PTCB Updated PTCE Exam Questions and Answers by denver

ARisk Evaluation and Mitigation Strategy (REMS)program is required by theFDAfor certain medications that have serious safety concerns, ensuring their risks do not outweigh their benefits.Mycophenolateis subject to a REMS program due to its severe teratogenic effects.

(A) Sertraline❌Not Subject to REMS

Sertraline (Zoloft) is aSelective Serotonin Reuptake Inhibitor (SSRI)used to treat depression and anxiety.

While SSRIs can carry arisk of birth defects (such as persistent pulmonary hypertension in newborns - PPHN),sertraline is not included in the REMS program.

(B) Ondansetron❌Not Subject to REMS

Ondansetron (Zofran) is anantiemeticused to prevent nausea and vomiting.

While some studies suggest a possible increased risk of congenital defects, it isnot part of a REMS program.

(C) Montelukast❌Not Subject to REMS

Montelukast (Singulair) is aleukotriene receptor antagonist (LTRA)used forasthma and allergies.

It has aBoxed Warningfor mental health side effects butis not subject to a REMS program for pregnancy risks.

(D) Mycophenolate✅Correct – Subject to REMS

Mycophenolate (CellCept, Myfortic)is animmunosuppressantused to prevent organ rejection in transplant patients.

It carries ahigh risk of birth defects and miscarriage, making pregnancy preventionmandatorywhile taking the medication.

TheMycophenolate REMS Programrequires:

Mandatory counselingon pregnancy risks

Negative pregnancy testsbefore starting therapy

Use of effective contraceptionbefore, during, and after treatment

FDA REMS Program for Mycophenolate:https://www.mycophenolaterems.com/

FDA REMS Program Overview: https://www.fda.gov/drugs/risk-evaluation-and-mitigation-strategies-rems

PTCB Exam Content Outline – Medication Safety & Risk Management

Analysis of Answer Choices:References for Pharmacy Technicians:

ISMP MERP (Institute for Safe Medication Practices – Medication Error Reporting Program)allows healthcare professionals toreport medication errorsto improve patient safety.

Common errors reported:

Incorrect medication dispensing

Wrong dosages

Look-alike, sound-alike drug errors

????Reference:ISMP Official Medication Error Guidelines.

Famotidine suspension is stable for 21 days when stored in the refrigerator (2°C–8°C or 36°F–46°F).

????Reference:FDA Famotidine Stability Guidelines, USP Storage Guidelines.

According tofederal law(Drug Enforcement Administration, DEA21 CFR § 1306.25), the transfer of aneligibleSchedule III, IV, or V controlled substance prescriptionmust occur directly between two licensed pharmacists.

Pharmacists Only:Transfers of controlled substance prescriptions canonlybe completed betweentwo licensed pharmacists.

Eligible Schedule Drugs:OnlySchedule III, IV, and Vprescriptions withremaining refillsmay be transferred.Schedule II prescriptions cannot be transferred.

Transfer Limitations:

Prescriptions may be transferredonly onceunless pharmacies share areal-time, electronic prescription database(e.g., chain pharmacies). In this case, refills can be transferred multiple times within allowed limits.

Transfer Documentation:The transferring pharmacist must:

Write"VOID"on the original prescription.

Record thereceiving pharmacy’sname, address, DEA number, and pharmacist’s name.

Record thedate of transferand their own name.

Receiving Pharmacist Responsibilities:

Write"Transfer"on the prescription.

Record all information from the original prescription, includingdate of issuance, original refills, refills remaining, and DEA information of the transferring pharmacy.

A. Two licensed pharmacy technicians.→ Incorrect. Pharmacy technicians are not authorized to transfer controlled substance prescriptions.

B. A licensed pharmacy technician and a licensed pharmacist.→ Incorrect. A pharmacist mustboth send and receivethe transferred prescription.

C. A licensed pharmacist and a licensed nurse.→ Incorrect. Nurses do not have the authority to receive transferred prescriptions.

DEA Pharmacist’s Manual – Prescription Transfers (21 CFR § 1306.25).

PTCB PTCE Exam Content Outline – Controlled Substance Regulations.

National Association of Boards of Pharmacy (NABP) Guidelines on Controlled Substance Transfers.

Mosby’s Pharmacy Technician: Principles and Practice – Prescription Transfers.

Key DEA Rules on Controlled Substance Prescription Transfers:Why the Other Answer Choices Are Incorrect:Pharmacy Technician References: