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schedules, or categories, for controlled substances according to abuse liability. 1983: The Orphan Drug Act The Orphan Drug Act was designed to promote the development and manufacture of drugs used in the treatment of rare diseases (orphan drugs). The act’s three primary incentives are: • federal funding of grants and contracts to perform clinical trials of orphan products; • a 50% tax credit for costs of clinical testing; and • exclusive rights to market the drug for 7 years from the marketing approvaldate. 1994: Dietary Supplement Health and Education Act This act established labeling requirements for dietary supplements and authorized the FDA to promote safe manufacturing practices. It classified dietary supplements as food. 1996:HealthInsurancePortabilityandAccountabilityAct The Health Insurance Portability and Accountability Act (HIPAA) of 1996 protects health insurance coverage for workers who change or lose their jobs and sets the standard for the privacy of individually identifiable health information. The act provides patients more control over their health information, including boundaries on the use and release of health records. 1997: The Food and Drug Administration Modernization Act The five provisions in this act are (1) review and use of new drugs is accelerated; (2) drugs can be tested in children before marketing; (3) clinical trial data are necessary for experimental drug use for serious or life-threatening health conditions; (4) drug companies are required to give information on off-label (non–FDA-approved) use of drugs and their costs; and (5) drug companies that plan to discontinue drugs must inform health professionals and patients at least 6 months before stopping drug production. 2002: Best Pharmaceuticals for Children Act The BPCA gives manufacturers a 6-month extension of patents to evaluate drugs on the market for their safety and efficacy in children. 2003: Pediatric Research Equity Act This act authorizes the FDA to require that drug manufacturers test certain drugs and biologic products for their safety and effectiveness in children, noting that “children are not small adults.” Additionally, studies that involve children must be conducted with the same drug and in the same disease process as adults. 2007: Food and Drug Administration Amendments Act This act allows the FDA to do more comprehensive reviews of potential new drugs, mandates postmarketing safety studies, and affects the distribution of drugs found to be not as safe as premarket studies indicated. 2010: Patient Protection and Affordable Care Act This act was signed into law in 2010 and became effective January 1, 2014. Essential provisions of the reform include: • quality, affordable health care for all Americans; • improved quality and efficiency of health care; • prevention of chronic disease and improved public health; • improved access to innovative medical therapies; and • community living services and supports. 2012: Food and Drug Administration Safety and Innovation Act (FDASIA) This act was signed into law on July 9, 2012. It strengthens the FDA’s ability to safeguard and advance public health by: • Collecting fees from industry to fund reviews of drugs with the “breakthrough therapy” designation, medical devices, generic drugs, and biosimilar biologicproducts Commented [SL28]: Breaking the text up with a bulleted list here helps students better parse the information and more clearly displays critical content for digital transformation. (p. 14) 10 • Expediting development of innovative, safe, and effective products • Increasing stakeholder engagement in FDAprocesses • Enhancing the safety of the global drug supply chain H2: Controlled Substances in the United States ELO: Describe the five schedules of controlled substances in the United States and nurses’ role in creating a culture of accountability. Based on their abuse potential and acceptable medical use practices, controlled substances are categorized into five schedules, which are listed in Table 1.1. Schedule I drugs are not approved for medical use and have high abuse potential; schedule II through V drugs have acceptable medical use and decreasing potential for abuse leading to psychological and/or physiologic
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