Pass the PTCB CPhT PTCE Questions and answers with CertsForce

The Master Formulation Record (MFR) is a standardized document that provides step-by-step instructions on how to compound a specificnonsterile preparation.

It includes:

Active and inactive ingredients

Mixing instructions

Equipment needed

Beyond-use dating (BUD)

Storage requirements

Why Other Options Are Incorrect:

A. Medication Guide?❌Intended for patient information, not compounding.

C. Patient Package Insert?❌Explains medication use but doesn’t contain compounding instructions.

D. Safety Data Sheet (SDS)?❌Contains safety and hazard information, not formulation instructions.

????Reference:USP <795> Nonsterile Compounding Standards, PTCB Compounding Study Guide.

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.

Mycophenolate is an immunosuppressant that can cause severe birth defects, requiring a REMS program to ensure patient safety.

????Reference:FDA REMS Drug List, PTCE Study Guide.

USP <800> mandates that hazardous drug exposure requires immediate decontamination.

Flushing the affected area with large amounts of water for at least 15minutes is the first step.

For eye exposure, an eye wash station must be used immediately.

Why Other Options Are Incorrect:

A. Writing a report first?❌Incident reports should be done AFTER flushing the area.

B. Ice bag?❌Ice can worsen chemical burns.

C. Soapy water?❌Soap may react with chemicals, causing further irritation.

????Reference:USP <800> Hazardous Drug Handling, OSHA Chemical Safety Guidelines.

During pregnancy, medication safety is classified by theFDA Pregnancy Categories(prior to 2015) or thePregnancy and Lactation Labeling Rule (PLLR)(current system).

Acetaminophen (Tylenol) is considered the safest analgesic for pregnant women, especially for treating mild to moderate pain or fever.

It hasno known teratogenic effectswhen used at recommended doses.

A. Isotretinoin❌→Severe risk in pregnancy (Category X / Contraindicated)

Causes severe birth defects(craniofacial, cardiac, and central nervous system malformations).

Requires enrollment in theiPLEDGE programto prevent pregnancy exposure.

C. Lovastatin❌→Not safe in pregnancy (Category X / Contraindicated)

Cholesterol-lowering statins are teratogenic, as fetal development requires cholesterol.

D. Triazolam❌→Not safe in pregnancy (Category X / Contraindicated)

A benzodiazepine that can cause birth defects, neonatal withdrawal syndrome, and CNS depression in the fetus.

FDA Pregnancy and Lactation Labeling Rule (PLLR)– Discusses medication risks in pregnancy.

American College of Obstetricians and Gynecologists (ACOG) Guidelines– Listsacetaminophen as the preferred pain reliever during pregnancy.

PTCB PTCE Exam Content Outline– Covers drug safety in special populations, including pregnancy.

Why Not the Other Options?Key References:

TheNational Drug Code (NDC)is a10- or 11-digit numberthat uniquely identifies drugs in the U.S.

NDC format:

First set of numbers (Labeler Code):Identifies the manufacturer.

Middle set of numbers (Product Code):Identifies the specificdrug, strength, and dosage form(important for accurate product selection).

Last set of numbers (Package Code):Identifies the package size and type.

Why Other Options Are Incorrect:

A. Identification of therapeutic class?❌NDC codes do not indicate a drug’s therapeutic class.

B. Locating expired medication?❌Expiration dates are printed separately on the packaging.

C. Proper storage of the medication?❌Storage requirements are determined by themanufacturer’s label, not the NDC.

????Reference:FDA NDC Directory Guidelines, PTCE Exam Study Guide.

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:

• In medication safety terminology used across pharmacy technician study materials and safety taxonomies, an adverse event (specifically, a preventable adverse drug event) occurs when a medication error reaches the patient and results in harm or has the clear potential for harm (e.g., incorrect patient’s medication taken for several doses).

• By contrast, near misses (or “close calls”) are errors that are intercepted before they reach the patient, such as when a pharmacist catches incorrect directions during counseling (Option A), when a technician detects that a prescription was bagged but not yet verified (Option C), or when a technician finds a prescription placed in the wrong will-call bin before pickup (Option D). These represent process breakdowns with potential for harm but no patient exposure once intercepted.

• Therefore, the scenario most likely to lead to an adverse event is Option B, where the patient has already ingested medication intended for another patient. That constitutes an error that reached the patient, with a meaningful risk of harm, aligning with definitions for preventable adverse drug events.

References (Pharmacy Technician documents/Study Guides):

• NCC MERP (National Coordinating Council for Medication Error Reporting and Prevention) Taxonomy and definitions on medication errors, near misses, and events reaching the patient.

• ISMP (Institute for Safe Medication Practices) medication safety terminology and event classification used in community and institutional pharmacy practice.

• PTCB/ExCPT-aligned Pharmacy Technician Certification study guides: sections on medication safety, event reporting, and error prevention (definitions of “adverse event,” “medication error,” and “near miss/close call”).

• ASHP guidelines on preventing medication errors in community pharmacy workflows (verification steps, counseling interception points, and will-call bin best practices).

Comprehensive and Detailed Step-by-Step Explanation:

Adispensing erroroccurs when a pharmacy provides amedication that differs from the prescribed order.This may involvewrong drug, dose, form, or incorrect labeling.

????Explanation of Answer Choices:✅D. Received by the patient→Correct.Adispensing error is an error in what the patient actually receives, not what they request.❌A. Requested by the patient→ Incorrect.A patient request does not determine dispensing errors.❌B. On the plan formulary→ Incorrect.Formulary status affects insurance, not dispensing accuracy.❌C. Supplied by the wholesaler→ Incorrect.Errors in supply do not qualify as dispensing errors.

????Reference:

ISMP Guidelines on Medication Errors

PTCB Medication Safety Guidelines

Prochlorperazine (Compazine suppository)requiresrefrigeration(store at2°C to 8°C / 36°F to 46°F) to maintain stability.

Other suppositories are stored atroom temperatureunless specified.

????Reference:Manufacturer Storage Guidelines, USP Storage Standards.