Mixed Deck — All KAPS Topics Flashcards

Under 21 CFR Part 314, what is the standard review period for a standard NDA after it is accepted for filing?

Answer: 10 months

The standard FDA review goal for an NDA under PDUFA is 10 months from the date of filing.

A pharmacist who disagrees with a physician's therapeutic choice for a patient should:

Answer: Consult with the physician professionally and present evidence-based alternatives

Pharmacists have a professional duty to communicate therapeutic concerns to prescribers collaboratively while respecting the prescriber's clinical authority.

Which spectroscopic technique measures the absorption of infrared radiation to identify functional groups in a drug molecule?

Answer: Infrared spectroscopy

Infrared spectroscopy identifies functional groups based on characteristic bond vibration frequencies in the IR region.

Which analytical technique provides both molecular weight and structural fragmentation information simultaneously?

Answer: Mass spectrometry

Mass spectrometry ionizes molecules and measures mass-to-charge ratios of the parent ion and fragment ions, giving MW and structural data.

In an IVIVC (in vitro–in vivo correlation), a Level A correlation is considered MOST valuable because it:

Answer: Provides a point-to-point relationship between in vitro dissolution and in vivo absorption

A Level A IVIVC provides the highest predictive value by establishing a point-to-point relationship between the entire in vitro dissolution profile and the in vivo absorption profile.

A pharmacist receives a prescription for nitroglycerin 0.4 mg sublingual tablets. Which counseling point about storage is MOST critical?

Answer: Store in original amber glass container, tightly closed, away from heat and light

Nitroglycerin is volatile and degrades when exposed to light, heat, or moisture; it must be stored in the original amber glass bottle tightly capped.

Which FDA database or system is used by manufacturers to submit electronic adverse event reports for marketed drugs under the MedWatch program?

Answer: FDA Adverse Event Reporting System (FAERS)

FAERS (FDA Adverse Event Reporting System) is the database that receives and stores adverse event reports submitted by manufacturers, healthcare professionals, and consumers for marketed drugs and biologics.

Under Joint Commission standards, which of the following is required for a pharmacy's emergency operations plan?

Answer: Annual testing of the emergency plan with documented drills

The Joint Commission requires healthcare organizations to annually test and document emergency operations plans through drills or exercises.

A pharmacist who self-discloses a substance use disorder to the state board is MOST likely to:

Answer: Be referred to a pharmacist health program and monitored recovery program

Most state boards offer peer assistance or monitoring programs that support pharmacists with substance use disorders through supervised recovery rather than outright revocation.

A pharmacy receives a partial delivery of a controlled substance. Which documentation action is required at that time?

Answer: Record the quantity received on the DEA Form 222 or CSOS record and note the shortage

The pharmacist must immediately record the quantity actually received on the DEA Form 222 or its electronic equivalent, noting any discrepancy from the ordered quantity.

Which anticoagulant mechanism of action is shared by both unfractionated heparin and low-molecular-weight heparins (LMWHs)?

Answer: Potentiation of antithrombin to inhibit factor Xa

Both UFH and LMWH bind antithrombin and enhance its inhibition of factor Xa; UFH also inhibits thrombin (factor IIa) due to its greater chain length, while LMWHs have minimal anti-IIa activity.

Which equation correctly describes the relationship between elimination half-life (t½), volume of distribution (Vd), and clearance (Cl)?

Answer: t½ = 0.693 × Vd / Cl

The equation t½ = 0.693 × Vd / Cl shows that half-life increases as the volume of distribution increases and decreases as clearance increases.

For a drug with a HIGH hepatic extraction ratio administered orally, which factor MOST significantly affects its systemic exposure?

Answer: Changes in hepatic blood flow

For high-extraction drugs, hepatic blood flow is the rate-limiting factor for clearance; even small changes in liver perfusion substantially alter drug exposure.

Renal clearance of a drug is reduced in a patient with kidney disease. What adjustment is typically required?

Answer: Decrease the dose or increase the dosing interval

Reduced renal clearance means the drug accumulates, so the dose should be reduced or the interval extended to avoid toxicity.

The optical rotation of a chiral drug is measured using which instrument?

Answer: Polarimeter

A polarimeter measures the rotation of plane-polarized light by chiral (optically active) substances.

Which element of health literacy is MOST directly assessed by asking a patient to read and follow a prescription label?

Answer: Functional health literacy

Functional health literacy refers to the ability to read, understand, and act on health-related text such as prescription labels and instructions.

What is the purpose of reassessment in ongoing patient care?

Answer: To monitor treatment effectiveness and adjust the care plan

Reassessment monitors how well the treatment plan is working and identifies needed adjustments to optimize patient outcomes.

A child ingests a button battery. The pharmacist advising the parent should IMMEDIATELY recommend:

Answer: Call Poison Control and go to the ER immediately

Button battery ingestion is a life-threatening emergency requiring immediate ER evaluation due to rapid tissue necrosis from electrical current.

What is the purpose of using a standard curve in pharmaceutical analysis?

Answer: To correlate concentration with response

A standard curve, also known as a calibration curve, is a graphical representation that plots the known concentrations of a substance against their corresponding analytical responses (e.g., absorbance, peak area). In pharmaceutical analysis, it is used to determine the concentration of an unknown sample by measuring its response and interpolating it on the established curve. This allows for accurate quantification of drug components.

What information should be provided when calling emergency services?

Answer: Location, nature of emergency, number of victims, and current condition

Complete information helps dispatchers send appropriate resources and provide pre-arrival instructions.