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Premium member Presentation Transcript ADVERSE DRUG REACTION Detection, Reporting and Management : ADVERSE DRUG REACTION Detection , Reporting and ManagementMethods of detecting an ADR : Methods of detecting an ADR Pre-marketing studies Post marketing studiesMethods of detecting an ADR Pre clinical studies : Methods of detecting an ADR Pre clinical studies A great deal of risk information may be obtained Specific tests like carcinogenicity, teratogenicity and mutagenecity can be assessedMethods of detecting an ADR: Methods of detecting an ADR Pre clinical studies Limitations : Animals can only serve as approximate models for humans The predictive value of the different animal tests is uncertain in all instancesMethods of detecting an ADR Clinical studies : Methods of detecting an ADR Clinical studies Clinical studies are carried out in three different phases prior to submission of marketing authorization - Phase I - Phase II - Phase IIIMethods of detecting an ADR Clinical studies : Methods of detecting an ADR Clinical studies Limitations: Limited patient numbers Restricted patient populations Limited duration of patient exposureMethods of detecting an ADR Clinical studies : Methods of detecting an ADR Clinical studies Patients with co morbidities and intercurrent diseases are excluded Rare and fatal reactions are often unnoticed during these studiesPost marketing Surveillance (Phase IV) : Post marketing Surveillance (Phase IV) Case reports Cohort studies Case control studies Prescription event monitoring Spontaneous reporting systemSpontaneous reporting : Spontaneous reporting Spontaneous reporting It was, and still is, the main way of detecting early drug safety signal Widely accepted method of ADR reporting worldwide Simple to operate, easy to report and cheap Limitations Under Reporting bias Incidence cannot be studiedHow do we detect? : How do we detect? Detection of an ADR is crucial in the management of any patient Always suspect a drug as cause of symptoms in a patient Assess the patient’s risks factors for developing an ADRDiagnosis and attribution of causality : Diagnosis and attribution of causality It should be part of the broader diagnosis in a patient Firstly, find out whether a patient taking a medicinal product Collect all the data pertaining to eventDiagnosis and attribution of causality : Diagnosis and attribution of causality Find out whether the effect could be due to a medicine . The temporal time relationship between the administration of the suspected drug and the reaction Background frequency of the eventDiagnosis and attribution of causality : Diagnosis and attribution of causality Possible involvement of other causes Outcome of the reaction upon de challenge Outcome of the reaction upon re challenge After assessing the causality, document the ADR in the patient's medical recordVarious Algorithms for causality assessment : Various Algorithms for causality assessment WHO probability Assessment Scale Naranjo’s ADR probability scale European ABO system Kramer’s algorithm Karch and Lasagna scale Bayesian probability approach French Imputation Method Jones Scale Spanish quantitative imputation scaleVarious Algorithms : Various Algorithms THEY TAKE INTO ACCOUNT Temporal time-relationship Alternative causes Previous reports and documentation Response to de-challenge Response to re-challenge Blood levels of the drugReporting of an ADR : Reporting of an ADR To report an ADR you need not be certain just be suspicious Make sure that sufficient /adequate information is available Who can report ? Reports can be completed by Doctors Dentists Pharmacists Nurses Consumer reporting is the need of the hourReporting - What should be the minimum information? : Reporting - What should be the minimum information? Description of reaction Exposure to the drug Temporal time relationship between the exposure and the reaction The underlying disease(s) Concomitant therapyWhat to report? : What to report? Serious and or life threatening reactions Fatal reactions Reactions resulted in disabilities/ permanent harm Reactions resulted in increased healthcare costsWhat to report ? : What to report ? Severe reactions of any type Any reactions to newer drugs Newer reactions to any drugs in the market Rare and uncommon adverse reactionsHow to report ? : How to report ? Reporting can be made through reporting forms Depending on the practice scenarioWhere to report? : Where to report? Local / peripheral centre Regional pharmacovigilance centre National pharmacovigilance centre WHO collaborating centre Manufactures (in case of trial drugs, non -marketed drugs, newly marketed drugs)Management of an ADR : Management of an ADR Rapid action is sometimes important First and foremost step is withdrawal of suspected drug (s) If the reaction is likely to be dose related, dose reduction should be consideredManagement of an ADR : Management of an ADR Treatment for suspected reaction Symptomatic SpecificWhile managing an ADR: While managing an ADR Always have a clear therapeutic objective in mind, do not treat for longer than is necessary , and review the patient regularly and look for ways to simplify managementConclusion : Conclusion ADRs are inevitable risk associated with drug therapy Prompt recognition of potential ADRs, and early detection and intervention may prevent : - morbidity and mortality - unnecessary investigations and treatments - unnecessary human suffering and healthcare costsTHANK YOU: THANK YOU You do not have the permission to view this presentation. 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ADR detection LANKAPRANEETH Download Post to : URL : Related Presentations : Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Uploaded from authorPOINT lite Insert YouTube videos in PowerPont slides with aS Desktop Copy embed code: (To copy code, click on the text box) Embed: URL: Thumbnail: WordPress Embed Customize Embed The presentation is successfully added In Your Favorites. Views: 118 Category: Entertainment License: All Rights Reserved Like it (0) Dislike it (0) Added: May 05, 2011 This Presentation is Public Favorites: 0 Presentation Description No description available. Comments Posting comment... Premium member Presentation Transcript ADVERSE DRUG REACTION Detection, Reporting and Management : ADVERSE DRUG REACTION Detection , Reporting and ManagementMethods of detecting an ADR : Methods of detecting an ADR Pre-marketing studies Post marketing studiesMethods of detecting an ADR Pre clinical studies : Methods of detecting an ADR Pre clinical studies A great deal of risk information may be obtained Specific tests like carcinogenicity, teratogenicity and mutagenecity can be assessedMethods of detecting an ADR: Methods of detecting an ADR Pre clinical studies Limitations : Animals can only serve as approximate models for humans The predictive value of the different animal tests is uncertain in all instancesMethods of detecting an ADR Clinical studies : Methods of detecting an ADR Clinical studies Clinical studies are carried out in three different phases prior to submission of marketing authorization - Phase I - Phase II - Phase IIIMethods of detecting an ADR Clinical studies : Methods of detecting an ADR Clinical studies Limitations: Limited patient numbers Restricted patient populations Limited duration of patient exposureMethods of detecting an ADR Clinical studies : Methods of detecting an ADR Clinical studies Patients with co morbidities and intercurrent diseases are excluded Rare and fatal reactions are often unnoticed during these studiesPost marketing Surveillance (Phase IV) : Post marketing Surveillance (Phase IV) Case reports Cohort studies Case control studies Prescription event monitoring Spontaneous reporting systemSpontaneous reporting : Spontaneous reporting Spontaneous reporting It was, and still is, the main way of detecting early drug safety signal Widely accepted method of ADR reporting worldwide Simple to operate, easy to report and cheap Limitations Under Reporting bias Incidence cannot be studiedHow do we detect? : How do we detect? Detection of an ADR is crucial in the management of any patient Always suspect a drug as cause of symptoms in a patient Assess the patient’s risks factors for developing an ADRDiagnosis and attribution of causality : Diagnosis and attribution of causality It should be part of the broader diagnosis in a patient Firstly, find out whether a patient taking a medicinal product Collect all the data pertaining to eventDiagnosis and attribution of causality : Diagnosis and attribution of causality Find out whether the effect could be due to a medicine . The temporal time relationship between the administration of the suspected drug and the reaction Background frequency of the eventDiagnosis and attribution of causality : Diagnosis and attribution of causality Possible involvement of other causes Outcome of the reaction upon de challenge Outcome of the reaction upon re challenge After assessing the causality, document the ADR in the patient's medical recordVarious Algorithms for causality assessment : Various Algorithms for causality assessment WHO probability Assessment Scale Naranjo’s ADR probability scale European ABO system Kramer’s algorithm Karch and Lasagna scale Bayesian probability approach French Imputation Method Jones Scale Spanish quantitative imputation scaleVarious Algorithms : Various Algorithms THEY TAKE INTO ACCOUNT Temporal time-relationship Alternative causes Previous reports and documentation Response to de-challenge Response to re-challenge Blood levels of the drugReporting of an ADR : Reporting of an ADR To report an ADR you need not be certain just be suspicious Make sure that sufficient /adequate information is available Who can report ? Reports can be completed by Doctors Dentists Pharmacists Nurses Consumer reporting is the need of the hourReporting - What should be the minimum information? : Reporting - What should be the minimum information? Description of reaction Exposure to the drug Temporal time relationship between the exposure and the reaction The underlying disease(s) Concomitant therapyWhat to report? : What to report? Serious and or life threatening reactions Fatal reactions Reactions resulted in disabilities/ permanent harm Reactions resulted in increased healthcare costsWhat to report ? : What to report ? Severe reactions of any type Any reactions to newer drugs Newer reactions to any drugs in the market Rare and uncommon adverse reactionsHow to report ? : How to report ? Reporting can be made through reporting forms Depending on the practice scenarioWhere to report? : Where to report? Local / peripheral centre Regional pharmacovigilance centre National pharmacovigilance centre WHO collaborating centre Manufactures (in case of trial drugs, non -marketed drugs, newly marketed drugs)Management of an ADR : Management of an ADR Rapid action is sometimes important First and foremost step is withdrawal of suspected drug (s) If the reaction is likely to be dose related, dose reduction should be consideredManagement of an ADR : Management of an ADR Treatment for suspected reaction Symptomatic SpecificWhile managing an ADR: While managing an ADR Always have a clear therapeutic objective in mind, do not treat for longer than is necessary , and review the patient regularly and look for ways to simplify managementConclusion : Conclusion ADRs are inevitable risk associated with drug therapy Prompt recognition of potential ADRs, and early detection and intervention may prevent : - morbidity and mortality - unnecessary investigations and treatments - unnecessary human suffering and healthcare costsTHANK YOU: THANK YOU