Module 1 Study Guide
Chapter 1 – Issues for the Practitioner in Drug Therapy
• FDA ensures safety through clinical trials and drug approval.
• Clinical Trial Phases:
- Phase I: Initial evaluation of drug safety.
- Phase II: Effectiveness on small patient groups.
- Phase III: Double-blind comparison with placebo.
- Phase IV: Post-marketing surveillance.
• Controlled Substances (Schedules I–V):
Schedule I (no accepted use, high abuse) → Schedule V (minimal abuse).
• Prescribing Process: Assess, diagnose, review pathophysiology, select therapy,
evaluate, and adjust.
• Electronic Prescriptions reduce errors and improve adherence.
• Pharmacogenomics: Genes influence drug metabolism and therapeutic outcomes.
Chapter 2 – Pharmacokinetic and Pharmacodynamic Principles
Pharmacokinetics (What the body does to the drug):
• Absorption: Enteral (oral, rectal) vs. Parenteral (IV, IM, SC, inhaled)
• Distribution: Protein binding and volume of distribution.
• Metabolism: Hepatic metabolism (CYP450 system).
• Elimination: Renal clearance and half-life.
Pharmacodynamics (What the drug does to the body):
• Receptors: Ion channels, enzyme-linked, G-protein coupled, intracellular.
• Agonist activates; antagonist blocks receptor.
• Dose–Response Relationship defines therapeutic range and toxicity.
• Influencing factors: Age, genetics, pathophysiology, diet, sex, ethnicity.
Chapter 3 – Impact of Drug Interactions and Adverse Events
Drug Interaction Categories:
• Drug–Drug, Drug–Food, Drug–Herb, Drug–Disease.
Pharmacokinetic Interactions:
• Absorption (pH, GI motility)
Distribution (protein binding),
Metabolism (enzyme induction/inhibition),
Excretion (urinary pH).
Pharmacodynamic Interactions:
• Similar effects cause potentiation; opposite effects reduce efficacy.
Examples:
• Grapefruit juice inhibits CYP3A4.
• Warfarin interacts with Vitamin K.
• MAOIs with tyramine foods.
• Herbal interactions: Kava/Valerian (CNS depression), Aloe (hypoglycemia), Bitter
orange (MAOI interference).
Adverse Drug Reactions (ADR):
• Type A (predictable), Type B (idiosyncratic).
• MedWatch program monitors post-market ADRs.
, Chapter 4 – Pharmacotherapy in Pediatrics, Pregnancy, and Lactation
Pediatric Pharmacokinetics:
• Absorption: Immature GI pH and motility.
• Distribution: High water, low protein binding.
• Metabolism: Reduced enzyme activity.
• Elimination: Decreased GFR, prolonged half-life.
Pregnancy:
• Placental transfer and fetal metabolism influence drug exposure.
• Avoid teratogenic drugs; assess risks.
Lactation:
• Drugs may pass into milk depending on solubility and pH.
Safe Prescribing:
• Pediatric doses via Body Surface Area (BSA).
• Valved holding chamber + mask for inhaled meds under age 4.
Chapter 5 – Pharmacotherapy Principles in Older Adults
Age-Related Changes:
• Decreased gastric acid, motility, albumin, liver, and renal function.
• Increased body fat → drug accumulation.
Adverse Effects:
• Falls, delirium, fractures, orthostatic hypotension.
Polypharmacy Risks:
• Interactions, prescribing cascade, adherence issues.
Safe Prescribing Guidelines:
• Use Beers Criteria.
• “Start Low, Go Slow.”
• Avoid antipsychotics for dementia unless necessary.
• Review meds regularly and prefer nonpharmacologic options.
Key Quotes:
• “Any symptom in an elderly patient should be considered a drug side effect until
proved otherwise.”
• “Start low and go slow, but get there.”
• “A medication only works if the patient takes it.”
Key Takeaways Across All Chapters
• Assess patient-specific variables (age, comorbidities, genetics).
• Monitor for ADRs and drug interactions.
• Educate patients to enhance adherence.
• Reevaluate therapy regularly for safety and efficacy.
Chapter 1 – Issues for the Practitioner in Drug Therapy
• FDA ensures safety through clinical trials and drug approval.
• Clinical Trial Phases:
- Phase I: Initial evaluation of drug safety.
- Phase II: Effectiveness on small patient groups.
- Phase III: Double-blind comparison with placebo.
- Phase IV: Post-marketing surveillance.
• Controlled Substances (Schedules I–V):
Schedule I (no accepted use, high abuse) → Schedule V (minimal abuse).
• Prescribing Process: Assess, diagnose, review pathophysiology, select therapy,
evaluate, and adjust.
• Electronic Prescriptions reduce errors and improve adherence.
• Pharmacogenomics: Genes influence drug metabolism and therapeutic outcomes.
Chapter 2 – Pharmacokinetic and Pharmacodynamic Principles
Pharmacokinetics (What the body does to the drug):
• Absorption: Enteral (oral, rectal) vs. Parenteral (IV, IM, SC, inhaled)
• Distribution: Protein binding and volume of distribution.
• Metabolism: Hepatic metabolism (CYP450 system).
• Elimination: Renal clearance and half-life.
Pharmacodynamics (What the drug does to the body):
• Receptors: Ion channels, enzyme-linked, G-protein coupled, intracellular.
• Agonist activates; antagonist blocks receptor.
• Dose–Response Relationship defines therapeutic range and toxicity.
• Influencing factors: Age, genetics, pathophysiology, diet, sex, ethnicity.
Chapter 3 – Impact of Drug Interactions and Adverse Events
Drug Interaction Categories:
• Drug–Drug, Drug–Food, Drug–Herb, Drug–Disease.
Pharmacokinetic Interactions:
• Absorption (pH, GI motility)
Distribution (protein binding),
Metabolism (enzyme induction/inhibition),
Excretion (urinary pH).
Pharmacodynamic Interactions:
• Similar effects cause potentiation; opposite effects reduce efficacy.
Examples:
• Grapefruit juice inhibits CYP3A4.
• Warfarin interacts with Vitamin K.
• MAOIs with tyramine foods.
• Herbal interactions: Kava/Valerian (CNS depression), Aloe (hypoglycemia), Bitter
orange (MAOI interference).
Adverse Drug Reactions (ADR):
• Type A (predictable), Type B (idiosyncratic).
• MedWatch program monitors post-market ADRs.
, Chapter 4 – Pharmacotherapy in Pediatrics, Pregnancy, and Lactation
Pediatric Pharmacokinetics:
• Absorption: Immature GI pH and motility.
• Distribution: High water, low protein binding.
• Metabolism: Reduced enzyme activity.
• Elimination: Decreased GFR, prolonged half-life.
Pregnancy:
• Placental transfer and fetal metabolism influence drug exposure.
• Avoid teratogenic drugs; assess risks.
Lactation:
• Drugs may pass into milk depending on solubility and pH.
Safe Prescribing:
• Pediatric doses via Body Surface Area (BSA).
• Valved holding chamber + mask for inhaled meds under age 4.
Chapter 5 – Pharmacotherapy Principles in Older Adults
Age-Related Changes:
• Decreased gastric acid, motility, albumin, liver, and renal function.
• Increased body fat → drug accumulation.
Adverse Effects:
• Falls, delirium, fractures, orthostatic hypotension.
Polypharmacy Risks:
• Interactions, prescribing cascade, adherence issues.
Safe Prescribing Guidelines:
• Use Beers Criteria.
• “Start Low, Go Slow.”
• Avoid antipsychotics for dementia unless necessary.
• Review meds regularly and prefer nonpharmacologic options.
Key Quotes:
• “Any symptom in an elderly patient should be considered a drug side effect until
proved otherwise.”
• “Start low and go slow, but get there.”
• “A medication only works if the patient takes it.”
Key Takeaways Across All Chapters
• Assess patient-specific variables (age, comorbidities, genetics).
• Monitor for ADRs and drug interactions.
• Educate patients to enhance adherence.
• Reevaluate therapy regularly for safety and efficacy.
