Special Access Research Articles

Geographic Remoteness Is Associated with Increased Blood Product Utilization and Higher Rates of Hospitalization and Deaths in Adults with Immune Thrombocytopenia

INTRODUCTIONImmune thrombocytopenia (ITP) is a hematological disease characterized by immune-mediated destruction of platelets. Prior to starting therapy for ITP it is critical to determine whether it is idiopathic or related to a secondary underlying condition as this informs treatment. There is significant use of blood products and components in patients with chronic ITP for management of thrombocytopenia and bleeding, including intravenous immune globulin (IVIg). Platelet transfusions are generally reserved for life-threatening bleeding or may be used in the preoperative setting in patients unresponsive to other therapies. The aims of this study are to identify gaps in process of care and to examine the impact of geographical remoteness on health service utilization and outcomes in adults with chronic ITP in Alberta.METHODSAdults who received rituximab, splenectomy, or thrombopoietin receptor agonists (TPO-RA) as second-line therapy for ITP during 2012-2019 in the province of Alberta, Canada were identified via the provincial special drug access database. Diagnostic workup including bone marrow biopsy results, abdominal imaging (ultrasound or CT scan), coagulation parameters, viral serologies for hepatitis, human immunodeficiency virus (HIV), serum protein electrophoresis (SPEP), and quantitative immunoglobulins were recorded and rates of completed tests were calculated. Utilization of IVIg, platelets, and packed red blood cells was assessed. Rates of hospitalization, mortality, and ITP-related deaths were calculated and compared according to geographic region.RESULTSOf the 204 patients identified for analysis 106 were female (52%). Most patients (123; 60%) lived within a major centre, whereas 21 (10%) lived over 250 km from a major centre. Review of diagnostic laboratory parameters revealed incomplete coagulation parameters in 117 patients (58%), and no coagulation parameters checked in 16%. Eighty-nine patients (44%) did not have quantitative immunoglobulins tested, and 57 (28%) did not have an SPEP performed. Fifty-three (26%) did not have any abdominal imaging performed to assess for splenomegaly or liver disease. Thirty-five (17%) did not have any viral serologies for hepatitis B, C, or HIV completed. Bone marrow aspirate and biopsy was performed in 110 patients (54%). Eighty-six (77%) of these biopsies yielded a normal result. Eight biopsies (7%) displayed a lymphoproliferative disorder or plasma cell disorder which was suspected or known prior to completing the test.There was significant geographic discrepancy in utilization of blood products and hospitalizations. During 527 patient years of follow up, 83 patients received a total of 343 doses of platelets. Eleven patients (13%) received platelet transfusions for inappropriate indications, and eight (9%) for unclear indications. One hundred twenty-seven patients received IVIg (mean 1290 g) with comparable usage across geographic regions. Compared to patients within 250 km from a major centre, those with geographic remoteness (>250 km from a major centre) utilized more platelets (mean 5.2 vs 1.2 doses; Figure 1) and packed red blood cells (mean 4.3 vs 1.2 units; Figure 2). Those with geographic remoteness also experienced a higher rate of ITP-related hospitalizations (mean 1.5 vs 1.1) and deaths (24% versus 9%). At a median follow-up of 3.42 years from ITP diagnosis, 27 patients (13%) were deceased. Fourteen of these deaths were ITP-related due to bleeding or infection (52%). There appears to be a gradient of rates of both all-cause and ITP-related deaths by distance from a major centre (Figures 3 and 4).DISCUSSIONThis study highlights gaps in quality of care in patients with chronic ITP in Alberta, Canada. A significant number of patients have an incomplete workup for ITP at the time of diagnosis with the most forgotten tests being coagulation studies, SPEP, quantitative immunoglobulins, viral serologies, and abdominal imaging. Additionally, we identified an unexpectedly high rate of bone marrow biopsies performed in our population. Most of these bone marrow examinations did not result in any change in management. Finally, this study identified that geographic remoteness is associated with increased health services utilization and ITP-related deaths. These data can be used to inform further quality improvement initiatives in chronic ITP and help address geographic inequities in healthcare outcomes. [Display omitted] DisclosuresSun: Bayer: Consultancy; Novo Nordisk: Consultancy; Pfizer: Consultancy; Shire: Consultancy; Octapharma: Consultancy, Research Funding.

Outcomes and Health Resource Utilization Among Second-Line Therapies for Immune Thrombocytopenia: A Provincial Retrospective Cohort Study

Introduction:Immune thrombocytopenia (ITP) is an immune-mediated disorder characterized by increased platelet destruction. Current guidelines recommend either rituximab, splenectomy, or thrombopoietin receptor agonist (TPO-RA) in chronic ITP patients who are unresponsive to first-line corticosteroids or who are corticosteroid-dependent. Though there are known practice variations in choice and timing of second-line therapy in Canada, there are scarce data comparing the outcomes and resource utilization in patients who received these second-line treatment strategies. In this multi-centre retrospective cohort study, we aim to identify differences in health services utilization and ITP-related outcomes in patients who received different second-line ITP therapies.Methods:Adults who received rituximab, splenectomy or TPO-RA as second-line therapy for ITP during 2012-2019 in the province of Alberta, Canada were identified via the provincial special drug access database. Institutional ethics board approval was obtained. We examined treatment patterns including sequencing of therapies and predictors of second-line therapies. Major outcomes documented included ITP-related hospitalizations (bleeding or infections), blood product utilization, major bleeding and thromboembolism, and all-cause mortality. Kaplan-Meier survival curves were used to estimate overall survival and the cumulative incidence of hospitalizations. Log-rank test was used to assess for differences between groups.Results:At the time of interim analysis, 189 adults with chronic ITP received second-line therapy. The median age at the time of second-line therapy was 58 years; 102 (54%) were female. Patients who received TPO-RA were significantly older than those who received rituximab or splenectomy (median 65 years vs 53 vs 49 years; P=0.0008). Rituximab was the most prescribed second-line therapy (108; 57%) followed by splenectomy (45; 24%) and TPO-RA (36; 19%) (Figure 1).Compared to recipients of rituximab, those who received TPO-RA had higher rates of hypertension (64% vs 33%, P=0.004), dyslipidemia (58% vs 20%, P <0.001), and prior history of myocardial infarction (22% vs 6%, P=0.02). On multivariable logistic regression, age (adjusted odds ratio [aOR] 1.03, 95% confidence interval [CI] 1.01-1.05, P=0.01) and a history of thromboembolism prior to second-line therapy (aOR 2.7, 95% 1.04-7.1, P=0.04) were significantly associated with TPO-RA prescription. Sex, rural residence, ITP etiology, major bleeding prior to second-line therapy, and abnormal bone marrow findings were not significant predictors of second-line therapy.During 773 person-years of follow-up, 23 deaths occurred, due to cardiac events (n=6), infections (n=5), malignancies (n=4), bleeding (n=3), and other or unclear causes (n=5). The 5-year overall survival was 88% (95% CI 82-94%), significantly shorter in recipients of second-line TPO-RA (80%) than rituximab (90%) and splenectomy (94%; log-rank P=0.04; Figure 2). The 5-year relapse-free survival was 55% (95% CI 46-65%), with no significant difference between treatment groups (log-rank P=0.8). Overall, 59 (31%) patients required ITP-related hospitalizations following second-line therapy. The median times to hospitalization were 5.1 years, 12.2 years, and not reached in patients receiving rituximab, splenectomy, and TPO-RA, respectively (log-rank P=0.1). Intravenous immunoglobulins and platelet transfusions were frequently utilized across all treatment groups (Table 2).DISCUSSION:Despite a myriad of therapeutic options for chronic ITP, patients still experience a high burden of hospitalization for bleeding or infections, and transfusion requirements. Patients with advanced age and a history of thromboembolism were more likely to receive TPO-RA as second-line ITP therapy. We did not observe a significant difference in relapse-free survival or ITP-related hospitalizations across different second-line therapies, although this may be limited by our sample size and duration of follow-up. At present, significant cost of TPO-RAs limits their availability as second-line therapy in many publicly funded healthcare systems. Real-world data are important in guiding future cost-effectiveness analysis to assess the impact of second-line therapies on the overall healthcare system. [Display omitted] DisclosuresSun: Shire: Consultancy; Octapharma: Consultancy, Research Funding; Pfizer: Consultancy; Novo Nordisk: Consultancy; Bayer: Consultancy.

Surgical Considerations for an Osseointegrated Steady State Implant (OSIA2®) in Children.

Surgical Considerations for an Osseointegrated Steady State Implant (OSIA2®) in Children.

Making Open Access Book Funding Work Fairly

In late 2020, COPIM, an Arcadia and Research England funded project, announced an innovative revenue model to sustainably fund open access (OA) monographs: Opening the Future. This initiative harnesses the power of collective library funding: increasing collections through special access to highly-regarded backlists, and expanding the global shared OA collection while providing a less risky path for smaller publishers to make frontlist monographs OA. We introduced this model at the 15th Munin Conference on Scholarly Publishing 2020 but this is no ‘story so far’ conference presentation proposal. Since Opening the Future launched, we’ve seen several other collective library funding models emerge in quick succession, including MIT’s Direct 2 Open, Michigan’s Fund to Mission, and Cambridge University Press’ Flip it Open. In the same year, the UK Research and Innovation’s (UKRI) new policy was announced, and it included OA requirements for monographs. The landscape is clearly changing rapidly - in this presentation we will appraise our model in the context of this changing environment.&#x0D; The programme has had success since its launch. Within a few months the first publisher to adopt the model, CEU Press, had accrued enough library support to fund their first three OA monographs. Soon thereafter the initiative was recognised by the publishing community and nominated for an ALPSP Award for Innovation in Publishing. And the programme is growing; a second well-respected publisher, Liverpool University Press, launched with Opening the Future in June 2021. The COPIM project has now begun to turn its focus to the thorny problem of scaling up. But herein lies a tension.&#x0D; OA monograph publishing needs to be sustainable not just for publishers, but also for libraries. Opening the Future was designed to be low-cost and simple, slotting into acquisitions budgets and existing library purchasing workflows. However, as we bring the programme to more university presses and libraries, how do we ensure we are not just adding another circle to the OA labyrinth that libraries are attempting to navigate? How might Opening the Future scale without increasing the administrative and decision-making burden already on collections and scholarly communications teams, who are already picking through a tangle of transformative agreements, pay-to-publish deals, author affiliations, and legacy subscriptions? &#x0D; In this session, we will engage the audience through these questions, as well as discuss the role of the programme in the wider policy landscape and how it is positioned alongside other emerging OA collective funding initiatives.

Baseline assessment of pharmacovigilance activities in four sub-Saharan African countries: a perspective on tuberculosis

BackgroundNew medicines have become available for the treatment of drug-resistant tuberculosis (DR-TB) and are introduced in sub-Saharan Africa (SSA) by the national TB programs (NTPs) through special access schemes. Pharmacovigilance is typically the task of national medicines regulatory agencies (NMRAs), but the active drug safety monitoring and management (aDSM) recommended for the new TB medicines and regimens was introduced through the NTPs.We assessed the strengths and challenges of pharmacovigilance systems in Eswatini, Ethiopia, Nigeria and Tanzania, focusing on their capacity to monitor safety of medicines registered and not registered by the NMRAs for the treatment of DR-TB.MethodsAssessment visits were conducted to all four countries by a multidisciplinary team. We used a pharmacovigilance indicator tool derived from existing tools, interviewed key stakeholders, and visited health facilities where DR-TB patients were treated with new medicines. Assessment results were verified with the local NMRAs and NTPs.ResultsMost countries have enabling laws, regulations and guidelines for the conduct of pharmacovigilance by the NMRAs. The relative success of NTP-NMRA collaboration is much influenced by interpersonal relationships between staff. Division of roles and responsibilities is not always clear and leads to duplication and unfulfilled tasks (e.g. causality assessment). The introduction of aDSM has increased awareness among DR-TB healthcare providers.ConclusionaDSM has created awareness about the importance of pharmacovigilance among NTPs. In the future, a push for conducting pharmacovigilance through public health programs seems useful, but this needs to coincide with increased collaboration with between public health programs and NMRAs with clear formulation of roles and responsibilities.

Introduction

Introduction

Factors Influencing the Access to and Utilization of Medical Rehabilitation Services Recommended after Care Assessment - Results of Qualitative Interviews with Professionals Involved in the Decision Process

In Germany, persons in need of care can receive a rehabilitation recommendation from the medical service of the health insurance companies. Approximately half of these recommendations lead to applications and every fourth recommendation to actual utilisation of medical rehabilitation. Little is known about the supporting factors for and barriers to this special access to medical rehabilitation for persons in need of care. To explore the influencing factors - both personal and procedural - from the perspectives of involved professionals. Interviews regarding on the access to medical rehabilitation were conducted with expert raters from the medical service of the German statutory health insurance system and with employees in long-term care and in health insurance. For data analysis systematic text condensation was used. Based on 53 interviews with 56 involved professionals, individual- and process-related influencing factors were identified. In addition to sociodemographic, health-related, personal and financial characteristics, rehabilitation-related attitudes and a strong attachment to the home environment seem to be particularly relevant. Furthermore, service-related (e. g. expectations and wishes) and process-related (e. g. care structures) characteristics also seem to have an impact. The importance of social support from relatives was emphasized. The results point to potential supporting factors and barriers in the access to rehabilitation by means of care assessment. They should be considered for possible improvements of the assessment and approval procedures as well as the necessary early and sufficient councelling of the concerned persons and their relatives.

The Prosthetic Imagination: A History of the Novel as Artificial Life. Peter Boxall. Cambridge: Cambridge University Press, 2020. Pp. xi+411.

<i>The Prosthetic Imagination: A History of the Novel as Artificial Life</i>. Peter Boxall. Cambridge: Cambridge University Press, 2020. Pp. xi+411.

Large-Scale Data Mining of Rapid Residue Detection Assay Data From HTML and PDF Documents: Improving Data Access and Visualization for Veterinarians.

Extra-label drug use in food animal medicine is authorized by the US Animal Medicinal Drug Use Clarification Act (AMDUCA), and estimated withdrawal intervals are based on published scientific pharmacokinetic data. Occasionally there is a paucity of scientific data on which to base a withdrawal interval or a large number of animals being treated, driving the need to test for drug residues. Rapid assay commercial farm-side tests are essential for monitoring drug residues in animal products to protect human health. Active ingredients, sensitivity, matrices, and species that have been evaluated for commercial rapid assay tests are typically reported on manufacturers' websites or in PDF documents that are available to consumers but may require a special access request. Additionally, this information is not always correlated with FDA-approved tolerances. Furthermore, parameter changes for these tests can be very challenging to regularly identify, especially those listed on websites or in documents that are not publicly available. Therefore, artificial intelligence plays a critical role in efficiently extracting the data and ensure current information. Extracting tables from PDF and HTML documents has been investigated both by academia and commercial tool builders. Research in text mining of such documents has become a widespread yet challenging arena in implementing natural language programming. However, techniques of extracting tables are still in their infancy and being investigated and improved by researchers. In this study, we developed and evaluated a data-mining method for automatically extracting rapid assay data from electronic documents. Our automatic electronic data extraction method includes a software package module, a developed pattern recognition tool, and a data mining engine. Assay details were provided by several commercial entities that produce these rapid drug residue assay tests. During this study, we developed a real-time conversion system and method for reflowing contents in these files for accessibility practice and research data mining. Embedded information was extracted using an AI technology for text extraction and text mining to convert to structured formats. These data were then made available to veterinarians and producers via an online interface, allowing interactive searching and also presenting the commercial test assay parameters in reference to FDA-approved tolerances.

Cannabis and its therapeutic value in the ageing population: Attitudes of health-care providers.

To explore the attitudes of health-care providers and the perceived barriers and facilitators regarding the use of cannabis-containing medicines (CCMs) in older patients. Semi-structured interviews with eleven health-care providers in rural New South Wales (NSW). A thematic analysis was performed. Themes and recommendations include attitudes towards CCMs for therapeutic purposes, their perceived uses, side effects, barriers to use and prescription (stigma, regulation, access and driving), difficulties encountered with the Special Access Scheme (SAS) and the need for ongoing research and education. An ecological framework demonstrated the complex interactions between patients and health-care providers and their social, community and political environment. Providers' attitudes towards CCM use in older patients are generally positive; however, there is a need for further high-quality evidence on efficacy and safety, alongside improved CCM education and training, to reduce barriers to their implementation. Barriers to prescription and access continue to evolve on personal, organisational and systemic levels.

DISCOURSE IN A CONTEXT OF POLITICAL POWER RELATIONS

The object of this research is modern political power relations. The discourse is studied in the traditions of postmodernism, including as a ‘picture of the world’, cognitive model, worldview and the limits of what is possible in the thinking and behaviour of individuals. According to the discourse theories, all objects of reality are discursive, that is, any phenomenon is inscribed in a context that gives it full meaning. All objects of the surrounding world can acquire different meanings (or identities) depending on the specific circumstances in which they are immersed. Discourse is a way of ordering reality, a mechanism for determining the values of people. The subject of power in this context is understood as a collective or individual actor who has special access to the discourse and can control it. According to Foucault’s theory, discourse can be identified with power. This research finds that discourse is the most efficient power resource because it touches every part of a person’s existence. The paper explains the problem from both sides: as the development of political discourse theories on the one hand and as the innovative research of modern power relations in a context of discursive technologies on the other hand. The research is based on the works of M. Foucault, T. Van Dijk, L. Althusser, A. Gramsci, E. Laclau and Sh. Mouff, all of whom measured discourse in a variety of ways. Thus, in our research, we used such theoretical methods for analysis, classification and comparison. The analysis of discourse undertaken here has extended our knowledge of political power relations. The findings in this study provide a new understanding of discourse as a cognition that actualises many questions for further investigations. The findings may be of interest for both scholars and students who study political power in general or discourse as a picture of the world in particular.

Mother and Child Protection in Val-de-Marne

In the department of Val-de-Marne, the Mother and Child Protection is characterised by a global approach to health, special accessibility of its services, multi-disciplinarity and the expertise of its teams. It is based on the concept of proportionate universalism and devotes a special place to partnership arrangements. Its working dynamics are based onthemethodology of the project system: it is a question of co-construction, activating transversality while advocating participatory democracy. The working dynamics are, therefore, diversified.

At-home HIV self-testing during COVID: implementing the GetaKit project in Ottawa

SettingIn March 2020, COVID-19 shuttered access to many healthcare settings offering HIV testing and there is no licensed HIV self-test in Canada.InterventionA team of nurses at the University of Ottawa and Ottawa Public Health and staff from the Ontario HIV Treatment Network (OHTN) obtained Health Canada’s Special Access approval on April 23, 2020 to distribute bioLytical’s INSTI HIV self-test in Ottawa; we received REB approval on May 15, 2020. As of July 20, 2020, eligible participants (≥18 years old, HIV-negative, not on PrEP, not in an HIV vaccine trial, living in Ottawa, no bleeding disorders) could register via www.GetaKit.ca to order kits.OutcomesIn the first 6 weeks, 637 persons completed our eligibility screener; 43.3% (n = 276) were eligible. Of eligible participants, 203 completed a baseline survey and 182 ordered a test. These 203 participants were an average of 31 years old, 72.3% were white, 60.4% were cis-male, and 55% self-identified as gay. Seventy-one percent (n = 144) belonged to a priority group for HIV testing. We have results for 70.9% (n = 129/182) of participants who ordered a kit: none were positive, 104 were negative, 22 were invalid, and 2 “preferred not to say”; 1 participant reported an unreadiness to test.ImplicationsOur results show that HIV self-testing is a pandemic-friendly strategy to help ensure access to sexual health services among persons who are good candidates for HIV testing. It is unsurprising that no one tested positive for HIV thus far, given the 0.08% positivity rate for HIV testing in Ottawa. As such, we advocate for scale-up of HIV self-testing in Canada.

Implementing co‐teaching with paraprofessionals to provide pre‐Kindergarten students with special rights access to dual language

The purpose of this study was to examine how paraprofessionals and other service providers participate in co‐teaching with a certified special education pre‐Kindergarten teacher during dual language (DL) instruction. The study took place in two DL special education preschool classrooms located in an urban public school district in the southwestern US. The district enlisted paraprofessionals as lead Spanish instructors when the lead teacher was not bilingual in Spanish and English to implement the DL programme effectively. Participants were one special education teacher, two paraprofessionals and one teaching artist, who participated in a year‐long professional development programme to employ drama strategies to develop children's Spanish and English literacy skills and promote inclusion. Findings indicated that the participants utilised multiple co‐teaching models to collaborate and meet the needs of their students during English and Spanish instruction. Through co‐teaching, all educators had opportunities to take lead and supporting roles in instruction.

Patient characteristics and cardiac surgical outcomes at a tertiary care hospital in Kenya, 2008-2017: a retrospective study.

BackgroundCardiac surgeries are high risk procedures that require specialized care and access to these procedures is often limited in resource-poor countries. Although fatalities for surgical patients across Africa are twice that of the global rate, cardiac surgical mortality continent-wide is only slightly higher than all-surgical mortality. Understanding demographic and health characteristics of patients and the associations of these characteristics with morbidity and mortality events is important in guiding care decisions. Therefore, the objectives of this study were to: (a) describe the characteristics of cardiac surgical patients; (b) identify the associations between these characteristics and morbidity and mortality events following cardiac surgery.MethodsPatient characteristics and post-surgical complications were abstracted for all cardiac surgical patients treated at a tertiary care hospital in Kenya from 2008 to 2017. Descriptive analyses of demographic factors, co-morbidities, peri-operative conditions, and post-surgical complications were conducted for adult and pediatric patients. Cochran-Armitage trend test was used to assess temporal trends in risk of death. Multivariable ordinary logistic and Firth logistic models were used to investigate predictors of surgical outcomes.ResultsThe study included a total of 181 patients (150 adult and 31 pediatric patients). Most (91.3%) adult patients had acquired conditions while 45.2% of the pediatric patients had congenital defects. Adult patients tended to have co-morbid conditions including hypertension (16.7%), diabetes mellitus (7.3%), and nephropathy (6.7%). Most patients (76.0% adults and 96.8% pediatric patients) underwent ≤ 2 surgical procedures during their hospital stay. Seventy percent of adult and 54.8% of the pediatric patients experienced at least one post-surgical complication including mediastinal hemorrhage, acute kidney injury and death. Patient characteristics played the greatest roles in predicting post-surgical complications. For adult patients, significant predictors of acute kidney injury included atrial fibrillation (OR = 18.25; p = .001), mitral valve replacement (OR = 0.14; p = .019), and use of cardiopulmonary bypass (OR = 0.06; p = .002). Significant predictors of 30-day mortality were age (OR = 1.05; p = .015) and atrial fibrillation (OR = 4.12, p = .018). Although the number of surgeries increased over the decade-long study period, there were no significant (p = .467) temporal trends in the risk of death.ConclusionsAwareness of demographic and peri-surgical factors that are predictors of complications is useful in guiding clinical decisions to reduce morbidity and mortality. Identification of co-morbidities as the most useful predictors of post-surgical complications suggests that patient characteristics may be a larger contributor to the incidence of complications than surgical practices.

Medication abortion: Advocating for mifepristone dispensing by pharmacists

Medication abortion consisting of an oral regimen of mifepristone and misoprostol has been available in the United States since 2000 when mifepristone was approved by the Food and Drug Administration (FDA) for this indication [1]. Special access and use restrictions have been imposed by the FDA since initial approval, and in 2008 mifepristone was transitioned into a Risk Evaluation and Mitigation Strategy (REMS) program. REMS programs are designed to ensure that benefits outweigh the risks for medications with serious safety concerns, and often strictly regulate access [2].

Cutaneous leishmaniasis control in Alta Verapaz (northern Guatemala): evaluating current efforts through stakeholders\u2019 experiences

BackgroundCutaneous leishmaniasis (CL), endemic in Guatemala, mostly affects poor people living in the northern region. A national control program that includes surveillance, diagnose, and treatment offered free of cost by the Ministry of Health (MoH) has been in place since 2003. However, the incidence is increasing and treatment rates are not optimal, suggesting that current efforts are not being effective. This study aimed to understand barriers and facilitators of CL control in Guatemala as experienced and perceived by key stakeholders in order to comprehend what works well and does not and suggest evidence-informed interventions.MethodsThe study was conducted in the Cobán municipality, the most endemic of Guatemala, situated in the Department of Alta Verapaz. Data were collected during May and June 2019 via focus groups and semi-structured interviews with key stakeholders, including local and national health personnel and residents of four communities of the endemic region. Thematic and content analysis of the collected data was conducted using NVIVO.ResultsThree overarching issues hamper the effectiveness of current CL efforts: resource scarcity, treatment challenges, and knowledge-action gaps. Scarce economic resources from the MoH and community residents negatively impact incidence, detection of cases and treatment rates in that preventive action is insufficient and healthcare access is low. In addition, local health workers often lack specialized CL training and access to the national CL control guidelines. With regards to the population living in the study area, misunderstanding of disease causation, shame associated with CL lesions, treatment pain fear, and long (often uncertain) waiting times for diagnose and treatment negatively affect people’s willingness to seek help, treatment adherence, and their trust on the healthcare provided.ConclusionsCulturally sensitive CL preventive action must be developed. Given the scarce economic resources available for CL control in the country, the involvement of trained community health workers and the inclusion of thermotherapy as a treatment option is also advised. Other cost-effective actions include: ensuring all health workers receive CL training and have access to national CL control guidelines, improving national procurement system to avoid treatment shortages, and provision of motorized vehicles to increase active surveillance and treatment rates.Graphical abstract

Medicinal psychedelics for mental health and addiction: Advancing research of an emerging paradigm.

The medical use of psychedelic substances (e.g. psilocybin, ayahuasca, lysergic acid diethylamide and 3,4-methylenedioxymethamphetamine) is attracting renewed interest, driven by a pressing need for research and development of novel therapies for psychiatric disorders, as well as promising results of contemporary studies. In this Viewpoint, we reflect upon the 'Clinical Memorandum on Psychedelics' recently released by the Royal Australian and New Zealand College of Psychiatrists and note subsequent developments including the application for down-scheduling of psilocybin and 3,4-methylenedioxymethamphetamine presently being considered by the Therapeutic Goods Administration and approvals for access via the Special Access Scheme. We suggest that this field is worthy of rigorous research to assess potential benefits, address safety parameters and clarify therapeutic mechanisms. To this end, we outline recent research findings, provide an overview of current knowledge relating to mechanisms of action and discuss salient aspects of the psychedelic-assisted psychotherapy treatment model. The sum of this research points towards medicinal psychedelics as a potential new class of psychiatric treatments when used within a medically supervised framework with integrated psychotherapeutic support. However, before widespread translation into clinical use can occur, appropriately designed and sufficiently powered trials are required to detect both potential positive and negative outcomes. Unique safety and regulatory challenges also need to be addressed. As for any new medical therapy, psychedelic research needs to be conducted in a rigorous manner, through the dispassionate lens of scientific enquiry. Carte blanche availability to practitioners, without specific protocols and appropriate training, would be potentially harmful to individuals and detrimental to the field.

Navigating the complex realm of drug access in paediatric care.

A Drug Access Navigator (DAN) is a role that has been established in patient care settings with the goal of expediting the process by which patients obtain drugs through the Health Canada Special Access Program (SAP), individual drug companies' patient access programs (PAP), and public and private drug plans. In the paediatric setting, the process of accessing many drugs has grown increasingly complex. The majority of paediatric prescriptions involve 'off-label' drug use. This leads to an increased need for drug access through the SAP and/or PAPs and demonstrates that the need for a DAN may be particularly prominent in the paediatric population. To our knowledge, there is no evidence in the literature of a DAN functioning in a paediatric setting, though there is a demonstrable need. We plan to address this need by introducing a DAN for shared use at BC Children's Hospital, a paediatric tertiary care centre.

P50.01 A Year Experience With Atezolizumab Plus Chemotherapy For Small Cell Lung Cancer In Alberta, Canada

The authors assessed the real-world effectiveness of newly approved regimen, atezolizumab plus carboplatin-etoposide (Atezo-CaE) for extensive stage (ES) small cell lung cancer (SCLC) in Alberta, Canada. Atezo-CaE is yet to be provincially funded for ES treatment but can be accessed through special access programs. Included in this study were confirmed ES patients treated with first-line Atezo-CaE at the tertiary and community cancer care centres in Alberta, Canada post FDA/ Health Canada approval (2019) up to the data cut-off date (September 1, 2020). Demographic and clinical data were extracted from the institutional Glans-Look Research Database. Any with active multiple malignancies and/or prior curative-intent treatment were excluded. Outcomes including overall response rate (ORR, RECIST v1.1), adverse events (CTCAE criteria v5), progression-free and overall survival were estimated using descriptive and Kaplan-Meier survival (Log-Rank) statistics. A priori statistical significance was p < 0.05. Analyses were performed using SPSS statistical software (version 25). There were 34 patients seen at the community care centres (18%) or academic tertiary institutions (82%). 53% were male, 24% had ECOG performance status ≥2 and the median age was 65 years. The median number of days from diagnosis to Atezo-CaE receipt was 40 (range: 14-128) days. 21% had no maintenance atezolizumab. In addition, 65% had radiotherapy treatment. 21% were still having ongoing atezolizumab treatment. The median duration of atezolizumab was 4.2 (range: 0.1-13.5) months. ORR was 62% with a median of 84 (range: 47-210) days time to best response. 18% have an ongoing response to atezolizumab. Disease progression was the commonest reason for 1L discontinuation while also accounting for the 2nd most common reason for no maintenance atezolizumab only after adverse events. Overall, progressive disease rate was 76%. The median duration of response was 98 (range: 35-635) days. 24% continued atezolizumab for ≥ 1 month past disease progression. 2L rate was 26%. The median progression-free and overall survival for all patients were 6 (95% CI: 4-8) and 11 (95% CI: 9-11) months while in those who received maintenance atezolizumab were 8 (p=0.01) and 13 (p<0.01) months respectively. Within a year of Atezo-CaE treatment for ES, there was 18% ongoing response to Atezo-CaE. The ORR (62 vs 60%), median treatment duration (4.2 vs 4.7 months) and overall survival outcomes (12.7 vs 12.3 months) appeared consistent in real-world versus clinical trial patients1. Future study to identify factors predicting Atezo-CaE treatment response and survival outcomes in SCLC is very much needed.