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Introducción: En Cuba han existido varias concepciones sobre planes de estudio. La necesidad de revisar y proponer cambios que aseguren los niveles de calidad deseados en el proceso de formación integral de los futuros profesionales motivó a investigar los elementos teóricos y metodológicos que regulan y orientan el proceso de enseñanza-aprendizaje en la asignatura Farmacología Clínica. Objetivo: Analizar el programa de Farmacología Clínica del plan de estudio E para la carrera de Medicina desde un enfoque crítico y sistematizado. Métodos: Se realizó un estudio cualitativo del programa de estudio de la asignatura Farmacología Clínica según el plan E, vigente en la Universidad de Ciencias Médicas de Santiago de Cuba, durante el 2022, para lo cual se utilizaron los métodos de revisión documental, los documentos rectores del proceso docente en la educación superior y la metodología propuesta por algunos autores. Resultados: Varios temas enunciaban un número excesivo de objetivos específicos sin tener en cuenta el nivel de asimilación; la forma de organización de la enseñanza más utilizada fue la conferencia. En las evaluaciones frecuentes no se tuvo en cuenta el trabajo investigativo independiente; en tanto, la bibliografía básica correspondió a una edición del 2002. Conclusiones: El programa no requirió trasformaciones temáticas, pero desde el punto de vista didáctico deben modificarse componentes del proceso de enseñanza-aprendizaje y, además, se debe actualizar la bibliografía básica pertinente.
Introduction: In Cuba several conceptions have existed on the study plans. The necessity to revise and propose changes that assure the levels of quality wanted in the process of integral formation of the future professionals motivated to investigate the theoretical and methodological elements that regulate and guide the teaching-learning process in the Clinical Pharmacology subject. Objective: To analyze the program of Clinical Pharmacology of the E plan study for the medicine career, from a critical and systematized approach. Methods: A qualitative study of the study program in the Clinical Pharmacology subject was carried out according to the E plan, effective in the University of Medical Sciences in Santiago de Cuba, during 2022, for which the methods of documental review, the rector documents of the teaching process in higher education and the methodology proposed by some authors were used. Results: Several topics enunciated an excessive number of specific objectives without taking into account the level of assimilation; the form of organization most used in teaching was the conference. Independent investigative work was not taken into account in frequent evaluations; meanwhile, the basic bibliography corresponded to an edition from 2002. Conclusions: The program did not require of thematic transformations, but from the didactic point of view components of the teaching-learning process should be modified, besides updating the pertinent basic literature.
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Antibody-drug conjugates (ADCs) are conjugated by a linker between an antibody drug targeting a specific antigen and a payload, such as a small cytotoxic drug. ADCs combine the potent killing effect of traditional small cytotoxic drugs with the tumor targeting property of antibody drugs. As of February 2022, the U.S. Food and Drug Administration (FDA) had approved 12 ADC antitumor agents. Based on the analysis of clinical pharmacology review reports of approved ADC drugs combined with relevant guidelines, it is found that in the development of ADC, in addition to the general research in clinical pharmacology, there are special considerations in dose selection and dose modification for special population due to the special anti-tumor mechanism of ADC. It is hoped that this paper will be enlightening to domestic researchers when developing ADC.
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Background: This comparative efficacy quantification research between metformin monotherapy and metformin combination therapy, and the subsequent systematic review, along with a consecutive meta-analysis of the different as well as wide-ranged study literature on oral hypoglycemic application rationality of metformin pharmacotherapeutics were performed, for a better comprehension of multicenter maintenance of rational pharmacotherapeutic aspects in the regular antidiabetic mono- and combination therapies prescribed to the new Type II diabetic patients. Aim and Objective: This clinical research study was conducted with the objective for a comparative quantitative evidence-based chronopharmacological efficacy research between metformin monotherapy and metformin combination therapy, and a systematic review, along with an accompanying meta-analysis, on the application rationalities of metformin pharmacotherapeutics. Materials and Methods: In this comparative quantitative evidence-based chronopharmacological efficacy research study, 100 patients suffering from newly detected early moderate grade Type II diabetes mellitus, were allotted into Group A consisting of 50 patients and Group B consisting of 50 patients. The Group A patients were prescribed the anti-diabetic treatment of orally administered metformin 500 mg, to be taken once daily for a span of 30 days, as metformin 1st line (only) monotherapy. The Group B patients were prescribed an oral hypoglycemic drug other than metformin, as 1st line anti-diabetic treatment, for the 1st 30 days, and then these Group B patients were gradually transferred to oral metformin combination therapy with another oral hypoglycemic drug, as metformin 2nd line (only) combination therapy, for the next 30 days. The derived study findings of comparative percentage efficacy quantification were statistically analyzed, on the basis of comparison between both the deduced results, for obtaining the comparative quantitative evidence-based chronopharmacological efficacy between metformin monotherapy and metformin combination therapy. Systematic review as well as meta-analysis is clinical research methods, comprising of a detailed, systematic and interpretative method of collecting, assessing and synthesizing the various medical evidences, to elaborate the research solution to a well-defined research question, in the form of a well-structured qualitative research review as well as quantitative analytical interpretations. Results: In this study, it was derived that the evidence-based chronopharmacological comparative percentage efficacy quantification of anti-diabetic metformin treatment showed 53% of percentage efficacy, when metformin was administered as 1st line (only) monotherapy, and 47% of percentage efficacy, when metformin was administered as 2nd line (only) combination therapy, with other oral hypoglycaemic drugs, prescribed in diabetes mellitus type II treatment regimens. The systematic review as well as meta-analysis in this study deduced 2482 refined, and also relevant, medical research database records, from total 3211 medical research database records, with a comprehensive qualitative and quantitative research database analyses. Conclusions: In this study, it was concluded that there was a slightly greater pharmacological efficacy of metformin 1st line (only) monotherapy than metformin 2nd line (only) combination therapy. The systematic review as well as meta-analysis derived a refined and conclusive medical research analysis, which was qualitatively synthesised, along with quantitative interpretations, on the various application rationalities of metformin pharmacotherapeutics.
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ABSTRACT Background: Sustained virologic response (SVR) rates after directly acting antivirals (DAAs) for hepatitis C virus (HCV) exceed 95%. This encouraged policymakers to put plans to achieve HCV elimination by 2030. The remaining percentage of non-SVR12 can affect HCV eradication strategies in the real-world especially the compliance of large numbers of treated persons to follow up for assessment of virologic response cannot be guaranteed. Objective: We aimed to assess predictors of failure to achieve SVR after receiving sofosbuvir plus NS5A inhibitor as an important step towards achieving better HCV eradication strategies. Methods: During the period from 1st November 2018 to 1st November 2019, 1581 treatment-naive patients received sofosbuvir plus daclatasvir ± ribavirin at our unit and 10 patients were referred to us with HCV relapse after the same regimens. A total of 163 out of the 1581 patients were lost for follow-up before assessment of virologic response and excluded from the analysis. 20 out of the remaining patients failed to achieve SVR12. Data from the 30 patients with non-SVR12 were included in the case-control analysis. Results: Every unit increase in estimated creatinine clearance using modification of diet in renal disease study (MDRD) score, total bilirubin, and INR was associated with 1.03, 13.92, and 80.08 times greater odds of non-SVR12 (P<0.001, P=0.0016, P=0.02) respectively. The presence of liver cirrhosis on ultrasonography increases the odds by 10.03. (P=0.009). Conclusion: Higher MDRD score, INR, total bilirubin, and presence of sonographic features of liver cirrhosis are predictors of failure to achieve SVR12 using sofosbuvir plus NS5A inhibitor.
RESUMO Contexto: As taxas de resposta virológica sustentada (SVR) após ação direta de antivirais (DAAs) para o vírus da hepatite C (VHC) excedem 95%. Isso encorajou os formuladores de políticas a colocar planos para alcançar a eliminação do VHC até 2030. O percentual remanescente de não-respondedores pode afetar as estratégias de erradicação do VHC no mundo real, especialmente a conformidade de um grande número de pessoas tratadas para acompanhamento para avaliação da resposta virológica não pode ser garantida. Objetivo: Nosso objetivo foi avaliar os preditores de não atingir o SVR após receber o inibidor sofosbuvir mais NS5A como um passo importante para alcançar melhores estratégias de erradicação do VHC. Métodos: No período de 1º de novembro de 2018 a 1º de novembro de 2019, 1581 pacientes receberam sofosbuvir mais daclatasvir ± ribavirin em nossa unidade e 10 pacientes foram encaminhados por recaída do VHC após os mesmos regimes. Um total de 163 dos 1581 pacientes foram perdidos para o acompanhamento antes da avaliação da resposta virológica e excluídos da análise. 20 dos demais pacientes não conseguiram a resposta virológica sustentada (SVR12). Os dados de 30 pacientes com não SVR12 foram incluídos na análise caso-controle. Resultados: Cada unidade aumentada no clearence estimado de creatinina usando o escore do estudo Modificação da Dieta em Doença Renal (MDRD), bilirrubina total e INR foram associadas a 1,03, 13,92 e 80,08 vezes maiores chances de não-SVR12 (P<0,001, P=0,0016, P=0,02) respectivamente. A presença de cirrose hepática na ultrassonografia aumenta as chances em 10,03. (P=0,009). Conclusão: Maior escore de MDRD, INR, bilirrubina total e presença de características sonográficas de cirrose hepática são preditores de falha na realização do SVR12 utilizando o inibidor sofosbuvir mais NS5A.
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As the number of novel coronavirus disease (COVID-19) continues to increase, the medical situation is still critical, and potential therapeutic drugs, vaccines and stem cell replacement approaches are emerging. Chloroquine has shown better clinical antiviral efficacy than lopinavir/litonavir (clazidine) in clinical trials of small sample size. Since pharmacological action mechanism of hydroxychloroquine is similar with chloroquine and hydroxychloroquine is safer than chloroquine in the treatment of malaria and immunological diseases, the clinical pharmacology characteristics of hydroxychloroquine was reviewed, hoping to provide theoretical support for clinical effect verification of hydroxychloroquine from the perspective of clinical pharmacology and quantitative pharmacology.
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The 2019 new coronavirus pneumonia (COVID-19) caused by the new coronavirus (SARS-Cov-2) infection has become a global pandemic, and currently there is a lack of specific antiviral drugs. Traditional Chinese medicine plays a critical role in the treatment of COVID-19. Scutellaria baicalensis is an important component of the Qingfei Paidu decoction recommended in the Chinese National Health Commission's Treatment Regimen and Wuhan Xiehe No.2 and No.3 prescriptions as well. Baicalein is the main ingredient in Scutellaria baicalensis, and has various pharmacological effects such as antiviral, antibacterial, antiallergic, and immunomodulatory activities, showing a broad prospect in new drug development. This article systemically reviewed the recent progress in the preclinical and clinical studies, potential drug interactions, and other aspects of baicalein, which will help further development and clinical application of the drug.
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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.
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Introducción. Se plantea la necesidad de conocer cuánto y qué se investiga en farmacología pediátrica en Argentina y determinar las diferencias con la población adulta. Objetivos. Comparar ensayos clínico-farmacológicos pediátricos y de adultos en relación con número, fases, diseños (utilización de placebo como comparador, proporción de ensayos ciegos/abiertos), enfermedades investigadas. En pediatría: determinar si las patologías investigadas coinciden con las principales causas de mortalidad infantil en Argentina. Métodos. Estudio analítico, observacional, transversal, realizado en la Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT), que incluyó ensayos autorizados entre 2011 y 2014. Resultados. Sobre 614 estudios, 552 (90 %) fueron de adultos y 62 (10 %), pediátricos. La fase III fue la más frecuente en adultos (77 %) y pediatría (69 %). En relación con los diseños: se usó más placebo en adultos (49 %) que en pediatría (31 %) y hubo mayor cegamiento en adultos (74 %) que en pediatría (58 %). Patologías más investigadas: en adultos, fueron tumorales; en pediatría, respiratorias y enfermedades del sistema osteomuscular y tejido conjuntivo. En pediatría, no hubo correlación entre las patologías y las causas de mortalidad infantil. Conclusiones. 1) Hubo más estudios en adultos que en niños; 2) La fase más frecuente fue la III; 3) Hubo diferencias en el diseño de los estudios entre ambas poblaciones; 4) Las patologías investigadas fueron diferentes en cada población; 5) En pediatría, no hubo correlación entre las enfermedades y las principales causas de mortalidad infantil en Argentina.
Introduction. It is necessary to know the extent and subject matter of pediatric clinical drug research in Argentina and establish the differences with the adult population. Objectives. To compare adult and pediatric clinical drug trials in terms of number, phase, design (placebo as control, proportion of blind/open-label trials), studied diseases. Specifically in pediatrics, to determine if studied diseases are consistent with the leading causes of infant and child mortality in Argentina. Methods. Analytical, observational, crosssectional study conducted at the National Drug, Food and Technology Administration of Argentina (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica, ANMAT) in trials approved between 2011 and 2014. Results. Out of 614 trials, 552 (90 %) were done in adults and 62 (10 %), in children. Phase III studies predominated in both adults (77 %) and children (69 %). In relation to study design, placebo control (49 %) and blinding (74 %) were more common in adults compared to children (31 % and 58 %, respectively). The most frequently studied diseases were tumors in adults and respiratory, musculoskeletal and connective tissue diseases in children. No correlation was observed between studied diseases and infant and child mortality. Conclusions. 1) More studies were done in adults than in children; 2) most studies corresponded to phase III; 3) differences in study design were observed between children and adults; 4) studied diseases were different in each population; 5) in pediatrics, no correlation was observed between the studied diseases and the leading causes of infant and child mortality in Argentina.
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Humans , Pharmacology, Clinical , Clinical Trial , Pediatrics , Argentina , Cross-Sectional StudiesABSTRACT
Digital therapeutics (DTx) is a new subsection of digital health that is primarily driven by software and will be of great interest to clinical pharmacologists. In this article, an overview of DTx, including definition, position in the landscape of therapeutics, product categories, benefits, and challenges, is provided. Discussions from the point of view of clinical pharmacology are presented, as DTx should have exposure-response relationships. The principles of clinical pharmacology can be applied to DTx as they are comparable to pharmacotherapy. Clinical pharmacology has great potential in the development, application, and regulation of DTx.
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Delivery of Health Care , Drug Therapy , Pharmacology, ClinicalABSTRACT
A multi-style collective lesson preparation model was designed and implemented after analyzing the current status of teaching faculty in the teaching and research section of clinical pharmacology,which includes hierarchical collective lesson preparation and exploration of WeChat collective lesson preparation; enrichment of the lesson-preparation content,bringing teaching skills,teaching strategies,courseware design and motivation of students' interest into collective lesson preparation.After carrying out this model,the construction of teaching faculty has been strengthened and the improvement of young teachers has been accelerated.At the same time,the procedures of collective lesson preparation should be made clearer and teachers' performance evaluation should include the assessment result of implementing this model so as to standardize the multi-style collective lesson preparation model.
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A multi-style collective lesson preparation model was designed and implemented after analyzing the current status of teaching faculty in the teaching and research section of clinical pharmacology,which includes hierarchical collective lesson preparation and exploration of WeChat collective lesson preparation; enrichment of the lesson-preparation content, bringing teaching skills, teaching strategies, courseware design and motivation of students' interest into collective lesson preparation. After carrying out this model, the construction of teaching faculty has been strengthened and the improvement of young teachers has been accelerated. At the same time, the procedures of collective lesson preparation should be made clearer and teachers' performance evaluation should include the assessment result of implementing this model so as to standardize the multi-style collective lesson preparation model.
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Background: Knowledge of pharmacology forms the basis of rational pharmacotherapy practice. Teaching the medical students about systematic application of pharmacology in patients’ care forms an essential component. It facilitates the medical students to develop a methodical approach in solving patients’ clinical problems.Methods: A questionnaire-based study was conducted, at Government Medical College Rajnandgaon involving second year MBBS students. Total 100 students participated in the study.Results: Hundred percent of the students responded that pharmacology was presently taught to them, seventy nine percent of them agreed with the fact that pharmacology was preferred to pass the MBBS, eighty eight percent of them responded that in pharmacokinetics was the least preferred topic, ninety seven of them were not aware of the essential drug list. Their suggestions regarding the change in teaching methodology was recorded.Conclusions: This study concludes that efforts are needed to develop a curriculum that encompasses important aspects of clinical pharmacology and therapeutics along with incorporation of the useful suggestions by the undergraduate students.
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Appropriate prescription writing is one of the critical medical processes affecting the quality of public health care. However, this is a complex task for newly qualified intern doctors because of its complex characteristics requiring sufficient knowledge of medications and principles of clinical pharmacology, skills of diagnosis and communication, and critical judgment. This study aims to gather data on the current status of undergraduate prescribing education in South Korea. Two surveys were administered in this study: survey A to 26 medical schools in South Korea to gather information on the status of undergraduate education in clinical pharmacology; and survey B to 244 intern doctors in large hospitals to gather their opinions regarding prescribing education and ability. In survey A, half of the responding institutions provided prescribing education via various formats of classes over two curriculums including lecture, applied practice, group discussions, computer-utilized training, and workshops. In survey B, we found that intern doctors have the least confidence when prescribing drugs for special patient populations, especially pregnant women. These intern doctors believed that a case-based practical training or group discussion class would be an effective approach to supplement their prescribing education concurrently or after the clerkship in medical schools or right before starting intern training with a core drug list. The results of the present study may help instructors in charge of prescribing education when communicating and cooperating with each other to improve undergraduate prescribing education and the quality of national medical care.
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Female , Humans , Curriculum , Diagnosis , Education , Education, Medical , Group Practice , Judgment , Korea , Pharmacology, Clinical , Pregnant Women , Prescriptions , Public Health , Schools, Medical , WritingABSTRACT
FDA issued the Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry (final guidance)in December 2016.The Guidance stipulated that clinical pharmacology section must contain three subsections—echanism of action,pharmacodynamics,and pharmacokinetics;If necessary,it can be added to microbiology and pharmacogenomics subsections etc.,as well as explained that the contents of each subsection should be included,also discussed the writing general principles and the format of the section.This paper introduces the main contents of the guidance,with the hope of helping writing and supervision on our country labeling.
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FDA released Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product Guidance for Industry in December,2016.The guidance describes the requirements of the trial designs and trial methods for the biosimilar clinical pharmacological studies,and especially points out the problems that should be paid special attention to in the studies.However there is no similar guidance in China.This paper introduces the guidance of FDA,which is beneficial to the research and regulation in China.
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Vitex agnus-castus is a small tree or shrub, belonging to the family Verbenaceae. It is a deciduous shrub native to European, Mediterranean, and Central Asian countries. V. agnus castus has a long tradition as a herbal remedy and was used in ancient times not only as an anaphrodisiac but also against diverse disturbances of the female genital system. The major constituents in V. agnus-castus are flavonoids, essential oils, diterpenes, and glycosides. The flavonoids (casticin, quercetagetin, and isovitexin) have been shown in vitro to affect estrogen receptors. V. agnus-castus could be used to treat acne, digestive complaints, menstrual irregularities, premenstrual syndrome (PMS), mastalgia, and infertility, and also for lactation support. Although V. agnus-castus has been used for centuries and enjoys wide support from practitioners and the general public for many gynecological complaints, few clinical studies support its documented uses. The presence of phytochemical and pharmacological activities has proved that the plant has a leading capacity for the development of new good efficacy drug in future.
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Pharmacology is the study of the actions of synthetic or semisynthetic chemicals or naturally occurring substances on molecules, cells, tissues, and living organisms, as seen in physiological and pathological systems, seeking to establish order, pattern, and sequence among them, aiming ultimately to determine the rules by which pathophysiological information can be coded into molecules, allowing prediction of both beneficial and harmful consequences. Clinical pharmacology is the application, informed by an understanding of pharmacology, of all aspects of the study and use of medicines in humans, whose practitioners, normally medically qualified, teach, do research, frame policy, and give information and advice about the actions and proper uses of medicines in humans and implement that knowledge in clinical practice. Clinical pharmacology expanded in the UK during the 1960s and 1970s and maintained a steady state during the 1980s, but thereafter started to decline. Since 2006 this decline has been halted and partly reversed through the efforts of the British Pharmacological Society, by demonstrating the need for clinical pharmacology in clinical practice, teaching, research, and policy making, and bringing that need to the attention of medical colleagues, regulators, government, and the public. Efforts continue to maintain and enhance this recovery, using the VOICE paradigm, which involves improving and maintaining the Visibility of the specialty, Outreach to advertise its attractiveness to potential trainees and creating a public image for the specialty, Integration with other disciplines, encouraging Coverage of neglected areas, and the use of Emissaries, particularly younger members of the discipline, to promote it, both within medicine and in the wider world. Fortuitously, translation of the five elements of this paradigm into Korean, and back-translation into English, with the addition of a sixth element, provides a RECIPE for the future of clinical pharmacology and therapeutics.
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Humans , Pharmacology , Pharmacology, Clinical , Policy Making , VoiceABSTRACT
This tutorial deals with basic concepts of volume of distribution, the second most important parameter in pharmacokinetics but often challenging for students in clinical pharmacology. Its relationships with dose, concentration and amount in the body are discussed using a physical model and examples of commonly used drugs, as well as its physiological aspects pertaining to the physical volume of differing organs. Finally, application of volume of distribution to the calculation of loading dose and half-life is used to show how it is essential in pharmacotherapy and clinical pharmacology.
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Humans , Drug Therapy , Half-Life , Pharmacokinetics , Pharmacology, ClinicalABSTRACT
This tutorial deals with basic concepts of absorption processes and links previous tutorials on clearance and volume of distribution to introduce the concept of half-life. The time course of both absorption and elimination are commonly described using a half-life. Half-life can also be used to describe drug accumulation. Understanding the principles underlying the time course of absorption and elimination are essential in pharmacotherapy and clinical pharmacology.
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Absorption , Drug Therapy , Half-Life , Pharmacokinetics , Pharmacology, ClinicalABSTRACT
Abstracts: Background: Interns being the most junior doctors involved in prescription of drugs in hospitals, there is a unmet need to obtain perceptions regarding undergraduate clinical pharmacology teaching on rationale prescription of drugs and level of retention of knowledge on clinical pharmacology .Hence this study was planned to assess the perceptions of Interns and faculty regarding undergraduate clinical pharmacology teaching on rationale prescription of drugs. Methodology: 58 internees and 52 faculties of JN medical college were administered with a structured questionnaire. The questionnaire sought information about demographics, undergraduate clinical pharmacology teaching, confidence in rationale drug prescription and experiences of adverse drug reactions. Results: Among 58 internees recruited, 26(44.8%) disagreed that training in clinical pharmacology has equipped them to prescribe rationally and 30(51.7%) Internees expressed lack of confidence while prescribing rationally. Out of 52 faculties recruited, it was observed that 20(38.5%) faculty disagreed that undergraduate training in clinical pharmacology has equipped interns to prescribe rationally and 29(55.8%) of faculty agrees that interns are not confident enough to prescribe rationally. Conclusion: The present study showed that interns are not adequately equipped to prescribe rationally and confidently based on undergraduate clinical pharmacology teaching. Hence there is a need of vigorous training in clinical pharmacology during their graduation. [