Reporting of ADRs

In clinical trials, the only ADRs occur which are common. Clinical trials are conducted under ideal conditions this is the inbuild limitation of clinical trials.  Due to this inbuild limitation Pharmacovigilance is necessary to establish the safety of the drug. Looking closely to a drug safety profile after approval is known as post marketing surveillance.  This is a sub part of Pharmacovigilance.

Drug can cause injury or death by ADRs.  ADRS may be produced due to

•medication error

•undetermined factors

•product quality defects

•ADRs may be avoidable or unavoidable

There all may lead to injury or death.

Initially it was thought that the drugs are safe. In 1961 Dr.MC bride wrote a letter to the lancet (journal).

“ I am observing the increased frequency with short limbs of new born and it seems this is due to thalidomide “

Types of Reporting of ADRs

1)spontaneous Reporting of ADRs

2)Case Reporting of ADRs

3)Analysis of secular trend of ADRs

5)Cohort studies for ADRs

A)prospective cohort studies

B)retrospective cohort studies

6)Case controlled studies for ADRs

7)cross sectional studies for ADRs

Spontaneous Reporting of ADRs:

It is the most common process of reporting ADRs in which reports are not collected systemically.

Newly marketed drugs has black inverted arrow this means that the drug is newly marketed and under a strict surveillance to observe unknown ADRs. This sign usually last for 2 years or may be longer.

In 1964 yellow card scheme was introduced in UK through which ADRs are reported. But only public officers can report patients are not allowed to report.

But in 2005 patients can also report. Every person ( physician, patient,  nurse, or pharmacist) can report any ADRs that may be mild or sever.

The conformation of ADRs whether it is actually happened is not necessary.  Suspection is enough, conformation is not necessary.

This is good for generating hypothesis where the claimed ADR may prove right of false.

Report all ADRs occur in pregnant women and babies. If you observe or suspect the specific ADR this is an ethical responsibility to report to the regulatory authority.

This type of ADRs reporting is known as spontaneous reporting.

Advantages of spontaneous reporting:

•through spontaneous reporting we can report the ADRs throughout the life of the product.

•in spontaneous reporting we can report ADRs of prescribed drugs,  herbs, and OTC drugs.

•spontaneous reporting is cheap and less expensive and easily operate able way of reporting

•Spontaneous reporting are good for generating hypothesis and signals.

Disadvantages of spontaneous reporting:

•under reporting is the biggest limitation.

•detecting an adverse event and differentiating from other diseases this is not any easy task because the same symptoms can resemble to other diseases.

•quantification can not be used

For example

If 50 people are using a drug . The adverse event is reported by a single person out 50, and the adverse event is not reported among the rest 49. This adverse event reported by a single (1 of 49) is neglected not be tested. This frequency is called quantification.

•usage of a drug product may be restricted or can be withdrawn from the market depending upon the ADR.

The other types of reporting of ADRs are explained in other blog.

For case reporting of ADRs click here 

For analysis of secular trends click here

For cohort studies click here

For prospective cohort studies click here

For retrospective cohort studies click here

For case controlled studies click here

For cross sectional studies click here

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