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OBJECTIVES: The Division of Drug Information (DDI) within the U.S. Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research receives telephone calls, e-mails, and letters from patients and industry. The consistently high number of contacts about drugs in the fluoroquinolone class indicates an opportunity to increase awareness about the drugs' evolving safety profile. DATA SOURCES: Database used by DDI to summarize inquiries. SUMMARY: Inquiries about fluoroquinolones peaked in 2016 and were highest after FDA Drug Safety Communications that were issued that year. Among the first fluoroquinolone, ciprofloxacin, was approved in 1987. Since then, the FDA has required class-wide labeling changes reflecting postmarket benefit-risk assessments of oral and injectable (systemic) fluoroquinolones, including changes in 1990, 2008, 2013, 2016, and 2018. CONCLUSION: Pharmacists have a role that is more critical than ever to ensure the safety of patients who are prescribed a systemic fluoroquinolone. Pharmacists should stay informed on this class of drugs, be prepared to suggest alternate therapies, counsel patients on potential benefits and risks, and work with patients to submit Medwatch reports to the FDA if adverse events occur.

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OBJECTIVES: To evaluate the impact of a Federal drug information center initiating engagement with stakeholders on a Facebook Page administered by a Federal Agency. SETTING: The U.S. Food and Drug Administration (FDA) Facebook page from July 21, 2014, to October 18, 2014. PRACTICE INNOVATION: FDA's Division of Drug Information (DDI) in the Center for Drug Evaluation and Research (CDER) Office of Communications serves as a federal drug information center providing timely, accurate, and useful information on CDER initiatives and CDER-regulated products. We report a 90-day (July 21 to October 18, 2014) pilot during which DDI pharmacists monitored and moderated comments received on FDA's Facebook page to identify those warranting a reply. Once identified, DDI pharmacists replied within 2 business days. EVALUATION: Impact was measured by comparing the average number of Likes, Shares, and Reach for Facebook posts before and after the pilot. Additional metrics collected include the number of DDI replies provided to stakeholders' comments and the number of DDI replies provided on time (within 2 business days). RESULTS: During the pilot, DDI contributed 14 posts. On average, each post reached 23,582 more individuals (an increase of 187% compared with pre-pilot posts). On average, each post also received 463 more Likes (450% increase) and 130 more Shares (271% increase). DDI pharmacists replied to 3% (121/3994) and hid 0.58% (23/3994) of Facebook comments received during the 90-day period. All actions were taken within 2 business days. CONCLUSION: Initiating social engagement had a positive impact on FDA's Facebook page.

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OBJECTIVES: Ensuring that the drugs patients take are safe and effective is critical to the Food and Drug Administration (FDA) mission and a major reason for testing an active pharmaceutical ingredient or currently marketed drug product. To address gaps in the assessment of drug quality, FDA's Center for Drug Evaluation and Research (CDER) has created the Office of Pharmaceutical Quality (OPQ). SUMMARY: This newly formed "super-office" within CDER launched a concerted new strategy that enhances the surveillance of drug manufacturing and will bring a comprehensive approach to quality oversight. CONCLUSION: With OPQ and these new performance measures in place, FDA can sharpen its focus on issues critical to quality and can identify and respond to manufacturing issues before they become major systemic problems.

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BACKGROUND: The U.S. Food and Drug Administration (FDA) is the regulatory agency responsible for approving all pharmaceutical products marketed in the United States. While the FDA does not conduct research for developing pharmaceutical products, the agency does review all of the scientific evidence that a pharmaceutical sponsor submits and ensures that it demonstrates U.S. regulatory standards for the product and meets approval requirements. OBJECTIVES: To provide insights, for the managed care pharmacist, into the agency's decision-making process and into the recommendations for appropriate usage and regulatory recommendations for risk mitigation by pharmaceutical sponsors. METHODS: The FDA website contains a vast amount of clinically useful and meaningful information. This review focused on specific topics within the website that can be useful for the managed care pharmacist, including the following: (a) the FDA's review and evaluation of new drug applications (NDA), supplemental new drug applications (s-NDA), and biological new drug applications (BLA); (b) materials regarding a therapeutic product presented to a public FDA advisory committee meeting; and (c) the postmarket requirements and commitments database that provides information on the studies that a sponsor must conduct to maintain a product's approval for marketing in the United States. RESULTS: This review examined the drug information contained on the FDA's website and summarized the FDA's medical and technical review, analysis and decision processes. Detailed drug information provided to the FDA by the pharmaceutical sponsor demonstrating a product's efficacy and safety is publically available upon the product's approval. CONCLUSION: For the managed care pharmacist involved with formulary review and recommendations, the FDA's website contains information that is available to provide insight into the agency's evaluation process and decision making for marketed pharmaceutical products. Use of these materials and understanding the regulatory context under which medical products are reviewed and approved may assist managed care pharmacists in making informed recommendations for use of the products within the context of their health systems.

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PURPOSE: The revised prescription drug labeling developed by the Food and Drug Administration (FDA) is described. SUMMARY: A new FDA final rule, "Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products," became effective in June 2006. The rule is part of FDA's initiative to manage the risks of medical product use and minimize adverse events. The new labeling reorders and reorganizes sections found in the previous labeling format. A label is now divided into highlights of prescribing information, contents of the full prescribing information (FPI), and the FPI. The highlights section is a half-page summary of the information that health care practitioners most commonly refer to and view as most important. This section contains cross-references to details in the FPI section. The contents section serves as a navigational tool that references all the sections in the FPI. The FPI section has been revised as to content, format, and order to make information clearer and more usable. FDA has instituted a flexible implementation schedule that phases in the new labeling requirements; more time to achieve compliance is provided for older products. The revision of labeling for products approved or submitted for approval under an abbreviated new drug application (ANDA) depends on the labeling of the listed drug referenced in the ANDA. The new requirements do not apply to nonprescription drug products. CONCLUSION: FDA has designed new labeling to help health care practitioners easily find, read, and convey information important for the safe and effective use of prescription drugs.

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OBJECTIVE: To review the history of drug regulation by the Food and Drug Administration (FDA) as it relates to unapproved drugs and FDA policy, along with the FDA's efforts to avoid future incidents by amending and enforcing those policies that are already in place. DATA SOURCES: Data from FDA history documents, FDA guidances, Code of Federal Regulations Title 21, and presentations by the FDA's Office of Compliance were gathered. STUDY SELECTION AND DATA EXTRACTION: All information identified from the data sources was evaluated, and all information deemed relevant was included for this review. DATA SYNTHESIS: Contrary to popular belief, there are drugs on the market that have not been evaluated for safety or efficacy by the FDA. For almost a century, the FDA has taken action against public health threats posed by unapproved drug products, and today's drugs and vaccines are required to demonstrate both safety and efficacy prior to marketing. The FDA has taken great strides to ensure the welfare of Americans by reacting to disasters that have occurred in the past and being proactive by setting regulations that will prevent such catastrophes from occurring in the future. CONCLUSIONS: The FDA recognizes that drug regulation is an ongoing process and that, although we have come a long way, there is still much to be done.

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