3.1 Legal Considerations

Federal laws and regulations form the backbone of drug safety and healthcare practices in the US. From the Food, Drug, and Cosmetic Act to HIPAA, these laws ensure drug efficacy, patient privacy, and controlled substance management.

State regulations and nursing practice guidelines further refine healthcare delivery. Nurse Practice Acts and State Boards of Nursing define scope of practice, licensure requirements, and disciplinary actions, tailoring regulations to each state's needs.

Federal Laws and Regulations

Federal laws for drug safety

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  National Center for Immunization and Respiratory Diseases - Wikipedia View original

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• Food, Drug, and Cosmetic Act (FDCA) of 1938 requires drug manufacturers to prove to the FDA that a drug is safe before it can be sold and prohibits the sale of misbranded or adulterated drugs (e.g., counterfeit or contaminated medications)
• Durham-Humphrey Amendment of 1951 defines the kinds of drugs that cannot be used safely without medical supervision (prescription drugs) and restricts their sale to prescription by a licensed practitioner (e.g., physician, dentist, veterinarian)
• Kefauver-Harris Amendment of 1962 requires drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval, mandates drug advertising to disclose accurate information about side effects, and requires generic drugs to be bioequivalent to brand-name counterparts (e.g., same active ingredients, dosage form, and strength)
• Controlled Substances Act (CSA) of 1970 classifies drugs with the potential for abuse into five schedules based on their medical use, potential for abuse, and safety (Schedule I: high abuse potential and no accepted medical use, to Schedule V: low abuse potential and accepted medical use) and regulates the manufacture, importation, possession, use, and distribution of controlled substances (e.g., opioids, stimulants, depressants)
• Health Insurance Portability and Accountability Act (HIPAA) of 1996 protects the privacy and security of individuals' identifiable health information (e.g., name, address, date of birth, Social Security number) and establishes national standards for electronic health care transactions and national identifiers for providers, health insurance plans, and employers

State Regulations and Nursing Practice

State nursing regulations

• Nurse Practice Acts (NPAs) are legislation enacted by each state to regulate nursing practice, define the scope of nursing practice, set requirements for licensure, and establish grounds for disciplinary action (e.g., negligence, substance abuse, criminal convictions)
• State Boards of Nursing (BONs) are regulatory bodies that oversee the practice of nursing in each state by:
  1. Issuing and renewing nursing licenses
  2. Establishing standards for nursing education programs
  3. Investigating complaints against nurses
  4. Taking disciplinary action against nurses who violate the NPA or other regulations (e.g., license suspension, revocation, fines)
• Scope of Practice is defined by each state's NPA and BON regulations, outlines the tasks, procedures, and actions that licensed nurses are permitted to perform (e.g., medication administration, wound care, patient education), and varies by state and type of nursing license (RN, LPN/LVN, APRN)

Legal Responsibilities of Nursing Students

Legal duties of nursing students

• Follow the policies and procedures of the clinical facility (e.g., infection control, patient safety protocols)
• Adhere to the standards of nursing practice and the student's scope of practice as defined by the state's NPA and BON
• Maintain patient confidentiality and privacy in accordance with HIPAA regulations (e.g., not discussing patient information in public areas, securing electronic health records)
• Report any errors, incidents, or near-misses to clinical instructors and appropriate facility staff (e.g., medication errors, falls, equipment malfunctions)
• Obtain informed consent from patients before performing procedures or treatments, ensuring they understand the risks, benefits, and alternatives
• Document all patient care activities accurately and completely in the patient's medical record (e.g., assessments, interventions, patient responses)
• Recognize personal limitations and seek guidance from clinical instructors when unsure about a task or procedure to ensure patient safety
• Maintain professional boundaries with patients and staff, avoiding inappropriate personal or financial relationships
• Engage in safe medication administration practices by:
  1. Verifying the "five rights" of medication administration: right patient, drug, dose, route, and time
  2. Checking for allergies and potential drug interactions
  3. Documenting medication administration accurately in the patient's medication administration record (MAR)

Legal Concepts in Nursing

Understanding legal liability

• Malpractice: A form of professional negligence where a healthcare provider fails to meet the standard of care, resulting in harm to the patient
• Negligence: Failure to exercise reasonable care, leading to harm or injury to another person
• Standard of care: The level of care that a reasonably competent healthcare professional would provide under similar circumstances
• Liability: Legal responsibility for one's actions or omissions that may result in harm to others
• Tort law: The area of law that deals with civil wrongs, including negligence and malpractice cases in healthcare