Course

UNIT I: PHARMACOEPIDEMIOLOGY: 3 hours

• Definition and Scope
• Origin and evolution of Pharmacoepidemiology 1 hour
• Need for Pharmacoepidemiology 1 hour
• Aims and applications of Pharmacoepidemology 1 hour

Measurement of outcomes in Pharmacoepidemiology                           7 hours

• Define and classify outcomes(ECHO model)- 1 hour
• Outcome measures and its classification 1 hour
• Statistical measures: Prevalence, incidence and incidence 2 hours
• Drug use measures: Monetary units, number of prescriptions, units of drugs dispensed, defined daily doses and prescribed daily doses, medication adherence measurement 3 hours

Concept of risk in pharmacoepidemiology                                               2 hours

• Measurement of risk, attributable risk and relative risk, time-risk relationship and odds ratio 1 hour
• Case studies and relevant examples of measuring risk in pharmacoepidemiology

1 hour

UNIT II PHARMACOEPIDEMIOLOGICAL METHODS 16 hours

Includes theoretical and practical aspects of pharmacoepidemiology explained with aid of case studies:

• Pharmacoepidemological methods: observational and interventional 1 hour
• Observational : descriptive and analytical(Case reports, case series, surveys of drug use, cross – sectional studies, cohort studies, case control studies, case – cohort studies, systematic review and meta – analysis studies, Drug utilization review (Relevance of DUR), 6 hours
• Interventional: Quasi-randomized trial, Randomised Control Trials including types of randomisation and trial design. 1 hour
• Spontaneous reporting 1 hour
• Prescription event monitoring and Record linkage 1 hour

Sources of data for pharmacoepidemiological studies                            3 hours

• Ad Hoc data sources and automated data

Selected special applications of pharmacoepidemiology                         3 hours

• Studies of vaccine safety
• Hospital pharmacoepidemiology
• Pharmacoepidemiology and risk management,
• Drug induced birth

UNIT III Pharmacoeconomics:

Definition, history, needs of pharmacoeconomic evaluations                        2hours

• Role in formulary management decisions
• Decision models in pharmacoeconomics: markov model & decision tree model and its analysis

Pharmacoeconomic evaluation                                                                      16 hours

• Outcome assessment and types of evaluation 4 hours
• Includes theoretical and practical aspects of pharmacoeconomics explained with aid of case studies : Cost – minimization, cost- benefit, cost – effectiveness, cost utility 12 hours

Applications of Pharmacoeconomics                                                             4 hours

• Software and case studies

ASSIGNMENTS

• Explain hospital-based pharmacoepidemiology, including drug use, ADR monitoring, and formulary decisions.
• Review recent pharmacoepidemiology advances and present key
• Discuss and compare vaccine types based on mechanism, efficacy, and
• Investigate challenges and ethics of pharmacoepidemiological studies in
• Review current pharmacoeconomics trends, policies, and
• Report on budget impact modeling processes and its importance in
• Analyze how Health Technology Assessments link pharmacoeconomics to healthcare

The course on the epidemiological and economical aspects of drugs and disease offers a comprehensive exploration into the intricate interplay between public health, pharmacology, and economics. Through an in-depth study of epidemiological patterns, students gain insights into how diseases propagate within populations and the corresponding utilization of pharmaceuticals. This includes analyzing disease prevalence, incidence rates, and the impact of various factors on health outcomes. The course delves into the economic dimensions of drug development, production costs, and the evaluation of cost-effectiveness in treatment modalities. By connecting theoretical frameworks with real-world scenarios, such as case studies and public health policies, students develop critical thinking skills essential for rational decision-making in healthcare settings. This includes assessing the risks and benefits of different therapies, interpreting epidemiological data, and understanding the broader implications of drug use on public health.

Ultimately, the course equips students with the knowledge and analytical tools necessary to navigate the complexities of drug utilization within populations, fostering a deep understanding of how to optimize healthcare practices while considering the economic implications, thereby preparing them for diverse roles in healthcare management, policy- making, and clinical practice.

Upon completion of the subject student shall be able to:

KNOWLEDGE

 K1: Recognize the ethical considerations involved in conducting pharmacoepidemiological studies, especially concerning patient privacy and data handling.

K2: Describe the role of pharmacoepidemiology in providing reliable data to support drug safety and efficacy assessments.

K3: Explain the importance of evidence-based practice in pharmacy and healthcare decision-making..

K4: Consolidate information from pharmacoepidemiological studies to draw evidence-based conclusions about drug effects and adverse events.

K5: Evaluate the strengths and limitations of different epidemiological study designs in assessing causal relationships between drug exposure and health outcomes.

K6: Assess pharmacoeconomic models and studies to make informed decisions on drug pricing, formulary management, and resource allocation in healthcare settings.

SKILLS

 S1: Identify epidemiological study designs and economic evaluation methods in pharmaceutical research.

S2: Apply pharmacoepidemiological methods to evaluate drug safety and effectiveness.

S3 Conduct analysis of pharmacoepidemiological data to identify drug-related effects

S4: Analyse the validity and reliability of pharmacoepidemiological studies and healthcare interventions.

S5:. Evaluate economic data to guide drug pricing and reimbursement decisions.

S6: Interpret trends in medication effectiveness to improve prescribing practices

ATTITUDE

 A1: Respect ethical considerations in patient privacy and data handling during studies.

A2: Uphold ethical principles in pharmacoeconomic evaluations for fair resource allocation.

A3: Recognize the importance of evidence-based practice in healthcare decision-making.

A4: Value pharmacoepidemiology’s role in ensuring drug safety and efficacy.

A5: Develop a problem-solving approach to address drug-related issues.

A6: Emphasize patient-centered care while considering economic implications on well- being.

• Strom BL, Kimmel SE, editors. Textbook of Pharmacoepidemiology: Strom/Textbook of Pharmacoepidemiology.6th ed.Chichester, England: John Wiley & Sons; 2006.
• Revikumar KG. Pharmacoepidemiology and Pharmacoeconomics: Concepts and Practice.2nd ed.Pharmamed Press; 2016.

REFERENCE BOOKS:

• Holdford DA. Renee J. G. Arnold (editor). Pharmacoeconomics: From theory to practice.2nd ed. Am J Pharm Educ; 2010.
• Parashar A,          Concept     Of     Pharmacoepidemiology And Pharmacoeconomics.1st ed. 2020.
• Nour S, Plourde G. Pharmacoepidemiology and pharmacovigilance. 1st ed. San Diego, CA: Academic Press; 2018.

JOURNALS

• Modern   Pharmacoeconomics  and Pharmacoepidemiology [Internet]. Pharmacoeconomics.ru. [cited 2022 Apr 11]. Available from: https://www.pharmacoeconomics.ru/jour
• Pharmacoepidemiology and drug Wiley; 2006.