Types of Adverse Drug Reactions (severity)
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Adverse drug reactions (ADRs) are classified into different types based on their severity. The severity of an ADR refers to the degree of harm or damage caused by the reaction. The following are the different types of ADRs based on severity: Mild ADRs: These are the least severe type of ADRs and are usually self-limiting. Mild ADRs do not require any specific treatment and usually resolve on their own. Examples of mild ADRs include nausea, headache, and mild allergic reactions. Moderate ADRs: These ADRs are more severe than mild ADRs and may require medical intervention or treatment. They may cause discomfort and can affect the patient's daily activities. Examples of moderate ADRs include severe allergic reactions, diarrhea, and dizziness. Severe ADRs: These are the most severe type of ADRs and can be life-threatening. They require immediate medical attention and may result in hospitalization or even death. Examples of severe ADRs include anaphylaxis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN). Serious ADRs: These are ADRs that result in hospitalization, prolongation of hospitalization, disability, or death. Serious ADRs are usually severe in nature and require immediate medical attention. Examples of serious ADRs include renal failure, liver failure, and pulmonary embolism. Unexpected ADRs: These are ADRs that are not listed in the product label or are not expected based on the known safety profile of the drug. Unexpected ADRs can be of any severity and require immediate reporting to regulatory authorities.
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This document provides an overview of adverse drug reactions (ADRs). It defines what constitutes an ADR and different types of ADRs such as Type A, B, C, D and E reactions. It notes that ADRs are common, increasing healthcare costs and hospital stays. Causes of ADRs include patient factors, drug factors and prescriber factors. Historical examples of drug-induced harms are provided. The importance of pharmacovigilance programs for post-marketing drug safety monitoring is highlighted.
Adverse drug reaction
This document discusses adverse drug reactions (ADRs), including their definition, frequency, impact on public health, classification, management, and prevention. Some key points:
- ADRs are the 4th-6th leading cause of death among hospitalized patients in the US.
- They are classified based on factors like onset (acute, subacute, latent), type (augmented, bizarre, continuous), and severity (minor to lethal).
- Common causes of ADRs include dosage errors, allergies, drug interactions, and failure to follow dosing regimens. Patient risk factors include age, sex, genetics, and concurrent diseases or medications.
- Prevention strategies include proper dosing, screening
Adverse drug reaction
The patient was prescribed ceftriaxone, paracetamol and vitamins for fever. After taking the medications, he developed a rash and macular lesion on his forearm. When the prescribing doctor replaced ceftriaxone with ampicillin, the lesion disappeared. This suggests the patient had an adverse drug reaction to ceftriaxone.
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The document discusses various types of adverse drug reactions (ADRs), including:
1. Predictable (Type A) reactions which are dose-dependent and based on the drug's pharmacological properties. These occur in normal patients and account for 80% of ADRs.
2. Unpredictable (Type B) reactions which are idiosyncratic, dose-independent, and related to the patient's peculiarities or immune response. These are less common but more serious.
3. Factors that influence the risk of ADRs like polypharmacy, use in elderly patients, prolonged drug therapy, and individual patient variability. Close monitoring is important to prevent adverse outcomes from medication.
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- ADRs are the 4th-6th leading cause of death among hospitalized patients in the US.
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- Common causes of ADRs include dosage errors, allergies, drug interactions, and failure to follow dosing regimens. Patient risk factors include age, sex, genetics, and concurrent diseases or medications.
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The patient was prescribed ceftriaxone, paracetamol and vitamins for fever. After taking the medications, he developed a rash and macular lesion on his forearm. When the prescribing doctor replaced ceftriaxone with ampicillin, the lesion disappeared. This suggests the patient had an adverse drug reaction to ceftriaxone.
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3. Factors that influence the risk of ADRs like polypharmacy, use in elderly patients, prolonged drug therapy, and individual patient variability. Close monitoring is important to prevent adverse outcomes from medication.
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1. An adverse drug reaction (ADR) is defined by the WHO as any unintended and harmful response to a drug that occurs at normal dosages.
2. ADRs are common, occurring in 5-30% of hospitalized patients and 3% of hospital admissions. They are more common in the elderly, young, and those taking multiple drugs.
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What is an adverse drug reaction and different types of ADRS
An adverse drug reaction (ADR) is any harmful or unintended response to a medication or drug, which occurs at doses normally used for prevention, diagnosis, or treatment of a disease or disorder. ADRs can range from mild symptoms such as a rash or nausea to severe reactions such as organ failure or death. Here are the different types of ADRs:
Type A ADRs: Type A ADRs are predictable and are related to the pharmacological action of the drug. These reactions are usually dose-dependent, and their incidence increases with the drug dose. Common examples include nausea, vomiting, constipation, dizziness, and sedation.
Type B ADRs: Type B ADRs are unpredictable and are not related to the pharmacological action of the drug. These reactions are usually idiosyncratic and occur in only a small percentage of patients. Examples include allergic reactions, drug-induced liver injury, and blood disorders.
Type C ADRs: Type C ADRs are chronic and occur after prolonged use of the drug. These reactions are usually dose-dependent and may lead to long-term damage or injury. Examples include bone loss, adrenal suppression, and Cushing's syndrome.
Type D ADRs: Type D ADRs are delayed reactions and occur after the patient has stopped taking the drug. These reactions are usually related to the long half-life of the drug or its metabolites. Examples include tardive dyskinesia, drug-induced cancer, and teratogenic effects.
Type E ADRs: Type E ADRs are end-of-treatment reactions and occur after the patient has completed a course of treatment with the drug. These reactions are usually related to the withdrawal of the drug and may include symptoms such as rebound hypertension, depression, or anxiety.
Type F ADRs: Type F ADRs are failure of therapy reactions and occur when the drug fails to produce the desired therapeutic effect. These reactions may be due to drug interactions, poor compliance, or underlying disease progression.
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The management of adverse drug reactions (ADRs) involves identifying, preventing, and treating any unwanted or harmful effects of a medication. Here are some key steps in the management of ADRs:
Identification: ADRs may present in a variety of ways, including changes in vital signs, laboratory values, or symptoms reported by the patient. It is important for healthcare professionals to be vigilant in identifying potential ADRs.
Assessment: Once an ADR is identified, a healthcare professional will assess the severity and potential causality of the reaction, taking into account patient factors such as age, medical history, and current medications.
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Reporting: Healthcare professionals are required to report any serious or unexpected ADRs to regulatory authorities, as well as to the manufacturer of the medication.
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By_ Mr. Nakul Dhore
❖ Introduction & Definition
❖ Common Adverse Drug Reactions
❖ Classification Based on_
• Alphabetical
• Onset of Events
• Severity
• Terminologies
❖ Multiple Choice Questions
Pharmacy Practice
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Adverse drug reactions.pdf
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Adverse drug reactions
Naranjo
WHO-UMC
Bayesian:
Bayesian
Expert Opinion:
CIOMS
Most commonly used:
Naranjo
WHO-UMC
Naranjo Causality Assessment Scale
Criteria Score
1. Previous conclusive reports on this reaction 0
1. Previous conclusive reports on this reaction +1
2. The adverse event appeared after the suspected drug was administered. +2
3. The adverse reaction improved when the drug was discontinued or a specific antagonist was administered. +1
4. The adverse reaction reappeared when the drug was readministered. +2
5. Alternative causes that could solely have
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Review and Evaluation of Data: Regulatory agencies review the data collected from clinical trials to assess the safety and efficacy of investigational drugs. They evaluate study results, adverse events, and other relevant information to make informed decisions about drug approval.
Drug Approval and Labeling: Based on the evaluation of clinical trial data, regulatory agencies decide whether to approve a drug for marketing and use. They also determine the appropriate labeling, including indications, dosages, contraindications, and warnings, to ensure safe and effective use by healthcare professionals and patients.
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Data Privacy and consent management .. .
Data privacy and consent management are critical aspects of ensuring that individuals' personal information is handled responsibly and ethically, particularly in healthcare settings where sensitive medical data is involved. Data privacy refers to the protection of personal information from unauthorized access, use, or disclosure, while consent management involves obtaining and managing individuals' permissions for the collection, storage, and processing of their data.
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Consent management plays a crucial role in ensuring that individuals have control over how their data is used. Patients should be informed about the purposes for which their data will be collected and processed, as well as any potential risks or benefits associated with its use. Obtaining informed consent involves providing individuals with clear and transparent information about their privacy rights and giving them the opportunity to consent to or decline the use of their data for specific purposes. Consent management systems help healthcare organizations track and manage patients' consent preferences, ensuring that data is used in accordance with their wishes and legal requirements.
Effective data privacy and consent management practices not only protect individuals' privacy rights but also foster trust and transparency in healthcare relationships. By implementing robust security measures, respecting patients' autonomy, and promoting informed decision-making, healthcare organizations can uphold the principles of data privacy and consent while leveraging data responsibly to improve patient care and outcomes.
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This document discusses adverse drug reactions (ADRs), defined as undesirable consequences from drug administration. It classifies ADRs based on type, severity, and other factors. Major categories of ADRs include side effects, allergic reactions, toxicity, dependence, withdrawal reactions, teratogenicity, and drug-induced diseases. The document also outlines various methods for preventing ADRs, such as appropriate use of drugs, considering patient characteristics, monitoring for interactions, and following administration techniques carefully.
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An adverse drug reaction (ADR) is any harmful or unintended response to a medication or drug, which occurs at doses normally used for prevention, diagnosis, or treatment of a disease or disorder. ADRs can range from mild symptoms such as a rash or nausea to severe reactions such as organ failure or death. Here are the different types of ADRs:
Type A ADRs: Type A ADRs are predictable and are related to the pharmacological action of the drug. These reactions are usually dose-dependent, and their incidence increases with the drug dose. Common examples include nausea, vomiting, constipation, dizziness, and sedation.
Type B ADRs: Type B ADRs are unpredictable and are not related to the pharmacological action of the drug. These reactions are usually idiosyncratic and occur in only a small percentage of patients. Examples include allergic reactions, drug-induced liver injury, and blood disorders.
Type C ADRs: Type C ADRs are chronic and occur after prolonged use of the drug. These reactions are usually dose-dependent and may lead to long-term damage or injury. Examples include bone loss, adrenal suppression, and Cushing's syndrome.
Type D ADRs: Type D ADRs are delayed reactions and occur after the patient has stopped taking the drug. These reactions are usually related to the long half-life of the drug or its metabolites. Examples include tardive dyskinesia, drug-induced cancer, and teratogenic effects.
Type E ADRs: Type E ADRs are end-of-treatment reactions and occur after the patient has completed a course of treatment with the drug. These reactions are usually related to the withdrawal of the drug and may include symptoms such as rebound hypertension, depression, or anxiety.
Type F ADRs: Type F ADRs are failure of therapy reactions and occur when the drug fails to produce the desired therapeutic effect. These reactions may be due to drug interactions, poor compliance, or underlying disease progression.
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This presentation summarizes adverse drug reactions (ADRs) and their monitoring. It defines an ADR and classifies them based on onset (acute, sub-acute, latent), severity (mild, moderate, severe), and type (Type A-F). Common risk factors for ADRs include age, gender, multiple medications, and organ dysfunction. ADRs can be detected through pre-marketing clinical trials, post-marketing surveillance studies, underreporting, and communication. Monitoring of ADRs involves identifying reactions, assessing causality, documenting cases, and reporting serious ADRs to pharmacovigilance authorities.
Management of Adverse drug reactions
The management of adverse drug reactions (ADRs) involves identifying, preventing, and treating any unwanted or harmful effects of a medication. Here are some key steps in the management of ADRs:
Identification: ADRs may present in a variety of ways, including changes in vital signs, laboratory values, or symptoms reported by the patient. It is important for healthcare professionals to be vigilant in identifying potential ADRs.
Assessment: Once an ADR is identified, a healthcare professional will assess the severity and potential causality of the reaction, taking into account patient factors such as age, medical history, and current medications.
Prevention: If a patient is at risk for an ADR, steps may be taken to prevent the reaction from occurring. This may include adjusting the medication dose or frequency, monitoring for potential ADRs, or switching to an alternative medication.
Treatment: If an ADR does occur, treatment may be necessary to alleviate symptoms or prevent complications. This may include discontinuing the medication, administering an antidote, or providing supportive care.
Reporting: Healthcare professionals are required to report any serious or unexpected ADRs to regulatory authorities, as well as to the manufacturer of the medication.
Follow-up: Patients who have experienced an ADR may require ongoing monitoring or follow-up care to ensure that the reaction has resolved and to prevent future occurrences.
Adverse Drug Reactions.ppt
The document discusses adverse drug reactions and their classification. It notes that drugs prescribed can themselves cause diseases or adverse health effects, ranging from minor issues to disability or death. It classifies adverse drug reactions into types A, B, C, D and E based on factors like predictability, dose dependence, time of onset, and relationship to normal drug pharmacology. Type B reactions are more serious idiosyncratic or allergic reactions that are unpredictable and unrelated to normal drug action. The document also discusses factors influencing individual variability in drug responsiveness, including differences in absorption, metabolism, receptor numbers, and downstream response components.
Adverse Drug Reactions
Adverse Drug Reactions
By_ Mr. Nakul Dhore
❖ Introduction & Definition
❖ Common Adverse Drug Reactions
❖ Classification Based on_
• Alphabetical
• Onset of Events
• Severity
• Terminologies
❖ Multiple Choice Questions
Pharmacy Practice
Semester 7
As per B Pharm PCI Syllabus (New)
Adverse drug reactions.pdf
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Adverse drug reactions
Naranjo
WHO-UMC
Bayesian:
Bayesian
Expert Opinion:
CIOMS
Most commonly used:
Naranjo
WHO-UMC
Naranjo Causality Assessment Scale
Criteria Score
1. Previous conclusive reports on this reaction 0
1. Previous conclusive reports on this reaction +1
2. The adverse event appeared after the suspected drug was administered. +2
3. The adverse reaction improved when the drug was discontinued or a specific antagonist was administered. +1
4. The adverse reaction reappeared when the drug was readministered. +2
5. Alternative causes that could solely have
Adr
This document discusses adverse drug reactions (ADRs), defined as noxious changes that occur from drugs used at normal doses. Common causes include dosage errors, allergies, interactions, and non-compliance. Factors affecting ADRs include patient characteristics like age, concurrent diseases, and number of medications. ADRs can be classified based on onset, severity, and type. Types include augmented (dose-related), bizarre (unpredictable), continuous (long-term), delayed, ending of use, and failure of efficacy reactions. The document outlines strategies for preventing and managing ADRs.
Seminar adverse drug reaction
This document discusses adverse drug reactions (ADRs). It defines ADRs and differentiates them from adverse drug events. It also defines serious adverse events. The document then covers the history of ADR monitoring and reporting, classifications of ADRs by type and category, organ-specific ADRs, and ADR reporting through pharmacovigilance programs. Overall, the document provides an overview of key concepts regarding ADRs, their classification, and monitoring.
Adverse Drug reaction (1).pptx
This document discusses adverse drug reactions (ADRs), defining them as adverse events with a causal link to a drug. It provides a detailed classification of ADRs based on factors like onset, type of reaction, severity and more. Some key types discussed include Type A, B, C reactions as well as idiosyncrasy, drug allergy and drug dependence. Methods for detecting drug interactions like spontaneous reporting and record linkage studies are also summarized. The document emphasizes the importance of ADR reporting and management to ensure drug safety.
Similar to Types of Adverse Drug Reactions (severity) (20)
What is an adverse drug reaction and different types of ADRS
What is an adverse drug reaction and different types of ADRS
Adverse Drug reactions and its types with examples
Adverse Drug reactions and its types with examples
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Role of Drug Regulatory agencies in Clinical Research.
Drug regulatory agencies play a pivotal role in overseeing and regulating clinical research to ensure the safety, efficacy, and quality of pharmaceutical products. Their primary responsibility is to protect public health by evaluating the data generated from clinical trials and determining whether a drug can be approved for marketing and use in patients. Here are some key roles of drug regulatory agencies in clinical research:
Approval and Oversight of Clinical Trials: Regulatory agencies review and approve clinical trial protocols, ensuring that they adhere to ethical and scientific standards. They assess the design, methodology, and objectives of trials to ensure patient safety and the reliability of data generated.
Regulatory Guidance and Standards: These agencies provide guidance and establish regulations governing the conduct of clinical trials, including Good Clinical Practice (GCP) guidelines, which outline standards for trial design, conduct, monitoring, and reporting.
Review and Evaluation of Data: Regulatory agencies review the data collected from clinical trials to assess the safety and efficacy of investigational drugs. They evaluate study results, adverse events, and other relevant information to make informed decisions about drug approval.
Drug Approval and Labeling: Based on the evaluation of clinical trial data, regulatory agencies decide whether to approve a drug for marketing and use. They also determine the appropriate labeling, including indications, dosages, contraindications, and warnings, to ensure safe and effective use by healthcare professionals and patients.
Post-Marketing Surveillance: Regulatory agencies continue to monitor the safety and effectiveness of approved drugs through post-marketing surveillance programs. They collect and analyze real-world data on adverse events and drug utilization to identify potential risks and take appropriate regulatory actions if safety concerns arise.
Enforcement of Regulations: Regulatory agencies enforce compliance with regulatory requirements and take enforcement actions against sponsors, investigators, or manufacturers who fail to adhere to ethical or regulatory standards in clinical research.
International Collaboration: Many regulatory agencies collaborate with counterparts in other countries to harmonize regulatory standards, exchange information, and streamline the drug approval process, facilitating global drug development and access to new therapies.
Data Privacy and consent management .. .
Data privacy and consent management are critical aspects of ensuring that individuals' personal information is handled responsibly and ethically, particularly in healthcare settings where sensitive medical data is involved. Data privacy refers to the protection of personal information from unauthorized access, use, or disclosure, while consent management involves obtaining and managing individuals' permissions for the collection, storage, and processing of their data.
In healthcare, patients entrust providers with their sensitive medical information, expecting that it will be kept confidential and used only for legitimate purposes related to their care. Robust data privacy measures include encryption, access controls, and anonymization techniques to safeguard patient data from unauthorized access or breaches. Additionally, healthcare organizations must adhere to regulatory standards such as HIPAA in the United States or GDPR in the European Union, which outline specific requirements for the protection of patient information and impose penalties for non-compliance.
Consent management plays a crucial role in ensuring that individuals have control over how their data is used. Patients should be informed about the purposes for which their data will be collected and processed, as well as any potential risks or benefits associated with its use. Obtaining informed consent involves providing individuals with clear and transparent information about their privacy rights and giving them the opportunity to consent to or decline the use of their data for specific purposes. Consent management systems help healthcare organizations track and manage patients' consent preferences, ensuring that data is used in accordance with their wishes and legal requirements.
Effective data privacy and consent management practices not only protect individuals' privacy rights but also foster trust and transparency in healthcare relationships. By implementing robust security measures, respecting patients' autonomy, and promoting informed decision-making, healthcare organizations can uphold the principles of data privacy and consent while leveraging data responsibly to improve patient care and outcomes.
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Presenting- Signal mining in Pharmacovigilance
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Patient centered Pharmacovigilance .. .
Patient-centered pharmacovigilance represents a pivotal shift in the landscape of healthcare, emphasizing the active involvement of patients in the monitoring and reporting of adverse drug reactions. Unlike traditional pharmacovigilance, which primarily relies on healthcare professionals to identify and document adverse events, this approach recognizes patients as critical stakeholders in ensuring medication safety. By empowering patients to share their experiences, concerns, and observations regarding medication effects, whether positive or negative, healthcare systems can gain a comprehensive understanding of drug safety and efficacy in real-world settings. Patient-centered pharmacovigilance fosters a collaborative partnership between patients, healthcare providers, and regulatory agencies, promoting transparency, accountability, and ultimately, better patient outcomes. Through increased patient engagement and the utilization of patient-reported data, this approach enables healthcare systems to identify potential safety issues earlier, tailor treatment strategies to individual needs, and enhance overall drug safety surveillance efforts.
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Precision medicine, with its focus on tailoring medical treatment to the individual characteristics of each patient, has ushered in a new era in healthcare. Within this paradigm, clinical trials play a pivotal role in testing and validating targeted therapies. This article explores the importance of adopting patient-centric approaches in precision medicine trials and outlines strategies to enhance their success. By prioritizing patient engagement, leveraging digital technologies, and fostering collaborative partnerships, precision medicine trials can not only advance scientific understanding but also ensure that patient perspectives and experiences are integral to the research process.
Collaborative Initiatives: How Patient Advocacy Groups Contribute to the Succ...
Collaborative initiatives involving patient advocacy groups play a crucial role in advancing the success of precision medicine. Precision medicine, also known as personalized medicine, tailors medical treatment and interventions to the characteristics of each patient, considering factors such as genetic makeup, lifestyle, and environment. Patient advocacy groups contribute to the success of precision medicine in several ways:
Raising Awareness and Education:
Patient advocacy groups are instrumental in raising awareness about precision medicine among their communities.
They provide education and resources to patients, caregivers, and the general public, promoting a better understanding of the benefits and implications of precision medicine.
Patient Empowerment:
Advocacy groups empower patients by providing them with information about their conditions and treatment options.
They help patients understand the importance of participating in precision medicine initiatives, including clinical trials and genetic testing.
Supporting Research and Development:
Patient advocacy groups often collaborate with researchers and industry stakeholders to support the development of targeted therapies and diagnostics.
By actively participating in research initiatives, advocacy groups contribute to the identification of genetic markers, biomarkers, and other factors that influence treatment response.
Influencing Policy and Regulation:
Advocacy groups advocate for policies that support the advancement of precision medicine.
They work to ensure that regulations promote patient access to personalized treatments and protect patient rights, privacy, and data security.
Fostering Collaboration:
Patient advocacy groups facilitate collaboration among patients, researchers, healthcare providers, and industry partners.
They create platforms for sharing information, experiences, and best practices, fostering a collaborative environment that accelerates progress in precision medicine.
Clinical Trial Recruitment:
Advocacy groups play a crucial role in recruiting patients for clinical trials related to precision medicine.
Their engagement helps ensure diverse and representative participant populations, leading to more robust and applicable research outcomes.
Feedback and Patient-Centric Approaches:
Advocacy groups provide valuable feedback on the patient experience, preferences, and priorities.
This patient-centric approach helps researchers and healthcare professionals tailor precision medicine strategies to better meet the needs and expectations of the individuals they serve.
Championing Access to Treatments:
Patient advocacy groups work to improve patient access to precision medicine treatments.
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In summary, patient advocacy groups play a multifaceted role in advancing precision medicine by fostering awareness,
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The Ethical dilemmas in precision medicine arise from balancing the potential benefits of tailored treatments with concerns about privacy, consent, equity, and the implications of genetic information. These Dilemmas include issues around informed consent for data sharing, ensuring equitable access to precision medicine technologies, and safeguarding against discrimination based on Information. The potential for misuse or unintended consequences further complicate the ethical landscape of precision medicine. The Precision medicine widely used in Data Integration, Biomarkers, Targeted Therapies, predictive modeling, Clinical Decision Support. Precision Medicine improves the Patient outcomes, enhancing treatment efficacy, and reducing healthcare costs by minimizing trial and error in treatment selection. The precision medicine also raises Ethical legal and social complications related to data privacy, consent and equitable access and the potential for Discrimination based on information.
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Clinical trials play a pivotal role in advancing medical research and ensuring the efficacy of new treatments. In the context of precision medicine, where therapies are tailored to individual characteristics, adaptive design emerges as a powerful strategy to optimize clinical trial outcomes. This approach deviates from traditional fixed trial designs, allowing for modifications based on accumulating data, thus enhancing efficiency, flexibility, and the likelihood of success in precision medicine endeavors.
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Clinical trials are a cornerstone of medical research, paving the way for new treatments and advancements in healthcare. In recent years, Artificial Intelligence (AI) has emerged as a transformative force, reshaping the landscape of clinical trials. This article explores the various ways in which AI is revolutionizing the design, execution, and analysis of clinical trials.
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Precision medicine, with its focus on tailoring healthcare interventions to individual characteristics, is undergoing a transformative evolution propelled by emerging technologies. From advanced genomic tools to artificial intelligence, these technologies are revolutionizing our ability to understand, diagnose, and treat diseases at an unprecedented level of specificity. This article explores the key emerging technologies shaping the future of precision medicine.
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Types of Adverse Drug Reactions (severity)
- 1. Welcome Types of Adverse Drug Reactions Name : Ramesh Pothala Qualification: MSc(O.C) Student ID : 032/022023 5/5/2023 www.clinosol.com | follow us on social media @clinosolresearch
- 2. Index Adverse drug reactions. Types of adverse drug reactions. Classification of adverse drug reactions based on severity. 5/5/2023 www.clinosol.com | follow us on social media @clinosolresearch 2
- 3. Adverse Drug Reaction(ADR): Any noxious change which is suspected to be due to a drug, occurs at doses normally used in man ,requires treatment or decrease in dose or indicates caution in future use of same drug. Therefore ,an adverse drug reaction is an adverse event with a causal link to a drug. 5/5/2023 www.clinosol.com | follow us on social media @clinosolresearch 3
- 4. Types Of Adverse Drug Reactions Type A (Augmented) Type B (Bizarre) Type C (Chemical) Type D (Delayed) Type E (Exit/End of treatment) Type F (Familial) Type G (Genotoxicity) Type H (Hypersensitivity) Type U (Un classified) 5/5/2023 www.clinosol.com | follow us on social media @clinosolresearch 4
- 5. Type A (Augmented) reactions Reactions which can be predicted from the known pharmacology of the drug. Dose dependent, Can be alleviated by a dose reduction. E.g. Anticoagulants – Bleeding, Nitrates – Headache. Type B (Bizarre) reactions Cannot be predicted from the pharmacology of the drug Not dose dependent, Host dependent factors important in predisposition E.g. Penicillin – Anaphylaxis. 5/5/2023 www.clinosol.com | follow us on social media @clinosolresearch 5
- 6. Type C (Chemical)reactions Biological characteristics can be predicted from the chemical structure of the drug/metabolite. E.g. Paracetamol – Hepatotoxicity Type D (Delayed) reactions Occurs after many years of treatment. Can be due to accumulation. E.g. Chemotherapy – Secondary tumours Analgesics – Nephropathy. 5/5/2023 www.clinosol.com | follow us on social media @clinosolresearch 6
- 7. Type E (End of treatment)reactions Occurs on withdrawal especially when drug is stopped abruptly. E.g. Phenytoin withdrawal – Seizures, Steroid withdrawal – Adrenocortical insufficiency. 5/5/2023 www.clinosol.com | follow us on social media @clinosolresearch 7
- 8. Classification of ADRs depending on severity Minor ADRs: No therapy ,antidote or prolongation of hospitalization is required. Moderate ADRs: Requires change in drug therapy , specific treatment or prologs hospital stay by at least one day. Severe ADRs: Potentially life threatening ,causes permanent damage or requires intensive medical treatment. Lethal: Directly or indirectly contributes to death of the patient. 5/5/2023 www.clinosol.com | follow us on social media @clinosolresearch 8
- 9. References: 1.Rawlins MD, Thompson JW. Pathogenesis of adverse drug reactions. In: Davies DM, ed. Textbook of adverse drug reactions. Oxford: Oxford University Press, 1977:10. 2. Aronson JK. Drug therapy. In: Haslett C, Chilvers ER, Boon NA, College NR, Hunter JAA, eds. Davidson's principles and practice of medicine 19th ed. Edinburgh: Elsevier Science, 2002. 5/5/2023 www.clinosol.com | follow us on social media @clinosolresearch 9
- 10. Thank You! www.clinosol.com (India | Canada) 9121151622/623/624 info@clinosol.com 5/5/2023 www.clinosol.com | follow us on social media @clinosolresearch 10