Pharmacovigilance involves monitoring approved drugs to detect adverse effects, assess risks, and prevent harm. It aims to improve patient safety by identifying unknown risks from drugs and informing regulatory decisions. Various methods are used, including spontaneous reporting of adverse drug reactions, active surveillance, and observational studies. Stringent pharmacovigilance is important given historical examples of drugs that caused significant harm after approval, demonstrating the need for ongoing monitoring of drug safety.
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.”
Drug Safety & Pharmacovigilance - Introduction - Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
These are some frequently asked questions in Pharmacovigilance Interview & its Preparation.
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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.”
Drug Safety & Pharmacovigilance - Introduction - Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
These are some frequently asked questions in Pharmacovigilance Interview & its Preparation.
"HANDS IN HANDS LEARNING"
FOR ENROLLMENT-
CONTACT US ON-
https://pristynresearch.com/
MAIL ID - pristynresearch@gmail.com
ADDRESS-
1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
2)T-21/4 ,Opposite To Expert Global, Garware Stadium Road , Software Technology Park of India(STPI), MIDC, Aurangabad-431001. Email: info@pristynresearch.com Call us: 09607709586
Pharmacovigilance is science of detection,
assessment, reporting and prevention of adverse
reactions to drug(s).
Major aims of pharmacovigilance are:
1. Early detection of hitherto unknown adverse
reactions and interactions
2. Detection of increases in frequency of (known)
adverse reactions
3. Identification of risk factors and possible
mechanisms underlying adverse reactions
4. Estimation of quantitative aspects of benefit/risk
analysis and dissemination of information needed to
improve drug prescribing and regulation.
An Individual Case Safety Report (ICSR) is a document that contains information about a single adverse event or suspected adverse reaction to a medicinal product. It is a critical component of pharmacovigilance, which is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.
ICSRs are typically generated by healthcare professionals, patients, or clinical trial investigators, and they include a detailed description of the adverse event, patient demographics, medical history, and details about the medicinal product(s) involved. The report also contains an assessment of the causal relationship between the adverse event and the medicinal product(s), as well as any medical interventions or outcomes that occurred.
ICSRs are essential for identifying potential safety issues with medicinal products and for assessing the risk-benefit profile of a product. They also help to ensure that regulatory authorities, such as the FDA or EMA, are notified of any safety concerns associated with a medicinal product.
ICSRs must comply with international reporting requirements, which specify the information that must be included in the report, as well as the timeframe for submission. The information in an ICSR must be accurate and complete to enable effective analysis and evaluation of the safety data.
ICSRs are a crucial aspect of pharmacovigilance and the regulatory process, as they provide valuable information for the ongoing evaluation of the safety of medicinal products. The prompt reporting of ICSRs is essential for ensuring the timely detection and assessment of any safety concerns associated with the use of medicinal products.
The NDA application is the vehicle through which drug sponsors, such as biotech and pharmaceutical companies, formally propose that the FDA approve a new pharmaceutical for sale and marketing
An overview of ICH-GCP guidelines of clinical trials.
Good clinical practice (GCP): a standard for the design , conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected.
ICH-GCP is an International Conference on Harmonization Good Clinical Practice.
The guideline was developed with consideration of the current good clinical practices of the European union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the world health organization
Concept of Pharmacovigilance, history and development of pharmacovigilance, WHO International drug monitoring programme, Pharmacovigilance programme of India
Pharmacovigilance Process Work Flow - Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance Process Work Flow for Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Organization and objectives of ICH, expedited reporting, ICSR, PSURs, post approval expedited reporting, pharmacovigilance Planning, good clinical practices
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
PHARMACOVIGILANCE COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated IN 202...Pristyn Research Solutions
Quick Job interview short guide For Pharma and all Life science jobseekers.All Medical | Biotech |Micro |B.Sc., M.Sc.
These are the commonly asked questions with their answers asked in job interviews. The file was updated in 2022.
https://pristynresearch.com/
MAIL ID - pristynresearch@gmail.com
FACEBOOK- https://www.facebook.com/pristynsolutions
INSTAGRAM- https://www.instagram.com/pristyn_res...
TWITTER- https://twitter.com/Pristynresearch
SLIDESHARE- https://www.slideshare.net/azherkhan5916
LINKEDIN- https://www.linkedin.com/in/pristyn-research-191072119/
ADDRESS-
1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
2)T-21/4, Opposite To Expert Global, Garware Stadium Road, Software Technology Park of India(STPI), MIDC, Aurangabad-431001. Email: info@pristynresearch.com Call us: 9028839789
Sample Questions are:
What is Pharmacovigilance (PV)?
What are the objectives of PV?
What is MedDRA?
WHAT ARE THE Role of Drug Safety
Associate?
What should narratives consist of?
What are Data assessments in PV?
Which products are covered by PV?
Methods of signal detection?
Why PV is required after clinical
trial?
What is an Adverse Drug Event (ADE)?
What
is the minimum criterion required
for a valid case according to WHO?
When
do you consider an event to be
serious?
What do you mean by causality?
Types of
Unsolicited reports
Sources of Solicited Reports
Name the core regulatory bodies
What is Volume 9A
What do you know
about E2a, E2b and E2c guidelines?
When do you consider a case to be medically confirmed?
What is CemFlow?
What is the yellow card in PV?
What are Comorbid conditions?
What is a medication error?
What is a signal?
Rechallenge
Dechallenge
What are WHO ART, WHO DD and MedDRA and the difference between them?
What is SUSAR?
Adverse Drug Reaction (ADR)
Effectiveness/risk
harm
Essential medicines
Frequency of ADRs
Individual Case Safety Report
ADR Reporting process in PV
VigiFlow
VigiMed
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Pharmacovigilance is science of detection,
assessment, reporting and prevention of adverse
reactions to drug(s).
Major aims of pharmacovigilance are:
1. Early detection of hitherto unknown adverse
reactions and interactions
2. Detection of increases in frequency of (known)
adverse reactions
3. Identification of risk factors and possible
mechanisms underlying adverse reactions
4. Estimation of quantitative aspects of benefit/risk
analysis and dissemination of information needed to
improve drug prescribing and regulation.
An Individual Case Safety Report (ICSR) is a document that contains information about a single adverse event or suspected adverse reaction to a medicinal product. It is a critical component of pharmacovigilance, which is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.
ICSRs are typically generated by healthcare professionals, patients, or clinical trial investigators, and they include a detailed description of the adverse event, patient demographics, medical history, and details about the medicinal product(s) involved. The report also contains an assessment of the causal relationship between the adverse event and the medicinal product(s), as well as any medical interventions or outcomes that occurred.
ICSRs are essential for identifying potential safety issues with medicinal products and for assessing the risk-benefit profile of a product. They also help to ensure that regulatory authorities, such as the FDA or EMA, are notified of any safety concerns associated with a medicinal product.
ICSRs must comply with international reporting requirements, which specify the information that must be included in the report, as well as the timeframe for submission. The information in an ICSR must be accurate and complete to enable effective analysis and evaluation of the safety data.
ICSRs are a crucial aspect of pharmacovigilance and the regulatory process, as they provide valuable information for the ongoing evaluation of the safety of medicinal products. The prompt reporting of ICSRs is essential for ensuring the timely detection and assessment of any safety concerns associated with the use of medicinal products.
The NDA application is the vehicle through which drug sponsors, such as biotech and pharmaceutical companies, formally propose that the FDA approve a new pharmaceutical for sale and marketing
An overview of ICH-GCP guidelines of clinical trials.
Good clinical practice (GCP): a standard for the design , conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected.
ICH-GCP is an International Conference on Harmonization Good Clinical Practice.
The guideline was developed with consideration of the current good clinical practices of the European union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the world health organization
Concept of Pharmacovigilance, history and development of pharmacovigilance, WHO International drug monitoring programme, Pharmacovigilance programme of India
Pharmacovigilance Process Work Flow - Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance Process Work Flow for Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Organization and objectives of ICH, expedited reporting, ICSR, PSURs, post approval expedited reporting, pharmacovigilance Planning, good clinical practices
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
PHARMACOVIGILANCE COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated IN 202...Pristyn Research Solutions
Quick Job interview short guide For Pharma and all Life science jobseekers.All Medical | Biotech |Micro |B.Sc., M.Sc.
These are the commonly asked questions with their answers asked in job interviews. The file was updated in 2022.
https://pristynresearch.com/
MAIL ID - pristynresearch@gmail.com
FACEBOOK- https://www.facebook.com/pristynsolutions
INSTAGRAM- https://www.instagram.com/pristyn_res...
TWITTER- https://twitter.com/Pristynresearch
SLIDESHARE- https://www.slideshare.net/azherkhan5916
LINKEDIN- https://www.linkedin.com/in/pristyn-research-191072119/
ADDRESS-
1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
2)T-21/4, Opposite To Expert Global, Garware Stadium Road, Software Technology Park of India(STPI), MIDC, Aurangabad-431001. Email: info@pristynresearch.com Call us: 9028839789
Sample Questions are:
What is Pharmacovigilance (PV)?
What are the objectives of PV?
What is MedDRA?
WHAT ARE THE Role of Drug Safety
Associate?
What should narratives consist of?
What are Data assessments in PV?
Which products are covered by PV?
Methods of signal detection?
Why PV is required after clinical
trial?
What is an Adverse Drug Event (ADE)?
What
is the minimum criterion required
for a valid case according to WHO?
When
do you consider an event to be
serious?
What do you mean by causality?
Types of
Unsolicited reports
Sources of Solicited Reports
Name the core regulatory bodies
What is Volume 9A
What do you know
about E2a, E2b and E2c guidelines?
When do you consider a case to be medically confirmed?
What is CemFlow?
What is the yellow card in PV?
What are Comorbid conditions?
What is a medication error?
What is a signal?
Rechallenge
Dechallenge
What are WHO ART, WHO DD and MedDRA and the difference between them?
What is SUSAR?
Adverse Drug Reaction (ADR)
Effectiveness/risk
harm
Essential medicines
Frequency of ADRs
Individual Case Safety Report
ADR Reporting process in PV
VigiFlow
VigiMed
ABBOTTS
COGNIZANT
I 3 GLOBAL DRUG
SAFETY
LAURUS LABS
PARAXEL
SRISTEK
ACCENTURE
CREST.
I GATE PATNI
COMPUTERS
MAHINDRA
SATYAMBSG
PIRAMAL
SUN
PHARMA
ALEMBIC
DIAGNOSEAR
CH
ICON
MAKROCARE
PPD
SYMOGEN
APC PHARMA.
DR REDDY’S
iMEDGlobal,
MANKIND
QUANTUM
SOLUTIONS
SYNOGEN
APCER
ECRON
ACUNOVA
IMS HEALTH
MEDHIMALAYAS
QUINTILES
TAKE
SOLUTIONS
APCER
EMCURE
INC RESEARCH
MEDPACE.
SCIFORMIX
RATIOPHARM
TCS
ASTRAZENECA
FDC
Infocorp
Soft
Solutions
MICRO LABS
RX MD
THOMSON
REUTERS
AUROBINDO
FORTIS
HEALTH CARE
INVENTIVE
MSD (MERCK)
SANTHA
BIOTECH
USV
LIMITED
BESTOCHEM
G7 INFOTECH
IPCA
LABORATORIES
NEKTAR
THERAPEUTICS
SCIFORMIX.
VIMTA LABS
BIOCAD
GENPACT
IPLEX
NORWICH
CLINICAL SERVICES
SHANTHA
BIOTECHNICS
WIPRO
BIOCON
GRANULES
JUBILIANT
BIOSYS NOVARTIS
SIRO
CLINPHARM
WNS
BIOLOGICAL E.
LTD
GVK
KINAPSE
NOVO NORDISK
SP softtech
WOCKHARD
T
BLUEFISH
HCL
LAMBDA
OMNICARECLINICA
L RESEARCH
SRI KRISHNA
PHARMA
4C
Pharma
Solutions
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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.
a presentation in CME activities by Saad Specialist Hospital, KSA
Pharmacovigilance - a regulator's perspectiveTGA Australia
This presentation provides an overview of the TGA's Pre-market and Post-market pharmacovigilance methods. It describes the role and content of Risk Management Plans as well as adverse event reporting and signal detection and investigation.
Managing an end to end Pharmacovigilance system from affiliates to regulatory...MyMeds&Me
MyMeds&Me CEO Dr. Andrew Rut explores how technology can help address the challenges facing Pharmacovigilance teams.
He reviews how the latest intake technology can influence end-user experience and effectiveness, as well as internal value & efficiency.
He concludes that a focus on simplifying case intake re-shapes the traditional PV system, enabling Pharma companies to reap significant process and efficiency benefits.
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
PHARMACOVIGILANCE TERMINOLOGIES ASKED IN INTERVIEWS-
For more information regarding PHARMACOVIGILANCE, CLINICAL RESEARCH, CLINICAL DATA MANAGEMENT & DRUG REGULATORY AFFAIRS kindly contact us on 9028839789
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
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.
Pharmacovigilance is a scientific discipline concerned with the collection, detection, assessment, monitoring, and prevention of adverse effects of pharmaceutical products.
Pharmacovigilance is a branch of Pharmacoepidemiology and is restricted to the study of adverse effects of drugs.
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
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The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
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NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
2. Introduction
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"Dying from a disease is sometimes unavoidable. But, dying from
an adverse drug reaction is unacceptable“
Pharmacovigilance is the science and activities related to;
o Detection,
o Assessment,
o Understanding
o Prevention of
Adverse effects or
Any other possible drug related problem.
3. Contd.
o The etymological roots are: pharmakon (Greek), “drug;” and
vigilare (Latin), “to keep awake or alert, to keep watch.”
o Pharmacovigilance is used to describe the processes for
monitoring and evaluating ADRs
o Recently, its concerns have been widened to include
herbals, traditional and complementary medicines, blood
products, biologicals, medical devices and vaccines“
(WHO, 2002)
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7. ADVERSE DRUG REACTION
o Adverse Drug Reaction: A response to a drug which is noxious
and unintended at the therapeutic level i.e. occurs at doses normally
used in man for the prophylaxis, diagnosis, or therapy of disease, or
for the modification of physiological function.
o 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 the treatment.
o Side Effect :Any unintended effect of a pharmaceutical product
occurring at doses normally used in man which is related to the
pharmacological properties of the drug.
8. Severity of ADR:
o Minor: No need of therapy, antidote,
or hospitalization
o Moderate: Requires drug change , specific
treatment, hospitalization
o Severe: Potentially life threatening,
permanent damage, and
prolonged hospitalization.
o Lethal: Directly or indirectly leads
to death.
MODERATE
SEVERE
LETHAL
LETHAL
9. PREDISPOSING FACTORS FOR ADRs
o The main clinical factors which increase the chance that patients
will experience an adverse reaction are listed below:
o Age
- the elderly and neonates are at greatest risk
o Gender
- women are generally at greater risk
o Race
- ethnic origin may affect drug metabolism
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10. Contd.
o Impaired excretory mechanisms
- reduced hepatic and/or renal function
o Polypharmacy
- drug interactions
o Any previous history of an adverse drug reaction
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12. FUNCTIONS OF PHARMACOVIGILANCE
Collects reports , data, ADR’s etc.
Analyses and assesses the reports.
Promotes the safe use of drugs.
Creates appropriate structures and means of communication needed to
perform its tasks.
Identifying new information about hazards associated with medicines.
Preventing harm to the patients.
13. PHARMACOVIGILANCE - A SHARED
RESPONSIBILITY
Company - legally and morally responsible for
monitoring their product.
Regulatory authorities – are responsible for the
safety of the newly licensed drugs.
Doctors – responsible for prescription of safe drugs
to patients.
Pharmacist & nurse – responsible for monitoring of
drug therapy given to patients and identification and
reporting of ADRs.
14. AIM OF PHARMACOVIGILANCE
o To improve public health and safety in relation to
medicines, cosmetics, herbal products etc.
o Early detection of unknown adverse reactions and interactions
o Identification of risk factors and possible mechanisms underlying
adverse reaction.
o Estimation of quantitative aspects of benefit/risk analysis of information
needed to improve drug prescribing and regulation.
o To promote understanding, education and clinical training in
pharmacovigilance and its effective communication to health
professionals and the public.
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17. PHARMACOVIGILANCE - DATA SOURCES
Spontaneous Reporting Systems
• National PV Centre / Drug Authority
Drug Bulletins
Adverse Reaction Case Reports by the MA (Master Agreement)
Periodic Safety Update Report (PSUR) provided by MA holder
20. ADR Detection Methods
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• Passive surveillance
Spontaneous reporting system (SRS)
Case series
• Stimulated reporting
• Active surveillance
Sentinel sites
Drug event monitoring
Registries
• Comparatives observational studies
Cross sectional study
Case control study
Cohort study
• Targeted clinical investigations
Descriptive studies
Natural history of disease
Drug utilization study
21. SPONTANEOUS REPORTS
A communication by consumers or health care professionals to a
company or Regulatory Authority that describes one or more
ADR in a patient who was given the drug.
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.
22. CASE SERIES
Series of case reports can provide evidence of an association of a
drug and AE.
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 anaemia, toxic epidermal
necrosis and Stevens- Johnson Syndrome.
23. STIMULATED REPORTING
A method used to encourage and facilitate reporting by health
professionals for new products.
On line reporting of AE; Systematic stimulation of reporting of AE.
Limitations
Data are often incomplete. Not useful to generate accurate
incidence rates.
ACTIVE SURVEILLANCE
More feasible to get comprehensive data on individual AE reports.
To ascertain completely the number of AE via a continuous pre-
organised process. E g : Follow up of patients treated with a
particular drugs.
24. SENTINEL SITES
Active surveillance carried out at Institutions, Nursing homes, hospitals
etc.
Provide information such as data from specific patient subgroups, drug
abuse etc.
LIMITATIONS
Selection biasness, Small number of patients and Increased costs.
25. 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 (including start dates), dosage, clinical
events, and reasons for discontinuation can be included in the
questionnaire.
Limitations:
Poor physician and patient response rates and unfocused nature of
data collection can obscure important signals.
26. REGISTRIES
A registry is a list of patients presenting with same characteristics.eg:
Disease registry, drug registry or pregnancy registry.
Differ from each other depending on type of patient.
Information can be obtained by using standard questionnaire.
Comparative Observational Studies
Traditional epidemiologic methods are a key component in the
evaluation of adverse events.
Observational study designs are useful in validating signals from
spontaneous reports or case series.
27. Types of designs
Cross sectional study.
Case control study.
Cohort study.
Cross-sectional study (survey)
Data collected from a population of patients at a single point in time
(or interval of time) regardless of exposure or disease status.
Primarily used to gather data for surveys or for ecological analyses
Major drawback:
Relationship between exposure and outcome cannot be directly
addressed.
28. Case-control study
Cases of disease (or events) are identified.
Controls, or patients without the disease or event of interest, are then
selected from the source population.
The controls should be selected : the prevalence of exposure among
the controls represents the prevalence of exposure in the source
population.
Exposure status of the two groups is then compared.
29. Cohort study
A population-at-risk for the disease (or event) is followed over time for
the occurrence of the disease (or event).
Information on exposure status is known throughout the follow-up and
hence incidence rates can be calculated.
Comparison cohorts of interest are selected on the basis of drug use
and followed over time.
Multiple adverse events can also be investigated using the same data
source in a cohort study.
30. Descriptive studies
Primarily used to obtain the background rate of outcome events and/or
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 patients 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.
31. Scope of Pharmacovigilance
Improve patient care and safety in relation to the use of
medicines, and all medical and paramedical interventions.
Improve public health and safety in relation to the use of medicines.
Contribute to the assessment of benefit, harm, effectiveness and risk
of medicines,
Encouraging their safe, rational and more effective (including cost-
effective) use, and
Promote understanding, education and clinical training in
pharmacovigilance and its effective communication to the public .
32. To monitor Adverse Drug Reactions (ADRs) in population.
To create awareness amongst health care professionals about the
importance of ADR reporting in India.
To monitor benefit-risk profile of medicines.
Generate independent, evidence based recommendations on the safety
of medicines.
Support the CDSCO for formulating safety related regulatory
decisions for medicines.
Create a national centre of excellence at par with global drug safety
monitoring standards
33. ORGANIZATIONS INVOLVED
WHO – collaborating center for international drug monitoring is
Uppsala monitoring centre provides activities and events in PV.
CIOMS – council for international organizations of medical sciences-
safety information communication between regulators and industries.
ICH – international conference on harmonization discusses scientific
and technical aspects of product registration.
WHO-ART – WHO adverse reaction terminology for coding clinical
information to drug therapy.
34. India's Central Drugs Standard Control Organization
(CDSCO)
o Headquartered in New Delhi, the CDSCO is India's main regulatory body
for pharmaceuticals and medical devices.
o The Drug Controller General of India (DCGI) is responsible for the
regulation of pharmaceuticals and medical devices.
o The DCGI is advised by the Drug Technical Advisory Board (DTAB) and
the Drug Consultative Committee (DCC).
o The CDSCO establishes safety, efficacy, and quality standards for
pharmaceuticals and medical devices.
o It publishes and updates the Indian Pharmacopoeia, a list of regulated
pharmaceuticals and devices.
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37. Product recall due to toxicity
A product recall is a request to return to the maker a batch or an
entire production run of a product, usually due to the discovery of
safety issues.
The recall is an effort to limit liability for corporate negligence
(which can cause costly legal penalties) and to improve or avoid
damage to publicity.
Recalls are costly to a company because they often entail
replacing there called product or paying for damage caused by use,
although possibly less costly than consequential costs caused by
damage to brand name and reduced trust in the manufacturer.
39. Drug name Withdrawn Remarks
Thalidomide 1950s–1960s
Withdrawn because of risk
of teratogenicity; returned
to market for use
in leprosy and multiple
myeloma under
FDA orphan drug rules.
Lysergic acid
diethylamide (LSD)
1950s–1960s
Marketed as a psychiatric
drug; withdrawn after it
became widely used
recreationally.
Diethylstilbestrol 1970s
Withdrawn because of risk
of teratogenicity.
Phenformin and Buformin 1978
Withdrawn because of risk
of lactic acidosis.
Ticrynafen 1982
Withdrawn because of risk
of hepatitis.
40. Phenacetin 1983
An ingredient in "A.P.C." tablet; withdrawn
because of risk of cancer and kidney disease.
Methaqualone 1984
Withdrawn because of risk
of addiction and overdose.
Zimelidine 1983
Withdrawn worldwide because of risk
of Guillain-Barré syndrome.
Nomifensine (Merital) 1986
Withdrawn because of risk of haemolytic
anaemia.
Triazolam 1991
Withdrawn in the United Kingdom because
of risk of psychiatric adverse drug reactions.
This drug continues to be available in the
U.S.
Terodiline (Micturin) 1991 Prolonged QT interval.
Temafloxacin 1992
Withdrawn in the United States because of
allergic reactions and cases of haemolytic
anemia, leading to three patient deaths.
41. restat (Alredase) 1997
Withdrawn because of risk of
severe hepatotoxicity
rfenadine (Seldane, Triludan) 1998
Withdrawn because of risk of cardiac
arrhythmias; superseded by fexofenadine
befradil (Posicor) 1998
Withdrawn because of dangerous interactions
with other drugs
retinate 1990s Risk of birth defects; narrow therapeutic index
capone (Tasmar) 1998 Hepatotoxicity
mazepam (Restoril,
hypnos, Normison,
mestan, Tenox, Norkotral)
1999
Withdrawn in Sweden and Norway because of
diversion, abuse, and a relatively high rate of
overdose deaths in comparison to other drugs
of its group. This drug continues to be
available in most of the world including the
U.S., but under strict controls.
temizole (Hismanal) 1999
Arrhythmias because of interactions with
other drugs
42. Conclusion
Current progress in pharmacovigilance is marked by
increasing use of databases and by attempts to make the
process more proactive and organized.
Attempts are being made to augment the spontaneous, random nature
of the generation of pharmacovigilance data and to make the process
more systematic and structured.
There has been a coming together of academic, regulatory and
industrial interests across many countries to produce the guidance
documents for the conduct of pharmacoepidemiology studies.