FDA Announces New Prescription Drug Information Format
The U.S. Food and Drug Administration (FDA) has revised the format of the standard prescription drug package insert for the first time in more than 25 years. The new format—a result of feedback from focus groups, national physician surveys, and a public meeting—is intended to draw attention to the most important pieces of information, making it easier for physicians to explain the benefits and risks of medications to their patients. Changes to the format include the addition of a “Highlights” section summarizing indications, dosages, and warnings; a “Table of Contents” referring physicians to detailed information; the inclusion of the initial date of product approval; a toll-free number for reporting suspected adverse effects; and a “Patient Counseling Information” section to guide communication between prescribers and patients. The revised format also will be more compatible with electronic resources and will be integrated into other FDA e-Health initiatives such as electronic labeling and drug barcode requirements. Prescription information in the new format will be available through the online health information clearinghouse DailyMed (http://dailymed.nlm.nih.gov). The new labeling requirements will be phased in slowly, but all drugs approved within the past five years will gradually be converted to the new format. For additional information, visit the FDA Web site athttp://www.fda.gov/cder/regulatory/physLabel/default.htm.
ASTM International Develops Continuity of Care Record
ASTM International (formerly the American Society for Testing and Materials) has developed a new standard for preserving and transferring health care information—E 2369, Specification for Continuity of Care Record (CCR). The CCR, a set of data that includes patients’ health status and treatment information, will be delivered to the appropriate health care professional whenever a patient is referred or transferred to another hospital or clinic. The standard was developed with the support of 11 sponsoring organizations, including the American Academy of Family Physicians (AAFP), the American Medical Association, and the American Health Care Association. It is intended to allow physicians easy access to patient information necessary for continuity of care, preventing unnecessary repeat testing and reducing the potential for medical errors. The AAFP has launched Project Continuity of Care to raise awareness of this standard and to speed the integration of the CCR into existing electronic health record software. For more information, see the ASTM Web site athttp://www.astm.org or the AAFP Web site athttps://www.aafp.org/x41169.xml.
HHS Launches Project to Test Electronic Prescribing for Medicare Part D
The U.S. Department of Health and Human Services (HHS) is conducting a project to test standards of electronic prescribing for the Medicare Part D prescription drug program. Four teams will assess the impact of electronic data transmission systems on patient safety and quality of care outcomes such as adverse drug events and appropriate use of medications. The teams will examine how efficiently prescriptions and related information (e.g., medication history, formulary details) can be communicated between prescribers and pharmacies, and will assess standards for naming clinical drugs and ingredients and providing patient instructions. Changes in pharmacy and physician office work flows will then be analyzed for any investment returns from e-prescribing. The project will run throughout 2006 and is being funded by nearly $6 million in competitively awarded agreements. The participants include Brigham and Women’s Hospital (Boston, Mass.), Brown University (Providence, R.I.), and Achieve Healthcare Information Technology (Minn.). For more information, visit the HHS Web site athttp://www.hhs.gov/news.
$100 Million Awarded for Local Pandemic Influenza Preparations
The HHS is distributing $100 million among states and municipalities to fund local preparedness for an influenza pandemic. These initial grants are part of a $350 million emergency appropriation fund passed by Congress in December. Each state will be given at least $500,000, with additional awards according to population. Funds will also be given to seven U.S. territories, the Commonwealth of Puerto Rico, the District of Columbia, New York City, Chicago, and Los Angeles County. The funds are to be used for the planning and implementation of practical, community-based procedures to prevent or delay the spread of an outbreak and to reduce the burden of illness should an outbreak occur. State funding ranges from $622,102 for Wyoming to $5,875,044 for Texas. For a full list of the funding distribution, go tohttp://www.hhs.gov/news/press/2006pres/20060112.html. More information on pandemic preparedness efforts is available online athttp://www.pandemicflu.gov.
FDA Advice Facilitates New Drug Development
In an effort to improve the development process for new medical treatments, the FDA has released guidance documents for researchers who plan to conduct early clinical studies in people. Studies at the early, exploratory stage use only small amounts of drugs and thus involve fewer potential risks for participants. In the past, however, researchers conducting early studies have had to comply with drug manufacturing procedures for companies who mass produce products, which prevented many leading medical research institutions from studying their discoveries. The new FDA guidance documents suggest approaches for safely producing and testing small amounts of drugs and advise medical researchers how to take advantage of built-in flexibility in data regulations. By facilitating the conduction of earlier studies, the FDA hopes to make safe and effective drugs for life-threatening disease more rapidly available to patients. For more information visit the FDA Web site athttp://www.fda.gov/bbs/topics/news/2006/NEW01296.html.
AAFP Offers Fellow ship in Medical Editing and Faculty Development
The AAFP is again offering a one-year AAFP fellowship in medical editing and faculty development based at Georgetown University Medical Center, Washington, D.C. The AAFP fellow acts as apprentice editor for the editor of American Family Physician (AFP), Jay Siwek, M.D., with responsibilities including soliciting, reviewing, and editing manuscripts; managing anAFP column; and writing content for AFP’s “Tips From Other Journals” and patient education material. In addition, the fellow serves as an instructor and junior faculty member at Georgetown University Medical Center, which involves seeing patients in a community health center, precepting family medicine residents, teaching medical students, participating in an on-call schedule, and making inpatient rounds. The fellowship begins in July, 2006, and applications are due by March 1. Those interested should submit a letter of interest and curriculum vitae to Dr. Siwek firstname.lastname@example.org.
Presenters Needed for Conference on Practice Improvement
Organizers of the Conference on Practice Improvement: Health Information and Patient Education (formerly the Conference on Patient Education) are taking applications for presenters. The 2006 conference, to be held November 9 to 12 in Denver, Colo., will focus on the management of chronic illness with the theme, “The Internet Changes Everything.” Proposals for presentation topics should come under patient education, practice enhancement, chronic illness management, or best practices for the new model of health care. Applications must be submitted by March 15. For more information call 800–274–2237 (extension 3142), or visit the AAFP Web site athttps://www.aafp.org/x41274.xml.