Week 1 - Historical and Legal Foundations in The USA Flashcards
Pure Food and Drug Act
1906
Gave the government authority to mandate accurate labeling and allowed them to prohibit and penalize the marketing of drugs that were “adulterated or misbranded or poisonous or deleterious”
Problem still existed that compounds could be marked without guarantee of effectiveness or safety
Food Drug and Cosmetic Act
1938
First Legislation to regulate drug SAFETY (introduced testing for toxicity)
Required new drugs to be reviewed by the FDA prior to approval
Harris-Kefauver Amendment
1962
Required proof of EFFECTIVENESS (first time companies had to show specific benefit)
Old drugs were also tested among them - rigorous testing procedures were established
Also established uniform drug names and standard labeling - ADRs were now to be reported by manufacturers
Controlled Substance Act
1970 - “Comprehensive Drug Abuse Prevention and Control Act”
Legisltion regarding the manufacture and distribution of drugs with potential for abuse
Established Categories I-V
Category I
The highest rate forpotential to abuse
More likely to be street drugs like cocaine, heoin, etc
Mariuana is still on here federally but this may change soon
Category II
Opioids sit here so nurses see these drugs quite a bit
Addictive but not as potentially abused as Category I drugs
Category V
Still problematic drugs but the category with the least amount of potential abuse
Accelerated Approval Process
1992
Begun for drugs to treat AIDS, cancers, and rare conditions
Mandates rigorous follow up after approval
Dietary Supplement Health and Education Act
1994
Created controls for misleading health claims for dietary supplements
*However, even today the processes for dietary supplements are much more lax than prescription or OTC medications
Food and Drug Administration Modernization Act
1997
Included innovations in the fast track system (expanded) - for serious and life threatening conditions
Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA)
2002 and 2003
Gave the FDA power for the first time to encourage and fund pediatric medication trials
USP and NF
The Pharmacopoeia of the USA and National Formulary
Important agencies that set (high) standards for drugs in the US
This is the agency that SETS STANDARDS regarding purity so you take what you believe you are taking in amount and ingredients
Packaging and Quality are also under their jurisdiction so any reliability, changes to packaging, and purity go through the USP
They also make the official drug list
What things does the USP have jurisdiction over for medications
strength
quality
purity
packaging safety
What does it mean if the USP verifies a dietary supplement?
It means a company paid for them to verify what is in their medication
Most companies will not do this however as it costs money
FDA
Food and Drug Administration
Regulates development/manufacture, control, sale, labeling, and distribution of drugs
Controls testing drugs, etc but does NOT do the testing - companies send the information to them (can have negatives if information is withheld)
Sets up the overall process companies have to follow
Does not need to listen to its advisroy board though
DEA
Drug Enforcement Administration (“Drug Police”)
Under the Department of Justice, enforces the controlled substances act
It is the nation’s sole legal drug enforcement agency
Responsible for control and distribution of potentially addictive drugs
Also makes sure prescribers have qualifications and gives prescribers a DEA number for tracking
Nurse Practice Acts
Important legislation that determines what you can do in practice in your state
varies state to state however
About how long does it take to bring a drug to market
6-12 years
About how much money does it cost to bring a drug to market
200-800 million dollars
Does the time and money put into developing a drug guarantee safety and benefits
no, it does not always guarantee safety and long term success
RCT
Randomized Clinical Trials
Required gold standard of testing products that require an intervention and control groups that are double blinded
What are the Stages of Drug Testing
Preclinical Phase Phase I Phase II Phase III Phase IV
Preclinical Phase
Animal studies
Finds out what a particular chemical does
It tests basic safety, pharmacology and efficacy data
IND
Investigational New Drug
What a drug is referred to as if it passes the preclinical phase and goes to phase I through IV
Looks hopeful but is not yet to market
Phase I of Drug Testing
Small numbers of HEALTHY volunteers take the medications in few doses and small groups
We look at what happens when healthy volunteers take them - college kids and armed service members are often targets for this phase as they are healthier groups
Phase II of Drug Testing
Actually give few doses of the medication to the group of interest/treatment, but this group fo interest have either a mild form of the issue or are in the early stages of it with not too many negative problems
This is done to find out therapeutic usefulness (!!) and dosages, etc
Phase III of Drug Testing
Large studies of thousands of patients trying to glean safety and efficacy of the drug (and see side effects not seen in smaller groups)
These are very large and more likely to pick up on adverse issues
Double blind and placebo controlled design is used
Phase IV of Drug Testing
Approval and post marketing monitoring
Follow up once release into the market to uncover other reactions missed now that anyone can take it
What are the issues with the Drug Testing Process
- Limited trials with women and children
- Adverse effects may not be detected into trials of small numbers
- Limited post marketing reporting and data
Why is the limited amount of women and children in drug testing an issue?
We do not want to work on women who could get or be pregnant nor do people want to sign up their kid for this
This leaves older women and giant groups left out
Why can adverse effects occur after market release post-drug testing
Adverse effects may not be seen in thousands of people in the testing, but when released to everyone some may begin to show adverse effects and the drug may need to be pulled from market
ex: Rezulin worked for diabetes but caused fatal liver disease
ex: Redux increased metabolism but gave young women strokes
ex: Vioxx was better at stopping arthritis but increased MI and stroke rate - the company was aware of this but left the data out for the FDA!!!!!!!!!!!
ex: Viagra - people died in ER due to massive vasdilation and past conditions
