Pharmacology Basic Principles

The FDA and big pharma

The Pure Food and Drug Act-1906
 Response to Upton Sinclair’s novel The Jungle
The Bureau of Chemistry was renamed the Food and Drug Administration (FDA)
 Original vision-to safeguard the public from artificial and processed foods containing
caffeine, bleached flour, benzoic/sulfurous acid, and carcinogens such as saccharin
Original FDA members stepped on too many toes (manufacturers, agriculture, etc.) and were
squeezed out.
New regime became “industry friendly” often turning a blind eye to adverse effects for the sake
of profits
The FDA does not perform independent studies.
The FDA merely examines studies presented by the drug manufacturer.
Who do you think is performing the drug studies presented for review to the FDA?
Harmful and dangerous drugs are rarely pulled from the market unless their liability supersedes
that of their profitability.
Example Vioxx- clinical trials evidenced a 7-fold increase in heart attack and stroke, yet it was
marketed as a “safe” NSAID. TV ads never mentioned this potential side-effect. Merck and the
FDA were aware roughly 35% of people taking Vioxx
Merck “voluntarily” removed it from the market. 38-55,000 DEATHS too late.

https://www.drugwatch.com/vioxx/recall/

The nursing process

 “Anybody can open a pill packet, drop the pill in a cup, and give it to a person. However,
safe medication administration demands (emphasis mine) an enormous amount of
knowledge and understanding about why a patient is receiving a medication, specific
actions needed to take before you give the medication, expected outcomes anticipated
from the dose of medication, and specific patient teaching needs.”

Elements of the nursing process address: Holistic Approach [ADPIE]

 Physical
 Emotional
 Spiritual
 Sexual
 Financial
 Cultural
 Cognitive

Pharmacologic principles [Terminology]

Drug any chemical that affects the physiologic processes of a living organism
Chemical name molecular structure
Generic name used on NCLEX and official drug compendiums
Trade name registered trademark name, used to market the drug to the public prior to
patent expiration.
Drug classification grouped by structure or therapeutic use (beta agonists, Bronchodilators)
Pharmaceutics is the study of how various dosage forms influence the way in which the
drug affects the body

Pharmacokinetics is the study of what the body does to the drug

Pharmacodynamics is the study of what the drug does to the body
Pharmacotherapeutics is the study of the clinical use of drug to prevent and treat diseases
Pharmacology basics pharmacokinetics

What happens to a drug from the time it is put into the body, until the parent drug and all
metabolites have left the body. Specifically drug:
 Absorption
 Distribution
 Metabolism
 Excretion

Absorption
Movement of a drug from site of administration into the the bloodstream for distribution to the
tissues AKA Bioavailability

Factors
 Route-Oral, Parenteral, Rectal, Buccal, Topical, Inhalation, Transdermal
 Form-Power, liquid, extended release
 Amount of blood flow
First-Pass effect-
 Intestine>Liver>% changed to inactive metabolites>less than 100% enters the circulation
 Parenteral-bypasses the first-pass effect
 Topical-bypasses the first-pass effect
 Sublingual-bypasses the first-pass effect
 Rectal-mixed first-pass effect
Absorption
Enteral absorption altered by:
 Acid changes in gut
 (antacid use)
 Short bowel syndrome
 Enteric coating
 Food/Empty Stomach
 Decreased blood flow
 (sepsis, intense exercise)

Distribution
 Transport of the drug by the bloodstream to the site of action.
 Distributed first to highly vascularized areas
 Rapid distribution to
 Heart
 Liver
 Kidneys
 Brain
 Only drugs that are not bound to plasma proteins can freely distribute to extravascular tissue
 Albumin-the most common blood protein
 Watch for drug toxicity in low albumin states
 Drug-Drug interaction-an unpredictable drug response that can occur when two highly
protein bound drugs compete for binding sites causing dramatic increase, or decrease in the
action of one or both.
 Difficult Distribution Sites-poor blood supply or physiological barrier such as the Blood-
Brain barrier

Metabolism
 Biotransformation-biochemical alteration of drug into an active metabolite, a more soluble
compound, a more potent active metabolite, or less active metabolite.
 The Liver- main organ responsible for metabolizing drugs.
 Cytochrome P-450 enzymes-
 Target lipophilic drugs that are more difficult to metabolize than hydrophilic
 Metabolizing capability of the liver varies from person to person
 Factors that alter biotransformation
 Genetics
 Diseases
 Concurrent use of other medications (enzyme inhibitors/inducers)

Excretion
 Excretion is the elimination of drugs from the body.
 All drugs must eventually be eliminated from the body.
 The Kidney is the main organ responsible for drug excretion. Less common routes include
intestines, lungs, sweat, salivary and mammary glands.

Pharmacokinetics
Half-Life Time required for ½ of drug to be eliminated from the body
Onset of action Time required to elicit a response
Peak effect Time required to reach max therapeutic response
Duration of action Time drug conc. Is sufficient to elicit therapeutic response
Peak level Highest blood level
Trough level Lowest blood level
Specific drugs  Digoxin
tested:  Vancomycin
 Theophylline
Pharmacodynamics
Pharmacodynamics Relates to the mechanisms of drug action in living tissues.
Therapeutic Drug A positive change in faulty body systems. The goal of drug therapy.
Effect
Mechanism of Action  A drugs ability to modify the rate or strength of the inherent
functioning of the cell or tissue
 A drug cannot cause a cell to perform a function that is not part of
its inherent natural physiology
 Not all drugs have an identifiable mechanism of action

Receptor interactions
 Joining of drug with a reactive site on the cell or tissue surface
 Agonist/Antagonist
Enzyme Interactions
 Interaction of drug with an enzyme
 Inhibit/enhance
Nonselective Interactions
 Do not interact with either receptors or enzymes
 Physically interfere/chemically alter

Pharmacotherapeutics
 Let’s go back to these guys…
 Therapeutics looks at drug therapy outcome goals.
 A thorough assessment is required to establish treatment goals.
 You must know your client.

Acute Therapy Intensive treatment to sustain life

 Vasopressors, chemo
Maintenance Prevent progression of disease
 Antihypertensives
Supplemental Replacement
 Thyroid hormone, insulin
Palliative Comforting, not curative
 High dose opiates at end of life
Supportive Helps keep the integrity of body functions while the body is healing
 Fluids, Blood products
Prophylactic/Empiric To prevent illness based on probability
 Vaccines, antibiotics

Monitoring
 Evaluation-part of the nursing process
 Must be familiar with drug’s intended effects and unintended or adverse effects.
 Therapeutic Index
 The ratio of a drug’s toxic level
 Low therapeutic index means that there is a narrow range of efficacy and toxicity
 Drug Concentration
 Patient’s Condition
 Tolerance
 Decreased response to repeated doses
 Dependence
 Physiological/psychological need
Pharmacotherapeutics
Intereactions
 Additive- 1+1=2
 Synergistic- 1+1=>2
 Antagonistic- 1+1=<2
 Incompatible-combination of 2 causes deterioration of both

Adverse Drug Events Any adverse occurrence involving medications.

Adverse Drug Reaction Any reaction to a drug that is unexpected and undesired at
therapeutic dose.
Allergic Drug Reaction An Immune system response
Idiosyncratic Reaction Unexpected and unknown client specific response, possibly
genetically mediated.
Paradoxical Reaction Opposite reaction to what was intended.

Legal and Ethical considerations for nurses

 Failure to assess
 Failure to ensure safety
 Medication errors
 Duty
 Breach of duty
 Causation
 Damage
 Patient’s right to refuse

Pharmacology Basics
 These basic pharmacological principles are the foundation of your safe nursing practice
for medication administration throughout your career.