Assessment of clinical pharmacology and competence during medicine clerkships

Abstract

Safe and effective prescribing is a competency recognized in frameworks created by various countries for medical students entering clinical practice. Clinical pharmacology education, when aligned with competency‐based medical education (CBME), offers an opportunity to improve pharmacotherapeutic decision‐making and medication safety. This narrative review summarizes the current assessment methods used to evaluate clinical pharmacology competencies of undergraduate medical students during clerkships, including objective structured clinical exams (OSCEs), mini‐clinical evaluation exercises (mini‐CEX), case‐based discussions, and written and oral exams. While these assessments are commonly used, their application to evaluate competencies related to clinical pharmacology is limited. The review illustrates the need for a structured, multimodal approach to assessment that emphasizes frequent formative feedback in a longitudinal manner, observable behaviours or tasks, and the implementation of online educational resources developed to target these competencies. Developing and aligning clinical pharmacology assessments with clear, specified competencies during clinical clerkships can potentially promote learner confidence, knowledge and skills necessary to optimize patient‐centred care.

What is already known about this subject

• Safe and effective prescribing, which relies heavily on the knowledge and application of clinical pharmacology, is internationally recognized as a core competency for undergraduate medical education (UME) to mitigate medication errors and patient harm.

• There has been a shift from traditional education to competency‐based medical education (CBME) which advocates for frequent formative assessments on clinical behaviours and patient outcomes, but literature on the standardized approaches to assessments for clinical pharmacology during medicine clerkships is limited.

What this study adds

• This review examines the prevalence of assessment modalities during medicine clerkships on clinical pharmacology, evaluates the alignment with competencies pertinent for safe and effective therapeutic management, and summarizes the challenges and resources to address the need for standardized national assessments.

1. INTRODUCTION

Medication prescription errors are a global concern, ¹ , ² , ³ , ⁴ as over three million deaths occur annually due to patient harm, and half of the preventable cases is due to medications. ⁵ Recent medical school graduates are responsible for most of the prescriptions in the inpatient setting. ⁶ Based on a study conducted in over 20 hospitals in the United Kingdom, postgraduate doctors have an average prescribing error rate of 8.8%. ⁷ Medical residents at a paediatric clinic in the United States had an overall prescribing error rate of 5.88%; the error rate for paediatric, family medicine and internal medicine residents were 4%, 11% and 8%, respectively, with antimicrobials and topical medications being the most prescribed. ⁸ A cross‐sectional study in Mexico City determined that junior medical residents had a prescription error ratio of 45.1% on antibiotics; this was negatively correlated with clinical competence, such as a narrow understanding of the drug therapy, effect of patient factors and dosing calculations. ⁹ Overall, most of the final‐year medical students (61%) in the European Union share that they are fairly well prepared for prescribing rather than well or extremely well prepared because there were not enough opportunities to practise real‐life prescribing in clinical practice. ¹⁰ These findings allude to the significance of clinical pharmacology education during medical training to better prepare junior doctors, reduce preventable prescribing and medication errors, and improve patient safety.

Clinical pharmacology is a translational discipline where basic and applied pharmacology are used to develop patient‐centred therapeutic drug treatments, and its role in the medical curriculum is crucial to promote rational prescribing and medication safety. ¹¹ , ¹² The duration of medical education globally ranges from 4 to 6 years, and the level of integration between basic and clinical sciences varies as well. ¹³ In North America and Australia, students must complete 3–4 years of undergraduate education in college for a bachelor's degree before they can undergo 4 years of graduate allopathic or osteopathic medical training. ¹⁴ The medical curriculum is typically split into 2 years of didactic education, and 2 years of clerkships or clinical rotations, where they receive supervised medical training providing patient care in the clinical setting. ¹⁵

Medical students in the United States are often required to pass the United States Medical Licensing Examination (USMLE) Step 1 before they can progress to start clerkships. In contrast, medical students complete the Medical Council of Canada Qualifying Examination (MCCQE) Part 1 within their final year of medical school before they can start postgraduate training. ¹⁶ Australia does not have a similar board exam during medical school, but they implement Membership of the Royal Colleges of Surgeons (MRCS) and Membership of the Royal College of Physicians (MRCP) exams after graduating medical school. ¹⁷ The USMLE Step 1 focuses on the basic sciences where approximately 10–20% is on pharmacology, ¹⁸ whereas the MCCQE Part 1 has multiple choice questions as well as clinical decision‐making cases on pharmacology, anatomy, biochemistry, pathology and more. ¹⁶ Therefore, for traditional medical curriculum globally, pre‐clerkship years focus on pharmacology principles such as pharmacokinetics and pharmacodynamics in the classroom setting, while the clerkship years focus on the application of clinical pharmacology in healthcare settings.

In European countries, the medical curriculum starts right after high school, lasting 5–6 years, and varies greatly in terms of structure and duration. Some schools divide the curriculum traditionally into a 2‐year preclinical segment and a 4‐year clinical segment, while other schools have been pushing towards more integrated models. In the United Kingdom, medical students generally start clerkships in their third year whereas in Germany, clerkships start in their final year. ¹⁴ Medical students in the United Kingdom need to pass the Prescribing Safety Assessment (PSA), Situational Judgement Test (SJT) and Medical Licensing Assessment (MLA) Part 1 in their final year, ¹⁹ whereas in Germany, medical students need to take a state boards exam (Staatsexamen) on anatomy, organic chemistry and physiology before they can start the clinical segment. ¹³ Considering the earlier introduction of clinical clerkships and the focus on safe prescribing through the PSA, the medical curriculum in the United Kingdom incorporates clinical pharmacology concepts relatively earlier on to better integrate the basic sciences and clinical application.

To promote patient‐centred outcomes, there has been a general shift from the traditional process‐based approach to competency‐based medical education (CBME), which is learner‐centred and patient‐focused. ²⁰ The Association of American Medical Colleges (AAMC) advocates for curriculums to use their six foundational competencies for undergraduate medication education to develop frequent, multifaceted and formative assessments rather than infrequent, high‐stakes exams. However, there is no standardized recommendation for what types of assessments should be used, especially for medical students on clerkships where they are actively developing safe prescribing skills under supervision. ¹⁰ Although clinical pharmacology is essential for safe prescribing, there remains a gap between nationally recommended prescribing competencies and concerns about whether current assessments effectively and validly measure those competencies.

Because clinical clerkships are the first time medical students apply the pharmacology learned during preclinical years to the actual patient care setting, it is imperative to align assessment methods with clinical pharmacology competencies in a comprehensive and standardized manner. This is to ensure that students are being evaluated on the pertinent skills needed for safe and effective prescribing to prevent medication errors amongst new graduates. Bearing this in mind, this narrative review examines the assessment methods used for medical students on clinical pharmacology during clerkships, and their potential alignment with the competency frameworks.

2. METHODS

The initial literature search in PubMed for this narrative review employed a structured strategy based on the following key terms: Objective Structured Clinical Examinations, Mini‐Clinical Evaluation Exercises, Case‐Based Discussions, written examinations, oral examinations, competency, medical education, clinical clerkships or clinical years, prescribing, and pharmacotherapy or pharmacotherapeutics. Web of Science and Google Scholar were used to search for additional relevant articles, and publicly available data from the Association of American Medical Colleges (AAMC), Royal College of Physicians and Surgeons of Canada, General Medical Council (GMC) and Australian Medical Council Limited were reviewed. In accordance with the recommendations for a narrative review, the sampling process had at least one author review every identified abstract for inclusion, and the team of authors has diverse specialties and experiences in medical education, pharmacology, pharmacotherapeutics, assessments and literature review. ²¹

3. COMPETENCY‐Based Education Provides A Roadmap For Assessment

The traditional approach to medical education is discipline‐based, where subjects such as pharmacology, anatomy, physiology and biochemistry are taught independently as distinct courses during pre‐clerkship years. Because of the memorization‐focused nature of the basic science concepts, medical students have less time to develop relevant skills for their clinical clerkships. ²² Besides, studies found that when teaching a discipline in isolation, there were no long‐term effects on knowledge retention, and no direct correlation between understanding the basic sciences and applying the concepts during problem solving. ²³ Considering the importance of teaching the basic sciences within a clinical context, and reinforcing the content during the clinical years of clerkship, there has been a shift towards a competency‐based medical education (CBME) curriculum that uses a standardized framework of competencies to develop outcome‐based medical education. ²⁴ , ²⁵ The key components of CBME are teaching and assessment, and they work together to not only provide medical students with the knowledge and skills they need, but also ensure that they can effectively apply them competently in the clinical setting to promote quality patient care. ²⁶ By obtaining these competencies, rather than just achieving the bare minimum for acceptable performance, medical graduates will be able to implement them into practice consistently, increase medical sophistication and mastery, and further advance the healthcare of the community. ²⁷ , ²⁸

Globally, the common problems with irrational prescribing include ordering unnecessary or excessive medications such as antibiotics, and initiating multiple medications simultaneously, which can contribute to polypharmacy and adverse drug reactions. ²⁹ These outcomes can be improved through the implementation of CBME for medical students to accomplish competency in safe prescribing. ²⁹ A practical example of the effectiveness of the CBME is the Cologne Model Study Course in Human Medicine at the University of Cologne in Germany that increased awareness of the subject of General Practice amongst students via their curricular changes. ³⁰ The traditional, discipline‐based core curriculum was reduced in hours, and supplemented with patient‐related, interdisciplinary teaching on important symptoms and reasons for patient appointments through “competence areas” and “compulsory elective blocks”. Following the introduction of the new outcome‐based curriculum, students felt more confident initiating discussions on prescriptions, and experienced an enhanced awareness of patient participation and adherence improvement. Systematic reviews have also demonstrated the potential of patient simulations for pharmacotherapy education amongst various healthcare disciplines to develop competencies in pharmacotherapy evaluation and application skills, and enhance students' responsibility towards medication safety. ³¹

Based on an AAMC report on the diverse medical education models across 145 accredited medical schools in the United States and Canada, CBME is continuing to grow with new content areas focused on social and behavioural health, wellness, professional identity formation, population health, exam preparation and preparation for residency. ³² The Royal College of Physicians and Surgeons of Canada's CanMEDS Physician Competency Framework, however, defines the two to four key competencies with their respective enabling competencies for each of the seven roles: Medical Expert (integrates all the CanMEDS roles), Communicator, Collaborator, Leader, Health Advocate, Scholar and Professional. ³³ For the United Kingdom, the General Medical Council (GMC) published outcomes for graduates listing the knowledge, skills and behaviours that new medical graduates must demonstrate, along with a supplemental document focusing on practical skills and procedures. ³⁴ The three outcomes include: (1) professional values and behaviours, such as patient safety and leadership; (2) professional skills, such as diagnosis and prescribing medications safely; and (3) professional knowledge, such as illness prevention, clinical research and scholarship. As for Australia, the graduate outcomes for medical education are grouped into four domains similarly to the CanMEDS framework: (1) practitioner, who provides person‐centred care; (2) professional and leader, who provides care relevant to standards of clinical and cultural competence; (3) health advocate, who partners with patients and caregivers; and (4) scientist and scholar, who expands the scientific and medical knowledge through research and clinical practice. ³⁵

The characteristics of CBME Guides from CBME‐developed countries (United States, United Kingdom, Canada, Singapore, Netherlands) were analysed to inform the revision process for the CBME Guide in Japan, a CBME‐developing country. ³⁶ While the CBME Guides had many similarities in terms of structure and content, the review noted differences in the terminology and forms of expression, reflecting variations in national systems, cultures and customs. Of the five countries studied, the structure of the United States' CBME guide was found to be unique because of the 13 core Entrustable Professional Activities (EPAs) within the chapters, each functioning as a toolkit for an EPA, compared to other CBME guides which only illustrated the fundamental competency frameworks. The eight domains of competence for the United States include patient care, knowledge for practice, practice‐based learning and improvement, interpersonal and communication skills, professionalism, systems‐based practice, interprofessional collaboration, and personal and professional development. ²⁰

The competency‐based medical education (CBME) framework was originally developed in 1996 as the CanMEDS framework by the Royal College of Physicians and Surgeons of Canada to list requirements physicians need to meet to deliver appropriate health care. ³⁷ However, foundational competencies for undergraduate medical education (UME), such as formulating therapeutic management plans for commonly encountered clinical conditions, were only recently developed for medical schools in the United States by the AAMC in 2024. EPAs were traditionally used to list clinical activities that medical students need to perform upon entering residency. ³⁸ Although competencies have been the foundation for assessments in graduate medical education (GME), the use of EPAs made assessments more practical, and organized the critical competencies needed to develop proficient behaviours. The 13 EPAs are also tied with eight competence domains, which have been revised from the six domains in the original Accreditation Council for Graduate Medical Education/American Board of Medical Specialties (ACGME/ABMS) framework in 1999. ³⁶ For instance, EPA 4 signifies the ability to enter and discuss orders and prescriptions, and encompasses the domains of competence for patient care, practice‐based learning and improvement, interpersonal and communication skills, and systems‐based practice. ²⁰ Unlike the overarching foundational competencies, the critical competencies are specific and include gathering essential patient information, making informed therapeutic interventions, and conducting patient management plans that are consistent with practice guidelines. The CanMEDS Physician Competency Framework lists the key competency of performing a patient‐centred clinical assessment and establishing a management plan under the role of Medical Expert, whereas Australia's graduate outcomes for Domain 1 as a Practitioner include prescribing and administering medications “safely, appropriately, effectively, sustainably and in line with quality and safety frameworks and clinical guidelines”, especially for fluids, electrolytes, blood products and inhalational agents. ³³ , ³⁵ As for the United Kingdom's CBME guidelines, there are 15 skills thoroughly described in order to prescribe medications safely, such as establishing an accurate medication history, carrying out a risk–benefit assessment, calculating safe medication doses, writing a safe and legal prescription, detecting and reporting adverse reactions, and recognizing the challenges of safe prescribing for vulnerable populations. ³⁴ Assessments on the progress and achievement of these EPAs and competencies are especially important during clerkship years, where medical students are actively applying clinical pharmacology concepts into practice.

4. ASSESSMENTS DURING CLERKSHIPS

Structured assessments in a longitudinal manner across different areas of clerkships are important to measure the progress and growth of medical students, as well as the areas of improvement that need to be addressed to achieve the defined competencies. One‐time, high‐stakes assessments are limited in evaluating clinical competence because they are highly influenced by several external factors, such as subjective or biased differences in evaluators' judgement, variability in the complexity of non‐standardized patients, fears of repercussions or reluctance to assign a poor grade, and student stress that can negatively impact performance. ³⁹ Also, these traditional assessments mostly evaluate what the students have currently achieved, but do not reflect on their development, progression and potential for growth; per constructivist learning theory, the dynamic and reactive nature of assessment is crucial for learning. ⁴⁰ The implementation of a structured assessment approach through multiple low‐stakes assessments over time to evaluate competence is valuable because the correlation between knowledge and optimized application can be shifted as students' knowledge, skills and focus change with time. ³⁹ , ⁴¹ This affects the students' competence score or placement result, especially during clinical clerkship years, as the lack of comparable grading rubrics across the specialties within the same institution could lead to inaccurate assessment of students' competence. ⁴²

One common framework used to address clinical competence in medical education is Miller's pyramid. ⁴³ , ⁴⁴ Miller's pyramid organizes assessment based on levels of knowledge: “knows,” “knows how,” “shows how” and “does” (Figure 1). In this narrative review, we will discuss the use of clinical assessments within Miller's pyramid model: objective structured clinical examinations (OSCEs), mini‐clinical evaluation exercises (mini‐CEX), which is a workplace‐based assessment (WBA), case‐based discussions, which is an educational concept that can be used as formative assessment for WBA, written examinations, and oral examinations (Figure 1). Educational portfolios aim to assess student performance, and they are more commonly used in graduate medical education. For undergraduate medical education, its use focuses primarily on reflection, professionalism and attitudes. An example of educational portfolio is using a logbook during clerkships, but the limited studies reported difficulty in its application. ⁴⁵ , ⁴⁶ Programmatic assessment (PA) has been gaining popularity as a structured approach to review selected data points through different low‐stake assessments longitudinally to evaluate progression and outcomes and provide timely feedback to medical students. ⁴⁷ For instance, authors in Australia and the Netherlands have assessed competency based on the combination of 12 mini‐CEX, six case‐based discussions and 12 multisource feedback. ⁴⁸ However, due to its innovative nature, details on PA implementation to assess competency towards prescribing safely specifically is unclear. ⁴⁹

FIGURE 1.

Organization of assessment methods and educational strategies in medical education per Miller's assessment pyramid.* Listed assessment/educational strategy in their primary focus for clerkships, but can span across different levels of the pyramid.Modified from Australian Medical Council Limited. About workplace based assessment. Accessed July 12, 2025. https://www.amc.org.au/workplace‐basedassessment/about‐workplace‐based‐assessment/.

4.1. Objective structured clinical examinations (OSCE)

The OSCE has been a cornerstone of evaluating the skills and knowledge of medical students in a clinical setting during clerkships since its introduction in 1975. ⁵⁰ Per the AAMC, OSCE and standardized patient exams are the second‐most used skills assessment during clinical clerkship experiences in 2022. ⁵¹ They are easily reproducible with standardized grading rubrics, directly observed by faculty, and structured to encompass a variety of topics and themes across multiple stations. However, the OSCE focuses mostly on history taking, physical exam, physician–patient interactions and patient counselling, and may not accurately reflect the students' clinical reasoning abilities. ⁵² OSCEs allow students the opportunity to demonstrate specific skills, placing them in the “shows how” level of Miller's pyramid (Figure 1). With OSCEs, there is a potential to incorporate clinical pharmacology as a theme, and assess learners' skills that align with the CBME framework. The basic features of the OSCE such as the design, clinical significance and relevance to prescribing skills have been shown to be unique in three different settings across the world. ⁵⁰

The faculty at the department of medical education, therapeutics, and medicine in Scotland first developed OSCEs by having students rotate through several stations. The two types of stations include: (1) having students carry out a procedure based on the written formula such as conducting an auscultation or neurological exam over a span of 5 minutes, and (2) asking students open‐ended and multiple‐choice type questions about their findings and interpretations from the previous procedural station. Evaluators had a checklist to assess the procedure, and the questions were mostly written as “which of the following are true” questions. There was no correlation between student performance during traditional clinical exams in the hospital wards and their scores on a written multiple‐choice exam on medicine, surgery and therapeutics; however, a significantly high correlation was found between scores during OSCEs and the written exam. The authors felt that the examination can be used both as part of a final assessment and a process evaluation, such as appraising medical students at the end of each three‐month period during the clinical years of the undergraduate's course. The OSCE can provide feedback to staff and students to a greater extent, but limitations include the amount of preparation needed before and during the day of the examination. Another disadvantage is how this approach may silo students' ability to apply knowledge in compartments rather than treating the patient holistically. ⁵⁰

In Spain, it is compulsory for medical students to pass a final assessment of clinical skills using an OSCE prior to obtaining a degree in Medicine. The faculty of medicine at the University of Málaga have created prescribing stations for final‐year medical students at the end of the course to use their critical thinking skills to create a therapeutic plan with justification and write a prescription electronically. At the prescribing stations, students reviewed a clinical case along with the physical exam, laboratory findings and medication history, and examples of assessments include recommending an antihypertensive treatment, or selecting an appropriate antibiotic based on an antibiogram. The study over an 8‐year span revealed the OSCE's function of providing effective feedback and pinpointing specific areas of improvement. The therapeutics stations were feasible, useful for assessing prescribing skills and showing a proficient level of discrimination. The assessment had a positive impact on students' confidence in therapeutic areas such as the safe use of prescribing, and determined gaps such as selecting the appropriate analgesia, renally dose‐adjusting medications and discontinuing inappropriate or unnecessary medications. Because of the low scores in clinical judgement and therapeutic management competencies compared to those for communication and other technical skills competencies, further practice on prescribing was needed to address the disconnect between knowledge and application. ⁵³

OSCEs are competency‐based and encouraged as final assessments for medical students, but there are challenges towards implementing them, such as the amount of time and resources to develop the different stations and rubrics, and train the standardized patients. ⁵⁴ , ⁵⁵ This assessment must be carried out in a setting that is as realistic as possible, using resources such as actors or real patients, simulation mannequins, reports, images and more. Pharmacotherapy OSCEs may also entail testing technical skills such as parenteral drug administration on simulated patients with real vials of medication. By gathering results from the currently implemented OSCEs, professional organizations and stakeholders could also collaborate to develop national OSCEs appropriate for different levels of medical education to standardize the assessments and promote accessibility to resource‐limited institutions.

4.2. Mini‐clinical evaluation exercises (mini‐CEX)

The mini‐CEX is one of the most commonly used workplace‐based assessment (WBA) where medical students are directly observed to perform clinical tasks and evaluators provide immediate, structured feedback. ⁵⁶ These are examples of assessment at the “does” level of Miller's pyramid (Figure 1), because learners are observed in clinical practice during their clerkships. Using a 9‐point scale, evaluators in the United States rate third‐year students based on their patient interviewing, physical exam, professionalism, clinical judgement, counselling, organization and efficacy, and overall competence during the fifth out of the sixth week of inpatient psychiatry clerkship. ⁵⁷ The amount of time spent on observing the student interview and providing feedback was on average 15 minutes and 9.71 minutes, respectively, for the 113 patient encounters. The complexities of the patient problems varied from high to moderate, and mostly included major depressive disorder, delirium, bipolar disorders, substance abuse/dependence and psychotic disorders. The counselling component includes explaining the rationale for recommended tests or treatments, such as adherence to antidepressants and other medications like antihypertensives. This enables evaluators to assess clinical judgement and decision‐making related to medication selection, dose selection and monitoring parameters. Almost all the student feedback was positive regarding the satisfaction and usefulness of the mini‐CEX module, as ratings for the psychiatry clerkship increased from 4.5 to 4.9. Evaluators' experiences were particularly good in this educational curriculum, even when interviewing patients during a busy clerkship rotation. The mini‐CEX is a learning experience that gives the examiner an opportunity to appreciate the value of teaching patient‐centred care throughout medical student clerkship. It also gave evaluators the opportunity to guide the students on balancing structured clinical interviews, empathetic engagement and bedside manners. One of the two constructive feedback aspects was to provide students with more advanced notice of the mini‐CEX to give students ample time for preparation to have a better experience. The other one was to have the students reflect on their performance right after the interview, and before the evaluator provides feedback within the first week of the clerkship.

A randomized controlled study in Norway has conducted 160 mini‐CEX assessments, where each fifth‐year medical student completed an average of 8.4 assessments during their 16‐week clinical placement at six hospitals either in general medicine, general surgery and orthopaedics, or anaesthesiology. Students were evaluated based on six competencies using a nine‐point scale; they demonstrated professionalism frequently (98.8%), but performed counselling (31.3%) and clinical reasoning (48.1%) the least. Most of the students had either positive or very positive feedback on using mini‐CEX during clinical placement, and some shared that its implementation enforced clinicians to observe and provide feedback. Mini‐CEX was also easier to conduct in certain departments such as medicine rather than surgery, where unpredictable surgical schedules, sterile environment and fast‐paced environment can serve as barriers. However, only about 58% of students found the mini‐CEX to be useful or very useful; many commented that they want more feedback on areas of improvement because with only positive feedback, “it loses its purpose”. Although a preliminary 45‐minute orientation session was held at each hospital for clinicians to review a video recording, complete a mini‐CEX assessment and have a group discussion, some students perceived that their clinician did not have training on how to conduct the mini‐CEX or give feedback. Students thought that feedback from more experienced clinicians, such as specialty registrars and consultants, would be more effective. Also, many students found it difficult to find time to participate because the evaluators were often busy, and the average time spent on observation and feedback was 149 and 140 minutes, respectively. Unlike the previous study, student perceptions on the mini‐CEX were mixed, and could potentially be optimized with extended time for the assessment, adequate training for evaluators on how to provide valuable constructive feedback, and implementation of procedures to promote accessibility in specific departments. ⁵⁶

Formative assessments and feedback through mini‐CEX were effective in motivating medical students to engage in learning activities, significantly increasing direct observation by faculty, and improving OSCE scores. ⁵⁸ , ⁵⁹ The Association for Medical Education in Europe (AAME) Guide recommends having 15‐minute patient encounters and 5–10 minutes of structured feedback for undergraduate medical training using their 9‐point scale (1–3 is unsatisfactory, 4–6 is satisfactory and 7–9 is superior), with at least four encounters with different patients and evaluators to have a 95% confidence interval less than one. ⁵⁹ There were a few studies where students considered mini‐CEX to be time‐consuming and not valuable, but this could be because of the amount or quality of feedback. ⁵⁶ Effective feedback needs to be timely and specific, towards the needs of the students and clinical activities pertinent to that workplace. ⁵⁹ Faculty development is vital to ensuring the quality and effectiveness of formative assessment, and strategies to encourage faculty participation are critical to its successful implementation. There is potential to reform the mini‐CEX to include competencies in clinical pharmacology through advocacy for its adoption and support with adequate resources, funding, and training for evaluators. These competencies can be based on the British Pharmacological Society (BPS) curriculum learning objectives for clinical pharmacology and prescribing, such as evaluating the pharmacokinetics, dose calculations or drug interactions. ⁶⁰ Practical procedures can include administering oxygen, setting up peripheral intravenous access for an infusion, dosing and administering insulin with a sliding scale, and counselling patients on inhalers.

4.3. Case‐based discussions

Clinical case‐based learning (CBL) is an active learning technique where small groups of medical students work collaboratively during discussions, and apply foundational knowledge and clinical reasoning through discussions to address clinical cases that resemble real‐world scenarios. The facilitator would be the content expert who corrects misconceptions or redirects students to the focused learning objectives. CBL has been shown to promote academic performance, interest and motivation by fostering an engaging and collaborative environment without the pressure of potentially causing harm on actual patients. ⁶¹ The social constructs that develop in small group collaborative learning can enhance perceived learning which can be linked to improved motivation and engagement, inciting the practice of social constructivism and self‐determination theory. Both encapsulate the concepts of intrinsic and extrinsic motivation into autonomous (self‐determined) and controlled motivation.

A survey study on the fifth‐year undergraduate medical students on clerkship in Sudan uncovered that students perceived CBL to be helpful in retaining information, improving teamwork skills and enhancing clinical reasoning skills. ⁶² To promote accessibility, CBL implementation through online learning has been shown to improve flexible work–life balance and connection with learners. ⁶¹ In terms of its popularity, 125 (80.6%) medical schools in the United States have implemented the use of computer case simulations. ⁵¹ Based on a scoping review of 13 articles, online CBL has been implemented in medical education through video‐based group discussions on Zoom and Google Classroom stream; resources can also be shared through the university learning management system to promote group learning. The advanced multimedia content and interactive activities helped the students develop critical thinking and promote peer discussions amongst groups in different locations. CBL has been shown to promote diagnostic competencies and positive perceptions have been presented amongst final‐year medical students, ⁶² but there is limited literature on the implementation of clinical pharmacology.

Before starting clinical years, CBL is primarily used for the lower tiers of Miller's assessment pyramid to recall knowledge and apply it to specific scenarios (Figure 1). Two studies have implemented CBL on pharmacology using a clinical case, multiple choice questions and student‐led presentations amongst second‐year medical students in India, covering topics such as hypertension, anaemia, peptic ulcers and malaria. ⁶³ , ⁶⁴ A majority of students enjoyed this method of assessment and perceived that CBL helped them correlate pharmacology with clinical sciences and promote self‐directed learning. Students even shared that difficult pharmacology topics such as autonomic nervous system, central nervous system and cardiovascular system should be taught via CBL so that they can better retain the knowledge and apply the knowledge in the clinic. ⁶³ However, faculty need to be mindful that students who have yet to start clinical years may have difficulty understanding the clinical case vignette, and more time and interaction will be needed with faculty members. ⁶⁴ Otherwise, students will perform better with didactic lectures rather than with CBL.

For clinical experience years, CBL can also be imbedded with direct observation or simulated patient cases to demonstrate students' ability to perform and thus is used to assess higher levels of Miller's pyramid (Figure 1). One study implemented a 4‐week, virtual elective on the application of clinical pharmacology principles for fourth‐year medical students in the United States in collaboration with pharmacists, physicians and basic science faculty to promote medication safety and its cost‐effective use. ⁶⁵ After each week of didactics, students had to review case studies on adverse drug reactions, drug interactions, antimicrobial therapy, and undergo CBL on intravenous fluids, electrolytes and common medication errors while using the electronic medical record. Though the number of student responses to the post‐elective survey was low (n = 10), all medical students agreed that the elective has reinforced their knowledge and increase their confidence in prescribing because of the case studies. In Australia and Malaysia, third‐ to fifth‐year medical students undergoing clinical years completed tutor‐led, online CBL. ⁶⁶ Although details on how the CBL was led have not been mentioned, students shared that this learning strategy enabled them to develop their clinical reasoning skills in history taking, case discussions and management. The majority of students either agreed or strongly agreed that they were able to develop treatment plans while considering evidence‐based clinical guidelines, and sharing their knowledge and resources with peers. They also believe that its online use can overcome the barriers of clinical environments that have limited face‐to‐face interactions. These challenging clinical settings may include fast‐paced, acute care settings such as emergency medicine or surgery, as well as rural or underserved areas that may have fewer clinicians or resources available for direct bedside teaching.

With the inclusion of drug‐related problems, CBL has potential for alignment with clinical pharmacology competencies due to its learner‐centred approach, outcome objectives, application of critical thinking and feedback from facilitators and peers to promote learning. Compared to in‐person teaching, clinical‐year medical students have shared that CBL enabled them to practice by providing explanations to patients, engaging in more in‐depth discussions and receiving more comprehensive feedback on their clinical reasoning skills. ⁶⁶ Common barriers to its implementation in the clinical setting include lack of funding, technical difficulties and lack of support for learners. ⁶² Suggestions to overcome these barriers comprise of using smaller groups such as 4–5 students to encourage participation, designing clinical cases with clear learning and outcome objectives, and offering support to promote digital competency to maximize the online learning environment. As CBL cases may be simplified where they are not consistent with real‐life patients, one recommendation was to use recorded consultations between experienced clinicians and actual patients so students can further develop their clinical reasoning skills.

4.4. Written examinations

Written examinations can not only evaluate factual recall and “knows” on Miller's pyramid through multiple‐choice questions, short answers and essays, but also assess for the “knows how” using modified, case‐based essay questions that require application of knowledge in context (Figure 1). The National Board of Medical Examiners (NBME) in the United States provides Basic Science and Clinical Science Subject exams to medical students, with the former targetting at first and second‐year medical students, and the latter at third‐year medical students. Similar national licensing examinations are the Medical Licensing Assessment series in the United Kingdom and the Australian Medical Council Examinations in Australia. Clinical Science Subject exams from the NBME, also known colloquially as “shelf exams”, assess medical students' knowledge in their core clinical rotations. The scores allow for comparison with nationally representative groups taking the same exam. These exams are typically administered at the end of each 3–12‐week clinical rotation. ⁶⁷ These subject exams allow medical students to obtain a broader understanding of a wide variety of conditions in each specialty, encompassing rare and region‐specific conditions that may not be encountered in their clerkships due to time constraints. In addition, students are incentivized to learn about topics outside of those that directly affect their patients. ⁶⁸ Because clinical clerkship grades play an extremely significant role in the United States for residency applicant selection, students are motivated to secure favourable evaluations. ⁶⁹ If subjective examinations were removed and clerkship grades depend solely on the preceptors' clinical evaluations, students would only learn about topics that impact their patients rather than obtain a strong overall foundation in the clinical sciences like pharmacotherapeutics.

Students are assessed on their ability to form differential diagnoses, recommend and interpret common diagnostic and screening tests. ⁷⁰ These subject exams allow for an objective, standardized way to assess applicants' knowledge unaffected by purely clinical evaluations. One of the Basic Science Subject exams provided by the NBME is the Pharmacology Subject Exam, which covers general principles of foundational science and drugs used in all organ systems. ⁷¹ The most recent data from the Liaison Committee on Medical Education (LCME) questionnaire found that only 32 of 136 surveyed allopathic medical schools in the United States required the Pharmacology Subject Exam in 2012–2013. ⁷² In contrast, Clinical Science Subject Exams put greater emphasis on pharmacotherapy, intervention and management as well as adverse effects of drugs. However, while OSCE and mini‐CEX directly observe the thinking process and rationale through clinical reasoning, these written exams can only indirectly assess how students interpret data, identify the information and apply the knowledge to select the most appropriate treatment through multiple‐choice questions.

While these national exams measure general pharmacology knowledge, they do not provide explicit guidance on specific clinical pharmacology knowledge gaps or prescribing safety. The primary missing link between the NBME Pharmacology Subject Exam and the Clinical Science Subject Exams lies in the integration of basic pharmacology principles with their clinical application. Basic pharmacology alone does not provide the context of how drugs are used in real‐world clinical settings, including specific patient populations, disease states and co‐morbidities. On the other hand, the clinical exam necessitates an understanding of how patient‐specific factors such as age, pregnancy and renal or hepatic function can influence drug efficacy and safety. It also requires knowledge on how pharmacological principles are applied to diagnose and treat specific medical conditions. While pharmacology covers the mechanisms of action, pharmacokinetics and pharmacodynamics of drugs, the Clinical Science Subject Exam needs to assess how this knowledge translates into patient care, diagnosis and treatment decisions.

4.5. Oral examinations

Oral examinations are commonly used amongst medical graduates, but they are not consistently implemented amongst undergraduate medical education during clerkships. Studies have shown that oral examinations were an opportunity to evaluate the students' knowledge and clinical reasoning skills on the level of “knows how” in Miller's pyramid, and students felt that the exam was an educational experience that covered material from clerkship better than the written shelf exam. ⁷³

An institution in the United States implemented a structured oral examination for third‐year medical students on the final week of surgery clerkship covering high‐yield topics such as septic shock and upper gastrointestinal bleeding to assess history and physical exam, diagnostic workup, laboratory and radiographic interpretation, and diagnosis. ⁷⁴ Students received prior notice of the potential topics, viewed a video demonstration of a mock oral examination, and were required to complete two formative exam scenarios online via Zoom. This assessment provided valuable information, as the examination did not correlate to achieved NBME scores, indicating an evaluation of clinical knowledge in domains that were not assessed by other methods of clerkship evaluation. During the oral examination, medical students struggled the most with the development of treatment plans, and a statistically significant difference in the mean number of errors was evident compared to other assessment domains.

Structured oral examinations present a valuable opportunity to assess clinical pharmacology knowledge and therapeutic competency amongst medical students in ways not fully captured by other evaluation methods, as they are comparatively less resource‐intensive and can be completed in a remote learning environment. Oral exams offer an interactive experience wherein students can express their understanding of various concepts in diverse ways. The OSCE, mini‐CEX and written examination tools focus on assessing specific tasks in a controlled environment, whereas oral exams generally involve a free‐flowing conversation on a wide range of concepts. The conventional oral examination usually involves asking a few relevant questions in a noticeably brief period of time, and would need as much time to prepare, observe and grade as the OSCE.

5. PHARMACOLOGY ASSESSMENT METHODS IN MEDICAL EDUCATION

Literature on the direct assessment of clinical pharmacology in correlation to the competencies amongst clerkship‐year medical students is limited. As noted, there are a variety of assessment types that are focused on knowledge, history‐taking, diagnosis, communication and professionalism. However, based on the clinical specialty, there is potential to include clinical pharmacology as one of these categories in the United States. Assessments and feedback on clinical pharmacology are crucial to not only gauge the student's learning, but also reinforce the development of core competencies such as safe prescribing and therapeutic decision‐making; these can better ensure that the medical graduates have attained the required knowledge, skills and judgement needed to practise clinically and mitigate prescribing errors and adverse drug events in unsupervised environments.

Table 1 compares these assessments based on distinctive features, such as standardization and reproducibility, which is the consistency and objectivity for assessment to be administered and scored in the same way to ensure an accurate comparison of student performance. Clinical context authenticity is the ability to mimic real‐world patient care scenarios and situations to better prepare students for independent real‐world clinical practice without a preceptor. Direct observation refers to witnessing the student's performance to congregate data about their competence in the working environment. Immediate feedback is constructive information about the student's performance offered directly after the task has been completed to reinforce learning and allow students to correct any misconceptions quickly. Resource and time‐intensiveness refers to the need for resources such as personnel, materials, equipment, space and time to develop, implement and grade the assessment. The final three rows of the table determine in general whether the assessments can be used to evaluate the process of clinical reasoning and decision‐making, practical skills and broad theoretical knowledge during clinical years. The definitions are ability to evaluate: a student's ability to analyse clinical information, use evidence‐based clinical guidelines and patient factors to develop a rational decision at each step; hands‐on clinical skills, such as medication administration, dosage calculations and patient counselling; and student's understanding of fundamental principles and concepts over a diverse range of topics including rarely seen diseases, respectively.

TABLE 1.

Types of clinical assessments for pharmacotherapy.

	OSCE	Mini‐CEX	Written exam	Oral exam
Standardization and reproducibility	✓		✓✓
Clinical context authenticity	✓	✓✓
Direct observation and immediate feedback	✓✓	✓✓		✓
Resource and time‐intensive	✓✓
Assess the process of clinical reasoning and decision‐making	✓	✓		✓
Assess the practical skills	✓	✓
Assess the broad theoretical knowledge			✓

✓ Moderate presence of a feature.

✓✓ Strong presence of a feature.

The OSCE's strengths are its ability to directly observe student performance, provide feedback in a timely manner, build confidence in therapeutic areas, and align outcomes with competencies, especially in clinical judgement and therapeutic management ⁷⁵ (Table 1). The types of practical skills that can be assessed include patient counselling on medications, calculating drug doses for adult, paediatric and special populations, and identifying drug–drug interactions or adverse drug reactions. Due to the simulated nature, OSCEs provide a safe environment for medical students to practise prescribing and managing drug‐related problems, and develop their knowledge, skills and confidence before they experience those problems in real life. However, amongst the assessments examined in this narrative review, the OSCE would relatively be considered the most resource‐ and time‐intensive, as it may require a simulated hospital or pharmacy setting, adequate rooms or stations for a large number of personnel, equipment like stethoscopes, medication props or computers for e‐prescribing, and training for the evaluators and standardized patients; a significant amount of time is also spent on administrative tasks such as scheduling and communicating with the team, designing the patient scenarios and developing checklists and rubrics with experts. Another caveat is that although the OSCE cases provide some clinical context authenticity, they may be overly simplified and unable to truly mirror complicated patient scenarios in real life. ⁷⁵ Some solutions include using virtual platforms to mimic the telehealth setting to reduce the resources and promote ease of access for the standardized patients, as well as role‐playing with peers but at the cost of authenticity.

Like the OSCE, the mini‐CEX can also directly observe and provide feedback, assess the process of students' critical thinking for clinical reasoning and decision‐making, and assess practical skills. Mini‐CEX has the most authenticity in the clinical context with the use of real patient encounters and the extensive scope of problems to enforce the concept of how medicine involves navigating many nuances. Students and evaluators appreciated the mini‐CEX experience. ⁵⁷ Although it is not as resource‐intensive as the OSCE, mini‐CEX does require adequate time and support for evaluators to learn about the process, forms, key pearls that students should know regarding pharmacotherapeutics and prescribing safety principles, and optimal methods to ask students for their reflection and deliver constructive criticism, including specific areas of improvement. Time constraints are also of concern, especially in busy clinical settings and certain departments, as studies above demonstrated that interviews and feedback given over 10–15 minutes were more feasible compared to those given over 140–150 minutes. ⁵⁶ , ⁵⁷ The structured process provides some standardization, but because of the real‐world patient encounters and the subjectivity of evaluators' judgement, the variability makes it difficult for mini‐CEX to be fully standardized and reproducible (Table 1). Finally, students undergo the mini‐CEX for a limited number of patient encounters, and since it is recommended for them to interact with different patients and evaluators, it is important to emphasize the documentation and communication of student performance, encounters and progress, as well as encourage evaluators to focus mini‐CEX assessments on patients with complex medical history and medication regimens. Although some students prefer having advanced notice regarding their mini‐CEX activity, ⁵⁷ there are also strengths in unannounced mini‐CEX encounters to accurately assess their practical skills that they would have for any of their patients, and identify knowledge gaps and cognitive dissonance to promote learning.

As for written exams (e.g., the NBME shelf exams), they are standardized and reproducible to provide benchmarks for comparing student understanding and application, and identifying areas of improvement. They can also assess broad theoretical knowledge by encompassing a wide variety of patient scenarios and diseases that may be rare and difficult to encounter during clinical years (Table 1). However, the level of complexity in the cases may vary. Also, unlike the OSCE, mini‐CEX or oral exam, written examinations cannot assess the process of clinical reasoning and decision‐making because the scores only reflect the students' final decision rather than the rational process that led to the conclusion. It also cannot evaluate practical skills or communication regarding medications. Therefore, although written examinations motivate students to study diverse conditions and medications to perform well for residency and successfully practice in medicine, the medical curriculum needs to supplement them with other assessments such as case‐based discussions or simulations to evaluate the progress of achieving competencies and provide valuable timely feedback.

Oral examinations allow evaluators to provide some immediate feedback and explore students' clinical reasoning to a certain extent. Evaluators can tailor their questions to probe the students' understanding of complex concepts, challenge their understanding and critical thinking skills, and reveal more information about their decision‐making process regarding the medication selection, dosing considerations and monitoring parameters. While oral examinations are not standardized or reproducible due to variability in format, questions and scoring across evaluators and institutions, their flexibility and adaptability are its strength, allowing its use among different clinical settings and pharmacotherapeutic topics (Table 1). Structured oral exam formats with clear questions, scoring rubrics and training for evaluators could strengthen its objectivity and ability for accurate comparison amongst other students. If possible, multiple evaluators may be employed to cross‐reference scores and reduce evaluator bias. However, they cannot assess practical skills as seen from the OSCE and mini‐CEX, so to promote its clinical context authenticity, case‐based scenarios should be implemented for students to apply pharmacotherapeutic knowledge and solve medication‐related problems.

Overall, there are many challenges to implement effective and diverse assessments for medical students during their clerkship years, and match them to targeted competencies to ensure they are prepared for medical practice. Based on an international survey study on over 180 European Union medical schools, clinical pharmacology and therapeutics are taught primarily through lectures (91%) and self‐study (57–59%) rather than patient simulations (4–24%) and one‐on‐one teaching with a preceptor (2–10%); less than one‐third of the medical schools provided opportunities for students to practise prescribing in real patient care settings under supervision. ¹⁰ Time constraints are a key concern especially in the clinical years when students experience peak burnout rates, ranging from 40% to 80%. ⁷⁶ Beyond the standardized written examinations, scores on student performance are subject to variability because the evaluators may have unconscious bias, differing levels of training on the assessment and clinical experience, varying focuses and feedback based on their own areas of expertise, and difficulties completing the scoring consistently. With the different clinical settings and patient populations, standardizing assessments can be a challenge to ensure that all students achieve the same core competencies. ⁷⁷

The medical curriculum needs to be mindful when implementing diverse assessment strategies and identifying the ideal number of assessments, allocated hours and topics to ensure alignment with a broad range but specific list of learning objectives, EPAs and competencies. First, the core competencies should be clearly defined for all students to achieve, regardless of their core or elective clinical experiences. These competencies should be framed as EPAs to represent specific tasks that students should be able to perform independently prior to graduation. For example, to demonstrate an understanding of pharmacology and consider patient‐specific factors, students should complete the EPA of entering accurate and safe prescriptions. These EPAs could be applied to the different clinical settings. Then, structured checklists, forms and rubrics that focus on the EPAs should be developed and used consistently within the institution, so that students are assessed on the same skills during OSCE, mini‐CEX and oral examinations. Although the mini‐CEX have optimized clinical context authenticity and implemented direct observation of student performance, it should also be supplemented with simulations such as standardized patients to boost student confidence and exposure to important or rare scenarios, as well as less resource and time‐intensive assessments such as written and oral examinations. Training and support for the administrators, faculty, evaluators, staff and students, as well as frequent and accurate documentation are recommended to monitor student performance and progression throughout the clinical years, and ensure students have completed the required, minimum number of EPAs consistently. Finally, considering the difficulty of developing reliable assessment aligned with a competency framework for students in their clinical years, conducting a sound reliability analysis using Generalizability (G) theory to identify any issues with the assessments during clerkship is recommended. ⁷⁷

6. GLOBAL RESOURCES FOR DEVELOPING PRESCRIBING ASSESSMENTS

Further implementation of and research on assessments pertaining to clinical pharmacology and other domains are needed to develop a competency‐aligned framework. Multi‐modal use of formative assessments should ideally assess observable behaviours using real or simulated tasks and scenarios, as well as provide immediate and specific feedback. Competency in formulating therapeutic management plans for commonly encountered clinical conditions could be broken down into several specific competency areas, and tracked longitudinally across several clerkships.

In the United Kingdom, the Prescribing Skills Assessment (PSA) is a 2‐hour online standardized examination to assess prescribing competencies amongst final‐year medical students, and students pass the exam within their first year of practice after graduating. ⁷⁸ , ⁷⁹ This is the first national prescribing assessment that has been developed by the British Pharmacological Society (BPS) and Medical Schools Council (MSC); it has since been implemented voluntarily by all medical schools within the country for over 10 years. The PSA assesses eight sections: “prescribing, prescription chart review, planning management, providing important information, drug calculation skills, adverse drug reactions, monitoring therapy and data interpretation”. ⁸⁰ This examination can serve as a guide on what specific domains should be assessed, and how they can be mapped to different types of assessments so that faculty are better equipped with longitudinal data to assess medical students' competencies in clinical pharmacology. Written examinations may not be as effective to assess patient counselling on the medications and the thought process to drug selection, but may be more appropriate for assessing patient‐specific dose calculations and adjustments. Unlike the multiple‐choice, traditional written examinations mentioned above, the PSA is a simulation‐based assessment. For instance, during the prescribing section, medical students are presented with realistic patient cases, and then use free‐text entry to write a prescription for acute and chronic conditions, and provide the rationale for their selection. ⁸⁰ This requires clinical reasoning and judgement to write the most appropriate drug, formulation, dose, dosing interval, and even duration of treatment in certain scenarios for common indications, in contrast to traditional written exams that lack the simulation component. The curriculum should also take advantage of online databases and integrate the technology into the assessments. Australia has a National Prescribing Curriculum (NPC) that was developed in accordance with the principles of the World Health Organization's Guide to Good Prescribing as a framework and learning resource for safe prescribing ⁸¹ ; it is a free series of interactive case‐based modules targeting medical and pharmacy students, but can be used by any health professional student, so they can learn how to write an appropriate prescription through selecting the best drug therapy and developing pertinent patient counselling points. ⁸² , ⁸³ The 28 interactive, case‐based modules cover diverse topics such as cardiology, infectious disease, pain management and polypharmacy. Although the NPC is not mandatory nationwide, it is a great resource that medical schools can choose to implement within their curriculum. Medical schools can refer to the outlined key competencies related to prescribing, use the case‐based modules for self‐directed learning, or adapt and modify the modules tailored to other learning objectives and competencies to develop OSCEs and other case‐based learning assessments. ⁸⁴

Another interactive, online learning resource is Prescribe UK, which was developed by theBPS to target undergraduate medical students' knowledge and outcomes recommended by the General Medical Council to better prepare medical students for the Prescribing Safety Assessment. ⁸⁵ Similar to the NPC, the interactive and realistic case studies in Prescribe UK can be used as a formative assessment, as well as modified into a diverse range of assessments. The competencies developed by the Safe Prescribing Working Group include writing a safe and legal prescription, critiquing others' prescriptions and detecting and reporting adverse drug events. ²⁸ The limiting caveat would be that this supplemental resource is only free for students who are registered with universities within the United Kingdom or organizations affiliated with the National Health Service. ⁸⁵

7. CONCLUSION

Assessments in clinical pharmacology play a crucial role in ensuring medical students, particularly during clerkships, develop the necessary competencies to prescribe medications safely and effectively. This is especially critical given the significant role that safe prescribing and medication safety serve globally on preventing patient harm. The international shift towards CBME highlights the need for structured, competency‐aligned assessments that can effectively evaluate whether students achieve the expected outcomes. Various assessments, including OSCEs, mini‐CEX, case‐based discussions and written or oral exams, are widely utilized, but few directly assess clinical pharmacology competencies comprehensively. To address this gap, educational stakeholders should reassess the efficacy of the existing assessments, and align them to specific clinical pharmacology competencies recommended by national frameworks, such as applying patient‐specific pharmacotherapeutic recommendations, dosing, drug interactions and monitoring parameters. Leveraging established resources can enhance assessment practices by providing standardized and validated tools aligned with best practices. Future research and collaborative efforts are necessary to refine assessment modalities and establish their validity for effectively determining medical students' clinical pharmacology competencies in hopes of advancing the transition between basic and clinical sciences and for best healthcare outcomes.

AUTHOR CONTRIBUTIONS

The authors meet the criteria for authorship as recommended by the International Committee of Medical Journal Editors (ICMJE). The first draft of the manuscript was written by NCC and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

CONFLICT OF INTEREST STATEMENT

The authors declared no potential conflicts of interest with respect to the research, authorship and/or publication of this article.

DATA AVAILABILITY STATEMENT

The statement is unavailable since data were not used for narrative review.