PTCE Exam Dumps - Pharmacy Technician Certification (CPhT) Exam

Anear miss(orclose call) is anerror that is identified and corrected before it causes harm to a patient.

Example:A technician picks uphydroxyzine (an antihistamine) instead of hydralazine (a blood pressure medication),but the pharmacist catches the mistake before dispensing.

Why Other Options Are Incorrect:

A. Adverse Drug Event (ADE)?❌Occurs when a patient is actually harmed by medication.

B. Recall?❌Issued by manufacturers or the FDA when a drug is defective or unsafe.

D. Root-Cause Analysis (RCA)?❌A method toanalyze errors AFTER they occurto prevent future mistakes.

📌Reference:ISMP Medication Safety Guidelines, PTCE Exam Study Guide on Error Prevention.

According tofederal law(Controlled Substances Act, CSA) andDrug Enforcement Administration (DEA) regulations, a prescription for aSchedule III or IV controlled substancemay be refilleda maximum of five (5) times within six (6) monthsfrom the date the prescription was written.

Refill Limit:A Schedule IV prescription may be refilled up to five (5) times within six (6) monthsfrom the issue date, if authorized by the prescriber.

Expiration:The prescription expiressix (6) monthsafter the date it was written.

Recordkeeping:The pharmacy must maintain accurate refill records either electronically or manually.

Additional Refills Beyond 5:If the patient needs refills after the 5-refill limit, anew prescriptionmust be issued by the prescriber.

Partial Fills:Partial dispensing is allowed, but the total quantity dispensed cannot exceed the originally prescribed amount.

A. 2 times in 3 months.→ Incorrect. Federal law allows more than 2 refills for Schedule IV drugs.

B. 3 times in 4 months.→ Incorrect. This underestimates the legal refill limit.

C. 4 times in 6 months.→ Incorrect. Schedule IV drugs may be refilledup to 5 times, not just 4, within 6 months.

DEA Pharmacist’s Manual – Controlled Substances Act (21 CFR 1306.22).

PTCB PTCE Exam Content Outline – Federal Pharmacy Law and Controlled Substances.

FDA and DEA Guidelines on Schedule III-V Prescription Refills.

Mosby’s Pharmacy Technician: Principles and Practice – Controlled Substances Regulations.

Key DEA Rules for Schedule III and IV Prescriptions:Why the Other Answer Choices Are Incorrect:Pharmacy Technician References:

Dilution formula:C₁V₁ = C₂V₂

C₁ = 20%, V₁ = 100 mL, C₂ = 2%

(20)(100) = (2)(V₂) → V₂ = 1000 mL(final volume after dilution).

Convert to oz:1000 mL ÷ 59 mL (2 oz) = 16 bottles.

📌Reference:PTCE Pharmacy Dilution Calculations, USP <795> Guidelines.

Cyclosporine is a cornerstone immunosuppressant for transplant recipients and is a narrow therapeutic index medication requiring close monitoring of drug levels and renal function due to risks such as nephrotoxicity, hypertension, and extensive drug–drug interactions (CYP3A4 substrate). While prednisone is commonly used post-transplant, it does not require serum level monitoring like cyclosporine. Acetaminophen and doxycycline do not have the same transplant-specific monitoring needs.

DEA requires allcontrolled substance prescriptionsto include thedate of issueas per21 CFR 1306.05(a).

Other required elements:

Patient’s full name and address

Drug name, strength, dosage form, quantity

Directions for use

Prescriber’s name, address,DEA number, and signature

📌Reference:DEA Controlled Substance Act;21 CFR 1306.05.

TheM-M-R II (Measles, Mumps, and Rubella) vaccinemust bereconstituted only with the manufacturer-supplied diluentto maintain its efficacy and stability.

The manufacturer-provided diluent contains stabilizing agents that preserve the live attenuated virus.

Using normal saline can alter the pH and degrade the vaccine, making it ineffective.

The vaccine must be discarded if reconstituted incorrectlyand not administered.

A. Administer the vaccine as the diluents are equivalent.❌→Incorrect

Normal saline is NOT equivalent to the manufacturer’s diluentand can compromise the vaccine’s potency.

B. Report the incident to the Drug Enforcement Administration (DEA).❌→Incorrect

Vaccine errors should be reported to the CDC’s Vaccine Adverse Event Reporting System (VAERS), not the DEA(which handles controlled substances, not vaccines).

C. Contact the Environmental Protection Agency (EPA) for guidance.❌→Incorrect

The EPA regulates hazardous waste, not vaccine errors.The CDC or vaccine manufacturer should be contacted for guidance.

CDC Vaccine Storage and Handling Guidelines– States thatvaccines must be reconstituted only with manufacturer-supplied diluents.

FDA Guidelines for M-M-R II Vaccine– Confirms that improper reconstitutionrenders the vaccine ineffective.

PTCB PTCE Exam Content Outline– Covers proper vaccine handling and error prevention.

Why Is Normal Saline Not an Acceptable Diluent?Why Not the Other Options?Key References:

Nurtec ODT (Rimegepant)is anorally disintegrating tablet (ODT)used for theacute treatment of migraines. Since it is designed to dissolve quickly in the mouth,it is highly sensitive to moisture. Exposure to moisture can cause the tablets to degrade, dissolve prematurely, or lose potency.

Storage Requirement:

Must be kept in the original blister packaging until usetoprevent moisture exposure.

Should not be stored in pill organizers or opened ahead of time.

B. Light→ Incorrect; Nurtec ODT isnot highly photosensitive.

C. Heat→ Incorrect; while heat can degrade many medications,moisture is the primary concernfor ODT formulations.

D. Cold→ Incorrect; refrigeration isnot required, and cold storage does not affect the drug’s stability.

Other Answer Choices Explained:References:

FDA Drug Label for Nurtec ODT (Rimegepant) – Storage and Handling Instructions

USP <795> Nonsterile Compounding & Drug Stability Guidelines

PTCB PTCE Exam Content Outline (Medication Storage & Handling)

FDA recall classifications are defined by the likelihood and severity of health consequences:

• Class I: Reasonable probability that use/exposure will cause serious adverse health consequences or death (e.g., microbial contamination of a sterile product or a life-threatening wrong drug situation).

• Class II: May cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse consequences is remote.

• Class III: Not likely to cause adverse health consequences; often labeling or packaging issues that do not impact safety/efficacy.

For nystatin suspension:

• Bacterial contamination (A) or fungal contamination (C) represents a clinically significant contamination with potential for harm—this aligns with Class I (or Class II in some limited contexts depending on product/route), but certainly not Class III.

• Wrong active ingredient present (B) (e.g., presence of carbamazepine) is a serious error that can cause significant harm and is typically Class I.

• Incorrect lot number on the label (D) is a labeling defect not likely to cause adverse health consequences, aligning with a Class III recall.