DEPARTMENT OF PHARMACOLOGY
UNIVERSITIES OF MEDICINE
Dip.Med. Sc. (CLINICAL PHARMACOLOGY)
Aim and Objectives
Aim: The primary purpose of postgraduate training in clinical pharmacology is the development of personnel who has the appropriate level of knowledge, skills, attitudes and competence to work independently and effectively as a consultant in clinical pharmacology.
Objectives
- Upon completion of the course, a graduate possesses abroad knowledge of the principles of pharmacotherapy of common diseases and be able to consult effectively on drug related problems.
- The graduate must demonstrate the requisite knowledge, and skills in clinical medicine at levels of competency defined in the Clinical Pharmacology training program.
- The graduates must demonstrate competence in the applied pharmacokinetics, pharmacodynamics, pharmacoeconomics, pharmacoepidemiology, drug development, clinical trial design, and evaluation of research proposal, trial protocols, critical appraisal, therapeutic drug monitoring, analytic methodology, applied statistics, drug regulation, drug utilization, education and teaching.
- The graduates must demonstrate knowledge and expertise in the performance of technical skills relevant to Clinical Pharmacology.
- The graduates should be able to give advice on the management and treatment of patients suffering from poisoning with drug and chemicals (clinical toxicology).
- The graduates should be able to conduct, implement, and monitor clinical trials to meet regulatory requirements.
- The graduates should be able to effectively evaluate drug registration dossiers submitted for registration, handle ADR reports and drug information queries, form ideas about the appropriate drug policy, develop Essential Medicine List for the country.
1. Selection of Candidates
Criteria for Application
Selection of candidates will be made by the Postgraduate Selection Board. The candidates must have M.Med.Sc. (Pharmacology) degree from one of the Medical Universities in The Republic of the Union of Myanmar or an equivalent degree recognized by the Myanmar Medical Council.
Selection Examination
Question type - Essay Questions on Applied Pharmacology and Therapeutics
Hours - 2 hours
Pass marks - 60%
2. Duration of the Course
The duration of the course is one year.
The course consists of seminars, journal reading, discussions, written assignments and laboratory works, field visits, hospital visits and clinical posting attachments. In addition, the candidate must duly submit the assignments on the topics provided by the course instructors.
3. Training Programme
Contents
Case based learning, hospital attachment 6 months (4 months in Medical ward, 1 month in Child ward, 2 weeks in OG and Surgery units) to achieve hand-on training, clinical and therapeutic skills. The course is also devoted to seminars, written assignments, discussions, clinical training, and laboratory works related to Clinical Pharmacology and Therapeutics.
Modules for Training and Training Units Identified
Module 1: Compulsory
1.1 Clinical Experience (Clinical Wards)
(16 weeks, 60 credits)
Training unit: Clinical Wards (6 months)
3 months in Medical ward &
1 month in Medical specialty wards
1 month in Pediatric ward
2 weeks in Obstetrics &Gynecology ward
2 weeks in Surgical ward
Objectives:
1.1. Demonstrate knowledge and skills in clinical medicine at levels of competency defined in the Clinical Pharmacology training program
1.1.1. To be able to prescribe drugs for common illnesses rationally
1.1.2. To be able to handle drugs safely and effectively in cases of medical emergencies
1.1.3. To be able to get more insight to antibiotic policy and preventing drug resistance
1.1.4. To be able to apply appropriate and best available guidelines
1.1.5. To recognize of drug toxicity, untoward effects and drug related problems in various clinical settings
Contents
- Rational prescription of drugs for common illnesses
- Rational prescription of drugs safely and effectively in cases of medical emergencies
- Antibiotic policy and preventing drug resistance
- EBM
- ADR and drug interactions in various clinical settings
Teaching learning methods
- Field visit
- Observation and report writing
- Video triggered discussion
Module Assessment
- Case based Patient + Charts
- To be able to prescribe drugs for common illnesses rationally
(10 credits = 5 for attendance +5 for case based)
- To be able to handle drugs safely in cases of medical emergencies
(10 credits = 5 + 5 credit for night duty + reflective case report)
(Project based assessment (PBA) 5 candidates / project)
- To be able to get more insight to antibiotic policy and preventing drug resistance
(10 credits)
Critical appraisal (3 persons) + Seminar
- To be able to apply appropriate and best available guidelines
(10 credits = 5+5) Data + Picture quiz (5)
1.2. Clinical Pharmacology in Special Situations
Objectives
1.2.1. Demonstrate knowledge of individual variation in drug response; genetic, age-related, and gender- related (including pregnancy and lactation), and co-existing renal, hepatic and other diseases
1.2.2. Recognize the need for individualization of therapy where necessary
1.2.3. Select drug and adjust dose regimens correctly based on individual factors
1.2.4. To be able to practice pharmaceutical care in clinical toxicology
Contents
- Pharmaceutical Care in children, elderly, pregnancy, and in organ failures such as cardiac, renal and liver etc.
- Pharmaceutical Care in Clinical Toxicology
Teaching learning methods
Project assignment for clinical monitoring
Module Assessment
- Log book (reflective case reports)
(20 credits = 5 for Attendance + 5 for each of 3 case reports)
Module 2: Compulsory
Generic Skills (Clinical Wards)
(8 weeks, 30 credits)
Objectives: Able to practice ethics, professionalism, communication skills (including team communication) and patient’s safety
Contents
2.1. Professionalism and ethics
2.2. Patient safety: Error reports, RCA, CPI, Audit
2.3 Communication skills: Patient interview, Informed consent, breaking bad news, conflict resolution, BCC, Team communication, Interdisciplinary communication
Teaching learning methods
Observation and report writing
Module Assessment
- Log book (ethical reflective writing)
(30 credits = 20 for 5 reflective cases (5x4) +10 for OSCE)
Module 3: Compulsory
Academic Clinical Pharmacology
(4 weeks, 20 credits)
Training unit: Department of Pharmacology
Objectives
3.1. Apply Pharmacokinetic-modeling, Pharmacokinetic-based drug interactions, Pharmacokinetic/Pharmacodynamic interrelations
3.2. Apply the knowledge in therapeutic drug monitoring in certain clinical conditions
Contents
Pharmacokinetic-modeling, Pharmacokinetic-based drug interaction, Pharmacokinetic/Pharmacodynamic interrelations
Teaching learning methods
Self-learning and Discussion
Module assessment
Presentation and discussion
Module 4: Optional
Regulatory Pharmacology (Drug Regulatory Authority)
(1 week, 10 credits)
Training unit: FDA (Nay Pyi Taw)
Objectives:
4.1. Demonstrate knowledge on the Drugs Law (Act)
4.2. Demonstrate knowledge on what criteria are used when drugs are registered in Myanmar FDA
4.3. Demonstrate knowledge on what a drug dossier is and what documents are included in a dossier
4.4. Have ability to evaluate drug registration dossier effectively
4.5. Form ideas about the appropriate drug policy for the country and contribute to effective drug regulation in the country
4.6. Analyze critically, drug promotional literature for proprietary preparation in terms of the pharmacological actions of ingredients, claims of Pharmaceutical companies, economics of use, rational or irrational nature of fixed dose drug combinations
Contents
- Drug Act and implementation of regulatory activities (Drug, Medical Devices, Cosmetics)
- Pharmaceutical Medicine and Regulatory Processes
- Regulatory Affairs
- Drug Policy
- Categorization of drugs as: OTC preparations, prescription-only medicines, controlled drugs
- Legal aspect of prescribing drugs
- The responsibilities associated with prescribing controlled drugs
- Regulatory requirements for New Pharmaceutical Compounds
- For initiating the clinical program
- For achieving the market authorization
Teaching learning methods
- Reading anddiscussion
- On job learning
- Observation and report writing
Module Assessment
- Assignment
- Presentation and discussion
Module 5: Optional
Industrial Pharmacology
(1 week, 10 credits)
Training unit: Research Department, Myanmar Pharmaceutical Industry
(Visit to a manufacturing plant)
Objectives:
5.1. Acquire the knowledge of Industrial aspect of drug development, Structure and Function of the Pharmaceutical Industry, and Good Manufacturing Practice (GMP)
5.2. Deal with pharmaceutical industry in a professionally and ethically acceptable manner
5.3. Demonstrate knowledge on ethical criteria of promotion of pharmaceuticals
5.4. Communicate effectively with representatives of the pharmaceuticals trade
5.5. Able to inspect and report about the local pharmaceutical industry regarding GMP practice
Contents
- Industrial aspect of drug development
- Structure and Function of the Pharmaceutical Industry
- Good Manufacturing Practice
- Criteria of promotion of pharmaceuticals
Teaching learning methods
- Field visit
- Observation and report writing
- Video triggered discussion
Module Assessment
- Assignment
- Presentation and discussion
Module 6: Compulsory
Clinical trials according to GCP guidelines
(4-5 weeks, 20 credits)
4. Evaluation
The candidate will be eligible to sit exam if they earn at least 200 credits out of 225 credits.
Final assessment will be viva voce for each module and score/marks of module assessment will also be considered.
Grading System
S = Excellent - 90-100
A = Very Good - 80-89
B = Good - 70-79
C = Satisfactory - 60-69
D = Fail - 0-59
Criteria for Distinction
Excellent score in each module must be obtained.
Board of Examiners
Chief Examiner: Chairman of the Board of Studies
Co-Examiners: Module supervisors/course instructors and any person who involved in teaching of the course
External-Examiners: Qualified personnel not belonging to the University of Medicine concerned
Supplementary Examination
If the candidate failed up to five modules (< 5) he/she needs to repeat failed modules in next academic year and pass/fail will be considered in final examination board.
Number of attempts
This is restricted to two. Maximum duration of study is 2 years. Candidature will be terminated if the candidate couldn’t finish necessary/repeated modules within 2 academic years or if the candidate failed in six modules ( > 6).
The candidate will be conferred with the degree only after he/she has satisfied the examiners in all chosen modules.
It is recommended that international training and collaboration with other universities should be encouraged to achieve the higher level expertise comparable to international standard.
