This document outlines various pharmacovigilance methods including passive surveillance through spontaneous reporting and case series, stimulated reporting, active surveillance using sentinel sites and drug event monitoring, targeted clinical investigations, and descriptive observational studies like cross-sectional, case-control, and cohort studies. Spontaneous reports play a major role in identifying safety signals for marketed drugs and provide information on rare adverse events. Case series and observational studies can help generate or validate hypotheses about potential drug-adverse event associations. Active surveillance methods aim to comprehensively capture adverse event data.
Pharmacovigilance Reporting and Communication: Collaboration between Stakehol...ClinosolIndia
Effective reporting and communication in pharmacovigilance play a vital role in ensuring the safety of medications and protecting public health. This paper explores the importance of collaboration between various stakeholders in the field of pharmacovigilance for efficient reporting and communication processes.
Pharmacovigilance reporting involves the collection, analysis, and evaluation of adverse drug reactions (ADRs) and other drug-related incidents. Prompt and accurate reporting of ADRs is crucial for detecting potential safety issues, identifying patterns or trends, and taking necessary actions to mitigate risks. However, the success of reporting relies on effective collaboration between healthcare professionals, regulatory agencies, pharmaceutical companies, and patients.
The paper highlights the role of healthcare professionals in recognizing and reporting ADRs. It emphasizes the importance of their active participation in pharmacovigilance activities, including the proper documentation and reporting of suspected adverse events. Additionally, the paper discusses the significance of education and training programs to enhance healthcare professionals' awareness and knowledge of pharmacovigilance principles and reporting systems.
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
Spontenous adr reporting in india
PASSIVE survillence system, data assement
data aciqsition, data interpretation, what all information required in ADR form, WHEN TO REPORT
BLUE CARD,YELLOW CARD, WHO CODES
Pharmacovigilance Reporting and Communication: Collaboration between Stakehol...ClinosolIndia
Effective reporting and communication in pharmacovigilance play a vital role in ensuring the safety of medications and protecting public health. This paper explores the importance of collaboration between various stakeholders in the field of pharmacovigilance for efficient reporting and communication processes.
Pharmacovigilance reporting involves the collection, analysis, and evaluation of adverse drug reactions (ADRs) and other drug-related incidents. Prompt and accurate reporting of ADRs is crucial for detecting potential safety issues, identifying patterns or trends, and taking necessary actions to mitigate risks. However, the success of reporting relies on effective collaboration between healthcare professionals, regulatory agencies, pharmaceutical companies, and patients.
The paper highlights the role of healthcare professionals in recognizing and reporting ADRs. It emphasizes the importance of their active participation in pharmacovigilance activities, including the proper documentation and reporting of suspected adverse events. Additionally, the paper discusses the significance of education and training programs to enhance healthcare professionals' awareness and knowledge of pharmacovigilance principles and reporting systems.
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
Spontenous adr reporting in india
PASSIVE survillence system, data assement
data aciqsition, data interpretation, what all information required in ADR form, WHEN TO REPORT
BLUE CARD,YELLOW CARD, WHO CODES
An Institutional Review Board (IRB), also known as an Independent Ethics Committee (IEC), is a committee responsible for reviewing and approving the ethical aspects of research involving human subjects. IRBs/IECs play a crucial role in protecting the rights, welfare, and safety of research participants. Here are some key points about IRBs/IECs
Concept of Pharmacovigilance, history and development of pharmacovigilance, WHO International drug monitoring programme, Pharmacovigilance programme of India
Vaccine safety monitoring is a critical aspect of pharmacovigilance, particularly given the widespread use of vaccines to prevent infectious diseases. Robust surveillance systems are essential to detect and assess any potential adverse events following vaccination. Here are some key pharmacovigilance strategies employed for vaccine safety monitoring:
Passive Surveillance Systems:
Passive surveillance systems rely on healthcare providers, patients, and other stakeholders to voluntarily report adverse events following vaccination. These reports are collected in databases such as the Vaccine Adverse Event Reporting System (VAERS) in the United States or the Vaccine Adverse Event Surveillance System (VAESS) in other countries. While these systems are valuable for signal detection, they may suffer from underreporting and reporting bias.
Active Surveillance Systems:
Active surveillance involves proactively monitoring a defined population for adverse events following vaccination. This can be done through electronic health records (EHRs), claims databases, and other health data sources. The Vaccine Safety Datalink (VSD) in the United States is an example of an active surveillance system that uses large databases to continuously monitor vaccine safety.
Enhanced Surveillance and Cohort Studies:
Enhanced surveillance involves more intensive monitoring of a specific population or group of interest. Cohort studies are prospective studies that follow a group of vaccinated individuals over time to assess vaccine safety. These studies provide more detailed and controlled data compared to passive or active surveillance.
Comparative Effectiveness Research:
Comparative effectiveness research compares the safety of different vaccines or vaccination schedules. By analyzing large datasets, researchers can evaluate the relative risks and benefits of vaccines and identify any safety concerns.
Signal Detection and Analysis:
Data mining and statistical techniques are used to identify potential safety signals from adverse event reports. Signals are further investigated through in-depth analysis to determine if there is a causal relationship between the vaccine and the adverse event.
Causality Assessment:
Similar to general pharmacovigilance, causality assessment methods (such as the Naranjo Algorithm, WHO-UMC System, and Bayesian methods) are used to evaluate the likelihood of a causal relationship between a vaccine and an adverse event.
Risk Communication and Public Awareness:
Effective communication strategies are crucial to ensure that healthcare providers and the public are informed about vaccine safety. This involves providing clear and accurate information about potential risks and benefits.
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
The safety monitoring in a clinical trail accompanies by common practices in safety monitoring, communicating safety information among stakeholders in a clinical trail.
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
An Institutional Review Board (IRB), also known as an Independent Ethics Committee (IEC), is a committee responsible for reviewing and approving the ethical aspects of research involving human subjects. IRBs/IECs play a crucial role in protecting the rights, welfare, and safety of research participants. Here are some key points about IRBs/IECs
Concept of Pharmacovigilance, history and development of pharmacovigilance, WHO International drug monitoring programme, Pharmacovigilance programme of India
Vaccine safety monitoring is a critical aspect of pharmacovigilance, particularly given the widespread use of vaccines to prevent infectious diseases. Robust surveillance systems are essential to detect and assess any potential adverse events following vaccination. Here are some key pharmacovigilance strategies employed for vaccine safety monitoring:
Passive Surveillance Systems:
Passive surveillance systems rely on healthcare providers, patients, and other stakeholders to voluntarily report adverse events following vaccination. These reports are collected in databases such as the Vaccine Adverse Event Reporting System (VAERS) in the United States or the Vaccine Adverse Event Surveillance System (VAESS) in other countries. While these systems are valuable for signal detection, they may suffer from underreporting and reporting bias.
Active Surveillance Systems:
Active surveillance involves proactively monitoring a defined population for adverse events following vaccination. This can be done through electronic health records (EHRs), claims databases, and other health data sources. The Vaccine Safety Datalink (VSD) in the United States is an example of an active surveillance system that uses large databases to continuously monitor vaccine safety.
Enhanced Surveillance and Cohort Studies:
Enhanced surveillance involves more intensive monitoring of a specific population or group of interest. Cohort studies are prospective studies that follow a group of vaccinated individuals over time to assess vaccine safety. These studies provide more detailed and controlled data compared to passive or active surveillance.
Comparative Effectiveness Research:
Comparative effectiveness research compares the safety of different vaccines or vaccination schedules. By analyzing large datasets, researchers can evaluate the relative risks and benefits of vaccines and identify any safety concerns.
Signal Detection and Analysis:
Data mining and statistical techniques are used to identify potential safety signals from adverse event reports. Signals are further investigated through in-depth analysis to determine if there is a causal relationship between the vaccine and the adverse event.
Causality Assessment:
Similar to general pharmacovigilance, causality assessment methods (such as the Naranjo Algorithm, WHO-UMC System, and Bayesian methods) are used to evaluate the likelihood of a causal relationship between a vaccine and an adverse event.
Risk Communication and Public Awareness:
Effective communication strategies are crucial to ensure that healthcare providers and the public are informed about vaccine safety. This involves providing clear and accurate information about potential risks and benefits.
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
The safety monitoring in a clinical trail accompanies by common practices in safety monitoring, communicating safety information among stakeholders in a clinical trail.
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
The pharma aspirants can read the important information provided in this presentation about Pharmacovigilance which is necessary to qualify the interviews of the same field
pharmacoepidemiology is the study of use and effect of drugs in large number of population.
pharmacoepidemiology enhances or supplements the information from the preclinical studies.
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The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
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Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
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Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
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2. Methods
Passive surveillance
Spontaneous reports
Case series
Stimulated reporting
Active surveillance
Sentinel sites
Drug event monitoring
Registries
Targeted clinical investigations
Comparative observational studies
Cross sectional study
Case control study
Cohort study
Descriptive studies
Natural history of disease, Drug utilization study
3. Spontaneous Reports
A communication by consumers or healthcare professionals to a company or
Regulatory Authority, that describes one or more ADR in a patient, who has given the
drug.
It plays a major role in the, identification of safety signals once the drug is marketed.
Gives alerts on rare AEs that were not detected in earlier clinical trials or pre
marketing studies.
Provides important information on at risk groups, risk factors and clinical features of
known serious ADRs.
4. Case series
Series of case reports can provide evidence of an association of a drug and AEs.
Generally more useful for generating hypothesis than for verifying an association
between drug exposure and outcome.
Certain distinct adverse events occur more frequently with drug therapy, such as
anaphylaxis, aplastic anemia and Stevens-Johnson syndrome events such as these are
spontaneously reported for detailed and rapid follow-up
5. Stimulated Reporting
A method used to encourage and facilitate reporting by health professionals for new
products, or for limited period.
Online reporting of AE, systematic stimulation of reporting of AEs.
Drawbacks- data are often incomplete.
Not useful to generate accurate incidence rates.
6. Active surveillance
To ascertain completely the no. of AEs via a continuous pre-organized process. E.g. follow
up of patient treated with a particular drug.
More feasible to get comprehensive data on individual AE reports.
7. Sentinel Sites
Active surveillance carried out at Institutions, Nursing Homes and Hospitals etc.
provides information such as data from specific patient subgroups, drug abuse etc.
8. Drug Event Monitoring
Patients are identified by electronic prescription data or automated health insurance
claims.
A follow up questionnaire can be sent to each physician or patient at specified intervals.
Information on patient demographics, indication for treatment, duration of therapy,
dosage, clinical events, and reasons for discontinuation can be included in the
questionnaire.
9. Registries
A registry is a list of patients presenting with same characteristics. E.g. Disease
registry, drug registry, pregnancy registry etc.
Differs from each other depending on type of patient.
10. Comparative Observational Studies
Traditional epidemiologic methods are a key component in the evaluation of AEs.
Observational study designs are useful in validating signals from spontaneous
reports or case series.
11. Cross Sectional Studies
Data collected from a population of patients at a single point in time regardless of
exposure or disease status.
Primarily used to gather data for surveys or for ecological analysis. Best used to
examine the prevalence of a disease at one time point or to examine trends over
time, when data for serial time points can be captured.
12. Case Control Study
In this case of disease are identified. Controls or patients without the disease or
event of interest, are selected from the source population. Exposure status of the
two groups is compared using the odds ratio.
13. Cohort Study
A population at risk for the disease is followed over a time for the occurrence of
the disease or events. Information on exposure status is known throughout the
follow up and hence incident rates can be calculated.
Comparison cohorts of interest are selected on the basis of drug use and followed
over time.
Multiple AEs can also be investigated using the same data source in a cohort study.
14. Targeted Clinical Investigations
When significant risks are identified from pre-approval clinical trials, further clinical
studies might be called, to evaluate the mechanism of action for ADRs.
PK and PD studies might be conducted.
Specific studies to investigate potential drug-drug interactions and food-drug
interactions might be called.
15. Descriptive Studies
Primarily used to obtain the background rate of outcome events and/or to
establish the prevalence of the use of drugs in specified populations.
Natural History of Disease- Focused on the natural history of disease, including
the characteristics of diseased patient and the distribution of disease in selected
populations, as well as estimating the incidence and prevalence of potential
outcomes of interest.
Drug Utilization Study- These studies provide data on specific populations, such
as the elderly, children, or patients with hepatic or renal dysfunction, often stratified
by age, gender, concomitant medication, and other characteristics.