Pass the PTCB CPhT PTCE Questions and answers with CertsForce

Comprehensive and Detailed Step-by-Step Explanation:

Lorazepam oral concentrate (Ativan)should be storedat controlled room temperature (20-25°C or 68-77°F)and protected fromlight. It should not be refrigerated or frozen.

????Explanation of Answer Choices:✅B. Lanoxin oral solution→Correct.LikeLorazepam, Lanoxin (Digoxin)requires room temperature storage.❌A. Lamictal chewable tablets→ Incorrect.Stored at room temperature, but not a liquid formulation.❌C. Lyumjev KwikPen→ Incorrect.Insulin pens require refrigeration.❌D. Lunesta tablets→ Incorrect.A solid dosage form, not comparable to a liquid oral concentrate.

????Reference:

USP <1079>: Storage and Handling of Pharmaceuticals

FDA Storage Recommendations for Lorazepam

Comprehensive and Detailed Step-by-Step Explanation:

Cephalexin suspension (Keflex)is anantibioticthat must berefrigerated after reconstitutionanddiscarded after 14 daysto maintain stability and potency.

????Explanation of Answer Choices:✅D. Keep refrigerated; Discard after 14 days→Correct.Proper storage is2-8°C (36-46°F), with a 14-day shelf life.❌A. Protect from light; Discard after 7 days→ Incorrect.Refrigeration is required, not just light protection.❌B. Protect from light; Discard after 14 days→ Incorrect.Light protection is not a major concern for cephalexin.❌C. Keep refrigerated; Discard after 7 days→ Incorrect.Cephalexin is stable for 14 days, not just 7.

????Reference:

USP <795>: Beyond-Use Dating for Reconstituted Suspensions

FDA Drug Stability Guidelines

Grapefruit juice inhibits CYP3A4 enzymes, increasingbudesonide levels inthe blood, leading tohigher risk of side effects (immune suppression, adrenal insufficiency).

Budesonide is a corticosteroid used for Crohn’s disease and asthma.

Why Other Options Are Incorrect:

B. Dairy products?❌No significant interaction.

C. Leafy greens?❌Affectswarfarin (not budesonide).

D. Aged cheese?❌Interacts withMAO inhibitors, not budesonide.

????Reference:FDA Drug-Food Interaction Guide, PTCB Medication Safety Guidelines.

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.

Comprehensive and Detailed Step-by-Step Explanation:

The FDA Orange BookprovidesTherapeutic Equivalence (TE) codesto indicate whether a generic drug isequivalentto a brand-name drug.

????Explanation of Answer Choices:✅B. The Orange Book→Correct.Liststherapeutic equivalence (TE) codesfor FDA-approved generics.❌A. Remington→ Incorrect.Pharmacy reference book, not used for TE codes.❌C. SDSs→ Incorrect.Used for chemical safety, not drug equivalence.❌D. Package insert→ Incorrect.Does not contain TE codes.

????Reference:

FDA Orange Book

PTCB Exam: Therapeutic Equivalence

Thevaricella (chickenpox) vaccine(brand nameVarivax) is alive attenuated virus vaccinethat requiresfreezingto maintain stability.

TheCDC and manufacturers (Merck) require that Varicella vaccine be stored in a freezer at:

Temperature range: -50°C to -15°C (-58°F to +5°F)

Acceptable range:-20°C to -10°C (-4°F to 14°F)

Do NOT store in the refrigerator–Refrigeration deactivates the live virus, making the vaccine ineffective.

Store in a stand-alone freezer(not in a refrigerator/freezer combo) to ensure temperature stability.

B. In the refrigerator (2°C to 8°C/36°F to 46°F)❌→Incorrect.

Refrigerationcompromises the vaccine’s potency, leading to inactivation of the live virus.

C. At room temperature (15°C to 30°C/59°F to 86°F)❌→Incorrect.

Room temperature storage causes rapid degradation of the live virus, rendering the vaccine ineffective.

D. In a warmer (30°C to 40°C/86°F to 104°F)❌→Incorrect & Unsafe.

Thisdestroysthe vaccine and makes it completely ineffective.

Centers for Disease Control and Prevention (CDC) Vaccine Storage and Handling Guidelines– States that varicella vaccinesmust be stored in the freezer at -50°C to -15°C (-58°F to +5°F).

Manufacturer (Merck) Guidelines for Varivax– Specifies strict freezer storage requirements.

USP <797> & USP <800> Guidelines– Discuss vaccine stability and proper storage conditions.

PTCB PTCE Exam Content Outline– Covers vaccine storage and handling protocols.

Proper Long-Term Storage Conditions for Varicella VaccineWhy Not the Other Options?Key References:

Comprehensive and Detailed Step-by-Step Explanation:

Clozapine (Clozaril)is anatypical antipsychoticused to treatschizophrenia. However, it has a severe side effect calledagranulocytosis, which causesa dangerous drop in white blood cells (WBCs) and neutrophils (ANCs), increasing the risk of infections.

????Explanation of Answer Choices:✅D. Clozapine→Correct.Patients must be enrolled in theClozapine REMS program, and pharmacies must verifyANC and WBC resultsbefore dispensing.❌A. Aripiprazole→ Incorrect.Aripiprazole (Abilify) does not require ANC monitoring.❌B. Fluoxetine→ Incorrect.Fluoxetine (Prozac) is an SSRI and does not require blood monitoring.❌C. Amitriptyline→ Incorrect.Amitriptyline is a tricyclic antidepressant and does not require ANC monitoring.

????Reference:

FDA Clozapine REMS Program

PTCB Exam: Medication Safety & Risk Evaluation

Lot numbers are required for drug recalls and tracking purposes.

Prescription numbers are pharmacy-specific and not on manufacturer packaging.

????Reference:FDA Drug Labeling Requirements, USP Manufacturing Guidelines.

When adrug recalloccurs due totemperature excursions(exposure to temperatures outside the manufacturer’s recommended range during transport or storage), the pharmacy mustimmediately remove all affected productfrom its inventory to prevent dispensing compromised medication.

Remove the Affected Product:Quarantine the recalled drug to ensure it is not dispensed.

Verify the Recall Details:Confirm the lot number, expiration date, and reason for the recall using FDA or manufacturer recall notices.

Document the Recall Action:Log details in the pharmacy's recall records for compliance.

Follow Manufacturer or FDA Instructions:Some recalls require returning the product, while others require disposal according to hazardous waste guidelines.

Notify Patients and Providers (If Necessary):If the medication has already been dispensed, further action may be needed depending on recall severity.

B. Contact patients who received a therapeutically equivalent product.→ Incorrect. The recall applies to thespecificaffected lot, not all similar medications. Pharmacists would first verify which patients received the recalled drugbefore contacting them.

C. Switch patients from the oral solution to oral capsules.→ Incorrect. The recall does not automatically require a formulation change. The pharmacy must verify availability of unaffected stock or alternative treatments before making substitutions.

D. Contact all prescribers who recently prescribed the product.→ Incorrect. While prescribersmayneed notification if the recall affects patient treatment, thefirst stepis ensuring the recalled product is removed from stock to prevent further dispensing.

PTCB PTCE Exam Content Outline – Medication Safety and Recall Procedures.

FDA Drug Recall Guidelines (www.fda.gov).

USP <1079> Good Storage and Distribution Practices for Pharmaceuticals.

National Association of Boards of Pharmacy (NABP) Recall Compliance Standards.

Manufacturer Recall Notices (Example: Pfizer, Eli Lilly, etc.).

Mosby’s Pharmacy Technician: Principles and Practice – Recall Classifications and Actions.

Steps to Follow in a Drug Recall:Why the Other Answer Choices Are Incorrect:Pharmacy Technician References:

Upon receiving a recall notice, thefirststep a pharmacy technician should take is toverify whether the recalled product is present in the pharmacy’s inventory. This is critical because:

Product Identification– The pharmacy must determine if it has the affected lot numbers, expiration dates, or specific product variations mentioned in the recall notice.

Patient Safety– If the product is in stock, it must be removed from inventory immediately to prevent accidental dispensing.

Regulatory Compliance– TheFDA, manufacturer, or wholesaleroften provides specific instructions for handling recalled medications, and the pharmacy must comply with those guidelines.

FDA Drug Recall Guidelines– Recalls are classified intoClass I, II, and III, and the process requires inventory verification before further actions.

PTCB PTCE Exam Content Outline– The PTCB exam emphasizes medication safety and regulatory compliance, which includes proper handling of recalls.

The Drug Supply Chain Security Act (DSCSA)– This federal law mandates tracking and traceability of pharmaceutical products, reinforcing the importance of inventory checks during recalls.

Pharmacy Policy & Procedures– Most pharmacies followStandard Operating Procedures (SOPs)where verification of stock is the first step before contacting patients or returning products.

Key References:????Why Not the Other Options?

A. Call any affected patients❌→ This step is necessaryafterthe recall is confirmed and documented. If the pharmacy does not have the recalled product, patient notification is unnecessary.

B. Put the recall notice in the inventory technician’s box for processing❌→ Delaying action by simply passing the notice alongwithout verifying stockcan lead to patient harm.

D. Send the product back❌→ While returning recalled products is part of the process, itshould only occur after verification and proper documentation.