University: Alexandria Faculty: Medicine Programme Specifications (Academic year: 2016/2017 )

Transcription

1 الهيئة القومية لضمان جودة التعليم واالعتماد University: Alexandria Faculty: Medicine Programme Specifications (Academic year: 2016/2017 ) A. Basic Information: 1. Program title: Master degree in clinical pharmacology 2. Department(s) offering the program: Department of clinical pharmacology 3. Date of program specifications approval: /1 /2016 B. Professional Information 1- Program Aims 1.1 prepare graduates who are able to share in improving the quality of patient care through optimal medication management based on sound pharmaco-therapeutic principles 1.2 Encourage the student to be capable of working confidently and adopting a mature, professional and safe attitude to their work 1.3 Increase the depth of the student s knowledge, technical and transferable skills in an integrated manner to enhance their current and future roles 1.4Encourage the student to develop independent and self-critical learning to maximize their own potential 1.5 Enhance critical, analytical problem-solving skills, evidence-based decision making skills and the use of information technology 1.6 Develop a deep understanding of human pharmacology, including its application in the clinical setting, as well as its relevance in the drug development process. 1.7 To develop students skills in experimental design, evaluation and interpretation of experimental data, literature searches, scientific writing, oral presentations, poster presentations and team working. 1.8 Develop an advanced understanding of how clinical, safety and regulatory principles underpin human trials 1.9 Develop the ability to critically review the scientific literature, critically analyze information, synthesize and summarize conclusions 3- Benchmarks: 3.1 Department of Pharmacology University of Oxford ( 3.2 Department of Clinical Pharmacology. Medical University of Vienna ( 3.3 American board of clinical pharmacology The Irish Committee on Higher Medical Training Curriculum For Higher Specialist Training In Clinical Pharmacology. October, %20Clinical%20Pharmacology%20Therapeutics%20-%20October% pdf 3.5 Specialty training curriculum for clinical pharmacology And therapeutic by Joint Royal Colleges Of Physicians Training Board-UK; May Y_AND_THERAPEUTICS/CPT_3_Jul_07_Curr_0010.pdf

2 الهيئة القومية لضمان جودة التعليم واالعتماد Domain A. Knowledge and understandin g B. Intellectual skills Academic Reference Standards ILOs A1. Review the fundamental principles of pharmacology, drug discovery and drug development. A2. Discuss the sources of individual variations in drug response A3. Explain in depth the molecular mechanisms underlying pharmacokinetics and pharmacodynamics and their relations to manifestations and therapy of drug toxicity; A4. Elucidate the cellular signaling pathways relevant to drug discovery and disease; considering the associated molecular and genetic techniques. A5. Discuss and appraise the clinical management of various clinical cases, illustrating their related problems; such as adverse drug reactions, interactions, contraindications, carcinogenicity and teratogenicity. A6. Summarize the drug use and management of diseases of special populations A7. Review Research ethics and reporting to research ethics committees (REC). A8. Describe in details clinical trials, and compare between its different phases. A9. Outline the concept of pharmacoeconomics. A10. Classify types of pharmacoeconomic analysis A11. Recognize Portfolio and Project Planning and Management in the Drug Discovery, Evaluation, Development, and Regulatory Review Process B1. Apply the pharmacokinetic information to justify drug plasma concentrations according to number of doses given to the patient and to optimize plasma drug concentration. B2. Design an evidence-based treatment strategies for a specific clinical cases in the light of studied pharmacological information to minimize medication errors B3. Write a report to research ethics committees (REC). B4. Design Non-Clinical Drug Development B5. Perform Preclinical Prediction of Human Pharmacokinetics B6. Design Phase I Clinical Studies B7. Construct Design of Clinical drug Development Programs B8. Review Role of the Administration (e.g. FDA) in Guiding Drug Development B9. Compare different types of pharmacoeconomic analysis. B10. Discuss future perspectives. B11. apply problem solving skills in experimental and clinical issues

3 الهيئة القومية لضمان جودة التعليم واالعتماد C. Professional skills D. General and transferrable skills E. Attitudes and ethical behavior C1. Assess drug pharmacokinetics (solubility, absorption/ bioavailability and bioequivalence, distribution and protein binding, biotransformation, renal excretion), and pharmacodynamics. C2. work effectively and safely in a clinical and laboratory environment C3.Recommend the drug (S) of choice for a particular clinical presentation. C4.Compare available classes of drugs. C5.Criticize specific drugs in specific situations C6.Criticize the Non-Clinical Drug Development C7.Design a pharmacoeconomic study. C8. Outline suggestions to improve patients adherence to prescribed drugs C9. Communicate basic information about drug therapy to patients and their families, including purpose of medication, how it works, possible adverse drug reactions, potential drug interactions, cost, and necessary follow-up C10. Identify and recommend appropriate corrections of prescription errors C11. Recognize drug compliance and administrations errors and communicate effectively with patients about them C12. Recognize patient preferences for treatment, patient concerns and goals about disease and treatment D1. Hold skills of class discussion and critical evaluation of evidence presented by publications or industry. D2- Write reports, design poster presentation and give oral presentations D3- Use web browsing to locate and use online data bases. D4. Apply effective listening skills and elicit and provide information using nonverbal, explanatory, and questioning skills. D5. Integrate effectively with others as a member or leader of a health care team. D6. Participate in community and professional organizations. D7. Report attended seminars, conferences and workshops for further development. D8. Plan training courses to improve practice and enhance performance of juniors. E1. Apply regulations and ethics that govern physicians in promotion and detailing of drugs. E2. Explain to patients the possible participation as human research subjects in clinical trials, E3. Integrate essential elements for informed consent E4. Obtain consent that is truly informed E5. Manage special challenges of performing clinical research in vulnerable populations E6. Manage confusion of roles in academic medical centers and problems with duplicative, interactive, or conflicting drug treatment

4 الهيئة القومية لضمان جودة التعليم واالعتماد plans E7. Integrate with other members of medical team to provide the patients the appropriate medical care E8. Apply regulations and ethics during laboratory work on experimental animals E9. Show respect to professors, colleagues, other members of medical team and to patients. Matrix of Program ILOs/Courses ILO A1 A2 A3 A4 A5 A6 A7 A8 A9 A10 A11 Course Clinical pharmacokinetics Basic Pharmacology-I Basic Pharmacology II Drug discovery and development-i Drug discovery and development-ii Optimizing and evaluative patient therapy and assessment of drug effects Pharmacotherapy (Rational use of drugs) Basic Pharmacoeconomics Drug metabolism and transport Applied internal medicine Applied emergency medicine ',,,,Clinical pediatrics Clinical geriatrics Drug poisoning. ILO B1 B2 B3 B4 B5 B6 B7 B8 B9 B10 B11 Course Clinical pharmacokinetics Basic Pharmacology-I Basic Pharmacology II Drug discovery and development-i Drug discovery and development-ii Optimizing and evaluative patient therapy and assessment of drug effects Pharmacotherapy (Rational use of drugs) Basic Pharmacoeconomics

5 الهيئة القومية لضمان جودة التعليم واالعتماد Drug metabolism and transport Applied internal medicine Applied emergency medicine Clinical pediatrics Clinical geriatrics Drug poisoning Course ILO C1 C2 C3 C4 C5 C6 C7 C8 C9 C10 C11 12 Clinical pharmacokinetics Basic Pharmacology-I Basic Pharmacology II Drug discovery and development-i Drug discovery and development-ii Optimizing and evaluative patient therapy and assessment of drug effects Pharmacotherapy (Rational use of drugs) Basic Pharmacoeconomics Drug metabolism and transport Applied internal medicine Applied emergency medicine Clinical pediatrics Clinical geriatrics Drug poisoning

6 الهيئة القومية لضمان جودة التعليم واالعتماد Course ILO D1 - D2 D3 D4 D5 D6 D7 D8 Clinical pharmacokinetics Basic Pharmacology-I Basic Pharmacology II Drug discovery and development-i Drug discovery and development-ii Optimizing and evaluative patient therapy and assessment of drug effects Pharmacotherapy (Rational use of drugs) Basic Pharmacoeconomics Drug metabolism and transport Applied internal medicine Applied emergency medicine Clinical pediatrics Clinical geriatrics Drug poisoning

7 الهيئة القومية لضمان جودة التعليم واالعتماد Course ILO E1 -E2 E3 E4 -E5 E6 E7 E8 -E9 Clinical pharmacokinetics Basic Pharmacology-I Basic Pharmacology II Drug discovery and development-i Drug discovery and development-ii Optimizing and evaluative patient therapy and assessment of drug effects Pharmacotherapy (Rational use of drugs) Basic Pharmacoeconomics Drug metabolism and transport Applied internal medicine Applied emergency medicine Clinical pediatrics Clinical geriatrics Drug poisoning 5- Curriculum Structure and Contents: 5.1 Programme duration: 40 credit hours 5.2 Programme structure:.. Programme courses: Obligatory:

8 الهيئة القومية لضمان جودة التعليم واالعتماد Course Code Course Title Number of Units No of Hours/Week Lectures Practical Clinical Basics of research Clinical pharmacokinetics Basic Pharmacology-I Basic Pharmacology II Drug discovery and 2 2 development-i Drug discovery and 2 2 development-ii Optimizing and evaluating patient's therapy and assessment of drug effects Pharmacotherapy (Rational use of drugs) Basic Pharmacoeconomics Drug metabolism and transport Applied internal medicine Applied emergency medicine Clinical pediatrics Clinical geriatrics Drug poisoning Curricular Contents: Clinical pharmacokinetics Code Course credit hours 2 Pre-requisites Theoretical 1 Practical This course aims at helping the student to acquire advanced knowledge and problem solving skills to guide drug prescribing based on pharmacokinetic properties of drugs. Basic Pharmacology-I Code Course credit hours 3 Pre-requisites Theoretical 2.5 Practical

9 الهيئة القومية لضمان جودة التعليم واالعتماد This course aims to provide the student with the basic knowledge of the essential principles in pharmacology, To build up the ability of applying this knowledge in recognizing the basic pharmacology of drugs targeting inflammation, autonomic nervous system, blood components, body fluid balance, hemostasis, renal system and skin disorders.to enable the student to apply these pharmacological knowledge in clinical situations in the field of therapeutics And to provide the student with essential practical skills in pharmacology Basic Pharmacology-II Code Course credit hours 3 Pre-requisites Theoretical 2 Practical The course includes knowledge about the essentials of basic pharmacology. Aiming to help students recognizing the basic pharmacology of drugs targeting infection, autoimmune diseases, cancer, central nervous, cardiovascular, gastrointestinal, pulmonary, and endocrine systems and to apply these knowledge in clinical situations in the field of therapeutics. Also it tends to provide the student with essential practical skills in pharmacology. Drug discovery and development-i Code Course credit hours 2 Pre-requisites Theoretical 2 Practical This course helps the student to acquire advanced knowledge and apply recent techniques that help in exploring Drug discovery and Development, implement Project Planning and Management in the Drug Discovery, Evaluation, Development, and Regulatory Review Process Drug discovery and development-ii Code Course credit hours 2 Pre-requisites Theoretical 2 Practical This course helps the student to Acquire advanced knowledge and apply recent techniques that help in exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding Drug Development Optimizing and evaluating patient's therapy and assessment of drug effects Code Course credit hours 1 Pre-requisites Theoretical 0.5 Practical This course helps student to Acquire advanced knowledge enabling the student to assess drug effect, evaluate and optimize drug therapy.. Pharmacotherapy (Rational use of drugs) Code Course credit hours 4 Pre-requisites

10 الهيئة القومية لضمان جودة التعليم واالعتماد Theoretical 2 Clinical This Course Aims To enable the student to recognize factors that make patients unique To build up the ability of applying basic pharmacology knowledge in drug use in common medical diseases, To provide the student with the essentials of rules and regulation that govern prescribing To enable the students to identify medication errors, adverse drug reactions and drug interactions. To develop in the students the skills of Good communication with patients and families, Obtaining accurate drug history, Developing a sound drug therapy plan, Using information technology and Finding evidence-based information Basic Pharmacoeconomics Code Course credit hours 1 Pre-requisites Theoretical 1 Practical At the end of the course the student will be able to Define pharmacoeconomic concepts and terminology. Compare different types of pharmacoeconomic analysis. Apply knowledge to provide healthcare decision-makers with valuable information and allowing optimal allocation of limited resources, and discuss future perspectives. Drug metabolism and transport Code Course credit hours 1 Pre-requisites Theoretical 0.5 Practical This course helps student to Acquire advanced knowledge related to variable types of drug transport and drug metabolic pathways. Applied internal medicine Code Course credit hours 3 Pre-requisites Theoretical 2.5 Clinical This course is designed To enable the student to recognize factors that make patients unique To build up the ability of applying basic pharmacology knowledge in drug use in common medical diseases, To provide the student with the essentials of rules and regulation that govern prescribing To enable the students to identify medication errors, adverse drug reactions, drug interactions and overdosage and To develop in the students the skills of Good communication with patients and families, Obtaining accurate drug history, Developing a sound drug therapy plan, Using information technology and Finding evidence-based information Applied emergency medicine Code Course credit hours 1 Pre-requisites Theoretical 0.5 Clinical The course Discussess basic and advanced measures for management of emergency situations. Recognize important pharmacokinetic and pharmacodynamic changes in critically ill patients. Gain advanced knowledge and apply recent guidelines to construct effective management plan in emergency room

11 الهيئة القومية لضمان جودة التعليم واالعتماد Clinical pediatrics Code Course credit hours 2 Pre-requisites Theoretical 1 Clinical The course aims to help the student to Gain advanced knowledge in optimizing use of medications for individual children and provide advanced clinical training in the areas of pediatric pharmacotherapy. The primary emphasis of the course is to develop independent problem-solving skills in pediatrics pharmacotherapy. This includes the establishment of a firm knowledge base in pediatric pharmacology and pharmacokinetics; and the ability to provide therapeutic interventions to enhance the management of pediatric patients. Clinical geriatrics Code Course credit hours 1 Pre-requisites Theoretical 0.5 Clinical The course aims to help the student to Acquire advanced knowledge and problem solving skills to guide prescribing in geriatric disorders based on updated guidelines and evidence-based practices. Drug poisoning Code Course credit hours 3 Pre-requisites evaluation Theoretical 2 Practical Gain advanced knowledge and apply recent laboratory techniques that helps in understanding the pharmacokinetic aspects of different therapeutic agents and its implications in the field of drug poisoning and toxicology with exploration of recent guidelines in their evaluation and management aiming to improve outcome and decrease in both drug related morbidity and mortality 7- Programme Admission Requirements: According to the regulations of the credit hour bylaws of the Faculty of Medicine Alexandria University (annex). 8- Regulations for Progression and Programme Completion: According to the regulations of the credit hour bylaws of the Faculty of Medicine Alexandria University (annex). 10- Methods of student assessment: Methods Intended Learning outcomes to be assessed 1. Essay A1-11, B Case studies A1-11, B1-11, C2-5, C7 3. Assignment A1-11, B1-11, D1-12, E Objective questions A1-11, B1-11, C OSCE/OSPE A1-11, B1-11, C1-12, D1-8, E1-9

12 الهيئة القومية لضمان جودة التعليم واالعتماد 11- Methods of programme evaluation: Evaluator Tool Sample 1. Questionnaires 2. Alumni 3. Stakeholders (Employers) 4. External Evaluator (s) 5. Others: Programme Director: Prof Dr Samya Mohamed Ali Programme coordinator: Prof. Dr Maged Misheal Date: / / Signature: Signature:

13 Course Specifications University: Alexandria Faculty: Medicine Department: clinical pharmacology Course Information Course Code: Program in which the Course is Given Course Name: Clinical Pharmacokinetics MSc in Clinical Pharmacology Number of Credit Hours Theoretical 1 Clinical/Practical 1 Course Aims Acquire advanced knowledge and problem solving skills to guide drug prescribing based on pharmacokinetic properties of drugs. Intended Learning Outcomes (ILOs) Program ILO (refer to program matrix) A. Knowledge and Understanding A1. Review the fundamental principles of pharmacology, drug discovery and drug development. A2. Discuss the sources of individual variations in drug response A3. Explain in depth the molecular mechanisms underlying pharmacokinetics and pharmacodynamics and their relations to manifestations and therapy of drug toxicity; Course ILOs A1.Define pharmacokinetics and pharmacodynamics A2. Discuss drug Clearance. A4. Explain Volume of distribution A5. State Half-life and elimination rate constant A6. Explain Michaelis-menten (saturable or nonlinear pharmacokinetics) A7. Outline factors affecting Drug Absorption, Bioavailability and Bioequivalence A8. Review the effects of Renal and Liver Disease on Pharmacokinetics A9. Compare between Noncompartmental and Compartmental Approaches to

14 B. Intellectual skills C.Professional and Practical Skills D. General Skills B1. Apply the pharmacokinetic information to justify drug plasma concentrations according to number of doses given to the patient and to optimize plasma drug concentration. B2. Design a evidence-based treatment strategies for a specific clinical cases in the light of studied pharmacokinetic information to minimize medication errors C1. Recommend the drug (S) of choice for a particular clinical presentation C2. work effectively and safely in a clinical and laboratory environment C3.Recommend the drug (S) of choice for a particular clinical presentation. C4.Compare available classes of drugs C8. Outline suggestions to improve patients adherence to prescribed drugs D1. Hold skills of class discussion and critical evaluation of evidence presented by publications or industry. D2- Write reports and give oral Pharmacokinetic Analysis A10. Describe the effects of liver and renal diseases on pharmacokinetics B1. Apply the pharmacokinetic equations for drug single dose administration B2. Apply the pharmacokinetic equations for drug multiple doses administration B3. Apply the pharmacokinetic equations to adjust timing to reach steady state situation B4. Adjust drug dosing in renal and hepatic impairment. B5. Design individualized dosage regimens using one-compartment and Multicompartment model equations. B6. Calculate of clearance, volume of distribution, and half-life in pharmacokinetic research studies. C1. Apply update pharmacokinetic knowledge to select the best drug for a particular clinical case C2.Solve problems of variations of drug concentration in diseases of organs of elimination. C3. Appraise the cardioprotective, neuroprotective and renoprotective effects of some drug classes that favor their use over other counterparts. C4. Criticize medication errors in some prescriptions and recommend changes to improve safety and efficacy of drug therapy. d1. Demonstrate competent presentation and knowledge in class and respect questions and inquires from colleagues and professors. d2. Prove efficient skills in searching databases and evidence-based guidelines.

15 presentations D3- Use web browsing to locate and use online data bases. D4. Communicate basic information about drug therapy to patients and their families, including purpose of medication, how it works, possible adverse drug reactions, potential drug interactions, cost, and necessary follow-up d3. Demonstrate clinical cases and Display good time-management during talk, case presentation and discussion. D4. Communicate basic information about drug pharmacokinetics to patients and their families D5. Apply effective listening skills during lectures and seminars. D5. Apply effective listening skills and elicit and provide information using nonverbal, explanatory, and questioning skills. E. Attitudes and ethical behavior E8. Apply regulations and ethics during laboratory work on experimental animals E9. Show respect to professors, colleagues, other members of medical team and to patients. E1. Apply regulations and ethical behavior toward experimental animals during laboratory work. E2. Show respect during listening, providing oral presentations and experimental work towards other team members. Course Content (Units/Topics) 1. Introduction to pharmacokinetics (Clinical pharmacokinetics vs pharmacodynamics) Teaching/Learning Methods Lectures self Practical/ learning Clinical Small group discussion Others

16 2. Clearance, Volume of distribution, Half-life and elimination rate constant 3. Michaelis-menten (saturable or nonlinear pharmacokinetics) 4. Drug Absorption, Bioavailability and Bioequivalence 5. One-compartment model equations for linear pharmacokinetics (Single dose, Multiple-Dose and Steady-State Equations 6. Designing individualized dosage regimens using one compartment model equations 7. Multicompartment models 8. Calculation of clearance, volume of distribution, and half-life in pharmacokinetic research studies 9. Effects of Renal Disease on Pharmacokinetics 10. Effect of Liver Disease on Pharmacokinetics 11. Noncompartmental versus Compartmental Approaches to Pharmacokinetic Analysis 12. Study problems Please check () the appropriate method. Student Assessment Methods of Assessment Essay Objective questions Case OSCE/OSPE Assignment Logbook fulfillment Others Schedule of Assessment Mid-term 40 % End of term 60 % Distribution of Marks Written Exam 80 % Practical/Clinical Exam 20 % Others (attendance/assignment)

17 List of Textbooks and References Lecture Notes Manuscripts of Assignment Topics prepared by candidates and revised by supervising professors. Course Text Books Suggested Extra Reading 1) Katzung basic and clinical Pharmacology 2) Lippincot' s Pharmacology review Journals and Periodicals, others 3) Goodman and Gillman Basic Pharmacology. Review articles on pubmed and Medscape on pharmacokinetics Course Instructor Name: Signature: Program Coordinator Name: Signature: Program Director (Head of Department) Name: Signature:

18 Course Specifications University: Alexandria Faculty: Medicine Department: clinical pharmacology Course Information Course Code: Program in which the Course is Given Course Name: Basic Pharmacology I MS in Clinical Pharmacology Number of Credit Hours Theoretical 2.5 Clinical/Practical 0.5 Course Aims To provide the student with the basic knowledge of the essential principles in pharmacology To build up the ability of applying this knowledge in recognizing the basic pharmacology of drugs targeting inflammation, autonomic nervous system, blood components, body fluid balance, hemostasis, renal system and skin disorders. To enable the student to apply these pharmacological knowledge in clinical situations in the field of therapeutics To provide the student with essential practical skills in pharmacology Intended Learning Outcomes (ILOs) Program ILO (refer to program Course ILOs matrix)

19 A. Knowledge and Understanding A1. Review the fundamental principles of pharmacology, drug discovery and drug development. A2. Discuss the sources of individual variations in drug response A3- Explain in depth the molecular mechanisms underlying pharmacokinetics and pharmacodynamics and their relations to manifestations and therapy of drug toxicity; A4. Elucidate the cellular signaling pathways relevant to drug discovery and disease; considering the associated molecular and genetic techniques. A5. Discuss and appraise the clinical management of various clinical cases, illustrating their related problems; such as adverse drug reactions, interactions, contraindications, carcinogenicity and teratogenicity. a1.describe in depth principles and facts related to the pharmacodynamics of drugs a2.identify the detailed pharmacology of drugs affecting the autonomic nervous system and their applications in the medical field a3.state the pharmacological aspects of different autacoids and their targeting by drugs a4.list drugs used in different types of anemia a5.point different diuretics and their site of action and adverse effects a6.outline vitamins and intravenous fluids replacement therapy a7. List drugs used in different dermatological diseases. B. Intellectual skills B1. Apply the pharmacokinetic information to justify drug plasma concentrations according to number of doses given to the patient and to optimize plasma drug concentration. B2. Design an evidence-based treatment strategies for a specific clinical cases in the light of studied pharmacological information to minimize medication errors B1.Describe the mechanism of action and drug interactions related to the autonomic nervous system, inflammation and homeostasis B2.Classify diuretics and discuss their side effects in relation to their mechanism of action B3.Describe vitamins and relate their physiological aspects to their use in different clinical states.

20 C. Professional and Practical Skills C1. Assess drug pharmacokinetics (solubility, absorption/ bioavailability and bioequivalence, distribution and protein binding, biotransformation, renal excretion), and pharmacodynamics. C2. work effectively and safely in a clinical and laboratory environment C3.Recommend the drug (S) of choice for a particular clinical presentation. C4.Compare available classes of drugs. C5.Criticize specific drugs in specific situations C8. Outline suggestions to improve patients adherence to prescribed drugs C9. Communicate basic information about drug therapy to patients and their families, including purpose of medication, how it works, possible adverse drug reactions, potential drug interactions, cost, and necessary follow-up C10. Identify and recommend appropriate corrections of prescription errors C1.Compare different diuretics and put a recommendation of the use of each group in specific clinical conditions C2.Organize a plan for therapeutic management of patients with coagulation disorders with different comorbidities C3.Apply the pharmacological knowledge in management of gout and other rheumatic disorders C4.Design systematic approaches for fluid replacement in different clinical conditions of fluid imbalance C5.Use practical experiments to evaluate the action of analgesics and autonomic drugs. C6.Identify examples of recently published advances in treatment of collagen disorders C7.Dicuss guidelines of different societies for the management of thrombotic disorders, rheumatoid arthritis and intravenous fluid replacement therapy C8. Identify problems causing failure of therapy, and Outline suggestions to avoid or correct them. C9. Communicate basic information (purpose of medication, how it works, possible adverse drug reactions, potential drug interactions, cost, and necessary follow-up) about drug therapy for anemia, renal and inflammatory diseases, to patients and their families. D. General Skills D1. Hold skills of class discussion and D1.Perform practice-based improvement

21 critical evaluation of evidence presented by publications or industry. D2- Write reports, design poster presentation and give oral presentations D3- Use web browsing to locate and use online data bases. D4. Apply effective listening skills and elicit and provide information using nonverbal, explanatory, and questioning skills. D7. Report attended seminars, conferences and workshops for further development. D8. Plan training courses to improve practice and enhance performance of juniors. activities using a systematic methodology D2.Appraise evidence from scientific studies D3.Participate in one audit related to pharmacology D4. Write two reports about two attended conferences D5. Use online data bases to identify the proper guidelines for certain clinical cases D6. Apply effective listening skills and elicit and provide information using nonverbal, explanatory, and questioning skills during lectures and during oral presentations D7. Plan experimental and clinical training courses to improve practice.. E. Attitudes and ethical behavior E1. Apply regulations and ethics that govern physicians in promotion and detailing of drugs E1. Apply regulations and ethics that govern physicians in promotion and detailing of the studied drugs E6. Manage confusion of roles in academic medical centers and problems with duplicative, interactive, or conflicting drug treatment plans E7. Integrate with other members of medical team to provide the patients the appropriate medical care E8. Apply regulations and ethics during laboratory work on experimental animals E9. Show respect to professors, colleagues, other members of medical E2. Manage confusion of roles in academic medical centers and problems with duplicative, interactive, or conflicting drug treatment plans related to anemia, gout and dermatological diseases E3. Integrate with other members of medical team to provide the renal, hepatic and cardiac patients the appropriate medical care E4. Apply regulations and ethics during laboratory work on experimental animals E5. Show respect to professors, colleagues

22 team and to patients. during lectures and oral presentations, and to other members of medical team and to patients during patient counselling. Course Content (Units/Topics) 1. General principles of drug action Teaching/Learning Methods Lectures self Practical/ learning Clinical Small group discussion Others 2. Drugs acting on the autonomic nervous system 3. Autacoids and ergots 4. Antiinflammatory agents and drugs used in treatment of gout and hyperuricemia 5. Drugs used in anemia and disorders of haemostasis 6. Drugs acting on the renal system 7. Fluids used in the intravenous fluid therapy 8. Vitamins 9. Drugs used in dermatologic diseases 10. Disinfectants and antiseptics

23 11. Practical: Effect of drugs on the eye Dose-response curve and drug antagonism Evaluation of analgesic activity of NSAIDs Please check () the appropriate method. Student Assessment Methods of Assessment Essay Objective questions Case OSCE/OSPE Assignment Others Logbook fulfillment Schedule of Assessment Mid-term 30 % End of term 70 % Distribution of Marks Written Exam 60 % Practical/Clinical Exam 20 % Others: essays (assignments) 20% List of Textbooks and References Lecture Notes Course Text Books Katzung Basic and Clinical Pharmacology Goodman and Gilmen s the Pharmacological Basis of Therapeutics Suggested Extra Reading --

24 Journals and Periodicals, others British journal of Pharmacology Pharmacological review Course Instructor Name: Program Coordinator Name: Signature: Signature: Program Director (Head of Department) Name: Signature:

25 Course Specifications University: Alexandria Faculty: Medicine Department: clinical pharmacology Course Information Course Code: Program in which the Course is Given Course Name: Basic Pharmacology II MS in Clinical Pharmacology Number of Credit Hours Theoretical 2 Practical 1 Course Aims To develop a deep knowledge of the essentials of basic pharmacology. To build up the ability of applying this knowledge in recognizing the basic pharmacology of drugs targeting infection, autoimmune diseases, cancer, central nervous, cardiovascular, gastrointestinal, pulmonary, and endocrine systems. To enable the student to apply these pharmacological knowledge in clinical situations in the field of therapeutics. To provide the student with essential practical skills in pharmacology. A. Knowledge and Understanding Program ILO (refer to program matrix) A1. Review the fundamental principles of pharmacology, drug discovery and drug development. A2. Discuss the sources of individual variations in drug response A3. Explain in depth the molecular mechanisms underlying pharmacokinetics and pharmacodynamics and their relations to manifestations and therapy of drug toxicity; A4. Elucidate the cellular signaling pathways relevant to drug discovery and Course ILOs A1. Classify drugs acting on CVS, CNS, Pulmonary and endocrinal systems A2. Identify the detailed pharmacology of drugs Acting on CVS, CNS, Pulmonary and endocrinal systems A3. Discuss drugs Used in Treatment of Infectious Diseases. A4. State the pharmacological aspects of different Drugs Used in Cancer Chemotherapy A5. Review recent guidelines for treatment of common cardiovascular, pulmonary, neurological and endocrinal diseases.

26 disease; considering the associated molecular and genetic techniques. A5. Discuss and appraise the clinical management of various clinical cases, illustrating their related problems; such as adverse drug reactions, interactions, contraindications, carcinogenicity and teratogenicity. A6. Explain in depth the molecular mechanisms underlying pharmacokinetics and pharmacodynamics of drugs acting on CVS, CNS, Pulmonary and endocrinal systems and anticancer drugs. and their relations to adverse drug reactions A7. Discuss the sources of individual variations in response to drugs acting on CVS, CNS, Pulmonary and endocrinal systems and to anticancer drugs A6. Summarize the drug use and management of diseases of special populations B. Intellectual skills B1. Apply the pharmacokinetic information to justify drug plasma concentrations according to number of doses given to the patient and to optimize plasma drug concentration. B2. Design an evidence-based treatment strategies for a specific clinical cases in the light of studied pharmacological information to minimize medication errors B8. Review Role of the Administration (e.g. FDA) in Guiding Drug Development B11. apply problem solving skills in experimental and clinical issues B1.Describe the mechanisms of action and drug interactions related to the CVS, CNS, Pulmonary and endocrinal systems B2.Classify Immunosuppressant Drugs and discuss their side effects in relation to their mechanism of action B3.Compare between different anticancer drugs regarding their mechanisms of action, therapeutic uses and adverse drug reactions. B4. Identify appropriate method to optimize plasma drug concentration during treatment of common cardiovascular, pulmonary, neurological and endocrinal diseases. B5. Review Role of the Administration (e.g. FDA) in Guiding Development of anticancer drugs and other pharmacological agents.

27 C. Professional and Practical Skills C1. Assess drug pharmacokinetics (solubility, absorption/ bioavailability and bioequivalence, distribution and protein binding, biotransformation, renal excretion), and pharmacodynamics. C2. work effectively and safely in a clinical and laboratory environment C3.Recommend the drug (S) of choice for a particular clinical presentation. C4.Compare available classes of drugs. C5.Criticize specific drugs in specific situations C8. Outline suggestions to improve patients adherence to prescribed drugs C9. Communicate basic information about drug therapy to patients and their families, including purpose of medication, how it works, possible adverse drug reactions, potential drug interactions, cost, and necessary follow-up C10. Identify and recommend appropriate corrections of prescription errors C11. Recognize drug compliance and administrations errors and communicate effectively with patients about them C1.Apply the pharmacological knowledge in management of clinical cases related to cardiovascular, respiratory, endocrinal C2. Select the appropriate drug for common clinical cases taking into considerations the causes of individual variations C3. Recommend drug therapy for common cardiovascular, infectious, endocrinal and respiratory diseases, using evidence based medicine. C4.Compare available classes of the studied drugs, and select specific drugs for each clinical case. C5.Criticize specific drugs in specific situations. C6. Identify problems causing failure of therapy, and Outline suggestions to avoid or correct them. C7. Conduct laboratory experiments to evaluate anticonvulsant activity of drugs, applying effective, safe and ethical measures. C8. Conduct laboratory experiments to Evaluate bronchodilators and Bronchoconstrictors applying effective, safe and ethical measures C9. Communicate basic information (purpose of medication, how it works, possible adverse drug reactions, potential drug interactions, cost, and necessary follow-up) about drug therapy for common cardiovascular, infectious, endocrinal and respiratory diseases, to patients and their families. D. General Skills D1. Hold skills of class discussion and critical evaluation of evidence presented D1.Perform practice-based improvement activities using a systematic methodology

28 by publications or industry. D2- Write reports, design poster presentation and give oral presentations D3- Use web browsing to locate and use online data bases. D4. Apply effective listening skills and elicit and provide information using nonverbal, explanatory, and questioning skills. D7. Report attended seminars, conferences and workshops for further development. D8. Plan training courses to improve practice and enhance performance of D2.Appraise evidence from scientific studies D3.Participate in one audit related to pharmacology D4. Write two reports about two attended conferences D5. Use online data bases to identify the proper guidelines for certain clinical cases D6. Apply effective listening skills and elicit and provide information using nonverbal, explanatory, and questioning skills during lectures and during oral presentations D7. Plan experimental and clinical training courses to improve practice. juniors.. E. Attitudes and ethical behavior E1. Apply regulations and ethics that govern physicians in promotion and detailing of drugs E1. Apply regulations and ethics that govern physicians in promotion and detailing of the studied drugs E6. Manage confusion of roles in academic medical centers and problems with duplicative, interactive, or conflicting drug treatment plans E7. Integrate with other members of medical team to provide the patients the appropriate medical care E8. Apply regulations and ethics during laboratory work on experimental animals E2. Manage confusion of roles in academic medical centers and problems with duplicative, interactive, or conflicting drug treatment plans related to cardiovascular, neurological and endocrinal disease E3. Integrate with other members of medical team to provide the cancer patients the appropriate medical care E4. Apply regulations and ethics during

29 E9. Show respect to professors, colleagues, other members of medical team and to patients. laboratory work on experimental animals E5. Show respect to professors, colleagues during lectures and oral presentations, and to other members of medical team and to patients during patient counselling. Course Content (Units/Topics) Teaching/Learning Methods Lectures self Practical/ learning Clinical 1. Drugs acting on central nervous system. 2. Drugs acting on cardiovascular system. 3. Drugs acting on gastrointestinal system. 4. Drugs acting on pulmonary system. 5. Drugs acting on endocrine system. 6. Drugs used in cancer chemotherapy 7. Immunosuppressant drugs 8. Drugs used in treatment of infectious disease. Small group discussion Others Student Assessment Methods of Assessment Essay Objective questions Case OSCE/OSPE Assignment Others Logbook fulfillment Schedule of Assessment Mid-term 30 % End of term 70 %

30 Distribution of Marks Written Exam 80 % Practical/Clinical Exam 20 % Others % List of Textbooks and References Lecture Notes Course Text Books Katzung Basic and Clinical Pharmacology Goodman and Gilmen s the Pharmacological Basis of Therapeutics. Suggested Extra Reading Journals and Periodicals, others British journal of Pharmacology Pharmacological review Course Instructor Name: Program Coordinator Name: Signature: Signature: Program Director (Head of Department) Name: Signature:

31 Course Specifications University: Alexandria Faculty: Medicine Department: clinical pharmacology Course Information Course Code: Course Name: Drug discovery and Development I Program in which the Course is Given MSc in Clinical Pharmacology Number of Credit Hours Theoretical 2 Clinical/Practical Course Aims Acquire advanced knowledge and apply recent techniques that help in exploring Drug discovery and Development, and implement Project Planning and Management in the Drug Discovery, Evaluation, Development, and Regulatory Review Process Intended Learning Outcomes (ILOs) Program ILO (refer to program matrix) Course ILOs

32 A. Knowledge and Understanding A1. Review the fundamental principles of pharmacology, drug discovery and drug development. A4. Elucidate the cellular signaling pathways relevant to drug discovery and disease; considering the associated molecular and genetic techniques A7. Review Research ethics and report to research ethics committees (REC). A11. Recognize Portfolio and Project Planning and Management in the Drug Discovery, Evaluation, Development, and Regulatory Review Process. a.1 Review Research ethics and report to research ethics committees (REC). a.2 Discuss Project Planning and Management? a.3 Define Project planning and management a.4 Discuss Project planning and management tools a.5 Distinguish Project team management and decision-making. a.6 Discuss Drug discovery philosophies and definition of drug targets a.7 Explain Generating diversity a.8 Describe lead structures a.9 Identify Qualifying leads for transition to early trials a.10 Identify Components of non-clinical drug development a.11 Distinguish Translational research in oncology drug development a.12 Discuss Microdosing a.13 Identify Allometry a.14 Distinguish Physiologic pharmacokinetics a.15 Recognize Preclinical Prediction of Human Pharmacokinetics

33 B. Intellectual skills B3. Write a report to research ethics committees (REC). B4. Design Non-Clinical Drug Development B5. Perform Preclinical Prediction of Human Pharmacokinetics B7. Construct Design of Clinical drug Development Programs b1. Design a report to research ethics committees (REC). b2. Report on and interpret Project Planning and Management? b3. Build Project planning and management b4. Construct Project planning and management tools b5. Relate Project team management and decision-making b6. Relate Drug discovery philosophies and definition of drug targets b7. Report Generating diversity b8. Build Definition of lead structures b9. Relate Qualifying leads for transition to early trials b10. Describe Components of non-clinical drug development b11. Construct Translational research in oncology drug development b12. interpret Microdosing b13. Analyze Allometry b14. Analyze Physiologic pharmacokinetics

34 C.Professional and Practical Skills C6.Criticize the Non-Clinical Drug Development C1. Apply update to predict and develop Components of non-clinical drug development C2. Solve problems of Translational research in oncology drug development...etc. D. General Skills d1. Hold skills of class discussion and critical evaluation of evidence presented by publications or industry. D2- Write reports, design poster presentation and give oral presentations D3- Use web browsing to locate and use online data bases. D4. Apply effective listening skills and elicit and provide information using nonverbal, explanatory, and questioning skills. D7. Report attended seminars, conferences and workshops for further development. d1. Demonstrate competent presentation and knowledge in class and respect questions and inquires from colleagues and professors. d2. Prove efficient skills in searching databases and evidence-based guidelines. d3. Display good time-management during talk, case presentation and discussion. D4. Report two attended conferences D5. Apply effective listening skills during lectures and oral presentations E. Attitudes and ethical behavior E1. Apply regulations and ethics that govern physicians in promotion and detailing of drugs. E9. Show respect to professors, colleagues, other members of medical team and to patients. E1. Apply regulations and ethics that govern physicians in designing pre-clinical and clinical drug development. E9. Show respect to professors, colleagues, other members of medical team and to patients.

35 Course Content (Units/Topics) 1. Research ethics and reporting to research ethics committees (REC). [in collaboration with Department of Forensic Medicine] 2. Portfolio and Project Planning and Management in the Drug Discovery, Evaluation, Development, and Regulatory Review Process. What Is Project Planning and Management? Project planning and management Project planning and management tools Project team management and decision-making 3. Drug Discovery Teaching/Learning Methods Lectures self Practical/ learning Clinical Small group discussion Others Drug discovery philosophies and definition of drug targets Generating diversity Definition of lead structures Qualifying leads for transition to early trials 4. Non-Clinical Drug Development Components of non-clinical drug development Translational research in oncology drug development 5. Preclinical Prediction of Human Pharmacokinetics Microdosing Allometry Physiologic pharmacokinetics Please check () the appropriate method. Student Assessment Methods of Assessment Essay Objective questions

36 Case OSCE/OSPE Assignment Logbook fulfillment Others Schedule of Assessment Mid-term 40 % End of term 60 % Distribution of Marks Written Exam 60 % Practical/Clinical Exam % Others (attendance/assignment) 40 % List of Textbooks and References Lecture Notes Course Text Books Manuscripts of Assignment Topics prepared by candidates and revised by supervising professors. Drug Discovery and Development UNDERSTANDING THE R&D PROCESS (by innovation.org) Biopharmaceutical Research & Development: The Process Behind New Medicines ( Suggested Extra Reading 1) Katzung basic and clinical Pharmacology 2) Lippincot' s Pharmacology review Journals and Periodicals, others 3) Goodman and Gillman Basic Pharmacology. Review articles on pubmed and Medscape on Drug discovery and Development Course Instructor Name: Signature:

37 Program Coordinator Name: Signature: Program Director (Head of Department) Name: Signature:

38 Course Specifications University: Alexandria Faculty: Medicine Department: clinical pharmacology Course Information Course Code: Program in which the Course is Given Course Name: Drug discovery and Development II MSc in Clinical Pharmacology Number of Credit Hours Theoretical 2 Clinical/Practical Course Aims Acquire advanced knowledge and apply recent techniques that help in exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in Guiding Drug Development. Intended Learning Outcomes (ILOs) Program ILO (refer to program Course ILOs matrix)

39 A. Knowledge and Understanding A1. Review the fundamental principles of pharmacology, drug discovery and drug development. A4. Elucidate the cellular signaling pathways relevant to drug discovery and disease; considering the associated molecular and genetic techniques. A7. Review Research ethics and reporting to research ethics committees (REC). A8. Describe in details clinical trials, and compare between its different phases. A11. Recognize Portfolio and Project Planning and Management in the Drug Discovery, Evaluation, Development, and Regulatory Review Process a.1 Define Phase I Clinical Studies a.2 Explain drug toxicity. a.3 Define Monoclonal antibodies a.4 Assay of macromolecules a.5 Describe Interspecies scaling of macromolecules: predictions in humans a.6 Explain Pharmacokinetic characteristics of macromolecules a.7 Describe Pharmacodynamics of macromolecules a.8 Discuss Principles of clinical development a.9 Distinguish Legal and regulatory requirements a.10 discuss Evidence-based, goal-directed clinical development a.11 Review Specific design issues in clinical development programs a.12 Review Personalized Medicine, Elderly and Pediatric Populations, Orphan Drugs, Comparative Effectiveness, Combination Treatments, Transparency) a.13 Recognize The role of the FDA office of clinical pharmacology.