PHARMACOVIGILANCE_SLIDE. Insight to pharmacovigilance, covering basics and various aspects, case processing types of ADR, basic terminologies adr reporting dverse vent, types of adr, meddrapptx
Insight to pharmacovigilance,
covering basics and various aspects, case processing types of ADR, basic terminologies
adr reporting dverse vent, types of adr, meddra
WHO AND PHARMACOVIGILANCE (Clinical Research & Pharmacovigilance.pptxDureshahwar khan
This presentation includes introduction to WHO International Drug Monitoring Program & its functions, Role of WHO in PV, Vigibase, regulatory terminology of ADR and evaluation of medication safety.
Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. WHO established its Programme for International Drug Monitoring in response to the thalidomide disaster detected in 1961. Together with the WHO Collaborating Centre for International Drug Monitoring, Uppsala, WHO promotes PV at the country level. At the end of 2010, 134 countries were part of the WHO PV Programme. The aims of PV are to enhance patient care and patient safety in relation to the use of medicines; and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.
Pharmacovigilance & Adverse drug reactionRahul Bhati
This document discusses pharmacovigilance and adverse drug reactions (ADRs). It begins by defining pharmacovigilance as the monitoring of drug safety, and describes how the thalidomide disaster in the 1960s prompted significant changes to drug safety systems worldwide. It then discusses various reasons for the need of pharmacovigilance like limited preclinical safety data and changing drug use patterns. The aims and methods of pharmacovigilance including spontaneous reporting, case studies, and periodic safety reports are summarized. It also provides an overview of the Pharmacovigilance Program of India and its goals of monitoring ADRs and ensuring drug benefits outweigh risks. Finally, it defines different types of ADRs and their
The document discusses pharmacovigilance and the establishment of a nationwide pharmacovigilance program in India. It describes how India launched the Pharmacovigilance Program of India (PvPI) in 2010 with the objectives of monitoring adverse drug reactions, analyzing safety risks and benefits of medicines, and supporting regulatory decision making. The PvPI operates through a national coordination center and network of reporting centers across India to collect adverse drug reaction reports and contribute to global pharmacovigilance efforts through the WHO.
The document discusses pharmacovigilance and adverse drug reactions (ADRs). It provides historical context on important events that increased focus on pharmacovigilance like the Thalidomide disaster. It describes the need for pharmacovigilance due to limitations of preclinical and clinical trials. It outlines the aims, methods like spontaneous reporting and causality assessment, and programs in India and by the WHO. It defines ADRs and provides classifications. In summary, the document overviews the importance and process of pharmacovigilance in monitoring drug safety post marketing.
WHO international drug monitoring programme.pptxashharnomani
The WHO Program for International Drug Monitoring (PIDM) was established in 1963 to systematically collect information on serious adverse drug reactions. It has grown from 10 founding members to 176 total member countries. The Uppsala Monitoring Centre serves as the WHO Collaborating Centre and maintains the global database VigiBase, where member countries submit adverse reaction reports. The PIDM aims to identify new safety issues, facilitate information exchange, and provide resources to support pharmacovigilance globally.
Adverse drug reaction, pharmacovigilance, spontaneous ADR monitoring, Good Pharmacovigilance Practices, drug safety, patient safety, an overview of regulatory guidelines, medicine safety, medical regulations.
Pharmacovigilance is the science of detecting adverse effects of pharmaceutical drugs. It became important after the thalidomide incident in the 1960s which caused birth defects. The key goals of pharmacovigilance are to improve patient safety, assess benefits and risks of drugs, and promote their rational use. Individual case safety reports are a primary data source and are collected, processed, and shared using systems like VigiFlow and the global database VigiBase. India established the Pharmacovigilance Programme of India in 2010 to monitor drug safety at a national level through regional centers and collaborations with medical organizations.
WHO AND PHARMACOVIGILANCE (Clinical Research & Pharmacovigilance.pptxDureshahwar khan
This presentation includes introduction to WHO International Drug Monitoring Program & its functions, Role of WHO in PV, Vigibase, regulatory terminology of ADR and evaluation of medication safety.
Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. WHO established its Programme for International Drug Monitoring in response to the thalidomide disaster detected in 1961. Together with the WHO Collaborating Centre for International Drug Monitoring, Uppsala, WHO promotes PV at the country level. At the end of 2010, 134 countries were part of the WHO PV Programme. The aims of PV are to enhance patient care and patient safety in relation to the use of medicines; and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.
Pharmacovigilance & Adverse drug reactionRahul Bhati
This document discusses pharmacovigilance and adverse drug reactions (ADRs). It begins by defining pharmacovigilance as the monitoring of drug safety, and describes how the thalidomide disaster in the 1960s prompted significant changes to drug safety systems worldwide. It then discusses various reasons for the need of pharmacovigilance like limited preclinical safety data and changing drug use patterns. The aims and methods of pharmacovigilance including spontaneous reporting, case studies, and periodic safety reports are summarized. It also provides an overview of the Pharmacovigilance Program of India and its goals of monitoring ADRs and ensuring drug benefits outweigh risks. Finally, it defines different types of ADRs and their
The document discusses pharmacovigilance and the establishment of a nationwide pharmacovigilance program in India. It describes how India launched the Pharmacovigilance Program of India (PvPI) in 2010 with the objectives of monitoring adverse drug reactions, analyzing safety risks and benefits of medicines, and supporting regulatory decision making. The PvPI operates through a national coordination center and network of reporting centers across India to collect adverse drug reaction reports and contribute to global pharmacovigilance efforts through the WHO.
The document discusses pharmacovigilance and adverse drug reactions (ADRs). It provides historical context on important events that increased focus on pharmacovigilance like the Thalidomide disaster. It describes the need for pharmacovigilance due to limitations of preclinical and clinical trials. It outlines the aims, methods like spontaneous reporting and causality assessment, and programs in India and by the WHO. It defines ADRs and provides classifications. In summary, the document overviews the importance and process of pharmacovigilance in monitoring drug safety post marketing.
WHO international drug monitoring programme.pptxashharnomani
The WHO Program for International Drug Monitoring (PIDM) was established in 1963 to systematically collect information on serious adverse drug reactions. It has grown from 10 founding members to 176 total member countries. The Uppsala Monitoring Centre serves as the WHO Collaborating Centre and maintains the global database VigiBase, where member countries submit adverse reaction reports. The PIDM aims to identify new safety issues, facilitate information exchange, and provide resources to support pharmacovigilance globally.
Adverse drug reaction, pharmacovigilance, spontaneous ADR monitoring, Good Pharmacovigilance Practices, drug safety, patient safety, an overview of regulatory guidelines, medicine safety, medical regulations.
Pharmacovigilance is the science of detecting adverse effects of pharmaceutical drugs. It became important after the thalidomide incident in the 1960s which caused birth defects. The key goals of pharmacovigilance are to improve patient safety, assess benefits and risks of drugs, and promote their rational use. Individual case safety reports are a primary data source and are collected, processed, and shared using systems like VigiFlow and the global database VigiBase. India established the Pharmacovigilance Programme of India in 2010 to monitor drug safety at a national level through regional centers and collaborations with medical organizations.
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.
Minimum requirements for a functional pharmacovigilance systemPriti Gupta
The document outlines minimum requirements for a functional national pharmacovigilance system. It defines pharmacovigilance and describes the development of minimum requirements through consultation with experts. The minimum requirements include: having a national pharmacovigilance center with dedicated staff and funding; a national system for spontaneous reporting of adverse drug reactions using a standard form; a national database for managing reports; a national advisory committee to provide technical assistance on assessing and managing risks; and a communication strategy for routine updates and crisis response.
This document discusses establishing pharmacovigilance centers in industry and national pharmacovigilance programs. It outlines the basic steps in setting up a pharmacovigilance center, including making contacts, designing reporting forms, educating staff, establishing a database, and promoting reporting. The document also discusses establishing pharmacovigilance programs in industry and the roles of contract research organizations and India's national pharmacovigilance program organization in monitoring drug safety.
Pharmacovigilance is defined as, The pharmacological science and activities concerned with the detection, assessment, understanding and prevention of adverse reactions to medicines or Pharmacovigilance is the name given to the mechanisms and controls that together map and ensure the safety of a medicine throughout its life span – from test tube to patient.
The document discusses the Pharmacovigilance Program of India (PvPI), which monitors adverse drug reactions in the country. It was initiated in 2010 to protect patient health and ensure the benefits of medicines outweigh the risks. The PvPI's objectives include establishing a nationwide reporting system, analyzing safety signals, assessing risk-benefit ratios of drugs, generating evidence-based safety information, and collaborating with other pharmacovigilance programs. It oversees spontaneous reporting of ADRs, targeted spontaneous reporting to evaluate specific risks, and cohort event monitoring of drug-exposed patient groups.
This document discusses pharmacovigilance, which is the science of monitoring the safety of pharmaceutical drugs. It aims to improve patient safety, public health, assess risk and benefits of drugs, and promote effective communication. A functional pharmacovigilance system requires a national center, reporting system, database, advisory committee, and communication strategy. Any adverse drug reactions or lack of efficacy should be reported. Periodic safety update reports provide an evaluation of the risk-benefit balance of drugs and are submitted to regulatory authorities on defined timelines.
This document discusses pharmacovigilance, which is the science of monitoring the safety of pharmaceutical drugs. It aims to improve patient safety, public health, assess risk and benefits of drugs, and promote effective communication. Pharmacovigilance systems collect, assess and monitor adverse drug reactions to prevent harm. Key requirements include a national pharmacovigilance center, individual case safety reporting system, and advisory committee for causality assessment. Periodic safety update reports provide aggregate analysis of post-market drug safety data to regulatory authorities.
The document discusses various methods of pharmacovigilance including passive surveillance methods like spontaneous reporting and case series, as well as active surveillance methods like sentinel sites and drug event monitoring. Comparative observational studies that can be used include cohort studies, case-control studies, and cross-sectional studies. Descriptive studies are also important for understanding the natural history of diseases and monitoring drug utilization. The key goal of pharmacovigilance is to detect, understand, and prevent adverse drug reactions.
This document provides an overview of pharmacovigilance. It defines pharmacovigilance as the science relating to detecting and assessing adverse drug reactions. The roles of pharmacovigilance include identifying drug problems, reducing risks, and increasing understanding of drug safety issues. Signal detection methods like spontaneous reporting and quantitative analyses are used to detect potential drug-adverse event associations. National pharmacovigilance centers and the WHO play important roles in global pharmacovigilance efforts.
Pharmacovigilance is the science of monitoring approved drugs to detect adverse effects. It aims to identify new risks, assess known risks, and prevent harm. Pharmacovigilance relies on collecting data on adverse drug reactions (ADRs) through passive and active methods. Data is analyzed to detect safety signals and assess risks and benefits of medicines to optimize safe use. Regulatory authorities use pharmacovigilance data to take actions like updating product information or withdrawing approval if risks outweigh benefits.
Pharmacovigilance aims to monitor the safety of medicines on the market and ensure their safe use. It is important because clinical trials are limited in scope and pre-marketing studies may miss adverse drug reactions. The national Pharmacovigilance Programme of India was established in 2010 to coordinate pharmacovigilance activities across the country through a three-tier structure. HIPAA was enacted to protect patient privacy and the security of personal health information. It requires covered entities like health plans and providers to safeguard protected health information.
Pharmacovigilance is the science of monitoring the effects of medicines after they have been licensed for use, in order to identify new risks or risks that were previously unknown. The World Health Organization established an international drug monitoring program in 1961 after the thalidomide tragedy. The Uppsala Monitoring Centre was established as the WHO collaborating center for pharmacovigilance in 1978. The Pharmacovigilance Programme of India was started in 2010 to monitor adverse drug reactions in the Indian population and ensure the benefits of medicines outweigh the risks.
The Role of Pharmacovigilance in Ensuring Drug Safety and EfficacyClinosolIndia
Pharmacovigilance plays a vital role in ensuring drug safety and efficacy throughout the entire lifecycle of a pharmaceutical product. Here are the key aspects of pharmacovigilance in safeguarding public health:
Early Detection of Adverse Drug Reactions (ADRs): Pharmacovigilance systems collect and analyze data on ADRs reported by healthcare professionals and patients. This enables the early detection of potential safety concerns associated with drugs, including known and previously unrecognized adverse effects.
Signal Detection and Evaluation: Pharmacovigilance activities involve the systematic identification and evaluation of safety signals, which are indications of potential risks associated with a drug. Signals are assessed by analyzing data from various sources, such as spontaneous reports, clinical trials, literature, and real-world evidence, to determine their clinical significance and inform regulatory action if necessary.
Risk Assessment and Benefit-Risk Evaluation: Pharmacovigilance assesses the balance between the benefits and risks of drugs. The collected data are evaluated to determine whether the benefits of a drug outweigh its risks or if any additional safety measures are required. This information guides regulatory decisions, such as labeling changes, restrictions, or even withdrawal of the drug from the market.
Post-Marketing Surveillance: Pharmacovigilance is crucial in monitoring the safety of drugs after they have been approved and marketed. It involves ongoing surveillance and analysis of real-world data, including ADR reports, electronic health records, and other sources, to identify new or rare adverse effects that may emerge in larger patient populations or specific subgroups.
PHARMACOVIGILANCE
The World Health Organization (WHO) defines Pharmacovigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.”
ADVERSE DRUG REACTION
According to WHO “ADR is a response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.”
This document discusses pharmacovigilance (PV), which involves monitoring the safety of medicines. PV focuses on detecting adverse drug reactions through spontaneous reporting systems. Signal detection involves data mining to identify unexpected adverse reactions requiring further evaluation. Signals are strengthened by evaluating factors like case reports and biological plausibility. National PV centers play a key role by collecting reports, communicating signals to WHO databases, and taking necessary actions. The WHO PV program has grown from 10 countries in 1968 to over 130 currently.
A brief description about Pharmacovigilance, aims and scope, need of pharmacovigilance, programs by WHO for international drug safety monitoring, UMC, VIGIBASE, WHO causality assessment scale and specific regulatory bodies of various countries
The safe use of medicines is perhaps the single most important criteria that any regulatory authority within a given country has to ensure in order both to protect the public health and the integrity of its health care system. For the same purpose pharmacovigilance was established. According to WHO, Pharmacovigilance is the science and activities related to the collection, detection, and assessment of ADR’s. It promotes the systematic, rational use and assures the confidence for the safety of drugs. It improves patient care and safety. Significance of pharmacovigilance is growing as the patients or consumers have become more responsive about the advantage and hazard of medicines. Pharmacovigilance is a complex process and a robust system is essential to undertake the activity. A good pharmacovigilance system will identify the hazard aspects in the short period of time. This review article tries to explain the some basic principles, history and developments, methods and some scope of this developing field i.e. Pharmacovigilance in India.
Thank You✨ ClinoSol Research Mujeebuddin Shaik (Founder & CEO)#Sir uma priya(Director) #Mem at ClinoSol Research Pvt. Ltd & Kabya Pratap (ClinoSol) at #Business #Development #Intern for giving me a great #opportunity in #internship at #ClinoSol Your all Best Efforts & Support helps me alot #Slideshare #innovation #pharmacovigilance #pv #linkedin #thankyou again ♂️拾
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - ...rightmanforbloodline
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - 34.
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - 34.
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - 34.
Similar a PHARMACOVIGILANCE_SLIDE. Insight to pharmacovigilance, covering basics and various aspects, case processing types of ADR, basic terminologies adr reporting dverse vent, types of adr, meddrapptx
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.
Minimum requirements for a functional pharmacovigilance systemPriti Gupta
The document outlines minimum requirements for a functional national pharmacovigilance system. It defines pharmacovigilance and describes the development of minimum requirements through consultation with experts. The minimum requirements include: having a national pharmacovigilance center with dedicated staff and funding; a national system for spontaneous reporting of adverse drug reactions using a standard form; a national database for managing reports; a national advisory committee to provide technical assistance on assessing and managing risks; and a communication strategy for routine updates and crisis response.
This document discusses establishing pharmacovigilance centers in industry and national pharmacovigilance programs. It outlines the basic steps in setting up a pharmacovigilance center, including making contacts, designing reporting forms, educating staff, establishing a database, and promoting reporting. The document also discusses establishing pharmacovigilance programs in industry and the roles of contract research organizations and India's national pharmacovigilance program organization in monitoring drug safety.
Pharmacovigilance is defined as, The pharmacological science and activities concerned with the detection, assessment, understanding and prevention of adverse reactions to medicines or Pharmacovigilance is the name given to the mechanisms and controls that together map and ensure the safety of a medicine throughout its life span – from test tube to patient.
The document discusses the Pharmacovigilance Program of India (PvPI), which monitors adverse drug reactions in the country. It was initiated in 2010 to protect patient health and ensure the benefits of medicines outweigh the risks. The PvPI's objectives include establishing a nationwide reporting system, analyzing safety signals, assessing risk-benefit ratios of drugs, generating evidence-based safety information, and collaborating with other pharmacovigilance programs. It oversees spontaneous reporting of ADRs, targeted spontaneous reporting to evaluate specific risks, and cohort event monitoring of drug-exposed patient groups.
This document discusses pharmacovigilance, which is the science of monitoring the safety of pharmaceutical drugs. It aims to improve patient safety, public health, assess risk and benefits of drugs, and promote effective communication. A functional pharmacovigilance system requires a national center, reporting system, database, advisory committee, and communication strategy. Any adverse drug reactions or lack of efficacy should be reported. Periodic safety update reports provide an evaluation of the risk-benefit balance of drugs and are submitted to regulatory authorities on defined timelines.
This document discusses pharmacovigilance, which is the science of monitoring the safety of pharmaceutical drugs. It aims to improve patient safety, public health, assess risk and benefits of drugs, and promote effective communication. Pharmacovigilance systems collect, assess and monitor adverse drug reactions to prevent harm. Key requirements include a national pharmacovigilance center, individual case safety reporting system, and advisory committee for causality assessment. Periodic safety update reports provide aggregate analysis of post-market drug safety data to regulatory authorities.
The document discusses various methods of pharmacovigilance including passive surveillance methods like spontaneous reporting and case series, as well as active surveillance methods like sentinel sites and drug event monitoring. Comparative observational studies that can be used include cohort studies, case-control studies, and cross-sectional studies. Descriptive studies are also important for understanding the natural history of diseases and monitoring drug utilization. The key goal of pharmacovigilance is to detect, understand, and prevent adverse drug reactions.
This document provides an overview of pharmacovigilance. It defines pharmacovigilance as the science relating to detecting and assessing adverse drug reactions. The roles of pharmacovigilance include identifying drug problems, reducing risks, and increasing understanding of drug safety issues. Signal detection methods like spontaneous reporting and quantitative analyses are used to detect potential drug-adverse event associations. National pharmacovigilance centers and the WHO play important roles in global pharmacovigilance efforts.
Pharmacovigilance is the science of monitoring approved drugs to detect adverse effects. It aims to identify new risks, assess known risks, and prevent harm. Pharmacovigilance relies on collecting data on adverse drug reactions (ADRs) through passive and active methods. Data is analyzed to detect safety signals and assess risks and benefits of medicines to optimize safe use. Regulatory authorities use pharmacovigilance data to take actions like updating product information or withdrawing approval if risks outweigh benefits.
Pharmacovigilance aims to monitor the safety of medicines on the market and ensure their safe use. It is important because clinical trials are limited in scope and pre-marketing studies may miss adverse drug reactions. The national Pharmacovigilance Programme of India was established in 2010 to coordinate pharmacovigilance activities across the country through a three-tier structure. HIPAA was enacted to protect patient privacy and the security of personal health information. It requires covered entities like health plans and providers to safeguard protected health information.
Pharmacovigilance is the science of monitoring the effects of medicines after they have been licensed for use, in order to identify new risks or risks that were previously unknown. The World Health Organization established an international drug monitoring program in 1961 after the thalidomide tragedy. The Uppsala Monitoring Centre was established as the WHO collaborating center for pharmacovigilance in 1978. The Pharmacovigilance Programme of India was started in 2010 to monitor adverse drug reactions in the Indian population and ensure the benefits of medicines outweigh the risks.
The Role of Pharmacovigilance in Ensuring Drug Safety and EfficacyClinosolIndia
Pharmacovigilance plays a vital role in ensuring drug safety and efficacy throughout the entire lifecycle of a pharmaceutical product. Here are the key aspects of pharmacovigilance in safeguarding public health:
Early Detection of Adverse Drug Reactions (ADRs): Pharmacovigilance systems collect and analyze data on ADRs reported by healthcare professionals and patients. This enables the early detection of potential safety concerns associated with drugs, including known and previously unrecognized adverse effects.
Signal Detection and Evaluation: Pharmacovigilance activities involve the systematic identification and evaluation of safety signals, which are indications of potential risks associated with a drug. Signals are assessed by analyzing data from various sources, such as spontaneous reports, clinical trials, literature, and real-world evidence, to determine their clinical significance and inform regulatory action if necessary.
Risk Assessment and Benefit-Risk Evaluation: Pharmacovigilance assesses the balance between the benefits and risks of drugs. The collected data are evaluated to determine whether the benefits of a drug outweigh its risks or if any additional safety measures are required. This information guides regulatory decisions, such as labeling changes, restrictions, or even withdrawal of the drug from the market.
Post-Marketing Surveillance: Pharmacovigilance is crucial in monitoring the safety of drugs after they have been approved and marketed. It involves ongoing surveillance and analysis of real-world data, including ADR reports, electronic health records, and other sources, to identify new or rare adverse effects that may emerge in larger patient populations or specific subgroups.
PHARMACOVIGILANCE
The World Health Organization (WHO) defines Pharmacovigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.”
ADVERSE DRUG REACTION
According to WHO “ADR is a response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.”
This document discusses pharmacovigilance (PV), which involves monitoring the safety of medicines. PV focuses on detecting adverse drug reactions through spontaneous reporting systems. Signal detection involves data mining to identify unexpected adverse reactions requiring further evaluation. Signals are strengthened by evaluating factors like case reports and biological plausibility. National PV centers play a key role by collecting reports, communicating signals to WHO databases, and taking necessary actions. The WHO PV program has grown from 10 countries in 1968 to over 130 currently.
A brief description about Pharmacovigilance, aims and scope, need of pharmacovigilance, programs by WHO for international drug safety monitoring, UMC, VIGIBASE, WHO causality assessment scale and specific regulatory bodies of various countries
The safe use of medicines is perhaps the single most important criteria that any regulatory authority within a given country has to ensure in order both to protect the public health and the integrity of its health care system. For the same purpose pharmacovigilance was established. According to WHO, Pharmacovigilance is the science and activities related to the collection, detection, and assessment of ADR’s. It promotes the systematic, rational use and assures the confidence for the safety of drugs. It improves patient care and safety. Significance of pharmacovigilance is growing as the patients or consumers have become more responsive about the advantage and hazard of medicines. Pharmacovigilance is a complex process and a robust system is essential to undertake the activity. A good pharmacovigilance system will identify the hazard aspects in the short period of time. This review article tries to explain the some basic principles, history and developments, methods and some scope of this developing field i.e. Pharmacovigilance in India.
Thank You✨ ClinoSol Research Mujeebuddin Shaik (Founder & CEO)#Sir uma priya(Director) #Mem at ClinoSol Research Pvt. Ltd & Kabya Pratap (ClinoSol) at #Business #Development #Intern for giving me a great #opportunity in #internship at #ClinoSol Your all Best Efforts & Support helps me alot #Slideshare #innovation #pharmacovigilance #pv #linkedin #thankyou again ♂️拾
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TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - ...rightmanforbloodline
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - 34.
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - 34.
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - 34.
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Myasthenia gravis is a neurological disease. It affects the grave muscles in our body. Myasthenia gravis affects how the nerves communicate with the muscles. Drooping eyelids and/or double vision are often the first noticeable sign. It is involving the muscles controlling the eyes movement, facial expression, chewing and swallowing. It also effects the muscles neck and lip movement and respiration.
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PHARMACOVIGILANCE_SLIDE. Insight to pharmacovigilance, covering basics and various aspects, case processing types of ADR, basic terminologies adr reporting dverse vent, types of adr, meddrapptx
2. PHARMACOVIGILANCE
• Pharmacovigilance (PV) is defined as the science and activities
relating to the detection, assessment, understanding and prevention
of adverse effects or any other drug-related problem.
• Pharmacovigilance (PV) Drug Safety
• Pharmakon -drug +Vigilare -to keep watch =PHARMACOVIGILANCE
3. Overview
• The tragedy of thalidomides in 1960s compelled health agencies
and regulators worldwide to deliberate on drug safety issues.
• Thousands of babies were born without limbs because of exposure
to thalidomide consumed by the pregnant mothers for morning
sickness.
4. • WHO initiated the project with cooperation of ten countries ,
which have their own pharmacovigilance systems
• These countries had well established national drug monitoring
centers receiving ADR reports from healthcare professionals.
• Received reports were analyzed locally and then forwarded to the
WHO database, which since 1978 has been maintained by the
WHO Collaborating Centers for International Drug Monitoring ,
located in Uppsala, Sweden.
• Thus the science of pharmacovigilance or drug safety emerged.
Gradually more countries joined the WHO program for
International Drug Monitoring (PIDM).
5. AIM OF PHARMACOVIGILANCE
• PATIENT CARE
To improve patient care & safety in relation to medicines & all
medical & para-medical interventions
• PUBLIC HEALTH
To improve public health & safety in relation to the use of
medicines
• RISK BENEFIT & ASSESSMENT
To contribute to the assessment of benefit, harm, effectiveness
and risk of medicines
6. • COMMUNICATION
To promote understanding, clinical training & effective
communication to health professionals & the public
• To promote rational and safe use of medicines
7. RESPONSIBILITIES
• Timely collection of data ,recording and notification
• Appropriate assessments (data completeness , seriousness)
• Expedited and periodic reporting
• Creates appropriate structures for communication
8. NEED OF PHARMACOVIGILANCE
HUMANITARIAN CONCERN
• Animal toxicology is often not a good predictor for
human effects .
• Evidence of safety from clinical trials is insufficient due to
some limitations
• LIMITATIONS (phase 1-3): limited size , narrow population
(age &sex specific), narrow indications (only specific disease),
short duration
9. 2. SAFE USE OF MEDICINES
it has been suggested that ADRs may cause 5700 deaths per
year in UK
3.ADRs MAY CAUSE SUDDEN DEATH
4.PROMOTING RATIONAL USE OF MEDICINES
5.ENSURING PUBLIC CONFIDENCE
6.ETHICAL CONCERN
not reporting serious reaction is unethical
10. The Minimum Requirements for a functional
Pharmacovigilance System
• A National Pharmacovigilance Centre with designated staff (at
least one full time), stable basic funding, clear mandates, well
defined structures and roles and collaborating with the WHO
Programme for International Drug Monitoring
• The existence of a National spontaneous reporting system with
a national individual case safety report (ICSR) form i.e. ADR
reporting form
11. • A national database or system for collating and managing
ADR reports
• A national ADR or pharmacovigilance advisory committee
able to provide technical assistance on causality assessment,
risk assessment, risk management case investigation and
where necessary crisis management including crisis
communication
• Clear communication strategy for routine communication and
crises communication
12. What informations should be reported
• On ADRs occurring
– in the course of the use of a drug
– from drug overdose whether accidental or intentional
– from drug abuse / misuse / non-approved use
– from drug withdrawal
– in the infant of a nursing mother
– possibly as a result of exposure of the mother or the fetus
during pregnancy
13. • ANY INFORMATION
on an ADR or lack of efficacy connected with the use of a
medical device/ drug product
• even if no ADR has been observed,
– From drug overdose whether accidental or intentional
– From drug abuse / misuse / non-approved use
– From drug administration during pregnancy
14. GOVERNING BODIES
• The pharmaceutical industry
• Regulatory authorities
• WHO collaborating centre for international drug monitoring
• CIOMS(Council for International Organization of Medical
Sciences )
15. ORGANISATIONS INVOLVED IN
PHARMACOVIGILANCE
• FDA: The Food and Drug Administration (FDA or USFDA) is
an agency of the United States Department of Health and
Human Services, one of the United States federal executive
departments
• responsible for protecting and promoting public health
through the regulation and supervision of food safety, tobacco
products, dietary supplements, prescription and over-
thecounter pharmaceutical drugs (medications), vaccines,
biopharmaceuticals, blood transfusions, medical devices,
electromagnetic radiation emitting devices (ERED), veterinary
products, and cosmetics.
16. • EMEA: The European Medicines Agency is a decentralised
body of the European Union located in London
• MHLW: Ministry of Health, Labor and Welfare,Japan
• CDSCO: The government of India with the assistance of
world bank has initiated the National pharmacovigilance
programme.
The central drugs standard control organization (CDSCO) is
coordinating the country wide pharmacovigilance programme
under the aegis of Ministry of health and family welfare,
DGHS New delhi
17. TERMINOLOGIES OF PHARMACOVIGILANCE
1.ADVERSE EVENT
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.
2.ADVERSE DRUG REACTION (ADR)
A response which is noxious and unintended, and which occurs at
doses normally used in humans for the prophylaxis, diagnosis, or
therapy of disease, or for the modification of physiological
function. (WHO, 1972).
18. 3.ALLOPATHY
Non-traditional, western scientific therapy, usually using
synthesised ingredients, but may also contain a purified active
ingredient extracted from a plant or other natural source, usually
in opposition to the disease.
4.ATTRIBUTABLE RISK
Difference between the risk in an
exposed population (absolute risk) and
the risk in an unexposed population (reference risk).
• Attributable risk is the result of an absolute comparison between
outcome frequency measurements, such as incidence.
19. 5.BIOLOGICAL PRODUCTS
Medical products prepared from biological material of human,
animal or microbiologic origin (such as blood products, vaccines,
insulin).
6.CASUAL RELATIONSHIP
A relationship between one phenomenon or event (A) and another
(B) in which A precedes and causes B. In pharmacovigilance; a
medicine causing an adverse reaction.
20. 7.CASUALITY ASSESSMENT
The evaluation of the likelihood that a
medicine was the causative agent of an
observed adverse reaction. Causality assessment is usually made
according established algorithms.
8.CAVEAT DOCUMENT
The formal advisory warning accompanying data release from the
WHO Global ICSR Database: it specifies the conditions and
reservations applying to interpretations and use of the data.
21. 9.CEM-FLOW
Software developed by UMC for collection and analysis of
data in Cohort Event Monitoring.
10.CLINICAL TRIAL
A systematic study on pharmaceutical products in human
subjects (including patients and other volunteers) in order to
discover or verify the effects of and/or identify any adverse
reaction to investigational products, and/or to study the
absorption, distribution, metabolism and excretion (ADME) of
the products with the objective of ascertaining their efficacy
and safety
22. 11.COHORT EVENT MONITORING
Cohort Event Monitoring (CEM) is a prospective, observational
study of events that occur during the use of medicines, for
intensified follow-up of selected medicinal products phase.
Patients are monitored from the time they begin treatment, and
for a defined period of time.
12.COMPLIANCE
Faithful adherence by the patient to the prescriber’s instructions.
23. 13.CONTROL GROUP
The comparison group in drug-trials not being given the
studied drug.
14.CO START
Coding Symbols for a Thesaurus of Adverse Reaction Terms
developed by USFDA . But recently COSTART was replaced
by MedDRA.
15.CRITICAL TERMS
Some of the terms in WHO-ART are marked as ‘Critical
Terms’. These terms either refer to or might be indicative of
serious disease states, and warrant special attention, because of
their possible association with the risk of serious illness which
may lead to more decisive action than reports on other terms.
24. 16.DATA MINING
• extract information from a data and transform it into an
understandable structure for further use
• it is practical machine learning tools &techniques with java
• the term data mining appeared around 1990.
• currently data mining and knowledge discovery are used
interchangeably
• A related term with essentially the same meaning is
‘pattern discovery’.
25. • In pharmacovigilance, the commonest application of data mining
is so called disproportionality analysis, for example using the
Information component (IC).
• Six tasks
a) anomaly detection –identification of unusual data &data errors
that require further investigations.
b) association rule learning-searching relationship between
variables
c) clustering-discovering groups that are in some way similar
d) classification-to apply to new data
e) regression-models the data with least error
f) summarization-compact representation of data
26. • Medical data mining-HITECH act(Health Information
Technology for Economic and Clinical Health act)
-by this data mining opportunities are maximized
a) Free open source data mining soft ware & applications
carrot 2
GATE
Orange
rapid miner
b) Commercial data mining software & application
1) clara bridge 2 ) oracle data mining
3) statistical data miner
27. 17.DE - CHALLENGE
The withdrawal of a drug from a patient; the point at which the
continuity, reduction or disappearance of adverse effects may be
observed.
18.DISPROPORTIONALITY ANALYSIS
Screening of ICSR databases for reporting rates which are
higher than expected. For drugADR pairs, common measures of
disproportionality are the Proportional Reporting Ratio (PRR),
the Reporting Odds Ratio (ROR), The Information Component
(IC), and the Empirical Bayes Geometrical Mean (EBGM).
There are also disproportionality measures for drug-drug-ADR
triplets, such as Omega (Ω).
28. 19.INFORMATION COMPONENT
The Information component (IC) measures the disproportionality
in the reporting of a drug- ADR pair in an ICSR database,
relative to the reporting expected based on the overall reporting
of the drug and the ADR. Positive IC values indicate higher
reporting than expected. The IC has also been implemented on
electronic health records, to detect interesting temporal
relationships between drug prescriptions and medical events.
20.INCIDENCE
Number of new cases of an outcome which develop over a
defined time period in a defined population at risk
29. 21.INDIVIDUAL CASE SAFETY REPORT (ICSR)
A report that contains ‘information describing a suspected
adverse drug reaction related to the administration of one or
more medicinal products to an individual patient’.
30. 22.MedDRA
MedDRA is the Medical Dictionary for Regulatory Activities.
WHO-ART, the WHO Adverse Reactions Terminology, is now
mapped to MedDRA
• International medical terminology dictionary -Originally
available in English &Japanese
• MedDRA is organized as System Organ Class(SOC).which is
divided into
a)High level group terms(HLGT)
b)High level terms(HLT)
c)Preferred terms(PT)
d)lower level terms(LLT)
31. • MedDRA is managed by MSSO(Maintenance and Support
Services Organization)
• MSSO releases new version in twice a year (march&
September)
• March release is the main ,contains changes at the HLT level
&above
• September release contains changes at the PT level
• Latest version(16.1) was updated on sept 2013
32. 23.MEMBER COUNTRIES
Countries which comply with the criteria for, and have joined
the WHO Programme for International Drug Monitoring.
24.NATIONAL PHARMACOVIGILANCE CENTRES
Organisations recognised by
governments to represent their
country in the WHO Programme
(usually the drug regulatory agency). A single, governmentally
recognized centre (or integrated system) within a country with
the clinical and scientific expertise to collect, collate, analyse
and give advice on all information related to drug safety.
33. 25.OMEGA(Ω)
A measure of disproportionate reporting for drug-drug-ADR
triplets in ICSR databases, designed to highlight potential
signals of drug- drug interactions. Just like the more
established disproportionality measures for drug-ADR pairs, Ω
is based on a contrast between the observed and expected
number of reports. A positive Ω indicates higher reporting than
expected
26.PANI-FLOW
Software developed by UMC for collection and analysis of
data in relation to vaccinations in a pandemic situation.
34. 27.PERIODIC SAFETY UPDATE REPORT
A systematic review of the global safety data which became
available to the manufacturer of a marketed drug during a
specific time period. Produced in an internationally agreed
format.
28.PHARMACOEPIDEMIOLOGY
Study of the use and effects of drugs in large populations.
29.PHARMACOENVIRONMENTOLOGY
form of pharmacovigilance which deals specifically with those
pharmacological agents that have impact on the environment
via elimination through living organisms subsequent to
pharmacotherapy.
35. 30.PREDISPOSING FACTORS
Any aspect of the patient’s history (other than the drug) which
might explain reported adverse events (genetic factors, diet,
alcohol consumption, disease history, polypharmacy or use of
herbal medicines, for example).
36. 31.PRESCRIPTION EVENT MONITORING(PEM)
System created to monitor adverse drug events in a population.
Prescribers are requested to report all events, regardless of
whether they are suspected adverse events, for identified
patients receiving a specified drug. Also more accurately named
Cohort Event Monitoring.
32.PREVALENCE
Number of existing cases of an outcome in a defined population
at a given point in time.
37. 33.RECORD LINKAGE
Method of assembling information contained in two or more
records, e.g. In different sets of medical charts, and in vital
records such as birth and death certificates. This makes it
possible to relate significant health events that are remote from
one another in time and place.
34.REFERENCE RISK
Risk in a population of unexposed persons; also called baseline
risk. Reference risk can be measured over time (incidence) or
at a given time (prevalence). The unexposed population refers
to a reference population, as closely comparable to the exposed
population as possible, apart from the exposure.
38. 35.RELATIVE RISK
Ratio of the risk in an exposed population (absolute risk) and
the risk in an unexposed population (reference risk). Relative
risk is the result of a relative comparison between outcome
frequency measurements, e.g. incidences.
39. 36.SIGNAL
• reported information on a possible causal relationship which is
being unknown or incompletely documented previously.
• usually more than 1 report is required to generate a signal
• depending upon the seriousness of the event and the quality of
the information. The publication of a signal usually implies the
need for some kind of review or action.
• before signals are published they are first clinically assessed
by PV experts at UMC(Uppsala monitoring centre ,Sweden)
40. • there are 3types of signals
1.confirmed signals-causal relationship between the drug and
adverse event
2.refuted(false) signals-no causal relationship
3.unconfirmed signals-require further investigation
37.SPONTANEOUS REPORTING
System whereby case reports of adverse drug events are
voluntarily submitted from health professionals and
pharmaceutical manufacturers to the national regulatory
authority.
41. 38.VIGIBASE
• a unique collection of international drug safety data. Vigibase is the
name of the WHO ICSR data base .
• Its consists of reports of adverse reactions
• common uses-
• signal detection
• updating product safety update reports
• compare the reports
• WHO member countries have access to the collected data and
analyze . Vigibase comprises 8million reports in which 2 lack new
reports are added quarterly
42. 39.VIGI FLOW
• Vigi -Flow is a complete ICSR management system created and
maintained by the UMC.
• It is web-based and built to adhere to the ICH-E2B standard.
• It can be used as the
national database for
countries in the WHO
Programme as it incor
porates tools for report
analysis, and facilitates sending reports to Vigi-Base.
43. a) input-ICSR data can be manually entered into vigiflow with
support from the latest version of terminologies such WHO-ART
or MedDRA
b) handICSRs-it ling of is easy to communicate within the
vigiflow by adding a digital note to the ICSR.
- once a report is complete the first version of the ICSR is
considered to be finalized.
c) analysis-search& statistics module is part of vigiflow .the
results can be exported in different output formats.
d) communication-data can be sent to external contacts such as
companies or other regulatory agencies
44. • Technical information-requirements are web browser , internet
connection.
• information stored in vigiflow is only accessible by users
within the same country.
• There are downloadable pdf information sheets available here
45. 40.VIGI-MED
Share point based conferencing facility, exclusive to member
countries of the WHO Programme for International Drug
Monitoring for fast communication of topical pharmacovigilance
issues
41.VIGI SEARCH
A search service for accessing ICSRs stored in the Vigi-Base
database offered by the UMC to national pharmacovigilance
centres and other third-party inquirers.
46. 42.VIGI-MINE
A statistical tool within Vigi-Search with vast statistical
material calculated for all DrugADR pairs (combinations)
available in Vigi-Base. The main features include the
disproportionality measure (IC value) stratified in
different ways and useful filter capabilities.
47. 43.VIGILYZE
during may & June 2013 vigisearch & vigimine were replaced
by this. Its a search and analysis tool that provide access to
vigibase.
44.WHO-ART
Terminology for coding clinical information in relation to drug
therapy. WHO-ART is maintained by UMC.