It is concerned with the safety and efficacy of drugs. 

Drugs can produce three types of actions

1)beneficial

2)harmful

3)unknown

Every drug has the ability to produce ADR.

“Pure food and drug acts" the first organization formed in US in 1906 , to look over the adulterated and misbranded brands in the market but still this organization were not bound to the safety of the drugs.

This act gave authority to the government to withdraw misbranded drugs in the market.

According to the current act, the manufacturer has to prove what he claimed in the label,  but at that time this act where limited to look at misbranded and adulterated drugs only.

How renal failure caused by sulfanilamide?

In 1937 cases of >100 deaths were reported due to renal failure caused by elixir of sulfanilamide the introduction of food drug and cosmetics act held by the response of this incidence .

According to this act pre clinical ( non human or animal ) studies should be conducted by the manufacturer prior to marketing of a drug.

How thalidomide cause phoecomedia ?

In 1950s chloramphenicol caused Aplastic anaemia by this response and in 1962, thalidomide disaster occurred results incidence of rarely phoecomedia happened caused by the exposure of thalidomide by pregnant women , has teratogenic effect of improper development of limbs. Investigation was done and this incidence was related to the causality of thalidomide.

By the response of these incidence another act was introduced the “ IND" according to this act the manufacturer has to prove the safety and efficacy of a drug pre clinical studies should be conducted.* aims of Pharmacovigilance 

Phases of clinical trials:

Pre clinical trials:

The drug is tested on non human subjects to gather efficacy,  toxicity and pharmacokinetic information.

OR

Testing on animals.

Clinical trial phase 1:

The drug is used on healthy volunteers for safety.

Clinical trial Phase 2:

The drug in therapeutic dose is tested on the intended patients i.e. hypertension to establish the efficacy and safety.

Clinical trial phase 3:

Drug is tested to reflects the real world population patient.

Clinical trial phase 4:

Post marketing surveillance.

Post marketing surveillance:

Monitoring of a drug safety after it has released on the market and is an important part of science of Pharmacovigilance.

Initially Pharmacovigilance was used synonymous to post marketing surveillance but now it is thought to be the part of Pharmacovigilance.

Rofecoxib in 2004 caused severe CV toxicity,  novalgine in 2006 is a risk of cancer , chloramphenicol not used in childrens because it causes grey baby syndrome,  aspirin cause reye syndrome.  These were proved from Pharmacovigilance.* aims of Pharmacovigilance 

Aims of Pharmacovigilance:

•identification and qualification of unknown ADR of drugs.

•drug usually marketed after established efficacy and safety in clinical trials.

Efficacy of drug:

Ability of a drug to produce the desired outcomes under ideal condition.

Effectiveness of drug:

Ability of a drug to produce the desired outcomes under real world condition.

In clinical trials the condition is ideal it is not necessary that drugs are always effective.

•Identification of sub groups of patients who are at the greater risk of developing ADR.

•evaluation and identification of drug drug , drug food , drug gerb and drug disease and drug medical instrument interaction.

•balance between harms and benefits remains acceptable .

•comparing the ADR profile of various drugs of the some therapeutic class.* aims of Pharmacovigilance 

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What is pure food and drug acts ?

How renal failure caused by sulfanilamide?

What is pre clinical trials ?

How aplastic anaemia caused by chloramphenicol?

How thalidomide cause phoecomedia?

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There is how many Phases of clinical trials?

What is clinical trial phase 1 ?

What is clinical trial phase 2 ?

What is clinical trial phase 3 ?

What is clinical trial phase 4?

What is post marketing surveillance?

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What are the four main components of pharmacovigilance?

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