Pass the PTCB CPhT PTCE Questions and answers with ValidTests

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:

"NS" stands for Normal Saline (0.9% sodium chloride solution), which isisotonic with blood plasmaand used forIV hydration and medication dilution.

Why Other Options Are Incorrect:

A. 0.45% sodium chloride?❌"Half-normal saline"(used in fluid-restricted patients).

C. 23.4% sodium chloride?❌Hypertonic saline(used in severe hyponatremia).

D. Any sodium chloride solution?❌Not specific to "NS" (Normal Saline).

????Reference:USP Intravenous Fluids Standardization.

Risk Evaluation and Mitigation Strategies (REMS)areFDA-required programsto ensure that thebenefits of certain medications outweigh their risks. REMS programsrestrict prescribing, dispensing, and monitoringdue to the potential for serious side effects or misuse.

Suboxoneis used foropioid dependenceand containsbuprenorphine, apartial opioid agonist, which can causeaddiction, misuse, and respiratory depressionif used improperly.

REMS Requirements for Suboxone:

Prescriber Certification:Only specially certified providers can prescribe Suboxone.

Patient Education:Patients must be informed about the risks of misuse, overdose, and dependence.

Limited Dispensing:Pharmacists must ensure prescriptions meet REMS criteria before dispensing.

A. Xarelto (Rivaroxaban).→ Incorrect. While Xarelto is an anticoagulant, it isnot under REMS.

C. Warfarin.→ Incorrect. Warfarin requires monitoring butdoes not have a REMS program.

D. Haloperidol.→ Incorrect. Haloperidol is an antipsychotic, but itdoes not have a REMS program.

FDA REMS Program List (www.accessdata.fda.gov).

Suboxone REMS Guidelines (www.suboxonerems.com).

PTCB PTCE Exam Content Outline – REMS and Medication Safety.

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

Why Is Suboxone (Buprenorphine/Naloxone) Under REMS?Why the Other Answer Choices Are Incorrect:Pharmacy Technician References:

Zyrtec (cetirizine)is asecond-generation antihistamineused to treatallergies.

Schizophreniais a psychiatric disorder treated withantipsychotics, NOT antihistamines.

This is likely aLook-Alike Sound-Alike (LASA) error, where the intended drug wasZyprexa (olanzapine), anantipsychoticcommonly used for schizophrenia.

The technician must alert the pharmacist before dispensing.

Why Other Options Are Incorrect:

A. Special Handling?❌No, Zyrtec is OTC and does not require special handling.

B. Exceeding Daily Dose?❌No, Zyrtec’s max daily dose is 10 mg for adults.

D. REMS Program?❌No, Zyrtec is not part of aRisk Evaluation and Mitigation Strategy (REMS) program.

????Reference:ISMP’s LASA Drug List,FDA Drug Labeling Guidelines.

The abbreviation"PO"means"by mouth" (per os).

The abbreviation"ac"stands for"before meals" (ante cibum).

The phrase"daily for 14 days"indicates that the patient should take the medication once a day for a total of 14 days.

Thus, the correct label instructions should be:"Take one capsule by mouth before a meal once daily for 14 days."

PTCB PTCE Exam Content Outline – Prescription Interpretation– Covers standard medical abbreviations.

ISMP (Institute for Safe Medication Practices) List of Common Pharmacy Abbreviations– Defines "PO" (by mouth) and "ac" (before meals).

USP Medication Labeling Standards– Ensures clear and accurate patient instructions.

Pharmacy Technician References:

Phenobarbital is abarbiturateused forseizure control, sedation, and epilepsy management. It is commercially available in both:

Oral tablet form(commonly used for long-term seizure control).

Injectable solution form(used in hospital settings for status epilepticus and acute seizure episodes).

B. Paroxetine❌→Available only as oral tablets and oral suspension.

C. Pioglitazone❌→Available only as oral tablets (for diabetes management).

D. Pramipexole❌→Available only as oral tablets (for Parkinson’s disease and restless legs syndrome).

FDA Drug Labeling Database– ListsPhenobarbital as available in oral and injection forms.

American Society of Health-System Pharmacists (ASHP) Drug Database– Confirmsinjectable and oral availability of Phenobarbital.

PTCB PTCE Exam Content Outline– Covers medication dosage forms and routes of administration.

Why Not the Other Options?Key References:

Vaccines come in different strengths for adults and children, and mix-ups can lead to underdosing or overdosing.

Storing pediatric and adult vaccines separately within the refrigerator reduces the risk of errors.

Example:PediatricCOVID-19 vaccines (lower dose) and adult doses look similar but have different concentrations.

Why Other Options Are Incorrect:

A. Repackaging?❌Against CDC and USP <797> guidelines, which require vaccines to remain in their original packaging.

B. Ordering from different manufacturers?❌Not practical; most pharmacies use a single supplier for consistency.

D. Automated dispensing systems?❌Not always available for vaccines.

????Reference:CDC Vaccine Storage & Handling Guidelines, ISMP Vaccine Safety Best Practices.

Risperdal Consta (risperidone long-acting injection) is an antipsychotic medication used to treat schizophrenia and bipolar disorder. It is supplied as a powder that must be reconstituted with a diluent before administration as an intramuscular (IM) injection.

According to the manufacturer’s storage guidelines:

Refrigeration Requirement:Risperdal Consta should be stored in a refrigerator (36°F to 46°F or 2°C to 8°C) to maintain stability.

Room Temperature Stability:If removed from refrigeration, Risperdal Consta can remain stable at room temperature (≤77°F or 25°C)for up to 14 days. After this period, the product should not be used if it has not been administered.

This stability information is critical for pharmacy technicians handling the medication, as it ensures proper storage and prevents medication degradation, which can affect efficacy and safety.

Risperdal Consta (Janssen Pharmaceuticals) Prescribing Information– Official manufacturer guidelines.

PTCB PTCE Exam Content Outline – Medication Storage and Stability– Covers best practices for proper drug storage and handling.

United States Pharmacopeia (USP) Standards– Guidelines on temperature control for pharmaceutical products.

Pharmacy Technician References:This information is essential for pharmacy technicians preparing Risperdal Consta for dispensing or administration, ensuring compliance with manufacturer and regulatory guidelines.

Comprehensive and Detailed Step-by-Step Explanation:

Underfederal law (21 CFR §1306.25),Schedule III-V controlled substances (e.g., Alprazolam)can be transferred ONCEfor refill purposes between licensed pharmacieswith a shared database.Schedule II drugs (e.g., Methylphenidate, Fentanyl, Hydromorphone) CANNOT be transferred.

????Explanation of Answer Choices:✅A. Alprazolam (C-IV)→Correct.Schedule III-V drugs can be transferred ONCEfor refill purposes.❌B. Methylphenidate (C-II)→ Incorrect.Schedule II drugs cannot be transferred.❌C. Fentanyl (C-II)→ Incorrect.C-II drugs are non-transferablebetween pharmacies.❌D. Hydromorphone (C-II)→ Incorrect.C-II drugs cannot be transferred.

????Reference:

DEA Controlled Substance Act (CSA)

21 CFR §1306.25 – Prescription Transfers

Arashis acommon allergic reactionto medications.Drug allergiesoccur when the immune system overreacts to a medication, leading to symptoms such as:

Skin rash (most common)

Hives (urticaria)

Swelling (angioedema)

Anaphylaxis (severe reaction)

A. Dizziness❌→Side effect, not an allergic reaction.

Some medications (e.g., antihypertensives) cause dizziness, but it isnot an immune system response.

B. Constipation❌→Side effect, not an allergic reaction.

Opioids (e.g., morphine, oxycodone) commonly cause constipation, but it isnot due to an allergy.

C. Nausea❌→Side effect, not an allergic reaction.

Many medications (e.g., antibiotics, chemotherapy) cause nausea, but this isnot an immune-mediated reaction.

American Academy of Allergy, Asthma & Immunology (AAAAI)– Defines allergic reactions to medications.

FDA Drug Allergy Guidelines– Lists common symptoms of drug allergies.

PTCB PTCE Exam Content Outline– Covers adverse drug reactions and medication safety.

Why Not the Other Options?Key References: