Drug Terminology & Resources

Flashcards covering drug terminology, classification, safety labeling, and pharmacology study resources based on Dr. Padowski's lecture.

How do USMLE Step 1 pharmacology questions typically differ from PMY 302 questions?

USMLE questions usually require multiple steps (e.g., assess clinical scenario → identify drug → determine mechanism), while PMY 302 questions are generally single-step.

According to the lecture, what five key pieces of information should be captured when studying a drug?

1. Drug name / class, 2. Clinical uses, 3. Mechanism of action, 4. Adverse effects, and 5. Unique / notable properties.

What is the difference between drug name usage in the USMLE versus clinical practice?

The USMLE tests only on generic names (e.g., fluoxetine), whereas physicians mainly use trade names (e.g., Prozac).

What requirements must a generic drug meet to be considered 'bioequivalent' to a reference drug by the FDA?

It must have the same active ingredient, strength, dosage form, and route of administration, and result in the same concentrations in the blood.

Contrast 'Chemical class,' 'Therapeutic class,' and 'Mechanistic class' for drugs.

Chemical class is based on structural similarity; Therapeutic class is based on the condition treated; Mechanistic class is based on the drug's mechanism of action.

Define 'Off-label use' of a drug.

The use of a drug for therapeutic purposes for an indication or in a population for which the drug is not FDA-approved (labeled).

Approximately what percentage of prescriptions are written off-label?

$$20\%$$

Using bupropion as an example, explain how a drug can have multiple mechanisms of action for different uses.

For depression and smoking cessation, bupropion blocks reuptake of dopamine and norepinephrine and also acts as an antagonist at nicotinic acetylcholine receptors.

What is the distinction between a 'side effect' and an 'adverse drug reaction' (ADR)?

A side effect is an expected and known effect that is not the intended outcome; an ADR is a harmful and unintended response to a drug used at normal clinical doses.

Define 'Contraindications' in drug labeling.

Scenarios where a drug must NOT be used (e.g., allergy or pregnancy) due to a high risk of severe harm.

What are 'Black box' or 'boxed' warnings?

The strictest labeling requirements mandated by the FDA to highlight serious or life-threatening adverse events.

What is a 'REMS' (Risk Evaluation and Mitigation Strategy)?

A monitoring program required by the FDA for drugs with the most serious risk profiles, which may include mandatory lab tests or provider certification.

Which resource is a free database on the NIH NLM website that includes package inserts?

DailyMed

According to the resource comparison table, which textbook is a physical copy available in the library and highlights key effects most likely seen on the USMLE?

First Aid for the USMLE Step 1

Which pharmacology textbook provides detailed information on effects but less on clinical uses, and is available via Access Medicine?

Pharmacological Basis of Therapeutics (Goodman & Gilman)