detail and complete study on the topic of adverse drug reactions by hr students under the guidance of teachers and senior students.
contain complete information regarding the given topic
Adverse drug reactions are unwanted effects that occur when taking medications. They can range from mild to severe or life-threatening. Monitoring adverse drug reactions involves identifying suspected reactions, assessing the causality between the drug and reaction, documenting the details of the case, and reporting serious reactions to regulatory authorities. Serious adverse reactions must be reported within 14 days, while investigators report them to sponsors and ethics committees within 24 hours and 7 days respectively to ensure patient safety.
This document discusses fixed drug dose combinations (FDC). It notes that FDC involves combining two drugs in a single formulation. The drugs should have similar half-lives and dosage ratios based on pharmacokinetics. An example given is amoxicillin and clavulanic acid. Advantages of FDC include convenience, enhanced effects, and reduced side effects. However, disadvantages include inability to adjust doses independently and increased adverse effects in some cases. Rational FDCs improve compliance and efficacy while irrational FDCs can cause harm.
Drug use evaluation (DUE) is a quality improvement process that reviews prescribing patterns to promote appropriate drug use. It involves identifying a drug or therapeutic area, developing criteria and standards, collecting data, evaluating results, providing feedback, and implementing interventions. The process then reevaluates drug use and revises the DUE program as needed. The presented document outlines the 11 steps of a DUE process focusing on monitoring renal function during aminoglycoside therapy.
This document deals with different CLINICAL STUDY DESIGNS, their methodologies, definitions, merits & associated demerits.
Relevant for the following subjects:
A. BIOSTATISTICS & RESEARCH METHODOLOGY
B. CLINICAL RESEARCH
C. PHARMACOEPIDEMIOLOGY & PHARMACOECONOMICS.
This document discusses adverse drug reactions, including definitions, classifications, monitoring, documentation, and reporting. It defines an adverse drug reaction as an unintended response to a drug that occurs at normal doses. Adverse events are classified as serious if they result in death, hospitalization, disability, or required intervention. Adverse reactions are categorized as Type A or Type B. Monitoring involves identifying reactions, assessing causality using methods like the Naranjo algorithm, documenting in forms, and reporting serious reactions to authorities.
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.
Pharmacovigilance is the science of monitoring approved drugs to detect adverse effects. It aims to identify new risks, assess known risks, and prevent harm. Pharmacovigilance relies on collecting data on adverse drug reactions (ADRs) through passive and active methods. Data is analyzed to detect safety signals and assess risks and benefits of medicines to optimize safe use. Regulatory authorities use pharmacovigilance data to take actions like updating product information or withdrawing approval if risks outweigh benefits.
Adverse drug reactions are unwanted effects that occur when taking medications. They can range from mild to severe or life-threatening. Monitoring adverse drug reactions involves identifying suspected reactions, assessing the causality between the drug and reaction, documenting the details of the case, and reporting serious reactions to regulatory authorities. Serious adverse reactions must be reported within 14 days, while investigators report them to sponsors and ethics committees within 24 hours and 7 days respectively to ensure patient safety.
This document discusses fixed drug dose combinations (FDC). It notes that FDC involves combining two drugs in a single formulation. The drugs should have similar half-lives and dosage ratios based on pharmacokinetics. An example given is amoxicillin and clavulanic acid. Advantages of FDC include convenience, enhanced effects, and reduced side effects. However, disadvantages include inability to adjust doses independently and increased adverse effects in some cases. Rational FDCs improve compliance and efficacy while irrational FDCs can cause harm.
Drug use evaluation (DUE) is a quality improvement process that reviews prescribing patterns to promote appropriate drug use. It involves identifying a drug or therapeutic area, developing criteria and standards, collecting data, evaluating results, providing feedback, and implementing interventions. The process then reevaluates drug use and revises the DUE program as needed. The presented document outlines the 11 steps of a DUE process focusing on monitoring renal function during aminoglycoside therapy.
This document deals with different CLINICAL STUDY DESIGNS, their methodologies, definitions, merits & associated demerits.
Relevant for the following subjects:
A. BIOSTATISTICS & RESEARCH METHODOLOGY
B. CLINICAL RESEARCH
C. PHARMACOEPIDEMIOLOGY & PHARMACOECONOMICS.
This document discusses adverse drug reactions, including definitions, classifications, monitoring, documentation, and reporting. It defines an adverse drug reaction as an unintended response to a drug that occurs at normal doses. Adverse events are classified as serious if they result in death, hospitalization, disability, or required intervention. Adverse reactions are categorized as Type A or Type B. Monitoring involves identifying reactions, assessing causality using methods like the Naranjo algorithm, documenting in forms, and reporting serious reactions to authorities.
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.
Pharmacovigilance is the science of monitoring approved drugs to detect adverse effects. It aims to identify new risks, assess known risks, and prevent harm. Pharmacovigilance relies on collecting data on adverse drug reactions (ADRs) through passive and active methods. Data is analyzed to detect safety signals and assess risks and benefits of medicines to optimize safe use. Regulatory authorities use pharmacovigilance data to take actions like updating product information or withdrawing approval if risks outweigh benefits.
This document discusses drug idiosyncrasy and adverse drug reactions. It defines drug idiosyncrasy as an abnormal genetic response to a drug in some individuals. Idiosyncratic reactions are non-dose related and unpredictable. The document categorizes and classifies different types of adverse drug reactions and discusses methods of detection, including pre-marketing clinical trials and post-marketing surveillance. It emphasizes the importance of reporting suspected adverse drug reactions to help prevent future harm.
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.
The document discusses drug levels in blood and their importance. It defines key pharmacokinetic parameters like Cmax, Tmax, and AUC which can be evaluated from plasma concentration-time profiles. Pharmacodynamic parameters like MEC, MSC, therapeutic range and index are also explained. Measuring drug levels in blood allows optimization of dosage regimens and monitoring of treatment progress. However, it requires specialized analytical techniques and repeated blood sampling can be inconvenient.
This PDF deals with important guidelines, with respect to usage of antibiotics. This PDF outlines the important strategies involved while using antibiotics, and important factors involving antibiotic selection.
This document discusses adverse drug reactions (ADRs). It defines ADRs and provides statistics on their frequency and impact. It discusses various factors that can influence ADRs, including patient characteristics like age and genetics. It also discusses drug properties and interactions that can lead to ADRs. The document classifies ADRs into types A-F based on mechanisms and timing. It provides many examples of common and serious ADRs to illustrate different types. The document emphasizes the importance of pharmacovigilance in monitoring and preventing ADRs.
Relationship between pharmacokinetics and pharmacodynamics.pptxMdHimelAhmedRidoy1
Statistical analysis is the collection and interpretation of data in order to uncover patterns and trends. It is a component of data analytics. Statistical analysis can be used in situations like gathering research interpretations, statistical modeling or designing surveys and studies
The document discusses hospital formularies, which are lists of approved medications used in hospitals. A pharmacy and therapeutics committee is responsible for developing and revising the formulary. This includes adding and removing drugs based on efficacy, safety, and cost. The formulary provides guidelines for procuring, prescribing, dispensing, and administering drugs in the hospital. It aims to promote rational and cost-effective drug use. Restrictions may be placed on certain drugs to ensure appropriate usage. Exceptions can be made for nonformulary drugs in special cases.
This document discusses physiological pharmacokinetic models, which describe drug movement and disposition in the body based on organ blood flow and organ spaces penetrated by the drug. It presents different types of models, including blood flow-limited models, models incorporating drug binding, and membrane-limited models. It discusses key concepts like mean residence time, mean absorption time, and mean dissolution time. Physiological pharmacokinetic models provide a more exact description of drug concentrations over time compared to non-physiological models.
The document summarizes the Causality Assessment Scale. It defines causality assessment as assessing the relationship between a drug treatment and adverse event. It describes various methods of causality assessment including expert judgment, algorithms like WHO-UMC and Naranjo scales. It provides examples of causality categories like certain, probable, possible using WHO scale and illustrates its terminology through cases of dechallenge and rechallenge.
The document outlines the steps that a poison information specialist should follow to properly handle a poison information query. The specialist must first collect details about the caller and exposure incident. They then assess the urgency of the situation and research treatment options using specialized databases and references. The specialist evaluates the information and provides a tailored response, either verbally or in writing. They may follow up on the case and document the interaction, maintaining confidentiality. The overall process ensures the specialist can safely and effectively assist those exposed to toxic substances.
This document discusses guidelines for bioavailability and bioequivalence studies. It defines key terms like bioavailability, bioequivalence, pharmaceutical equivalents and alternatives. It outlines when bioequivalence studies are necessary, such as for modified release drugs, and when they are not required, such as for parenteral solutions. It also describes the different types of studies including pharmacokinetic, pharmacodynamic and clinical endpoint studies. Finally, it provides details on study design, population, conditions and statistical evaluation for pharmacokinetic bioequivalence studies.
This document discusses adverse drug reactions (ADRs), including definitions, classifications, mechanisms, and predisposing factors. It defines an ADR as an unintended, harmful reaction to a medication. ADRs are classified based on factors like type (dose-related vs unpredictable), timing (onset), and individual susceptibility. The mechanisms of different ADR types are explained in terms of pharmaceutical, pharmacokinetic, and pharmacodynamic factors. Polypharmacy, multiple diseases, age, drug properties, and genetics can predispose patients to ADRs.
clinical and preclinical approaches to drug discovery.Here we mainly deals with preclinical approaches, ie. Pharmacological approach and toxicological approach
Advesre drug reaction- Types, Reporting, Evaluation, Monitoring, Preventing &...Suhas Reddy C
This document discusses adverse drug reactions (ADRs), including their definition, classification, types, reporting, evaluation, monitoring, prevention and management. It defines an ADR as an unintended reaction to a drug that occurs at normal doses. ADRs can be classified based on incidence (very common to very rare) or severity (mild to severe). Types of ADRs include dose-dependent (Type A), unpredictable hypersensitivity reactions (Type B), continuous effects of long-term drug use (Type C), and withdrawal reactions (Type E). The document outlines what information should be reported for an ADR, who is responsible for reporting, when and how to report ADRs, and where completed reports should be submitted
The document discusses the history and development of clinical pharmacy in India. It notes that clinical pharmacy began emerging in India in the 1980s and 1990s in response to issues with drug misuse and safety. Several key developments followed, including revisions to pharmacy education regulations and the establishment of early master's programs in pharmacy practice. Today, clinical pharmacy practice has expanded further, with pharmacists taking on roles like providing drug information, managing medication therapy, and counseling patients in both hospital and community settings.
This document discusses the detection and monitoring of adverse drug reactions (ADRs). It outlines that ADRs are detected through pre-marketing studies such as acute toxicity and specific animal tests as well as clinical trials. Post-marketing surveillance also plays an important role in ADR detection through spontaneous reporting systems and epidemiological methods. In hospitals, healthcare professionals can detect ADRs by closely monitoring high-risk patients and collecting detailed patient data to assess causality and severity of suspected ADRs.
The document outlines the key elements of a bioequivalence study protocol, including:
1. The objective is to show that the test and reference drug products have similar bioavailability when administered at the same dose.
2. The study design typically involves both fasting and fed conditions, uses a crossover or parallel group design, and involves pharmacokinetic analysis of blood samples taken over time.
3. Subject selection criteria aim to minimize variability through screening and exclusion of those with health issues that could impact drug absorption.
This document discusses linear and nonlinear pharmacokinetics. [1] Linear pharmacokinetics follow first-order kinetics where the rate of drug absorption, distribution, metabolism and excretion is proportional to dose. [2] Nonlinear pharmacokinetics occur when these processes become saturated at high doses due to limited enzyme or transporter capacity. [3] Michaelis-Menten kinetics are often used to model nonlinear processes and estimate parameters like Vmax and Km.
This document discusses adverse drug reactions (ADRs), defined as any undesirable or unintended consequence of drug administration. ADRs are classified as either predictable (type A) or unpredictable (type B) reactions. Predictable reactions include excessive pharmacological effects, secondary pharmacological effects, and rebound effects on drug discontinuation. Unpredictable reactions include allergic drug reactions, idiosyncrasy, and genetically determined toxicity. The document also covers ADR detection methods like patient interviews, ADR reporting approaches, and ADR management based on reaction severity and importance of continued treatment.
Adverse drug reactions (ADRs) remain a major health issue worldwide. They affect the treating outcomes, increase the admission rate to hospitals, increase the morbidity and mortality, increase the cost of therapy, affect the quality of life, and affect the patient satisfaction of health care. This chapter aims to discuss the ADRs-related issues, such as history, types, causes, management and reporting of ADRs, as well as highlight the challenges of ADRs and their reporting in the developing countries, and provide recommendations to overcome the challenges in order to improve practices in the developing countries.
This document discusses adverse drug reactions (ADRs). It defines ADRs and notes that they can range from mild to severe/life-threatening. The document then discusses populations more susceptible to ADRs and two classification systems for ADRs - the Rawlin and Thompson ABCD classification and the traditional Type A and B classification. Type A reactions are related to the pharmacological action of the drug and are common and predictable, while Type B reactions are unpredictable and can be severe. The document provides examples of different types of ADRs and mechanisms by which they can occur.
This document discusses drug idiosyncrasy and adverse drug reactions. It defines drug idiosyncrasy as an abnormal genetic response to a drug in some individuals. Idiosyncratic reactions are non-dose related and unpredictable. The document categorizes and classifies different types of adverse drug reactions and discusses methods of detection, including pre-marketing clinical trials and post-marketing surveillance. It emphasizes the importance of reporting suspected adverse drug reactions to help prevent future harm.
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.
The document discusses drug levels in blood and their importance. It defines key pharmacokinetic parameters like Cmax, Tmax, and AUC which can be evaluated from plasma concentration-time profiles. Pharmacodynamic parameters like MEC, MSC, therapeutic range and index are also explained. Measuring drug levels in blood allows optimization of dosage regimens and monitoring of treatment progress. However, it requires specialized analytical techniques and repeated blood sampling can be inconvenient.
This PDF deals with important guidelines, with respect to usage of antibiotics. This PDF outlines the important strategies involved while using antibiotics, and important factors involving antibiotic selection.
This document discusses adverse drug reactions (ADRs). It defines ADRs and provides statistics on their frequency and impact. It discusses various factors that can influence ADRs, including patient characteristics like age and genetics. It also discusses drug properties and interactions that can lead to ADRs. The document classifies ADRs into types A-F based on mechanisms and timing. It provides many examples of common and serious ADRs to illustrate different types. The document emphasizes the importance of pharmacovigilance in monitoring and preventing ADRs.
Relationship between pharmacokinetics and pharmacodynamics.pptxMdHimelAhmedRidoy1
Statistical analysis is the collection and interpretation of data in order to uncover patterns and trends. It is a component of data analytics. Statistical analysis can be used in situations like gathering research interpretations, statistical modeling or designing surveys and studies
The document discusses hospital formularies, which are lists of approved medications used in hospitals. A pharmacy and therapeutics committee is responsible for developing and revising the formulary. This includes adding and removing drugs based on efficacy, safety, and cost. The formulary provides guidelines for procuring, prescribing, dispensing, and administering drugs in the hospital. It aims to promote rational and cost-effective drug use. Restrictions may be placed on certain drugs to ensure appropriate usage. Exceptions can be made for nonformulary drugs in special cases.
This document discusses physiological pharmacokinetic models, which describe drug movement and disposition in the body based on organ blood flow and organ spaces penetrated by the drug. It presents different types of models, including blood flow-limited models, models incorporating drug binding, and membrane-limited models. It discusses key concepts like mean residence time, mean absorption time, and mean dissolution time. Physiological pharmacokinetic models provide a more exact description of drug concentrations over time compared to non-physiological models.
The document summarizes the Causality Assessment Scale. It defines causality assessment as assessing the relationship between a drug treatment and adverse event. It describes various methods of causality assessment including expert judgment, algorithms like WHO-UMC and Naranjo scales. It provides examples of causality categories like certain, probable, possible using WHO scale and illustrates its terminology through cases of dechallenge and rechallenge.
The document outlines the steps that a poison information specialist should follow to properly handle a poison information query. The specialist must first collect details about the caller and exposure incident. They then assess the urgency of the situation and research treatment options using specialized databases and references. The specialist evaluates the information and provides a tailored response, either verbally or in writing. They may follow up on the case and document the interaction, maintaining confidentiality. The overall process ensures the specialist can safely and effectively assist those exposed to toxic substances.
This document discusses guidelines for bioavailability and bioequivalence studies. It defines key terms like bioavailability, bioequivalence, pharmaceutical equivalents and alternatives. It outlines when bioequivalence studies are necessary, such as for modified release drugs, and when they are not required, such as for parenteral solutions. It also describes the different types of studies including pharmacokinetic, pharmacodynamic and clinical endpoint studies. Finally, it provides details on study design, population, conditions and statistical evaluation for pharmacokinetic bioequivalence studies.
This document discusses adverse drug reactions (ADRs), including definitions, classifications, mechanisms, and predisposing factors. It defines an ADR as an unintended, harmful reaction to a medication. ADRs are classified based on factors like type (dose-related vs unpredictable), timing (onset), and individual susceptibility. The mechanisms of different ADR types are explained in terms of pharmaceutical, pharmacokinetic, and pharmacodynamic factors. Polypharmacy, multiple diseases, age, drug properties, and genetics can predispose patients to ADRs.
clinical and preclinical approaches to drug discovery.Here we mainly deals with preclinical approaches, ie. Pharmacological approach and toxicological approach
Advesre drug reaction- Types, Reporting, Evaluation, Monitoring, Preventing &...Suhas Reddy C
This document discusses adverse drug reactions (ADRs), including their definition, classification, types, reporting, evaluation, monitoring, prevention and management. It defines an ADR as an unintended reaction to a drug that occurs at normal doses. ADRs can be classified based on incidence (very common to very rare) or severity (mild to severe). Types of ADRs include dose-dependent (Type A), unpredictable hypersensitivity reactions (Type B), continuous effects of long-term drug use (Type C), and withdrawal reactions (Type E). The document outlines what information should be reported for an ADR, who is responsible for reporting, when and how to report ADRs, and where completed reports should be submitted
The document discusses the history and development of clinical pharmacy in India. It notes that clinical pharmacy began emerging in India in the 1980s and 1990s in response to issues with drug misuse and safety. Several key developments followed, including revisions to pharmacy education regulations and the establishment of early master's programs in pharmacy practice. Today, clinical pharmacy practice has expanded further, with pharmacists taking on roles like providing drug information, managing medication therapy, and counseling patients in both hospital and community settings.
This document discusses the detection and monitoring of adverse drug reactions (ADRs). It outlines that ADRs are detected through pre-marketing studies such as acute toxicity and specific animal tests as well as clinical trials. Post-marketing surveillance also plays an important role in ADR detection through spontaneous reporting systems and epidemiological methods. In hospitals, healthcare professionals can detect ADRs by closely monitoring high-risk patients and collecting detailed patient data to assess causality and severity of suspected ADRs.
The document outlines the key elements of a bioequivalence study protocol, including:
1. The objective is to show that the test and reference drug products have similar bioavailability when administered at the same dose.
2. The study design typically involves both fasting and fed conditions, uses a crossover or parallel group design, and involves pharmacokinetic analysis of blood samples taken over time.
3. Subject selection criteria aim to minimize variability through screening and exclusion of those with health issues that could impact drug absorption.
This document discusses linear and nonlinear pharmacokinetics. [1] Linear pharmacokinetics follow first-order kinetics where the rate of drug absorption, distribution, metabolism and excretion is proportional to dose. [2] Nonlinear pharmacokinetics occur when these processes become saturated at high doses due to limited enzyme or transporter capacity. [3] Michaelis-Menten kinetics are often used to model nonlinear processes and estimate parameters like Vmax and Km.
This document discusses adverse drug reactions (ADRs), defined as any undesirable or unintended consequence of drug administration. ADRs are classified as either predictable (type A) or unpredictable (type B) reactions. Predictable reactions include excessive pharmacological effects, secondary pharmacological effects, and rebound effects on drug discontinuation. Unpredictable reactions include allergic drug reactions, idiosyncrasy, and genetically determined toxicity. The document also covers ADR detection methods like patient interviews, ADR reporting approaches, and ADR management based on reaction severity and importance of continued treatment.
Adverse drug reactions (ADRs) remain a major health issue worldwide. They affect the treating outcomes, increase the admission rate to hospitals, increase the morbidity and mortality, increase the cost of therapy, affect the quality of life, and affect the patient satisfaction of health care. This chapter aims to discuss the ADRs-related issues, such as history, types, causes, management and reporting of ADRs, as well as highlight the challenges of ADRs and their reporting in the developing countries, and provide recommendations to overcome the challenges in order to improve practices in the developing countries.
This document discusses adverse drug reactions (ADRs). It defines ADRs and notes that they can range from mild to severe/life-threatening. The document then discusses populations more susceptible to ADRs and two classification systems for ADRs - the Rawlin and Thompson ABCD classification and the traditional Type A and B classification. Type A reactions are related to the pharmacological action of the drug and are common and predictable, while Type B reactions are unpredictable and can be severe. The document provides examples of different types of ADRs and mechanisms by which they can occur.
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.
Drugs can have both beneficial and harmful effects. While drugs save lives and improve health, they can also threaten life. It is important to consider whether the potential benefits of a medication outweigh the risks for a given individual. Adverse drug reactions (ADRs) are a common clinical problem that can have serious consequences for patients, including death. Anyone taking medication can experience an ADR, but some groups are at higher risk, such as the elderly, those taking multiple drugs, and those with multiple medical conditions. Proper diagnosis and management of ADRs is important to prevent further harm.
Adverse drug reactions (ADRs) are adverse events with a causal link to a drug. ADRs can be classified based on onset, type of reaction, and severity. Common types include augmented (Type A), bizarre (Type B), chemical (Type C), and delayed (Type D) reactions. ADRs range from minor to lethal in severity. Examples of ADR classifications and historical events related to ADRs, such as the thalidomide disaster, are discussed in detail in the document.
Drugs can have both beneficial and harmful effects. While drugs save lives and improve health, they can also threaten life. Whether the potential benefits of a medication outweigh the risks depends on the individual taking it. Adverse drug reactions (ADRs) are a common clinical problem that can have serious consequences for patients, from mere inconvenience to death. Anyone taking medication can experience an ADR, but some groups are at higher risk, such as the elderly, those taking multiple drugs, and those with multiple medical conditions. ADRs should be considered if new symptoms appear after starting or increasing a drug dose and disappear after stopping the drug. The most common causes of ADRs are antibiotics, anticancer drugs, cardiovascular drugs,
This document discusses adverse drug reactions and pharmacovigilance. It defines adverse drug reactions as noxious changes suspected to be caused by a drug. Adverse drug reactions are classified based on their timing (immediate, delayed), severity (minor to lethal), predictability (type A - dose-dependent and type B - unpredictable), and other characteristics. The document also discusses preventing adverse reactions through appropriate drug use and monitoring patients for new symptoms after starting treatment. Pharmacovigilance aims to detect, understand and prevent adverse drug reactions through postmarketing surveillance.
This document discusses adverse drug reactions (ADRs). It defines ADRs as noxious changes suspected to be caused by a drug. It notes the incidence is higher in populations like the elderly, children, and immunosuppressed individuals. ADRs can develop immediately or after prolonged medication use, and are graded based on their severity. ADRs are broadly classified as Type A (predictable) or Type B (unpredictable). It also discusses concepts like idiosyncrasy, allergy, dependence, withdrawal, teratogenicity, and pharmacovigilance monitoring of ADRs.
This document discusses adverse drug reactions (ADRs). It defines ADRs as noxious changes suspected to be caused by a drug. It notes the incidence of ADRs is higher in populations like the elderly, children, and pregnant women. ADRs can develop immediately or after prolonged medication use, and are classified based on their severity from minor to lethal. The document also categorizes ADRs and discusses types like augmented, bizarre, chronic, delayed, and ending drug use. It covers topics such as pharmacovigilance, preventing ADRs, drug interactions, and classifications including side effects, toxicity, intolerance, and idiosyncrasy.
This document discusses adverse drug reactions (ADRs), defined as any noxious change suspected to be caused by a drug. It provides definitions of key terms like adverse event and adverse drug event. It also categorizes different types of ADRs based on factors like onset, reaction type, severity, and more. Examples are given for each category to illustrate different types of ADRs like augmented, bizarre, chemical, delayed, and others. The document discusses concepts like side effects, secondary effects, toxic effects, intolerance, idiosyncrasy, drug allergy, and more.
1. An adverse drug reaction (ADR) is defined by the WHO as any unintended and harmful response to a drug that occurs at normal dosages.
2. ADRs are common, occurring in 5-30% of hospitalized patients and 3% of hospital admissions. They are more common in the elderly, young, and those taking multiple drugs.
3. ADRs can range from mild to severe or life-threatening. They can occur immediately after drug administration or after prolonged use. Common causes of ADRs include dose-related effects, allergic reactions, and idiosyncratic responses.
This document discusses adverse drug reactions (ADRs). It defines an ADR as an unwanted change caused by a drug taken at normal doses. ADRs can range from minor to severe/lethal. They are classified based on timing (immediate vs. delayed), mechanism (predictable type A vs. unpredictable type B), chronicity, and severity. High-risk groups for ADRs include the elderly, children, and those with multiple illnesses or medications. Pharmacovigilance aims to detect, understand, and prevent ADRs through postmarketing surveillance. The Uppsala Monitoring Centre in Sweden coordinates international pharmacovigilance efforts.
This document defines and classifies adverse drug reactions (ADRs). It notes that ADRs are any undesirable consequences of drug administration and can range from minor to lethal. ADRs are classified as predictable or unpredictable, and mild, moderate or severe. The science of pharmacovigilance relates to monitoring and preventing ADRs. ADRs are further classified as side effects, secondary effects, toxic effects, intolerance, idiosyncrasy, drug allergy, photosensitivity, drug dependence, withdrawal reactions, teratogenicity, mutagenicity/carcinogenicity, and drug-induced diseases. The document provides examples and definitions for each classification of ADR.
The document defines adverse drug reactions (ADRs) and describes the different types and classifications of ADRs. It states that according to WHO, an ADR is an unintended or unwanted effect of a drug that occurs at standard therapeutic doses. The document then outlines various factors that can influence ADRs like age, sex, dosage, and genetic factors. It describes the different types of ADRs as Type A, B, C, D and E reactions and provides examples of each type. Finally, it discusses methods of assessing ADR severity and causality.
This document discusses adverse drug reactions and pharmacovigilance. It defines an adverse drug reaction as an unwanted change caused by a drug at normal doses that requires treatment or a dose decrease. Adverse drug events are untoward occurrences during treatment that are not necessarily caused by the treatment. The document classifies adverse drug reactions into types A, B, C, D and E based on factors like dose, time of onset, and mechanism. It also discusses preventing adverse drug effects through appropriate use and monitoring for new symptoms after starting treatment. Pharmacovigilance aims to detect, understand and prevent adverse drug reactions through postmarketing surveillance.
The document discusses adverse drug reactions (ADRs). It defines ADRs and different types including: Type A reactions which are augmented/predictable effects; Type B which are bizarre/unpredictable; Type C seen with continuous use; Type D which are delayed effects; Type E occurring at the end of a dose; and Type F resulting from treatment failure. It provides examples and management strategies for each type of ADR.
The document discusses adverse drug reactions (ADRs), defining them as unintended harmful effects that occur from drugs used for treatment or diagnosis. It classifies ADRs into different types based on predictability (Type A/predictable vs. Type B/unpredictable) and timing (Type C associated with long-term use, Type D delayed effects, Type E withdrawal effects). It also discusses hypersensitivity reactions, drug abuse/dependence, teratogenicity, photosensitivity, iatrogenic disease, and effects on oral tissues like dry mouth, aphthous ulcers, and teeth discoloration.
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
Patient compliance with medical adviceRavish Yadav
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
This document defines osmosis and osmotic pressure, and describes how osmotic systems utilize these principles for controlled drug delivery. It discusses the basic components of osmotic systems, including drugs, osmotic agents, semi-permeable membranes, and plasticizers. It also describes various types of osmotic systems for both oral and implantable drug delivery, including elementary osmotic pumps, push-pull osmotic pumps, and implantable mini-osmotic pumps. The document provides equations to describe drug release from these systems driven by osmotic pressure.
The document discusses opioid analgesics and their mechanisms of action. It notes that the body has an endogenous analgesic system centered in the brainstem that is stimulated by opioids. Opioids work by binding to mu, delta, and kappa receptors in the brain and spinal cord, inhibiting pain signal transmission. Several opioid analgesics are described, including morphine, codeine, heroin, fentanyl, and methadone. Tolerance, side effects, metabolism, and antagonists are also discussed. The future of opioid analgesics is seen to involve further study of the kappa receptor and endogenous opioid peptides to develop safer drugs.
Infrared spectrum / infrared frequency and hydrocarbonsRavish Yadav
This document provides information about infrared (IR) spectroscopy and analyzing IR spectra of different functional groups. It discusses:
1. The conditions required for IR absorption and the division of the IR spectrum into the functional group and fingerprint regions.
2. The characteristic IR absorptions of common functional groups like alkanes, alkenes, alkynes, alcohols, phenols, ethers, aldehydes, ketones, carboxylic acids, esters, amides, amines, and aromatics. Specific examples and their spectra are provided.
3. Factors that affect IR frequencies, such as bond strength, mass of atoms, resonance, conjugation, and hydrogen bonding.
Neurotransmitters are endogenous chemicals that transmit signals between neurons. The major categories are small-molecule neurotransmitters like acetylcholine and amino acids, and large peptides. They act on ligand-gated ion channels or G protein-coupled receptors. After release, they are typically removed from the synapse by reuptake back into the presynaptic neuron or breakdown by enzymes. Examples include acetylcholine, which activates nicotinic and muscarinic receptors, and glutamate, the main excitatory neurotransmitter in the brain. GABA is the primary inhibitory neurotransmitter and binds GABAA/B/C receptors. Neuropeptides are longer amino acid chains that modulate synaptic transmission.
Narcotic drugs and psychotropic substances act, 1985Ravish Yadav
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The all the content in this profile is completed by the teachers, students as well as other health care peoples.
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Medicinal and toilet preparations (excise duties) act, 1995 and rules, 1956Ravish Yadav
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Lipids can be classified by their structure as simple lipids like fats and oils or complex lipids like phospholipids. They can also be classified based on whether they undergo hydrolysis in alkaline solutions. Lipids are made up of fatty acids and glycerol, forming triglycerides. Fats are usually saturated while oils contain some unsaturated fatty acids. Waxes differ from fats and oils in that they are esters of long-chain alcohols and fatty acids with higher melting points. Lipids serve important functions and have many applications, such as in soaps, foods, and cosmetics.
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The document summarizes the tricarboxylic acid (TCA) cycle, also known as the Krebs cycle or citric acid cycle. It discusses that the TCA cycle involves the oxidation of acetyl-CoA to carbon dioxide and water and is the final common pathway for carbohydrates, fats, and amino acids. The cycle occurs in the mitochondrial matrix and generates energy in the form of NADH and FADH2 that are used in the electron transport chain to produce ATP. Key enzymes and reactions in the cycle are described, including the generation of citrate, isocitrate, alpha-ketoglutarate, succinyl-CoA, fumarate, oxaloacetate
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Anti mycobacterial drugs (tuberculosis drugs)Ravish Yadav
This document discusses anti-mycobacterial drugs used to treat tuberculosis. It begins by describing tuberculosis and how it is caused by the bacterium Mycobacterium tuberculosis. First-line drugs to treat tuberculosis are listed as isoniazid, rifampin, pyrazinamide, ethambutol, and streptomycin. Each drug's mechanism of action and potential resistance issues are then explained individually. Second-line drugs discussed include ethionamide, capreomycin, cycloserine, aminosalicylic acid, and fluoroquinolones. Common adverse drug reactions are also outlined.
This document provides information on various anti-malarial agents. It discusses the life cycle of Plasmodium parasites and the four species that cause malaria in humans. It then describes various classes of anti-malarial drugs including those derived from natural sources like cinchona alkaloids and artemisinin, as well as synthetic agents like chloroquine, primaquine, mefloquine, and antifolate drugs. For each class, it provides details on examples, mechanisms of action, structure-activity relationships, resistance issues, and pharmacological properties. The document aims to comprehensively cover the major therapeutic options available to treat malaria.
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How to Make a Field Mandatory in Odoo 17Celine George
In Odoo, making a field required can be done through both Python code and XML views. When you set the required attribute to True in Python code, it makes the field required across all views where it's used. Conversely, when you set the required attribute in XML views, it makes the field required only in the context of that particular view.
How to Setup Warehouse & Location in Odoo 17 InventoryCeline George
In this slide, we'll explore how to set up warehouses and locations in Odoo 17 Inventory. This will help us manage our stock effectively, track inventory levels, and streamline warehouse operations.
2. Adverse Drug Reactions
(ADR)
Harm associated with the use of a given
medications
OR
•Unwanted or harmful reaction
experienced after the administration of a
drug or combination of drugs under
normal conditions of use
3. •ADR= significant morbidity & mortality
•Range from mild reactions
(drowsiness, nausea, itching& rash);
disappear after discontinuation of drug
OR
•Severe reactions (respiratory
depression, neutorpenia, hepatocellualr
injury, hemorrhage, anaphylaxis
4. ADR most common in
• Women
• Elderly (>60 y old)
• Very young (1-4 y)
• Patients taking more than one drug
5. Classification of ADR
Rawlin & Thompson classification ABCD
Traditional classification A & B
About 80% of ADR----Type A reactions
1) Type A Reactions
a) Related to pharmacological action of drug
Extensions of the principal pharmacological
action of the drug
Cont.
6. b) Predictable
Relatively easily predicted by preclinical and clinical
pharmacological studies
c) Common
Type A reactions not serious---common
d) Dose-dependent
Usually dose dependent
7. Type A reactions (classes)
i) Toxicity of overdose (Drug overdose)
An adverse drug reaction caused by excessive dosing
e.g., hepatic failure with dose of paracetamol
Headache with antihypertensives
hypoglycemia with sulfonylurea;
8. ii) Side Effects
Nearly unavoidable secondary drug effect produced by therapeutic
doses
• intensity is dose dependent
• Occur immediately after initially taking drug or may not appear until
weeks after initiation of drug use
• E.g., sedation with antihistamines
9. iii) Secondary Effects
Secondary pharmacological effect
• E.g., development of diarrhea with antibiotic therapy due to altered
GIT bacterial flora
• Orthostatic hypotension with a phenothiazine
10. iv) Drug Interactions
When two drugs taken together & they effect each other’s response
pharmacologically or kinetically
• E.g., one drug slow metabolism of 2nd drug blood conc.= toxicity
•Theophylline toxicity in presence of erythromycin
11. 2) Type B Reactions
Unrelated to known pharmacological
actions of drug
Unpredictable
Often caused by immunological &
pharmacogenetic mechanisms
Unrelated to dosage
Comparatively rare & cause serious illness
or death cont.
12. •Results (more likely) in withdrawal of
marketing authorization
•Often not discovered until after drug is
marketed
•Both environmental & genetic factors =
important in this reaction
13. Type B Reactions (classes)
i) Drug Intolerance
Lower threshold to normal pharmacological action of a drug
e.g., tinnitus (single average dose of aspirin)
ii) Hypersensitivity (immunological reaction)
Immune mediated response to a drug agent in
sensitized patient
e.g., anaphylaxis with penicillin
14. iii) Pseudoallergic Reaction
Direct mast cell activation & degranulation by drugs
(opiates, vancomycin & radiocontrast media)
Clinically indistinguishable form Type I
hypersensitivity but not involve IgE (non immunologic
reactions)
15. iv) Idiosyncratic Reactions
•An uncommon & abnormal response to drug
•Usually due to genetic abnormality
•Affect drug metabolism & receptor sensitivity
•Harmful even fatal, appear in low doses
E.g., Anemia (hemolysis) by antioxidant drugs
(G6PD deficiency)
Paralysis due to succinylcholine (enzyme deficiency)
16. 3) Type C (chronic) Reactions
•Associated with long-term drug therapy
•Well known and can be anticipated
•Adaptation occurs = discontinuation of
drug=abstinence syndrome
E.g. opoids, alcohol, barbiturates
17. 4) Type D (delayed) Reactions
Carcinogenic & teratogenic effects
Delayed in onset
Very rare
Carcinogenic Effect
Medication lead to cancer; take >20 y to develop
Teratogenic Effect
Drug- induced birth defects
18. Sign & Symptoms of ADR
•Mild, moderate, severe or lethal
•Sign & symptoms manifest soon after 1st dose or
only after chronic use
e.g., Allergic reactions occur soon after drug is taken usually 2nd time (
itching, rash, eruption, upper or lower airway edema with dyspnea &
hypotension)
Idiosyncratic reactions=any unpredicted symptom
19. Mechanisms of ADR
Type A =non immunological, reversible with reduction of dose, non
serious, extension of pharmacological effects
Type B
Biochemical mechanism unrelated to pharmacological
Immunologic = Hypersensitivity (Type I, II, III, IV)
OR
Non immunologic (direct)= Pseudoallergic, idiosyncratic, intolerance
20. Mechanism of Type B Reactions
i) Often mediated by a chemically reactive
metabolite
Non detoxification of metabolite
Direct cytotoxicity
Direct tissue damage + necrosis
21. ii) Bind to NA altered gene product
• Bind to a larger macromolecule inducing immune response
(produce Ab & bind to Ab)
22. Drug Hypersensitivity (allergic) Reaction
• Common form of adverse response to drugs
Classification (Gell & Coombs)
Type I reactions (IgE-mediated)
Type II reactions (cytotoxic)
Type III reactions (immune complex)
Type IV (delayed, cell mediated)