Curriculum | Pharmacovigilance (THEORY) | B. Pharmacy

Course: B. Pharmacy 8thSem/ 4th year
Name of Subject: Pharmacovigilance (THEORY)
Subject Code:  BP 805ET
S No. Contents of the Topics Learning objectives

(In the end of lecture, the student must be able to)

 

Teaching Guidelines Methodology Time

(Hrs)

 
1.       Introduction to Pharmacovigilance

 

History and development of Pharmacovigilance

 

Importance of safety monitoring of Medicine

 

WHO international drug monitoring programme

 

Pharmacovigilance Program of  India(PvPI)

Introduction to adverse drug reactions

 

Definitions and classification of ADRs

 

Detection and reporting

 

Methodsin Causality assessment

 

Severity and seriousness assessment

 

Predictability and preventability assessment

 

Management of adverse drug reactions

Basic terminologies used in pharmacovigilance

Terminologies of adverse medication related events

 

Regulatory terminologies

describe concept of Pharmacovigilance, detection and reporting of adverse drug reactions

 

 

Introduction to pharmacovigilance

and adverse drug reactions

Instructive, Through Chart, Tutorial, Instructive

Power point presentation

Group discussion

 

   
10  
2.       Drug and disease classification

 

Anatomical, therapeutic and chemical classification of drugs

 

International classification of diseases

 

Daily defined doses

 

International Non proprietary Names for drugs

Drug dictionaries and coding in pharmacovigilance

 

WHO adverse reaction terminologies

 

MedDRA and Standardized MedDRA queries

 

WHO drug dictionary

 

Eudravigilance medicinal product dictionary

Information resources in pharmacovigilance

 

Basic drug information resources

 

Specialised resources for ADRs

Establishing pharmacovigilance programme

 

Establishing in a hospital

 

Establishment & operation of drugsafety department in industry

 

Contract Research Organisations (CROs)

 

Establishing a national programme

 

explain international classification of diseases and different classifications of drugs,

discuss terms used by WHO and in various databases,

identify reliable resources in pharmacovigilance,

enumerate requirements for establishing pharmacovigilance programme

Classification of drug and disease and discussion about information resources in pharmacovigilance Instructive, Through Chart, Tutorial, Instructive

Power point presentation

Group discussion

10  
3.       Vaccine safety surveillance

 

Vaccine Pharmacovigilance

 

Vaccination failure

 

Adverse events following immunization

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

Communication in pharmacovigilance

 

Effective communication in Pharmacovigilance

 

Communication in Drug Safety Crisis management

 

Communicating with Regulatory Agencies, Business Partners, Healthcare facilities & Media

 

discuss about the pharmacovigilance of vaccines, describe methods of ADR monitoring and

explain importance of proper communication in pharmacovigilance

Vaccine safety surveillance

Pharmacovigilance methods

Communication in pharmacovigilance

 

Instructive, Through Chart, Tutorial, Instructive

Power point presentation

Group discussion

10  
4.       Statistical methods for evaluating medication safety data

Safety data generation

 

Pre clinical phase

 

Clinical phase

 

Post approval phase

ICH Guidelines for Pharmacovigilance

 

Organization and objectives of ICH

Expedited reporting

Individual case safety reports

Periodic safety update reports

Post approval expedited reporting

Pharmacovigilance planning

Good clinical practice in pharmacovigilance studies

 

 

describe methods for evaluating data of different phases

enumerate  ICH guidelines and their significance in pharmacovigilance

Statistical methods for evaluating medication safety data

Safety data generation

ICH Guidelines for Pharmacovigilance

 

 

Instructive, Through Chart, Tutorial, Instructive

Power point presentation

Group discussion

 

8  
      5. Pharmacogenomics of adverse drug reactions

Drug safety evaluation in special population

Paediatrics, Pregnancy and lactation, Geriatrics

CIOMS

CIOMS Working Groups, CIOMS Form

CDSCO (India) and Pharmacovigilance

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

 

demonstrate  pharmacogenomics and various health conditions in relevance of pharmacovigilance the difference between Indian and global pharmacovigilance requirements,

enumerate role of CIOMS in ADR reporting and enumerate

differences between Indian and global pharmacovigilance requirements

Pharmacogenomics of adverse drug reactions

 

Drug safety evaluation in special population

CDSCO (India) and Pharmacovigilance

 

 

Instructive, Through Chart, Tutorial, Instructive

Power point presentation

Group discussion

7