This document discusses drug-induced diseases and adverse drug reactions. It begins by defining a drug-induced disease as an unintended effect of a drug that results in symptoms requiring medical attention or hospitalization. It then discusses various terms used to describe adverse drug effects such as adverse drug reactions, adverse events, unexpected adverse reactions, and serious adverse events. The document notes that drug reactions can be categorized as either type A reactions, which are exaggerated pharmacological effects, or type B reactions, which are unpredictable and idiosyncratic. It also discusses factors that can influence individual responses to drugs such as genetics, organ dysfunction, and fluid and electrolyte imbalances.
OVER THE COUNTER SALE_ RDP_PHARMACY PRACTICErishi2789
OTC drugs are medications that can be purchased without a prescription. They include analgesics, cough and cold medicines, antacids, and topical products. OTC drugs are considered low risk but can still interact with other medications or cause side effects if misused. Pharmacists play an important role in counseling patients on the safe use of OTC drugs through open-ended questions to understand medical history and current medications, then providing instructions on proper dosage, administration, storage, and potential drug interactions. While convenient, OTC drugs still require guidance to ensure safe self-medication.
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.
Drug use in elderly and techniques to avoid polypharmacyDrSahilKumar
The document discusses drug use in the elderly and techniques to avoid polypharmacy. It notes that the elderly population is growing and takes a significant portion of medications while also being more sensitive to drug effects due to physiological changes. Polypharmacy, defined as taking more than 5 medications, is common in the elderly due to multiple comorbidities and providers. This can increase risks of adverse drug reactions, interactions, and non-adherence. The document recommends techniques for optimal prescribing in the elderly like reviewing all medications, simplifying regimens, and eliminating unnecessary drugs to help prevent polypharmacy and its risks.
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.
• Definition of terms associated with Adverse Drug Reactions (ADRs)
• Classification of ADRs
• Discussion on each type of ADR with examples
• Role of the Pharmacists
This presentation summarizes adverse drug reactions (ADRs) and their monitoring. It defines an ADR and classifies them based on onset (acute, sub-acute, latent), severity (mild, moderate, severe), and type (Type A-F). Common risk factors for ADRs include age, gender, multiple medications, and organ dysfunction. ADRs can be detected through pre-marketing clinical trials, post-marketing surveillance studies, underreporting, and communication. Monitoring of ADRs involves identifying reactions, assessing causality, documenting cases, and reporting serious ADRs to pharmacovigilance authorities.
OVER THE COUNTER SALE_ RDP_PHARMACY PRACTICErishi2789
OTC drugs are medications that can be purchased without a prescription. They include analgesics, cough and cold medicines, antacids, and topical products. OTC drugs are considered low risk but can still interact with other medications or cause side effects if misused. Pharmacists play an important role in counseling patients on the safe use of OTC drugs through open-ended questions to understand medical history and current medications, then providing instructions on proper dosage, administration, storage, and potential drug interactions. While convenient, OTC drugs still require guidance to ensure safe self-medication.
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.
Drug use in elderly and techniques to avoid polypharmacyDrSahilKumar
The document discusses drug use in the elderly and techniques to avoid polypharmacy. It notes that the elderly population is growing and takes a significant portion of medications while also being more sensitive to drug effects due to physiological changes. Polypharmacy, defined as taking more than 5 medications, is common in the elderly due to multiple comorbidities and providers. This can increase risks of adverse drug reactions, interactions, and non-adherence. The document recommends techniques for optimal prescribing in the elderly like reviewing all medications, simplifying regimens, and eliminating unnecessary drugs to help prevent polypharmacy and its risks.
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.
• Definition of terms associated with Adverse Drug Reactions (ADRs)
• Classification of ADRs
• Discussion on each type of ADR with examples
• Role of the Pharmacists
This presentation summarizes adverse drug reactions (ADRs) and their monitoring. It defines an ADR and classifies them based on onset (acute, sub-acute, latent), severity (mild, moderate, severe), and type (Type A-F). Common risk factors for ADRs include age, gender, multiple medications, and organ dysfunction. ADRs can be detected through pre-marketing clinical trials, post-marketing surveillance studies, underreporting, and communication. Monitoring of ADRs involves identifying reactions, assessing causality, documenting cases, and reporting serious ADRs to pharmacovigilance authorities.
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.
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.
This document discusses polypharmacy in the elderly, defined as using more than 5 medications. It notes that polypharmacy prevalence increases with age, reaching 50% in those over 65. Consequences can include adverse drug reactions, reduced quality of life, and increased healthcare costs. Pharmacokinetic changes in aging like decreased liver and kidney function must be considered. The Beers Criteria provide guidance on inappropriate medications in elders. Interventions to reduce polypharmacy risk include regular medication reviews, educating patients, and using a personal health record.
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.
Term paper presentation 3- Adverse Drug Reactions & Drug ToxicityAnsh Dev
The document discusses drug toxicity and adverse drug reactions. It defines these terms and classifies adverse drug reactions into six types based on dose and time factors. Drug toxicity can result from too high of a dose or the body's inability to remove a drug. Common symptoms of drug toxicity are also listed. The document emphasizes keeping accurate medication records and informing all doctors of all drugs and supplements taken to avoid potential toxic reactions.
Adverse drug reactions (ADRs) are injuries caused by medications and can occur from a single dose or prolonged use of one or more drugs. ADRs include side effects which occur at therapeutic doses and are usually predictable, as well as toxic effects which happen at higher than usual doses. Some ADRs are allergic reactions that are not dose-related and involve the immune system. ADRs can affect many body systems and organs and cause issues like stimulation or depression of the central nervous system, changes in cardiovascular functions, respiratory effects, gastrointestinal irritation, and liver or kidney damage. The document also discusses drug interactions, withdrawal reactions, carcinogenicity, mutagenicity, teratogenicity, and definitions of acute,
This document defines and discusses adverse drug reactions (ADRs). It begins by defining an ADR as an unwanted, uncomfortable or dangerous effect from a drug. ADRs can occur due to known side effects or previously unrecognized effects. The document then defines an ADR more specifically as a noxious and unintended response to a medication. It notes that the incidence and severity of ADRs varies depending on patient characteristics like age as well as drug factors like dosage. It describes three main types of ADRs - dose-related, allergic, and idiosyncratic reactions. The document concludes by discussing signs and symptoms of ADRs and providing some examples of mild, moderate, severe and lethal classifications.
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.
An adverse drug reaction (ADR) is an unintended effect of a medication. Common types include Type A reactions which are dose-dependent and predictable, and Type B reactions which are unpredictable and sometimes life-threatening like anaphylaxis. Factors causing ADRs include patient factors like age and genetics as well as drug factors. Manifestations can affect various organs. Pharmacovigilance aims to monitor ADRs to educate clinicians and regulate drug use to reduce harm.
Thalidomide was a sedative that was prescribed to pregnant women in the late 1950s to treat morning sickness. It was later found to cause severe birth defects in over 10,000 babies worldwide, with malformed limbs being the most common defect. Thalidomide was withdrawn from the market in 1961 after the link to birth defects was established. This tragedy highlighted the need for rigorous safety testing of drugs, especially for teratogenic effects, and led to the establishment of regulatory frameworks for drug approval and pharmacovigilance systems like the Yellow Card Scheme to monitor adverse drug reactions.
Pharmacotherapy considerations in elderly adultsSafaa Ali
Pharmacotherapy considerations in elderly adults focuses on how aging affects the body's processing of drugs. Key changes include reduced absorption in the gastrointestinal tract, altered distribution in tissues due to changes in body composition, and decreased metabolism and excretion due to reduced liver and kidney function. These pharmacokinetic changes mean drugs for elderly patients often require dosage adjustments to avoid adverse drug reactions. Common issues include increased risk of drug interactions due to slower drug clearance and greater sensitivity to pharmacodynamic effects like sedation or hypotension.
Phenytoin is a commonly used anticonvulsant with a narrow therapeutic window, making toxicity a risk. Acute toxicity from overdose causes neurological symptoms like nystagmus and ataxia in a concentration-dependent manner, while chronic use risks side effects like gingival enlargement. Factors like changes in dose, medications, albumin levels and disease states can affect phenytoin levels. Evaluation includes phenytoin levels and albumin. Treatment focuses on supportive care, with activated charcoal for acute overdoses and hemodialysis in severe cases. Prognosis is generally good but deaths can occur at very high concentrations.
This document discusses adverse drug reactions (ADRs), defined as undesirable consequences from drug administration. It classifies ADRs based on type, severity, and other factors. Major categories of ADRs include side effects, allergic reactions, toxicity, dependence, withdrawal reactions, teratogenicity, and drug-induced diseases. The document also outlines various methods for preventing ADRs, such as appropriate use of drugs, considering patient characteristics, monitoring for interactions, and following administration techniques carefully.
Adverse drug reactions can be categorized as Type A or Type B reactions. Type A reactions are exaggerated pharmacological responses caused by factors like dosage or interactions with other drugs. Type B reactions are unpredictable and bizarre, caused by mechanisms like immune reactions, genetics, or formation of reactive metabolites. It is important for healthcare providers to monitor for adverse drug reactions using pharmacovigilance programs in order to prevent harm, understand the causes of reactions, and update drug information and labeling.
This document discusses polypharmacy and aging. It covers several topics related to challenges of geriatric pharmacology including how aging affects pharmacokinetics and pharmacodynamics. Pharmacokinetics like absorption, distribution, metabolism and elimination can all be impacted by aging. Factors like reduced liver and kidney function, lower muscle mass and protein levels can influence how drugs are processed in older patients. Pharmacodynamics may also be altered, with some drugs having increased effects. Careful consideration of age-related changes is important for safe and effective prescribing in geriatric patients.
This document summarizes geriatric pharmacology and aging-related changes. It discusses theories of aging, how aging affects drug absorption, distribution, metabolism, and excretion. It also covers age-related changes in drug sensitivity and interactions, principles of prescribing for older adults, and common diseases in the elderly. Potential anti-aging therapies like calorie restriction, DHEA, and estrogen/progesterone are also mentioned.
This document discusses adverse drug effects and their classification. It defines an adverse drug reaction and describes various types including predictable, unpredictable, chronic, and delayed reactions. It outlines the severity of reactions from minor to lethal. Adverse drug effects are also categorized including side effects, toxicity, intolerance, idiosyncrasy, allergy, photosensitivity, dependence, withdrawal, teratogenicity, mutagenicity, carcinogenicity, and drug-induced diseases. The document provides examples and mechanisms for different types of reactions and discusses prevention of adverse drug effects.
The document discusses multidrug use in the elderly. It notes that the elderly population is growing and consuming more prescription drugs. Age-related changes to pharmacokinetics and pharmacodynamics can increase risks of adverse drug events from polypharmacy. Drugs are metabolized and cleared more slowly from the body due to reduced liver and kidney function. The elderly also experience increased drug sensitivity. Careful monitoring is needed to balance treatment benefits and risks.
Pharmacovigilance AND ADVERSE DRUG REACTIONS.
MONITORING REPORTING ROLE OF PHARMACIST.
CLASSIFICATION OF ADR. MECHANISM OF ADR
ROLE OF PHARMACIST IN MANAGING ADR. AUGMENTED, BIZZARE, CONTINOUS, DELAYED, END OF TREATMENT, ABCD, ABCDE.
This document discusses adverse drug reactions (ADRs), including definitions from WHO and FDA, classification of ADRs as Type A or B reactions, factors affecting ADR incidence and severity, and methods for detecting and monitoring ADRs. It provides details on the national pharmacovigilance program in Nepal and the role pharmacists play in ADR monitoring and pharmacovigilance.
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.
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.
This document discusses polypharmacy in the elderly, defined as using more than 5 medications. It notes that polypharmacy prevalence increases with age, reaching 50% in those over 65. Consequences can include adverse drug reactions, reduced quality of life, and increased healthcare costs. Pharmacokinetic changes in aging like decreased liver and kidney function must be considered. The Beers Criteria provide guidance on inappropriate medications in elders. Interventions to reduce polypharmacy risk include regular medication reviews, educating patients, and using a personal health record.
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.
Term paper presentation 3- Adverse Drug Reactions & Drug ToxicityAnsh Dev
The document discusses drug toxicity and adverse drug reactions. It defines these terms and classifies adverse drug reactions into six types based on dose and time factors. Drug toxicity can result from too high of a dose or the body's inability to remove a drug. Common symptoms of drug toxicity are also listed. The document emphasizes keeping accurate medication records and informing all doctors of all drugs and supplements taken to avoid potential toxic reactions.
Adverse drug reactions (ADRs) are injuries caused by medications and can occur from a single dose or prolonged use of one or more drugs. ADRs include side effects which occur at therapeutic doses and are usually predictable, as well as toxic effects which happen at higher than usual doses. Some ADRs are allergic reactions that are not dose-related and involve the immune system. ADRs can affect many body systems and organs and cause issues like stimulation or depression of the central nervous system, changes in cardiovascular functions, respiratory effects, gastrointestinal irritation, and liver or kidney damage. The document also discusses drug interactions, withdrawal reactions, carcinogenicity, mutagenicity, teratogenicity, and definitions of acute,
This document defines and discusses adverse drug reactions (ADRs). It begins by defining an ADR as an unwanted, uncomfortable or dangerous effect from a drug. ADRs can occur due to known side effects or previously unrecognized effects. The document then defines an ADR more specifically as a noxious and unintended response to a medication. It notes that the incidence and severity of ADRs varies depending on patient characteristics like age as well as drug factors like dosage. It describes three main types of ADRs - dose-related, allergic, and idiosyncratic reactions. The document concludes by discussing signs and symptoms of ADRs and providing some examples of mild, moderate, severe and lethal classifications.
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.
An adverse drug reaction (ADR) is an unintended effect of a medication. Common types include Type A reactions which are dose-dependent and predictable, and Type B reactions which are unpredictable and sometimes life-threatening like anaphylaxis. Factors causing ADRs include patient factors like age and genetics as well as drug factors. Manifestations can affect various organs. Pharmacovigilance aims to monitor ADRs to educate clinicians and regulate drug use to reduce harm.
Thalidomide was a sedative that was prescribed to pregnant women in the late 1950s to treat morning sickness. It was later found to cause severe birth defects in over 10,000 babies worldwide, with malformed limbs being the most common defect. Thalidomide was withdrawn from the market in 1961 after the link to birth defects was established. This tragedy highlighted the need for rigorous safety testing of drugs, especially for teratogenic effects, and led to the establishment of regulatory frameworks for drug approval and pharmacovigilance systems like the Yellow Card Scheme to monitor adverse drug reactions.
Pharmacotherapy considerations in elderly adultsSafaa Ali
Pharmacotherapy considerations in elderly adults focuses on how aging affects the body's processing of drugs. Key changes include reduced absorption in the gastrointestinal tract, altered distribution in tissues due to changes in body composition, and decreased metabolism and excretion due to reduced liver and kidney function. These pharmacokinetic changes mean drugs for elderly patients often require dosage adjustments to avoid adverse drug reactions. Common issues include increased risk of drug interactions due to slower drug clearance and greater sensitivity to pharmacodynamic effects like sedation or hypotension.
Phenytoin is a commonly used anticonvulsant with a narrow therapeutic window, making toxicity a risk. Acute toxicity from overdose causes neurological symptoms like nystagmus and ataxia in a concentration-dependent manner, while chronic use risks side effects like gingival enlargement. Factors like changes in dose, medications, albumin levels and disease states can affect phenytoin levels. Evaluation includes phenytoin levels and albumin. Treatment focuses on supportive care, with activated charcoal for acute overdoses and hemodialysis in severe cases. Prognosis is generally good but deaths can occur at very high concentrations.
This document discusses adverse drug reactions (ADRs), defined as undesirable consequences from drug administration. It classifies ADRs based on type, severity, and other factors. Major categories of ADRs include side effects, allergic reactions, toxicity, dependence, withdrawal reactions, teratogenicity, and drug-induced diseases. The document also outlines various methods for preventing ADRs, such as appropriate use of drugs, considering patient characteristics, monitoring for interactions, and following administration techniques carefully.
Adverse drug reactions can be categorized as Type A or Type B reactions. Type A reactions are exaggerated pharmacological responses caused by factors like dosage or interactions with other drugs. Type B reactions are unpredictable and bizarre, caused by mechanisms like immune reactions, genetics, or formation of reactive metabolites. It is important for healthcare providers to monitor for adverse drug reactions using pharmacovigilance programs in order to prevent harm, understand the causes of reactions, and update drug information and labeling.
This document discusses polypharmacy and aging. It covers several topics related to challenges of geriatric pharmacology including how aging affects pharmacokinetics and pharmacodynamics. Pharmacokinetics like absorption, distribution, metabolism and elimination can all be impacted by aging. Factors like reduced liver and kidney function, lower muscle mass and protein levels can influence how drugs are processed in older patients. Pharmacodynamics may also be altered, with some drugs having increased effects. Careful consideration of age-related changes is important for safe and effective prescribing in geriatric patients.
This document summarizes geriatric pharmacology and aging-related changes. It discusses theories of aging, how aging affects drug absorption, distribution, metabolism, and excretion. It also covers age-related changes in drug sensitivity and interactions, principles of prescribing for older adults, and common diseases in the elderly. Potential anti-aging therapies like calorie restriction, DHEA, and estrogen/progesterone are also mentioned.
This document discusses adverse drug effects and their classification. It defines an adverse drug reaction and describes various types including predictable, unpredictable, chronic, and delayed reactions. It outlines the severity of reactions from minor to lethal. Adverse drug effects are also categorized including side effects, toxicity, intolerance, idiosyncrasy, allergy, photosensitivity, dependence, withdrawal, teratogenicity, mutagenicity, carcinogenicity, and drug-induced diseases. The document provides examples and mechanisms for different types of reactions and discusses prevention of adverse drug effects.
The document discusses multidrug use in the elderly. It notes that the elderly population is growing and consuming more prescription drugs. Age-related changes to pharmacokinetics and pharmacodynamics can increase risks of adverse drug events from polypharmacy. Drugs are metabolized and cleared more slowly from the body due to reduced liver and kidney function. The elderly also experience increased drug sensitivity. Careful monitoring is needed to balance treatment benefits and risks.
Pharmacovigilance AND ADVERSE DRUG REACTIONS.
MONITORING REPORTING ROLE OF PHARMACIST.
CLASSIFICATION OF ADR. MECHANISM OF ADR
ROLE OF PHARMACIST IN MANAGING ADR. AUGMENTED, BIZZARE, CONTINOUS, DELAYED, END OF TREATMENT, ABCD, ABCDE.
This document discusses adverse drug reactions (ADRs), including definitions from WHO and FDA, classification of ADRs as Type A or B reactions, factors affecting ADR incidence and severity, and methods for detecting and monitoring ADRs. It provides details on the national pharmacovigilance program in Nepal and the role pharmacists play in ADR monitoring and pharmacovigilance.
Synthetic Drugs/Hormones - Boon or Bane- Concept of Dooshivisha and Gara VishaIJARIIT
21st century is the world full of synthetics and everyone are living in the influence of synthetic substances. Altered life
styles, food habits and irregular sleep pattern had resulted not only Non communicable disease but also resulting in reduced
immunity and is risking the person more for infections. Pharma Industry has grown as big as hierarchy in recent centauries
and introduces new chemical molecules quoting as capable for treating diabetes, hypertension etc. But bitter truth is prolonged
usage these medications itself has adverse effect on liver and kidneys causes hepatotoxicity and nephrotoxicity or organs
specific toxicity.
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
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Introduction to adverse drug reactions
Definitions and classification of ADRs
Detection and reporting
Methods in Causality assessment
Severity and seriousness assessment
Predictability and preventability assessment
Management of adverse drug reactions
ADE
INCIDENCE OF ADR
GREADING OF SEVERITY OF ADR
CLASSIFICATIONS
PHARMACOVIGILANCE
CATAGORIES
CAUSES OF ADR
DRUG INDUCED HEPATIC DYSFUNCTION
DRUG INDUCED ENDOCRINE DYSFUNCTION
DRUG INDUCED PHERIPHERAL NEUROPATHY
MANAGEMENT OF ADR
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
This document provides an overview of adverse drug reactions (ADRs). It defines what constitutes an ADR and different types of ADRs such as Type A, B, C, D and E reactions. It notes that ADRs are common, increasing healthcare costs and hospital stays. Causes of ADRs include patient factors, drug factors and prescriber factors. Historical examples of drug-induced harms are provided. The importance of pharmacovigilance programs for post-marketing drug safety monitoring is highlighted.
This document discusses adverse drug reactions (ADRs), their classification and monitoring. It defines an ADR as an unintended effect of a drug that occurs at normal dosages. ADRs are classified into types A-H based on mechanisms and timing. Factors that increase risk of ADRs include polypharmacy, age, drug characteristics, and genetic predispositions. ADRs are detected through pre-marketing clinical trials, post-marketing surveillance programs, and healthcare professional reporting. Vigilant monitoring of at-risk patients can help identify ADRs.
This document discusses adverse drug reactions (ADRs). It begins by defining ADRs according to the WHO as any unintended and noxious response to a drug. It then provides a brief history of notable ADR events. The document goes on to classify ADRs based on factors like onset, type of reaction, and severity. It describes each type of reaction with examples. Finally, it discusses other drug-related concepts like side effects, toxicity, dependence, and teratogenicity.
Adverse drug reactions are undesirable effects that occur when taking medications. They can be caused by the drug itself, drug interactions, or other factors. Common types of reactions include dose-related reactions due to the drug's pharmacological effects (Type A), and unpredictable reactions unrelated to the drug's effects (Type B). Reporting adverse reactions helps monitor drug safety. Prevention strategies include assessing risk factors, avoiding unnecessary medications, and encouraging medication compliance.
This document discusses adverse drug reactions (ADRs). It defines ADRs according to the WHO and UMC as unintended, harmful reactions that occur at normal drug doses. It discusses the history of ADR monitoring and important events like the Thalidomide tragedy. It also defines various ADR terminology and categorizes ADRs into types A-F based on factors like dose, time, and withdrawal. Finally, it discusses pharmacovigilance - the science of detecting, assessing and preventing ADRs - and methods used like spontaneous reporting and intensive monitoring.
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.
The document discusses the history of adverse drug reactions and defines an adverse drug reaction. It describes several important incidents that increased awareness and regulation of drug safety, such as reactions to sulfanilamide in 1937 which led to the establishment of the FDA. It also discusses the thalidomide incident in the 1960s and the teratogenic effects it caused. The document estimates the incidence of adverse drug reactions for hospital inpatients and admissions. It examines various types of adverse drug reactions and factors that can influence them.
adverse drug reactions and adrs monitoringRaj Kumar
adverse drug reaction includes ..typeA to type F..very useful to undergraduates..including post graduates..various types of reactions like side effect,toxicity,teratogenecity,allergic reactions..carcinogenicity and mutagenecity
This document discusses adverse drug reactions, including their definition, classification, causes, and the role of nurses. It defines an adverse drug reaction as an unintended, harmful response to a medication. Reactions are classified as Type A or B, with Type A reactions being dose-dependent and Type B being unpredictable. Common causes of reactions include medication errors, biological differences between patients, and drug interactions. The document outlines how nurses can help identify, document, monitor, prevent, and report adverse drug reactions.
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,
Cephalosporins are a group of semisynthetic antibiotics derived from cephalosporin-C obtained from the fungus Cephalosporium. They have a β-lactam ring and are effective against many gram-positive and some gram-negative bacteria. Cephalosporins work by inhibiting the transpeptidation step in peptidoglycan synthesis, disrupting bacterial cell wall formation. They bind to penicillin-binding proteins and prevent cross-linking of peptidoglycan chains. Bacteria can develop resistance through β-lactamase production or mutations in penicillin-binding proteins. First generation cephalosporins are effective against gram-positive cocci
This document defines asthma and describes its types, symptoms, causes, risk factors, diagnosis, treatment and pathophysiology. Asthma is a chronic inflammatory lung disease characterized by airway hyperresponsiveness and reversible airflow obstruction. It is usually caused by allergic triggers like pollen or dust but can also be triggered by non-allergic factors like viruses or pollution. Diagnosis involves patient history, exams, lung function tests and allergy testing. Treatment includes bronchodilators, corticosteroids, leukotriene modifiers and immunotherapy. The pathophysiology involves type 2 inflammation, IgE production and eosinophil recruitment leading to bronchoconstriction.
This document discusses the various applications and uses of computers in the field of pharmacy. It begins by outlining the main roles of computers in receiving, storing, processing, and disseminating drug information. It then describes 15 specific applications of computers in pharmacy, including their use in retail pharmacy, drug design, hospital pharmacy, data storage/retrieval, pharmaceutical industry information systems, diagnostic laboratories, and more. The document provides details on several of these applications over 3 pages of text.
This study examined the risk of recurrent stroke or death among older patients treated with clopidogrel after a stroke, and whether concurrent use of a proton pump inhibitor (PPI) increased this risk. The study used healthcare databases in Ontario, Canada to identify patients aged 66 and older who were newly prescribed clopidogrel within 30 days of hospital discharge after a stroke between 2002-2008. The study identified 118 patients who were readmitted for stroke and 472 control patients. After adjusting for potential confounding factors, current use of a PPI within 60 days was not found to be associated with a significantly increased risk of recurrent stroke or death among these older patients treated with clopidogrel after a stroke.
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- The elderly are more susceptible to adverse drug reactions due to age
This document summarizes drug-induced cardiovascular diseases. It discusses how drugs can cause cardiac arrhythmias, heart failure, changes in blood pressure, and other issues. Digitalis, quinidine, antiarrhythmics, antidepressants, and sympathomimetics are some of the drugs that can induce arrhythmias. Beta-blockers may precipitate heart failure in vulnerable patients. Alcohol, anthracyclines, and catecholamines can cause cardiomyopathy. Contraceptive steroids increase the risk of hypertension, myocardial ischemia, and venous thrombosis. Corticosteroids, licorice, and nonsteroidal anti-inflammatories may also raise blood pressure.
Applications of computer_science_in_pharmacyKshitijMankar
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This case report describes a 73-year-old female patient who experienced reversible smell and taste disturbances from antiarrhythmic drugs. When taking metoprolol for her arrhythmia, she developed dysosmia (impaired smell) after 3 weeks. Her smell recovered after tapering off metoprolol. However, her arrhythmia worsened so she was given amiodarone, which caused hypogeusia (impaired taste) after 2 weeks. Both her smell and taste fully recovered after discontinuing the drugs. The report concludes these side effects should be made aware to patients on antiarrhythmic drugs.
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Did 1
1. INTRODUCTION
A drug-induced disease is the unintended effect of a drug,
which results in mortality or morbidity with symptoms
sufficient to prompt a patient to seek medical attention
and/or require hospitalization. Drug-induced disease
can result from unanticipated or anticipated drug effects.
Disease also can occur from product impurities, as was
the case with deaths attributed to the use of contaminated
heparin in 2008.Vigilance on the part of regulatory
authorities, drug manufacturers, clinicians, and patients is
necessary to minimize the potential harm that is inherent
in drug use.
The adverse events due to drugs are extensive and is not
limited to drug induced diseases. Let us first of all look in
to various terminologies used to describe the untoward
effects due to drugs.
1. Adverse Drug Reaction (ADR): The World Health
Organization defines an adverse drug reaction
(ADR)asanynoxious,unintentional,andundesired
effect of a drug, which occurs at doses used in
humans for prophylaxis, diagnosis, or therapy.
2. Adverse event (AE): Medical occurrence temporally
associated with the use of a medicinal product,
but not necessarily causally related. The essential
difference fromADR is thatAE need not be causally
related to the drug in use.
3. Unexpected adverse reaction (UAR) : Usually
adverse drug reactions of a drug will be described in
the product information. UAR is not consistent with
applicable product information or characteristics of
drug.
4. Side effect : Unintended effect occurring at normal
dose related to the pharmacological properties.
5. Serious adverse event (SAE) : Any untoward
medical occurrence that at any dose results in
death, Life threatening situation, requires inpatient
hospitalization or prolongation of existing
hospitalization, results in deformity or incapacity.
SAE is especially important when you are doing
drug trials/drug development studies.
6. Serious Unexpected Suspected Adverse Reaction
(SUSAR): It is an adverse drug rection which is
suspected but unexpected and serious.
Any drug may cause an adverse drug reaction.
Undoubtedly, all drugs produce an ADR in someone who
has used them.
HISTORY
Public and professional concern about drug induced
diseases first arose in the late 19th
century.In 1922, there
was an enquiry into the jaundice associated with the
use of SALVARSAN, an organic arsenical used in the
treatment of Syphilis. In 1937 in the USA, 107 people died
from taking an elixir of sulfanilamide that contained the
solvent diethylene glycol. This led to the establishment
of the Food and Drug Administration (FDA), which
was given the task of enquiring into the safety of new
drugs before allowing them to be marketed. The major
modern catastrophe that changed professional and
public opinion towards medicines was the thalidomide
tragedy. The thalidomide incident led to a public
outcry, to the institution all round the world of drug
regulatory authorities, to the development of a much
more sophisticated approach to the preclinical testing
and clinical evaluation of drugs before marketing, and
to a greatly increased awareness of adverse effect of
drugs and methods of detecting them. With the adverse
reactions some drugs have been withdrawn from use or
for some the label has been changed.
ADVERSE DRUG REACTIONS
It is estimated that 3-5% of hospital admissions are caused
by ADRs. The incidence of serious and fatal adverse
reactions in hospital patients has been reported between
0.32% and 6.7%.
Adverse drug reactions is mainly devided into two
groups, Type A and Type B.
Type A reactions: are expected exaggerations of the
drugs known effect. These are usually dose dependent
and predictable and account for the majority of ADRs.
Characteristics Type A reactions include: higher than
normal dose administered, impaired metabolism or
excretion, or very sensitive individuals. These reactions
are often found in the FDA approved product labelling.
Type B reactions: are idiosyncratic and usually unrelated
to the drug’s known pharmacology. Normally they are
not related to the dose, are unpredictable, uncommon,
and usually more serious than Type A. Examples are
carcinogen and teratogens. These reactions are more
commonly reported after a drug has been on the market
for a number of years.
OTHER DRUG REACTIONS
Dose related adverse reactions: Dose related adverse
reactions have led to the concept of the therapeutic
C H A P T E R
79
Drug Induced Diseases
TK Suma
2. 436
MISCELLANEOUS
index, or the toxic: therapeutic ratio. This indicate the
margin between the therapeutic dose and the toxic dose.
Examples of drugs with a low toxic: therapeutic ratio are
anticoagulants (warfarin, heparin), hypoglycemic drugs
(insulin, sulfonylurea), antiarrythmic drugs (lidocaine,
amiodarone), cardiac glycosides (digoxin, digitoxin),
aminoglycoside antibiotics (gentamicin, netilmicin),
oral contraceptives, cytotoxic and immunosuppressive
drugs (cyclosporine, methotrexate, azathioprine),
antihypertensive drugs ( betaadrenoceptors antagonists,
ACE inhibitors)
I. Pharmaceutical Variation: ADR occur because
of alterations in the systemic availability of
a formulation. Examples include phenytoin
intoxication, by a change in one of the excipients
in the phenytoin capsules from calcium sulfate to
lactose, which increase the systemic availability of
phenytoin.
ADR due to presence of a contaminant: Examples
are pyrogens or even bacteria in intravenous
formulations.
Out of date formulations: can sometimes cause
adverse reactions, because of degradation products.
Out-dated tetracycline causing Fanconi’s syndrome
is an example.
II. Pharmacokinetic Variations
a. Pharmacogenetic Effects
1. Acetylation: Acetylation shows genetic variability.
There are fast and slow acetylators.
Several drugs are acetylated by n- acetyl transferase.
Fast acetylation is autosomal dominant and slow
acetylation is autosomal recessive.
Drugs whose Acetylation is genetically determined
are: Isoniazid, Hydralazine, Procainamide.
Dapsone, Some sulfonamides. Increased incidence
of peripheral neuropathy is observed in slow
acetylators of Isoniazid.
2. Oxidation: Oxidation also shows genetic variability.
There are individuals with impaired oxidation and
with normal oxidation. Impaired oxidation ones
are called as poor metbolizers and the ones with
normal are called extensive metabolizers.
3. hydroxylation: CYP2D6 is a cytochrome P450
enzymeandcarriesoutDebrisoquinehydroxylation.
Impaired hydroxylation of Debrisoquine is an
autosomal recessive defect of this cytochrome.
Drugs that are affected besides Debrisoquine are:
Captopril, Metoprolol, Phenformin, Perhexitine,
Nortryptiline
Poor hydroxilators are more likely to show dose
related adverse effect of these drugs. In case of
toxic metabolites risk would be greater in extensive
hydroxilators.
Succinylcholine Hydrolysis: Succinylcholine is
hydrolyzed by pseudocholinestrase. In some
individuals pseudocholinestrase is abnormal and
does not metabolize. In such cases drug persist in
blood and continue to produce neuro muscular
blockade for several hours. This result in respiratory
paralysis called scoline apnoea.
b. Hepatic Disease
Adverse drug reaction due to impaired hepatic
metabolism are not so common. Hepatocellular
dysfunction, as in several hepatitis or advanced
cirrhosis, can reduce the clearance of drugs like
phenytoin, theophylline and warfarin. A reduction
in hepatic blood flow, as in heart failure, can reduce
the hepatic clearance of drugs that have an high
extraction ratio for e.g. propranolol, morphine and
pethidine. Reduced production of plasma proteins
(for e.g. albumin) by the liver in cirrhosis can lead
to reduced protein binding of drugs.
c. Renal Disease
If a drug or active metabolite is excreted by
glomerular filtration or tubular secretion, it will
accumulate in renal insufficiency and toxicity will
occur.
d. Cardiac Disease
Cardiac failure, particularly congestive cardiac
failure, can alter the pharmacokinetic properties of
drugs by several mechanisms:
1. Impaired absorption, due to intestinal mucosal
edema and a poor splanchnic circulation, can
alter the efficacy of some oral diuretic, such as
Furosemide.
2. Hepatic congestion and reduced liver blood flow
may impair the metabolism of some drugs (e.g.
Lidocaine).
3. Poor renal perfusion may result in reduced renal
elimination (e.g. Procainamide).
4. Reduction in the apparent volumes of distribution
of some cardio active drugs, by mechanisms that
are not understood cause reduced loading dose
requirements (e.g. Procainamide, Lidocaine,
Quinidine).
III. Pharmacodynamic Variations
a. Hepatic Disease:
Hepatic disease can alter pharmacodynamic
responses to drugs in several ways;
1. Reduced Blood Coagulation: In cirrhosis and
acute hepatitis, production of clotting factor is
impaired and patients bleed more readily. Drugs
that impair blood clotting, that impair homeostasis,
or that predispose to bleeding by causing gastric
ulceration should be avoided or used with care for
e.g. Anticoagulants and NSAIDS.
3. CHAPTER79
4372. Hepatic Encephalopathy: In patients with, or on the
border line of, hepatic encephalopathy, the brain is
more sensitive to the effects of drugs with sedative
actions. If such drugs are used, coma can result. It
is therefore wise to avoid Opioids & other narcotic
analgesics and barbiturates.
3. Sodium and Water Retention: In hepatic cirrhosis,
sodium and water retention can be exacerbated
by certain drugs. Drugs that should be avoided or
used with care include NSAIDS, Corticosteroids,
Carbamazepine and formulations containing large
amount of sodium.
b. Altered Fluid And Electrolyte Balance
The pharmacodynamic effects of some drugs are
altered by changes in fluid and electrolyte balance.
Example; The toxic effect of cardiac glycosides
are potentiated by both Hypokalaemia and
Hypercalcaemia. The Class1 of Antiarrhythmic
drugs such as Quinidine, Procainamide and
Disopyramide are more arrhythmogenic if there is
hypokalaemia.
NON-DOSE RELATED ADVERSE DRUG REACTIONS
Include
a. Immunological and
b. Pharmacogenetic mechanisms of adverse reactions.
IMMUNOLOGICAL REACTIONS
(Drug Allergy)
Features of allergic drug reactions
There is no relationship to the usual pharmacological
effects of the drug; There is often a delay between the
first exposure to the drug and the occurrence of the
subsequent adverse reaction; There is no formal dose-
response curve; The illness is often recognizable as a
form of immunological reaction like rash, serum sickness,
urticaria etc.
There are genetic factors that make some patients more
likely to develop allergic reactions than others: A history
of allergic disorders HLA status (antigens on human
lymphocytes).
Classified acc. to the classification of hypersensitivity
reactions, i.e. into four types, types I-IV.
Type 1 Reactions (anaphylaxis; immediate
hypersensitivity):
The drug or metabolite interacts with IgE molecules fixed
to cells, particularly tissue mast cells and basophiles
leukocytes. This triggers a process that lead to the release
of pharmacological mediators like histamine, 5-HT,
kinins, and arachidonic acid derivatives, which cause
allergic response. Manifest as urticaria, rhinitis, bronchial
asthma, angio-oedema and anaphylactic shock. Drugs
likely to cause type 1 are Penicillins, Streptomycin, local
anaesthetics etc.
TYPE II REACTIONS (CYTOTOXIC REACTIONS)
A circulating antibody of the IgG, IgM, or IgA class
interact with an antigen formed by hapten. Complement
is then activated and cell lysis occurs. Example:
thrombocytopenia, haemolyticanaemia quinidine or
quinine.
TYPE 111 REACTIONS (IMMUNE COMPLEX REACTIONS)
Antibody (IgG) combines with antigen i.e. the hapten-
protein complex in circulation Complex thus formed is
deposited in the tissues, complement is activated, and
damage to capillary endothelium results. Serum sickness
is the typical drug reaction of this type. Penicillins,
Sulfonamides & Anti thyroid drugs may be responsible.
TYPE 1V REACTIONS (CELL MEDIATED)
T-lymphocytes are sensitized by a hapten-protein
antigenic complex. Inflammatory response ensues when
lymphocytes come in contact with the antigen. E.g.
Dermatitis caused by local anesthetic creams, topical
antibiotics and antifungal creams.
PSEUDO ALLERGIC REACTIONS
Term applied to reactions that resemble allergic reactions
clinically but for which no immunological basis can be
found. Asthma and skin rashes caused by aspirin are the
examples.
BLOOD DISORDERS
• Thrombocytopenia, neutropenia, hemolytic
anaemia, and aplastic anaemia can all occur as
adverse drug reactions.
RESPIRATORY DISORDERS
• Asthma occurring as a pseudo allergic reaction to
Aspirin, other NSAIDS and Tartarzine is an e.g.
adverse drug reaction.
PHARMACOGENETIC VARIATION CAUSING NON DOSE-
RELATED REACTIONS
Red cell enzyme defects
Unusual drug reaction occur in individuals whose
erythrocytes are deficient in any one of three different
but functionally related enzymes such as glucose-6-
phosphate dehydrogenase, glutathione reductase and
methaemoglobin reductase.
LONG TERM ADVERSE EFFECTS
a. Adaptive Changes
Examples include development of tolerance to and
physical dependence on the narcotic analgesics
and the occurrence of tardive dyskinesia in some
patients receiving long term neuroleptic drug
therapy for schizophrenia.
b. Rebound and Withdrawal Phenomena
During long term therapy sudden withdrawal
of the drug can result in rebound reactions.
Examples are typical syndromes occurring after
4. 438
MISCELLANEOUS
sudden withdrawal of narcotic analgesic or of
alcohol (delirium tremens), sudden withdrawal
of Barbiturates result in restlessness , mental
confusion and convulsions, Sudden withdrawal
of β-adrenoceptors antagonists result in rebound
tachycardia which can precipitate myocardial
ischemia, Sudden withdrawal of corticosteroids
results in syndrome of adrenal insufficiency.
DELAYED ADVERSE EFFECTS
Carcinogenesis
There are three major mechanisms of carcinogenesis:
i. Hormonal: incidence of vaginal adenocarcinoma is
increased in daughters of women who have taken
stilboestrol during pregnancy for the treatment of
threatened abortions.
Increased risk of breast cancers is about 50% and
woman taking hormone replacement therapy
(HRT) for more than five years.
ii. Gene Toxicity: Occurs when certain molecules
bind to nuclear DNA and produce changes in gene
expressions. Examples: bladder cancer in patient
taking long term cyclophosphamide, carcinomas
of renal pelvis associated with phenacetin abuse,
non lymphocytic leukemia in patients receiving
alkylating agents such as melphalan, chlorambucil
etc.
iii. Suppression of immune responses: patients taking
immunosuppressive drugs such as azathioprine
with corticosteroids have increased risk of
developing lymphomas.
EFFECTS CONCERNED WITH REPRODUCTION
A. Impaired Fertility: Cytotoxic drugs can cause
female infertility through ovarian failure with
amenorrhea.
Reversible impairment can be caused by
sulfasalazine, nitrofurantoin, MAO inhibitors and
antimalarial drugs; Irreversible impairment, due
to azospermia, can be caused by cytotoxic drugs,
such as alkylating agents cyclophosphamide
and chlorambucil. Male fertility can be reduced
by impairment of spermatozoal production or
function and can be either reversible or irreversible
B. Teratogenesis: Teratogenesis occurs when a drug
taken during early stages of pregnancy causes a
developmental abnormality in a fetus.
Drugs can affect fetus at 3 stages:
1. Fertilization and Implantation: Conception to 17
days causes failure of pregnancy which often goes
unnoticed.
2. Organogenesis: 18 to 55 days of gestation- Most
vulnerable period, deformities are produced
3. Growth and Development: 55 days onwards-
development and functional abnormalities can
occur.
ACE inhibitors can cause hypoplasia of organs. NSAIDs
may induce premature closure of ductus arteriosus
Different teratogenic drugs are:
Thalidomide, Methotrexate, Warfarin, Phenytoin,
Phenobarbitone, Valproate Sod. Lithium, etc.
Approach to adverse reactions: Type A reactions
include medication errors. Therefore, there may be some
difficultly in deciding the correct reporting procedure. If
the reaction is caused by a prescribing, administering or
monitoring error, a medication error has occurred and
medication error report should be completed.
If the patient develops an ADR when the prescribing,
administering and monitoring are appropriately carried
out, an adverse drug reaction report form should be
completed.
The FDA compiles information on adverse drug events. If
a medicine causes a serious adverse event due to a either
medication error or ADR the FDA should be notified. If
a medication is commonly associated with medication
errors the FDA should be notified. This feedback is
essential so that the package labeling can be updated and
the risk benefit ratio of the drug may be better understood.
In order for drugs to obtain FDA approval they must
be proven safe and effective. The 1962 amendment
to the federal food, drug, and Cosmetic Act requires
manufacturers to report adverse drug events detected in
postmarketing settings to the FDA. The Food and Drug
Modernization act of 1997 states that substantial evidence
of drug effectiveness may consist of data from one
adequate and well-controlled clinical investigation plus
confirmatory evidence.
Most drugs are studied in less than 4,000 patients before
FDA approval. Drug reactions that occur in less than 1
in 1000 patients are difficult to detect. Premarketing
trials generally excluded special populations such as
children, elderly, and women of child bearing age. Most
drug withdrawn from the market for serious side effects,
are withdrawn within 1-2 years of FDA approval, as
experience is gained in a larger population outside of the
narrow confines of clinical trials.
PHARMACOVIGILANCE PROGRAM INDIA
In India, the national coordinating centre (NCC for
pharmacovigilance is ALL Institute of Medical Sciences.
Medical colleges and major centres are ADR monitoring
centres which will report the ADRs to the NCC. If there
is a significant ADR that will be reported to WHO
pharmacovigilance collaborating centre in Upsala.