ADR detection

Views:
 
Category: Entertainment
     
 

Presentation Description

No description available.

Comments

Presentation Transcript

ADVERSE DRUG REACTION Detection, Reporting and Management :

ADVERSE DRUG REACTION Detection , Reporting and Management

Methods of detecting an ADR :

Methods of detecting an ADR Pre-marketing studies Post marketing studies

Methods 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 assessed

Methods 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 instances

Methods 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 III

Methods of detecting an ADR Clinical studies :

Methods of detecting an ADR Clinical studies Limitations: Limited patient numbers Restricted patient populations Limited duration of patient exposure

Methods 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 studies

Post marketing Surveillance (Phase IV) :

Post marketing Surveillance (Phase IV) Case reports Cohort studies Case control studies Prescription event monitoring Spontaneous reporting system

Spontaneous 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 studied

How 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 ADR

Diagnosis 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 event

Diagnosis 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 event

Diagnosis 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 record

Various 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 scale

Various 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 drug

Reporting 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 hour

Reporting - 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 therapy

What to report? :

What to report? Serious and or life threatening reactions Fatal reactions Reactions resulted in disabilities/ permanent harm Reactions resulted in increased healthcare costs

What 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 reactions

How to report ? :

How to report ? Reporting can be made through reporting forms Depending on the practice scenario

Where 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 considered

Management of an ADR :

Management of an ADR Treatment for suspected reaction Symptomatic Specific

While 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 management

Conclusion :

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 costs

THANK YOU:

THANK YOU

authorStream Live Help