Pharmacology · chapter 3 · Ethics, Legal Considerations, and Safety
Legal Considerations
The 14 things this section of the textbook says that you are most likely to be asked about — quoted word for word, not retold. Then 6 practice questions with the reasoning.
Key points
Drug regulation origins
The Pure Food and Drug Act of 1906 controlled the manufacture, labeling, and sale of drugs.
HIPAA protection standards
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.
Privacy Rule scope
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.
HIPAA violation penalties
Individual practitioners and health care institutions may have civil or criminal penalties levied against them for violation of the HIPAA Privacy Rule.
Client confidentiality rights
Each client has the right to confidentiality and to determine who has access to their PHI.
Medication history privacy
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.
PHI disclosure exceptions
There are certain conditions under which PHI can be disclosed without the consent of the client.
HITECH and EHR adoption
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 record s (EHRs) across the United States.
Interoperability program focus
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.
ACA coverage provisions
It also allowed individuals with preexisting conditions to obtain and keep insurance coverage and provided preventive care.
BON public protection
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.
NPA legal scope
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.
Licensure requirements
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.
Student nurse accountability
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.
Terms to know
- Health Insurance Portability and Accountability Act (HIPAA)
- The Health Insurance Portability and Accountability Act (HIPAA) was enacted by Congress in 1996.
- protected health information (PHI)
- 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).
- 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 record s (EHRs) across the United States.
- nurse practice act (NPA)
- Each state and territory within the United States has legislated a nurse practice act (NPA) to create a board of nursing (BON).
- National Council Licensure Examination [NCLEX]
- 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.
Practice questions
Stuck on select-all-that-apply? How to take them one option at a time.
The graded version needs JavaScript. Every question is below anyway, with the answer and why.
Every question here, with the answer
A nurse needs to obtain a client's medication history, including medications that may reveal treatment for specific diseases. Which action best protects the client's legal right to confidentiality?
- Discuss the medication list with a family member who is nearby.
- Ask the client about medications at the nurses' station to save time.
- Delay the medication history because medication information is not protected health information.
- Review the medication list with the client in a private area.
Answer: Review the medication list with the client in a private area.
Medication information can reveal sensitive health information, so the nurse should protect privacy during the discussion. The other actions risk sharing confidential information without the client's express authorization or minimize the confidentiality required when obtaining a medication history.
A nurse is teaching a new employee about when protected health information may be disclosed without the client's consent. Which situations should the nurse include? Select all that apply.
- Providing PHI to an insurance company involved in the client's care.
- Sharing relevant PHI with another provider who is treating the client.
- Releasing PHI in cases of abuse or neglect.
- Releasing PHI when required by law or court order to protect public health.
- Discussing the client's condition in the cafeteria while using the client's name.
Answer: Providing PHI to an insurance company involved in the client's care., Sharing relevant PHI with another provider who is treating the client., Releasing PHI in cases of abuse or neglect., Releasing PHI when required by law or court order to protect public health.
PHI may be shared with treating providers and insurance companies, and it may also be released when required by law or court order for public health protection or in abuse or neglect cases. Discussing a client by name in a cafeteria is a common-area disclosure risk and violates the need to protect confidentiality.
A client asks why current drug approval requires evidence that a medication works, not just that it is safe. Which federal legislation should the nurse identify as first requiring proof of both effectiveness and safety?
- Kefauver-Harris Amendments to the Food, Drug, and Cosmetic Act
- Durham-Humphrey Amendment to the Food, Drug, and Cosmetic Act
- Controlled Substances Act
- Pure Food and Drug Act of 1906
Answer: Kefauver-Harris Amendments to the Food, Drug, and Cosmetic Act
The Kefauver-Harris Amendments were the first to require manufacturers to release proof of a drug's effectiveness as well as safety. The Pure Food and Drug Act focused on labeling and interstate drug sales, the Durham-Humphrey Amendment distinguished prescription from nonprescription drugs, and the Controlled Substances Act addressed controls for habit-forming drugs.
A nurse educator is explaining the Meaningful Use element associated with adoption of electronic health records. Which objectives should the educator include? Select all that apply.
- Replacing the HIPAA Privacy Rule for protected health information.
- Prohibiting drug labels from containing false or misleading information.
- Advancing clinical processes to improve the quality of health care.
- Use of the EHR in a meaningful, significant way.
- Improving client outcomes through the use of quality measures.
Answer: Advancing clinical processes to improve the quality of health care., Use of the EHR in a meaningful, significant way., Improving client outcomes through the use of quality measures.
Meaningful Use objectives included meaningful EHR use, advancing clinical processes, and improving client outcomes through quality measures. It did not replace HIPAA privacy protections, and prohibiting false or misleading drug labels is associated with federal drug-labeling legislation, not Meaningful Use.
A nurse with a multistate license issued in Oklahoma accepts a nursing assignment in Texas. Which statement best reflects the nurse's legal responsibility?
- The nurse must know and follow Texas nursing laws while practicing in Texas.
- The nurse is exempt from state nursing laws because the license is multistate.
- The nurse follows only Oklahoma nursing laws because Oklahoma issued the license.
- The nurse practices under the Texas board of nursing's license while in Texas.
Answer: The nurse must know and follow Texas nursing laws while practicing in Texas.
A multistate license allows practice under a single license, but the nurse remains responsible for knowing and following the laws of the state where care is provided. Renewal and disciplinary actions remain the responsibility of the state issuing the license, but that does not remove the duty to follow the practice state's laws.
A nursing student is preparing for clinical practice and is concerned about safety and accountability. Which actions are consistent with the section's guidelines for students in the practice setting? Select all that apply.
- Performing a procedure outside the student's scope if a staff nurse is busy.
- Ensuring understanding of the educational program's and facility's policies before accepting an assignment.
- Never going to a clinical site while impaired, including from sleep deprivation.
- Seeking assistance if not prepared for a procedure.
- Informing the faculty when unprepared for an assignment.
Answer: Ensuring understanding of the educational program's and facility's policies before accepting an assignment., Never going to a clinical site while impaired, including from sleep deprivation., Seeking assistance if not prepared for a procedure., Informing the faculty when unprepared for an assignment.
Students should inform faculty when unprepared, seek assistance for procedures, avoid clinical practice while impaired, and understand program and facility policies before accepting assignments. Performing outside the scope of practice is specifically prohibited and conflicts with safe, effective client care.
Where every quote comes from
Section 3.1 Legal Considerations of Pharmacology for Nurses by Tina Barbour-Taylor, Leah Mueller (Sabato), Donna Paris, Dorie Weaver, OpenStax, 2024. Read the whole section free at openstax.org.
The textbook is licensed under CC BY-NC-SA 4.0. This page quotes it word for word and adds the headings, the order and the practice questions; references to the book's figures and stray spaces left by its formatting are removed. The page is shared under the same licence. Nothing here is sold.