Pharmacovigilance - continued
Improving the detection and reporting of safety problems
ADR reporting remains the cornerstone of Pharmacovigilance, but there is widespread interest among regulators, sponsors, and the medical profession to improve current systems and practices. WHO has made a number of recommendations for streamlining ADR detection, including facilitating the rapid availability of data that may have international relevance. WHO also recommends standardizing definitions within the ADR reporting process to ensure universal understanding of the reported data.
In the U.S. most drug surveillance today relies on spontaneous reporting for signal detection. Researchers are currently working on alternative methodologies to complement spontaneous reporting in order to deliver a more comprehensive view and deeper insights into a drug’s safety profile. Health care providers and patients alike want to know more about drug interactions, about the effect of so-called “inactive” ingredients and about the effect of drug residues in the body. From a public safety perspective, the broader question is how to balance the excitement and promise of drug discovery with the potential consequences of introducing those products to the public when little is known about the product’s safety profile.
Since the FDA Modernization Act of 1997 allowing early approval of life saving products, the push for accelerated approvals means that many drugs come on to the market with a lot of “unknowns” attached to them. “Fast-track status has resulted in accelerated approvals of potent products without exposure data of significant maturity to signal severely harmful side effects,” says Dr. Jackson. “As a result, post-marketing surveillance has become critical for many drugs, and may even be a condition for their approval.”
Preventing crises in drug safety–a shared responsibility
The importance of an efficient system for dealing with drug safety risks and crises has become increasingly evident in recent years. Drug recalls and safety crises could be alleviated or minimized through the development of better systems for collecting, assessing and sharing information. Companies must apply objectivity and standardization to risk management by identifying risk tolerances and priorities and developing detailed mitigation plans in advance of drug-safety events. Health professionals and consumers must be educated more about rational drug use. Accurate and unbiased information should be freely available. The media should be encouraged and educated to take on a more responsible role in promoting the safe use of medications. Regulatory bodies must integrate pharmacovigilance activities into regulations, guidelines and policies. Finally, it is incumbent on all parties to manage the public’s expectations regarding the criteria used to define a drug as “safe.”
These measures, applied globally, will result in fewer safety issues, and place and keep on the market even safer effective drugs.