Clozapine Outpatient initiation

Transcription

1 Clozapine Outpatient initiation 1. Introduction The licence for clozapine enables commencement of clozapine as an outpatient. Hospital admission for initiating clozapine has been recommended in the past in view of some adverse reactions e.g. hypotension, tachycardia, sedation, seizures, hyperthermia. However, patients are often reluctant to be admitted to start medication and furthermore, beds are often not available for initiating patients. Patients who are started on clozapine as out-patients are subject to the same requirements and processes as in-patients. As would be expected for an in-patient they should have a full history and clinical examination. Additionally they should be subject to the same amount of clinical monitoring as an in-patient regardless of whether they are initiated in day-care or at home. Day-care and home initiation should not be seen as separate entities. For some patients it may be most appropriate to use a combination of the two with patients attending day-care on some days and being visited by a healthcare professional in their homes on others. N.B. Clozapine treatment can only be initiated by a Consultant 2. Essential monitoring details Denzapine Specific Product Characteristics 1. Weekly white cell (WBC) and neutrophil(anc) counts during the first 18 weeks of therapy, then at least every 2 weeks for the first year of therapy. After 1year if patient has stable ANC counts over that period, then monitoring may be changed to 4 week interval. 2. WBC and differential blood counts must be performed within 10 days prior to initiating clozapine treatment to ensure that only patients with normal WBC counts (WBC count greater than 3500/mm3 (3.5 x 109/L) and ANC above 2000/mm3 (2.0 x 109/L)) will receive the drug. 3. Blood cell count Absolute Neutrophil Count Action required WBC/mm 3 (/L) ANC/mm 3 (/L) >3500 (>3.5x10 9 ) >2000 (>2.0x10 9 ) Continue clozapine treatment (3.0 x x 10 9 ) (1.5 x x 10 9 ) Continue clozapine treatment, sample blood twice weekly until counts stabilise or increase <3000 (< 3.0x10 9 ) <1500 (<1.5 x 10 9 ) Immediately STOP clozapine treatment, sample blood daily until haematological abnormality is resolved, monitor for infection. Do not re-expose the patient. 4. Patients who have been on clozapine for more than 18 weeks and have had their treatment interrupted for more than 3 days but less than 4 weeks should have their WBC count and ANC monitored weekly for an additional 6 weeks and if there is no haematological abnormalities then DMS will inform that original monitoring schedule can be resumed. 1

2 5. At each consultation, a patient receiving clozapine should be reminded to contact the treating physician immediately if any kind of infection begins to develop NB sore toat or flu-like complaints and a repeat blood is recommended 6. In the event of tombocytopenia, discontinuation of clozapine therapy is recommended if the platelet count falls below /mm 3 (50 x 10 9 /L). 7. Myocarditis or cardiomyopathy should be suspected in patients who experience persistent tachycardia at rest, especially in the first two months of treatment, and/or palpitations, arrhythmias, chest pain and other signs and symptoms of heart failure (e.g. unexplained fatigue, dyspnoea, tachypnoea), or symptoms that mimic myocardial infarction. Clozapine should be stopped. 8. Patients should be monitored for common side effects- especially on initiation of treatment or dose changes e.g. drowsiness, postural hypotension, constipation(it is vital that it is recognised and treated adequately), nausea & vomiting, hypersalivation and other side effects listed in the Oxford Health NHS FT clozapine patient information leaflet located on the Choice and Medications Website: 9. During clozapine therapy, patients may experience transient temperature elevations above 38 C, with the peak incidence within the first 3 weeks of treatment. This fever is generally benign. Occasionally, it may be associated with an increase or decrease in the WBC count. Patients with fever should be carefully evaluated to rule out the possibility of an underlying infection or the development of agranulocytosis. In the presence of high fever, the possibility of neuroleptic malignant syndrome (NMS) must be considered. 10. Impaired glucose tolerance and/or development or exacerbation of diabetes mellitus has been reported rarely during treatment with clozapine. 11. Clozapine may lower the seizure teshold in a dose-dependent manner and may induce myoclonic jerks or generalised seizures. These symptoms are more likely to occur with rapid dose increases and in patients with pre-existing epilepsy. In such cases the dose should be reduced and, if necessary, anticonvulsant treatment initiated 12. Dose-changes of clozapine may be necessary when there is a change in caffeine-drinking habit. 13. In cases of sudden cessation of smoking, the plasma clozapine concentration may be increased, thus leading to an increase in adverse effects(see Oxford Health NHS FT nicotine replacement therapy guidelines) 3. Patient and prescription review for Outpatient Clozapine Treatment Suitability of patients for out-patient care will be based on their current symptomatology and safety risk. Avoid complex cross titration of antipsychotics Patients should consent to clozapine treatment and blood tests and be aware of and agree to the necessity for daily attendance/home visits Ideally someone should be available to stay overnight with the patient for the first week A full medical history & physical examination is required including weight, pulse, temperature, and BP. Baseline monitoring should be carried out according to OBMH psychotropic monitoring guidelines Caution: patients with diabetes, history of cardiac disease, seizures, NMS, or patients receiving potent sedatives or benzodiazepines who may be more appropriate for in-patient initiation. Elderly patients may require a slower titration due to susceptibility to some side effects. 2

3 Concomitant medications - look for possible interactions, e.g. bone marrow suppressants, benzodiazepines, anticholinergics, antihypertensives, alcohol, MAOIs, CNS depressants, highly protein bound drugs, phenytoin, lithium, citalopram, drugs which inhibit or potentiate CYP isoenzymes:1a2 eg caffeine, paroxetine, omeprazole; 3A4 e.g. cimetidine, erytomycin. Check current British National Formulary (BNF) for interactions Patients, family members/carers should be provided with information about clozapine including recognition of adverse reactions to clozapine and what to do if they occur, explanation of the possible timeframe to recovery and potential rebound psychosis if treatment is stopped abruptly. Patients GP must be informed of clozapine start date and provided with a copy of the guidelines and an emergency contact number for the treating team. All patients should start treatment on a Monday (In Oxfordshire Warneford and Banbury Day Hospital will carry out the first 2 days of monitoring after which community teams will monitor patients) Dose increases will be less than in-patient initiation due to once daily dosing, however, some patients may require an even slower dose titration depending on side effects experienced. It is advisable not to increase the clozapine dose at weekends or on bank holidays 4. Home initiation pathway Oxfordshire (Buckinghamshire - CMHT to agree monitoring with Day Hospital & Crisis Teams) 1. Review elegibility of patient for clozapine home-treatment including any concomitant physical illness, complex prescription and home support available (see section 3) 2. Obtain patient s consent to treatment and give OBMH patient information leaflet to patient/carer 3. Where CommunityTeam requires Day Hospital support for first 2 days only notify Day Hospital well in advance of planned initiation & agree which Monday treatment* can commence 4. Notify pharmacy of intention to initiate home treatment who will support registration of patient* with Denzapine Monitoring Service(DMS) the week before commencement 5. Plan how scheduled monitoring will be done by Community Team during treatment initiation, and liaise with crisis team where appropriate. 6. Obtain medical history and physical examination and carry out baseline blood monitoring according to OBMH psychotropic monitoring guidelines. Baseline FBC should be taken Tuesday before commencement of treatment the following Monday 7. Review current prescription and assess potential drug interactions, plan cross titration of current psychotropic medication where necessary 8. Collate care plan, signed OBMH clozapine home-treatment prescription, and relevant information about patient and discuss with Day Hospital as necessary 9. Order first 4 days clozapine from pharmacy to be sent to Day Hospital on Friday prior to startdate these will be dispensed in 4 labelled daily boxes or a flexi-plus nomad as appropriate 10. The patient should see a doctor regularly - a minimum of once weekly during clozapine titration. They should assess the patient for: a)any suicidal risk b)clozapine adverse reactions 3

4 c)adjusting titration rate c)managing anti-psychotic cross-titration d)reassuring the patient. 5. Home Initiation Prescribing & monitoring Day 1 - Monday. The healthcare professional must remain with the patient in his/her home for at least the first 6 hours after administering the clozapine dose: pulse, temperature and blood pressure should be taken before giving the clozapine and every hour after initial dose for 6 hours(nb patient may attend day-care for this first two days if previously arranged), different healthcare professionals may stay with the patient in shifts toughout the day Day 1 patient will require a full blood count(fbc) to enable a further supply of clozapine by Thursday Day 2 Patient presents to community team/day hospital/ or is visited by healthcare professional as arranged. The patient is asked about any adverse effects of treatment and pulse, temperature, standing and lying BP are performed before the next dose is given and recorded on home-treatment monitoring chart. Monitoring must be repeated between 4-6s after dose Day 3-5 Patient presents to community team/is visited by healthcare professional as arranged. The patient is asked about any adverse effects of treatment and pulse, temperature, standing and lying BP are performed before the next dose is given and recorded on home-treatment monitoring chart. Monitoring must be repeated between 4-6s after dose Day 3 The home-treatment initiation prescription is sent to pharmacy for the next 7 days supply to be dispensed Day 5 Review need for monitoring over the weekend the dose remains the same from day 5-7. If there are no concerns about monitoring, the patient will be given a number to call in case of adverse effects and the dispensed doses for Day 6 & 7. Day 8 Patient requires FBC. Thereafter it is preferable to do blood tests on Mondays to ensure results are back in Pharmacy for supply on Thursdays. Day The patient should have continued twice daily (before morning dose and after 4-6s) adverse effect, blood pressure, pulse and temperature monitoring during the second week of titration. However, if it is felt that the patient is well supported during the second week of treatment and there have been no problems with adverse effects or concerns about the patient s current condition the team may decide to review the necessity for twice daily monitoring and plan to monitor less regularly recording the reasons for their decisions. For the 2nd week of treatment the dose is given twice daily. If there are concerns about adverse effects/risks the prescription should be reviewed. Day 11/12(Thurs/Fri) - A new prescription should be sent to pharmacy which will usually be increasing the dose to 300mg over the following week. Adverse effect, blood pressure, pulse and temperature monitoring should be carried out around dose increases. When dose is stabilised a clozapine outpatient prescription(located in the pharmacy documents section of the intranet) should be completed and sent to pharmacy for repeat dispensing. * For most home-treatment clozapine patients it is preferable that this is planned well in advance 4

5 Chart of Blood sampling and prescribing for Home Initiation of Clozapine Day Suggested Dose Blood sample Prescription Pharmacy Register patient & send 1st wk s prescription(rx) -5 Obtain local result 1=Mon 12.5mg OM Obtain new local result 2=Tues 25mg OM 3=Weds 37.5mg OM 4=Thurs 50mg OM 5=Fri 6=Sat 7=Sun 8=Mon 25mg ON 9=Tues 50mg ON 10=Weds 75mg ON 11=Thurs 100mg ON 12=Fri 100mg ON 13=Sat 100mg ON 14=Sun 100mg ON 15=Mon 125mg ON 16=Tues 150mg ON 17=Weds 175mg ON 18=Thurs 200mg ON Fr-Th 200mg ON Fr-Th 250mg ON Fr-Th 300mg ON Obtain local result (& on consecutive Mondays) Obtain local result Monday sampling day Monday sampling day Monday sampling day Send 2 nd Wk Rx to pharmacy Write a new prescription for Day15-19 supply Send pharmacy new Rx Tues:Send new Rx for weekly 50mg dose Tues:Send new Rx for weekly 50mg dose New Rx. Monitor side effects & leave dose at mg daily for 1/12 then review Do steady state(constant dose for 4 days) levels if any concerns about dose Supply prescription in daily doses Supply 2nd wk if green result Supply days if green result Supply for days On receipt of green result supply 1/52 On receipt of green result supply 1/52 On receipt of green result supply 1/52 The Healthcare professional takes the patient s pulse, temperature and BP and asks about any side effects experienced every hour for 6 hours on DAY 1 & before administering the dose & after 4-6s for the first two weeks (or at least for the first 5 days of treatment) 5

6 CLOZAPINE OUTPATIENT TITRATION PRESCRIPTION CHART Patient Name Consultant DMS No D.O.B. Unit No. Chart must be attached to standard prescription chart (where applicable), which must be endorsed Clozapine as per Titration Chart. Prescription must be sent/faxed to pharmacy the Wednesday before Monday start-date so that they can be sent in time. Each dose will be labelled separately with a specific date. The second week s supply should be requested in time to arrive for Monday Wk 2 Once on a maintenance dose, clozapine should be prescribed on a standard prescription chart and weekly repeat prescriptions requested from pharmacy If side effects become intolerable the prescriber may amend doses indicated to enable a slower dose titration. Amendments must be clear, and signed and dated by the prescriber. Dose changes should be faxed to pharmacy & previously dispensed doses returned. DAY DATE DRUG MORNING DOSE GIVEN EVENING DOSE GIVEN Time: BY* Time: BY* 1 Mon CLOZAPINE 12.5mg CLOZAPINE 25mg CLOZAPINE 37.5mg CLOZAPINE 50mg CLOZAPINE 75mg CLOZAPINE 75mg CLOZAPINE 75mg CLOZAPINE 75mg 25mg 9 CLOZAPINE 75mg 50mg 10 CLOZAPINE 75mg 75mg 11 CLOZAPINE 75mg 100mg 12 CLOZAPINE 100mg 100mg 13 CLOZAPINE 100mg 100mg 14 CLOZAPINE 100mg 100mg * Signature of Person giving dose to patient Dr. s Signature Date Blood tests Initial sample date Second sample due(mon of 1 st wk) Third sample due(mon of 2 nd wk) Date Clozapine Started Initial when done Pharmacy Use(dispense daily doses separately) Date Disp by Checked by Week one dispensing: Days 1-4(mon-thurs) Week two dispensing: Days 5-11(fri-thurs) Week two dispensing Days 12-14(fri-sun) Wk 3 Clozapine doses to be prescribed on new Drug Chart. Dose to be increased by 25mg at night (daily) to and 200mg ON and then left at this dose for rest of the week. Wk 4 onwards Increase doses by 50mg/weekly to treatment dose of mg if side effects are not troublesome. Leave at this dose for 1 month to assess benefits and carry out clozapine level if there are excessive side effects or no therapeutic benefit at this dose. 6

7 Multipurpose Chart for Clozapine Outpatient Titration Monitoring (blood pressure, heart rate and temperature) Recommended hourly for the first six hours then BD Name: Consultant CPMS N o D.O.B. Unit Number Date Time Day st 2 nd 3 rd 4 th 5 th 6 th am pm am pm am pm am pm am pm am pm am pm am pm TEM P C o BP pulse May need to Contact Doctor if there is: 1) A drop in blood pressure >20mmHg (diastolic) 2) Pulse over 100 beats per minute 3) Pyrexia (esp. > 38.5 o C) Monitor side effects e.g.dizziness, drowsiness, hypersalivation, constipation. Side Effect Date Action Taken Any concerns about monitoring or side effects contact Pharmacy:tel: or pharmacist-linked to community team 7