NursingLesson 1 of 3 in the course Ethics, Legal Considerations, and Safety

Legal Frameworks for Nursing: Drug Regulation, Privacy, and Licensure

5 flashcards · 4 quiz questions · 5 match pairs · 5 fill-in sentences · English

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Summary

This lesson introduces major federal laws that regulate drugs in the United States. These laws developed in response to unsafe products, misleading claims, and the need to protect the public.

Before 1906, there were few legal controls over drug quality or sales. Products could be sold with undisclosed ingredients and exaggerated claims, sometimes causing harm rather than providing the advertised cure. The Pure Food and Drug Act of 1906, also called the Wiley Act, began federal regulation of interstate drug sales. It emphasized accurate labeling, prohibited certain ingredients, and restricted the interstate sale of contaminated or misbranded foods and drugs. It also established the National Formulary (NF) and the U.S. Pharmacopeia (USP) as standards for products.

All flashcards

What did the Sherley Amendment of 1912 prohibit?
False or misleading claims on drug labels.
What controls did the Controlled Substances Act establish?
Controls on manufacturing, distributing, and prescribing habit-forming drugs, along with drug schedules and treatment-program provisions.
What is interoperability in health information technology?
The ability of health information systems to exchange and use information across settings.
What is the purpose of a nurse practice act?
To set state statutes governing nursing education, licensure, practice, and grounds for discipline.
What are the three primary aims of the Affordable Care Act?
Broaden access to affordable insurance, expand Medicaid, and support care-delivery approaches intended to lower costs.

Quiz questions

  1. What did the Durham-Humphrey Amendment of 1952 authorize the FDA to do?Answer: Distinguish prescription drugs from nonprescription drugs.
  2. Under HIPAA, when may relevant health information generally be shared among providers?Answer: When the providers are treating the client.
  3. What did HITECH seek to encourage through its Meaningful Use incentive program?Answer: Purposeful adoption and use of electronic health records.
  4. A nurse with a multistate license provides care in another participating state. Which practice rules must the nurse follow?Answer: The laws and rules of the state where care is provided.

Based on Pharmacology for Nurses by Tina Barbour-Taylor, Leah Mueller (Sabato), Donna Paris, Dorie Weaver (OpenStax), licensed CC BY 4.0. Adapted into a summary, flashcards and quizzes.

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