Mental Health Medicines Management Pilot Community Pharmacy High Dose Antipsychotic Screening, Education & Advice Service Approved Version 1 Date of First Issue Review Date Date of Issue Author / Contact Aaron Coulter Group / Committee Final Approval
Consultation and Change Record Contributing Authors: Aaron Coulter Consultation Process: Distribution: Change Record Date Author Change Version Section Title Page 1 Introduction 3 2 Scope 3 3 Clinical Information for Community Pharmacists 4 4 Further Information 5 Appendix 1 Standard Operating Procedure Template 2
1. Introduction The Prescribing Observatory Mental Health-UK (POMH-UK) in 2009 concluded that 10% of patients where prescribed regular high dose antipsychotics (For the purposes of this guidance high dose is defined as any dose of a single anti-psychotic or combination of two or more antipsychotics, which exceeds the BNF maximum recommended dose), 9% of people where prescribed a regular combination of antipsychotics and of these 23% of people where prescribed a first and second generation antipsychotic concurrently. A consensus statement published by the Royal College of Psychiatrists in 2006 outlined concerns that the use of high dose anti-psychotics may have played a part in the sudden deaths of some psychiatric patients. Community pharmacists are ideally placed to undertake a screening survey of antipsychotic prescribing using a similar tool to POMH-UK. This will help to identify potential areas where medication could be better utilised and potentially reduced leading to improved outcomes for patients due to decreased side effect burden and cost savings from reduced drug expenditure. The law states that people have the right to make an informed decision about which treatment(s) to have. To consent to any treatment including high dose antipsychotic prescribing properly, people need to have enough information to understand what the treatment is, what its benefits should be, possible harms it might cause, its chance of success, and available alternative treatments. Prescribed medication should come with a patient information leaflet (PIL); the PIL contains only the most important information as required by law. Often people would like to have information about medication before they start taking it or other information not normally provided in the PIL, the community pharmacy is in a position to offer this information. Choiceandmedication.org.hscni is a website designed to help patients taking medication for mental health to find out more about their conditions and treatments. I have not been given good information about side effects. I have 35 years of the mental health system and not once was I given adequate information. You have to find everything out for yourself. There s an information blackout. (Man, 57, with schizophrenia) The NICE guidance for Schizophrenia 2009 states that when using an antipsychotic medication the patient should be Provided information on the benefits and side effects of each antipsychotic and discussed. The choice of drug should be made by the service user and healthcare professional together, considering: o the relative potential of individual antipsychotic drugs to cause extrapyramidal side effects(including akathisia), metabolic side effects (including weight gain) and other side effects (including unpleasant subjective experiences) 2. Scope This guidance applies to all community pharmacists working within HSC. A template for a Standard Operating Procedure is included in appendix 1 for information or adaptation. 3
3. Clinical Information for Community Pharmacists Most people with a psychotic illness should only receive one antipsychotic at a time ( antipsychotic monotherapy ). What happens in practice? The use of more than one antipsychotic medication ( combined antipsychotics ) for an individual patient is a common clinical strategy. Prescribing surveys show that 10-20% of outpatients with schizophrenia are prescribed a combination of antipsychotic drugs. Why? To manage chronic behavioural disturbance To manage relapse in a patient previously stabilised on a single antipsychotic To speed up the onset of effect or enhance the size of the therapeutic effect While switching from one drug to another Individual patient s/carer s choice Treatment resistance Combining Antipsychotics How good is the evidence that two antipsychotics are better than one? None Some evidence supports the effectiveness of clozapine (monotherapy) in managing chronic aggression Poor Studies have shown that increasing the dose of an established antipsychotic in a relapsed patient is no more effective than continuing the same dose. Combinations have not been systematically studied. Poor Response takes time. High initial doses do not speed up the onset of response. Combinations have not been studied. There is no evidence that combinations improve outcome. Limited The dose of some antipsychotics (eg clozapine) needs to be increased slowly and cross titration is sensible. This should be complete in 4-6 weeks. Limited Choice is not real choice unless it is informed. If the patient can understand the potential benefits and risks of antipsychotic combinations and come to a reasoned decision, this should be supported. Equivocal Combinations involving clozapine should be considered before those involving other antipsychotic drugs. A lack of good evidence for the therapeutic effectiveness of this approach, and concerns about possible harm. 4
What are the potential problems? Difficulty determining cause and effect Higher than necessary total dosage Complex regime increasing the risk of non-adherence How good is the evidence for this? Not knowing which antipsychotic has helped in the short term may lead to the patient receiving a higher than necessary dose (and more side effects) in the longer term. There is no evidence that high doses of antipsychotics are more effective than standard doses. The major cause of high dose prescribing is combinations of antipsychotics. In the general population, simple medication regimens involving a small number of tablets are more likely to be taken than complex regimens. Increased cost Some antipsychotics are expensive ( 100-200/month). Two cost more than one. Increased side effects (acute or long term) Drug interactions (pharmacokinetic and pharmacodynamic) Increased duration of hospitalisation Increased mortality??? All antipsychotics have side effects. Profiles differ. One study shows that patients who receive combinations have 50% more side effects than those who receive 1 drug. The safety of combinations of antipsychotics has not been studied systematically but there are many published case reports of serious side effects such as cardiac arrhythmias and neuroleptic malignant syndrome. One study found that the average length of hospital stay was more than 50% longer in patients who were prescribed combinations of antipsychotics. One study found that patients who were prescribed combinations were 4. Further Information Contacts Clinical Advice Aaron Coulter Community Mental Health Pharmacist, Bluestone Unit, CAH. aaron.coulter@southerntrust.hscni.net Payment and other enquires Dr Susan Patterson. Pharmacy and Medicines Management Adviser, HSCB. Susan.patterson@hscni.net 5
Appendix 1: Standard Operating Procedure Template Standard Operating Procedure for Use of Community Pharmacy High Dose Antipsychotic Screening Education & Advice Service Name of Pharmacy: Purpose To ensure that the High dose antipsychotic screening, education and advice service is correctly implemented To ensure that the screening tool is used correctly To ensure that all patients have been given sufficient information about their medication for mental health Scope This procedure relates to the use of the MHMM Community Pharmacy High dose antipsychotic, education & advice service and includes actions which must be followed in addition to those contained in other SOPs. Procedures/ Process Responsibility 1) Consent Ensure all patients sign the consent form which allows the pharmacist to share information with the relevant people 2) Enrolment Ensure that those patients prescribed antipsychotics have their details completed in the MHMM community pharmacy antipsychotic screening record and that a unique reference number is allocated, such as health and care number. 3) Screening Complete the MHMM antipsychotic screening tool filling in the patient details required. Use the current prescription and your PMR to document the all the known current antipsychotic medication prescribed including PRN for each patient. The ready reckoners should then be consulted to determine what % of the maximum dose has been prescribed. Depot medication should calculated as the equivalent weekly dose; PRN medication should be calculated as the % possible at the least frequent interval. When this process is complete for each antipsychotic the % should be added together to give the total prescribed dose. 6
Procedures/ Process Responsibility 4) Education and Advice For those patients who have been identified as prescribed high dose antipsychotic ensure that the appropriate www.choiceandmedication.org.hscni PILs are supplied and ensure that the patient is aware of the importance of regular review of medication. 5) Action Encourage the patient to attend for regular physical health monitoring, which normally includes weight, glucose, lipids BP and where appropriate prolactin levels. Advise the patient to make an appointment with the prescriber if required If necessary complete the referral to Community Mental Health Pharmacist form for urgent follow up, for example on high dose and not known to secondary care Consultant. 6) Audit Ensure a duplicate copy of the screening tool is returned to community mental health pharmacist. 7
Review Procedure This procedure will be reviewed when there are any new professional recommendations or in the event of critical incidents. In the absence of any of these events, it will be reviewed every two years. Known Risks Prepared by: Signature: Date of preparation: Date effective from: Version number: Date of review: I have signed to say that I have read the procedure and understand its implications. Name Signature Date 8
Appendix 2 Commonly used antipsychotics ORAL MHMM High Dose Antipsychotic Screening, Education & Advice Dosage Ready Reckoner Percentage of BNF maximum Percentage adult of BNF daily maximum dose adult daily dosage 5 10 15 20 25 30 33 40 45 50 55 60 67 70 75 80 85 90 95 100 Total daily dose mg/day (*) No max dose stated in BNF or SPC; 50mg used by convention Amisulpride 400 600 800 1000 (83%) Aripiprazole 10 15 20 30 Chlorpromazine 100 250 500 750 1000 Clozapine 150 (17%) 300 450 600 900 Haloperdiol 1.5 3 5 (17%) 10 15 20 30 Olanzapine 2.5 (12.5%) Quetiapine 100 (12.5%) 5 10 15 20 200 400 600 800 Paliperidone 3 9 12 Risperidone 2 (12.5%) 4 6 (37.5%) 8 12 16 Sulpiride 400 (17%) 800 1200 1600 2400 Trifluoperazine (*) 5 10 25 40 50 Zuclopenthixol 20 (12.5%) 50 100 150 DEPOT Equivalent dose mg/week Flupentixol 20 40 100 200 400 Fluphenazine 12.5 25 37.5 50 Haloperidol 25 37.5 50 75 Olanzapine 75 101 150 Paliperidone 12.5 18.75 25 37.5 Pipotiazine 12.5 25 37.5 50 Risperidone 12.5 18.75 25 Zuclopentixol 100 (17%) 200 300 400 500 (83%) 600 1200 MHMM High Dose Antipsychotic Screening, Education & Advice Dosage Ready Reckoner Percentage of BNF maximum adult daily dose Percentage of BNF maximum adult daily dosage Less Common antipsychotics 5 10 15 20 25 30 33 40 45 50 55 60 67 70 75 80 85 90 95 100 ORAL Total daily dose mg/day Beneperidol 0.5 0.75 1 1.5 Flupentixol 3 (17%) 6 9 12 18 Levomepromazine 100 250 500 750 1000 Pericyazine 75 100 150 200 300 Perphenazine 4 (17%) 12 16 24 Pimozide 2 4 6 8 10 12 20 Promazine 150 (18.5%) 300 (37.5%) 400 800 To calculate a total daily prescribed antipsychotic doe as a percentage of the BNF maximum: determine the percentage of BNF maximum dosage for each antipsychotic that is prescribed, and then sum the percentages e.g. for a patient prescribed olanzapine 15mg a day and chlorpromazine 50mg bd prn, the respective percentages would be 75% and 10%, giving a total antipsychotic prescribed of 85% of the BNF maximum e.g. for a patient prescribed risperidone 50mg every 2/52 and risperidone 2mg od, the respective percentages would be 100% and 12.5%, giving a total antipsychotic prescribed of 112.5% of the BNF maxmimum, this is an example of HIGH DOSE ANTIPSYCHOTIC prescribing.