Course

Unit 1

UNIT I- Introduction to Pharmacoepidemiology: 10 hours

• Definition, Scope, Aims & Applications of Pharamcoepedemiology

1hr.

• Outcome measurement:
  • Outcome measures, Drug use measures: Monetary units, Number of prescriptions, units of drug dispensed, defined daily doses

2hr.

• Prescribed daily doses, Diagnosis and Therapy surveys, Prevalence, Incidence rate
• Monetary units, number of prescriptions, unit of drugs dispensed, defined daily doses and prescribed daily doses
• Medications adherence 1hr.
• Concept of risk: Measurement of risk, Attributable risk and relative risk, Time- risk relationship and odds ratio

Unit 2

UNIT II- Pharmacoepidemiological Methods: 8 hours

• Qualitative models: Drug Utilization Review
• Quantitative models: case reports, case series, Cross sectional studies, Cohort and case control studies
• Calculation of Odds’ ratio, Meta-analysis models
• Applications and relevance of the above in pharmacoepidemiology

1hr.

• Drug effects study in populations: Spontaneous reporting, Prescription Event Monitoring, Post marketing surveillance, Record linkage systems, Applications of Pharmacoepidemiology `

Unit 3

UNIT III- Introduction to Pharmacoeconomics . 8 hours

• Definition, history of Pharmacoeconomics, Need of Pharmacoeconomic studies in Indian healthcare system.
• Cost categorization and resources for cost estimation: Direct costs. Indirect costs. Intangible costs.
• Outcomes and Measurements of Pharmacoeconomics: Types of outcomes: Clinical outcome, Economic outcomes, Humanistic outcomes; Quality Adjusted Life Years, Disability Adjusted Life Years
• Incremental Cost Effective Ratio, Average Cost Effective Ratio, Person Time, Willingness To Pay, Time Trade Off and Discounting

Unit 4

UNIT IV- Pharmacoeconomic evaluations 6 hours

• Definition, Steps involved, Applications, Advantages and disadvantages of the following Pharmacoeconomic models
• Cost Minimization Analysis (CMA)
• Cost Benefit Analysis (CBA)
• Cost Effective Analysis (CEA), Cost Utility Analysis (CUA)
• Cost of Illness (COI), Cost Consequences Analysis (COA)

Unit 5

UNIT V 5 hours

• Health related quality of life (HRQOL): Definition, Need for measurement of HRQOL, Common HRQOL measures.

· Applications of the following:

• Decision Analysis and Decision tree, Sensitivity analysis
• Markov Modeling, Software used in pharmacoeconomic analysis

1hr.

• Applications of Pharmacoeconomics

Unit 6

UNIT VI 5hr.

• Health Technology assessment

• HTA in Practice (US, UK, EU, LMICs)
• Economic Evaluation in Healthcare
• Designing clinical studies for HTA
• Health economics and outcomes research (HEOR)
• Budget impact analysis

Pharmacoepidemiology and pharmacoeconomics play critical roles in ensuring that drug therapies are safe, effective, and economically sustainable, ultimately contributing to improved public health outcomes. Pharmacoepidemiology is the study of the uses and effects of drugs in large populations. Students can bridge the gap between clinical pharmacology and epidemiology, offering insights into drug safety, effectiveness, and patterns of use. Pharmacoeconomics evaluates the economic impact of pharmaceutical products and therapies, focusing on cost-effectiveness, cost-benefit, and cost-utility analyses.

Pharmacoepidemiology and pharmacoeconomics reflect a dynamic and interdisciplinary approach, leveraging advanced technologies, real-world data, and a focus on personalized and value-based healthcare to improve drug safety, effectiveness, and economic sustainability. students are prepared to contribute to improved patient care outcomes through informed decision-making and effective resource management. Students can exhibit this holistic approach to ensures that clinical pharmacy services are continuously enhanced, leading to safer and more cost- effective healthcare solutions.

Upon successful completion of the course, the student shall be able to:

KNOWLEDGE

K1: Implement the various pharmacoepidemiological methods

K2: Carryout the applications of pharmacoepidemiology and pharmacoeconomics in clinical settings

K3: Design the various pharmacoepidemiological outcome measures

K4: Generate the concept of risk in pharmacoepidemiology and different methods of measuring risk

K5: Modify the current pharmacoeconomic evaluation methods as per need.

K6: Differentiate the methods to measure outcomes in pharmacoecnomic studies

SKILL

S1: Manage the time-risk relationship curves

S2: Categorize different types of cost analysis

S3: Articulate the updated vaccine safety guidelines

S4: Interface with Ad Hoc data sources and automated data systems

S5: Coordinate the surveys of drug use

S6: Grade the appropriate software in pharmacoeconomics

ATTITUDE

A1: Demonstrate to Pharmacoepidemiology qualitative and quantitative models

A2: Value cost-minimization analysis for two competing drug therapies.

A3: Develop the methodology of a published pharmacoeconomic evaluation to assess its applicability to a specific patient population.

A4: Exhibit budget impact model for a new treatment to predict its financial implications for a healthcare system.

A5: Cultivate an interdisciplinary perspective, enabling them to collaborate effectively with researchers.

A6: Display the advantages and limitations of randomized controlled trials versus observational studies in drug safety research.

REFERENCES BOOKS:

1. Rascati K. Essentials of pharmacoeconomics. Lippincott Williams & Wilkins;
2. Juan E. del Llano-Señarís, Carlos Campillo-Artero. Health Technology Assessment and Health Policy Today: A Multifaceted View of their Unstable Crossroads. Springer. 2015.
3. Drummond MF, Sculpher MJ, Claxton K, Stoddart GL, Torrance GW. Methods for the economic evaluation of health care programmes. Oxford university press; 2015.
4. Walley, Tom. “Pharmacoeconomics.” Getting Health Economics into Practice. CRC Press, 2018.

JOURNALS

1. Expert Review of Pharmacoeconomics and Outcomes Research (Taylor & Francis).
2. Pharmacoepidemiology and Drug Safety (Wiley).

ASSIGNMENTS:

1. Link between pharmacoepidemiology and pharmacovigilance
2. Tools to support health technology Group discussion on Vaccines
3. Different databases in pharmacoepidemiological research
4. Hospital-based aspects of pharmacoepidemiology
5. Perform a literature search on recent advancements in pharmacoepidemiology and do a presentation on the same.
6. Global survey on HTA and Health benefit
7. ISPOR’s Patient-Centered Special Interest Group
8. Practical session on software like SPSS, EPIINFO and
9. Perform a cost-effective analysis of the interventions during clinical postings
10. Health intervention and technology assessment in support of universal health coverage