Ramdan Hours:
Sun - Thu
9.30 AM - 2.30 PM
Iftar in --:--:--
🌙 Maghrib: --:--

Essentials of pharmacovigilance / (Record no. 11996)

MARC details
000 -LEADER
fixed length control field 06387nam a22003017i 4500
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20201006113307.0
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 200217s2019 ii a|||| |||| 001 0 eng d
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 9789352704965
040 ## - CATALOGING SOURCE
Original cataloging agency EG-NcFUE
Description conventions rda
082 00 - DEWEY DECIMAL CLASSIFICATION NUMBER
Classification number 615.7
Item number B.H.E
Edition number 23
100 1# - MAIN ENTRY--PERSONAL NAME
Personal name Baweja, Himanshu
Relator term author
245 10 - TITLE STATEMENT
Title Essentials of pharmacovigilance /
Statement of responsibility, etc Himanshu Baweja ; Forwards Sangeeta Sharma, Yatin Mehta.
250 ## - EDITION STATEMENT
Edition statement First edition
264 #1 - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT)
Place of publication, distribution, etc New Delhi,
Name of publisher, distributor, etc JAYPEE BROTHERS MEDICAL P,
Date of publication, distribution, etc 2019.
300 ## - PHYSICAL DESCRIPTION
Extent xxv, 225 pages :
Other physical details illustrations ;
Dimensions 24 cm
336 ## - CONTENT TYPE
Source rdacontent
Content type term text
337 ## - MEDIA TYPE
Source rdamedia
Media type term unmediated
338 ## - CARRIER TYPE
Source rdacarrier
Carrier type term volume
500 ## - GENERAL NOTE
General note Includes Index.
505 0# - FORMATTED CONTENTS NOTE
Formatted contents note 1. Pharmacovigilance: A Complete Study about<br/>the Knowledge of Adverse Drug Reaction 1<br/>„ Categorization of Adverse Drug Reactions (ADRS): Based on Intensity 2<br/>„ Why Pharmacovigilance in India? 4<br/>„ Why Do We Need Pharmacovigilance? 4<br/>„ Who Program for International Drug Monitoring 5<br/>„ Specific Aims of Pharmacovigilance 6<br/>„ Global Perspective of Pharmacovigilance 6<br/>„ Scope of Pharmacovigilance Program of India 7<br/>„ Major Aims of Pharmacovigilance 7<br/>2. History of Pharmacovigilance 11<br/>„ Origin of Pharmacovigilance (PV) 11<br/>„ History 12<br/>3. Aim and Importance of Pharmacovigilance 19<br/>„ Aim of Pharmacovigilance 19<br/>„ Objective of Pharmacovigilance 19<br/>„ Definition of Adverse Drug Reaction (ADR) and Its Types 20<br/>„ Importance of Pharmacovigilance 21<br/>„ International Response to Drug Safety Issues 23<br/>„ Major Challenges 24<br/>4. Role of Healthcare Professionals in Pharmacovigilance 27<br/>„ HCPS and ADRS Reporting 29<br/>5. Importance of Pharmacovigilance in<br/>Special Groups such as Infants, Elderly and Pregnant Women 35<br/>„ Drug Monitoring in Special Population 36<br/>„ Drugs Prescribed in Pregnancy 36<br/>6. Legal Aspects of Pharmacovigilance 41<br/>„ Global Regulations in Pharmacovigilance 42<br/>„ Summary of Product Characteristics (SPC) 42<br/>„ Pharmacovigilance: Toward the Next Millennium 42<br/>7. Pharmacovigilance Programme of India 45<br/>„ The Indian Pharmacopoeia Commission (IPC) 46<br/>„ Pharmacovigilance Programme of India 46<br/>„ WHO–UMC (Uppsala Monitoring Centre) and India 48<br/>8. Practical Aspects of Pharmacovigilance Practices at Corporate Hospital 51<br/>„ Introduction of Clinical Pharmacology Department 51<br/>„ Why Clinical Pharmacists are Required in Hospital? 52<br/>„ Objective of Clinical Pharmacology Department 53<br/>„ Responsible Staff Involved in Clinical Pharmacology Department 53<br/>„ Role of Clinical Pharmacology Department 53<br/>„ Drug Information Center 54<br/>„ Pharmacovigilance Center 54<br/>„ Standard Operating Procedures (SOP) of<br/>Clinical Pharmacology Department in Hospital 54<br/>„ Monitoring on Electronic Information System (E-Prescription) 57<br/>„ Report and Documentation 57<br/>9. Medication Errors, Its Practical<br/>Analysis and Resolution 59<br/>„ Types of Medication Errors Involved 60<br/>„ Root Cause Analysis of Medication Error 60<br/>„ Corrective and Preventive Action 61<br/>„ Six Rights of Medication Safety 61<br/>„ Categorization of Medication Errors 61<br/>„ Definition and Levels of Adverse Drug Reaction (ADR) 61<br/>„ Practical Analysis of Medication Errors 62<br/>„ Practical Resolution of Medication Errors 63<br/>10. Recording and Reporting of Adverse Drug Reactions 65<br/>„ Methods of ADR Reporting 65<br/>„ Spontaneous Reporting 67<br/>„ Good Reporting Practices 68<br/>„ Suspected ADR Reporting Form 68<br/>„ ICSR and Its Detailed Components 69<br/>„ ADR Reporting Form for Healthcare Professionals 72<br/>„ Who Can Report? 73<br/>„ Why to Report? 73<br/>„ What to Report? 73<br/>„ How and Whom to Report? 73<br/>„ Characteristics of a Good Case Report 73<br/>„ Limitations of Spontaneous Reporting in India 74<br/>„ Recent Initiatives to Enhance the Reporting in PVPI 74<br/>„ Establishment of an AMC 75<br/>„ Data Flow and Establishment of AMC 75<br/>„ Assessment of Individual Case Safety Reports 75<br/>„ Utilization of the Data 76<br/>„ Reporting Requirements in Special Population 77<br/>„ Reporting in the Event of a Public Health Emergency 77<br/>„ Reports of Overdose, Abuse, Off-Label Use, Misuse or OTC 78<br/>11. Periodic Safety Update Report 79<br/>„ Common Forms in Pharmacovigilance 80<br/>„ Definitions of Various Terminologies Used in Common<br/>Forms in Pharmacovigilance Across World 81<br/>„ Severity Versus Seriousness 81<br/>„ Causality Assessment 83<br/>„ Prescribing Information 83<br/>„ Global Regulations in Pharmacovigilance 85<br/>„ Databases and Commercial Software<br/>Tools Used in Pharmacovigilance 85<br/>12. Causality Assessment of Drugs and Medical Devices: Logic and Method 87<br/>„ Materiovigilance 88<br/>„ Why Causality Assessment of Medical Devices 88<br/>„ Causality Assessment Scales 89<br/>„ Causality Term: Assessment Criteria 90<br/>„ Indian Regulation of Drug/All Medical Devices Adverse Event Reporting 91<br/>„ General Design of Causality Assessment2,3 92<br/>„ Four Basic Criteria 92<br/>„ Various Conditions in Causality Assessment 92<br/>13. Cure To Prescription: E-Prescription 97<br/>„ Purpose of Prescription 98<br/>„ Electronic Prescription (E-Prescription) 98<br/>14. Drug–Drug Interactions in Tertiary Care Hospital 105<br/>„ Epidemiology 106<br/>„ Severity of Drug–Drug Interactions 106<br/>„ Risk Factors of Drug–Drug Interactions 106<br/>„ Mechanism of Drug–Drug Interactions 107<br/>„ Effects: Hospital Stay and Cost 107<br/>„ Prevention 115<br/>„ Corrective Measures 116<br/>15. Therapeutic Drug Monitoring 117<br/>„ Drug Therapy Monitoring 118<br/>„ Clinical Review of Medication Administration Chart 120<br/>„ Ward Round Participation 120<br/>„ Role of Pharmacist in the Management of ADRS 121<br/>„ Patient Counseling 121<br/>„ Clinical Usefulness of TDM 122<br/>16. Postmarket Surveillance Program Concepts, Goals and Practices 123<br/>„ Postmarket Surveillance for Medical<br/>Devices-Associated Adverse Events 125<br/>„ Components of a Postmarket Surveillance Program 126<br/>„ A Model Postmarket Surveillance Program Structure 139<br/>17. Hemovigilance 143<br/>„ Objective of Reporting Adverse Reactions and<br/>Adverse Reactions in Transfusion 144<br/>„ Roles and Responsibilities of HVPI Units 144<br/>18. Case Studies (With Answers) 151<br/>Index 171
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Pharmacoepidemiology.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Drugs
General subdivision Side effects.
650 #4 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Pharmaceutical Preparations
General subdivision adverse effects.
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Sharma, Sangeeta
Relator term foreword
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Mehta, Yatin
Relator term foreword
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Source of classification or shelving scheme Dewey Decimal Classification
Koha item type Books
Holdings
Lost status Source of classification or shelving scheme Damaged status Not for loan Collection code Home library Current library Shelving location Date acquired Source of acquisition Cost, normal purchase price Acquisition method Total Checkouts Full call number Barcode Date last seen Copy number Price effective from Koha item type
  Dewey Decimal Classification     Pharmacy ( Microbiology ) Main library Main library A11 17/02/2020 Al Ahram 489.00 Purchase 2020   615.7 B.H.E 00015285 19/02/2025 1 17/02/2020 Books