The development and validation of a medicines optimisation tool to protect the physical health of people with severe mental illness (OPTIMISE).

BACKGROUND: The life expectancy of people with severe mental illness (SMI) is shorter than those without SMI, with multimorbidity and poorer physical health contributing to health inequality. Screening tools could potentially assist the optimisation of medicines to protect the physical health of people with SMI. The aim of our research was to design and validate a medicines optimisation tool (OPTIMISE) to help clinicians to optimise physical health in people with SMI. METHODS: A review of existing published guidelines, PubMed and Medline was carried out. Literature was examined for medicines optimisation recommendations and also for reference to the management of physical illness in people with mental illness. Potential indicators were grouped according to physiological system. A multidisciplinary team with expertise in mental health and the development of screening tools agreed that 83 indicators should be included in the first draft of OPTIMISE. The Delphi consensus technique was used to develop and validate the contents. A 17-member multidisciplinary panel of experts from the UK and Ireland completed 2 rounds of Delphi consensus, rating their level of agreement to 83 prescribing indicators using a 5-point Likert scale. Indicators were accepted for inclusion in the OPTIMISE tool after achieving a median score of 1 or 2, where 1 indicated strongly agree and 2 indicated agree, and 75th centile value of ≤ 2. Interrater reliability was assessed among 4 clinicians across 20 datasets and the chance corrected level of agreement (kappa) was calculated. The kappa statistic was interpreted as poor if 0.2 or less, fair if 0.21-0.4, moderate if 0.41-0.6, substantial if 0.61-0.8, and good if 0.81-1.0. RESULTS: Consensus was achieved after 2 rounds of Delphi for 62 prescribing indicators where 53 indicators were accepted after round 1 and a further 9 indicators were accepted after round 2. Interrater reliability of OPTIMISE between physicians and pharmacists indicated a substantial level of agreement with a kappa statistic of 0.75. CONCLUSIONS: OPTIMISE is a 62 indicator medicines optimisation tool designed to assist decision making in those treating adults with SMI. It was developed using a Delphi consensus methodology and interrater reliability is substantial. OPTIMISE has the potential to improve medicines optimisation by ensuring preventative medicines are considered when clinically indicated. Further research involving the implementation of OPTIMISE is required to demonstrate its true benefit. TRIAL REGISTRATION: This article does not report the results of a health care intervention on human participants.

Clozapine Use in a Cohort of First-Episode Psychosis.

PURPOSE/BACKGROUND: For approximately one third of individuals treated for psychosis or schizophrenia, antipsychotic medications will have little or no therapeutic benefit. Clozapine remains the sole medication approved for treatment-resistant schizophrenia, and studies have demonstrated its superior efficacy in reducing psychotic symptoms. METHODS/PROCEDURES: Data were collected from the medical records of people who originally presented with a first-episode psychosis between 1995 and 1999 (N = 171). Data were obtained from first presentation up to December 31, 2013 or until the patient was discharged or transferred. Information on service use and physical health was gathered using a data collection template designed specifically for this audit. FINDINGS/RESULTS: Twenty-eight (16.3%) of the cohort were prescribed clozapine. Data were available for 24 individuals. Of this clozapine subsample, the mean age at baseline was 23.11 (SD = 4.58); 82.14% (n = 23) were male; and 82.14% (n = 23) had a baseline diagnosis of schizophrenia. The mean time to first trial of clozapine was 6.7 years. The mean number of antipsychotics prescribed before clozapine trial was 4.85. After the initiation of clozapine, the mean number of hospital admissions reduced from 6.04 per year to 0.88 per year. IMPLICATIONS/CONCLUSIONS: Nearly 1 in 5 of the original cohort was considered to have a suboptimal response to trials of antipsychotic medication. The use of clozapine for treatment-resistant schizophrenia is underutilized, and better understanding of the barriers to prescribing clozapine is necessary given the implications for patient's quality of life and hospital admission rates. Physical health data further emphasizes the importance of physical health monitoring in this vulnerable population.

What works for whom, how and why in mental health education for undergraduate health profession students? A realist synthesis protocol.

INTRODUCTION: It has been shown that mental health education can support positive attitudes of health profession students towards people with mental health challenges, which supports them to provide optimal healthcare to this group. There are many different approaches to designing and delivering mental health education to health profession students. Each has their own advantages and disadvantages, and often mental health education programmes incorporate a multimodal approach in order to reap the benefits of a variety of teaching and learning approaches. The aim of this study is to understand the current landscape of teaching and learning approaches to mental health education for undergraduate health profession students. We will examine the features of successful outcomes for health profession students for:Learning environment.Knowledge development and retention.Confidence. MOTIVATION: Preparedness for professional practice. METHODS: For this, a realist synthesis has been chosen in order to review the literature. Realist synthesis lends itself to the review of complex interventions such as mental health education for undergraduate health profession curricula because it seeks to uncover the range of different mechanisms and context configurations that produce different outcomes. Health profession education and education practice, in general, is complex. A patient and public involvement (PPI) group is involved throughout this study and includes undergraduate health profession students, and members of the St John of Gods Hospital Consumers and Carers Council who are involved at every stage of the research. This study will engage with a stakeholder group who will support the refining of the programme theory. ETHICS AND DISSEMINATION: Ethical approval has been sought and approved by Royal College of Surgeons, Ireland Ethical Committee (REC number: 212622783). We will aim to write up and publish the full synthesis as a journal article. We will also discuss ways of dissemination outside of academia with our PPI group.

Pharmacy student attitudes to mental illness and the provision of mental health care: a repeated cross-sectional survey.

BACKGROUND: Attitudes to mental illness are an important factor in the willingness of professionals to engage in mental health care. AIM: The aim of this study was to understand attitudes of undergraduate pharmacy students in Ireland to severe mental illness and the provision of medicines optimisation services as well as the variation in these attitudes throughout the undergraduate course. METHOD: A survey instrument was compiled using existing published research and validated questionnaires. The survey was distributed to students in their first, third and Master of Pharmacy years annually between 2014 and 2019. Although designed as a longitudinal study, following the matching process there were a limited number of students who completed more than one survey and therefore data were treated as independent samples. RESULTS: The overall average response rate was 25% per survey (n = 191 participants) Notwithstanding generally positive attitudes, a sizeable proportion of students felt people with severe depression and schizophrenia were hard to talk to (n = 48, 25.3%; n = 54, 29.2%) Less than half of MPharm students expressed confidence and competence in caring for people with more severe mental illnesses such as bipolar disorder and schizophrenia and 29% (n = 60) of students would feel awkward asking someone about their antipsychotic medication. Almost two thirds (n = 120, 63.8%) expressed an interest in a career in mental health. CONCLUSION: Irish pharmacy students have generally positive attitudes towards people with severe mental illness and provision of medicines optimisation services. There is an opportunity to improve pharmacy graduates perceived competence and confidence to provide mental health services.

Cardiometabolic risk in people under 40 years with severe mental illness: reading between the guidelines.

People with severe mental illness (SMI) have a shorter life expectancy than the rest of the population. Multimorbidity and poorer physical health contribute to this health inequality. Cardiometabolic multimorbidity confers a significant mortality risk in this population. Multimorbidity is not restricted to older people and people with SMI present with multimorbidity earlier in life. Despite this, most screening, prevention and treatment strategies target older people. People under 40 years with SMI are underserved by current guidelines for cardiovascular risk assessment and reduction. Research is needed to develop and implement interventions to reduce cardiometabolic risk in this population.

Pharmacist-led medicines optimisation service in an inpatient mental health setting.

Medicines optimisation ensures that people get the best possible outcomes from their medicines. As those with severe mental illness (SMI) are frequently prescribed psychotropic medicines with potentially significant side-effects, poor adherence to treatment and physical morbidity are common. This results in suboptimal symptom control, physical health problems and negative health outcomes. The specialist mental health pharmacist (SMHP) is best placed to provide leadership for medicines optimisation in the inpatient mental health setting. By adopting a patient-centred approach to providing information, improving adherence, screening, initiating and maintaining medicines, and supporting self-advocacy, the SMHP can ensure the patients' experience of taking medicines is optimised. As there is currently limited understanding of what a baseline clinical pharmacy service in a mental health setting looks like, we aim to outline a framework for pharmacist-led medicines optimisation for those with SMI. This framework is suitable to be scaled and adapted to other settings.

Metformin in the management of antipsychotic-induced weight gain in adults with psychosis: development of the first evidence-based guideline using GRADE methodology.

BACKGROUND: Adjunctive metformin is the most well-studied intervention in the pharmacological management of antipsychotic-induced weight gain (AIWG). Although a relatively unaddressed area, among guidelines recommending consideration of metformin, prescribing information that would facilitate its applied use by clinicians, for example, provision of a dose titration schedule is absent. Moreover, recommendations differ regarding metformin's place in the hierarchy of management options. Both represent significant barriers to the applied, evidence-based use of metformin for this indication. OBJECTIVE: To produce a guideline solely dedicated to the optimised use of metformin in AIWG management, using internationally endorsed guideline methodology. METHODS: A list of guideline key health questions (KHQs) was produced. It was agreed that individual recommendations would be 'adopted or adapted' from current guidelines and/or developed de novo, in the case of unanswered questions. A systematic literature review (2008-2020) was undertaken to identify published guidelines and supporting (or more recent) research evidence. Quality appraisal was undertaken using the Appraisal of Guidelines Research and Evaluation II tool, A Measurement Tool to Assess Systematic Reviews (AMSTAR) assessment,and the Cochrane Risk of Bias 2 tool, where appropriate. Assessment of evidence certainty and recommendation development was undertaken using Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. FINDINGS: We confirmed that no published guideline-of appropriate quality, solely dedicated to the use of metformin to manage AIWG was available. Recommendations located within other guidelines inadequately addressed our KHQs. CONCLUSION: All 11 recommendations and 7 supporting good practice developed here were formulated de novo. CLINICAL IMPLICATIONS: These recommendations build on the number and quality of recommendations in this area, and facilitate the optimised use of metformin when managing AIWG.

Priorities for future research on reducing and stopping psychiatric medicines using a James Lind Alliance priority setting partnership: The PROTECT study protocol.

Background: There is a growing number of service users looking to discontinue use of psychiatric medicines. Tapering is the recommended approach for reducing and/or discontinuing the use of psychiatric medicines. This involves gradually reducing the dose over time to minimise the potential for withdrawal symptoms. However, many uncertainties exist regarding the process of reducing and stopping psychiatric medicines. This study will use a James Lind Alliance Priority Setting Partnership to determine the Top 10 unanswered questions and uncertainties about reducing and stopping psychiatric medicines. Methods : The Priority Setting Partnership will be conducted using the James Lind Alliance methodology. It will involve seven stages: (i) creating an international Steering Group of representatives from key stakeholder groups that will include people with lived experience of taking and/or stopping psychiatric medicines, family members, carers/supporters and healthcare professionals, and identifying potential partners to support key activities (e.g. dissemination); (ii) gathering uncertainties about reducing and stopping psychiatric medicines from key stakeholders using an online survey; (iii) data processing and summarising the survey responses; (iv) checking the summary questions against existing evidence and verifying uncertainties; (v) shortlisting the questions using a second online survey; (vi) determining the Top 10 research questions through an online prioritisation workshop; (vii) disseminating results. Conclusions : This study will use a Priority Setting Partnership to generate a Top 10 list of research questions and uncertainties about reducing and stopping psychiatric medicines. This list will help to guide future research and deliver responsive and strategic allocation of research resources, with a view to ultimately improving the future health and well-being of individuals who are taking psychiatric medicines.

Prescribing pattern of antipsychotic medication for first-episode psychosis: a retrospective cohort study.

OBJECTIVE: Guidelines for antipsychotic use in first-episode psychosis (FEP) recommend that medication be chosen initially on the basis of side effect profile with doses at the lower end of the range. Our objective was to describe the pattern of antipsychotic use in FEP over a period of 21 years in the context of changing clinical guidelines and the development of specialist early intervention in psychosis (EIP) services. SETTING: A community-based mental health service in South County Dublin (population 187 000) and a large private hospital. PARTICIPANTS: Participants included 465 patients with FEP (146 from an epidemiological study (1995-1999) and 319 from a specialist EIP service (2005-2016)). Treatment with antipsychotic medication did not exceed 30 days at study entry. OUTCOME MEASURES: This is a descriptive study of prescribing practices in the context of service development and changing guidelines. RESULTS: First-generation antipsychotics were prescribed for 65% of the early cohort compared with 4.3% of the EIP cohort. Olanzapine was initially prescribed for 79.7% of EIP patients. Initial doses of medication were frequently low (≤50% British National Formulary (BNF) maximum) in both cohorts (71% and 78.6%). The demographic and clinical factors investigated did not influence the initial choice of antipsychotic medication significantly. Univariate logistic regression analysis suggested inpatient treatment setting was associated with a higher initial dose (>50% BNF maximum) of antipsychotic medication. Increasing dose requirements over the first month of engagement with an EIP service was associated with poorer global functioning at baseline, greater positive symptoms at baseline and the inpatient treatment setting. However, these associations were not seen in the multivariable model. CONCLUSIONS: Second-generation antipsychotic prescribing predominates, but guidelines are often overlooked when choosing olanzapine notwithstanding lower initial dosages. EIP services should include proactive support for optimising medicines in line with evidence-based guidelines.

Check the effects: systematic assessment of antipsychotic side-effects in an inpatient cohort.

BACKGROUND: Antipsychotics are associated with a range of side-effects that can influence patients' subjective well-being negatively resulting in poor adherence. In order to limit the negative consequences of side-effects, they should be regularly systematically assessed. The aim of this study was to systematically assess antipsychotic side-effects in an inpatient cohort using validated rating scales. METHODS: Eligible individuals prescribed an antipsychotic for at least 2 weeks were invited to have their side-effects assessed systematically. RESULTS: A total of 208 individuals were assessed systematically for antipsychotic side-effects; 71.5% (n = 138) stated that they had not reported side-effects to their clinician prior to the assessment. The most commonly reported side-effects were daytime drowsiness (75%), dry mouth (58.2%) and weight gain (50.0%), while the most distressing side-effects reported were erectile dysfunction (35.0%), sexual dysfunction (26.3%) and amenorrhoea (26.3%). There was no evidence of an association between side-effect severity/number of side-effects reported/distress caused by those taking high dose/combination antipsychotics versus standard dose monotherapy. CONCLUSION: Side-effects must be regularly and systematically assessed using a validated rating scale. As distress caused by side-effects plays a major role in non-adherence, assessment should examine distress and data on distressing side-effects should be available to those choosing an antipsychotic. Given the lack of correlation between high dose/combination antipsychotics and side-effects, treatment should be tailored to the individual based on response/tolerance and dose reduction/avoidance of polypharmacy should not be recommended to minimise side-effects.

Clozapine use - has practice changed?

BACKGROUND: One-third of individuals with schizophrenia have treatment-resistant illness. Of these, up to 60% will respond to clozapine treatment. AIMS: This study retrospectively examined clozapine prescribing patterns against National Institute for Health and Care Excellence (NICE) guidelines as treatment-resistant illness emerged in a first-episode psychosis cohort. METHODS: A total of 339 individuals with a first-episode psychosis were included in the study. Clozapine prescribing patterns were compared against the NICE guidelines and the impact of clozapine use on one index of service utilisation (hospitalisation) was assessed. RESULTS: A total of 32 individuals (9.4%) from the cohort were prescribed clozapine. The mean time to clozapine trial was 2.1 years (SD 1.95; range 0.17-6.25). The mean number of adequate trials of antipsychotic prior to starting clozapine was 2.74 (SD 1.13; range 1-5). Following clozapine initiation, mean hospital admissions per year reduced from 2.3 to 0.3 (p=0.00). Mean hospital days pre- and post-clozapine also reduced (147 vs. 53; p=0.00). In total, 18 patients discontinued clozapine use during follow-up - 5 temporarily and 13 permanently. CONCLUSIONS: Patients are being prescribed clozapine earlier than previously demonstrated, though delays are still evident, and many patients discontinue treatment. More work needs to be undertaken to understand and address factors which lead to its discontinuation.

Pharmacy Students' Reflections on an Experiential Learning Visit to a Psychiatric Hospital.

Objective. To create a brief, experiential educational intervention for undergraduate pharmacy students aimed at developing appropriate attitudes, knowledge, and skills for the delivery of recovery-focused pharmacy services to people with mental illness, and to elicit student perceptions of the value and impact of the intervention. Methods. A brief intervention was developed in which a cohort of 44 fourth-year pharmacy students attended a psychiatric teaching hospital in groups of 10 to12. The intervention was integrated into the therapeutics module, and was based on Fink's taxonomy of learning. Delivery of the intervention included input from a multidisciplinary team of mental health professionals and the use of active-learning strategies to give students an insight into the holistic approach to care and the patient journey. Students participated in an exercise in reflective practice following the visit. Content analysis was performed on the reflective writings of consenting students to identify themes and insights gained. Results. Thirty-eight of the 44 students gave their consent for their reflective writings to be analyzed for the purpose of this research. Students expressed some apprehension before their visit to the hospital, but later gained an appreciation of the patient experience of care in the psychiatric setting. Students also described having a greater appreciation of the role of the pharmacist in caring for psychiatric patients as well as an insight into the role of other health care professionals and interventions supporting recovery. Conclusion. A brief experiential intervention helped students integrate their learning and appreciate the value of their expertise in supporting those experiencing mental illness.

Optimising prescribing for patients with severe mental illness: the need for criteria.

The life expectancy of people with severe mental illness (SMI) is considerably shorter than those without SMI. Multimorbidity and poorer physical health outcomes contribute significantly to this health inequality. Psychotropic medicines, including antipsychotics, antidepressants, mood stabilisers and anxiolytic medicines, are the mainstay of treatment for SMI, and overall improve life expectancy and quality of life. Optimising medicines is required to ensure adequate control of symptoms while avoiding complications and negative physical health outcomes. Screening tools would offer an opportunity to assist clinicians in decision making and optimising medicines for people with SMI, who are particularly vulnerable to medication-related problems and poorer physical health.

Patients and Caregivers Helping to Shape the Undergraduate Pharmacy Mental Health Curriculum.

Objective. To develop a model system for involving patients and caregivers in curriculum development of mental health education in an undergraduate pharmacy program. Methods. Purposive recruitment was used to convene a focus group of nine people with experience in using mental health services from either the patient or caregiver perspective. Group members were asked about their experience with using pharmacy services and their suggestions for enhancement of the undergraduate curriculum. Thematic analysis was conducted independently by two researchers. Results. Patients and caregivers believed that pharmacists could contribute to the care of people who experience mental health conditions by supporting shared decision making, providing information, actively managing side effects of psychotropic medication, and conducting regular medication review. Subjects suggested that the pharmacy undergraduate curriculum should introduce mental health from the beginning, include self-care for students, integrate mental and physical health education, and enhance students' communication skills. The curriculum should include broader issues relevant to mental health beyond the use of medication, such as stigma, the recovery approach, and interprofessional cooperation. These changes could support graduates in engaging proactively with people experiencing mental health difficulties. Conclusion. Involving patients and caregivers in the design of an undergraduate pharmacy curriculum in mental health resulted in a more person-centered and student-centered approach to mental health education at our university. Ultimately, the changes made to the undergraduate curriculum will improve the ability of pharmacy graduates to better meet the needs of patients.

Pharmacological guidelines for schizophrenia: a systematic review and comparison of recommendations for the first episode.

OBJECTIVES: Clinical practice guidelines (CPGs) support the translation of research evidence into clinical practice. Key health questions in CPGs ensure that recommendations will be applicable to the clinical context in which the guideline is used. The objectives of this study were to identify CPGs for the pharmacological treatment of first-episode schizophrenia; assess the quality of these guidelines using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument; and compare recommendations in relation to the key health questions that are relevant to the pharmacological treatment of first-episode schizophrenia. METHODS: A multidisciplinary group identified key health questions that are relevant to the pharmacological treatment of first-episode schizophrenia. The MEDLINE and EMBASE databases, websites of professional organisations and international guideline repositories, were searched for CPGs that met the inclusion criteria. The AGREE II instrument was applied by three raters and data were extracted from the guidelines in relation to the key health questions. RESULTS: In total, 3299 records were screened. 10 guidelines met the inclusion criteria. 3 guidelines scored well across all domains. Recommendations varied in specificity. Side effect concerns, rather than comparative efficacy benefits, were a key consideration in antipsychotic choice. Antipsychotic medication is recommended for maintenance of remission following a first episode of schizophrenia but there is a paucity of evidence to guide duration of treatment. Clozapine is universally regarded as the medication of choice for treatment resistance. There is less evidence to guide care for those who do not respond to clozapine. CONCLUSIONS: An individual's experience of using antipsychotic medication for the initial treatment of first-episode schizophrenia may have implications for future engagement, adherence and outcome. While guidelines of good quality exist to assist in medicines optimisation, the evidence base required to answer key health questions relevant to the pharmacological treatment of first-episode schizophrenia is limited.

Glasgow Antipsychotic Side-effects Scale for Clozapine - Development and validation of a clozapine-specific side-effects scale.

OBJECTIVE: The authors developed and validated a clozapine-specific side-effects scale capable of eliciting the subjectively unpleasant side-effects of clozapine. METHODS: Questions from the original Glasgow Antipsychotic Side-effects Scale (GASS) were compared to a list of the most commonly reported clozapine side-effects and those with a significant subjective burden were included in the GASS for Clozapine (GASS-C). The original authors of the GASS and a group of mental health professionals from the UK and Ireland were enlisted to comment on the questions in the GASS-C based on their clinical experience. 110 clozapine outpatients from two sites completed the GASS-C, the original GASS and a repeat GASS-C. Statistical analyses were performed using SPSS for Windows version 19. RESULTS: The GASS-C was shown to have construct validity, in that Spearman's correlation coefficient was 0.816 (p<0.001) with the original GASS, whilst Cohen's kappa coefficient was >0.77 (p<0.001) for one question and >0.81 (p<0.001) for remaining relevant questions. GASS-C was also shown to have strong test-retest reliability, in that Cronbach's alpha coefficient was >0.907 (p<0.001), whilst Cohen's kappa coefficient was >0.81 (p<0.001) for 12 questions and >0.61 (p<0.001) for the remaining four questions. CONCLUSION: The GASS-C is a valid and reliable clinical tool to enable a systematic assessment of the subjectively unpleasant side-effects of clozapine. Future research should focus on how the scale can be utilised as a clinical tool to improve real-world outcomes such as adherence to clozapine therapy and quality of life.