ABSTRACT
Several surveillance procedures are involved during the lifetime of
a drug. Half of the 10 years needed for new drug development are
dedicated to clinical trials testing drug harmlessness and efficiency.
However, when drugs are approved for marketing, knowledge
regarding their safety is still incomplete. The subsequent population
experience with a product is usually much broader than that
derived from the clinical trials as many new situations as well
as rare severe adverse effects may occur later. The postmarketing
surveillance process and the prevention of drug-related adverse
events or adverse drug reactions (ADRs) area major issue in public
health, to protect the population and to optimize the benefit-
risk of drugs. Indeed, ADRs impose a remarkable burden on the
health care system. Serious ADRs are a major leading cause of
death and result in billions of dollars in health care costs. Failure
to effectively manage drug safety data and the postmarketing
surveillance processes can affect patient well-being, jeopardize a
drug’s potential for benefit, and create a regulatory nightmare [29].
