Unit 1 Flashcards
Drug
Substance that changes the chemical makeup of your body (Not including food)
-Can be legal
-Can be illegal
Acute VS Chronic Drug Taking
Acute - Drug is taken, even the first time
Chronic - Multiple use, even over years
Drug Diversion
Stealing or buying someone else’s drugs, or acquiring them from doctors, pharmacies, or even veterinarians without a valid prescription
Poly-Drug Users
Using more than one drug
Drug Scale in US
1) Tobacco
2) Alcohol
3) All illegal drugs
4) Marijuana
5) Rx drug misuse
Monitoring the Future (MTF)
Association survey 8th, 10th, and 12th graders for their drug use
National Survey on Drug Use & Health (NSDUH)
Those 12 and up. Similar questions while asking about treatment.
-Those who used drugs within the last 30 days are considered regular users
Instrumental VS Recreational Drug Use
Instrumental - Medical use
Recreational - Like how it feels
During early US (first ~100 years), most common drugs
Tobacco, alcohol, and opium
-Mostly taken orally
-OTC (no prescriptions)
-Expired, adulterated, or poorly made
Medical use of early drugs in the US
-Alcohol and opium were anesthetics and painkillers
-Alcohol was (and is) commonly used as a disinfectant.
-Opium and its derivatives (like morphine, codeine, and heroin) are effective against coughing and diarrhea
-Cocaine is a pretty good local anesthetic; it was replaced by Novocain
United States Pharmacopeia (USP)
Database of all medicinal drugs, with a set of standards in how they are made, and recommendations for approved uses
-1820
The First and Second Opium Wars
British East India Company, US via Turkey, began to sell opium to China. Emperor felt that too much money was used to get opium and started a war (mostly w/ UK). Resulting in no control of opium sales, influencing US drug laws.
Opium Discovery
Friedrich Setürner isolate chemical from a plant, discovered morphine in opium in 1804.
-Named after Morpheus due to drowsy, dreamlike effects of opium
Cocaine Discovery
In 1859 Albert Niemann would discover cocaine in coca.
-Drug and chemical experimentation, Bayer markets heroin after altering morphine molecule in 1895
-Vin Mariani, had 36 mg of cocaine
-Powder popular in the 1900s
Route of Administration (ROA)
How a drug is taken
Oral ROA
-Slow route
-Stomach > small intestine > liver (breaks down drug) > bloodstream > brain
-Stomach is v acidic w/ enzymes, breaking down drugs majorly
Insufflation (snorting) / intranasal / transmucosal administration ROA
-Fast
-Nasal mucosa > bloodstream
-Can cross can mucus membrane including sex organs and the rectum
-Sublingual route (under the tongue), also using mucosa
Intravenous ROA
Veins > bloodstream (bypassing digestive system and liver)
-After 1844
-only delivery system w/ no barriers to cross
-Drip - Pump regulates flow in fluid bag
-Push - Quantity of drug pushed into the vein all at once
Chinese Opium Dens
-Commonly smoked by Chinese
-Drank in US as well as morphine
-During gold rush, dens were opened and used by all races
-First US drug law: San Francisco banned opium dens in 1875
Patent Medicines
Businesses making their own “medicines.”
-Claims of miraculous effects, pain relief, ect
-Snake oil salesman
COCA Cola
John Pemberton made a tonic of coca wine and kola nut extract (natural caffeine source) to help morphine addiction from Civil War
-Coca Cola was invented, sold OTC 1886
-Cocaine removed as ingredient in 1903
Freud and Cocaine
1884 wrote a medical article praising cocaine use (praising Pemberton)
-Believed it had mental and medical benefits (curing opium and alcohol addiction)
-Stopped personal cocaine use in 1894 from aversive effects
Pure Food and Drug Act in 1906
Passed by congress doing:
-Require all food and drug needed to be honestly labeled
-Gave authority to what would be the FDA
-Leading to fall out of patent medicine
Elixir Sulfanilamide
1937 used to treat strep infections, led to the death of hundreds because it dissolved easily in diethylene glycol, which was poisonous.
-FDA could only fine them
-1938 a law was passed that companies have to prove their product is safe
Thalidomide
Used as an anesthetic with almost no risk of OD (Common w/ barbiturates)
-Cause the 1962 Kefauver-Harris Amendment
-Used to prevent morning sickness in UK and Germany, later leading to baby death or birth defects
-Is a teratogen
+ & - of the Modern Drug Approval Process
Advantages:
-Drugs legally sold should be reasonably safe
-Better medical decision making
-Prevents companies from misleading the public
Disadvantages:
-Can take 10-15 years
-Is expensive to government and company
-Increases their cost, even in generic medicines
Dirty Drugs
Drugs with more than one action
Investigational New Drug (IND) Application Leads to Clinical Trials
Once FDA is involved, drug goes through three trials. Less than 10% are approved. Prove:
-Drug does what intended
-Dosage and time interval
-Side effects & how to manage them
-Metabolism and how long active
-Other substances safe & unsafe to take w/ drug
Phase I Clinical Trial
-Usually the first time it is given to people
-20-80, 10-100 HEALTHY people
-Show how drug works
-Drug is safe and side effects are well-tolerated
-How long a drug is active, body takes to break down & excrete the drug (metabolism)
-Find maximum tolerated dosage
-Route of administration
-Regimen
Phase II Clinical Trials
-Randomized, controlled experiment
-Usually done many times, costing 10s of millions of dollars
-100-300 participants
-Average of 31% make it
-Testing people with the disease/sickness
-Double-blind placebo-controlled experiment
Phase III Clinical Trials
-Large, multicenter (meaning studies are being carried out at multiple sites), randomized, controlled studies
-Enrolling thousands
-Last about one or two years
-Conducted in as close to normal, real-world medical settings as possible
-Larger sample allows to better see effectiveness
-At least 2 trials
-No minors or pregnant women
Label use
Specific uses for which a drug has been shown to be effective
-DR can prescribe drug for off label use
MedWatch
System for DRs or patients to report side effects as part of post marketing surveillance
Vioxx
approved in 1999 but withdrawn in 2004 after causing heart attacks when company wasn’t required to do clinical trials.
-Peer reviewed journals were required to pre-announcements/pre-registration
-Clinical trial plans must be pre-written
Phase IV Clinical Trials
Not usually required by FDA
-Studies of the drug undertaken after approval
-Can be large scale monitoring of patients prescribed, randomized trials, ect.
-FDA can demand a trial be done and more research be done
-Easier to study once approved
-Sometimes serious side effects only happen in a small number of people
-Can be initiated by the company themselves
-Can approve drugs for more than one use
Black Box Warning
FDA decides benefit outweighs risk of drug, warns of severe side effect
Generic Drugs
Manufactured after original drug’s patent ends
-Selling same product for cheaper
-FDA’s office of generic drugs make sure that the drug is almost identical
-Company must submit an Abbreviated New Drug Application (ANDA)
-Prove does not contain anything harmful, is made safely and consistently, and has the same label as name brand
Evergreening
Companies modify product to extend patent before patent runs out
-Creating an extended-release formulation of a drug
-Creating a new combination of old drugs
OTC Drugs
Drugs deemed safe enough for people to self diagnose, buy drug, and then take it without supervision.
-Drug companies want to sell more OTC because anyone can easily buy an OTC drug, sales go up.
GRASE
Generally Regarded As Safe and Effective.
-Food additives
-Not considered new drugs, do not have to go through clinical trials, but usually cannot be patented
Dietary Supplements
Not considered drugs
-Herbal supplements are like gingko biloba or Echinacea, vitamin and mineral supplements, fish oil, and also blends of natural ingredients that are touted to help you lose weight, focus better, or have more energy.
-Do not have to go through clinical trials, show safety, or effectiveness
-Little regulation
-FDA can removed those mis-labeled and those deemed unsafe
Spanish-American War (1898)
US got territories overseas, Philippines in 1898, which had a growing opium problem, due in part to its proximity to China.
-Potential contribution from Cholera breakout in 1902, Philippines thought that opium cured/prevented cholera.
1914 - Harrison Narcotics Tax Act
At this time everything was considered to be a narcotic
-Required that “every person who produces, imports, manufactures, compounds, deals in, dispenses, sells, distributes, or gives away opium or coca leaves or any compound, manufacture, salt, derivative [thus including heroin, morphine, and cocaine powder], or preparation thereof,” register with the IRS and pay a tax. Done so in hopes to limit trade and possession of drugs.
-In short, GOVT can tax drug trade, sale, and purchase
Marijuana Tax Act
Harry Anslinger, a native of Altoona, PA, huge advocate for stricter laws regarding all drugs of abuse.
Prohibition
1920-1933
Comprehensive Drug Abuse Prevention and Control Act (1970)
-Controlled Substances Act
-DEA created
-Department of Justice
-Meth, LSD
-Schedule 1-5
Schedule I
Heroine, marijuana
-High abuse potential
-Addiction
-No medical use
Schedule II
Cocaine, morphine
-Medical use, 1 prescription no refills, prescription has to be renewed
-Same risk as Schedule I
Schedule III
Steroids
-Less abuse/addictive potential
Schedule IV & V
IV: Xanax
V: Cough syrup with codeine
Drug Action
What a drug does on a microscopic chemical level in the body
Drug Effect
Visible signs of what a drug does on a psychological or medical level
-Observable changes