DMARD Shared Care Guidelines

1. DMARD Shared Care Guidelines Sam Thomson 8/9/2010

2. DMARDS

3. DMARDs • Azathioprine = 6 Mercaptopurine • Ciclosporin • Sodium Aurothiomalate = Myocrisin = Gold • Hydroxychloroquine • Leflunomide • Methotrexate • Penicillamine • Sulfasalazine

4. JAPC Shared Care Agreement • Derbyshire Joint Area Prescribing Committee • Based on British Society of Rheumatology Guidelines

5. Introduction • Due to the potentially serious side-effects that Disease Modifying Anti-Rheumatic Drugs (DMARDs) can occasionally cause, regular blood monitoring is necessary. • In Derbyshire DMARDs are classified as AMBER drugs i.e. considered suitable for GP prescribing following specialist initiation of therapy and patient stabilisation, with specific long term monitoring for toxicity needing ongoing specialist support.

6. The concept of drugs that GPs would not routinely initiate and therefore would not normally be familiar with is encompassed in Dept. of Health EL(91)127 “Responsibility for prescribing between Hospitals and GPs”.

7. Referral Criteria • Shared Care is only appropriate if it provides the optimum solution for the patient. • Prescribing responsibility will only be transferred when it is agreed by the consultant and the patient’s GP that the patient’s condition is stable or predictable.

8. Referral Criteria • Safe prescribing must be accompanied by effective monitoring • Patients will only be referred to the GP once the GP has agreed in each individual case. • Once stable the patient will be given a supply of Methotrexate sufficient for 4 weeks maintenance therapy.

9. Three Areas of Responsibility • GP • Consultant • Patient

10. GP 1. Ensure compatibility with other concomitant medication. 2. Prescribe the dose and formulation recommended. 3. Monitor FBC, U&E, creatinine, LFTs at recommended frequencies and refer if abnormal. 4. Adjust the dose as advised by the specialist.

11. GP 5. Stop treatment on the advice of the specialist or immediately if any urgent need to stop treatment arises. 6. Report adverse events to the specialist and CSM. 7. Update the patient’s methotrexate booklet 8. Always prescribe oral methotrexate using multiples of the 2.5mg strength tablet, AVOID USING THE 10mg STRENGTH.

12. Consultant 1. Discuss the possible benefits and side effects of treatment with the patient. 2. Perform baseline tests (FBC, U&E, & LFT, CXR. PFTs may be undertaken in some patients 3. Provide results of baseline tests 4. Prescribe methotrexate for the first month or until the patient is stable. 5. Recommend dose of the drug and frequency of monitoring.

13. Consultant 6. Periodically review the patient and advise the GP promptly on when to adjust the dose, stop treatment or consult with the specialist. 7. Ensure that clear backup arrangements exist for GPs to obtain advice and support. 8. Report adverse events to the CSM and GP. 9. Provide the patient with the NPSA hand held methotrexate booklet 10. Where parenteral methotrexate is used ensure that the patient is trained and able to administer their methotrexate injections or alternative appropriate arrangements for administration are in place

14. Patient 1. Report to the specialist or GP if there is not a clear understanding of the treatment and share any concerns in relation to treatment. 2. Inform specialist or GP of any other medication being taken including over-the-counter products. 3. Report any adverse effects or warning symptoms to the specialist or GP whilst taking the drug. 4. Carry and present their methotrexate booklet to their GP and community pharmacy at each prescribing and dispensing activity

15. Local Enhanced Services - LES Or how the GP gets paid! • Standard A – Specialist/Clinic interprets bloods & physical monitoring and advises GP is safe to continue to prescribe with any changes to prescription of DMARD • £6.50 per patient per year

16. LES • Standard B – GP interprets bloods & physical monitoring as per shared care protocol to determine if safe to prescribe. If out of range to contact specialist for advice and make changes to DMARD as instructed • Fees - £30.00 per patient as a one off administration fee - £5.00 a month per patient on the register

17. GP Tasks • Keep a register of patients • Evidence of robust, systematic and responsive recall system for monitoring and review as laid down in the shared care guideline • Mechanisms to deal with non-attendees

18. BSR Guidelines

19. General Advice • Beware drug interactions • Review individual monitoring protocols when dose changes are implemented • Patients should not receive immunisation with live vaccines • Beware infections treat vigorously - check FBC and U&E

20. General Advice • Beware oral ulceration, sorethroats, nosebleeds, bruising, rash • If patients come into close contact with Herpes Zoster, consider passive immunisation • If BP >140/90 manage hypertension according to NICE Hypertension Guidance

21. Frequency of Monitoring • See quick reference guide for specifics • Any discretionary reduction in the frequency of monitoring should only be on the instruction of a Rheumatology specialist • Enter result in patient-held record book

22. Withhold treatment & liaise with Specialist if:- • Severe rash or bruising or ulceration of mucous membranes. • Any unexplained illness occurs including nausea or diarrhoea • If urinary protein on dipstick is 2+ send a MSU for culture. If MSU confirms infection, treat appropriately. If sterile proteinuria – seek advice

23. Seek Help If : • WCC falls <3.5 x 109/l • Neutrophils <2.0 x 109/l • Eosinophils >0.5 x 109/l • Platelet count falls below <150 x 109/l • MCV > 105 f/l • Creatinine >30% of baseline • LFTs (ALT or AST) increase > 2 fold rise above upper limit reference range (Leflunomide special rules – see above and full text)

24. Who to contact • In hours, Rheumatology helpline - 01332 787710 Out of hours, On call Pharmacist - 01332 340131 bleep 1395

25. Websites