This document outlines a lecture on adverse drug reactions (ADRs). It will define ADRs, discuss their importance and preventability, classify ADR mechanisms into types A and B, cover adverse drug events, and evaluate ADRs through clinical examples. The learning objectives are to differentiate type A and B mechanisms, recognize examples of each, and apply ADR knowledge to cases. Key points include that ADRs are a major health issue, some are preventable, and types include predictable dose-related reactions and unpredictable idiosyncratic or allergic responses.
This document discusses adverse drug reactions (ADRs). It begins by defining an ADR as an unwanted reaction to a medication. It then describes different types of ADRs, including type A reactions related to overdose, type B idiosyncratic reactions, and type C reactions related to long-term drug use. The document also discusses mechanisms of ADRs including direct toxicity and hypersensitivity reactions. It classifies ADRs based on onset and type, and provides examples of cutaneous drug reactions. In closing, it lists and describes additional categories of ADRs such as side effects, toxicity, tolerance, and withdrawal reactions.
For all III YouTube Live Video lecture series of this topic click:
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- For More Such Learning You Can Subscribe to My YouTube Channel.
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Facebook Page: https://www.facebook.com/asacademylearningforever
Website Blog: https://itasacademy.blogspot.com/
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
This document provides information on adverse drug reactions (ADRs), including:
1. It defines ADRs and differentiates them from adverse drug events, and outlines some common causes of events that are excluded from being considered ADRs.
2. It describes various types and classifications of ADRs, including by intensity/severity, outcome, mechanism of production, and pharmacoepidemiological criteria.
3. It discusses methods of pharmacovigilance for detecting ADRs and standards for determining the imputability or likelihood that a reaction was caused by a drug.
This document defines adverse drug reactions and discusses their epidemiology and risk factors. It states that adverse drug reactions are any unintended and harmful responses to a medication. It notes that 4% of hospital admissions, 1 in 1000 deaths in medical wards, and 10-20% of inpatients experience adverse drug reactions. Risk factors include simultaneous use of multiple drugs, advanced age, pregnancy, breastfeeding, hereditary factors, and disease states. Common culprit medications are anti-coagulants, NSAIDs, corticosteroids, antihypertensives, antibiotics, diuretics and insulin.
This document summarizes a talk on adverse reactions to oral contraceptives (birth control pills). It discusses how third generation oral contraceptives with modern progesterone types have a higher risk of venous thromboembolism than second generation pills. It also notes that the new progesterone drospirenone seems to increase the risk compared to older pills. While risks exist, the overall benefits of oral contraceptives in preventing pregnancy and some cancers outweigh the risks. The talk aims to examine the evidence behind controversies on health risks and discuss implications for the growing number of potential oral contraceptive users in India.
Naranjo
WHO-UMC
Bayesian:
Bayesian
Expert Opinion:
CIOMS
Most commonly used:
Naranjo
WHO-UMC
Naranjo Causality Assessment Scale
Criteria Score
1. Previous conclusive reports on this reaction 0
1. Previous conclusive reports on this reaction +1
2. The adverse event appeared after the suspected drug was administered. +2
3. The adverse reaction improved when the drug was discontinued or a specific antagonist was administered. +1
4. The adverse reaction reappeared when the drug was readministered. +2
5. Alternative causes that could solely have
This document defines adverse drug reactions (ADRs) and describes how they are classified and factors that can predispose patients to them. It defines ADRs as any noxious, unintended response to a drug given at normal doses. ADRs are classified into types A-F based on factors like when they occur or their relationship to the drug's normal pharmacology. Common predisposing factors include patient characteristics, drug interactions, and multiple drug use. The document outlines steps for monitoring, preventing, and managing ADRs.
This document discusses adverse drug reactions (ADRs). It begins by defining an ADR as an unwanted reaction to a medication. It then describes different types of ADRs, including type A reactions related to overdose, type B idiosyncratic reactions, and type C reactions related to long-term drug use. The document also discusses mechanisms of ADRs including direct toxicity and hypersensitivity reactions. It classifies ADRs based on onset and type, and provides examples of cutaneous drug reactions. In closing, it lists and describes additional categories of ADRs such as side effects, toxicity, tolerance, and withdrawal reactions.
For all III YouTube Live Video lecture series of this topic click:
https://youtube.com/playlist?list=PLBVbJ9HCa1BbWpd06N6RcV2q0K3JT29Wv
- For More Such Learning You Can Subscribe to My YouTube Channel.
https://www.youtube.com/channel/UC5o-WkzmDJaF7udyAP2jtgw/featured?sub_confirmation=1
Facebook Page: https://www.facebook.com/asacademylearningforever
Website Blog: https://itasacademy.blogspot.com/
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
This document provides information on adverse drug reactions (ADRs), including:
1. It defines ADRs and differentiates them from adverse drug events, and outlines some common causes of events that are excluded from being considered ADRs.
2. It describes various types and classifications of ADRs, including by intensity/severity, outcome, mechanism of production, and pharmacoepidemiological criteria.
3. It discusses methods of pharmacovigilance for detecting ADRs and standards for determining the imputability or likelihood that a reaction was caused by a drug.
This document defines adverse drug reactions and discusses their epidemiology and risk factors. It states that adverse drug reactions are any unintended and harmful responses to a medication. It notes that 4% of hospital admissions, 1 in 1000 deaths in medical wards, and 10-20% of inpatients experience adverse drug reactions. Risk factors include simultaneous use of multiple drugs, advanced age, pregnancy, breastfeeding, hereditary factors, and disease states. Common culprit medications are anti-coagulants, NSAIDs, corticosteroids, antihypertensives, antibiotics, diuretics and insulin.
This document summarizes a talk on adverse reactions to oral contraceptives (birth control pills). It discusses how third generation oral contraceptives with modern progesterone types have a higher risk of venous thromboembolism than second generation pills. It also notes that the new progesterone drospirenone seems to increase the risk compared to older pills. While risks exist, the overall benefits of oral contraceptives in preventing pregnancy and some cancers outweigh the risks. The talk aims to examine the evidence behind controversies on health risks and discuss implications for the growing number of potential oral contraceptive users in India.
Naranjo
WHO-UMC
Bayesian:
Bayesian
Expert Opinion:
CIOMS
Most commonly used:
Naranjo
WHO-UMC
Naranjo Causality Assessment Scale
Criteria Score
1. Previous conclusive reports on this reaction 0
1. Previous conclusive reports on this reaction +1
2. The adverse event appeared after the suspected drug was administered. +2
3. The adverse reaction improved when the drug was discontinued or a specific antagonist was administered. +1
4. The adverse reaction reappeared when the drug was readministered. +2
5. Alternative causes that could solely have
This document defines adverse drug reactions (ADRs) and describes how they are classified and factors that can predispose patients to them. It defines ADRs as any noxious, unintended response to a drug given at normal doses. ADRs are classified into types A-F based on factors like when they occur or their relationship to the drug's normal pharmacology. Common predisposing factors include patient characteristics, drug interactions, and multiple drug use. The document outlines steps for monitoring, preventing, and managing ADRs.
Adverse drug reactions among critically ill patients at cairoAlexander Decker
The study aimed to assess the frequency and outcomes of adverse drug reactions among critically ill patients at Cairo University Hospital. The study found that 21% of the 150 critically ill patients studied experienced adverse drug reactions, ranging from mild to moderate or severe. Over half of the reactions were life-threatening. Due to the prevalence of adverse drug reactions in critically ill patients and their potential severity, the study recommends hospitals establish policies for managing adverse drug reactions and for healthcare providers to closely monitor patients and potential drug interactions when initiating new medications.
This document defines adverse drug reactions and discusses their epidemiology, classification, detection, and monitoring. It provides definitions of adverse drug reactions from WHO and other organizations. It describes the incidence, costs, and preventability of ADRs. It classifies ADRs into types A-F based on mechanisms and discusses methods to determine causality, including the Naranjo algorithm. It outlines the pharmacovigilance system in India including monitoring centers coordinated by AIIMS.
Adverse drug reactions can occur when the pharmacological actions of drugs are exaggerated or when unintended responses happen. Some reactions are predictable like hypotension from antihypertensives or hypoglycemia from insulin. Adverse drug reactions are defined as any noxious and unintended response to a drug used for treatment or diagnosis. Types of adverse drug reactions include side effects, which are pharmacological effects; untoward effects that are undesirable; allergic reactions that can range from mild to life-threatening anaphylaxis; idiosyncratic reactions that are genetically determined peculiar responses; and teratogenic effects where some drugs cause birth defects if taken during the first three months of pregnancy.
The document discusses adverse drug reactions (ADRs). It defines an ADR as an undesirable effect from drug administration. ADRs can range from trivial to fatal and exclude overdoses or poisonings. An adverse drug event is any untoward medical occurrence during treatment that may not have a causal relationship. The epidemiology section notes ADRs are a leading cause of death in hospitals, with estimates of 6.7% incidence of serious ADRs and 0.3-7% of hospital admissions due to ADRs. Risk is higher in the elderly, children, and those with multiple diseases or medications. ADRs can be classified as type A, predictable effects, or type B, unpredictable immunological reactions
The document discusses drug induced diseases (DIDs), which are unintended harmful effects caused by medications. DIDs can affect many organ systems and cause conditions like skin disorders, lung disease, gastrointestinal issues, and neurological or kidney problems. Common causes of DIDs include nonsteroidal anti-inflammatory drugs, antibiotics, anticancer drugs, and anticonvulsants. DIDs are diagnosed based on symptoms occurring after drug intake. Treatment involves stopping the causative medication and managing symptoms. Preventing DIDs requires informing doctors of medical histories and only taking drugs as prescribed. DIDs remain an important health issue requiring more comprehensive research.
1. Adverse drug reactions (ADRs) refer to harmful, unintended effects of drugs that occur at normal doses used for treatment or diagnosis.
2. ADRs are commonly classified based on their onset, severity, and whether they are due to the known pharmacological effects of a drug (Type A) or unpredictable reactions (Type B). Type A reactions are more common while Type B reactions tend to be more serious.
3. The document discusses various types of ADRs in detail, their causes and risk factors. Factors like age, gender, genetic variations, concurrent diseases, and polypharmacy can increase a patient's risk of experiencing an ADR.
A) Obtaining a thorough history from the patient, family members, or witnesses is essential to determine what toxin or drug was ingested, how much, and when. The physical examination focuses on vital signs, eyes, skin, nervous system, lungs and heart to identify symptoms that can indicate the toxin class. Recognizing a toxidrome pattern of signs and symptoms can help identify the possible toxin. Initial treatment priorities are stabilizing the airway, breathing, circulation and providing dextrose for altered mental status.
The document discusses adverse drug reactions (ADRs), including definitions, types, monitoring and reporting. It defines an ADR as an unwanted effect of a medication that is harmful and unintended. ADRs are classified into types A-G based on mechanism and timing. Type A reactions are augmented pharmacological effects, type B are bizarre reactions unrelated to a drug's known effects, type C occur with long-term use, and type D have delayed onset. Pharmacovigilance aims to detect, assess and prevent ADRs through monitoring and signal generation. However, ADR reporting is still limited in India due to lack of awareness and appreciation of pharmacists' role in reporting. Improving education and infrastructure could help strengthen pharmac
The document provides information about the legal requirements for establishing a pharmacy or drug store in Bangladesh. It discusses the qualifications needed, minimum space requirements, and license requirements. A pharmacy must be run under the supervision of a registered pharmacist with a pharmacy degree. The license needs to be renewed every 5 years and should be prominently displayed. Adverse drug reactions are also discussed, including monitoring, reporting, types, and predisposing factors. Underreporting of ADRs is common due to various reasons like lack of time or knowledge of reporting procedures.
This document defines and describes various types of adverse drug reactions and events. It discusses pharmacovigilance, which is the science related to detecting, assessing, understanding, and preventing adverse drug effects. The document categorizes adverse drug effects into side effects, allergy reactions, toxicity, intolerance, idiosyncrasy, photosensitivity, dependence, withdrawal reactions, teratogenicity, mutagenicity, carcinogenicity, and drug-induced diseases. It provides examples and treatments for different types of reactions. Pharmacovigilance helps educate doctors about adverse drug reactions and regulates safe drug use.
Pharmacovigilance is the science related to detecting, assessing, understanding, and preventing adverse effects from drugs. It plays an important role in rational drug use and safety assessment. Adverse drug reactions are unintended effects that occur at normal drug doses, while adverse drug events may or may not be causally related to treatment. Adverse effects can be categorized as side effects, interactions, toxic effects, idiosyncrasies, allergies, withdrawal reactions, teratogenicity, mutagenicity, carcinogenicity, and drug-induced diseases. Minimizing inappropriate use, using correct doses, considering patient variables and history, checking for interactions, and monitoring can help reduce adverse drug reactions.
This document provides an overview of antibiotics. It discusses the history and introduction of antibiotics, their classification, principles of antibiotic therapy, side effects, resistance and failures. It covers individual drug chemistry, mechanisms of action, spectra, sensitive and resistant organisms, adverse effects and uses. It also discusses special conditions like pregnancy, renal/hepatic failure and diabetes. The document outlines newer antibiotics, anticancer drugs and whether antibiotics should be used. It provides terminology related to antibiotics and discusses their sources, types of action and organisms they target.
Adverse Drug Reactions (ADR)- Ravinandan A PRavinandan A P
The World Health Organization (WHO) defines an adverse drug reaction (ADR) as “any response to a drug which is noxious (harmful/toxic), unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of a disease, or for the modification of physiological function ".
This document summarizes an article on antibiotic allergies. It discusses how antibiotic allergies are commonly documented but often unknown or not remembered by patients. Inaccurate antibiotic allergy labels can lead to increased use of broad-spectrum antibiotics and antibiotic resistance. Most patients labeled as penicillin allergic are not actually allergic when appropriately tested. The review provides an update on antibiotic allergy epidemiology, classification, mechanisms, diagnosis and management, with a focus on addressing unverified penicillin allergy labels as a threat to public health.
Forensic pharmacovigilance: Newer dimension of pharmacovigilanceRosmirella Cano Rojas
This document discusses the emerging field of forensic pharmacovigilance, which involves applying pharmacovigilance expertise to help solve legal cases. Pharmacovigilance aims to ensure patient safety by monitoring adverse drug events, while forensic sciences investigate legal matters. Forensic pharmacovigilance can help determine if a drug caused an adverse effect in a victim. It may provide expert opinions on illicit drug use, help solve criminal or civil cases involving drugs, and identify counterfeit or substandard drugs. Challenges include reluctance of medical professionals to participate in legal proceedings and limitations of extrapolating data to real cases. Overall, forensic pharmacovigilance represents a new dimension for pharmacovigilance that
This document discusses adverse drug reactions (ADRs), including definitions, classifications, detection, reporting, causality assessment and prevention. It defines an ADR as an unintended response to a drug that occurs at normal doses. ADRs are classified based on type, onset, severity and mechanism. They can be detected through pre-marketing clinical trials and post-marketing surveillance methods like spontaneous reporting. Healthcare professionals should report all suspected serious ADRs to pharmacovigilance centers to assess causality and ensure patient safety. Preventing ADRs requires monitoring patients at high risk and considering interactions between drugs.
This document provides definitions and classifications of adverse drug reactions and drug allergies. It discusses how drugs can act as antigens and cause immune-mediated reactions. Drugs can be antigens by themselves as foreign macromolecules, or they can gain antigenicity through metabolism into haptenic forms that bind to proteins and activate the immune system. Adverse drug reactions are classified in different ways, including by mechanism (pharmacodynamic, toxic, allergic), time of onset (acute, delayed), or clinical manifestations. Drug allergies represent a subset of reactions that involve demonstrated immunological mechanisms.
This case report describes a 28-year-old female patient who presented with hypersensitivity reactions after being treated with ceftriaxone (a third-generation cephalosporin antibiotic) for a bacterial infection. The patient developed urticaria (hives) after a few days of ceftriaxone therapy. Tests ruled out other potential causes, and causality assessment scales determined the reactions were probably caused by ceftriaxone. The antibiotic was stopped and the patient recovered from the hypersensitivity reactions after 10 days. The report discusses how cephalosporins can rarely cause immediate IgE-mediated allergic reactions like urticaria.
The document discusses adverse drug reactions (ADRs), defined as harm caused by a medication at normal doses during normal use. It describes the types of ADRs, including type A reactions which are augmented and predictable, and type B reactions which are bizarre and unpredictable. The mechanisms of ADRs are also explained, including humoral reactions mediated by antibodies and cell-mediated reactions involving T-lymphocytes. Finally, the document outlines some ways to prevent ADRs, such as avoiding inappropriate drug use, considering a patient's history, and watching for potential drug interactions.
This document discusses adverse drug reactions (ADRs), including definitions, statistics, factors that affect ADRs, classifications, and pharmacovigilance. It defines an ADR according to the WHO as an unwanted effect from a medication taken as prescribed. Statistics provided indicate that ADRs are a common cause of hospitalization and that certain drug classes like antibiotics and NSAIDs are frequently associated with ADRs. The document outlines numerous patient-related and drug-related factors that can influence ADRs and describes various types and classifications of ADRs. It emphasizes the importance of ADR reporting and monitoring through pharmacovigilance programs.
Adverse drug reactions among critically ill patients at cairoAlexander Decker
The study aimed to assess the frequency and outcomes of adverse drug reactions among critically ill patients at Cairo University Hospital. The study found that 21% of the 150 critically ill patients studied experienced adverse drug reactions, ranging from mild to moderate or severe. Over half of the reactions were life-threatening. Due to the prevalence of adverse drug reactions in critically ill patients and their potential severity, the study recommends hospitals establish policies for managing adverse drug reactions and for healthcare providers to closely monitor patients and potential drug interactions when initiating new medications.
This document defines adverse drug reactions and discusses their epidemiology, classification, detection, and monitoring. It provides definitions of adverse drug reactions from WHO and other organizations. It describes the incidence, costs, and preventability of ADRs. It classifies ADRs into types A-F based on mechanisms and discusses methods to determine causality, including the Naranjo algorithm. It outlines the pharmacovigilance system in India including monitoring centers coordinated by AIIMS.
Adverse drug reactions can occur when the pharmacological actions of drugs are exaggerated or when unintended responses happen. Some reactions are predictable like hypotension from antihypertensives or hypoglycemia from insulin. Adverse drug reactions are defined as any noxious and unintended response to a drug used for treatment or diagnosis. Types of adverse drug reactions include side effects, which are pharmacological effects; untoward effects that are undesirable; allergic reactions that can range from mild to life-threatening anaphylaxis; idiosyncratic reactions that are genetically determined peculiar responses; and teratogenic effects where some drugs cause birth defects if taken during the first three months of pregnancy.
The document discusses adverse drug reactions (ADRs). It defines an ADR as an undesirable effect from drug administration. ADRs can range from trivial to fatal and exclude overdoses or poisonings. An adverse drug event is any untoward medical occurrence during treatment that may not have a causal relationship. The epidemiology section notes ADRs are a leading cause of death in hospitals, with estimates of 6.7% incidence of serious ADRs and 0.3-7% of hospital admissions due to ADRs. Risk is higher in the elderly, children, and those with multiple diseases or medications. ADRs can be classified as type A, predictable effects, or type B, unpredictable immunological reactions
The document discusses drug induced diseases (DIDs), which are unintended harmful effects caused by medications. DIDs can affect many organ systems and cause conditions like skin disorders, lung disease, gastrointestinal issues, and neurological or kidney problems. Common causes of DIDs include nonsteroidal anti-inflammatory drugs, antibiotics, anticancer drugs, and anticonvulsants. DIDs are diagnosed based on symptoms occurring after drug intake. Treatment involves stopping the causative medication and managing symptoms. Preventing DIDs requires informing doctors of medical histories and only taking drugs as prescribed. DIDs remain an important health issue requiring more comprehensive research.
1. Adverse drug reactions (ADRs) refer to harmful, unintended effects of drugs that occur at normal doses used for treatment or diagnosis.
2. ADRs are commonly classified based on their onset, severity, and whether they are due to the known pharmacological effects of a drug (Type A) or unpredictable reactions (Type B). Type A reactions are more common while Type B reactions tend to be more serious.
3. The document discusses various types of ADRs in detail, their causes and risk factors. Factors like age, gender, genetic variations, concurrent diseases, and polypharmacy can increase a patient's risk of experiencing an ADR.
A) Obtaining a thorough history from the patient, family members, or witnesses is essential to determine what toxin or drug was ingested, how much, and when. The physical examination focuses on vital signs, eyes, skin, nervous system, lungs and heart to identify symptoms that can indicate the toxin class. Recognizing a toxidrome pattern of signs and symptoms can help identify the possible toxin. Initial treatment priorities are stabilizing the airway, breathing, circulation and providing dextrose for altered mental status.
The document discusses adverse drug reactions (ADRs), including definitions, types, monitoring and reporting. It defines an ADR as an unwanted effect of a medication that is harmful and unintended. ADRs are classified into types A-G based on mechanism and timing. Type A reactions are augmented pharmacological effects, type B are bizarre reactions unrelated to a drug's known effects, type C occur with long-term use, and type D have delayed onset. Pharmacovigilance aims to detect, assess and prevent ADRs through monitoring and signal generation. However, ADR reporting is still limited in India due to lack of awareness and appreciation of pharmacists' role in reporting. Improving education and infrastructure could help strengthen pharmac
The document provides information about the legal requirements for establishing a pharmacy or drug store in Bangladesh. It discusses the qualifications needed, minimum space requirements, and license requirements. A pharmacy must be run under the supervision of a registered pharmacist with a pharmacy degree. The license needs to be renewed every 5 years and should be prominently displayed. Adverse drug reactions are also discussed, including monitoring, reporting, types, and predisposing factors. Underreporting of ADRs is common due to various reasons like lack of time or knowledge of reporting procedures.
This document defines and describes various types of adverse drug reactions and events. It discusses pharmacovigilance, which is the science related to detecting, assessing, understanding, and preventing adverse drug effects. The document categorizes adverse drug effects into side effects, allergy reactions, toxicity, intolerance, idiosyncrasy, photosensitivity, dependence, withdrawal reactions, teratogenicity, mutagenicity, carcinogenicity, and drug-induced diseases. It provides examples and treatments for different types of reactions. Pharmacovigilance helps educate doctors about adverse drug reactions and regulates safe drug use.
Pharmacovigilance is the science related to detecting, assessing, understanding, and preventing adverse effects from drugs. It plays an important role in rational drug use and safety assessment. Adverse drug reactions are unintended effects that occur at normal drug doses, while adverse drug events may or may not be causally related to treatment. Adverse effects can be categorized as side effects, interactions, toxic effects, idiosyncrasies, allergies, withdrawal reactions, teratogenicity, mutagenicity, carcinogenicity, and drug-induced diseases. Minimizing inappropriate use, using correct doses, considering patient variables and history, checking for interactions, and monitoring can help reduce adverse drug reactions.
This document provides an overview of antibiotics. It discusses the history and introduction of antibiotics, their classification, principles of antibiotic therapy, side effects, resistance and failures. It covers individual drug chemistry, mechanisms of action, spectra, sensitive and resistant organisms, adverse effects and uses. It also discusses special conditions like pregnancy, renal/hepatic failure and diabetes. The document outlines newer antibiotics, anticancer drugs and whether antibiotics should be used. It provides terminology related to antibiotics and discusses their sources, types of action and organisms they target.
Adverse Drug Reactions (ADR)- Ravinandan A PRavinandan A P
The World Health Organization (WHO) defines an adverse drug reaction (ADR) as “any response to a drug which is noxious (harmful/toxic), unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of a disease, or for the modification of physiological function ".
This document summarizes an article on antibiotic allergies. It discusses how antibiotic allergies are commonly documented but often unknown or not remembered by patients. Inaccurate antibiotic allergy labels can lead to increased use of broad-spectrum antibiotics and antibiotic resistance. Most patients labeled as penicillin allergic are not actually allergic when appropriately tested. The review provides an update on antibiotic allergy epidemiology, classification, mechanisms, diagnosis and management, with a focus on addressing unverified penicillin allergy labels as a threat to public health.
Forensic pharmacovigilance: Newer dimension of pharmacovigilanceRosmirella Cano Rojas
This document discusses the emerging field of forensic pharmacovigilance, which involves applying pharmacovigilance expertise to help solve legal cases. Pharmacovigilance aims to ensure patient safety by monitoring adverse drug events, while forensic sciences investigate legal matters. Forensic pharmacovigilance can help determine if a drug caused an adverse effect in a victim. It may provide expert opinions on illicit drug use, help solve criminal or civil cases involving drugs, and identify counterfeit or substandard drugs. Challenges include reluctance of medical professionals to participate in legal proceedings and limitations of extrapolating data to real cases. Overall, forensic pharmacovigilance represents a new dimension for pharmacovigilance that
This document discusses adverse drug reactions (ADRs), including definitions, classifications, detection, reporting, causality assessment and prevention. It defines an ADR as an unintended response to a drug that occurs at normal doses. ADRs are classified based on type, onset, severity and mechanism. They can be detected through pre-marketing clinical trials and post-marketing surveillance methods like spontaneous reporting. Healthcare professionals should report all suspected serious ADRs to pharmacovigilance centers to assess causality and ensure patient safety. Preventing ADRs requires monitoring patients at high risk and considering interactions between drugs.
This document provides definitions and classifications of adverse drug reactions and drug allergies. It discusses how drugs can act as antigens and cause immune-mediated reactions. Drugs can be antigens by themselves as foreign macromolecules, or they can gain antigenicity through metabolism into haptenic forms that bind to proteins and activate the immune system. Adverse drug reactions are classified in different ways, including by mechanism (pharmacodynamic, toxic, allergic), time of onset (acute, delayed), or clinical manifestations. Drug allergies represent a subset of reactions that involve demonstrated immunological mechanisms.
This case report describes a 28-year-old female patient who presented with hypersensitivity reactions after being treated with ceftriaxone (a third-generation cephalosporin antibiotic) for a bacterial infection. The patient developed urticaria (hives) after a few days of ceftriaxone therapy. Tests ruled out other potential causes, and causality assessment scales determined the reactions were probably caused by ceftriaxone. The antibiotic was stopped and the patient recovered from the hypersensitivity reactions after 10 days. The report discusses how cephalosporins can rarely cause immediate IgE-mediated allergic reactions like urticaria.
The document discusses adverse drug reactions (ADRs), defined as harm caused by a medication at normal doses during normal use. It describes the types of ADRs, including type A reactions which are augmented and predictable, and type B reactions which are bizarre and unpredictable. The mechanisms of ADRs are also explained, including humoral reactions mediated by antibodies and cell-mediated reactions involving T-lymphocytes. Finally, the document outlines some ways to prevent ADRs, such as avoiding inappropriate drug use, considering a patient's history, and watching for potential drug interactions.
This document discusses adverse drug reactions (ADRs), including definitions, statistics, factors that affect ADRs, classifications, and pharmacovigilance. It defines an ADR according to the WHO as an unwanted effect from a medication taken as prescribed. Statistics provided indicate that ADRs are a common cause of hospitalization and that certain drug classes like antibiotics and NSAIDs are frequently associated with ADRs. The document outlines numerous patient-related and drug-related factors that can influence ADRs and describes various types and classifications of ADRs. It emphasizes the importance of ADR reporting and monitoring through pharmacovigilance programs.
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Classifying_Adverse_Drug_Reactions.pdf
1. Outline
TCH (Tan Chay Hoon)
phctanch@nus.edu.sg
Adverse Drug Reactions (ADRs)
1. What are Adverse Drug Reactions (ADRs)?
2. How important are ADRs and are they preventable?
3. What are the classifications and mechanisms of ADRs?
4. Adverse-Drug Events
5. Evaluate the various types of ADRs using clinical examples
WHAT
WHY
HOW
2. Learning Objectives
At the end of the lecture, you should begin to think of patient’s
safety, and be able to:
1. Differentiate the underlying mechanisms for Type A and
Type B ADRs
2. Recognize important examples of Type A and Type B
ADRs
3. Apply the knowledge of ADRs to clinical scenarios
3. 3
Prince: cause of death
http://www.bbc.com/news/world-us-canada-37151146
http://www.ashp.org/DocLibrary/Bookstore/
P2418-Chapter1.aspx
4. 4
WHO definition: An adverse reaction is any response to a
drug that is noxious and unintended, and that occurs at
doses normally used in humans for prophylaxis, diagnosis
or therapy of disease.
(Excluding overdose, drug abuse, and medication errors)
Adverse Drug Reactions (ADRs)
5. 5
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3853675/
Adverse drug reactions (ADRs) are unwanted drug effects that have
considerable economic as well as clinical costs as they often lead to hospital
admission, prolongation of hospital stay and emergency department visits
Clinical and economic burden of adverse drug
reactions
J Pharmacol Pharmacother. 2013 Dec; 4(Suppl1): S73–S77
ADRs accounts for
30% of hospital admissions in the USA and Canada
20% of admissions in Australia
11% of admissions in Europe
5.2% of ADRs in children lead to hospitalization up to 40% in pediatric patients can
be life-threatening or fatal
Up to 36% of emergency department visits in older adults are due to drug-related
causes
6. Outline
1. What are Adverse Drug Reactions (ADRs)?
2. How important are ADRs and are they preventable?
3. What are the classifications and mechanisms of ADRs?
4. How about Adverse-Drug Events ?
5. Evaluate the various types of ADRs using clinical examples
7. 7
ADRs are of great concern to drug regulatory
authority in all countries because of the
issues of:
SAFETY, EFFICACY and QUALITY
• From Pre-clinical phase I studies
• From Clinical trial Phase I to Phase III
• Post marketing surveillance
• Spontaneous reports of suspected ADRs
• continuous monitoring of drugs after issuance of
license is necessary
How do we gather ADRs information?
8. 8
Incidence of ADRs in Hospitalized Patients: A Meta-
analysis of Prospective Studies
JAMA. 1998;279:1200-1205.
Objective.— To estimate incidence of serious and fatal ADRs in hospital
patients.
Data Synthesis.—ADRs : fourth to sixth leading cause of death.
Conclusions.—ADRs represent an important clinical issue.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4168391/
9. 9
Fatal ADRs: 3% of all deaths in the general population.
Haemorrhage: 2/3 of the Fatal ADRs, antithrombotic agents
are implicated in more than half of the suspected Fatal
ADRs.
Incidence of fatal ADRs: a population study
Br J Clin Pharmacol 2008; 65:573-579
10. 10
ADRs in United States Hospitals
Pharmacotherapy 2006;26:601-608
Conclusion: ADRs are a significant public health problem in
our health care system. For the 12 millions Medicare
patients admitted to US hospitals, ADRs were projected to
cause 3000 deaths
Up to 50% of ADRs are preventable, more attention to their
detection and management is warranted
11. Outline
1. What are Adverse Drug Reactions (ADRs)?
2. How important are ADRs and are they preventable?
3. What are the classifications and mechanisms of ADRs?
4. How about Adverse-Drug Events ?
5. Evaluate the various types of ADRs using clinical examples
13. 13
Classifications of ADRs
According to Rawlins and Thompson (1998)
Type A
Predictable
Type B
Unpredictable
idiosyncratic
immunological (classified as Type I -IV hypersensitivity)
15. 15
Type A (Predictable ADRs)
ADRs related to Pharmacological actions of drug
Dose-related, recognized as possible ADRs
during clinical trials (account for ~2/3 of ADRs)
• ADRs as unwanted or excessive
Pharmacological effects
16. 16
Examples of Type A, Predictable ADRs
•Bleeding …………
•Sedation …………
•Hypoglycemic coma ……
•Tremors …………………..
•Respiratory depression ……..
Unwanted or excessive Pharmacological effects
17. 17
Examples of Type A, Predictable ADRs
•Bleeding …………
•Sedation …………
•Hypoglycemic coma ……
•Tremors …………………..
•Respiratory depression ……..
Unwanted or excessive Pharmacological effects
How to prevent ADRs?
anticoagulant (warfarin), antiplatelet drugs
anti-anxiety drug, (diazepam)
insulin
ß2 agonists (salbutamol)
morphine
18. Mechanism of the ADRs of Gentamicin
Ototoxic Nephrotoxic
toxic to the sensory cells
of the inner ear,
sometimes causing
complete hearing loss
inhibit protein synthesis in renal cells,
causes necrosis of cells in the proximal
tubule, resulting in acute tubular
necrosis, can lead to acute renal failure
usually if taken at high doses
or for prolonged periods of time,
if multiple doses accumulate over a
course of treatment,
Example of Type A, Predictable ADRs
21. 21
Unpredictable (Type B) ADRs
Idiosyncratic (often linked to genetic anomalies)
• Glucose- 6-phosphate dehydrogenase (G6PD)
deficiency --- hemolysis with maloprim (antimalarial)
• Acetylator polymorphism – slow acetylator ---
peripheral neuropathy with isoniazid (anti-TB)
22. 22
Drug itself or its metabolites can act as a hapten by
interacting with protein to become immunogenic
Immunogenic Hypersensitivity or Allergic
reactions
Unpredictable (Type B) ADRs
23. 23
Characteristics of an immunogenic response are:
• Prior exposure
• May be delayed in onset
• Can occur with subsequent low doses
• Reactions conform to immunogenic responses,
Type I, II, III and IV
Unpredictable (Type B) ADRs
24. 24
Type I, II and III are antibody-mediated reactions
while Type IV is cell mediated
Types of hypersensitivity/allergic reactions to drugs
From: AJ Atkinson Jr et al. Principles of Clinical Pharmacology 2007
25. 25
antibody mediated hypersensitivity - Acute allergic reactions to
stings, pollens, certain food, or drugs. The substance evokes
release of IgE
IgE fixed to tissue mast cells and basophils
After interaction with antigen, the cells release potent
mediators.
Localised: rhinitis, asthma, rash, urticaria
Generalised: anaphylactic shock
e.g. of drugs: penicillin, streptokinase…food
Type I:
27. Drug Allergy – case summary
• Pt admitted electively for minor surgery
• The doctor noted from the note that patient was
allergic to Aspirin
• Same doctor ordered Synflex in the operating theater
• Patient noted to have acute periorbital swelling, blocked
nose + watery eyes after he she returned home and
taken the Synflex.
28. 28
Antibody-dependent cytolytic hypersensitivity – Reaction
is directed at “foreign” host cells. Cells (eg. blood cells)
can be made “foreign” by drugs.
Type II:
ADRs Drugs responsible
Thrombocytopenia carbamazepine, ticlopidine
Agranulocytosis, neutropenia Carbamazepine, phenytoin, carbimazole,
ganciclovir
Systemic- Drug induced SLE
30. 30
Reactions due to elevated levels of antigen-antibody
complexes. Complexes deposited in e.g. vascular
endothelium to cause inflammatory responses/tissue injury
(1-24 h) - serum sickness.
ADRs Drugs responsible
Serum sickness syndrome penicillins, NSAIDS
Stevens-Johnson syndrome sulphonamides
carbamazepine
Type III:
31. 31
Description Suspected active ingredient
Stevens-Johnson,
TEN
Acyclovir, allopurinol, amitriptyline, amoxicillin,
carbamazepine (7), cotrimoxazole(6),
coamoxiclav (2), omeprazole(3), phenytoin(7)
Analysis of ADR reports
E.g of drugs causing serious ADRs
32. 32
Toxic Epidermal Necrolysis
(TEN)
immune-complex mediated
Stevens-Johnson syndrome
(SJS)
immune-complex–mediated
Both SJS and TEN are erythema multiforme. SJS (If <10% of body surface
affected); TEN (>30% of body is affected). Mixed SJS/TEN when 10-30% body
surface affected.
Sulphonamides (“sulpha” drugs) e.g. co-trimoxazole, most common cause
Pictures-from HSA, Adverse Drug Reaction News July 2004, - courtesy NSC
33. 33
The reaction involves drug-sensitised T cells, which in
response to antigen - release cytokines like lymphokines
and interleukins.
e.g. latex gloves or drugs topically applied to the skin that
cause contact dermatitis and photosensitivity
Manifestations: usually mild skin rash but may be fatal
exfoliation, autoimmune diseases, fever.
Type IV:
34. Outline
1. What are Adverse Drug Reactions (ADRs)?
2. How important are ADRs and are they preventable?
3. What are the mechanisms of ADRs?
4. How about Adverse-Drug Events ?
5. Evaluate the various types of ADRs using clinical examples
35. 35
Adverse Drug Event
Any undesirable experience associated
with use of a medical product in a patient:
Includes ADRs and any other adverse
events:
medication errors (prescribing, preparation, dispensing or administration),
overdose, drug abuse
36. Medication Error - insulin
Incident : Actrapid 6units was given to
patient instead of Aspart 6 units ordered
38. Medication errors occurred
before when these medication
vials were not coloured.
Pharmaceutical companies
have since produced colour
coded vials to minimize errors.
41. 42
How to prevent or reduce the
incidence of ADRs
• Knowledge and awareness of important ADRs of
drugs that you are prescribing
• Ask questions about concurrent drug therapy
• Cautious with dose and duration of exposure
• Knowledge of drug-drug interactions
• Be aware of age of patient
• Be aware of patient’s disease states –organ
dysfunction
42. 43
WHO Collaborating Centre for
International Drug Monitoring
The WHO Programme for International Drug Monitoring
established in 1960s, (http://www.who-umc.org), Sweden
has the world’s largest database of 3 million recorded
cases of ADRs
43. 44
• Record patient’s drug medication history and known
allergies
• Contact the local Medical Council to register the
allergy of the individual. Some Medical association
supplies bracelets and cards stating allergies
• Use information from local and International
collaboration databases
How to report incidence of ADRs