USP
The pharmacopoeia of the USA/National Formulary (NF)
sets (high) standards for drugs used in the US
official drug list
includes: strength, quality, purity, and packaging safety
an example of what USP does?
- may oversee childproof caps or think of people with arthritic conditions so modifications are made to the top (use a bulkier top)
purpose of dietary supplements submitting to USP
they can write USP verified on the label
assures you that what is said to be in there, is actually in there
DOES NOT ASSURE YOU THAT IT DOES WHAT THE PACKAGE SAYS
FDA (food and drug administration)
- regulate development/manufacture, control, sale, labeling and distribution of drugs (controls testing drugs, etc. BUT DOES NOT DO THE TESTING)
- FDA reviews the data but does not complete the data
Does FDA test drugs?
NO THEY DO NOT DO THE TESTING!
DEA (drug enforcement administration)
- is under the department of justice
- nations sole legal drug enforcement agency
- responsible for control and distribution of potentially addictive drugs “drug police”
- track down and monitor the sale of controlled substances
- any potential addictive drug gets their notice
what does the DEA enforce?
controlled substances act
what happens if a physician is overprescribing?
- each physician gets a DEA number
- if they are overprescribing then this will be a “red flag” activity
legislation
- state laws affect practice (particularly nurse practice acts)
- nurse practice acts vary from state to state
- ex like scope of practice
How much/how long does it take for drugs to be developed?
6-12 years
200 million to 800 million to bring a drug to the market
what is required in new drug development?
randomized clinical trials are required in testing
Cons of drug development
- there is no guarantee that the medication will work
someone can be developing a drug for 10 years and then realize that there are too many side effects or medication does not serve its intended use - it is extremely costly, that is why when drugs first hit the market they are so expensive
stages in drug testing, preclinical and stages 1-4
preclinical (animal studies) - basic safety, pharmacology and efficacy data
phase 1 - healthy volunteers given few doses; small groups, sometimes college students, sometimes military members ** usually young and healthy people
phase 2 - few doses to patients (therapeutic usefulness and dosages, etc)
this is a patient who would benefit from the drug but does not have any other health issues
phase 3 - patients (Safety and efficacy); use double blind, placebo-controlled design… now this is a LARGE, BROAD, group but still want the best group so people who don’t have other health problems
phase 4 - approval and post marketing monitoring, sometimes you don’t find out about things until its taken by many
what happens to the drug in the preclinical stage?
it becomes an IND (investigational new drug)
what does phase 2 test?
therapeutic usefulness
what design does phase 3 use?
double-blind
placebo-controlled design
example of stage 4 side effects/contraindications discovered
viagra!
causes impressive dilation
BP could fall too far with people who have heart conditions
