Tina Barbour-Taylor; Leah Mueller (Sabato); Donna Paris; Dorie Weaver

Learning Outcomes

By the end of this section, you should be able to:

3.1.1 Discuss federal legislative acts affecting nursing.
3.1.2 Describe the function of state nurse practice acts.

Federal Legislative Acts

Prior to 1906, there were no legal controls over the sale or quality of any drugs. Before this time, rattlesnake oil for pain and inflammation and other tonics could be sold out of the back of a covered wagon, a general store, or a doctor’s office. There was nothing in place to protect the consumer from fraud or harm. The manufacturers were not required to list any of the ingredients in their elixirs, pills, or potions. It was not unusual for the medicine sold to ultimately cause harm rather than provide the cure that was advertised.

The Pure Food and Drug Act of 1906 controlled the manufacture, labeling, and sale of drugs. Although the law emphasized the importance of accurate labeling, it also prohibited certain ingredients from being used within drugs. It also prohibited contaminated or misbranded foods and drugs for either humans or animals from being sold across state lines (Petruzzello, 2023). It also established the National Formulary (NF) and the U.S. Pharmacopeia (USP) as the standards for such products. A brief description of important federal legislation is provided in Table 3.1.

Year	Law	Purpose
1906	Pure Food and Drug Act (also known as the Wiley Act)	Initiated government regulation of interstate drug sales Led to the creation of a government agency that would later become the Food and Drug Administration (FDA) Focused on accurate product labeling
1912	Sherley Amendment to the Pure Food and Drug Act	Prohibited drug labels from containing false or misleading information
1938	Food, Drug, and Cosmetic Act	Addressed drug safety Required drug manufacturers to test all drugs for harmful effects, though it did not mandate that drugs be effective Required that labels indicate if a drug was habit-forming
1952	Durham-Humphrey Amendment to the Food, Drug, and Cosmetic Act	Gave the FDA the power to distinguish between prescription and nonprescription drugs
1962	Kefauver-Harris Amendments to the Food, Drug, and Cosmetic Act	For the first time, this act required drug manufacturers to release proof of a drug’s effectiveness as well as its safety Established new guidelines for reporting adverse effects and contraindications of drugs
1970	Controlled Substances Act	Led to the establishment of the Drug Enforcement Administration (DEA) in 1973 Delineated the controls for manufacturing, distributing, and prescribing habit-forming drugs Established drug schedules and provided drug treatment programs for individuals with substance use disorders
1994	Dietary Supplement Health and Education Act	Reclassified herbal medicines, vitamins, minerals, amino acids, and other chemicals used for health purposes as “dietary supplements”
2013	Drug Supply Chain Security Act	Outlined steps to trace drug products at the package level to identify and trace certain prescription drugs distributed across the United States Established national licensure standards for wholesale distributors

Table 3.1 Summary of Federal Legislation Regarding the Safety of Medications in the United States

Other important federal legislation impacting health care in the United States include the Health Insurance Portability and Accountability Act (HIPAA), the Health Information Technology for Economic and Clinical Health (HITECH) Act, and the Affordable Care Act (ACA).

Health Insurance Portability and Accountability Act (HIPAA)

The Health Insurance Portability and Accountability Act (HIPAA) was enacted by Congress in 1996. It is a federal law that set forth standards to protect sensitive health information from being divulged without the consent or knowledge of the client. Its purpose was to:

Establish the Privacy Rule
Establish the Security Rule for protecting electronic health information
Ensure that covered entities report and resolve any breaches in security

This discussion will focus on the Privacy Rule, which protects a client’s individually identifiable health information no matter what form the information is in—oral, written, or transmitted. The Privacy Rule designates this information as protected health information (PHI) and essentially covers any data by which the individual can be identified (name, date of birth, Social Security number, address, phone number, etc.) in relation to their health condition, provision of health care, or payment (past, present, and future) (U.S. Department of Health and Human Services, 2021). It allows PHI to be shared between health care providers and insurance companies to provide high-quality health care. Individual practitioners and health care institutions may have civil or criminal penalties levied against them for violation of the HIPAA Privacy Rule. Nurses should be alert to situations in which violations might occur, such as discussions in common areas where one might be overheard, inappropriate use of social media, or deliberate violations where one intentionally discloses personal information. In cases of deliberately violating the Privacy Rule, the penalties to the health care worker and the institution can be quite severe.

Each client has the right to confidentiality and to determine who has access to their PHI. Health care providers should not share confidential information obtained from the client with others without their express authorization. Once the nurse obtains the client’s health information (biographical information, chief complaint, medical and surgical history, medications and allergies, family history, social history, signs and symptoms of present illness, and physical assessment), the nurse should ascertain how it is to be treated and who will be given access to it. Confidentiality should still be observed when obtaining a medication history because some medications will reveal the treatment of specific diseases; for example, if a client is taking carbidopa/levodopa, they likely have Parkinson’s disease. However, an incorrect assumption could also be made. Aripiprazole (Abilify) is used for the treatment of psychosis; however, it also treats depression. The nurse should not assume that the client has schizophrenia or psychosis because they have been prescribed that drug. When reviewing medication information with the client, it is important to protect the client’s privacy by providing a private area for the discussion. The U.S. Department of Health and Human Services provides more information about how HIPAA affects health care professionals.

There are certain conditions under which PHI can be disclosed without the consent of the client. The information may be given to other providers who are treating the client, as well as insurance companies, but it also can be released if required by law or a court order for the intent of protecting public health or in cases of abuse or neglect.

Clinical Tip

HIPAA

Nurses should take HIPAA concerns very seriously. No PHI should be shared unless it is on a “need-to-know” basis. Information should be shared only in secure locations. Be alert to situations where information could be overheard unintentionally, such as in elevators or the cafeteria.

Health Information Technology for Economic and Clinical Health (HITECH) Act

The Health Information Technology for Economic and Clinical Health (HITECH) Act was enacted in 2009 to improve the efficiency and quality of care for clients through the adoption of electronic health records (EHRs) across the United States. Prior to the adoption of the EHR, records were handwritten or typed notes by providers, which were then stored in paper files in a medical records department. The HITECH Act also had a meaningful use (MU) element whose purpose was to provide an incentive for institutions and providers to adopt the EHR. In the beginning, the Centers for Medicare and Medicaid Services (CMS) provided financial incentives to physicians, and then physicians proved MU by reporting clinical quality measures for the purpose of improving client outcomes (Brooks et al., 2022). CMS had several objectives for MU:

Use of the EHR in a meaningful, significant way
Advancing clinical processes to improve the quality of health care
Improving client outcomes through the use of quality measures

In 2018, CMS renamed the Meaningful Use program to the Promoting Interoperability Program. This expanded the focus to the interoperability of EHRs with the goal of improving client access to health information, health information exchange among health care providers, and data collection.

Approximately 98% of hospitals have adopted some type of EHR, regardless of whether it would be described as basic or comprehensive (Apathy et al., 2021). The adoption of EHRs and the use of health information technology (HIT) has presented several challenges, including cost, usability, and a lack of interoperability. The Office of the National Coordinator for Health Information Technology is a U.S. government organization that has developed various strategies to assist with the burden related to HIT and to help agencies, institutions, and clinicians become more efficient through the use of technology.

The addition of the electronic medication administration record is an important component of the EHR, and many institutions now use e-prescriber or computerized prescriber order entry (CPOE). This is discussed more in the last section of this chapter.

The Affordable Care Act (ACA)

President Barack Obama signed the Affordable Care Act (ACA) into law in 2010. This law (sometimes called Obamacare) had three primary aims:

Make health insurance available and affordable to more Americans
Expand the Medicaid program by expanding the federal poverty level
Support innovative medical care delivery methods with the objective of lowering health care costs (HealthCare.gov, n.d.)

The ACA prohibited insurance companies from charging excessive amounts for premiums and contained measures to ensure that the consumer received value for the cost of their premiums. It raised the age limit to 26 years of age for children to continue to be covered by a parent’s insurance. It also allowed individuals with preexisting conditions to obtain and keep insurance coverage and provided preventive care. Under the ACA, there are medications with limited cost-sharing; these drugs are covered with little to no copay. Some of these medications include contraceptives, vaccines, aspirin, statins, tobacco cessation products, and breast cancer primary prevention drugs. This law was considered controversial when passed and has undergone several changes since 2010; however, many Americans consider the ACA positively (Kaiser Family Foundation [KFF], 2023). Although many more Americans are now insured, unfortunately, 27.5 million individuals in the United States still do not have insurance coverage (Tolbert et al., 2022).

State Nurse Practice Acts

All clients have the right to safe, competent nursing expertise. Each state and territory within the United States has legislated a nurse practice act (NPA) to create a board of nursing (BON). The focus of a BON is to protect and promote the welfare of the public across the state, and it is responsible for implementing and enforcing the NPA. It does so by ensuring that each person licensed to practice as a nurse is competent to practice. For an individual to become licensed, they must meet the minimum competencies set forth by each board. The NPA is a series of state statutes that contains the laws related to prospective nurses and the nurses’ education, licensure, practice, and grounds for disciplinary actions.

Each BON sets the educational standards for all nursing programs across the state, which prepares individuals to become licensed registered nurses. This includes prelicensure programs as well as advanced practice. All applicants must complete specific educational requirements, pass a national licensing exam (the National Council Licensure Examination [NCLEX]), and obtain clearance through a background check that looks for any criminal conviction that might make the applicant unfit for licensure. Criminal conviction may or may not disqualify an individual from being licensed as a nurse; most states decide on a case-by-case basis, depending on the crime. Some states require proof of continuing competency for licensure renewal. This might be in the form of a certain number of hours of continuing education in the area of the nurse’s practice or a national nursing certification. There are many board-recognized credentialing agencies and providers.

Link to Learning

State Boards of Nursing

As mentioned above, each state and territory within the United States has legislated a nurse practice act to create a board of nursing or like entity. Find the board of nursing for the state where you hope to practice after completing nursing training. Click on the individual state board of nursing site to familiarize yourself with the information available. Compare and contrast the different sites.

Most BONs were established about 100 years ago and have evolved over time. Many BONs have expanded their scope and now provide remediation for licensed nurses who have had some type of practice issue. The BON monitors compliance with the NPA and state laws. It is responsible for taking action against nurses who are unsafe or have engaged in professional misconduct.

State BONs often participate in multistate licensure compacts and may even act as a forum for individuals to report concerns about specific nursing services they have received. The states and territories that participate in these nurse licensure compacts allow a nurse to practice under a single license; for example, an individual holding a multistate license in Oklahoma is able to practice in Texas. Renewal and disciplinary actions are the responsibility of the state issuing the license (Oklahoma, in this case); however, the nurse is responsible for knowing and following the laws of the state in which they are practicing (Texas, in this example).

NPAs typically allow nursing students to practice nursing while under the auspices of an accredited nursing education program and under the supervision of qualified nursing faculty. Student nurses do not practice on a faculty member’s license. Each nursing student is responsible for answering for any action they have taken and are held accountable to the same standards as a licensed nurse.

Strategies for Students in the Practice Setting

The nurse’s primary responsibility is safe, effective care of the client. Understanding the expectations of faculty, the institution, and the BON is important for the nursing student. Some common guidelines for clinical practice that may be helpful to the student include:

Providing safe, effective nursing care.
Ensuring understanding of the educational program’s and facility’s policies before accepting any assignment.
Demonstrating knowledge of the client’s disease process, medications, nursing interventions, and plan of care.
Informing the faculty when unprepared for an assignment.
Seeking assistance if not prepared for a procedure (Callahan, 2023).
Never practicing outside their scope of practice.
Never going to a clinical site while impaired (this includes sleep deprivation).
Being accountable for learning.
Recognizing the limitations of their knowledge.

3.1 Legal Considerations