PDR Network Delivers Six Million Drug Alerts & REMS
Electronic Delivery of REMS Fulfills FDA Guidance
MONTVALE, NJ, [October 7, 2010] – PDR Network, already the largest distributor of FDA-approved drug information and Drug Alerts to U.S. prescribers, announced that this month it will surpass six million Drug Alerts and Risk Evaluation and Mitigation Strategies (“REMS”) program alerts delivered to prescribers. FDA-approved Drug-Alerts have been delivered electronically to prescribers by PDR Network’s Health Care Notification Network (HCNN) service since 2008.
REMS programs are becoming increasingly common, and often more complex, for both newly-approved drugs as well as those already on the market. Over 140 drugs now have REMS programs required by the FDA. In some instances the REMS consists largely of an FDA-approved medication guide while in other cases prescribers must take additional training to prescribe the drug. But in every case it is important for prescribers to know the details of the FDA-approved labels and REMS programs, and PDR Network provides this information directly to prescribers online.
"Immediate delivery of drug information to physicians is critical for the safe and effective practice of medicine," explained Nancy Dickey, M.D., former president of the American Medical Association (AMA) and current chair of the iHealth Alliance that governs the use of PDR Drug Alerts for communicating REMS Alerts to prescribers. "Six million Alerts delivered is a major milestone worthy of note particularly as patient safety issues have gained national attention."
The electronic delivery of FDA-approved Drug Alerts and REMS replacing paper-based delivery began in 2006 with the release of updated FDA Guidance promoting the use of electronic delivery of Drug Alerts and the launch of the Health Care Notification Network, the only online network for delivery of these Drug Alerts.
“Having worked on the launch of the HCNN several years ago while at J&J, it is particularly rewarding to see how prescriber participation in the network has grown and this milestone has been reached by PDR,” noted Christine Côté, M.D., PDR Network’s chief medical officer and former vice president of the Corporate Office of Science and Technology at Johnson & Johnson.
In addition to delivering REMS programs and Drug Alerts, PDR Network will also offer CME credits to prescribers who read the REMS materials and Alerts and answer related patient safety questions, through a partnership with the Texas Medical Association as well as The Doctors Company, the country’s largest professional liability carrier.
“Immediate access for physicians to drug safety information and up-to-date FDA-approved drug labeling is important to protect patient safety and help reduce professional liability,” explained David Troxel, M.D., medical director for The Doctors Company. “FDA-approved labeling, including REMS programs, often represents the standard to which physicians are held in medical malpractice litigation, and we are pleased to collaborate with PDR Network both in the distribution of this important information and in the creation of CME programs that increase their value to prescribers.”
Edward Fotsch, M.D., CEO of PDR Network, added: “The six million Alerts and REMS milestone is rewarding and it is important to note the many efforts of liability carriers, medical societies, the FDA and many other partners in making this a reality. But we are not stopping here as we add more value to the REMS services – including our work to integrate them into electronic health records.”
About PDR Network
PDR Network LLC, is the leading distributor of drug labeling information, product safety Alerts, and REMS programs, including Physicians’ Desk Reference (PDR®), the most highly trusted and commonly used drug information reference available in the U.S, PDR.net, mobilePDR®, and Health Care Notification Network (HCNN), the only service providing specialty-specific electronic delivery of FDA-approved safety Alerts to physicians. HCNN is governed by the not-for-profit iHealth Alliance. For more information, visit www.pdrnetwork.com.
About The Doctors Company
Founded by doctors for doctors in 1976, The Doctors Company (www.thedoctors.com) is relentlessly committed to advancing, protecting, and rewarding the practice of good medicine. The Doctors Company is the largest national insurer of physician and surgeon medical liability with 55,000 member physicians, $3 billion in assets, an A rating by Fitch Ratings, and an A- rating by A.M. Best Company.
About The Texas Medical Association
The Texas Medical Association was organized by 35 physicians in 1853 to serve the people of Texas in matters of medical care, prevention and cure of disease, and the improvement of public health. Today, with nearly 45,000 physician and medical student members, TMA's vision is still to "improve the health of all Texans." TMA supports Texas physicians by providing distinctive solutions to the challenges they encounter in the care of patients.