Post-marketing Surveillance of Prescription Drugs

What is post-marketing surveillance of prescription drugs? How is it done? What does it mean for clinicians?

As prescription drug abuse continues to be a problem, new technologies are being developed to track prescription drug abuse around the country. In this roundtable, clinicians and researchers will discuss post-marketing surveillance of prescription drugs, how it is done, and what the implications are for clinicians.

Nathaniel Katz, M.D., M.S.,:

Nathaniel Katz, M.D., M.S., is the Senior Consulting Advisor at Inflexxion Inc. in Newton, MA. Dr. Katz is an Adjunct Assistant Professor of Anesthesia at Tufts University School of Medicine. Dr. Katz was an Associate Editor at the Clinical Journal of Pain, and Associate Editor (Pain) for the Encyclopedia of Neurological Sciences.

Nathaniel Katz will be answering the question, what does post-marketing surveillance mean to clinicians?

Post marketing surveillance allows regulatory, pharmaceutical industry, clinicians, and public health community to continually evaluate the safety of a product in a "real-world setting". Clinical trials conducted prior to the launch of a product cannot fully assess the effects of drugs in specific subgroups (minorities, geographic areas, age groups, etc.), interactions with other drugs, nor interactions among patients with complicated medical histories. Additionally, such trials may not be able to detect uncommon, but serious life threatening adverse events or events that require a long time period to manifest. Surveillance data provides supplementary safety information that may not be uncovered in homogenous conditions of pre-market clinical trials.

In regards to prescription opioid abuse, post marketing surveillance provides clinicians information needed to better assess the risk benefit ratios for particular opioids in their area. The prevalence of prescription opioid abuse varies among particular populations and geographic locations. Post marketing surveillance can detect "hot spots"of abuse across the country in order to guide the implementation of interventions and inform clinicians of issues in their area to guide appropriate prescribing. For clinicians, post marketing surveillance provides a linkage between drug safety information and prescribing guidelines.