Prescribing of antivirals for COVID-19 in a South Australian local health network according to statewide guidelines.

Antiviral drugs were rapidly implemented into clinical practice for the treatment of high-risk patients with COVID-19, prompting the development of statewide guidelines. This South-Australian study reviewed guideline adherence, assessed prescribing patterns and highlighted the inappropriate management of relative drug-drug interactions and dosing for renal function. Additionally, it evaluated the impact of inappropriate antiviral drug use and suggested methods to improve quality use of medicines.

Multidisciplinary perspectives on roles of hospital pharmacists in tertiary settings: a qualitative study.

In today's complex healthcare landscape, exacerbated by resource constraints at various levels, optimization of health professionals' roles is becoming increasingly paramount. Interprofessional collaboration, underpinned by role recognition and teamwork, leads to improved patient and organizational outcomes. Hospital pharmacists play a pivotal role in multidisciplinary teams, and it is imperative to understand multidisciplinary viewpoints on hospital pharmacists' roles to guide role prioritization and organizational efficiency. However, no study extensively investigated multidisciplinary views on values of diverse pharmacist roles in tertiary settings. This study aims to address this gap by examining non-pharmacist health professionals' views on hospital pharmacists' roles, recognizing their specialized niches as a crucial step towards optimizing their roles and services in Australia and internationally. Multiple focus group discussions and interviews were held via a virtual conferencing platform. Study participants were recruited using the study investigators' professional networks who were non-pharmacist health professionals with experience working with pharmacists in hospital settings. Data were collected from transcripts of the focus group recordings, which were later summarized using descriptive statistics and thematic analysis. Overarching themes were categorized and mapped against work system models to conceptualize organizational implications of multidisciplinary feedback, linking them to patient and organizational outcomes. Twenty-seven health professionals participated across focus groups and interviews, with the majority of professions being doctors and nurses. Three major themes were identified as follows: (i) overarching perceptions regarding hospital pharmacists; (ii) professional niches of hospital pharmacists; and (iii) future opportunities to optimize hospital pharmacy services. Valued professional niches included patient and health professional educators, transition-of-care facilitators, and quality use of medicines analysts. The study highlights critical insights into hospital pharmacists' roles in Australia, identifying their niche expertise as vital to healthcare efficiency and success. Based on multidisciplinary feedback, the study advocates for strategic role optimization and targeted research for enhanced clinical, economic, and organizational outcomes.

What is impacting clinical pharmacists' participation in an interprofessional ward round: a thematic analysis of a national survey.

The ward round (WR) is an important opportunity for interprofessional interaction and communication enabling optimal patient care. Pharmacists' participation in the interprofessional WR can reduce adverse drug events and improve medication appropriateness and communication. WR participation by clinical pharmacists in Australia is currently limited. This study aims to explore what is impacting clinical pharmacists' participation in WRs in Australian hospitals. A self-administered, anonymous national survey of Australian clinical pharmacists was conducted. This study describes the outcomes from qualitative questions which were analyzed thematically in NVivo-2020 according to Braun and Clarke's techniques. Five themes were constructed: "Clinical pharmacy service structure", "Ward round structure", "Pharmacist's capabilities", "Culture" and "Value". A culture supportive of pharmacist's contribution with a consistent WR structure and flexible delivery of clinical pharmacy services enabled pharmacists' participation in WR. Being physically "absent" from the WR due to workload, workflow, and self-perception of the need for extensive clinical knowledge can limit opportunities for pharmacists to proactively contribute to medicines decision-making with physicians to improve patient care outcomes. Bidirectional communication between the interprofessional team and the pharmacist, where there is a co-construction of each individual's role in the WR facilitates consistent and inter-dependent collaborations for effective medication management.

Effect of an ongoing pharmacist service to reduce medicine-induced deterioration and adverse reactions in aged-care facilities (nursing homes): a multicentre, randomised controlled trial (the ReMInDAR trial).

OBJECTIVE: To assess the effectiveness of a pharmacist-led intervention using validated tools to reduce medicine-induced deterioration and adverse reactions. DESIGN AND SETTING: Multicenter, open-label parallel randomised controlled trial involving 39 Australian aged-care facilities. PARTICIPANTS: Residents on ≥4 medicines or ≥1 anticholinergic or sedative medicine. INTERVENTION: Pharmacist-led intervention using validated tools to detect signs and symptoms of medicine-induced deterioration which occurred every 8 weeks over 12 months. COMPARATOR: Usual care (Residential Medication Management Review) provided by accredited pharmacists. OUTCOMES: Primary outcome was change in Frailty Index at 12 months. Secondary outcomes included changes in cognition, 24-hour movement behaviour by accelerometry, grip strength, weight, adverse events and quality of life. RESULTS: 248 persons (median age 87 years) completed the study; 120 in the interventionand, 128 in control arms. In total 575 pharmacist, sessions were undertaken in the intervention arm. There was no statistically significant difference for change in frailty between groups (mean difference: 0.009, 95% CI: -0.028, 0.009, P = 0.320). A significant difference for cognition was observed, with a mean difference of 1.36 point change at 12 months (95% CI: 0.01, 2.72, P = 0.048). Changes in 24-hour movement behaviour, grip strength, adverse events and quality of life were not significantly different between groups. Point estimates favoured the intervention arm at 12 months for frailty, 24-hour movement behaviour and grip strength. CONCLUSIONS: The use of validated tools by pharmacists to detect signs of medicine-induced deterioration is a model of practice that requires further research, with promising results from this trial, particularly with regards to improved cognition.

Opioid-sparing effects of ketorolac in palliative care patients receiving opioids for chronic cancer-related pain: A systematic literature review.

BACKGROUND: Standard of care in treatment of cancer-related pain involves opioids in combination with non-steroidal anti-inflammatory drugs (NSAID). Ketorolac, a NSAID, has demonstrated opioid-sparing effects in other clinical settings. AIM: This systematic literature review investigated ketorolac's opioid-sparing effects in patients receiving opioids for chronic, cancer-related pain. DESIGN: The primary outcome was total daily dose of opioids. Secondary outcomes included frequency of opioid use, use and frequency of 'rescue' medication and adverse events. Outcomes were described, and meta-analysed where possible. PROSPERO registration CRD42019130894. DATA SOURCES: Articles included original research, from any study phase or methodology, published in English in a peer-reviewed journal or conference between 1990 and 2020; included subjects >18 years; had chronic cancer-related pain and described the use of opioid-sparing effect of ketorolac. RESULTS: Nine articles were included. While there was significant heterogeneity, ketorolac may have an opioid-sparing effect, with significant reductions in total daily dose of morphine observed in a single randomised controlled trial (SMD -4.30 mg, 95% CI -5.36 to -3.25), but the changes in the before and after studies were not statistically significant -0.46 mg (95% CI -1.14 to 0.22). Ketorolac was associated with greater likelihood of complete pain relief, but the data were heterogeneous. Insufficient data were available to analyse frequency of opioid use, or rescue medication requirements. CONCLUSIONS: Given the heterogeneity of the data, adequately powered, randomised controlled trials are required to establish any opioid-sparing effect of ketorolac. For patients not responding to conventional pain management, ketorolac may have a role in treatment augmentation.

Pharmacovigilance in hospice/palliative care: Net effect of amitriptyline or nortriptyline on neuropathic pain: UTS/IMPACCT Rapid programme international consecutive cohort.

BACKGROUND: Real-world effectiveness of interventions in palliative care need to be systematically quantified to inform patient/clinical decisions. Neuropathic pain is prevalent and difficult to palliate. Tricyclic antidepressants have an established role for some neuropathic pain aetiologies, but this is less clear in palliative care. AIM: To describe the real-world use and outcomes from amitriptyline or nortriptyline for neuropathic pain in palliative care. DESIGN: An international, prospective, consecutive cohort post-marketing/phase IV/pharmacovigilance/quality improvement study of palliative care patients with neuropathic pain where the treating clinician had already made the decision to use a tricyclic antidepressant. Data were entered at set times: baseline, and days 7 and 14. Likert scales graded benefits and harms. SETTING/PARTICIPANTS: Twenty-one sites (inpatient, outpatient, community) participated in six countries between June 2016 and March 2019. Patients had clinician-diagnosed neuropathic pain. RESULTS: One hundred and fifty patients were prescribed amitriptyline (110) or nortriptyline (40) of whom: 85% had cancer; mean age 73.2 years (SD 12.3); mean 0-4 scores for neuropathic pain at baseline were 1.8 (SD 1.0). By day 14, doses of amitriptyline were 57 mg (SD 21) and nortriptyline (48 mg (SD 21). Fifty-two (34.7%) patients had pain improvement by day 14 (amitriptyline (45/110 (43.3%); nortriptyline (7/40 (18.9%)). Thirty-nine (27.7%) had new harms; (amitriptyline 29/104 (27.9%); nortriptyline 10/37 (27.0%); dizziness (n = 23), dry mouth (n = 20), constipation (n = 14), urinary retention (n = 10)). Benefits without harms occurred (amitriptyline (26/104 (25.0%); nortriptyline (4/37 (10.8%)). CONCLUSIONS: Benefits favoured amitriptyline while harms were similar for both medications.

Clinicians' delirium treatment practice, practice change, and influences: A national online survey.

BACKGROUND: Recent studies cast doubt on the net effect of antipsychotics for delirium. AIM: To investigate the influence of these studies and other factors on clinicians' delirium treatment practice and practice change in palliative care and other specialties using the Theoretical Domains Framework. DESIGN: Australia-wide online survey of relevant clinicians. SETTING/PARTICIPANTS: Registered nurses (72%), doctors (16%), nurse practitioners (6%) and pharmacists (5%) who cared for patients with delirium in diverse settings, recruited through health professionals' organisations. RESULTS: Most of the sample (n = 475): worked in geriatrics/aged (31%) or palliative care (30%); in hospitals (64%); and saw a new patient with delirium at least weekly (61%). More (59%) reported delirium practice change since 2016, mostly by increased non-pharmacological interventions (53%). Fifty-five percent reported current antipsychotic use for delirium, primarily for patient distress (79%) and unsafe behaviour (67%). Common Theoretical Domains Framework categories of influences on respondents' delirium practice were: emotion (54%); knowledge (53%) and physical (43%) and social (21%) opportunities. Palliative care respondents more often reported: awareness of any named key study of antipsychotics for delirium (73% vs 39%, p < 0.001); changed delirium treatment (73% vs 53%, p = 0.017); decreased pharmacological interventions (60% vs 15%, p < 0.001); off-label medication use (86% vs 51%, p < 0.001: antipsychotics 79% vs 44%, p < 0.001; benzodiazepines 61% vs 26%, p < 0.001) and emotion as an influence (82% vs 39%, p < 0.001). CONCLUSION: Clinicians' use of antipsychotic during delirium remains common and is primarily motivated by distress and safety concerns for the patient and others nearby. Supporting clinicians to achieve evidence-based delirium practice requires further work.

Pragmatic randomised controlled trial of a personalised intervention for carers of people requiring home oxygen therapy.

We used a pragmatic randomised controlled trial to evaluate a behavioural change strategy targeting carers of chronically hypoxaemic patients using long-term home oxygen therapy. Intervention group carers participated in personalised educational sessions focusing on motivating carers to take actions to assist patients. All patients received usual care. Effectiveness was measured through a composite event of patient survival to hospitalisation, residential care admission or death to 12 months. Secondary outcomes at baseline, 3, 6 and 12 months included carer and patient emotional and physical well-being. No difference between intervention (n = 100) and control (n = 97) patients was found for the composite outcome (hazard ratio (HR) 1.22, 95% confidence interval (CI) = 0.89, 1.68; p = 0.22). Improved fatigue, mastery, vitality and general health occurred in intervention group patients (all p values < 0.05). No benefits were seen in carer outcomes. Mortality was significantly higher in intervention patients (HR = 2.01, 95% CI = 1.00, 4.14; p = 0.05; adjusted for Australia-modified Karnofsky Performance Status), with a significant diagnosis-intervention interaction (p = 0.028) showing higher mortality in patients with COPD (HR 4.26; 95% CI = 1.60, 11.35) but not those with interstitial lung disease (HR 0.83; 95% CI = 0.28, 2.46). No difference was detected in the primary outcome, but patient mortality was higher when carers had received the intervention, especially in the most disabled patients. Trials examining behavioural change interventions in severe disease should stratify for functionality, and both risks and benefits should be independently monitored. Trial registration: Australian New Zealand Clinical Trials Registry (ACTRN12607000177459).

Clinicians' perceptions of opioid error-contributing factors in inpatient palliative care services: A qualitative study.

BACKGROUND: Opioid errors are a leading cause of patient harm and adversely impact palliative care inpatients' pain and symptom management. Yet, the factors contributing to opioid errors in palliative care are poorly understood. Identifying and better understanding the individual and system factors contributing to these errors is required to inform targeted strategies. OBJECTIVES: To explore palliative care clinicians' perceptions of the factors contributing to opioid errors in Australian inpatient palliative care services. DESIGN: A qualitative study using focus groups or semi-structured interviews. SETTINGS: Three specialist palliative care inpatient services in New South Wales, Australia. PARTICIPANTS: Inpatient palliative care clinicians who are involved with, and/or have oversight of, the services' opioid delivery or quality and safety processes. METHODS: Deductive thematic content analysis of the qualitative data. The Yorkshire Contributory Factors Framework was applied to identify error-contributing factors. FINDINGS: A total of 58 clinicians participated in eight focus groups and 20 semi-structured interviews. Nine key error contributory factor domains were identified, including: active failures; task characteristics of opioid preparation; clinician inexperience; sub-optimal skill mix; gaps in support from central functions; the drug preparation environment; and sub-optimal clinical communication. CONCLUSION: This study identified multiple system-level factors contributing to opioid errors in inpatient palliative care services. Any quality and safety initiatives targeting safe opioid delivery in specialist palliative care services needs to consider the full range of contributing factors, from individual to systems/latent factors, which promote error-causing conditions.

Quantifying the burden of opioid medication errors in adult oncology and palliative care settings: A systematic review.

BACKGROUND: Opioids are the primary pharmacological treatment for cancer pain and, in the palliative care setting, are routinely used to manage symptoms at the end of life. Opioids are one of the most frequently reported drug classes in medication errors causing patient harm. Despite their widespread use, little is known about the incidence and impact of opioid medication errors in oncology and palliative care settings. AIM: To determine the incidence, types and impact of reported opioid medication errors in adult oncology and palliative care patient settings. DESIGN: A systematic review. DATA SOURCES: Five electronic databases and the grey literature were searched from 1980 to August 2014. Empirical studies published in English, reporting data on opioid medication error incidence, types or patient impact, within adult oncology and/or palliative care services, were included. Popay's narrative synthesis approach was used to analyse data. RESULTS: Five empirical studies were included in this review. Opioid error incidence rate was difficult to ascertain as each study focussed on a single narrow area of error. The predominant error type related to deviation from opioid prescribing guidelines, such as incorrect dosing intervals. None of the included studies reported the degree of patient harm resulting from opioid errors. CONCLUSION: This review has highlighted the paucity of the literature examining opioid error incidence, types and patient impact in adult oncology and palliative care settings. Defining, identifying and quantifying error reporting practices for these populations should be an essential component of future oncology and palliative care quality and safety initiatives.

Developing interprofessional communication skills for pharmacists to improve their ability to collaborate with other professions.

Successful communication between health professionals is a prerequisite for collaborative practice. Clinical pharmacists completed a learning and practice module introducing them to a framework for successful interprofessional communication (IPC) in the course of their postgraduate studies. A face-to-face discussion of a contemporary clinical topic with a health professional was then scheduled, mainly with junior doctors, in their practice setting. An exploratory case study methodology was employed to investigate pharmacists' written reflections on their experience applying their newly acquired IPC skills. Thematic analysis of reflections developed five categories relating to interprofessional collaboration, learning, and education. Themes describing pharmacists' preconceptions about the health professional and scheduled interprofessional encounter, how it allowed them to learn about doctors' and other health professionals' practice and build collaborative relationships were identified. Reflections also elaborated that applying the communication framework and strengthening of collaboration created opportunities for IPE, with added observations about these increasing potential impact on patient care and change of practice. Analysis of anonymous feedback provided by the health professionals yielded similar themes and was integrated for triangulation. Applying successful IPC skills in healthcare settings may increase interprofessional collaboration and create practice models which facilitate interprofessional learning in health profession programmes.

Potential economic impact on hospitalisations of the Palliative Care Clinical Studies Collaborative (PaCCSC) ketamine randomised controlled trial.

OBJECTIVE: The aim of the present study was to estimate the potential healthcare cost savings associated with reduced prescribing of subcutaneous ketamine for the treatment of chronic cancer pain after publication of the Palliative Care Clinical Studies Collaborative (PaCCSC) ketamine randomised controlled trial (RCT), to provide further reasons to modify ketamine prescribing practice in this setting. METHODS: Potential cost savings in this setting were estimated from a health system perspective using a 1-year impact model. The model was populated with estimates derived using an epidemiological approach informed by morbidity and prevalence data, the PaCCSC feasibility study, ketamine RCT and national ketamine utilisation survey results, as well as clinical opinion. RESULTS: The total estimated annual hospitalisation costs associated with subcutaneous ketamine prescribing were A$3 899 600 (2605 bed-days). A 17% reduction in ketamine prescribing lowered hospitalisation costs to A$3 236 668 (2162 bed-days), a reduction of A$662 932 (443 bed-days) because of reduced in-patient stays associated with ketamine toxicity and prescribing process. CONCLUSIONS: The findings from the modelled impact analysis suggest that dissemination of the PaCCSC ketamine RCT results may have saved the Australian healthcare system approximately A$663 000 in annual hospitalisation costs and freed up 443 in-patient bed-days, although there was high uncertainty within the study. Wider dissemination over time and targeted, local de-adoption strategies could result in further savings.

Academic detailing of general practitioners by a respiratory physician for diagnosis and management of refractory breathlessness: a randomised pilot study.

BACKGROUND: Academic detailing (AD; also known as educational visiting) facilitates the translation of evidence into practice and has been widely adopted internationally to facilitate practice change. The potential of AD linked to a specific patient and delivered by a specialist physician to general practitioners has not been evaluated. This pilot study assessed the feasibility and acceptability of AD on the knowledge and confidence of GPs caring for people with advanced cancer who had breathlessness at the end of life. METHODS: In this randomised controlled pilot, 35 patient/GP dyads were randomised to AD or usual care. Key messages included: ensuring reversible causes were optimally treated; non-pharmacological and pharmacological treatments were considered; and oxygen considered for hypoxaemic patients. RESULTS: Acceptability: The majority of GPs randomised to AD agreed to participate, reporting benefits to practice. The majority of GPs in the control group requested a copy of academic detailing written materials at study completion. Feasibility: AD visits to GPs' offices could be timetabled reasonably easily, with 24 detailing visits occurring. Self-reported knowledge and beliefs: Ninety two percent of GPs reported the topics covered in the AD sessions were useful, with 83% reporting an increase in knowledge and confidence. AD sessions resulted in 58% of GPs reporting a change in their approach to the management of breathlessness. By contrast, 81% of the usual care group reported low confidence in the management and knowledge of breathlessness. CONCLUSION: AD was acceptable and feasible to participating GPs. This pilot supports proceeding to a fully powered study.

Clinical networks influencing policy and practice: the establishment of advanced practice pharmacist roles for specialist palliative care services in South Australia.

OBJECTIVES: To operationalise the concept of 'advanced practice roles' in pharmacy within the new integrated regionalised palliative care service model outlined in the Palliative Care Services Plan 2009-2016, SA Health. METHODS: A working group was established under the auspices of the Palliative Care Clinical Network to progress the development of advanced practice pharmacist roles for regionalised palliative care services. A pharmacy stakeholder forum was conducted in December 2010 to provide further guidance on the advanced practice pharmacist roles in the following domains: education; network links and partnerships; quality and safety; and research. RESULTS: Advanced practice pharmacist positions were created for each of the three regionalised palliative care services in South Australia (SA). Funding was obtained for a Statewide Palliative Care Pharmacy Network project, to build a sustainable community-based palliative care pharmacy network. Advanced practice pharmacists commenced in the regionalised palliative care services of SA on 4 October 2011. CONCLUSIONS: The Statewide Palliative Care Clinical Network and the SA Palliative Care Plan provided a policy framework that supported involvement and advocacy in the planning of the advanced practice pharmacist roles. Collaboration between leaders in workforce reform, service planners, specialist palliative care providers and the pharmacy sector was a key enabler for developing the advanced practice pharmacist positions for regionalised palliative care services. What is known about the topic? The advanced practice palliative care pharmacist role reflects a new direction for the discipline of pharmacy and has been embraced at a time when a nationally endorsed Advanced Pharmacy Practice Framework has been published, while recognising that registration for pharmacists in Australia currently does not have specific endorsement for advanced practice. What does this paper add? This paper outlines the value of collaboration across settings and sectors. There is an opportunity for these roles to align with the new nationally endorsed framework for advanced practice in pharmacy. What are the implications for practitioners? These new positions strengthen the links between the hospital and community pharmacy sectors to enhance a quality use of medicines approach with improved access to end-of-life medicines for home-based palliative care clients, which actively facilitates a home death for those who choose it.

Exploration of 'micro' level factors that affect the involvement of clinical pharmacists in interprofessional ward rounds in hospitals: Through the lens of social cognitive theory.

BACKGROUND: Macro and meso level factors that influence the participation by clinical pharmacists in ward rounds include pharmacy management culture, commitment to ward rounds and adequate time for ward rounds being included in workload models. The 'micro' level factors that affect the involvement of clinical pharmacists in ward rounds have not been widely explored. OBJECTIVE: Explore 'micro' level factors to gain insight into clinical pharmacists' participation in interprofessional ward rounds in inpatient settings through the lens of social cognitive theory. METHOD: A qualitative focused ethnographic study with five clinical pharmacists, four medical practitioners, one allied health professional and one nurse was conducted in three metropolitan hospitals in Southern Australia. Seven hours of semi-structured interview (n = 11) and 76-h of observations (n = 5) were conducted. A qualitative descriptive analysis was conducted (guided by Spradley) followed by reflexive thematic-analysis (according to Braun and Clarke's technique). RESULTS: Three micro level factors influencing clinical pharmacist participation in ward rounds are: (1) Cognitive mindset of clinical pharmacists, (2) Behavioural conduct of clinical pharmacists, and (3) Social rules of the ward. Clinical pharmacists that did not participate in ward round reconciled their moral distress by transferring information without clinical judgement or interpretation of the patient scenario to medical practitioners. Clinical pharmacists that did participate in ward rounds demonstrated credibility by making relevant recommendations with a holistic lens. This enabled clinical pharmacists to be perceived as trustworthy by medical practitioners. Positive experiences of participating in ward rounds contributed to their cognitive upward spiral of thoughts and emotions, fostering continued participation. CONCLUSION: Clinical pharmacists participate in ward rounds when they develop a positive mindset about ward round participation and perceive ward rounds as an enabler to the establishment of trusted professional relationships with medical practitioners. This trusted relationship creates an environment where the pharmacist develops confidence in making relevant recommendations.

National Trends in Antidepressant Use in Australian Residential Aged Care Facilities (2006-2019).

OBJECTIVES: Antipsychotics have been the focus of reforms for improving the appropriateness of psychotropic medicine use in residential aged care facilities (RACFs). Comprehensive evaluation of antidepressant use in RACFs is required to inform policy and practice initiatives targeting psychotropic medicines. This study examined national trends in antidepressant use among older people living in RACFs from 2006 to 2019. DESIGN: National repeated cross-sectional study. SETTING AND PARTICIPANTS: Individuals aged 65 to 105 years who were permanent, long-term (≥100 days) residents of Australian RACFs between January 2006 and December 2019 were included. METHODS: Annual age- and sex-adjusted antidepressant prevalence rates and defined daily doses (DDDs) supplied per 1000 resident-days from 2006 to 2019 were determined. Age- and sex-adjusted prevalence rate ratios (aRRs) and 95% confidence intervals (CIs) were estimated using Poisson and negative binomial regression models. RESULTS: A total of 779,659 residents of 3371 RACFs were included (786,227,380 resident-days). Overall, antidepressant use increased from 46.1% (95% CI, 45.9-46.4) in 2006 to 58.5% (95% CI, 58.3-58.8) of residents in 2019 (aRR, 1.02; 95% CI, 1.02-1.02). Mirtazapine use increased from 8.4% (95% CI, 8.2-8.5) to 20.9% (95% CI, 20.7-21.1) from 2006 to 2019 (aRR, 1.07; 95% CI, 1.07-1.07). Antidepressant use increased from 350.3 (95% CI, 347.6-353.1) to 506.0 (95% CI, 502.8-509.3) DDDs/1000 resident-days (aRR, 1.03; 95% CI, 1.03-1.03), with mirtazapine utilization increasing by 6% annually (aRR, 1.06; 95% CI, 1.06-1.06). CONCLUSIONS AND IMPLICATIONS: This nationwide study identified a substantial increase in antidepressant use among residents of Australian RACFs, largely driven by mirtazapine. With nearly 3 in every 5 residents treated with an antidepressant in 2019, findings highlight potential off-label use and suggest that interventions to optimize care are urgently needed.

Gabapentin for Pain in Pediatric Palliative Care.

OBJECTIVE: Gabapentin is commonly used to treat pain in children receiving pediatric palliative care. This study describes the real-world use of gabapentin and the associated benefits and adverse effects/events (AEs). METHODS: A prospective, multicenter cohort of standardized data collection after a clinical decision was made to use gabapentin for managing neuropathic or nociplastic pain in children attended on by a pediatric palliative care service. It was conducted across 11 sites in seven countries including hospital, inpatient, and outpatient services. Clinical outcomes were graded using pain scales validated for age and cognitive ability and the National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE) at baseline, 14 days, 28 days, six weeks and 12 weeks after initiation of gabapentin. Ad-hoc safety reporting continued throughout the study. RESULTS: Data were collected from 127 children with a median age of 4.7 years (IQR 0.1-17.9); 61% had a neurological disorder, 21% advanced cancer and the cohort had a high level of disability (Lansky/Karnofsky performance score 37.1). Gabapentin was prescribed at standard pediatric doses. On average, 76% of children had a reduction in pain and 42% experienced a potential AE. The mean pain score decreased from 6.0 (SD 2.6) at baseline to 3.3 (SD 2.4) at 14 days and 1.8 (SD 1.8) after 12-weeks of gabapentin therapy. Ten percent had increased pain at each time point. AEs did not increase when individual changes over time were accounted for except for somnolence (7%). Serious AEs attributable to gabapentin were possible or probable in 3% of children. CONCLUSIONS: Gabapentin prescribed at standard doses for advanced cancer and severe neurological injury in children under a pediatric palliative care service was associated with generally improved pain intensity at previously described levels of adverse effects.

Off-label prescribing in palliative care - a cross-sectional national survey of palliative medicine doctors.

BACKGROUND: Regulatory bodies including the European Medicines Agency register medications (formulation, route of administration) for specific clinical indications. Once registered, prescription is at clinicians' discretion. Off-label use is beyond the registered use. While off-label prescribing may, at times, be appropriate, efficacy and toxicity data are often lacking. AIM: The aim of this study was to document off-label use policies (including disclosure and consent) in Australian palliative care units and current practices by palliative care clinicians. DESIGN: A national, cross-sectional survey was conducted online following an invitation letter. The survey asked clinicians their most frequent off-label medication/indication dyads and unit policies. Dyads were classified into unregistered, off-label and on-label, and for the latter, whether medications were nationally subsidised. SETTING/PARTICIPANTS: All Australian palliative medicine Fellows and advanced trainees. RESULTS: Overall, 105 clinicians responded (53% response rate). The majority did not have policies on off-label medications, and documented consent rarely. In all, 236 medication/indication dyads for 36 medications were noted: 45 dyads (19%) were for two unregistered medications, 118 dyads (50%) were for 26 off-label medications and 73 dyads (31%) were for 12 on-label medications. CONCLUSIONS: Off-label prescribing with its clinical, legal and ethical implications is common yet poorly recognised by clinicians. A distinction needs to be made between where quality evidence exists but registration has not been updated by the pharmaceutical sponsor and the evidence has not been generated. Further research is required to quantify any iatrogenic harm from off-label prescribing in palliative care.