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CPhT — Certified Pharmacy Technician (NHA)

Prepare for CPhT — Certified Pharmacy Technician (NHA) with practice questions covering 43 topics. Build your knowledge, track your progress, and study effectively with AH Prep.

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What’s in it.

6 units

Sample questions

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A few questions from this module, with the answer and a full explanation. The complete bank is available when you start practising.

  1. What is the Hatch-Waxman Act and what did it establish for the generic drug industry?

    • The Prescription Drug User Fee Act of 1992, which authorised FDA to collect fees from manufacturers for drug reviews
    • The Biologics Price Competition and Innovation Act of 2010, which created the biosimilar approval pathway
    • The Drug Price Competition and Patent Term Restoration Act of 1984, which created the ANDA pathway for generic drug approval via bioequivalence and established patent/exclusivity protections for innovator drugs
      Correct answer
    • The Safe Drugs for Children Act of 1997, which established paediatric exclusivity incentives only
    Explanation

    The Drug Price Competition and Patent Term Restoration Act of 1984, commonly called the Hatch-Waxman Act, created the modern ANDA framework for generic drug approval via bioequivalence, established patent term extensions for innovator drugs, and created multiple exclusivity periods (5-year NCE exclusivity, 3-year clinical investigation exclusivity, etc.) to balance innovation incentives with access to affordable generics. Key takeaway: The Hatch-Waxman Act (1984) is the law that created the ANDA pathway and the modern framework for generic drug competition.

  2. What is profile-based dispensing and why is it the preferred ADC safety model?

    • A dispensing method that relies on the prescriber entering orders directly into the ADC
    • A workflow in which medications are accessible only after pharmacist verification; it prevents access to unverified orders
      Correct answer
    • A feature that allows nurses to override the ADC using a patient's medical record number
    • A configuration that limits the ADC to dispensing only Schedule II controlled substances
    Explanation

    Profile-based dispensing is the ADC workflow in which medications are only accessible after the pharmacist has verified the order in the pharmacy information system. The nurse then selects from that patient's verified profile. This is the preferred safety model because it ensures every medication dispensed from the ADC has been reviewed for appropriateness, drug interactions, and dosing. Key takeaway: Profile-based dispensing links ADC access to pharmacist-verified orders, making it the safest dispensing model.

  3. During LAFW certification, the certifier performs a DOP (dioctyl phthalate) or PAO (poly-alpha olefin) challenge test. What does this test specifically evaluate?

    • The integrity of the HEPA filter, verifying that there are no pinholes, cracks, or bypass leaks that would allow unfiltered air to reach the work surface
      Correct answer
    • The airflow velocity at the work surface to confirm it meets minimum feet-per-minute specifications
    • The viable (microbial) contamination level on the LAFW work surface using contact plates
    • The temperature uniformity across the HEPA filter face to detect hot spots
    Explanation

    The DOP (dioctyl phthalate) or PAO (poly-alpha olefin) aerosol challenge test, also called the HEPA filter integrity test or smoke test, is specifically designed to detect physical defects in the HEPA filter. A known concentration of aerosol is introduced upstream of the filter; a photometer or particle counter then scans the downstream side for any aerosol penetration. A penetration level above the defined threshold indicates a defect (pinhole, frame leak, or bypass). Airflow velocity and ISO 5 particle counts are measured separately using different methods. Key takeaway: DOP/PAO challenge = HEPA filter integrity test; detects pinholes and bypasses that would allow unfiltered air to penetrate the filter.