Pharmacovigilance: The changing role of drug safety in today’s development process
The “Modern Era” in Pharmacovigilance
In 1938 the U.S. Congress passed legislation requiring drug makers to demonstrate the safety of their products. Only much later, in response to the Thalidomide tragedy of 1961, did FDA require demonstration of efficacy prior to approval of new drug applications, which, in retrospect, introduced the concept of balancing benefit with risk. In 1963 the World Health Assembly adopted a resolution calling for more monitoring of drug effects and reactions. This resolution led to a World Health Organization (WHO) pilot project on drug safety monitoring in 1968, and to the creation of systems for reporting and sharing patient case histories and adverse drug events. With this background, the modern era of Pharmacovigilance began.
Pharmacovigilance may be defined as the ongoing observation and assessment of the benefits and risks of medicinal products in order to ensure that the products maintain the quality, safety, and efficacy compatible with their approved status. Over time, the purview of pharmacovigilance has expanded to include drugs, herbals, non-traditional medicines, biologicals, medical devices and vaccines.
In “The Importance of Pharmacovigilance” (2002), the World Health Organization sets forth the role of pharmacovigilance: “to improve patient care and safety” in relation to the use of medicine, and “to contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost-effective) use.
As the number and potency of drugs available to consumers keeps increasing, the potential for adverse reactions has also increased, making pharmacovigilance a critical component of the drug development process. And the concerns of pharmacovigilance are widening, as researchers start to look beyond drugs to examine the safety of herbal and biological treatments, food supplements, cosmetics and medical devices.
According to Doniel Jackson, M.D., Director of Drug Safety & Medical Affairs at ICON, “Pharmacovigilance and drug safety have only recently begun to capture the attention they deserve within the drug development process. Once, they were poorly understood sub-disciplines, mainly focused on adverse drug reactions (ADRs) and frequently viewed as an afterthought to development. Today, drug safety issues are reviewed and studied at every stage of clinical development.”
Much of the increased attention being paid to pharmacovigilance can be traced to the high-profile failures of once-blockbuster drugs such as Celebrex, Propulsid and fen-phen, which led to increased regulatory demands on drug developers. But while regulatory requirements are driving much of the growth in pharmacovigilance, medical, ethical and economic concerns are also important considerations for drug and device manufacturers. In fact, WHO calls pharmacovigilance “a source of vigour and originality that contributes much to international drug development practice and standards.”