ADRs
Classifications of ADRs
Thompson and DoTS system classification
Factors: age, gender, Co-morbidities, ethnicity, Pharmacogenetics,G6PD deficiency, porphyrias
Immunological reactions
Classifications
Epidemiology and pharmacovigilance of ADRs
Yellow card scheme,
Thalidomide tragedy
Factors that may raise or suppress suspicion of a drug
This document provides information about adverse drug reactions. It begins with defining an adverse drug reaction as an unintended effect of a drug occurring at normal doses. Adverse drug reactions are common, with 3% of medical admissions due to them. It then classifies adverse drug reactions and discusses various types like predictable reactions, allergic reactions, and interactions. It describes methods for detecting adverse drug reactions like spontaneous reporting, record linkage studies, cohort studies, and case control studies.
The number of chemicals, poisonous household products and medicines on the Indian market it is increasing day by day which can frequently increases the risk of misuse of these products and leads to Greater incidence of intentional and unintentional poisoning.
Introduction to daily activities of clinical pharmacist.
Drug therapy monitoring,
Medication chart review
Clinical Progress
Pharmacist intervention
Detection and management of ADRs
Nuclear pharmacy involves the preparation of radioactive materials for diagnosis and treatment in nuclear medicine. Pharmacists working in nuclear pharmacy are responsible for calculating dosages, ordering, transferring, transporting, and dispensing radiopharmaceuticals using protective measures. Radiopharmaceuticals must be stored, distributed, and transported according to strict safety regulations due to their radioactive nature. The role of the nuclear pharmacist is important for ensuring radiopharmaceuticals are properly prepared and administered to patients.
This document discusses pharmacokinetic drug interactions, which occur when one drug alters the concentration of another drug in the body. It classifies these interactions based on how a drug affects another drug's absorption, distribution, metabolism, or elimination. Key points include that absorption can be impacted by changes in gastrointestinal pH, chelation, or motility. Distribution interactions commonly involve protein binding displacement. Metabolism may be induced or inhibited by other drugs. Elimination interactions can impact renal blood flow, urine pH, active secretion, or forced diuresis. The document provides examples to illustrate each type of pharmacokinetic drug interaction.
Hospital pharmacy involves the practice of pharmacy within a hospital setting under the supervision of a pharmacist. Key functions include forecasting drug demand, purchasing drugs, manufacturing sterile or non-sterile preparations, quality control, distribution, dispensing, providing drug information, studies on drug utilization, patient counseling, and maintaining relationships between medical staff and patients. Objectives are to professionalize pharmaceutical services, ensure drug availability at affordable costs, perform management functions like inventory, counsel on drugs, serve as an information source, manufacture critical drugs, implement committee decisions, conduct research and education, and interact with other hospital departments.
This document provides information about adverse drug reactions. It begins with defining an adverse drug reaction as an unintended effect of a drug occurring at normal doses. Adverse drug reactions are common, with 3% of medical admissions due to them. It then classifies adverse drug reactions and discusses various types like predictable reactions, allergic reactions, and interactions. It describes methods for detecting adverse drug reactions like spontaneous reporting, record linkage studies, cohort studies, and case control studies.
The number of chemicals, poisonous household products and medicines on the Indian market it is increasing day by day which can frequently increases the risk of misuse of these products and leads to Greater incidence of intentional and unintentional poisoning.
Introduction to daily activities of clinical pharmacist.
Drug therapy monitoring,
Medication chart review
Clinical Progress
Pharmacist intervention
Detection and management of ADRs
Nuclear pharmacy involves the preparation of radioactive materials for diagnosis and treatment in nuclear medicine. Pharmacists working in nuclear pharmacy are responsible for calculating dosages, ordering, transferring, transporting, and dispensing radiopharmaceuticals using protective measures. Radiopharmaceuticals must be stored, distributed, and transported according to strict safety regulations due to their radioactive nature. The role of the nuclear pharmacist is important for ensuring radiopharmaceuticals are properly prepared and administered to patients.
This document discusses pharmacokinetic drug interactions, which occur when one drug alters the concentration of another drug in the body. It classifies these interactions based on how a drug affects another drug's absorption, distribution, metabolism, or elimination. Key points include that absorption can be impacted by changes in gastrointestinal pH, chelation, or motility. Distribution interactions commonly involve protein binding displacement. Metabolism may be induced or inhibited by other drugs. Elimination interactions can impact renal blood flow, urine pH, active secretion, or forced diuresis. The document provides examples to illustrate each type of pharmacokinetic drug interaction.
Hospital pharmacy involves the practice of pharmacy within a hospital setting under the supervision of a pharmacist. Key functions include forecasting drug demand, purchasing drugs, manufacturing sterile or non-sterile preparations, quality control, distribution, dispensing, providing drug information, studies on drug utilization, patient counseling, and maintaining relationships between medical staff and patients. Objectives are to professionalize pharmaceutical services, ensure drug availability at affordable costs, perform management functions like inventory, counsel on drugs, serve as an information source, manufacture critical drugs, implement committee decisions, conduct research and education, and interact with other hospital departments.
Therapeutic drug monitoring (TDM) refers to measuring drug concentrations in biological fluids to optimize a patient's drug therapy by maintaining drug levels within a targeted therapeutic range. TDM combines pharmacokinetics, pharmacodynamics, and clinical medicine to assess medication efficacy and safety. It aims to promote optimal treatment by keeping serum drug concentrations within a therapeutic range and can help minimize toxicity, detect drug interactions, and assess medication compliance. Factors like a patient's medical history, therapeutic goals, drug therapy, and problems associated with treatment must be considered during TDM.
This document discusses different methods for assessing the causality of adverse drug reactions (ADRs). It describes three main types of methods: 1) Expert opinion or clinical judgment methods like the WHO causality assessment scale, 2) Algorithmic methods like the Naranjo scale that use questionnaires and scoring systems, 3) Probabilistic or Bayesian methods that calculate the probability of drug causation based on prior probabilities. The WHO scale and Naranjo scale are discussed in detail as examples of each method.
The document discusses clinical pharmacy and its status in Bangladesh. It defines clinical pharmacy as dealing with patient care and advising on safe drug use. In Bangladesh, clinical pharmacy services are still in early stages of development compared to other countries. The pharmacy education focuses more on industrial practices rather than patient care. There is a lack of clinical training and roles for pharmacists in patient care settings. The goals of clinical pharmacy are outlined as maximizing treatment effects, minimizing adverse events, and minimizing costs of treatment.
The document discusses hospital formularies, which are lists of approved medications used in hospitals. A hospital formulary is developed and revised by the Pharmacy and Therapeutics Committee to reflect the current views of medical staff. It includes generic drugs when possible to help control costs. The formulary provides essential information on approved medications to guide doctors' prescribing and aid rational drug use. It undergoes annual revisions to add new drugs and remove outdated ones.
Community pharmacy provides pharmaceutical care and serves the public's need for medicines. In India, community pharmacies are privately owned medicine shops that serve local communities. Community pharmacists play an important role in providing patients access to healthcare by managing their medication needs. They are regulated under the Pharmacy Act of 1948 and must maintain certain legal records. To run a pharmacy properly, pharmacists must select an appropriate site, design an effective layout, stock medicines correctly, hire qualified staff, and keep various financial and legal records.
The document discusses the Biopharmaceutics Classification System (BCS), which is a framework developed by the FDA to classify drugs based on their aqueous solubility and intestinal permeability. The BCS aims to improve drug development and review processes by identifying when clinical bioequivalence tests are not necessary. It classifies drugs as Class I (high solubility, high permeability), Class II (low solubility, high permeability), Class III (high solubility, low permeability) or Class IV (low solubility, low permeability) based on their solubility and permeability parameters. The classification can help determine if in vitro dissolution tests alone can demonstrate bioequivalence or if in vivo testing is still required.
The document defines a hospital and hospital pharmacy. A hospital pharmacy is responsible for supplying medications to patients and is headed by a qualified pharmacist. The goals of hospital pharmacy are to provide qualified pharmacists, establish standards, promote research, and disseminate pharmaceutical knowledge. Key components are procurement, distribution, and drug information. Minimum standards require administration, facilities, drug control/distribution, information, and assuring rational drug therapy. Pharmacy technicians' roles include receiving prescriptions, verifying information, preparing medications, and maintaining patient profiles.
This document discusses rational use of over-the-counter (OTC) medications. It provides examples of common OTC drug categories and explains that rational use means using the appropriate medication, in the proper dose, for the right duration and indication. Irrational or improper use can lead to antimicrobial resistance, adverse reactions, financial costs, and erosion of patient confidence in the healthcare system. Factors contributing to irrational use include lack of knowledge and unethical drug promotion. Improving rational use requires guidelines, education, availability of essential medicines, and eliminating financial incentives for improper prescribing. Several examples of irrational fixed-dose drug combinations are also provided that combine drugs with different mechanisms or indications.
This document discusses therapeutic drug monitoring (TDM), which uses drug concentration measurements to help manage patients receiving drug therapy. TDM aims to attain safe and effective drug concentrations within the therapeutic range to optimize treatment. It coordinates various medical fields and removes empirical approaches. The document outlines drugs that commonly require TDM due to pharmacokinetic variability and concentration-dependent effects. It also discusses the TDM process, including deciding when to monitor, collecting patient information, measuring drug levels using various laboratory techniques, and using results to guide dosing adjustments. TDM provides benefits like side effect monitoring, shorter hospital stays, and better disease control through individualized dosing.
Therapeutic drug monitoring (TDM) involves measuring specific drug levels in patients to maintain concentrations in the therapeutic range. The goals are to individualize drug dosing for optimal benefit and assess drug efficacy and safety. TDM is indicated when drugs have a narrow therapeutic index, clinical response is difficult to assess, or metabolism varies between patients. The TDM process includes deciding when to measure levels, collecting samples, analyzing samples using validated methods, communicating results, and clinicians interpreting results in the context of the patient's treatment. TDM aims to promote optimal drug therapy by maintaining therapeutic drug concentrations.
Drug distribution in hospital pharmacyRaju Sanghvi
The document discusses various aspects of hospital pharmacy operations including definitions, inpatient and outpatient dispensing systems, and controlled drug handling. It describes the key functions of hospital pharmacies like procurement, storage, manufacturing and distribution of medications. For inpatients, it explains individual prescription ordering as well as floor stock systems including charge, non-charge and unit dose methods. Outpatient dispensing involves dispensing medications to patients not admitted. Proper storage, documentation and authorization are needed for controlled substances.
Drug information centers provide unbiased drug information to healthcare professionals and patients. The first drug information center was established in 1960 at the University of Kentucky. In Nepal, drug information centers are still in their infancy. The Drug Information Network of Nepal was established in 1996 with participation from government, academic, and non-government organizations to disseminate drug information. The network aims to optimize drug use and decision making in Nepal through sharing up-to-date, evaluated information on drugs.
14ab1t0024 roles and responsibilities of hospital pharmacistRamesh Ganpisetti
Hospital pharmacists play several important roles in ensuring patients receive the most appropriate treatment. They advise patients and medical staff on all aspects of medications, including type, dosage, and administration method based on individual needs. Pharmacists can recommend the best form of medication such as tablets, injections, or inhalers. They are also seen as experts who can advise on safe drug combinations and solutions to specific patient problems. In addition, pharmacists monitor treatment effects to ensure safety, effectiveness, and appropriateness for each user.
Poison information center (Structural Organization and functions)Dr. Abhimanyu Prashar
The document discusses the functions and roles of poison information centers (PICs). It outlines that PICs provide toxicological information and advice, manage poisoning cases, provide laboratory services, conduct education and training, and engage in toxicovigilance activities like identifying risks and preventing poisoning. PICs also contribute to areas like drug information, substances of abuse, environmental toxicology, and disaster planning. Effective PICs require cooperation with various medical and government organizations.
Introduction to clinical pharmacy, Concept and Objectives of clinical pharmacy, Function and responsibilities of clinical pharmacist, Clinical Pharmacy services.
Adverse drug reaction monitoring and reportingTHUSHARA MOHAN
This document discusses types of adverse drug reactions and factors influencing them. It describes types A-E reactions, which include augmented, bizarre, chemical, delayed and end of treatment reactions. Polypharmacy, age, drug characteristics, gender, race and genetic factors can influence susceptibility. Detection methods include pre-marketing studies, post-marketing surveillance, underreporting and communicating reactions. Healthcare professionals should monitor high-risk patients and gather information to assess causality between drugs and adverse events. Underreporting is common due to various barriers but can be addressed through improved reporting systems and education.
This document discusses pharmacovigilance and adverse drug reaction reporting. It covers several topics: methods of detecting ADRs like pre-marketing safety evaluation, post-marketing surveillance, and causality assessment; communicating ADR information to health professionals; and methods for reporting ADRs like spontaneous reporting and standardized case report forms. The key aspects of ADR reporting include who should report, what to report, and where to send reports for evaluation. Accurate documentation of patient information, suspected drugs, and reactions is important for assessment.
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.
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.
Therapeutic drug monitoring (TDM) refers to measuring drug concentrations in biological fluids to optimize a patient's drug therapy by maintaining drug levels within a targeted therapeutic range. TDM combines pharmacokinetics, pharmacodynamics, and clinical medicine to assess medication efficacy and safety. It aims to promote optimal treatment by keeping serum drug concentrations within a therapeutic range and can help minimize toxicity, detect drug interactions, and assess medication compliance. Factors like a patient's medical history, therapeutic goals, drug therapy, and problems associated with treatment must be considered during TDM.
This document discusses different methods for assessing the causality of adverse drug reactions (ADRs). It describes three main types of methods: 1) Expert opinion or clinical judgment methods like the WHO causality assessment scale, 2) Algorithmic methods like the Naranjo scale that use questionnaires and scoring systems, 3) Probabilistic or Bayesian methods that calculate the probability of drug causation based on prior probabilities. The WHO scale and Naranjo scale are discussed in detail as examples of each method.
The document discusses clinical pharmacy and its status in Bangladesh. It defines clinical pharmacy as dealing with patient care and advising on safe drug use. In Bangladesh, clinical pharmacy services are still in early stages of development compared to other countries. The pharmacy education focuses more on industrial practices rather than patient care. There is a lack of clinical training and roles for pharmacists in patient care settings. The goals of clinical pharmacy are outlined as maximizing treatment effects, minimizing adverse events, and minimizing costs of treatment.
The document discusses hospital formularies, which are lists of approved medications used in hospitals. A hospital formulary is developed and revised by the Pharmacy and Therapeutics Committee to reflect the current views of medical staff. It includes generic drugs when possible to help control costs. The formulary provides essential information on approved medications to guide doctors' prescribing and aid rational drug use. It undergoes annual revisions to add new drugs and remove outdated ones.
Community pharmacy provides pharmaceutical care and serves the public's need for medicines. In India, community pharmacies are privately owned medicine shops that serve local communities. Community pharmacists play an important role in providing patients access to healthcare by managing their medication needs. They are regulated under the Pharmacy Act of 1948 and must maintain certain legal records. To run a pharmacy properly, pharmacists must select an appropriate site, design an effective layout, stock medicines correctly, hire qualified staff, and keep various financial and legal records.
The document discusses the Biopharmaceutics Classification System (BCS), which is a framework developed by the FDA to classify drugs based on their aqueous solubility and intestinal permeability. The BCS aims to improve drug development and review processes by identifying when clinical bioequivalence tests are not necessary. It classifies drugs as Class I (high solubility, high permeability), Class II (low solubility, high permeability), Class III (high solubility, low permeability) or Class IV (low solubility, low permeability) based on their solubility and permeability parameters. The classification can help determine if in vitro dissolution tests alone can demonstrate bioequivalence or if in vivo testing is still required.
The document defines a hospital and hospital pharmacy. A hospital pharmacy is responsible for supplying medications to patients and is headed by a qualified pharmacist. The goals of hospital pharmacy are to provide qualified pharmacists, establish standards, promote research, and disseminate pharmaceutical knowledge. Key components are procurement, distribution, and drug information. Minimum standards require administration, facilities, drug control/distribution, information, and assuring rational drug therapy. Pharmacy technicians' roles include receiving prescriptions, verifying information, preparing medications, and maintaining patient profiles.
This document discusses rational use of over-the-counter (OTC) medications. It provides examples of common OTC drug categories and explains that rational use means using the appropriate medication, in the proper dose, for the right duration and indication. Irrational or improper use can lead to antimicrobial resistance, adverse reactions, financial costs, and erosion of patient confidence in the healthcare system. Factors contributing to irrational use include lack of knowledge and unethical drug promotion. Improving rational use requires guidelines, education, availability of essential medicines, and eliminating financial incentives for improper prescribing. Several examples of irrational fixed-dose drug combinations are also provided that combine drugs with different mechanisms or indications.
This document discusses therapeutic drug monitoring (TDM), which uses drug concentration measurements to help manage patients receiving drug therapy. TDM aims to attain safe and effective drug concentrations within the therapeutic range to optimize treatment. It coordinates various medical fields and removes empirical approaches. The document outlines drugs that commonly require TDM due to pharmacokinetic variability and concentration-dependent effects. It also discusses the TDM process, including deciding when to monitor, collecting patient information, measuring drug levels using various laboratory techniques, and using results to guide dosing adjustments. TDM provides benefits like side effect monitoring, shorter hospital stays, and better disease control through individualized dosing.
Therapeutic drug monitoring (TDM) involves measuring specific drug levels in patients to maintain concentrations in the therapeutic range. The goals are to individualize drug dosing for optimal benefit and assess drug efficacy and safety. TDM is indicated when drugs have a narrow therapeutic index, clinical response is difficult to assess, or metabolism varies between patients. The TDM process includes deciding when to measure levels, collecting samples, analyzing samples using validated methods, communicating results, and clinicians interpreting results in the context of the patient's treatment. TDM aims to promote optimal drug therapy by maintaining therapeutic drug concentrations.
Drug distribution in hospital pharmacyRaju Sanghvi
The document discusses various aspects of hospital pharmacy operations including definitions, inpatient and outpatient dispensing systems, and controlled drug handling. It describes the key functions of hospital pharmacies like procurement, storage, manufacturing and distribution of medications. For inpatients, it explains individual prescription ordering as well as floor stock systems including charge, non-charge and unit dose methods. Outpatient dispensing involves dispensing medications to patients not admitted. Proper storage, documentation and authorization are needed for controlled substances.
Drug information centers provide unbiased drug information to healthcare professionals and patients. The first drug information center was established in 1960 at the University of Kentucky. In Nepal, drug information centers are still in their infancy. The Drug Information Network of Nepal was established in 1996 with participation from government, academic, and non-government organizations to disseminate drug information. The network aims to optimize drug use and decision making in Nepal through sharing up-to-date, evaluated information on drugs.
14ab1t0024 roles and responsibilities of hospital pharmacistRamesh Ganpisetti
Hospital pharmacists play several important roles in ensuring patients receive the most appropriate treatment. They advise patients and medical staff on all aspects of medications, including type, dosage, and administration method based on individual needs. Pharmacists can recommend the best form of medication such as tablets, injections, or inhalers. They are also seen as experts who can advise on safe drug combinations and solutions to specific patient problems. In addition, pharmacists monitor treatment effects to ensure safety, effectiveness, and appropriateness for each user.
Poison information center (Structural Organization and functions)Dr. Abhimanyu Prashar
The document discusses the functions and roles of poison information centers (PICs). It outlines that PICs provide toxicological information and advice, manage poisoning cases, provide laboratory services, conduct education and training, and engage in toxicovigilance activities like identifying risks and preventing poisoning. PICs also contribute to areas like drug information, substances of abuse, environmental toxicology, and disaster planning. Effective PICs require cooperation with various medical and government organizations.
Introduction to clinical pharmacy, Concept and Objectives of clinical pharmacy, Function and responsibilities of clinical pharmacist, Clinical Pharmacy services.
Adverse drug reaction monitoring and reportingTHUSHARA MOHAN
This document discusses types of adverse drug reactions and factors influencing them. It describes types A-E reactions, which include augmented, bizarre, chemical, delayed and end of treatment reactions. Polypharmacy, age, drug characteristics, gender, race and genetic factors can influence susceptibility. Detection methods include pre-marketing studies, post-marketing surveillance, underreporting and communicating reactions. Healthcare professionals should monitor high-risk patients and gather information to assess causality between drugs and adverse events. Underreporting is common due to various barriers but can be addressed through improved reporting systems and education.
This document discusses pharmacovigilance and adverse drug reaction reporting. It covers several topics: methods of detecting ADRs like pre-marketing safety evaluation, post-marketing surveillance, and causality assessment; communicating ADR information to health professionals; and methods for reporting ADRs like spontaneous reporting and standardized case report forms. The key aspects of ADR reporting include who should report, what to report, and where to send reports for evaluation. Accurate documentation of patient information, suspected drugs, and reactions is important for assessment.
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.
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.
This document discusses theragenomic knowledge management for individualized drug safety. It describes how severe adverse drug reactions are a major problem and the leading cause of drug withdrawals. Individualized drug safety aims to prospectively identify patients genetically predisposed to serious adverse reactions. A knowledge management platform called OKAPI was created to efficiently organize and integrate knowledge from multiple disciplines related to theragenomics and individualized drug safety. SafeBase is an implementation of OKAPI and provides an innovative platform to store, manage and visualize knowledge to support drug discovery and development strategies focusing on individualized safety.
The document discusses adverse drug reactions and their classification. It notes that drugs prescribed can themselves cause diseases or adverse health effects, ranging from minor issues to disability or death. It classifies adverse drug reactions into types A, B, C, D and E based on factors like predictability, dose dependence, time of onset, and relationship to normal drug pharmacology. Type B reactions are more serious idiosyncratic or allergic reactions that are unpredictable and unrelated to normal drug action. The document also discusses factors influencing individual variability in drug responsiveness, including differences in absorption, metabolism, receptor numbers, and downstream response components.
Personalized medicine involves the prescription of specific therapeutics best suited for an individual based on their genetic or proteomic profile. This talk discusses current approaches in drug discovery/development, the role of genetics in drug metabolism, and lawful/ethical issues surrounding the deployment of new health technology. I highlight some bioinformatic roles in the drug discovery process, and discuss the use of semantic web technologies for data integration and knowledge discovery..
The document discusses adverse drug reactions (ADRs), including definitions, types, monitoring and reporting. It defines an ADR as an unwanted effect of a medication that is harmful and unintended. ADRs are classified into types A-G based on mechanism and timing. Type A reactions are augmented pharmacological effects, type B are bizarre reactions unrelated to a drug's known effects, type C occur with long-term use, and type D have delayed onset. Pharmacovigilance aims to detect, assess and prevent ADRs through monitoring and signal generation. However, ADR reporting is still limited in India due to lack of awareness and appreciation of pharmacists' role in reporting. Improving education and infrastructure could help strengthen pharmac
Polypharmacy appropriate and inappropriate based on risk and benefit assessment case study, negative consequences of polypharmacy, deprescribing tools,
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.
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
Pharmacogenetics and individual variation of drug responseNarasimha Kumar G V
This document discusses pharmacogenetics and individual variation in drug response. It begins by outlining how individuals can metabolize and respond to drugs differently due to genetic factors like polymorphisms. Three key discoveries in the 1950s helped establish the field of pharmacogenetics by showing how genetic differences can impact drug metabolism and efficacy. The document then examines specific genetic variations that influence drug pharmacokinetics and pharmacodynamics, such as differences in metabolizing enzymes and receptors. Understanding these genetic factors can help optimize drug therapy for each individual patient.
The document discusses adverse drug reactions (ADRs). It defines an ADR as an undesirable effect from drug administration. ADRs can range from trivial to fatal and exclude overdoses or poisonings. An adverse drug event is any untoward medical occurrence during treatment that may not have a causal relationship. The epidemiology section notes ADRs are a leading cause of death in hospitals, with estimates of 6.7% incidence of serious ADRs and 0.3-7% of hospital admissions due to ADRs. Risk is higher in the elderly, children, and those with multiple diseases or medications. ADRs can be classified as type A, predictable effects, or type B, unpredictable immunological reactions
The liver performs many essential functions, including processing nutrients, manufacturing bile, and breaking down toxic substances. Inflammation of the liver can interfere with these processes. Drugs are a common cause of liver injury, with over 900 drugs reported to cause hepatotoxicity. Risk factors for drug-induced liver injury include both drug-related factors like dose and concomitant medications, as well as host-related factors like age, sex, preexisting liver disease, and genetic differences affecting drug metabolism. Common drugs that can damage the liver include antibiotics, antipsychotics, statins, antifungals, antihypertensives, and herbal supplements.
This document discusses drug-induced liver injury (DILI). It begins by stating that multiple drugs can cause hepatotoxicity through various mechanisms. It then discusses the epidemiology of DILI, noting that its worldwide annual incidence is estimated between 1.3 to 19.1 per 100,000 exposed individuals. The document outlines the pathogenesis, clinical presentation, diagnosis, classification, histology, and management of DILI. Regarding histology, it describes various patterns of injury that can be seen such as hepatocellular necrosis, cholestasis, steatosis, and sinusoidal obstruction syndrome. The primary treatment for DILI is withdrawal of the causative drug, with specific therapies for certain cases like
Idiosyncratic drug-induced liver injury (DILI) is an important cause of morbidity and mortality following drugs taken in therapeutic doses. Hepatotoxicity is a leading cause of attrition in drug development, or withdrawal or restricted use after marketing. Get For More Info Visit Us http://www.jcehapatology.com
This document discusses adverse drug reactions (ADRs), including definitions, classifications, mechanisms, and predisposing factors. It defines an ADR as an unintended, harmful reaction to a medication. ADRs are classified based on factors like type (dose-related vs unpredictable), timing (onset), and individual susceptibility. The mechanisms of different ADR types are explained in terms of pharmaceutical, pharmacokinetic, and pharmacodynamic factors. Polypharmacy, multiple diseases, age, drug properties, and genetics can predispose patients to ADRs.
Pharmacogenetics of antipsychotic and antidepressentismail sadek
The document discusses the role of genetics and pharmacogenomics in personalized medicine and treatment of major depressive disorder. It outlines several genes and genetic variants that have been associated with variability in antidepressant drug response, including genes involved in drug metabolism (CYP2D6, CYP1A2, ABCB1), drug targets (SLC6A4, SLC6A3, HTR2A), and downstream signaling pathways (COMT, MAO-A, ADRB1, GNB3). Large clinical studies still need to determine how pharmacogenomic testing can improve clinical outcomes for depression.
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.
Drug resistant epilepsy (DRE) is a distressing problem for patients and doctors. Approximately 20-60% of epilepsy cases become resistant to antiepileptic drugs (AEDs). DRE is defined as failure to achieve seizure freedom after trials of two tolerated AEDs. Causes of apparent DRE include misdiagnosis and non-adherence. Treatment options for true DRE include further AED trials, epilepsy surgery, vagus nerve stimulation, and ketogenic diet. Resective surgery offers the highest chance of remission, especially for temporal lobe epilepsy where seizure freedom rates can be over 90%.
Adverse drug reactions attributed to genetic differences Ayesha Younas
Genetic differences between individuals can lead to variability in responses to drugs and adverse drug reactions. Some key points:
- About 30% of adverse drug reactions may be due to genetic polymorphisms affecting drug metabolism. Enzymes like CYP2D6 play an important role.
- Genes can impact how the body processes and breaks down drugs (pharmacokinetics) and how drugs interact with receptors (pharmacodynamics).
- Single nucleotide polymorphisms are variations in DNA sequences that can alter protein structure and drug responses. They have been linked to prolonged muscle relaxation after cholinergic drugs and hemolytic anemia from antimalarial drugs.
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
All manuscripts are subject to rapid peer review. Those of high quality (not previously published and not under consideration for publication in another journal) will be published without delay.
It was one of my presentation for my master's in pharmacy. It assisted me in better understanding the many pharmacy research fields as well as what to do before, during, and following a research project. I am hoping that it will also provide the readers a better understanding of the fascinating world of research.
It was an assignment of mine when i was undergraduate, studying at Gono Bishwabidyalay. this assignment contains:
Introduction, Definitions, Unique characteristics, categories, routes, advantages and dis-advantages.
On insulin part i focused on:
Introduction, different formulations of insulin, injectable insulin preparation, methods of insulin preparation, quality control of insulin, quality control parameter, common quality control tests, packaging and packaging materials..
COVID-19:
Introduction
immunosenescence, ARDS,
Hyperinflammation and mortality
Cytokine storm , Inflammatory storm,
Treatment of COVID-19,
Acalabrunitib, Tocilizumab, Anakinra and Itolizumab,
Roleof itolizumab in suppressing the cytokine storm.
Approval status of Itolizumab.
Treatment with the anti-CD6 MAb Itolizumab.
Current status of itolizumab in the treatment of COVID-19,
Common side effects of itolizumab.
Expert opinion
Biopharmaceutics & Pharmacokinetics (Ultimate final note)MdNazmulIslamTanmoy
Intravenous Infusion (IV): Define intravenous infusion. Write down advantages and disadvantages of intravenous infusion,
Write down the pharmacokinetics of IV infusion, Calculate the plasma drug concentration at steady-state after IV infusion, Determine the half life (t1/2) by IV infusion method, Show that in case of IV infusion the time to reach 99% steady-state is 6.65 t1/2.
Multiple-Dosage Regimens: Write a short note on Multiple-Dosage Regimens. What are the basic considerations for multiple dosage regimen?, What are the purposes of multiple-dosage regimens (MDR)? Write down the importance of MDR, Write short note on repetitive intravenous injections, Prove that C∞av is not arithmetic average of C∞max and C∞min, Give brief description on superposition principle and Plateau principle?.
Individualization: Write down about individualization of drug dosing regimen? What are the advantages of individualization? How will you optimizing dosage regimen?, What are the sources of variability in drug response? What are the causes of Inter subject Pharmacokinetics Variability? Write down the steps involved in individualization of dosage regimen?, Write short note on – dosing of drug in obese patient and also discuss about dosing of drug in neonates, infants and children?, Write down about dosing of drug in elderly and hepatic disease? Give some examples of drugs who's conc. Changes due to hepatic impairment?, Explain some clinical experience with individualization and optimization based on plasma drug levels?
NON-linear pharmacokinetics: Derive the Michaelis-Menten Equation or Non-Liner pharmacokinetic and Linear pharmacokinetic model, Define non-linear pharmacokinetics. Why it is called dose dependent pharmacokinetics?, Why Michaelis-Menten equation is termed as mixed order kinetics?, A given drug is metabolized by capacity-limited pharmacokinetics. Assume KM is 50훍g/mL, Vmax is 20훍g/mL per hour and apparent VD is 20 L/kg, Differentiate between linear & non-linear Pharmacokinetics.
Non-compartment model: Briefly describe compartment model?, Briefly describe non-compartment model?, What is MRT? Write down the importance of MRT?, What is MAT? Write down the importance of MAT?, Compare between compartment model and non-compartment models.
Carcinogenesis
Theories of carcinogenesis
Hallmarks of cancer
Important Oncogenes
RB & p53 genes
Metastasis
Aetiology and Pathogenesis of cancer
Tests for carcinogenicity
How to repair damaged DNA?
Basic DNA repair mechanism
Repair of double stranded break
Hydrogels,
introduction,
historical background,
properties,
classification,
difference between chemical and physical hydrogels,
common uses,
pharmaceutical applications,
preparation methods,
list of monomers used,
analytical machines,
advantages,
disadvantages,
conclusion
Spermatogenesis steps, hormonal regulation and abnormalitiesMdNazmulIslamTanmoy
Spermatogenesis is the process by which sperm cells are produced in males. It occurs in three stages: spermatocytogenesis where spermatogonia proliferate into primary spermatocytes, meiosis where primary spermatocytes undergo two divisions to form spermatids, and spermiogenesis where spermatids undergo changes to form spermatozoa. Hormones like testosterone, LH, FSH, growth hormone, and estrogen regulate spermatogenesis by stimulating Leydig and Sertoli cells. Abnormalities can result in conditions like azoospermia, oligozoospermia, and teratozoospermia.
Enzyme catalysed reactions, enzyme kinetics and it’s mechanism of action.MdNazmulIslamTanmoy
Enzymes are protein catalysts that regulate chemical reactions in living organisms. They accelerate reactions by lowering the activation energy of transition states through interactions with substrates. Enzymes are classified based on the type of reaction they catalyze, such as oxidoreductases, transferases, hydrolases, lyases, isomerases, and ligases. Enzyme kinetics follow the Michaelis-Menten model where the enzyme-substrate complex breaks down into products. The catalytic activity of enzymes is explained by thermodynamic changes in transition states and specific interactions between the enzyme and substrate at its active site.
Spli2 is launching a new portable water filter called Spli2 to provide consumers with affordable and environmentally friendly access to clean drinking water. The filter removes bacteria and other contaminants at rates exceeding EPA standards. It is a low-cost alternative to bottled water that also reduces plastic waste. Spli2 aims to market the filter through displays in grocery and convenience stores near bottled water. It will target health-conscious urban consumers and emphasize the product's affordability, portability, quality and environmental benefits over bottled water.
E. Salt form of the drug
F. Lipophilicity of the drug
pH partition theory
Assumption of PH partition theory
Diagram showing the transfer of drug across the membrane
Limitations of pH-partition hypothesis
(Q.U): Mathematical problem
Formulation factors affecting drug availability
First pass effect
Gastric emptying time
Gastrointestinal motility
Short note on Gastric emptying and motility
Physicochemical factors affecting drug absorption
A. Drug solubility and dissolution rate
B. Particle size and surface area of drugs
C. Polymorphism and amorphism
D. Hydrate or solvates
Biopharmaceutical classification system of drug
This document introduces physiological factors influencing drug availability, including the circulatory system and mechanisms of drug absorption across membranes. The circulatory system transports nutrients, oxygen, and wastes through the heart, blood, and vessels. There are three types of circulation: systemic circulation carries oxygenated blood from the heart to cells and back, pulmonary circulation moves deoxygenated blood between the heart and lungs, and portal circulation transports blood from the intestines to the liver. Drug absorption is influenced by membrane physiology, with mechanisms including carrier-mediated transport like active transport against gradients and facilitated diffusion, as well as non-carrier mediated simple diffusion down concentration gradients.
This document introduces concepts related to biopharmaceutics including Fick's first law of diffusion, gastrointestinal physiology, and the relationship between drug products and their pharmacological action. It defines key terms such as absorption, distribution, metabolism, and excretion. Fick's first law states that the rate of diffusion across a membrane is proportional to the difference in drug concentration on each side. The document also describes the anatomy and protective mucous layer of the gastrointestinal tract, and explains that orally administered drugs must dissolve before being absorbed and distributed throughout the body, where they may act, be stored, metabolized, or excreted.
The liver is the largest gland in the body and performs many critical metabolic functions like carbohydrate and protein metabolism. It also plays an important role in hormone regulation, bile production, and blood clotting factor synthesis. Chronic liver disease can lead to liver fibrosis and cirrhosis over many years. Cirrhosis is characterized by liver scarring and nodule formation, resulting in loss of liver function. Common causes include alcohol abuse, viral hepatitis, and non-alcoholic fatty liver disease. Complications arise due to portal hypertension and liver failure. Diagnosis involves liver biopsy or lab tests showing abnormalities in liver enzymes and clotting factors.
HPLC
Chromatography
Mobile Phase & Stationary Phase
CLASSIFICATION OF CHROMATOGRAPHY
Characteristics of HPLC
Purpose
Superiority of HPLC
TYPES OF HPLC TECHNIQYES
Principle
PHASING SYSTEM & (normal vs reversed phase)
INSTRUMENTATION
Flow diagram of HPLC instrument
Advantages of HPLC
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Kat...rightmanforbloodline
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TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
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Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotesPsychoTech Services
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Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
2. An ADR as “ a response to a drug that is noxious and unintended and occurs at doses
normally used in man for the prophylaxis , diagnosis or therapy of disease , or for
modification of physiological function ( WHO , 1972 ) .
3. Rawlins-Thompson classification
The Rawlins-Thompson system of classification divides ADRS into two main groups:
Type A and Type B (Rawlins, 1981).
Type A reactions are the normal, but quantitatively exaggerated, pharmacological
effects of a drug. They include the primary pharmacological effect of the drug, as
well as any secondary pharmacological effects of the drug, for example, ADRS
caused by the antimuscarinic activity of tricyclic antidepressants. Type A reactions
are most common, accounting for 80% of reactions.
4. Types of reaction Features Examples
Type A: Augmented pharmacological
effect
Common, predictable effect, Dose
dependent, Low morbidity, Low
mortality
Bradycardia associated with a beta-
adrenergic receptor antagonist
Type B: Bizzare effects not related
to pharmacological effect
Uncommon, Unpredictable, Not
dose dependent, High morbidity,
High mortality
Anaphylaxis associated with a
penicillin antibiotic
Type C: Dose-related and time-
related
Uncommon, Related to the
cumulative dose
Hypothalamic pituitary- adrenal axis
suppression by corticosteroids
Type D: Time related Uncommon, Usually dose related,
Occurs or becomes apparent some
time after use of the drug
Carcinogenesis
Type E: Withdrawal Uncommon, Occurs soon after
withdrawal
Opiate withdrawal syndrome
Type F: Unexpected failure of
therapy
Common, Dose- related, Often
cause by drug interactions
Failure of oral contraceptive in
presence of enzyme inducer
5. Dose relatedness Time relatedness Susceptibility
Toxic effects: ADR S that occur
at doses higher than the usual
therapeutic dose Collateral
effects: ADR s that occur at
standard therapeutic doses
Hyper-susceptibility reactions:
ADRS that occur at sub-
therapeutic doses in susceptible
Patients
Time-independent reactions: ADR s
that occur at any time during
treatment. Time-dependent reactions:
Rapid reactions occur when a drug is
administered too rapidly. Early
reactions occur early in treatment then
abate with continuing treatment
(tolerance). Intermediate reactions
occur after some delay, but if reaction
does not occur after a certain time,
little or no risk exists. Late reactions
risk of ADR increases with continued-
to-repeated exposure, including
withdrawal reactions. Delayed
reactions occur some time after
exposure, even if the drug is withdrawn
before the ADR occurs.
Raised susceptibility may be
present in some individuals,
but not others. Alternatively,
susceptibility may follow a
continuous distribution -
increasing susceptibility with
impaired renal function.
Factors include: genetic
variation, age, sex, altered
physiology, exogenous factors
(interactions) and disease.
6. A number of general factors which affect susceptibility to ADRS and others which affect
the propensity of specific drugs to cause ADRS have been elucidated.
(i) Age
(ii) Gender
(iii) Co-morbidities and concomitant medicines use
(iv) Ethnicity
(v) Pharmacogenetics
(vi) Erythrocyte glucose-6-phosphatase dehydrogenase (G6PD) deficiency
(vii) Porphyrias
7. Elderly patients may be more prone to ADRS, with age- related decline in both the
metabolism and elimination of drugs from the body. They also have multiple cos
morbidities and are, therefore, exposed to more prescribed drugs. Children differ
from adults in their response to drugs. Neonatal differences in body composition,
metabolism and other physiological parameters can increase the risk of specific
adverse reactions. Differences in drug metabolism and elimination and end-organ
responses can also increase the risk. Chloramphenicol, digoxin, and ototoxic
antibiotics such as streptomycin are examples of drugs that have a higher risk of
toxicity in the first weeks of life.
8. Women may be more susceptible to ADRS. In addition, there are particular adverse
reactions that appear to be more common in women than men. For example,
impairment of concentration and psychiatric adverse events associated with the
anti-malarial mefloquine are more common in females. Females are more
susceptible to drug-induced torsade de pointes, a ventricular arrhythmia linked to
ventricular fibrillation and death. Women are also over-represented in reports of
torsades de pointes associated with cardiovascular drugs (such as sotalol) and
erythromycin. This increased susceptibility in women is thought to be due to their
longer QTc interval compared to mên.
9. In cardiology, the QT interval is a
measure of the time between the start of
the Q wave and the end of the T wave in
the heart's electrical cycle. A lengthened
QT interval is a marker for the potential
of ventricular tachyarrhythmias like
torsades de pointes and a risk factor for
sudden death.
Torsades de pointes (TdP) is a specific
form of polymorphic ventricular
tachycardia occurring in the context of
QT prolongation; it has a characteristic
morphology in which the QRS complexes
"twist" around the isoelectric line. For
TdP to be diagnosed, the patient has to
have evidence of both PVT and QT
prolongation.
10. Reductions in hepatic and renal function substantially increase the risk of ADRSs. A
recent study examining factors that predicted repeat admissions to hospital with
ADRS in older patients showed that co-morbidities such as congestive cardiac
failure, diabetes, and peripheral vascular, chronic pulmonary, rheumatological,
hepatic, renal, and malignant diseases were strong predictors of readmissions for
ADRS, while advancing age was not. Reasons for this could be pharmacokinetic and
pharmacodynamic changes associated with pulmonary, cardiovascular, renal and
hepatic insufficiency, or drug interactions because of multiple drag therapy.
11. Ethnicity is the fact or state of belonging to a social group that has a common
national or cultural tradition. It has also been linked to susceptibility to ADRS, due
to inherited traits of metabolism. For example, that the cytochrome P450 genotype,
involved in drug metabolism, has varied distribution among people of differing
ethnicity (CYP2C9 alleles associated with poor metabolism can affect warfarin
metabolism and increase the risk of toxicity). This occurs more frequently in white
individuals compared to black individuals.
- Examples of ADRS linked to ethnicity include the increased risk of angioedema with
the use of ACE inhibitors in black patients,
- the increased propensity of white and black patients to experience central nervous
system ADRS associated with mefloquine compared to patients of Chinese or
Japanese origin,
- differences in the pharmacokinetics of rosuvastatin in Asian patients which may
expose them to an increased risk of myopathy.
12. Pharmacogenetics is the study of inherited genetic |differences in drug metabolic
pathways which can affect individual responses to drugs, both in terms of
therapeutic effect as well as adverse effects. It influence an individual's response to
drugs, and examines polymorphisms that code for drug transporters, drug-
metabolising enzymes and drug receptors. Examples of pharmacogenetics are
hypersensitivity reactions to abacavir used in the treatment of HIV and cutaneous
ADRS Steven- Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) to
antiepileptic drugs such as carbamazepine and phenytoin.
13. Glucose-6-phosphate dehydrogenase deficiency (G6PDD) is an inborn error of
metabolism that predisposes to red blood cell breakdown. Most of the time, those
who are affected have no symptoms. Following a specific trigger, symptoms such as
yellowish skin, dark urine, shortness of breath, and feeling tired may develop.
G6PD deficiency is present in over 400 million people worldwide. It is a sex- linked
inherited enzyme deficiency, leading to susceptibility to haemolytic anaemia.
Patients with low levels of G6PD are predisposed to haemolysis with oxidant drugs
such as primaquine, sulphonamides and nitrofurantoin.
14. Porphyrins are a group of heterocyclic macrocycle organic compoupds, composed of
four modified pyrrole subunits interconnected at their a carbon atoms via methine
bridges. These disorders are usually inherited, meaning they are caused by
abnormalities in genes passed from parents to children. When a person has a
porphyria, cells fail to change body chemicals called porphyrins and porphyrin
precursors into heme, the substance that gives blood its red color. The porphyrias
are a heterogeneous group of inherited disorders of haem biosynthesis. The effects
of drugs are of most importance in patients with acute porphyrias, in which certain
commonly prescribed agents may precipitate life-threatening attacks. Other trigger
factors include alcohol and changes in sex hormone balance. In the acute
porphyrias, patients develop abdominal and neuropsychiatric disturbances, and they
excrete in their urine excessive amounts of the porphyrin precursors 5-
aminolaevulinic acid (ALA) and porphobilinogen.
15. Immunologic response - a bodily defense reaction that recognizes an invading
substance (an antigen: such as a virus or fungus or bacteria or transplanted organ)
and produces antibodies specific against that antigen. immune reaction, immune
response. The immune system is able to recognize drugs as foreign substances,
leading to allergic reactions. Smaller drug molecules (<600 Da) can bind with
proteins to trigger an immune response, or larger molecules can trigger an immune
response directly. The immune response is not related to the pharmacological action
of the drug and prior exposure to the drug is required. Immunological reactions are
often distinct recognizable responses. Allergic reactions range from rashes, serum
sickness and angioedema to the life-threatening bronchospasm and hypotension
associated with anaphylaxis. Patients with a history of atopic or allergic disorders
are at higher risk. Immunological (hypersensitivity) reactions are split into four main
types.
16. Classification Mechanism Symptoms/signs and examples
Type I (immediate) Drug/lgE complex to mast cells
release of histamine and
leukotrienes.
Symptoms/signs and examples
Pruritis, urticaria,
bronchoconstriction, angioedema,
hypotension, shock, for example,
penicillin anaphylaxis.
Type II (cytotoxic) IgG and complement binding to
(usually) red blood cell. Cytotoxic T-
cells lyse the cell.
Haemolytic anaemia and
thrombocytopaenia, for example,
associated with cephalosporins,
penicillins and rifampicin.
Type II (immune complex) Drug antigen and I gG or I gM form
immune complex, attracting
macrophages and complement
activation.
Cutaneous vasculitis, serum
sickness, for example, associated
with chlorpromazine and
sulphonamides
Type IV (delayed type) Antigen presentation with major
histocompatibility complex protein
to T-cells and cytokine and
inflammatory mediator release.
Usually occur after 7-20 days.
Macular rashes and organ failure,
including Stevens-Johnson syndrome
and toxic epidermal necrolysis, for
example, associated with neomycin
and sulnhonamides
17. Epidemiology is the branch of medicine which deals with the incidence, distribution,
and possible control of diseases and other factors relating to health. ADRS are
widespread, as shown by both systematic reviews and large-scale studies. A review
of 69 studies from many countries in 2002 found that ADRS were responsible for an
estimated 2.6% of admissions to hospitals and that between 3.5% and 7.3% of in-
patients may suffer an ADR. A prospective study found that 6.5% out of 18,820
admissions to medical units were caused by ADRS, with 2.3% of patients dying as a
result. A similar prospective study of 3695 in- patient found that 14.7% of those
admitted to medical or surgical wards experienced an ADR during their stay. These
were more common in women, older patients and in those admitted to surgical
wards (Davies et al., 2009)
18. Pharmacovigilance is defined as 'the study of the safety of
marketed drugs under the practical conditions of clinical use
in large communities'. Pharmacovigilance is concerned with
the detection, assessment and prevention of adverse effects
or any other possible drug-related problems, with the
ultimate goal of achieving rational and safe therapeutic
decisions in clinical practice.
19. Spontaneous reporting
Pharmacovigilance uses multiple methods, but the following will focus on spontaneous reporting
systems. Spontaneous reporting systems collect data about suspected ADRs in a central database.
Cases are not collected in a systematic manner, but accumulate through reports submitted
spontaneously by people who make a connection between a drug and a suspected drug induced
event. In the UK, the spontaneous reporting scheme is the Yellow Card scheme. In some countries
reporting is a voluntary activity, in others reporting is a legal requirement.
Advantages:
- It is relatively cheap to administer,
- can follow a product throughout its life and
- can also accept reports to over-the-counter medication and herbal treatments.
Disadvantage:
- Their is inability to quantify the risk. Such systems supply a numerator (the number of reports), but
estimates of the incidence of reactions cannot be made because the population exposed to the
drug cannot be ascertained accurately.
20. The UK's Yellow Card Scheme was established in 1964
following the thalidomide tragedy. The Scheme is
operated by the Medicines and Health care Products
Regulatory Authority (MHRA). Information from
Yellow Card reports is entered into a database,
suspected reactions are categorized using the
internationally accepted Medical Dictionary for
Regulatory Affairs (MedDRA) and the resultant signals
generated by the combined reports are then assessed
for causality.
21. The thalidomide disaster is one
of the darkest episodes in
pharmaceutical research history.
The drug was marketed as a mild
sleeping pill safe even for
pregnant women. However, it
caused thousands of babies
worldwide to be born with
malformed limbs. The damage
was revealed in 1962.
22. The first suspicions of a less common or unpredictable reaction may
often be seen in a case report from a practitioner. As seen by the
cases of thalidomide and practolol clinicians submitting case reports
to the medical press has been of importance in drug safety. Case
reports have been described as a form of non-systematic voluntary
reporting. Editors may demand a case series, requiring higher
standards of investigation than regulatory agencies demand from a
spontaneous report. These high standards can prevent case histories
from reaching publication. It takes time for a case report about a
suspected ADR to be published could be several months, during which
time more patients may be exposed to the potential risk.
23. Cohort studies are prospective pharmaco-epidemiological studies
that monitor a large group of patients taking a particular drug over
a period of time. Ideally such studies compare the incidence of a
particular adverse event in two groups of patients, those taking the
drug of interest and, another group matched for all important
characteristics except the use of the drug. These studies can
indicate the relative risks associated with the adverse event in
people exposed to the drug being studied.
24. Case - control studies compare the extent of drug usage in a group of patients who
have experienced the adverse event with the extent of usage among a matched
control group who are similar in potentially confounding factors, but have not
experienced the event. By comparing the prevalence of drug taking between the
groups, it may be possible to identify whether significantly more people who
experienced the event also took a particular drug. Examples of associations which
have been established by case control studies are Reye's syndrome (Reye's (Ryes)
syndrome is a rare but serious condition that causes swelling in the liver and brain.
Reye's syndrome most often affects children and teenagers.) And aspirin and the
relationship between maternal diethylstilboestrol ingestion and vaginal
adenocarcinoma in female offspring. Case - control studies are an effective method
of confirming whether or not 1.0ta drug causes a given reaction once a suspicion has
been raised.
25. Identifying and Assessing Standards in Clinical Practice.
Preventing ADRs
Monitoring Therapy
Explaining Risks to Patents
26. The temporal relationship between the exposure to the drug and the subsequent event
The clinical and pathological characteristics of the event - events which are known to be
related to drug use, rather than disease processes
The pharmacological plausibility - based on the observer's knowledge of pharmacology
Existing information in published drug information sources - whether or not the event has been
noted by others
Concomitant medication - which may be considered the cause of an event
Underlying and concurrent illnesses - may alter the event or be considered the cause of the
event
De - challenge - disappearance of symptoms after dose reduction or cessation of therapy
Re - challenge - reappearance of symptoms after dose increases or recommendation of therapy
Patient characteristics and previous medical history - past history of the patient may color the
view of the event
The potential for drug interactions.