PTCE Exam Dumps - PTCB CPhT Questions and Answers

Comprehensive and Detailed Step-by-Step Explanation:

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Explanation of Answer Choices:✅B. 10→Correct.❌A. 1→ Incorrect.1 tablet contains 100 mg, not 1000 mg.❌C. 100→ Incorrect.Overdose.❌D. 1000→ Incorrect.Severe overdose.

????Reference:

USP <795> Pharmaceutical Calculations

PTCB Dosage Conversions

Comprehensive and Detailed Step-by-Step Explanation:

Root-Cause Analysis (RCA)is asystematic approachused toidentify the underlying causes of medication errors. RCA focuses onsystems and processes, not individual blame.

????Explanation of Answer Choices:✅B. Focusing primarily on systems and processes rather than individual performance→Correct.RCA aims toprevent future errors by improving systems.❌A. Termination of employment→ Incorrect.Blaming individuals does not address system failures.❌C. Immediate reporting to the state board→ Incorrect.RCA is an internal investigation process.❌D. Criminal charges→ Incorrect.RCA focuses on improvement, not legal punishment.

????Reference:

ISMP Guidelines on Root-Cause Analysis

PTCB Medication Safety Principles

NTI drugs have small differences between effective and toxic doses.

Examples:Warfarin, Digoxin, Lithium, Theophylline.

Requires close monitoring (lab tests, dose adjustments).

????Reference:FDA NTI Drug List, PTCB Medication Safety Guidelines.

Controlled substances (Schedules I–V) are classified by the DEA based on their potential for abuse, medical use, and dependence risk.

Schedule I (highest risk, no medical use):Heroin, LSD, Ecstasy.

Schedule II (high abuse potential, medical use):Oxycodone, Morphine, Fentanyl.

Schedule III (moderate abuse potential):Codeine combinations, Ketamine.

Schedule IV (low abuse potential):Alprazolam, Zolpidem.

Schedule V (lowest risk):Cough syrups with low doses of codeine.

Why Other Options Are Incorrect:

B. All contain hydrocodone?❌OnlySchedule II and IIImay contain hydrocodone.

C. FDA-approved indications?❌Schedule I drugs haveno FDA-approved medical use.

D. Insurance verification?❌Not all controlled drugs require insurance verification.

????Reference:DEA Controlled Substance Act, PTCB Controlled Substances Guide.

Oxybutynin (Ditropan, Oxytrol)is ananticholinergic/antispasmodicmedication thatrelaxes the bladder musclesto treatoveractive bladder (OAB).

It reduces symptoms such asfrequent urination, urgency, and urinary incontinenceby blockingmuscarinic receptorsthat control bladder contractions.

Why Other Options Are Incorrect:

A. Bronchitis?❌No, bronchitis is treated withbronchodilators, steroids, or antibiotics.

B. Hyperlipidemia?❌No, hyperlipidemia (high cholesterol) is treated withstatins (e.g., atorvastatin).

D. Pancreatitis?❌No, pancreatitis is managed withIV fluids, pain control, and pancreatic enzyme therapy.

????Reference:FDA Oxybutynin Drug Label, Pharmacology of Urinary Anticholinergics.

Comprehensive and Detailed Step-by-Step Explanation:

TheNational Drug Code (NDC)is a10- or 11-digit numberidentifying a drug'smanufacturer, product, and package size.

????NDC Format:

XXXXX−YYYY−ZZ\text{XXXXX} - \text{YYYY} - \text{ZZ}XXXXX−YYYY−ZZ

First 5 digits= Manufacturer

Middle 4 digits= Drug, strength, and formulation

Last 2 digits=Package size

✅A. Package size→Correct.Since the first two segments(00781-1506)are identical, the difference is in thelast segment, which representspackage size.❌B. Dosage→ Incorrect. Thedosage (mg strength) remains the same.❌C. Manufacturer→ Incorrect. Themanufacturer is the same (first 5 digits are identical).❌D. Strength→ Incorrect. Thestrength is unchanged.

????Reference:

FDA NDC Directory

PTCB Inventory Management Guidelines

Lyrica (pregabalin) is an anticonvulsant that causes drowsiness, dizziness, and sedation.

It is commonly prescribed for nerve pain, epilepsy, and fibromyalgia.

????Reference:FDA Pregabalin Drug Label, PTCE Medication Safety Guide.

Thevaricella (chickenpox) vaccine(brand nameVarivax) is alive attenuated virus vaccinethat requiresfreezingto maintain stability.

TheCDC and manufacturers (Merck) require that Varicella vaccine be stored in a freezer at:

Temperature range: -50°C to -15°C (-58°F to +5°F)

Acceptable range:-20°C to -10°C (-4°F to 14°F)

Do NOT store in the refrigerator–Refrigeration deactivates the live virus, making the vaccine ineffective.

Store in a stand-alone freezer(not in a refrigerator/freezer combo) to ensure temperature stability.

B. In the refrigerator (2°C to 8°C/36°F to 46°F)❌→Incorrect.

Refrigerationcompromises the vaccine’s potency, leading to inactivation of the live virus.

C. At room temperature (15°C to 30°C/59°F to 86°F)❌→Incorrect.

Room temperature storage causes rapid degradation of the live virus, rendering the vaccine ineffective.

D. In a warmer (30°C to 40°C/86°F to 104°F)❌→Incorrect & Unsafe.

Thisdestroysthe vaccine and makes it completely ineffective.

Centers for Disease Control and Prevention (CDC) Vaccine Storage and Handling Guidelines– States that varicella vaccinesmust be stored in the freezer at -50°C to -15°C (-58°F to +5°F).

Manufacturer (Merck) Guidelines for Varivax– Specifies strict freezer storage requirements.

USP <797> & USP <800> Guidelines– Discuss vaccine stability and proper storage conditions.

PTCB PTCE Exam Content Outline– Covers vaccine storage and handling protocols.

Proper Long-Term Storage Conditions for Varicella VaccineWhy Not the Other Options?Key References:

Comprehensive and Detailed Step-by-Step Explanation:

MedWatchis theFDA's Safety Information and Adverse Event Reporting Program, used totrack drug and device safety concerns.Pharmacists and healthcare professionals should report:

Adverse drug reactions (ADRs).

Medical device failures or malfunctions.

Medication errors that lead to harm.

Product quality issues related to safety.

????Explanation of Answer Choices:✅D. Medical device malfunctions→Correct.MedWatch monitors medical device safety, including pacemakers, insulin pumps, and inhalers.❌A. Medication reimbursement complaints→ Incorrect.Billing and insurance issues are not handled by MedWatch.❌B. Damaged medications received from a wholesaler→ Incorrect.These issues should be reported to the wholesaler or manufacturer, not MedWatch.❌C. Complaints about pharmacy staff→ Incorrect.These concerns should be reported to the state board of pharmacy.

????Reference:

FDA MedWatch Program

PTCB Exam: Medication Safety & Reporting

Methadone is a Schedule II controlled substanceunder theControlled Substances Act (CSA).

Pharmacies must useDEA Form 222orCSOS (Controlled Substance Ordering System)to orderSchedule II drugs.

Why Other Options Are Incorrect:

A. Buspirone?❌NOT a controlled substance(used for anxiety).

B. Nortriptyline?❌NOT a controlled substance(an antidepressant).

D. Sildenafil (Viagra)?❌NOT a controlled substance(used for erectile dysfunction).

????Reference:DEA Controlled Substance Ordering Requirements (21 CFR 1305).