11 19 Pharmacies Drugstores three different drugs available prescription Rx drugs medicinal drugs used to treat medical condition available to public only with approval from medical professional pharmacist dispensary 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 class Prescription 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 compound 2 purify the active ingredients 3 preliminary determination of toxicity toxicity tests in 2 species of lab animals determine LD50 study pregnant animals for teratogenic effects 4 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 to health 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 those without 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 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 treatment of symptoms generic name loratadine zyrtec generic manufacturers can even apply to have their drug converted to OTC ex prilosec OTC for heartburn patents generic drugs Drug Companies Profit 2012 US Fourth Quarter