clozapine physical health monitoring

Jump to search results. Community initiation of clozapine may be considered if the patient is in good physical health and home treatment is deemed as an alternative to inpatient or day hospital ... including additional support required for clozapine monitoring. 3. Saravane D, Feve B, Frances Y, Corruble E, Lancon C, Chanson P, Maison P, Terra JL, Azorin JM; avec le soutien institutionnel du laboratoire Lilly. 8600 Rockville Pike Therapeutic interventions to treat adverse effects are underused yet may significantly improve the quality of life of patients. assessing participant results and physical health status), pharmacies, pharmacists, centre co-ordinators and assistants, and treating centres or clinics involved with the distribution of clozapine must be registered with the relevant clozapine patient monitoring program. Documented pretreatment measures of blood pressure, pulse rate, body weight, plasma lipids, plasma glucose and a general physical examination in 481 patients who had been treated with clozapine for fewer than 18 weeks. Conflict of interest statement: TREB has been a member of scientific advisory boards for Lundbeck, Newron and Gedeon Richter/Recordati and received an honorarium for a lecture from Janssen. Weight gain is a very common side effect associated with clozapine treatment, but the data suggest that, aside from the possible use of aripiprazole for this purpose, this was not managed with pharmacological strategies in the majority of cases; such an approach is consistent with the limited effect that anti-obesity medicines have on mitigating clozapine-related weight gain.41. At least two-thirds of all patients who had been prescribed clozapine for more than 1 year were prescribed other medications to help manage the side effects of clozapine treatment. The incidence of neutropenia among clozapine-treated patients is 2% and agranulocytosis 0.8%. doi: 10.1136/bmjopen-2016-013116. Treatment options for clozapine resistance, BAP guidelines on the management of weight gain, metabolic disturbances and cardiovascular risk associated with psychosis and antipsychotic drug treatment, Safety and tolerability of antipsychotic polypharmacy, Effects of antipsychotics, antidepressants and mood stabilizers on risk for physical diseases in people with schizophrenia, depression and bipolar disorder, Side effect burden of antipsychotic drugs in real life – impact of gender and polypharmacy, Using a clinical process map to identify prescribing cascades in your patient, The role of the prescribing observatory for mental health, Improving physical health monitoring in secondary care for patients on clozapine, Audit of monitoring of the parameters of metabolic syndrome in patients on clozapine, Evaluation of a clozapine decision support tool in a mental health facility, Using junior doctors to improve patient care: creating a clinic to monitor the physical health of patients prescribed clozapine, SAGE Publications Ltd unless otherwise noted. You can be signed in via any or all of the methods shown below at the same time. NHS trusts/healthcare organisations participated in a clinical audit in the context of a UK quality improvement programme addressing clozapine-prescribing practice. For the 450 eligible patients, Figure 2 shows that during the first 2 weeks of clozapine treatment there was documented daily measurement of body temperature in 77% and measurement less frequently than daily in an additional 13%. Filter ... from physical health monitoring of patients in a secondary care clozapine clinic compared with follow-up in a... Read Summary. In the 5908 patients prescribed clozapine for at least 1 year, blood pressure and body weight/body mass index were documented in at least 80%, plasma lipids in 78% and plasma glucose in 73%, with an ECG in 55%. Marder SR, Essock SM, Miller AL, Buchanan RW, Casey DE, Davis JM, Kane JM, Lieberman JA, Schooler NR, Covell N, Stroup S, Weissman EM, Wirshing DA, Hall CS, Pogach L, Pi-Sunyer X, Bigger JT Jr, Friedman A, Kleinberg D, Yevich SJ, Davis B, Shon S. Am J Psychiatry. 14 While the elements of screening and on-treatment monitoring relating to body weight, plasma lipids, glycaemic control, blood pressure and heart rate are included in most relevant protocols, monitoring for clozapine-… Monitoring Each brand of clozapine is associated with a mandatory monitoring service to detect any drop in white blood cells. The secondary care team should maintain responsibility for monitoring the person's physical health and the effects of any antipsychotic medication for the first 12 months of treatment, or until the person's condition has stabilised (whichever is the longest). Ongoing Treatment and Monitoring 7.1 Clozapine clinics The Clozapine Clinic is a centralised resource and information centre for patients, carers and other Health Professionals. CRP or CK had been measured in 945 (16%) patients and troponin or BNP had been measured in 295 (5%), while an echocardiogram had been conducted for 59 (1%). Clozapine – Monitoring Summary 32 6.3. All health care professionals involved in the supply of clozapine at particular centres must be registered with the relevant monitoring system database. Please enable it to take advantage of the complete set of features! The physical health and side-effect monitoring of patients prescribed clozapine: data from a clinical audit conducted in UK mental health services. Contact us if you experience any difficulty logging in. -. 5.6 The Clozapine Maintenance Care Plan should be kept up to date in RiO Service Specific Files > Physical Treatment > Clozapine Documentation. Monitoring of physical health needs should be recorded in a timely and structured manner. Day 2 Onwards 6.4. For longer-term monitoring of patients on continuing clozapine treatment, assessments of body weight/BMI, plasma lipids, plasma glucose and ECG are generally recommended annually.15,17,22,23,37 In the subsample of patients prescribed clozapine for at least 1 year, there were documented measures of blood pressure and BMI in the last year for four out of every five patients, while for measures of plasma lipids and plasma glucose this proportion was slightly lower at around three out of every four. The drug is subject to strict monitoring requirements because it is associated with serious side effects, such as neutropenia, agranulocytosis, seizures, myocarditis and cardiomyopathy. Two-thirds were prescribed medication to manage side effects of clozapine and one third of those with a diagnosis of schizophrenia were prescribed a second antipsychotic medication. Ellis, P, Harrison-Woolrych, M, McLean, R. Every-Palmer, S, Newton-Howes, G, Clarke, MJ. Monitoring for clozapine-induced myocarditis during the early risk period using markers of inflammation such as CRP, and cardiac damage such as troponin and BNP, was less consistent. antipsychotic medication; clozapine; physical health monitoring; quality improvement; schizophrenia; side effects. Encephale. Day 2 Onwards ... affect physical health. MP5z - Appendix 4c - Physical monitoring during Community clozapine initiation – for display in clinic or team base.dotx; MP5z - Appendix 2d - Physical health monitoring (baseline and during Inpatient dose titration).dotx; MP5z - Appendix 2c - Inpatient Slow Clozapine Titration over 28 days for those sensitive to side effects.dotx In addition, the data collected from clinical records included psychiatric diagnoses, other psychotropic medication prescribed, the reasons for the initiation of clozapine treatment, whether clozapine was prescribed outside of its licensed indication (‘off-label’) and clozapine treatment history. It is proven that serious physical health problems are more common among patients with severe mental health illness (SMI), this monitoring can be challenging and there is a need for improvement. Where increased frequency of monitoring is required due to a break in therapy (> 3 days, less than 4 weeks), weekly haematological monitoring as per the relevant clozapine monitoring system protocol should continue. Conduct necessary blood test monitoring at agreed schedule (see Clinical Monitoring section) and communicate results to the mental health team if required 4. In addition, there are side effects that may become serious if overlooked, such as constipation,7–9 weight gain and metabolic syndrome,10,11 and others that are potentially discomfiting or distressing such as hypersalivation, sedation, orthostatic hypotension and nocturnal enuresis.12 Clozapine is associated with high rates of cardio-metabolic risk factors which may be both under-detected and under-treated.13 The prevalence of specific side effects changes during the course of treatment, and effective monitoring of clozapine side effects should take this into account. 2 Appendix F Clozapine Monitoring 16 Appendix G Guideline for the monitoring and management of ... or physical illness. Conflict of interest statementTREB has been a member of scientific advisory boards for Lundbeck, Newron and Gedeon Richter/Recordati and received an honorarium for a lecture from Janssen. Monitoring for clozapine-induced myocarditis during the early risk period using markers of inflammation such as CRP, and cardiac damage such as troponin and BNP, was less consistent. -, Barnes TR, Drake R, Paton C, et al. Thanks are also due to members of the POMH-UK team aside from the co-authors of this paper: Gavin Herrington, Brittany McConnell and Olivia Rendora. Initiation (Day 1) 6.3.2. Monitoring for clozapine-induced myocarditis during the early risk period using markers of inflammation such as CRP, and cardiac … Randomised controlled trials of conventional antipsychotic versus new atypical drugs, and new atypical drugs versus clozapine, in people with schizophrenia responding poorly to, or intolerant of, current drug treatment. Checking that processes are operating effectively and efficiently e.g. Green result Amber result Red result WBC greater than 3.5 x 109/L AND Neutrophils greater than 2.0 x 109 /L WBC 3.0 - 3.5 x 109/L AND/OR Neutrophils 1.5 - 2.0 x 109 /L WBC less than < 3.0 x 109/L AND/OR The vast majority of patients prescribed clozapine for more than 1 year had a diagnosis of a schizophrenia spectrum disorder, of whom almost a third were coprescribed a second antipsychotic medication. Patients taking clozapine should have fasting blood glucose tested at baseline, after one months’ treatment, then every 4–6 months. Inform Pharmacy and the clozapine clinic nurse of any changes to the patient’s prescription, and request clozapine prescription for amendment/provide new clozapine prescription. -, Rubio JM, Kane JM. Information should be readily available to staff Sharing links are not available for this article. The relatively common coprescription of medications for the majority of people on longer-term clozapine treatment may well further increase side-effect burden and physical health risks, reinforcing the need for continuing systematic monitoring. 2.2 The majority of NTW patients prescribed clozapine are managed within the Trust’s clozapine clinics. Initiation (Day 1) 6.3.2. Approved by: ABUHB Mental Health D+T Review by date: 30/01/2017 7. 7. 1. A centre is defined as a hospital, clinic or other facility that is involved with the use of clozapine. The clinical symptoms and signs of clozapine-induced myocarditis may be rather nonspecific and there are no definitive diagnostic criteria.4,28 Further, treatment guidelines vary regarding the utility of monitoring using markers of inflammation (CRP, erythrocyte sedimentation rate) and cardiac damage (troponin, BNP).15,16,18,36 The current Australian and New Zealand guidelines23 recommend a baseline measure of troponin while the Maudsley prescribing guidelines18 refer to a monitoring algorithm for the detection of treatment-emergent myocarditis15 that includes weekly CRP and troponin measures in the first month of treatment. Manuscript content on this site is licensed under Creative Commons Licenses, The physical health and side-effect monitoring of patients prescribed clozapine: data from a clinical audit conducted in UK mental health services, https://creativecommons.org/licenses/by-nc/4.0/, https://us.sagepub.com/en-us/nam/open-access-at-sage, http://www.hra-decisiontools.org.uk/research/docs/DefiningResearchTable_Oct2017-1.pdf, Resolution without discontinuation: heart failure during clozapine treatment, Ivabradine, a novel treatment for clozapine-induced sinus tachycardia: a case series, Management of clozapine treatment during the COVID-19 pandemic. Login failed. However, the impact of the feedback on the baseline audit data to clinical services in this POMH QI programme will be tested with a re-audit after 2 years. Documented daily measurements of temperature, pulse rate and blood pressure in the first 2 weeks of clozapine treatment in 450 patients who had been treated with clozapine for between 2 weeks and 18 weeks. White blood cell (WBC) and Neutrophil count (NC) are measured weekly for 18 weeks and every 28 days thereafter, continuing for the duration of treatment with clozapine. The two clozapine patient monitoring systems or services require all patients, prescribing doctors, dispensing pharmacists, centre coordinators and centres using clozapine to be registered. Physical examination was documented for 3275 (55%) patients. 2. Fatal overdoses have been reported with Clozapine, generally at doses above 2500 mg. 2012 Oct;73(10):1307-12. doi: 10.4088/JCP.11r06977. 2009 Sep;35(4):330-9. doi: 10.1016/j.encep.2008.10.014. Unfortunately it is associated with a range of troublesome side-effects some of which can have a profound effect on a patient’s on-going physical health. The findings suggest that for most patients treated with clozapine in UK mental health services, physical health screening and side-effect monitoring follow recommended practice, but there was limited use of structured side-effect assessment tools. Due to the complex nature of Clozapine treatment in relation to physical risks, side effects and required monitoring, this guidance is intended to provide a framework to support clinicians to initiate and use Clozapine safely and effectively. Beyond white blood cell monitoring: screening in the initial phase of clozapine therapy. While it is likely that some of the less specific tests may have been undertaken as part of routine monitoring, the more specific the test, the higher the probability that it was conducted because the patient had symptoms that were suspected to be cardiac in origin. There have also been reports of patients recovering from overdoses well in excess of 4 g. -, Patel RK, Moore AM, Piper S, et al. Do n o T Wr IT e I n THIS b I n DI n G MA r GI n Clozapine Blood Results Monitoring System Recommended Action Green Range WBC greater than 3.5 x 109/L and Neutrophils greater than 2.0 x 109/L Continue clozapinetherapy. The e-mail addresses that you supply to use this service will not be used for any other purpose without your consent. The purpose of the clinic is to monitor the physical health of the person receiving clozapine including monitoring of side effects, weight, and providing education. People taking clozapine are managed exclusively in secondary care. It does not constitute a full physical health screen and service users/carers and Analysis of the data collected in this national clinical audit suggests that for the majority of patients prescribed clozapine in mental health services, physical health screening and side-effect monitoring are in line with recommended practice, although there was only limited use of structured side-effect assessment tools. He is a shareholder in LB Pharma and the Vanguard Research Group. GPs should make sure people have an annual health check. Monitoring for clozapine-induced myocarditis during the early risk period using markers of inflammation such as CRP, and cardiac damage such as troponin and BNP, was less consistent. Acta Psychiatr Scand 2020; 141: 178–189. 2006 May;10(17):iii-iv, ix-xi, 1-165. doi: 10.3310/hta10170. Conduct necessary blood test monitoring at agreed schedule (see Clinical Monitoring section) and communicate results to the mental health team if required 4. IBM Corp . 5.4 Additional physical health monitoring should be recorded in the Core Physical Health Monitoring Form. Ronaldson, KJ, Fitzgerald, PB, McNeil, JJ. A total of 5633 (95%) patients had a diagnosis of schizophrenia spectrum disorder, of whom 1803 (32%) were prescribed a second antipsychotic in combination with clozapine. Two-thirds were prescribed medication to manage side effects of clozapine and one third of those with a diagnosis of schizophrenia were prescribed a second antipsychotic medication. Find out about Lean Library here, If you have access to journal via a society or associations, read the instructions below. From the clinical records of the 5908 patients treated with clozapine for more than 1 year, data were collected on the measurement of blood pressure, pulse rate, body weight, plasma lipids and plasma glucose, as well as a general physical examination. Neither set of requirements subsumes the other; both should be conducted on patients on clozapine antipsychotic polypharmacy who are in … In a subsample of 411 patients, of the 72% who had weekly side-effect assessments documented in the first month of treatment, a structured assessment tool had been used in 29%. Prior to initiating treatment with clozapine, perform a careful physical examination, medical history, and concomitant medication history. This site uses cookies. IBM SPSS Statistics for Windows, version 21.0. The findings suggest that for most patients treated with clozapine in UK mental health services, physical health screening and side-effect monitoring follow recommended practice, but there was limited use of structured side-effect assessment tools. Clozapine Treatment and Monitoring in Patients with Benign Ethnic Neutropenia (see Table 3) ... are healthy, and do not suffer from repeated or severe infections. Clozapine is a highly effective drug for treatment-resistant schizophrenia, however careful monitoring for, and accurate diagnosis of, clozapine-related adverse effects is essential. Tachycardia developed should be checked with reference to the baseline heart rate measured before commencing Clozapine. This page gives advice on drug monitoring during COVID-19 for clozapine. JMK has received honoraria for lectures and/or consulting from Alkermes, Allergan, Intra-Cellular Therapies, Janssen, LB Pharma, Lundbeck, Merck, Neurocrine Biosciences, Newron, Otsuka, Reviva, Roche, Sunovion, Sumitomo Dainippon and Teva. See this image and copyright information in PMC. Where increased frequency of monitoring is required due to a break in therapy (> 3 days, less than 4 weeks), weekly haematological monitoring as per the relevant clozapine monitoring system protocol should continue. Clozapine Outpatients ... affect physical health. Aside from the mandatory haematological monitoring, guideline recommendations for clinicians for the physical health and side-effect monitoring of patients prescribed clozapine treatment are not entirely consistent. APPLICABILITY Compliance with this document is required by all Alberta Health Services employees, members of the medical and midwifery staffs, … He is a shareholder in LB Pharma and the Vanguard Research Group. Some society journals require you to create a personal profile, then activate your society account, You are adding the following journals to your email alerts, Did you struggle to get access to this article? Vermeulen JM, van Rooijen G, van de Kerkhof MPJ, et al. BMI, body mass index; HbA1c, haemoglobin A1c. The antipsychotic medication, clozapine, has the most convincing evidence for benefit in treatment-resistant schizophrenia and there are indications that it can reduce aggression, suicidality and mortality in schizophrenia.1–3 Weighing up the risks and benefits of clozapine treatment in any individual involves the assessment of adverse effects. The relatively common coprescription of medications for the majority of people on longer-term clozapine treatment may well further increase side-effect burden and physical health risks, reinforcing the need for continuing systematic monitoring. Patients taking clozapine require more frequent monitoring of these parameters: every 3 months for the first year, then yearly. View or download all the content the society has access to. Treatment monitoring up to 18 weeks included an ECG in 90%, C-reactive protein (CRP) or creatine kinase in 42%, and troponin or B-type natriuretic peptide (BNP) in 29%. National Institute for Health and Care Excellence . “In addition, we developed a clozapine physical health monitoring booklet, which empowers patients to take onboard the management and monitoring of their own physical health and mental health,” said Mrs Dawda. Patient should present by 9-9.30am. Methods: A limitation of these audit data is that it is not known whether such tests were conducted as routine monitoring, or prompted by cardiac symptoms or aberrant investigation results, such as raised eosinophils. Augmentation strategies for clozapine refractory schizophrenia: a systematic review and meta-analysis. The Transition to Maintenance Therapy 27 7.1 Models of Clozapine … Documented pretreatment measures of blood pressure, pulse rate, body weight, plasma lipids, plasma glucose and a general physical examination in 481 patients who had been treated with clozapine for fewer than 18 weeks. In 422 (7%) of these patients, none of these physical health checks were documented in the clinical records in the previous year. 4.6 Blood monitoring requirements 7 4.7 Clozapine serum level monitoring 8 4.8 Treatment breaks and omitted breaks 11 4.9 Monitoring requirements following clozapine discontinuation 12 4.10 Prescribing clozapine 12 4.11 Drug interactions 13 4.12 Physical health monitoring requirements 14 4.13 One-stop clozapine clinic 15 Monitor the patient’s overall physical health and well-being 6. Psychosis and schizophrenia in adults: prevention and management. During the first 2 weeks of clozapine treatment there was documented daily measurement of both heart rate and blood pressure in 82% and body temperature in 77%. Acknowledgements are due to the clinicians and other staff in participating services who collected and submitted the audit data. It is estimated that up to 60% of patients who are prescribed clozapine experience constipation and although rare, death from complications arising from constipation is estimated at more than three times the rate of death from agranulocytosis. In primary care, the prescribing of clozapine should be flagged To identify areas of improvement in practice. Anıl Yağcıoğlu, AE, Ertuğrul, A, Karakaşlı, AA. Advice should be given t o contact the treating Medical Officer or Local Medical Officer immediately if signs of … Carry out the following physical monitoring continuing to use the NEWS Clozapine Titration. Scottish Intercollegiate Guidelines Network . If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. Documented measurements in the previous year of blood pressure, pulse rate, body weight, plasma lipids, plasma glucose and a general physical examination in 5908 patients treated with clozapine for more than 1 year. Every centre estimates that clozapine saves around 492 schizophrenic patients from suicide per 100000 clozapine patient-years, but weight gain associated with the drug kills 416 patients.5 Patients have their full blood count monitored frequently because of the risk of agranulocytosis. Treatment for symptomatic oesophageal reflux was prescribed for one patient in five. However, most patients had a baseline ECG in their clinical records. Clozapine Observation Monitoring Chart (Inpatients) 33 6.3.1. Quality of prescribing of antipsychotic medication for people with intellectual disability under the care of UK mental health services: a cross-sectional audit of clinical practice. There was documented evidence that an ECG had been conducted in the last year for 3072 (52%) patients in this subsample receiving continuing clozapine treatment for at least 1 year. under “Normal Range” monitoring once ANC ≥1000/μL or at patient’s baseline Source: Clozapine and the Risk of Neutropenia: An Overview for Healthcare Providers Version 2.0 – December 23, 2014 Clozapine can cause neutropenia or agranulocytosis, and frequent monitoring of the full blood count is required. , p. 204512532093790. 3. In 2019, the baseline audit was conducted for a QI programme on the use of clozapine, one aim of which was to determine compliance with evidence-based practice standards for monitoring of physical health, aside from the obligatory haematological monitoring for neutropenia and agranulocytosis.

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