Guidelines of ADR reporting are mentioned. Where to report? How to report? Whom to report? These are the major part of the ppt. Normal people can understand about the drug safety process.
Aris G is a leading pharmacovigilance system that enables companies to reduce safety risks for drugs, devices, vaccines and combination products. It improves case processing workflows and integrates with other systems. Vigi Flow is an ICSR management system developed by UMC that allows entry, assessment, storage and transmission of safety reports in accordance with ICH E2B standards. Both systems provide features for adverse event reporting, but Vigi Flow is web-based while Aris G can be installed locally.
Safety pharmacology is a branch of pharmacology with its aim to predict the potential clinical risk profile of new chemical entities (NCEs).
It has the ability to predict the potential off-target drug effects on major organ systems which are associated with exposure in the therapeutic range and above.
As an essential part of the spectrum of drug discovery and development, safety pharmacology studies are generally conducted to determine the relative drug effect on main organs, including respiratory system, central nervous system, and cardiovascular system.Safety pharmacology is an essential part of the drug development process that aims to identify and predict adverse effects prior to clinical trials.
SP studies are described in the international conference on harmonization (ICH) S7A and S7B Guidelines.
The document discusses the Investigational New Drug (IND) application process with the FDA. An IND application allows a company to ship an experimental drug across state lines and begin clinical trials. It must include preclinical data to show the drug is safe for initial human use as well as protocols for proposed studies. The FDA reviews the IND for 30 days before clinical trials may begin to ensure subject safety. The overall goal of an IND is to facilitate testing of new drugs while protecting clinical trial participants.
This document discusses the requirements for an investigational new drug (IND) application. An IND is required to initiate clinical trials of an unapproved drug and must contain information on animal studies, manufacturing, and clinical trial protocols. The core battery of safety pharmacology studies evaluates effects on major organ systems like the cardiovascular, central nervous, and respiratory systems. These studies are designed to identify potential adverse effects and safety risks before human clinical trials.
Free radicals are highly reactive molecules that can damage cells. The field of free radical pharmacology studies how free radicals influence health and disease, and how antioxidants may help reduce oxidative stress. Research suggests free radicals play a role in aging and diseases like cancer, while antioxidants in fruits and vegetables may help counter the effects of free radicals in the body.
Aris G is a leading pharmacovigilance system that enables companies to reduce safety risks for drugs, devices, vaccines and combination products. It improves case processing workflows and integrates with other systems. Vigi Flow is an ICSR management system developed by UMC that allows entry, assessment, storage and transmission of safety reports in accordance with ICH E2B standards. Both systems provide features for adverse event reporting, but Vigi Flow is web-based while Aris G can be installed locally.
Safety pharmacology is a branch of pharmacology with its aim to predict the potential clinical risk profile of new chemical entities (NCEs).
It has the ability to predict the potential off-target drug effects on major organ systems which are associated with exposure in the therapeutic range and above.
As an essential part of the spectrum of drug discovery and development, safety pharmacology studies are generally conducted to determine the relative drug effect on main organs, including respiratory system, central nervous system, and cardiovascular system.Safety pharmacology is an essential part of the drug development process that aims to identify and predict adverse effects prior to clinical trials.
SP studies are described in the international conference on harmonization (ICH) S7A and S7B Guidelines.
The document discusses the Investigational New Drug (IND) application process with the FDA. An IND application allows a company to ship an experimental drug across state lines and begin clinical trials. It must include preclinical data to show the drug is safe for initial human use as well as protocols for proposed studies. The FDA reviews the IND for 30 days before clinical trials may begin to ensure subject safety. The overall goal of an IND is to facilitate testing of new drugs while protecting clinical trial participants.
This document discusses the requirements for an investigational new drug (IND) application. An IND is required to initiate clinical trials of an unapproved drug and must contain information on animal studies, manufacturing, and clinical trial protocols. The core battery of safety pharmacology studies evaluates effects on major organ systems like the cardiovascular, central nervous, and respiratory systems. These studies are designed to identify potential adverse effects and safety risks before human clinical trials.
Free radicals are highly reactive molecules that can damage cells. The field of free radical pharmacology studies how free radicals influence health and disease, and how antioxidants may help reduce oxidative stress. Research suggests free radicals play a role in aging and diseases like cancer, while antioxidants in fruits and vegetables may help counter the effects of free radicals in the body.
Roles and Responsibilities in Clinical Trials of Investigator, Study Coordinator, Sponsor, Monitor, a Contract research organization.
The clinical trial, definition, description, Different types of clinical trials, phases of clinical trial.
The clinical trial study team.
Requirements of the clinical trial study team.
Clinical research team role.
GCP- Good clinical practices.
This document provides guidelines for safety pharmacology studies for human pharmaceuticals from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidelines discuss the objectives, scope, general principles, test systems, experimental design, dose levels/concentrations, duration of studies, and studies on metabolites for safety pharmacology evaluations. The goal is to help protect clinical trial participants and patients by identifying potential adverse effects of pharmaceuticals early in development.
INTERNATIONAL NON PROPRIETARY NAMES FOR DRUGS1.pptxE Poovarasan
International Nonproprietary Names (INNs) provide a unique name for each pharmaceutical substance to aid clear identification and safe use worldwide. The WHO manages the INN system, selecting names through a process involving proposed names, an objection period, and final recommended INNs. INNs aim to identify substances uniquely while avoiding names that could cause confusion or be proprietary. Principles for selection include being distinctive, concise, and avoiding confusion with other names. Stem elements are often used to group related substances.
This document provides guidelines for reporting adverse drug reactions (ADRs). It outlines the essential information to include in an ADR report under five sections: (1) patient information including demographics, medical history, and test results; (2) suspected drugs and their details; (3) suspected ADR description, treatment, outcomes, and seriousness; (4) other medications; and (5) reporter information. For a valid report, the mandatory fields that must be included are patient initials, age, gender, reaction details, suspected drug name and dosage, seriousness, and outcomes as well as the reporter's name and date of reporting. Complete information is ideal but at minimum the mandatory fields should be reported.
This document outlines the requirements for toxicological studies as specified in Schedule Y of the Drugs and Cosmetics Act of India. It discusses the various medical organizations involved in clinical research regulation and drug development in India. It then describes the key aspects of Schedule Y, including the appendices that cover requirements for non-clinical animal toxicity studies. The appendices specify the types of studies needed, such as single dose toxicity studies, repeated dose toxicity studies, reproductive toxicity studies, and carcinogenicity studies, along with the testing parameters and number of animals required for each.
Role of nuclicacid microarray &protein micro array for drug discovery processmohamed abusalih
role of nuclic acid microarray and protein microarray for drug discovery process
1.introduction about microarray technique and genomics
2.process of drug discovery
3.microarray techiques
4.microarray analysis in drug discovery
5.steps involved in the micro array analysis
Reproductive toxicology studies ACCORDING TO OECD guidlines 422 SONALPANDE5
Reproductive toxicity studies are conducted according to OECD Guideline 422 to evaluate effects on fertility and development. The study involves administering graduated doses of a test chemical to male and female rats for at least 4 weeks prior to mating. Males continue dosing until sacrifice, while females are dosed throughout mating, pregnancy, and lactation until sacrifice on postnatal day 13. Offspring are observed for signs of toxicity. Clinical observations and pathology examinations are conducted to identify any reproductive or developmental effects.
TOXICOKINETICS EVALUATION IN PRECLINICAL STUDIES.pptxAnmolkanda06
This document discusses toxicokinetics evaluation and saturation kinetics in preclinical studies. It defines toxicokinetics and its primary and secondary objectives in preclinical testing according to ICH guidelines. It outlines the general principles and types of toxicokinetic studies conducted at different stages of preclinical development, including safety assessment studies, single/rising dose studies, repeated dose toxicity studies, genotoxicity studies, reproduction toxicity studies, and carcinogenicity studies. It also discusses saturation kinetics, how non-linear pharmacokinetics can occur due to saturation of absorption, distribution, metabolism or excretion processes, and how non-linearity is detected.
IND (Investigational New Drug) industrial perspectiveAYESHA NAZEER
Describing the Industry's/sponsor's/drug manufacturers' perspective of the Investigational New Drug Application (IND) program based on the survey conducted by the Office Of Inspector General (OIG).
This presentation provides a knowledge about Safety Pharmacology, It's aim & objectives, issues, consideration in selection and design of study and test study, duration of study, various studies involved in safety pharmacology, its guidelines, preclinical safety pharmacology. An assignment for the subject, Clinical Research and Pharmacovigilance, 1st year M.Pharm, 2nd semester.
Regulatory guidelines for conducting toxicity studies by ichAnimatedWorld
The document outlines regulatory guidelines for conducting toxicity studies established by the International Council on Harmonization (ICH). ICH provides guidelines on quality, safety, and efficacy for pharmaceutical registration. The safety guidelines cover areas like carcinogenicity studies, genotoxicity testing, toxicokinetics, duration of chronic toxicity testing, reproductive toxicity testing, immunotoxicity studies, phototoxicity evaluation, and nonclinical safety testing to support pediatric medicine development. Expert working groups establish the guidelines to ensure a consistent approach to nonclinical safety assessment is applied across regions.
A brief introduction about Pharmacology of free radicals, generation of free radicals, Antioxidants, Free radicals causing disorders such as cancer diabetes, neuro degenerative disorders such as Parkisonism's Disease
Alternative methods to animals testing are the development and implementation of test method that avoid use of live animals or use of less animals in method.
The council directive on protection of animals used for experiments and scientific purpose in article 23
“The commission and member states should encourage
research into development and validation of alternative methods which could provide the same level of information as that obtained in experiment using animals but which involves less animal”.
Alternative methods able to do:
Reduce Refine Replace
collectively called as “The 3Rs Principle”.
Needs for alternative methods
Because in laboratory animals may be:
Poisoned.
Deprived of food water and sleep.
Applied with skin and eye irritants.
Subjected to psychological stress.
Deliberately infected with the infected disease.
Regulatory terminology of ADR and Establishing pharmacovigilance center's i...SIRAJUDDIN MOLLA
This document defines various regulatory terminology used in pharmacovigilance and adverse drug reaction reporting. It defines terms related to side effects like adverse events, serious adverse events, adverse drug reactions, and others. It also defines drug safety terms like causal relationship, important medical events, and temporal relationship. Further, it defines risk terminology like identified risks, potential risks, important risks, and missing information. Finally, it defines general pharmacovigilance terms like company core data sheet and company core safety information. The document provides clear definitions for specialized terminology to establish a common understanding in the field of pharmacovigilance.
ROLES AND RESPONSIBLITIES OF CLINICAL TRIAL PERSONNEL-INVESTIGATOR.pptxE Poovarasan
This document outlines the roles and responsibilities of key personnel in clinical trials, including the investigator, study coordinator, and other members of the research team. It describes that the investigator is responsible for conducting the trial according to the protocol and protecting participants. The study coordinator works under the investigator and is responsible for coordinating study visits, obtaining consent, and ensuring compliance. Other duties of the research team include reporting adverse events, maintaining proper records, and following Good Clinical Practice standards.
The document describes the hERG assay, which is used to test for potential drug-induced prolongation of the QT interval. It discusses the hERG gene and potassium channel, how mutations can cause long QT syndrome. It then summarizes three methods for conducting the hERG assay: electrophysiological assay using whole-cell patch clamping, Fluorometric imaging plate reader-based thallium flux assay, and radioligand binding with 35S-MK-499. Details are provided on cell preparation and protocol for each type of hERG assay.
Origin and principles of international conference on harmonization- Good clin...AbhishekJoshi312
The ppt gives a basic information about ICH-GCP, how it originated , what led to the formation of ICH-GCP guidelines and what are the principles of the guidelines.
This document provides information about reproductive toxicology studies. It discusses that reproductive toxicology refers to alterations that affect the reproductive system in males and females. The document outlines the three segments of reproductive toxicology studies - effects on fertility in males and non-pregnant females, developmental toxicity in pregnant or lactating females, and prenatal and post-natal studies assessing fertility and early embryonic development. It provides examples of study designs and parameters assessed in reproductive toxicology studies, including dosing, observation of parental animals and offspring, and histopathological examination.
1) All health care professionals and pharmaceutical companies can report any suspected adverse drug reactions (ADRs), regardless of severity, to the nearest ADR monitoring center.
2) The ADR reporting process involves reporting to peripheral centers, then regional, zonal, and finally the national coordinating center (NPC) and Central Drugs Standard Control Organization (CDSCO). International reporting also occurs to the WHO Uppsala Monitoring Centre (WHO-UMC).
3) Complete information is required for ADR reporting, including patient information, a description of the adverse reaction, details on the suspected drug, management of the reaction, and reporter information.
The thalidomide tragedy of the late 1950s demonstrated the importance of pharmacovigilance. Pharmacovigilance is the monitoring of medications post-marketing to identify adverse drug reactions. It aims to improve patient safety and assess medication risks and benefits. The thalidomide birth defects showed that not all adverse effects are found in clinical trials. Healthcare professionals and patients can report any serious or non-serious adverse reactions to their nearest monitoring center. Reported reactions are analyzed for new safety signals and to continuously evaluate medications' risk-benefit profiles. Ongoing pharmacovigilance is important for patient safety and optimal drug use.
Roles and Responsibilities in Clinical Trials of Investigator, Study Coordinator, Sponsor, Monitor, a Contract research organization.
The clinical trial, definition, description, Different types of clinical trials, phases of clinical trial.
The clinical trial study team.
Requirements of the clinical trial study team.
Clinical research team role.
GCP- Good clinical practices.
This document provides guidelines for safety pharmacology studies for human pharmaceuticals from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidelines discuss the objectives, scope, general principles, test systems, experimental design, dose levels/concentrations, duration of studies, and studies on metabolites for safety pharmacology evaluations. The goal is to help protect clinical trial participants and patients by identifying potential adverse effects of pharmaceuticals early in development.
INTERNATIONAL NON PROPRIETARY NAMES FOR DRUGS1.pptxE Poovarasan
International Nonproprietary Names (INNs) provide a unique name for each pharmaceutical substance to aid clear identification and safe use worldwide. The WHO manages the INN system, selecting names through a process involving proposed names, an objection period, and final recommended INNs. INNs aim to identify substances uniquely while avoiding names that could cause confusion or be proprietary. Principles for selection include being distinctive, concise, and avoiding confusion with other names. Stem elements are often used to group related substances.
This document provides guidelines for reporting adverse drug reactions (ADRs). It outlines the essential information to include in an ADR report under five sections: (1) patient information including demographics, medical history, and test results; (2) suspected drugs and their details; (3) suspected ADR description, treatment, outcomes, and seriousness; (4) other medications; and (5) reporter information. For a valid report, the mandatory fields that must be included are patient initials, age, gender, reaction details, suspected drug name and dosage, seriousness, and outcomes as well as the reporter's name and date of reporting. Complete information is ideal but at minimum the mandatory fields should be reported.
This document outlines the requirements for toxicological studies as specified in Schedule Y of the Drugs and Cosmetics Act of India. It discusses the various medical organizations involved in clinical research regulation and drug development in India. It then describes the key aspects of Schedule Y, including the appendices that cover requirements for non-clinical animal toxicity studies. The appendices specify the types of studies needed, such as single dose toxicity studies, repeated dose toxicity studies, reproductive toxicity studies, and carcinogenicity studies, along with the testing parameters and number of animals required for each.
Role of nuclicacid microarray &protein micro array for drug discovery processmohamed abusalih
role of nuclic acid microarray and protein microarray for drug discovery process
1.introduction about microarray technique and genomics
2.process of drug discovery
3.microarray techiques
4.microarray analysis in drug discovery
5.steps involved in the micro array analysis
Reproductive toxicology studies ACCORDING TO OECD guidlines 422 SONALPANDE5
Reproductive toxicity studies are conducted according to OECD Guideline 422 to evaluate effects on fertility and development. The study involves administering graduated doses of a test chemical to male and female rats for at least 4 weeks prior to mating. Males continue dosing until sacrifice, while females are dosed throughout mating, pregnancy, and lactation until sacrifice on postnatal day 13. Offspring are observed for signs of toxicity. Clinical observations and pathology examinations are conducted to identify any reproductive or developmental effects.
TOXICOKINETICS EVALUATION IN PRECLINICAL STUDIES.pptxAnmolkanda06
This document discusses toxicokinetics evaluation and saturation kinetics in preclinical studies. It defines toxicokinetics and its primary and secondary objectives in preclinical testing according to ICH guidelines. It outlines the general principles and types of toxicokinetic studies conducted at different stages of preclinical development, including safety assessment studies, single/rising dose studies, repeated dose toxicity studies, genotoxicity studies, reproduction toxicity studies, and carcinogenicity studies. It also discusses saturation kinetics, how non-linear pharmacokinetics can occur due to saturation of absorption, distribution, metabolism or excretion processes, and how non-linearity is detected.
IND (Investigational New Drug) industrial perspectiveAYESHA NAZEER
Describing the Industry's/sponsor's/drug manufacturers' perspective of the Investigational New Drug Application (IND) program based on the survey conducted by the Office Of Inspector General (OIG).
This presentation provides a knowledge about Safety Pharmacology, It's aim & objectives, issues, consideration in selection and design of study and test study, duration of study, various studies involved in safety pharmacology, its guidelines, preclinical safety pharmacology. An assignment for the subject, Clinical Research and Pharmacovigilance, 1st year M.Pharm, 2nd semester.
Regulatory guidelines for conducting toxicity studies by ichAnimatedWorld
The document outlines regulatory guidelines for conducting toxicity studies established by the International Council on Harmonization (ICH). ICH provides guidelines on quality, safety, and efficacy for pharmaceutical registration. The safety guidelines cover areas like carcinogenicity studies, genotoxicity testing, toxicokinetics, duration of chronic toxicity testing, reproductive toxicity testing, immunotoxicity studies, phototoxicity evaluation, and nonclinical safety testing to support pediatric medicine development. Expert working groups establish the guidelines to ensure a consistent approach to nonclinical safety assessment is applied across regions.
A brief introduction about Pharmacology of free radicals, generation of free radicals, Antioxidants, Free radicals causing disorders such as cancer diabetes, neuro degenerative disorders such as Parkisonism's Disease
Alternative methods to animals testing are the development and implementation of test method that avoid use of live animals or use of less animals in method.
The council directive on protection of animals used for experiments and scientific purpose in article 23
“The commission and member states should encourage
research into development and validation of alternative methods which could provide the same level of information as that obtained in experiment using animals but which involves less animal”.
Alternative methods able to do:
Reduce Refine Replace
collectively called as “The 3Rs Principle”.
Needs for alternative methods
Because in laboratory animals may be:
Poisoned.
Deprived of food water and sleep.
Applied with skin and eye irritants.
Subjected to psychological stress.
Deliberately infected with the infected disease.
Regulatory terminology of ADR and Establishing pharmacovigilance center's i...SIRAJUDDIN MOLLA
This document defines various regulatory terminology used in pharmacovigilance and adverse drug reaction reporting. It defines terms related to side effects like adverse events, serious adverse events, adverse drug reactions, and others. It also defines drug safety terms like causal relationship, important medical events, and temporal relationship. Further, it defines risk terminology like identified risks, potential risks, important risks, and missing information. Finally, it defines general pharmacovigilance terms like company core data sheet and company core safety information. The document provides clear definitions for specialized terminology to establish a common understanding in the field of pharmacovigilance.
ROLES AND RESPONSIBLITIES OF CLINICAL TRIAL PERSONNEL-INVESTIGATOR.pptxE Poovarasan
This document outlines the roles and responsibilities of key personnel in clinical trials, including the investigator, study coordinator, and other members of the research team. It describes that the investigator is responsible for conducting the trial according to the protocol and protecting participants. The study coordinator works under the investigator and is responsible for coordinating study visits, obtaining consent, and ensuring compliance. Other duties of the research team include reporting adverse events, maintaining proper records, and following Good Clinical Practice standards.
The document describes the hERG assay, which is used to test for potential drug-induced prolongation of the QT interval. It discusses the hERG gene and potassium channel, how mutations can cause long QT syndrome. It then summarizes three methods for conducting the hERG assay: electrophysiological assay using whole-cell patch clamping, Fluorometric imaging plate reader-based thallium flux assay, and radioligand binding with 35S-MK-499. Details are provided on cell preparation and protocol for each type of hERG assay.
Origin and principles of international conference on harmonization- Good clin...AbhishekJoshi312
The ppt gives a basic information about ICH-GCP, how it originated , what led to the formation of ICH-GCP guidelines and what are the principles of the guidelines.
This document provides information about reproductive toxicology studies. It discusses that reproductive toxicology refers to alterations that affect the reproductive system in males and females. The document outlines the three segments of reproductive toxicology studies - effects on fertility in males and non-pregnant females, developmental toxicity in pregnant or lactating females, and prenatal and post-natal studies assessing fertility and early embryonic development. It provides examples of study designs and parameters assessed in reproductive toxicology studies, including dosing, observation of parental animals and offspring, and histopathological examination.
1) All health care professionals and pharmaceutical companies can report any suspected adverse drug reactions (ADRs), regardless of severity, to the nearest ADR monitoring center.
2) The ADR reporting process involves reporting to peripheral centers, then regional, zonal, and finally the national coordinating center (NPC) and Central Drugs Standard Control Organization (CDSCO). International reporting also occurs to the WHO Uppsala Monitoring Centre (WHO-UMC).
3) Complete information is required for ADR reporting, including patient information, a description of the adverse reaction, details on the suspected drug, management of the reaction, and reporter information.
The thalidomide tragedy of the late 1950s demonstrated the importance of pharmacovigilance. Pharmacovigilance is the monitoring of medications post-marketing to identify adverse drug reactions. It aims to improve patient safety and assess medication risks and benefits. The thalidomide birth defects showed that not all adverse effects are found in clinical trials. Healthcare professionals and patients can report any serious or non-serious adverse reactions to their nearest monitoring center. Reported reactions are analyzed for new safety signals and to continuously evaluate medications' risk-benefit profiles. Ongoing pharmacovigilance is important for patient safety and optimal drug use.
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.
lecture presented at 3rd. March 2024 about the Iraqi pharmacovigilance system as part of the newly appointed pharmacist training course (2024),
Update was performed depending on the latest version of the (Iraqi Pharmacovigilance Guidelines for Healthcare Professionals) 2024
This document discusses adverse drug reaction (ADR) reporting, including the objectives, benefits, procedures, and tools available for ADR reporting in India. It defines an ADR and explains that anyone can report suspected ADRs using standardized forms submitted to the National Coordinating Centre or nearest ADR Monitoring Center. Several forms and an Android app are available for reporting. The Vigiflow database is also introduced as a free web-based tool for managing individual case safety reports.
Side effects of drugs products, medical devices & drugs healthcare data...PEPGRA Healthcare
Rapid growth in the use of medical devices in health-care sectors has been enabled by technological advancements. Prescription drugs and medical devices can come with dangerous side effects and complications. A side effect will become severe, so it is essential to contact your doctor or pharmacy specialist if you face ant difficulties. In this blog, Pepgra lists the reporting of side effects and its necessities.
Read More: http://bit.ly/3j0wisP
Contact Us:
Website : https://bit.ly/33Fwsye
Email us: sales.cro@pepgra.com
Whatsapp: +91 9884350006
The document discusses spontaneous reporting systems for adverse drug reactions (ADRs). It describes how healthcare professionals voluntarily submit case reports of suspected ADRs to national pharmacovigilance centers. The primary aim is to detect unknown serious ADRs. It provides details on the UK's Yellow Card scheme where reports are submitted to the Medicines and Healthcare Products Regulatory Agency and analyzed to identify safety signals and update drug information. Guidelines for ADR reporting include providing patient details, suspected drugs, reaction description, and reporter information. Underreporting remains a limitation but analysis of reports helps improve drug safety.
HERE I INCLUDED HISTORY, RESPONSIBILITIES, TERMINOLOGY AND METHODS INVOLVED .
HOPE IT WILL BE USEFUL FOR YOU TO UNDERSTAND THE BASICS OF PHARMACOVIGILANCE.
The document provides information about the legal requirements for establishing a pharmacy or drug store in Bangladesh. It discusses the qualifications needed, minimum space requirements, and license requirements. A pharmacy must be run under the supervision of a registered pharmacist with a pharmacy degree. The license needs to be renewed every 5 years and should be prominently displayed. Adverse drug reactions are also discussed, including monitoring, reporting, types, and predisposing factors. Underreporting of ADRs is common due to various reasons like lack of time or knowledge of reporting procedures.
ADR Reporting Exercises for Undergraduate studentsPharmacolvigilance practs.pptxSURAJ PANCHAL
This document discusses adverse drug reactions (ADRs), including defining ADRs, differentiating them from adverse drug events, classifying types and severity of ADRs. It describes pharmacovigilance programs and processes for detecting, reporting, and assessing ADRs using tools like Naranjo's algorithm or WHO causality categories. The importance of ADR reporting to national and international centers is explained to help prevent future occurrences.
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
AN OVERVIEW AND IMPORTANCE OF PHARMACOVIGILANCERamakrishna K
An introduction to pharmacovigilance, basic types like active pharmacovigilance and passive pharmacovigilance, purpose, adverse event reporting, data processing, causality, assessement, signal detection, risk management plans and analysis
ADVERSE DRUG REACTION | PHARMACY PRACTICE | PDF | SHIVAM DUBEY B PHARMA | PHA...MrHotmaster1
PHARMACY PRACTICE
SHIVAM DUBEY
BPYN1PY18041
ADVERSE DRUG REACTION Abstract
We define an adverse drug reaction as "an appreciably harmful or
unpleasant reaction
Feeding plate for a newborn with Cleft Palate.pptxSatvikaPrasad
A feeding plate is a prosthetic device used for newborns with a cleft palate to assist in feeding and improve nutrition intake. From a prosthodontic perspective, this plate acts as a barrier between the oral and nasal cavities, facilitating effective sucking and swallowing by providing a more normal anatomical structure. It helps to prevent milk from entering the nasal passage, thereby reducing the risk of aspiration and enhancing the infant's ability to feed efficiently. The feeding plate also aids in the development of the oral muscles and can contribute to better growth and weight gain. Its custom fabrication and proper fitting by a prosthodontist are crucial for ensuring comfort and functionality, as well as for minimizing potential complications. Early intervention with a feeding plate can significantly improve the quality of life for both the infant and the parents.
The best massage spa Ajman is Chandrima Spa Ajman, which was founded in 2023 and is exclusively for men 24 hours a day. As of right now, our parent firm has been providing massage services to over 50,000+ clients in Ajman for the past 10 years. It has about 8+ branches. This demonstrates that Chandrima Spa Ajman is among the most reasonably priced spas in Ajman and the ideal place to unwind and rejuvenate. We provide a wide range of Spa massage treatments, including Indian, Pakistani, Kerala, Malayali, and body-to-body massages. Numerous massage techniques are available, including deep tissue, Swedish, Thai, Russian, and hot stone massages. Our massage therapists produce genuinely unique treatments that generate a revitalized sense of inner serenely by fusing modern techniques, the cleanest natural substances, and traditional holistic therapists.
Healthy Eating Habits:
Understanding Nutrition Labels: Teaches how to read and interpret food labels, focusing on serving sizes, calorie intake, and nutrients to limit or include.
Tips for Healthy Eating: Offers practical advice such as incorporating a variety of foods, practicing moderation, staying hydrated, and eating mindfully.
Benefits of Regular Exercise:
Physical Benefits: Discusses how exercise aids in weight management, muscle and bone health, cardiovascular health, and flexibility.
Mental Benefits: Explains the psychological advantages, including stress reduction, improved mood, and better sleep.
Tips for Staying Active:
Encourages consistency, variety in exercises, setting realistic goals, and finding enjoyable activities to maintain motivation.
Maintaining a Balanced Lifestyle:
Integrating Nutrition and Exercise: Suggests meal planning and incorporating physical activity into daily routines.
Monitoring Progress: Recommends tracking food intake and exercise, regular health check-ups, and provides tips for achieving balance, such as getting sufficient sleep, managing stress, and staying socially active.
International Cancer Survivors Day is celebrated during June, placing the spotlight not only on cancer survivors, but also their caregivers.
CANSA has compiled a list of tips and guidelines of support:
https://cansa.org.za/who-cares-for-cancer-patients-caregivers/
Chandrima Spa Ajman is one of the leading Massage Center in Ajman, which is open 24 hours exclusively for men. Being one of the most affordable Spa in Ajman, we offer Body to Body massage, Kerala Massage, Malayali Massage, Indian Massage, Pakistani Massage Russian massage, Thai massage, Swedish massage, Hot Stone Massage, Deep Tissue Massage, and many more. Indulge in the ultimate massage experience and book your appointment today. We are confident that you will leave our Massage spa feeling refreshed, rejuvenated, and ready to take on the world.
Visit : https://massagespaajman.com/
Call : 052 987 1315
MBC Support Group for Black Women – Insights in Genetic Testing.pdfbkling
Christina Spears, breast cancer genetic counselor at the Ohio State University Comprehensive Cancer Center, joined us for the MBC Support Group for Black Women to discuss the importance of genetic testing in communities of color and answer pressing questions.
Under Pressure : Kenneth Kruk's StrategyKenneth Kruk
Kenneth Kruk's story of transforming challenges into opportunities by leading successful medical record transitions and bridging scientific knowledge gaps during COVID-19.
Empowering ACOs: Leveraging Quality Management Tools for MIPS and BeyondHealth Catalyst
Join us as we delve into the crucial realm of quality reporting for MSSP (Medicare Shared Savings Program) Accountable Care Organizations (ACOs).
In this session, we will explore how a robust quality management solution can empower your organization to meet regulatory requirements and improve processes for MIPS reporting and internal quality programs. Learn how our MeasureAble application enables compliance and fosters continuous improvement.
Unlocking the Secrets to Safe Patient Handling.pdfLift Ability
Furthermore, the time constraints and workload in healthcare settings can make it challenging for caregivers to prioritise safe patient handling Australia practices, leading to shortcuts and increased risks.
LGBTQ+ Adults: Unique Opportunities and Inclusive Approaches to CareVITASAuthor
This webinar helps clinicians understand the unique healthcare needs of the LGBTQ+ community, primarily in relation to end-of-life care. Topics include social and cultural background and challenges, healthcare disparities, advanced care planning, and strategies for reaching the community and improving quality of care.
Rate Controlled Drug Delivery Systems, Activation Modulated Drug Delivery Systems, Mechanically activated, pH activated, Enzyme activated, Osmotic activated Drug Delivery Systems, Feedback regulated Drug Delivery Systems systems are discussed here.
Can Allopathy and Homeopathy Be Used Together in India.pdfDharma Homoeopathy
This article explores the potential for combining allopathy and homeopathy in India, examining the benefits, challenges, and the emerging field of integrative medicine.
Dr. David Greene R3 stem cell Breakthroughs: Stem Cell Therapy in CardiologyR3 Stem Cell
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TEST BANK For Accounting Information Systems, 3rd Edition by Vernon Richardson, Verified Chapters 1 - 18, Complete Newest Version
TEST BANK For Accounting Information Systems, 3rd Edition by Vernon Richardson, Verified Chapters 1 - 18, Complete Newest Version
TEST BANK For Accounting Information Systems, 3rd Edition by Vernon Richardson, Verified Chapters 1 - 18, Complete Newest Version
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Guidelines For ADR Reporting.pptx
1. Guidelines For ADR Reporting
Submitted by- Soham Chakrabarti.
Reg. No.- PGD/2021/3487
M. Pharm (Pharmacology)
Email- drxsohamchakrabarti@gmail.com
2. ADR
Any noxious change which is suspected to be due to a drug, occurs at doses normally
used in human, requires treatment or decrease in dose or indicates caution in future
use of the same drug.
3. Adverse Event (AE)
Adverse Event (AE): Any untoward medical occurrence that may present
during treatment with a pharmaceutical product but which does not
necessarily have a causal relationship with this treatment.
Therefore, an adverse drug reaction is an adverse event with a causal link
to a drug.
4. Classification of ADRs
Depending upon…
Onset of event: Acute(<60 mins), Sub-acute(1-24 hrs.), Latent(>2 days)
Type of reaction: Type A (Augmented), B (Bizarre), C (Chemical),D
(Delayed), E (Exit),
Severity: Minor, Moderate, Severe, Lethal ADRs
Others: Side effects, Secondary effects, Toxic effects, Intolerance,
Idiosyncrasy, Drug allergy, Photosensitivity, Drug Dependence, Drug
Withdrawal Reactions, Teratogenicity, Mutagenicity, Carcinogenicity, Drug
induced disease (Iatrogenic)
5. Type A (Augmented) reaction
Reactions which can be predicted from the known pharmacology
of the drug
Dose dependent
Can be alleviated by a dose reduction
E.g.
Anticoagulants Bleeding
Beta blockers Bradycardia
Nitrates Headache
Prazosin Postural hypotension
6. Type B (Bizarre) reaction
Cannot be predicted from the pharmacology of the drug
Not dose dependent
Host dependent factors important in predisposition
E.g.
Penicillin Anaphylaxis
Anticonvulsant Hypersensitivity
7. Type C (Chemical) reaction
Biological characteristics can be predicted from the chemical
structure of the drug/metabolite
E.g.
Paracetamol Hepatotoxicity
8. Type D (Delay) reaction
Occur after many years of treatment.
Can be due to accumulation.
E.g.
Chemotherapy Secondary tumours
Phenytoin during pregnancy Teratogenic effects
Antipsychotics Tardive dyskinesia
Analgesics Nephropathy
9. Type E (Exit) reaction
Occur on withdrawal especially when drug is stopped abruptly
E. g.
Phenytoin withdrawal Seizures,
Steroid withdrawal Adrenocortical insufficiency.
10. What to Report
All types of suspected ADRs reporting whether they
are known, unknown, serious, or nonserious, frequent,
or rare regardless of an established causal relationship
between a drug and the reaction.
ADRs related with the use of allopathic medicines
vaccines, traditional medicines, medical devices,
contrast media, etc., can be reported.
11. Where to Report
All healthcare professionals (clinicians, dentists, pharmacists, nurses) and
patient/consumers can report ADRs to NCC or AMCs. The pharmaceutical
companies can also send individual case safety reports for their product
to NCC.
Duly filled Suspected Adverse Drug Reaction Reporting Form can be
send to the nearest Adverse Drug Reaction Monitoring Centre (AMC)
or directly to the National Coordination Centre (NCC).
Or can directly mail this filled form to pvpi@ipcindia.net or
pvpi.ipcindia@gmail.com
A list of nationwide AMCs is available at: http://www.ipc.gov.in,
http://www.ipc.gov.in/PvPI/pv_home.html
12. Where to Report
Patient/ consumer can directly approach to FDA for post approval drug
disturbance.
Use one of the methods below to submit voluntary adverse event
reports to the FDA:
Report Online
Consumer Reporting Form FDA 3500B. Follow the instructions
on the form to either fax or mail it in for submission.
Call FDA at 1-800-FDA-1088 to report by telephone
Reporting Form FDA 3500 commonly used by health
professionals.
13. How to report
Suspected ADR reporting forms for healthcare professionals
and consumers are available on the website of IPC to report
ADR.
To remove language barrier in ADR reporting, the consumer
reporting form are made available in 10 vernacular languages
(Hindi, Tamil, Telugu, Kannada, Bengali, Gujarati, Assamese,
Marathi, Oriya, and Malayalam).
14.
15. Post reporting work
A reporter can send filled ADR reporting form directly to NCC or
their nearest AMC. In case of AMC, these reports are confirmed
by healthcare professionals and entered into Vigiflow and sent
to NCC for further assessment. These reports are then finally
reviewed at NCC and committed to WHO-Uppsala Monitoring
Centre. The obtained information is entered in the drug safety
database, analyzed, and assessed by the experts to identify new
signals.
The submitted ADR report does not have any legal implication
on the reporters. The patients’ identity are held in strict
confidence and protected to the fullest extent.
Therefore, healthcare providers are encouraged to report ADRs
for better understanding of the risk associated with the use of
medicines and to safeguard the health of patients.
16. LIST OF DRUGS PROHIBITED FOR MANUFACTURE AND SALE THROUGH
GAZETTE NOTIFICATIONS UNDER SECTION 26A OF DRUGS & COSMETICS
ACT 1940 BY THE MINISTRY OF HEALTH AND FAMILY WELFARE WITH THEIR
PRESENT STATUS AS ON 22.11.2021.
Fixed dose combinations of Corticosteroids with any other
drug [excluding Fixed Dose Combination of Tamsulosin HCl
0.4mg (as film coated modified release tablet) + Deflazacort
30mg in hard gelatin capsule] for internal use except for
preparations meant for meter dose inhalers and dry powder
inhalers. (7/4/21)
Hydrochlorothiazide + Ramipril +Losartan Potassium(11/1/19)