chapter 2 Study Guide on Legal, Regulatory, and Ethical Aspects of Drug Administration
Legal, Regulatory, and Ethical Aspects of Drug Administration
Learning Outcomes
Describe the legal, regulatory, and ethical responsibilities of a nurse for drug administration.
Explain the meaning of controlled substances (scheduled drugs) and why drugs are placed in this category.
Describe the legal responsibilities for managing controlled substances.
Key Terms
as needed or PRN drug order: An order for a drug to be given as needed based on a nurse's judgment about safety and patient need.
black box warning: A special designation from the FDA indicating that the drug has a higher-than-normal risk for causing serious or life-threatening problems in addition to its positive benefits for some people.
controlled substances: Drugs that are highly regulated because they are commonly abused; also known as scheduled drugs.
emergency or stat drug order: A one-time drug order to be given immediately.
high-alert drugs: Drugs that have the potential to cause significant harm to patients.
legal responsibility: The nurse's authority as defined by the Nurse Practice Act in each state, involving the nurse's judgment and actions while performing professional duties.
Nurse Practice Act: The state law that licenses LPNs/VNs, registered nurses, nurse anesthetists, nurse practitioners, and nurse midwives. This Act describes the minimal educational preparation and professional requirements for performing specific functions including drug administration.
over-the-counter (OTC) drugs: Category of drugs identified by federal legislation that pose a low risk to patients; they may be purchased without a prescription.
physical dependence: The physical symptoms that occur with drug withdrawal (e.g., shaking, increased heart rate, pain, confusion, seizures).
prescription drugs: Drugs regulated by federal legislation because they are considered dangerous and must be controlled; they may be purchased only when prescribed. Examples include antibiotics and oral contraceptives.
prescriptive authority: The authority designated by an individual state determining who is legally permitted to write an order or prescription for drugs.
professional responsibility: The obligation of nurses to perform appropriately, ethically, and to the best of their ability.
psychological dependence: Feelings of anxiety, stress, or tension when access to a medication is restricted.
single drug order: A one-time order to be given at a specified time.
standing drug order: A drug order that indicates the drug is to be given until discontinued or for a specified number of doses.
Introduction
Nurses must fully understand their legal, ethical, and professional responsibilities when administering drugs, as their decisions can significantly affect patient outcomes.
Responsibilities include:
Understanding the drugs administered.
Interpreting drug orders accurately.
Conducting safe medication administration practices.
Engaging in the nursing process related to drug therapy.
Failing to adhere to these responsibilities can lead to drug errors and patient harm.
Ethical considerations include ensuring communication with patients and families, especially regarding mixing drugs with food or drink, which could be viewed as covert drug administration if not disclosed.
Ethical Considerations in Drug Administration
Mixing drugs with food/drink requires:
Informing the patient's provider, patient, and family.
Documenting this practice in the patient's care plan.
Checking drug handbooks for contraindications (e.g., grapefruit juice).
Drug Administration Errors
Legal and ethical issues such as drug diversion (the illegal transfer of regulated drugs) lead to significant risks in patient safety.
Nurse responsibilities include reporting suspected drug diversion.
Signs of impaired nurses may include:
Increased absences or lateness.
Unexplained disappearances.
Decreased alertness.
Patient reports of unmanaged pain despite drug administration.
Regulation of Drug Administration
Nurses must adhere to three levels of drug administration rules:
Federal laws: Control how certain drugs are administered.
State laws: Define prescriptive authority and drug administration processes.
Agency rules: Outline specific guidelines for drug delivery and recordkeeping.
Federal Laws on Drug Administration
The US Food and Drug Administration (FDA) monitors the testing, approval, and marketing of drugs, making U.S. drugs among the safest globally.
Legislation defines three drug categories:
Controlled substances: Includes opioids and certain sedatives.
Prescription drugs: Dangerous drugs requiring a medical prescription (e.g., antibiotics).
Over-the-counter (OTC) drugs: Low-risk drugs available without prescriptions.
Understanding Substance Abuse and Misuse
Substance abuse is harmful use of psychoactive substances, while drug misuse refers to inappropriate use or taking prescribed drugs differently than intended.
Substance use disorders occur when chronic drug use interferes with responsibilities.
Controlled Substances
The Controlled Substances Act of 1970 classifies drugs into five schedules based on their abuse potential and medical utility (e.g., Schedule I drugs like heroin have no accepted medical use).
Possession of controlled substances without a prescription is illegal, and all states provide guidelines on who can prescribe.
Schedule of Controlled Substances
Schedule I: High potential for abuse; no accepted medical use (e.g., heroin).
Schedule II: High potential for abuse; medical use accepted (e.g., opioids).
Schedule III: Moderate potential for abuse; medical use accepted (e.g., certain combination drugs).
Schedule IV: Lower potential for abuse; medical use accepted (e.g., benzodiazepines).
Schedule V: Lowest potential for abuse; medical use accepted (e.g., cough medicine with codeine).
Legal Responsibilities in Drug Administration
Nurses and healthcare providers are legally accountable for the administration of controlled substances under their state Nurse Practice Acts.
Controlled substances must be counted and recorded correctly, stored securely, and monitored for potential abuse.
Nurses must adhere strictly to federal, state, and institutional regulations regarding controlled substances to avoid penalties such as fines or loss of licensure.
Distribution and Storage of Controlled Substances
Distribution: Controlled substances are ordered in single doses and must be verified upon receipt.
Storage: Stored in double-locked cabinets; keys must be secured. Nurses responsible for access must count them at each shift change.
Documentation: All doses must be recorded, and discrepancies must be accounted for with explanations.
Prescription Drugs
Governed by the Federal Prescription Drug Marketing Act (1987).
Only licensed professionals can prescribe, and misuse leads to adverse interactions.
Older adults are particularly at risk for negative interactions.
Over-the-Counter Drugs
OTC drugs are available for minor ailments but can still cause adverse reactions.
Always offer guidance on safe usage and potential interactions with other drugs.
Canadian Drug Legislation
The Health Products and Food Branch of Canada parallels the FDA, regulating drug safety and efficacy.
Recognizes categories of drugs: non-prescription, prescription, and restricted drugs, along with the need for proper handling of such substances.
The Drug Order: Legal Prescriptions
Prescriptions must include patient information, drug name, dosage, route, signature, and any special instructions.
Legal authority for prescriptions is granted only to licensed professionals.
Types of Drug Orders
Standing order: Continuous until cancelled.
Emergency/stat order: Immediate action required.
Single drug order: Administered at a specific time.
As needed (PRN) order: Administered when required.
Verbal Orders
Must be documented correctly and co-signed by the prescriber within 24 hours.
The Nine Rights of Drug Administration
Check patient's identity, drug, dose, route, time, reason, documentation, and response.
Patients have the right to refuse medications.
Reporting Drug Errors
All medication errors must be reported regardless of perceived severity.
Immediate patient assessment, provider notification, and adherence to agency protocols for reporting are crucial.
The Importance of Technology in Drug Administration
Adoption of electronic medical records (EMR), barcode scanning, and computerized order entry enhances safety and reduces errors.
The Role of The Joint Commission (TJC)
TJC promotes safety standards by discouraging ambiguous abbreviations and introducing measures to reduce medication errors.
High-Alert Drugs
High-alert drugs pose serious risks for errors and require meticulous monitoring.
These drugs are often associated with black box warnings from the FDA, requiring heightened awareness from the administering nurse.
Medication Reconciliation
The process compares a patient’s drug orders with their current medications to avoid errors during transitions of care.
Conclusion
Nurses must understand and comply with both the legal and ethical dimensions of drug administration.
Continuous education about laws, regulations, and the latest healthcare practices is imperative for all nurses, ensuring patient safety and effective care delivery.