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
Why is limited post marketing reporting and data a problem for drug testing
People do not report possible drug related events as often as they should and they may not connect or report adverse effects as being related
Chemical Name
precise, chemical composition and molecular structure
Generic Name
non proprietary - independent of manufacturer
Assigned to indicate pharmacologically related drugs; simpler, but often derived from the chemical name - sometimes there can be variability between sources
Used universally, unlike differing trade names
Trade Names
brand; proprietary
selected by drug company selling it, and is copyrighted; a drug is only marketed by one trade name until the patent expires
then, other companies may produce generics that are therapeutically equivalent
What may differ between a drug of trade v generic name at the store?
Generic is cheaper and has the active ingredient
Trade names are more expensive and may have different coating, flavor, or formulation but have the same active ingredient
OTC
Over the Counter Medications
May be purchased without a prescription
Many drugs have changed over time from prescription only to OTC
HUGE Business, but tend to be cheaper
The 3 Most Important Drug Characteristics
Effectiveness
Safety
Selectivity
Why may effectiveness be more important than drug safety
Because a drug can be very effective, but have severe side effects such as cancer drugs with significant issues occurring from taking them
Selectivity
Referring to a medications ability to only do the thing we want it to do (or as little as possible)
We want it doing the thing but not a bunch of other stuff
Ex: Anti-infectives will kill organisms but are non-selective and cause GI Issues
Components of Drugs
Active Ingredient
Additives
Active Ingredient
The ingredient giving the drug the desired effect
Additives
things added to the drug to make it more appealing
Less important in the hospital but in OTC drugs it is very common
Vehicles
What carries the drug through the body
What are some additives that can be found in a drug
Vehicles
Fillers
Binders
Disintegrators
Lubricants
Dyes
Flavorings
Preservatives
What are the 3 important things to assess when doing the nursing process in pharmacology
The Patient
The Drug
The Environment
What things might the nurse assess about the patient regarding drugs
Individual pt. variables
Age - very young or old have increased intensity and more SE
Body mass - wt to ht ratio and looking at composition
Inherited factors, Coexisting Conditions, Compliance, Attitude
Medical Diagnoses - especially involving liver, kidney, CV
Individual Immune System
Psychological and Psychiatric Factors
Aspects of Self Medications
Pregnancy and Lactation
OTC Meds
Why is compliance and attitude to drugs important to assess
The human brain is the most powerful “drug” and if a person believes that a drug will not work then it will not work for them as well - and the opposite is true
Why are medical diagnoses so important to assess regarding drugs
We need to know everything is functioning and if the liver and kidneys still have their abilities to rid the body of waste and drugs
Why might psychological and psychiatric factors be so important regarding assessment for drugs
We need to see how it affects adherence and compliance to medication routines, if confusion makes them stop taking their medication, or if they need help
OTC is ___ business
big
Why is it important to know the OTC drugs a patient takes when assessing the patient?
OTC drugs they take may impact usefulness and safety of other drugs (sometimes they even can remain in the system for 6 months)
Same goes for any prescription drugs they take already
If a person states they are allergic to a drug, but can take small amounts that dont lead to throat constriction, what may this mean
It was not anaphylaxis but rather just an intolerance
You can however also be allrgic to something in the formulation or extra aside from the active ingredient - especially if it is extremely rare for people to be allergic to that specific drug class
When assessing a patient it is very important to assess what aspects of their drug history
current meds including prescription and OTC
OTC that were taken regularly but have been discontinued within 6 months
reactions like “allergies” or “intolerance”
Things to Know and Assess regarding the Drug during the Nursing Process
Classification
Name
Clinical Indication and Contraindications
Mechanism of Action
Adverse Effects
Pharmacokinetics
Dosages and Frequency
routes
Drug Interactions
Client Education
Outset
Nurse must interpret medication order correctly (confirm with MAR, etc)
Standard or Routine Med Orders
Most orders are of this kind
ex: Take ___ mg of ___ 3x daily PO
PRN Med Orders
Pro Re Nata
Mutual discussion (sometimes not always mutual though and up to the nurse)
Taken as needed - not regularly scheduled
Single Order Med Orders
1 time med order (like before going into surgery)
STAT Med Orders
As soon as practically possible
Maybe within 20 minutes - not instantaneous
Protocol Med Orders
A set of criteria by the institution
Ex: Sliding Scale Insulin and BP meds based on BP
*ONLY DO IT IF IT IS WRITTEN DOWN NOT JUST “THAT IS THE WAY IT IS”
What does it mean to assess the environment during the nursing process
It is a broad definition for anything that is not the drug or the person that will affect the patient
It can be resources, facilities, equipment, support persons (like a family member who gives insulin), and nurse practice acts determining what we can and cannot do
The larger environment may include institutional policy, professionalism, practice acts, legal standards, and precedents along with various laws and agents - also, the Controlled Substance Act requirements
What is important information to gather regarding drugs and the patient in the nursing process
Gather data relative to drug therapy
Direct observation, interview with patient, relatives and friends, measure physical parameters - Patient Based Information
Review med chart, evaluate lab test, x ray, dx tests, comprehensive health history and med hx - Drug and Patient Information
Why interview, observe, and speak to the person regarding their drug information
It can reveal situations such as if they take or do not take their medications and why or why not
For example it may reveal opportunities for education
Why are physical parameters such important information
The physical parameters can be effected by medications and we need to know whether we want to alter them or if they are safe
ex: BP should be taken before giving BP meds, Lasix may lower K levels - double check physicals and lab values
Why may health hx be so important to know
If they have a kidney or other issue they may be unable to excrete drugs
What are some good sources for drug information
- Medline Plus - nlm.nih.gov
- Drug Tests - not every drug will be here though
- The medical Letter / Prescriber’s Letter - very current
- Online and Cell phone drug information apps like drugs.com, epocrates and other drug handbooks
- Experts - pharmacists, poison control, pharmaceutical representatives
What are not good sources for drug information
Info only from a drug company as they want their drug to sound good and better than it may be
Package insert - FDA approval label - No nursing implications and often little action
Physicians Desk Reference - for the purpose of nursing this is not helpful
Why can the internet be both a good and bad source of information
It can be very good, informational and unbiased, but other information can be company sponsored with bias or incorrect overall.
You have to be careful and think critically over what may be what
Schedule I Drug
Illegal drugs or use is restricted to research
High abuse potential
Not accepted for medicinal use in the U.S. (*Marijuana is still included here, though it clearly has some therapeutic uses and is legal for medical and/or recreational purposes in certain states
Examples of Schedule I
Ecstasy (MDMA), Hallucinogens (LSD), Heroin, Marijuana *
Schedule II
Requires prescription; High abuse potential
Examples of Schedule II
amphetamines
barbiturates
cocaine
opioids (morphine, codeine, fentanyl, oxycodone, hydrocodone, etc)
methadone
Schedule III
Requires prescription
Moderate Abuse potential
Examples of Schedule III
Anabolic Steroids
Ketamine
Schedule IV
Requires prescription; Low/moderate abuse potential
Examples of Schedule 4 drugs
Appetite suppressants
Benzodiazepines
Sedatives and Hypnotics
Schedule V
Requires prescription, or may be restricted to OTC in some states
Limited abuse potential
Examples of Schedule V
Antidiarrheal or Antitussives (with opioid or opioid derivatives)
