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Prescription drugs defined

Non-prescription drugs are defined as Non-narcotic medicines or drugs which may be sold without a prescription and which are prepackaged for use by the... [Pg.48]

A generic drug is defined as a drug that is equivalent to a prescription drug approved by the FDA, but for which the patent validity has expired. An ANDA approval is required (Fig. 8.6). [Pg.249]

The Ten Most Common Conditions identified from Direct-to-Consumer Advertising (DTCA) Visits. DTCA visits were defined as physician visits in which the patient initiated discussion about a prescription drug that had been advertised on broadcast media. Data are from Weissman et al. ... [Pg.190]

Durham-Humphrey Amendment (1951). Until this law, there was no requirement that any drug be labeled for sale by prescription only. The amendment defined prescription drugs as those unsafe for self-medication and which should be used only under a doctor s supervision. [Pg.89]

Because of the problems that resulted from self-regulation, another law, the Dietary Supplement and Non-Prescription Drug Consumer Protection Act, was approved in 2006. This law requires manufacturers, packers, or distributors of supplements to submit reports of serious adverse events to the FDA. Serious adverse events are defined as death, a life-threatening event, hospitalization, a persistent or significant disability or incapacity, congenital anomaly or birth defect, or an adverse event that requires medical or surgical intervention to prevent such outcomes based on reasonable medical judgment. If this requirement were enforced, and consumers cooperated, these reports would make it possible to identify trends in adverse effects and would help to alert the public to safety issues. [Pg.1353]

Hubert Humphrey, Democratic senator from Minnesota from 1949 to 1964, and again from 1971 to 1978, and vice president of the United States from 1965 to 1969. A pharmacist before going into politics, Humphrey cosponsored the 1951 Prescription Drug Amendment that defined the distinction between prescription drugs that required supervision by a physician and OTC drugs. The law remains a key to the system of prescription drugs today. [Pg.120]

Parrish, Richard Henry, II. Defining Drugs How Government Became the Arbiter of Pharmaceutical Fact. New Brunswick, N.J. Transaction Publishers, 2003. The author believes that the government more than physicians and pharmacists has taken the power to decide what prescription drug treatments are suitable for patients. He presents much historical detail on the evolution of policy and criticizes the loss of physician and patient choice in treatments. [Pg.151]

A common vocabulary has not been established in the field of prescription drug abuse. Because much of the survey data collected in this area refer to nonmedical use of prescription drugs, this definition of abuse, rather than that of the Diagnostic and Statistical Manual of Mental Disorders (DSM), is used. Also, because physical dependence to prescription medications can develop during medically supervised appropriate use, the term addiction is used to reflect dependence as defined by the DSM. [Pg.242]

Prescription drug users assume that products approved by the FDA are safe but know little about what goes into the review process. This document, updated July 10, 2009, describes the process and defines some commonly used terms. [Pg.243]

Understand the basic principles of third-party reimbursement for prescription drugs and define commonly used reimbursement terminology. [Pg.265]

This scenario is a common occurrence in pharmacies of all sizes and types across the country. Pharmacy managers and owners are forced to make difficult decisions about whether to accept or reject third-party plans pharmacists and patients deal with the consequences of those decisions. A thirdparty is defined as an organization that reimburses a pharmacy or patient for all or part of the patient s prescription drug costs. Since most prescriptions dispensed in pharmacies today are paid for by third parties, it is essential that pharmacy managers and pharmacists understand the effect of third parties on pharmacy operations. [Pg.266]

With regard to prescription drug use, it is also important to define the difference between drug addiction and physical dependence so that we may appropriately identify drug abuse and addiction. This helps prevent confusion with appropriate drug use, which over time may lead to physical dependence. [Pg.13]

Lubrizol offers its employees benefits including tuition reimbursement life, business travel accident and long-term disability insurance a 401 (k) plan a defined benefit pension plan and medical, dental and prescription drug coverage. [Pg.367]

A prescription is defined as a verbal, written, or electronic order for a drug issued by a properly licensed and authorized health care practitioner. The prescription generally completes the initial prescriber-patient encoimter but initiates a series of actions on the part of pharmacists that are designed to ensure that the health outcome of patients is optimal. [Pg.54]

The FDA has jurisdiction over prescription drug advertising and promotion, while the FTC has jurisdiction over the advertising and promotion of over-the-counter (OTC) medicines, as well as dietary supplements and medical devices (other than restricted devices as defined in the FD C Act). The FDA retains full jurisdiction over the labeling of all medical products, including OTC drugs and dietary supplements. [Pg.63]

One mechanism of gaining general recognition status for non-prescription drugs approved by the FDA s OTC review was through an NDA. NDA is necessary for a drug that is defined by law as NRASE until it has been precleared and approved by the FDA. Because of the OTC drug review, excess of 40 primary products have been reclassified from prescription to OTC. [Pg.2420]


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