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PATHOPHARMACOLOGY
Introduction to Pathopharmacology and
Over-the-Counter and Dietary/Herbal Therapies
Readings:
1.Over-the-Counter Drug and Herbal Remedies Handout (on Bb)
2.You tube video “Genetics and Health” (on Bb)
Objectives: Introduction to
Pathopharmacology
 1. Describe how pharmacogenomics impacts safety in
the prescribing of medications.
 2. State nursing interventions that are used to
minimize adverse drug reactions.
 3. Explain the 5 classes of scheduled drugs controlled
by the Drug Enforcement Agency (DEA).
Introduction to Pathopharmacology
“Disease and Drugs used to treat the disease”
Pathophysiology
and disease
Medications used to TREAT the disease
Pharmacology
 Pharmacology – the study of drugs and their interactions with
living systems.
 Clinical Pharmacology – the study of drugs in humans.
(patients/healthy volunteers)
 Pharmacology is a science that draws on:
 Anatomy
 Physiology
 Psychology
 Chemistry
 Microbiology
 Genetics
Definitions
 Pathology- study and diagnosis of disease by studying
organs, cells, fluids from the body, and tissue
 Physiology- functioning of organisms (mechanical,
physical, and biochemical)
 PATHOphysiology- study of ABNORMALITIES in
human functioning- study of diseases
Genetics and
pathopharmacology
 Genetics is increasingly important in the etiology,
pathogenesis, and pharmacologic treatment of
diseases
 Genes: invisible,information containing elements that exist in
cells and are passed on to a daughter cell when a cell divides
 Genes are the basic units of inheritance
 Genes are composed of
DNA located on 46 chromosomes
 Genes control the day-to-day activities of the cell by controlling the
production of proteins
 Human genome contains 25,00 genes encoded by 4 different
molecules
Pharmacogenomics
 Pharmacogenomics is the study of how an
individual's genetic inheritance affects the body's
response to drugs
 Understanding an individual’s genetic makeup is
thought to be the key to creating PERSONALIZED drugs
with greater efficacy and safety
 **Assignment: watch the you tube video of BB
“Genetics and Health”
Chromosomal Abnormalities
 About 1 in 200 newborn infants has some form of
chromosomal abnormality
 Chromosomal abnormalities usually d/t:
 an abnormal number of chromosomes OR
 alterations in the structure of one or more
chromosomes
 Examples:
 Down’s syndrome- an extra 21st chromosome
 Turner syndrome – only one normal X chromosome and
no Y chromosome
What are teratogens?
 Teratogenic- teratogens are substances (chemicals, radiation, and
viral infections) that may cause congential malformation in
the developing fetus
 Examples

thalidomide

alcohol (ETOH)
some medications

Child with congenital missing arms from
thalidomide exposure during utero
 Suseptibility depends on the:




amount of exposure
developemental age of the fetus when exposed
genetic predisposition of the fetus
prior condition of the mother
Etiologic Classifications of Disease
 Congenital- inborn
 ½ of birth malformations are associated with genetic factors
 teratogens
 Degenerative
 DJD= degenerative joint disease. Ex. Knee osteoarthritis
 Iatrogenic- caused from a MEDICAL treatment:

Ex. anaphylaxis from penicillin administration; mouth sores from chemotherapy)
 Idiopathic- unknown cause







Immunologic autoimmune Ex. diabetes and thyroid diseases
Inherited/genetic . Ex. Huntington’s disease
Metabolic
Neoplastic
Nutritional deficiency (B12,thiamine, iron)
Physical agent
Psychogenic
Pathogenesis
 Describes how a disease develops from the inciting
event to the manifestations of the disease
 Etiologic factors alter the body’s normal physiology
which results in the manifestations of disease
 Dynamic process
 Communication between cells, tissue, organs, and
systems
Clinical Manifestations
 Signs of a disease
 Objective data gathered
from history, physical
exam, diagnostic imaging
(x-rays, CT scans, MRI),
and laboratory testing
 Symptoms
signs
and
 subjective feelings of
abnormality experienced
by the patient and
reported to another
person
symptoms
Stages and Clinical Course
 Acute (hours- weeks) severe manifestations lasting a
short period
 Chronic long lasting (months to years)
 Some disease progress from acute to chronic states
 Clinical Term: acute on chronic
 Exacerbations/flare (sudden increase in the symptoms
of a disease) often alternates with remission (decrease in
symptoms)
 COPD exacerbation
 Asthma flare
 Cure- chronic remission (> 5 years)
 Convalescence- stage of recovery
Drugs and Nursing


Understanding
drugs is essential for
nursing practice
Nurses need to:
1.
2.
Anticipate patient
responses to drugs
Apply principles of
pharmacology to patient
care
Goal of drug therapy
To obtain the maximum therapeutic
effect and minimize adverse drug
reactions
Nursing Role:
1. Collect baseline data
2. Identify high risk patients
3. Administer right drug, right route,
right time, right dose, to the right
patient.
4. Minimize adverse drug effects and
interactions
5. Manage prn decisions
6. Manage drug toxicities
Prototype
 Individual drugs that represent groups of drugs
 New drugs are compared to these prototypes
 Examples:
 diphenhydramine (Benadryl) – represents the class
antihistamines Claritin, Allegra, Zyretec

ibuprofen (Advil) – represents the class NSAIDs
(non-steroidal anti-inflammatory drugs)
Remember: No drug is ideal . . .
 But the perfect drug would be:
 Most importantly
 EFFECTIVE
 SAFE
 SELECTIVE . . . . And
 have reversible action
 be predictable
 easy to administer
 free from interactions
 inexpensive
 chemically stable
 simply named
Trivia
 To go from a chemical  drug on the market:
 Takes ~ 7 years to make
 5 out of 100,000 chemicals will make it to a marketable
drug
 Costs ~ $1 billlion
 Drug company selects a trade name; gets sole
proprietary rights of drug for 20 years (from the time they
start the process, preclinical trials and clinical trials can take up to
10 years before the drug ever makes it to market)
 At that point, patent runs out and ‘anyone’ can sell the
drug

Example: fexofenadine (Allegra) – patent ran out October
2005; now Kroger brand of fexofenadine (75% of original cost)
CONTROLLED Substances Act (1970)
Enforced by the DEA (Drug Enforcement Agency)
 Schedule I (C-1)… NOT approved for medical use
 No reason to ever give medically (may be used for research)
 NOT prescribed by any HCP
 VERY high abuse potential (Heroin, LSD)
 Schedule II (c-2)…used medically
 HIGH abuse potential
 prescribed by MD’s only (No refills allowed – morphine, opium,
amphetamines, Ritalin, methadone, Oxycontin)
 Schedule III (C-3) …
 less potential for abuse than those in I and II
 PA and NP can prescribe in some states (5 refills allowed, example:
codeine with an NSAID such as Tylenol = Tylenol #3)
Controlled Substances Act
(1970)
 Schedule IV (C-4) … some potential for abuse

prescribed by PA and NPs in some states (Xanax. Valium,
Ambien)
 Schedule V (C-5).... Low potential for abuse
 contain moderate amount of controlled substances –
cough suppressants with small amounts of codeine, ephedrine/amphetamines
& anti-diarrheals containing paregoric...some do not require a RX
 Read Davis Drug Book, Appendix J, p. 1417
Moving on………..
Objectives: Prescription (RX) vs OTC
drugs and Herbal Remedies
 1. Compare and contrast prescription, over-the-
counter (OTC) and herbal medications
 2. Differentiate between the chemical, generic,
and trade names of drugs.
 3. Explain the differences in federal legislation that
govern the promotion and sale of prescription versus
OTC and herbal medication,
 4. Describe the advantages and disadvantages of OTC
and herbal medications.
Different Drug Names
I.
Chemical name
II.
Generic name
III.
Trade name
Drug Names

Three types of drug names
1. Chemical name (N-acetyl-para-aminophenol) long &
complex
2. Generic name (acetaminophen)



Only 1 generic name
Usually more complicated than the trade name
Lower case
Trade name (Tylenol)
3.






brand names
marketing name created by drug company
easier to remember and pronounce
may be multiple companies and thus multiple names
must be approved by the FDA
Upper case
Sources of Drugs
 Plants
 morphine  poppy plant
 Animals
 insulin  cow/pig pancreas tissue
 Genetically engineered
 manipulates RNA/DNA
 insulin  advantage: purity
 Minerals
 gold  rheumatoid arthritis
 Synthetic
 pure vs. semi-synthetic  many antibiotics
Prescription to OTC status
 Consumer must be able to easily:
 1. diagnose the condition
 2. monitor the effectiveness of the med
 Safe
 Low risk of incidence of SE
 SE not too serious
 Low abuse potential
 Easy to use & monitor
 More than 200 products that were available only by Rx 10
years ago are now OTC
Over-the-Counter Medications
 Examples of OTCs
 Antihistamines
 Sleep aids
 Nasal sprays
 Weight-control meds
 Analgesics
 Antacids
 Laxatives
 Cough and cold meds
 Antifungals
 Anti-itch meds
FDA “OTC Drug Review”
 Completed in 1983
 Over 500 products reviewed
 Of those reviewed only 1/3 were found to be
safe/effective
 1/3 were totally ineffective!
 1/3 were potentially dangerous and were either
transferred to Rx status or taken off the market!
What are herbal/dietary supplements?
 Herbal medicine is the use of plant derived products to
promote health and relieve symptoms of disease.
 Herbal medicine is a form of alternative/complementary
medicine
 Herbal products are available without a prescription
 Remedies can be made from roots, barks, leaves, fruits, berries,
and flowers.
 Some are effective
 Some are not effective
 Some are harmful
Dietary Supplements
 Includes herbs because they are
“edible” plants
 Can only claim to have an
affect on a body structure or
function
 Whereas Rx meds will belong to
a drug classification and have
‘INDICATIONS’ (MOA) listed.
 For example: anti-depressant
such as fluoxetine/Prozac is
INDICATED for the treatment
of major depression
St John’s Wort “help maintain a
healthy emotional balance.”
Are Herbal/Dietary Supplements
Safe?
 FDA now responsible for
overseeing safety of
herbs/dietary supplements
 Only regulate POST
marketing….do not do ANY
testing PRIOR to
supplement coming to
market
 Supplements are presumed
safe until proven
hazardous
What is the DSHEA?
 Dietary Supplement Health Education Safety Act of
1994
 Established purity standards
 Herbs now classified as dietary supplements
 Restrictions on labeling:
 Required the following statement on dietary
supplements:
 “This product has not been evaluated by the
FDA.
 This product is not intended to diagnose,
treat, cure, or prevent disease.”
1997 FDA warning “Just because a product is
labeled ‘natural’ or from an herbal source, it
is not guaranteed to be safe.”
Natural does NOT = Safe
Recent FDA actions
HIGHLIGHTS OF RECENT ENFORCEMENT ACTIONS
April 2004
Dietary Supplements Promoted Online for Weight Loss
In April 2004, FDA sent warning letters to 16 dietary supplement distributors
making false or misleading claims for weight loss products promoted over the
Internet. Many of these products claim to block starch, carbohydrates, and fat
calories, while maintaining that consumers would lose weight without any changes
in lifestyle. For example, some of the product labels have claimed:
"Eat All You Want! Block the Starch and Lose Weight!"
"Neutralize up to 66 percent of the starch consumed in a meal."
"This advanced dietary-fat inhibitor helps block the absorption of fat calories."
"Take 3 capsules before bedtime. Watch the fat disappear!"
"Guaranteed to block the breakdown of carbohydrates and simple sugars from
being converted into fat."
Adverse interactions between
herbals and conventional drugs
 ADR/SE (adverse drug reaction/side effect) can be in
the form of
 INCREASED TOXICITY or
 DECREASED therapeutic EFFECTS of the Rx drug
 Some examples:
 Ginko biloba and garlic suppress platelet aggregation
therefore can increase the risk of bleeding in patients on
antiplatelet and anticoagulant drugs (blood thinners)
 Ma huang (ephedra) contains ephedrine, a compound which can  B/P and

HR.

Therefore, use of ephedra by patients on cardiac stimulants or
antihypertensives can counteract the beneficial effects of these drugs
Nursing Assessment Responsibilities
JUST ASK AND THEN DOCUMENT
‘The label for “Fish Oil” can
describe it as an “antiplatelet” drug
0%
Fa
ls e
0%
ue
2.
True
False
Tr
1.
Herbal Labeling
CAN state that Fish Oil has been shown to benefit
cardiovascular health
Studies HAVE demonstrated that fish oil reduces
triglycerides.
Which of the following statements would the
DSHEA permit on a dietary supplement label?
Protects
against cancer
2. Reduces pain
and stiffness
of arthritis
3. Improves
symptoms of
Alzheimer’s
disease
1.
0%
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A Final Note . . .
 In 2004 as many as 18.4% of Americans were using
dietary supplements

Big money in ‘natural products’  11.3 billion dollar
industry in 2000!
 DSHEA does not regulate the accuracy of the label
 Top selling supplements in 2000 were the 3 “G’s”
1. Garlic (hypertension)
2. Gingko biloba (antioxidant &
circulatory problems)
3.
Glucosamine (arthritis)