IMPORTANCE OF ADR REPORTING IN INDIA

Adverse Drug Reactions are fourth to sixth leading cause of death among hospitalised patients and it occurs in 0.3 per cent to 7 per cent of all hospital admissions. The incidence of serious ADRs is 6.7 per cent (Joshi et al).

There is a rapid increase in the number of new drugs entering the market from last few decades,India being the second most populated country has over one billion potential drug consumers, and no amont of pre-clinical and clinical data is sufficient to conclude the complete safety of a drug, under this scenario it becomes necessary to report any untoward reaction of any pharmaceutical product to assess its safety and efficacy to ensure maximal patient health.

In India, general practitioners, with an large outpatient base tend to be among the first ones to use the drugs entering the market, hence they are in the best position to assess the adverse drug reactions associated with drugs.


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IMPORTANCE OF POST MARKETING SURVEILLANCE AND ADR REPORTING

Tests in animals are insufficient to predict human safety,

Patients used in clinical trials are selected and limited in number, the

conditions of use differ from those in clinical practice and the duration of trials is limited,

By the time of licensing exposure of less than 5000 human subjects to a drug allows only the more common ADR to be detected,

At least 30,000 people need to be treated with a drug to be sure that

you do not miss at least one patient with an ADR which has an incidence of 1 in 10,000 exposed individuals,

Information about rare but serious adverse reactions, chronic toxicity, use in special groups (such as children, the elderly or pregnant women) or drug interactions is often incomplete or not available,

Therefore reporting of an adverse event by healthcare professionals can save lives of many patients.

SOURCE(WHO,2002)

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CHARACTERISTICS OF A GOOD ADVERSE DRUG REACTION REPORT


Good case reports include the following elements:


1. Description of the adverse events or disease experience, including time to onset of signs
or symptoms.


2. Suspected and concomitant product therapy details (i.e., dose, lot number, schedule, dates, duration), including over-the-counter edications, dietary supplements, and recently discontinued medications.


3. Patient characteristics, including demographic information (e.g., age, race, sex), baseline medical condition prior to product therapy, co-morbid conditions, use of concomitant medications, relevant family history of disease, and presence of other risk factors.


4. Documentation of the diagnosis of the events, including methods used to make the diagnosis.


5. Clinical course of the event and patient outcomes (e.g., hospitalization or death).


6. Relevant therapeutic measures and laboratory data at baseline, during therapy, and subsequent to therapy, including blood levels, as appropriate.


7. Information about response to dechallenge and rechallenge.


8. Any other relevant information (e.g., other details relating to the event or information on benefits received by the patient, if important to the assessment of the event).

SOURCE (FDA)