Essentials of pharmacovigilance / Himanshu Baweja ; Forwards Sangeeta Sharma, Yatin Mehta.

Includes Index.

1. Pharmacovigilance: A Complete Study about
the Knowledge of Adverse Drug Reaction 1
„ Categorization of Adverse Drug Reactions (ADRS): Based on Intensity 2
„ Why Pharmacovigilance in India? 4
„ Why Do We Need Pharmacovigilance? 4
„ Who Program for International Drug Monitoring 5
„ Specific Aims of Pharmacovigilance 6
„ Global Perspective of Pharmacovigilance 6
„ Scope of Pharmacovigilance Program of India 7
„ Major Aims of Pharmacovigilance 7
2. History of Pharmacovigilance 11
„ Origin of Pharmacovigilance (PV) 11
„ History 12
3. Aim and Importance of Pharmacovigilance 19
„ Aim of Pharmacovigilance 19
„ Objective of Pharmacovigilance 19
„ Definition of Adverse Drug Reaction (ADR) and Its Types 20
„ Importance of Pharmacovigilance 21
„ International Response to Drug Safety Issues 23
„ Major Challenges 24
4. Role of Healthcare Professionals in Pharmacovigilance 27
„ HCPS and ADRS Reporting 29
5. Importance of Pharmacovigilance in
Special Groups such as Infants, Elderly and Pregnant Women 35
„ Drug Monitoring in Special Population 36
„ Drugs Prescribed in Pregnancy 36
6. Legal Aspects of Pharmacovigilance 41
„ Global Regulations in Pharmacovigilance 42
„ Summary of Product Characteristics (SPC) 42
„ Pharmacovigilance: Toward the Next Millennium 42
7. Pharmacovigilance Programme of India 45
„ The Indian Pharmacopoeia Commission (IPC) 46
„ Pharmacovigilance Programme of India 46
„ WHO–UMC (Uppsala Monitoring Centre) and India 48
8. Practical Aspects of Pharmacovigilance Practices at Corporate Hospital 51
„ Introduction of Clinical Pharmacology Department 51
„ Why Clinical Pharmacists are Required in Hospital? 52
„ Objective of Clinical Pharmacology Department 53
„ Responsible Staff Involved in Clinical Pharmacology Department 53
„ Role of Clinical Pharmacology Department 53
„ Drug Information Center 54
„ Pharmacovigilance Center 54
„ Standard Operating Procedures (SOP) of
Clinical Pharmacology Department in Hospital 54
„ Monitoring on Electronic Information System (E-Prescription) 57
„ Report and Documentation 57
9. Medication Errors, Its Practical
Analysis and Resolution 59
„ Types of Medication Errors Involved 60
„ Root Cause Analysis of Medication Error 60
„ Corrective and Preventive Action 61
„ Six Rights of Medication Safety 61
„ Categorization of Medication Errors 61
„ Definition and Levels of Adverse Drug Reaction (ADR) 61
„ Practical Analysis of Medication Errors 62
„ Practical Resolution of Medication Errors 63
10. Recording and Reporting of Adverse Drug Reactions 65
„ Methods of ADR Reporting 65
„ Spontaneous Reporting 67
„ Good Reporting Practices 68
„ Suspected ADR Reporting Form 68
„ ICSR and Its Detailed Components 69
„ ADR Reporting Form for Healthcare Professionals 72
„ Who Can Report? 73
„ Why to Report? 73
„ What to Report? 73
„ How and Whom to Report? 73
„ Characteristics of a Good Case Report 73
„ Limitations of Spontaneous Reporting in India 74
„ Recent Initiatives to Enhance the Reporting in PVPI 74
„ Establishment of an AMC 75
„ Data Flow and Establishment of AMC 75
„ Assessment of Individual Case Safety Reports 75
„ Utilization of the Data 76
„ Reporting Requirements in Special Population 77
„ Reporting in the Event of a Public Health Emergency 77
„ Reports of Overdose, Abuse, Off-Label Use, Misuse or OTC 78
11. Periodic Safety Update Report 79
„ Common Forms in Pharmacovigilance 80
„ Definitions of Various Terminologies Used in Common
Forms in Pharmacovigilance Across World 81
„ Severity Versus Seriousness 81
„ Causality Assessment 83
„ Prescribing Information 83
„ Global Regulations in Pharmacovigilance 85
„ Databases and Commercial Software
Tools Used in Pharmacovigilance 85
12. Causality Assessment of Drugs and Medical Devices: Logic and Method 87
„ Materiovigilance 88
„ Why Causality Assessment of Medical Devices 88
„ Causality Assessment Scales 89
„ Causality Term: Assessment Criteria 90
„ Indian Regulation of Drug/All Medical Devices Adverse Event Reporting 91
„ General Design of Causality Assessment2,3 92
„ Four Basic Criteria 92
„ Various Conditions in Causality Assessment 92
13. Cure To Prescription: E-Prescription 97
„ Purpose of Prescription 98
„ Electronic Prescription (E-Prescription) 98
14. Drug–Drug Interactions in Tertiary Care Hospital 105
„ Epidemiology 106
„ Severity of Drug–Drug Interactions 106
„ Risk Factors of Drug–Drug Interactions 106
„ Mechanism of Drug–Drug Interactions 107
„ Effects: Hospital Stay and Cost 107
„ Prevention 115
„ Corrective Measures 116
15. Therapeutic Drug Monitoring 117
„ Drug Therapy Monitoring 118
„ Clinical Review of Medication Administration Chart 120
„ Ward Round Participation 120
„ Role of Pharmacist in the Management of ADRS 121
„ Patient Counseling 121
„ Clinical Usefulness of TDM 122
16. Postmarket Surveillance Program Concepts, Goals and Practices 123
„ Postmarket Surveillance for Medical
Devices-Associated Adverse Events 125
„ Components of a Postmarket Surveillance Program 126
„ A Model Postmarket Surveillance Program Structure 139
17. Hemovigilance 143
„ Objective of Reporting Adverse Reactions and
Adverse Reactions in Transfusion 144
„ Roles and Responsibilities of HVPI Units 144
18. Case Studies (With Answers) 151
Index 171