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Aims: There are increasing concerns about harms related to suboptimal antipsychotic use. Here we describe recent population‐based trends in antipsychotic use and harms in Australia and identify population groups exhibiting patterns of use likely to contribute to these harms. Methods: Using population‐based data from the Australian Pharmaceutical Benefits Scheme (2015‐2020), poisoning calls to the New South Wales (NSW) Poisons Information Centre (2015‐2020) and poisoning deaths in all coronial records (2005‐2018) in Australia, we measured trends in the prevalence of antipsychotic use and related deaths and poisonings. We applied latent class analyses to identify patterns of antipsychotic use that may contribute to harms. Results: Quetiapine and olanzapine had the highest prevalence of use between 2015 and 2020. Noteworthy trends included increases of 9.1% and 30.8% in quetiapine use and poisonings, while olanzapine use decreased by 4.5% but poisonings increased by 32.7%. Quetiapine and olanzapine poisonings and related deaths had the highest rates of co‐ingestion of opioids, benzodiazepines and pregabalin compared to other antipsychotics. We identified six distinct population groups using antipsychotics: (i) ongoing high‐dose use with sedatives (8%), (ii) ongoing use (42%), (iii) ongoing use with analgesics and sedatives (11%), (iv) long‐term low‐dose use (9%), (v) sporadic use (20%) and (vi) sporadic use with analgesics (10%). Conclusion: Ongoing potentially suboptimal antipsychotic use and associated harms highlight the need to monitor such patterns of use, for example through prescription monitoring systems. [ABSTRACT FROM AUTHOR]

With the development of trade companies started transacting business across its boarders attaining the character of Transnational Corporation's/Multinational Corporation's which in some cases taken over by the sovereign country what has been called as expropriation. The expropriation at initial stage proceeded towards immovable and movable properties attracting the attention of international community to ponder over the issue with the result permitting the expropriation but after satisfying limitations like public purpose, good faith, non-discriminatory followed by compensation. With the developments in law and technology, the intellectual property as a patent has also come within the ambit of expropriation. In developing phase of jurisprudence, the expropriation was said to be either direct or in direct and/or creeping. The Australian case of concessional rights in favour of US company regarding coral reef and its cancelation had been subject of debate inter alia as an expropriation. In the world of technology and drug pharmacy, the manufacturing units of drugs in most of the cases registered their patents with local law protection under the coverage of WIPO. An emerging concern has been Eli Lilly case of Canada where the patent of the two drugs namely olanzapine and atomexetine was invalidated in Canada resulting in the litigation. The Company lost both at original stage as well as before the appellate court in Canada. But before the NAFTA Tribunal the orders of national courts were reversed in the favour of ELI Lilly. The case has thrown new dimensions towards expropriation,besides, the status of NAFTA tribunal overruling national courts. In the context the research article is of essence and is based on doctrinal methodology. [ABSTRACT FROM AUTHOR]

Background: Behavioural emergencies (BEs) are complex situations in the emergency department (ED) setting. Treatment decisions always must be made within a limited time and are based on incomplete patient data. As a result of the urgency and complexity, patients often are exposed to increased risk of harm. Aim: The aim of this paper is to describe the prescribing patterns and adverse events (AEs) associated with parenteral sedation for the management of BEs in Australian EDs. Methods: Ten Australian EDs enrolled a convenience sample of adult patients (aged ≥18 years) requiring parenteral sedative medication for BEs. Data were collected prospectively between March 2015 and April 2017 using a designated case report form. Results: In all, 564 cases were enrolled in this study. Incomplete cases (n = 17; 3%) were excluded. Of the 547 remaining cases, 63% were male and the median age was 34 years (range 18–95 years). Approximately half the patients (n = 230; 42.1%) required mechanical restraint and parenteral sedation to manage their BEs. Intramuscular monotherapy was administered in most cases (n = 390; 71.3%). The main sedative medications used as monotherapy were droperidol (n = 381; 69.7%), midazolam (n = 54; 9.9%) and olanzapine (n = 26; 4.8%). The most common combination therapy was midazolam + droperidol (n = 36; 6.6%). The incidence of AEs from sedative administration was 13.5%. No deaths or irreversible AEs were reported. Conclusions: Overall, the participating EDs provided safe pharmacological management for BEs. AEs following parenteral sedation are common, although serious AEs are rare. Because all patients receiving parenteral sedation for BEs are at risk of AEs, ongoing monitoring of vital signs after parenteral sedation should be a standard protocol in all EDs. [ABSTRACT FROM AUTHOR]

Objective: We carried out a bibliometric study on the scientific papers related to secondgeneration antipsychotic drugs (SGAs) in Malaysia. Methods: With the SCOPUS database, we selected those documents made in Malaysia whose title included descriptors related to SGAs. We applied bibliometric indicators of production and dispersion, as Price's law and Bradford's law, respectively. We also calculated the participation index of the different countries. The bibliometric data were also been correlated with some social and health data from Malaysia (total per capita expenditure on health and gross domestic expenditure on R&D). Results: We found 105 original documents published between 2004 and 2016. Our results fulfilled Price's law, with scientific production on SGAs showing exponential growth (r = 0.401, vs. r = 0.260 after linear adjustment). The drugs most studied are olanzapine (9 documents), clozapine (7), and risperidone (7). Division into Bradford zones yields a nucleus occupied by the Medical Journal of Malaysia, Singapore Medical Journal, Australian and New Zealand Journal of Psychiatry, and Pharmacogenomics. Totally, 63 different journals were used, but only one in the top four journals had an impact factor being greater than 3. Conclusion: The publications on SGAs in Malaysia have undergone exponential growth, without evidence a saturation point. [ABSTRACT FROM AUTHOR]

Aim To examine the efficacy and safety of (1) midazolam-droperidol versus droperidol and (2) midazolam-droperidol versus olanzapine for methamphetamine-related acute agitation. Design and setting A multi-centre, randomized, double-blind, controlled, clinical trial was conducted in two Australian emergency departments, between October 2014 and September 2015. Participants Three hundred and sixty-one patients, aged 18-65 years, requiring intravenous medication sedation for acute agitation, were enrolled into this study. We report the results of a subgroup of 92 methamphetamine-affected patients. Intervention and comparator Patients were assigned randomly to receive either an intravenous bolus of midazolam 5 mg-droperidol 5 mg combined, droperidol 10 mg or olanzapine 10 mg. Two additional doses were administered, if required: midazolam 5 mg, droperidol 5 mg or olanzapine 5 mg, respectively. Measurements The primary outcome was the proportion of patients sedated adequately at 10 minutes. Odds ratios with 95% confidence intervals (ORs, 95% CI) were estimated. Findings The baseline characteristics of patients in the three groups were similar. At 10 minutes, significantly more patients in the midazolam-droperidol group [29 of 34 (85.3%)] were sedated adequately compared with the droperidol group [14 of 30 (46.7%), OR = 6.63, 95% CI = 2.02-21.78] or with the olanzapine group [14 of 28 (50.0%), OR 5.80, 95% CI = 1.74-19.33]. The number of patients who experienced an adverse event (AE) in the midazolam-droperidol, droperidol and olanzapine groups was seven of 34, two of 30 and six of 28, respectively. The most common AE was oxygen desaturation. Conclusion A midazolam-droperidol combination appears to provide more rapid sedation of patients with methamphetamine-related acute agitation than droperidol or olanzapine alone. [ABSTRACT FROM AUTHOR]

Objective: To analyse average treatment duration with antipsychotics reimbursed for concession card holders under the Pharmaceutical Benefits Scheme; the proportion of initial prescribing by general practitioners, psychiatrists and other physician; and the trend in drug choice in Australia. Method: Based on a representative 10% sample of patients receiving Pharmaceutical Benefits Scheme prescriptions since 2005, antipsychotics redeemed by concession card holders in the period from 2010 to 2013 were analysed. A 5-year baseline period was used to exclude prevalent users from incident users. Treatment duration was estimated using the epidemiological equation: prevalence/incidence = average duration. Results: The overall average treatment duration was 3.0 years, ranging from 1.5 years in patients aged 75 years and older to more than 4 years among patients aged 25-64 years. The most commonly used antipsychotics were olanzapine, risperidone and quetiapine, with average duration of 2.9, 2.1 and 1.7 years, respectively. Amisulpride was used longest with an average duration of 3.7 years. Quetiapine is currently the most prescribed antipsychotic and the main antipsychotic prescribed by psychiatrists to new users. The increased prescribing of quetiapine among general practitioners explains the rapid increase in the overall use of quetiapine. General practitioners initiated therapy in about 70% of cases, while psychiatrists and other physicians in about 15% each. In children younger than 15 years of age, paediatricians initiated such treatment in 47%. Conclusion: General practitioners both initiate and maintain treatment with antipsychotics for most adults, while paediatricians mainly begin such treatment in children. The substantial increase in use of quetiapine among general practitioners, along with the short treatment duration for quetiapine, strengthens a concern about antipsychotics increasingly used for less severe disorders. Increased collaboration between paediatricians and psychiatrists regarding the youngest and between general practitioners and psychiatrists or geriatricians regarding adults and older patients seems required. [ABSTRACT FROM AUTHOR]

Objective: Past traumatic events have been associated with poorer clinical outcomes in people with bipolar disorder. However, the impact of these events in the early stages of the illness remains unclear. The aim of this study was to investigate whether prior traumatic events were related to poorer outcomes 12 months following a first episode of psychotic mania. Methods: Traumatic events were retrospectively evaluated from patient files in a sample of 65 participants who had experienced first episode psychotic mania. Participants were aged between 15 and 28 years and were treated at a specialised early psychosis service. Clinical outcomes were measured by a variety of symptomatic and functioning scales at the 12-month time-point. Results: Direct-personal traumatic experiences prior to the onset of psychotic mania were reported by 48% of the sample. Participants with past direct-personal trauma had significantly higher symptoms of mania (p=0.02), depression (p=0.03) and psychopathology (p=0.01) 12 months following their first episode compared to participants without past direct-personal trauma, with medium to large effects observed. After adjusting for baseline scores, differences in global functioning (as measured by the Global Assessment of Functioning scale) were non-significant (p=0.05); however, participants with past direct-personal trauma had significantly poorer social and occupational functioning (p=0.04) at the 12-month assessment with medium effect. Conclusions: Past direct-personal trauma may predict poorer symptomatic and functional outcomes after first episode psychotic mania. Limitations include that the findings represent individuals treated at a specialist early intervention centre for youth and the retrospective assessment of traumatic events may have been underestimated. [ABSTRACT FROM AUTHOR]

Accessible summary Women with serious mental illness are frequently on antipsychotic medications to maintain their mental health (MI)., Antipsychotic medications are currently not approved for use in pregnancy because of the lack of evidence about their risk of harming the baby. These include kidney malformations, limb malformation and congenital heart disease., This case study series identifies the outcomes for 10 babies of women with serious MI., Gestation of the 10 babies at birth ranged between 29 and 40 weeks, average weight 2.9 kg. Two babies were born preterm., This study identifies the neonatal complications for these vulnerable babies as not outside the norm for births in Australia., There was however a high rate of mother-baby separation (4/10) which is of great concern., Abstract Women with serious mental illness are frequently on antipsychotic medications to maintain their mental health. During pregnancy there is much debate as to whether to continue or cease these medications. The possibility of adverse effects is of concern to clinicians and the women. This study used a case study methodology to identify the outcomes for 10 babies of women with a history of serious mental illness. The results provide further evidence in regard to women and the use of antipsychotic medications throughout pregnancy and during the first year after birth. Separation of mother and baby occurred in five of the 10 babies. This study identifies the neonatal complications for these vulnerable babies as not outside the norm for births in Australia. The high rate of mother-baby separation is of great concern and needs further longitudinal studies. [ABSTRACT FROM AUTHOR]

The article offers updates on Australia. Its Governor-General in Council approved the Intellectual Property Legislation Amendment on March 14, 2013 which provides important details to the Intellectual Property Laws Amendment Act 2012. It reports on Middleton J's finding of infringement and validity of Eli Lilly's pharmaceutical patent on the drug olanzapine used for treating schizophrenia and Tracey J's findings of contempt and dismissal of contempt charges in a Russian broadcasting case.

To describe the prescribing practice of emergency medicine clinicians in the management of highly agitated patients and to identify perceived barriers to management and the gaps in training. We undertook an anonymous cross-sectional mail survey of the Australasian College for Emergency Medicine (ACEM) members (fellows and advanced trainees) between June and September 2009. A questionnaire including a case vignette of a hypothetical patient and three clinical scenarios was employed to ascertain prescribing practice and assess perceived barriers to management, confidence and the perceived usefulness of existing and future Clinical Practice Guidelines (CPGs). All 2052 ACEM members were surveyed. However, seven had incorrect postal addresses and could not be reached. Of the remaining 2045, 786/2052 (38.3%, 95% CI 36.2-40.5) responses were received. Of the 786 respondents, 783 were practicing clinicians. If monotherapy was chosen, 622/783 (79.4%, 95% CI 76.4-82.2) of respondents preferred midazolam to manage the common scenario where no history was available, followed by haloperidol 45/783 (5.8%, 95% CI 4.3-7.7) and olanzapine 38/783 (4.9%, 95% CI 3.5-6.7). Most respondents 500/783 (63.9%, 95% CI 60.4-67.2) would also administer another sedative (combination therapy). Important perceived barriers to agitation management included lack of both training (352/783 [45.0%, 95% CI 41.4-48.5]) and a national CPG (313/783 [40.0%, 95% CI 36.5-43.5]). Respondents were generally confident in all aspects of management, although relatively fewer trainees were confident in determining dosing. Institutional CPGs were considered most useful for 415/783 (53.0%, 95% CI 49.4-56.5) respondents. If an ACEM-endorsed CPG were to be developed in the future, 634/783 (81.0%, 95% CI 78.0-83.6) respondents would consider this useful. There is considerable variation in the management of hypothetical cases of acute agitation in Australasian EDs. Benzodiazepines and antipsychotics, either alone or in combination, are commonly used. An ACEM-endorsed, Australasian CPG was perceived as useful. [ABSTRACT FROM AUTHOR]

Improved drug therapy for schizophrenia may represent the best strategy for reducing the costs of schizophrenia and the recurrent chronic course of the disease. Olanzapine and risperidone are atypical antipsychotic agents developed to meet this need. We report a multicenter, double-blind, parallel, 30-week study designed to compare the efficacy, safety, and associated resource use for olanzapine and risperidone in Australia and New Zealand. The study sample consisted of 65 patients who met DSM-IV criteria for schizophrenia, schizoaffective disorder, or schizophreniform disorder. Olanzapine-treated patients showed a significantly greater reduction in Positive and Negative Syndrome Scale (PANSS) total, Brief Psychiatric Rating Scale (BPRS) total, and PANSS General Psychopathology scores at endpoint compared to the risperidone-treated patients. Response rates through 30 weeks showed a significantly greater proportion of olanzapine-treated patients had achieved a 20% or greater improvement in their PANSS total score compared to risperidone-treated patients. Olanzapine and risperidone were equivalent in their improvement of PANSS positive and negative scores and Clinical Global Impression-Severity of Illness scale (CGI-S) at endpoint. Using generic and disease-specific measures of quality of life, olanzapine-treated patients showed significant within-group improvement in most measures, and significant differences were observed in favor of olanzapine over risperidone in Quality of Life Scale (QLS) Intrapsychic Foundation and Medical Outcomes Study Short Form 36-item instrument (SF-36) Role Functioning Limitations—Emotional subscale scores. Despite the relatively small sample size, our study suggests that olanzapine has a superior risk:benefit profile compared to risperidone. [Copyright &y& Elsevier]

Background: Antipsychotic medications can be prescribed in Australia by medical and nurse practitioners under the Pharmaceutical Benefits Scheme (PBS). The current pharmacoepidemiology study aims to determine the dispensing rates of antipsychotic medicines in Australia, and to produce and examine a time-trend of the dispensing patterns of these medicines., Methods: Dispensing counts of antipsychotic medication from 2006 to 2018 were accessed from the PBS dataset. All of the antipsychotic medicines dispensed were included for time trend analysis. Cumulative dispensing counts and defined daily dose (DDD) per 1000 concessional population days (DPD) were analysed for the purpose of time trend analysis., Results: Sixteen antipsychotic medications were assessed and had a total cumulative dispensing count of 33, 732, 404. Olanzapine had the highest cumulative prescription count and Quetiapine experienced the highest average dispensing count and rate as determined by DPD. Twelve out of the sixteen medications were second-generation antipsychotics (SGAs). Overall, eleven out of the sixteen medications (aripiprazole, asenapine, brexpiprazole, clozapine, flupentixol, lurasidone, olanzapine, paliperidone, quetiapine, ziprasidone, zuclopenthixol) had an increase in both dispensing count and rate, as expressed per DPD., Conclusions: The current study highlights the increasing prescription rates of SGAs and the stagnation of FGA prescription among Australian health practitioners. This is observed through particularly large increase in the dispensing rates of Olanzapine and Quetiapine. Further interdisciplinary investigation is required to ensure that these medications are being prescribed under the appropriate medical rationale, particularly to groups that are vulnerable to the adverse effects of the medications., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Focuses on the association of neuroleptic malignant syndrome and the use of olanzapine in patient with Schizoaffective disorder. Identification of the syndrome as a side effect of antipsychotic therapy; Manifestation of increase creatine kinase; Treatment of the syndrome with intravenous fluid replacement.

The article presents a case study of a 17-year-old male who had traumatic brain injury (TBI) and was admitted to the hospital for treatment of psychosis. Topics discussed include the head and chest injuries suffered by him as a toddler, the psychotic symptoms shown by him at the age of 16, and his treatment with olanzapine. Also mentioned is the electroconvulsive therapy (ECT) that was used to treat him.

Reports that the Australian Adverse Drug Reactions Advisory Committee has received reports related to the antipsychotic agent, olanzapine. Most frequent adverse reactions; Prescribers' need to be aware that white cell disorders, seizures and neuroleptic malignant syndrome can all occur in association with olanzapine.

Background: The Bipolar Comprehensive Outcomes Study (BCOS) is a 2-year, prospective, non-interventional, observational study designed to explore the clinical and functional outcomes associated with 'real-world' treatment of participants with bipolar I or schizoaffective disorder. All participants received treatment as usual. There was no study medication., Methods: Participants prescribed either conventional mood stabilizers (CMS; n = 155) alone, or olanzapine with, or without, CMS (olanzapine ± CMS; n = 84) were assessed every 3 months using several measures, including the Young Mania Rating Scale, 21-item Hamilton Depression Rating Scale, Clinical Global Impressions Scale - Bipolar Version, and the EuroQol Instrument. This paper reports 24-month longitudinal clinical, pharmacological, functional, and socioeconomic data., Results: On average, participants were 42 (range 18 to 79) years of age, 58%; were female, and 73%; had a diagnosis of bipolar I. Polypharmacy was the usual approach to pharmacological treatment; participants took a median of 5 different psychotropic medications over the course of the study, and spent a median proportion of time of 100%; of the study on mood stabilizers, 90%; on antipsychotics, 9%; on antidepressants, and 5%; on benzodiazepines/hypnotics. By 24 months, the majority of participants had achieved both symptomatic and syndromal remission of both mania and depression. Symptomatic relapse rates were similar for both the CMS alone (65%;) and the olanzapine ± CMS (61%;) cohorts., Conclusions: Participants with bipolar I or schizoaffective disorder in this study were receiving complex medication treatments that were often discordant with recommendations made in contemporary major treatment guidelines. The majority of study participants demonstrated some clinical and functional improvements, but not all achieved remission of symptoms or syndrome.

Background: The Bipolar Comprehensive Outcomes Study (BCOS) is a 2-year, observational study of participants with bipolar I or schizoaffective disorder examining clinical, functional, and economic outcomes associated with naturalistic treatment., Methods: Participants prescribed mood stabilisers were assessed using various measures, including the Young Mania Rating Scale (YMRS), 21-item Hamilton Depression Rating scale (HAMD21), Clinical Global Impressions-Bipolar Version Severity of Illness scale (CGI-BP), and the EuroQol instrument (EQ-5D)., Results: 240 participants were recruited from two sites. On average, participants were 41.8+/-12.7 years of age (mean+/-SD), 58.3% were female, and 73.3% had a diagnosis of bipolar I disorder at study entry. The majority of participants were moderately ill, with an average CGI-BP Overall score of 3.8+/-1.3. Most participants had subthreshold mania and depression symptoms, indicated by HAMD21 Total 13.4+/-8.6, CGI-BP Depression 3.2+/-1.3, YMRS Total 8.2+/-8.5 and CGI-BP Mania 3.0+/-1.6 average scores. For bipolar participants, 94.6% of hospitalisations for psychiatric treatment in the past 3 months were single admissions (vs. 65.2% for schizoaffective participants, p=.002). Bipolar participants rated their overall health state higher (EQ-5D scores: 68.2+/-18.8 vs. 61.6+/-22.7, p=.023), had a higher mean weekly wage ($500-$999, 21.3% vs. 6.3%), lower unemployment (22.2% vs. 48.4%), and higher romantic relationship status (47.1% vs. 26.6%)., Limitations: The observational design and small sample size may have limited the causal relationships and generalisability within the current findings., Conclusions: Participants were characterised by social and occupational dysfunction at entry, but schizoaffective participants appeared to be more severely affected. Effective treatment is required to address both clinical and functional impairment.

Objective: Studies of how differences in systems of care, including cultural differences, affect prescribing practice and patient outcomes are important and can help answer questions such as the effectiveness of clozapine in routine practice. This study examined the use of clozapine in Maryland and in Victoria, Australia., Methods: This study used medical record data to examine the use of clozapine in January 2000 for people with schizophrenia in two different countries. Data were gathered from all six public inpatient facilities in Maryland and from the two main community outpatient centers in Victoria. Outpatients were studied in Victoria because Australia's inpatient mental health facilities have closed and people with treatment-resistant schizophrenia are managed exclusively as outpatients., Results: In Maryland 591 inpatients with schizophrenia were given a prescription for second-generation antipsychotics; in Victoria 356 outpatients with schizophrenia were given such a prescription. Among second-generation antipsychotics, clozapine was used significantly more frequently in Australia than in Maryland for the treatment of schizophrenia (173 prescriptions, or 49 percent, compared with 144 prescriptions, or 19 percent). Both systems used clozapine mostly for the treatment of schizophrenia (94 percent in Victoria compared with 88 percent in Maryland). The mean clozapine dosages that were used for the treatment of schizophrenia were significantly higher in Maryland than in Australia (522 mg per day compared with 431 mg per day)., Conclusions: Significant differences in use and dosages of clozapine were found in two populations that were similar in diagnoses and demographic characteristics.