Generic vs. Brand-Name Medications

• Same chemical composition and effects.
• Generic = cheaper than brand-name.
• One generic name only (official, universal).
• Generic names start with lowercase. Brand name ⇒ Uppercase.
• Brand/trade name = proprietary, can vary by manufacturer.
• Abuse potential: No difference between generic and brand.

Prescription vs. Nonprescription

• Prescription medications: Require a healthcare provider’s authorization.
• Nonprescription/Over-the-counter (OTC): Do not require a prescription because the FDA designates them as safe for self-use without supervision.

Pharmaceutics (Study of drugs)

Focuses on:

• How medication form affects dissolution.
• How dissolution affects the absorption rate.
• How absorption affects the onset of action.

Oral Medications

• Forms: tablets, capsules, powders, liquids.
• Absorption depends on form.
• Inhaled powders → lungs.
• Oral disintegrating tablets (ODT) → dissolve in the mouth. No need to chew.

• Special formulations:
• Immediate-release: dissolve quickly after swallowing.
• Enteric-coated (EC): dissolve in the intestine (protects stomach or drug). Do not crushed or disolved
‣
Extended-release (ER, XL, SR, XR, SA): release over time.

Tablet Rules

• Scored tablets → may be split.

• Never crush:
• Capsules
• Extended-release (ER, SR, XR, XL, SA)
• Enteric-coated (EC)

Parenteral (Injectable) Medications

You can administer parenteral medications three main ways:

• IV (Intravenous): Into a vein.
• SUBQ (Subcutaneous): Into subcutaneous tissue.
• IM (Intramuscular): Into muscle tissue.

Parenteral meds are usually:

• Liquid form, ready for injection.
• Dry form requiring reconstitution (adding liquid to dissolve).

Parenteral Medication Absorption & Onset

✅ Key point to remember for exams:

IV → fastest → immediate. IM → second fastest (10–30 min).

SUBQ → slower, more variable.

Topical or Transdermal Medications

• Definition: Medications applied to the skin or mucous membranes (eyes, ears, nose, rectum, vagina, or lungs).
• Action:
• Deliver a constant amount of medication over an extended period.
• Slower onset of action compared to oral or parenteral routes.
• Longer duration of action.

Pharmacokinetics vs Pharmacodynamics

• Pharmacokinetics is what the body does to the drug (absorption, distribution, metabolism, excretion).
• Pharmacodynamics is what the drug does to the body (mechanism, effects, potency, efficacy).

Pharmacokinetics (PK) = What the body does to the drug

📌 Definition: The study of how the body absorbs, distributes, metabolizes, and excretes a drug.

✅ Think: PK = The journey of the drug inside the body.

🔹 4 Key Processes (ADME):

1. Absorption – How the drug enters the bloodstream (oral, IV, IM, SUBQ, etc.). Movement of a medication from the site of administration into the bloodstream.
‣
Expand
2. Distribution (Blood-stream) – How the drug is transported through the body (e.g., binding to proteins, reaching target tissues). Transport of the medication by the circulatory system to the site of action.
‣
Expand
3. Metabolism (Biotransformation) – How the liver (mostly) or other organs break down the drug. Conversion of the medication into a more or less potent or more soluble form (mainly in liver, also kidneys, intestines, etc.). Example: First-pass effect in oral meds.
‣
Expand
4. Excretion – How the drug leaves the body. Elimination of the medication or its metabolites (kidneys = urine, liver = bile, lungs = exhalation).

Pharmacodynamics (PD) = What the drug does to the body

📌 Definition: The study of the biological and physiological effects of the drug on the body and its mechanism of action.

🔹 Key Concepts:

• Receptor binding (agonist vs antagonist).
• Dose–response relationship (higher dose = stronger effect, up to a limit).
• Therapeutic effect (intended action).
• Adverse effects / side effects.
• Potency & efficacy:
• Potency: How much drug is needed for an effect.
• Efficacy: How strong the maximum effect can be.

✅ Think: PD = The effect the drug has on the body.

• Maximal Efficacy: The point at which increasing a drug’s dosage no longer increases the desired therapeutic response. Beyond this point, additional dosing only raises the risk of adverse or toxic effects without improving benefit.
• Tachyphlaxis: Acute, rapid decrease in response to a drug.

🔹 Therapeutic Index (TI)

• Definition: Ratio between a drug’s toxic dose and its therapeutic dose.
• Formula:

TI = Toxic Dose (TD₅₀) ÷ Effective Dose (ED₅₀)

• Narrow TI (e.g., digoxin, lithium) → requires close monitoring.
• Wide TI (e.g., penicillin) → safer margin between effective and toxic doses.

✨ Quick Memory Trick:

• Kinetics = move → What the body does to the drug (movement through ADME).
• Dynamics = do → What the drug does to the body (effects, mechanisms).

⏱ Medication Timing

• Half-life → time for drug level to ↓ by 50%.

• Onset → time to first therapeutic effect.
• Peak → max effect.

• Duration → how long effect lasts.

• Peak & trough → blood samples; peak = max level, trough = lowest level.

🔐 Mechanisms of Action

• Agonist (trigger) → activates receptor.
• Antagonist (blocker) → blocks receptor.
• Selective → acts only on specific receptor.

Competitive vs Non-Competitive Antagonism

• Competitive (👥 same seat): Competes for receptor; ↑ agonist can overcome; effect curve shifts right.
• Non-competitive (🔒 broken seat): Irreversible/different site; ↑ agonist cannot overcome; max effect reduced.

💊 Drug Interaction Types (Short + Explained)

• Additive Effect

➤ 1 + 1 = 2

Two drugs work together; their effects simply add up.

✅ Example: Tylenol + Ibuprofen for pain relief.

• Synergistic Effect / Potentiation

➤ 1 + 1 = 3 (or more)

Two drugs boost each other, creating a stronger effect than either alone.

✅ Example: Alcohol + Sedatives = dangerous sedation.

⚠️ Adverse Drug Reactions (ADR)

• ADR = unintended bad effect at therapeutic dose.
• Most severe → allergic reaction.
• Anaphylaxis: massive histamine release →
• Hypotension, tachycardia.
• Wheezing, difficulty breathing.
• Airway swelling (tongue, face, throat).
• Tx = airway, oxygen, epinephrine, diphenhydramine.


NOTE: Bradichardia is not a sign of anaphylaxis

📉 Medication Issues

• Tolerance → ↓ response over time (ex: opioids).
• Withdrawal → abrupt stop → symptoms.
• Toxicity → excessive level (overdose or impaired excretion).
• Cumulative effect → body can’t clear before next dose.
• Sensitivity → exaggerated response.

⚖️ Precautions & Contraindications

• Use extra caution in chronic/multiple conditions.
• Boxed warning → strongest FDA warning.
• Contraindication → don’t give (unless rare emergency).
• Dosage adjustments often needed in children (based on age, weight, surface area).

🍊 Food & Drug Interactions

➕➖ Drug Interactions

• Additive (sum of effects):
• Ex: acetaminophen + codeine → stronger pain relief.
• ✅ Clients need lower doses.
• ✅ Both drugs have similar actions.
• Synergistic (greater than sum).
• Antagonistic (one reduces effect of other).

👩‍🍼 Postpartum Medication & Baby

• Factors to consider in breastfeeding:
• Baby’s weight (lighter → higher risk).
• Amount of breast milk consumed.
• We can not give or add medication to a baby bottle of milk cause if the baby doesn’t consume the hole bottle, then we won’t be able to know how much of the drug was actually consumed.
• Medication properties (fat solubility, transfer).
• Balance benefits vs risks.
• ❌ Route of administration → not protective (any systemic med can pass).

🧠 Learning Factors (Patient Teaching)

• Affect learning:
• Impaired cognition/developmental level.
• Language barrier.
• Discomfort/pain.
• Lack of readiness (denial, distress).
• Enhance learning:
• Repetition, practice, reinforcement.

🧠 Controlled Substance Schedules Overview\

📌 Study Tip:

Use this mnemonic to remember abuse potential:

"I Have Absolutely No Medical Use!"

II = Intense

III = In Between

IV = Very light

V = Very minimal

⚖ Misfeasance, Malfeasance, Nonfeasance

🔹 1. Misfeasance ⇒ Simple Mistake.

• Doing something legal, but doing it wrongly.

• ❌ Right act, wrong way.

• Example: Giving the correct medication, but by the wrong route. Making a simple mistake in the procedure.

🔹 2. Malfeasance ⇒ Maleficent

• Doing something completely wrong or illegal.

• ❌ Wrong act, on purpose or reckless.

• Example: Stealing meds from a patient, or hitting a patient.

🔹 3. Nonfeasance ⇒ No action.

• Failing to act when you should have.

• ❌ No action at all.

• Example: Not calling the doctor when a patient’s condition worsens.

🧠 Memory Trick

Think of the first part of the word:

• Mis- = mistake (did it, but wrong).

• Mal- = malicious/bad (bad or illegal act).

• Non- = none (did nothing at all).

🧪 Drug Development Process (Overview)

🔷 1. Basic Research (Up to 6 years)

• Activities:
• Genetics
• Pathophysiology
• Mechanism of disease
• Goal: Understand the biology of the disease and identify drug targets

🧬 2. Drug Target Identification & Validation

• Activities:
• Finding a molecular target (e.g., protein, enzyme)
• Validating it through experiments

🧫 3. Preclinical Assessment

• Includes:
• Pharmacology & Toxicology (Animal studies)
• In vitro & in vivo testing
• ADME (Absorption, Distribution, Metabolism, Excretion)

🔄 4. IND Application (Investigational New Drug)

• Submitted to the FDA to get permission to begin human testing

👨‍⚕️ Clinical Development Phases (Up to 9 years)

🔹 Phase I: Safety

• Participants: 20–100 healthy volunteers
• Focus:
• Safety
• Tolerability
• Pharmacokinetics (PK)
• Pharmacodynamics (PD)

🔸 Phase II: Efficacy & Dose Optimization

• Participants: 100–300 patients
• Goal:
• Find effective dose
• Begin testing in people with the condition
• Monitor side effects

🔻 Phase III: Large-Scale Efficacy & Monitoring

• Participants: 1,000–5,000 patients
• Goal:
• Confirm effectiveness
• Monitor adverse reactions
• Compare to current treatments
• Pivotal for FDA approval

📦 5. Post-Marketing Surveillance (Phase IV)

• Continues after FDA approval
• Focus on long-term safety, rare side effects, and effectiveness in real-world use

💵 Total Time & Cost

• ⏱️ 10–15 years total
• 💰 Approximate cost: $2.6 billion

🍼 FDA Pregnancy Risk Categories (Old System)

💡 Easy Mnemonic:

A = "Alright"

B = "Be careful"

C = "Caution"

D = "Danger"

X = "X = NO"

💊Rights of Medication Administration

1. 🧍 Right Patient

Always verify patient identity with at least two identifiers.

2. 💊 Right Drug

Confirm medication name matches the order.

3. 📏 Right Dose

Ensure dosage is accurate for patient age, weight, and condition.

4. 🩸 Right Route

Verify correct route (oral, IV, IM, SQ, etc.).

5. 🕒 Right Time

Administer at the correct time and frequency.

6. 🙅 Right to Refuse (Patient & Nurse)

Respect patient autonomy and nurse’s ethical safety concerns.

7. 📚 Right Knowledge & Understanding

Ensure patient education and your own full comprehension of the drug.

8. ❓ Right Questions or Challenges

Speak up if something seems unclear, unsafe, or incorrect.

9. 🗣️ Right Advice

Provide clear instructions about medication use and precautions.

10. 👀 Right Response

Monitor and evaluate the patient’s reaction to the medication.

🔹 Nonselective vs Nonspecific

• Epinephrine = Nonselective (acts on alpha & beta receptors)
• Cholinergic receptors = Selective (non-specific) (specific to acetylcholine)

🔍 Explanation

• Nonselective drugs like epinephrine activate multiple types of receptors (α1, β1, β2), leading to broad effects.
• Cholinergic receptors (muscarinic & nicotinic) are more targeted, so drugs that affect them tend to be selective in action.

QUIZES

Learn: Pharmacology Exam 1 - Multiple Choice | Quizlet

Quizlet has study tools to help you learn anything. Improve your results and reach your goals today with flashcards, practice tests and expert-written solutions.

quizlet.com

In order for drugs to cross the blood-brain barrier, they must be LIPID SOUBLE Drug absortion is faster for Lipidic drugs. Membranes are lipidics.