Summary of Remarks
John Clarke, MD
Vice President, Epidemiology and Risk Management
United Biosource Corporation Late Stage, Inc.
April 18, 2007

Dr. John Clarke discussed the recent trends that have led to an increased interest in medication safety. According to Dr. Clarke, there has been an increased interest in medication safety because of increasing social expectations; people anticipate better drugs that will prevent and protect them from harmful effects. There has been an increase in the availability of safety information via the Internet, and the media has affected the perception of drug safety in the population. The emphasis on medication safety is also a result of legal action due to medication errors and adverse effects that lead to impairment. All of these factors have led to increased regulatory action. 

Dr. Clarke also described the effects of adverse events and suggestions in order to minimize or eliminate these events. An adverse event is an occurrence after a medication has been taken. Factors that can influence an event are the use of more then one drug, an overdose, addiction, medical errors, product defects, and product tampering or counterfeiting. Dr. Clarke discussed several suggestions that could reduce adverse events and increase drug safety. These include improved data/system validation standards, personnel performance standards, the creation of stricter organizational standards, better regulations, and improved communication on all levels.

 
Nyquanna Manning
MPH Student