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Table of Contents
Front Cover
Drug Safety in Developing Countries
Copyright Page
Dedication
Contents
List of contributors
Preface
Acknowledgments
1 Drug safety-relates issues
1 Introduction: Why do we need a book on drug safety in developing countries?
1.1 Background
1.2 What is drug safety?
1.3 Importance of drug safety
1.4 Why do we need a special textbook on drug safety for developing countries?
1.5 The scope of the present textbook
1.6 Key features
1.7 Section 1: Drug safety relates issues
1.8 Sections 2-5
1.9 Section 6: Comparisons and conclusions
References
2 Medications safety-related terminology
2.1 Medication safety-related terminology: introduction
2.1.1 Methods for the new definitions
2.1.2 Drug/medicine
2.1.3 Drug (medication)
2.1.4 Medicinal product
2.1.5 Herbal medicine
2.1.6 Herbal medicine
2.1.7 Effectiveness/risk
2.1.8 Pharmacoepidemiology
2.1.9 Drug safety
2.1.10 Drug (medication) safety
2.1.11 Drug regulation
2.1.12 Drug regulatory authority
2.1.13 Drug (medication) safety system
2.2 Pharmacovigilance-related terminology
2.2.1 Pharmacovigilance
2.2.2 National pharmacovigilance center
2.2.3 Risk evaluation
2.2.4 Risk management
2.2.5 Effectiveness/risk
2.2.6 Signal
2.2.7 Postmarketing surveillance
2.2.8 Spontaneous reporting
2.2.9 Adverse drug reactions
2.2.10 Unexpected adverse reaction
2.2.11 Adverse event
2.2.12 Adverse drug event
2.2.13 Side effect
2.2.14 Classifications of adverse drug reactions-related terminology
2.3 Medication errors-related terminology
2.3.1 Definitions of medication errors
2.3.2 Prescribing error
2.3.3 Prescription writing errors
2.3.4 Dispensing errors
2.3.5 Dispensing errors (for dispensing prescriptions and orders).
2.3.6 Dispensing errors [for patient's self-medication, prescribing and dispensing nonprescriptions medications (over-the-c...
2.4 Drug-related problems-related terminology
2.4.1 Drug-related problems definitions
2.4.2 Drug-related problems, Hepler and Strand definition, 1990
2.4.3 Drug-related problem, Strand et al., 1990 definition
2.4.4 Drug-related problems, Segal definition, 1997
2.4.5 Drug-related problems, Pharmaceutical Care Network Europe definition, 1999
2.4.6 Drug-related problems, Van den Bernt et al., 2000 definition
2.4.7 Drug-related problems, Krähenbühl-Melcher et al., 2007 definition
2.4.8 Drug-related problems
2.4.9 Classifications of drug-related problems-related terminology
2.5 Self-medications-related terminology
2.5.1 WHO definition
2.5.2 International Pharmaceutical Federation and World Self-Medication Industry definition
2.5.3 Other definitions
2.6 Counterfeit medications-related terminology
2.6.1 Definitions
2.6.2 World Health Organization (WHO), 1992
2.6.3 World Health Organization (WHO), 2009
2.6.4 World Health Organization (WHO), 2011
2.6.5 IMPACT, 2003
2.6.6 International Pharmaceutical Federation, 2003
2.6.7 International Federation of Pharmaceutical Manufacturers and Associations, 2010
2.6.8 World Medical Association, 2012
2.6.9 FDA, 2019
2.6.10 Substandard
2.6.11 Unregistered/unlicensed
2.6.12 Falsified
2.7 Medications abuse-related terminology
2.7.1 Medication abuse
2.7.2 Medication misuse
2.7.3 Addiction
2.7.4 Physical and psychological dependence
2.7.5 Diversion
2.7.6 Nonmedical or nontherapeutic use
2.7.7 Controlled substances
2.8 Other related terminology
2.8.1 Antibiotics resistance
2.8.2 Antibiotics stewardship
2.8.3 Cross-sectional studies
2.8.4 Descriptive studies
2.8.5 Case-control study.
2.8.6 Clinical trial
2.8.7 Cohort study
2.8.8 Case reports
2.8.9 Case series
2.8.10 Ecological studies
2.8.11 Case-crossover studies
2.8.12 Evidence-based medicine
2.8.13 Evidence-based medication safety
2.9 Conclusion
References
3 Medications registration and marketing: safety-related issues
3.1 Background
3.2 What is pharmaceutical regulations?
3.3 Pharmaceutical regulations goals
3.4 History of pharmaceutical regulations
3.5 Pharmacopoeia
3.6 Medication life cycle
3.7 Medication development process
3.8 Designing clinical trials
3.9 Medications licensing and relicensing
3.10 Medications marketing
3.11 Pharmaceutical marketing ethical codes
3.12 Medications postmarketing safety issues
3.13 Generic medicines
3.14 Medicine policy
3.15 Medications registration and marketing in developing countries
3.15.1 Drug authorities' system challenges
3.15.2 Medication registration challenges
3.15.3 Pharmaceutical marketing challenges
3.15.4 Postmarketing drug surveillance challenges
3.15.5 Generic medicines challenges
3.15.6 Medicine policy
315.7 Education
3.15.8 Research
3.16 Conclusion
References
Further reading
4 Pharmacovigilance
4.1 Background
4.2 Definitions of pharmacovigilance
4.3 History of pharmacovigilance
4.4 Importance of pharmacovigilance
4.5 Objectives of pharmacovigilance
4.6 Pharmacovigilance system
4.6.1 Functions of a national pharmacovigilance system
4.6.2 Minimum requirements for a functional national pharmacovigilance system
4.7 International collaborations
4.8 Pharmacovigilance of herbal medicines
4.9 Pharmacovigilance of vaccines
4.9.1 Vaccine pharmacovigilance steps
4.10 Pharmacovigilance of self-medication
4.11 Pharmacovigilance in developing countries.
4.11.1 Pharmacovigilance system challenges
4.11.2 Workforce challenges
4.11.3 Financial challenges
4.11.4 Education and training
4.11.5 Knowledge and attitude
4.11.6 Reporting challenges
4.11.7 Counterfeit medications
4.11.8 Research
4.11.9 International collaboration
4.11.10 Quality and accreditations of pharmacovigilance systems and programs
4.11.11 Technology challenges
4.11.12 Regulations and guidelines challenges
4.11.13 Documentation challenges
4.11.14 Patients and public engagement
4.12 Conclusion
References
Further reading
5 Adverse drug reactions
5.1 Background
5.2 Definitions of adverse drug reactions
5.3 History of adverse drug reactions
5.3.1 Chloroform-related problems (1848)
5.3.2 Salvarsan-related problems (1915)
5.3.3 Sulfonamide-related problems (1937)
5.3.4 Acetylsalicylic acid-related problems (1938)
5.3.5 Diododiethyl tin (1954)
5.3.6 Thalidomide-related problems 1961
5.3.7 Chloramphenicol (1966)
5.3.8 Clioquinol (1975)
5.3.9 Practolol (1977)
5.3.10 Benoxaprofen (1982)
5.3.11 Indoprofen (1984)
5.3.12 Spironolactone (1988)
5.3.13 Tacrolimus (1995)
5.3.14 Cisapride (2000)
5.3.15 Rofecoxib (2004)
5.3.16 Rosiglitazone (2010)
5.4 Types of adverse drug reactions
5.4.1 Primary and secondary classification system
5.4.1.1 Primary adverse drug reactions
5.4.1.1.1 Characteristics
5.4.1.1.2 Examples
5.4.1.1.3 Management
5.4.1.2 Secondary adverse drug reactions
5.4.1.2.1 Characteristics
5.4.1.2.2 Examples
5.4.1.2.3 Management
5.4.2 Type A and B adverse drug reactions classification system
5.4.2.1 Type A adverse drug reactions
5.4.2.1.1 Characteristics
5.4.2.1.2 Examples
5.4.2.1.3 Management
5.4.2.2 Type B reactions
5.4.2.2.1 Characteristics
5.4.2.2.2 Examples
5.4.2.2.3 Management.
5.4.3 ABCDEF classification system
5.4.3.1 Type A adverse drug reactions: dose-related (augmented)
5.4.3.1.1 Characteristics
5.4.3.1.2 Examples
5.4.3.1.3 Management
5.4.3.2 Type B adverse drug reactions: non dose-related (Bizarre)
5.4.3.2.1 Characteristics
5.4.3.2.2 Examples
5.4.3.2.3 Management
5.4.3.3 Type C adverse drug reactions: dose-related and time-related (chronic)
5.4.3.3.1 Characteristics
5.4.3.3.2 Examples
5.4.3.3.3 Management
5.4.3.4 Type D adverse drug reactions: time-related (delayed)
5.4.3.4.1 Characteristics
5.4.3.4.2 Examples
5.4.3.4.3 Management
5.4.3.5 Type E adverse drug reactions: withdrawal (end of use)
5.4.3.5.1 Characteristics
5.4.3.5.2 Examples
5.4.3.5.3 Management
5.4.3.6 Type F adverse drug reactions: unexpected failure of therapy (failure)
5.4.3.6.1 Characteristics
5.4.3.6.2 Examples
5.4.3.6.3 Management
5.4.4 Pharmacological mechanisms classification system
5.4.4.1 Pharmaceutical
5.4.4.2 Examples and mechanisms
5.4.4.3 Pharmacokinetic
5.4.4.4 Examples and mechanisms
5.4.4.5 Pharmacodynamic
5.4.4.6 Examples and mechanisms
5.4.4.7 Drug-drug interaction
5.4.4.8 Examples and mechanisms
5.4.4.9 Genetics
5.4.4.10 Examples and mechanisms
5.4.5 Severity classification system
5.4.6 EIDOS classification system
5.4.7 DoTS classification system
5.4.8 Susceptibility classification system
5.5 Immunologic and nonimmunologic drug reactions
5.5.1 Immunologic drug reactions
5.5.1.1 Type I reaction (IgE-mediated)
5.5.1.2 Type II reaction (cytotoxic)
5.5.1.3 Type III reaction (Immune complex)
5.5.1.4 Type IV reaction (delayed, cell-mediated)
5.5.1.5 Specific T-cell activation
5.5.1.6 Fas/Fas ligand-induced apoptosis
5.5.1.7 Others
5.5.2 Nonimmunologic drug reactions.
5.5.2.1 Predictable nonimmunologic drug reactions.
Drug Safety in Developing Countries
Copyright Page
Dedication
Contents
List of contributors
Preface
Acknowledgments
1 Drug safety-relates issues
1 Introduction: Why do we need a book on drug safety in developing countries?
1.1 Background
1.2 What is drug safety?
1.3 Importance of drug safety
1.4 Why do we need a special textbook on drug safety for developing countries?
1.5 The scope of the present textbook
1.6 Key features
1.7 Section 1: Drug safety relates issues
1.8 Sections 2-5
1.9 Section 6: Comparisons and conclusions
References
2 Medications safety-related terminology
2.1 Medication safety-related terminology: introduction
2.1.1 Methods for the new definitions
2.1.2 Drug/medicine
2.1.3 Drug (medication)
2.1.4 Medicinal product
2.1.5 Herbal medicine
2.1.6 Herbal medicine
2.1.7 Effectiveness/risk
2.1.8 Pharmacoepidemiology
2.1.9 Drug safety
2.1.10 Drug (medication) safety
2.1.11 Drug regulation
2.1.12 Drug regulatory authority
2.1.13 Drug (medication) safety system
2.2 Pharmacovigilance-related terminology
2.2.1 Pharmacovigilance
2.2.2 National pharmacovigilance center
2.2.3 Risk evaluation
2.2.4 Risk management
2.2.5 Effectiveness/risk
2.2.6 Signal
2.2.7 Postmarketing surveillance
2.2.8 Spontaneous reporting
2.2.9 Adverse drug reactions
2.2.10 Unexpected adverse reaction
2.2.11 Adverse event
2.2.12 Adverse drug event
2.2.13 Side effect
2.2.14 Classifications of adverse drug reactions-related terminology
2.3 Medication errors-related terminology
2.3.1 Definitions of medication errors
2.3.2 Prescribing error
2.3.3 Prescription writing errors
2.3.4 Dispensing errors
2.3.5 Dispensing errors (for dispensing prescriptions and orders).
2.3.6 Dispensing errors [for patient's self-medication, prescribing and dispensing nonprescriptions medications (over-the-c...
2.4 Drug-related problems-related terminology
2.4.1 Drug-related problems definitions
2.4.2 Drug-related problems, Hepler and Strand definition, 1990
2.4.3 Drug-related problem, Strand et al., 1990 definition
2.4.4 Drug-related problems, Segal definition, 1997
2.4.5 Drug-related problems, Pharmaceutical Care Network Europe definition, 1999
2.4.6 Drug-related problems, Van den Bernt et al., 2000 definition
2.4.7 Drug-related problems, Krähenbühl-Melcher et al., 2007 definition
2.4.8 Drug-related problems
2.4.9 Classifications of drug-related problems-related terminology
2.5 Self-medications-related terminology
2.5.1 WHO definition
2.5.2 International Pharmaceutical Federation and World Self-Medication Industry definition
2.5.3 Other definitions
2.6 Counterfeit medications-related terminology
2.6.1 Definitions
2.6.2 World Health Organization (WHO), 1992
2.6.3 World Health Organization (WHO), 2009
2.6.4 World Health Organization (WHO), 2011
2.6.5 IMPACT, 2003
2.6.6 International Pharmaceutical Federation, 2003
2.6.7 International Federation of Pharmaceutical Manufacturers and Associations, 2010
2.6.8 World Medical Association, 2012
2.6.9 FDA, 2019
2.6.10 Substandard
2.6.11 Unregistered/unlicensed
2.6.12 Falsified
2.7 Medications abuse-related terminology
2.7.1 Medication abuse
2.7.2 Medication misuse
2.7.3 Addiction
2.7.4 Physical and psychological dependence
2.7.5 Diversion
2.7.6 Nonmedical or nontherapeutic use
2.7.7 Controlled substances
2.8 Other related terminology
2.8.1 Antibiotics resistance
2.8.2 Antibiotics stewardship
2.8.3 Cross-sectional studies
2.8.4 Descriptive studies
2.8.5 Case-control study.
2.8.6 Clinical trial
2.8.7 Cohort study
2.8.8 Case reports
2.8.9 Case series
2.8.10 Ecological studies
2.8.11 Case-crossover studies
2.8.12 Evidence-based medicine
2.8.13 Evidence-based medication safety
2.9 Conclusion
References
3 Medications registration and marketing: safety-related issues
3.1 Background
3.2 What is pharmaceutical regulations?
3.3 Pharmaceutical regulations goals
3.4 History of pharmaceutical regulations
3.5 Pharmacopoeia
3.6 Medication life cycle
3.7 Medication development process
3.8 Designing clinical trials
3.9 Medications licensing and relicensing
3.10 Medications marketing
3.11 Pharmaceutical marketing ethical codes
3.12 Medications postmarketing safety issues
3.13 Generic medicines
3.14 Medicine policy
3.15 Medications registration and marketing in developing countries
3.15.1 Drug authorities' system challenges
3.15.2 Medication registration challenges
3.15.3 Pharmaceutical marketing challenges
3.15.4 Postmarketing drug surveillance challenges
3.15.5 Generic medicines challenges
3.15.6 Medicine policy
315.7 Education
3.15.8 Research
3.16 Conclusion
References
Further reading
4 Pharmacovigilance
4.1 Background
4.2 Definitions of pharmacovigilance
4.3 History of pharmacovigilance
4.4 Importance of pharmacovigilance
4.5 Objectives of pharmacovigilance
4.6 Pharmacovigilance system
4.6.1 Functions of a national pharmacovigilance system
4.6.2 Minimum requirements for a functional national pharmacovigilance system
4.7 International collaborations
4.8 Pharmacovigilance of herbal medicines
4.9 Pharmacovigilance of vaccines
4.9.1 Vaccine pharmacovigilance steps
4.10 Pharmacovigilance of self-medication
4.11 Pharmacovigilance in developing countries.
4.11.1 Pharmacovigilance system challenges
4.11.2 Workforce challenges
4.11.3 Financial challenges
4.11.4 Education and training
4.11.5 Knowledge and attitude
4.11.6 Reporting challenges
4.11.7 Counterfeit medications
4.11.8 Research
4.11.9 International collaboration
4.11.10 Quality and accreditations of pharmacovigilance systems and programs
4.11.11 Technology challenges
4.11.12 Regulations and guidelines challenges
4.11.13 Documentation challenges
4.11.14 Patients and public engagement
4.12 Conclusion
References
Further reading
5 Adverse drug reactions
5.1 Background
5.2 Definitions of adverse drug reactions
5.3 History of adverse drug reactions
5.3.1 Chloroform-related problems (1848)
5.3.2 Salvarsan-related problems (1915)
5.3.3 Sulfonamide-related problems (1937)
5.3.4 Acetylsalicylic acid-related problems (1938)
5.3.5 Diododiethyl tin (1954)
5.3.6 Thalidomide-related problems 1961
5.3.7 Chloramphenicol (1966)
5.3.8 Clioquinol (1975)
5.3.9 Practolol (1977)
5.3.10 Benoxaprofen (1982)
5.3.11 Indoprofen (1984)
5.3.12 Spironolactone (1988)
5.3.13 Tacrolimus (1995)
5.3.14 Cisapride (2000)
5.3.15 Rofecoxib (2004)
5.3.16 Rosiglitazone (2010)
5.4 Types of adverse drug reactions
5.4.1 Primary and secondary classification system
5.4.1.1 Primary adverse drug reactions
5.4.1.1.1 Characteristics
5.4.1.1.2 Examples
5.4.1.1.3 Management
5.4.1.2 Secondary adverse drug reactions
5.4.1.2.1 Characteristics
5.4.1.2.2 Examples
5.4.1.2.3 Management
5.4.2 Type A and B adverse drug reactions classification system
5.4.2.1 Type A adverse drug reactions
5.4.2.1.1 Characteristics
5.4.2.1.2 Examples
5.4.2.1.3 Management
5.4.2.2 Type B reactions
5.4.2.2.1 Characteristics
5.4.2.2.2 Examples
5.4.2.2.3 Management.
5.4.3 ABCDEF classification system
5.4.3.1 Type A adverse drug reactions: dose-related (augmented)
5.4.3.1.1 Characteristics
5.4.3.1.2 Examples
5.4.3.1.3 Management
5.4.3.2 Type B adverse drug reactions: non dose-related (Bizarre)
5.4.3.2.1 Characteristics
5.4.3.2.2 Examples
5.4.3.2.3 Management
5.4.3.3 Type C adverse drug reactions: dose-related and time-related (chronic)
5.4.3.3.1 Characteristics
5.4.3.3.2 Examples
5.4.3.3.3 Management
5.4.3.4 Type D adverse drug reactions: time-related (delayed)
5.4.3.4.1 Characteristics
5.4.3.4.2 Examples
5.4.3.4.3 Management
5.4.3.5 Type E adverse drug reactions: withdrawal (end of use)
5.4.3.5.1 Characteristics
5.4.3.5.2 Examples
5.4.3.5.3 Management
5.4.3.6 Type F adverse drug reactions: unexpected failure of therapy (failure)
5.4.3.6.1 Characteristics
5.4.3.6.2 Examples
5.4.3.6.3 Management
5.4.4 Pharmacological mechanisms classification system
5.4.4.1 Pharmaceutical
5.4.4.2 Examples and mechanisms
5.4.4.3 Pharmacokinetic
5.4.4.4 Examples and mechanisms
5.4.4.5 Pharmacodynamic
5.4.4.6 Examples and mechanisms
5.4.4.7 Drug-drug interaction
5.4.4.8 Examples and mechanisms
5.4.4.9 Genetics
5.4.4.10 Examples and mechanisms
5.4.5 Severity classification system
5.4.6 EIDOS classification system
5.4.7 DoTS classification system
5.4.8 Susceptibility classification system
5.5 Immunologic and nonimmunologic drug reactions
5.5.1 Immunologic drug reactions
5.5.1.1 Type I reaction (IgE-mediated)
5.5.1.2 Type II reaction (cytotoxic)
5.5.1.3 Type III reaction (Immune complex)
5.5.1.4 Type IV reaction (delayed, cell-mediated)
5.5.1.5 Specific T-cell activation
5.5.1.6 Fas/Fas ligand-induced apoptosis
5.5.1.7 Others
5.5.2 Nonimmunologic drug reactions.
5.5.2.1 Predictable nonimmunologic drug reactions.