Pass the PTCB CPhT PTCE Questions and answers with CertsForce

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

According to USP <1079> Good Storage and Distribution Practices, the most accurate source for determining proper storage conditions of a medication is the manufacturer's label or package insert, which contains specific temperature and humidity requirements (e.g., refrigeration, protection from light). This information is required by FDA labeling regulations and is essential for maintaining drug stability and potency.

Additionally, the Mosby’s Pharmacy Technician Review Guide states:

“Storage requirements should always be verified using the product’s official labeling or manufacturer’s monograph, as these contain validated stability data.”

PerUSP standards, a drug with an expiration date ofMarch 2025is consideredvalid until the last day of the month, which isMarch 31, 2025. This applies unless otherwise specified by the manufacturer.

If a drug is labeledMM/YYYY, itremains valid until the last day of that month.

If a drug is labeled with aspecific day (MM/DD/YYYY), itexpires at the end of that day.

A. February 28, 2025→ Incorrect; the expiration is at the end ofMarch, not February.

B. March 1, 2025→ Incorrect; the drug is stillusable until March 31.

D. March 1, 2026→ Incorrect; the drugexpires in March 2025, not 2026.

Expiration Date Rules:Other Answer Choices Explained:References:

USP <797> Pharmaceutical Compounding – Expiration and Beyond-Use Dating (BUD) Guidelines

FDA Drug Expiration Date Regulations

PTCB PTCE Exam Content Outline (Pharmaceutical Storage & Stability)

Step 1: Convert pounds to kilograms

1 kg = 2.2 lbs

132 lbs ÷ 2.2 = 60 kg

Step 2: Calculate total dose

5 mg/kg × 60 kg = 300 mg

Thus, the correct answer isC. 660 mg.

????Reference:PTCE Calculation Guide, Pediatric Dosage Calculations.

AUstands for"auris utraque", meaning"both ears".✅

Sig codes (Signa codes)are abbreviations used in prescriptions to indicate how a medication should be taken or applied.

Why Other Options Are Incorrect:

q.s. (quantum satis):Means "a sufficient quantity," NOT"shake well."❌

IN:Refers tointranasal, NOTintramuscular (IM).❌

q.i.d. (quater in die):Means"four times a day,"NOT"three times a day".❌

????Reference:PTCB Official Sig Code List,Institute for Safe Medication Practices (ISMP) Approved Abbreviations.

HCTZ (hydrochlorothiazide) is a diuretic, but the abbreviation can be confused with hydrocortisone (a corticosteroid).

To prevent errors, ISMP recommends writing out "hydrochlorothiazide" instead of using "HCTZ."

????Reference:ISMP Do Not Use List, PTCE Medication Safety Guidelines.

Comprehensive and Detailed Step-by-Step Explanation:

Shingrix (Zoster Vaccine Recombinant)must be stored in therefrigerator (2°C to 8°C / 36°F to 46°F)and shouldnever be frozen.

????Explanation of Answer Choices:✅C. Shingrix that was stored in a freezer→Correct.Shingrixloses potencywhen frozen.❌A. Boostrix (Tdap) stored in a refrigerator→ Incorrect.Proper storage condition.❌B. Havrix (Hepatitis A vaccine) stored in a refrigerator→ Incorrect.Proper storage condition.❌D. Varivax (Varicella vaccine) stored in a freezer→ Incorrect.Varivax must be stored frozen (-50°C to -15°C).

????Reference:

CDC Vaccine Storage & Handling Guidelines

USP <1079>: Vaccine Storage

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:

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:

Aricept (Donepezil) is a cholinesterase inhibitorused for treatingmild, moderate, or severe Alzheimer's disease dementia.

Itworks by increasing acetylcholine levels in the brain, improving memory and cognitive function.

FDA-approved for all stages of Alzheimer’s disease.

B. Azilect❌→Used for Parkinson’s disease, not Alzheimer's.

Azilect (Rasagiline) is a monoamine oxidase-B (MAO-B) inhibitorthat helps manage Parkinson’s symptoms but is not indicated for dementia.

C. Ambien❌→Used for insomnia, not Alzheimer's dementia.

Ambien (Zolpidem) is a sedative-hypnotic for sleep disordersand does not treat cognitive decline.

D. Atacand❌→Used for hypertension, not dementia.

Atacand (Candesartan) is an angiotensin receptor blocker (ARB) used to treat high blood pressure and heart failure.

FDA Approved Uses for Donepezil (Aricept)– Confirms its indication for all stages of Alzheimer’s disease.

Alzheimer’s Association Treatment Guidelines– Listscholinesterase inhibitors as first-line therapy for dementia.

PTCB PTCE Exam Content Outline– Covers pharmacologic treatments for cognitive disorders.

Why Not the Other Options?Key References: