This document discusses adverse drug reactions (ADRs). It defines ADRs and provides various classifications based on type, onset, and severity. It also outlines methods for detecting, reporting, and assessing causality of ADRs. Key points covered include pre-marketing and post-marketing surveillance strategies, the roles of healthcare professionals in detection, and the importance of reporting all suspected ADRs to pharmacovigilance centers. Preventing ADRs requires rational prescribing, risk communication, and close patient monitoring.
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
Adverse drug reaction , types ,Detection and Reporting,severity and seriousness(Hartwig'severity assessment), preventibility(Schumock and thornston) and predictability, causality assessment Naranjo"s algotithm, WHO UMC causality scale
Reporting and Management of Adverse Drug ReactionSoniya Sunil
Reporting and Management of Adverse Drug Reactions.
Pharmacy Practice
Semester 7, B. Pharm
Soniya M. Sunil
Mar Dioscorus College of Pharmacy, Trivandrum.
pharmacovigilance from pharmaceutical administration topic presented by konatham kumar reddy from chilkur balaaji college of pharmacy hyderabad telangana
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
Adverse drug reaction , types ,Detection and Reporting,severity and seriousness(Hartwig'severity assessment), preventibility(Schumock and thornston) and predictability, causality assessment Naranjo"s algotithm, WHO UMC causality scale
Reporting and Management of Adverse Drug ReactionSoniya Sunil
Reporting and Management of Adverse Drug Reactions.
Pharmacy Practice
Semester 7, B. Pharm
Soniya M. Sunil
Mar Dioscorus College of Pharmacy, Trivandrum.
pharmacovigilance from pharmaceutical administration topic presented by konatham kumar reddy from chilkur balaaji college of pharmacy hyderabad telangana
Introduction to adverse drug reactions
Definitions and classification of ADRs
Detection and reporting
Methods in Causality assessment
Severity and seriousness assessment
Predictability and preventability assessment
Management of adverse drug reactions
Pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines.
pharmacovigilance, adverse effects, causality assessment,methods, who-umc method with case study, FOR DOWNLOAD PPT MAIL ME ON iamgauravchhabra@gmail.com
Acetabularia Information For Class 9 .docxvaibhavrinwa19
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.
Introduction to adverse drug reactions
Definitions and classification of ADRs
Detection and reporting
Methods in Causality assessment
Severity and seriousness assessment
Predictability and preventability assessment
Management of adverse drug reactions
Pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines.
pharmacovigilance, adverse effects, causality assessment,methods, who-umc method with case study, FOR DOWNLOAD PPT MAIL ME ON iamgauravchhabra@gmail.com
Acetabularia Information For Class 9 .docxvaibhavrinwa19
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.
Model Attribute Check Company Auto PropertyCeline George
In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
Honest Reviews of Tim Han LMA Course Program.pptxtimhan337
Personal development courses are widely available today, with each one promising life-changing outcomes. Tim Han’s Life Mastery Achievers (LMA) Course has drawn a lot of interest. In addition to offering my frank assessment of Success Insider’s LMA Course, this piece examines the course’s effects via a variety of Tim Han LMA course reviews and Success Insider comments.
Palestine last event orientationfvgnh .pptxRaedMohamed3
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.
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
The Roman Empire A Historical Colossus.pdfkaushalkr1407
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.
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 Empire’s 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.
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.
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
June 3, 2024 Anti-Semitism Letter Sent to MIT President Kornbluth and MIT Cor...Levi Shapiro
Letter from the Congress of the United States regarding Anti-Semitism sent June 3rd to MIT President Sally Kornbluth, MIT Corp Chair, Mark Gorenberg
Dear Dr. Kornbluth and Mr. Gorenberg,
The US House of Representatives is deeply concerned by ongoing and pervasive acts of antisemitic
harassment and intimidation at the Massachusetts Institute of Technology (MIT). Failing to act decisively to ensure a safe learning environment for all students would be a grave dereliction of your responsibilities as President of MIT and Chair of the MIT Corporation.
This Congress will not stand idly by and allow an environment hostile to Jewish students to persist. The House believes that your institution is in violation of Title VI of the Civil Rights Act, and the inability or
unwillingness to rectify this violation through action requires accountability.
Postsecondary education is a unique opportunity for students to learn and have their ideas and beliefs challenged. However, universities receiving hundreds of millions of federal funds annually have denied
students that opportunity and have been hijacked to become venues for the promotion of terrorism, antisemitic harassment and intimidation, unlawful encampments, and in some cases, assaults and riots.
The House of Representatives will not countenance the use of federal funds to indoctrinate students into hateful, antisemitic, anti-American supporters of terrorism. Investigations into campus antisemitism by the Committee on Education and the Workforce and the Committee on Ways and Means have been expanded into a Congress-wide probe across all relevant jurisdictions to address this national crisis. The undersigned Committees will conduct oversight into the use of federal funds at MIT and its learning environment under authorities granted to each Committee.
• The Committee on Education and the Workforce has been investigating your institution since December 7, 2023. The Committee has broad jurisdiction over postsecondary education, including its compliance with Title VI of the Civil Rights Act, campus safety concerns over disruptions to the learning environment, and the awarding of federal student aid under the Higher Education Act.
• The Committee on Oversight and Accountability is investigating the sources of funding and other support flowing to groups espousing pro-Hamas propaganda and engaged in antisemitic harassment and intimidation of students. The Committee on Oversight and Accountability is the principal oversight committee of the US House of Representatives and has broad authority to investigate “any matter” at “any time” under House Rule X.
• The Committee on Ways and Means has been investigating several universities since November 15, 2023, when the Committee held a hearing entitled From Ivory Towers to Dark Corners: Investigating the Nexus Between Antisemitism, Tax-Exempt Universities, and Terror Financing. The Committee followed the hearing with letters to those institutions on January 10, 202
Digital Tools and AI for Teaching Learning and Research
ADRppt.pptx
1. ADVERSE DRUG
REACTIONS
Presented By:
Kajal Rajdev
M.Pharm (IInd Semester)
Department of Pharmacology
ISF College of Pharmacy
Moga, Punjab
Checked and Confirmed By:
Dr. Sidharth Mehan
Associate Professor
Department of Pharmacology
ISF College of Pharmacy
(ISFCP)
2. Definition of ADR
Classification of ADR
Detection of ADR
Reporting of ADR
Causality Assesment
Prevention of ADRs
Terminology of ADRs
CONTENTS
3. Definition Of Adverse Drug Reactions
•According to WHO (1972)
“A response to a drug which
is noxious and unintended and
which occurs at doses
normally used in man for
prophylaxis, diagnosis, or
therapy of disease or for the
modification of physiologic
function”.
4. Classification of ADRs
Depending upon……..
Type of reaction:
•Type A
•Type B
•Type C
•Type D
•Type E
•Type F
Onset of event: Acute (<60 minutes)
Sub-acute (1-24 hrs)
Latent (>2 days)
Severity: Minor, Moderate, Severe, Lethal ADRs.
5. • A (Dose Related)
• Bizzare (Non-Dose Related)
• Chronic (Dose Related and Time Related)
• Delayed (Time Related)
• End of Use (Withdrawal)
• Failure (Unexpected Failure of Therapy)
6. Features
• Common Related to the pharmacologic action of the drug – exaggerated
pharmacologic response
• Predictable
• Low mortality
Example
•Dry mouth with Tricyclic Antidepressants
•Respiratory Depression with Opioids
• Bleeding with Warfarin
Management
•Reduce Dose or Withhold Drug
• Consider effects of concomitant therapy
Bleeding with Warfarin
7. Features
•Uncommon
•Not related to the pharmacologic action of the drug
•Unpredictable
•High mortality
Example
•Immunologic reactions: anaphylaxis to penicillin
•Idiosyncratic reactions: malignant hyperthermia with general anesthetics
Management
•Withhold and avoid in future
Penicillin Allergy
8. Features
•Uncommon
•Related to the cumulative dose
Example
•Hypothalamic-pituitary-adrenal axis suppression
by corticosteroids.
•Osteonecrosis of the jaw with bisphosphonates
Management
•Reduce dose or use an alternate day therapy
•withdrawal may have to be prolonged
Osteonecrosis of Jaw
with Bisphosphonates
9. Features
•Uncommon
•Usually dose related
•Occurs or becomes apparent sometime after use of the drug
Example
•Carcinogenesis
•Teratogenesis
•Tardive dyskinesia
•Leucopenia with lomustine
Management
•Often intractable
Tardive dyskinesia
10. Features
•Uncommon
•Occurs soon after withdrawal of the drug
Example
•Withdrawal syndrome with opiates or
benzodiazepines (e.g., insomnia, anxiety)
Management
•Reintroduce drug and withdraw slowly
Insomnia
11. Features
•Common
•Dose related
•Often caused by drug interactions
Example
•Inadequate dosage of an oral contraceptive when used with an enzyme inducer.
•Resistance to antimicrobial agents
Management
•Increase dosage
•Consider effects of concomitant therapy
12. •Minor ADRs: No therapy, antidote or prolongation of
hospitalization is required.
• Moderate ADRs: Requires change in drug therapy,
specific treatment or prolongs hospital stay by atleast 1
day.
• Severe ADRs: Potentially life threatening, causes
permanent damage or requires intensive medical
treatment.
• Lethal: Directly or indirectly contributes to death of the
patient.
13. Detecting adverse drug reaction(ADR).
Assessing causality between drug and
suspected reaction
Documentation of ADR
Reporting serious ADRs to
pharmacovigilance centers
14. Detection of ADRs
Pre- Marketing Studies Post– Marketing Surveillance
Spontaneous
adverse
reaction
reporting
Epidemiological
methods
Case Control
Studies
Cohort
Studies
Phase 1
Phase 2
Phase 3
15. PRE- MARKETING STUDIES
•During the development of new medicines, their safety is tested in
animal models.
• A great deal of risk information may be obtained from such tests, such
as the level of acute toxicity and which organs will be affected in case
of toxicity.
• If animal test do not reveal worrying results, safety tests proceed onto
testing in human.
• Clinical trials are carried out in three different phases prior to
submission of a marketing authorisation application
• Consequence of above is that at the time of general marketing of a new
medicine only the most common (Type A) adverse reactions will be
known.
16. • Passive and Active pharmacovigilance methodologies are used for
detection of risk and for the collection of risk information.
Spontaneous adverse reaction reporting
• Powerful and cost effective system for the identification of unknown
drug-related risk.
• Health care practitioner should see it as their duty to report any
suspicion of drug causing risk situation in patient under his care.
•Spontaneous reporting creates signals of previously unknown problems
17. •These methods are used to verify the hypothesis of a causal
link between drug exposure and an adverse outcome.
•Two epidemiological methods most commonly used are:
Cohort Studies
Case Control
studies
Exposure Outcome
Exposed Outcome ?
Not Exposed Outcome ?
Exposed ? Outcome
Exposed ? Control
18. COHORT STUDIES CASE CONTROL STUDIES
Patients exposed to a
particular drug are
followed up actively and
systematically and ADR
frequencies are compared
to an unedxposed control
population.
Advantage: Reveals
unsuspected ADRs
Individuals affected by the
adverse event being studied are
identified.
Each case is matched with
several disease – free control
patients, randomly recruited
from the study base.
Drug histories of both the
groups are traced backwards for
the comparison.
The suspicion is strengthened
if high association is found.
Advantage: Can be analysed
quickly as number of patients
analysed is small.
19. Collection of Data For Detection of ADR
Patient Related
•Patient’s demographic
information.
•Presenting Complaints
•Past medication history
•Drug therapy details including
over the counter
•Current medications
•Lab data such as haematological,
liver and renal function tests.
Details of suspected ADR
• Time of onset and duration of
reaction and severity of reaction
• Details of dose , frequency, and
time of administration of drug
• Duration of treatment and
plasma concentration of Drug
• Data on other risk factors and
predisposing factors.
20. Role of Healthcare Professionals in Detecting ADRs
Possibility of an ADR should always be considered during
differential diagnosis.
ADR may be detected during ward round with the medical team.
Patient counselling , medication history interview and
communicating with other healthcare professional may provide
additional clues.
Patients who are at higher risk should be monitored closely
• Patients with renal or hepatic impairment.
• Patients who had histrory of allergic reactions.
• Patients taking multiple drugs.
• Pregnant and breastfeeding women.
21. Reporting an ADR
All healthcare professionals (clinicians, dentists, pharmacists,
nurses etc) and
Non-healthcare professionals including consumers can report
suspected adverse drug reaction.
What may happen
when you don’t
report?
A) Who can Report?
22. Duly filled Suspected Adverse Drug Reaction Reporting Form
can be send to the nearest Adverse Drug Reaction Monitoring
Centre (AMC) or directly to the National Coordination Centre
(NCC).
Call on Helpline (Toll Free) 1800 180 3024 to report ADRs.
Or can directly mail this filled form to pvpi@ipcindia.net or
pvpi.ipcindia@gmail.com
A list of nationwide AMCs is available at:
http://www.ipc.gov.in, http://www.ipc.gov.in/PvPI/pv_home.html
B) Where to report ?
23. Report serious adverse drug reactions. A reaction is serious when
the patient outcome is:
• Life-threatening
• Hospitalization (initial or prolonged)
• Disability (significant, persistent or permanent)
• Congenital anomaly
• Required intervention to prevent permanent impairment or
damage
Report non-serious, known or unknown, frequent or rare adverse
drug reactions due to Medicines, Vaccines and Herbal products.
C) What to report ?
24. Patient initials,
Age at onset of reaction,
Reaction term(s),
Date of onset of reaction,
Suspected medication(s)
reporter information.
D) Mandatory field for
suspected ADR
reporting form.
25. D) What happens to the submitted information?
ADR reported by
HCP, Patient or
Others
Causality
assessment at
AMCs
Forwaded to
NCC-PvPI
through ADR
database
Data is
Analysed &
forwarded
Global
Pharmacovigilance
Database
(Managed by WHO-
UMC)
Reports are
periodically
reviewed by the
NCC-PvPI
Information is
submitted to the
Steering committee
of PvPI
Suggests required
interventions
26. Assessing Causality
Causality assessment is the method by which the extent of
the relationship between a drug and a suspected reaction is
estimated .
Methods Of Causality Assessment
Group-1
Opinion of Experts,
Clinical Judgment or
Global introspection
methods
Group-2
Algorithms (with or
without scoring) or
standardised
assesment methods
27. Group-1 Opinion of Experts, Clinical Judgment or
Global Introspection methods
Causation is established based on the clinical judgment of the expert or panel of
the experts. Such Judgements are mostly based on the
WHO-UMC causality assesment scale given below.
Causality term Assessment criteria*
Certain • Event or laboratory test abnormality, with plausible time
relationship to drug intake
• Cannot be explained by disease or other drugs
• Response to withdrawal plausible (pharmacologically,
pathologically)
• Event definitive pharmacologically or phenomenologically
(i.e. an objective and specific medical disorder or a recognised
pharmacological phenomenon)
• Rechallenge satisfactory, if necessary
Probable/ Likely • Event or laboratory test abnormality, with reasonable time
relationship to drug intake
• Unlikely to be attributed to disease or other drugs
• Response to withdrawal clinically reasonable
• Rechallenge not required
28. Causality term Assessment criteria*
Possible •Event or laboratory test abnormality, with reasonable time
relationship to drug intake
• Could also be explained by disease or other drugs
• Information on drug withdrawal may be lacking or unclear
Unlikely •Event or laboratory test abnormality, with a time to drug intake
that makes a relationship improbable (but not impossible)
• Disease or other drugs provide plausible explanations
Conditional/
Unclassified
• Event or laboratory test abnormality
• More data for proper assessment needed, or
• Additional data under examination
Unassessable/
Unclassifiable
• Report suggesting an adverse reaction
• Cannot be judged because information is insufficient or
contradictory
• Data cannot be supplemented or verified
29. Group-2 Algorithms (Naranjo’s Algorithms)
S.No Questions Yes No Don’t
Know
1 Are there previous conclusive reports on this reaction? -1 0 0
2 Did the adverse event appear after the suspected drug was
given?
+2 -1 0
3 Did the adverse reaction improve when the drug was
discontinued or a specific antagonist was given?
+1 0 0
4 Did the adverse reaction appear when the drug was
readministered?
+2 -1 0
5 Are there alternative causes that could have caused the
reaction?
-1 2 0
6 Did the reaction reappear when a placebo was given? -1 +1 0
7 Was the drug detected in any body fluid in toxic
concentrations?
+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
drugs in any previous exposure?
+1 0 0
30. But Still There Is No Universally AcceptedMethodFor The
Causality Assessment Of Adrs
Definite ≥ 9
Probable 5-8
Possible 1-4
Unlikely ≤ 0
Scoring
32. Adverse Drug Reaction: A Response to a medicine which is
noxious and which occurs at doses normally used in man.
Adverse Drug Event: Any untoward medical occurance that
may present during the treatment with a medicine but which does
not necessarily have a causal relationship with this treatment.
Side Effects: an unpleasant effect of a drug that happens in
addition to the main effect.
Benefit and risk analysis: Examination of favorable (benefit)
& Unfavorable result of undertaking a special cause of action.
Adverse Case Report: A case report in ADR is a notification
relating to a patient with an adverse effect or laboratory test
abnormality suspected to be induced by medicinal product
33. Country Drug Therapeutic
Action
Reported ADR
Oman Voriconazole Anti Fungal Hepatotoxicity and
neurologic adverse effects
(e.g. hallucinations,
confusion)
Zimbabwe Efavirenz,
Saquinavir
Anti Viral Gynaecomastia
34. 1. Adverse Drug Reactions By Stephanie N. Schatz, Pharm.D., BCPS; and Robert J.
Weber, Pharm.D., BCPS Reviewed by Kyle E. Hultgren, Pharm.D.; Erin M. Timpe
Behnen, Pharm.D., BCPS; and Michael C. Barros, Pharm.D., BCPS, BCACP.
2. https://www.who-umc.org/media/2768/standardised-case-causality-assessment.pdf.
3. Naranjo et.al. Clin Pharmacol Ther. 1981 Aug;30(2):239-45
4. http://www.ephor.nl/media/1223/naranjo-causality-scale.pdf
5. http://www.who.int/medicines/regulation/medicines-safety/npvc-
meeting/Bloolet_poci2016.pdf
6. A Textbook of clinical Pharmacy by Parthasarathi, Nyfort –Hansen, Nahata, Second
Edition.
35. If you suspect an ADR do not assume someone
else will report it……