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020			_a9789352704965
040			_aEG-NcFUE _erda
082	0	0	_a615.7 _bB.H.E _223
100	1		_aBaweja, Himanshu _eauthor
245	1	0	_aEssentials of pharmacovigilance / _cHimanshu Baweja ; Forwards Sangeeta Sharma, Yatin Mehta.
250			_aFirst edition
264		1	_aNew Delhi, _bJAYPEE BROTHERS MEDICAL P, _c2019.
300			_axxv, 225 pages : _billustrations ; _c24 cm
336			_2rdacontent _atext
337			_2rdamedia _aunmediated
338			_2rdacarrier _avolume
500			_aIncludes Index.
505	0		_a1. 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
650		0	_aPharmacoepidemiology.
650		0	_aDrugs _xSide effects.
650		4	_aPharmaceutical Preparations _xadverse effects.
700	1		_aSharma, Sangeeta _eforeword
700	1		_aMehta, Yatin _eforeword
942			_2ddc _cBK