Shared Care Guideline for Olanzapine (Zyprexa )

Transcription

1 Shared Care Guideline for Olanzapine (Zyprexa ) Development Process This guidance has been produced by Sarah Hudson Lead Pharmacist SWYPFT following an AMBER classification status of Olanzapine by the Barnsley Area Prescribing Committee. This guideline has been subject to consultation and endorsement by the Area Prescribing Committee on 10 th December 2014 and the LMC on 10 th March 2015 Introduction Indication/Licensing information Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder Dosage and administration Adults Schizophrenia: The recommended starting dose for olanzapine is 10 mg/day. Manic episode: The starting dose is 15 mg as a single daily dose in monotherapy or 10 mg daily in combination therapy (see section 5.1). Preventing recurrence in bipolar disorder: The recommended starting dose is 10 mg/day. For patients who have been receiving olanzapine for treatment of manic episode, continue therapy for preventing recurrence at the same dose. If a new manic, mixed, or depressive episode occurs, olanzapine treatment should be continued (with dose optimisation as needed), with supplementary therapy to treat mood symptoms, as clinically indicated. During treatment for schizophrenia, manic episode, and recurrence prevention in bipolar disorder, daily dosage may subsequently be adjusted on the basis of individual clinical status within the range 5-20 mg/day. An increase to a dose greater than the recommended starting dose is advised only after appropriate clinical reassessment and should generally occur at intervals of not less than 24 hours. Paediatric population Olanzapine is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy. A greater magnitude of weight gain, lipid and prolactin alterations has been reported in short-term studies of adolescent patients than in studies of adult patients Elderly A lower starting dose (5 mg/day) is not routinely indicated but should be considered for those 65 and over when clinical factors warrant Page 1 of 6

2 Responsibilities of the specialist initiating treatment 1. Initiate and stabilise treatment with olanzapine (this phase is expected to last at least three months). To initiate therapy, arrange prescription and evaluate over the first 3 months. To establish baseline and after 3 months of treatment weight, blood pressure, fasting blood glucose or HbA1c and full lipid screen (where possible). FBC and LFT should be measured where appropriate. Baseline renal function 2. Discuss the benefits and side effects of treatment with the patient and DOCUMENT it in their communications 3. Ask the GP whether he or she is willing to participate in shared care and agree with the GP as to who will discuss the shared care arrangement with the patient. 4. Periodically review the patient s condition and communicate promptly with the GP when treatment is changed. To review the patient and treatment at least once a year until the patient is discharged from the mental health service where this is possible. 5. Advise the GP on when to adjust the dose, stop treatment, or consult with the specialist 6. Report adverse events to the MHRA and GP 7. Ensure that clear backup arrangements exist for GPs to obtain advice and support 8. Specialists should be clear in their communication (letters) to GPs if they want GP to take over prescribing or if the letter is just a treatment progress information / feedback to GPs. 9. Specialist needs to enclose a completed SC Agreement form with the letter when requesting GP to take over prescribing. 10. Specialist should indicate specific diagnosis clearly in their letter. They should also make sure the diagnosis is covered by the SCG before requesting GPs to take over prescribing. Baseline Tests Prolactin, Urea & Electrolytes (U&Es), Weight, Fasting Plasma Glucose(FPG) /HbA1c or Oral Glucose Tolerance Test (OGTT), Blood Lipids Routine Tests Prolactin if symptoms occur, U&Es 6 monthly, Weight as needed, Creatine Phosphokinase (CPK) if NMS suspected, Blood Lipids after 3 months then yearly, Fasting Plasma Glucose FPG/HbA1c - annually Disease monitoring If the service user deteriorates please refer back to secondary care Responsibilities of other prescribers Acceptance of Responsibility by the Primary Care Clinician It is optional for GPs to participate in taking on responsibility for shared care for the patient. GPs will take on shared care only if they are willing and able. 1 Reply to the request for shared care as soon as practicable 2 Prescribe olanzapine at the dose recommended 3 Adjust the dose as advised by the specialist 4 To monitor physical parameters such as weight, fasting blood sugar and full lipid screen where necessary. 5. To request earlier specialist review or seek specialist advice when necessary 6 Report to and seek advice from the specialist on any aspect of patient care that is of concern to the GP and may affect treatment. 7 Refer back to specialist if the patient s condition deteriorates, as advised 8 Stop treatment on the advice of the specialist or immediately if an urgent need to stop treatment arises 9. Report adverse events to the specialist and MHRA 10. GPs should not routinely issue prescriptions until they are asked to take over prescribing by the specialist Page 2 of 6

3 Clinical Particulars BNF therapeutic class Cautions and Contraindications Antipsychotic drugs; Atypical antipsychotic drugs Contraindications Hypersensitivity to the active substance or to any of the excipients. Patients with known risk of narrow-angle glaucoma Cautions Dementia-related psychosis and/or behavioural disturbances Parkinson's disease Neuroleptic Malignant Syndrome (NMS). Hyperglycaemia and diabetes Lipid alterations Anticholinergic activity Hepatic function Neutropenia QT interval Thromboembolism Adverse Drug Reactions The most commonly reported Adverse Drug Reactions (ADRs) with olanzapine are mild, transient antimuscarinic effects (very rarely precipitation of angle-closure glaucoma); drowsiness, speech difficulty, exacerbation of Parkinson s disease, abnormal gait, hallucinations, akathisia, asthenia, fatigue, increased appetite, increased body temperature, raised triglyceride concentration, oedema, hyperprolactinaemia (but clinical manifestations uncommon); eosinophilia; less commonly hypotension, bradycardia, QT-interval prolongation, urinary incontinence, and photosensitivity; rarely seizures, leucopenia, and rash; very rarely hepatitis, pancreatitis, thromboembolism, hypercholesterolaemia, hypothermia, urinary retention, priapism, thrombocytopenia, neutropenia, rhabdomyolysis, and alopecia; As with other antipsychotics, weight gain, syncope, neuroleptic malignant syndrome, leucopenia, neutropenia and peripheral oedema, have been associated with olanzapine Pregnancy and Lactation Pregnancy - use only if potential benefit outweighs risk; neonatal lethargy, tremor, and hypertonia reported when used in third trimester Breast feeding - avoid present in milk Monitoring Baseline Prolactin Urea & electrolytes (U&Es) Weight Fasting Plasma Glucose (FPG)/HbA1c or Oral Glucose Tolerance Test (OGTT) Blood Lipids Continuation Prolactin U&Es 6 monthly Weight as needed Creatine Phosphokinase (CPK) if NMS suspected Blood Lipids after 3 months then yearly Fasting Plasma Glucose FPG/HbA1c - annually Page 3 of 6

4 Interactions Include clinically important interactions and their management. Benzodiazepines Carbamazepine Ciprofloxacin Fluvoxamine Ritonavir Increased risk of hypotension, bradycarida and respiratory depression when intramuscular olanzapine given with parenteral benzodiazepines Metabolism of olanazpine accelerated by carbamazepine (reduced plasma concentration) Plasma concentration of olanazpine possibly increased by ciprofloxacin Plasma concentration of olanzapine increased by fluvoxamine Plasma concentration of olanzapine reduced by ritonavir- consider increasing dose of olanzapine Communication Specialist to GP The specialist will inform the GP when they have initiated Olanzapine. When the patient is near completing the satisfactory initiation period, the specialist will write to the GP to request they take over prescribing and where possible give an indication as to the expected length of treatment. The Specialist will also send a Shared care request form to support the GP in undertaking shared (Appendix A) GP to specialist If the GP has concerns over the prescribing of olanzapine, they will contact the specialist as soon as possible. Contact names and details Contact Details Telephone number Sarah Hudson Lead Pharmacist Sarah.hudson@swyt.nhs.uk Medicines Information Med.Information@swyt.nhs.uk Dr S Chari (North Team) Suresh.Chari@swyt.nhs.uk References Dr G Kirk (Central Team) Gill.Kirk@swyt.nhs.uk Dr A Karan (South Team) Anil.Karan@swyt.nhs.uk Dr H Malik (Dearne Team) Humayun.Malik@swyt.nhs.uk Dr Viswanath Dr Niaz Dr Rele BNF 64 NICE Guidance Page 4 of 6

5 Appendix A Shared Care request form (Amber) Specialist to complete when requesting GP to enter a shared care arrangement. GP to return signed copy of form. Both parties should retain a signed copy of the form in the patient s record. From (Specialist): To (GP): Patient details Name: Address: ID Number: DOB: Diagnosed condition: Amber Drug details Drug name: Date of initiation: Dose: Length of treatment: The patient will be reviewed by the Consultant on: Telephone number(s) for contact: The patient should be reviewed by the GP by: Consultant: Date: Monitoring The following monitoring should be undertaken by the GP: Parameter Date next test due Frequency Page 5 of 6

6 Communication Consultant Telephone number: Fax number: address: Specialist Nurse Telephone number: Fax number: address: Confirmation of acceptance of shared care Specialist (Doctor/Nurse) name: Specialist (Doctor/Nurse) signature: Date: I, Dr.., can confirm I : accept the request to participate in shared care for the patient named above. reject the request to participate in shared care for the patient named above. The reason for this being.. GP signature: Date: Page 6 of 6