Download Methotrexate monitoring

Revised 24.02.09
NHS Doncaster
Local Enhanced Service
Provision of near-patient monitoring - METHOTREXATE
Introduction
All practices are expected to provide essential and those additional services they are
contracted to provide to all their patients. This enhanced service specification
outlines the more specialized services to be provided. The specification of this
service is designed to cover the enhanced aspects of clinical care of the patient all of
which are beyond the scope of essential services. No part of the specification by
commission, omission or implication defines or redefines essential or additional
services.
Background
This Local Enhanced Service acknowledges the existence of current ‘shared care
protocols for Rheumatology. The treatment of several diseases within the fields of
medicine, particularly in rheumatology, is increasingly reliant on drugs that, while
clinically effective, need regular blood monitoring. This is due to the potentially
serious side-effects that these drugs can occasionally cause. It has been shown that
the incidence of side-effects can be reduced significantly if this monitoring is carried
out in a well-organised way, close to the patient’s home.
This LES requires both the Specialist Consultant and GP to care for the patient and
those who provide this service must abide by this. Its purpose is to provide
Methotrexate monitoring and treatment to patients receiving NHS rheumatology care
not covered by the RHEMOS system. This LES has been developed to provide a
specialist service for those patients and practices this affects.
This does not include rheumatology patients who attend Doncaster Royal infirmary,
who are covered by the Rhemos system.
Aims
The near patient monitoring service is designed to be one in which:
i.
the maintenance of patients, first stabilized on Methotrexate in the secondary
care setting, will be properly controlled by a defined programme of monitoring
in primary care
the service to the patient is convenient
the use of resources by the National Health Service is efficient.
there is consistency with the existing shared care protocol for Methotrexate
prescribing
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Service outline
This local enhanced service will fund:
(i) a shared care drug monitoring service which is specifically for Methotrexate
and for the management of rheumatology patients not attending DRI.
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Prescribe monthly oral Methotrexate once patient stable and shared care has
been agreed
Identify adverse events if the patient presents with any signs and liaise with
the hospital specialist if any complications of treatment arise
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Perform the required blood tests at the correct frequencies
Monitor blood results and action as detailed
Stop treatment on the advice of the hospital specialist or if the GP feels it is
clinically indicated
Monitoring in primary care:
FBC and LFTs (including AST or ALT) – monthly
U&E (ELU) – 6 monthly
Review patient for potencies and side effects – opportunistically
Take appropriate action if patient presents with symptoms of potential
adverse effects
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See Appendix A for full details.
This will also require:
a register. Practices must be able to produce and maintain an up-to-date register of
all such patients on Methotrexate, indicating patient name, date of birth and the
indication and duration of treatment, last hospital and next expected out-patient
appointment date and any significant events.
call and recall. To ensure that systematic call and recall of patients on this register is
taking place in accordance with the monitoring schedule attached
continuing information for patients. To ensure that all patients (and/or their carers
and support staff when appropriate) are informed of how to access appropriate and
relevant information
individual management plan. To ensure that the patient has received from
secondary care an individual management plan, which gives the reason for
treatment, the planned duration, the monitoring timetable and, if appropriate, the
therapeutic range to be obtained
professional links. To work together with other professionals as appropriate. Any
health professionals involved in the care of patients in the programme should be
appropriately trained
referral policies. Where appropriate to refer patients promptly to other necessary
services and to the relevant support agencies using locally agreed guidelines where
these exist. This will also include referral back to the consultant when specific need
arises as a result of the monitoring programme
record keeping. To maintain adequate records of the service provided, incorporating
all known information relating to any significant events e.g. hospital admissions,
death of which the practice has been notified
training. Each practice must ensure that all staff involved in any clinical aspect of
care under this scheme has sufficient knowledge and experience or receive sufficient
training and skills to undertake this LES
annual review. All practices involved in the scheme must submit an annual report to
primary care, which will include:
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a) The process and protocols utlilised in this monitoring scheme, including
details of any computer-assisted decision-making equipment used and
arrangements for internal and external quality assurance
b) Details as to any near-patient testing equipment used and arrangements for
internal and external quality assurance
c) Details of training, education, the knowledge and experience relevant to the
drug monitoring service
d) Audit of the standards used by staff for the control of the relevant condition as
detailed in the shared care protocol attached
Untoward events
It is a condition of participation in this LES that practitioners will give notification, in
addition to their statutory obligations, within 72 hours of the information becoming
known to him/her, to the PCT Director of Quality and Clinical Assurance, of all
emergency admissions or deaths of any patient covered under this service, where
such admission or death is or may be due to usage of the drug(s) in question or
attributable to the relevant underlying medical condition.
Accreditation
Those doctors who have previously provided services similar to the proposed
enhanced service and who satisfy at appraisal and revalidation that they have such
continuing medical experience, training and competence as is necessary to enable
them to contract for the enhanced service shall be deemed professionally qualified to
do so.
Costs
In 2008/9 each practice contracted to provide this service will receive a level cost per
patient on the register of £50.75 per quarter.
Payment Mechanism
Practices will submit claims under this LES on a quarterly basis using the
PCTs approved form. With affect from the 1st April 2009 all claims for this
service must be submitted by the following quarter
e.g.:Q1 information should be submitted by 30th September
Q2 information should be submitted by 30th December
Q3 information should be submitted by 30th March
Q4 information should be submitted by 30th June
This enhanced service will be subject to review and can be terminated by the
PCT or the contractor with 3 months notice
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Appendix A
SHARED CARE GUIDELINE FOR METHOTREXATE
Indication:
Treatment of Rheumatoid Arthritis
Prescribing:
 5 mg – 25 mg Methotrexate, as a single dose, once every week with/after
food (prescribe 2.5 mg strength tablets only) – specifying total dose in mg
and number and strength of tablets eg.
10 mg (four x 2.5 mg tablets)
 Reduce Methotrexate dose in mild renal impairment (creatinine > 150
micromoles/l) or frail elderly
 Prescribe folic acid – 5 mg once a week, 2-3 days after Methotrexate
Hospital Consultant Responsibilities:
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To assess the suitability of the patient for treatment including consideration of
contra-indications and possible drug interactions and to ensure that there are
no interactions with any other medications initiated
To perform baseline tests
To inform the patient of:
 the benefits and side effects of Methotrexate treatment
 the weekly dosing and long term monitoring required
Issue patient information booklet before initiating treatment
Advise and document requirement to avoid alcohol
To initiate and stabilise treatment and supply patient with a Methotrexate
monitoring booklet
To assess and monitor the patient’s response to treatment
To monitor the patient for adverse events and report any to the CSM and GP
To adjust treatment as clinically necessary until stable
Invite the GP to participate in shared care, not less than 4 weeks after
invitation to participate in shared care sent, and discuss the shared care
arrangement with the patient
Complete and send proforma to GP
Supply a further month’s medication to patient
Inform patient of changed arrangements for blood tests and prescriptions
Support and advise the GP
Retain clinical responsibility for patients requiring treatment with high dose
Methotrexate (above 25 mg per week)
Advise patient to make appointment with GP 4 weeks’ hence
Monitoring in secondary care:
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Baseline FBC, full LFTs (including GGT), U&Es (ELU), creatinine, chest xray
I. FBC and LFT (including AST or ALT) – fortnightly until 4 weeks after last dose
increase. If then stable, monthly
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II. U&E – 6 monthly or more frequently if deterioration in renal function
suspected or likely
GP Responsibilities:
 To prescribe monthly oral Methotrexate once patient stable and shared care
has been agreed
 To identify adverse events if the patient presents with any signs and liaise
with the hospital specialist if any complications of treatment arise
 To perform the required blood tests at the correct frequencies
 Monitor blood results and action as detailed
 To stop treatment on the advice of the hospital specialist or if the GP feels it is
clinically indicated
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Monitoring in primary care:
FBC and LFTs (including AST or ALT) – monthly
U&E (ELU) – 6 monthly
Review patient for potencies and side effects – opportunistically
Take appropriate action if patient presents with symptoms of potential
adverse effects
Stop Methotrexate and contact Secondary Care
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<4 x 109/l
<2 x 109/l
<150 x 109/l
>2 fold increase on 2 occasions or significant rise
from baseline
MCV
>105 fl
New rash, photosensitivity, nausea, alopecia
Unexplained bruising / bleeding, fever, sore throat, oral or pharyngeal
ulceration (obtain urgent FBC)
Unexplained, new or increasing dyspnoea, cough
Deterioration in renal function (>10% of normal) or creatinine >300
micromoles/l
Unexplained fall in albumin
Presentation with chicken pox or varicella zoster
WBC
Neutrophils
Platelets
AST/ALT
Change of Dose or Medication
In the case of changed therapy, Secondary care assumes responsibility for the
monitoring and re-prescription of Methotrexate until stable dose has been
successfully achieved. GP will then be re-contacted and invited to participate in
shared care arrangements.
Contra-Indications:
 Hepatic disease / alcoholism
 Pregnancy / planned pregnancy within 3 months of treatment (men & women)
 Breast feeding
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Active infection / immunodeficiency syndromes
Known allergy or sensitivity to Methotrexate
Moderate / severe renal impairment (creatinine >300 micromoles/l)
Previous Methotrexate induced lung disease
NB:
I. Avoid vaccination with live vaccine, eg. Rubella, Yellow Fever, BCG,
Polio
II. Take specialist advice before household contacts receive live
vaccinations eg. Rubella, BCG, Yellow Fever, Polio
III. Pneumovax and annual influenza vaccination are recommended and
should be offered
IV. Before treatment inititated, patients should be advised to avoid alcohol
Drug Interactions:
 Anaesthetics – eg. Nitrous oxide
 Analgesics – eg. NSAID
 Antibacterials – eg. Ciprofloxacin AVOID Co-Trimoxazole and Trimethoprim
 Antiepileptics – eg. Phenytoin
 Antimalarials
 Antipsychotics
 Immunosuppresants – eg. Ciclosporin/Corticosteroids
 Cytotoxics
 Uricosurics
 Xanthines
 Proton Pump Inhibitors
If any problems occur or you have any concerns, please contact the relevant
specialist:
Debra Battersby (Specialist Nurse) - contact number 01909 502398
[email protected]
Dr Al-Koffash - contact number 01909 502694
Bassetlaw Pharmacy - contact number 01909 500990
References:
British Society for Rheumatology: National guidelines for the monitoring of
Second Line Drugs
(2000)
MTRAC Template – Effective Shared Care Agreement (Methotrexate) 2004
SIGN guideline 48 (Dec 2000, updated 2004)
BNF No. 50 2005
North Nottinghamshire Rheumatology Shared care Guidelines (2003)
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SHARED CARE PROFORMA
METHOTREXATE
PATIENT DETAILS
Name ..................................................
DOB ......................
NHS No ……………………..
Address........................................................................................................................................
Consultant
Dr Al-Koffash
GP
………………………………………………………
CLINICAL CONDITION
Condition
Rheumatoid arthritis
Drug, Dosage & Route
Methotrexate …………..mg orally, as a single dose ONCE a week
Folic Acid 5 mg once a week, 2-3 days post Methotrexate
Relevant Past Medical History: -
................................................................................…...................
……………………………………………………………..……………
Date Methotrexate Initiated by Consultant ………………………………………………………..……..
Expected duration……………………………………………...
Date GP requested to prescribe from ……..……………………
…………………………………..
…………………………………….
……………………………………..
OR: Current Medication list appended: YES
NO
Other regular medication: -
Baseline Investigations done (indicate
readings outside normal range):
FBC
…………….. Chest x-ray …………….
Date ………………… Date ……………………
LFTs
…………….. Creatinine ………….….
Date ………………… Date ……………………
U&Es …………….
Date …………………
GP monitoring arrangements: Please see over
Potential Adverse Reactions: - Hepatotoxicity, pulmonary toxicity, bone marrow toxicity
Responsibility / Action in case of problems: - The GP will contact secondary care who will be
responsible for contacting the patient and advising
patient on action to take.
Proposals for future management: The GP will stop repeat prescription until invited to resume shared
care arrangements by secondary care.
i) Specialist Nurse (office hours):
ii) Consultant Rheumatologist:
Debra Battersby
contact number 01909 502398
[email protected]
Dr Al-Koffash
contact number 01909 502694
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iii)
Bassetlaw Pharmacy contact number 01909 500990
Hospital review date (not more than 12 months) ………………………………………………………
We agree to undertake monitoring and act on results according to the agreed guidelines in this Shared Care proposal:
…………………………………
(signature – Dr Al-Koffash)
………………….
(date)
……………………………….
(GP signature)
…………..……..
(date)
………….…………………………………………..
(Name – BLOCK CAPITALS)
MONITORING ARRANGEMENTS
1.
Side effects enquiry:
Opportunistically check for:
Rash or oral ulceration
New or increasing cough / dyspnoea
Abnormal bruising
Sore throat
2.
Stop Methotrexate and contact Secondary Care if ANY of the Following Occur:
WBC
Neutrophils
Platelets
AST/ALT
MCV
<4 x 109/l
<2 x 109/l
<150 x 109/l
>2 fold increase on 2 occasions or significant rise from baseline
>105fl
New rash, photosensitivity, nausea, alopecia
Unexplained bruising/bleeding, fever, sore throat with oral or pharyngeal ulceration (obtain urgent
FBC)
New or increasing dyspnoea and/or cough
Deterioration in renal function ( >10% rise in creatinine or creatinine >300 micromoles/l)
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