ࡱ> QSNOP @ objbj00 &vRbRbg3\\\\\\\pxxx8Lx$pxp2p|p|"|||y{{{{{{$,R~\\\||L\|\|yyr\\|d| Ix$Eݗʨ0SV"pp\\\\\4,pppx*XppxDORSET AND SOMERSET PRESCRIBING FORUMS TRAFFIC LIGHT SYSTEM Summary BACKGROUND Aim The traffic light system defines where responsibility for prescribing between primary and secondary care should lie through categorising individual drugs as red, amber or green. The system is intended to encourage appropriate shifts in prescribing between hospital clinicians and general practitioners (GPs) consistent with clinical responsibility and supported by shared care arrangements. Following review of clinical data on efficacy, safety and cost-effectiveness by the Dorset or Somerset Prescribing Forums, drug treatments will either be: recommended, following which they will receive a traffic light category as follows: red - for hospital prescribing; amber - appropriate for shared care; green appropriate for prescribing in primary and secondary care; not recommended, that is where prescribing is not generally recommended in primary or secondary care. Drugs not categorised as red, amber, green, or not recommended will not have been referred to the Prescribing Forums. Prescribing of these will be at the discretion of individual NHS Trusts and GPs. Where drug treatments have been appraised by the National Institute for Health and Clinical Excellence (NICE), their categorisation will be consistent with the recommendations that have been made. For unlicensed medicines the prescriber, patient and GP should be aware of unlicensed nature of the drug and reference to the protocol on the use of unlicensed drugs should be made. CATEGORIES Red These are drugs for which it is considered that responsibility for prescribing should be retained within secondary care. These will generally be specialist treatments requiring special monitoring or where rigorous supervision is required due to their side-effect profile. Other criteria for categorising a drug as red are set out in the full guidance. Amber These are drugs for which transfer of responsibility for prescribing, from secondary to primary care, is considered appropriate when: the GP has agreed to accept clinical responsibility for an individual patient, this should be in the form of a signed proforma. It is the responsibility of the consultant to approach the GP with the drug and patient information, any relevant shared care guideline and the proforma of acceptance; The shared care agreement in place between the clinician and GP. should clarify to the doctor accepting responsibility what monitoring is required and at what point further advice should be sought; where appropriate, a shared care guideline should be developed and accepted by the Prescribing Forum to support the transfer of clinical responsibility. It should be noted that an amber categorisation is made on the basis that: the hospital clinician is usually responsible for initiating and stabilising treatment; where possible, the GP is contacted to agree future shared care prior to initiating treatment in secondary care; monitoring requirements and responsibility for monitoring treatment have been clearly defined; the drug is being used for the indication and in accordance with the shared care guidance that has been agreed; a GP may choose not to accept clinical responsibility on the basis of lack of familiarity or experience with a drug or if it is being used outside of the guidance that has been agreed. Green Drugs categorised as green are not complex specialist drugs and their introduction is regarded as appropriate in both primary and secondary care. Categorisation of a drug as green is on the basis that it is considered to offer significant benefit over existing treatment and that its use as a first, second or third-line drug has been defined. Not Recommended For a drug treatment to be categorised as not recommended it will have been referred to, and been reviewed by, the Dorset or Somerset Prescribing Forums. A drug treatment may also be categorised as not recommended as an interim measure pending review of the drug treatment. When this is the case, it should be clearly stated and a date for completion of the review agreed. It should be noted that there may be occasions where the use of a drug treatment that has been categorised as not recommended is considered appropriate. This should be managed by NHS Trusts and Primary Care Trusts on an individual patient basis. Summary of Traffic Light Drugs The table attached provides a summary of the drugs categorised as red, amber, green and not recommended listed in alphabetical order. A line at the right hand side of the table indicates entries that have been added or amended since the previous edition. The Dorset Prescribing Guide should also be referred to for drugs categorised as green. Information on the traffic light system, guidelines included in the Dorset Prescribing Guide and shared care guidelines can be accessed on the Dorset and Somerset Health and Social Care Extranet (nww.dorsetsomerset.nhs.uk). Further information can be obtained from Primary Care Trust Prescribing Leads and Pharmaceutical Advisers or NHS Trust Chief Pharmacists. November 2005 SUMMARY OF TRAFFIC LIGHT DRUGS Drug CategoryNotesAcamprosate (Campral EC)AmberFor maintenance of abstinence in alcohol dependent patients in accordance with locally agreed shared care guideline. Adalimumab (Humira)Red (Dorset)For rheumatoid arthritis in accordance with locally agreed guidance and the recommendations made by NICE for Etanercept and Infliximab (Appraisal No. 36 March 2002). To be endorsed by the Somerset Prescribing Forum. Alglucerase (Ceredase)Red Trusts are responsible for making the necessary arrangements for patients to receive intravenous treatment. Alprostadil (Caverject, Viridal, MUSE)Green (erectile dysfunction) When used in accordance with Health Service Circular 1999/148 * Alprostadil (Prostin VR)Red (Somerset)For congenital heart defects in neonates prior to corrective surgery. Amisulpride (Solian)AmberIn accordance with the recommendations made by NICE for the use of atypical antipsychotic drugs for the treatment of schizophrenia (Appraisal No. 43 June 2002) and locally agreed shared care guideline. Refer also to the guidance on drug treatment of newly diagnosed schizophrenia included in the Dorset Prescribing Guide. Anastrozole (Arimidex)AmberFor second-line endocrine treatment of postmenopausal patients with advanced oestrogen receptor-positive breast cancer, in accordance with locally agreed shared care guideline. Anti-D RedFor routine antenatal anti-D prophylaxis for RhD-negative women in accordance with the recommendations made by NICE (Appraisal No. 41 May 2002). Anti-retrovirals for HIV RedApomorphine (Britaject)Red Treatment is managed by the Parkinsons disease speciality nurses. Apomorphine (Uprima)GreenWhen used in accordance with Health Service Circular 1999/148 *Aripiprazole (Abilify)AmberIn accordance with the recommendations made by NICE for the use of atypical antipsychotic drugs for the treatment of schizophrenia (Appraisal No. 43. June 2002) and locally agreed shared care guideline. Refer also to the guidance on drug treatment of newly diagnosed schizophrenia included in the Dorset Prescribing Guide. Asasantin Retard  Green Separate ingredients are the preferred option. Use to be in accordance with the recommendations made by NICE for the use of clopidogrel and dipyridamole in vascular disease (Appraisal No 90. May 2005). Atomoxetine (Strattera)AmberSecond-line use according to locally agreed shared care guideline Azathioprine (Imuran)AmberIn accordance with the guidance on the use of disease modifying anti-rheumatic drugs included in the Dorset Prescribing Guide. Bicalutamide (Casodex)Amber (provisional) Red (Dorset)Role in management of prostate cancer to be clarified and shared care guideline to be developed. For locally advanced disease as an alternative to LHRH and also as neo-adjuvant/adjuvant treatment prior to and after radiotherapy.Bupropion (Zyban)GreenAs an adjunct to smoking cessation in combination with motivational support in accordance with the recommendations made by NICE (Appraisal No. 39 March 2002). Buserelin (Suprefact, Suprecur) Amber Shared care guideline to be developed for use in prostatic cancer and endometriosis. Cancer drugs Red Red Hospital Trusts are responsible for making the necessary arrangements for patients to receive intravenous treatment. Red category also includes oral cancer treatments Drug treatments reviewed and recommended by NICE. CAPD (Continuous Ambulatory Peritoneal Dialysis fluids) RedSpecial purchasing arrangements in place through secondary care. Celecoxib (Celebrex)GreenIn accordance with the recommendations made by NICE (Appraisal No. 27 July 2001). Refer also to locally agreed guidance (not included within Poole and Bournemouth formularies) and national safety guidance from CSM.Cerazette (under Desogestrel) Chorionic gonadotrophin (Choragon, Pregnyl, Profasi) RedSpecial purchasing arrangements in place through secondary care. Ciclosporin (Neoral, Sandimmun)Amber (Dorset) Red (Somerset)Treatment initiated in Plymouth for renal transplant. Shared care guideline to be reviewed. For transplant patients. Ciclosporin (Neoral, Sandimmun) AmberIn accordance with the guidance on the use of disease modifying anti-rheumatic drugs included in the Dorset Prescribing Guide. Cidofovir (Vistide)Red Hospital Trusts are responsible for making the necessary arrangements for patients to receive intravenous treatment. Clinical trial drugsRed Clopidogrel (Plavix) Green Amber For patients hypersensitive to aspirin or patients not tolerating low-dose aspirin or a combination of low-dose aspirin + gastroprotective agent. In accordance with the recommendations made by NICE for the use of clopidogrel and dipyridamole in vascular disease (Appraisal No 90. May 2005). In accordance with the recommendations made by NICE for the use of clopidogrel in the treatment of non-ST-segment-elevation acute coronary syndrome (appraisal No.80 July 2004) clopidogrel should be used for up to 12 months. Post stent insertion (unless follows acute coronary syndrome, see above): Clopidogrel should be used for one month following insertion of a non-drug eluting stent. Clopidogrel should be used for six months following insertion of a drug-eluting stent Clozapine (Clozaril)Red (Amber in original pilot sites) In accordance with the recommendations made by NICE for the use of atypical antipsychotic drugs for the treatment of schizophrenia (Appraisal No. 43 June 2002). Refer also to the guidance on drug treatment of newly diagnosed schizophrenia included in the Dorset Prescribing Guide. Colistin RedInhaled use as an adjunct to standard antibacterial therapy in patients with cystic fibrosis. Continuous subcutaneous insulin infusion (under Insulin) Cyproterone (Cyprostat)AmberShared care guideline to be developed.  Deflazacort (Calcort)Not recommendedInsufficient evidence of significant additional clinical benefit over Prednisolone. Desferrioxamine (Desferal)RedSpecialist use only. Desogestrel (Cerazette) GreenIn accordance with local guideline agreed with Dr A Vaughan. Dipyridamole m/r capsules (Persantin Retard)GreenIn accordance with the recommendations made by NICE for the use of clopidogrel and dipyridamole in vascular disease (Appraisal No 90 May 2005). Disodium pamidronate (Aredia)RedFor use in the management of multiple myeloma. Donepezil (Aricept)AmberIn accordance with the recommendations made by NICE (Appraisal No. 19 January 2001). Refer also to the guidance on drug treatment of Alzheimers disease included in the Dorset Prescribing Guide and locally agreed shared care guideline.Dornase alfa (Pulmozyme)Amber (Dorset) Red (Somerset) Local guidance and category to be reviewed. Dressings not prescribable available in primary care RedDrotrecogin alfa (Xigris)RedIn accordance with locally agreed interim guidance. Arrangements to be reviewed in the light of the recommendations made by NICE. Eflornithine (Vaniqa)Red (Dorset) Not recommended (Somerset)Use should be discussed at local drug and therapeutics committees where required. Alternative treatments available locally. Entacapone (Comtess) Amber Used as an adjunct to levodopa therapy in patients who cannot be stabilised, particularly those with end-of-dose fluctuations. Refer to locally agreed guidance on drug treatment of Parkinsons disease and shared care guideline. Eplerenone (Inspra)AmberUsed, in addition to standard therapy, to reduce the risk of cardiovascular mortality and morbidity after recent myocardial infarction in stable patients with left ventricular dysfunction and clinical evidence of heart failure, as an alternative to spironolactone, where sex hormone mediated adverse effects experienced. Epoprostenol (Flolan) RedHospital Trusts are responsible for making the necessary arrangements for patients to receive intravenous treatment. Erythropoietin (Eprex, NeoRecormon)Red Red (Dorset) For renal use. For use in patients with ovarian cancer in accordance with locally agreed guideline. Etanercept (Enbrel)RedFor rheumatoid arthritis in accordance with the recommendations made by NICE (Appraisal No. 36 March 2002).Etonogestrel (Implanon)GreenFor use by doctors with appropriate training and up-to-date documentary evidence of competency from the Faculty of Family PlanningExemestane (Aromasin)AmberIn accordance with locally agreed shared care guideline. Ezetimibe (Ezetrol)GreenTo be reserved for patients not reaching target lipid levels on maximum tolerated doses of statins. Flutamide (Drogenil) AmberShared care guideline to be developed. Follitropin alfa and beta (GonalF, Puregon)RedSpecial purchasing arrangements in place through secondary care. Formestane (Lentaron)AmberShared care guideline to be developed. Foscarnet (Foscavir)RedHospital Trusts are responsible for making the necessary arrangements for patients to receive intravenous treatment. Galantamine (Reminyl)AmberIn accordance with the recommendations made by NICE (Appraisal No. 19 January 2001). Refer also to the guidance on drug treatment of Alzheimers disease included in the Dorset Prescribing Guide and locally agreed shared care guideline. Ganciclovir (Cymevene)Red Hospital Trusts are responsible for making the necessary arrangements for patients to receive intravenous treatment. Gold (Auranofin, Myocrisin)AmberIn accordance with the guidance on the use of disease modifying anti-rheumatic drugs included in the Dorset Prescribing Guide. Goserelin (Zoladex) Amber Shared care guideline to be developed for use in prostatic cancer and endometriosis. Growth hormone (Genotropin, Humatrope, Norditropin, NutropinAq, Saizen, Zomacton) Children - Red Adults RedIn accordance with the recommendations made by NICE (Appraisal No. 42 May 2002). Arrangements through Southampton (Dr Betts) and Poole (Dr McAuley). In accordance with the recommendations made by NICE (Appraisal No. 64 Aug 2003)Hyaluronic acid and derivatives (Arthrease, Durolane, Fermathron, Hyalgan, Orthovisc, Ostenil, Supartz, Suplasyn, Synvisc) RedOn the basis of a locally agreed guideline. Hydroxychloroquine (Plaquenil)AmberIn accordance with the guidance on the use of disease modifying anti-rheumatic drugs included in the Dorset Prescribing Guide. Implanon (under Etonogestrel) Infliximab (Remicade)Red RedFor rheumatoid arthritis in accordance with the recommendations made by NICE (Appraisal No. 36 March 2002). For Crohns disease in accordance with the recommendations made by NICE (Appraisal No. 40 April 2002). Insulin (Continuous subcutaneous insulin infusion)Red In accordance with the recommendations made by NICE (Appraisal No. 57 February 2003). Refer also to locally agreed guidance (Dorset). Insulin glargine (Lantus)GreenIn accordance with the recommendations made by NICE (Appraisal No. 53 December 2002). Refer also to locally agreed guidance. Interferon alfa Interferon alfa / Peginterferon alfaRed RedFor chronic myeloid leukaemia. Chronic hepatitis C in accordance with the recommendations made by NICE (Appraisal Nos. 14 and 75, October 2000 and January 2004). Interferon beta (Avonex, Rebif, Betaferon)RedIn accordance with the recommendations made by NICE (Appraisal No. 32 January 2002) and Department of Health guidance contained in HSC 2002/004. Intravenous antibioticsRedHospital Trusts are responsible for making the necessary arrangements for patients to receive intravenous treatment. Intravenous immunoglobulinsRedHospital Trusts are responsible for making the necessary arrangements for patients to receive intravenous treatment. Isotretinoin (Roaccutane)RedSide-effects require specialist supervision. Lanreotide (Somatuline LA)RedThird-line treatment for acromegaly (secondline if patient is unfit for surgery). Leflunomide (Arava)Amber (Dorset) Red (Somerset) For third-line use in patients with active rheumatoid arthritis when treatment with sulphasalazine and methotrexate is contra-indicated or has been found to be ineffective or not tolerated. Treatment is initiated by a consultant rheumatologist who will prescribe for the first month. Refer to locally agreed shared care guideline. Leuprorelin (Prostap SR) Amber Shared care guideline to be developed for use in prostatic cancer and endometriosis. Levonorgestrel (Levonelle-2)GreenEmergency post-coital contraception. Memantine (Ebixa)Red In accordance with locally agreed guideline. Menotrophin (Menogon, Menopur) RedSpecial purchasing arrangements in place through secondary care. Methotrexate (Maxtrex)Amber Red - Injectable methotrexate (Somerset) In accordance with the guidance on the use of disease modifying anti-rheumatic drugs included in the Dorset Prescribing Guide. Appropriate safeguards and liability issues to be considered and shared care arrangements agreed. Methylphenidate (Ritalin, Concerta XL)AmberIn accordance with the recommendations made by NICE (Appraisal No. 13 October 2000). Refer also to locally agreed shared care guideline. The prolonged-release formulation Concerta XL should be reserved for patients experiencing problems with conventional tablets. Treatment should be initiated by the consultant, on an individual patient basis, following review and the patients GP informed of the rationale for this decision. Minocycline (Minocin)AmberIn accordance with the guidance on the use of disease modifying anti-rheumatic drugs included in the Dorset Prescribing Guide. Montelukast (Singulair)AmberFor use in asthma in accordance with locally agreed guideline.Mycophenolate mofetil (CellCept) RedNafarelin (Synarel) RedUse in vitro fertilisation. Special purchasing arrangements in place through secondary care. Naltrexone (Nalorex)Red AmberAs an adjunct to prevent relapse in detoxified, formerly opioid-dependent patients. Naltrexone may be used as an amber drug in accordance with locally agreed shared care guideline where supporting infrastructure is available to primary care.Octreotide (Sandostatin)RedThird-line treatment for acromegaly (secondline if patient is unfit for surgery). Octreotide (Sandostatin)Red For carcinoid syndrome and use in palliative care. Olanzapine (Zyprexa)AmberIn accordance with the recommendations made by NICE for the use of atypical antipsychotic drugs for the treatment of schizophrenia (Appraisal No. 43 June 2002) and locally agreed shared care guideline. Refer also to the guidance on drug treatment of newly diagnosed schizophrenia and guidance on drug treatment of psychotic conditions other than schizophrenia included in the Dorset Prescribing Guide. Orlistat (Xenical)GreenIn accordance with the recommendations made by NICE (Appraisal No. 22 March 2001). Oseltamivir (Tamiflu) GreenIn accordance with the recommendations made by NICE (Appraisal No. 58 February 2003 and Appraisal No. 67 September 2003). Vaccination, particularly targeting high risk patients, remains the mainstay of influenza management. Peginterferon alfa (under Interferon alfa)Penicillamine (Distamine)AmberIn accordance with the guidance on the use of disease modifying anti-rheumatic drugs included in the Dorset Prescribing Guide. Pimecrolimus (Elidel)AmberIn accordance with the recommendations made by NICE for the use of tacrolimus and pimecrolimus for atopic eczema (Appraisal No.82 August 2004) and locally agreed shared care guideline.Pioglitazone (Actos)GreenIn accordance with the recommendations made by NICE (Appraisal No. 63 August 2003). Pramipexole (Mirapexin)GreenIn accordance with locally agreed guidance on drug treatment of Parkinsons disease. Pregabalin (Lyrica)Not recommendedCategorisation to be reviewed in the light of peer-reviewed evidence. Patients currently receiving drug should be maintained on therapy if they are deriving benefit from it.Quetiapine (Seroquel)AmberIn accordance with the recommendations made by NICE for the use of atypical antipsychotic drugs for the treatment of schizophrenia (Appraisal No. 43 June 2002) and locally agreed shared care guideline. Refer also to the guidance on drug treatment of newly diagnosed schizophrenia and guidance on drug treatment of psychotic conditions other than schizophrenia included in the Dorset Prescribing Guide. Raloxifene (Evista)GreenIn accordance with the recommendations made by NICE (Appraisal No.87 January 2005).Ribavirin (Rebetol)RedFor use in combination with interferon alfa in the management of hepatitis C in accordance with the recommendations made by NICE (Appraisal Nos. 14 and 75, October 2000 and January 2004). Riluzole (Rilutek)AmberIn accordance with the recommendations made by NICE (Appraisal No. 20 January 2001). Refer also to locally agreed shared care guideline. Risperidone (Risperdal) Risperidone injection (Risperdal Consta)Amber RedIn accordance with the recommendations made by NICE for the use of atypical antipsychotic drugs for the treatment of schizophrenia (Appraisal No. 43 June 2002) and locally agreed shared care guidance. Refer also to the guidance on drug treatment of newly diagnosed schizophrenia and guidance on drug treatment of psychotic conditions other than schizophrenia included in the Dorset Prescribing Guide. Rivastigmine (Exelon)AmberIn accordance with the recommendations made by NICE (Appraisal No. 19 January 2001). Refer also to the guidance on drug treatment of Alzheimers disease included in the Dorset Prescribing Guide and locally agreed shared care guideline. Rosiglitazone (Avandia)GreenIn accordance with recommendations made by NICE (Appraisal No. 63 August 2003). Sevelamer (Renagel) AmberIn accordance with the guidance agreed with Dorset Renal Unit. Refer to shared care guideline. Sibutramine (Reductil)GreenIn accordance with the recommendations made by NICE (Appraisal No. 31 October 2001). Sildenafil (Viagra)GreenWhen used in accordance with Health Service Circular 1999/148 * Sodium clodronate (Bonefos, Loron)Red (Dorset) Amber (Somerset)For use in the management of multiple myeloma. Stalevo (Co-careldopa with Entacapone)AmberRefer to the locally agreed guidance on drug treatment of Parkinsons disease and shared care guideline. Tacrolimus (Prograf)RedPrescribed by West Dorset Renal Unit. Tacrolimus (Protopic) AmberIn accordance with the recommendations made by NICE for the use of tacrolimus and pimecrolimus for atopic eczema (Appraisal No.82. August 2004) and locally agreed shared care guideline.Teriparatide (Forsteo)RedIn accordance with locally agreed interim guidance. Arrangements to be reviewed in the light of the recommendations made by NICE. Tiotropium (Spiriva)GreenIn accordance with locally agreed guidance. Tizanidine (Zanaflex)RedIn accordance with local guideline agreed with Dr J Burn. Tolterodine (Detrusitol)GreenFor second-line use in patients who are unable to tolerate or who do not respond to oxybutynin. Total parenteral nutrition (TPN)RedHospital Trusts are responsible for making the necessary arrangements for TPN. Triptorelin (De-capeptyl sr)Amber Shared care guideline to be developed for use in prostatic cancer and endometriosis. Urofollitropin (Metrodin)RedSpecial purchasing arrangements in place through secondary care. YasminNot recommendedInsufficient evidence of benefit over existing preparations and absence of long-term safety data. Zafirlukast (Accolate)AmberFor use in asthma in accordance with locally agreed guideline.Zanamivir (Relenza)GreenIn accordance with the recommendations made by NICE (Appraisal No. 58 February 2003). Vaccination, particularly targeting high risk patients, remains the mainstay of influenza management.  *TREATMENT OF IMPOTENCE Summary of Health Service Circular 1999/148 General practitioners may issue National Health Service prescriptions (endorsed SLS) to those men whom, in their clinical judgement, are suffering from erectile dysfunction and have any of the following medical conditions: diabetes; multiple sclerosis; Parkinsons disease; poliomyelitis; prostate cancer; prostatectomy (including TURP); radical pelvic surgery; renal failure treated by dialysis or transplant; severe pelvic injury; single gene neurological disease; spinal cord injury; spina bifida. In addition, men who were receiving a course of drug treatment for impotence on the National Health Service on 14 September 1998 can continue to receive a drug treatment for impotence from their general practitioner on the National Health Service. For example, a man who was prescribed a course of Caverject on the National Health Service on 10 September 1998 may continue to receive prescriptions for Caverject or may be changed to a different drug for impotence if necessary. Men who do not fall into either of the above categories but who are suffering from severe distress on account of their impotence may be able to obtain treatment from specialist services. Guidelines for use of these services locally have been prepared.     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