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Marketing to health-care providers takes three main forms: activity by pharmaceutical sales representatives, provision of drug samples, and sponsoring continuing medical education (CME). [1] The use of gifts, including pens and coffee mugs embossed with pharmaceutical product names, has been prohibited by PHRMA ethics guidelines since 2008.
The Prescription Drug Marketing Act (PDMA) of 1987 (P.L. 100-293, 102 Stat. 95) is a law of the United States federal government.It establishes legal safeguards for prescription drug distribution to ensure safe and effective pharmaceuticals and is designed to discourage the sale of counterfeit, adulterated, misbranded, sub potent, and expired prescription drugs.
As healthcare providers move to implement these new regulations, e-prescribing can be expected to reduce paperwork for pharmacies and practitioners, reduce prescription forgery and help integrate prescription records in electronic medical records. [2]
[code of federal regulations] [title 21, volume 5] [revised as of april 1, 2015] [cite: 21cfr314.50] title 21food and drugs chapter ifood and drug administration department of health and human services subchapter ddrugs for human use part 314 applications for fda approval to market a new drug
In the United States, regulation of drugs was originally a state right, as opposed to federal right. But with the increase in fraudulent practices due to private incentives to maximize profits and poor enforcement of state laws, the need for stronger federal regulation increased. [7]
Food and Drug Administration Amendments Act of 2007; Long title: To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes.
Producer/Provider: includes all types of retail pharmacies (including chains, independents, and online pharmacies), pharmaceutical manufacturers, and long-term care providers. Payer/Processor: includes pharmacy benefit management companies, health insurers, state and federal agencies, and health maintenance organizations.
The Medicare Prescription Drug, Improvement, and Modernization Act, [1] also called the Medicare Modernization Act or MMA, is a federal law of the United States, enacted in 2003. [2] It produced the largest overhaul of Medicare in the public health program's 38-year history.