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1 With thanks to WEL CCGs and Surrey Heartland MMT May 2020
Drug Monitoring for autoimmune conditions During Covid-19
This document has been produced in conjunction with General practitioners in primary care, Homerton hospital specialists and the City and Hackney Medicines Management Team. This document is only to be used during the COVID-19 pandemic and for those patients that require shielding.
Contents Purpose of document ........................................................................................................... 2
General definition of stable and patient selection ................................................................. 2
How are patients being contacted about ‘shielding’? ............................................................ 3
Immunosuppressive medication used in Inflammatory Bowel Disease (IBD) conditions ...... 4
Disease Modifying Anti Rheumatic Agents (DMARDs) used in rheumatologic conditions .... 6
Immunosuppressive medications used in dermatological conditions .................................... 8
Hydroxycarbamide for Myeloproliferative disorders and Sickle cell patients ....................... 10
Homerton Contacts ................................................................................................................ 11
Barts Health contacts ......................................................................................................... 11
References ......................................................................................................................... 12
2 With thanks to WEL CCGs and Surrey Heartland MMT May 2020
Purpose of document The COVID-19 pandemic has resulted in the need to significantly alter general medical practice. In order to assist with this, a number of national bodies have issued advice on how certain drugs can be managed in light of the pandemic to both offer safe and effective treatment and also reduce the risk of exposure to COVID-19. The aim of this document is to provide a concise tailored resource to help manage some high risk medicines. Guidance issued by the UK Department of Health on 24th March 2020, 'Shielding and protecting people defined on medical grounds as extremely vulnerable from COVID-19’, issued advice shielding for people on immunosuppression therapies sufficient to significantly increase risk of infection have been identified as one of the patient cohorts for intervention. High risk drugs that require routine management are usually considered as a role that should continue. Specialists at Homerton University Hospital NHS Foundation Trust (HUHFT) have been consulted along with advice from national bodies to provide altered monitoring requirements in order to assist primary care management of high risk drugs for immunosuppressive conditions. All recommendations should however be considered on an individual case by case basis taking into consideration individual characteristics. The final decision must be based on clinical judgement as these drugs are generally shared care drugs. Hospital specialists should be contacted for individualised advice if needed (see contacts section). If any results come back as abnormal, monitoring should revert back to the original schedule. Previous monitoring guidelines will resume once it is safe to do so. This document is accurate at the time of writing and will be updated by the City and Hackney medicines management team. Prescribers are however advised to also note UK Government advice and national bodies (see references).
General definition of stable and patient selection This may change for individual drugs see correct section for specific advice. In general, in situations where patients are required to remain shielded for 3 months, the following advice can be given: Patients who have been on treatment for less than 12 months and/or on their current
dose for less than 6 weeks should continue to be monitored as per the standard shared care agreement schedule.
For patients under shared care who have been on treatment for > 12 months AND where their last TWO blood monitoring tests have been normal AND current dose has been stable for THREE months may be suitable for extended monitoring. In rheumatology patients on a stable dose for 6 weeks can be considered for extended monitoring.
3 With thanks to WEL CCGs and Surrey Heartland MMT May 2020
Extension of drug monitoring is not suitable if the patient has: Poor renal function with CKD ≥ 3. Severe liver disturbance or abnormal liver results due to DMARDs within previous 3
months. Severe abnormal WBC results due to DMARDs within previous 3 months.
How are patients being contacted about ‘shielding’? NHS England have asked Trust providers and GP practices to contact patients using
correspondence letters. Trust providers can identify and should contact patients on biologic therapies/monoclonal antibodies, small molecule immunosuppressants or cyclophosphamide infusions.
GP practices can identify and should contact patients on a combination of immunosuppressants, high dose prednisolone or immunosuppressant and corticosteroid dual therapy using the COVID-19 patient shielding GP letter template.
Advice on practice searches can be found on the NHS digital COVID-19 information page link
The Clinical Effectiveness Group have developed searches to help identify patients. This can be accessed under EMIS Library SNOMED Searches EMIS Clinical Utilities Drug Monitoring
4 With thanks to WEL CCGs and Surrey Heartland MMT May 2020
Immunosuppressive medication used in Inflammatory Bowel Disease (IBD) conditions Advice for management of IBD (Crohn’s disease and ulcerative colitis) patients is based on the followings: Public Health England (PHE) ‘Guidance on shielding and protecting people who are
clinically extremely vulnerable from COVID-19’. The British Society of Gastroenterology (BSG) ‘Consensus advice for the
management of IBD during the COVID-19 pandemic’. Consultation with local IBD teams.
Which patients should be ‘shielded’? Please click here to see shielding advice from the BSG. Patients with short gut syndrome requiring nutritional support or those requiring parenteral nutrition are also ‘high risk’ – these patients should be managed by specialists from hospital. How do we monitor ‘shielded’ IBD patients on immunomodulators A majority of the ‘high risk’ patient groups will continue to be managed by the specialists, through telephone consultations, e.g. those on drug therapies prescribed and monitored by the hospital only. Extended monitoring schedule may be appropriate for patients under shared
care who have been on treatment for > 12 months AND where their last TWO blood monitoring tests have been normal AND current dose has been stable for THREE months:
Medication Current monitoring schedule
Suggested schedule during COVID
Methotrexate (MTX) 3 monthly 6 monthly
Azathioprine 3 monthly 6 monthly
Mercaptopurine 3 monthly 6 monthly
No monitoring is required for patients on sulfasalazine after 1 year, For patients on
treatment <1 year, 3 monthly monitoring should continue. Extending blood monitoring is not suitable if the patient has:
o Poor renal function with CKD ≥ 3 o Severe liver disturbance or abnormal liver results due to DMARDs within
previous 3 months o Severe abnormal WBC results due to DMARDs within previous 3 months
5 With thanks to WEL CCGs and Surrey Heartland MMT May 2020
What if my patient develops symptoms of COVID-19? Seek clinical advice from the Specialist Gastroenterology teams before making any
changes: o Stopping immunosuppressive medicine in IBD may cause a flare which will
increase the risk of complications. Patients must not suddenly stop prednisolone (both oral and rectal). 5ASA (5-aminosalicylic acid e.g. mesalazine, balsalazie, olsalazine, sulfasalazine)
medicines are safe and should be continued. Patients can take paracetamol to manage symptoms, ibuprofen and NSAIDs should
be avoided
Patient information For patients who are well but concerned, the most up to date advice can be found on: Crohns and Colitis UK website, which has links to the latest government and Public
Health England advice. The British Society of Gastroenterology advice-on-covid-19-for-patients-
withgastrointestinal-or-liver-conditions and Patients can enter their details on the COVID-19 UK IBD-registry to support the
identification of high-risk patients.
6 With thanks to WEL CCGs and Surrey Heartland MMT May 2020
Disease Modifying Anti Rheumatic Agents (DMARDs) used in rheumatologic conditions Which patients should be ‘shielded’? Please click here to see shielding advice from The British Society of Rheumatology (BSR). Note use of either hydroxychloroquine and/or sulfasalazine alone is not considered to cause immunosuppression. Other COVID-19 resources from BAD including patient template letters can be found here.
How do we monitor ‘shielded’ patients? Patients who have been on treatment for less than 12 months and/or on their
current dose for less than 6 weeks should continue to be monitored as per the
standard shared care agreement schedule.
Patients who experience flare ups for joint flares, IM Depomedrone 120mg can be
given.
Extended monitoring schedule may be appropriate for patients under shared
care who have been on treatment for > 12 months AND where their last TWO
blood monitoring tests have been normal AND current dose has been stable
for 6 weeks.
Medication Current monitoring schedule
Suggested schedule during COVID-19
Methotrexate (MTX) 3 monthly 6 monthly
Azathioprine 3 monthly 6 monthly
Mercaptopurine 3 monthly 6 monthly
Penicillamine 3 monthly 6 monthly
Leflunomide 3 monthly 6 monthly
Hydroxychloroquine* Nil Nil
*For hydroxychloroquine consider suspending annual eye assessment with ophthalmologist advice Standard monitoring schedule for 12 months based on shared care guidelines, then no routine monitoring needed unless abnormalities are detected in FBC or LFTs are detected in last 3 months. For patients on treatment <1 year, 3 monthly monitoring should continue. No monitoring is required for patients on sulfasalazine after 1 year, based on current
shared care schedule. For patients on treatment <1 year, 3 monthly monitoring should continue.
Patients on leflunomide, alongside methotrexate or an immunosuppressant are at high risk of adverse effects, and current monitoring should continue as advised by specialist.
7 With thanks to WEL CCGs and Surrey Heartland MMT May 2020
What if my patient develops symptoms of COVID-19? Patients can take paracetamol to manage symptoms, ibuprofen and other NSAIDs
should be avoided, unless clinically indicated for an existing condition. Patients must not suddenly stop prednisolone. Patients can continue hydroxychloroquine and sulfasalazine if they are infected with
coronavirus. If a patient is infected with coronavirus, they should temporarily stop their
conventional DMARDs, JAK inhibitors and biological therapies. In cases of coronavirus with mild symptoms, patients should restart their usual
medications as soon as they are systemically well after 14 days from the onset of symptoms, and/or have finished course of antibiotics.
Only contact the rheumatology service for advice regarding re-start of medication for cases with severe/persisting symptoms or requiring hospital admission. There is a also a Homerton hospital website containing further information on this www.homerton.nhs.uk/rheumatology/
Patient information Communicate with patients and support their mental wellbeing, signposting to charities and support groups (such as ARMA, which has a list of relevant organisations, and NHS Volunteer Responders) where available, to help alleviate any anxiety and fear they may have about COVID-19. www.nhs.uk/oneyou/every-mind-matters/coronavirus-covid-19-staying-at-home-tips/
8 With thanks to WEL CCGs and Surrey Heartland MMT May 2020
Immunosuppressive medications used in dermatological conditions Which patients should be ‘shielded’? Please click here for shielding advice from the British Association of Dermatologists (BAD). Other COVID-19 resources from BAD including patient template letters can be found here. How do we monitor ‘shielded’ patients? Patients who have been on treatment for less than 12 months and/or on their
current dose for less than 6 weeks should continue to be monitored as per the standard shared care agreement schedule. If this is not possible contact the relevant specialist for advice.
For patients who experience flare ups that are severe they should contact the medical Dermatology Team and they can arrange for urgent review.
For patients under shared care who have been on treatment for > 12 months AND where their last TWO blood monitoring tests have been normal AND current dose has been stable for THREE months consider the following monitoring schedule:
Medication Current monitoring Schedule
Suggested schedule during covid-19
Methotrexate 3 Monthly 4 Monthly
Azathioprine 3 Monthly 4 Monthly
Mycophenolate 3 Monthly 4 Monthly
Ciclosporin 3 Monthly 4 Monthly
Acitretin 3 Monthly 6 Monthly
Hydroxychloroquine* Nil Nil
*For hydroxychloroquine consider suspending annual eye assessment with ophthalmologist advice What if my patient develops symptoms of COVID-19? Patients can take paracetamol to manage symptoms, ibuprofen and NSAIDs should
be avoided, unless clinically indicated for an existing condition. Patients should continue with topical treatments. Patients must not suddenly stop prednisolone. Patients can continue hydroxychloroquine, chloroquine, mepacrine, dapsone and
sulfasalazine if they are infected with coronavirus. If a patient is infected with coronavirus, they should temporarily stop their
conventional DMARDs, novel small-molecule immunosuppressants and biological therapies.
In cases of coronavirus with mild symptoms, patients should restart their usual medications once they are symptom free and if oral antibiotics have been prescribed for a concomitant infection, once the prescribed course has been completed.
9 With thanks to WEL CCGs and Surrey Heartland MMT May 2020
Only contact the dermatology service for advice regarding re-start of medication for cases with severe symptoms or requiring hospital admission.
Patient information Communicate with patients, their families and carers, and support their mental health and wellbeing to help alleviate any anxiety and fear they may have about COVID-19. Signpost to sources of online information (such as the British Association of Dermatologists' patient hub), support groups (including NHS Volunteer Responders) and UK government guidance on the mental health and wellbeing aspects of COVID-19.
10 With thanks to WEL CCGs and Surrey Heartland MMT May 2020
Hydroxycarbamide for Myeloproliferative disorders and Sickle cell patients Hydroxycarbamide (also known as hydroxyurea) is an Amber shared care drug in City and Hackney. The local SCG covers psoriasis, sickle cell anaemia and myeloproliferative disorders. Patients in City and Hackney usually obtain their supply of hydroxycarbamide either directly from HUHFT pharmacy or via their GP. In order to maintain consistency patients should continue to receive their medication from their usual prescriber. However, in light of COVID-19 there has been some slight changes to the usual recommendations.
Monitoring of patients There is a temporary recommendation that all stable patients on hydroxycarbamide
have monitoring delayed for an additional 12 weeks. Patients with an unchanged hydroxycarbamide dose for at least 6 months and stable
counts (with fluctuations within 100 range) for at least 12 months are considered as stable.
Stable patients should remain on their current dose of hydroxycarbamide with no changes in dosing until further review.
HUHFT pharmacy team are posting 3 to 4 months’ worth of prescriptions to patients who normally receive their medication directly from the Homerton pharmacy.
City and Hackney GPs who normally prescribe hydroxycarbamide are being asked to continue to prescribe for stable patients at their current dose.
All patients on hydroxycarbamide should be advised not to collect their own medication. Medication should be collected from the community pharmacy either via family or friends or by accessing C&H pharmacy delivery service. GPs should issue patients with their usual one month supply of medication to maintain supplies in the community.
Patients who have not been on a stable dose of hydroxycarbamide should contact the relevant specialist for an individual care plan.
Communication The majority of HUHFT patients with myeloproliferative disorders have been sent a letter explaining that their medication (hydroxycarbamide) is being kept at their current dose for now. Patients should be urged to remain on their usual hydroxycarbamide dosages to maintain good health and avoid hospital admissions.
11 With thanks to WEL CCGs and Surrey Heartland MMT May 2020
Homerton Contacts
Homerton department Contact
Consultant or Registrar on-call via switchboard
020 8510 5555
Homerton pharmacy medicines information 0208 510 7000 [email protected]
City & Hackney CCG medicines management team
0203 816 3224 [email protected]
Dermatology Via advice and guidance on eRS Helpline: 0208 510 7690
Gastroenterology [email protected] Helpline: 07920 546 260
Haematology – myeloproliferative disorders
Haematology – sickle cell centre 0207 683 4570 [email protected]
Rheumatology [email protected] Helpline: 07917 521 117 Nurse Specialist Advice Line: 0208 510 7200 Rheumatology secretary telephone: 0208 510 7612 (for any other queries)
There is also the A+G query line available on eRS
Barts Health contacts
Barts Health department Contact
Switchboard for Mile End, St Bartholomew’s and The Royal London
0207 377 7000
Switchboard for Whipps Cross 0207 476 4000
Switchboard for Newham 0208 539 5522
Barts Health pharmacy medicines information
0208 535 6971
Dermatology [email protected] Out of hours: bleep SpR or consultant on-call via switchboard for the relevant site
Gastroenterology IBD helpline 020 3594 3700
Rheumatology As per contact detail on patient’s clinic letter Out of hours: bleep SpR or consultant on-call via switchboard for the relevant site
Neurology
12 With thanks to WEL CCGs and Surrey Heartland MMT May 2020
References
1. Guidance on shielding and protecting people defined on medical grounds as extremely vulnerable from COVID-19. Public Health England. Updated 30 March 2020. https://www.gov.uk/government/publications/guidance-on-shielding-and-protecting-extremelyvulnerable-persons-from-covid-19/guidance-on-shielding-and-protecting-extremely-vulnerablepersons-from-covid-19
2. COVID-19: guidance for rheumatologists. British Society for Rheumatology. April 2020. https://www.rheumatology.org.uk/news-policy/details/covid19-coronavirus-update-members
3. SPS - Specialist Pharmacy Service advice on drug monitoring in primary care during COVID19 April 2020. https://www.sps.nhs.uk/articles/dmard-drug-monitoring-in-primary-care-duringcovid-19/
4. BSG expanded consensus advice for the management of IBD during the COVID-19 pandemic, British Society of Gastroenterology (BSG), https://www.bsg.org.uk/covid-19-advice/bsg-advice-for-management-of-inflammatory-bowel-diseases-during-the-covid-19-pandemic/ - accessed online May 2020
5. Dermatology Advice Regarding Self-Isolation and Immunosuppressed Patients: Adults, Paediatrics and Young People, British Association of Dermatologists (BAD). https://www.bad.org.uk/healthcare-professionals/covid-19/covid-19-immunosuppressed-patients - accessed online May 2020
6. National Institute for Health and Care Excellence (2020) COVID-19 rapid guideline: dermatological conditions treated with drugs affecting the immune response NG 169 Available at https://www.nice.org.uk/guidance/ng169 -accessed May 2020
7. National Institute for Health and Care Excellence (2020) COVID- 19 rapid guideline: rheumatological autoimmune, inflammatory and metabolic bone disorders NG 167 Available at https://www.nice.org.uk/guidance/ng167accessed May 2020
8. National Institute for Health and Care Excellence (2020) COVID-19 rapid guideline: gastrointestinal and liver conditions treated with drugs affecting the immune response NG 172 Available at- https://www.nice.org.uk/guidance/ng172 -accessed May 2020
