Bedfordshire Joint Prescribing Committee Shared Care Protocol for Methotrexate in the Treatment

Attachment 8A

BEDFORDSHIRE & LUTON JOINT PRESCRIBING COMMITTEE SHARED CARE PROTOCOL FOR USE OF SULFASALAZINE (SULPHASALAZINE) IN THE TREATMENT OF RHEUMATOID ARTHRITIS OR INFLAMMATORY BOWEL DISEASE IN ADULT PATIENTS

PART ONE - BACKGROUND TO SHARED CARE ARRANGEMENTS

PART TWO – SHARED CARE RESPONSIBILITIES OF SPECIALIST, GP AND PATIENT

PART THREE – SPECIFIC INFORMATION RELATING TO THE USE OF SULFASALAZINE (SULPHASALAZINE) IN THE TREATMENT OF RHEUMATOID ARTHRITIS (ADULT PATIENTS)

PART FOUR - SPECIFIC INFORMATION RELATING TO THE USE OF SULFASALAZINE (SULPHASALAZINE) IN THE TREATMENT OF INFLAMMATORY BOWEL DISEASE (ADULT PATIENTS)

BEDFORDSHIRE JOINT PRESCRIBING COMMITTEE SHARED CARE PROTOCOLS GUIDELINES PROMOTING GOOD PRACTICE Guidelines RA Issued: Sept 2005, Revised Jan 2008 Guidelines IBD Issued Jan 2008 Review Date: Attachment 8A

PART ONE – BACKGROUND TO SHARED CARE ARRANGEMENTS A balance is needed between meeting patient need for appropriate treatment delivered in a timely and accessible manner, and the need under clinical governance for GPs to undertake shared care in a manner that ensures their competence and the patient’s safety.

“Shared care” occurs when a hospital specialist retains a responsibility for the on-going monitoring or review of a patient after the point in time when they consider it clinically appropriate for the GP to take over responsibility of routine prescribing.

The NHS Management Executive issued its guidance on prescribing at the hospital/GP interface through EL(91)127 – “Responsibility for prescribing between hospitals and GPs”. Although issued in November 1991 this guidance is still applicable. It reinforces the basic premise that it is for the doctor who has clinical responsibility for a patient to undertake prescribing, and focuses on the concept of shared care, emphasising the need for proper handover procedures from hospital. The doctor who prescribes the medication legally assumes a clinical responsibility for the drug and the consequence of its use.

Shared care guidelines are intended to provide clear guidance to General Practitioners and hospital prescribers regarding the procedures to be adopted when clinical (and therefore prescribing and financial) responsibility for a patient’s treatment with a shared-care drug is transferred from secondary to primary care. Shared care arrangements for individual patients do not always require that a comprehensive written guideline of this type is produced. A verbal agreement between the Consultant and GP may suffice, provided that written confirmation is supplied to the GP of what they are required to monitor and what the key indicators are for referral of the patient back to secondary/tertiary care services for review or to manage suspected adverse effects.

With the introduction of the new GMS contract in April 2004, the Bedfordshire PCTs and General Practitioners had requested that formal shared care guidelines be developed to help support the nationally enhanced service (NES) – Provision of near-patient testing. Consequently the Bedfordshire Joint Prescribing Committee had agreed to develop shared care guidelines for: -  Methotrexate (oral)

 Sulfasalazine (Sulphasalazine), Sodium aurothiomalate, Penicillamine, Auranofin (Combined Shared Care Guidelines for the Prescribing and Monitoring Disease Modifying Anti-rheumatic Drugs {DMARDs})

The Methotrexate Shared Care Guideline was previously issued in March 2005 and considers the use of this drug for Psoriasis in addition to Rheumatoid Arthritis. The Bedfordshire Joint Prescribing Committee has attempted to agree a shared care guideline for the other DMARDs listed above, however local Specialists indicated that it would only be worthwhile to produce such a document with respect to Sulfasalazine as the other drugs are used so infrequently. This shared care guideline covers the use of sulfasalazine for adult patients in the treatment of Rheumatoid Arthritis and Inflammatory Bowel Disease

Given the referral patterns of Bedfordshire patients to secondary care, it is recognised that specific monitoring of patients may differ between Trusts e.g. patients referred to Bedfordshire providers (the Luton & Dunstable and Bedford Hospitals) will have blood tests undertaken at the hospital whereas patients referred to Hospitals outside Bedfordshire may have blood tests undertaken at GP surgeries. In addition the recommendations on frequency of monitoring may differ slightly between different Trusts. Consequently, the shared care guideline may be adapted by agreement between a PCT and its local hospital/specialists to meet local need e.g. availability and location of monitoring/testing facilities.

References: 1. Toolkit to support development of medicines management arrangements with secondary and tertiary care services, Medicines Management, Pharmacy and Prescribing SIG High Priority Competencies, NaTPACT, March 2004. 2. Shared Care Protocol Template, Bedfordshire Joint Prescribing Committee, 1998.

PART TWO SHARED CARE ARRANGEMENTS OF SPECIALIST, GP AND PATIENT FOR USE OF SULFASALAZINE IN THE TREATMENT OF RHEUMATOID ARTHRITIS (ADULT PATIENTS) OR INFLAMMATORY BOWEL DISEASE (ADULT PATIENTS)

PATIENT’S NAME:

PATIENT’S ADDRESS:

HOSPITAL NAME AND NUMBER / PATIENT IDENTIFIER:

CONSULTANT’S NAME:

NAME OF GP:

(A) Hospital Specialist Responsibilities

Assessment and Monitoring  Confirm diagnosis and indication for drug treatment.  Discuss potential benefits and side-effects of treatment with patient.  Carry out baseline monitoring requirements and initiate therapy. The GP will receive copies of the baseline test results.  Appropriate blood tests will normally be undertaken by secondary care and the results monitored by the Specialist. A copy of the blood test results will be sent to the GP for information.  Blood tests may be carried out by the GP by negotiation. If this occurs, the Specialist will advise on the appropriate tests and frequency of monitoring required. Copies of the results will be sent to the Specialist.  Monitor the patient’s response to therapy.  Monitor the patient for any side-effects to therapy and inform the GP if any occur. Report any serious side-effects to the CSM.  Decide when to stop therapy.

Prescribing Arrangements  Continue to prescribe for the patient after initiation of treatment until such time as the patient’s GP agrees to accept prescribing responsibility and provide prescriptions for the patient under an agreed shared care arrangement.  An initial prescription for 1-3 months (may vary depending on drug and time to stabilisation) therapy will be provided by the Specialist.  The GP will be asked to take over prescribing responsibility when the dosage is stabilised (see point above).  The Specialist will advise the GP of any dosage adjustments required, with reasons.

Communication  The Specialist will formally ask the GP to take over prescribing responsibility after the patient’s therapy is stabilised.  The Specialist will provide the GP with a copy of the Shared Care Guidelines.  The Specialist will supply the patient with a ‘patient held record’ and explain its role.  Blood test results, dosage adjustments, will be recorded in the patient held record and hospital medical record.  The dosage regimen should be clearly explained to the patient.

 The patient should be asked to report side-effects (see individual drug fact sheet for specific information)

(B) General Practitioner Responsibilities Assessment and Monitoring  Receive copies of any blood test results carried out in secondary care for information. Blood tests may be carried out by the GP by negotiation - copies of blood test results will be sent to the Specialist.  Monitor the patient for any side-effects to therapy and refer back to the Specialist should any serious side-effect occur.  Refer back to the Specialist if the medication becomes less effective.

Prescribing Arrangements  Take over prescribing of drug after the patient has been stabilised – after about 1-3 months of therapy (but this may vary depending on drug used and time to stabilisation).  Provide repeat prescriptions and adjust dosages on the advice of the Specialist.  Advise Specialist of any other dosage adjustments made, with reasons.

Communication  To ensure that all relevant staff and patients are aware of the shared care arrangements.  GPs and practice nurses need to check that the patient held records are used and presented at all consultations.  Blood test results, dosage adjustments, will be recorded in the patient held record and GP medical record. Any dosage adjustments will also be recorded in computer-based prescribing systems.  The dosage regimen should be clearly explained to the patient.  The patient should be asked to report side-effects (see individual drug fact sheet for specific information)

(C) Patient’s Responsibilities  Discuss potential benefits and side-effects of treatment with the Specialist and GP.  Share any concerns they have in relation to their treatment.  To report any side-effects to the Specialist or GP (see individual drug fact sheet for specific information).  To ensure that the patient held record is presented at every consultation (in primary or secondary care).  To participate in the monitoring of therapy (including having blood tests carried out at agreed intervals) and assessment of outcomes, to assist health professionals to provide safe, appropriate treatment.  To avoid excessive alcohol intake.  To use adequate contraception and report any suspected pregnancy to the GP and/or Specialist.  To inform GP/Specialist of all medicines (including OTC preparations) that the patient is currently taking.

BACK-UP ADVICE AND SUPPORT Relevant contact details to be completed by the Secondary Care at the time of issue of shared care guidelines. This should include details of out of hours support available.

References: - 1. Toolkit to support development of medicines management arrangements with secondary and tertiary care services, Medicines Management, Pharmacy and Prescribing SIG High Priority Competencies, NaTPACT, March 2004. 2. Shared Care Protocol Template, Bedfordshire Joint Prescribing Committee, 1998. 3. Shared Care Guidelines for the Prescribing and Monitoring of Disease Modifying Anti- inflammatory Drugs, (Consultation Document), Reading PCT, March 2004. BEDFORDSHIRE JOINT PRESCRIBING COMMITTEE SHARED CARE PROTOCOLS GUIDELINES PROMOTING GOOD PRACTICE Guidelines RA Issued: Sept 2005, Revised Jan 2008 Guidelines IBD Issued Jan 2008 Review Date: Attachment 8A

PART THREE SPECIFIC INFORMATION RELATING TO THE USE OF SULFASALAZINE (SULPHASALAZINE) ENTERIC COATED TABLETS IN THE TREATMENT OF RHEUMATOID ARTHRITIS (ADULT PATIENTS)

FOR TREATMENT OF RA - ENTERIC-COATED TABLETS ARE USED

Background(1,2) Rheumatoid arthritis (RA) is the most common chronic inflammatory joint disease affecting 0.5 to 1% of the population. Of these approximately 15% have severe disease.

Up to 20% of patients experience a single episode of inflammatory polyarthritis and do not suffer further, but the disease generally has a lifelong course. Up to 10% have acute and rapidly progressive disease, 50% of those affected will be unable to work within ten years and between 6.5% and 12% of patients will become severely disabled. Radiographic damage is seen in more than 70% of patients within the first two years. Life expectancy decreases by three to seven years.

Diagnosis and Treatment (1,2) A diagnosis of RA is made on the basis of clinical symptoms; there is no definitive test.

The present aim of treatment is to control joint inflammation as early as possible after diagnosis. This should lead to pain reduction and maintain the range of joint movement, minimise loss of function, prevent deformity and keep patients mobile and independent. Pharmacological treatments for managing RA include NSAIDs, corticosteroids, disease-modifying anti-rheumatic drugs (DMARDs including methotrexate) and biological drugs.

Indication * (3,4) Treatment of active rheumatoid arthritis (3) Sulfasalazine is one of the usual first choice DMARDs(4)

Dosage and administration * (3,5) Orally - Initially 500mg daily, increased by 500mg daily at weekly intervals to a maximum of 2-3g daily in divided doses.

Contra-indications * (3,5,6)  Patients with a significant hypersensitivity to sulfasalazine, sulphonamides (e.g. co- trimoxazole) or salicylates.  Acute intermittent porphyria (associated with acute attacks).

Cautions * (3,5) (Please see BNF or SPC for complete list)  G-6-PD deficiency: sulfasalazine may cause haemolysis  Slow acetylator status: may cause drug induced lupus like syndrome  Renal impairment (moderate): may cause significant crystalluria and must ensure high fluid intake.  In case of severe renal failure: avoid (7)  Hepatic Impairment

Side-effects * (3,5) (See BNF/SPC for complete listing) About 75% of side effects occur within 3 months of starting therapy, and over 90% by 6 months. Commonly reported are:  nausea, headache, rash, loss of appetite and raised temperature. Blood disorders include:  myelosuppression (resulting in anaemia, leucocytopenia, neutropenia or thrombocytopenia)  other haematological disorders (please see BNF/SPC for disorders listed) Other side effects include:  hypersensitivity reactions (including photosensitisation)  ocular complications BEDFORDSHIRE JOINT PRESCRIBING COMMITTEE SHARED CARE PROTOCOLS GUIDELINES PROMOTING GOOD PRACTICE Guidelines RA Issued: Sept 2005, Revised Jan 2008 Guidelines IBD Issued Jan 2008 Review Date: Attachment 8A

 GI reactions: stomatitis, parotitis  pancreatitis  hepatitis  CNS effects (please see BNF/SPC for reactions listed)  kidney reactions: crystalluria, haematuria, proteinuria and nephrotic syndrome.  oligospermia (reversible)  may colour urine yellow, contact lenses may be stained, tears may be stained.

Drug Interactions* (3,5,8)  Absorption of digoxin or folate may be reduced.  Azathioprine or mercaptopurine – increased risk of haematological toxicity including leucopenia  Antibacterials (except metronidazole) – may reduce the effect of sulfasalazine but information limited to patients when used for inflammatory bowel disease and extent of reduced effect not assessed, Therefore, applicability to RA patients unclear.  Ciclosporin - increased levels of ciclosporin when sulfasalazine stopped (isolated case report, insufficient evidence to recommend increased monitoring, but be aware in case of an unexpected response to treatment.)  Warfarin – INR reduced (isolated case report and its validity has been debated, but be aware in case of an unexpected response to treatment).  Etanercept – decrease in neutrophil counts but clinical significance is not known.  Hypoglycaemic agents – potential for hypoglycaemia.

Monitoring N.B. THE BEDFORDSHIRE JOINT PRESCRIBING COMMITTEE AGREED THAT LOCAL SPECIALISTS COULD REPLACE THIS MONITORING SECTION WITH THEIR DEPARTMENTAL MONITORING GUIDELINES. IN THE ABSENCE OF ALTERNATIVE MONITORING GUIDELINES, GPs ARE ADVISED TO FOLLOW THE RECOMMENDATIONS OUTLINED BELOW. Baseline investigations: FBC, U&Es LFT’s(9), ESR or CRP. Monitoring(9):FBC and LFT’s every month for the first 3 months and then every 3 months. If during the first year, dose and blood results have been stable, 6 monthly tests will suffice for the second year and then monitoring of blood for toxicity could be discarded if stable Following dose changes: Repeat FBC and LFT’s one month after dose increases. Reviews: 6 monthly U&Es and CRP/ESR or plasma viscosity to monitor disease activity

Urgent FBC if patient complains of intercurrent illness during initiation of treatment. (Patient should be asked about the presence of rash or oral ulceration at each visit. Patients should be advised to report immediately any unexplained bleeding, bruising, purpura, sore throat, fever, malaise or unexpected non-specific illness (CSM and SPC warnings)

ACTION TO BE TAKEN (9) WBC < 3.5 or 4.0 x 109 /l or WITHHOLD AND DISCUSS WITH Neutrophil < 2.0 x 109/l or RHEUMATOLOGIST Platelets < 150 X 109/l or >2 fold rise in AST or ALT (from upper limit of reference range) or Oral ulceration

Unexplained acute widespread rash WITHHOLD AND SEEK URGENT SPECIALIST (PREFRABLY DERMATOLOGICAL) ADVICE

Abnormal bruising or severe sore throat CHECK FBC IMMEDIATELY AND WITHHOLD UNTIL RESULTS AVAILABLE.

DISCUSS WITH SPECIALIST IF NECESSARY.

MCV >105fl Withold and check B12 and folate, and TSH. If normal, discuss with Specialist. If folate low, restart treatment with folate supplementation and appropriate monitoring.

Nausea/dizziness/headache If possible continue, may have to reduce dose or stop if symptoms severe. Discuss with Specialist.

PLEASE NOTE THAT IN ADDITION TO ABSOLUTE VALUES OF HAEMATOLOGICAL INDICES A RAPID FALL OR A CONSISTENT DOWNWARD TREND IN ANY VALUE SHOULD PROMPT CAUTION AND EXTRA VIGILANCE

Annual Cost – Sulfasalazine enteric coated tablets £399.75# (Based on a maintenance dose of 1g twice daily) # Prices from Drug Tariff Jan 08. References 1. Developments in the Treatment of Rheumatoid Arthritis, NPC/UKDIPG, May 2000. 2. NICE final scope for clinical guideline, “Rheumatoid arthritis: the management and treatment of rheumatoid arthritis in adults” (Feb 2007) 3. BNF No 54 September 2007 4. Rheumatoid arthritis (PRODIGY Guidance). Clinical Knowledge Summaries Service. Last revised July 2005. Accessed from www.cks.library.nhs.uk on January 24th 08. 5. Summary of Product Characteristics, Salazopyrin En – Tabs, Pharmacia Ltd (Date of Revision 24th August 2006 accessed via http://www.medicines.org.uk/ 6. Martindale, The complete Drug Reference accessed via Medicines Complete on 25th January 08 7. Ashley, C et al The Renal Drug Handbook 2nd edition Radcliffe Medical Press 8. Stockley, I.H, Stockley’s Drug Interactions, Pharmaceutical Press accessed via Medicines complete on 25th January 08 9. Chakravarty K et al BSR & BHPR guideline for disease-modifying anti-rheumatic drug therapy (DMARD) in consultation with the British Association of Dermatologists Rheumatology 2006; 1-18.

*Consult SPC/BNF for full prescribing details.

PART FOUR– SPECIFIC INFORMATION RELATING TO THE USE OF SULFASALAZINE (SULPHASALAZINE) IN THE TREATMENT OF INFLAMMATORY BOWEL DISEASE (ADULT PATIENTS)

Background (1,2) Ulcerative colitis (UC) and Crohn’s disease (CD) are the most common forms of inflammatory bowel disease (IBD). UC causes inflammation and ulceration of the rectum and colon. Symptoms include bloody diarrhoea and rectal bleeding. CD usually causes inflammation and ulceration of the small intestine, but it can affect any part of the digestive tract. The main symptoms are abdominal pain, diarrhoea and weight loss. Extraintestinal manifestations may also exist in IBD. Both diseases are chronic conditions characterised by periods of clinical relapse and remission.

Up to 240 000 people are affected by IBD in the UK, and although the incidence of UC is stable it may be increasing for CD. The peak incidence of both diseases is between the ages of 10 and 40 years, however they may affect people of any age and 15% of people are over the age of 60 at diagnosis. After the first year approximately 90% of UC patients are fully capable of work, whereas CD tends to cause greater disability with only 75% of patients fully capable of work in the year after diagnosis and 15% of patients unable to work after 5–10 years of disease. There is a small increase in mortality for both diseases, largely dependent on age and distribution of disease.

Diagnosis and Treatment (1,2,3,4) The diagnosis of IBD is confirmed by clinical evaluation and a combination of investigations.

Effective management of IBD requires drug therapy, attention to nutrition, and in severe or chronic active disease, surgery. Aim of drug therapy is to treat acute attacks promptly and effectively, and then to maintain remission. The choice and formulation of drug depends largely on the severity of the disease and the areas of the bowel that are affected.

Treatment of acute mild to moderate IBD includes the use of aminosalicylates (e.g. sulfasalazine) and corticosteroids. In severe cases other immunosuppressants may also be indicated.

For maintaining remission, lifelong therapy is generally recommended for all patients with UC. For CD, the efficacy of drug therapy appears to depend on whether remission was achieved with medical or surgical therapy, on the risk of relapse, and site of disease. Aminosalicylates are effective at preventing relapse of UC but are of less value in CD (sulfasalazine is not licensed for maintenance of CD(3,5)). Steroids are generally not suitable for maintenance treatment. In resistant or frequently relapsing cases immunosuppressive therapy is considered.

Indication (3,5) UC; Treatment of mild to moderate and severe ulcerative colitis and maintenance of remission. CD: Active Crohn's disease.

Dosage and administration * (3,5) Orally – acute attack of UC & CD: 1–2 g 4 times daily until remission occurs, reducing to a maintenance dose of 500 mg 4 times daily (remission treatment for UC only). Rectally – suppositories (alone or in conjunction with oral treatment) 0.5–1 g morning and night after a bowel movement.

Contra-indications * (3,5,6)  Patients where there is a significant hypersensitivity to sulfasalazine, sulphonamides (e.g. co- trimoxazole) or salicylates.  Acute intermittent porphyria (associated with acute attacks). Cautions* (3,5) Please see BNF or SPC for complete list)  G-6-PD deficiency: sulfasalazine may cause haemolysis  Slow acetylator status: may cause drug induced lupus like syndrome BEDFORDSHIRE JOINT PRESCRIBING COMMITTEE SHARED CARE PROTOCOLS GUIDELINES PROMOTING GOOD PRACTICE Guidelines RA Issued: Sept 2005, Revised Jan 2008 Guidelines IBD Issued Jan 2008 Review Date: Attachment 8A

 Renal impairment (moderate): may cause significant crystalluria and must ensure high fluid intake.  In case of severe renal failure: avoid (7)  Hepatic Impairment

Side-effects * (3,5) (See BNF/SPC for complete listing) See BNF/SPC for complete listing) About 75% of side effects occur within 3 months of starting therapy, and over 90% by 6 months. Commonly reported are:  nausea, headache, rash, loss of appetite and raised temperature. Blood disorders include:  myelosuppression (resulting in anaemia, leucocytopenia, neutropenia or thrombocytopenia)  other haematological disorders (please see BNF/SPC for disorders listed) Other side effects include:  hypersensitivity reactions (including photosensitisation)  ocular complications  GI reactions: stomatitis, parotitis  pancreatitis  hepatitis  CNS effects (please see BNF/SPC for reactions listed)  kidney reactions:crystalluria, haematuria, proteinuria and nephrotic syndrome.  oligospermia (reversible)  may colour urine yellow, contact lenses may be stained, tears may be stained.

Drug Interactions* (3,5,8)  Absorption of digoxin or folate may be reduced (oral sulfasalazine only)  Azathioprine or mercaptopurine – increased risk of haematological toxicity including leucopenia  Antibacterials (except metronidazole) – may reduce the effect of sulfasalazine in IBD patients but extent of reduced effect not assessed, therefore as a precaution be alert for this effect.  Ciclosporin - increased levels of ciclosporin when sulfasalazine stopped (isolated case report, insufficient evidence to recommend increased monitoring, but be aware in case of an unexpected response to treatment.)  Warfarin – INR reduced (isolated case report and its validity has been debated, but be aware in case of an unexpected response to treatment).  Etanercept – decrease in neutrophil counts but clinical significance is not known.  Hypoglycaemic agents – potential for hypoglycaemia

Monitoring N.B. THE BEDFORDSHIRE JOINT PRESCRIBING COMMITTEE AGREED THAT LOCAL SPECIALISTS COULD REPLACE THIS MONITORING SECTION WITH THEIR DEPARTMENTAL MONITORING GUIDELINES. IN THE ABSENCE OF ALTERNATIVE MONITORING GUIDELINES, GPs ARE ADVISED TO FOLLOW THE RECOMMENDATIONS OUTLINED BELOW. Baseline investigations(2,9): FBC, U&Es LFT’s, ESR or CRP Monitoring(9): FBC and LFT’s every month for the first 3 months and then every 3 months. If during the first year, dose and blood results have been stable, 6 monthly tests will suffice for the second year and then monitoring of blood for toxicity could be discarded if stable. Patients should be asked about the presence of rash or oral ulceration at each visit. Following dose changes(9): Repeat FBC and LFT’s one month after dose increases. Reviews(9): 6 monthly U&Es and CRP/ESR

Urgent FBC if patient complains of intercurrent illness during initiation of treatment. (Patient should be asked about the presence of rash or oral ulceration at each visit. Patients should be advised to report immediately any unexplained bleeding, bruising, purpura, sore throat, fever, malaise or unexpected non-specific illness (CSM and SPC warnings)

ACTION TO BE TAKEN (9) WBC < 3.5 or 4.0 x 109 /l or WITHHOLD AND DISCUSS WITH Neutrophil < 2.0 x 109/l or RHEUMATOLOGIST Platelets < 150 X 109/l or >2 fold rise in AST or ALT (from upper limit of reference range) or Oral ulceration Unexplained acute widespread rash WITHHOLD AND SEEK URGENT SPECIALIST (PREFRABLY DERMATOLOGICAL) ADVICE

Abnormal bruising or severe sore throat CHECK FBC IMMEDIATELY AND WITHHOLD UNTIL RESULTS AVAILABLE. DISCUSS WITH SPECIALIST IF NECESSARY. MCV >105fl Withhold and check B12 and folate, and TSH. If normal, discuss with Specialist. If folate low, restart treatment with folate supplementation and appropriate monitoring. Nausea/dizziness/headache If possible continue, may have to reduce dose or stop if symptoms severe. Discuss with Specialist.

PLEASE NOTE THAT IN ADDITION TO ABSOLUTE VALUES OF HAEMATOLOGICAL INDICES A RAPID FALL OR A CONSISTENT DOWNWARD TREND IN ANY VALUE SHOULD PROMPT CAUTION AND EXTRA VIGILANCE

Cost – Oral:# Acute attack: £33.72 – £67.44 per 28 days treatment Maintenance: £219.18 per annum Rectal##: £240.24 - £480.48 per annum

# Prices from Drug Tariff Jan 08. ## - Chemist and Druggist Feb 2008 References 1. NICE Guidance Leukapheresis of IBD June 2005 2. Carter M J et al on behalf of IBD Section of the British Society of Gastroenterology Guidelines for the management of inflammatory bowel disease in adults Gut 2004;53(Suppl V):v1 – 16 3. BNF 54 September 2007 4. Baumgart D C and Carding S R Inflammatory Bowel Disease: clinical aspects and established and evolving therapies Lancet 2007;369:1641-1657 5. Summary of Product Characteristics - Salazapyrin EN (Date of Revision [DOR] 24th August 06, Salazopyrin Tablets (DOR – 10th Jan 06), Salazopyrin Suspension (DOR – 19th Oct 05) Salazopyrin Suppositories (DOR – 8TH Aug 07) accessed via http://www.medicines.org.uk/ 6. Martindale, The complete Drug Reference accessed via Medicines Complete on 25th January 08 7. Ashley, C et al The Renal Drug Handbook 2nd edition Radcliffe Medical Press 8. Stockley, I.H, Stockley’s Drug Interactions, Pharmaceutical Press accessed via Medicines complete on 25th January 08 9. Chakravarty K et al BSR & BHPR guideline for disease-modifying anti-rheumatic drug therapy (DMARD) in consultation with the British Association of Dermatologists Rheumatology 2006; 1- 18.

*Consult SPC/BNF for full prescribing details.

BEDFORDSHIRE JOINT PRESCRIBING COMMITTEE SHARED CARE PROTOCOLS GUIDELINES PROMOTING GOOD PRACTICE Guidelines RA Issued: Sept 2005, Revised Jan 2008 Guidelines IBD Issued Jan 2008 Review Date: