This program is preliminary and subject to change.
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MONDAY SEPTEMBER 14 |
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1145-1200 UTC |
Welcome Remarks |
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1200-1300 UTC |
Concurrent Symposia |
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1305-1405 UTC |
Concurrent Symposia |
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1410-1510 UTC |
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TUESDAY SEPTEMBER 15 |
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1155-1200 UTC |
Participant Login |
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1200-1300 UTC |
Concurrent Symposia |
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1305-1405 UTC |
Concurrent Symposia |
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1410-1510 UTC |
Glyphosate: A Case Study for Understanding Modern Safety Evaluations in a Global Context |
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WEDNESDAY SEPTEMBER 16 |
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1155-1200 UTC |
Participant Login |
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1200-1300 UTC |
Concurrent Symposia |
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1305-1405 UTC |
Concurrent Symposia |
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1410-1510 UTC |
Concurrent Symposia
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1510-1530 UTC |
Invitation to Rome 2021! |
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WEDNESDAY SEPTEMBER 23 |
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1650-1700 UTC |
Participant Login |
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1700-1800 UTC |
Quantitative Harm Reduction Drug Checking with PaperSpray Mass Spectrometry During the COVID-19 Pandemic Response |
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WEDNESDAY OCTOBER 7 |
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1650-1700 UTC |
Participant Login |
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1700-1800 UTC |
Sponsored by Waters Corporation |
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WEDNESDAY OCTOBER 14 |
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1650-1700 UTC |
Participant Login |
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1700-1800 UTC |
LC-MS/MS in the Clinical Laboratory: Current Challenges and Future Perspectives for Expansion in Routine |
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WEDNESDAY OCTOBER 21 |
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1650-1700 UTC |
Participant Login |
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1700-1800 UTC |
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Concurrent Symposium 1: Pro/Con Therapeutic Drug Monitoring of Monoclonal AntiBody in Oncology
Monday September 14, 1200-1300 (UTC)
Joseph Ciccolini, Aix Marseille Université U105, Institut Paoli Calmettes & APHM
Etienne Chatelut, Institut Universitaire du Cancer-Toulouse, France
Jeroen J.M.A. Hendrikx, The Netherlands Cancer Institute – Amsterdam, The Netherlands
D.J.A.R Moes, Leiden University Medical Center, The Netherlands
Learning Objectives:
At the end of this session participants will be able to:
- Describe the current challenges and pitfalls of TDM in Oncology.
- Discuss pharmacokinetic-pharmacodynamic relationships of Mab in Onco-Hematology.
- Formulate their own opinion on this pending issue (i.e., TDM of Mab in Oncology).
Session Outline:
Arguments supporting the perspective of TDM of Mab used as targeted therapy or immunotherapy of cancers will be confronted to those considering there is no rationale for considering TDM of these drugs:
- Why, when and how performing TDM in Oncology (Joseph Ciccolini)
- Pro TDM of Mab (D.J.A.R Moes)
- Con TDM of Mab (Etienne Chatelut)
- Alternative administration schedules of Mab (Jeroen J.M.A. Hendrikx)
- Open discussion
Concurrent Symposium 2: Implementation of TDM – Secrets of Success
Monday September 14, 1200-1300 (UTC)
Presenter:
Ron Keizer, Insight Rx, USA
Stephanie Reuter-Lange, University of South Australia, Australia
Sophie Stocker, St Vincent’s Hospital, Sydney, Australia
Christophe Stove, Ghent University Belgium
Learning Objectives:
At the end of this session participants will be able to:
- Consider the practical advice provided by the speakers to ensure successful implementation of TDM at their institution.
- Discuss the role and governance structures of each stakeholder in the TDM process to enhance the clinical utility of TDM.
- Confidently interact with experts in other disciplines to inform improvement of TDM processes.
This symposium will bring together all of the “stakeholders” in the therapeutic drug monitoring (TDM) process. The symposium is designed to highlight how TDM stakeholders need to work as a cohesive team to ensure that we are meeting the needs of the health professionals making the dosing decisions. Four speakers from around the world, who have an excellent international reputation and significant expertise in essential aspects of TDM will present their latest research.
Concurrent Symposium 3: Therapeutic Drug Monitoring of Biologics in Immune Mediated Inflammatory Diseases: Reflections for the Present and Future
Monday September 14, 1300-1400 (UTC)
Presenters:
Konstantinos Papamichail, Harvard Medical School, USA
Michael Wiese, University of South Australia, Australia
Utilizing Therapeutic Drug Monitoring of Biologics in IBD
Konstantinos Papamichail, Harvard Medical School, USA
Learning Objectives:
At the end of this session participants will be able to:
- Discuss the role of reactive therapeutic drug monitoring (TDM) of biologics in patients with inflammatory bowel disease (IBD).
- Discuss the role of proactive TDM of biologics in patients with IBD.
- Identify the knowledge gaps regarding the utilization of TDM of biologics in IBD.
Session Outline:
Biologic therapy has revolutionized the treatment of inflammatory bowel diseases (IBD). However, not all patients respond to induction therapy, so called primary non-response (PNR) and many others lose response over time, phenomenon well known as secondary loss of response (SLR). Reactive therapeutic drug monitoring (TDM), defined as the evaluation of drug concentration and anti-drug antibodies (ADA) in the setting of PNR or SLR to a biologic agent, has helped to explain and better manage these negative therapeutic outcomes. Based on reactive TDM both PNR and SLR have been attributed to either pharmacokinetic issues, characterised by inadequate drug concentrations (with or without the development of ADA), or pharmacodynamic issues, so called mechanistic failure. Numerous prospective exposure-response relationship studies and post-hoc analyses of randomized controlled trials show a positive correlation between biologic drug concentrations and favorable clinical outcomes in IBD. Recent data suggest that proactive TDM, defined as the evaluation of drug concentration and ADA levels with the goal of optimizing biologics to achieve a threshold drug concentration, is associated with better therapeutic outcomes when compared to empiric dose optimization and/or reactive TDM of anti-TNF therapy in IBD. Moreover, proactive TDM can also effectively guide infliximab de-escalation in patients with IBD in remission. However, there are perceived knowledge gaps regarding the role of TDM of biologics in IBD that have hampered the wide implementation of TDM-based algorithms in real-life clinical practice, as reflected also in some of the current guidelines and recommendations.
Biologics/TDM/RA
Michael Wiese, University of South Australia, Australia
Concurrent Symposium 4: Pragmatic Approaches to Improvements in Pediatric Drug Therapy
Monday September 14, 1300-1400 (UTC)
Presenters:
Geert ‘t Jong, Children’s Hospital Research Institute of Manitoba (CHRIM), Canada
Michael Rieder, University of Western Ontario, Canada
Catherine M Sherwin, Wright State University Boonshoft School of Medicine Dayton Children’s Hospital, USA
Learning Objectives:
At the end of this session participants will be able to:
- Discuss novel methods for drug dose estimation in infants and children based on pre-clinical and adult data and how to effectively communicate this knowledge to researchers, health care providers and patients and their families.
- Discuss the regulatory initiatives taken in the US, Canada, and the EU, and how they enhance the development of appropriate drugs and formulation through legislation and funding opportunities.
- Assess partnership with industry to promote commercialization of pediatric formulations.
- How to improve expertise of and access to paediatric formulations (Geert ‘t Jong)
- Drug Safety in Pediatrics; shifting from catching up to moving forward (Michael Rieder)
- Moving forward in Pediatric Therapeutics; the roles of academia, industry and government (Catherine M Sherwin)
Children are a patient group who have not fully benefited from the Therapeutic Revolution and for whom therapy often lags treatment in adults. There have been several new developments in pharmacology, clinical trial design, and pharmacotherapy that will greatly enhance the ability of investigators, industry, and regulators to provide evidence to support the use of new therapeutic agents in children. Several grass-root and regulatory initiatives to enhance the development, regulation, and utilization of suitable paediatric therapy will inform the audience.
Plenary Session: Introduction to Artificial Intelligence and Application in Healthcare
Monday September 14, 1400-1500 (UTC)
Presenter:
Johan Saba, SEED AI, Canada
Learning Objectives:
At the end of this session participants will be able to:
- Explain the role and importance of domain translation in data science and artificial intelligence.
- Describe artificial intelligence and machine learning with concrete examples.
- Discuss the recommended methodology for organization AI adoption and transformation based on concrete examples.
Concurrent Symposium 5: Fast and Furious! Personal Pithy Patient Practice Points
Tuesday September 15, 1200-1300 (UTC)
Chairs:
Dario Cattaneo, ASST Fatebenefratelli Sacco University Hospital, Italy
Debbie Marriott, St Vincent’s Hospital, Australia
Speakers in no particular order:
Alan Abdulla, Erasmus Medical Center, Netherlands
Jan-Willem Alffenaar, The University of Sydney, Australia
Sumith Mathew, Christian Medical College, India
Dario Cattaneo, Università degli Studi di Milano, Italy
Debbie Marriott, St Vincent’s Hospital, Australia
Abdullah Alsultan, King Saud University, Saudi Arabia
Roger Brüggemann, Radboud University Nijmegen Medical Centre, Netherlands
Carsten Müller, Universität zu Köln, Germany
Michael Neely, Children’s Hospital Los Angeles, University of Southern California, USA
Sophie Stocker, St Vincent’s Hospital, Australia
Session Outline:
Five minutes is all the time allowed for your colleagues to present an instructive case with an important message.
9 presentations, sixty minutes of fun-filled, fast-paced education highlighting the important clinical role of antimicrobial TDM. It will be memorable so don’t miss it!
Concurrent Symposium 6: Precision Dosing in Psychiatry: TDM and PK/PD in the Psychiatric Patient Further Explained
Tuesday September 15, 1200-1300 (UTC)
Presenters:
Sanne Kloosterboer, Erasmus MC, Netherlands
Birgit Koch, Erasmus MC, Netherlands
George Schoretsanitis, Zucker Hillside Hospital, USA
Learning Objectives:
At the end of this session participants will be able to:
- Describe the current opinion of TDM of antipsychotics in general.
- Explain what is the PK of antipsychotics in children and when to do TDM in this population.
- Discuss what is the PK and the added value of TDM in pregnant patients with regard to antipsychotics and antid.
Session Outline:
- Introduction of PK and TDM in psychiatry, from cradle to grave (Birgit Koch)
- PK and TDM of antipsychotics in children (Sanne Kloosterboer)
- PK and TDM of antidepressants and antipsychotics during pregnancy (George Schoretsanitis)
Psychotropic drugs have been proven effective for the treatment of a wide range of psychiatric disorders. However, the use of psychotropic drugs faces several challenges, what is the best dose to give considering all side effects and what is the best effect to target. To establish precision dosing, more knowledge on PK/PD of psychotropic drugs is needed and eventually the added value of TDM needs to unraveled for all psychotropic drugs. In this session basic PK/PD and TDM of antidepressants and antipsychotics are explained.
Furthermore, we will focus on children and antipsychotics, peripartum use of antidepressants and antipsychotics and a short description of the use at the end of life. Questions answered will be: What do we know of the PK in these patient groups, what is the experience of TDM and need in these populations with regards to antidepressants and antipsychotics and what are the future perspectives to focus research on with regards to antipsychotics and antidepressants in children and pregnant patients. And what are the future goals to reach when targeting precision psychiatry.
Concurrent Symposium 7: Non-conventional but Critical Sources of Exposure to Endocrine Disrupting Compounds (EDC)
Tuesday September 15, 1300-1400 (UTC)
Presenters:
Guillaume Binson, University of Poitiers, France
Marina Goumenou, University of Crete, Greece
Sami Haddad, University of Montreal, Canada
Session Outline:
Endocrine disrupting chemicals (EDCs) are mostly man-made chemicals. Evidence has now emerged that EDCs can produce adverse health effects, even at low doses that are assumed safe. EDCs are commonly present in a myriad of household products such as plastics from beverage and food storage containers, metal cans, textiles and personal care products. But there are lesser known sources of exposure to EDCs of critical importance.
Guillaume Binson: Pharmaceutical products and medical devices as a source of EDCs
Pharmaceutical products and medical devices are some of these non-conventional sources. Parabens are used as excipients in pharmaceutical products such as liquid oral dosage forms whereas bisphenol A and phthalates are used in the production of medical devices. This presentation will review EDCs found in medicines and medical devices, their impact in term of exposure and health hazards especially when administered to vulnerable patients such as paediatric patients.
Marina Goumenou: Metals as EDCs
Little consideration has been given to the fact that many metals (Pb, Cd, As, Hg, Cr, Ni) are confirmed or suspected endocrine disruptors. In this presentation the exposure and the effects of exposure to different metals that exhibit endocrine disrupting properties will be evaluated.
Sami Haddad: Modeling Exposure from Multiple Sources and Routes
This presentation will describe how exposure to EDCs can be modelled in a context of multiple sources and routes of exposure.
Through this symposium, one will enable to identify non-conventional sources of exposure to EDCs. It will summarize key findings regarding contamination arising from these sources, how it can be quantified and analysed through modelling tools and how it can be avoided.
Concurrent Symposium 8: Young Scientist Committee Symposium
Tuesday September 15, 1300-1400 (UTC)
Co-Chairs:
Laure Elens, catholic University of Louvain (UCLouvain), Belgium
Tomoyuki Mizuno, Cincinnati Children’s Hospital Medical Center and University of Cincinnati, USA
Presenters:
Jan-Willem Alffenaar, The University of Sydney, Australia
Sophie Stocker, St Vincent’s Hospital, Australia
Lea Wagmann, Institute of Experimental and Clinical Pharmacology and Toxicology Saarland University, Germany
Learning Objectives:
At the end of this session participants will be able to:
- Explain why and which physiological changes are important to consider when performing pharmacokinetics study and to weigh the importance of aging in the different PK processes.
- Discern the problem of mushroom poisoning in daily life and how to manage intoxications in the clinics and from the lab side.
- Describe what are the important steps in writing a project proposal for competitive grants and how to turn one’s project into a successful application.
- Physiological changes affecting pharmacokinetics – from cradle to the grave and everything in between (Sophie Stocker)
- Mushrooms poisoning: Global patterns, lab and clinical management (Lea Wagmann)
- Writing a successful competitive grant proposal (Jan-Willem Alffenaar)
Plenary Session: Glyphosate: A Case Study for Understanding Modern Safety Evaluations in a Global Context
Tuesday September 15, 1400-1500 (UTC)
Presenter:
Laura Vandenberg, University of Massachusetts Amherst, USA
Learning Objectives:
At the end of this session participants will be able to:
- Explain a shortcoming of exposure assessments for chemicals used as pesticides, such as glyphosate.
- Describe how the results of hazard assessments can conflict with epidemiology studies.
- Discuss how IARC uses data to draw conclusions about carcinogenesis, and why these might differ from regulatory agencies.
Session Outline:
Glyphosate is a high-volume pesticide, widely used as an herbicide. Its use has increased drastically over a period of two decades as it is paired with genetically modified crops, designed to withstand its herbicidal properties. Yet, its use has had unintended consequences, including the development and spread of superweeds. It has also gained significant attention due to legal proceedings, utilizing epidemiology data to suggest that use of glyphosate-based herbicides may be associated with an increased risk of Non-Hodgkin Lymphoma. The story of glyphosate is one that can inform us about how data are used by regulatory agencies; understand and identify weaknesses in hazard and exposure assessments that can lead to underestimates of risk; and discuss controversies regarding how different agencies can review data yet draw different conclusions.
Concurrent Symposium 9:The Growing Problem of Dosing the Obese Patient: What the Product Information Doesn’t Tell You
Wednesday September 16, 1200-1300 (UTC)
Chairs:
Dario Cattaneo, ASST Fatebenefratelli Sacco University Hospital, Italy
Debbie Marriott, St Vincent’s Hospital, Australia
Speakers:
Anders Åsberg, Oslo University Hospital–Rikshospitalet, Norway
Dario Cattaneo, Università degli Studi di Milano, Italy
Catherijne A.J. Knibbe, St Antonius Hospital Nieuwegein, Leiden University, Netherlands
Deborah JE Marriott, St Vincent’s Hospital, Australia
Introduction and Dosing the Obese Elderly Patient
Dario Cattaneo, ASST Fatebenefratelli Sacco University Hospital, Italy
Learning Objectives:
At the end of this session participants will be able to:
- Discuss how obesity represents an important source of drugs PK variability.
- Consider the patient’s body composition when calculating doses.
- Explain the advantages and disadvantages of body size metrics of obese patients.
- consider aging as an additional contributor of drug variability in obese patients.
Few studies have quantified the influence of body size on PK or PD of many common drugs. Generally, licensed dosing recommendations are based on clinical trials in which people with obesity are under-represented or excluded and evidence-based dosing guidelines are lacking. This may result in arbitrary dose selection leading to therapeutic failure or drug toxicity.
Drug doses are usually calculated using a patient’s total body weight. This is often inappropriate for obese patients, and clinicians may therefore dose using alternative body size descriptors.
The prevalence of obesity among elderly populations is a matter of increasing concern. Elderly obesity is a pathophysiologically complex issue, and predictions regarding obesity-related comorbidity and weight management are challenging. As individuals age, changes in the body composition, such as increase in fat mass and decrease in muscle mass, are observed even in the absence of changes in body weight and body mass index. Hence, body mass index and other indices of obesity should be cautiously interpreted in the elderly, and weight loss should be recommended for obese elderly individuals with functional limitations or metabolic complications that may improve with weight loss.
Anti-Infective Dosing in the Obese Child
Catherijne A.J. Knibbe, St Antonius Hospital Nieuwegein, Leiden University, Netherlands
Learning Objectives:
At the end of this session participants will be able to:
- Define pediatric overweight and obesity.
- Explain the differences in influence of obesity on pharmacokinetics between drugs.
- Discuss the differences in obesity-related influence on pharmacokinetics between obese adults and obese children.
- Reflect on the use of total bodyweight or other weight measures for dosing in obese children.
Over the years the prevalence of childhood obesity has increased rapidly, with to date around 20% of children aged 5 – 18 year in the US being considered obese. Since the body mass index (BMI) increases physiologically with age, pediatric overweight and obesity is commonly defined using growth charts with age and sex specific values for BMI. The Centre for Disease Control and Prevention (CDC) defines overweight and obesity as a BMI in the 85th-95th percentile, or above the 95th percentile of these charts, respectively.
In adults, it has been shown that depending on the drug properties obesity may or may not impact drug pharmacokinetics as a result of altered physiological processes, such as cardiac output, renal and hepatic perfusion or function of drug transporting or metabolizing enzyme. While it is often assumed that changes reported in obese adults also apply to obese children, it has been found that this depends on the drug involved, with some drugs showing similar changes and other changes related to obesity in obese children.
A specific question when dosing drugs in obese children is whether and how body weight has to be used. In non-obese or lean children, body weight increases with age (average weight for age and sex) and when dosing on weight, bodyweight is considered a proxy for growth and maturation. In contrast, in obese children, their total body weight also contains weight related to overweight or obesity (excess weight) of which it may be unknown whether or not it should be considered for dosing.
In the presentation, examples on studies on drugs pharmacokinetics in obese children, adolescents and adults with or without other covariates like renal dysfunction or ICU admittance are presented and discussed in order to provide a guide for dosing for this special patient group.
Dosing the Patient with Obesity; Changes with Weight Reduction
Anders Åsberg, Oslo University Hospital–Rikshospitalet, Norway
Learning Objectives:
At the end of this session participants will be able to:
- Explain differences in CYP activities over a wide range of bodyweights.
- Discuss the effect of weight reduction on CYP activities.
Individual doses are in many cases based on simple body weight adjustment, e.g. dosed by mg/kg. But what is the actual difference in metabolizing enzymes activity with different body weights? And how do the metabolizing phenotype change with body weight reduction? Data from a large study where both in vivo and ex vivo CYP activities have been determined in patients ranging from BMI 18 to 63 kg/m2.
The Obese Patient in the Intensive Care Unit
Debbie Marriott, St Vincent’s Hospital, Australia
Learning Objectives:
At the end of this session participants will be able to:
- Describe the pathophysiological changes associated with critical illness.
- Determine the impact of obesity on these changes.
- Discuss the literature concerning antimicrobial dosing in the obese critically ill patient.
- Explain the role of antimicrobial therapeutic drug monitoring in this clinical setting.
It is 10.30 am and the daily Infectious Diseases/Microbiology/Antimicrobial Stewardship ward round is taking place in the Intensive Care Unit. In bed 6 is a frail 78 year old lady weighing 55 kg treated with intra-venous flucloxacillin for a deep sternal wound infection and an eGFR >90. In the next bed is a 29 year old male with S. aureus endocarditis. He weighs 145 kg and his eGFR is >90. Antibiotic guidelines suggest that they should be treated with the same dose of flucloxacillin despite the significant variation in body composition associated with age and weight. Should we alter the dose of antimicrobial agents in obese critically ill patients? Are there any studies to guide us? Can we apply broad rules to drug classes or should we individualise dosage recommendations for obese patients? Does TDM have a role in patient management?
Obesity is a global health issue with over 30% of some populations such as the United States now defined as obese and 2/3 overweight or obese. Despite this there is remarkably little data on the pharmacokinetics and pharmacodynamics of antimicrobial therapy in obese critically ill patients; in fact there are few publications concerning antimicrobial dosing in obesity in general. It is likely that the pathophysiological changes in obesity and critical illness will have interacting effects on drug pharmacokinetics yet most dose finding studies were undertaken in healthy volunteers of normal weight. This presentation will review the available data on antibiotic dosing in the critically ill obese patient and the role of therapeutic drug monitoring in managing this complex patient group.
Concurrent Symposium 10: The Role of Medical Cannabis in Chronic Pain
Wednesday September 16, 1200-1300 (UTC)
Presenter:
Lori Montgomery, Alberta Health Services Calgary Pain Program, Canada
Learning Objectives:
At the end of this session participants will be able to:
- Describe the level of evidence that exists for the use of cannabis in pain medicine.
- Explain the key challenges for clinicians in counselling patients regarding cannabis use.
- Discuss the impact of legalization on medical use.
The role of cannabis is being debated in the popular press as much as it is in clinical literature, and we are faced with questions from patients, colleagues, friends, and family. This presentation will summarize what we know (and perhaps more importantly, what we don’t know) about the efficacy of cannabis for chronic pain, as well as the risks and adverse effects. We will also reflect on the changing role of medical cannabis in the context of legalization of cannabis in Canada.
Concurrent Symposium 11: Dose Adjustment in Patients with Changing Renal Function
Wednesday September 16, 1300-1400 (UTC)
Presenters:
Teun van Gelder, Leiden University Medical Center, Netherlands
Brenda de Winter, Erasmus Medical Center, Netherlands
Augmented Renal Clearance and TDM
Teun van Gelder, Leiden University Medical Center, Netherlands
Tools to Individualize Drug Dose in Daily Practice
Brenda de Winter, Erasmus Medical Center, Netherlands
Learning Objectives:
At the end of this session participants will be able to:
- Explain why patients presenting with SIRS often have under-exposure to antibiotics.
- Identify patients at risk of having augmented renal clearance.
- Mention tools to assist health care providers in choosing the right dose in patients with either impaired or augmented renal function.
Concurrent Symposium 12: Screening for the Known Unknown and the Unknown Unknown NPS
Wednesday September 16, 1300-1400 (UTC)
Presenters:
Markus Meyer, Saarland University, Germany
Cristiana Stefan, Centre for Addiction and Mental Health, Toronto, Canada
Alain Verstraete, Ghent University Hospital, Belgium
Learning Objectives:
At the end of this session participants will be able to:
- Develop or adapt an analytical method using GC-MS or LCMSMS for screening for NPS.
- Use the collaborative platforms and databases like HighresNPS, MzCloud, Cayman Chemical and SWGDrug to expand the scope of NPS screening.
- Distinguish the five levels of identification confidence in high resolution mass spectrometric analysis.
Session Outline:
After a short introduction on NPS and (un)known unknowns, three speakers will present their strategy for detecting known unknown and the unknown unknown NPS and illustrate it with cases.
Alain Verstraete will describe a GCMS method (using Cayman Chemical and SWGDrug libraries) and a high-resolution, data-dependent acquisition method on an orbitrap-based instrument, that uses the information from HighresNPS and MzCloud.
Cristiana Stefan will present combined analytical strategies and algorithms (Orbitrap HR/MS DDA protocols, retrospective data mining and NPS intelligence resources) used by her laboratory to identify newer (unknown) psychoactive substances in response to physicians’ inquiries and/or drug checking requests.
Markus Meyer will present the general (in house) strategies for tentative identification by MS of suspected compounds in human samples.
Concurrent Symposium 13A: How Comparable Are We? Lessons From The College Of American Pathologists Proficiency Testing Surveys
Wednesday September 16, 1400-1430 (UTC)
Presenter:
Christine Snozek, Mayo Clinic Arizona, USA
Learning Objectives:
At the end of this session participants will be able to:
- Compare and contrast performance of participating laboratories in CAP toxicology proficiency testing surveys.
- Outline areas for improvement for laboratories performing the tests included in CAP toxicology proficiency testing surveys.
Session Outline:
Proficiency testing (PT) surveys are used to assess comparability of performance across laboratories. The College of American Pathologists (CAP) provides PT surveys to toxicology and drug monitoring laboratories throughout North America and increasingly in other areas of the world. Although most labs participate in external PT surveys, generally the focus when evaluating results is on individual laboratory or method performance rather than a global view. However, looking at survey data more holistically over time reveals important trends, for example whether laboratories adapt their practices to changing drug use patterns, or if pushing methods to achieve analytical sensitivity (i.e., lower reporting cutoffs) has compromised overall test performance.
Recent studies have evaluated trends in PT results from surveys addressing urine drug screening (UDS), ethanol biomarkers (ETB), and therapeutic drug monitoring of antiepileptics and other medications (ZE). While laboratories participating in the ZE survey have maintained consistent performance over time, the UDS and ETB surveys have revealed some potentially concerning trends including high variability between drug of abuse assays in detection of opiates and other drug classes, substantial inter-laboratory variability in interpretive cutoffs and detection of alcohol biomarkers, and slow adaptation to changing drug abuse patterns. Given that those results contribute to key medical and legal decisions, these types of issues can significantly impact clinical care. This session will highlight key findings from recent CAP toxicology and therapeutic drug monitoring PT surveys, including practice improvement recommendations for laboratories performing these tests.
Concurrent Symposium 14: Alternative Sampling Strategies to Evaluate in utero Drug Exposure
Wednesday September 16, 1400-1500 (UTC)
Presenters:
Kamisha Johnson-Davis, University of Utah / ARUP Laboratories, USA
B.C.P. Koch, Erasmus MC, Netherlands
Testing for Neonatal Drug Exposure in Umbilical Cord
Kamisha Johnson-Davis, University of Utah / ARUP Laboratories, USA
Learning Objectives:
At the end of this session participants will be able to:
- Discuss the importance of drug testing to assess in utero drug exposure.
- Discuss the strengths and weaknesses of umbilical cord tissue for drug testing.
- Describe the pros/cons of drug testing via ELISA screen vs mass spectrometry.
Session Outline:
More than 50% of women take prescription/over-the-counter and illicit drugs during pregnancy. Drug use during pregnancy can lead to adverse health consequences, such as preterm labor, birth defects or neonatal abstinence syndrome. This presentation will highlight the role of the laboratory and the importance clinical testing to assess in utero drug exposure.
Drugs and Placenta Exposure: New Methods Using Placenta Models, Meconium and Innovative Biomarkers
B.C.P. Koch, Erasmus MC, Netherlands
Learning Objectives:
At the end of this session participants will be able to:
- Explain placenta transfer.
- Discuss meconium and drugs analysis.
- Discuss new biomarkers and drug abuse.
Industry Workshop 1: Quantitative Harm Reduction Drug Checking with PaperSpray Mass Spectrometry During the COVID-19 Pandemic Response
Wednesday September 23, 1700-1800 (UTC)
Speaker:
Prof. Chris Gill, PhD, P. Chem
Applied Environmental Research Laboratories (AERL)
Vancouver Island University
Co-Director-Department of Chemistry
Learning Objectives:
At the end of this session participants will be able to:
- Explain how to conduct rapid, direct drug analysis in urine and illicit drug checking in response to the opioid crisis.
- Discuss how to navigate the COVID-19 pandemic challenges to offer continued harm reduction services.
- Describe how to make rapid, direct quantitative chemical measurements using paper spray ionization for mass spectrometry.
Session Outline:
The opioid overdose crisis has had global impacts, and it is being exacerbated by the COVID-19 pandemic. In British Columbia, the overdose death toll in the month May 2020 exceeded the total number of COVID-19 mortalities. Reduced harm reduction services and social distancing measures implemented during the pandemic response are possible causes, as is increased stress and the presence of new drugs in the illicit street drug supply. Providing rapid, quantitative information to people who use drugs regarding dangerous drugs before they use them is a form of harm reduction which can reduce overdoses and mortality, but is aimed ultimately at engaging them with the medical system and recovery options. We present the use of paper spray mass spectrometry (PS-MS), a relatively new strategy for ambient ionization, for quantitative, on-site harm reduction drug checking, and our efforts to move forward with improved drug checking services during the COVID-19 pandemic response.
The Thermo Scientific VeriSpray source represents the latest evolution in PS-MS source technology, allowing high throughput, automated, sensitive chemical measurements aimed at clinical and other applications. Our research involvement with PS-MS includes selected applications, including direct drug analysis in urine and on-site illicit drug checking for harm reduction in the opioid overdose crisis.
Industry Workshop 2: Use and potential benefits of Mitra micro-sampling devices for the assessment of Therapeutic Drugs, Tacrolimus and Creatinine
Wednesday October 7, 1700-1800 (UTC)
Speaker:
David Marshall
Clinical Scientist in the Department of Clinical Biochemistry, Wythenshawe Hospital, UK
The use of microsampling devices has long been a topic of conversation in Therapeutic Drug Monitoring, but what are the potential benefits of using these devices? In this talk by David Marshall, Clinical Scientist at Wythenshawe Hospital, you will gain a better understanding of microsampling and how they might be beneficial for use in therapeutic drug monitoring.
Attend this talk if you have an interest in:
- Therapeutic drug monitoring
- Microsampling devices
- LC-MS/MS assay development
- Patient monitoring with LC-MS/MS
Industry Workshop 3: LC-MS/MS in the clinical laboratory: Current Challenges and Future Perspectives for Expansion in Routine
Wednesday October 14, 1700-1800 (UTC)
Speakers:
Y. Victoria Zhang, PhD, MBA, DABCC, FAACC
University of Rochester Medical Center
Vice Chair Clinical Enterprise Strategy
Chief of Clinical Chemistry Division
Associate Professor of Department of Pathology and Laboratory Medicine
Prof. Dr. sc. nat. Katharina Rentsch
University Hospital Basel
Head of Laboratory Medicine, Head of Clinical Chemistry, Laboratory Medicine
University Basel
Associate Professor-Clinical Chemistry, Medical Faculty
Part 1: Current barriers to implementation of LC-MS/MS, what’s needed by clinical labs, and perspectives on LC-MS/MS developments and solutions
Y. Victoria Zhang
Part 2: A fully automated LC-MS/MS clinical analyzer: Experience from the routine clinical laboratory
Katharina Rentsch
Learning Objectives:
At the end of this session participants will be able to:
- Discuss the challenges and perspectives of the LC-MS/MS implementation in clinical laboratory.
- Explain how to implement LC-MS/MS easily in your clinical laboratory.
- Explore the Cascadion SM Clinical Analyzer through a daily routine experience.
Session Outline:
LC-MS/MS is recognized as Gold Standard technology for many applications in the clinical lab, traditionally which in some cases can be difficult to implement and manage, as it needs a lot of expertise and manual intervention. The scope of this workshop is to give an overview of the current challenges with existing LC-MS/MS solutions and the needs of the clinical lab, in order to illustrate how “easy” it can be to implement a fully automated LC-MS/MS clinical analyzer for use in a 24/7 daily routine.
Industry Workshop 4: Opioid Addiction: Overview and Testing Options
Wednesday October 21, 1700-1800 (UTC)
Speakers:
H. Roma Levy, MS, Medical Writer, Educator
Siemens Healthineers
Session Outline:
Worldwide opioid addiction has increased dramatically in the last decade, with the greatest rise documented in the United States. A primary factor driving this growth has been the use of prescription opioids (e.g., oxycodone, hydrocodone, and morphine) for chronic pain in outpatient care. Recreational use of heroin also continues to contribute to opioid addiction. Education and awareness are the first steps in addressing this public-health crisis.