PTCB Updated PTCE Exam Questions and Answers by aniyah

TheDrug Enforcement Administration (DEA)requires that theft or significant loss ofcontrolled substancesbe reported usingDEA Form 106.

(A) Pregabalin✅Schedule V (Controlled Substance – Must be Reported to DEA)

Pregabalin (brand name:Lyrica) is classified as aSchedule V controlled substanceunder theControlled Substances Act (CSA).

Pharmacies must report its theft or significant loss to the DEA using DEA Form 106.

(B) Piroxicam❌Not a Controlled Substance – No Reporting Required

Piroxicam is anonsteroidal anti-inflammatory drug (NSAID).

It isnot a controlled substance, so DEA reporting isnot requiredfor theft or loss.

(C) Prochlorperazine❌Not a Controlled Substance – No Reporting Required

Prochlorperazine is anantiemetic and antipsychotic.

It isnot a controlled substance, so DEA reporting isnot requiredfor theft or loss.

(D) Pioglitazone❌Not a Controlled Substance – No Reporting Required

Pioglitazone (brand name:Actos) is anantidiabetic medication (thiazolidinedione).

It isnot a controlled substance, so DEA reporting isnot requiredfor theft or loss.

Thepharmacist-in-charge (PIC)must fileDEA Form 106in the event of a significant loss or theft of anySchedule II–V controlled substance.

The loss must be reportedwithin one business dayto theDEAand local law enforcement.

Minor losses due to inventory miscounts do not require DEA reporting but should be documented internally.

DEA Controlled Substances Act (CSA): https://www.deadiversion.usdoj.gov/21cfr/21usc/

DEA Form 106 – Reporting Theft/Loss of Controlled Substances: https://www.deadiversion.usdoj.gov/21cfr_reports/theft/

PTCB Exam Content Outline – Pharmacy Laws & Regulations

Controlled Substance Classification of Each Drug:DEA Reporting Requirements for Pharmacy Technicians:References for Pharmacy Technicians:

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.

Comprehensive and Detailed Step-by-Step Explanation:

Methotrexate is a hazardous antineoplastic drug listed by NIOSH (National Institute for Occupational Safety and Health). It requires PPE when handled or cleaned up.

????Explanation of Answer Choices:

✅C. Methotrexate → Correct. Listed as a hazardous drug requiring PPE.

❌A. Amiodarone → Incorrect. Not classified as hazardous.

❌B. Atorvastatin → Incorrect. A statin, not hazardous.

❌D. Midazolam → Incorrect. A benzodiazepine, not hazardous.

????Reference:

NIOSH List of Hazardous Drugs (2020)

USP <800>: PPE Requirements for Hazardous Drugs

Drug interactions (like IV compatibility with heparin)must be evaluated bya pharmacisttoavoid adverse effects.

Pharmacy technicians can answer questions about generic names, drug schedules, and insurance issues but cannot provide clinical recommendations.

????Reference:ASHP Pharmacy Technician Scope of Practice, PTCE Guidelines.