PHARMACY PRACTICE
SHIVAM DUBEY
BPYN1PY18041
ADVERSE DRUG REACTION Abstract
We define an adverse drug reaction as "an appreciably harmful or
unpleasant reaction
This document defines medication error and outlines procedures for reporting medication errors. It also lists common types of medication errors including prescribing errors, omission errors, wrong time errors, and improper dose errors. Causes of errors include look-alike and sound-alike drug names, illegible handwriting, and unapproved abbreviations. Nursing responsibilities in preventing errors and standard precautions are discussed.
Detection, reporting and management of adverse eventsKatla Swapna
This document discusses adverse drug reactions (ADRs), including definitions, classifications, detection, reporting, and management. It notes that ADRs are a major clinical problem that can cause suffering and increased healthcare costs. It emphasizes the importance of monitoring and reporting ADRs to improve patient safety. Pharmacists can play an important role by monitoring high-risk patients and drugs, educating on ADR reporting, and assisting in the detection and assessment of ADRs. Timely reporting of ADRs is crucial to help prevent human suffering and unnecessary costs from drug-related injuries.
complete description of causality assessment with the definition of basic terminologies.& relation with an adverse event and adverse drug reaction, causality terms & assessment criteria.
PTC: Pharmacy and Therapeutics committeeSHIVANEE VYAS
The pharmacy and therapeutics committee is a policy framing and recommending body to the medical staff and the administration of the hospital on matters related to the therapeutic use of drugs.
Therapeutic drug monitoring (TDM) refers to measuring drug levels in the blood to optimize drug therapy and ensure concentrations remain in the therapeutic range to maximize efficacy and minimize toxicity. TDM is used for drugs with a narrow therapeutic index, non-linear kinetics, or high inter-individual variability in metabolism. It allows clinicians to individualize dosing regimens to maintain therapeutic concentrations and avoid sub-therapeutic or toxic levels. Common drugs monitored include digoxin, theophylline, aminoglycosides, and anti-epileptics.
Based on the information provided:
- Mrs. Tigist's drug-related need is for effective treatment of her depression
- Recommending an OTC sleep aid would not meet this need and could potentially cause harm
- The appropriate action would be to advise Mrs. Tigist that her symptoms suggest she may be depressed and recommend she see her physician for evaluation and treatment
This document defines medication error and outlines procedures for reporting medication errors. It also lists common types of medication errors including prescribing errors, omission errors, wrong time errors, and improper dose errors. Causes of errors include look-alike and sound-alike drug names, illegible handwriting, and unapproved abbreviations. Nursing responsibilities in preventing errors and standard precautions are discussed.
Detection, reporting and management of adverse eventsKatla Swapna
This document discusses adverse drug reactions (ADRs), including definitions, classifications, detection, reporting, and management. It notes that ADRs are a major clinical problem that can cause suffering and increased healthcare costs. It emphasizes the importance of monitoring and reporting ADRs to improve patient safety. Pharmacists can play an important role by monitoring high-risk patients and drugs, educating on ADR reporting, and assisting in the detection and assessment of ADRs. Timely reporting of ADRs is crucial to help prevent human suffering and unnecessary costs from drug-related injuries.
complete description of causality assessment with the definition of basic terminologies.& relation with an adverse event and adverse drug reaction, causality terms & assessment criteria.
PTC: Pharmacy and Therapeutics committeeSHIVANEE VYAS
The pharmacy and therapeutics committee is a policy framing and recommending body to the medical staff and the administration of the hospital on matters related to the therapeutic use of drugs.
Therapeutic drug monitoring (TDM) refers to measuring drug levels in the blood to optimize drug therapy and ensure concentrations remain in the therapeutic range to maximize efficacy and minimize toxicity. TDM is used for drugs with a narrow therapeutic index, non-linear kinetics, or high inter-individual variability in metabolism. It allows clinicians to individualize dosing regimens to maintain therapeutic concentrations and avoid sub-therapeutic or toxic levels. Common drugs monitored include digoxin, theophylline, aminoglycosides, and anti-epileptics.
Based on the information provided:
- Mrs. Tigist's drug-related need is for effective treatment of her depression
- Recommending an OTC sleep aid would not meet this need and could potentially cause harm
- The appropriate action would be to advise Mrs. Tigist that her symptoms suggest she may be depressed and recommend she see her physician for evaluation and treatment
The document discusses the principles and importance of rational drug therapy and essential drug concepts, which aim to maximize treatment effectiveness and safety while minimizing costs by prescribing the most appropriate medications. It outlines factors that contribute to irrational drug use and the role pharmacists can play in counseling patients and physicians, reporting adverse drug reactions, procuring cost-effective drugs, and promoting rational drug utilization. The document also provides examples of commonly used essential drugs and steps that can improve rational prescribing.
This document discusses factors that affect medication adherence. It identifies several patient-related factors like age, gender, education level, and health literacy. Social and economic barriers include low income, limited access to healthcare, and high medication costs. Health system factors involve poor provider-patient communication and relationships. The document also outlines strategies for pharmacists to improve adherence through clear education, active listening, simplifying dosing regimens, and monitoring side effects. It provides a formula to calculate medication adherence percentage and emphasizes the pharmacist's role in assessing patient knowledge and habits.
The document outlines procedures for identifying, recording, and reporting adverse reactions and serious adverse reactions that may occur during clinical trials. It defines key terms like adverse events, adverse reactions, serious adverse reactions, and suspected unexpected serious adverse reactions. It describes the responsibilities of investigators and sponsors in assessing adverse events, reporting serious adverse reactions to licensing authorities within 14 days, and ensuring medical care for subjects experiencing adverse reactions. Flowcharts are provided to illustrate the processes for identifying adverse reactions and determining expectedness and implications for reporting.
Pharmaceutical care concepts - clinical pharmacy ShaistaSumayya
This document summarizes the concept of pharmaceutical care as presented by Shaista Sumayya, a 4th year PharmD student. It defines pharmaceutical care as the direct provision of medication-related care to improve patient outcomes. The pharmacist's role involves identifying and resolving drug-related problems by designing treatment plans, monitoring outcomes, and preventing potential issues. Key aspects of pharmaceutical care include collecting patient data, evaluating treatment alternatives, individualizing drug regimens, and documenting provided care. The overall goal is to cure diseases, reduce symptoms, and improve a patient's quality of life through optimized medication management.
The document outlines the evolution of pharmacy practice from product-focused to patient-centered care. It discusses how practice has shifted from emphasizing identification, preparation, and dispensing of products to providing clinical services like medication management. This includes comprehensive medication reviews, resolving drug-related issues, and monitoring treatment outcomes. The document also describes new pharmacy services like immunizations, prescribing for minor ailments, and point-of-care testing. It addresses some risks to the pharmacy profession from advances in technology but also outlines expanding roles for pharmacists in areas like chronic disease management and specialty practices.
Medication Errors in General Medicine wards of a tertiary care teaching Hospi...Dr. Abhimanyu Prashar
Medication errors are common in healthcare and can cause harm or death. A study identified 571 medication errors in 390 patients over 6 months at a tertiary care hospital. The most common errors were prescribing errors (71%), followed by administration errors (26%) and dispensing errors (3%). The majority of errors were caused by clinicians (49%), nurses (24%), and pharmacists (15%). Common types of errors included wrong dose, frequency, and drug omission. Most errors were classified as causing no harm. The study recommends strategies like systematic documentation, generic prescribing, treatment chart review, and drug utilization evaluation to prevent common medication errors in the hospital.
medication Adherence defined as the act of filling a new prescription for the first time.
The extent to which the patients take medications as prescribed by the prescriber.
This document discusses medication errors, which are preventable events that can cause inappropriate medication use or harm to a patient. It defines medication errors based on definitions from the American Society of Health-System Pharmacists and the National Coordinating Committee on Medication Error Reporting and Prevention. Common types of medication errors include prescribing errors, dispensing errors, administration errors, and compliance errors. The document also discusses causes of medication errors and strategies to prevent errors, including standardized ordering processes, double checks, limiting abbreviations, and use of computerized prescriber order entry systems.
Establishing a drug information centerkatta amulya
This document discusses establishing a drug information center. It begins by introducing the main functions of a drug information center which is to provide written or verbal drug-related information to healthcare professionals and the public. It then classifies drug information centers into hospital based, industry based, and community based. The document outlines the need for drug information centers by discussing their primary function of responding to drug therapy inquiries and services like drug evaluation, education, and pharmacovigilance. It also covers staffing, resources, literature databases, and concludes by emphasizing the importance of efficient drug information centers for optimal patient care.
This document provides an introduction to clinical pharmacy presented by Ian and Judith Coombes to students in Sri Lanka. In 3 sentences:
The presentation discusses the role of clinical pharmacy in improving patient care by identifying and resolving medication-related issues, outlines differences between healthcare systems in Australia and Sri Lanka, and emphasizes the need for pharmacists to adopt a patient-centered approach through effective communication and consultation to optimize drug therapy and prevent adverse events.
The document outlines the roles and functions of a Drug and Therapeutics Committee (DTC) in a hospital. The DTC advises on drug-related issues, develops drug policies, evaluates drugs for inclusion in the hospital formulary, promotes rational drug use, manages adverse drug reactions, and monitors drug safety. It is composed of physicians, pharmacists, nurses, and administrators. The DTC meets regularly to assess drug use, identify issues, and conduct interventions to improve prescribing and reduce costs while maintaining patient safety.
This document discusses adverse drug reactions, including their definition, classification, causes, and the role of nurses. It defines an adverse drug reaction as an unintended, harmful response to a medication. Reactions are classified as Type A or B, with Type A reactions being dose-dependent and Type B being unpredictable. Common causes of reactions include medication errors, biological differences between patients, and drug interactions. The document outlines how nurses can help identify, document, monitor, prevent, and report adverse drug reactions.
This document discusses pharmaceutical care, which aims to improve patient outcomes through responsible drug therapy. It defines pharmaceutical care as providing medication to achieve therapeutic outcomes that enhance quality of life. These may include curing disease, reducing symptoms, or slowing disease progression. The document outlines the basic elements of pharmaceutical care, which include being patient-oriented, addressing both acute and chronic issues, and emphasizing prevention of drug-related problems through documented care plans and collaboration with other providers. It also discusses various tools used in pharmaceutical care, such as SOAP notes, CORE pharmacotherapy plans, and FARM analyses to identify, resolve, and prevent drug-related issues.
This document discusses rational drug use and defines it as using the appropriate drug for the right patient in the proper dose and form to maximize efficacy and minimize harm. It outlines criteria for rational use and types of irrational use such as incorrect diagnosis, prescription, and dispensing. Common reasons for irrational drug use include financial incentives, easy drug availability, and lack of education. The roles of pharmacists in promoting rational drug use include educating patients, following essential drug lists, and maintaining proper stock control.
This document discusses the importance of evaluating clinical literature and provides guidance on how to systematically approach literature evaluation. It describes how to identify the level and type of reference (tertiary, secondary, primary), and provides tips for evaluating different aspects of clinical studies, such as the objective, subjects, treatment administration, setting, methods, controls, and data analysis. The document also discusses how the FDA communicates important drug safety information to healthcare professionals and the public.
The document discusses rational use of drugs and strategies to promote rational use. Rational use means using the right drug, for the right indication, at the right dose and duration, for the right patient. Irrational use can lead to ineffective treatment, adverse drug events, increased resistance, and costs. Common causes of irrational use include lack of information, diagnostic uncertainty, patient demands, and promotional activities. Strategies to promote rational use include educational programs for providers, printed materials, media campaigns, essential drug lists, structured order forms, generic substitution, and regulating promotions. Rational prescribing involves defining the problem, setting objectives, selecting strategies, writing prescriptions, and monitoring treatment.
Patient compliance describes how closely a patient follows medical advice, particularly with respect to medication, but also other treatments like device use or therapy. It is important for conditions requiring ongoing treatment, replacement therapies like insulin, or controlling diseases of public health concern. Rates of compliance are assessed through various objective and subjective methods like pill counts, health outcomes, and patient interviews. Improving compliance requires addressing barriers like cost and complex regimens through subsidization, generic drugs, and education by pharmacists and other providers.
The document discusses medication errors and strategies to address them. It notes that medication errors can occur at various stages of treatment and provides examples. Strategies to reduce errors include establishing multidisciplinary teams to develop standards, introducing punishment-free error reporting systems, and requiring legible prescriptions and patient identification verification. Adverse drug reactions are also addressed, including definitions and Nepal's pharmacovigilance program which involves regional hospital centers reporting reactions to the national regulatory agency.
Pharmacovigilance: The conscientious today for safe tomorrowpharmaindexing
This document discusses pharmacovigilance, which is the detection, assessment, understanding, and prevention of adverse drug reactions. It describes traditional pharmacovigilance methods like spontaneous reporting systems and their limitations. It also outlines new approaches to strengthen pharmacovigilance, including broadening reporter bases to include patients, using quantitative signal detection methods to analyze large reporting databases, and leveraging electronic health records and administrative databases for observational studies.
The document discusses the principles and importance of rational drug therapy and essential drug concepts, which aim to maximize treatment effectiveness and safety while minimizing costs by prescribing the most appropriate medications. It outlines factors that contribute to irrational drug use and the role pharmacists can play in counseling patients and physicians, reporting adverse drug reactions, procuring cost-effective drugs, and promoting rational drug utilization. The document also provides examples of commonly used essential drugs and steps that can improve rational prescribing.
This document discusses factors that affect medication adherence. It identifies several patient-related factors like age, gender, education level, and health literacy. Social and economic barriers include low income, limited access to healthcare, and high medication costs. Health system factors involve poor provider-patient communication and relationships. The document also outlines strategies for pharmacists to improve adherence through clear education, active listening, simplifying dosing regimens, and monitoring side effects. It provides a formula to calculate medication adherence percentage and emphasizes the pharmacist's role in assessing patient knowledge and habits.
The document outlines procedures for identifying, recording, and reporting adverse reactions and serious adverse reactions that may occur during clinical trials. It defines key terms like adverse events, adverse reactions, serious adverse reactions, and suspected unexpected serious adverse reactions. It describes the responsibilities of investigators and sponsors in assessing adverse events, reporting serious adverse reactions to licensing authorities within 14 days, and ensuring medical care for subjects experiencing adverse reactions. Flowcharts are provided to illustrate the processes for identifying adverse reactions and determining expectedness and implications for reporting.
Pharmaceutical care concepts - clinical pharmacy ShaistaSumayya
This document summarizes the concept of pharmaceutical care as presented by Shaista Sumayya, a 4th year PharmD student. It defines pharmaceutical care as the direct provision of medication-related care to improve patient outcomes. The pharmacist's role involves identifying and resolving drug-related problems by designing treatment plans, monitoring outcomes, and preventing potential issues. Key aspects of pharmaceutical care include collecting patient data, evaluating treatment alternatives, individualizing drug regimens, and documenting provided care. The overall goal is to cure diseases, reduce symptoms, and improve a patient's quality of life through optimized medication management.
The document outlines the evolution of pharmacy practice from product-focused to patient-centered care. It discusses how practice has shifted from emphasizing identification, preparation, and dispensing of products to providing clinical services like medication management. This includes comprehensive medication reviews, resolving drug-related issues, and monitoring treatment outcomes. The document also describes new pharmacy services like immunizations, prescribing for minor ailments, and point-of-care testing. It addresses some risks to the pharmacy profession from advances in technology but also outlines expanding roles for pharmacists in areas like chronic disease management and specialty practices.
Medication Errors in General Medicine wards of a tertiary care teaching Hospi...Dr. Abhimanyu Prashar
Medication errors are common in healthcare and can cause harm or death. A study identified 571 medication errors in 390 patients over 6 months at a tertiary care hospital. The most common errors were prescribing errors (71%), followed by administration errors (26%) and dispensing errors (3%). The majority of errors were caused by clinicians (49%), nurses (24%), and pharmacists (15%). Common types of errors included wrong dose, frequency, and drug omission. Most errors were classified as causing no harm. The study recommends strategies like systematic documentation, generic prescribing, treatment chart review, and drug utilization evaluation to prevent common medication errors in the hospital.
medication Adherence defined as the act of filling a new prescription for the first time.
The extent to which the patients take medications as prescribed by the prescriber.
This document discusses medication errors, which are preventable events that can cause inappropriate medication use or harm to a patient. It defines medication errors based on definitions from the American Society of Health-System Pharmacists and the National Coordinating Committee on Medication Error Reporting and Prevention. Common types of medication errors include prescribing errors, dispensing errors, administration errors, and compliance errors. The document also discusses causes of medication errors and strategies to prevent errors, including standardized ordering processes, double checks, limiting abbreviations, and use of computerized prescriber order entry systems.
Establishing a drug information centerkatta amulya
This document discusses establishing a drug information center. It begins by introducing the main functions of a drug information center which is to provide written or verbal drug-related information to healthcare professionals and the public. It then classifies drug information centers into hospital based, industry based, and community based. The document outlines the need for drug information centers by discussing their primary function of responding to drug therapy inquiries and services like drug evaluation, education, and pharmacovigilance. It also covers staffing, resources, literature databases, and concludes by emphasizing the importance of efficient drug information centers for optimal patient care.
This document provides an introduction to clinical pharmacy presented by Ian and Judith Coombes to students in Sri Lanka. In 3 sentences:
The presentation discusses the role of clinical pharmacy in improving patient care by identifying and resolving medication-related issues, outlines differences between healthcare systems in Australia and Sri Lanka, and emphasizes the need for pharmacists to adopt a patient-centered approach through effective communication and consultation to optimize drug therapy and prevent adverse events.
The document outlines the roles and functions of a Drug and Therapeutics Committee (DTC) in a hospital. The DTC advises on drug-related issues, develops drug policies, evaluates drugs for inclusion in the hospital formulary, promotes rational drug use, manages adverse drug reactions, and monitors drug safety. It is composed of physicians, pharmacists, nurses, and administrators. The DTC meets regularly to assess drug use, identify issues, and conduct interventions to improve prescribing and reduce costs while maintaining patient safety.
This document discusses adverse drug reactions, including their definition, classification, causes, and the role of nurses. It defines an adverse drug reaction as an unintended, harmful response to a medication. Reactions are classified as Type A or B, with Type A reactions being dose-dependent and Type B being unpredictable. Common causes of reactions include medication errors, biological differences between patients, and drug interactions. The document outlines how nurses can help identify, document, monitor, prevent, and report adverse drug reactions.
This document discusses pharmaceutical care, which aims to improve patient outcomes through responsible drug therapy. It defines pharmaceutical care as providing medication to achieve therapeutic outcomes that enhance quality of life. These may include curing disease, reducing symptoms, or slowing disease progression. The document outlines the basic elements of pharmaceutical care, which include being patient-oriented, addressing both acute and chronic issues, and emphasizing prevention of drug-related problems through documented care plans and collaboration with other providers. It also discusses various tools used in pharmaceutical care, such as SOAP notes, CORE pharmacotherapy plans, and FARM analyses to identify, resolve, and prevent drug-related issues.
This document discusses rational drug use and defines it as using the appropriate drug for the right patient in the proper dose and form to maximize efficacy and minimize harm. It outlines criteria for rational use and types of irrational use such as incorrect diagnosis, prescription, and dispensing. Common reasons for irrational drug use include financial incentives, easy drug availability, and lack of education. The roles of pharmacists in promoting rational drug use include educating patients, following essential drug lists, and maintaining proper stock control.
This document discusses the importance of evaluating clinical literature and provides guidance on how to systematically approach literature evaluation. It describes how to identify the level and type of reference (tertiary, secondary, primary), and provides tips for evaluating different aspects of clinical studies, such as the objective, subjects, treatment administration, setting, methods, controls, and data analysis. The document also discusses how the FDA communicates important drug safety information to healthcare professionals and the public.
The document discusses rational use of drugs and strategies to promote rational use. Rational use means using the right drug, for the right indication, at the right dose and duration, for the right patient. Irrational use can lead to ineffective treatment, adverse drug events, increased resistance, and costs. Common causes of irrational use include lack of information, diagnostic uncertainty, patient demands, and promotional activities. Strategies to promote rational use include educational programs for providers, printed materials, media campaigns, essential drug lists, structured order forms, generic substitution, and regulating promotions. Rational prescribing involves defining the problem, setting objectives, selecting strategies, writing prescriptions, and monitoring treatment.
Patient compliance describes how closely a patient follows medical advice, particularly with respect to medication, but also other treatments like device use or therapy. It is important for conditions requiring ongoing treatment, replacement therapies like insulin, or controlling diseases of public health concern. Rates of compliance are assessed through various objective and subjective methods like pill counts, health outcomes, and patient interviews. Improving compliance requires addressing barriers like cost and complex regimens through subsidization, generic drugs, and education by pharmacists and other providers.
The document discusses medication errors and strategies to address them. It notes that medication errors can occur at various stages of treatment and provides examples. Strategies to reduce errors include establishing multidisciplinary teams to develop standards, introducing punishment-free error reporting systems, and requiring legible prescriptions and patient identification verification. Adverse drug reactions are also addressed, including definitions and Nepal's pharmacovigilance program which involves regional hospital centers reporting reactions to the national regulatory agency.
Pharmacovigilance: The conscientious today for safe tomorrowpharmaindexing
This document discusses pharmacovigilance, which is the detection, assessment, understanding, and prevention of adverse drug reactions. It describes traditional pharmacovigilance methods like spontaneous reporting systems and their limitations. It also outlines new approaches to strengthen pharmacovigilance, including broadening reporter bases to include patients, using quantitative signal detection methods to analyze large reporting databases, and leveraging electronic health records and administrative databases for observational studies.
Problems and challenges faced in consumer reporting of adverse drug reactions...Mohammed Alshakka
This document discusses consumer reporting of adverse drug reactions (ADRs) in developing countries like Yemen, Nepal, and Malaysia. It finds that Malaysia has a good system for consumer involvement, while Yemen lacks drug policies and regulation. Nepal's system is still developing and lacks consumer reporting. Consumer reporting can provide additional information to national pharmacovigilance programs and help reduce ADR-related illness, but is still not widely implemented in developing countries.
HERE I INCLUDED HISTORY, RESPONSIBILITIES, TERMINOLOGY AND METHODS INVOLVED .
HOPE IT WILL BE USEFUL FOR YOU TO UNDERSTAND THE BASICS OF PHARMACOVIGILANCE.
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
Adverse drug reactions among critically ill patients at cairoAlexander Decker
The study aimed to assess the frequency and outcomes of adverse drug reactions among critically ill patients at Cairo University Hospital. The study found that 21% of the 150 critically ill patients studied experienced adverse drug reactions, ranging from mild to moderate or severe. Over half of the reactions were life-threatening. Due to the prevalence of adverse drug reactions in critically ill patients and their potential severity, the study recommends hospitals establish policies for managing adverse drug reactions and for healthcare providers to closely monitor patients and potential drug interactions when initiating new medications.
This document discusses adverse drug reactions (ADRs), including:
1) Defining ADRs and distinguishing them from adverse drug events. ADRs are unintended effects caused directly by a drug, while adverse events can have other causes.
2) Around 5-10% of hospitalized patients experience an ADR, contributing to increased costs and length of stay. ADRs can reduce quality of life and rarely cause death.
3) Pharmacovigilance aims to detect, understand, and prevent ADRs through monitoring, reporting, and research on drug safety. Pharmacists play a key role in pharmacovigilance.
1) Adverse drug reactions (ADRs) are unwanted or harmful effects experienced after taking a medication. They can range from mild to severe or lethal. Elderly patients, women, and those taking multiple medications are most at risk.
2) Common ADR symptoms include skin irritation, nausea, vomiting, diarrhea, and breathing problems. Over 80% of ADRs are type A reactions, meaning they are dose-dependent and predictable based on a drug's known pharmacology.
3) In India, ADRs are monitored and reported through the Pharmacovigilance Program of India. Healthcare providers report suspected ADRs to monitoring centers to safeguard public health and inform regulatory decisions on drug safety.
1) Adverse drug reactions (ADRs) are unwanted or harmful effects experienced after taking a medication. They can range from mild to severe or lethal. The elderly, very young, and those taking multiple medications are most at risk.
2) ADRs are classified into 6 types based on their mechanism and predictability. Type A reactions are dose-dependent and common, while Type B reactions are unpredictable.
3) Common symptoms of ADRs include skin irritation, nausea, vomiting, and breathing problems. Suspected ADRs should be reported to the National Coordinating Centre to be monitored and help ensure safe medication use in India.
pharmacovigilance from pharmaceutical administration topic presented by konatham kumar reddy from chilkur balaaji college of pharmacy hyderabad telangana
Pharmacovigilance involves monitoring the safety of drugs at all stages, from development through post-marketing. It aims to detect, understand, and prevent adverse drug reactions through activities like adverse event reporting, drug monitoring, and studying medication errors and drug-related deaths. Pharmacovigilance is important for protecting public health as patterns of drug use change over time with globalization and advances in technology and medicine.
Pharmacovigilance involves monitoring approved drugs to detect adverse effects, assess risks, prevent harm and promote safe use. It aims to improve public health by identifying unknown risks from case reports and studies. Several methods are used including spontaneous reporting, active surveillance and observational studies. Organizations like WHO and regulatory authorities play important roles in pharmacovigilance. The goal is continual assessment of benefit-risk profiles to optimize treatment outcomes.
Pharmacovigilance involves monitoring approved drugs to detect adverse effects, assess risks, and prevent harm. It aims to improve patient safety by identifying unknown risks from drugs and informing regulatory decisions. Various methods are used, including spontaneous reporting of adverse drug reactions, active surveillance, and observational studies. Stringent pharmacovigilance is important given historical examples of drugs that caused significant harm after approval, demonstrating the need for ongoing monitoring of drug safety.
Reporting Methods _ Global Pharmacovigilance1Hafsa Hafeez
This document discusses pharmacovigilance reporting methods and signal detection in the USA. It outlines several methods for reporting adverse drug reactions including passive surveillance like spontaneous reporting and case series, as well as active surveillance through sentinel sites and clinical investigations. It describes the FDA's role in pharmacovigilance including maintaining the FAERS database and evaluating safety signals. Signals are detected through data mining this database and can be validated by obtaining additional information from various sources.
The document discusses the importance of pharmacovigilance in health care. It defines pharmacovigilance as the science related to detecting, assessing, understanding, and preventing adverse effects of drugs. The main goals of pharmacovigilance are to improve patient safety, assess the risk-benefit profiles of medicines, and encourage their safe and effective use. Pharmacists can play important roles in pharmacovigilance by monitoring for and reporting adverse drug reactions. Pharmacovigilance programs in health systems should include ongoing surveillance, reporting, analysis, and education to prevent adverse drug events.
This document summarizes a talk on adverse reactions to oral contraceptives (birth control pills). It discusses how third generation oral contraceptives with modern progesterone types have a higher risk of venous thromboembolism than second generation pills. It also notes that the new progesterone drospirenone seems to increase the risk compared to older pills. While risks exist, the overall benefits of oral contraceptives in preventing pregnancy and some cancers outweigh the risks. The talk aims to examine the evidence behind controversies on health risks and discuss implications for the growing number of potential oral contraceptive users in India.
Medication therapy is becoming increasingly more complex as new drugs are developed and more therapeutic targets are elucidated. In addition, polypharmacy (≥5 scheduled medications) has become exceedingly common in geriatric patients and in patients with chronic disease states. As the complexity of drug therapy and the number of medications increase, patients are at a high risk for medication errors and adverse drug events (ADEs), or injuries resulting from medication. The type of adverse events may be associated with professional practices, healthcare products, procedures, and systems including prescription, communication through instructions, drug labeling, packaging and nomenclature, reformulation, dissolution, distribution, administration, education, monitoring, and use. Classification and evaluation of medication errors according to their importance may constitute an important factor for process improvement in order to render the administration of medicines as safe as possible. In hospitals, medication errors occur at a rate of about one per patient per day. A dispensing error is one made by pharmacy staff when distributing medications to nursing units or directly to patients in an ambulatory-care pharmacy; the error rates for doses dispensed via the cart-filling process range from 0.87% to 2.9%. Technology has grown to be a constituent part of medicine these days. A few advantages that technology can supply are categorized as follows: the assisting of communication between clinicians; enhancing medication safety; decreasing potential medical errors and adverse events; rising access to medical information and encouraging patient-centered healthcare. The aim of this article is to provide a compendious literature review regarding Medication errors
Thesis_PhD_Improving medication safety in the elderlyHA VO THI
The document discusses medication safety issues for elderly patients, noting that physiological changes with aging increase their risk of adverse drug reactions and interactions from polypharmacy. Polypharmacy, defined as using multiple medications, is common in elderly patients due to multiple chronic conditions but can increase problems with adherence and side effects. Improving medication safety for elderly patients requires addressing polypharmacy issues through individualized treatment reviews that consider life expectancy, treatment goals and targets.
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----------------------------------------------------------------------------------------------
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Plant breeding for disease resistance is a strategy to reduce crop losses caused by disease. Plants have an innate immune system that allows them to recognize pathogens and provide resistance. However, breeding for long-lasting resistance often involves combining multiple resistance genes
Deep Behavioral Phenotyping in Systems Neuroscience for Functional Atlasing a...Ana Luísa Pinho
Functional Magnetic Resonance Imaging (fMRI) provides means to characterize brain activations in response to behavior. However, cognitive neuroscience has been limited to group-level effects referring to the performance of specific tasks. To obtain the functional profile of elementary cognitive mechanisms, the combination of brain responses to many tasks is required. Yet, to date, both structural atlases and parcellation-based activations do not fully account for cognitive function and still present several limitations. Further, they do not adapt overall to individual characteristics. In this talk, I will give an account of deep-behavioral phenotyping strategies, namely data-driven methods in large task-fMRI datasets, to optimize functional brain-data collection and improve inference of effects-of-interest related to mental processes. Key to this approach is the employment of fast multi-functional paradigms rich on features that can be well parametrized and, consequently, facilitate the creation of psycho-physiological constructs to be modelled with imaging data. Particular emphasis will be given to music stimuli when studying high-order cognitive mechanisms, due to their ecological nature and quality to enable complex behavior compounded by discrete entities. I will also discuss how deep-behavioral phenotyping and individualized models applied to neuroimaging data can better account for the subject-specific organization of domain-general cognitive systems in the human brain. Finally, the accumulation of functional brain signatures brings the possibility to clarify relationships among tasks and create a univocal link between brain systems and mental functions through: (1) the development of ontologies proposing an organization of cognitive processes; and (2) brain-network taxonomies describing functional specialization. To this end, tools to improve commensurability in cognitive science are necessary, such as public repositories, ontology-based platforms and automated meta-analysis tools. I will thus discuss some brain-atlasing resources currently under development, and their applicability in cognitive as well as clinical neuroscience.
ESPP presentation to EU Waste Water Network, 4th June 2024 “EU policies driving nutrient removal and recycling
and the revised UWWTD (Urban Waste Water Treatment Directive)”
hematic appreciation test is a psychological assessment tool used to measure an individual's appreciation and understanding of specific themes or topics. This test helps to evaluate an individual's ability to connect different ideas and concepts within a given theme, as well as their overall comprehension and interpretation skills. The results of the test can provide valuable insights into an individual's cognitive abilities, creativity, and critical thinking skills
ANAMOLOUS SECONDARY GROWTH IN DICOT ROOTS.pptxRASHMI M G
Abnormal or anomalous secondary growth in plants. It defines secondary growth as an increase in plant girth due to vascular cambium or cork cambium. Anomalous secondary growth does not follow the normal pattern of a single vascular cambium producing xylem internally and phloem externally.
2. 2
Abstract
We define an adverse drug reaction as "an appreciably harmful or
unpleasant reaction, resulting from an intervention related to the
use of a medicinal product, which predicts hazard from future
administration and warrants prevention or specific treatment, or
alteration of the dosage regimen, or withdrawal of the product."
Such reactions are currently reported by use of WHO's Adverse
Reaction Terminology, which will eventually become a subset of
the International Classification of Diseases. Adverse drug
reactions are classified into six types (with mnemonics): dose-
related (Augmented), non-dose-related (Bizarre), dose-related
and time-related (Chronic), time-related (Delayed), withdrawal
(End of use), and failure of therapy (Failure). Timing, the pattern
of illness, the results of investigations, and rechallenge can help
attribute causality to a suspected adverse drug reaction.
Management includes withdrawal of the drug if possible and
specific treatment of its effects. Suspected adverse drug reactions
should be reported. Surveillance methods can detect reactions
and prove associations.
An adverse drug reaction (ADR) can be defined as ‘an appreciably
harmful or unpleasant reaction resulting from an intervention related
to the use of a medicinal product; adverse effects usually predict
hazard from future administration and warrant prevention, or specific
treatment, or alteration of the dosage regimen, or withdrawal of the
product’.Since 2012, the definition has included reactions occurring as
a result of error, misuse or abuse, and to suspected reactions to
medicines that are unlicensed or being used off-label in addition to the
authorised use of a medicinal product in normal doses. While this
change potentially alters the reporting and surveillance carried out by
manufactures and medicines regulators, in clinical practice it should
not affect our approach to managing ADRs. Seminal research
undertaken in the late 20th and early 21st
century in the USA and the
UK demonstrated that ADRs are a common manifestation in clinical
practice, including as a cause of unscheduled hospital admissions,
occurring during hospital admission and manifesting after discharge.
The incidence of ADRs has remained relatively unchanged over time,
with research suggesting that between 5% and 10% of patients may
suffer from an ADR at admission, during admission or at discharge,
despite various preventative efforts. Inevitably, the event frequency is
associated with the method used to identify such events and the
majority of ADRs do not cause serious systemic manifestations.
Nevertheless, this frequency of potential harm needs to be considered
3. 3
carefully because it has associated morbidity and mortality, can be
financially costly and has a potentially negative effect on the
prescriber-patient relationship.
Reporting of adverse drug reactions
The mainstay of detecting potential ADRs over the last half a century
has been spontaneous reporting systems such as the Yellow Card
Scheme in the UK, operated by the Medicines and Healthcare Products
Regulatory Agency (MHRA) and the Commission on Human Medicines
(CHM). The scheme wa founded in 1964 following the thalidomide
disaster in the late 1950s. Through spontaneous reporting, the scheme
collects data on suspected ADRs related to all licensed and unlicensed
medicines and vaccines, including those issued on prescription or
purchased over the counter. For a report to be valid, only four items of
information are required: an identifiable patient, a reaction, a
suspected medicinal product and an identifiable reporter. However,
reporters are encouraged to provide as much information as possible,
ie to provide additional data and clinical context for assessors. The UK
scheme continues to receive in the region of 25,000 reports per year
and provides the medicine regulators an insight into the occurrence of
ADRs. Unfortunately, underreporting remains a key challenge, with
fewer than 5% of all ADRs estimated as being reported in practice.
This limits the ability of systems to give accurate incidence data. In
2014, NHS England and the MHRA issued a joint alert: Improving
medication error incident reporting and learning . As part of this, ADRs
occurring as a result of medication errors reported to the National
Reporting and Learning System (NRLS) will automatically be reported
to the Yellow Card Scheme.
Patients are increasingly involved in their own therapeutic
management and, because an early assessment of patient Yellow Card
reporting proved the value of this approach, 16 all patients are now
actively encouraged to report ADRs. Paper reports (on the original
yellow cards) have largely been superseded by online reporting
systems or use of the Yellow Card app. Electronic health records used
in general practice and in some hospitals can also include integrated
reporting that sends data on ADRs directly to central agencies for
processing before entry into national and international databases.
4. 4
Managing adverse drug reactions
Altering a dosage regimen or withdrawing a medicine suspected of
causing an ADR are common methods of managing ADRs in practice.
However, the course taken to manage an ADR is likely to vary from
clinician to clinician. Under EU legislation, the approval of all new
medicines onto the market must now be accompanied by a robust risk
management plan from the marketing authorisation holder, which may
involve the development of specific treatments for managing specific
ADRs, as well as ongoing safety trials. Such has been the case with
antidotes for direct oral anticoagulantinduced bleeding.
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