pharm legal notes
Learning Objectives in Drug Administration
Legal, Regulatory and Ethical Responsibilities: Nurses are responsible for understanding and fulfilling their legal, regulatory, and ethical obligations concerning drug administration.
Controlled Substances: The definition and categorization of controlled substances, known as scheduled drugs, along with the rationale for their classification.
Legal Responsibilities for Controlled Substances: Clear delineation of the legal parameters surrounding the management of controlled substances.
Information for Legal Drug Orders
Requirements for a Legal Drug Order or Prescription: Overview of the essential information required to create a legal drug order or prescription.
Types of Drug Orders: Identification and description of four distinct types of drug orders within healthcare.
Response to Drug Errors: Procedures to follow in the event of a medication error, outlining accountability and corrective steps.
Pharmacology and Regulations
Federal Guidelines: Guidelines established by the federal government regarding medication management and nursing practices.
State Guidelines: Regulations defined by the Board of Nursing at the state level impacting nursing practices.
Facility Guidelines: Specific rules and procedures established by individual healthcare facilities where nurses practice.
Federal Laws and Drug Categories in the United States
Regulatory Categories:
Controlled (Scheduled) Substances: Drugs that have a high potential for abuse, are dangerous, and require a prescription for legality of use.
Prescription Drugs (Legend Drugs): Drugs that necessitate a prescription but are not inherently classified as easily abused substances.
Over-the-Counter (OTC) Medications: Medications that can be purchased without a prescription by consumers.
Controlled Substances
Abuse and Regulation of Controlled Substances: Extensive regulations exist primarily for controlled substances due to their potential for abuse among patients and illicit users. The Controlled Substances Act of 1970 established five schedules categorizing these drugs, now referred to as scheduled drugs. Under both federal and state regulations, possessing controlled substances without a prescription is illegal.
Possession by Nurses: Nurses may only possess controlled substances if:
They are administering the drug to the patient it was prescribed for.
They are the patient for whom the medication has been legally prescribed.
They have been designated responsibility for the unit supply of the medication.
Violations of the Controlled Substance laws can result in severe penalties, including fines and imprisonment.
Distribution of Controlled Substances and Drugs
Ordering from the Pharmacy: The procedure for ordering drugs from the pharmacy involves:
Receiving drugs in single-dose units or prefilled syringes along with a special inventory record.
The individual receiving the order must verify the drug's condition and return a signed acknowledgment to the pharmacy.
Management of Narcotics:
Narcotics must be kept in a locked cabinet, signifying increased security measures.
Any narcotics are required to be officially signed out prior to their administration.
Contents of the narcotic cabinet must be counted at the beginning of each shift for accountability.
Nurses must verify the order, dosage, and previous administration before accessing the controlled drug.
Prescription Drugs
Evaluation and Control: Prescription drugs undergo rigorous testing before marketing approval, and their administration is under strict regulation.
Risks in Special Populations: Special consideration is necessary for geriatric, pediatric, and critically ill patients, as safety profiles may be less established, particularly for children.
Over-the-Counter Medications
Safety and Availability: OTC medications are generally perceived as low risk when utilized appropriately due to lower dosages and are available for consumer purchase.
Legality in Hospitals: Even in hospital settings, OTC medications require a legal prescriber’s authorization. Furthermore, herbal medications often lack thorough testing for safety and efficacy.
Legal Prescriptions and Drug Orders
Prescriptive Authority: Limited to specific roles, including physicians, dentists, nurse practitioners, nurse midwives, nurse anesthetists, and physician assistants according to state law and agency policy.
Details Required in a Legal Prescription:
Patient's full name
Date of prescription
Name of drug (with DAW - dispense as written for non-substitution cases)
Route of administration
Dosage
Frequency and duration of administration
Prescriber’s signature
Types of Drug Orders
Standing Order: A predefined order allowing for routine administration.
Emergency (Stat) Order: An urgent order requiring immediate medication administration.
Single Order: A one-time order for medication.
As-Needed (Prn) Order: Medication administration as required by the patient's condition.
State Law and Healthcare Agency Policies
Nursing Authority and Accountability: Nursing authority and responsibilities are determined by state law and healthcare agency policies, which vary across jurisdictions; nurses must comply with their respective Nurse Practice Acts.
Nursing Professional and Legal Responsibilities
Legal Accountability: Each nurse holds a legal responsibility for their actions, established by the Nurse Practice Act, which dictates the scope of a nurse's authority and level of responsibility.
Delegation: Nurses must ensure they have the authority to delegate tasks to individuals capable of executing those tasks.
Nursing Process
Stages of Nursing Practice:
Assessment: Comprehensive evaluation of the patient’s condition.
Diagnosis: Identifying specific health issues based on assessment data.
Planning: Establishing care plans tailored to the patient's needs.
Implementation: Delivering the planned interventions.
Evaluation: Assessing the effectiveness of the interventions and modifying the care plan as necessary.
Drug Administration Systems
Kardex System: Traditional paper-based system that compiles essential information from the patient's summary and physician's orders, regularly updated but not legally binding and discarded upon patient discharge.
Electronic Medical Records (EMR): Increasing use of an electronic bar-coded drug administration system integrated with the EMR for enhanced security and accuracy in medication administration.
Drug Errors
Occurrence Points: Drug errors may occur at:
During drug preparation.
While transporting the drug to the patient.
At the time of administering the drug to the patient.
High-Alert Drugs
Drugs with Significant Risk: Certain drugs are classified as high-alert due to their potential for causing severe harm in the event of an error. For example, the PINCH acronym indicates these high-alert drugs:
Potassium (usually via IV)
Insulin (may be IV or subcutaneous)
Narcotics (opioids)
Cancer chemotherapy drugs, IV calcium
Heparin or drugs that disrupt normal blood coagulation (including IV and other routes).
Black Box Designation
Serious Risk Warnings: Certain drugs carry a Black Box warning indicating a higher-than-normal risk for serious or life-threatening side effects in addition to the medication’s therapeutic benefits; this warning is formatted distinctly to alert physicians and patients accordingly.
Medication Reconciliation
Practice of Comparison: Medication reconciliation involves systematically comparing a patient's current medication orders to all medications previously taken by the patient. This practice is aimed at avoiding medication errors that may stem from incorrect dosages, duplication of medications, or omitted drugs.
Protection of Healthcare Workers
Health Safety Protocols: Procedures established to protect healthcare workers include:
Proof of vaccination for preventable diseases (e.g., Hepatitis B).
A structured plan for minimizing the risk of needlestick injuries.
Availability of safe sharps disposal methods.
Providing the safest available equipment to ensure worker safety.