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6 Cards in this Set
- Front
- Back
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Durham-Humphrey Amendment
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-established two classes of drugs, Rx and OTC
-FDA must prove 2 issues to change OTC to Rx or establish Rx drug -considered misbranding if no legend for Rx drugs -FDA is authorized to switch Rx to OTC -legalization of the verbal transmission of Rxs -Pharmacists are legally able to honor refill authorizations indicated by physicians in the initial prescription -considered misbranding if dispensed without authorization |
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practitioner
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a person holding a license to practice medicine and surgery
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prescriptive authority
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-determined entirely by state law, no federal regulations
-various types of prescriptive authority depending on the type of practitioner: *Physicians and osteopaths have unlimited prescribing authority that comes from being licensed *for dentists, podiatrists, and vets, limited by the scope of practice (to the oral cavity, foot, and to treating animals) *Optometrists and advanced nurse practitioners have independent prescriptive authority, but the following are in place: optometrist: must get license, take a course, and pass exam -and use/prescribing of drugs is limited to diagnostic pharmaceutical agents and therapeutic pharmceutical agents Advanced nurse practitioner: must get license, certifiction, pass course and exam -prescribing limited by the area of competence - some sch. II and anabolic steroid limits -a physician assistant does not have independent prescribing authority, must follow MD guidelines |
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third class of drugs
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OTC drugs that are sold exclusively by pharmacists and are stored behind the Rx counter in the pharmacy
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collaborative practice agreements
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these are agreements that give pharmacists the authority to initiate or adjust drug therapies in collaboration with a physician
-a written contractual agreement in the form of protocals and procedures -extent of authority varies greatly |
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Plan B
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considered to be in the "third class of drugs" category
-stocked behind the counter and can only be sold by the pharmacist -pt. must be 18 or older to purchase OTC without a Rx, can be purchased by both men and women *should be made available to sexual assault victims in clinic setting |
