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‣ The effect of an Rx-to-OTC switch on medication prescribing patterns and utilization of physician services: the case of vaginal antifungal products.

Gurwitz, J H; McLaughlin, T J; Fish, L S
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
Publicado em /12/1995 Português
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626.9236%
OBJECTIVE. We examined the impact of over-the-counter (OTC) availability of vaginal antifungal products, beginning in January 1991, on medication prescribing patterns and utilization of physician services. DATA SOURCES AND STUDY SETTING. Data on utilization of health care services and prescription medications by female members (ages 11 and older) of the Fallon Community Health Plan (FCHP), a group model health maintenance organization and a component of the Fallon Health Care System of central Massachusetts. The census for such individuals increased from 49,551 in January 1990 to 67,365 in December 1992. DESIGN. Time-series analyses were employed to assess changes in prescribing patterns of vaginal antifungal products and physician visits for vaginitis from January 1, 1990 through December 31, 1992. Monthly numbers of prescriptions for vaginal antifungal products and physician visits per 100 members were measured. Monetary savings relating to the prescription-to-OTC switch were also estimated. DATA COLLECTION METHODS. The computerized management information system of FCHP contains records on utilization of all health care services and prescriptions filled, collected as part of routine fiscal activities. We identified all vaginally administered products on the FCHP formulary used for the treatment of vaginal candidiasis and determined the number of prescriptions filled for these agents during each month of the study period. We also identified the number of physician office visits characterized by the ICD-9-CM code 616.10 ("vaginitis and vulvovaginitis...

‣ Economic Impact of a triptan Rx-To-OTC Switch in Six EU Countries

Millier, Aurelie; Cohen, Joshua; Toumi, Mondher
Fonte: Public Library of Science Publicador: Public Library of Science
Tipo: Artigo de Revista Científica
Publicado em 19/12/2013 Português
Relevância na Pesquisa
386.64906%

‣ THE FDA AND PLAN B: The Legislative History of the Durham-Humphrey Amendments and the Consideration of Social Harms in the Rx-OTC Switch

Reilly, Gregory W.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
Português
Relevância na Pesquisa
564.72695%
The 1951 Durham-Humphrey Amendments limited the FDA’s power over the Rx-OTC decision by enacting an objective definition of a prescription drug that would be applied primarily by drug manufacturers. Under this regime, Congress likely intended the Rx-OTC decision to be limited to consideration of medical or scientific harms so as to insure the most limited role for the FDA, maximize the ability of the public to self-medicate, and insure consistency in different manufacturer’s Rx-OTC determinations. However, the 1962 Drug Amendments expanded the FDA’s power regarding Rx to OTC switches by requiring the FDA to balance the costs and benefits of a drug to determine whether it was in the best interest of society for the drug to be marketed OTC. Thus, social harms are appropriate considerations for the Rx-OTC decision if they are true societal costs of a drug, specifically, if they are quantifiable, generally accepted, and a reasonable probability. Applying these lessons to the proposed Rx to OTC switch of the emergency contraceptive Plan B, the FDA seems to have exceeded its authority by considering social harms—increased teen promiscuity and decreased teen condom use—that are not reasonably probable. Moreover...

‣ Identification of Phthalates in Medications and Dietary Supplement Formulations in the United States and Canada

Kelley, Katherine E.; Hernández-Díaz, Sonia; Chaplin, Erica L.; Hauser, Russ B.; Mitchell, Allen Avrom
Fonte: National Institute of Environmental Health Sciences Publicador: National Institute of Environmental Health Sciences
Tipo: Artigo de Revista Científica
Português
Relevância na Pesquisa
341.541%
Background: In animal studies, some :ortho-phthalates, including di(2-ethylhexyl) phthalate (DEHP) and di-n-butyl phthalate (DBP), have been shown to be reproductive and developmental toxicants. Human studies show widespread population exposure to background levels of phthalates. Limited evidence suggests that particularly high exposure levels may result from orally ingested medicinal products containing phthalates as excipients (inactive ingredients). Objective: In this study we aimed to identify and describe the scope of prescription (RX) and nonprescription (over-the-counter; OTC) medicinal products and dietary supplements marketed in the United States and Canada since 1995 that include phthalates as excipients.: Methods: We used lists of modified-release drug products to identify potential drug products. Inclusion of phthalates was verified using available electronic databases, print references, published package inserts, product packages, and direct communication from manufacturers. Additional products were identified using Internet searches utilizing keywords for phthalates. Results: Based on labeling information, 6 RX drug products included DBP as an excipient, and 45 specified the use of diethyl phthalate (DEP). Phthalate polymers with no known toxicity—hypromellose phthalate (HMP)...

‣ Sweetening the Bitter Pill: Rx to OTC Switches Via a Third Class of Drugs

Price, L. L.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
Português
Relevância na Pesquisa
386.64906%
The United States faces a health care crisis in the years ahead. Spiraling costs are quickly outpacing the rate of inflation. Many people do not feel the immediate pressure as the true cost of America's health care is borne by employer or government provided insurance. One can rest assured the consumer is the ultimate payer however.

‣ The H2 Blockers' Rx-to OTC Switch: For Whom Will It Spell Relief?

Kisloff, Michelle A.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
Português
Relevância na Pesquisa
1047.2421%
Tylenol. Advil. Monistat 7. Imodium AD. These are some of the most commonly used, widely available, and successful drugs in the United States. All of them began as drugs only available by a prescription. All of them made a successful prescription-only to over-the-counter (Rx-to-OTC) switch through the switch" mechanisms of the Food and Drug Administration (FDA). Due to the amount of money that pharmaceutical companies can make with an Rx-to-OTC switch, the FDA has received dozens of switch requests in the last few years, and it expects to receive many more in the near future.