Liquids, elixirs, and syrups are fastest. Then euspension solutions->powders->capsules->tablets->coated tablets->enteric-coated tablets are slowest
Enteral route comes in what forms?
*oral, sublingual, and rectal*
Tablets, pills, elixirs, suspensions, emulsions, lozenges or troches, rectal suppositories, etc.
Parenteral route comes in what forms?
*Subcutaneous (SQ or SC), Intramuscular (IM), Intravenous (IV), Intradermal (ID)
Injectable forms, solutions, suspensions, emulsions, powders for reconstitution
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)
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.
Harrison Narcotic Act
Established word narcotic as legal term. Regulated manufacture, sale, and distribution of narcotics
Food, Drug, and Cosmetic Act of 1938
Required proper testing of proof of safety and FDA approval before drug could be marketed.
Recognizes OTC drugs by defining what drugs require a prescription.
Required proof of both safety and efficacy before marketing.
Comprehensive Drug Abuse Prevention and Control Act "Controlled Substance Act"
Categorizes drugs according to abuse potential
Poison Prevention Act
Requires "childproof" packaging
Food and Drug Administration Modernization Act
fast-track approval of drugs for serious illnesses; drug testing on children
Schedule I drugs
High abuse potential: no accepted medical use and may not be prescribed (heroin, cocain *used as local anesthetic*, hallucinogens)
High abuse potential but accepted medical use. Includes most narcotics, amphetamines, strong sedatives. No Rx refill.
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.
Includes meds w/ small amt of narcotic; some incl OTC drugs
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)
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
Three Pre-Marketing Phases of Human Testing or "Clinical Trials"
Primarily healthy subjects. Proves safety in humans, determine safe dosage, route of administration, metabolism, etc.
patients w/ disease the durg is designed to treat. results to prove effectivensee, monitor for side effects, refine therapeutic range
up to several thousand with disease to treat. further prove safety, effectiveness, and appropriate dosage