Off-label use of medical products in radiation therapy: summary of the report of AAPM Task Group No. 121.

Medical products (devices, drugs, or biologics) contain information in their labeling regarding the manner in which the manufacturer has determined that the products can be used in a safe and effective manner. The Food and Drug Administration (FDA) approves medical products for use for these specific indications which are part of the medical product's labeling. When medical products are used in a manner not specified in the labeling, it is commonly referred to as off-label use. The practice of medicine allows for this off-label use to treat individual patients, but the ethical and legal implications for such unapproved use can be confusing. Although the responsibility and, ultimately, the liability for off-label use often rests with the prescribing physician, medical physicists and others are also responsible for the safe and proper use of the medical products. When these products are used for purposes other than which they were approved, it is important for medical physicists to understand their responsibilities. In the United States, medical products can only be marketed if officially cleared, approved, or licensed by the FDA; they can be used if they are not subject to or specifically exempt from FDA regulations, or if they are being used in research with the appropriate regulatory safeguards. Medical devices are either cleared or approved by FDA's Center for Devices and Radiological Health. Drugs are approved by FDA's Center for Drug Evaluation and Research, and biological products such as vaccines or blood are licensed under a biologics license agreement by FDA's Center for Biologics Evaluation and Research. For the purpose of this report, the process by which the FDA eventually clears, approves, or licenses such products for marketing in the United States will be referred to as approval. This report summarizes the various ways medical products, primarily medical devices, can legally be brought to market in the United States, and includes a discussion of the approval process, along with manufacturers' responsibilities, labeling, marketing and promotion, and off-label use. This is an educational and descriptive report and does not contain prescriptive recommendations. This report addresses the role of the medical physicist in clinical situations involving off-label use. Case studies in radiation therapy are presented. Any mention of commercial products is for identification only; it does not imply recommendations or endorsements of any of the authors or the AAPM. The full report, containing extensive background on off-label use with several appendices, is available on the AAPM website (http://www.aapm.org/pubs/reports/).

AAPM Task Group 103 report on peer review in clinical radiation oncology physics.

This report provides guidelines for a peer review process between two clinical radiation oncology physicists. While the Task Group's work was primarily focused on ensuring timely and productive independent reviews for physicists in solo practice, these guidelines may also be appropriate for physicists in a group setting, particularly when dispersed over multiple separate clinic locations. To ensure that such reviews enable a collegial exchange of professional ideas and productive critique of the entire clinical physics program, the reviews should not be used as an employee evaluation instrument by the employer. Such use is neither intended nor supported by this Task Group. Detailed guidelines are presented on the minimum content of such reviews, as well as a recommended format for reporting the findings of a review. In consideration of the full schedules faced by most clinical physicists, the process outlined herein was designed to be completed in one working day.