Pharmacotherapy involves the safe and effective management of drug administration and requires an understanding of the drug, disease, patient, and context of treatment. Drug dosage depends on inherent potency, pharmacokinetic properties, and the degree of response needed. Dose types include standard, regulated, target level, and titrated. Fixed drug combinations have advantages like convenience but also disadvantages like inability to adjust individual doses and potential for increased side effects. Many factors can modify a drug's effects including age, genetics, disease states, and interactions with other drugs. Rational drug use requires appropriate medication for a patient's needs with proper dosing, monitoring, and information provided. The drug development process involves extensive preclinical and clinical testing over 10-15
Aspects of Pharmacotherapy, Clinical Pharmacology and Drug DevelopementAnshuNautiyal1
This slide contains all the necessary detalis regarding the aspects of pharmacotherapy along with Clinical Pharmacology and explains the important steps undertaken during Drug Development.
This slide is a work of Dr Ankit Bairwa, 2nd Year at All India Institute of Medical Sciences, Bathinda
▪ Pharmacology is the study of drugs and their interactions with living systems. It encompasses the physical/chemical properties of drugs as well as their biochemical and physiological effects.
▪ The most important properties of an ideal drug are effectiveness, safety, and selectivity. However, there is no completely safe or selective drug. The goal of drug therapy is to provide maximum benefit with minimum harm by tailoring treatment to each individual patient.
▪ Nurses play an important role in applying pharmacology through activities like assessing patients, administering drugs correctly, monitoring for therapeutic and adverse effects, educating patients, and managing toxicity. This helps optimize drug therapy while minimizing risks.
Factors modifying drug action by SandipSandip Maity
This document discusses various factors that can modify drug action in the human body. It identifies physiological factors like age, sex, pregnancy and food; pathological factors like liver and kidney disease; genetic factors; and environmental factors like route of administration and disease conditions as influencing drug response. It also covers drug interactions, noting that some drug combinations can produce synergistic or additive effects while others result in antagonism where the drugs oppose each other's actions. Understanding these modifying factors is important for choosing the appropriate drug and dose for each individual patient.
- Older patients are more likely to be prescribed multiple medications due to increased prevalence of chronic illnesses, which increases their risk of adverse drug reactions and interactions.
- A comprehensive geriatric assessment is important for designing effective management plans focused on broad functional outcomes and disease alleviation. It also helps assess medication risks and benefits in the context of comorbidities.
- Principles of prescribing for older adults include starting with low doses and slow titration, using fewer daily doses if possible, being aware of altered pharmacokinetics, and closely monitoring for adverse drug events.
- Polypharmacy can be appropriate if aimed at specific goals agreed upon with the patient, but becomes inappropriate if including unnecessary drugs, not achieving goals,
Dr. Yash N. Panchal presented information on pharmacology considerations for elderly patients. Key points included physiological changes with aging that impact drug absorption, distribution, metabolism and elimination. Pharmacodynamic changes can result in increased or decreased drug responses. Challenges in prescribing for the elderly include polypharmacy, non-adherence, economic stress, adverse drug reactions, and potentially inappropriate medications. Careful evaluation and precautions are needed when prescribing for this population.
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.
This document provides an overview of pharmacology topics for nurses, including the nursing process in pharmacology, drug names, pharmacology basics, educating patients, drug interactions, routes of administration, considerations across the life span, and schedules of controlled substances. It discusses assessing, analyzing, planning, implementing, and evaluating the nursing care related to drug administration and monitoring therapeutic and adverse effects. Key aspects of pharmacokinetics, pharmacodynamics, and pharmacotherapeutics are defined. The importance of patient education on drugs is emphasized.
Aspects of Pharmacotherapy, Clinical Pharmacology and Drug DevelopementAnshuNautiyal1
This slide contains all the necessary detalis regarding the aspects of pharmacotherapy along with Clinical Pharmacology and explains the important steps undertaken during Drug Development.
This slide is a work of Dr Ankit Bairwa, 2nd Year at All India Institute of Medical Sciences, Bathinda
▪ Pharmacology is the study of drugs and their interactions with living systems. It encompasses the physical/chemical properties of drugs as well as their biochemical and physiological effects.
▪ The most important properties of an ideal drug are effectiveness, safety, and selectivity. However, there is no completely safe or selective drug. The goal of drug therapy is to provide maximum benefit with minimum harm by tailoring treatment to each individual patient.
▪ Nurses play an important role in applying pharmacology through activities like assessing patients, administering drugs correctly, monitoring for therapeutic and adverse effects, educating patients, and managing toxicity. This helps optimize drug therapy while minimizing risks.
Factors modifying drug action by SandipSandip Maity
This document discusses various factors that can modify drug action in the human body. It identifies physiological factors like age, sex, pregnancy and food; pathological factors like liver and kidney disease; genetic factors; and environmental factors like route of administration and disease conditions as influencing drug response. It also covers drug interactions, noting that some drug combinations can produce synergistic or additive effects while others result in antagonism where the drugs oppose each other's actions. Understanding these modifying factors is important for choosing the appropriate drug and dose for each individual patient.
- Older patients are more likely to be prescribed multiple medications due to increased prevalence of chronic illnesses, which increases their risk of adverse drug reactions and interactions.
- A comprehensive geriatric assessment is important for designing effective management plans focused on broad functional outcomes and disease alleviation. It also helps assess medication risks and benefits in the context of comorbidities.
- Principles of prescribing for older adults include starting with low doses and slow titration, using fewer daily doses if possible, being aware of altered pharmacokinetics, and closely monitoring for adverse drug events.
- Polypharmacy can be appropriate if aimed at specific goals agreed upon with the patient, but becomes inappropriate if including unnecessary drugs, not achieving goals,
Dr. Yash N. Panchal presented information on pharmacology considerations for elderly patients. Key points included physiological changes with aging that impact drug absorption, distribution, metabolism and elimination. Pharmacodynamic changes can result in increased or decreased drug responses. Challenges in prescribing for the elderly include polypharmacy, non-adherence, economic stress, adverse drug reactions, and potentially inappropriate medications. Careful evaluation and precautions are needed when prescribing for this population.
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.
This document provides an overview of pharmacology topics for nurses, including the nursing process in pharmacology, drug names, pharmacology basics, educating patients, drug interactions, routes of administration, considerations across the life span, and schedules of controlled substances. It discusses assessing, analyzing, planning, implementing, and evaluating the nursing care related to drug administration and monitoring therapeutic and adverse effects. Key aspects of pharmacokinetics, pharmacodynamics, and pharmacotherapeutics are defined. The importance of patient education on drugs is emphasized.
Factors such as age, weight, gender, and genetic variations can modify how individuals respond to drugs. Drug-related factors like dosage, interactions, and tolerance also impact outcomes. Adverse drug reactions may be predictable based on pharmacology or unpredictable due to immune or genetic factors. Close monitoring of drug therapy is needed to optimize benefits and prevent harm.
The document discusses principles of pharmacology as it relates to national EMS education standards. It covers topics such as pharmacokinetics, medication administration routes, factors affecting drug response, and types of drug effects. Specifically, it outlines competencies for medication safety, legislation, classifications, storage, and administration techniques within the scope of paramedic practice. The goal is to integrate pharmacology knowledge to formulate treatment plans that mitigate emergencies and improve patient health outcomes.
Drugs and the Body discusses the pharmacokinetics and pharmacodynamics of how drugs act on the body. Pharmacokinetics describes the absorption, distribution, metabolism and excretion of drugs in the body. Pharmacodynamics examines how drugs produce their effects by interacting with receptor sites or replacing missing chemicals. Nursing management of drug administration involves ensuring the "rights" of giving the right drug to the right patient via the right route and dose. The nursing process - which includes assessment, nursing diagnosis, planning, interventions and evaluation - is used to properly manage a patient's drug therapy.
The document discusses posology, which is the science of determining drug doses. It provides formulas to calculate child doses based on age, weight, and body surface area. Several factors can influence drug dosing, including age, sex, weight, route of administration, time of administration, presence of disease, and drug interactions. The document outlines how these factors can impact drug metabolism, excretion, accumulation and a person's response to medication.
Factors that can modify a drug's effect include body size, age, sex, genetics, route of administration, environmental factors, psychological state, other diseases, other drugs taken simultaneously, drug accumulation over time, and the development of tolerance. These factors can change the amount of drug in the bloodstream and tissues (quantitative factors) or change the type of response produced (qualitative factors). Accounting for these modifying factors helps ensure patients receive appropriate and effective drug dosages.
The document discusses factors that can modify drug effects, including individual differences in pharmacokinetics, receptors, and physiological states. It describes several factors such as body size, age, sex, genetics, disease states, and other drugs that can impact drug response either quantitatively by altering concentrations or qualitatively by changing the type of response. Understanding these modifying factors is important for physicians to consider when determining individualized drug dosing and avoiding adverse reactions.
This document discusses the treatment of epilepsy through antiepileptic medications and new treatments. It provides a history of antiepileptic medications from 1912 to the present, describing key medications introduced over time. It discusses factors that influence drug selection and compliance, side effects of medications, and newer antiepileptic medications that have been approved. It also briefly discusses non-medication treatments for epilepsy including neurostimulators, deep brain stimulation, and magnetoencephalography.
This document discusses factors that can modify a drug's effects in the body. It summarizes that individual responses to drugs can vary due to differences in pharmacokinetics and pharmacodynamics. Genetic and non-genetic factors like age, disease states, diet, and concurrent medications can impact drug absorption, distribution, metabolism, and excretion. Drug interactions, tolerance, and cumulative effects are also reviewed. The document emphasizes considering a patient's individual factors when determining appropriate drug dosing to achieve the desired therapeutic effects while avoiding unnecessary adverse reactions.
Title: Clinical Pharmacy: Enhancing Patient Care through Medication Optimization
Description:
Welcome to the world of Clinical Pharmacy, where pharmaceutical expertise meets patient-centered care! In this SlideShare presentation, we dive into the fascinating realm of Clinical Pharmacy, exploring its vital role in healthcare and how it contributes to improved patient outcomes.
Clinical Pharmacy is an evolving field that combines the knowledge of pharmacology and therapeutics with direct patient care. It focuses on the optimization of medication therapy to ensure safe, effective, and personalized treatment regimens for patients of all ages. This SlideShare presentation provides a comprehensive overview of Clinical Pharmacy, highlighting its significance in modern healthcare settings.
Within this presentation, we explore the key pillars of Clinical Pharmacy, including:
1. Medication Therapy Management: Discover how Clinical Pharmacists work collaboratively with healthcare teams to optimize medication therapy. Learn about the process of medication reconciliation, drug therapy monitoring, and medication counseling to enhance patient adherence and safety.
2. Pharmacotherapy Expertise: Gain insights into the in-depth knowledge of Clinical Pharmacists in pharmacology, drug interactions, and pharmacokinetics. Understand how this expertise helps them make evidence-based decisions, select appropriate medications, and customize treatment plans to individual patient needs.
3. Translational Research: Explore the role of Clinical Pharmacists in conducting research to bridge the gap between scientific discoveries and clinical practice. Learn how they contribute to the development and evaluation of new therapies, ensuring their safety, efficacy, and cost-effectiveness.
4. Interprofessional Collaboration: Recognize the importance of collaboration among healthcare providers in achieving optimal patient outcomes. Explore how Clinical Pharmacists actively engage with physicians, nurses, and other healthcare professionals to provide comprehensive patient care.
5. Patient Education and Advocacy: Delve into the patient-centered approach of Clinical Pharmacy, emphasizing the significance of patient education, shared decision-making, and promoting medication adherence. Understand how Clinical Pharmacists empower patients to actively participate in their treatment plans.
By the end of this SlideShare presentation, you will have a deeper understanding of Clinical Pharmacy's multifaceted nature and its pivotal role in enhancing patient care. Whether you are a healthcare professional seeking to expand your knowledge or a curious individual interested in the intersection of pharmacy and patient care, this presentation is an excellent resource to explore the exciting world of Clinical Pharmacy.
Join us on this enlightening journey, and let Clinical Pharmacy open doors to new perspectives and possibilities for improved patient outcomes and healthcare excellence.
Briefly described by Dr. Nizar Muhammad, with a clinical perspective, for the students of Pharmacy and specially for nursing students, the data is taken from an american book, named as Clinical Pharmacology_anonim.
This document discusses pharmacogenomics, which is the study of how genetic factors influence individual responses to drugs. It begins by defining pharmacogenomics and noting its relationship to pharmacogenetics. The document then provides background on the origins of pharmacogenomics and its promise for personalized medicine by optimizing drug therapy for each person's unique genetics. Several examples are given of pharmacogenomic tests that guide treatment decisions. The rest of the document outlines challenges and applications of pharmacogenomics, including improving drug safety and efficacy through predictive prescribing based on a person's metabolic status.
This document provides information on rational use of drugs and discusses factors that contribute to irrational drug use. It covers rational prescribing criteria including making a diagnosis, selecting a drug and dose, monitoring treatment and educating patients. Common errors in prescribing, dispensing and diagnosis are outlined. Irrational use can lead to increased costs, adverse effects and drug resistance. Ensuring appropriate indications, dosages, patient education and evaluation are important for rational drug use.
This document defines and classifies adverse drug reactions and drug-related harms. It discusses predictable and unpredictable reactions, side effects versus adverse effects, and different types of reactions including hypersensitivity, idiosyncrasy, toxicity and dependence. It also covers teratogenicity, pharmacovigilance, and methods for monitoring and reporting adverse drug reactions.
Adverse drug reactions can be harmful or unpleasant effects that occur even at normal therapeutic doses. They are classified as either type A, which are augmented and dose-related effects based on the drug's known pharmacological properties, or type B, which are unpredictable reactions based on patient peculiarities like allergies or idiosyncrasies. Adverse effects range from minor to severe/life-threatening and can be side effects, toxic effects, secondary effects, intolerances, idiosyncrasies, allergies, or cause teratogenicity or drug-induced diseases. Understanding adverse reactions through pharmacovigilance helps prevent them by rational drug use and monitoring.
The document discusses drug interactions, outlining their types, mechanisms, effects, and examples. It defines a drug interaction as when the effect of one drug is changed by another substance like another drug, food, or herb. Drug interactions can increase or decrease a drug's therapeutic effects and cause adverse reactions. The main types discussed are drug-drug, drug-food, and drug-disease interactions. The document also examines mechanisms like pharmaceutical, pharmacokinetic, and pharmacodynamic interactions that can occur inside or outside the body. It emphasizes the pharmacist's role in monitoring for interactions and educating patients to reduce risks.
This document provides an overview of pharmacology concepts for paramedics performing interfacility transfers. It defines important pharmacological terms and concepts like pharmacokinetics, pharmacodynamics, and classifications of medications. It emphasizes that the most common reason for interfacility transfers is to administer or monitor medications outside of a typical paramedic drug box. Paramedics must have sound knowledge of pharmacology to safely transport patients who require medication administration or monitoring.
This document provides an overview of pharmacology concepts for paramedics conducting interfacility transfers. It defines important pharmacological terms and concepts like pharmacokinetics, pharmacodynamics, and the autonomic nervous system. It also lists the 18 classes of medications paramedics are authorized to administer during transfers, including anticoagulants, anticonvulsants, antihypertensives, and narcotics. The document stresses the importance of understanding medication administration and monitoring, checking for correct drugs and dosages, and being prepared to address any issues during transport.
BasicPHARMACOLOGYReview.pptBriefly review information that you have already h...RiyazAhmed21126
Briefly review information that you have already had in your paramedic programs. The purpose of this program is not to teach new concepts of pharmacology.
General prescribing guidelines for Pediatrics geriatrics pregnancy lactating...Koppala RVS Chaitanya
1. The document discusses physiological differences between pediatric and adult patients that are important to consider when selecting and dosing medications.
2. It outlines age classifications for pediatric patients from preterm neonates to adolescents and describes how drug absorption, distribution, metabolism, and excretion can vary significantly across age groups.
3. Selecting appropriate doses and accounting for changing pharmacokinetics is essential for safe and effective pharmacotherapy in pediatric patients.
Drug interaction - Potential antimicrobial drug interaction in a hospital set...Dr. Jibin Mathew
A drug interaction is a situation in which a substance affects the activity of a drug when both are administered together. This action can be synergistic or antagonistic or a new effect can be produced that neither produces on its own
Asthma is a chronic inflammatory lung disease that causes narrowing of the airways. It affects over 300 million people worldwide. The hallmark symptoms of asthma include wheezing, coughing, chest tightness, and shortness of breath. Asthma is caused by a combination of genetic and environmental factors that lead to airway inflammation and constriction. Common triggers include allergens, viruses, exercise, and air pollution. Diagnosis involves lung function tests to measure airflow limitation and its improvement with bronchodilator medication. Treatment focuses on reducing symptoms with bronchodilators and preventing exacerbations with anti-inflammatory drugs like corticosteroids.
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Factors such as age, weight, gender, and genetic variations can modify how individuals respond to drugs. Drug-related factors like dosage, interactions, and tolerance also impact outcomes. Adverse drug reactions may be predictable based on pharmacology or unpredictable due to immune or genetic factors. Close monitoring of drug therapy is needed to optimize benefits and prevent harm.
The document discusses principles of pharmacology as it relates to national EMS education standards. It covers topics such as pharmacokinetics, medication administration routes, factors affecting drug response, and types of drug effects. Specifically, it outlines competencies for medication safety, legislation, classifications, storage, and administration techniques within the scope of paramedic practice. The goal is to integrate pharmacology knowledge to formulate treatment plans that mitigate emergencies and improve patient health outcomes.
Drugs and the Body discusses the pharmacokinetics and pharmacodynamics of how drugs act on the body. Pharmacokinetics describes the absorption, distribution, metabolism and excretion of drugs in the body. Pharmacodynamics examines how drugs produce their effects by interacting with receptor sites or replacing missing chemicals. Nursing management of drug administration involves ensuring the "rights" of giving the right drug to the right patient via the right route and dose. The nursing process - which includes assessment, nursing diagnosis, planning, interventions and evaluation - is used to properly manage a patient's drug therapy.
The document discusses posology, which is the science of determining drug doses. It provides formulas to calculate child doses based on age, weight, and body surface area. Several factors can influence drug dosing, including age, sex, weight, route of administration, time of administration, presence of disease, and drug interactions. The document outlines how these factors can impact drug metabolism, excretion, accumulation and a person's response to medication.
Factors that can modify a drug's effect include body size, age, sex, genetics, route of administration, environmental factors, psychological state, other diseases, other drugs taken simultaneously, drug accumulation over time, and the development of tolerance. These factors can change the amount of drug in the bloodstream and tissues (quantitative factors) or change the type of response produced (qualitative factors). Accounting for these modifying factors helps ensure patients receive appropriate and effective drug dosages.
The document discusses factors that can modify drug effects, including individual differences in pharmacokinetics, receptors, and physiological states. It describes several factors such as body size, age, sex, genetics, disease states, and other drugs that can impact drug response either quantitatively by altering concentrations or qualitatively by changing the type of response. Understanding these modifying factors is important for physicians to consider when determining individualized drug dosing and avoiding adverse reactions.
This document discusses the treatment of epilepsy through antiepileptic medications and new treatments. It provides a history of antiepileptic medications from 1912 to the present, describing key medications introduced over time. It discusses factors that influence drug selection and compliance, side effects of medications, and newer antiepileptic medications that have been approved. It also briefly discusses non-medication treatments for epilepsy including neurostimulators, deep brain stimulation, and magnetoencephalography.
This document discusses factors that can modify a drug's effects in the body. It summarizes that individual responses to drugs can vary due to differences in pharmacokinetics and pharmacodynamics. Genetic and non-genetic factors like age, disease states, diet, and concurrent medications can impact drug absorption, distribution, metabolism, and excretion. Drug interactions, tolerance, and cumulative effects are also reviewed. The document emphasizes considering a patient's individual factors when determining appropriate drug dosing to achieve the desired therapeutic effects while avoiding unnecessary adverse reactions.
Title: Clinical Pharmacy: Enhancing Patient Care through Medication Optimization
Description:
Welcome to the world of Clinical Pharmacy, where pharmaceutical expertise meets patient-centered care! In this SlideShare presentation, we dive into the fascinating realm of Clinical Pharmacy, exploring its vital role in healthcare and how it contributes to improved patient outcomes.
Clinical Pharmacy is an evolving field that combines the knowledge of pharmacology and therapeutics with direct patient care. It focuses on the optimization of medication therapy to ensure safe, effective, and personalized treatment regimens for patients of all ages. This SlideShare presentation provides a comprehensive overview of Clinical Pharmacy, highlighting its significance in modern healthcare settings.
Within this presentation, we explore the key pillars of Clinical Pharmacy, including:
1. Medication Therapy Management: Discover how Clinical Pharmacists work collaboratively with healthcare teams to optimize medication therapy. Learn about the process of medication reconciliation, drug therapy monitoring, and medication counseling to enhance patient adherence and safety.
2. Pharmacotherapy Expertise: Gain insights into the in-depth knowledge of Clinical Pharmacists in pharmacology, drug interactions, and pharmacokinetics. Understand how this expertise helps them make evidence-based decisions, select appropriate medications, and customize treatment plans to individual patient needs.
3. Translational Research: Explore the role of Clinical Pharmacists in conducting research to bridge the gap between scientific discoveries and clinical practice. Learn how they contribute to the development and evaluation of new therapies, ensuring their safety, efficacy, and cost-effectiveness.
4. Interprofessional Collaboration: Recognize the importance of collaboration among healthcare providers in achieving optimal patient outcomes. Explore how Clinical Pharmacists actively engage with physicians, nurses, and other healthcare professionals to provide comprehensive patient care.
5. Patient Education and Advocacy: Delve into the patient-centered approach of Clinical Pharmacy, emphasizing the significance of patient education, shared decision-making, and promoting medication adherence. Understand how Clinical Pharmacists empower patients to actively participate in their treatment plans.
By the end of this SlideShare presentation, you will have a deeper understanding of Clinical Pharmacy's multifaceted nature and its pivotal role in enhancing patient care. Whether you are a healthcare professional seeking to expand your knowledge or a curious individual interested in the intersection of pharmacy and patient care, this presentation is an excellent resource to explore the exciting world of Clinical Pharmacy.
Join us on this enlightening journey, and let Clinical Pharmacy open doors to new perspectives and possibilities for improved patient outcomes and healthcare excellence.
Briefly described by Dr. Nizar Muhammad, with a clinical perspective, for the students of Pharmacy and specially for nursing students, the data is taken from an american book, named as Clinical Pharmacology_anonim.
This document discusses pharmacogenomics, which is the study of how genetic factors influence individual responses to drugs. It begins by defining pharmacogenomics and noting its relationship to pharmacogenetics. The document then provides background on the origins of pharmacogenomics and its promise for personalized medicine by optimizing drug therapy for each person's unique genetics. Several examples are given of pharmacogenomic tests that guide treatment decisions. The rest of the document outlines challenges and applications of pharmacogenomics, including improving drug safety and efficacy through predictive prescribing based on a person's metabolic status.
This document provides information on rational use of drugs and discusses factors that contribute to irrational drug use. It covers rational prescribing criteria including making a diagnosis, selecting a drug and dose, monitoring treatment and educating patients. Common errors in prescribing, dispensing and diagnosis are outlined. Irrational use can lead to increased costs, adverse effects and drug resistance. Ensuring appropriate indications, dosages, patient education and evaluation are important for rational drug use.
This document defines and classifies adverse drug reactions and drug-related harms. It discusses predictable and unpredictable reactions, side effects versus adverse effects, and different types of reactions including hypersensitivity, idiosyncrasy, toxicity and dependence. It also covers teratogenicity, pharmacovigilance, and methods for monitoring and reporting adverse drug reactions.
Adverse drug reactions can be harmful or unpleasant effects that occur even at normal therapeutic doses. They are classified as either type A, which are augmented and dose-related effects based on the drug's known pharmacological properties, or type B, which are unpredictable reactions based on patient peculiarities like allergies or idiosyncrasies. Adverse effects range from minor to severe/life-threatening and can be side effects, toxic effects, secondary effects, intolerances, idiosyncrasies, allergies, or cause teratogenicity or drug-induced diseases. Understanding adverse reactions through pharmacovigilance helps prevent them by rational drug use and monitoring.
The document discusses drug interactions, outlining their types, mechanisms, effects, and examples. It defines a drug interaction as when the effect of one drug is changed by another substance like another drug, food, or herb. Drug interactions can increase or decrease a drug's therapeutic effects and cause adverse reactions. The main types discussed are drug-drug, drug-food, and drug-disease interactions. The document also examines mechanisms like pharmaceutical, pharmacokinetic, and pharmacodynamic interactions that can occur inside or outside the body. It emphasizes the pharmacist's role in monitoring for interactions and educating patients to reduce risks.
This document provides an overview of pharmacology concepts for paramedics performing interfacility transfers. It defines important pharmacological terms and concepts like pharmacokinetics, pharmacodynamics, and classifications of medications. It emphasizes that the most common reason for interfacility transfers is to administer or monitor medications outside of a typical paramedic drug box. Paramedics must have sound knowledge of pharmacology to safely transport patients who require medication administration or monitoring.
This document provides an overview of pharmacology concepts for paramedics conducting interfacility transfers. It defines important pharmacological terms and concepts like pharmacokinetics, pharmacodynamics, and the autonomic nervous system. It also lists the 18 classes of medications paramedics are authorized to administer during transfers, including anticoagulants, anticonvulsants, antihypertensives, and narcotics. The document stresses the importance of understanding medication administration and monitoring, checking for correct drugs and dosages, and being prepared to address any issues during transport.
BasicPHARMACOLOGYReview.pptBriefly review information that you have already h...RiyazAhmed21126
Briefly review information that you have already had in your paramedic programs. The purpose of this program is not to teach new concepts of pharmacology.
General prescribing guidelines for Pediatrics geriatrics pregnancy lactating...Koppala RVS Chaitanya
1. The document discusses physiological differences between pediatric and adult patients that are important to consider when selecting and dosing medications.
2. It outlines age classifications for pediatric patients from preterm neonates to adolescents and describes how drug absorption, distribution, metabolism, and excretion can vary significantly across age groups.
3. Selecting appropriate doses and accounting for changing pharmacokinetics is essential for safe and effective pharmacotherapy in pediatric patients.
Drug interaction - Potential antimicrobial drug interaction in a hospital set...Dr. Jibin Mathew
A drug interaction is a situation in which a substance affects the activity of a drug when both are administered together. This action can be synergistic or antagonistic or a new effect can be produced that neither produces on its own
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Asthma is a chronic inflammatory lung disease that causes narrowing of the airways. It affects over 300 million people worldwide. The hallmark symptoms of asthma include wheezing, coughing, chest tightness, and shortness of breath. Asthma is caused by a combination of genetic and environmental factors that lead to airway inflammation and constriction. Common triggers include allergens, viruses, exercise, and air pollution. Diagnosis involves lung function tests to measure airflow limitation and its improvement with bronchodilator medication. Treatment focuses on reducing symptoms with bronchodilators and preventing exacerbations with anti-inflammatory drugs like corticosteroids.
Asthma is a chronic disease characterized by inflammation of the airways causing coughing, wheezing, chest tightness, and difficulty breathing. It is usually caused by allergic triggers like pollen, dust mites, or animal dander that lead to bronchospasms and airway obstruction. Diagnosis involves patient history, physical exam, pulmonary function tests, and allergy testing. Treatment includes bronchodilators, corticosteroids, leukotriene modifiers, and monoclonal antibodies to reduce inflammation and prevent symptoms.
Ischaemic heart disease is caused by an imbalance between the heart's supply and demand for oxygenated blood, usually due to atherosclerosis narrowing the coronary arteries. The main symptoms are chest pain or discomfort known as angina. There are different types of angina that vary based on their triggers and patterns. Diagnosis involves tests like ECG, echocardiogram, stress tests and angiography. Treatment options include medications to reduce demands on the heart like nitrates, beta-blockers, and calcium channel blockers, as well as interventions like angioplasty, stents and bypass surgery.
Atherosclerosis is a disease where plaque builds up in the arteries. Over time, the plaque hardens and narrows the arteries, limiting blood flow. Risk factors include age, family history, smoking, high blood pressure, high cholesterol, diabetes, and obesity. Complications arise when blood flow is reduced to organs like the heart, brain, kidneys, and limbs, potentially causing heart attacks, strokes, chronic kidney disease, or poor circulation. Treatment focuses on lifestyle changes and medications to control risk factors and symptoms.
This document provides an outline for a lecture on hypertension. It begins with objectives to understand hypertension's etiology, risk factors, and complications. It then covers definitions of hypertension, classifications based on cause and clinical features, risk factors, pathogenesis, regulation of blood pressure, vascular changes in hypertension, and complications affecting the heart, blood vessels, kidneys, eyes, and brain. The lecture topics include primary and secondary causes, benign vs malignant hypertension, endocrine factors influencing blood pressure, and target organ damage.
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This document discusses various appetite stimulants, digestants, and carminatives. It describes how appetite is influenced by several factors in the hypothalamus and gut-brain pathways. Common appetite stimulants mentioned include lemon pickles, bitter orange peel, and soups containing aromatic oils. Some medications can increase appetite but also have side effects. The document also discusses various digestive enzymes and bile acids that may aid digestion, though evidence for their efficacy is limited. Finally, it outlines several common carminative herbs and spices that can relieve gas and bloating.
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Ginger and asafoetida are plants with medicinal properties. Ginger is native to Southeast Asia and cultivated in many tropical regions. It has buff-colored rhizomes with an aromatic odor and taste. Chemical constituents include volatile oils and phenolic compounds that give ginger its flavor and pharmacological effects. Asafoetida is an oleo-gum-resin obtained from Ferula plants. It occurs in tear or mass forms, has an intense odor, and chemical tests detect umbelliferone. Both ginger and asafoetida have traditional uses as carminatives, expectorants, and to treat conditions like nausea, flatulence, and asthma. They can be subject to adulteration
Leprosy is caused by Mycobacterium leprae. It primarily affects the skin and peripheral nerves, causing hypopigmented patches and thickening of nerves. There are two main forms - tuberculoid leprosy, which causes localized lesions, and lepromatous leprosy, which involves multiple organs. Diagnosis involves skin smears and biopsies to identify acid-fast bacilli. Treatment involves multidrug chemotherapy regimens containing dapsone, rifampicin, and clofazimine. Prevention focuses on contact tracing, chemoprophylaxis, isolation during reactions, and rehabilitation.
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Stroke is the 5th leading cause of death in the US. There are three main types of stroke: ischemic, hemorrhagic, and transient ischemic attacks (TIAs). Ischemic strokes, which account for 85% of cases, occur when a blood clot blocks an artery supplying blood to the brain. Hemorrhagic strokes occur when a brain artery ruptures due to conditions like hypertension. TIAs are temporary and cause no permanent damage but indicate risk for future strokes. Symptoms of stroke appear suddenly and include face drooping, arm weakness, speech difficulties, and severe headache. Diagnostic tests help determine the type and location of stroke. Lifestyle changes and medical treatment can help prevent strokes.
The thyroid gland is located in the neck below the larynx. It produces thyroid hormones including thyroxine (T4) and triiodothyronine (T3) which increase metabolism in nearly every organ system. Iodine is necessary for thyroid hormone production. Disorders include hypothyroidism, where thyroid hormone production is inadequate, and hyperthyroidism, where production is excessive. Graves' disease is an autoimmune cause of hyperthyroidism. Cretinism results from untreated congenital hypothyroidism and causes severe physical and mental impairment.
Inflammatory bowel disease (IBD) represents a group of chronic disorders that cause prolonged inflammation of the digestive tract. The two main types are ulcerative colitis, which causes inflammation and ulcers in the lining of the large intestine, and Crohn's disease, which is a chronic inflammatory disease that can affect any part of the gastrointestinal tract from mouth to anus. IBD is treated through a combination of medications, dietary changes, and sometimes surgery, with the goals of inducing and maintaining remission of symptoms, preventing complications, and avoiding surgery if possible. Treatments include aminosalicylates, corticosteroids, immunosuppressants, biologics that target tumor necrosis factor, and antimicrobial agents.
Tannins are polyphenolic compounds found in many plants. They are classified as hydrolysable tannins, condensed tannins, or pseudo-tannins. Hydrolysable tannins are hydrolyzed by acids into gallic acid or ellagic acid, while condensed tannins are more resistant to hydrolysis. Tannins are extracted using mixtures of polar and non-polar solvents due to their high molecular weight. Identification tests for tannins include the gelatin test, Goldbeater's skin test, and reactions with ferrous sulfate or ferric chloride that produce colors. Pterocarpus marsupium, or Bijasal, is a plant source of k
This document discusses various drug classes used in the treatment of heart failure, including their mechanisms and effects. Diuretics reduce preload on the heart by reducing extracellular fluid volume through natriuresis. Vasodilators such as nitroglycerin and ACE inhibitors reduce preload and afterload by dilating blood vessels. Nesiritide is a natriuretic peptide that causes vasodilation and natriuresis. β-blockers improve outcomes in heart failure by inhibiting the deleterious effects of sympathetic activation on the heart.
Tuberculosis (TB) is a bacterial infection caused by Mycobacterium tuberculosis that most commonly infects the lungs. It can be treated with antibiotics. TB is spread through airborne droplets when an infected person coughs or sneezes. While latent TB means the immune system has contained the infection and the person is not infectious, active TB means the person is sick and can spread the disease. Standard TB treatment involves a combination of antibiotics like isoniazid, rifampin and ethambutol over a period of 6-9 months.
The document discusses infectious diseases and infectious agents. It covers host barriers to infection like the skin, respiratory system, gastrointestinal tract, and urogenital tract. It describes how these barriers can fail and allow infection. It also discusses the different classes of infectious agents including bacteria, viruses, fungi and parasites. The document outlines the different types of inflammatory responses infections can cause like suppurative inflammation, granulomatous inflammation, and cytopathic responses. It covers how microbes can evade the immune system and the various ways infections can be transmitted.
The document defines key terms related to the electrophysiology of the heart such as action potential, membrane potential, refractory period, and threshold potential. It then describes the four phases of the cardiac action potential: Phase 0 involves stimulation and sodium/calcium influx causing depolarization; Phase 1 involves partial repolarization through ion efflux; Phase 2 involves a plateau phase through continued ion fluxes; Phase 3 involves full repolarization through ion efflux slower than depolarization. Phase 4 is the interval between repolarizations. The cardiac action potential triggers mechanical contraction. An electrocardiogram detects and records the summed action potentials to analyze patterns like the P, QRS, and T waves related to atrial depolarization, ventricular depolarization
Level 3 NCEA - NZ: A Nation In the Making 1872 - 1900 SML.pptHenry Hollis
The History of NZ 1870-1900.
Making of a Nation.
From the NZ Wars to Liberals,
Richard Seddon, George Grey,
Social Laboratory, New Zealand,
Confiscations, Kotahitanga, Kingitanga, Parliament, Suffrage, Repudiation, Economic Change, Agriculture, Gold Mining, Timber, Flax, Sheep, Dairying,
🔥🔥🔥🔥🔥🔥🔥🔥🔥
إضغ بين إيديكم من أقوى الملازم التي صممتها
ملزمة تشريح الجهاز الهيكلي (نظري 3)
💀💀💀💀💀💀💀💀💀💀
تتميز هذهِ الملزمة بعِدة مُميزات :
1- مُترجمة ترجمة تُناسب جميع المستويات
2- تحتوي على 78 رسم توضيحي لكل كلمة موجودة بالملزمة (لكل كلمة !!!!)
#فهم_ماكو_درخ
3- دقة الكتابة والصور عالية جداً جداً جداً
4- هُنالك بعض المعلومات تم توضيحها بشكل تفصيلي جداً (تُعتبر لدى الطالب أو الطالبة بإنها معلومات مُبهمة ومع ذلك تم توضيح هذهِ المعلومات المُبهمة بشكل تفصيلي جداً
5- الملزمة تشرح نفسها ب نفسها بس تكلك تعال اقراني
6- تحتوي الملزمة في اول سلايد على خارطة تتضمن جميع تفرُعات معلومات الجهاز الهيكلي المذكورة في هذهِ الملزمة
واخيراً هذهِ الملزمة حلالٌ عليكم وإتمنى منكم إن تدعولي بالخير والصحة والعافية فقط
كل التوفيق زملائي وزميلاتي ، زميلكم محمد الذهبي 💊💊
🔥🔥🔥🔥🔥🔥🔥🔥🔥
CapTechTalks Webinar Slides June 2024 Donovan Wright.pptxCapitolTechU
Slides from a Capitol Technology University webinar held June 20, 2024. The webinar featured Dr. Donovan Wright, presenting on the Department of Defense Digital Transformation.
Andreas Schleicher presents PISA 2022 Volume III - Creative Thinking - 18 Jun...EduSkills OECD
Andreas Schleicher, Director of Education and Skills at the OECD presents at the launch of PISA 2022 Volume III - Creative Minds, Creative Schools on 18 June 2024.
Philippine Edukasyong Pantahanan at Pangkabuhayan (EPP) CurriculumMJDuyan
(𝐓𝐋𝐄 𝟏𝟎𝟎) (𝐋𝐞𝐬𝐬𝐨𝐧 𝟏)-𝐏𝐫𝐞𝐥𝐢𝐦𝐬
𝐃𝐢𝐬𝐜𝐮𝐬𝐬 𝐭𝐡𝐞 𝐄𝐏𝐏 𝐂𝐮𝐫𝐫𝐢𝐜𝐮𝐥𝐮𝐦 𝐢𝐧 𝐭𝐡𝐞 𝐏𝐡𝐢𝐥𝐢𝐩𝐩𝐢𝐧𝐞𝐬:
- Understand the goals and objectives of the Edukasyong Pantahanan at Pangkabuhayan (EPP) curriculum, recognizing its importance in fostering practical life skills and values among students. Students will also be able to identify the key components and subjects covered, such as agriculture, home economics, industrial arts, and information and communication technology.
𝐄𝐱𝐩𝐥𝐚𝐢𝐧 𝐭𝐡𝐞 𝐍𝐚𝐭𝐮𝐫𝐞 𝐚𝐧𝐝 𝐒𝐜𝐨𝐩𝐞 𝐨𝐟 𝐚𝐧 𝐄𝐧𝐭𝐫𝐞𝐩𝐫𝐞𝐧𝐞𝐮𝐫:
-Define entrepreneurship, distinguishing it from general business activities by emphasizing its focus on innovation, risk-taking, and value creation. Students will describe the characteristics and traits of successful entrepreneurs, including their roles and responsibilities, and discuss the broader economic and social impacts of entrepreneurial activities on both local and global scales.
THE SACRIFICE HOW PRO-PALESTINE PROTESTS STUDENTS ARE SACRIFICING TO CHANGE T...indexPub
The recent surge in pro-Palestine student activism has prompted significant responses from universities, ranging from negotiations and divestment commitments to increased transparency about investments in companies supporting the war on Gaza. This activism has led to the cessation of student encampments but also highlighted the substantial sacrifices made by students, including academic disruptions and personal risks. The primary drivers of these protests are poor university administration, lack of transparency, and inadequate communication between officials and students. This study examines the profound emotional, psychological, and professional impacts on students engaged in pro-Palestine protests, focusing on Generation Z's (Gen-Z) activism dynamics. This paper explores the significant sacrifices made by these students and even the professors supporting the pro-Palestine movement, with a focus on recent global movements. Through an in-depth analysis of printed and electronic media, the study examines the impacts of these sacrifices on the academic and personal lives of those involved. The paper highlights examples from various universities, demonstrating student activism's long-term and short-term effects, including disciplinary actions, social backlash, and career implications. The researchers also explore the broader implications of student sacrifices. The findings reveal that these sacrifices are driven by a profound commitment to justice and human rights, and are influenced by the increasing availability of information, peer interactions, and personal convictions. The study also discusses the broader implications of this activism, comparing it to historical precedents and assessing its potential to influence policy and public opinion. The emotional and psychological toll on student activists is significant, but their sense of purpose and community support mitigates some of these challenges. However, the researchers call for acknowledging the broader Impact of these sacrifices on the future global movement of FreePalestine.
2. Pharmacotherapy
• It is the safe and effective management of drug administration.
• It requires the understanding of the drug, the disease, the
patient and the milieu in which it is undertakne
3
3. Drug Dosage
• Dose is the appropriate amount of a drug needed to produce a certain degree of
response in a given patient.
• E.g. the analgesic dose of aspirin for headache is 0.3-0.6 g, its antiplatelet dose is 60-
150 mg/day, while its anti-inflammatory dose for rheumatoid arthritis is 3-5 g per day.
• The dose of a drug is governed by its inherent potency, i.e. the concentration at which
it should be present at the target site, and its pharmacokinetic characteristics
4
4. Types of Dose:
1. Standard dose : the same dose is appropriate for most patients-individual
variations are minor or the drug has a wide safety margin so that a large
enough dose can be given to cover them, e.g. oral contraceptives, penicillin
2. Regulated dose : the dosage is accurately adjusted by repeated measurement
of the affected physiological parameter, e.g. anti- hypertensives,
hypoglycaemics, anticoagulants, diuretics, general anaesthetics. In their case.
measurement of plasma drug concentration is not needed.
5
5. 3. Target level dose : the response is not easily measurable but has been demonstrated
to be obtained at a certain range of drug concentration in plasma. An empirical dose
aimed at attaining the target level is given in the beginning.
4. Titrated dose: the dose needed to produce maximal therapeutic effect cannot be
given because of intolerable adverse effects. Optimal dose is arrived at by titrating it
with an accept able level of adverse effect.
6
7. Fixed Dose Combinations (FDCs) of drugs
A large number of pharmaceutical preparations contain two or more drugs in a fixed
dose ratio.
Advantages:
• convenience and better patient compliance.
• certain drug combinations are synergistics, e.g. levodopa + carbidopa
• therapeutic effect of two components being same may add up.
• the reduction of number of pills, improve patient compliance.
8
8. Disadvantages:
• the dose of any component cannot be adjusted independently.
• some fixed dose combinations show more adverse effects.
• there will be increase in price if unnecessary drugs are included.
• contraindication to one component contraindicates the whole product.
• it becomes difficult to identify one particular drug which is causing
harmful/beneficial effects
9
9. Factors modifying drugs action
Responses variation to a Drug:
1. person to person; and
2. also same person on different occasions.
• Individuals differ in pharmacokinetic handling of drugs –
Varying plasma/target site conc.
• Variation in number or state of receptors, coupling proteins or other components of
response effectuation.
• Variations in hormonal/neurogenic tone or concentrations.
10
10. Factors modify drug action either
▶ Quantitatively: the plasma concentration and/or the action of the drug is increased or
decreased.
▶ Qualititatively: the type of response is altered, e.g. drug allergy or idiosyncrasy.
11
11. Factors are as follows:
1. Body Size
Influences the conc. of the drug attained at the site of action – obese/lean/children –
Body weight (BW) and Body Surface area (BSA)
• Individual dose = BW(kg)/70 x average adult dose
• Individual dose = BSA(m2)/1.7 x average adult dose
• BSA can be calculated by Dubois Formula
• BSA (m2) = BW (kg)0.425 x Height (cm)0.725 X 0.007184
12
2. Age
• Young`s formula
Child dose = (Age/Age+12) x adult dose
• Dilling`s formula
12. ▶ Sex
• Females have smaller body size – required doses are lower
• Digoxin in Maintenance therapy of heart failure – mortality higher in female
• Beta blockers, methyldopa, diuretics – sexual function interference in males
• Gynaecomastia – Metoclopramide, chlorpromazine, ketoconazole etc.
• Pregnancy – particularly 3rd trimester
14
13. ▶ Species and Race
• Species variation in drugs responses do exist
• Some strains of rabbits – resistant to atropine
• Rat and mice are resistant to digitalis
• Race – racial differences have been observed
• Blacks require higher doses of atropine and ephedrine, while Mongols require
lower doses
• Africans – beta blockers are less effective
15
14. ▶ Genetics
Determinants of drug responses – transporter, enzymes, ion channels, receptors and
couplers – controlled genetically – Individual variation of responses
Pharmacogenetics: The study of genetic basis for variability in drug response is called
'Pharmacogenetics'. It deals with genetic influences on drug action as well as on drug
handling by the body.
Pharmacogenomics: Use of genetic information to guide the choice of drug and dose on
an individual basis – to identify individuals who are either more likely or less likely
respond to a drug
• G-6PD deficiency – Primaquine, chloroquin, quinine, dapsone, aspirin
• Malignant hypothermia with halothane etc.
• Low variants of CYP2C9 – Warfarin bleeding; Isoniazid - acetylators
16
15. ▶ Route of administration
• Route determines the speed and intensity of drug response – Parenteral for speedy action.
• A drug may have different actions via different routes.
• Ex - Magnesium Sulfate given orally causes purgation, applied on sprained joints it decreases
swelling.
18
▶ Environmental factors
o Drug metabolism may get induced – exposure to insecticides, carcinogens, tobacco
smoke and charcoal broiled meat etc.
o Food interferes absorption of some drugs while enhances some drugs – ampicillin
gets reduced griseofulvin gets enhanced.
o Hypnotics taken at night.
16. ▶ Psychological factors
• Efficacy of a drug can be affected by patient`s beliefs, attitudes and expectations –
particularly CNS drugs – more GA in nervous and anxious patients – alcohol impairs
performance
• Nocebo: Negative psychodynamic effects of drugs.
• Placebo: An inert substance which is given in the garb of medicine. Works by
psychodynamic effects (not pharmacodynamics) – sometimes responses equivalent to
active drugs.
• Placebo reactors
• Induce psychological responses – release of endorphins in brain
• Uses – Control device in clinical trials and to treat a patient
• Lactose tablet/capsules or water injections etc .
20
17. ▶ Pathological states
• Diseases can influence drug disposition – GIT diseases, Liver diseases, Kidney diseases,
Congestive heart failure and Thyroid etc.
• GIT: Achlorhydria – Reduced aspirin absorption – NSAIDs aggravate peptic ulcer
• Liver diseases: Liver disease (cirrhosis) influence drug action Increased bioavailability of
drugs with high first pass metabolism
• Serum albumin reduced – protein bound drugs like Warfarin – more freedrug
• Kidney diseases: Pharmacokinetics of many drugs are affected
• Plasma protein, albumin reduced – binding of acidic drugs affected
• Permeability of BBB increased – Opiates etc. more CNS depressionThyroid diseases:
• Hypothyroid states – sensitive to digoxin, morphine and CNS depressants;
• Hyperthyroid states – resistant to inotropic action – prone to cause arrhythmia by digoxin
22
18. ▶Presence of other drugs:
Drug interactions – Pharmacokinetic and Pharmacodynamic
▶Cummulation:
If Rate of administration > Rate of elimination – cumulataion. Slowly eliminating drugs
are prone – Prolonged use of Chloroquine
24
19. ▶ Tolerance
• Requirement of higher dose of a drug to produce a given response – refractoriness
– sulfonylureas in type 2 diabetes and beta-2 agonists in bronchial asthma - adaptive biological
phenomena
• Natural: Species/individual inherently less sensitive – Rabbits to atropine and Blacks to beta – blockers.
• Acquired: Repeated use of a drug in an individual who was initially responsive become non-
responsive (tolerant) – CNS depressants.
• Cross tolerance: Tolerance to pharmacologically related drugs – alcoholics to barbiturates and GA;
Morphine and Pethidine
• Tachyphylaxis (Tachy – fast’ phylaxis – protection): Rapid development of tolerance when a drug
is repeated in quick succession – reduction of responses
• Usually with indirectly acting drugs – Ephedrine, tyramine, nicotine etc. Also down regulation of
receptors
25
20. Rational Use of Medicines
As per the WHO- 'rational use of medicines requires that the patients receive
medication appropriate to their clinical needs in doses that meet their own individual
requirements for an adequate period of time and at the lowest cost to them and to their
community
27
22. Criteria to evaluate rational prescribing:
▶ Appropriate indication
▶ Appropriate drug
▶ Appropriate dose, route and duration
▶ Appropriate patient
▶ Correct dispensing with appropriate information
▶ Adequate monitoring
29
23. Irrationalities in prescribing:
• It is helpful to know the commonly encountered irrationalities in prescribing so
that a conscious effort is made to avoid them
• Use of drug when none is needed; e.g. anti-biotics for viral fevers and nonspecific diarrhoea
• Incorrect route of administration: injection when the drug can be given orally Compulsive co-
prescription of vitamins/tonics
• Use of drug not related to diagnose
• Selection of the wrong drug
• Prescribing ineffective drug
• Unnecessary use of drug combination.
30
24. Expiry date of pharmaceutical:
• It is a legal requirement that all pharmaceutical products must carry the date
of manufacture and date of expiry on their label.
• The period between the two dates is called the 'life period' or 'shelf-life' of
the medicine.
• Under specified storage conditions, the product is expected to remain stable
(retain>95% potency) during this period.
• In India, the schedule P (Rule 96) of Drugs and Cosmetics Act (1940) specifies
the life period.
• The expiry date does not mean that the medicine has actually been found to
lose potency or become toxic after it.
31
25. Evidence based medicine
▶ There is gradually transform in the practice of medicine from 'experience based'
wherein clinical decisions are made based on the experience (or rather impression)
of the physician to 'evidence- based' wherein the same are guided by scientifically
credible evidence from well designed clinical studies.
32
26. Grades of strength of evidence:
Grade I Systematic reviews/Meta
analysis
Most reliable, may form the
basis of clinical decisions
Grade II Well powered randomized
controlled trial/more than one
trials
Reliable, but may be supported
or refuted by similar studies
Grade III Open label trials/pilot
studies/observational (cohort
and case-control) studies
(prospective or retrospective)
Less reliable, need more
rigorous testing, may indicate
further investigation
Grade IV Case reports/anecdotal
reports/clinical experience
Least reliable; may serve as
pointers to initiate formal
studies
33
27. New Drug Development
• Drug development now is a highly complex, tedious, competitive, costly and
commercially risky process
• From the synthesis/identification of the molecule to marketing, a new drug takes at
least 10 years and costs millions
34
Approcahes to Drug Discovery
Exploration of natural sources
• Random or targeted chemical synthesis
• Rational approach
• Molecular modelling
• Combinatorial chemistry
• Biotechnology
28. Preclinical & Non Clinical Studies
• After synthesizing/identifying a prospective compound It is tested on animals to
expose the whole pharmacological profile.
• As the evaluation progresses unfavourable compounds get rejected at each step
• so that only a few out of thousands reach the stage when administration to man is
considered.
36
29. The following types of tests are performed:
1. Screening tests: these are simple and rapidly performed tests to indicate presence or
absence of a particular pharmacodynamic activity that is sought like analgesic or
hypoglycaemic activity.
2. Tests on isolated organs, bacterial cultures, etc: These also are preliminary tests to
detect specific activity, such as antihistaminic, anti-secretory, vasodilator, anti-
bacterial.
3. Tests on animal models of human disease: Such as kindled seizures in rats,
spontaneously (genetically) hypertensive rats, alloxan induced diabetes in rat or dog
etc
37
30. 40
4. Confirmatory tests and analogous activities: More elaborate tests which confirm and
characterize the activity. Other related activities, e.g. antipyretic and anti-inflammatory
activity in an analgesic are tested
5. Systemic pharmacology irrespective of the primary action of the drug, its effects on major
organ systems such as nervous, cardiovascular, respiratory, renal, g.i.t are worked out.
6. Quantitative tests The dose-response relationship, maximal effect and comparative
potency/efficacy with existing drugs is ascertained.
7. Pharmacokinetics
8. Toxicity tests: Acute toxicity, Subacute toxicity, Chronic toxicity, Reproduction and
teratogenicity, Mutagenicity, Carcinogenicity
32. Clinical Trails
‘A systematic study of new drug(s) in human subject(s) to generate data for discovering
and/or verifying the clinical, pharmacological (including pharmacodynamic and
pharmacokinetic) and/or adverse effects with the objective of determining safety and/or
efficacy of the new drug‘.
42
33. Begin only when
all the preclinical studies have been completed
an approval has been received from the drug regulation authority (DRA)
India - Central Drug Standard Control Organization (CDSCO)/Drug
Controller General of India (DCGI)
Prior to the conduct of a clinical trial, an IND (Investigational New Drug)
application must be filled
standards for the design, ethics, conduct, monitoring, auditing, recording
and analyzing data and reporting of clinical trials have been laid down in
the form of 'Good Clinical Practice' (GCP) guidelines by an International
Conference on Harmonization (ICH)
43
34. Phase 0: Micro-dosing Studies
• Very low doses, generally about 1/100th of the estimated human dose, are
administered to healthy volunteers
• These sub-pharmacological doses are not expected to produce any therapeutic or
toxic effects, but yield human pharmacokinetic information.
• Costly phase 1 human trials could be avoided for candidate drugs which would
have later failed due to unsuitable human pharmacokinetics
• Micro dose pharmacokinetics may be quite different from that at pharmacological
doses.
• The phase O studies have not yet been technically fully developed or adequately
evaluated.
• They are neither established nor mandatory
45
35. Phase 1: Human Pharmacology and Safety
• Designed to assess the safety, tolerability, pharmacokinetics and
pharmacodynamics
• Subjects: total 20-80 subjects
• Mostly healthy volunteers
• Sometimes patients(anticancer drugs, AIDS therapy).
• Starting with the lowest estimated dose (1/100 to 1/10) and increasing stepwise
to achieve the effective dose.
• Unpleasant side effects are noted,
• human pharmacokinetics parameteres are measured for 1st time.
• No blinding is done: studies open labelled.
47
36. Phase 2: Therapeutic exploration and dose ranging
• This is conducted by physicians who are trained as clinical investigators.
• 100-500 patients selected according to specific inclusion and exclusion criteria
• The primary aim is establishment of therapeutic efficacy, dose range and ceiling
effect in a controlled setting.
• The study is mostly controlled and randomized, and may be blinded or open
label.
• The candidate drug may get dropped at this stage if the desired level of clinical
efficacy is not obtained
49
37. Phase 3: Therapaeutic confirmation/comparison
• These are randomized double blind comparative trials.
• larger patient population (500-3000)
• The aim is the value of the drug in relation to existing therapy.
• Safety and tolerability are assessed on a wider scale.
• Indications are finalized and guidelines for therapeutic use are formulated.
• A new drug application' (NDA) is submitted to the licensing authority (like
FDA), who if convinced give marketing permission.
• Restricted marketing permission for use only in hospitals with specific
monitoring facilities.
50
38. Phase 4: Post Marketingsurveillance/Data gathering studies
• Done after drug has been marketed
• No fixed duration/patient population
• Open label(no blinding)
• It is done to detect unexpected adverse effects and drug interactions Also, to
explore new uses for drugs
• Periodic Safety Update Reports to be submitted every six months for the first
two years after approval of the drug
• For subsequent two years need to be submitted annually and may be extended
if necessary.
• Harmful effects discovered may result in restriction or no longer sold
52
39. Synthesis/isolation of the compound: 1-2 years
Preclinical studies: screening, evaluation, pharmacokinetic and
short-term toxicity testing in animals:
2-4 years
Scrutiny and grant of permission for clinical trials: 3-6 months
Pharmaceutical formulation, standardization of
chemical/biological/immuno-assay of the compound:
0.5-1 years
Clinical studies: phase I, phase II, phase III trials; long-term animal
toxicity testing:
3-10 years
Review and grant of marketing permission: 0.5-2 years
Postmarketing surveillance: Phase IV studies
Stages in new drug development