Managed Healthcare Executive - January 2009 - (Page 23)

{ PHARMACY BEST PRACTICES } Post-marketing surveillance brings added drug safety Initial clinical trials can’t reveal all risks, but better data collection and FDA involvement can help BY MARI EDLIN T Mari Edlin is a frequent contributor to MANAGED HEALTHCARE EXECUTIVE. She is based in Sonoma, Calif. requires post-approval studies of clinical trials to assess a known risk or signals of a serious risk, and to identify an unexpected serious risk. “Clinical trials, which typically study only several thousand patients, do not reveal all of the risks,” says Paul Seligman, MD, associate director of safety policy and communication for FDA’s Center for Drug Evaluation and Research (CDER). “A rare problem may only come to light after the drug is used in millions of people. Post-marketing surveillance is one way to monitor a drug’s safety on an ongoing basis.” He says that better data, science and communication are the basis of post-marketing drug safety. The data is provided by the new Sentinel Initiative, a publicprivate partnership. It will enable FDA to query speci c adverse event data in large databases—including patient registries, claims and Medicare data—to verify if reported data from professionals and patients match up with what has been found. Understanding the science behind HREE INITIATIVES HAVE converged to why certain people adversely react to place the spotlight on drug safety: the Senti- medications and ensuring providers and nel Initiative, which is a long-term e ort to patients receive risk information advance create a national electronic system for monitoring the safety e orts in the post-marketing medical product safety; mandating manufacturers to phase of a drug’s lifecycle. develop a Risk Evaluation and Mitigation Strategy Most of the post-marketing safety re(REMS) for certain drugs and biological products ports are submitted to drug manufacturto ensure the bene ts outweigh the risks; and the ers by physicians, nurses, pharmacists or Nationwide Health Information Network (NHIN). other healthcare providers. Once they are The rst two strategies are the results of the U.S. assessed, the drug companies turn the Food and Drug Administration Amendment Act reports over to FDA. of 2007 (FDAAA). Information is derived from clinical The Act also establishes a timetable for inclu- trials, adverse event reports, post-approval sion of new safety information on drug labels and studies, peer-reviewed biomedical literaJANUARY 2009 PhotoAlto/Getty Images 23

Table of Contents Feed for the Digital Edition of Managed Healthcare Executive - January 2009

Managed Healthcare Executive - January 2009 Contents Editorial Advisors For Your Benefit News Analysis Politics & Policy Letter of the Law Managed Care Outlook New Day 5 New Realities of Disease Management Pharmacy Best Practices Health Management Technology State Report: Hawaii MHE Resource Ad/Edit Index

Managed Healthcare Executive - January 2009

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