Guidelines For The Use Of Melperone

Document Control Summary Title Guideline For The Use Of Melperone

Purpose of document Electronic file reference (network of intranet) Status Version

To provide a guide for the use of melperone in East London NHS Foundation Trust Policies and Guidelines /Pharmacy/Guideline For The Use Of Melperone Draft for version 2.0 2.0 Prof. Frank Rohricht, Clinical Director, Adults, Newham Medicines Committee and Senior Pharmacists Medicines committee September 2011 January 2008 July 2011 July 2014 Prescribers and All Pharmacists Charity Okoli

Name of originator/author Circulated to Approved by First Edition Second Edition Review date Target audience All comments and amendments to

Version Control Summary Version 1.0 Date January 2008 Author Prof. Frank Rohricht & Seema Gadhia Reviewed by Charity Okoli Comment Final

2.0

July 2011

Draft: Updated with addition of appendix containing the Melperone initiation form, Pharmacy contact details, Draft of Trusts Patient Information Leaflet for Melperone

Contents

Section 1.0 Introduction 2.0 Consent 3.0 Indication 4.0 Dosing 5.0 Baseline Physical Observations 6.0 Prescribing of Melperone 7.0 Appendix 7.1 Appendix A: Melperone Initiation form 7.2 Appendix B: Patient Information Leaflet (draft) 7.3 Appendix C: document for repeat prescription 7.4 Appendix D: Pharmacy Contact Details

Page 4 4 4 4 4 4-5 6 6-7 8 -10 11 12

Guidelines For The Use Of Melperone

1.0 Introduction

1.1 Following the approval by the Trusts Medicines Committee for the use of melperone, these guidelines are intended to ensure that this medicine is used safely and effectively.

1.2 Melperone should be initiated by Consultants only. The repeat prescriptions should be written by the consultant or the specialist registrar delegated by the consultant to cover in their absence.

2.0 Consent 2.1 This drug is not licensed in the UK. The patients consent for use of an unlicensed drug must be sought and clearly documented in their medical notes. For the policy for the use of unlicensed drug click here

3.0 Indication

3.1 The drug should be considered for patients with a diagnosis of treatment-refractory schizophrenia that have not responded to or cannot tolerate clozapine.

4.0 Dosing 4.1 Start at 25mg at night and increase according to tolerability. In non-refractory illness, doses of 100300mg a day are effective. Higher doses may be needed in refractory illness. Scandinavian SPCs allow doses of up 600mg/day in exceptional circumstances. 4.2 The daily dose must be given in divided doses, with a higher evening dose being selected in order to achieve a more pronounced sedative effect. It is best taken after meals and before bedtime.

5.0 Baseline physical observations

5.1 Before starting melperone, take a full blood count, ECG and measure blood pressure. 5.2 A baseline BPRS would also be required before treatment is started.

6.0 Prescribing of Melperone 6.1 Melperone should be used alone and not in conjunction with another antipsychotic, although periods of overlap with previously prescribed antipsychotic may be necessary. 6.2 For every patient prescribed melperone, a Melperone initiation form must be completed to allow monitoring and audit of patients. This should be sent to the pharmacy department. A copy of this should also be filed in the patients medical note. 6.3 A copy of the baseline BPRS should be sent to pharmacy with the prescription. BPRS would also be carried out at 6 weeks, at 3 months, 6 months and during each review of the patient.

6.4 On discharge, the prescribing of melperone should not be transferred to primary care. Prescribing should be continued by secondary care. 6.5 Request for repeat prescriptions should be made by using the Trust discharge liaison form (see copy on appendix D). The completed repeat prescription should be forwarded to pharmacy department (see appendix C) for pharmacy contact details. 6.6 Melperone should not be prescribed on FP10 prescription pad.

6.7 All data relating to patients prescribed melperone in this Trust will be reviewed after 12 months.

7.1 Appendix

Medicines Committee

Melperone initiation form

This form must be completed in full for all patients being initiated on melperone.

Patient name.
Gender M/F

Age

Diagnosis (choose one)

Refractory Schizophrenia Schizophrenia Schizoaffective disorder Bipolar affective disorder Other (state) ..

Race (choose one)

White Black African Black Caribbean Asian Other (state) ..

Duration of illness

..years

months

(i.e. time since first diagnosis of above)

Duration of current staydays

Prescribed antipsychotic(s) immediately before melperone (state)....

History of prior clozapine prescription

Y/N

Reason for starting melperone (choose one) Intolerance to clozapine: Neutropenia Other (state).. 6

Ineffectiveness of prior treatment

Other (state) ..

Starting dose of melperone:

List all other drugs currently co-prescribed (dosing details not required; include PRN but state which)

1. 2. 3. 4. 5.
Physical Healthcare Baseline Observations: ECG Blood pressure FBC

Y/N
_____ / ______ Y/N

Date Baseline BPRS Score 6/52 BPRS Score 3/12 BPRS Score 6/12 BPRS Score

Score

Prescribers name Consultant

.. ..

Directorate/borough.. Date

Please return the form to Pharmacy

7.2 Appendix B

Melperone
What is melperone used for? Melperone belongs to a group of medicines called butyrophenone antipsychotics. Although melperone is not licensed in United Kingdom, it used for the treatment of sleep disorders, confusional state, for relieve of agitation and aroused states especially in people with mental illness and emotional disorders. It is also used to treat psychosis. Medicines are often used to treat more than one condition, so if you are not sure why you have been prescribed melperone, you should discuss with your doctor. What are the benefits of taking melperone? People suffering from psychosis or other mental disorders may have a range of symptoms which can include hearing voices, or experiencing strange things such as seeing or feeling things that may not be real or having mistaken beliefs. Some people may feel suspicious or paranoid or even feel that other people can read their thoughts. Sometimes people may become too active or inactive and withdrawn from their normal daily activities. Melperone can help to treat some of these symptoms and keep them under control. By treating these symptoms, it could help people feel less confused; less agitated and helps them think more clearly. This can help them to cope better with their everyday life.

What is the usual dose of melperone and how should it be taken? Melperone is usually given in several divided doses, with a higher dose in the evening in order to achieve a more calming effect. Depending on the mental illness, the usual starting dose is 25mg to 75mg a day and the dose gradually increased to 400mg in a day. The usual maintenance dose is between 200mg and 400mg depending on individual illness and response to treatment. Do not change your dose of melperone without checking with your doctor, as this may be harmful to you or make you get unwell. Melperone is best taken after meals and with fluid, not with coffee, tea or milk as these can affect the absorption of melperone. Melperone can form insoluble compounds with coffee, tea and milk, thereby impairing its effect. How quickly does melperone work? There is normally no time limit for therapy with melperone. Sometimes, the desired antipsychotic effects will appear only after two to three weeks of therapy, but it may take several weeks until it has full effect. It is important to know, that it is not everybody that benefits from melperone but some people do. If you do not feel any benefit or improvement in your symptoms after six to eight weeks of taking melperone, you should discuss this with your doctor.

For how long should I take Melperone? The duration you have to take your medication depends on the type of your illness and your doctor will discuss with you how long you will need to be on melperone. Some people may need to take medication for a few years and others need to stay on medication for a longer period. Treatment with melperone can normally be continued indefinitely. Complying with your medication may prevent you from becoming unwell. Speak to your doctor or pharmacist if you are under the impression that the effect of melperone is too strong or too weak for you. Your doctor will review your medication to check whether you are experiencing any unwanted effects and make sure that your dose is still right for you. If you want to stop treatment, you must discuss this with your doctor. Do not take it upon yourself to stop taking your melperone without medical advice. This may jeopardise the success of the treatment. If you have forgotten to take or miss a dose? If you miss or forgot to take a dose at your usual time, but remember with an hour, take it straight away. However, if it is longer than this, take the prescribed dose at the next scheduled time. Never take extra medication at the next dose. What are the side effects of Melperone? As with all medicines there is a risk of unwanted effects (side effects). Some can occur soon after starting the treatment so you may experience this before you feel better. Some of the side effects can be temporary and should go away after some time. It is important to note that it is not everyone that gets side effects; many people experience them to different degrees. If you feel that you have side effects that are causing you discomfort, discuss this with your doctor, pharmacist, nurse or healthcare worker.

Some of the possible side effects of melperone are listed in the table on the next page. What about alcohol? During treatment with melperone it is not recommended that you drink alcohol, as alcohol alters and enhances the effect of melperone in unpredictable ways. Drinking alcohol can also make psychosis worse.

Taking Melperone in conjunction with other medications? There are a number of other medicines that can affect the action of melperone or impair the effect of the other medicine if taken together. Please inform your doctor or pharmacist if you are taking/using other medicinal or herbal products, including non-prescription medicines you can buy from pharmacy stores. When special care is necessary If any of these situations apply to you, you should tell your doctor immediately: If you are pregnant or plan to become pregnant. This is very important as melperone could harm the baby. If you are breastfeeding. If you have previous damage to the heart or if you have slow heart rate. If you have diseases of the haematopoietic (blood forming) system. If you notice symptoms of inflammation of the mouth, throat, temperature or flu-like symptoms occur. If you are taking sleeping tablets, antihistamines (medicines to treat allergies), antidepressants, other medicines suppressing the central nervous system, and medicines used to treat Parkinsons disease (e.g. levodopa). If you are allergic to melperone or other ingredients in melperone tablet. If you have breast tumours.

Some Side effects of Melperone Fatigue Movement disorders/parkinsonian syndromes. These especially occur at higher doses. Hypotension

What is it? Tiredness, lack of energy. This occurs especially at start of treatment. Symptoms may include tremor, shaking or spasm, muscle stiffness Drop in blood pressure Allergic skin reaction

Exanthema ( occurs on rare occasions) Sexual dysfunction (rarely) Menstrual disturbance Galactorrhoea and gynaecomastia in few cases Intrahepatic cholestasis Headaches, visual disturbance, dry mouth, constipation, nausea, vomiting, diarrhoea and difficulty passing urine could also occur Neuroleptic malignant syndrome Change in sex drive Excretion of milk in women and enlarged breast in men in few cases Gall bladder drainage disorders

Blood cell damage in form of leucopenia and thrombocytopenia ( in rare cases)

Fever, confusion, sweating, muscle rigidity, difficulty in moving and increased heart rate. (CONTACT YOUR DOCTOR IMMEDIATELY IF THIS HAPPENS) Blood cell damage such as reduction of white blood cells and reduction of platelets in the blood (this could result in bleeding into the skin or spontaneous bruising)

The speed of reactions to such an extent that the ability to drive a vehicle or to use machinery could also be affected.

Note: This leaflet gives you some information about melperone tablet. It does not replace the expert information or decision of your doctor, pharmacist or other healthcare professional. It is not a manufacturers patient information leaflet and is not to be taken as a substitute for manufacturers information or advice about melperone. If you have any questions or concerns about your medicine or if you are worried about anything you think might be a side effect, ask your doctor, pharmacist or nurse. This leaflet has been written by East London NHS Foundation Trust, 22 Commercial Street, London E1 61P Tel: 020 7655 4000

East London NHS Foundation Trust NHS Foundation Trust Publication date: 02 July 2011

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7.3 Appendix C

GP Discharge Liaison Form

Name of the Patient : Address GP Name: Address:

DOB: NHS No: Date of Admission: Ward: Consultant: Care coordinator: Yes Contact details: No

TEL: Ward: Hospital No Date of Discharge: time:

Planned Discharge Unplanned discharge (self discharge etc) Diagnosis on Discharge: ICD 10:

Aftercare Arrangements (provided by Mental Health Service): Community Team

Out Patient

Mental Health Act Yes S 25 Yes No No S117 CPA LEVEL Standard: Enhanced: Yes No DAY HOSPITAL Contact details: Yes No Yes No By: 7-day follow Up: Yes No

No
m Home Treatment Team (HTT)

Assertive Outreach Team (AOT) Yes

Others (specify): Drug Sensitivity:

Medication for a maximum of 4 weeks can be supplied. MEDICATION 1 2 3 4 5 6 7 9

DOSE FREQUENCY DURATION PHARMACY

Medication that needs monitoring or reviewing:

By: Completed By SHO: Date: Sign: Tel

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Appendix D: 7.4 Pharmacy Contact Details

7.4.1 Pharmacy Department Newham Centre for Mental Health Cherry tree Way Glen Road Plaistow, London Tel: 02075404380 Ext: 2130 OR bleep pharmacist via Switch board Fax: 02075404200

NCMH Link Pharmacist for Melperone: Charity Okoli

7.4.2 Pharmacy department Mile End Hospital Bancroft Road London E1 4DG Tel: 02082238014 Fax: 02082238065 7.4.3 Pharmacy department City & Hackney East Wing Homerton Hospital Homerton Row London E9 6SR Tel: 02085108174/7250 Fax: 02085107251

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