PTCE Pharmacy Technician Certification (CPhT) Exam Questions and Answers

Comprehensive and Detailed Step-by-Step Explanation:

Retin-A (Tretinoin)is atopical retinoidused foracne treatmentandshould be stored with other topical medicationsatroom temperature (68-77°F or 20-25°C).

????Explanation of Answer Choices:✅D. Topical preparations→Correct.Retin-A is atopical medicationand should be stored accordingly.❌A. Liquid preparations→ Incorrect.Retin-A is not an oral liquid.❌B. Chemotherapy drugs→ Incorrect.Tretinoin is not classified as chemotherapy.❌C. Refrigerated drugs→ Incorrect.Retin-A should not be refrigerated.

????Reference:

USP <1079>: Storage of Pharmaceuticals

Manufacturer’s Storage Guidelines for Retin-A

Eliquis (apixaban) is a direct oral anticoagulant (DOAC) that increases the risk of serious bleeding.

High-alert medications have anarrow therapeutic indexand requirespecial monitoring.

????Reference:ISMP High-Alert Medication List, FDA Eliquis Safety Warnings.

Pantoprazole (Protonix)is aproton pump inhibitor (PPI)that isonly available by prescriptionfor treatingGERD, Zollinger-Ellison syndrome, and peptic ulcers.

Omeprazole (Prilosec), Lansoprazole (Prevacid), and Esomeprazole (Nexium)are availableOTC and by prescriptionin different strengths.

Prescription PPIsare typically higher strength than OTC versions.

????Reference:FDA Drug Approvals for OTC and Prescription PPIs.

To calculate how muchamoxicillin suspensionwill be used in the first5 days, we follow these steps:

Amoxicillin concentration:250 mg per5 mL

Dosage:1 tsp (5 mL) three times daily (tid)

Duration:First5 days

Step 1: Identify Given InformationStep 2: Calculate Total Daily Volume5 mL×3=15 mL per day5 \text{ mL} \times 3 = 15 \text{ mL per day}5 mL×3=15 mL per day

Step 3: Multiply by 5 Days15 mL/day×5 days=75 mL15 \text{ mL/day} \times 5 \text{ days} = 75 \text{ mL}15 mL/day×5 days=75 mL

Thus, the patient will use75 mLof medication in the first5 days.

A. 25 mL→ Incorrect; this would be correct if taken onlyonce dailyinstead ofthree times daily.

B. 50 mL→ Incorrect; this is the correct amount for3.3 days, not 5 days.

D. 150 mL→ Incorrect; this is thefull 10-day course, not just the first 5 days.

Other Answer Choices Explained:References:

PTCB PTCE Exam Content Outline (Pharmaceutical Calculations – Dosage & Volume Calculations)

USP <795> Nonsterile Compounding Guidelines

Lexicomp Drug Monograph for Amoxicillin Suspension

Comprehensive and Detailed Step-by-Step Explanation:

Mycophenolateis animmunosuppressantused inorgan transplantsand isteratogenic (causes birth defects).It requiresRisk Evaluation and Mitigation Strategies (REMS).

????Explanation of Answer Choices:✅B. Mycophenolate→Correct.High risk ofbirth defects, requiring REMS.❌A. Miconazole→ Incorrect.An antifungal with no REMS requirement.❌C. Phentermine→ Incorrect.Used for weight loss, not teratogenic.❌D. Phenytoin→ Incorrect.Has risks but no REMS requirement.

????Reference:

FDA REMS Program for Mycophenolate

PTCB Exam: Medication Safety & REMS

Chemotherapy drugs (e.g., methotrexate, cisplatin)arehigh-alertdue to theirtoxicity, risk of overdose, and narrow therapeutic index.

????Reference:ISMP High-Alert Medication List, PTCE Study Materials.

Prilosec (omeprazole) is a PPIused to reduce stomach acid forGERD and ulcers.

????Reference:FDA PPI Drug Classification Guide.

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.

Comprehensive and Detailed Step-by-Step Explanation:

Step 1: Use the formula

A math equations with black text Description automatically generated with medium confidence

Explanation of Answer Choices:✅C. 2.5→Correct.2.5 mL provides the required25 mg dose.❌A. 0.5→ Incorrect. Too low.❌B. 2→ Incorrect. Under-dose.❌D. 5→ Incorrect. Over-dose.

????Reference:

USP <795>: Pharmaceutical Calculations

PTCB Exam: Dosage Conversions

TheInstitute for Safe Medication Practices (ISMP)classifiesInsulin U-500as ahigh-alert medication in acute care settingsbecause it isfive times more concentratedthan standardU-100 insulin. Errors in dosing or administration can result insevere hypoglycemiaorhyperglycemia, leading to life-threatening consequences.

A. Normal saline solution→ Incorrect;0.9% sodium chloride (NS)isnot a high-alert medication, as it is a commonly used IV fluid with a wide safety margin.

B. Transdermal lidocaine→ Incorrect; although lidocaine is alocal anesthetic, its transdermal form isnot considered high-alert.

C. Dextrose 5% solution (D5W)→ Incorrect; while used inIV therapy,D5Wisnot classified as high-alertin acute care settings.

Other Answer Choices Explained:References:

ISMP List of High-Alert Medications in Acute Care Settings (2023 Update)

PTCB PTCE Exam Content Outline (Medication Safety & High-Alert Medications)

USP <800> Handling of High-Alert Medications

Risedronate (Actonel)is abisphosphonateused to treat osteoporosis.

Bisphosphonates can causesevere esophagitis and esophageal ulcersif not taken properly.

Patients must take the medication witha full glass of waterand remainupright for at least 30 minutesafter administration to reduce esophageal irritation.

Other medications in the options:

Ropinirole: A dopamine agonist for Parkinson’s disease; no such requirement.

Repaglinide: A meglitinide for diabetes; no such requirement.

Rifampin: An antibiotic for tuberculosis; no such requirement.

????Reference:PTCE study materials; drug administration guidelines forbisphosphonates.

A spacer is a non-prescription medical devicethat enhances the delivery of medication from anMDI (metered dose inhaler).

Since the patient never picked it up and it isnot a controlled or perishable item, the pharmacy canreturn it to dispensing stock for resale.

Why Other Options Are Incorrect:

A. Damaged stock?❌Only if the spacer was opened, broken, or contaminated.

B. The manufacturer?❌Not necessary unless it is defective.

C. The study sponsor?❌Applies only to clinical trial supplies.

????Reference:ISMP Safe Handling of Medical Devices, PTCE Study Guide.

Comprehensive and Detailed Step-by-Step Explanation:

Hazardous drugs (HDs)must be handled withpersonal protective equipment (PPE), including:

Gloves (chemotherapy-rated)

Gown (disposable, impermeable material)

Eye protection (if splashing risk exists)

Respirator (if airborne exposure is possible)

????Explanation of Answer Choices:✅B. Wearing personal protective equipment→Correct.USP <800> mandatesPPEfor handling hazardous drugs.❌A. In a chemical safety cabinet→ Incorrect.Only sterile hazardous drugs require a biological safety cabinet.❌C. Using disposable gloves washed between each use→ Incorrect.Disposable gloves should be discarded, not washed.❌D. In a positive-pressure clean room→ Incorrect.Hazardous drugs require negative pressure rooms, not positive pressure.

????Reference:

USP <800>: Hazardous Drug Handling

NIOSH Guidelines on PPE for Hazardous Drugs

Isotretinoin (Accutane) is regulated under the iPLEDGE program.

Only a 30-day supply is allowed, and pregnancy tests are required each month for females.

????Reference:FDA iPLEDGE Program, PTCB High-Risk Medication Guidelines.

TheFDA classifies recalls into three levels, withClass III being the least severe:

Class I Recall→Most severe→ Issued when a drugmay cause serious harm or death.

Class II Recall→Moderate severity→ The drug may causetemporary or medically reversible adverse effects.

Class III Recall→Least severe→ The productis unlikely to cause harm but violates FDA regulations(e.g., labeling errors, minor packaging issues).

A. Is issued when there is a reasonable probability that the product will cause serious adverse health consequences or death.❌→Incorrect

Describes a Class I recall, not Class III.

B. Is initiated by the FDA if a manufacturer has violated the adulteration provisions of the Food, Drug, and Cosmetic Act (FDCA).❌→Incorrect

FDA action due to adulteration typically leads to Class I or Class II recalls, depending on severity.

C. Occurs when a product may cause temporary or medically reversible adverse health consequences.❌→Incorrect

Describes a Class II recall, not Class III.

FDA Drug Recall Guidelines– Defines Class I, II, and III recalls.

PTCB PTCE Exam Content Outline– Covers recall classifications and pharmacy responsibilities.

FDA Enforcement Report– Lists real-world examples of Class III recalls (e.g.,mislabeling, incorrect expiration dates).

Why Not the Other Options?Key References:

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:

Diflucan (Fluconazole) is an antifungal medicationused to treatsystemic and local fungal infections, including:

Candidiasis (oral thrush, vaginal yeast infections)

Cryptococcal meningitis

Fungal infections in immunocompromised patients (HIV/AIDS, chemotherapy patients, etc.)

Fluconazole works byinhibiting fungal ergosterol synthesis, which is essential for fungal cell membrane integrity.

A. Bacterial infections❌→Incorrect

Fluconazole does NOT treat bacterial infections; antibiotics are required instead.

B. Gastroesophageal reflux disease (GERD)❌→Incorrect

Proton pump inhibitors (PPIs) or H2 blockers(e.g., omeprazole, ranitidine) are used for GERD.

C. Altitude sickness❌→Incorrect

Acetazolamide (Diamox) is used for altitude sickness, not fluconazole.

FDA Fluconazole Drug Label– Confirms antifungal indications.

Centers for Disease Control and Prevention (CDC) Guidelines– Lists fluconazole asa treatment for candidiasis and cryptococcal meningitis.

PTCB PTCE Exam Content Outline– Covers antifungal medications and their indications.

Why Not the Other Options?Key References:

Comprehensive and Detailed Step-by-Step Explanation:

Phenazopyridine (Pyridium) is a urinary analgesic that turns urine orange/red, so the correct auxiliary label should warn patients about this effect.

????Explanation of Answer Choices:

✅A. May discolor urine → Correct. Phenazopyridine causes urine discoloration.

❌B. May cause drowsiness → Incorrect. Does not cause sedation.

❌C. Chew or crush the tablets → Incorrect. Should not be crushed.

❌D. Take with food or milk → Incorrect. Not required.

????Reference:

FDA Drug Label for Phenazopyridine

Apidra (insulin glulisine)is arapid-acting insulinthat must bestored between 36°F and 46°F (2°C to 8°C)in the refrigerator. If frozen,it is no longer usableand shouldnever be thawed or dispensed. The best course of action is toreturn it to the distributorto ensure medication integrity and patient safety.

A. Thawed and stored in a refrigerator→ Incorrect;frozen insulin loses its potencyand shouldnot be used.

B. Sent to the prescriber→ Incorrect; the prescriber does not handle medication storage or replacements.

C. Dispensed to a patient→ Incorrect;frozen insulin is ineffectiveand could harm the patient.

Other Answer Choices Explained:References:

FDA Insulin Storage and Handling Guidelines

USP <797> Sterile Preparations – Storage Conditions

Manufacturer Storage Requirements for Apidra (Sanofi-Aventis)

????Reference:USP <797> Sterile Compounding Guidelines.

Cyanocobalamin (Vitamin B12)is used to treatpernicious anemia, a condition caused byVitamin B12 deficiencydue to the body’s inability to absorb it properly.

Pernicious anemiais an autoimmune disorder where the stomach does not produceintrinsic factor, a protein needed for Vitamin B12 absorption.

Symptoms includefatigue, weakness, neurological issues (numbness, tingling), and megaloblastic anemia.

Cyanocobalamin is given viaIM injection or high-dose oral supplementation.

(A) Pernicious anemia✅Correct – Cyanocobalamin is the primary treatment.

(B) Alcohol withdrawal❌Incorrect – Thiamine (Vitamin B1) is used for alcohol withdrawal, not cyanocobalamin.

(C) Hypothyroidism❌Incorrect – Treated withlevothyroxine (Synthroid), not Vitamin B12.

(D) Narrow-angle glaucoma❌Incorrect – Treated withtimolol, acetazolamide, or surgery, not cyanocobalamin.

Cyanocobalamin Prescribing Information (NIH): https://medlineplus.gov/druginfo/meds/a607038.html

PTCB Exam Content Outline – Disease States & Medications

Key Facts About Cyanocobalamin & Pernicious Anemia:Analysis of Answer Choices:References for Pharmacy Technicians:

Emulsionsaremixtures of two immiscible liquids (e.g., oil and water) stabilized by an emulsifying agent.

When an emulsion breaks (phase separation occurs), the oil and water separate permanently, rendering the medication unusable.

Why Other Options Are Incorrect:

A. Tinctures?❌Alcohol-based solutions with dissolved drug, no phase separation occurs.

B. Solutions?❌Homogeneous mixtures that do NOT separate.

C. Suspensions?❌May settle over time but can be re-mixed by shaking.

????Reference:USP <795> Compounded Dosage Forms, PTCE Compounding Guidelines.

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.

In prescription terminology,"troche" refers to a dosage form, specifically alozengethat dissolves slowly in the mouth to release medication.

Atroche (or lozenge)is asolid, flavoredmedication thatdissolves in the mouthover time, allowing for gradual drug absorption.

Used for:

Local effects(e.g., sore throat relief with benzocaine troches)

Systemic effects(e.g., hormone replacement therapy troches)

A. Time❌→ Incorrect

"Troche" doesnotindicate when to take the medication.

C. Rate❌→ Incorrect

"Troche" doesnotindicate how fast the drug is absorbed.

D. Route❌→ Incorrect

"Troche"describes the dosage form, whilerouterefers to how a drug is administered (e.g., oral, IV).

USP-NF (United States Pharmacopeia–National Formulary)– Defines dosage forms, including lozenges/troches.

PTCB PTCE Exam Content Outline– Covers pharmaceutical dosage forms and prescription terminology.

ISMP Medication Safety Guidelines– Includes troches in standard medication formulations.

Definition of Troche:Why Not the Other Options?Key References:

Comprehensive and Detailed Step-by-Step Explanation:

ACE inhibitors (Angiotensin-Converting Enzyme inhibitors)are medications thatrelax blood vesselsandlower blood pressure. Drugs in this class typically end in "-pril" (e.g.,Lisinopril, Enalapril, Ramipril).

????Explanation of Answer Choices:✅C. ACE inhibitors→Correct.These lowerblood pressure and reduce strain on the heart.❌A. Beta blockers→ Incorrect.End in "-olol" (e.g., Metoprolol, Propranolol), reduce heart rate.❌B. Calcium channel blockers→ Incorrect.End in "-dipine" (e.g., Amlodipine, Nifedipine), lower blood pressure differently.❌D. Statins→ Incorrect.End in "-statin" (e.g., Atorvastatin, Simvastatin), used for cholesterol, not blood pressure.

????Reference:

American Heart Association (AHA) Guidelines

FDA Drug Classification Database

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)

TheNational Drug Code (NDC)is a unique 10- or 11-digit number assigned to each drug product in the U.S.Understanding how NDC numbers are structuredis key to answering this question correctly.

The NDC format is as follows:XXXXX-YYYY-ZZ

First segment (XXXXX)→Labeler (Manufacturer or Distributor)

Second segment (YYYY)→Product Code (Specific Drug, Strength, and Formulation)

Third segment (ZZ)→Package Size (Quantity in the Package)

How to Find the Correct Answer?The given NDC:76439-103-10

76439= Manufacturer/Labeler Code

103= Product Code (Specific Drug & Strength)

10= Package Size

To matchthe same medication, theManufacturer (76439) and Product Code (103) must remain the same. Only thepackage size (last segment) can change.

A. 76439-208-10❌→Incorrect

Product Code (208) does not match (103).

B. 76439-103-50✅→Correct

Same manufacturer (76439) and same drug (103), but different package size (50 instead of 10).

C. 74693-103-10❌→Incorrect

Different manufacturer (74693 instead of 76439).

D. 74693-206-50❌→Incorrect

Different manufacturer (74693) and different product code (206).

FDA NDC Directory– Provides details on NDC structure and product identification.

PTCB PTCE Exam Content Outline– Covers NDC interpretation and drug identification.

Drug Supply Chain Security Act (DSCSA)– Reinforces correct medication identification using NDC.

Analyzing the Answer Choices:Key References:

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:

According toUSP <800>andOSHA guidelines, exposure control forhazardous drugs (HDs)must begin as soon as the drugenters the facilityto ensure proper handling, storage, and administration safety. This includes:

Receiving:

Hazardous drugs must beunpacked in a designated areathat isseparate from regular medications.

They shouldnot be opened in sterile or positive-pressure areasto prevent contamination.

Storage:

HDs must be stored in anegative-pressure room with proper ventilation.

They must be placed indesignated binsto reduce exposure risks.

Handling and Compounding:

Usepersonal protective equipment (PPE)such as gloves, gowns, and masks when handling hazardous drugs.

Use abiological safety cabinet (BSC) or compounding aseptic containment isolator (CACI)when preparing hazardous drugs.

A. Is dispensed→ Incorrect;control measures must start earlier, before dispensing.

C. Is compounded→ Incorrect; safety measures beginbefore compounding, when the drug arrives at the pharmacy.

D. Is placed on the pharmacy shelf→ Incorrect;exposure control measuresbegin before storage, duringreceiving and handling.

Other Answer Choices Explained:References:

USP <800> Hazardous Drug Handling Guidelines

OSHA Hazardous Drug Safety Standards

NIOSH (National Institute for Occupational Safety and Health) Hazardous Drug List

PTCB PTCE Exam Content Outline (Medication Safety & Hazardous Drug Handling)

Formula: Dose ÷ Concentration = Volume (mL)

30 mg ÷ 20 mg/mL = 1.5 mL

????Reference:PTCB Calculation Guide, Pharmacy Dosage Conversions.

Comprehensive and Detailed Step-by-Step Explanation:

Anear miss(also called aclose call) occurs whenan error is detected and corrected before it reaches the patient.Since the incorrect strength was caught before dispensing, this is classified as a near miss.

????Explanation of Answer Choices:✅A. Near miss→Correct.The error wasidentified before reaching the patient, preventing harm.❌B. Adverse drug reaction→ Incorrect.An ADR occurs when a patient experiences an unintended effect from a properly administered drug.❌C. Drug allergy→ Incorrect.An allergic reaction involves the immune system (e.g., rash, anaphylaxis), not a dispensing mistake.❌D. Sentinel event→ Incorrect.Sentinel events involve severe patient harm or death (e.g., wrong drug leading to death).

????Reference:

ISMP Guidelines on Error Reporting

PTCB Exam: Medication Safety & Risk Management

Multiple-dose vials (MDVs)containpreservativesto inhibit microbial growth. These vials are designed formultiple withdrawalsover time, increasing the risk of contamination. Preservatives, such asbenzyl alcohol or phenol, help prevent bacterial or fungal contamination after repeated needle insertions.

A. stability and compatibility→ Incorrect. Preservatives do not inhibit drug stability; they prevent microbial contamination.

B. sorption and leaching→ Incorrect. Sorption (adsorption/absorption of drugs onto container surfaces) and leaching (release of chemicals from containers) are unrelated to preservatives.

D. synergistic reactions→ Incorrect. Synergistic reactions refer to drug interactions, not contamination prevention.

Incorrect Answer Choices:Pharmacy Technician References:

PTCB PTCE Exam Content Outline (Sterile and Non-Sterile Compounding)

USP <797> Guidelines for Sterile Compounding

American Society of Health-System Pharmacists (ASHP) Guidelines on Multiple-Dose Vials

Mosby’s Pharmacy Technician Exam Review

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.

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.

Breaking Down the SIG Code:"Sig: 1 tab PO q.i.d. p.c. & h.s."

Abbreviation

Meaning

1 tab

Take one tablet

PO

By mouth (oral route)

q.i.d.

Four times daily

p.c.

After meals (post cibum)

h.s.

At bedtime (hora somni)

"Take one tablet by mouth four times daily after meals and at bedtime."✅

(A) Take one tablet by mouth five times daily with meals and at bedtime.❌Incorrect – "q.i.d." means four times daily, not five.

(B) Take one tablet by mouth four times daily without meals and at bedtime with a snack.❌Incorrect – "p.c." meansafter meals, not without meals.

(C) Take one tablet by mouth four times daily before meals and at bedtime.❌Incorrect – "p.c." meansafter meals, not before.

(D) Take one tablet by mouth four times daily after meals and at bedtime.✅Correct – Matches the SIG interpretation.

ISMP List of Common SIG Codes and Abbreviations:https://www.ismp.org

PTCB Exam Content Outline – Prescription Interpretation & SIG Code Reading

Putting It Together:Analysis of Answer Choices:References for Pharmacy Technicians:

Levigating agentsreduce theparticle sizeof powders to make themeasier to mix into an ointment base.

Common levigating agents includemineral oil, glycerin, and propylene glycol.

Why Other Options Are Incorrect:

A. Emulsifying agents?❌Help mix oil and water but do NOT help incorporate solids into ointments.

B. Diluents?❌Used toincrease bulk volume(e.g., lactose in tablets).

D. Preservatives?❌Prevent microbial growth, but do NOT help mix solids into ointments.

????Reference:USP <795> Nonsterile Compounding Guidelines.

Filgrastim (Neupogen) injection is a refrigerated biologicthat must be storedbetween 2°C and 8°C (36°F–46°F).

Other optionscan be stored at room temperature.

????Reference:USP Refrigeration Guidelines, Manufacturer Storage Instructions.

Oxybutynin (Ditropan, Oxytrol)is ananticholinergic/antispasmodicmedication thatrelaxes the bladder musclesto treatoveractive bladder (OAB).

It reduces symptoms such asfrequent urination, urgency, and urinary incontinenceby blockingmuscarinic receptorsthat control bladder contractions.

Why Other Options Are Incorrect:

A. Bronchitis?❌No, bronchitis is treated withbronchodilators, steroids, or antibiotics.

B. Hyperlipidemia?❌No, hyperlipidemia (high cholesterol) is treated withstatins (e.g., atorvastatin).

D. Pancreatitis?❌No, pancreatitis is managed withIV fluids, pain control, and pancreatic enzyme therapy.

????Reference:FDA Oxybutynin Drug Label, Pharmacology of Urinary Anticholinergics.

Meclizine (Bonine, Dramamine Less Drowsy)is anover-the-counter (OTC) antihistamineused to treatmotion sickness and vertigo. It works by blockinghistamine (H1) receptorsin thevestibular system, reducing nausea and dizziness associated with motion sickness.

B. Olanzapine→ Incorrect; olanzapine is anatypical antipsychoticused forschizophrenia and bipolar disorder, not motion sickness.

C. Promethazine→ Incorrect; promethazine is anantihistaminethat treatsnausea and motion sickness, but it isonly available by prescription (Rx).

D. Scopolamine→ Incorrect; scopolamine is aprescription (Rx) medicationintransdermal patch formused formotion sickness prevention.

Other Answer Choices Explained:References:

FDA Drug Monograph for Meclizine (OTC Drug Labeling)

PTCB PTCE Exam Content Outline (OTC Medications & Indications)

Lexicomp Drug Monographs for Meclizine, Promethazine, and Scopolamine

Comprehensive and Detailed Step-by-Step Explanation:

Ahazardous drug spill kitisrequiredunderUSP <800>, which outlinessafe handling practices for hazardous drugs (HDs). The kit must contain:

Disposable scoop and scraper(to safely collect broken glass and contaminated material).

Absorbent pads or spill control pillows(for liquid spills).

Chemotherapy-rated gloves, gown, goggles, and mask(for protection).

A hazardous waste disposal bag(to properly dispose of contaminated materials).

????Explanation of Answer Choices:✅D. A disposable scoop for glass fragments→Correct.Adisposable scoop is essentialto safely removehazardous drug spills containing broken glass.❌A. Permeable, disposable protective garments→ Incorrect. PPE for hazardous drug spills must beimpermeable(e.g., coated gowns).❌B. Sufficient supplies to absorb a spill of about 10,000 mL→ Incorrect.Most spill kits are designed for smaller spills (≤1000 mL), not massive industrial spills.❌C. Reusable absorbent sponges or toweling→ Incorrect.All absorbent materials must be disposable to prevent contamination.

????Reference:

USP <800>: Handling Hazardous Drugs in Healthcare Settings

NIOSH List of Hazardous Drugs (2020 Update)

PTCB Exam: Medication Safety & Hazardous Drug Management

Withdrawal occurs when a drug-dependent individual stops taking the drug abruptly, leading to physiological symptoms.

Example:Opioid withdrawal can cause nausea, sweating, and tremors.

Withdrawal differs from addiction, which involvescompulsive drug-seeking behavior.

????Reference:DEA Controlled Substance Abuse Guide, PTCE MedicationSafety Guidelines.

Carvedilol (Coreg) and labetalol are both non-selective beta-blockersused to treathypertension and heart failure.

Therapeutic substitutionis allowed whentwo drugs have similar effects but different chemical structures.

Carvedilol is often used in place of labetalol, especially in heart failure patients.

Why Other Options Are Incorrect:

A. Albuterol?❌Abronchodilator for asthma/COPD, not a beta-blocker.

C. Tramadol?❌Apain reliever (opioid-like), not a beta-blocker.

D. Estradiol?❌Ahormone replacement therapy, not a beta-blocker.

????Reference:PTCE Medication Classification Guide, FDA Beta-Blocker Comparisons.

Comprehensive and Detailed Step-by-Step Explanation:

TheInstitute for Safe Medication Practices (ISMP)is anon-profit organizationdedicated tomedication safetyanderror preventionthrougheducation, research, and advocacy.

????Explanation of Answer Choices:✅B. ISMP (Institute for Safe Medication Practices)→Correct.The ISMP providesmedication safety guidelines, high-alert drug lists, and error-prevention strategies.❌A. FDA (Food and Drug Administration)→ Incorrect. TheFDA regulates drug safetybut isnot a non-profit organization.❌C. DEA (Drug Enforcement Administration)→ Incorrect. TheDEA enforces controlled substance laws, not medication safety education.❌D. CDC (Centers for Disease Control and Prevention)→ Incorrect. TheCDC focuses on public health, not medication error prevention.

????Reference:

ISMP Official Website

PTCB Exam: Medication Safety & Risk Management

Look-alike/sound-alike (LASA) medications pose asignificant risk of medication errors. To reduce this risk, pharmacies should:

Use both brand and generic nameson labels to clarify drug identity.

Example:"Celexa (Citalopram)" vs. "Celebrex (Celecoxib)."

B. Place the drug next to another look-alike/sound-alike drug on the shelf if they are alphabetical.❌→Incorrect

LASA drugs shouldnotbe stored next to each other.

Example:Hydroxyzine and Hydralazine should be stored separatelyto avoid mix-ups.

C. Review the first five digits of the NDC to confirm the correct product.❌→Incorrect

The first five digits (manufacturer code) only identify the manufacturer, not the specific drug.

Instead, checking theentire NDC (all 10-11 digits) is necessary.

D. Take hazardous drug precautions.❌→Incorrect

LASA errors are a labeling issue, not a hazardous drug issue.

Institute for Safe Medication Practices (ISMP) LASA Guidelines– Recommends usingboth brand and generic names on labels.

FDA & Joint Commission LASA Drug Safety Recommendations– Emphasizes labeling improvements for LASA drugs.

PTCB PTCE Exam Content Outline– Covers medication safety and error prevention strategies.

Why Not the Other Options?Key References:

Sertraline (Zoloft)is anSSRI antidepressantused formajor depressive disorder (MDD), anxiety, and other mood disorders.Suicidal ideation(thoughts of self-harm) is aserious and potentially life-threatening side effect, especially inyoung adults. A pharmacy technicianmust notify the pharmacist immediatelyif a patient reportssuicidal thoughts, as this may require immediate medical intervention.

A. Presents new insurance coverage→ Incorrect; this is an administrative issue, not a clinical concern.

B. Requests the refill two days early→ Incorrect; a slight early refill request does not indicate a safety concern.

D. Reports improved interest and motivation→ Incorrect; this is apositive treatment response, not an urgent issue.

Other Answer Choices Explained:References:

FDA Black Box Warning for SSRIs – Suicide Risk in Young Adults

PTCB PTCE Exam Content Outline (Medication Safety & Patient Communication)

Lexicomp Drug Monograph for Sertraline (Zoloft)

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

TheU.S. Food and Drug Administration (FDA)requires aMedication Guide (MedGuide)to be provided when dispensing certain medications that have significant safety concerns.Zyprexa (Olanzapine), anatypical antipsychotic, requires aMedication Guidedue to serious risks such as:

Increased mortality in elderly patients with dementia-related psychosis

Metabolic side effects(e.g., weight gain, hyperglycemia, and dyslipidemia)

Neuroleptic malignant syndrome (NMS)

A. Zafirlukast→ Incorrect; while used forasthma(leukotriene receptor antagonist), it doesnot require a Medication Guide.

B. Zestril (Lisinopril)→ Incorrect; anACE inhibitorfor hypertension, it doesnot require a Medication Guide.

C. Zinc→ Incorrect; adietary supplementthat does not require a Medication Guide.

Other Answer Choices Explained:References:

FDA Medication Guide Requirements for Olanzapine (Zyprexa)

PTCB PTCE Exam Content Outline (Medication Safety & Patient Counseling)

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.

Folic acid (Vitamin B9) is crucial for fetal development, reducing the risk of neural tube defects like spina bifida.

Recommended dose: At least 400 mcg daily before pregnancy and during the first trimester.

????Reference:CDC Folic Acid Pregnancy Guidelines, PTCE Vitamin & Supplement Guide.

Comprehensive and Detailed Step-by-Step Explanation:

Levothyroxine (Synthroid)is athyroid hormone replacementused to treathypothyroidism. It must be takenon an empty stomachbecause food, calcium, and ironinterfere with its absorption.

Administration Guidelines for Levothyroxine:

Take30-60 minutes before breakfastwith afull glass of water.

Avoidcalcium, iron, and antacidsfor4 hoursafter taking it.

????Explanation of Answer Choices:✅A. Levothyroxine→Correct.Absorption is reduced by food, calcium, and iron.❌B. Amlodipine→ Incorrect.A calcium channel blocker that can be taken with or without food.❌C. Cyclobenzaprine→ Incorrect.A muscle relaxant with no food restrictions.❌D. Loratadine→ Incorrect.An antihistamine that does not require fasting.

????Reference:

American Thyroid Association (ATA) Levothyroxine Guidelines

FDA Drug Labeling for Synthroid

Intradermal (ID) injectionsare deliveredinto the dermis (just below the epidermis).

Used forallergy testing, tuberculosis (TB) testing, and some vaccines.

Theneedle angle is 10–15 degrees, and only asmall volume (0.1 mL – 0.5 mL)is injected.

Why Other Options Are Incorrect:

A. Intraperitoneal?❌Injected into theperitoneal cavity, used in animal research.

B. Intravenous (IV)?❌Injected into aveinfor rapid drug action.

C. Intramuscular (IM)?❌Injecteddeep into the muscle(e.g., vaccines, pain medications).

????Reference:CDC Injection Guidelines, PTCE Exam Study Guide.

Pseudoephedrineis regulated under theCombat Methamphetamine Epidemic Act (CMEA)of 2005 due to its potential use in methamphetamine production.

It is availableover-the-counter (OTC) but behind the pharmacy counter, and its sale requires:

Proof of ID

Purchase limits (3.6 g per day, 9 g per month)

A log of purchases maintained by the pharmacy

Loratadine, acetaminophen, and naproxendo not have federal restrictions like pseudoephedrine.

????Reference:U.S.Combat Methamphetamine Epidemic Act (CMEA)of 2005.

Cleaning counting trays removes medication residue to prevent cross-contamination, especially with penicillin or sulfa drugs.

????Reference:ISMP Pharmacy Cleaning and Contamination Prevention Guidelines.

Concerta = Methylphenidate (extended-release) used for ADHD.

Other ADHD drugs:

Dexmethylphenidate = Focalin

Dextroamphetamine = Adderall

Lisdexamfetamine = Vyvanse

????Reference:FDA ADHD Drug Classifications, PTCB Medication Guide.

When abody area is exposed to a hazardous substance, thefirst actionshould be tothoroughly flush the area with watertoimmediately remove the contaminantand reduce absorption into the skin.

Flush the affected area with water for at least 15 minutes.

Remove contaminated clothing.

Seek medical attention if needed.

Report the incident to the pharmacy manager.

A. Notify the pharmacy manager→ Incorrect;the immediate priorityis to flush the area.Reporting comes after decontamination.

C. Call environmental services for cleanup→ Incorrect; personal exposure should be addressed before worrying about cleanup.

D. Go to the emergency department→ Incorrect; first aid (flushing with water) should beperformed immediatelybefore seeking additional care if necessary.

Proper Emergency Response:Other Answer Choices Explained:References:

USP <800> Guidelines for Handling Hazardous Drugs

OSHA (Occupational Safety and Health Administration) Hazardous Substance Exposure Protocols

PTCB PTCE Exam Content Outline (Medication Safety & Hazardous Drug Handling)

1 pint =473 mL(since 1 pint = 16 fluid ounces, and 1 fluid ounce = 29.5735 mL).A1% suspensionmeans1 g (1000 mg) of rifampin per 100 mLof suspension.

Total dose required:2 tbsp daily =30 mL per day(1 tbsp = 15 mL).

Total volume of the suspension:473 mL

Total rifampin required:(473 mL × 1000 mg) ÷ 100 mL =4730 mg

Each rifampin capsule contains300 mg.So,4730 mg ÷ 300 mg/capsule = 15.77 capsules, which rounds up to16 capsules.

Thus, the correct answer isC. 32 capsules(since the full pint must be compounded).

????Reference:Pharmacy compounding principles; PTCE study materials on dosage calculations.

Linaclotide (brand name: Linzess)must be dispensed in its original containerbecause:

It is highly moisture-sensitive, and removing it from its original container may lead to degradation.

The manufacturer provides a desiccantin the original packaging toprotect against humidity.

A. Furosemide❌→Does not require original container.

While furosemide tablets should be stored properly,they do not require dispensing in the original container.

C. Valsartan❌→Does not require original container.

Valsartan tablets arestable outside the original container.

D. Sertraline❌→Does not require original container.

Sertraline (Zoloft)can be repackagedwithout stability issues.

FDA Linzess Storage Guidelines– States that Linzessmust be stored in its original container with desiccant.

USP <797> & <800> Guidelines– Cover proper storage and handling of moisture-sensitive drugs.

PTCB PTCE Exam Content Outline– Includes special drug storage requirements.

Why Not the Other Options?Key References:

Methotrexateis achemotherapy agentand animmunosuppressantused for cancer and autoimmune diseases.

It is classified ashazardous pharmaceutical wasteunderResource Conservation and Recovery Act (RCRA)due to itstoxicity.

It must be disposed of followingEPA guidelines for hazardous waste disposal.

????Reference:RCRA hazardous waste disposal regulations;USP <800> guidelines for hazardous drugs.

Comprehensive and Detailed Step-by-Step Explanation:

A math formula on a white background Description automatically generated

Explanation of Answer Choices:✅C. 20→Correct.2 tablets per day × 10 days = 20 tablets.❌A. 5→ Incorrect. Under-dose.❌B. 10→ Incorrect. Under-dose.❌D. 40→ Incorrect. Over-dose.

????Reference:

USP <795> Pharmaceutical Calculations

PTCB Exam: Dosing Conversions

According to theCDC Hand Hygiene Guidelines,alcohol-based hand sanitizershould be used:

Before and after direct patient contact(if hands are not visibly dirty).

Before and after wearing gloves(if no contamination is visible).

Before handling medication or sterile supplies.

A. Are about to touch a contaminated surface❌→Incorrect

Hand sanitizer should not be used before touching a contaminated surface.Instead, gloves should be worn, and hand hygiene should be performedaftertouching a contaminated surface.

B. Have just performed an aseptic task❌→Incorrect

Before aseptic tasks (e.g., preparing IV medications), soap and water or hand sanitizer is used.Afterward, contamination risk determines if sanitization is needed.

C. Are about to remove their gloves❌→Incorrect

Gloves do not completely prevent contamination; hand hygiene should be performedafterremoving gloves, not before.

CDC Guidelines for Hand Hygiene in Healthcare Settings– Recommends hand sanitizer use after patient contact.

USP <797> Sterile Compounding Guidelines– Reinforces aseptic hand hygiene practices.

PTCB PTCE Exam Content Outline– Covers infection control and proper use of hand hygiene techniques.

Why Not the Other Options?Key References:

ANarrow Therapeutic Index (NTI) drugis a medication in whichsmall differences in dose or blood concentrationcan lead to serioustoxicityorsubtherapeutic effects. These drugs requirecareful dosing and monitoringto avoid adverse effects or treatment failure.

Small Margin of Safety:The difference between theminimum effective concentration (MEC)and theminimum toxic concentration (MTC)is very narrow.

Requires Therapeutic Drug Monitoring (TDM):Blood levels of the drug must be regularly monitored to maintain efficacy while avoiding toxicity.

High Risk of Adverse Effects:Even minor dosage adjustments or variations in patient metabolism can cause toxicity.

Strict Pharmacokinetic and Pharmacodynamic Considerations:Factors likerenal and hepatic function, drug interactions, and patient weightsignificantly impact the drug’s effect.

Warfarin (Coumadin) → Risk of bleeding.

Digoxin → Risk of toxicity affecting the heart.

Phenytoin → Risk of severe neurological effects.

Levothyroxine → Risk of under- or over-treatment of thyroid disorders.

Theophylline → Risk of respiratory or cardiac toxicity.

Carbamazepine → Risk of serious neurological side effects.

A. Shorter window of guaranteed stability.→ Incorrect. NTI drugs do not necessarily have a shorter shelf-life or stability concerns compared to other drugs. Stability depends on formulation and storage conditions.

B. Incompatibility with therapeutic monitoring.→ Incorrect. NTI drugsrequiretherapeutic monitoring, not the opposite.

C. Synergistic effect on other medications.→ Incorrect. While NTI drugs can interact with other drugs, not all exhibit a synergistic effect (where combined drugs produce a greater effect than expected).

PTCB PTCE Exam Content Outline – Medication Safety and Quality Assurance(Monitoring NTI drugs).

FDA Narrow Therapeutic Index Drug List(Guidelines on NTI medications).

Lexicomp and Micromedex Drug Databases(Provide monitoring recommendations for NTI drugs).

USP <800> Hazardous Drugs and USP <797> Sterile Compounding Guidelines(Ensure safe handling and dispensing of NTI drugs).

Mosby’s Pharmacy Technician: Principles and Practice(NTI drug classification and monitoring).

Key Characteristics of NTI Drugs:Examples of NTI Drugs:Why the Other Answer Choices Are Incorrect:Pharmacy Technician References:

Comprehensive and Detailed Step-by-Step Explanation:

Levetiracetam (Keppra)is classified as ananticonvulsantused to treatseizures (epilepsy).It works by stabilizing electrical activity in the brain.

????Explanation of Answer Choices:✅C. Anticonvulsant→Correct. Levetiracetam is indicated forpartial-onset, myoclonic, and tonic-clonic seizures.❌A. Antibiotic→ Incorrect. Levetiracetam does not treat bacterial infections.❌B. Antihyperglycemic→ Incorrect. Antihyperglycemics lowerblood sugar(e.g., metformin, glipizide).❌D. Antihypertensive→ Incorrect. Antihypertensives lowerblood pressure(e.g., amlodipine, lisinopril).

????Reference:

PTCB Exam: Pharmacology for Technicians

FDA Approved Drug Database (Levetiracetam)

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