ADR Monitoring System

ADR monitoring system maybe broadly classified as active and passive surveillance.
The mainstay of passive methods include mostly spontaneous (voluntary) reporting system (SRS). The active system are done by various methods which mainly comes under post marketing surveillance (PMS) or pharmaco-epidemiological studies. These methods are described below in short:40, 58
(1) Anecdotal reporting24, 32, 40, 57
The majority of the first information of ADR usually comes through anecdotal reports from individual doctors when a patient has suffered some specific or suspected side effect (e.g. in journals). Such anecdotal reports need to be verified by expert authority and/or by further studies. They sometimes fail to confirm problem. Advantage being

In this way it may be possible to match illness events with drugs prescribed. A specific example of the use of record linkage is the so-called prescription event-monitoring scheme (PEM in UK) where all the prescriptions issued by selected practitioners for a particular drug are obtained from the authority. The prescribers are then asked to inform any events in the patients who are taking the drugs. This system is less expensive than other surveillance methods and excellent in output if done in a comprehensive manner. Disadvantages beingtime consuming, retrospective and rely on accurate records and are limited by missing data and inability to determine

Also known as voluntary organized reporting system,which includes computerized surveillance systems like WHO’s monitoring programme, the Committee on Safety of Medicines’ yellow card system and the FDA’s Adverse Drug Reaction file system. In this system, healthcare professionalsare encouragedto report any or all reactions that are believed to be associated with drug use. Usually, attention is focused on new drugs and serious ADRs. The rationale for SRS is to generate signals of potential drug problems, to identify rare ADRs, drug-drug/drug-food interactions and theoretically to monitor continuously all drug used in a variety of real conditions from the time they have first appeared in the market. The advantage being it is simple to perform and being a non-interventional one, bears a low cost when a coordinated and functional system is in place. But under reporting, reporting bias, inability to detect delayed reactions, poor data quality due to missing data or data errors are it’s major