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:

  1. 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
  2. the service to the patient is convenient
  3. the use of resources by the National Health Service is efficient.
  4. there is consistency with the existing shared care protocol for Methotrexate prescribing

Service outline

This local enhanced service will fund:

(i) a shared care drug monitoring service whichis specifically for Methotrexate and for the management of rheumatology patients not attending DRI.

  • 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
  • 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

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:

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

Appendix A

SHARED CARE GUIDELINE FOR METHOTREXATE

Indication:Treatment of Rheumatoid Arthritis

Prescribing:

  • 5 mg – 25 mg Methotrexate, as a single dose, onceevery 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:

  • 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:

  • Baseline FBC, full LFTs (including GGT), U&Es (ELU), creatinine, chest x-ray
  1. FBC and LFT (including AST or ALT) – fortnightly until 4 weeks after last dose increase. If then stable, monthly
  2. 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

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

  • WBC <4 x 109/l
  • Neutrophils<2 x 109/l
  • Platelets<150 x 109/l
  • AST/ALT>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 urgentFBC)
  • 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

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
  • Active infection / immunodeficiency syndromes
  • Known allergy or sensitivity to Methotrexate
  • Moderate / severe renal impairment (creatinine >300 micromoles/l)
  • Previous Methotrexate induced lung disease

NB:

  1. Avoid vaccination with live vaccine, eg. Rubella, Yellow Fever, BCG, Polio
  2. Take specialist advice before household contacts receive live vaccinations eg. Rubella, BCG, Yellow Fever, Polio
  3. Pneumovax and annual influenza vaccination are recommended and should be offered
  4. 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

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)

SHARED CARE PROFORMA

METHOTREXATE

PATIENT DETAILS

Name ...... DOB ...... NHS No ……………………..

Address......

ConsultantDr Al-KoffashGP………………………………………………………

CLINICAL CONDITION

Condition Rheumatoid arthritis

Drug, Dosage & Route

Relevant Past Medical History: - ...... …......

……………………………………………………………..……………

Date Methotrexate Initiated by Consultant ………………………………………………………..……..

Expected duration……………………………………………...

Date GP requested to prescribe from ……..……………………

Other regular medication: - …………………………………..

…………………………………….

……………………………………..

OR: Current Medication list appended: YES NO

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):Debra Battersby contact number 01909 502398

ii) Consultant Rheumatologist:Dr Al-Koffash contact number 01909 502694

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<4 x 109/l

Neutrophils<2 x 109/l

Platelets <150 x 109/l

AST/ALT>2 fold increase on 2 occasions or significant rise from baseline

MCV>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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