Podcast
Questions and Answers
What was established by the Good Manufacturing Practices (GMP)?
What was established by the Good Manufacturing Practices (GMP)?
- Requirements for drug efficacy testing
- Guidelines for patient confidentiality
- Controlled substances scheduling
- Standardized processes for drug manufacturing (correct)
Which act regulates the sales of pseudoephedrine and ephedrine-containing products?
Which act regulates the sales of pseudoephedrine and ephedrine-containing products?
- Controlled Substance Act
- Food and Drug Administration Amendments Act
- Child Safety Act
- Combat Methamphetamine Epidemic Act (correct)
What does the Hatch-Waxman Act promote?
What does the Hatch-Waxman Act promote?
- The development of generic drugs (correct)
- The approval of biologics
- The development of new controlled substances
- Strengthening patent protections
Which federal law established requirements for child-resistant packaging?
Which federal law established requirements for child-resistant packaging?
What is one of the main purposes of the Affordable Care Act?
What is one of the main purposes of the Affordable Care Act?
What significant regulatory focus was established by the FDAAA?
What significant regulatory focus was established by the FDAAA?
What is the primary distinction between generic drugs and biosimilar drugs?
What is the primary distinction between generic drugs and biosimilar drugs?
Which book is used to determine the equivalency of generic drugs?
Which book is used to determine the equivalency of generic drugs?
Which factor distinguishes dietary supplements from drugs?
Which factor distinguishes dietary supplements from drugs?
Under which act are dietary supplements regulated?
Under which act are dietary supplements regulated?
What is true about the safety and efficacy of generic drugs?
What is true about the safety and efficacy of generic drugs?
Which of the following is NOT classified as a drug?
Which of the following is NOT classified as a drug?
How do biosimilar drugs relate to their brand-name counterparts?
How do biosimilar drugs relate to their brand-name counterparts?
What do the good manufacturing practices (GMPs) ensure for dietary supplements?
What do the good manufacturing practices (GMPs) ensure for dietary supplements?
Which statement about herbal medicine is correct?
Which statement about herbal medicine is correct?
What identifies whether a drug is a generic or a brand-name product?
What identifies whether a drug is a generic or a brand-name product?
What is one of the general expectations of the profession of pharmacy?
What is one of the general expectations of the profession of pharmacy?
Which option correctly describes a pharmacist's role in drug therapy?
Which option correctly describes a pharmacist's role in drug therapy?
Which regulatory body is primarily responsible for the approval of new drugs?
Which regulatory body is primarily responsible for the approval of new drugs?
What is a correct definition of dietary supplements?
What is a correct definition of dietary supplements?
What is one of the professional expectations of a pharmacist?
What is one of the professional expectations of a pharmacist?
In what context might a pharmacist prescribe medication?
In what context might a pharmacist prescribe medication?
What role does a pharmacist play in health promotion?
What role does a pharmacist play in health promotion?
Which of the following is NOT a responsibility of pharmacists?
Which of the following is NOT a responsibility of pharmacists?
What is a primary focus of pharmacy practice?
What is a primary focus of pharmacy practice?
What must dietary supplements include on their labels according to the law?
What must dietary supplements include on their labels according to the law?
What is one requirement for someone to be licensed as a pharmacist?
What is one requirement for someone to be licensed as a pharmacist?
Which of the following best defines a drug according to the FDA?
Which of the following best defines a drug according to the FDA?
What does the Dietary Supplement and Nonprescription Drug Consumer Protection Act (2006) mandate manufacturers to do?
What does the Dietary Supplement and Nonprescription Drug Consumer Protection Act (2006) mandate manufacturers to do?
Who regulates the advertising of dietary supplements?
Who regulates the advertising of dietary supplements?
What is the minimum passing score for the NAPLEX exam?
What is the minimum passing score for the NAPLEX exam?
Drugs can have various forms. Which of the following is NOT a type of drug?
Drugs can have various forms. Which of the following is NOT a type of drug?
What action can the FDA take if a dietary supplement is found to be unsafe?
What action can the FDA take if a dietary supplement is found to be unsafe?
Which of the following statements is NOT true regarding dietary supplements?
Which of the following statements is NOT true regarding dietary supplements?
How do drugs primarily work within the body?
How do drugs primarily work within the body?
What is the primary focus of federal law in relation to pharmacy?
What is the primary focus of federal law in relation to pharmacy?
What total number of hours of advanced practice experience must be completed to be licensed as a pharmacist?
What total number of hours of advanced practice experience must be completed to be licensed as a pharmacist?
Which option is NOT considered a step in determining when to use or stop a drug?
Which option is NOT considered a step in determining when to use or stop a drug?
How do additional regulations affect dietary supplements?
How do additional regulations affect dietary supplements?
What must manufacturers do if they identify serious side effects from their dietary supplements?
What must manufacturers do if they identify serious side effects from their dietary supplements?
Which of these statements about drug definitions is true?
Which of these statements about drug definitions is true?
Under which circumstance can the FDA take action against dietary supplements?
Under which circumstance can the FDA take action against dietary supplements?
What type of drug cannot be administered orally?
What type of drug cannot be administered orally?
Which statement best describes the relationship between state law and federal law in pharmacy?
Which statement best describes the relationship between state law and federal law in pharmacy?
Which of the following is NOT included as a characteristic of a drug?
Which of the following is NOT included as a characteristic of a drug?
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Study Notes
Pharmacy and Pharmacists
- Pharmacy integrates the preparation, dispensing, and appropriate use of medications alongside clinical drug services such as medication therapy management (MTM).
- Pharmacists play a critical role in drug therapy recommendations, monitoring, health promotion, and occasionally prescribing medications under specific collaborations.
- Pharmacists must be licensed, at least 21 years old, of good moral character, graduates from accredited pharmacy programs, and pass both the NAPLEX and MPJE exams with a minimum score of 75.
- Completion of 1500 hours of advanced practice experience is required for licensure.
Definition of a Drug
- A drug is classified by the FDA as any substance intended for diagnosis, cure, treatment, prevention of disease, or affecting body structure/function.
- Drugs may include small chemical molecules or proteins, and the definition excludes devices and their components.
Mechanism of Action
- Drugs exert their effects by binding to receptors located on or within cells, thus altering physiological processes.
Generic Drugs and Biosimilars
- Generic drugs contain identical active ingredients as brand-name drugs and are typically less expensive.
- Biosimilars are biologic drugs with similar active ingredients to brand-name products, regulated under the FDA's Purple Book for interchangeability.
- The FDA confirms that both generic and biosimilar products are safe and effective if they meet specific criteria.
Dietary Supplements and Herbal Products
- Common dietary supplements can include vitamins and minerals, while herbal products may consist of extracts like ginkgo biloba and turmeric.
- Governed by the Dietary Supplement Health and Education Act (DSHEA, 1994), they are not pre-approved by the FDA before marketing but must follow good manufacturing practices (GMPs).
- Companies can make claims about structural or functional effects but are prohibited from claiming to treat or cure diseases.
Regulation and Safety of Supplements
- Manufacturers must report serious adverse events linked to dietary supplements, and the FDA can take action against unsafe products.
- The Federal Trade Commission (FTC) regulates advertising, ensuring no misleading claims regarding efficacy.
Pharmacy Law Overview
- Federal laws regulate drug availability and efficacy, while state laws dictate pharmacy practice standards.
- Key federal laws include:
- Controlled Substance Act (1970): Establishes drug schedules based on abuse potential.
- Poison Prevention Packaging Act (1970): Mandates child-resistant packaging for certain products.
- Hatch-Waxman Act (1987): Facilitates generic drug approval and strikes a balance between market entry and patent protection.
- HIPAA (1996): Protects patient health information privacy in health care.
Additional Major Federal Laws
- FDA Modernization Act (1997): Streamlines drug approval processes and enhances pediatric drug development.
- Combat Methamphetamine Epidemic Act (2005): Regulates sales of pseudoephedrine-containing products.
- FDA Amendments Act (2007): Increases emphasis on drug safety and post-market surveillance.
- Biologics Price Competition and Innovation Act (2009): Establishes regulatory frameworks for biosimilars and interchangeable biological products.
- Affordable Care Act (2010): Expands healthcare coverage and preventive care measures.
- Comprehensive Addiction and Recovery Act (2016): Boosts efforts in addiction prevention and recovery.
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