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Fastest to slowest drug absorption of oral preps.
Liquids, elixirs, and syrups are fastest. Then euspension solutions->powders->capsules->tablets->coated tablets->enteric-coated tablets are slowest
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Enteral route comes in what forms?
- *oral, sublingual, and rectal*
- Tablets, pills, elixirs, suspensions, emulsions, lozenges or troches, rectal suppositories, etc.
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Parenteral route comes in what forms?
- *Subcutaneous (SQ or SC), Intramuscular (IM), Intravenous (IV), Intradermal (ID)
- Injectable forms, solutions, suspensions, emulsions, powders for reconstitution
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Topical routes come in what forms?
- *abosorbed via surface*
- Aerosols, powders, solutions, foams, transdermal patches, inhalers, rectal and vaginal suppositories, and oitment and cream (semi-solids)
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Pure Food & Drug Act
First law to restrict manufacture and distribution of drugs by requiring government preapproval of a drug. Established FDA. Did not require proof of safety or effectiveness.
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Harrison Narcotic Act
Established word narcotic as legal term. Regulated manufacture, sale, and distribution of narcotics
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Food, Drug, and Cosmetic Act of 1938
Required proper testing of proof of safety and FDA approval before drug could be marketed.
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Durham-Humphrey Amendment
Recognizes OTC drugs by defining what drugs require a prescription.
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Kefauver-Harris Amendment
Required proof of both safety and efficacy before marketing.
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Comprehensive Drug Abuse Prevention and Control Act "Controlled Substance Act"
Categorizes drugs according to abuse potential
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Poison Prevention Act
Requires "childproof" packaging
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Food and Drug Administration Modernization Act
fast-track approval of drugs for serious illnesses; drug testing on children
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Schedule I drugs
High abuse potential: no accepted medical use and may not be prescribed (heroin, cocain *used as local anesthetic*, hallucinogens)
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Schedule II
High abuse potential but accepted medical use. Includes most narcotics, amphetamines, strong sedatives. No Rx refill.
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Schedule III & IV
Varying degree of abuse potential. Prescription valid for 6 months or 5 refills. Schedule III includes steroids; Schedule IV includes most tranquilizers, sleeping pills.
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Schedule V
Includes meds w/ small amt of narcotic; some incl OTC drugs
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Florida's "Negative Formulary" Law
Requires pharmacist to offer generic forms of drug unless: physician specifies no substitution, drug appears on this "neg. formulary" which is a list of drugs which cannot be substituted (only about 7 drugs)
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New Drug Approval Process
1. Animal testing 2. clinical trials in humans 3. human testing in 3 phases followed by phase IV which is evaluation 4. each phase requires FDA approval before moving to next phase
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Three Pre-Marketing Phases of Human Testing or "Clinical Trials"
Phase I:
Primarily healthy subjects. Proves safety in humans, determine safe dosage, route of administration, metabolism, etc.
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Phase II
patients w/ disease the durg is designed to treat. results to prove effectivensee, monitor for side effects, refine therapeutic range
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Phase III
up to several thousand with disease to treat. further prove safety, effectiveness, and appropriate dosage
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