PTCE Exam Dumps - PTCB CPhT Questions and Answers

Bupropion (Wellbutrin, Zyban) requires a Medication Guide due to risks of suicidal thoughts and neuropsychiatric effects.

Medication Guides are FDA-required leaflets given with specific medications that have serious risks.

Examples of Medications Requiring a Medication Guide:

Antidepressants (e.g., SSRIs, SNRIs, bupropion) → Suicide risk

NSAIDs → GI bleeding risk

Opioids → Addiction risk

Fluoroquinolones → Tendon rupture risk

????Reference:FDA Medication Guide Requirements, ISMP Patient Safety Guidelines.

Meclizine (Bonine, Dramamine Less Drowsy)is anover-the-counter (OTC) antihistamineused to treatmotion sickness and vertigo. It works by blockinghistamine (H1) receptorsin thevestibular system, reducing nausea and dizziness associated with motion sickness.

B. Olanzapine→ Incorrect; olanzapine is anatypical antipsychoticused forschizophrenia and bipolar disorder, not motion sickness.

C. Promethazine→ Incorrect; promethazine is anantihistaminethat treatsnausea and motion sickness, but it isonly available by prescription (Rx).

D. Scopolamine→ Incorrect; scopolamine is aprescription (Rx) medicationintransdermal patch formused formotion sickness prevention.

Other Answer Choices Explained:References:

FDA Drug Monograph for Meclizine (OTC Drug Labeling)

PTCB PTCE Exam Content Outline (OTC Medications & Indications)

Lexicomp Drug Monographs for Meclizine, Promethazine, and Scopolamine

Prilosec (omeprazole) is a PPIused to reduce stomach acid forGERD and ulcers.

????Reference:FDA PPI Drug Classification Guide.

Grapefruit juice inhibits CYP3A4 enzymes, increasingbudesonide levels inthe blood, leading tohigher risk of side effects (immune suppression, adrenal insufficiency).

Budesonide is a corticosteroid used for Crohn’s disease and asthma.

Why Other Options Are Incorrect:

B. Dairy products?❌No significant interaction.

C. Leafy greens?❌Affectswarfarin (not budesonide).

D. Aged cheese?❌Interacts withMAO inhibitors, not budesonide.

????Reference:FDA Drug-Food Interaction Guide, PTCB Medication Safety Guidelines.

TheFDA classifies recalls into three levels, withClass III being the least severe:

Class I Recall→Most severe→ Issued when a drugmay cause serious harm or death.

Class II Recall→Moderate severity→ The drug may causetemporary or medically reversible adverse effects.

Class III Recall→Least severe→ The productis unlikely to cause harm but violates FDA regulations(e.g., labeling errors, minor packaging issues).

A. Is issued when there is a reasonable probability that the product will cause serious adverse health consequences or death.❌→Incorrect

Describes a Class I recall, not Class III.

B. Is initiated by the FDA if a manufacturer has violated the adulteration provisions of the Food, Drug, and Cosmetic Act (FDCA).❌→Incorrect

FDA action due to adulteration typically leads to Class I or Class II recalls, depending on severity.

C. Occurs when a product may cause temporary or medically reversible adverse health consequences.❌→Incorrect

Describes a Class II recall, not Class III.

FDA Drug Recall Guidelines– Defines Class I, II, and III recalls.

PTCB PTCE Exam Content Outline– Covers recall classifications and pharmacy responsibilities.

FDA Enforcement Report– Lists real-world examples of Class III recalls (e.g.,mislabeling, incorrect expiration dates).

Why Not the Other Options?Key References:

Aricept (Donepezil) is a cholinesterase inhibitorused for treatingmild, moderate, or severe Alzheimer's disease dementia.

Itworks by increasing acetylcholine levels in the brain, improving memory and cognitive function.

FDA-approved for all stages of Alzheimer’s disease.

B. Azilect❌→Used for Parkinson’s disease, not Alzheimer's.

Azilect (Rasagiline) is a monoamine oxidase-B (MAO-B) inhibitorthat helps manage Parkinson’s symptoms but is not indicated for dementia.

C. Ambien❌→Used for insomnia, not Alzheimer's dementia.

Ambien (Zolpidem) is a sedative-hypnotic for sleep disordersand does not treat cognitive decline.

D. Atacand❌→Used for hypertension, not dementia.

Atacand (Candesartan) is an angiotensin receptor blocker (ARB) used to treat high blood pressure and heart failure.

FDA Approved Uses for Donepezil (Aricept)– Confirms its indication for all stages of Alzheimer’s disease.

Alzheimer’s Association Treatment Guidelines– Listscholinesterase inhibitors as first-line therapy for dementia.

PTCB PTCE Exam Content Outline– Covers pharmacologic treatments for cognitive disorders.

Why Not the Other Options?Key References:

Pantoprazole (Protonix)is aproton pump inhibitor (PPI)that isonly available by prescriptionfor treatingGERD, Zollinger-Ellison syndrome, and peptic ulcers.

Omeprazole (Prilosec), Lansoprazole (Prevacid), and Esomeprazole (Nexium)are availableOTC and by prescriptionin different strengths.

Prescription PPIsare typically higher strength than OTC versions.

????Reference:FDA Drug Approvals for OTC and Prescription PPIs.

HCTZ (hydrochlorothiazide) is a diuretic, but the abbreviation can be confused with hydrocortisone (a corticosteroid).

To prevent errors, ISMP recommends writing out "hydrochlorothiazide" instead of using "HCTZ."

????Reference:ISMP Do Not Use List, PTCE Medication Safety Guidelines.

AClass I recallis themost seriousrecall issued when amedication labeling erroror contaminationcould result in serious harm or death.

Enoxaparin (Lovenox)is ananticoagulant, whilephytonadione (Vitamin K1)is anantidote for warfarin toxicity—confusing these could lead to life-threatening bleeding or clotting issues.

TheFDA mandates an immediate Class I recallfor errors that could causefatal outcomes.

Why Other Options Are Incorrect:

B. Class II?❌Used formoderate health risks(e.g., subpotent drugs).

C. Class III?❌Used forminor errors(e.g., misprinted labels, minor defects).

D. Misbranding?❌Misbranding is a regulatory issue butnot a recall classification.

????Reference:FDA Drug Recall Guidelines, ISMP Medication Safety Alerts.

Linaclotide (brand name: Linzess)must be dispensed in its original containerbecause:

It is highly moisture-sensitive, and removing it from its original container may lead to degradation.

The manufacturer provides a desiccantin the original packaging toprotect against humidity.

A. Furosemide❌→Does not require original container.

While furosemide tablets should be stored properly,they do not require dispensing in the original container.

C. Valsartan❌→Does not require original container.

Valsartan tablets arestable outside the original container.

D. Sertraline❌→Does not require original container.

Sertraline (Zoloft)can be repackagedwithout stability issues.

FDA Linzess Storage Guidelines– States that Linzessmust be stored in its original container with desiccant.

USP <797> & <800> Guidelines– Cover proper storage and handling of moisture-sensitive drugs.

PTCB PTCE Exam Content Outline– Includes special drug storage requirements.

Why Not the Other Options?Key References: