How ADRs are Reported

How ADRs are reported

Types of Reporting of ADRs

•Case Reporting of ADRs

•Analysis of secular trend of ADRs

•Cohort studies for ADRs

A)prospective cohort studies

B)retrospective cohort studies

•Case controlled studies for ADRs

•Cross sectional studies for ADRs

•spontaneous Reporting of ADRs

Case reporting of ADRs:

When the report of a single person is published in a medical journal is called case reporting.

Most ADRs are reported in a medical journal through case reporting.  For publishing a case report conformation is necessary.

E.g. dechallenge and rechallenge , lab investigations,  dose reduction etc is necessary for conformation.

It is a long process because a case report is build when there is large number of reports of ADRs are available.  It can’t be formed on a single report. It is formed on the similar reports of multiple cases.

Analysis of secular trends / ecological correlated studies:

It is evaluated to that whether the trend between the suspected cause concide with the suspected event or not.

For example:

In 1981, by the introduction of oral contraceptives,  the cases of pulmonary thromboembolism increased as their consumption increased.

Cohort studies:

Compare the group of individuals having the same characteristics or experience.

Cohort study is research comparative study. Cohort studies used for testing the hypothesis.

For example:

Two patients one is taking diclofenac and another is taking ibuprofen both are taking NSAIDs but different.  All the characteristics of patients must be similar the only difference is the use of drugs they are using.

For example:

200 patients suffers from joint pain the patients are of similar characteristics.  100 are taking Rofecoxib and 100 are taking celecoxib.

Out of 100 who are taking rofecoxib 15 deaths occur due to CVS toxicity.

Out of 100 who are taking celecoxib 5 deaths occur due to CVS toxicity.

The study shows that the incidence of CVS toxicity is higher with the use of rofecoxib .

For example:

group of hypertension patients,  pharmaceutical industry patients/people.

There are 2 types of cohort studies

1)prospective cohort studies

2)retrospective cohort studies

1)prospective cohort studies:

In prospective cohort studies we look for development of disease in future.

Group of individuals showing the same characteristics. Prospective cohort studies are observational studies.

Prospective cohort studies is a longitudinal cohort studies that follow over a group of similar individuals (cohort) who differs with the respect to certain factors .Under study to determine how these factors affect rate of certain outcomes.

For example:

One might follow a cohort of middle aged truck drivers who vary in terms of smoking habits, to test the hypothesis that 20 years incidence rate of lung cancer will be highest among heavy smokers followed by moderate smokers and then non smokers.

2)Retrospective cohort studies:

In retrospective cohort studies we check the previous records. We look back in time, thus using existing data such as medical records or claim database.

Advantages of cohort studies:

•cohort studies are authentic

•in cohort studies multiple outcomes can be evaluated for single exposure/risk factor.

Disadvantages of cohort studies:

•cohort studies is time consuming

•cohort studies is expensive

•chance of follow up

•quitting the studies

Case controlled studies:

Case controlled studies is used for establishing case and effect relationship. Individuals are categorized on the basis of outcomes. Those patients who developed the ADRs or the outcomes of interest are known as case. Those patients who do not developed the ADRs are called controlled.

Cross sectional studies:

In cross sectional studies outcomes and cases are evaluated at the same time .

E.g. it is just like taking a picture you can’t established the time effect / temporal relationship.  We can’t establish cause and effect relationship.

They are good for generating hypothesis but are not good for testing hypothesis. The hypothesis are usually tested from cohort studies.

For spontaneous reporting click here

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