Unit I

Introduction to Pharmacovigilance

1. History and development of Pharmacovigilance
2. Importance of safety monitoring of Medicine
3. WHO international drug monitoring programme
4. Pharmacovigilance Program of India(PvPI)

Introduction to adverse drug reactions

1. Definitions and classification of ADRs
2. Detection and reporting
3. Methods in Causality assessment
4. Severity and seriousness assessment
5. Predictability and preventability assessment
6. Management of adverse drug reactions

Basic terminologies used in pharmacovigilance

1. Terminologies of adverse medication related events
2. Regulatory terminologies

(10 Hours)

Unit II

Drug and disease classification

1. Anatomical, therapeutic and chemical classification of drugs
2. International classification of diseases
3. Daily defined doses
4. International Non proprietary Names for drugs

Drug dictionaries and coding in pharmacovigilance

1. WHO adverse reaction terminologies
2. MedDRA and Standardised MedDRA queries
3. WHO drug dictionary
4. Eudravigilance medicinal product dictionary

Information resources in pharmacovigilance

1. Basic drug information resources
2. Specialised resources for ADRs

Establishing pharmacovigilance programme

1. Establishing in a hospital
2. Establishment & operation of drug safety department in industry
3. Contract Research Organisations (CROs)
4. Establishing a national programme

(10 Hours)

Unit III

Vaccine safety surveillance

1. Vaccine Pharmacovigilance
2. Vaccination failure
3. Adverse events following immunization

Pharmacovigilance methods

1. Passive surveillance – Spontaneous reports and case series
2. Stimulated reporting
3. Active surveillance – Sentinel sites, drug event monitoring and registries
4. Comparative observational studies – Cross sectional study, case control study and cohort study
5. Targeted clinical investigations

Communication in pharmacovigilance

1. Effective communication in Pharmacovigilance
2. Communication in Drug Safety Crisis management
3. Communicating with Regulatory Agencies, Business Partners, Healthcare facilities & Media

(10 Hours)

Unit IV

Safety data generation

1. Pre clinical phase
2. Clinical phase
3. Post approval phase (PMS)

ICH Guidelines for Pharmacovigilance

1. Organization and objectives of ICH
2. Expedited reporting
3. Individual case safety reports
4. Periodic safety update reports
5. Post approval expedited reporting
6. Pharmacovigilance planning
7. Good clinical practice in pharmacovigilance studies

(08 Hours)

Unit V

Pharmacogenomics of adverse drug reactions

1. Genetics related ADR with example focusing PK parameters.

Drug safety evaluation in special population

1. Paediatrics
2. Pregnancy and lactation
3. Geriatrics

CIOMS

1. CIOMS Working Groups
2. CIOMS Form

CDSCO (India) and Pharmacovigilance

1. D&C Act and Schedule Y
2. Differences in Indian and global pharmacovigilance requirements

(07 Hours)

‘Pharmacovigilance – Theory’ is a course offered in the eighth semester of B. Pharm program at School of Pharmacy, Health Sciences campus, Amrita Vishwa Vidyapeetham.

Course Duration: 45 Hours

Scope:

This paper will provide an opportunity for the student to learn about development of pharmacovigilance as a science, basic terminologies used in pharmacovigilance, global scenario of Pharmacovigilance, train students on establishing pharmacovigilance programme in an organization, various methods that can be used to generate safety data and signal detection. This paper also develops the skills of classifying drugs, diseases and adverse drug reactions.

Objectives:

At completion of this paper it is expected that students will be able to (know, do, and appreciate):

1. Why drug safety monitoring is important?
2. History and development of pharmacovigilance
3. National and international scenario of pharmacovigilance
4. Dictionaries, coding and terminologies used in pharmacovigilance
5. Detection of new adverse drug reactions and their assessment
6. International standards for classification of diseases and drugs
7. Adverse drug reaction reporting systems and communication in pharmacovigilance
8. Methods to generate safety data during pre clinical, clinical and post approval phases of drugs’ life cycle
9. Drug safety evaluation in paediatrics, geriatrics, pregnancy and lactation
10. Pharmacovigilance Program of India (PvPI) requirement for ADR reporting in India
11. ICH guidelines for ICSR, PSUR, expedited reporting, pharmacovigilance planning
12. CIOMS requirements for ADR reporting
13. Writing case narratives of adverse events and their quality.

Recommended Books (Latest Editions)

1. Textbook of Pharmacovigilance: S K Gupta, Jaypee Brothers, Medical Publishers.
2. Practical Drug Safety from A to Z By Barton Cobert, Pierre Biron, Jones and Bartlett Publishers.
3. Mann’s Pharmacovigilance: Elizabeth B. Andrews, Nicholas, Wiley Publishers.
4. Stephens’ Detection of New Adverse Drug Reactions: John Talbot, Patrick Walle, Wiley Publishers.
5. An Introduction to Pharmacovigilance: Patrick Waller,Wiley Publishers.
6. Cobert’s Manual of Drug Safety and Pharmacovigilance: Barton Cobert,Jones& Bartlett Publishers.
7. Textbook of Pharmacoepidemiolog edited by Brian L. Strom, Stephen E Kimmel, Sean Hennessy,Wi- ley Publishers.
8. A Textbook of Clinical Pharmacy Practice -Essential Concepts and Skills:G. Parthasarathi, Karin NyfortHansen,Milap C. Nahata
9. National Formulary of India
10. Text Book of Medicine by Yashpal Munjal
11. Text book of Pharmacovigilance: concept and practice by GP Mohanta and PK Manna
12. ICH
13. CIOMS
14. CDSCO
15. World Health Organization
16. Pharmaceutical Programme of India