Fundamentals Concepts of Pharmacology Phases of Drug Development

Definition of Terms • Pre-Clinical Trials: Testing

chemicals for therapeutic activity
• Pharmacology: The science that
and toxicity.
studies the nature and effects of
drugs on living tissues. • Phase I Studies: Eliminating
chemicals lacking therapeutic effects
• Drugs: Substances taken into the
or causing adverse reactions.
body for prevention, relief, or cure of
diseases. • Phase II Studies: Removing drugs
less effective or too toxic for
• Materia Medica: Involves the
patients.
preparation of drugs and agents used
in disease treatment. • Phase III Studies: Evaluating drugs
for safety and efficacy before FDA
• Pharmacy: The science and art of
approval.
preparing drugs for medical use,
including dosage and measurements. • Phase IV Studies: Post-marketing
surveillance of approved drugs.
• Toxicology: Study of poisons, their
effects, detection, and treatment.
• Therapeutics: Branch of medical Drug Names and Identification
science dealing with disease
• Chemical Name: Specific chemical
treatment methods.
composition of the drug.
• Generic Name: Non-proprietary
Sources of Drugs name listed in the National
Formulary.
• Plants: Provide alkaloids,
glycosides, resins, and oils. • Trade Name: Brand name registered
to the drug manufacturer.
• Animal Products: Supply
hormones, vitamins, enzymes, and • Official Name: The name under
vaccines. which the US FDA lists the drug.
• Synthetic Sources: Derived from • NDC Number: Unique 10-digit code
genetic engineering and chemical to identify a specific drug.
structures.
• Lot Number: Batch number of the
• Inorganic Compounds: Obtained drug for recall purposes.
from metallic and non-metallic
sources.
Routes of Administration and Storage Animal Sources
• Routes: Include enteral, parenteral, • Hormones: Insulin and thyroxin
and percutaneous methods. sourced from pig and cow tissues.
• Storage Information: Guidelines • Vitamins: Obtained from animal
for storing drugs to maintain products like cod liver oil.
efficacy.
• Enzymes and Vaccines: Examples
• Prescription Status: Indicates include pepsin and antirabies
whether a drug requires a vaccines.
prescription or is over-the-counter.
• Drug Manufacturers:
Synthetic Sources
Pharmaceutical companies producing
the drugs. • Genetic Engineering: Utilized to
derive drugs from chemical
• Expiration Date: Date after which
structures.
the drug should not be used.
• Examples: Meperidine HCl,
cephalosporin, volatile anesthetics,
Pharmacology Sources and Examples and antimicrobial drugs.
Plants Source
• Earliest Drug Source: Utilized Inorganic Sources
leaves, roots, fruits, and blossom
• Metallic Sources: Include
extracts.
magnesium sulfate, calcium
• Alkaloids: Active components in carbonate, and copper sulfate.
plants like atropine, morphine, and
• Non-Metallic Sources: Examples
quinine.
are potassium iodide, hydrogen
• Glycosides: Plant components with peroxide, and carbon (charcoal).
toxic and beneficial effects like
lanoxin and digoxin.
Drug Classification and Manufacturers
• Synthetic Versions: Replicate active
chemicals found in plants, e.g., Prescription Drugs vs. Over-the-Counter
dronabinol from marijuana. Drugs
• Resins and Oils: Examples include • Prescription drugs like antibiotics
laxatives, eucalyptus oil, and olive and narcotics require a doctor's
oil. prescription.
• Over-the-counter drugs (OTC) like
Paracetamol and Mefenamic Acid
 can be purchased without a • Graded Dose Response Relationship
prescription. helps understand the effect of
different drug doses on an organism.
• Dose Response Curve illustrates the
Drug Manufacturers
relationship between drug dose and
• Pharmaceutical houses like United response.
Laboratory, Wyeth, Pfizer, Compact
Company, Sanofi, and Pagoda
produce drugs. Drug Potency and Efficacy
• Potency refers to the amount of drug
needed to produce a specific effect.
Pharmacodynamics
• Clinical Efficacy denotes the
Understanding Pharmacodynamics
maximal response achievable with a
• Pharmacodynamics is the science of drug.
drug action, focusing on the effects
• Understanding relative potency helps
and mechanisms of drugs.
compare drug effectiveness.
• It involves studying drug
• Cellular Receptors play a vital role in
concentration and its effects on the
drug interactions and responses.
body, including primary and
secondary effects.
• Therapeutic Index (TI) measures the Drug Receptor Interactions
ratio between lethal dose (LD₅₀) and
• Drugs can act as agonists (causing
effective dose (ED₅₀).
activity) or antagonists (preventing
• TI in human beings indicates the activity) at receptor sites.
safety margin of a drug.
• Competitive and non-competitive
• Graded Dose Response Relationship antagonists affect receptor binding
describes the effect of varying drug differently.
doses on an organism.
• Drug-enzyme interactions and
selective toxicity are essential
mechanisms of drug action.
Therapeutic Index and Graded Dose
Response
• Therapeutic Index (TI) is crucial for Pharmacokinetics
assessing drug safety and efficacy.
Understanding Pharmacokinetics
• Examples like Warfarin & Digoxin
• Pharmacokinetics studies how the
(low TI) and Penicillin (high TI)
body processes drugs, focusing on
showcase varying safety margins.
drug movement within the body.
 • Liberation, Absorption, Distribution, • Types of Absorption: Passive
Metabolism, Excretion, and absorption (diffusion-based, common
Response (LADMER) are key in oral medications), active
stages. absorption (requires carriers like
enzymes or proteins), and
• Critical Concentration is the level at
pinocytosis (cells engulf drug
which a drug is effective in reactive
particles).
tissues.
• Bioavailability: The percentage of
• Factors like absorption, distribution,
an administered drug dose that
metabolism, and excretion influence
reaches systemic circulation, with
drug action.
oral routes typically having less than
100% bioavailability.

Dosage and Equilibrium

• Dosage is based on reaching a Factors Affecting Absorption
critical concentration for the drug to
• Administration Route: Influences
be effective.
absorption rate.
• Loading Dose is used for drugs that
• Food or Fluids: Administered with
require a quick onset of action.
the drug.
• Dynamic Equilibrium represents the
• Dosage Formulation
actual drug concentration in the
body. • Absorptive Surface Status
• Blood Flow to Small Intestine
Drug Absorption and Excretion • Acidity of Stomach
Liberation and Absorption • GI Motility
• Liberation: The process of releasing
a drug from its pharmaceutical form,
Drug Distribution
such as capsules or tablets.
• Process: Availability of the drug to
• Common Routes of Drug
body fluids and tissues, facilitated by
Administration: Injection,
the bloodstream.
inhalation, per-oral, dermal, rectal,
with less common routes like buccal, • Factors Influencing Distribution:
sublingual, and intra-articular. Blood flow, tissue affinity, plasma-
protein binding, barriers to drug
• Absorption: Refers to the time it
administration, and receptor
takes for a drug to enter the
combinations.
bloodstream, influenced by dosage
form, route of administration, lipid • Areas of Rapid Distribution: Heart,
solubility, and gastric emptying time. liver, kidneys, brain.
 • Areas of Slow Distribution: • Types of Effects: Therapeutic, sub-
Muscle, skin, fat. therapeutic, side effects, toxic
effects, adverse effects.
• Half-Life: Time taken for the drug
Drug Metabolism
amount in the body to decrease by
• Process: Chemical events altering a half.
drug in the body, primarily occurring
in the liver.
Drug Movement Through the Body
• Factors Affecting Metabolism:
Age, nutrition, hormonal levels. • Drug Actions: Cellular processes in
drug-cell interactions.
• Delayed Metabolism Results:
Accumulation of drugs, prolonged • Drug Effects: Physiological
drug action, diminished reactions of the body to the drug.
pharmacologic effects.
• Variables Influencing Drug Action:
Age, gender, weight,
physiological/psychological factors,
Drug Excretion/Elimination
pathological conditions, liver/kidney
• Process: Elimination of drugs from diseases, genetic factors,
the body via kidneys (main route), environment.
intestines, lungs, mammary glands,
• Tolerance: Increased resistance to a
sweat, and salivary glands.
drug's effect.
• Renal Excretion: Carried out by
• Dependence: Manifestation of signs
glomerular filtration and tubular
and symptoms upon drug cessation.
secretion.
• Drug Interactions: Influence at
• Factors Affecting Excretion: Blood
absorption, distribution, metabolism,
concentration levels, interactions
and excretion levels.
with other drugs.
• Creatinine Clearance: Accurate test
for determining renal function. Pharmacotherapeutics
• Branch of Pharmacology: Focuses
on using drugs to prevent, treat, and
Drug Response and
diagnose diseases.
Pharmacotherapeutics
• Types of Pharmacotherapeutics:
Response to Drugs
Acute, empirical, supplemental,
• Site of Action: Where the drug supportive, palliative.
exerts its effects.
• Adverse Effects: Harmful or
undesirable effects of a drug,
 categorized as dose-related or Nursing Classification System
patient-related.
• Provides a standardized language for
• Drug Actions: Primary (simple reporting and analyzing
overdose), secondary (good or bad individualized nursing care.
effects), hypersensitivity reactions.
• Encourages input from
• Drug Allergy: Body forms multidisciplinary teams to enhance
antibodies to a drug, leading to holistic care.
immune responses upon re-exposure.
• Enables the measurement and
• Idiosyncratic Effect: Genetic in validation of nursing diagnoses and
origin, not directly related to interventions.
pharmacology.
• Iatrogenic Effect: Drug reaction
Components of Nursing Process
mimicking a pathology.
• Assessment: Involves collecting data
on symptoms, medical history, and
Pharmagenetics and Pharmacognosy diagnostic results to identify
problems requiring intervention.
• Pharmagenetics: Variation in drug
action due to genetic factors. • Specific Assessment Related to
Pharmacology: Includes drug
• Pharmacognosy: Deals with
history, allergies, disease processes,
physical and chemical characteristics
and organ function results.
of crude drugs, their sources, and
preparations. • Types of Assessment: Such as
subjective cues, objective signs, and
specialized assessments like
Foundation and Framework dermatological evaluations.

• The nursing process serves as the

foundation for clinical nursing
Nursing Assessment
practice.
Dermatological Assessment
• It offers a framework for consistent
nursing actions, emphasizing a • Rash/Hives: Evaluation includes
problem-solving approach over color, turgor, and pattern assessment.
intuition.
• Interventions: Emphasize frequent
• Additionally, it facilitates the skin care and measures to avoid
evaluation of therapy outcomes. irritation.
• Stomatitis: Observation for oral
issues like gingivitis, with
interventions focusing on oral care
and diet evaluation.
 • Super Infection: Monitoring signs Nursing Diagnosis and Classification
of infection and promoting proper
Types of Nursing Diagnosis
hygiene and medication adjustments.
• Actual: Identifying current health
• Blood Dyscrasia: Assessment
issues.
involves monitoring blood
parameters and implementing • Risk/High-Risk: Recognizing
supportive measures. potential problems.
• Health Promotion and Wellness:
Focusing on preventive care.
Toxicity Assessment
• Syndrome: Addressing clusters of
• Liver Toxicity: Symptoms include
symptoms.
fever, jaundice, and altered mental
status, with interventions like rest • Examples: Pain management,
and medication adjustments. noncompliance, skin integrity issues,
and nutritional imbalances.
• Renal Toxicity: Evaluation of urine
characteristics and renal function,
with interventions emphasizing
accurate fluid balance and Formulating Nursing Diagnosis
medication changes. • NANDA Format: Utilized for
• Alteration in Glucose Metabolism: accurate diagnosis based on
Assessment of hypoglycemia and assessment data.
hyperglycemia symptoms, with • PE vs. PES: Differentiating between
corresponding interventions. problem and etiology with or without
• Electrolyte Imbalance: Assessment signs and symptoms.
and interventions for conditions like • Related Factors: Identifying
hypokalemia and hyperkalemia to underlying causes for nursing
prevent complications. diagnoses.

Sensory Effects Assessment Nursing Diagnoses and Planning

• Occular Toxicity: Monitoring visual Nursing Diagnoses
changes and providing supportive
care. • Noncompliance related to
forgetfulness
• Auditory Toxicity: Assessing
hearing acuity and implementing • Diarrhea related to drug side effects
preventive measures and • Imbalanced Nutrition: less than body
symptomatic treatment. requirement related to GI effects,
alteration in taste, superinfections
 • Impaired skin integrity related to Implementation
rash and photosensitivity
• Meet physical and emotional needs
• Risk for injury related to side effects
• Provide for patient safety
of drugs (dizziness and drowsiness)
• Perform/modify nursing
• Knowledge deficit: drug effects
interventions
related to lack of previous experience
• Monitor for potential side effects
• Perform ongoing assessments
Planning
• Document care delivered and patient
• Set priorities
responses
• Develop written outcome statements
• Formulate nursing interventions
Ten Rights of Medication Administration
• Formulate anticipated therapeutic
'P’TRADDERED'
outcomes
• Patient
• Integrate outcomes/classification
systems into critical pathways and/or • Time
care plan
• Route
• Assessment
Qualities of Effective Goal Setting
• Drug
• Specific
• Dose
• Measurable
• Education
• Attainable
• Refuse
• Realistic
• Evaluation
• Time bounded
• Documentation

Implementation and Evaluation

Evaluation
Parts of Implementation
• Document/revise outcome statement
• Independent (Goal met, Partially met, Unmet)
• Dependent • Continue care or start referral to
community-based health agency or
• Collaborative
discharge process
 • Monitoring the patient’s response to • Assess health needs, research, and
drug therapy teaching
• Guide for diagnosis, treatment, and
evaluation
Records and Nursing Reports
• Aid in self-evaluation of medical
practice
Purposes of Records
• Document nursing service rendered
Purpose Description

Communication Essential for conveying Principles of Recording

information between
• Develop a clear and appropriate
healthcare providers
method of expression
Financial billing Documentation for billing • Write records immediately after an
and reimbursement purposes interview or care

Education Source of learning for • Ensure records are confidential and

healthcare professionals and contain facts based on observation
patients
• Electronic Medical Records should
be permanent, secure, and maintain
Assessment Record observations and
confidentiality
evaluations of a patient's
health status • Guidelines for quality documentation
include factual basis, accuracy,
Research Data collection for studies completeness, organization, and
and analysis confidentiality
Auditing and Ensuring quality and
monitoring compliance with standards
Nursing Reports
Legal aspect Legal documentation for • Information about a patient, either
protection and accountability written or oral
• Types of reports include change of
shift, telephone, transfer, incident,
and legal reports
Importance of Records in Hospital
• Criteria for a good report:
• Serve as the history of the client promptness, clarity, completeness,
emphasis on important points, and
• Assist in continuity of care
signature of the reporter
• Provide evidence in legal issues
 General Principles in Preparing • Stay with the client until medication
Medication is taken and assist as needed.

Verification and Preparation Documentation and Reporting

• Verify all new and questionable • Give medication within 30 minutes
orders on the medication of the prescribed time.
administration record (MAR).
• Chart administration in ink and mark
• Prepare medication in a quiet, clean, initials.
and well-lighted environment.
• Circle initials and document
• Wash hands and observe universal rationale if a drug is not
precautions. administered.
• Review MAR for medication details, • Report errors immediately and
dosage, route, expiration date, and complete institutional
frequency. documentation.
• Research drug compatibilities, • Observe for reactions and document
actions, contraindications, and side responses.
effects.
• Follow the ten rights of medication
• Confirm normal dose ranges, administration.
especially in pediatrics.

Conversion Systems
Administration Safety Measures
Types of Conversion Systems
• Check expiration dates and look for
• Conversions within systems and
any changes indicating
among systems are necessary.
decomposition.
• Conversion systems include Metric,
• Compare medication label three
Apothecary, and Household systems.
times to eliminate errors.
• Confirm medications for each client
and check for any allergies. Metric System
• Provide privacy if needed and • Units of measurement: Meter (m) for
perform special assessments before length, Gram (g) for weight, Liter
administration. (L) for volume.
• Confirm client's identity through • Based on the decimal system with
various mechanisms. basic units of 10.
 • Detailed units of length, volume, and • The left side of the ratio represents
weight in the Metric system. known quantities, while the right
side represents the desired dose.
• Example: If 375mg of a medication
Equipment and Forms of Drugs
is needed, and the stock
• Forms of drugs include Tablet, concentration is 500mg/5mL, the
Capsule, Suspension, Syrup, Drops, calculation involves setting up a
Vial, Ampule, Suppository. proportion to find the required
volume to administer.
• Equipment for dosage measurement
in Oral and Parenteral routes.
• Medical abbreviations for drug Applying Ratios in Medication
orders based on routes, frequencies, Calculations
and general terms.
• Use the formula S/D = Q/X to set up
proportions for medication
calculations.
Dosage Calculation Formulas
• Cross-multiply to solve for the
Basic Formula and Example unknown quantity.
• Basic formula: X=D/S x Q (Amount • Example: Calculating the volume of
of drug = Dose ordered / Stock on medication to administer based on
hand x Quantity). the given stock concentration and
• Example calculation for a drug order required dose.
using the basic formula.

Fractional Equations in Medication

Other Calculation Methods Calculations

• Ratio & Proportion: Small:Large = • Fractional equations are used to

Small:Large. solve for unknown quantities in
medication calculations.
• Additional formulas and methods for
calculating dosages. • The formula Sx = QD is fundamental
in fractional calculations.
• Example: Determining the number of
Ratios and Proportions in Medication capsules to administer based on the
Calculations given dosage.
Understanding Ratios and Proportions
• Ratios in medication calculations
involve relating known quantities to
desired doses.
 Intravenous Fluid Formulas • Example: Calculating pediatric doses
based on age and weight using
Continuous Infusion Calculations
specific formulas.
• Calculating infusion rates for
medications like Lidocaine and
Pronestyl involves converting Preventing Medication Errors
between volume per hour and
Strategies to Minimize Errors
milligrams per minute.
• Minimize verbal or telephone orders
• Steps include converting volume to
by ensuring written documentation.
milligrams and then calculating the
hourly dosage. • Avoid medical shorthand and always
clarify ambiguous orders.
• Example: Calculating the infusion
rate for a specific medication based • Emphasize the importance of
on the prescribed dosage. questioning unclear or illegible
prescriptions.

Specific Formulas for Different

Medications Ensuring Accurate Medication
Administration
• Different medications require
specific formulas for calculating • Double-checking drug orders and
infusion rates. verifying patient allergies are crucial
steps.
• Examples include formulas for
Lidocaine, Nitroglycerine, and • Following the '10 rights' of
Dopamine. medication administration enhances
safety.
• Calculations involve patient weight,
drug concentration, and desired • Always communicate with patients
infusion rates. regarding their medications and
address any concerns.

Pediatric Dosing Calculations

Proper Preparation for Drug
• Various rules like Fried's Rule,
Administration
Young's Rule, and Clark's Rule are
used for pediatric dosing • Adhering to the '5+5 rights' ensures
calculations. accurate medication administration.
• These rules consider the child's age, • Standard precautions like
weight, and average adult doses for handwashing and checking
accurate medication administration. expiration dates are essential.
 • Documenting medications given and and bolus administrations should be
verifying patient identification are followed accurately.
key steps in preparation.
• Utilizing volume-controlled
Routes of Drug Administration administration sets and infusion
pumps ensures precise medication
Various Injection Techniques
delivery.
• Different needle angles are used for
Significance of Pharmacology in Nursing
intramuscular (IM), subcutaneous
(SC), and intradermal (ID) Nursing Responsibilities in Drug Therapy
injections.
• Administering drugs, assessing drug
• Specific sites like the ventrogluteal, effects, and intervening to improve
vastus lateralis, and deltoid are drug regimens are key nursing
preferred for IM injections. responsibilities.
• Techniques like the Z-track method • Nurses also provide patient
are employed for IM injections to education on drugs and their
prevent leakage. regimens.
• This unique position allows nurses to
ensure safe and effective medication
Administration of Topical Drugs
administration.
• Topical medications include eye
drops, ear drops, nasal drugs, and
inhaled medications. Legal Regulation of Drugs in the United
States
• Proper administration techniques for
each type of topical drug are
essential for efficacy.
Regulatory Bodies
• Instructions for administering skin
• Food and Drug Administration
medications, including lotions and
(FDA): Responsible for drug
transdermal patches, should be
regulation and approval.
followed meticulously.
• Drug Enforcement Agency (DEA):
Manages controlled substances and
Intravenous Medication Preparation prevents drug abuse.
• Needle safety protocols, Federal Legislation Impacting Drug Use
compatibility checks, and proper
• Pure Food and Drug Act, 1906:
disposal of needles are crucial in
Prevented the sale of adulterated
intravenous drug preparation.
drugs and mandated accurate
• Techniques for adding medications labeling.
to primary IV bags, secondary lines,
 • Federal Food, Drug and Cosmetic • Category C: Benefits may outweigh
Act, 1938: Introduced drug toxicity risks, limited human data available.
testing and recall procedures.
• Category D: Evidence of fetal risk
• Controlled Substances Act, 1970: but benefits may justify use.
Classified drugs based on abuse
• Category X: Demonstrated fetal
potential and enforced strict controls.
abnormalities or risks.
•
Key Acts and Amendments
DEA Schedules of Controlled Substances
• Durham-Humphrey Amendment,
• Regulates drugs with abuse potential
1951: Tightened control over certain
and enforces manufacturing and
drugs and required prescription
distribution.
labeling.
• Divided into 5 schedules based on
• Kefauver-Harris Act, 1962:
abuse potential and dependence.
Ensured drug quality and efficacy,
granting FDA regulatory power. •

• Orphan Drug Act, 1983: Provided Examples of DEA Controlled Schedules

incentives for developing drugs for
rare diseases. Schedule Examples

Schedule I LSD, Heroin, Marijuana

Laws Affecting Nursing Practice
Schedule II Cocaine, Morphine,
• Generics Act of 1988 (R.A. 6675): Methadone
Promotes the use of drugs identified
by their generic names. Schedule III Anabolic steroids, Ketamine

• Dangerous Drug Act (R.A. 6425): Schedule IV Valium, Xanax, Phenobarbital

Penalizes the sale and distribution of
prohibited drugs. Schedule V Codeine, Opium, Loperamide

FDA Pregnancy Categories and DEA Legal and Ethical Considerations in

Schedules Medication Administration
FDA Pregnancy Categories Drug Development and Evaluation
• Category A: No fetal risk • Control: Regulating drug
demonstrated in the first trimester. development and evaluation
processes.
• Category B: No proven risk but
limited human studies.
 • Evaluation: Involves pre-clinical
trials and phases I-IV studies for
drug approval.
• Pregnancy Categories: A-X
classification based on fetal risk.

Production and Dispensing

• Production: Includes controlled
substances, generic drugs, and
orphan drugs.
• Dispensing: Covers OTC drugs,
generic drugs, and drugs dispensed
as written (DAW).