Drug Product Selection Act Overview
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Questions and Answers

What must appear on the prescription label when a pharmacist substitutes a generic drug for a brand name drug?

  • Only the name of the brand drug
  • The name of the prescribing practitioner
  • Only the name of the generic drug
  • The brand name, name of the generic drug, and a statement of substitution (correct)

    • What phrase is used to indicate that a pharmacist has substituted an interchangeable biological product?

  • Similar to
  • Generic for
  • Equivalent to
  • Interchangeable with (correct)

    • Under what condition may the name of the drug not appear on the prescription label after a substitution?

  • If the pharmacist deems it unnecessary
  • If the prescribing practitioner specifically requests it (correct)
  • If the drug is a controlled substance
  • If the patient's insurance does not allow it

    • According to the law, who is responsible for ensuring the correct labeling occurs during drug substitution?

    <p>The pharmacist</p> Signup and view all the answers

    What must pharmacists include when substituting a generic drug according to the 1994 amendment?

    <p>The name of the generic drug listed first, followed by 'substituted for' the brand name</p> Signup and view all the answers

    What does the 2002 amendment substitute 'shall' with in subsection (A)?

    <p>An</p> Signup and view all the answers

    Which substitution relates to prescriptions that are paid for with Medicaid funds?

    <p>Substitution is permitted unless specified.</p> Signup and view all the answers

    What key term was added to subsection (D) in the 2017 Act?

    <p>Interchangeable biological product</p> Signup and view all the answers

    What does Section 39-24-50 state about prescriptions issued before the chapter's effective date?

    <p>They are exempt from new provisions.</p> Signup and view all the answers

    Which of the following prescriptions can registered pharmacists fill according to Section 39-24-60?

    <p>Prescriptions from outside the state and U.S. Government prescriptions</p> Signup and view all the answers

    In subsection (C), what term was substituted for 'shall'?

    <p>Must</p> Signup and view all the answers

    What does the 2002 amendment imply about the nature of written prescriptions?

    <p>Written prescriptions can be substituted with verbal approval.</p> Signup and view all the answers

    What change was made in subsection (E) regarding the term 'shall'?

    <p>'Shall' was replaced with 'may'.</p> Signup and view all the answers

    What is meant by the term 'therapeutically equivalent' in the context of the Drug Product Selection Act?

    <p>The same efficacy and toxicity in the same dosage form</p> Signup and view all the answers

    Who qualifies as a 'practitioner' under the Drug Product Selection Act?

    <p>Physicians, veterinarians, or other authorized individuals to prescribe drugs</p> Signup and view all the answers

    Which of the following best defines 'substitute' as per the Drug Product Selection Act?

    <p>Dispensing a therapeutically equivalent generic drug authorized by the practitioner</p> Signup and view all the answers

    What does 'generic name' refer to in the context of this law?

    <p>The official title of a drug as per pharmacopoeia or formulary</p> Signup and view all the answers

    What year was the Drug Product Selection Act established?

    <p>1978</p> Signup and view all the answers

    What can be considered a 'Substitute' under this Act?

    <p>An interchangeable biological product authorized by the practitioner</p> Signup and view all the answers

    What does the term 'brand name' signify in this context?

    <p>The proprietary name used for marketing a drug</p> Signup and view all the answers

    As per the 2017 amendment, what additional product type was included in the definition of 'substitute'?

    <p>Interchangeable biological products</p> Signup and view all the answers

    What must a prescription state regarding the substitution of drugs?

    <p>It must provide authorization from the practitioner for substitution.</p> Signup and view all the answers

    Which statement is true about the substitution of interchangeable biological products?

    <p>Prescriptions for specifics biological products may be substituted with interchangeable products.</p> Signup and view all the answers

    What happens if a prescription is to be paid for with Medicaid funds?

    <p>The directions for substitution are not required.</p> Signup and view all the answers

    What is required for a written prescription to be valid?

    <p>It must contain two signature lines for the practitioner.</p> Signup and view all the answers

    Which of the following is TRUE regarding a written prescription?

    <p>It must have the words 'DISPENSE AS WRITTEN' or 'SUBSTITUTION PERMITTED'.</p> Signup and view all the answers

    What must a pharmacist do before substituting a drug?

    <p>Advise the patient that the practitioner has authorized substitution and obtain their consent.</p> Signup and view all the answers

    What is the significance of the pharmacist noting the substituted drug on the prescription file copy?

    <p>It is a regulatory requirement to ensure accountability.</p> Signup and view all the answers

    Which factor does NOT allow for drug substitution?

    <p>Lack of consent from the patient.</p> Signup and view all the answers

    Study Notes

    Drug Product Selection Act Overview

    • Known as the "Drug Product Selection Act of 1978," established procedures for drug substitution in South Carolina.
    • A pharmacist can substitute a generic drug for a prescribed brand-name drug if permitted.

    Generic Drug Substitution

    • When substituting a generic, the prescription label must display:
      • Brand name of the prescribed drug.
      • Name of the generic drug and its manufacturer.
      • Language such as "generic for" to indicate substitution.
    • Substitution is not permitted if the prescribing practitioner expressly forbids it.

    Interchangeable Biological Product Substitution

    • Pharmacists can substitute an interchangeable biological product for a prescribed specific biological product.
    • The label must include:
      • Brand name of the prescribed biological product.
      • Name of the interchangeable product and its manufacturer.
      • Language such as "interchangeable with" to indicate substitution.
    • Similar to generic drugs, this cannot occur if explicitly prohibited by the prescriber.

    Legislative Amendments

    • The 1994 amendment required the generic name to be listed first on the label when substituting a brand-name drug.
    • The 2002 amendment refined language and designated subsections for clarity on substitution rules, including specifics for Medicaid prescriptions.
    • The 2017 amendment expanded the definitions and provisions for interchangeable biological products.

    Prescription Requirements

    • All written prescriptions must clearly indicate whether substitution is permitted with two signature lines for the prescriber:
      • "DISPENSE AS WRITTEN"
      • "SUBSTITUTION PERMITTED"
    • Oral prescriptions must also specify substitution permissions, documented by the pharmacist.
    • Substitution is only valid if the patient is informed and consents.

    General Definitions

    • Brand Name: Proprietary name on the drug's packaging.
    • Generic Name: Official name recognized by pharmacopoeia.
    • Substitute: Dispensing a therapeutically equivalent generic or interchangeable biological product.
    • Therapeutically Equivalent: Same effect and safety when given in the same dosage form.
    • Practitioner: Includes authorized individuals like physicians, veterinarians, etc.

    Additional Provisions

    • Prescriptions from outside South Carolina and U.S. government prescriptions are still valid under this act.
    • The act has retroactive provisions; however, rules do not apply to prescriptions issued before its effective date unless authorized by the prescriber.

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    Description

    This quiz covers the Drug Product Selection Act of 1978, focusing on regulations regarding generic and interchangeable biological product substitutions in South Carolina. It highlights the labeling requirements for both generic drugs and biological products, as well as the conditions under which substitutions can occur.

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