Federal Pharmacology Laws in Nursing Part 2

The five provisions of 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- 72 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.

This act, designed to remedy the escalating problem of drug abuse, included several provisions: (1) promotion of drug education and research into the prevention and treatment of drug dependence; (2) strengthening of enforcement authority; (3) establishment of treatment and rehabilitation facilities; and (4) designation of schedules, or categories, for controlled substances according to abuse liability.

Health Insurance Portability and Accountability Act was established during _____.

It classified dietary supplements as food. And established labeling requirements for dietary supplements and authorized the FDA to promote safe manufacturing practices. (ans in: YR:ACT)

Drug companies that plan to discontinue drugs must inform health professionals and patients at least_____ before stopping drug production.

The ____ gives manufacturers a_____ month extension of patents to evaluate drugs on the market for their safety and efficacy in children. (ans in:ACT-MONTH)

Allows the FDA to do more comprehensive reviews of potential new drugs, mandates post marketing safety studies, and affects the distribution of drugs found to be not as safe as premarket studies indicated.

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 biologic products • Expediting development of innovative, safe, and effective products • Increasing stakeholder engagement in FDA processes • Enhancing the safety of the global drug supply chain

Essential provisions of the reform include (1) quality, affordable health care for all Americans; (2) improved quality and efficiency of health care; (3) prevention of chronic disease and improved public health; (4) improved access to innovative medical therapies; and (5) community living services and supports.

The Patient Protection and Affordable Care Act was signed into law in 2010 and became effective in