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Pharm D Year 5 Syllabus

This page gives the complete syllabus for Year 5 of the Pharm D course, exactly as prescribed by the Pharmacy Council of India (PCI) in the Pharm.D. Regulations 2008. Every subject of the year is listed below with its full syllabus. Along with the three theory subjects, the fifth year carries Clerkship, attending ward rounds on a daily basis, and the Project work of six months, which are given here as the regulations present them.

Subjects in this year

• Attending ward rounds on daily basis, as noted in the PCI course table for this year.

5.1 Clinical Research (Theory)

1. Drug development process: Introduction. Various Approaches to drug discovery

2. Pharmacological

3. Toxicological
4. IND Application
5. Drug characterization

6. Dosage form

7. Clinical development of drug:

8. Introduction to Clinical trials

9. Various phases of clinical trial.
10. Methods of post marketing surveillance
11. Abbreviated New Drug Application submission.
12. Good Clinical Practice - ICH, GCP, Central drug standard control organisation (CDSCO) guidelines
13. Challenges in the implementation of guidelines
14. Ethical guidelines in Clinical Research
15. Composition, responsibilities, procedures of IRB / IEC
16. Overview of regulatory environment in USA, Europe and India.
17. Role and responsibilities of clinical trial personnel as per ICH GCP a. Sponsor b. Investigators c. Clinical research associate d. Auditors e. Contract research coordinators f. Regulatory authority
18. Designing of clinical study documents (protocol, CRF, ICF, PIC with assignment)
19. Informed consent Process
20. Data management and its components
21. Safety monitoring in clinical trials.

5.2 Pharmacoepidemiology and Pharmacoeconomics (Theory)

1. Pharmacoepidemiology:

Definition and scope: Origin and evaluation of pharmacoepidemiology need for pharmacoepidemiology, aims and applications.

Measurement of outcomes in pharmacoepidemiology: Outcome measure and drug use measures - Prevalence, incidence and incidence rate. Monetary units, number of prescriptions, units of drugs dispensed, defined daily doses and prescribed daily doses, medication adherence measurement

Concept of risk in pharmacoepidemiology: Measurement of risk, attributable risk and relative risk, timerisk relationship and odds ratio

Pharmacoepidemiological methods: Includes theoretical aspects of various methods and practical study of various methods with the help of case studies for individual methods - Drug utilization review, case reports, case series, surveys of drug use, cross - sectional studies, cohort studies, case control studies, case -cohort studies, meta - analysis studies, spontaneous reporting, prescription event monitoring and record linkage system.

Sources of data for pharmacoepidemiological studies: Ad Hoc data sources and automated data systems.

Selected special applications of pharmacoepidemiology: Studies of vaccine safety, hospital pharmacoepidemiology, pharmacoepidemiology and risk management, drug induced birth defects.

2. Phrmacoeconomics:

Definition, history, needs of pharmacoeconomic evaluations. Role in formulary management decisions

Pharmacoeconomic evaluation: Outcome assessment and types of evaluation. Includes theoretical aspects of various methods and practical study of various methods with the help of case studies for individual methods: Cost - minimization, costbenefit, cost - effectiveness, cost utility

3. Applications of Pharmacoeconomics

Software and case studies

5.3 Clinical Pharmacokinetics & Pharmacotherapeutic Drug Monitoring (Theory)

1. Introduction to Clinical pharmacokinetics.
2. Design of dosage regimens: Nomograms and Tabulations in designing dosage regimen, Conversion from intravenous to oral dosing, Determination of dose and dosing intervals, Drug dosing in the elderly and pediatrics and obese patients.
3. Pharmacokinetics of Drug Interaction: a. Pharmacokinetic drug interactions b. Inhibition and Induction of Drug metabolism c. Inhibition of Biliary Excretion.
4. Therapeutic Drug monitoring: a. Introduction b. Individualization of drug dosage regimen (Variability - Genetic, Age and Weight , disease, Interacting drugs). c. Indications for TDM. Protocol for TDM. d. Pharmacokinetic/Pharmacodynamic Correlation in drug therapy. e. TDM of drugs used in the following disease conditions: cardiovascular disease, Seizure disorders, Psychiatric conditions, and Organ transplantations.
5. Dosage adjustment in Renal and hepatic Disease. a. Renal impairment b. Pharmacokinetic considerations c. General approach for dosage adjustment in Renal disease. d. Measurement of Glomerular Filtration rate and creatinine clearance. e. Dosage adjustment for uremic patients. f. Extracorporeal removal of drugs. g. Effect of Hepatic disease on pharmacokinetics.
6. Population Pharmacokinetics. a. Introduction to Bayesian Theory. b. Adaptive method or Dosing with feed back. c. Analysis of Population pharmacokinetic Data.
7. Pharmacogenetics a. Genetic polymorphism in Drug metabolism: Cytochrome P-450 Isoenzymes. b. Genetic Polymorphism in Drug Transport and Drug Targets. c. Pharmacogenetics and Pharmacokinetics/Pharmacodynamic considerations

5.4 Clerkship

Clerkship in the fifth year is attending ward rounds on daily basis. The regulations provide for practical training in Chapter III of the Pharm.D. Regulations 2008 as follows:

Hospital posting. - Every student shall be posted in constituent hospital for a period of not less than fifty hours to be covered in not less than 200 working days in each of second, third & fourth year course. Each student shall submit report duly certified by the preceptor and duly attested by the Head of the Department or Institution as prescribed. In the fifth year, every student shall spend half a day in the morning hours attending ward rounds on daily basis as a part of clerkship. Theory teaching may be scheduled in the afternoon.

Clerkship examination - Oral examination shall be conducted after the completion of clerkship of students. An external and an internal examiner will evaluate the student. Students may be asked to present the allotted medical cases followed by discussion. Students' capabilities in delivering clinical pharmacy services, pharmaceutical care planning and knowledge of therapeutics shall be assessed.

5.5 Project work (Six Months)

Project work. - (1) To allow the student to develop data collection and reporting skills in the area of community, hospital and clinical pharmacy, a project work shall be carried out under the supervision of a teacher. The project topic must be approved by the Head of the Department or Head of the Institution. The same shall be announced to students within one month of commencement of the fifth year classes.

Project work shall be presented in a written report and as a seminar at the end of the year. External and the internal examiners shall do the assessment of the project work.

(2) Project work shall comprise of objectives of the work, methodology, results, discussions and conclusions.

Objectives of project work. - The main objectives of the project work is to - (i) show the evidence of having made accurate description of published work of others and of having recorded the findings in an impartial manner; and (ii) develop the students in data collection, analysis and reporting and interpretation skills.

Methodology. - To complete the project work following methodology shall be adopted, namely: - (i) students shall work in groups of not less than two and not more than four under an authorised teacher; (ii) project topic shall be approved by the Head of the Department or Head of the Institution; (iii) project work chosen shall be related to the pharmacy practice in community, hospital and clinical setup. It shall be patient and treatment (Medicine) oriented, like drug utilisation reviews, pharmacoepidemiology, pharmacovigilance or pharmacoeconomics; (iv) project work shall be approved by the institutional ethics committee; (v) student shall present at least three seminars, one in the beginning, one at middle and one at the end of the project work; and (vi) two page writeup of the project indicating title, objectives, methodology anticipated benefits and references shall be submitted to the Head of the Department or Head of Institution.

Source: Pharmacy Council of India, New Delhi, Pharm.D. Regulations 2008 (published in the Gazette of India, No.19, Part III, Section 4, New Delhi, 10th May, 2008), Appendix-A (see regulation 8), Pharm.D. Syllabus, and Chapter III, Practical training. Syllabus text above is reproduced from the PCI syllabus and regulations.