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
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
DIOXI’NS IN SHAMPOOS, SKIN CREAMS AND DRINKS FROM PLASTIC LINED CONTAINERS MAY INCREASE CANCER Additional source of dietary ‘estrogens’ team reports. The pH of the food did notappear to affect leaching. these included corn, artichoke hearts, mush-contain small quantities of an estrogenlikequantities -just 4 to 22 micrograms per 300BPA turned up in roughly half of the
LEEDS METROPOLITAN UNIVERSITY FACULTY OF HEALTH (STUDENT SUPPORT OFFICE D803) COURSE: Notes to Candidates: Answer ALL questions in Section A (contributes 50% of total mark) Answer ONE question in Section B (contributes 50% of total mark) Use separate answer books for Sections A and B You may consult your Practical Portfolio for Section B only after handing in your Section A SEC
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.