JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

Course Objectives

This course is designed to impart knowledge and skills in vigilance,

epidemiology, economics and of various diseases. This will enable the students to understand cost effectiveness in the management of disease and ADRS

Course Outcome

At completion of this subject, the students are expected to understand risk of

pharmacoepidemiology history and need of pharmacoeconomics and assessment of pharmocovigilance.

UNIT - I

Introduction to adverse drug reactions. Definitions and classification of ADRs. Detection and

reporting. Causality assessment.Severity and seriousness assessment. Predictability and preventability assessment. Management of adverse drug reactions .Role of pharmacist in management of ADRs.

UNIT - II: Pharmacovigilance Scope, definition and aims of Pharmacovigilance .Introduction to

pharmacovigilance. History and development of pharmacovigilance. Importance of safety monitoring/ Why pharmacovigilance. National and international scenario: Pharmacovigilance in India, Pharmacovigilance global perspective, WHO international drug monitoring programme. Drug dictionaries and coding in pharmacovigilance: WHO adverse reaction terminologies. Med DRA and Standardised Med DRA queries. WHO drug dictionary, EudraVigilance medicinal product dictionary.

UNIT - III: Basic terminologies used in pharmacovigilance

Terminologies of adverse medication

related events. Regulatory terminologies. Information resources in pharmacovigilance: Basic drug information resources. Specialised resources forADRs Critical evaluation of medication safety literature Pharmacovigilance methods: Passive surveillance – Spontaneous reports and case series. Stimulated reporting. Active surveillance – Sentinel sites, drug event monitoring and registries. Comparative observational studies – Cross sectional study, case control study and cohort study. Targeted clinical investigations. Vaccine safety surveillance

UNIT - IV: Pharmacoepidemiology

Definition and scope: Origin and evaluation of

pharmacoepidemiology need for pharmacoepidemiology, aims and applications. Measurement of outcomes in pharmacoepidemiology. 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.

UNIT - V: Pharmacoeconomics

Definition, history, need of pharmacoeconomic evaluations Role in

formulary management decisions. Pharmacoeconomic evaluation Outcomes 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, cost - benefit, cost – effectiveness, cost utility Applications of Pharmacoeconomics, Softwares used and case studies.

TEXT BOOKS:

• 1. Textbook of Pharmacovigilance: Concept & practice- KG. Revikumar.
• 2. Textbook of Pharmacovigilance: Concept & practice- Mohanta,Pharmamed press.
• 3. SK GUPTA Textbook of PharmacovigilanceIcri Institute of Clinical Research, India. R16 B.PHARMACY IV YEAR

REFERENCES:

• 1. Goodman & Gilman’s The Pharmcological basis of Therapeutics Ed. J.G. Hardman, L.E. Limbird, P.B. Molinoff and R. W. Ruddon. International Edition. McGraw Hil.
• 2. G Katzung, Basic and Clinical Pharmacology. Bertram, 9th edn Lange Publications, 2004. R16 B.PHARMACY IV YEAR