Pass the PTCB CPhT PTCE Questions and answers with CertsForce

Comprehensive and Detailed Step-by-Step Explanation:

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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

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)

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:

FDA recall classifications are defined by the likelihood and severity of health consequences:

• Class I: Reasonable probability that use/exposure will cause serious adverse health consequences or death (e.g., microbial contamination of a sterile product or a life-threatening wrong drug situation).

• Class II: May cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse consequences is remote.

• Class III: Not likely to cause adverse health consequences; often labeling or packaging issues that do not impact safety/efficacy.

For nystatin suspension:

• Bacterial contamination (A) or fungal contamination (C) represents a clinically significant contamination with potential for harm—this aligns with Class I (or Class II in some limited contexts depending on product/route), but certainly not Class III.

• Wrong active ingredient present (B) (e.g., presence of carbamazepine) is a serious error that can cause significant harm and is typically Class I.

• Incorrect lot number on the label (D) is a labeling defect not likely to cause adverse health consequences, aligning with a Class III recall.

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:

DEA requires allcontrolled substance prescriptionsto include thedate of issueas per21 CFR 1306.05(a).

Other required elements:

Patient’s full name and address

Drug name, strength, dosage form, quantity

Directions for use

Prescriber’s name, address,DEA number, and signature

????Reference:DEA Controlled Substance Act;21 CFR 1306.05.

Pharmacy technicians may collect and relay information as part of supportive roles but do not interpret, assess, or make clinical decisions. Reporting out-of-range lab values to the pharmacist (B) is appropriate. Determining dosages (A), identifying potential interactions (C), and recommending diagnostic tests (D) are clinical judgment activities reserved for the pharmacist or prescriber.

References (Pharmacy Technician documents/Study Guides):

• ASHP Model Curriculum/Scope of Practice for Pharmacy Technicians—roles include data collection and communication, not clinical decision-making.

• PTCB/ExCPT study guides—delineation of technician vs. pharmacist responsibilities (technician: gather/report; pharmacist: evaluate/assess/decide).

• Pharmacy operations policy examples on technician duties in monitoring programs.

Varenicline is a partial agonist at α4β2 nicotinic acetylcholine receptors indicated for smoking cessation to aid in quitting tobacco use. It is not indicated for ulcerative colitis, seasonal affective disorder, or sleepwalking.

References (Pharmacy Technician documents/Study Guides):

• FDA-approved indications for varenicline; pharmacology overview in technician certification guides.

• PTCB/ExCPT drug indications: smoking cessation therapies (varenicline, bupropion SR, NRTs).

• Standard pharmacy references on CNS agents used for tobacco cessation.

Pharmacy technicians in certain states may initiate the transfer of non-controlled prescriptions under pharmacist supervision.

Controlled substance transfers MUST be done by pharmacists.

????Reference:State Board of Pharmacy Regulations.