PHARMACOLOGY 2.

Information output by a sensing device

or organ that includes both useful and
LECTURE irrelevant or redundant information and
must be processed to be meaningful
Lesson 1
❖ In healthcare practice, data is any
NURSING PROCESS AND DRUG
THERAPHY information about the patient.

NURSING PROCESS Sources of Health Data

✓ Well-established, research- ✓ Patient

supported framework for ✓ Patient’s family, caregiver, or
professional nursing practice significant other
✓ Ongoing, constantly changing, ✓ Patient’s medical records
and evolving Methods of Data Collection
✓ Applied to all facets of nursing
care, including medication ✓ Interviewing
administration ✓ Direct and indirect questioning
✓ Systematic method by which ✓ Observation
nurses plan and provide care for ✓ Medical records review
patients ✓ Head-to-toe physical examination
✓ Involves problem solving ✓ Nursing assessment
approach that identify patient
Two types of Data
problems and potential problems
✓ Goal: Delivery of thorough, OBJECTIVE
individualized, and quality nursing
care to patients ✓ Available through the senses

FIVE PHASES OF NURSING PROCESS ✓ Seen, felt, heard, and smelled

Assessment ✓ Sources: Medical record, laboratory

results, reports of diagnostic procedures,
Initial phase of the nursing process
physical assessment, and examination
Data collection, data review, and data findings
analysis
✓ Example: Age, weight, height,
What is DATA? allergies, medical profile, health history
DEFINITION according to Merriam- SUBJECTIVE
Webster:
✓ All spoken information shared by
1. Factual information used as a basis for
reasoning, discussion, or calculations the patients such as complaints,
problems, or stated needs.
 Medication History ✓ Dosage Frequency

✓ Allergies of any type ✓ Route of Administration

✓ Listing of prescribed medications ✓ Prescriber Signature/ Prescriber Name

and License
✓ Use of home and folk remedies, herbal
or homeopathic treatments, plant or Medication Compliance vs
animal extracts, and dietary supplements Adherence

✓ Intake of alcohol, tobacco, and caffeine

✓ Current or past history of illegal drug

use

✓ Use of over-the-counter (OTC)

medications

✓ Use of hormonal drugs

✓ Past and present history and

associated drug regimen

✓ Familial history and racial, ethnical and

or cultural attributes, with attention to
specific or different responses to
medications, as unusual individual
responses Steps in Assessment
✓ Growth and developmental stage with 1. Gathering of Data
attention to issues related to patient’s 2. Review of Data
age and medication regimen. 3. Analysis of Data
Prescription

✓Name

✓ Address

✓ Age/Sex
DEVELOPMENT OF HUMAN NEED
✓ Date
STATEMENTS/ NURSNG DIANOSIS
✓ Drug (Generic/Brand) Example of NANDA- 1 Nursing
✓ Dosage/Form Diagnostic Statement
 Maslow’s Hierarchy of Needs

Human Need Statements

Formulated through analyses of objective

and subjective data about the patient and
the drug
Example: Altered sensory integrity, Comparison of Nursing vs Medical
decreased, related to medication- vs Collaborative Diagnosis
induced altered level of consciousness
as evidenced by sleepiness, decreased
reflexes, decreased orientation to space
and time
Prioritized in order of criticality based on
the patient needs or problems
Basis of prioritization is the ABCs of care
(airway, breathing, and circulation) Planning with Outcome
Identification
Human need statements that involve
actual responses are always ranked Purpose: prioritize the human needs and
above statements that involve only risks specify the outcomes including the time
frame of achievement
Provides time to obtain special
equipment for interventions, review
possible procedures and techniques to
be used, and gather information for
oneself (nurse) or for the patient.
Outcomes
Requires constant communication with
the patient, family/ caregivers and the
health care team
With medication administration, you need
to know about the patient and about each
medication prescribed.

✓ Must be objective, measurable, and 9 Rights of Medication

realistic with an established time frame Administration
for their achievement 1. Right Drug
✓ Reflect expected and measurable 2. Right Dose
changes in behavior through nursing
care and are developed in collaboration 3. Right Time
with the patient 4. Right Route and Form
✓ Categorized into physiologic, 5. Right Patient
psychological, spiritual, sexual, cognitive,
6. Right Documentation
motor, and/or other domains
7. Right Reason or Indication
✓ Also includes expectations for behavior
(predicted changes with a specific time 8. Right Response
frame or deadline)
9. Right to Refuse
✓ GOAL FOR DRUG THERAPY: Safe
and effective administration of
medications and may address the
following outcomes:
▪ Special storage and handling
techniques
▪ Administration procedures
▪ Equipment needed
▪ Drug interactions, adverse effects, and
contraindications

Implementation

Guided by the preceding phases of the

nursing process
 Evaluation

Occurs after the nursing care plan has

been implemented, but also needs to
occur in each phase of the nursing
process.
Systematic, ongoing, and dynamic phase
as related to drug therapy.
Inclusions:
FLOW CHART OF PATIENT
✓ Monitoring of the Fulfillment of PROCESS
Outcomes

✓ Monitoring of Drug Therapy

▪ Patient’s therapeutic dose to the drug

▪ Adverse and toxic effects of the drug

✓ Documentation

▪ Clear, concise, and abbreviation-free

▪ Records information related to goals
and outcome criteria; information related
to any aspect of medication
administration process (including
therapeutic effects versus adverse
effects or toxic effects of medications)

✓ Monitoring of the Implementation of

Standards of Care
▪ The Joint Commission Guidelines for
Nursing Services
▪ ANA Code of Ethics
▪ Patient’s Rights statement
Lesson 2 ✓Pharmacognosy

✓Toxicology
PHARMACOLOGIC PRINCIPLES
DRUG
PHARMACOLOGY – science of drugs
✓Any chemical or substance that affects
TOPICS
the physiologic processes of a living
✓ Absorption organism

✓ Biochemical effects ✓ Comes in three names

✓ Biotransformation 1. Chemical name

✓ Distribution ✓ chemical composition and molecular

structure
✓ Drug history
2. Generic name
✓ Drug origin
✓ nonproprietary name
✓ Excretion
✓ shorter and simpler
✓ Mechanisms of action
✓ used in most official drug guides
✓ Physical and Chemical properties
3. Brand/ trade name
✓ Physical effects
✓ proprietary name
✓ Drug receptor mechanism
✓ drug’s registered trademark
✓ Therapeutic effects
✓ its commercial use is restricted to the
✓ Toxic effects owner or the patent of the drug

SUB SPECIALTIES ❖ Patent - right granted to an inventor by

the government that permits the inventor
✓Pharmaceutics to exclude others from making, selling or
✓Pharmacokinetics using the invention for a time period.

✓Pharmacodynamics ❖ Patent life – usually 17 years

✓Pharmacogenomics ❖ Biosimilars – copy version of an

already authorized biological product /
✓Pharmacoeconomics example:

✓Pharmacotherapeutics
Reference drug: infliximab (Remicade) ✓ Grouping of drugs based on their
Biosimilar drug: infliximab-axxq similar properties
(Avsola)
✓ CLASS
DRUG NAMES
o Broad classification
1. Chemical name: N-acetyl-P-
Amino Phenol o Structure (beta-adrenergic blockers)
2. Generic name: Acetaminophen o Therapeutic use (antibiotics,
or Paracetamol antihypertensives, antidepressants)
3. Brand names: Biogesic, Bioflu,
Tempra, Aekil ✓ SUBCLASS

o smaller groups in each class

o Example: penicillin is a subclass within
the b-lactam antibiotics

❖PROTOTYPICAL DRUGS

o First drug in a class of drugs

o Key drugs

THERAPEUTIC EQUIVALENCE

✓one drug in a class of several drugs is

chosen as the preferred agent, even
though the drugs do not have the same
active ingredient.

DRUG CLASSIFICATION
 ✓ Study of how various dosage forms
influence the way in which the drug
affects the body

✓Different dosage forms have different

pharmaceutical properties

✓Dosage form determines the rate at

which drug dissolution occurs

3 BASIC AREAS OF
PHARMACOLOGY

✓ Describes the relationship of the dose

of the drug and the activity of that drug in
treating a disorder

✓ Pharmaceutics, pharmacokinetics,
pharmacodynamics

DOSAGE FORMS

ORAL FORMS

✓ drugs ingested orally

✓ solid (tablet, capsule, powder) or liquid

Pharmaceutics form (solution or suspension)
✓ rely on gastric and intestinal enzymes
and PH environments
TOPICAL FORMS
✓ Applied directly on the surface of the
skin
✓ Work immediately
✓ Work slowly (skin acts as a barrier) –
example: fentanyl transdermal patches
for pain
PARENTAL FORM
✓ Dosage forms that are administered
via injection
✓ PH of injections must be similar to that
of the blood for these drugs to
administered safely
✓ Usually in aqueous or oily forms
FACTORS THAT AFFECT
SOLUBILITY OF DRUGS
1. Solution Process
✓ usually liquid forms are
dissolved and absorbed faster
than solid tablet forms
✓ aqueous or lipid soluble
✓ temperature
2. Particle Size
✓ smaller the size of the particle the
faster it is dissolved and absorbed
3. PH and Delivery methods
✓ Extended-release forms – example:
divalproex sodium (depakote extended-
release tablet)
✓ Immediate release forms – example:
paracetamol + ibuprofen (alaxan fr)
✓ Enteric coating – example: diclofenac
e/c
4. Ingredients
✓ Combination drug forms - presence of
multiple drugs in one dose
✓ Example: amlodipine
besilate/atorvastatin calcium (norvasc)
1. ABSORTION
✓ Movement of drug from its site of
administration into the bloodstream for
distribution to the tissues

Pharmacokinetics ❖BIOAVAILABILITY – a measure of the

extent of drug absorption for a given drug

✓ Study of what the body does to the
drug
✓ Involves the process of absorption,
distribution, metabolism, and
excretion
✓What happens to a drug from the time
it is put into the body until the parent drug
and its metabolites have left the body
and route (from 0 to 100%)
❖FIRS-PASS EFFECT – the initial
metabolism in the liver of a drug
absorbed from the GI tract before the
drug reach systemic circulation through
the blood stream.

✓ Movement of drugs through the body

❖Parent drug – chemical forms of a

drug that is
administered before it is metabolized by
the body into its active or inactive
metabolites

❖Prodrug – parent drug that is inactive

then metabolized into pharmacologically
active metabolites.
ADMINISTRATION VS
BIOAVAILABILITY

2. DISTRIBUTION
✓ Transport of a drug by the blood
stream to the site of action
✓ Distributed first to areas with extensive
blood supply
✓ Areas of rapid distribution: heart, liver,
kidneys, and brain
✓ Areas of slow distribution: muscle,
skin, fat
❖Bound drugs – usually drugs bound to
plasma proteins (e.g., albumin) and
pharmacologically inactive
❖Unbound drugs – free drugs and
pharmacologically active, with risk of
toxicity.
DRUG-TO-DRUG INTERACTION
✓ Occurs when the presence of one drug
decreases or increases the actions of
another drug
✓ Occurs when patient is taking 2 or
more drugs
 VOLUME OF DISTRIBUTION

✓ Theoretical volume

✓ Describe the various areas in which

drugs may be distributed

✓ Compartments:
3. METABOLISM
1. Blood (intravascular space)
✓ Also referred to as biotransformation
2. Total body water
✓ Involves the biochemical alteration of a
3. Body fat drug into an:
4. Other body tissues or organs 1. Inactive metabolite
✓ Hydrophilic drugs have smaller 2. A more soluble compound
volume of distribution and high blood
3. A more potent metabolite (conversion
concentrations
of an inactive prodrug to its active form
✓ Lipophilic drugs have larger volume
Example: levodopa to dopamine)
of distribution and low blood
concentrations 4. Or a less active metabolite

✓ Sites that are difficult to distribute ✓ Major organ: liver

drugs
✓ Other organs: skeletal muscle,
1. Poor blood supply (bone) kidneys, lungs, plasma, intestinal
mucosa
2. Physiologic barriers (blood-brain
barrier in brain) HEPATIC METABOLISM OF DRUGS

✓ Involves cytochrome p-450 enzymes

✓ Target lipophilic drugs
✓ 2 phases:
1. Phase i: oxidation, reduction,
hydrolysis
2. Phase ii: conjugation
❖ Enzyme Inhibitors – drugs that inhibit
drug-metabolizing enzymes/ can lead to
drug toxicity
❖ Enzyme Inducers – drugs that
stimulate drug metabolism / decrease
pharmacological effects
4. EXCRETION
✓ Elimination of drugs from the
body
✓ Primary organ: kidneys
1. Glomerular filtration
2. Active tubular reabsorption
3. Active tubular secretion
❖ Free drugs and metabolites –> passive
glomerular filtration
✓ two other organs: liver and the bowel
HALF-LIFE
✓ Time required for one half (50%) of a
given drug to be removed from the body
✓ Measure of rate at which the drug is
eliminated from the body
✓ Example: peak level of a drug is 100
mg/l, measured drug level in 8 hours ism
50 mg/l,
then estimated half-life is 8 hours
✓ Most drugs are effectively removed
after about 5 half-lives
✓ Clinically useful in determining steady
state
❖ Steady-state therapeutic dose, and minimize drug
toxicity.
➢ Physiologic state in which the amount
of drug removed via elimination
(example: kidneys) is equal to amount of
drug absorbed with each dose

➢ Once steady state blood levels have

been reached, there are consistent levels
of drug in the body that correlate with
maximum benefits
ONSETS, PEAK, AND DURATION

✓ Describe the effects of the drug

✓ Drug effects are the physiologic

reactions of the body to the drug

✓ Peak and trough are described drug

concentrations
Pharmacodynamics
Onset of action – time required for drug
to elicit a therapeutic response ✓ Study of what the drug does to the
Peak effect – time required for the drug body
to reach its maximum therapeutic
✓ Involves drug-receptor relationship
response
Mechanism of Action of Drug
Duration of action – length of time that
a drug concentration is sufficient (without ✓ Drug-induced changes in normal
more doses) to elicit a therapeutic physiologic functions
response
Therapeutic Effect
Peak level – highest blood level; if too
high drug toxicity may occur ✓ Positive change in a faulty physiologic

Trough level – lowest blood level; if too system

low then drug may not be therapeutic
✓ Goal of drug therapy
levels
Therapeutic drug monitoring – peak
and trough values are measured to verify
adequate drug exposure, maximize
 ✓ Joining of a drug molecule with a
reactive site

✓ Once drug binds to receptor, a

pharmacologic response is produced
Affinity

✓ Degree to which a drug attaches to and

binds with a receptor

MECHANISMS OF ACTION

✓ Actions (therapeutic effects) produced

by drugs

✓ Depends on the characteristics of the

cells or target tissue by the drug

✓ At the site of reaction, a drug can

modify (increase or decrease) the rate at
which the cell functions, or it can modify
the strength function of that cell or tissue
3 mechanisms of actions DRUG RECEPTOR INTERACTION

1. Receptor interactions
2. Enzymes
3. Nonselective interactions
RECEPTOR INTERACTIONS

Receptor

✓ Reactive site on the surface or inside ENZYME INTERACTION AND NON-

of a cell SEKECTIVE INTERACTION
✓ Protein structure in cell membrane Enzyme Interaction

✓ Enzymes are substances that catalyze

nearly every biochemical reaction in a
cell
Drug-receptor Interaction
✓ Drugs interact with enzyme systems
and produce effects
✓ Selective interaction
✓ Inhibition or enhancement of enzyme
action when drug binds to enzyme
molecule
Nonselective Interaction
✓ Drug with nonspecific mechanisms of
action that do not interact with receptors
or enzymes
✓ Main targets: cell membranes and
various
cellular processes such as metabolic
activities
✓ Can physically interfere or chemically
alter cellular structures or processes
✓ Cause a defect in the final product or
state
✓ Defects: improperly formed cell wall or
lack of necessary energy substrate
✓ Examples: cancer drugs and some
antibiotics
Pharmacotherapeutics
✓ Also called therapeutics
✓ Focuses on the clinical use of drugs to
treat diseases
✓ Defines the principles of drug actions
✓ Drugs are categorized into their
pharmacologic classes according to
physiological functions (ex. beta-
adrenergic blockers) and primary
disease states (anticonvulsants, anti-
infective)
✓ Follows the nursing process
✓ Goal: desired therapeutic outcomes
PATIENT ASSESSMENT
✓ Process by which a practitioner
integrates his or her knowledge of
medical and drug-related facts with
information about a specific patient’s
medical and social history
✓ Items to be considered:
1. Drugs currently used
(Prescription, otc, herbal, illicit or street
drugs)
2. Pregnancy and breastfeeding status
3. Concurrent illnesses
TYPES OF THERAPY
1. Acute therapy
✓ Improve a life threatening or serious
condition
✓ intensive drug tx (intensive chemo for
px with ca)
2. Maintenance therapy
✓ Prevent progression of disease or 5. Interactions
condition (antihypertensives) 6. Adverse drug events
3. Supplemental therapy 7. Other drug effects
✓ Avoid a deficiency (vitamins)

✓ Provide substance that is insufficient

(insulin)
4. Palliative therapy

✓ Reduce severity of a condition or pain

(opioid analgesics)
5. Supportive therapy

✓ maintains integrity of body functions

while recovering (blood products)
6. Prophylactic therapy
✓ prevent disease (antibiotics before
surgery)
7. Empiric therapy
✓ Given before lab results are available
(antibiotics)
MONITORING
✓ Evaluation of clinical response of the
patient to the treatment
THERAPEUTIC INDEX
✓ ratio of drug’s toxic level to level that
provides therapeutic benefits
✓ Low therapeutic index means the
difference between a therapeutically
active dose and toxic dose is small/ can
cause an adverse reaction example:
warfarin and digoxin
✓ High therapeutic index is rarely
associated with overdose events
Example: amoxicillin

✓ Requires familiarity with both drug’s

intended therapeutic action and its
possible adverse effects (adrs)

✓ Includes:

1. Therapeutic effects
DRUG CONCENTRATION
2. Drug concentration
✓ Important tool for evaluating the clinical
3. Patient’s condition
response to drug therapy
4. Tolerance and dependence
✓ Certain drug levels are associated with
therapeutic responses while other drug
levels are associated with toxic effects
✓ Toxic drug levels are usually seen
when the body’s metabolism and
excretion of drugs are compromised;
occurs when liver or kidneys are impaired
or immature
✓ Dosage adjustments are made to
accommodate the patient’s condition
PATIENT’S CONDITION
✓ Patient’s concurrent diseases or other
medical conditions
✓ Patient’s response depends on
physiologic and psychological demands
✓ Disease of any kind, infection,
cardiovascular function, and gi function
can alter a patient’s therapeutic response
✓ Stress, depression, and anxiety are
important psychological factors affecting
response
TOLERANCE AND DEPENDENCE
Tolerance
✓ Decreasing response to repeated drug
doses
Dependence
✓ Physiologic or psychological need for a
drug
• Physical dependence is the
physiologic need for a drug to avoid
physical withdrawal symptoms (example:
tachycardia in an opioid-addicted patient)
• Psychological dependence is also
known as addiction and it is the
obsessive desire for the euphoric effects
of a drug. usually involves recreational
use of drugs like opioids,
benzodiazepines, amphetamines
INTERACTIONS
✓ Drugs may interact with other drugs,
with foods, or with agents administered
as part of laboratory tests
Combination Effects
Additive effects – when 2 drugs of
similar actions combine (1+1=2)
Synergistic effects – when 2 drugs
combined effects are greater than the
sum of effects (1+1= greater than 2)
Antagonistic effects – when 2 drugs
combined action effects are less than the
sum (1+1 = less than 2)
Incompatibility – when 2 parenteral
drugs or solutions are mixed, and the
result is the deterioration of one or both
drugs

ADVERSE DRUG EVENTS (ADE)
✓ Broad term for any undesirable
occurrence involving medications
✓ Part of drug misadventures
✓ Vary from no effects to mild discomfort
to life- threatening complications,
permanent disability, disfigurement, or
death
✓ Preventable (medication errors) or
nonpreventable (adverse drug
withdrawal event)
✓ External (errors by caregivers or
malfunctioning equipment) or internal
(patient- induced)
✓ Medication errors occur during
prescribing, dispensing, administering, or
monitoring of drug therapy
ADVERSE DRUG REACTION
✓ Any reaction to a drug that is
unexpected and undesirable and occurs
at therapeutic drug dosages
✓ May or may not be caused by
medication errors
✓ May be caused by hospital admission,
prolongation of hospital stays, change in
drug therapy, initiation of supportive
treatment, or complication of a patient’s
disease state
✓ Allergic reaction
✓ Idiosyncratic reaction
✓ Drug interaction
OTHER DRUG EFFECTS
Teratogenic
✓ Result in structural defects in fetus
✓ Drugs capable of crossing the placenta
mutagenic
✓ Permanent changes in the genetic
composition of living organisms and
consists of alterations in chromosome
structure, the no. of chromosomes, or the
genetic code of the DNA molecule ✓ Example is use of cost- benefit
analysis in choosing which antibiotics to
✓ Radiation, viruses, chemicals, and
put in the formulary
drugs carcinogenic

✓ Cancer-causing effects of drugs, other

chemicals, radiation, and viruses

Toxicology

✓ Study of the adverse effects of drugs

and other chemicals on living systems

✓ Toxic effects are often an extension of

a drug’s therapeutic action

✓ Clinical toxicology deals specifically

Pharmacognosy with the care of the poisoned patient

✓ Range from drug overdose to ingestion

✓ Study of natural drug sources of household cleaning agents to
snakebites
✓ Four main sources: plants, animals,
minerals, laboratory synthesis

✓ Plants: alkaloids

✓ Animals: hormone drugs

example: insulin

✓ Mineral: salicylic acid, aluminum

hydroxide, sodium chloride

Pharmacoeconomics

✓ Study of economic factors influencing

cost of drug therapy
 TREATMENT FOR POISONS
1. First Priority

✓ Preserve vital functions

✓ Airway, breathing, and circulation

2. Second Priority

✓ Prevent absorption of the toxic

substance and / or speed up its
elimination from the body using one or
more of the varieties of clinical methods
available (e.g., use of antidotes)
Lesson 3
LIFE SPAN CONSIDERATIONS IN
DRUG THERAPHY
DRUG THERAPHY DURING
PREGNANCY
➢ First trimester of pregnancy is the
period of greatest danger of drug-
induced developmental defects
➢ Last trimester of pregnancy, the
greatest percentage of maternally
absorbed drug gets to the fetus
➢ Drugs cross the placenta by diffusion
➢ Factors that affect safety of drug
therapy during pregnancy:
✓ Drug properties
✓ Fetal gestational age
✓ Maternal factors
➢ US-FDA implemented pregnancy
safety categories
DRUG THERAPHY DURING
BREAST-FEEDING
➢Breastfed infants are at risk
exposure to drugs
consumed by the mother
➢Drugs cross from mother’s maternal
circulation into the breast milk and to the
breast feeding infant
➢Consider risk-to-benefit ratio; case to
case basis if breast-feeding should be
discontinued
CLASSIFICATIONS OF CHILDREN
ACCORDING TO AGE
➢ Premature infants = less than 36
weeks gestational age
➢ Full-term infants = 36-40 weeks
gestational age
➢ Neonates = first 4 postnatal weeks of
life
➢ Infants = 5-52 weeks postnatal weeks
➢ Children = 1 to 12 years
➢ Adolescents = 13- 16 years
➢ Young adults = 17-18years
PHARMACOLOKINETIC
CONSIDERATIONS DURING
NEONATAL AND PEDIATRIC AGE
Absorption
✓ Gastric pH is less acidic until 1 to 2
years of age
✓ Gastric emptying is slowed due to slow
or irregular peristalsis
✓ First-pass effect is reduced because of
to immaturity of liver and reduced levels of
enzymes
✓ Intramuscular absorption is faster and ✓Lungs have weaker mucous barriers
irregular
✓Body temperature is less well-
Distribution regulated, and dehydration occurs easily

✓Liver and kidneys are immature, and

✓ Total body water is greater than fat therefore drug metabolism and excretion
content are impaired
✓ Decreased level of plasma protein DRUG THERAPHY FOR OLDER
binding of drugs ADULT PATIENTS
✓ Immature blood-brain barrier = more ➢Geriatric age: Older than 65 years old
drugs enter the brain
➢Drug therapy is more likely to result in
Metabolism adverse
effects and toxicity
✓ Immature liver; does not produce
enough enzymes ➢High use of medication

✓ Older children may have increased ➢Polypharmacy

metabolism, requiring higher doses than
infants ➢Noncompliance, non-adherence

✓ Other factors: Liver enzyme ➢Increased incidence of chronic

production, genetic differences, and illnesses
substances to which the mother was ➢Sensory and motor deficits
exposed during pregnancy

Excretion

✓ Glomerular filtration rate, tubular

secretion, and resorption are decreased

✓ Decreased perfusion rate of kidneys

may reduce excretion of drugs
GERIATRIC DRUG DOSAGE
DRUG DOSAGE CONSIDERATIONS
CONSIDERATIONS
FOR PEDIATRIC PATIENTS
✓Altered pharmacokinetics secondary to
✓Skin is thinner and more permeable
organ system degeneration
✓Stomach lacks acid to kill bacteria
✓Multiple and severe illnesses
✓Multi-drug therapy ✓ Reduced concentration of serum
albumin
✓Poor adherence
• Free drug level rise
PHARMACOKINETIC
CONSIDERATIONS IN GERIATRIC Metabolism
PATIENTS
✓ Rates of hepatic metabolism decrease
Absorption with age

✓ Gastric pH is less acidic due to less
production of HCl in the stomach
✓ Gastric emptying is slower due to
decline in smooth muscle tone and motor
activity
✓ Movement through the GI tract is
slower because of decreased muscle
tone and activity
• Reduced hepatic blood flow, reduced
liver mass, decreased activity of some
liver enzymes
• Drug half-lives may increase
Excretion
✓ GFR is decreased due to decreased
blow flow

✓ Blow flow to GI tract is reduced due to ✓ Number of intact nephrons is

decreased cardiac output and decreased decreased
perfusion
✓ Drugs are cleared less effectively
✓ Absorptive surface of GI tract is because of decreased excretion
reduced due to blunting and flattening of
✓ Look for creatinine clearance =
villi
indicator of renal function
Distribution

✓ Increased percent body fat

• Lipid soluble drugs are stored,

decreasing plasma levels of drugs

✓ Decreased lean body mass

• Water soluble drugs distributed in

smaller volume increasing concentration
of drugs

✓ Decreased total body water

• Same as above
Lesson 4 ✓ Responsiveness to medical treatment

✓ Religious practices and beliefs

CULTURAL, LEGAL, AND ETHICAL
CONSIDERATIONS IN DRUG ✓ Support from the patient’s cultural
THERAPY
community
CULTURAL CONSIDERATIONS
✓ Dietary habits
✓ Ethnopharmacology – specific
LEGAL CONSIDERATIONS
impact of cultural factors on patient drug
response Food and Drug Administration (FDA)
United States of America
✓ Pharmacogenomics – study of
✓ Federal agency of the Department of
genetics in drug response
Health and Human Services
✓ Drug polymorphism – variation in
✓ Responsible for protecting and
response to a drug because of a patient’s promoting public health through control
age, gender, size, and/or body and supervision of food safety, tobacco
composition products, dietary supplements,
prescription and OTC pharmaceutical
✓ Compliance level with therapy
drugs, vaccines, biopharmaceuticals,
✓ Environmental and economic blood transfusions, medical devices,
considerations electromagnetic radiation emitting
devices, cosmetics, animal foods and
✓ Barriers to adequate healthcare for feeds, and veterinary products
culturally diverse
Food and Drug Administration (FDA)
CULTURAL ASSESSMENT
Philippines
✓ Languages spoken
✓ Formerly Bureau of Food and Drug
✓ Health beliefs and practices Administration (BFAD)

✓ Past uses of medication ✓ Agency under the Department of

✓ Herbal treatments, folk remedies,
home remedies
✓ Over-the-counter drugs and
treatment
✓ Usual response to illness
Health
✓ Responsible for licensing, monitoring,
and regulation of cosmetics, drugs,
foods, household hazardous products,
medical devices and electromagnetic
radiation emitting devices, pesticides,
tobacco and related products and
vaccines
 NEW DRUG DEVELOPMENT US FOOD AND DRUG APPROVAL
PROCESS
✓ Investigational New Drug (IND)
Application

✓ Informed Consent

✓ US-FDA DRUG APPROVAL

PROCESS
1. Preclinical Testing
2. Clinical Studies
APPLICATION FOR CLINICAL
➢ Phase I-IV TRIAL IN THE PHILIPPINES- FDA
3. Investigational Drug Studies
4. Expedited Drug Approval – Fast track
approval

LEGAL CONSIDERATIONS

Drug Enforcement Agency (DEA)

(United States of America)

✓ United States federal law enforcement

agency under the US Department of

Justice
✓ Tasked with combating drug trafficking LEGAL NURSING
and distribution within the US CONSIDERATIONS

✓ Lead agency for domestic enforcement ✓ State and federal legislation

of the Controlled Substances Act
✓ Nurse Practice Acts
✓ Has sole responsibility for coordinating
➢ Scope of nursing practice
and pursuing US drug investigations both
domestically and abroad ➢ Expanded nursing roles
Philippine Drug Enforcement Agency ➢ Educational requirements
(PDEA)
➢ Standards of care
(Philippines)
➢ Minimally safe nursing practice
✓ Lead anti-drug law enforcement
agency ➢ Differences between nursing and
medical practice
✓ Responsible for preventing,
investigating, and combating any ➢ Guidelines from professional nursing
dangerous drugs, controlled precursors groups
and essentials within the Philippines
➢ Institutional policies and procedures,
✓ Tasked with enforcement of the state and federal hospital licensing
Comprehensive Dangerous Drug Act of
2002 ➢ Case law or common law

✓ Implementing arm of the Dangerous ➢ Health Insurance Portability and

Drug Board (DDB) Accountability Act (HIPAA) of 1996

✓ PDEA and DDB are both under the ETHICAL CONSIDERATIONS

supervision of the Office of the President ✓ American Nurses Association (ANA)
of the Philippines Code of Ethics for Nurses
CONTROLLED SUBTANCES
✓ International Council for Nurses (ICN)
SCHEDULES (US)
Code of Ethics for Nurses

✓ Code of Ethics for Filipino Nurses

✓ Board of Nursing – Professional

Regulation Commission
Lesson 5 • Delays patients from seeking
medical care until they are very ill
OVER-THE-COUNTER DRUG AND • Misinterpretation of use
HERBAL AND DIETARY • Misuse or Abuse
SUPPLEMENTS • May cause toxicity especially if
taken in combination with other
OVER-THE-COUNTER DRUGS drugs
(0TC) ✓ Hepatoxicity
✓ Nephrotoxicity
✓ Other adverse effects/
reactions

DIETARY SUPPLEMENTS

✓ Broad term for orally administered

CRITERIA FOR OVER-THE-
COUNTER STATUS
Indication for Use
The consumer must be able to easily:
alternative medicines and includes the
herbal supplements
✓ Intended to augment the diet and
include vitamins, minerals, herbs, or
other botanicals, amino acids, and
enzymes

✓ Diagnose the condition ✓ Produced in many forms: tablets,

✓ Monitor the effectiveness capsules, liquids, and powders
Safety Profile ✓ Can be found in nutritional breakfast,
Drugs must have: snack, or health food bars; drinks; and
shakes
✓ Favorable adverse event profile
✓ Limited interaction with other HERBS
drugs ✓ Come from nature
✓ Low potential for abuse ✓ Used for thousand of years to
✓ High therapeutic index maintain good health
Practicality for OTC ✓ 30% of all modern drugs are
derived from plants
Drug must be: ✓ Lost ground to new synthetic
✓ Easy to use medicines in the early part of the
✓ Easy to monitor 20th century
✓ Herbal medicine use in the
DANGER OF OTC USE 1970’s gave rise to Alternative
Medicine
 ✓ Does not need approval from FDA
before they are marketed

✓ Requires no proof of efficacy

✓ No standards for quality control

❖ In 2007, US-FDA announced that

all manufacturers of dietary
supplements would be required to
comply with the same good
COMPLEMENTARY manufacturing practices as
MEDICINE prescription manufacturers
✓ Simultaneous use of both ➢ Must demonstrate product identity,
traditional and alternative composition, quality, purity and
medicine strength of active ingredients
✓ Also referred as integrative
medicine ➢ Must demonstrate that products
are free from contaminants such as
✓ Five Categories
microbes, pesticides, and heavy
1. Alternative medical systems
metals
2. Mind-body interventions
3. Biologically based therapies ➢ May claim an effect but cannot
4. Manipulative and body-based promise a specific cure on the product
methods label
5. Energy therapies

DIFFERENCE OF DIETARY AND

HERBAL SUPPLEMENTS WITH
PRESCRIPTIONS DRUGS
Papa, Jen Yehbel I.