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Sunderland Joint Formulary
NHS Sunderland Clinical Commissioning Group
South Tyneside and Sunderland NHS Foundation Trust
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 Formulary Chapter 8: Malignant disease and immunosuppression - Full Chapter
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08.02  Expand sub section  Drugs affecting the immune response
Blinatumomab (Blincyto®)
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Formulary
Red

Vials: 38.5microgram

 
Link  NICE TA 450: Blinatumomab for previously treated Philadelphia-chromosome-negative acute lymphoblastic leukaemia
Link  NICE TA 589: Blinatumomab for treating acute lymphoblastic leukaemia in remission with minimal residual disease activity
   
08.02  Expand sub section  Immunosuppressant therapy
08.02.01  Expand sub section  Antiproliferative immunosuppressants
Cytotoxic Drug Azathioprine
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Formulary
Amber

Tablets: 25mg & 50mg
unlicensedunlicensed Suspension: 50mg in 5ml
Injection: 50mg

 
   
Mycophenolate Mofetil
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Formulary
Amber
High Cost Medicine

Capsules: 250mg
Tablets: 500mg
Oral suspension: 1g in 5ml (200mg/ml)
Vial for preparing IV infusion: 500mg

 
Link  NICE TA 481: Immunosuppressive therapy for kidney transplant in adults
   
Mycophenolate Sodium (Myfortic®)
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Formulary
Amber

E/C tablets: 180mg & 360mg
– 2nd line therapy in patients who do not tolerate mycophenolate mofetil

 
Link  NICE TA 481: Immunosuppressive therapy for kidney transplant in adults
   
08.02.02  Expand sub section  Corticosteroids and other immunosuppressants
Antithymocyte immunoglobulin (horse)
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Red

unlicensedunlicensed Injection: 250mg in 5ml -NETAG approved for aplastic anaemia in adults

 
   
Antithymocyte immunoglobulin (rabbit)
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Red
High Cost Medicine

Injection: 25mg injection
– used in the management of transplant rejection

 
   
Basiliximab (Simulect®)
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Formulary
Red
High Cost Medicine

Vial for preparing IV infusion: 20mg


-approved for limited use in adult renal translplant patients with high risk of acute organ rejection


-approved for severe graft versus host disease post haematopoietic stem cell transplantation


 

 
Link  NICE TA 481: Immunosuppressive therapy for kidney transplant in adults
Link  NICE TA 482: Immunosuppressive therapy for kidney transplant in children and young people
   
Ciclosporin (Neoral®)
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Formulary
Amber
High Cost Medicine

Capsules: 10mg, 25mg, 50mg & 100mg
Sugar free oral solution (oily): 100mg in 1ml

 
   
Ciclosporin (Sandimmun®)
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Amber

Original oral formulations Sandimmun supplied on request for patients who cannot take Neoral
unlicensedunlicensed Capsules: 25mg & 100mg
Sugar-free oral solution (oily): 100mg in 1ml

 
   
Ciclosporin (Sandimmun®)
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Formulary
Red

IV Infusion: 50mg in 1ml & 250mg in 5ml concentrate (oily)

 
   
Cytotoxic Drug Sirolimus
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Amber
High Cost Medicine

Tablets: 1mg & 2mg
Oral solution: 1mg per ml

 
Link  NICE TA 482: Immunosuppressive therapy for kidney transplant in children and young people
   
Tacrolimus
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Formulary
Amber

500 microgram Capsules: 1mg & 5mg (Prograf & Adoport)
unlicensedunlicensed Oral suspension: 5mg/5mL  
RED - Concentrate for preparing IV infusion: 5mg in 1 ml
- approved for renal transplantation in children and adolescents in line with NICE

 

MR Capsules (Advagraf): 500microgram, 1mg, 3mg & 5mg
- only approved for use for prophylaxis of organ rejection in kidney and liver transplantation. Advagraf® is approved for use in patients who are currently prescribed Prograf, and de novo patients should be prescribed Adoport®.

 

MR tablets (Envarsus): 750microgram, 1mg, 4mg
- approved for the treatment of renal and liver transplant patients who are suffering from neurotoxicity with other formulations or for patients requiring large doses of tacrolimus.

 
Link  NICE TA 482: Immunosuppressive therapy for kidney transplant in children and young people
   
08.02.03  Expand sub section  Anti-lymphocyte monoclonal antibodies to top
Alemtuzumab
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Formulary
Red

Concentrate for IV infusion: 30mg in 1ml
- for use in lymphocytic leukaemia & prevention of graft vs. host disease on bone marrow transplant patients
-approved for use in high-risk kidney and pancreas transplantation


Concentrate for IV infusion 12mg in 1.2ml
-approved as an option for treating adults with active relapsing– remitting multiple sclerosis in line with NICE (subject to NHS ENGLAND funding)


 

 
Link  NICE TA 312: Alemtuzumab for treating relapsing‑remitting multiple sclerosis
   
Isatuximab (Sarcusa®)
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Red
High Cost Medicine
NHS England

Vill: concentrate for infusion 100 mg/5 mL and 500 mg/25 mL

 
Link  NICE TA 658: Isatuximab with pomalidomide and dexamethasone for treating relapsed and refractory multiple myeloma
   
Obinutuzumab (Gazyvaro ®)
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Red
High Cost Medicine

Concentrate for IV infusion: 1000mg in 40ml


-for use in chronic lymphocytic leukaemia in combination with chlorambucil in patients who have co-morbitities that make fulldose fludarabinebased therapy unsuitable for them, only if bendamustinebased therapy is not suitable and the company provides obinutuzumab with the discount agreed in the patient access scheme in line with NICE (subject to NHS England funding)

 
Link  NICE TA 343: Obinutuzumab in combination with chlorambucil for untreated chronic lymphocytic leukaemia
Link  NICE TA 513: Obinutuzumab for untreated advanced follicular lymphoma
   
OcrelizumabBlack Triangle (Ocrevus®)
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Formulary
Red
High Cost Medicine
NHS England
Solution for infusion 30mg per 1mL 
Link  NICE TA 533: Ocrelizumab for treating relapsing–remitting multiple sclerosis
Link  NICE TA 585: Ocrelizumab for treating primary progressive multiple sclerosis
Link  NICE TA 629: Obinutuzumab with bendamustine for treating follicular lymphoma after rituximab
   
Rituximab
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Red
High Cost Medicine

Concentrate for IV infusion: 100mg in 10ml & 500mg in 50ml


-for musculoskeletal indications see chapter 10
-approved for first line use in NHL in combination with CHOP in line with NICE
-approved for maintenance therapy in follicular NHL that has responded to first line induction therapy with rituximab in combination with chemotherapy in line with NICE
-approved for stage III and IV follicular lymphoma in previously untreated people in line with NICE
-approved for replased or refractory follicular NHL in line with NICE
-approved for Post-transplant lymphoproliferative disease
- approved for first line use in CLL in combination with fludarabine and cyclophosphamide in line with  NICE
-approved for combination with fludarabine and cyclophosphamide for relapsed or refractory CLL in line with NICE
-approved for autoimmune haematological conditions (where conventional treatments have failed)
– Autoimmune haemolytic anaemia
(AIHA), Evans syndrome, pure red cell aplasia (PRCA), acquired haemophilia A & thrombocytopenia purpura (TTP).
- Combination with bendamustine for first line use in CLL (Binet stage B or C) in patients for whom fludarabine combination chemotherapy is not appropriate.
- a
pproved for vasculitis (including Wegener’s granulomatosis in adults and children) that has not responded adequately to conventional treatment (e.g. corticosteroids, cyclophosphamide) NICE and additional NHS England criteria
-NECDAG approved for the treatment of NLPHL
-NECDAG approved for newly diagnosed mantle cell NHL in patients aged <60 years old approved in combination with bendamustine for first line use in CLL (Binet stage B or C) in patients for whom fludarabine combination chemotherapy is not appropriate NICE
-NECDAG approved in combination with bendamustine for patients with CLL not fit for FCR chemotherapy or for patients who relapse within 2 years of FCR chemotherapy and not fit for alemtuzumab.
-NECDAG approved with salvage chemotherapy for patients relapsing > 12 months post 1st line -therapy with R-CHOP
-NECDAG approved with a standard NHL induction regimen in patients who cannot be given an anthracycline. Rituximab with other chemotherapy regimens is an alternative treatment option e.g. DECC, CVP for this group of patients, as part of their first line therapy. Also in addition to the MACOP-B regimen for the small number of young patients with DLBCL, subtype Primary Mediastinal B cell Lymphoma
-NECDAG approved for the treatment of hairy Cell Leukaemia (HCL) or Hairy cell Leukaemia varian (HCL-v) who:


        -relapse early after purine analogue therapy (< 2 years post treatment)
        -are refractory to purine analogues.
-NTAG approved for the treatment of immune (idiopathic) thrombocytopenic purpura (ITP) in adults and children NTAG
-approved for the treatment of immunobullous disease in line with NHS England Commissioning Policy



SC injection: 1.4g solution


-approved for use as maintenance single agent therapy in FL, mantle cell lymphoma, marginal zone lymphoma and lymphoplasmacytic lymphoma in line with NHS ENGLAND SSC1434

 
Link  NICE TA 137: Lymphoma (follicular non-Hodgkin’s) - rituximab
Link  NICE TA 174: Leukaemia (chronic lymphocytic, first line) - rituximab
Link  NICE TA 193: Leukaemia (chronic lymphocytic, relapsed) - rituximab
Link  NICE TA 226: Lymphoma (follicular non-Hodgkin’s) - rituximab
Link  NICE TA 243: Follicular lymphoma - rituximab (review)
Link  NICE TA 308: Rituximab in combination with glucocorticoids for treating anti-neutrophil cytoplasmic antibody-associated vasculitis
Link  NICE TA 627: Lenalidomide with rituximab for previously treated follicular lymphoma
   
08.02.04  Expand sub section  Other immunomodulating drugs
BCG Connaught
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Red
High Cost Medicine

Vial: 81mg for bladder instillation

 
   
Brodalumab (Kyntheum ® )
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Red
High Cost Medicine

210mg solution for infusion

Brodalumab for treating moderate to severe plaque psoriasis (TA511) 21.3.18

 
   
Cemiplimab (Libtayo®)
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Red
Cancer Drugs Fund

Cemiplimab (Libtayo®) is recommended for use within the Cancer Drugs Fund as an option for treating locally advanced or metastatic cutaneous squamous cell carcinoma in adults when curative surgery or curative radiotherapy is not appropriate.

It is recommended only if the conditions in the managed access agreement are followed.

 
Link  NICE TA 592: Cemiplimab for treating metastatic or locally advanced cutaneous squamous cell carcinoma
   
Dimethyl fumarate
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Formulary
Red
High Cost Medicine

Capsules: 120mg, 240mg

 
Link  NICE TA 303: Teriflunomide for treating relapsing–remitting multiple sclerosis
Link  NICE TA 320: Dimethyl fumarate for treating relapsing‑remitting multiple sclerosis
   
Cytotoxic Drug Dinutuximab beta (Qarziba®)
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Red
High Cost Medicine
NHS England
  • 20mg/4.5mL concentrate for solution for infusion
  • Approved for the treatment of high-risk neuroblastoma in people aged 12 months and over in line with NICE 
  • Link  NICE TA 538: Dinutuximab beta for treating neuroblastoma
       
    Durvalumab (Imfinzi®)
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    Red
    Cancer Drugs Fund

    Durvalumab (Imfinzi®) monotherapy is recommended for use within the Cancer Drugs Fund as an option for treating locally advanced unresectable non-small cell lung cancer in adults whose tumours express PD‑L1 on at least 1% of tumour cells and whose disease has not progressed after platinum-based chemoradiation only if:

    • they have had concurrent platinum-based chemoradiation, and
    • the conditions in the managed access agreement are followed.
     
    Link  NICE TA 578: Durvalumab for treating locally advanced unresectable non-small-cell lung cancer after platinum-based chemoradiation
       
    Fingolimod
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    Formulary
    Red

    Capsules: 500microgram - - approved for the treatment of highly active relapsing–remitting multiple sclerosis in line with NICE - approved for patients who have progressed on glatiramer acetate and for those patients who are at high risk of progressive multifocal leukoencephalopathy (PML) in line withNHS EnglandClinical Commissioning Policy

     
    Link  NICE TA 254: Fingolimod for the treatment of highly active relapsing–remitting multiple sclerosis
       
    Lenalidomide
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    Formulary
    Red
    High Cost Medicine
    Cancer Drugs Fund

    Capsules: 5mg, 10mg, 15mg, & 25mg

     
    Link  NICE TA 171: Multiple myeloma - lenalidomide
    Link  NICE TA 322: Lenalidomide for treating myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality
    Link  NICE TA 505: Ixazomib with lenalidomide and dexamethasone for treating relapsed or refractory multiple myeloma
    Link  NICE TA 586: Lenalidomide plus dexamethasone for multiple myeloma after 1 treatment with bortezomib
    Link  NICE TA 587: Lenalidomide plus dexamethasone for previously untreated multiple myeloma
    Link  NICE TA 627: Lenalidomide with rituximab for previously treated follicular lymphoma
    Link  NICE TA 680: Lenalidomide maintenance treatment after an autologous stem cell transplant for newly diagnosed multiple myeloma
       
    Mifamurtide
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    Formulary
    Red

    Vial: 4mg

     
    Link  NICE TA 235: Mifamurtide for the treatment of osteosarcoma
       
    Nivolumab
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    Formulary
    Red

    Concentrate for IV infusion: 10mg in 1ml concentrate for IV infusion as (4ml, 10ml & 24ml vials)

     

     

     

    For the treatment of locally advanced or metastatic squamous nonsmall cell lung cancer (NSCLC) after prior chemotherapy in adults

     
    Link  NICE TA 417: Nivolumab for previously treated advanced renal cell carcinoma
    Link  NICE TA 462: Nivolumab for treating relapsed or refractory classical Hodgkin lymphoma
    Link  NICE TA 581: Nivolumab with ipilimumab for untreated advanced renal cell carcinoma
    Link  NICE TA384: Nivolumab for treating advanced (unresectable or metastatic) melanoma
    Link  NICE TA 400: Nivolumab in combination with ipilimumab for treating advanced melanoma
    Link  NICE TA 558: Nivolumab for adjuvant treatment of completely resected melanoma with lymph node involvement or metastatic disease
    Link  NICE TA 655: Nivolumab for advanced squamous non-small-cell lung cancer after chemotherapy
       
    Pomalidomide (Imnovid®)
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    Formulary
    Red
    High Cost Medicine
    Cancer Drugs Fund

    Capsules: 1mg, 2mg, 3mg, 4mg

     
    Link  NICE TA 427: Pomalidomide for multiple myeloma previously treated with lenalidomide and bortezomib
       
    Siponimod (Mayzent®)
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    Formulary
    Red
    High Cost Medicine
    NHS England

    Tablet: 250 micrograns and 2 mg

     
    Link  NICE TA 656: Siponimod for treating secondary progressive multiple sclerosis
       
    Teriflunomide
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    Formulary
    Red
    High Cost Medicine

    Film coated tablets: 14mg

     
    Link  NICE TA 303: Teriflunomide for relapsing remitting MS
       
    Thalidomide
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    Formulary
    Red
    High Cost Medicine

    Capsules: 50mg


    - approved in combination with an alkylating agent and a corticosteroid for the first-line treatment of multiple myeloma in line with NICE
    - approved for the treatment of bleeding from bowel angiodysplasia in patients with an inherited/acquired bleeding disorder on specialist advice only.
    -approved for the treatment of severe epistaxis as a result of hereditary haemorrhagic telangiectasia (HHT) who have failed all other treatments.

     
    Link  NICE TA 228: Bortezomib and thalidomide for the first‑line treatment of multiple myeloma
       
    08.02.04  Expand sub section  Interferon Alfa
    Interferon alfa-2b
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    Formulary
    Red

    Multidose pen injections: 10 mega units, 30 mega units

     
       
    Peginterferon alfa-2a
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    Formulary
    Red

    Injections in prefilled syringes 135 microgram, 180 microgram
    Prefilled pens: 135 micrograms and 180 micrograms

     
    Link  NICE TA 75: Interferon alfa (pegylated and non-pegylated) and ribavirin for the treatment of chronic hepatitis C
    Link  NICE TA 96: Adefovir dipivoxil and peginterferon alfa-2a for the treatment of chronic hepatitis B
    Link  NICE TA 106: Peginterferon alfa and ribavirin for the treatment of mild chronic hepatitis C
    Link  NICE TA 200: Peginterferon alfa and ribavirin for the treatment of chronic hepatitis C
    Link  NICE TA 300: Peginterferon alfa and ribavirin for treating chronic hepatitis C in children and young people
       
    Peginterferon alfa-2b
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    Formulary
    Red

    Prefilled injection pens: 50, 80, 100, 120, 150 micrograms
    -approved for chronic hepatitis C as peginterferon alffa 2a

     
       
    08.02.04  Expand sub section  Interferon beta
    Interferon beta-1a
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    Formulary
    Red

    Prefilled pen (Avonex): 30 micrograms (6 million units)
    Prefilled pen (Rebif): 22 microgram (6 million units) & 44 microgram (12 million units)
    Cartridge for use in rebismart device: 22 microgram per 0.5ml and 44 microgram per 0.5ml
    Prefilled pen: 44 microgram per 0.5ml (Rebidose)
    -approved for use when the cartridges and prefilled syringes are unsuitable.

     
       
    Interferon beta-1b
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    Formulary
    Red

    Vials for preparing 750 microgram in 3ml injection (Betaferon)
    Vials for preparing 250 microgram in 1ml injection (Extavia)

     
       
    Peginterferon beta-1a
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    Formulary
    Red

    Prefilled pen: 125 microgram (Plegridy)

     
    Link  NICE TA 624:Peginterferon beta-1a for treating relapsing–remitting multiple sclerosis
       
    08.02.04  Expand sub section  Aldesleukin
    08.02.04  Expand sub section  Glatiramer acetate to top
    Glatiramer Acetate
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    Formulary
    Red
    High Cost Medicine

    Prefilled syringe injection: 20mg

     
    Link  NICE TA 527: Beta interferons and glatiramer acetate for treating multiple sclerosis
       
    08.02.04  Expand sub section  Natalizumab
    Natalizumab
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    Formulary
    Red
    High Cost Medicine

    Vial for preparing infusions: 300mg in 15ml (20mg/ml)
    - approved for rapidly evolving severe relapsing remitting multiple sclerosis in line with NICE

     
    Link  NICE TA127: Multiple sclerosis - natalizumab
       
     ....
     Non Formulary Items
    Aldesleukin  (Proleukin®)

    View adult BNF View SPC online
    Non Formulary
    High Cost Medicine
     
    Belatacept  (Nulojix®)

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    Non Formulary
    High Cost Medicine
     
    Canakinumab  (Ilaris®)

    View adult BNF View SPC online
    Non Formulary
    High Cost Medicine
     
    Cediranib  (Recentin®)

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    Non Formulary
     
    Cobimetinib  (Cotellic®)

    View adult BNF View SPC online
    Non Formulary
     
    Daclizumab  (Zenapax®)

    View adult BNF View SPC online
    Non Formulary
     
    Fampridine

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    Non Formulary
    High Cost Medicine
     
    Modigraf®

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    Non Formulary
     
    Pemrolizumab  (Keytruda®)

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    Non Formulary
     
    Prednisolone

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    Non Formulary
     
    Prednisolone

    View adult BNF View SPC online
    Non Formulary
     
    Prograf®

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    Non Formulary
     
      
    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 SPCs
    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

    Red

    Drugs for hospital use or use by a specialist within specialist centre only. Initiation and monitoring of treatment should remain under the total responsibility of the appropriate hospital clinician or specialist. These drugs should only be prescribed under the direct supervision of that clinician or specialist and are not suitable for shared care arrangements. The drug should be supplied via the hospital or specialist centre for the duration of treatment.   

    Amber

    These are specialist drugs which must be initiated by secondary care specialist prescribers, but with the potential to transfer prescribing to primary care within written and agreed shared care protocols and according to the agreed process for transfer of care. For these drugs, in order to ensure patient safety, some aspects of care must remain with the specialist due to their complexity e.g. monitoring of disease or drug response. Other more routine aspects can be transferred to the GP e.g. monitoring of adverse effects and supply of the medicine. The specific responsibilities of the specialist and GP are defined in the shared care agreement for each drug. Shared care agreements are still under development for some amber drugs. Until these are available, it would be expected that any shared care request from secondary care to a GP would be accompanied by written information which defines prescribing and monitoring responsibilities. The hospital specialist should also provide the GP with enough information and support to allow the safe transfer and ongoing management of prescribing into primary care.   

    Green +

    Drugs which should usually be initiated in secondary care, or by a specialist clinician, but can be safely maintained in primary care with very little or no monitoring required. In some cases there may be a further restriction for use outlined - these will be defined in each case.  

    Green

    These are defined as new and established drugs, which may be prescribed, initiated, changed or maintained on FP10 by the GP and, if appropriate, discontinued without recourse to secondary care. N.B. DRUGS NOT IDENTIFIED IN THE FORMULARY BY A RED, AMBER OR GREEN+ SYMBOL ARE CLASSIFIED AS GREEN.   

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