedUnlicensed - Medium Risk

Amber Traffic Light  Amber Protocol - to be used in accordance with Azathioprine for use in Rheumatology, Dermatology, Gastroenterology and Respiratory Medicine - Shared Care protocol (BHTCG 787FM)
Red Traffic Light  Restricted - for all uses other than in accordance with Shared Care Protocol above
In primary care this is a pharmaceutical special

 
Link  Azathioprine for use in Rheumatology, Dermatology, Gastroenterology and Respiratory medicine - Shared Care Protocol (BHTCG 787FM)
Link  Blood Monitoring Requirements for Amber Drugs - Primary/Secondary Care Guideline (BHTCG 821FM)
   
Azathioprine 25mg, 50mg
(tablet)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted

Amber Traffic Light Amber Protocol - to be used in accordance with Azathioprine for use in Rheumatology, Dermatology, Gastroenterology and Respiratory Medicine - Shared Care protocol (BHTCG 787FM)
Red Traffic Light Restricted - for all uses other than in accordance with Shared Care Protocol above

 
Link  Azathioprine for use in Rheumatology, Dermatology, Gastroenterology and Respiratory medicine - Shared Care Protocol (BHTCG 787FM)
Link  Blood Monitoring Requirements for Amber Drugs - Primary/Secondary Care Guideline (BHTCG 821FM)
   
Azathioprine 50mg
(injection)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
 
   
Mycophenolate Mofetil 250mg
(capsule)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted Red Traffic Light  Restricted to prescribing by
1. Consultant Dermatologists and Rheumatologists
2. Consultant Repiratory physicians when recommended by a tertiary centre for interstitial lung disease.
3. Consultant Gastroenterologists when recommended by a tertiary centre for autoimmune hepatitis

Amber Traffic Light  Amber Protocol - Restricted - Renal transplant patients  
Link  MHRA Drug Safety Update - February 2018: Mycophenolate mofetil, mycophenolic acid: updated contraception advice for male patients
   
Mycophenolate Mofetil 500mg
(tablet)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted Red Traffic Light  Restricted to prescribing by
1. Consultant Dermatologists and Rheumatologists
2. Consultant Repiratory physicians when recommended by a tertiary centre for interstitial lung disease.

Amber Traffic Light  Amber Protocol - Restricted - Renal transplant patients  
Link  MHRA Drug Safety Update - February 2018: Mycophenolate mofetil, mycophenolic acid: updated contraception advice for male patients
Link  Mycophenolate Mofetil for Dermatology and Rheumatology Hospital Only guideline (BHTCG 221FM)
   
 ....
Key
note Notes
Section Title Section Title (top level)
Section Title Section Title (sub level)
First Choice Item First Choice item
Non Formulary Item Non Formulary section
Restricted Drug
Restricted Drug
Unlicensed Drug
Unlicensed
Track Changes
Display tracking information
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
CCG
CCG

Traffic Light Status Information

Status Description

Black

Not recommended for use because of lack of evidence of clinical effectiveness, cost effectiveness or safety.
Drugs which have been evaluated and rejected by the Medicines Value Group (MVG)
Drugs defined as ‘Low Priority’ by the South Central Priorities Committee
New drugs which have not as yet been evaluated by the MVG
Any drug not listed in the Buckinghamshire Formulary  

Red

Drugs which should only be prescribed in secondary care by a specialist.
Require specialist knowledge and/or equipment for patient selection and initiation
Require long term on-going monitoring and dose adjustment to ensure efficacy and minimise toxicity by a specialist
Designated as “hospital only“ by product licence, NICE, DoH or BNF
May need further evaluation by a specialist
Are hospital initiated clinical trial materials  

Red Specialist Centre

As for ‘red’ (above) with the addition of the following:
Designated by NHS England to require initiation by or in prior agreement with a Specialist Centre. Continuation where appropriate by BHT (or other secondary care provider)
Detailed requirements for Specialist Centre initiation to be described in the wording of the formulary restriction  

Amber Protocol

Drugs which should be initiated in secondary care by the specialist with follow-on prescription and monitoring according to a drug specific Shared Care Protocol(SCP). Prescribing may be continued in primary care following the SCP
Require specialist knowledge and/or equipment for patient selection and initiation
Require short or medium term (eg. 3 to 6 months) specialist monitoring of efficacy or toxicity. The need for stabilisation will vary with different drugs and patients, but is usually a minimum of 2 months (see principles for shared care)
Require significant long term monitoring
Require ongoing communication between the GP and the specialist
Have clearly defined consultant, GP and patient responsibilities documented in a shared care protocol (see responsibilities for amber protocol drugs)  

Amber Initiation

Drugs suitable for primary care prescribing following specialist initiation
Require specialist knowledge and/or equipment for patient selection
Monitoring does not require specialist knowledge or equipment
If the drug is one with which the primary care prescriber is unfamiliar the specialist is expected to provide sufficient information on the drug indication, dose, duration , monitoring and any further necessary dose adjustments
Require the first prescription to be written by the specialist  

Amber Recommended

Drugs suitable for primary care prescribing following specialist recommendation
As for amber initiation except that:- The first prescription may be written by the GP after specialist recommendation.  

Green

Drugs for which primary care prescribers would normally take full responsibility for prescribing and monitoring
Drugs not included in the Traffic Light list but included on joint formulary.
New drugs classified as red or amber but as greater experience regarding their safety and efficacy is established may move to Green after re-consideration by the MVG and APC.  

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