Clinical Pharmacology And Therapeutics Research Articles

Activities of clinical pharmacologists across Europe: A survey by the European association of clinical pharmacology and therapeutics.

In order to explore clinical pharmacology and therapeutics (CPT) teaching and practices across continental Europe, the European Association of Clinical Pharmacology and Therapeutics (EACPT) made a survey in 2022 amongst its 27 affiliated societies. The survey was made available online to EACPT representatives, and 47 filled-in questionnaires were received from 25 countries (one to five per country), representing all geographic areas of Europe. Clinical pharmacologists (CPs) spend 25%, 30%, 15%, and 25% of their time in teaching, hospital activities, committees, and research, respectively, with large variations across and within countries. CPT courses are given at Schools of Medicine in all the countries except one, mostly organized and taught by medical doctors (MDs). In Central, Western, and Southern Europe, the teachers may have medicine or pharmacy training. Therapeutic drug monitoring and pharmacovigilance were the hospital activities most frequently reported, and clinical/forensic toxicology, rounds of visits, and pharmacogenetics the least. Two-thirds of the panel think CPs should be MDs. However, the transversal nature of CPT was underlined, with patients/diseases and drugs as gravity centres, thus calling for the complementary skills of MDs and PharmDs. Besides, most respondents reported that clinical pharmacists in their country are involved in rounds of visits, pharmacovigilance, TDM, and/or pharmacogenetic testing and that collaborations with them would be beneficial. CPT comes with a plurality of backgrounds and activities, all required to embrace the different pathologies and the whole lifecycle of medicinal products, but all of them being rarely performed in any given country. The willingness to use common CPT teaching material and prescribing exams at the European level is a good sign of increasing harmonisation of our discipline Europewide.

The European List of Key Medicines for Medical Education: A Modified Delphi Study.

Rational prescribing is essential for the quality of health care. However, many final-year medical students and junior doctors lack prescribing competence to perform this task. The availability of a list of medicines that a junior doctor working in Europe should be able to independently prescribe safely and effectively without supervision could support and harmonize teaching and training in clinical pharmacology and therapeutics (CPT) in Europe. Therefore, our aim was to achieve consensus on such a list of medicines that are widely accessible in Europe. For this, we used a modified Delphi study method consisting of three parts. In part one, we created an initial list based on a literature search. In part two, a group of 64 coordinators in CPT education, selected via the Network of Teachers in Pharmacotherapy of the European Association for Clinical Pharmacology and Therapeutics, evaluated the accessibility of each medicine in his or her country, and provided a diverse group of experts willing to participate in the Delphi part. In part three, 463 experts from 24 European countries were invited to participate in a 2-round Delphi study. In total, 187 experts (40%) from 24 countries completed both rounds and evaluated 416 medicines, 98 of which were included in the final list. The top three Anatomical Therapeutic Chemical code groups were (1) cardiovascular system (n = 23), (2) anti-infective (n = 21), and (3) musculoskeletal system (n = 11). This European List of Key Medicines for Medical Education could be a starting point for country-specific lists and could be used for the training and assessment of CPT.

Educating Medical Students on How to Prescribe Anti-Hyperglycaemic Drugs: A Practical Guide

In the light of the rapidly increasing global incidence of, and therapeutic arsenal for, diabetes type 2, this brief report underscores the need for advancements in clinical pharmacology and therapeutics (CPT) education with regard to diabetes type 2. We advocate for the comprehensive training of medical students and junior doctors in line with current guidelines, and emphasize the importance of teaching how to draw up individualized treatment plans based on patients’ specific risk factors and conditions, such as cardiovascular risks, weight, and risk of hypoglycaemia. Within the curriculum, traditional teaching approaches should be replaced by innovative methods such as problem-based learning, which has been shown to be more effective in developing prescribing knowledge and skills. The inclusion of real-world experience and interprofessional learning via so-called student-run clinics is also recommended. Subsequently, innovative assessment methods like the European Prescribing Exam and objective structured clinical examinations (OSCE) are highlighted as essential for evaluating knowledge and practical skills. By adopting these educational advances, medical education can better equip future practitioners to adequately manage the complex pharmacological treatment of diabetes.

The impact of a summative national prescribing assessment and curriculum type on the development of the prescribing competence of junior doctors

PurposeThe primary aim of this study was to investigate the effect of including the Dutch National Pharmacotherapy Assessment (DNPA) in the medical curriculum on the level and development of prescribing knowledge and skills of junior doctors. The secondary aim was to evaluate the relationship between the curriculum type and the prescribing competence of junior doctors.MethodsWe re-analysed the data of a longitudinal study conducted in 2016 involving recently graduated junior doctors from 11 medical schools across the Netherlands and Belgium. Participants completed three assessments during the first year after graduation (around graduation (+ / − 4 weeks), and 6 months, and 1 year after graduation), each of which contained 35 multiple choice questions (MCQs) assessing knowledge and three clinical case scenarios assessing skills. Only one medical school used the DNPA in its medical curriculum; the other medical schools used conventional means to assess prescribing knowledge and skills. Five medical schools were classified as providing solely theoretical clinical pharmacology and therapeutics (CPT) education; the others provided both theoretical and practical CPT education (mixed curriculum).ResultsOf the 1584 invited junior doctors, 556 (35.1%) participated, 326 (58.6%) completed the MCQs and 325 (58.5%) the clinical case scenarios in all three assessments. Junior doctors whose medical curriculum included the DNPA had higher knowledge scores than other junior doctors (76.7% [SD 12.5] vs. 67.8% [SD 12.6], 81.8% [SD 11.1] vs. 76.1% [SD 11.1], 77.0% [12.1] vs. 70.6% [SD 14.0], p < 0.05 for all three assessments, respectively). There was no difference in skills scores at the moment of graduation (p = 0.110), but after 6 and 12 months junior doctors whose medical curriculum included the DNPA had higher skills scores (both p < 0.001). Junior doctors educated with a mixed curriculum had significantly higher scores for both knowledge and skills than did junior doctors educated with a theoretical curriculum (p < 0.05 in all assessments).ConclusionOur findings suggest that the inclusion of the knowledge focused DNPA in the medical curriculum improves the prescribing knowledge, but not the skills, of junior doctors at the moment of graduation. However, after 6 and 12 months, both the knowledge and skills were higher in the junior doctors whose medical curriculum included the DNPA. A curriculum that provides both theoretical and practical education seems to improve both prescribing knowledge and skills relative to a solely theoretical curriculum.

Teaching resources for the European Open Platform for Prescribing Education (EurOP2E)—a nominal group technique study

The European Open Platform for Prescribing Education (EurOP2E) seeks to improve and harmonize European clinical pharmacology and therapeutics (CPT) education by facilitating international collaboration and sharing problem-based, online, open educational resources. The COVID-19 pandemic forced teachers to switch to virtual modalities, highlighting the need for high-quality online teaching materials. The goal of this study was to establish the online problem-based teaching resources needed to sustain prescribing education during the pandemic and thereafter. A nominal group technique study was conducted with prescribing teachers from 15 European countries. Results were analyzed through thematic analysis. In four meetings, 20 teachers from 15 countries proposed and ranked 35 teaching materials. According to the participants, the most necessary problem-based-online teaching materials related to three overarching themes. Related to learning outcomes for CPT, participants proposed creating prescription scenarios, including materials focusing on background knowledge and resources on personalized medicine and topical/ethical issues such as the prescription’s impact on planetary health. Second, related to teaching, they proposed online case discussions, gamification and decision support systems. Finally, in relation to faculty development, they recommend teacher courses, a repository of reusable exam questions and harmonized formularies. Future work will aim to collaboratively produce such materials.

The Impact of IL28B Gene Polymorphisms on Drug Responses

To achieve high therapeutic efficacy in the patient, information on pharmacokinetics, pharmacodynamics, and pharmacogenetics is required. With the development of science and technology, especially genetic sequencing technology, more and more research on pharmacogenomics has been conducted. The relationship between the genome and the response of a person to drugs is being explored to support personalized medicine, which shows efficacy in clinical treatment. In particular, the IL28B gene polymorphisms have been studied and shown to have impacts on drug responses in the treatment of many diseases, such as chronic hepatitis C, chronic hepatitis B, and myeloproliferative neoplasms. However, pharmacogenetic studies of the IL28B gene have not given exact recommendations for dose adjustment in treatment; they only show the impact tendency that individuals with an unfavorable genotype (usually the genotype of the mutant allele) show poor response to treatment compared to those with a favorable genotype. The frequency of mutant alleles varies among different ethnic groups and between different viral genotypes. Identifying and predicting the possibility of successful treatment helps both clinicians and patients make better choices of treatment decisions to optimize treatment possibilities, and reduce side effects and treatment costs.&#x0D; Keywords&#x0D; IL28B polymorphism, drug response, hepatitis C, hepatitis B, myeloproliferative disorders.&#x0D; References&#x0D; [1] V. M. Lauschke, M. I. 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Thuy et al., The Different Impacts of IL28B Genotype in Treatment Vietnamese Patients with Chronic Hepatitis C Genotype 1 and 6, Journal of Hepatobiliary Vietnam, Vol. 29, 2014, pp. 108-109 (in Vietnamese).&#x0D;  &#x0D;  &#x0D;  &#x0D;  

EurOP2E \u2013 the European Open Platform for Prescribing Education, a consensus study among clinical pharmacology and therapeutics teachers

PurposeSharing and developing digital educational resources and open educational resources has been proposed as a way to harmonize and improve clinical pharmacology and therapeutics (CPT) education in European medical schools. Previous research, however, has shown that there are barriers to the adoption and implementation of open educational resources. The aim of this study was to determine perceived opportunities and barriers to the use and creation of open educational resources among European CPT teachers and possible solutions for these barriers.MethodsCPT teachers of British and EU medical schools completed an online survey. Opportunities and challenges were identified by thematic analyses and subsequently discussed in an international consensus meeting.ResultsData from 99 CPT teachers from 95 medical schools were analysed. Thirty teachers (30.3%) shared or collaboratively produced digital educational resources. All teachers foresaw opportunities in the more active use of open educational resources, including improving the quality of their teaching. The challenges reported were language barriers, local differences, lack of time, technological issues, difficulties with quality management, and copyright restrictions. Practical solutions for these challenges were discussed and include a peer review system, clear indexing, and use of copyright licenses that permit adaptation of resources.ConclusionKey challenges to making greater use of CPT open educational resources are a limited applicability of such resources due to language and local differences and quality concerns. These challenges may be resolved by relatively simple measures, such as allowing adaptation and translation of resources and a peer review system.

Student selected components as an educational platform for teaching medical students about clinical pharmacology and quality improvement activities

Student selected components (SSCs) are increasingly described elements of medical undergraduate education, training and curricula. SSCs offer the potential for integration into both traditional (‘pre-clinical’ versus ‘clinical’) medical curricula, as well as into other innovative or evolving medical training curricula. This article employs a structured and descriptive approach to exemplify the process by which year 1 medical students were supported in a practical manner to undertake a distinct small group SSC project. In this illustration, the SSC was focused on a quality improvement (QI) topic of relevance to clinical pharmacology and therapeutics (CPT), and involved a review of the anticholinergic burden of inpatient prescriptions for a defined cohort. The SSC was completed in the context of a teaching hospital’s medicine of the elderly (MoE) clinical service. In a sequential manner, the paper describes experiential learning points from the perspective of a supervisor of an SSC project. The paper offers educational value with a potential for generalisable application to non-clinical and clinical educationalists. Furthermore, the paper offers guidance to supervisors, teachers, tutors and facilitators, with encouragement to consider how they may design similar projects for the training of undergraduate medical students in centres that they are affiliated with. The paper also highlights another key driver for productive SSCs i.e. the central principle of striving to promote projects and activities that support active student engagement, rather than merely passive inclusion.

Switching from a traditional undergraduate programme in (clinical) pharmacology and therapeutics to a problem-based learning programme

PurposeThe pharmacology and clinical pharmacology and therapeutics (CPT) education during the undergraduate medical curriculum of NOVA Medical School, Lisbon, Portugal, was changed from a traditional programme (i.e. discipline-based, lectures) to a problem-based learning (PBL) programme (i.e. integrated, case-based discussions) without an increase in teaching hours. The aim of this study was to investigate whether this change improved the prescribing competencies of final-year medical students.MethodsFinal-year students from both programmes (2015 and 2019) were invited to complete a validated prescribing assessment and questionnaire. The assessment comprised 24 multiple-choice questions in three subdomains (working mechanism, side-effects and interactions/contraindications), and five clinical case scenarios of common diseases. The questionnaire focused on self-reported prescribing confidence, preparedness for future prescribing task and education received.ResultsIn total, 36 (22%) final-year medical students from the traditional programme and 54 (23%) from the PBL programme participated. Overall, students in the PBL programme had significantly higher knowledge scores than students in the traditional programme (76% (SD 9) vs 67% (SD 15); p = 0.002). Additionally, students in the PBL programme made significantly fewer inappropriate therapy choices (p = 0.023) and fewer erroneous prescriptions than did students in the traditional programme (p = 0.27). Students in the PBL programme felt more confident in prescribing, felt better prepared for prescribing as junior doctor and completed more drug prescriptions during their medical training.ConclusionChanging from a traditional programme to an integrated PBL programme in pharmacology and CPT during the undergraduate medical curriculum may improve the prescribing competencies of final-year students.

Harmonizing and improving European education in prescribing: An overview of digital educational resources used in clinical pharmacology and therapeutics.

AimImprovement and harmonization of European clinical pharmacology and therapeutics (CPT) education is urgently required. Because digital educational resources can be easily shared, adapted to local situations and re‐used widely across a variety of educational systems, they may be ideally suited for this purpose.MethodsWith a cross‐sectional survey among principal CPT teachers in 279 out of 304 European medical schools, an overview and classification of digital resources was compiled.ResultsTeachers from 95 (34%) medical schools in 26 of 28 EU countries responded, 66 (70%) of whom used digital educational resources in their CPT curriculum. A total of 89 of such resources were described in detail, including e‐learning (24%), simulators to teach pharmacokinetics and/or pharmacodynamics (10%), virtual patients (8%), and serious games (5%). Together, these resources covered 235 knowledge‐based learning objectives, 88 skills, and 13 attitudes. Only one third (27) of the resources were in‐part or totally free and only two were licensed open educational resources (free to use, distribute and adapt). A narrative overview of the largest, free and most novel resources is given.ConclusionDigital educational resources, ranging from e‐learning to virtual patients and games, are widely used for CPT education in EU medical schools. Learning objectives are based largely on knowledge rather than skills or attitudes. This may be improved by including more real‐life clinical case scenarios. Moreover, the majority of resources are neither free nor open. Therefore, with a view to harmonizing international CPT education, more needs to be learned about why CPT teachers are not currently sharing their educational materials.

Concept of clinical pharmacology and therapeutics sensitization and training for interns

Background: Rational prescribing of the medicines is an essential skill required by all the doctors. Interns are not prepared or confident in rational prescription either because of inadequate training or knowledge is not retained by the time they come to internship or due to fast change in the concepts or protocols in pharmacology. The objectives of the study were to introduce and assess a short sensitization and training for interns regarding clinical pharmacology and therapeutics (CPT).Methods: It was a quasi-experimental type of interventional study done on 30 pediatrics interns. A short sensitization and training was given regarding CPT using flipped classroom model. Pre-test and post-test was conducted to know the effectiveness of the sensitization/training. Students’ opinion was also taken regarding the training and incorporation of similar training in other departments.Results: The mean percentage scores of the objective type questions in the pretest was 40.6±3.25 which increased significantly (p&lt;0.05) to 74±2.95 in post-test. The mean percentage scores of the problem solving type questions in the pretest was 30.78±5.25 which increased significantly (p&lt;0.05) to 65.21±4.65 in post-test.Conclusions: The sensitization and training was effective and there was overall satisfaction of conduct of such training among pediatrics interns. Further detailed research has to be conducted in different departments and faculties’ opinion regarding incorporation of CPT training and feasibility has to be considered before we recommend such training during internship.

Pharmacovigilance 2030: Invited Commentary for the January 2020 "Futures" Edition of Clinical Pharmacology and Therapeutics.

Pharmacovigilance 2030: Invited Commentary for the January 2020 "Futures" Edition of Clinical Pharmacology and Therapeutics.

Global Pharmacogenomics Within Precision Medicine: Challenges and Opportunities.

K.M.G. is a cofounder of Apricity Therapeutics, Inc. As Deputy Editor-in-Chief of Clinical Pharmacology & Therapeutics (CPT), K.M.G. was not involved in the review or decision process for this paper. M.S. is an unpaid member of numerous scientific advisory boards. A.R.S. receives compensation as a full-time employee of Regeneron Pharmaceuticals. M.V.R. receives investigator-initiated research funding from Servier. R.F.T. has consulted for Apotex, Quinn Emanuel, and Ethismos, is an unpaid member of numerous scientific advisory boards, and was an associate editor for CPT at the time of writing. R.F.T. was not involved in the review or decision process for this paper. The other authors declare no conflicts of interest. Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.

Interns perception towards pharmacology during clinical postings at RIMS, Raichur, India

Background: Every medical graduate must have the intention to prescribe rationally. It is pharmacology which teaches rational of prescribing of drug in undergraduate medical course. Therefore, many eminent medical educationists believe that pharmacology is the most essential part of the medical curriculum. Medical graduates join as interns in their respective teaching hospital immediately after graduation. Although interns work is usually under the supervision of a senior consultant but there are occasions, when they need to make their own decision. Internship is the intermediate period between under-graduation and general practice. The dexterity of health professional relies upon prescribing practices. Clinical pharmacology and therapeutics (CPT) is a crucial discipline for interns to acquire safe and rational prescription of drugs. This study was conducted with the intention to provide some light about the knowledge of pharmacology among the interns in RIMS Hospital Raichur, Karnataka.Methods: The study was done on interns of RIMS, Raichur. It was a descriptive questionnaire-based prospective study. A structured questionnaire modified from the work of Oshikoya et al, was used in the study which included four major categories namely basic demographic information, undergraduate CPT teaching, experience of adverse drug reaction (ADR) and any deficiency in the under-graduate CPT teaching.Results: Out of these 107 participants 54 (42%) rated pharmacology knowledge is good, while another 53(40%) had average understanding. As high as 80% (85) intern population feel that undergraduate training has prepared them to prescribe safely. 45 (41%) interns have already observed cases of adverse drug reactions in their short active clinical life.Conclusions: The present study has identified that pharmacology and therapeutics course curriculum is not enough to produce safe prescribers.

Curriculum development in undergraduate clinical pharmacology

Background Education in clinical pharmacology and therapeutics (CPT) is fundamental for the successful practice of medicine. Medical education is moving away from distinct pre-clinical/clinical phases and evolving curricula are largely integrated with early clinical experience. Integrated curricula require careful mapping of the different components to ensure coherent coverage of individual subjects. We developed a new Clinical Pharmacology, Therapeutics and Prescribing (CPTP) strand and mapped this onto the five year MBBS (Medicine and Surgery) degree programme at Newcastle University UK. This strand aimed to include more experiential learning to provide students with an experience which more closely mirrors the clinical workplace. Methods A range of new educational tools and strategies were developed and employed in the CPTP strand. These included flipped classroom sessions, team and case based learning, online quizzing, interprofessional education and high-fidelity simulation using the sophisticated virtual patient SimMan. SimMan simulations of medical emergencies were delivered both in the lecture theatre, and in an interprofessional education conference for pharmacy and medical students. At a series of key clinical points throughout each scenario the students are asked to vote on the most appropriate course of action (e.g. which drug should be administered). The option with the most votes is applied to SimMan and the students then observe the physiological effects this has in real time. Results Following CPTP strand implementation, overall student satisfaction with CPTP units was amongst the highest of any MBBS course, ranging from 90-97% satisfaction. Mixed method evaluation of simulations and interprofessional education activities highlighted high satisfaction and a vast range of knowledge (e.g. 'how to choose the right antibiotics for different scenarios') and skills gained (e.g. 'how to complete a prescription'), and reflections induced (e.g. 'importance of good communication in an interprofessional team). Conclusions Interprofessional education and simulation are educational approaches which can be used in early year undergraduate pharmacology education to contextualise the importance of basic pharmacology principles for clinical practice. These pedagogies enable students to develop clinical decision making, problem-solving, team-working and critical evaluation skills.

CYP2D6 and Endoxifen in Tamoxifen Therapy: A Tribute to David A. Flockhart.

This issue of Clinical Pharmacology & Therapeutics (CPT) includes the Clinical Pharmacogenetics Implementation Consortium (CPIC) guideline for using CYP2D6 genotyping to guide tamoxifen therapy for breast cancer patients. CYP2D6 metabolizes tamoxifen to its more active metabolite, endoxifen, and patients with reduced CYP2D6 activity have reduced circulating endoxifen concentrations. In this associated commentary, we recognize and honor the late Dr. David Flockhart, who began the research and made early fundamental discoveries on tamoxifen that have now resulted in this guideline.

Key Learning Outcomes for Clinical Pharmacology and Therapeutics Education in Europe: A Modified Delphi Study

Harmonizing clinical pharmacology and therapeutics (CPT) education in Europe is necessary to ensure that the prescribing competency of future doctors is of a uniform high standard. As there are currently no uniform requirements, our aim was to achieve consensus on key learning outcomes for undergraduate CPT education in Europe. We used a modified Delphi method consisting of three questionnaire rounds and a panel meeting. A total of 129 experts from 27 European countries were asked to rate 307 learning outcomes. In all, 92 experts (71%) completed all three questionnaire rounds, and 33 experts (26%) attended the meeting. 232 learning outcomes from the original list, 15 newly suggested and 5 rephrased outcomes were included. These 252 learning outcomes should be included in undergraduate CPT curricula to ensure that European graduates are able to prescribe safely and effectively. We provide a blueprint of a European core curriculum describing when and how the learning outcomes might be acquired.

Association between attendance and overall academic performance on a module within a professional pharmacy degree

Background and purposeAs the higher education (HE) classroom begins to adopt newer internet-based technologies, the relationship between attendance and performance needs to be re-evaluated, particularly for professional degree courses such as pharmacy. In the present study, we aimed to establish if an association exists between attendance at all timetabled classes and academic performance, in a Clinical Pharmacology and Therapeutics (CPT) module, as part of the Master of Pharmacy (MPharm) degree course at Ulster University. Educational activity and settingData on attendance, final examination and coursework performance were collected over two academic years (2013–14 and 2014–15) of the CPT module at Ulster. In total 67 students were analysed. The MPharm degree at Ulster University implements an attendance policy, both as a pastoral support tool and to reinforce the need for professional conduct as a pharmacist. FindingsStudent (2013–14 and 2014–15, n = 35 and 32, respectively) attendance on the module across both year groups was approximately 80%. We observed positive, and statistically significant relationships between attendance and performance on the examination, and especially in the coursework elements of the module. Student failure (below 40%) in the final examination was linked to attendance below an 80% threshold in nine of 12 cases. Reasons for not attending class varied, but illness was unquestionably the most commonly cited extenuation. DiscussionTaken together, these data confirm a convincing association between student attendance and academic achievement. SummaryOur studies promote the use of attendance monitoring policies for professional degree courses such as pharmacy.

Peer Review Certifies Quality and Innovation in Clinical Pharmacology &amp; Therapeutics

Clinical Pharmacology & Therapeutics (CPT) is an established voice of the discipline, a trusted source of new knowledge showcasing discovery, translation, and application of novel therapeutic paradigms to advance the management of patients and populations. Identifying, evaluating, prioritizing, and disseminating the best science along the discovery-development-regulatory-utilization continuum are responsibilities shared through peer review. To enhance the uniformity of this essential component of quality assurance and innovation, and maximize the value of the journal and its contents to authors, reviewers, and the readership, we review key concepts concerning peer review as it specifically relates to CPT.

Pharmacology and Therapeutics Education in the European Union Needs Harmonization and Modernization: A Cross-sectional Survey Among 185 Medical Schools in 27 Countries.

Effective teaching in pharmacology and clinical pharmacology and therapeutics (CPT) is necessary to make medical students competent prescribers. However, the current structure, delivery, and assessment of CPT education in the European Union (EU) is unknown. We sent an online questionnaire to teachers with overall responsibility for CPT education in EU medical schools. Questions focused on undergraduate teaching and assessment of CPT, and students' preparedness for prescribing. In all, 185 medical schools (64%) from 27 EU countries responded. Traditional learning methods were mainly used. The majority of respondents did not provide students with the opportunity to practice real‐life prescribing and believed that their students were not well prepared for prescribing. There is a marked difference in the quality and quantity of CPT education within and between EU countries, suggesting that there is considerable scope for improvement. A collaborative approach should be adopted to harmonize and modernize the undergraduate CPT education across the EU.