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Lecture one, units 1 2 pharm
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Lecture 1
Units 1 & 2
N307:Pharmacology for Nursing
By Juan M Gonzalez BSN, RN
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History of Pharmacology
(from Greek words meaning medicine and study)
Began with the use of plants (Herbal Medicine)
Known as “Materia Medica”
Term Pharmacology
1st used in text 1693 (Samuel Dale)
Modern Pharmacology
Fredrick Serturner (morphine from opium) 1805
Injected himself and 3 friends with massive dose… survived it
1st Dept. of Pharm 1847 in Estonia
American Pharm John Jacob Abel
Father of American Pharmacology
1890 1st Pharm Dept in US
University of Michigan
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Nursing & Pharmacology
Pharmacology was developed in the early stages to relieve
suffering
To comprehend pharmacology, other areas such as patho and
chemistry must be understood
Medications used improperly is the most common cause of
harm to our patients
Nurses are the frontline of medication in patients
It‟s not enough to know the medication, you must know the
patient
All medications are potentially fatal
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Definitions
Therapeutics
Branch of medicine to relieve suffering and disease prevention
Pharmacotherapy
Application of drugs for disease prevention and relief of suffering
Drug
Chemical agent before it‟s administered
Medication
Chemical agent that has been given
Biologics
Naturally produced agents (hormones, antibodies)
OTC
Over-the-counter
Formulary
List of drugs and their recipes
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Regulations & the FDA
1906- pure food & drug act
1912- Shirley amendment
1938- Food, drug, & cosmetic act (FDA)
1st law preventing sale of non-tested drugs
1988- FDA established (improved)
Agency of the US Dept of Health & Human Services
Center for Drug Evaluation & Research (CDER)
Center for Biologic Evaluation & Research (CBER)
Center for Food Safety & Applied Nutrition (CFSAN)
1994- Dietary supplement health & education act
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FDA
US Dept of Health & Human Services
1988- FDA established as an agency
Center for Drug Evaluation & Research (CDER)
Controls PTC & Rx drugs
Must show safety & efficacy before selling drug
Decides if they are allowed to be used in US
All information should be clear for safe use
ALL Rx MUST get FDA approval to be used in US
Center for Biologic Evaluation & Research (CBER)
Regulations vaccines, blood, & serums
1986- Childhood vaccine act
Center for Food Safety & Applied Nutrition (CFSAN)
Monitors & regulates herbal supplements
These do not have to have FDA approved (1938)
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Approval Stages
4 Phases
1. Preclinical investigation
2. Clinical investigation
3. Review of the New Drug Application (NDA)
4. Postmarketing surveillance
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Preclinical Investigation
Can take up to 3 years
Use of animal studies & cultured cells
Need to try and determine safety
Will it cause harm to humans?
Tested in variety of doses
Actual human risk is not determined
Results are inconclusive
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Clinical Investigation
3 Stages
Clinical Phase trials 1-3
Longest part of approval process
Can take up to 10 years
Average is 5 years
Start with healthy individuals, then large groups with the
disease
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Clinical Phase Trials
Phase I
A „new drug application‟ must be submitted before moving to the
next stage
An IND (investigational new drug) application may be submitted for
Phase I if there is enough evidence to prove safety in humans and
there are significant benefits to getting the medication out to the
public (cancer, AIDS)
Naming the drug begins here
Phase II
Phase III
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NDA review
Finalizing the „brand name‟ of the drug
Clinical Phase III and animal testing continue depending on
results from pre-clinical testing
May take up to 24 months
FDA has 6 months to initially review this by law
Approved- will move to next stage
Rejected- process is suspended until concerns are addressed
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Postmarketing surveillance
Final stage in the FDA approval process
Looking for any harmful effects in a very large population
Looking for adverse effects that take time to be discovered
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FDA Recalls
At any given time, the FDA has the power to pull drugs that
have been approved off the market
There must be significant harm to humans before they pull a
drug
The benefits must outweigh the risks for any drug
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Recent Changes
Due to the cost ($802 million) to bring a drug to market and the
lengthy waiting time for the approval process, the Prescription
Drug User Fee act (1992-1996) was negotiated. Over a 5-year
period, manufacturers provide a yearly product fee that goes to
fund more personnel and restructuring in the approval
departments. This decreases the time needed to reach approval
status
In 1997, the FDA Modernization Act reauthorized the Prescription
Drug User Fee Act
In 2007 the FDA Amendments Act expanded the reform
In 2008 target base revenue for new drugs was over $392 million
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Nursing & Approval Process
Most commonly nurses participate in the approval process
during the postmarketing surveillance
In clinical trial phase II & III, nurses monitor for side
effects, adverse effects, and therapeutic benefits
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Definitions in Classes and
Schedules of Drugs
Therapeutic classification Combination drug
Pharmacologic classification Bioavailability
Mechanism of action Negative formulary
list
Prototype
Dependence
Chemical name
Withdrawal
Generic name
Scheduled drugs
Trade name
Controlled substance
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Classification of Drugs
Therapeutic classification- how it‟s useful in treatment of a
disease (usually too broad to really learn the drug)
Pharmacologic classification- the way it works at a molecular or
system level (more specific)
See tables 2.1 & 2.2 page 12 in text
Nurses use both of these classifications to learn the drugs, and
to monitor their patients‟ safety and benefits from the drugs
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Prototypes
A drug that is well understood in the classification
May be one that is seldom used now due to newer, safer drugs
available
If you learn the prototype correctly, you will be able to ascertain
outcomes and averse effects of any drug in the same class
Prototypes differ from text to text and source to source
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Drug Names
Combination Drugs
Chemical Name
Has only 1
Names the physical and chemical properties
Very hard to remember most of these
Generic Name
Assigned by the US Adopted Name Council
Usually less complicated than the chemical names
Only 1 generic name
Lower case
Trade Name
Assigned by the company that marketed it
US gives them the rights for 17 years after a NDA is submitted
Helps the developing company get back some of the cost
Also called the product or brand name
Capitalized
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Brand Name or Generic???
Does it really matter?
Dosages may be the same, but the formulary may not be
May have a different „look‟ (tablet, capsule)
Look for the bioavailability of the drug
How long it takes to get to the source of the problem
Inert ingredients can hinder this
Negative Formulary List (Florida)
Can‟t dispense as generic version
Brand Name
For the 1st 17 years, the only available form is the brand name drug
It‟s typically expensive because it has „cornered‟ the market
Generic Name
Less expensive (usually) than brand name
Some can be automatically used in lieu of brand name
No generic if prescription states do not substitute
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Controlled & Scheduled
Scheduled drugs are classified by their potential to be abused
Not all scheduled drugs are controlled
I-V (V has lowest potential of abuse)
II- has a LOT of limitations
I- usually in cancer patients OR research
DEA #s are recorded and monitored as to how much each provider
dispenses
Some states are trying to limit the amounts providers and pharmacies
can dispense
Controlled is a drug that has restrictions, and requires a „count‟ at
the end and beginning of all shifts
Doesn‟t have to be a scheduled medication
Some hospitals count Protonix
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Pharmacokinetics (Definitions)
Pharmacokinetics Active Transport
Absorption Passive (diffuse) Transport
Distribution Affinity
Drug-protein Complexes Blood-Brain Barrier
Fetal-Placental Barrier Conjugates
Cytochrome P-450 Prodrugs
Enzyme induction 1st Pass Effect
Excretion Minimum Effect Concentration
Toxic Concentration Therapeutic range
Plasma ½ Life Loading Dose
Maintenance Dose
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How the Body Handles Meds
Pharmacokinetics means „medicine‟ & „movement/motion‟
The greatest barrier is crossing membranes
As a drug is taken, it changes formulary each time it crosses a
system or membrane
Depending on how the drug enters the body determines which
barriers it comes up against
Stomach acid
Liver enzymes
Immune system
If seen as a threat to the body
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Passing Through
Lipid Bilayers
May use other means to produce effects
Bind to receptors
Activate a 2nd messenger within the cell
Impermeable to large molecules/ions & water soluble
Ionized drugs & water soluble drugs
Easily permeated if molecules are small, nonionized, and lipid soluble
Urea, alcohol, water (lipid soluble)
Active Transport
Passive (Diffuse) Transport
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Active transport
the movement of solutes (or molecules) across a plasma membrane from a region of
low concentration to a region of high concentration which requires energy.
Think of this as you requiring energy to carry pebbles from the
bottom of a mountain up and putting them on a huge pile of
pebbles at the top of the mountain.
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Diffuse (Passive) Transport
the movement of solutes down the concentration gradient across a plasma membrane
from a region of high concentration to a region of low concentration.
Think of this as flowing down the concentration gradient: going
from being crowded to not crowded. The molecule wants space
so this is what it will naturally do, so it doesn't take any energy,
like a waterfall.
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Medication Absorption
Involves movement from the site of administration, across
membranes, to circulating fluids
Can be across skin or membranes
Primary factor determining how long it takes to get an effect of
the drug
Speed of absorption depends on form of drug
The critical nature of a patient‟s condition depends on a faster
absorption rate of a medication
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Absorption Factors
Dose of medications can affect the rate of absorption
Ionization of the meds
pH of the local environment
Drug-Drug & Food-Drug factors affect it as well
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Absorption in the Lifespan
Pregnancy & Lactation
Hormone changes
Slowed GI motility & increased acidity
Increased respiratory rate
Teratogens
Categories (7.1)
Lactating
Shorter ½ life is best
High protein-binding ability best
Children
IM sites vary on age & muscle mass
Safety containers
Middle-Age
Health-wise is comparable with the young adult until after the age of 45
Elderly
Need lower doing
Polypharmacy is an issue
Higher rate for adverse effects
Slower absorption rate, faster toxicity levels
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Distribution
How the drug (agent) is transported through the body to the
system
Factors that can affect this include:
Amount of blood flow to the tissues
Lipid solubility of the med
Type of tissue and affinity
Adipose tissue, bone marrow, teeth, eyes
Calcium salts, lipid-soluble vitamins, valium
Drug-Protein complexes have to be unbound
Competing medications
Barriers
Blood-brain
Fetal-Placental
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Lifespan &
Distribution/Metabolism/Excretion
Pregnancy & Lactation
Higher circulating volume
Children
Depending greatly upon development age and maturity of systems
Middle-Age Adult
After 45 y/o, may begin taking multiple meds for Dz
Elderly
Increased body fat leads to more drug storage
Have decrease in plasma levels because of this
Easily dehydrate, increasing toxicity possibility
Aging liver, heart, kidneys
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Metabolism
Chemical conversion of a drug to a form the body can access and then
eliminate
Sites of metabolism
Liver
Primary site for majority
Cytochrome P-450 enzyme
Can inactivate a drug to be excreted
Can increase activation of a drug
Prodrugs have no action until they are changed into their active form
Enzyme induction is the increase of metabolic activity in the liver
They need higher doses to reach a beneficial effect
Kidney
Cells
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Metabolism Factors
Age
Elderly and children
Always start low and go slow
Can become toxic easily
First Pass Effect
Oral meds are the biggest problem here
These meds need to be administered in alternate forms if too much
of the med is inactivated by the 1st pass (hepatic metabolic reaction)
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Excretion
Removing the drugs from the body
Factors that can affect this:
Renal failure
Liver failure
Sites of excretion
Bile
Biliary secretion can take several weeks
Saliva, sweat, breast milk
Respiratory
Faster the breaths per minute the faster the excretion
Kidneys (most common)
Glomerulus
Renal tubule
Distal tubule of the nephron
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Plasma, ½ Life, Dosing
Therapeutic responses correlate with plasma levels
Minimum effective concentration
Toxic concentration
Therapeutic range
½ Life
Determines how long a drug stays in circulation
Determines dosing regimen
Loading Dose
Larger than the maintenance dose
To bring up plasma levels
Maintenance Dose
To keep plasma levels at a constant
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Pharmacodynamics
Means „medicine‟ & „change‟
Therapeutic indexes, dose-response relationships, & drug-receptor interactions determine
course of treatment
Therapeutic index
Tells us the safety issue in the range of dosing
Median lethal dose (LD50)
Differentiate between toxic and lethal
The higher the LD50 the safer the drug
Dose-response relationship
To find the most beneficial dose at the lowest mg
Potency- the more potent the drug, means a therapeutic effect is reached at a low dose
range
Efficacy- MORE important… it works best for the problem
Drug-receptor interaction
Drugs bind to specific receptors
They can stimulate or inhibit
They compete for receptor sites (survival of the fittest)
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Psychosocial, Cultural, & Gender
Issues
Holistic Care
Taking into account the entire individual
Psychosocial Influences
It‟s not just about the disease, but how they view themselves spiritually, have hope, and support
Worrying about how other‟s view them
Cultural & Ethnic Influences
Does it go along with their belief system
Does it correlate with their religious practices
Community & Environmental Influences
Financial restraints
Transportation issues
Genetic Influences
Certain ethnicities are predisposed to diseases
Some drugs have been found to either work better or are less than effective depending on the ethnicity
Gender Influences
Men and women are vary different when it comes to medications
Some meds work better for men, others for women
Some side effects of meds effect the genders in ways that will prevent compliance with the regimen