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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?
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?
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?
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?
According to the law, who is responsible for ensuring the correct labeling occurs during drug substitution?
What must pharmacists include when substituting a generic drug according to the 1994 amendment?
What must pharmacists include when substituting a generic drug according to the 1994 amendment?
What does the 2002 amendment substitute 'shall' with in subsection (A)?
What does the 2002 amendment substitute 'shall' with in subsection (A)?
Which substitution relates to prescriptions that are paid for with Medicaid funds?
Which substitution relates to prescriptions that are paid for with Medicaid funds?
What key term was added to subsection (D) in the 2017 Act?
What key term was added to subsection (D) in the 2017 Act?
What does Section 39-24-50 state about prescriptions issued before the chapter's effective date?
What does Section 39-24-50 state about prescriptions issued before the chapter's effective date?
Which of the following prescriptions can registered pharmacists fill according to Section 39-24-60?
Which of the following prescriptions can registered pharmacists fill according to Section 39-24-60?
In subsection (C), what term was substituted for 'shall'?
In subsection (C), what term was substituted for 'shall'?
What does the 2002 amendment imply about the nature of written prescriptions?
What does the 2002 amendment imply about the nature of written prescriptions?
What change was made in subsection (E) regarding the term 'shall'?
What change was made in subsection (E) regarding the term 'shall'?
What is meant by the term 'therapeutically equivalent' in the context of the Drug Product Selection Act?
What is meant by the term 'therapeutically equivalent' in the context of the Drug Product Selection Act?
Who qualifies as a 'practitioner' under the Drug Product Selection Act?
Who qualifies as a 'practitioner' under the Drug Product Selection Act?
Which of the following best defines 'substitute' as per the Drug Product Selection Act?
Which of the following best defines 'substitute' as per the Drug Product Selection Act?
What does 'generic name' refer to in the context of this law?
What does 'generic name' refer to in the context of this law?
What year was the Drug Product Selection Act established?
What year was the Drug Product Selection Act established?
What can be considered a 'Substitute' under this Act?
What can be considered a 'Substitute' under this Act?
What does the term 'brand name' signify in this context?
What does the term 'brand name' signify in this context?
As per the 2017 amendment, what additional product type was included in the definition of 'substitute'?
As per the 2017 amendment, what additional product type was included in the definition of 'substitute'?
What must a prescription state regarding the substitution of drugs?
What must a prescription state regarding the substitution of drugs?
Which statement is true about the substitution of interchangeable biological products?
Which statement is true about the substitution of interchangeable biological products?
What happens if a prescription is to be paid for with Medicaid funds?
What happens if a prescription is to be paid for with Medicaid funds?
What is required for a written prescription to be valid?
What is required for a written prescription to be valid?
Which of the following is TRUE regarding a written prescription?
Which of the following is TRUE regarding a written prescription?
What must a pharmacist do before substituting a drug?
What must a pharmacist do before substituting a drug?
What is the significance of the pharmacist noting the substituted drug on the prescription file copy?
What is the significance of the pharmacist noting the substituted drug on the prescription file copy?
Which factor does NOT allow for drug substitution?
Which factor does NOT allow for drug substitution?
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.
