Adverse drug reactions voluntary system

One of the most important aspects of the UK regulatory system is the scheme that provided for the voluntary reporting of adverse reactions to a marketed drug. Because most serious adverse drug reactions (ADRs) are rare events, they are unlikely to be detected in early clinical trials. The problem is essentially one of numbers, as relatively few patients are exposed to a new drug before it is released on to the market. Marketing, therefore, may be the first adequate safety trial. 

Adverse Drug Reaction (ADR) Monitoring System. Voluntary reports on ADRs are sent to the MHW from around 3000 facilities designated by the MHW, including national hospitals, and university and municipal hospitals it is also called the hospital monitoring system . 

The ramifications of the thalidomide tragedy were many-fold but the key lesson for the development of pharmacovigilance was that active systems for detecting hazards are needed. Within a few years this had been taken forward with the introduction of voluntary (or spontaneous ) schemes for reporting of suspected adverse drug reactions (ADRs). These have stood the test of time as an alerting mechanism or early warning system and wiU be covered in more detail in Chapter 3. 

Griffin JP, Weber JCP Voluntary systems of adverse reaction reporting. Part I. Adv Drug React Ac Pois Rev 1985 4 213-30. 

One of the most important aspects of the UK regulatory system is the scheme that provides for the voluntary reporting of adverse reactions to a marketed drug. Since most serious ADRs are rare... 

Voluntary reporting. Doctors, nurses and pharmacists are supplied with cards on which to record suspected adverse reaction to drugs. In the UK, this is called the Yellow Card system and the Committee on Safety of Medicines collates the results and advises the government s Medicines Control Agency. It is recommended that for ... 

ADRAC utilizes a spontaneous, voluntary reporting system to identify suspected adverse reactions to drugs... 

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