Pharmacy Profession Overview

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Questions and Answers

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?

Controlled Substance Act

Food and Drug Administration Amendments Act

Child Safety Act

Combat Methamphetamine Epidemic Act (correct)

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?

Poison Prevention Packaging Act Signup and view all the answers

What is one of the main purposes of the Affordable Care Act?

To expand healthcare coverage and preventive care Signup and view all the answers

What significant regulatory focus was established by the FDAAA?

Increased drug safety and pharmacovigilance Signup and view all the answers

What is the primary distinction between generic drugs and biosimilar drugs?

Generic drugs contain small molecules, while biosimilars are biologic products. Signup and view all the answers

Which book is used to determine the equivalency of generic drugs?

FDA Orange Book Signup and view all the answers

Which factor distinguishes dietary supplements from drugs?

Dietary supplements can make claims about their effects on body structure or function. Signup and view all the answers

Under which act are dietary supplements regulated?

Dietary Supplement Health and Education Act Signup and view all the answers

What is true about the safety and efficacy of generic drugs?

The FDA requires generic drugs to meet certain criteria for safety and efficacy. Signup and view all the answers

Which of the following is NOT classified as a drug?

Ginkgo biloba extract Signup and view all the answers

How do biosimilar drugs relate to their brand-name counterparts?

They have a similar active ingredient and share similar safety and efficacy outcomes. Signup and view all the answers

What do the good manufacturing practices (GMPs) ensure for dietary supplements?

That they are made to quality standards during manufacturing. Signup and view all the answers

Which statement about herbal medicine is correct?

Herbal medicine comprises common herbs used in traditional practices. Signup and view all the answers

What identifies whether a drug is a generic or a brand-name product?

The use of the FDA Orange Book for equivalency. Signup and view all the answers

What is one of the general expectations of the profession of pharmacy?

Conducting drug therapy monitoring Signup and view all the answers

Which option correctly describes a pharmacist's role in drug therapy?

Reviews appropriate drug use and recommends therapies Signup and view all the answers

Which regulatory body is primarily responsible for the approval of new drugs?

Food and Drug Administration (FDA) Signup and view all the answers

What is a correct definition of dietary supplements?

Products meant to supplement the diet but not regulated like drugs Signup and view all the answers

What is one of the professional expectations of a pharmacist?

To engage in research and provide medication consultations Signup and view all the answers

In what context might a pharmacist prescribe medication?

Under collaborative agreements with healthcare providers Signup and view all the answers

What role does a pharmacist play in health promotion?

They advise on vaccination and health-related decisions Signup and view all the answers

Which of the following is NOT a responsibility of pharmacists?

Preparing medications only in retail settings Signup and view all the answers

What is a primary focus of pharmacy practice?

Ensuring the safe and effective use of medications Signup and view all the answers

What must dietary supplements include on their labels according to the law?

This statement has not been evaluated by the FDA. Signup and view all the answers

What is one requirement for someone to be licensed as a pharmacist?

Must have graduated from an accredited School of Pharmacy Signup and view all the answers

Which of the following best defines a drug according to the FDA?

A component meant for use in diagnosing or treating diseases Signup and view all the answers

What does the Dietary Supplement and Nonprescription Drug Consumer Protection Act (2006) mandate manufacturers to do?

Report serious adverse events to the FDA. Signup and view all the answers

Who regulates the advertising of dietary supplements?

the FTC Signup and view all the answers

What is the minimum passing score for the NAPLEX exam?

75 points Signup and view all the answers

Drugs can have various forms. Which of the following is NOT a type of drug?

Devices that assist in drug delivery Signup and view all the answers

What action can the FDA take if a dietary supplement is found to be unsafe?

Issue a warning letter. Signup and view all the answers

Which of the following statements is NOT true regarding dietary supplements?

They must show efficacy in treating diseases to be marketed. Signup and view all the answers

How do drugs primarily work within the body?

By binding to receptors on or inside cells Signup and view all the answers

What is the primary focus of federal law in relation to pharmacy?

Regulating the availability of drugs in the US. Signup and view all the answers

What total number of hours of advanced practice experience must be completed to be licensed as a pharmacist?

1500 hours Signup and view all the answers

Which option is NOT considered a step in determining when to use or stop a drug?

Evaluating moral character Signup and view all the answers

How do additional regulations affect dietary supplements?

They increase the potential for adverse drug reactions. Signup and view all the answers

What must manufacturers do if they identify serious side effects from their dietary supplements?

Report them to the FDA immediately. Signup and view all the answers

Which of these statements about drug definitions is true?

Not all substances affecting body function are considered drugs Signup and view all the answers

Under which circumstance can the FDA take action against dietary supplements?

If the product is found unsafe or violates laws. Signup and view all the answers

What type of drug cannot be administered orally?

Proteins (peptides) Signup and view all the answers

Which statement best describes the relationship between state law and federal law in pharmacy?

Stricter regulations from either state or federal must be followed. Signup and view all the answers

Which of the following is NOT included as a characteristic of a drug?

Only for enhancing athletic performance Signup and view all the answers

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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Description

This quiz focuses on the essential aspects of the pharmacy profession, including the qualifications and expectations for pharmacists. It also covers the definition of drugs and the regulatory processes involved in drug approval. Ideal for students in PHAR 672, this quiz will enhance your understanding of pharmacy fundamentals.