- Email: [email protected]
Student-Led Education
Clinical Therapeutics on clinical benefit and safety outcomes is the key driver of the final decision for reimbursement. Conclusions: Advices launched by the TC are “scientific”, but 20 of the 25 members of the TC are first physicians with an everyday practice, and second highly skilled in methodology and clinical practice. Physicians are involved in drug selection policies in France.
The drug information centre in 2015 – still a valid concept? L.A. Reppe1,2; J. Schjøtt3; and O. Spigset2,4 1 Nord-Trøndelag University College, Steinkjer, Norway; 2 Norwegian University of Science and Technology, Trondheim, Norway; 3University of Bergen, Bergen, Norway; and 4St. Olav University Hospital, Trondheim, Norway Educational Objectives: Participants should be able to identify factors that may increase and/or decrease the quality of DICs’ written responses. Purpose: To assess the quality of written responses to drug-related queries, in order to identify factors increasing and/or decreasing their quality. Methods: During an 8-week period in 2013, 6 drug-related study queries were posed simultaneously by e-mail to 7 Scandinavian DICs. The DICs were informed about the study, but staff members were blinded in terms of which queries were study queries, as the study queries were sent from local general practitioners in their own names. Six general practitioners (external experts) and seven clinical pharmacologists (internal experts) assessed the responses individually using a registry form allowing qualitative assessment. Results: Responses were generally concordant in terms of professional content, but varied in terms of quality of references, advice and conclusions. In total, internal and external experts gave 334 comments. With 3 to 4 exceptions, the 42 responses were assessed as satisfactorily to good. Both expert groups were concerned with whether specific conclusions and/or advices were given, especially in patient-specific queries. Use of secondary and tertiary sources as references, as opposed to primary sources, was criticised by some experts. Conclusions: To our knowledge, this is the first study using qualitative data to identify factors increasing and/or decreasing the quality of DICs’ responses. The presentation of specific advices and conclusions seem to be especially important when responding to drug-related queries. The study has prompted discussions about quality of the written responses in the participating DICs, and the results may also attain a more general interest.
Impact of Bariatric Surgery on Drug Transport And Metabolism W. Siegmund Department of Clinical Pharmacology, University Medicine Greifswald, Germany Bariatric surgery often provides for patients with morbid obesity the only alternative to achieve sustaining weight loss and substantial improvement or remission of obesity related comorbidity. The surgical intervention as the Roux-en-Y gastric bypass technique leads to substantial anatomical and physiological changes associated with micronutrient deficiency and changes in pharmacokinetics of drugs. However, the changes are complex and poorly understood, and longlasting mucosal adaptation of intestinal functions may occur. Therefore, potential transcriptional and posttranscriptional adaptation mechanisms in the small intestine of patients with morbid obesity one year after RYGB surgery will be discussed, primarily with reference to intestinal drug metabolizing enzymes and drug
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transporters. Data are provided as obtained by genome-wide mRNA, microRNA, and targeted proteom analysis in the jejunum and by a pharmacokinetic study using probe drugs before and after bypass surgery. The results are compared with data obtained from healthy subjects (organ donors). There is evidence that multiple adaptation processes may compensate initial changes in drug absorption after bypass surgery.
Systematic Introduction of New Therapies Within The Stockholm County and The Karolinska University Hospital R.E. Malmström; and C.-O. Stiller Drug Safety and Evaluation Sector, Clinical Pharmacology, Karolinska University Hospital, SE-171 76 Stockholm, Sweden Ten years ago, a model for structured introduction of new medicines in Stockholm County was suggested as these were concluded to drive drug expenditures in years to come. The model is led by the Stockholm Drug and Therapeutics Committee and has since been stepwise implemented including a) horizon scanning and early drug evaluations, b) forecasting of drug expenditures, and c) projects to secure a structured introduction and follow-up of new medicines. Part of the model is currently a national collaboration, whereby a couple of counties contribute and all has access to the findings and deliverables. Meanwhile, at the Karolinska University Hospital, strategic funds can, when available, be claimed for new drugs or indications through the Hospital Medicines Council that provides a recommendation to the Priority Council of the Hospital Board. Pivotal questions that need to be addressed in connection with these requests include type of indication, estimated number of patients, evidence for efficacy (symptoms, quality of life, survival, biomarker, etc) and responder rate, cost per treated patient, and priority of the drug in national and international guidelines, by the pharmaceutical benefits agency, and by the Regional Drug and Therapeutics committee. Based on the above information, the Hospital Medicines Council review and propose horizontal prioritization of any strategic resources available to Priority Council to decide how these are keyed out on operations. Further, the prerequisites for structured introduction of new medicines include a description of the treatment decision process and follow-up procedures and a treatment decision protocol including clinical criteria to fulfill for treatment. Inclusion and exclusion criteria are selected according to pivotal documentation for the approved indication, steps to avoid indication drift and uncontrolled introduction with unclear benefits/safety at an early stage. A protocol for each patient is completed, signed, and sent to the Hospital Medicines Council for the go-ahead, and subsequent registration and monitoring of a continued rigorous implementation process.
Student-Led Education M.A. van Agtmael VU university medical center – Internal Medicine, Amsterdam, Netherlands Educational Objectives: After this presentation participants should be able to recognize the value of a new concept of education. Purpose: Pharmacotherapeutic skills are best learned in the context of clinical practice; learning by doing. By giving medical students responsibility and independence they will gain intrinsic motivation and this is associated with deep learning. Methods: Evidence to support the concept of student-led education is discussed in part 1 of the presentation. It is illustrated by the project “student-run clinic,” presented by a student in part 2.
Volume 37 Number 8S
Parallel Session Abstracts Results: Students reported improved skills and indicated that they had acquired knowledge they were unlikely to have gained elsewhere in the curriculum. The quality of specific aspects of care delivered by students was comparable with that of regular care. Conclusions: Students should take the lead in their own education, coached by the senior teacher. Medical students should be trained as professionals with responsibility for patient care.
chronic kidney disease (CKD), as well as for drug dosage adaptation. The prevalence of CKD is very high in the elderly, due to physiological aging of the kidney, to lifelong pathological insults, and to comorbidities. However, the GFR estimating equations, such as the Cockcroft-Gault, MDRD, and CKD-EPI equations, have not been developed specifically in elderly patients. The presentation will review the performances of the GFR estimating equations in studies which included elderly patients, and discuss which methodology should be preferred in this population.
Literature Reference 1. Learning in student-run clinics: a systematic review. T. Schutte ea. Medical Education 2015:49:249–263
Alert fatigue – an overdose of drug information? I.H. van der Sijs Erasmus University Medical Center, Rotterdam, the Netherlands Educational Objectives: At the end of this presentation, the participants should be able to explain what alert fatigue is, and what its causes and consequences are. Furthermore, they understand how both alert fatigue and potential measures to avoid it can be investigated. Purpose: Define alert fatigue, its causes, consequences and investigational challenges. Methods: Literature review, disguised observation, retrospective analysis of alert overrides, think-aloud study, chart review. Results: Alert Fatigue is the mental state that is the result from alerts consuming too much time and energy, which can cause relevant alerts to be unjustifiably overridden among clinical irrelevant ones. Unjustified overriding is a medication error that may result in adverse drug events, although this causal relationship has not been confirmed in studies yet. Alert fatigue is often caused by low specificity of alerts, but other error-producing conditions in the electronic prescribing system, insufficient training, and cultural aspects may also play a role. The optimal specificity and sensitivity are unknown, as are other aspects affecting alert fatigue. To investigate alert fatigue, override reasons are an important source of information, but often difficult to obtain. Clinical pharmacologists may play a role in determining cut-off points for alert generation. Conclusions: Alert fatigue is a ubiquitous problem and much is still unknown. To gain optimal benefit of electronic prescribing with clinical decision support, more research should be performed on this topic.
Literature References 1. Van der Sijs IH. Drug Safety Alerting in Computerized Physician Order Entry. Unraveling and Counteracting Alert Fatigue (PhD Thesis http://repub.eur.nl/pub/16936). 2. Coleman J et al. On the alert: future priorities for alerts in clinical decision support for computerized physician order entry identified from a European workshop. BMC. BMC Med Inform Decis Mak. 2013;13:111.
Renal Function In Older People - Validity of the Gfr-Estimating Equations And Implication for Clinical Practice E. Vidal-Petiot Department of Physiology – Hopital Bichat, Paris, France Glomerular filtration rate (GFR) is the best marker of renal function. Its evaluation is mandatory for diagnosis and classification of
August 2015
Variability In Drug Response and Clinical Reality: the Example of Psychiatric Diseases E. Vieta Hospital Clinic, University of Barcelona, IDIBAPS, CIBERSAM, Barcelona, Catalonia, Spain Educational Objectives: At the conclusion of this presentation, the participants should be able to demonstrate a deep understanding of the major causes of heterogeneity and variability of drug response in clinical practice, and in particular in the area of psychiatry. Purpose: To identify and summarize the main factors involved in drug response variability in patients with mental disorders, and its implications. Methods: A systematic review of the topic was carried out using “variability”, “drug response” and mental disorders” as PubMed key words. Results: The systematic review yielded 741 PubMed publications. After careful screening, 18 were considered truly relevant for the study purpose. The current evidence, based on the 18 selected publications, indicates that Psychiatry is an area with blurred borders between conditions and high variability of treatment response. Conclusions: Drugs do not have the same effects in all patients. Part of that variability may be genetically mediated and part may be environment-dependent. Psychiatry is an area of medicine where variability of drug response is particularly high. The results of clinical trials cannot be directly extrapolated to individuals. Even drugs with very similar mechanism of action may work differently in the same patient and the same drug may work differently in the same patient across different illness episodes. Drugs for psychiatric conditions cannot be judged exclusively based on their efficacy and tolerability. Stratification is needed in psychiatry to identify specific subpopulations that may be more or less responsive to given drugs.
Literature References 1. Vieta E, Pappadopulos E, Mandel FS, Lombardo I. Impact of geographical and cultural factors on clinical trials in acute mania: lessons from a ziprasidone and haloperidol placebo-controlled study. Int J Neuropsychopharmacol. 2011 Sep;14(8):1017–1027. 2. Vieta E. Personalized medicine applied to mental health: Precision psychiatry. Rev Psiquiatr Salud Mental, 2015, in press.
Uk Translational Medicine and Therapeutics (Tmat) Phd Training D.J. Webb Clinical Pharmacology Unit, University of Edinburgh, Edinburgh, UK Within the last 10 years, 2 major UK funding bodies (Medical Research Council [MRC] and Wellcome Trust) have supported clinical PhD programmes designed to build capacity in clinical pharmacology and therapeutics, focusing on the translational difficulties in
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The drug information centre in 2015 – still a valid concept? L.A. Reppe1,2; J. Schjøtt3; and O. Spigset2,4 1 Nord-Trøndelag University College, Steinkjer, Norway; 2 Norwegian University of Science and Technology, Trondheim, Norway; 3University of Bergen, Bergen, Norway; and 4St. Olav University Hospital, Trondheim, Norway Educational Objectives: Participants should be able to identify factors that may increase and/or decrease the quality of DICs’ written responses. Purpose: To assess the quality of written responses to drug-related queries, in order to identify factors increasing and/or decreasing their quality. Methods: During an 8-week period in 2013, 6 drug-related study queries were posed simultaneously by e-mail to 7 Scandinavian DICs. The DICs were informed about the study, but staff members were blinded in terms of which queries were study queries, as the study queries were sent from local general practitioners in their own names. Six general practitioners (external experts) and seven clinical pharmacologists (internal experts) assessed the responses individually using a registry form allowing qualitative assessment. Results: Responses were generally concordant in terms of professional content, but varied in terms of quality of references, advice and conclusions. In total, internal and external experts gave 334 comments. With 3 to 4 exceptions, the 42 responses were assessed as satisfactorily to good. Both expert groups were concerned with whether specific conclusions and/or advices were given, especially in patient-specific queries. Use of secondary and tertiary sources as references, as opposed to primary sources, was criticised by some experts. Conclusions: To our knowledge, this is the first study using qualitative data to identify factors increasing and/or decreasing the quality of DICs’ responses. The presentation of specific advices and conclusions seem to be especially important when responding to drug-related queries. The study has prompted discussions about quality of the written responses in the participating DICs, and the results may also attain a more general interest.
Impact of Bariatric Surgery on Drug Transport And Metabolism W. Siegmund Department of Clinical Pharmacology, University Medicine Greifswald, Germany Bariatric surgery often provides for patients with morbid obesity the only alternative to achieve sustaining weight loss and substantial improvement or remission of obesity related comorbidity. The surgical intervention as the Roux-en-Y gastric bypass technique leads to substantial anatomical and physiological changes associated with micronutrient deficiency and changes in pharmacokinetics of drugs. However, the changes are complex and poorly understood, and longlasting mucosal adaptation of intestinal functions may occur. Therefore, potential transcriptional and posttranscriptional adaptation mechanisms in the small intestine of patients with morbid obesity one year after RYGB surgery will be discussed, primarily with reference to intestinal drug metabolizing enzymes and drug
e168
transporters. Data are provided as obtained by genome-wide mRNA, microRNA, and targeted proteom analysis in the jejunum and by a pharmacokinetic study using probe drugs before and after bypass surgery. The results are compared with data obtained from healthy subjects (organ donors). There is evidence that multiple adaptation processes may compensate initial changes in drug absorption after bypass surgery.
Systematic Introduction of New Therapies Within The Stockholm County and The Karolinska University Hospital R.E. Malmström; and C.-O. Stiller Drug Safety and Evaluation Sector, Clinical Pharmacology, Karolinska University Hospital, SE-171 76 Stockholm, Sweden Ten years ago, a model for structured introduction of new medicines in Stockholm County was suggested as these were concluded to drive drug expenditures in years to come. The model is led by the Stockholm Drug and Therapeutics Committee and has since been stepwise implemented including a) horizon scanning and early drug evaluations, b) forecasting of drug expenditures, and c) projects to secure a structured introduction and follow-up of new medicines. Part of the model is currently a national collaboration, whereby a couple of counties contribute and all has access to the findings and deliverables. Meanwhile, at the Karolinska University Hospital, strategic funds can, when available, be claimed for new drugs or indications through the Hospital Medicines Council that provides a recommendation to the Priority Council of the Hospital Board. Pivotal questions that need to be addressed in connection with these requests include type of indication, estimated number of patients, evidence for efficacy (symptoms, quality of life, survival, biomarker, etc) and responder rate, cost per treated patient, and priority of the drug in national and international guidelines, by the pharmaceutical benefits agency, and by the Regional Drug and Therapeutics committee. Based on the above information, the Hospital Medicines Council review and propose horizontal prioritization of any strategic resources available to Priority Council to decide how these are keyed out on operations. Further, the prerequisites for structured introduction of new medicines include a description of the treatment decision process and follow-up procedures and a treatment decision protocol including clinical criteria to fulfill for treatment. Inclusion and exclusion criteria are selected according to pivotal documentation for the approved indication, steps to avoid indication drift and uncontrolled introduction with unclear benefits/safety at an early stage. A protocol for each patient is completed, signed, and sent to the Hospital Medicines Council for the go-ahead, and subsequent registration and monitoring of a continued rigorous implementation process.
Student-Led Education M.A. van Agtmael VU university medical center – Internal Medicine, Amsterdam, Netherlands Educational Objectives: After this presentation participants should be able to recognize the value of a new concept of education. Purpose: Pharmacotherapeutic skills are best learned in the context of clinical practice; learning by doing. By giving medical students responsibility and independence they will gain intrinsic motivation and this is associated with deep learning. Methods: Evidence to support the concept of student-led education is discussed in part 1 of the presentation. It is illustrated by the project “student-run clinic,” presented by a student in part 2.
Volume 37 Number 8S
Parallel Session Abstracts Results: Students reported improved skills and indicated that they had acquired knowledge they were unlikely to have gained elsewhere in the curriculum. The quality of specific aspects of care delivered by students was comparable with that of regular care. Conclusions: Students should take the lead in their own education, coached by the senior teacher. Medical students should be trained as professionals with responsibility for patient care.
chronic kidney disease (CKD), as well as for drug dosage adaptation. The prevalence of CKD is very high in the elderly, due to physiological aging of the kidney, to lifelong pathological insults, and to comorbidities. However, the GFR estimating equations, such as the Cockcroft-Gault, MDRD, and CKD-EPI equations, have not been developed specifically in elderly patients. The presentation will review the performances of the GFR estimating equations in studies which included elderly patients, and discuss which methodology should be preferred in this population.
Literature Reference 1. Learning in student-run clinics: a systematic review. T. Schutte ea. Medical Education 2015:49:249–263
Alert fatigue – an overdose of drug information? I.H. van der Sijs Erasmus University Medical Center, Rotterdam, the Netherlands Educational Objectives: At the end of this presentation, the participants should be able to explain what alert fatigue is, and what its causes and consequences are. Furthermore, they understand how both alert fatigue and potential measures to avoid it can be investigated. Purpose: Define alert fatigue, its causes, consequences and investigational challenges. Methods: Literature review, disguised observation, retrospective analysis of alert overrides, think-aloud study, chart review. Results: Alert Fatigue is the mental state that is the result from alerts consuming too much time and energy, which can cause relevant alerts to be unjustifiably overridden among clinical irrelevant ones. Unjustified overriding is a medication error that may result in adverse drug events, although this causal relationship has not been confirmed in studies yet. Alert fatigue is often caused by low specificity of alerts, but other error-producing conditions in the electronic prescribing system, insufficient training, and cultural aspects may also play a role. The optimal specificity and sensitivity are unknown, as are other aspects affecting alert fatigue. To investigate alert fatigue, override reasons are an important source of information, but often difficult to obtain. Clinical pharmacologists may play a role in determining cut-off points for alert generation. Conclusions: Alert fatigue is a ubiquitous problem and much is still unknown. To gain optimal benefit of electronic prescribing with clinical decision support, more research should be performed on this topic.
Literature References 1. Van der Sijs IH. Drug Safety Alerting in Computerized Physician Order Entry. Unraveling and Counteracting Alert Fatigue (PhD Thesis http://repub.eur.nl/pub/16936). 2. Coleman J et al. On the alert: future priorities for alerts in clinical decision support for computerized physician order entry identified from a European workshop. BMC. BMC Med Inform Decis Mak. 2013;13:111.
Renal Function In Older People - Validity of the Gfr-Estimating Equations And Implication for Clinical Practice E. Vidal-Petiot Department of Physiology – Hopital Bichat, Paris, France Glomerular filtration rate (GFR) is the best marker of renal function. Its evaluation is mandatory for diagnosis and classification of
August 2015
Variability In Drug Response and Clinical Reality: the Example of Psychiatric Diseases E. Vieta Hospital Clinic, University of Barcelona, IDIBAPS, CIBERSAM, Barcelona, Catalonia, Spain Educational Objectives: At the conclusion of this presentation, the participants should be able to demonstrate a deep understanding of the major causes of heterogeneity and variability of drug response in clinical practice, and in particular in the area of psychiatry. Purpose: To identify and summarize the main factors involved in drug response variability in patients with mental disorders, and its implications. Methods: A systematic review of the topic was carried out using “variability”, “drug response” and mental disorders” as PubMed key words. Results: The systematic review yielded 741 PubMed publications. After careful screening, 18 were considered truly relevant for the study purpose. The current evidence, based on the 18 selected publications, indicates that Psychiatry is an area with blurred borders between conditions and high variability of treatment response. Conclusions: Drugs do not have the same effects in all patients. Part of that variability may be genetically mediated and part may be environment-dependent. Psychiatry is an area of medicine where variability of drug response is particularly high. The results of clinical trials cannot be directly extrapolated to individuals. Even drugs with very similar mechanism of action may work differently in the same patient and the same drug may work differently in the same patient across different illness episodes. Drugs for psychiatric conditions cannot be judged exclusively based on their efficacy and tolerability. Stratification is needed in psychiatry to identify specific subpopulations that may be more or less responsive to given drugs.
Literature References 1. Vieta E, Pappadopulos E, Mandel FS, Lombardo I. Impact of geographical and cultural factors on clinical trials in acute mania: lessons from a ziprasidone and haloperidol placebo-controlled study. Int J Neuropsychopharmacol. 2011 Sep;14(8):1017–1027. 2. Vieta E. Personalized medicine applied to mental health: Precision psychiatry. Rev Psiquiatr Salud Mental, 2015, in press.
Uk Translational Medicine and Therapeutics (Tmat) Phd Training D.J. Webb Clinical Pharmacology Unit, University of Edinburgh, Edinburgh, UK Within the last 10 years, 2 major UK funding bodies (Medical Research Council [MRC] and Wellcome Trust) have supported clinical PhD programmes designed to build capacity in clinical pharmacology and therapeutics, focusing on the translational difficulties in
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