psychophram final Flashcards
3 categories of drugs
over the counter/non-prescription
prescription drugs- some of which are controlled substances (more govt oversight)
illegal drugs (all are controlled substances)
what drugs could you get in the mail
morphine and cocaine
patent medicines
ingredients were secret because they were patented
usually poor people who couldn’t afford to go to the doctor
kola nut
sw
pure food and drug act
s
Harrison Narcotic Act 1914
ss
Consequences of HNA
- First time black market for drug trafficking
- first time govt came in between Dr and patient
- non-medical and medical drug classification (moral failing)
- started prescriptions, as record keeping tools, tax and record keeping
* *no intended to be used to prosecute ppl but it started
The marijuana tax act 1937
- mimic of the HNA but for cannbis and its products
- intention was to get rid of the use of weed which was a “threat” to society
- a lot of info about how bad weed was was used for propaganda
- Tax and record but not really used for that and classified weed as narcotics even though it isn’t
- Resulted in a decline of cannabis use during 40s and 50s and those who used weed were seen has deviants (beatniks)
federal bureau of narcotics
- precursor to FBI or DEA
2. reported use of weed was causing rape and violent crimes, suicide but no scientific evidence to support this
what is not regulated in 2021
food supplements
“new patent medicines”
patent medicines
problem from 1800s-1900s
pure food and drug act admitted to shut this down
Comprehensive Drug abuse and prevention control act 1970
- also called controlled substances act
- created a category of drugs called controlled substances
- alcohol, coffee, and nicotine were not on it
- designed to control abuse of drugs that are taken recreationally
- enforced by the DEA and the DOJ
schedules
1 is the most dangerous 5 is the least dangerous
can change state by state ( difference between 1 and 2 is that 2 has medical use)
created under controlled substances act
FDA testing process
Stage 1- investigations new drug stage happens before drug is even brought to the FDA, hw the company has to do (IND)
Stage 1
IND
has to submit evidence that it has threptic effectives in animals and it shows promise for humans
and appears safe for testing on humans
(and it depends on the disease because if it has serious side effects but it can cure cancer that make sense ) balancing act between its effect and its side effects
info included in IND (6)
- range of effective doses
- doses where side effects occur
- figure out the lethal dose
- safety and toxicity with single and long term usage
- this is done in a minimum of 3 different species
- risk/benefit ratio must be determined (formula)
* **secretory of health education and welfare sees this report
stage 2
human testing stage
three phases
1. initial clinical trials, purpose is to establish safety, side effects, and range of doses
2. pharmacological testing, placebo effects and investigator bias tightly controlled to see if the drug is effective (double blind)
3. Extended clinical, drug is distributed widely across the country and everything is documented
stage 3
new drug application
drug sponsor applies to market the drug and sends a report of all information from 1 and 2
post marketing surveillance
has to be scrutinized several times when first come out and then every year have a report about aversive event whole time the drug is marketed
3 decisions FDA makes after stage 3
- approve
- disallow NDA
- Defer decision until more data
Carcinogenicity
can the drug produce cancer, long term
one of the two expensive animal tests
teratogenicity
test whether the drug effects a baby in the fetus
one of the two expensive animal tests
physician’s desk reference
contains 200 pages about all the info about the drug
marketing tool as well
doctors use this to match medications to diseases
**production info section most important
sources of drug info
- american gov’t USP and NF (national formulary)
drug names
most have three or four names
4 types
Proprietary name
brand name/trade name
copyrighted
given by the drug company that made the drug
generic name
assigned by the US adopted name council
you can talk about the drug without endorsing the company that made it
identical to the name in USP and NF
Purpose-general recognition
USP and NF name
same as the generic name unless the drug that has been around for a long time
chemical name
describes the drugs molecular structure
chemically equivalent
two drugs has the same chemically and physically standards
biologically equivalent
two drugs cause a similar concentrations in blood and tissues
Therapeutically equivalent
two drugs provide the equal therapeutic benefits
FDA and equivalents
drugs that are biologically equivalent are assumed to be therapeutically equivalent
bioavailability
drugs can differ in biology and therapeutically because of this
due to manufactory the drug
**primarily a problem for drugs are absorbed poorly
causes of bioavailability differences
shape of crystal
particular size
characteristic of pill due to poor manufactory quality control
what two categories are hallucinogenic drugs put into
- indoleamine-like, looks like serotonin (LSD, psilcbin, DMT)
- phenethylamine-like, looks like NE (amphetamine, mesaclaine, DOM, TMA)
Mesacaline
- from peyote cactus , from north America
Family of drugs that resembles mesacline and amphetamines
methoxylated or substituted amphetamines
substituted amphetamines
are stimulant like at low levels