AU HIST 208 - Pharmacies & Drugstores

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11/19Pharmacies & Drugstores-three different drugs available:-prescription (Rx) drugs: medicinal drugs (used to treat medical condition), available to public only with: approval from medical professional, pharmacistdispensary-over-the-counter (OTC) drugs: medicinal drugs (used to treat medical condition), available to the public without the requirement of a prescription, some have age/quantity restrictions, also called: nonprescription drugs-dietary supplements: products (other than tobacco) added to the diet that contain: vitamin, mineral, amino acid, herb or other botanical product, enzyme, organic tissue, metabolites, or a combination of these substances (these are not medicinal but supplementary (additional))distributed with the intention of supplementing the diet-regulated differently depending on classPrescription Medications-consumer product-locked behind pharmacist counter: DEA registered pharmacists work with and distribute (technicians-unlicensed- are overseen), annual and surprise inspections by DEA-purchase requires a prescription: indicates true medical use, indicates appropriate dosage level, indicates quantity and ability to refill-even with protections in place, diversion occurs:-diversion-sale/possession/use of medication intended for another use-Rx stimulant medications -Rx opiate narcotic medications History of Rx Regulation-prior to 1906-NO regulation of Rx drugs -50,000 patent medicines available for purchase-no guarantee of ingredients & purity levels-dangerous -1906: food and drug act-sparked by outrage over unregulated drug industry -sparked by outrage over meat packing industry conditions (upton sinclair’s the jungle)-all food and drug inspected for purity & consistency-all ingredients must be labeled-1938-federal food, drug and cosmetic (FDC) act -basic F&D law in the US-still basis for today’s standards -must demonstrate safety of ingredients with research-must accurately label & quantify all ingredients-1962 Amendment-drug companies required to prove drug effective-Food and Drug Administration (FDA)-regulates all food and drug manufacture & sale in US (federal) since 1938-imposes sanctions for violations-major actions=preventative via inspection & certification FDA and Drug Regulation-from 1960-2009 things have changed based on events-1962: Kefauver-harris amendment-new drugs must be effective as well as safe-1976: medical device amendment-health care product/devices must be effective and safe-1983: anti-tampering act-tamper-resistant packaging for OTC drugs-1983: orphan drug act-tax credits to drug companies investigating low profit drugs-1994: dietary supplement health & education act-guidelines for marketing of vitamins/herbal preparations-2008: ryan height act-restricted access to Rx medication illegally sold online-2009: family smoking prevention and tobacco control act-regulatory authority given to FDA for tobacco products FDA Approval Process-pharmaceutical companies (ex: Pfizer, AstraZeneca, Merck) have research laboratories:1) identify new compound2) purify the active ingredients 3) preliminary determination of toxicity: toxicity tests in 2+ species of lab animals, determine LD50, study pregnant animals for teratogenic effects4) if drug is determined to be unsafe: stop 5) if drug is determined to be safe in animal models: company notifies the FDA, fill out a Notice of Claimed Investigational Exemption for a New Drug (IND) (requests permission to test in humans=clinical trials-human clinical proceed in phases-phase 1 trials (first stage of clinical testing): 10-100 healthy volunteers administered the drug, and asks questions: absorption rate? Rate of Metabolism and elimination completed? side effects? Range of doses is effective (ED50), specific dosing regimens eliminate adverse effects (once a day, three times a day, with food, etc.)experimental drug is administered tohealth volunteers to check for possible side effects & determine patterns of absorption & elimination -phase 2 (second stage of clinical testing): proceeds if phase 1 is successful, 100-500 patients with illness the drug is trying to treat, carefully select thosewithout any other medical conditions that would confound effects of trial, double-blind placebo-controlled design (eliminates patients expectancies, eliminates researcher bias, gold standard in experimental research)experimental drug is given to a small population of patients who have the edical condition for which the drug is considered a possible treatment-phase 3 (third stage of clinical testing): proceeds if phase 2 is successful, 1000-3000 patients tested for safety & effectiveness & proper dosage, reporting of side effects no mater how rare, lengthy and expensive portion of the approval process (identify a 1:1000 chance of developing a problem, testing 3,000 people allows research to be sure), getting through phase 3 takes at least 3 years-mininum (avg=7 years)experimental drug is given to a large population of patients through which issues of safety, effectiveness & proper dosage levels are finalized-NDA review: proceeds if phase 3 is successful, drug company submits new drug application (NDA) to the FDA (contains all data of animal models & Phases 1-3, less than 30% new compounds make it this far), FDA has 6 months to review the application, final approval will not happen in under 1 year from the beginning of phase 4-Phase 4 (fourth stage of clinical testing): release onto the market has occurred with approval, monitoring for unforeseen side effects/toxic reactions, federal program-medwatch=results determined (drug stays on the market, additional warnings are needed, if anything about marketing/use must change)possible adverse reactions to a drug that is already available to the public are monitored by phsyicians who have prescribed it-patents & generic drugs-FDA approval grants drug company a patent -patent-exclusive right of a drug company to market a particular drug. The duration is 20 years (clock starts with IND was submitted to FDA, general receive 10-20 years of protection, brand name drug: zyrtec)-after the patent expires, other drug companies may market the same compound under a different name=generic medication (significantly less expensive, insurance companies can force patients to use generic, must be bioequivalent-both versions must be pharmacologically and chemical (physiological) identical, can have different bioavailability-absorption & metabolism (can produce different

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AU HIST 208 - Pharmacies & Drugstores

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