Shared Care Guideline
Hydroxychloroquine (Adults)Introduction / This shared care agreement outlines the responsibilities between the specialist and the generalist for managing the prescribing of hydroxychloroquine for indications listed below.
Indication / Rheumatoid arthritis and inflammatory osteoarthritis, discoid and systemic lupus erythematosus, and dermatological conditions caused or aggravated by sunlight.
Licensing information / Treatment of rheumatoid arthritis, discoid and systemic lupus erythematosus, and dermatological conditions caused or aggravated by sunlight.
Dosage and administration / Usually started at a dose of 200mg twice daily for the first three months and then reduced to 200mg daily as a maintenance dose if effective (aim for 3-5mg/kg/day using ideal bodyweight ideally not exceeding 6.5mg/kg).
Contraindications and cautions / Contraindications
· Known hypersensitivity to 4-aminoquinoline compounds eg chloroquine.
· Pre-existing maculopathy of the eye.
· Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
Cautions
· Hepatic and renal disease, and in those taking drugs known to affect those organs.
· Severe gastrointestinal, neurological (especially history of epilepsy) or blood disorders.
· Sensitivity to quinine, those with glucose-6-phosphate dehydrogenase deficiency, those with porphyria cutanea tarda which can be exacerbated by hydroxychloroquine and in patients with psoriasis since it appears to increase the risk of skin reactions.
· Severe hypoglycaemia has been reported, even in the absence of anti-diabetic medication.
· May aggravate Myasthenia gravis.
· Safe for use in Pregnancy and Breast Feeding
Adverse drug reactions / The most commonly reported adverse reactions were :
Gastrointestinal disturbances such as nausea, diarrhoea, anorexia and
abdominal pain – usually resolve with dose reduction or on drug discontinuation.
Headache - resolves on drug discontinuation.
Skin reactions including skin rashes sometimes occur- these usually resolve on drug discontinuation. Treatment may exacerbate porphyria cutanea tarda or psoriasis.
Corneal deposits - These occur early and may be transient. They are reversible on stopping treatment.
Retinal damage- may be permanent: see monitoring requirements. The occurrence of retinopathy is rare if the recommended daily dose is not exceeded. This is dose dependant so lowest effective dose is used.
Muscle myopathy- Is rare and reversible after discontinuation of the drug but recovery may take many months.
Bone marrow depression is rare. Ensure patient is informed on how to identify signs of infection.
For full list see BNF or SPC at www.medicines.org.uk/EMC
Drug Interactions / · Amiodarone, moxifloxacin and droperidol increased risk of ventricular arrhythmias AVOID concomitant use
· Ciclosporin - concomitant use increases plasma levels of ciclosporin
· Digoxin- concomitant use increases plasma levels of digoxin.
Monitor digoxin levels closely.
· Insulin and antidiabetic drugs- doses of such medication may need decreasing due to enhanced effects caused by hydroxychloroquine.
· Antacids: absorption reduced by antacids.
For full list see BNF or SPC at www.medicines.org.uk/EMC
Duration of Treatment / For rheumatic disease treatment should be discontinued if there is no improvement by 6 months. If effective the treatment is likely to be lifelong or as long as it is effective.
Responsibilities of the specialist initiating treatment / General:
· To assess the suitability of the patient for treatment.
· To ensure that the patient/carer has received counselling and understands the therapy, its benefits, limitations, continued monitoring (where applicable), adverse effects and need for reliable method of contraception.
· Inform the GP of the information provided to the patient.
· To review the patient as agreed intervals and copy all relevant results to the GP
· Carry out disease and drug monitoring as listed below
· At reviews, enquire if patient has visited optometrist for visual acuity check – recommend yearly review
· Formally hand over to GP by letter and patient informed - send a copy (either electronically or paper copy) of the Shared Care Guideline to the GP and ask whether they are willing to participate in shared care.
Prescribing:
· Initiate treatment with hydroxychloroquine. The GPs will be typically asked to take up the monitoring and prescribing after one month of treatment.
Disease & drug monitoring:
· Monitor bloods according to schedule: baseline
FBC, LFTs, U+Es / Baseline
Ophthalmological examination / If pre-existing ocular pathology or visual disturbance.
Otherwise Ask patient about visual impairment (not corrected by glasses
Recommend baseline optometrist review then yearly whilst on treatment. If remaining on treatment at 5 years then Ophthalmology review.
· Discuss shared care arrangement with patient.
· Support and advise GPs as required.
· Assess response to treatment and initiate any dose changes as clinically appropriate including discontinuation of treatment.
Responsibilities of the General Practitioner / General and Prescribing:
· Monitor and prescribe as recommended by the specialist. The GPs will be typically asked to take up the monitoring and prescribing of hydroxychloroquine approximately one month after initiation.
· Contact specialist if not able to prescribe/monitor.
· Notify specilaist if treatment with hydroxychloroquine is discontinued.
· Ensure there are no drug interactions with any other medications initiated in primary care.
· Obtain satisfactory assurance from patient of regular annual visual acuity check by optometrist.
Disease & drug monitoring:
· Carry out drug monitoring as listed – and communicate abnormal results to the Specialist.
· Urgent drug discontinuation/ referral to specialist as clinically appropriate
· To stop treatment on the advice of the specialist.
· To refer back to the Specialist if the patient’s condition deteriorates.
· To identify adverse effects if the patient presents with any signs and liaise with the hospital Specialist where necessary. To report adverse effects to the Specialist and where appropriate to the Commission on Human Medicines/MHRA (Yellow Card scheme).
Unless otherwise stated by the secondary care Specialist, apply the following monitoring frequencies following handover from secondary care:
Renal function / In over 70s or if pre-existing renal impairment or known hypertension/ diabetes, Annual check should be carried out.
Ophthalmological examination / Annual visual acuity/ fundoscopy and amsler charting by optometrist.
Refer to ophthalmologist if visual acuity changes or if vision is blurred. Also in patients who have taken hydroxychloroquine for more than 5 years.
· Stop medication and contact specialist if: Photophobia/Haloes/Visual field defects/reduced acuity/abnormal colour vision/ pigmentary abnormality/ muscle weakness
Responsibilities of the Patient/ Carer / · Must report any disturbances of vision to their GP and/or specialist.
· Report any other adverse effects to their GP and/or specialist.
· Attend annual check of vision by optometrist.
· .
· Ensure they attend for monitoring requirements.
Communication / Specialist to GP:
· The specialist will inform the GP when they have initiated hydroxychlorquine and when there are any subsequent changes in treatment – standard clinic letter.
· Send a copy (either electronically or paper copy) of the Shared Care Guideline to the GP and ask whether they are willing to participate in shared care.
· Inform the GP of the information provided to the patient
GP to Specialist:
· Inform specialist if unable to prescribe/monitor
· Irrespective of whether you accept prescribing responsibility or not, you should inform the specialist of relevant medical information regarding the patient and changes to the patient’s medication regime irrespective of indication.
· Notify specialist if treatment with hydroxychloroquine is discontinued.
Specialist
Contacts / Department of Rheumatology – 01423 553389
Department of Dermatology – 01423 553740
Medicines Information – 01423 553084
References / · British National Formulary accessed online 5/5/17
· Summary of Product Characteristics www.medicines.org.uk Accessed
· Yorkshire Regional Rheumatology DMARD Guidelines, 6th Edition, revised May 2014.
· Julia Flint, et.al, on behalf of the BSR and BHPR Standards, Guidelines and Audit Working Group; BSR and BHPR guideline on prescribing drugs in pregnancy and breastfeeding—Part I: standard and biologic disease modifying anti-rheumatic drugs and corticosteroids. Rheumatology (Oxford) 2016; 55 (9): 1693-1697. doi: 10.1093/rheumatology/kev404. Available from: https://academic.oup.com/rheumatology/article/55/9/1693/1744535/BSR-and-BHPR-guideline-on-prescribing-drugs-in
Reviewed: May 2017
Review date : May 2019