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AClass III recallis issued whena drug is unlikely to cause adverse health effects but has a labeling defect, packaging issue, or a minor violation of manufacturing regulations.

Example:A bottle of tablets with a slightly misprinted label.

Pharmacies must remove affected stock but are NOT required to notify patients or physicians.

Why Other Options Are Incorrect:

A. Posting signs?❌Only required for certain urgent recalls.

C. Notifying physicians?❌Required forClass I and some Class II recalls, not Class III.

D. Contacting patients?❌Not needed fornon-health-threatening recalls.

????Reference:FDA Drug Recall Guidelines, PTCE Exam Study Guide.

Phenytoin (Dilantin)is ananticonvulsantthatstabilizes neuronal membranesbyblocking sodium channels, reducing seizure activity.

Used forepilepsy, tonic-clonic seizures, and status epilepticus.

Why Other Options Are Incorrect:

A. Clonidine?❌Used forhypertension and ADHD, NOT seizures.

B. Atomoxetine?❌Used forADHD, NOT seizures.

C. Guanfacine?❌Used forhypertension and ADHD, NOT seizures.

????Reference:FDA Drug Label for Phenytoin, Epilepsy Foundation Guidelines.

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:

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.

Lisinopril is anangiotensin-converting enzyme (ACE) inhibitor, commonly used forhypertension (high blood pressure)andheart failure. A well-known side effect of ACE inhibitors is apersistent dry, hacking cough.

The cough is caused bybradykinin accumulation, which occurs due to ACE inhibition.

This coughdoes not respond to cough suppressantsand can be bothersome for patients.

If the cough is severe, thepharmacist may recommend switching to an angiotensin II receptor blocker (ARB) such as losartan, which does not cause this side effect.

B. Purchase fexofenadine for seasonal allergies❌→ No significant interaction between lisinopril and fexofenadine.

C. Mention that they have lowered their cholesterol❌→ Cholesterol levels do not affect lisinopril’s mechanism of action.

D. Report that their blood pressure has been normal lately❌→ This is expected with effective treatment and does not require pharmacist intervention unless the patient wants to discontinue the medication.

PTCB PTCE Exam Content Outline– Covers drug interactions, side effects, and patient counseling.

American Heart Association (AHA) Guidelines– Lists ACE inhibitor side effects, including dry cough.

FDA Lisinopril Medication Guide– Mentions dry cough as a common adverse effect requiring pharmacist consultation.

Why is the Cough Significant?Why Not the Other Options?Key References:

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.

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

????Reference:PTCE Pharmacy Dilution Calculations.

Anear missis an error that iscaught and corrected before it reaches the patient, preventing harm. In this case, the pharmacistidentified that ampicillin was incorrectly entered as amoxicillinandcorrected the error before dispensing, meaning the patient never received the wrong medication.

B. Dispensing error→ Incorrect; adispensing erroroccursonly if the incorrect drug is given to the patient. Since the error was caught before dispensing, it is classified as anear miss.

C. Adverse event→ Incorrect; anadverse eventis aharmful effectexperienced by the patient, which did not happen here.

D. Unauthorized drug→ Incorrect; anunauthorized drugrefers to a drugdispensed without a valid prescription, which is not the case here.

Other Answer Choices Explained:References:

ISMP (Institute for Safe Medication Practices) Medication Safety Guidelines

FDA Medication Error Reporting and Prevention Guidelines

PTCB PTCE Exam Content Outline (Quality Assurance & Medication Safety – Error Prevention)

Comprehensive and Detailed Step-by-Step Explanation:

Hospitals mayredispenseunopened, sealed, unit-dose medicationsreturned frominpatients, as long as they areproperly storedand not tampered with.

????Explanation of Answer Choices:✅C. Unopened units-of-use returned from inpatients may be redispensed→Correct.Hospital pharmacies canredispense sealed unit-dose medications from inpatients.❌A. Unlabeled medications may be dispensed by the nurse at discharge→ Incorrect.Unlabeled meds cannot be dispensed due to safety concerns.❌B. Unopened units-of-use returned from outpatients may be redispensed→ Incorrect.Medications dispensed to outpatients cannot be returned to stock.❌D. Crediting of unused doses is not feasible→ Incorrect.Many hospitals have systems for crediting unused doses.

????Reference:

USP <795> and <797>: Hospital Medication Storage

PTCB Medication Safety Regulations