Organization and objectives of ICH, expedited reporting, ICSR, PSURs, post approval expedited reporting, pharmacovigilance Planning, good clinical practices
pharmacovigilance, adverse effects, causality assessment,methods, who-umc method with case study, FOR DOWNLOAD PPT MAIL ME ON iamgauravchhabra@gmail.com
Causality Assessment in PharmacovigilanceClinosolIndia
Ā
Causality assessment is the process of determining whether a particular drug or medical intervention is the cause of an adverse event or reaction that has occurred in a patient. The following are some key principles and factors that are considered in causality assessment:
Temporal relationship: The timing of the adverse event in relation to the drug or intervention is a key factor in causality assessment. If the adverse event occurs shortly after the drug is administered or the intervention is performed, this may suggest a causal relationship.
Biological plausibility: The biological mechanisms by which the drug or intervention could cause the adverse event should be considered. If there is a plausible biological mechanism for the adverse event, this may support a causal relationship.
Alternative explanations: Other factors that could have caused the adverse event, such as pre-existing medical conditions, should be considered and ruled out before attributing the event to the drug or intervention.
Dose-response relationship: If there is a clear dose-response relationship between the drug or intervention and the adverse event, this may suggest a causal relationship.
Rechallenge: If the adverse event reoccurs when the drug or intervention is readministered, this may provide further evidence for a causal relationship.
There are several methods for conducting causality assessment, including the Naranjo algorithm, the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) system, and the Liverpool Causality Assessment Tool (LCAT). These methods use different criteria and scoring systems to evaluate the likelihood of a causal relationship between the drug or intervention and the adverse event.
GCP: An international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.
PV: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
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.
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
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
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADRāS
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
Pharmacovigilance AND ADVERSE DRUG REACTIONS.
MONITORING REPORTING ROLE OF PHARMACIST.
CLASSIFICATION OF ADR. MECHANISM OF ADR
ROLE OF PHARMACIST IN MANAGING ADR. AUGMENTED, BIZZARE, CONTINOUS, DELAYED, END OF TREATMENT, ABCD, ABCDE.
Organization and objectives of ICH, expedited reporting, ICSR, PSURs, post approval expedited reporting, pharmacovigilance Planning, good clinical practices
pharmacovigilance, adverse effects, causality assessment,methods, who-umc method with case study, FOR DOWNLOAD PPT MAIL ME ON iamgauravchhabra@gmail.com
Causality Assessment in PharmacovigilanceClinosolIndia
Ā
Causality assessment is the process of determining whether a particular drug or medical intervention is the cause of an adverse event or reaction that has occurred in a patient. The following are some key principles and factors that are considered in causality assessment:
Temporal relationship: The timing of the adverse event in relation to the drug or intervention is a key factor in causality assessment. If the adverse event occurs shortly after the drug is administered or the intervention is performed, this may suggest a causal relationship.
Biological plausibility: The biological mechanisms by which the drug or intervention could cause the adverse event should be considered. If there is a plausible biological mechanism for the adverse event, this may support a causal relationship.
Alternative explanations: Other factors that could have caused the adverse event, such as pre-existing medical conditions, should be considered and ruled out before attributing the event to the drug or intervention.
Dose-response relationship: If there is a clear dose-response relationship between the drug or intervention and the adverse event, this may suggest a causal relationship.
Rechallenge: If the adverse event reoccurs when the drug or intervention is readministered, this may provide further evidence for a causal relationship.
There are several methods for conducting causality assessment, including the Naranjo algorithm, the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) system, and the Liverpool Causality Assessment Tool (LCAT). These methods use different criteria and scoring systems to evaluate the likelihood of a causal relationship between the drug or intervention and the adverse event.
GCP: An international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.
PV: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
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.
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
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
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADRāS
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
Pharmacovigilance AND ADVERSE DRUG REACTIONS.
MONITORING REPORTING ROLE OF PHARMACIST.
CLASSIFICATION OF ADR. MECHANISM OF ADR
ROLE OF PHARMACIST IN MANAGING ADR. AUGMENTED, BIZZARE, CONTINOUS, DELAYED, END OF TREATMENT, ABCD, ABCDE.
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
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An EFL lesson about the current events in Palestine. It is intended to be for intermediate students who wish to increase their listening skills through a short lesson in power point.
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It is possible to hide or invisible some fields in odoo. Commonly using āinvisibleā attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
Macroeconomics- Movie Location
This will be used as part of your Personal Professional Portfolio once graded.
Objective:
Prepare a presentation or a paper using research, basic comparative analysis, data organization and application of economic information. You will make an informed assessment of an economic climate outside of the United States to accomplish an entertainment industry objective.
Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
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This slides describes the basic concepts of ICT, basics of Email, Emerging Technology and Digital Initiatives in Education. This presentations aligns with the UGC Paper I syllabus.
The Roman Empire A Historical Colossus.pdfkaushalkr1407
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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 Caesarās dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empireās birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empireās society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
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.
Acetabularia Information For Class 9 .docxvaibhavrinwa19
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Acetabularia acetabulum is a single-celled green alga that in its vegetative state is morphologically differentiated into a basal rhizoid and an axially elongated stalk, which bears whorls of branching hairs. The single diploid nucleus resides in the rhizoid.
Biological screening of herbal drugs: Introduction and Need for
Phyto-Pharmacological Screening, New Strategies for evaluating
Natural Products, In vitro evaluation techniques for Antioxidants, Antimicrobial and Anticancer drugs. In vivo evaluation techniques
for Anti-inflammatory, Antiulcer, Anticancer, Wound healing, Antidiabetic, Hepatoprotective, Cardio protective, Diuretics and
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Francesca Gottschalk from the OECDās Centre for Educational Research and Innovation presents at the Ask an Expert Webinar: How can education support child empowerment?
7. ā¢ Everytime we give a drug we take a risk
ā¢ Public and professional concern about
these matters first arose in the late 19th
century.
ā¢ In 1922, there was an enquiry into the
JAUNDICE associated with the use of
SALVARSAN, an organic arsenical used in
the treatment of Syphillis.
8. ā¢ In 1937 in USA,
107 people died from taking
an Elixir Of Sulfalinamide
that contained the Solvent
Di-ethylene Glycol
This led to establishment of FOOD AND DRUG
ADMINISTRATION (FDA), which was given the task
of enquiring into the safety of new drugs before
allowing them to be marketed
9.
10. ā¢ In 1961, it was reported in West Germany that
there was an outbreak of PHOCOMELIA
(hypoplastic and aplastic limb deformities) in
the new born babies.
11. ā¢ The Thalidomide Incident led to
development of a much more
sophisticated approach to preclinical
testing & clinical evaluation of drugs
before marketing, & greatly increased
awareness of adverse effect of drugs and
methods of detecting them.
13. Adverse event
ā¢ Any untoward medical occurrence that may
present during treatment with a
pharmaceutical product
ā¢ But doesnāt have a causal relation with this Rx
14. Adverse drug reaction
ā¢ Response which is noxious and unintended ,
which occurs at doses normally used in
humans for the Px, Dx or therapy of the
disease or for modification of physiological
function
ā¢ All ADR are AE but not vice versa
15. Side effect
ā¢ Any unintended effect (unwanted but unavoidable of a product
occurring at normal dose which is related to the pharmacological
properties of the drug )
Unwanted but often unavoidable pharmacodynamic effects of a drug at
therapeutic dosesā
As Extension of therapeutic effect
Atropine - dry mouth
As distinctly different effect
Promethazine ā Sedation.
Side effect exploited for therapeutic use
Codeine ā Diarrhoea
22. ā¢ Ever-increasing number of new drugs in
the market
ā¢ Number of drugs prescribed are high
ā¢ Medication errors
ā¢ Lack of awareness of a system for
reporting ADRāS
23. Common causes
ļ± Failing to take the correct dose at the correct times
ļ±Overdosing
ļ± Allergies to chemical components of the medicine
ļ± Combining the medicine with alcohol
ļ± Taking other drugs or preparations that interact with
the medicine
25. ļ¶ Age
ļ¶ Genetic influences
ļ¶ Concurrent diseases (Renal, Liver, Cardiac)
ļ¶ Previous allergies or adverse drug reactions
ļ¶ Compliance with dosing regimen
ļ¶ Total number of medications
ļ¶ Misc. (diet, smoking, environmental
exposure)
27. Idiosyncracy
ā¢ Genetically determined abnormal reaction to
the agent
ā¢ Interaction of the drug with the unique
feature of the individual
ā¢ Produces uncharacteristic reaction
29. Rawlins and Thompson classification -1991
Type A Predictable
-More Common(80%)
-Augmented normal
response
-Dose dependent
-Hypo/Hyper response
Type B Unpredictable
-Less common (6-10%)
-Abnormal/bizarre
response
-Dose Independent
-Genetic/Immunological
30. Type A Predictable
-Low Mortality
-d/t Pharmacological activity
of drug
-Rx : Dose Adjustment
Eg., S/E, Toxic effect,
Withdrawal effect
Diarrhea due to antibiotics
Type B Unpredictable
-High Mortality
-d/t Patient peculiarities
-Rx : Withdrawal of drug
Eg., Allergy, Idiosyncrasy
Hypersensitivity to
penicillin
Types of ADRās ā Contdā¦
31. Type C (Chronic)
- Reactions due to prolonged use of the
Drug.
e.g. HPA axis suppression by corticosteroids
32. Type D (Delayed)
ā¢ Occuring years after the treatment
ā¢ Can be due to accumulation
E.g : Teratogenisis
33. Type E (End of use)
ā¢ Occur on withdrawal especially when drug
is stopped abruptly
E.g.
ā¢ Steroid withdrwal
34. Type F (Failure of drug)
ā¢ Underdosing of medications
ā¢ Drug interactions
Eg: OCP failure
35. Type Mnemonic Example
A Augmented Diarrohea due to antibiotics
B Bizzare Hypersensitivity due to
penicillin
C Chronic Steroid decrease HPA axis
D Delayed Teratogenicity, carcinogenesis
E End of use Precipitation of MI by Ī²
blocker withdrawal
F Failure OCP failure
Types of ADRās in Brief:
36. Mild No need of Rx, antidote or Hospitalization
Moderate Requires drug change specific
Rx, hospitalization
Severe Potentially life threatening; permanent
damage, and prolonged hospitalization.
Lethal Directly or indirectly leads to
death
ADR GRADING
38. Who can get an ADR?
Anyone who takes medicine
Differential diagnosis should include
the possibility of an ADR if the
patient is taking any form of
medication
39. If symptoms,
ļ¼Appears soon after a new drug is
started
ļ¼Appears after an increase in dose
ļ¼Disappears when the drug is stopped
ļ¼Reappears when a drug is restarted
When To Report :
43. ā¢ SPONTANEOUS REPORTING SYSTEM :
ā¢ Communication by HCP/ consumers/ pharma
company to NCC/CDSCO/AMC
44. Why is ADR Monitoring Needed?
ā¢ Unreliability of pre-clinical studies
ā¢ Limitations of pre-marketing phases of clinical trial
ā¢ Aggressive marketing strategies of pharmaceutical companies
45. Limitations of pre-marketing phases of clinical
trial
ā¢ Conducted in strictly controlled conditions, in highly
selected and limited number of patients
ā¢ Fails to detect rare and delayed ADRs
ā¢ Do not provide data ā
- In children, elderly patients, pregnant/lactating
women
- In patient suffering from other disease
- In patient receiving other drugs
- On interpopulation difference
46. What to report
ā¢ All types of suspected ADRs irrespective of
whether they r known / uk, serious or non
serious , frequent or rare, and regardless of an
established causal relationship
ā¢ Pharma meds and vaccines, drugs used in
traditional meds , medical devices, contrast
media
ā¢ Any AE
47. ā¢ Doctors
ā¢ Dentists
ā¢ Nurses
ā¢ Pharmacists
Health care
professionals
ā¢ Patients
ā¢ Consumers
ā¢ Relatives
Others
Who can report ??
48. Problems in ADR reporting
Patient Related
(i) Cannot recognize ADR
(ii) Recognize but do not
report
(iii) Illiteracy
Health professional
Related
(i) Cannot recognize ADR
(ii) Recognize but do not report due
to
- Lack of time
- Hesitancy
- Ignorance
- Fear of litigation
- Guilt
ā¢
55. Causality Assessment
ā¢ Routine procedure in Pharmacovigilance
ā¢ Relationship of cause & effect
ā¢ Most outcomes : multiple interacting causes
ā¢ Aim : to define contribution due to drugs
ā¢ Problems:
ADRs rarely specific
Diagnostic tests usually absent
Re challenge rarely ethically justified
56. Causality Assessment Methods
Algorithmic:
Series of questions
Answers are weighted
Overall score determines causality category
e.g. Naranjoās scale
Probalistic:
Set of explicitly defined causality categories
e.g. WHO UMC method
57. Questions Yes No Donāt
Know
1) Are there previous conclusive reports on this reaction? +1 0 0
2) Did the ADR appear after the suspected drug was
administered?
+2 -1 0
3) Did the ADR improve when the drug was discontinued? +1 0 0
4) Did the ADR appear with re-challenge? +2 -1 0
5) Are there alternative causes for the ADR? -1 +2 0
6) Did the reaction appear when placebo was given? -1 +1 0
7) Was the drug detected in blood at toxic levels? +1 0 0
8) Was the reaction more severe when the dose was
increased, or less severe when the dose was decreased?
+1 0 0
9) Did the patient have a similar reaction to the same or
similar drug in any previous exposure?
+1 0 0
10) Was the ADR confirmed by any objective evidence? +1 0 0
58. The Naranjo Probability Scale
The score :-
ā„ 9 = Definite
5-8 = Probable
1-4 = Possible
0 = Doubtful
70. Take home messageā¦
ā¢ Every drug which has an effect has an adverse effect every
time a drug is given risk is involved
ā¢ For rational use of drug not only its clinical indications are
important but the knowledge of adverse effects as well
ā¢ Early detection of adverse effects and its proper
management can be life saving in many situations
ā¢ ADR Reporting (Pharmacovigilance) plays a important
role in the evolution and life history of a drug