Pharmacoepidemiology And Phamacoeconomics D.Pharm Question Bank : web.tnmgrmu.ac.in
Name of the University : The Tamilnadu Dr. M.G.R. Medical University
Degree : D.Pharm
Subject Code/Name : 3824/Pharmacoepidemiology And Phamacoeconomics
Year : V
Paper : II
Document Type : Question Bank
Website : web.tnmgrmu.ac.in
Download Model/Sample Question Paper :
2011-2014 : https://www.pdfquestion.in/uploads/web.tnmgrmu.ac.in/PHARMACY/3822-383826KX.pdf
Pharmacoepidemiology & Phamacoeconomics :
Sub. Code: 3826
DOCTOR OF PHARMACY (PHARM. D / POST BACCALAUREATE) DEGREE EXAMINATION
PAPER II : PHARMACOEPIDEMIOLOGY AND PHAMACOECONOMICS
Q.P. Code : 383826
Related : TNMGRMU Clinical Pharmacokinetics And Pharmacotherapeutic Drug Monitoring D.Pharm Question Bank : www.pdfquestion.in/3823.html
Time : 3 hours
Maximum : 100 marks
(180 Min)
Answer ALL questions in the same order. :
I. Elaborate on :
1. Define the term Pharmacoecconomics, the need for pharmacoecconomics in Indian scenario. Discuss the types of pharmacoeconomic evaluations
2. Discuss the description, strength and weakness of automated data bases. Write about Group health Co-operative data base.
II. Write notes on :
1. Define cross-sectional and meta-analysis studies with an example
2. Give the applications of pharmacoecconomics
3. Role of pharmacoecconomics in formulary management decision
4. Need of pharmacoepidemiology and Evidence based medicine
5. Define Drug utilization review and mention the steps involved
6. Describe cost effectiveness analysis with an example
7. Define cumulative incidence, prevalence and odd’ ratio
8. Define attributable risk and relative risk
9. Drug use measures in terms of units of use
10. Write about prescription event monitoring
OCTOBER 2013 :
I. Elaborate on: (2 x 20 = 40)
1. Discuss the significance and steps of drug utilization review.
2. What are the various types of pharmacoeconomic evaluations? Explain.
II. Write notes on: (10 x 3 = 30)
1. Describe
(a) cross sectional studies
(b) cohort studies
(c) case-control studies
2. Discuss briefly positive and negative outcomes of pharmacoepidemiological studies
3. Discuss Odds ratio and Relative Risk
4. Medication adherence and its measurement
5. Applications of epidemiological model
6. Record linkage system
7. Illustrate the use of softwares in pharmacoeconomics
8. Role of pharmacoeconomics in formulary management decisions
9. What is defined daily dose and prescribed daily dose
10. Discuss case reports and case series.
APRIL 2014 :
I. Elaborate on : (2×20=40)
1. How do you express the outcome of drug use in pharmacoepidemiologic studies? Discuss briefly on meta-analysis.
2. Discuss various criteria for pharmacoeconomic studies. Explain cost-minimization analysis and cost-effectiveness analysis. What are the various applications of pharmacoeconomics?
II. Write notes on : (10×3=30)
1. Methods of medication adherence measurement.
2. Randomized controlled trials and case control studies.
3. Applications of pharmacoepidemiology and pharmacoeconomics.
4. Use of software in pharmacoeconomics.
5. Origin and evolution of pharmacoepidemiology.
6. Briefly discuss the ‘concept of risk’ in pharmacoepidemiology.
7. Describe Ad Hoc data sources and automated data systems.
8. Explain cost benefit analysis and cost utility analysis.
9. Define pharmacoeconomics and discuss the need of pharmacoeconomic evaluations.
10. Prescription event monitoring and record linkage system.
Syllabus :
Clinical Research [Theory]
1. Drug development process :
Introduction :
Various Approaches to drug discovery
1. Pharmacological
2. Toxicological
3. IND Application
4. Drug characterization
5. Dosage form
2. Clinical development of drug :
1. Introduction to Clinical trials
2. Various phases of clinical trial.
3. Methods of post marketing surveillance
4. Abbreviated New Drug Application submission.
5. Good Clinical Practice – ICH, GCP, Central drug standard control organisation (CDSCO) guidelines
6. Challenges in the implementation of guidelines
7. Ethical guidelines in Clinical Research
8. Composition, responsibilities, procedures of IRB/IEC
9. Overview of regulatory environment in USA, Europe and India.
10. Role and responsibilites 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
11. Designing of clinical study documents (protocol, CRF, ICF, PIC with assignment)
12. Informed consent Process
13. Data management and its components
14. Safety monitoring in clinical trials
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 dose, medication adherence measurement.
Concept of risk in pharmacoepidemiology :
Measurement of risk, attributable risk and relative risk, time-risk 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.