Adverse Event Reporting in Pharmacovigilance: Principles and ChallengesClinosolIndia
Adverse event reporting is a crucial component of pharmacovigilance, the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. Here are the principles and challenges associated with adverse event reporting in pharmacovigilance:
Principles:
Timeliness: Adverse events should be reported promptly to ensure timely assessment and appropriate action. Reporting delays can hinder the detection of safety signals and the implementation of necessary interventions.
Completeness: Comprehensive reporting of all relevant information regarding the adverse event is vital. This includes patient demographics, medical history, drug details (name, dose, route of administration), onset and duration of the event, outcomes, and any concomitant medications.
Causality Assessment: Adverse events should be evaluated for their potential causality with the suspected drug. This involves considering factors such as temporal relationship, dechallenge/rechallenge information, and the presence of alternative explanations or confounding factors.
Confidentiality and Privacy: Adverse event reporting must uphold patient confidentiality and privacy. Personal identifiable information should be protected, and data should be handled in accordance with applicable data protection regulations.
Collaboration and Communication: Effective communication and collaboration between healthcare professionals, regulatory authorities, pharmaceutical companies, and patients are essential. Sharing information and feedback helps in improving patient safety and optimizing the understanding of adverse events.
This document discusses adverse drug reactions (ADRs), including definitions, classifications, detection, reporting, causality assessment and prevention. It defines an ADR as an unintended response to a drug that occurs at normal doses. ADRs are classified based on type, onset, severity and mechanism. They can be detected through pre-marketing clinical trials and post-marketing surveillance methods like spontaneous reporting. Healthcare professionals should report all suspected serious ADRs to pharmacovigilance centers to assess causality and ensure patient safety. Preventing ADRs requires monitoring patients at high risk and considering interactions between drugs.
pharmacovigilance-training Pharmacovigilance in INDIA.pptxMrSALAJKHARE
- Pharmacovigilance is the process of monitoring the safety of medicines to protect patients and public health. It involves detecting, assessing, understanding, and preventing adverse effects.
- The investigator is responsible for detecting, assessing, and reporting adverse events and serious adverse events that occur during a clinical trial to allow for continuous safety monitoring. Serious adverse events must be reported to the sponsor within 24 hours.
- All adverse event information reported by the investigator must be verifiable in source documents and assessed for causality, severity, and expectedness according to the reference safety information.
This document provides information on pharmacovigilance responsibilities in clinical trials. It defines key terms like adverse events, serious adverse events, and suspected unexpected serious adverse reactions. The investigator is responsible for detecting, assessing and reporting adverse events to the sponsor within defined timelines. The sponsor is responsible for assessing events, understanding safety issues, and preventing harm through ongoing risk assessment, medical monitoring, and regulatory reporting of suspected unexpected serious reactions. Both parties work to ensure accurate and timely safety monitoring and reporting in clinical trials.
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.
1) Adverse drug reactions can range from minor to lethal and are classified based on their severity and type. Types include augmented (dose-dependent), bizarre (unpredictable allergic reactions), chronic, delayed, end of use effects, and treatment failure.
2) Pharmacovigilance aims to detect, understand, and prevent adverse drug reactions through post-marketing surveillance, assessing causality of reactions, communicating findings to healthcare professionals, and monitoring methods like spontaneous reporting and surveys.
3) Serious or uncommon adverse drug reactions should be reported to local monitoring centers along with patient details, suspected drugs, reaction description, and management to allow for analysis and prevention of future harm.
This document provides an overview of pharmacovigilance presented by Dr. S P Srinivas Nayak. It begins with a case study of a patient who experienced an allergic reaction after receiving ondansetron. It then defines key terms like adverse drug reaction and adverse event. It describes different types of ADRs based on factors like onset, mechanism and severity. It discusses pharmacovigilance including definitions, objectives, ADR reporting and the pharmacist's role in detecting, assessing and managing ADRs. The presentation concludes with definitions of key pharmacovigilance concepts and a thank you from Dr. Nayak.
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.
Adverse Event Reporting in Pharmacovigilance: Principles and ChallengesClinosolIndia
Adverse event reporting is a crucial component of pharmacovigilance, the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. Here are the principles and challenges associated with adverse event reporting in pharmacovigilance:
Principles:
Timeliness: Adverse events should be reported promptly to ensure timely assessment and appropriate action. Reporting delays can hinder the detection of safety signals and the implementation of necessary interventions.
Completeness: Comprehensive reporting of all relevant information regarding the adverse event is vital. This includes patient demographics, medical history, drug details (name, dose, route of administration), onset and duration of the event, outcomes, and any concomitant medications.
Causality Assessment: Adverse events should be evaluated for their potential causality with the suspected drug. This involves considering factors such as temporal relationship, dechallenge/rechallenge information, and the presence of alternative explanations or confounding factors.
Confidentiality and Privacy: Adverse event reporting must uphold patient confidentiality and privacy. Personal identifiable information should be protected, and data should be handled in accordance with applicable data protection regulations.
Collaboration and Communication: Effective communication and collaboration between healthcare professionals, regulatory authorities, pharmaceutical companies, and patients are essential. Sharing information and feedback helps in improving patient safety and optimizing the understanding of adverse events.
This document discusses adverse drug reactions (ADRs), including definitions, classifications, detection, reporting, causality assessment and prevention. It defines an ADR as an unintended response to a drug that occurs at normal doses. ADRs are classified based on type, onset, severity and mechanism. They can be detected through pre-marketing clinical trials and post-marketing surveillance methods like spontaneous reporting. Healthcare professionals should report all suspected serious ADRs to pharmacovigilance centers to assess causality and ensure patient safety. Preventing ADRs requires monitoring patients at high risk and considering interactions between drugs.
pharmacovigilance-training Pharmacovigilance in INDIA.pptxMrSALAJKHARE
- Pharmacovigilance is the process of monitoring the safety of medicines to protect patients and public health. It involves detecting, assessing, understanding, and preventing adverse effects.
- The investigator is responsible for detecting, assessing, and reporting adverse events and serious adverse events that occur during a clinical trial to allow for continuous safety monitoring. Serious adverse events must be reported to the sponsor within 24 hours.
- All adverse event information reported by the investigator must be verifiable in source documents and assessed for causality, severity, and expectedness according to the reference safety information.
This document provides information on pharmacovigilance responsibilities in clinical trials. It defines key terms like adverse events, serious adverse events, and suspected unexpected serious adverse reactions. The investigator is responsible for detecting, assessing and reporting adverse events to the sponsor within defined timelines. The sponsor is responsible for assessing events, understanding safety issues, and preventing harm through ongoing risk assessment, medical monitoring, and regulatory reporting of suspected unexpected serious reactions. Both parties work to ensure accurate and timely safety monitoring and reporting in clinical trials.
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.
1) Adverse drug reactions can range from minor to lethal and are classified based on their severity and type. Types include augmented (dose-dependent), bizarre (unpredictable allergic reactions), chronic, delayed, end of use effects, and treatment failure.
2) Pharmacovigilance aims to detect, understand, and prevent adverse drug reactions through post-marketing surveillance, assessing causality of reactions, communicating findings to healthcare professionals, and monitoring methods like spontaneous reporting and surveys.
3) Serious or uncommon adverse drug reactions should be reported to local monitoring centers along with patient details, suspected drugs, reaction description, and management to allow for analysis and prevention of future harm.
This document provides an overview of pharmacovigilance presented by Dr. S P Srinivas Nayak. It begins with a case study of a patient who experienced an allergic reaction after receiving ondansetron. It then defines key terms like adverse drug reaction and adverse event. It describes different types of ADRs based on factors like onset, mechanism and severity. It discusses pharmacovigilance including definitions, objectives, ADR reporting and the pharmacist's role in detecting, assessing and managing ADRs. The presentation concludes with definitions of key pharmacovigilance concepts and a thank you from Dr. Nayak.
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.
This document discusses adverse events and serious adverse events in clinical trials. It defines key terms like adverse event, adverse drug reaction, serious adverse event, and unexpected adverse event. It describes the importance of collecting and reporting adverse events in clinical trials from regulatory and ethical perspectives to protect human subjects. It provides examples and criteria for assessing severity, causality, expectedness, and timeframes for reporting serious and unexpected adverse events to regulatory agencies, institutional review boards, and other investigators. It also addresses managing reporting for blinded trials and reactions associated with active comparators.
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
Adverse drug reaction and adverse drug eventssuser7add2a
This document discusses adverse drug reactions (ADRs), defined as harmful or unpleasant reactions resulting from medication use. It describes different types of ADRs including type A (predictable) dose-dependent reactions and type B (unpredictable) reactions related to immunity or genetics. It also discusses factors that increase ADR risk like polypharmacy, age, and disease status. The document outlines methods for classifying, grading, and preventing ADRs, and the role of pharmacovigilance in monitoring drug safety post-marketing.
The document outlines international patient safety goals and guidelines for incident reporting. It discusses 6 main safety goals, including correctly identifying patients, improving communication, and reducing healthcare-associated infections. It also defines different types of incidents like near misses, adverse events, and sentinel events. For reporting, it specifies the immediate actions required and that all incidents must be reported to the quality department within 24 hours. The purpose is to distinguish between different adverse events to improve patient safety.
How to recognize ADRs in patients.@ Clinical PharmacyDrpradeepthi
This document discusses methods for detecting adverse drug reactions (ADRs) and summarizes four main approaches: case-control studies, cohort studies, spontaneous case reports, and vital statistics/record linkage studies. It provides details on how each method works, its advantages and limitations. The document also outlines steps for properly assessing possible ADRs in patients and stresses the importance of reporting any suspected reactions to help improve patient safety.
Detection, reporting and management of adverse eventsKatla Swapna
This document discusses adverse drug reactions (ADRs), including definitions, classifications, detection, reporting, and management. It notes that ADRs are a major clinical problem that can cause suffering and increased healthcare costs. It emphasizes the importance of monitoring and reporting ADRs to improve patient safety. Pharmacists can play an important role by monitoring high-risk patients and drugs, educating on ADR reporting, and assisting in the detection and assessment of ADRs. Timely reporting of ADRs is crucial to help prevent human suffering and unnecessary costs from drug-related injuries.
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
This document provides an overview of pharmacovigilance including key concepts like Individual Case Safety Reports (ICSRs), signal management, and risk minimization measures. ICSRs contain safety information for individual patients and must include the reporter, patient, adverse reaction, and suspected product. Causality, expectedness, dechallenge/rechallenge are assessed for ICSRs. Signals are potential new safety issues identified from ICSRs, literature or other sources that require verification. Confirmed signals become safety issues which may need risk minimization actions like updating product labels or restrictions.
The document discusses patient safety definitions, goals, and best practices. It defines patient safety as working to avoid, manage, and treat unsafe acts in healthcare through the use of best practices leading to optimal patient outcomes. The goals are to provide a safe environment for all individuals by promoting a proactive, non-punitive culture that facilitates reporting of hazards, errors, near-misses, and other unsafe conditions. Key aspects that should be reported include unanticipated outcomes, infections, errors, near misses, and safety concerns. Effective communication, identifying patients correctly, improving medication safety, ensuring correct procedures, reducing infections, and mitigating fall risks are emphasized as important areas of focus.
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
This document discusses pharmacovigilance, which involves monitoring the safety of drugs after they have been approved. It defines pharmacovigilance and explains why it is needed given limitations of clinical trials. It describes types of adverse drug reactions and how they are classified. It outlines the goals and processes of pharmacovigilance programs, including reporting adverse reactions, conducting causality assessments, and submitting periodic safety update reports. The overall aim is to ensure safe and effective use of medicines through continual monitoring and regulatory action.
This document defines key terms related to adverse drug reactions such as adverse events, adverse drug reactions, and medication errors. It describes the etiology and various classification systems for adverse drug reactions. The document outlines methods for detecting, reporting, and assessing the severity and seriousness of adverse drug reactions. It also covers predicting and preventing adverse drug reactions, and how to manage adverse drug reactions when they occur. The document emphasizes the importance of reporting all suspected adverse drug reactions to assist in ensuring drug safety.
Adverse drug reactions, Drug interactions, Drug discovery and clinical evalua...Dr Ravikiran S
This document discusses adverse drug reactions and pharmacovigilance. It defines adverse drug reactions as any noxious change suspected to be caused by a drug. Adverse reactions are classified as predictable or unpredictable. Predictable reactions are based on the pharmacological properties of the drug, while unpredictable reactions are based on patient peculiarities. The severity of adverse drug reactions is also graded.
The document then discusses the process of pharmacovigilance, which involves monitoring adverse drug reactions post-marketing through voluntary reporting systems and disseminating data on reactions to healthcare professionals. Pharmacovigilance centers analyze reported reactions and provide expertise in assessing causality and severity. The goals of pharmacovigilance are detection, understanding and
This document discusses the natural history of disease and prevention. It defines the natural history of a disease as its progression in the absence of intervention, going through stages of exposure, incubation, clinical disease, and sometimes disability. Primary prevention aims to promote health and avoid risk factors to prevent susceptibility. Secondary prevention uses early detection and treatment to halt disease progression. Tertiary prevention focuses on managing long-term complications to improve quality of life. The document provides examples of different prevention levels and discusses population-based versus high-risk approaches.
The document provides information on adverse drug reactions and drug intolerance. It discusses the background and history of pharmacovigilance, the process of monitoring drug safety. It defines key terms like adverse drug reaction and classification of reactions. Investigations for adverse drug reactions include serum tryptase tests and skin testing. Examples of drug intolerances discussed are local anesthetics, beta-lactam antibiotics, NSAIDs, and metronidazole. Management strategies for common drug reactions are also outlined.
This one paragraph document provides information about a unit presentation. Mr. Rajat Goyal, an assistant professor at MMCP, MM(DU), will be presenting unit 1. The document lists his name, title, and location but does not include any other details about the content or topic of the upcoming presentation.
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Chapter-1
Introduction to objective, scope and outcome the subject
Chapter 2
Introduction: Scope and Specialization of Civil Engineering, Role of civil Engineer in Society, Impact of infrastructural development on economy of country.
Chapter 3
Surveying: Object Principles & Types of Surveying; Site Plans, Plans & Maps; Scales & Unit of different Measurements.
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Chapter 5
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Chapter 6
Environmental Engineering: Environmental Pollution, Environmental Acts and Regulations, Functional Concepts of Ecology, Basics of Species, Biodiversity, Ecosystem, Hydrological Cycle; Chemical Cycles: Carbon, Nitrogen & Phosphorus; Energy Flow in Ecosystems.
Water Pollution: Water Quality standards, Introduction to Treatment & Disposal of Waste Water. Reuse and Saving of Water, Rain Water Harvesting. Solid Waste Management: Classification of Solid Waste, Collection, Transportation and Disposal of Solid. Recycling of Solid Waste: Energy Recovery, Sanitary Landfill, On-Site Sanitation. Air & Noise Pollution: Primary and Secondary air pollutants, Harmful effects of Air Pollution, Control of Air Pollution. . Noise Pollution Harmful Effects of noise pollution, control of noise pollution, Global warming & Climate Change, Ozone depletion, Greenhouse effect
Text Books:
1. Palancharmy, Basic Civil Engineering, McGraw Hill publishers.
2. Satheesh Gopi, Basic Civil Engineering, Pearson Publishers.
3. Ketki Rangwala Dalal, Essentials of Civil Engineering, Charotar Publishing House.
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2. WHO definition of
pharmacovigilance
It is the science and activities relating to the detection, assessment,
understanding and prevention of adverse effects or any other
medicine related problem.
1] Detection
2] Assessment and understanding
3] Prevention of adverse effects
Pharmacovigilance
3. Reason forAdverse event
collection and reporting
• The most important responsibilities of investigator and sponsor in
clinical research studies.
• Protection of human subjects.
• Collection of clean and reproducible data.
• They need to analyze the data and determine Risk/benefits before
giving permission market.
ADVERSE EVENT:
Definition- Any unwanted medical occurrence in a patient or clinical
investigation subject administered a pharmaceutical product and which
does not necessarily to a casual relationship with this treatment. As per
ICH E2A
4. ADVERSE EVENT[AE]
• Any unfavorable and
unintended sign.
• Including an abnormal
laboratory finding
• Symptom
• Disease
UNWANTED EFFECTS
• Symptoms [headache,
nausea]
• Physical findings [BP,
lump, edema]
• Abnormal lab values
[increased liver enzymes,
decreased hemoglobin]
• Overdoses important to
define what% cut-off to
be taken as adverse
events.
5. Examples
Unfavorable deviation from baseline health, which
includes-
• Headache present at baseline was mild, now become severe.
• Worsening of conditions present at onset of the study.
Unfavorable deviation from baseline health, which
includes-
• Patient deterioration due to primary disease.
• BPH study-patient going into acute retention of urine.
• Antibiotic study: URTI progressing to lower respiratory tract
infection.
6. Adverse drug reaction [ADR]
In the pre-approval clinical experience:
Defined as all noxious and unintented responsed to a medicinal
product related to any dose should be considered adverse drug
reactions.
The phrase ‘ response to a medical products’ means that a casual
relationship between a medicinal product and an adverse event is
at least a reasonable possibility, i.e. relationship can’t be ruled
out.
7. CONTT..
UNEXPECTED ADVERSE DRUG REACTION:
An adverse reaction, the nature or severity of which is not
consistent with the applicable product information.
[E.g. Investigator’s brochure for an unapproved investigational
medicinal product]
SERIOUS ADVERSE DRUG REACTION:
• Results in death.
• Life-threatening
• Requires inpatient hospitalization or prolongation of existing.
• Hospitalization.
• Birth defect.
8. LIFE-THREATENING
• Any AE that places the patient or subject, in the view of the
investigator, at immediate risk of death from the reaction as it
occurred.
• Does not include a reaction that, had it occurred in a more
severe form, might have caused death.
• EXAMPLES-
1. Pacemaker failure
2. Gastrointestinal hemorrhage
3. Infusion pump failure
4. Excessive IV fluid dosing
5. Toxic drug levels
9. INTENSITY
• Severity of the Adverse Event [ WHO Classification ]
1.MILD: Awareness of sign, symptom, or event, but easily
tolerated.
2.MODERATE: Discomfort enough to cause interference with
usual activity and may warrant intervention.
3.SEVERE: Incapacitating with inability to do usual activities or
significantly affects clinical status, and warrants intervention
required.
10. EXAMPLES
• Dizziness, Patient feels the symptom, but can go on with
routine activities.
• Non Serious AE with Mild intensity.
• Myocardinal infraction.
• Affecting only 10% myocardium.
• Serious AE, with mild intensity, Headache.
• Causing a person to take leave, not able to work, needs
medication.
• Non Serious AE , with severe intensity.
11. REPORTING TIME FRAMES
• 1.REGULATORY 2.IRB/IEC 3.PARTICIPATING
INVESTIGATORS
• Serious Unexpected Fatal or Life-threatening unexpected
ADRs
• Fatal or life-threatening, unexpected ADRs occurring in
clinical investigations qualify for every rapid reporting.
• Regulatory agencies should be notified [e.g. By telephone ,
facsimile transmission, or in writing] as soon as possible but
no later than 7 calendar days after first knowledge by the
sponsor that a case qualifies, followed by within 8 additional
calendar days the complete report.
• This report should include an assessment of the importance
and implication of the findings including relevant previous
experience with the same or similar medicinal products.