DMARD Shared Care DMARD Shared Care GuidelinesGuidelines

Sam ThomsonSam Thomson8/9/20108/9/2010

DMARDSDMARDS

DMARDsDMARDs

Azathioprine = 6 MercaptopurineAzathioprine = 6 Mercaptopurine CiclosporinCiclosporin Sodium Aurothiomalate = Myocrisin = GoldSodium Aurothiomalate = Myocrisin = Gold HydroxychloroquineHydroxychloroquine LeflunomideLeflunomide MethotrexateMethotrexate PenicillaminePenicillamine SulfasalazineSulfasalazine

JAPC Shared Care AgreementJAPC Shared Care Agreement

Derbyshire Joint Area Prescribing Derbyshire Joint Area Prescribing CommitteeCommittee

Based on British Society of Rheumatology Based on British Society of Rheumatology GuidelinesGuidelines

IntroductionIntroduction

Due to the potentially serious side-effects that Due to the potentially serious side-effects that Disease Modifying Anti-Rheumatic Drugs Disease Modifying Anti-Rheumatic Drugs (DMARDs) can occasionally cause, regular blood (DMARDs) can occasionally cause, regular blood monitoring is necessary. monitoring is necessary.

In Derbyshire DMARDs are classified as AMBER In Derbyshire DMARDs are classified as AMBER drugs i.e. considered suitable for GP prescribing drugs i.e. considered suitable for GP prescribing following specialist initiation of therapy and patient following specialist initiation of therapy and patient stabilisation, with specific long term monitoring for stabilisation, with specific long term monitoring for toxicity needing ongoing specialist support.toxicity needing ongoing specialist support.

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

Referral CriteriaReferral Criteria Shared Care is only appropriate if it Shared Care is only appropriate if it

provides the optimum solution for the provides the optimum solution for the patient.patient.

Prescribing responsibility will only be Prescribing responsibility will only be transferred when it is agreed by the transferred when it is agreed by the consultant and the patient’s GP that the consultant and the patient’s GP that the patient’s condition is stable or predictable.patient’s condition is stable or predictable.

Referral CriteriaReferral Criteria

Safe prescribing must be accompanied by Safe prescribing must be accompanied by effective monitoringeffective monitoring

Patients will only be referred to the GP once Patients will only be referred to the GP once the GP has agreed in each individual case.the GP has agreed in each individual case.

Once stable the patient will be given a Once stable the patient will be given a supply of Methotrexate sufficient for 4 weeks supply of Methotrexate sufficient for 4 weeks maintenance therapy.maintenance therapy.

Three Areas of ResponsibilityThree Areas of Responsibility

GPGP ConsultantConsultant PatientPatient

GPGP1. Ensure compatibility with other 1. Ensure compatibility with other

concomitant medication.concomitant medication.2. Prescribe the dose and formulation 2. Prescribe the dose and formulation

recommended.recommended.3. Monitor FBC, U&E, creatinine, LFTs at 3. Monitor FBC, U&E, creatinine, LFTs at

recommended frequencies and refer if recommended frequencies and refer if abnormal.abnormal.

4. Adjust the dose as advised by the 4. Adjust the dose as advised by the specialist.specialist.

GPGP

5. Stop treatment on the advice of the 5. Stop treatment on the advice of the specialist or immediately if any urgent need specialist or immediately if any urgent need to stop treatment arises.to stop treatment arises.

6. Report adverse events to the specialist and 6. Report adverse events to the specialist and CSM.CSM.

7. Update the patient’s methotrexate booklet7. Update the patient’s methotrexate booklet8. Always prescribe oral methotrexate using 8. Always prescribe oral methotrexate using

multiples of the 2.5mg strength tablet, multiples of the 2.5mg strength tablet, AVOID USING THE 10mg STRENGTH.AVOID USING THE 10mg STRENGTH.

ConsultantConsultant

1. Discuss the possible benefits and side 1. Discuss the possible benefits and side effects of treatment with the patient.effects of treatment with the patient.

2. Perform baseline tests (FBC, U&E, & 2. Perform baseline tests (FBC, U&E, & LFT, CXR. PFTs may be undertaken in LFT, CXR. PFTs may be undertaken in some patients some patients

3. Provide results of baseline tests3. Provide results of baseline tests4. Prescribe methotrexate for the first month 4. Prescribe methotrexate for the first month

or until the patient is stable.or until the patient is stable.5. Recommend dose of the drug and 5. Recommend dose of the drug and

frequency of monitoring.frequency of monitoring.

ConsultantConsultant6. Periodically review the patient and advise the 6. Periodically review the patient and advise the

GP promptly on when to adjust the dose, stop GP promptly on when to adjust the dose, stop treatment or consult with the specialist.treatment or consult with the specialist.

7. Ensure that clear backup arrangements exist for 7. Ensure that clear backup arrangements exist for GPs to obtain advice and support.GPs to obtain advice and support.

8. Report adverse events to the CSM and GP.8. Report adverse events to the CSM and GP.9. Provide the patient with the NPSA hand held 9. Provide the patient with the NPSA hand held

methotrexate bookletmethotrexate booklet10. Where parenteral methotrexate is used ensure 10. Where parenteral methotrexate is used ensure

that the patient is trained and able to administer that the patient is trained and able to administer their methotrexate injections or alternative their methotrexate injections or alternative appropriate arrangements for administration are appropriate arrangements for administration are in placein place

PatientPatient

1. Report to the specialist or GP if there is not a clear 1. Report to the specialist or GP if there is not a clear understanding of the treatment and share any understanding of the treatment and share any concerns in relation to treatment.concerns in relation to treatment.

2. Inform specialist or GP of any other medication 2. Inform specialist or GP of any other medication being taken including over-the-counter products.being taken including over-the-counter products.

3. Report any adverse effects or warning symptoms 3. Report any adverse effects or warning symptoms to the specialist or GP whilst taking the drug.to the specialist or GP whilst taking the drug.

4. Carry and present their methotrexate booklet to 4. Carry and present their methotrexate booklet to their GP and community pharmacy at each their GP and community pharmacy at each prescribing and dispensing activityprescribing and dispensing activity

Local Enhanced Services - LESLocal Enhanced Services - LES

Or how the GP gets paid!Or how the GP gets paid!

Standard A – Specialist/Clinic interprets Standard A – Specialist/Clinic interprets bloods & physical monitoring and advises bloods & physical monitoring and advises GP is safe to continue to prescribe with any GP is safe to continue to prescribe with any changes to prescription of DMARDchanges to prescription of DMARD

£6.50 per patient per year£6.50 per patient per year

LESLES Standard B – GP interprets bloods & Standard B – GP interprets bloods &

physical monitoring as per shared care physical monitoring as per shared care protocol to determine if safe to prescribe. If protocol to determine if safe to prescribe. If out of range to contact specialist for advice out of range to contact specialist for advice and make changes to DMARD as and make changes to DMARD as instructedinstructed

Fees - £30.00 per patient as a one off Fees - £30.00 per patient as a one off administration feeadministration fee

- £5.00 a month per patient on the - £5.00 a month per patient on the registerregister

GP TasksGP Tasks

Keep a register of patientsKeep a register of patients Evidence of robust, systematic and Evidence of robust, systematic and

responsive recall system for monitoring and responsive recall system for monitoring and review as laid down in the shared care review as laid down in the shared care guidelineguideline

Mechanisms to deal with non-attendeesMechanisms to deal with non-attendees

BSR GuidelinesBSR Guidelines

General AdviceGeneral Advice

Beware drug interactions Beware drug interactions Review individual monitoring protocols Review individual monitoring protocols

when dose changes are implementedwhen dose changes are implemented Patients should not receive immunisation Patients should not receive immunisation

with live vaccines with live vaccines Beware infections treat vigorously - check Beware infections treat vigorously - check

FBC and U&EFBC and U&E

General AdviceGeneral Advice

Beware oral ulceration, sorethroats, Beware oral ulceration, sorethroats, nosebleeds, bruising, rash nosebleeds, bruising, rash

If patients come into close contact with If patients come into close contact with Herpes Zoster, consider passive Herpes Zoster, consider passive immunisation immunisation

If BP >140/90 manage hypertension If BP >140/90 manage hypertension according to NICE Hypertension Guidance according to NICE Hypertension Guidance

Frequency of MonitoringFrequency of Monitoring

See quick reference guide for specificsSee quick reference guide for specifics Any discretionary reduction in the frequency Any discretionary reduction in the frequency

of monitoring should only be on the of monitoring should only be on the instruction of a Rheumatology specialist instruction of a Rheumatology specialist

Enter result in patient-held record book Enter result in patient-held record book

Withhold treatment & liaise with Withhold treatment & liaise with Specialist if:- Specialist if:-

Severe rash or bruising or ulceration of Severe rash or bruising or ulceration of mucous membranes. mucous membranes.

Any unexplained illness occurs including Any unexplained illness occurs including nausea or diarrhoea nausea or diarrhoea

If urinary protein on dipstick is 2+ send a If urinary protein on dipstick is 2+ send a MSU for culture. If MSU confirms infection, MSU for culture. If MSU confirms infection, treat appropriately. If sterile proteinuria – treat appropriately. If sterile proteinuria – seek adviceseek advice

Seek Help If :Seek Help If :

WCC falls <3.5 x 109/l WCC falls <3.5 x 109/l Neutrophils <2.0 x 109/l Neutrophils <2.0 x 109/l Eosinophils >0.5 x 109/l Eosinophils >0.5 x 109/l Platelet count falls below <150 x 109/l Platelet count falls below <150 x 109/l MCV > 105 f/l MCV > 105 f/l Creatinine >30% of baseline Creatinine >30% of baseline LFTs (ALT or AST) increase > 2 fold rise above LFTs (ALT or AST) increase > 2 fold rise above

upper limit reference range (Leflunomide special upper limit reference range (Leflunomide special rules – see above and full text) rules – see above and full text)

Who to contactWho to contact

In hours, Rheumatology helpline In hours, Rheumatology helpline - 01332 787710- 01332 787710

Out of hours, On call PharmacistOut of hours, On call Pharmacist- 01332 340131 bleep 1395- 01332 340131 bleep 1395

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