The new European Union Pharmacovigilance legislation was published in December 2010 and regulations go into effect in early July 2012. A number of significant changes will take place. The Regulations and Directives are legally binding.
One of the major changes is found in signal detection. Industry will now need to have specific measures in place that document the process of signal detection. Issues that need to be considered are the frequency of monitoring data, prioritization of signals...and a documented process.
This change has potential advantages and disadvantages. Capturing and identifying signals in a timely fashion is essential. The benefit to early detection of an Adverse Drug Reaction (ADR) is the possibility of improving patient safety. ADR determination is based on a number of pharmacological and medical considerations. Sometimes an ADR determination is made after a number of events are detected. For serious and rare ADRs it is reasonable to make a determination with fewer events; one event may be enough to make an ADR association between the drug and the adverse reaction.
Considering the Benefit : Risk ratio or profile is quite important. As in many of life's situations there are associated benefits and risks to any medical intervention. Before starting a treatment or having a procedure these need to be taken into consideration. The same holds true during the development of a product; the pros and cons must be weighed during this period as well as into the later stages of the product's lifecycle. Patients who are on a treatment or who have received a medical device need to understand the potential impact of the detection of a signal that is related to their treatment or medical device in order to make an informed decision regarding choices that they may make in their healthcare.
For some people the benefit will be of greater importance than a possible risk. Others will not want to take on the risk associated with a particular treatment.
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