PTCB Updated PTCE Exam Questions and Answers by nela

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:

The NDC number (National Drug Code) is the most effective way to ensure the correct drug is selected.

Hydralazine (blood pressure medication) and hydroxyzine (antihistamine) are Look-Alike, Sound-Alike (LASA) drugsthat can cause serious medication errors if mixed up.

????Reference:ISMP LASA Guidelines, FDA NDC Number Verification.

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

Formula: Dose ÷ Concentration = Volume (mL)

30 mg ÷ 20 mg/mL = 1.5 mL

????Reference:PTCB Calculation Guide, Pharmacy Dosage Conversions.