Spontaneous ADR reporting systems

Despite the limitations discussed, it is clear that we will continue to need systems that fulfil the purpose of spontaneous ADR reporting schemes for the foreseeable future. It is also clear that, for most drugs, relying on spontaneous reporting alone is insufficient and a proactive approach to studying safety using pharmacoepidemio-logical studies is needed. 

This spontaneous adverse reaction reporting system was the brainchild of Professor Leslie Witts and was, and still is, based upon the submission of ADR reports by doctors and dentists by means of reply-paid yellow cards, and hence it is popularly known as the Yellow Card Scheme. ... 

Given the perceived failure of spontaneous reporting systems and the paucity of ADR reports/ some institutions have instituted more active methods of ADR detection to supplement spontaneous reports. Medication order screening has become a common practice in U.S. hospitals. Manual chart reviews and audits and computer programs are used for retrospective/ concurrent/ and prospective medication utilization evaluation. Certain events often prompt an evaluation of a suspected adverse reaction. These include abrupt discontinuation of a medication/ abrupt dosage reduction/ orders for antidotes and emergency medications/ orders for special tests or serum drug concentration measurements/ and abnormal results from laboratory tests and medical procedures. 

Additional advantages of spontaneous reporting systems include the detection of extremely rare ADRs and ability to identify at-risk subgroups. In order to enhance the spontaneous reporting system approach, the FDA developed the MedWatch form. This form can be faxed to the agency (1-800-FDA-1078) or called in (l-800-FDA-1088). ° The forms also can be... 

Pharmacoepidemiology is used to detect ADRs. Several types of systems use pharmacoepidemiologic methods. These include spontaneous reporting, studies of therapeutic classes, and studies of specific medical syndromes. 

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. 

Prescription event monitoring (PEM) is a pharmacoepidemiological system which uses the cohort design and was developed in England around 1980. It is mostly focused on new medicines, particularly those used for chronic diseases and is complementary to spontaneous reporting as a method of identifying unexpected ADRs. 

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