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TAMESIDE & GLOSSOP PCT
Service Specification for Local Enhanced Service
Monitoring of Disease Modifying Drugs for Rheumatological and other Medical Conditions

1. Service Users

The Local Enhanced Service for the Monitoring of Disease Modifying Drugs for Rheumatological
and other Medical Conditions shall be provided to Registered Patients that are taking the drugs
described below.
2. Service Requirements

The Provider shall meet the following service requirements:
Provide a shared care drug monitoring service, in accordance with the monitoring requirements in respect of the following specified drugs (Appendix A): o Penicillamine; o Auranofin; o Sulfasalazine; o Methotrexate; o Sodium Aurothiomalate; o Leflunomide; o Azathioprine; and o Ciclosporin; Produce and maintain an up-to-date register of all shared care drug monitoring service Patients, indicating Patient name, date of birth and the indication and duration of treatment and last hospital appointment; Ensure that systematic call and recall of Patients on the register is taking place either in a Educate all newly diagnosed/treated Patients (and/or their carers when appropriate) and advice on management and prevention of secondary complications of their condition that includes written information where appropriate; Inform all Patients (and/or their carers and support staff when appropriate) of how to access appropriate and relevant information in accordance with the Patient’s clinical need; Produce an individual management plan that gives the reason for treatment, the planned duration, the monitoring timetable and, if appropriate, the therapeutic range to be obtained; Work together with other professionals when appropriate, in accordance with Patient’s Refer Patients promptly to other necessary services and to the relevant support agencies using any locally agreed guidelines where these exist; Maintain adequate records of the service provided, incorporating all known information relating to any Adverse Incidents e.g. hospital admissions, death of which the Provider has been notified; All Clinical Staff involved in providing any aspect of care under this service shall have the Perform an annual review which includes: o Brief details as to arrangements for each of the aspects of the Monitoring of Disease Modifying Drugs for Rheumatological and other Medical Conditions Service; o Details as to any computer-assisted decision-making equipment used and arrangements for internal and external quality assurance; o Details as to any near-patient testing equipment used and arrangements for internal o Details of training and education relevant to the Monitoring of Disease Modifying Drugs for Rheumatological and other Medical Conditions Service; o Details of the standards used for the control of the relevant condition; and o Assurance that any Clinical Staff responsible for prescribing must have developed the necessary skills to prescribe safely.
3. Accreditation / Training Requirements

To deliver the Monitoring of Disease Modifying Drugs for Rheumatological and other Medical
Conditions Service the Provider will need to gain the following accreditation/training:
Those Clinical Staff who have previously provided services similar to the Monitoring of Disease Modifying Drugs for Rheumatological and other Medical Conditions 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 be deemed professionally qualified to do so. Apply to the Service Lead for accreditation which will include signing a declaration that the provider is complying to the requirements of the scheme.
4. Costs
Payments will be made on a quarterly basis at a rate of £12.50 for each patient monitored for each
drug i.e. if a patient is receiving two of the listed drugs and is being monitored on each drug the
payment will be £25.00 per quarter.
Appendix A
Monitoring Requirements for Patients on Disease Modifying Drugs for Rheumatological and
other Medical Conditions


Penicillamine PROTOCOL NUMBER: 04
Indication: Rheumatoid arthritis
General guidance
This protocol sets out details for the shared care of Patients taking PENICILLAMINE.
Background
Penicillamine is an effective second-line drug used in the treatment of rheumatoid arthritis.


Dosage Regimes
125mg daily, increasing by 125mg increments every 4 weeks to 500mg daily if tolerated. Some
Patients respond to a lower dose, occasionally 750mg a day is required. If no response in 1 year
discontinue treatment. Not to be taken within 2 hours of food.
Monitoring
FBC, U&E, LFTs prior to treatment.
Urinalysis prior to treatment.
FBC, urinalysis every 2 weeks for 8 weeks, 1 week after any dosage increment, monthly
thereafter.

Source: NES Specification for Near Patient Testing
Auranofin PROTOCOL NUMBER: 09
Indication: Rheumatoid Arthritis
General guidance
This protocol sets out details for the shared care of Patients taking AURANOFIN.
Background
Auranofin in general is less effective, less toxic and slower to induce a remission than
intramuscular gold, and clinical benefit may not become apparent for up to 3-6 months

Dosage Regimes
3. 6mg daily - either 6mg before breakfast, or 3mg bd before meals.
Monitoring
FBC, U&E, LFTs prior to treatment
Urinalysis prior to treatment
FBC, urinalysis every 2 weeks for 3 months then monthly

Source: NES Specification for near Patient Testing
Sulfasalazine
Indication: Rheumatoid Arthritis
General guidance
This protocol sets out details for the shared care of Patients taking SULFASALAZINE.
Background
Sulfasalazine (Salazopyrin) is widely used for the long term treatment of rheumatoid arthritis.
There are two preparations in use, Salazopyrin EN, (oval, film coated) and generic Sulfasalazine
(round, uncoated). The former is considered to have less GI side effects.

Dosage Regimes
500mg daily increasing by 500mg weekly until maintenance dose 2-3g daily
Some Patients may respond to a lower dose. Treatment may be continued indefinitely, the usual
reason for stopping being loss of benefit. Sulfasalazine is sometimes co-prescribed with other anti-
rheumatic agents.
Monitoring
FBC, U&E, LFTs prior to treatment.
FBC, LFTs at 3, 6 & 12 weeks, every 3 months thereafter.
Urgent FBC if Patient complains of intercurrent illness during initiation of treatment.

Source: PCT scheme
Methotrexate

Indication: Rheumatoid Arthritis, Psoriasis
General guidance
This protocol sets out details for the shared care of Patients taking METHOTREXATE.
Background
Methotrexate is an effective second-line drug used in the treatment of rheumatoid arthritis and
psoriasis. It has both immunosuppressant and anti-inflammatory effects.


Dosage Regimes
Initially 5mg to 20mg orally once weekly, usually as a single dose
Annual flu vaccine should be given .
Monitoring
FBC inc differential count ALL fortnightly for 6 weeks then monthly
WCC; platelets, ESR, LFTs provided dose stable
U & Es, creatinine Monthly

Source: PCT scheme

Sodium Aurothiomalate (Myocrisin) PROTOCOL NUMBER: 08

Drug Indication: Rheumatoid Arthritis
General guidance
This protocol sets out details for the shared care of Patients taking SODIUM AUROTHIOMALATE.
Background
Sodium aurothiomalate is a slow-acting drug effective in controlling disease activity in 60-70% of
Patients with rheumatoid arthritis. Improvement can be expected after 2-3 months (400-600 mg
total dose), and in the absence of toxicity gold injections can be continued indefinitely

Dosage Regimes

10mg IM test dose then 50mg one week later followed by 50mg weekly to a total dose of 500mg. If
there is a clinical response, the frequency of injections can be reduced to every 2 weeks up to a
total dose of 1g. In the absence of an improvement continue at 50mg weekly to a total dose of 1g.
If after 1g there is clinical improvement, reduce the frequency of injections to every 3-4 weeks. If
no response after 1g total dose stop gold.
Dose record cards are available from the hospital and must be carefully maintained.
Monitoring

FBC, U+E, LFTs prior to treatment
Urinalysis prior to treatment
FBC, urinalysis prior to each injection
(ESR/CRP is useful to assess response to therapy)

Source: NES Specification for Near Patient Testing
LEFLUNOMIDE (ARAVA)


Dosage Regimes
100 mgs per day for 3 days, followed by 10 – 20 mgs daily. Leflunomide should not be used
in conjunction with other DMARDS

Monitoring

FBC inc differential count Fortnightly until dose stable then monthly
WCC: platelets, ESR It is permissible to work one FBC in arrears
Blood pressure and LFTs Monthly

Source: PCT scheme
AZATHIOPRINE (Imuran)


Dosage Regimes
1.5 – 2.5 mg/kg daily with food
Monitoring

FBC including differential count, All fortnightly for 8 weeks then every 4 weeks unless dose
WCC, ESR, LFTs changed

Source: PCT scheme
CICLOSPORIN


Dosage Regimes
2.5 mgs/kg daily in 2 divided doses. If no response at 6 weeks increase dose gradually to 4 mg.kg
daily.
Monitoring

B/P & Serum Creatinine x 2 Before commencing treatment
B/P & Serum Creatinine Fortnightly for 12 weeks then every 4 weeks if dose
Stable
LFTs If NSAID co-prescribed


Source: http://www.tamesideandglossopccg.org/uploaded_files/files/CORPORATE/Enhanced_Services/Service_Spec-DMARDs-amendedApril2010.pdf

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