P o l i c i e s a n d P o l i t i c s are unclear, and the risk for personal harm to patients weighs on the clinical staff in a unique way. Balancing protection of the public, protection of providers and building a more cost-effective healthcare system are likely to remain as major challenges of the 21st century. A third factor that altered the policy and regulatory environment was the rise of expanded enforcement activities beyond FDA, by federal and state attorneys general and plaintiffs7lawyers, using novel legal theories and laws never before applied to prescription drug regulation. These activities are described in more detail in the accompanying chapters by Kamp and Pines, and Berkowitz, herein. The fourth factor that influenced communications policy development was the release of a group of reports by the prestigious Institute of Medicine in the United States under the Quality Chasm Series banner. A 2006 report in that series3declared that "'medication errors" result in an estimated 1.5 million injuries and billions of dollars in costs each year. While the report defines such errors broadly as those caused by over- the-counter products, vitamins, minerals, herbal supplements, and prescription drugs, press reports widely attributed the problem to prescription drugs alone. The combined impact of these events on public perception of the pharmaceutical industry led to a steep decline in the drug industry's reputation and calls for Congressional action to rectify its perceived shortcomings, including industry participation as sponsors of continuing medical education, advertising Rx drugs directly to the public, editorial assistance in the preparation of research reports, and many other communications activities. As of this writing, a renewed campaign for universal healthcare has been underway for the better part of two years; the legislative outcome has not yet been decided. Harry Sweeney References: 1) Omenn GS, in Medicine Ave 2 page 38. 2) Amalberti R, Auroy Y, Berwick D, and Barach P (2005). Five system barriers to achieving ultrasafe healthcare. Arch Int Med. 142(9):756-764. 3) Aspden V, Wolcott J, Bootman JL, Cronenwett LR, eds. Committee on Identifying and Preventing Medication Errors. Preventing Medication Errors. Quality Chasm Series. Washington, DC: National Academies Press; 2007. www.nap.edu/catalog.php7record_idM 1623. 51
RkJQdWJsaXNoZXIy NDMwNDAx