Adverse drug events , regulatory

The aims of causality assessment are manifold. Adverse events need to be classified, a decision needs to be made whether a drug has caused this event, regulatory requirements need to be satisfied, signal recognition can be aided, and finally, at the end of this process, a label change may be necessary. 

Adverse event documentation and reporting The investigator and staff must understand the regulatory requirement for reporting adverse drug... 

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. 

Chapter VI. clinical safety deals with the reporting of adverse drug reactions and events by the investigator to the sponsor, who shall report to the regulatory authority of the member state where the trial is in progress. The member state has the obligation to ensure that all serious adverse reactions and events are reported immediately to the EMEA. 

In order to study the possible association antidepressant drugs and adverse suicidal events in adult patients, FDA planned and conducted a meta-analysis study of randomized trials of antidepressants. The meta-analysis had several key features that supported its quality and utility for regulatory actions (1) hypotheses generated from previous and independent evidence provided the meta-analysis objectives (2) the meta-analysis was based on well-defined inclusion criteria and an exhaustive set of trials with patient-level data available (3) the meta-analysis employed rigorous and consistent outcome definitions across trials and patients and (4) the meta-analysis was based on prespecified statistical analysis plan. 

Decisions have to be made by pharmaceutical companies and regulatory authorities about whether a drug can cause a particular adverse event (AE) so that an appropriate action can be taken. What does can cause mean Does it imply certainty In many cases to wait for certainty before taking action would entail many patients suffering unnecessarily. The degree of certainty or probability required will vary according to the situation. 

Any adverse events are reported and acted on to ensure patients welfare is not compromised by the drug. Serious events are reported to regulatory authorities within a specified time and, if deemed necessary, the drug is recalled or doctors and patients are notified. 

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