1. Legal Aspects Affecting the Administration of Medications
Chapter 3
Legal Aspects Affecting the Administration of Medications
Copyright © 2016 by Mosby, an imprint of Elsevier Inc.

2. Pharmacology and Regulations
Federal Guidelines (government)
State Guidelines (Board of Nursing)
Facility Guidelines (where you are practicing
Federal laws control how certain drugs may be given.
State laws address who may prescribe, dispense, and administer medications and the process to be implemented.
Agency or facility guidelines indicate how and when drugs are to be given and the records to be kept about a drug’s use.
Facility must adhere to state and federal guidelines also.
Copyright © 2016 by Mosby, an imprint of Elsevier Inc.

3. Copyright © 2016 by Mosby, an imprint of Elsevier Inc.
Federal Laws
Three drug categories in the United States:
Controlled substances – drugs that may be easily abused, are dangerous, and require a prescription
Prescription, or legend, drugs – drugs that require a prescription but are not as easily abused
Over-the-counter (OTC) medications – drugs patients may buy without a prescription
The Food and Drug Administration (FDA) was created by Congress to supervise the testing, approval, and marketing of new drugs.
U.S. drugs are some of the most pure and protected drugs in the world.
Many laws have been passed to control drugs that might easily be abused and are dangerous. See Table 3-1
Copyright © 2016 by Mosby, an imprint of Elsevier Inc.

4. Controlled Substances
Most regulations are written for controlled substances, because they are often abused both by patients and by people using them illegally.
After the Controlled Substances Act of 1970 classed these medications into five “schedules,” they became known as scheduled drugs.
Federal and state laws make it a crime for anyone to have controlled substances without a prescription.
The degree of control, record keeping required, the order forms, and other regulations are different for each of these five classes.
Drugs may be moved from one class to another if it becomes clear they are being abused.
Copyright © 2016 by Mosby, an imprint of Elsevier Inc.

5. Controlled Substances (cont.)
Nurses may possess these only if:
They are administering the drugs to the patient for whom they were prescribed
They themselves are the patient for whom the legal prescriber has ordered the medication.
They have been delegated the responsibility for the unit supply
If it is found that the nurse has violated the Controlled Substance laws, the nurse may be punished by a fine, a prison sentence, or both.
It is essential that the nurse understand and adhere to facility, state, and federal regulations while administering medications.
It is a crime to possess controlled substances without a prescription.
LPNs/LVNs may administer controlled substances under the guidance of an RN. The RN is accountable for errors made.
Drug abuse is the number one reason nurses lose their license.
Copyright © 2016 by Mosby, an imprint of Elsevier Inc.

6. Prescription, or Legend, Drugs
Carefully tested prior to marketing
Use is carefully controlled
Prescription is required
Majority of drugs nurses administer in the hospital
Geriatric, pediatric, and critically ill patients are at special risk
Safety may not have been determined for children
Although prescription drugs have been shown to be safe and effective, the nurse must carefully observe for adverse effects.
Geriatric patients are at particular risk because of poor eyesight, coordination, or memory.
Many patients are receiving a variety of prescription drugs. Interactions between the drugs may make it difficult to determine the effectiveness of one drug.
The Omnibus Budget Reconciliation Acts of 1989, 1990, and 1991 limited the types of drugs that may be ordered for Medicare or elderly patients and established a preferred drug and cost list.
Are generic drugs the same as trade name drugs?
Copyright © 2016 by Mosby, an imprint of Elsevier Inc.

7. Over-the-Counter Medications
Low risk for patient when taken appropriately
Low dosage
Patients buy on their own
May have hidden chemicals
Require a legal prescriber’s order in the hospital
Herbal medications have not been tested for safety and effectiveness
What are some of the factors that make it difficult to determine the safety of herbal medications?
Can herbal medications interact with prescribed medications?
Benadryl, diphenhydramine, is an OTC medication. In addition, this medication requires a prescription in some situations. Can you determine why?
What OTC medications have been linked to the manufacture of methamphetamine?
Copyright © 2016 by Mosby, an imprint of Elsevier Inc.

8. Canadian Drug Legislation
The Canadian Health Protection Branch of the Department of National Health and Welfare is responsible for the administration and enforcement of federal legislation.
Three major classes of drugs under the Food and Drugs Act: nonprescription drugs, prescription drugs, and restricted drugs.
All persons authorized to be in possession of a narcotic must keep a record of the names and quantities of all narcotics dispensed, and they must ensure the safekeeping of all narcotics.
OTC drugs are regulated in Canada by the Canadian Food and Drugs Act.
Copyright © 2016 by Mosby, an imprint of Elsevier Inc.

9. State Law and Healthcare Agency Policies
Determines the level of authority and responsibility of the nurse
Different levels of nursing will have different levels of authority and accountability
Nurses must adhere to the Nurse Practice Act in the state in which they are practicing
Responsibilities may vary in State Nurse Practice Acts
It is essential that all nurses understand how the State Nurse Practice Act describes drug administration responsibilities.
In addition to state guidelines, the LPN/LVN should be provided with written policy statements regarding educational preparation of nurses administering medications and agency or institutional policies LPNs/LVNs must follow.
In addition, LPNs/LVNs must be oriented to particular policies, procedures, and documentation guidelines within the agency.
Some states recognize the license of the nurse in another state through a regional nursing agreement called a Compact.
Copyright © 2016 by Mosby, an imprint of Elsevier Inc.

10. Nursing Professional and Legal Responsibilities
All nurses have legal responsibility for their actions.
The Nurse Practice Act determines the level of responsibility and authority of the nurse.
Nurses must have the authority to delegate to a person with the authority to carry out the task.
Each nurse must understand and be accountable (responsible) for the rules that govern nursing practice.
When the responsibility for performing a task is passed from one person to another, it is “delegated.”
The Registered Nurse has the authority, or the legal recognition, to delegate tasks to the LPN/LVN and nurse aide.
The LPN/LVN has the authority to delegate tasks to the nurse aide.
The nurse delegating a task remains accountable for verifying the task was properly completed.
Copyright © 2016 by Mosby, an imprint of Elsevier Inc.

11. Nursing Professional and Legal Responsibilities (cont.)
Nursing Process
Assessment
Diagnosis
Planning
Implementation
Evaluation
What type of assessments must be made before administering medication to a patient?
When planning for medication administration, why is it essential to understand the patient’s diagnosis?
What types of skills will you learn to enable you to implement medication administration?
What assessments can you make to evaluate the effectiveness of a medication?
The nurse is professionally and legally responsible for carrying out the following steps of the nursing process when administering medications.
Copyright © 2016 by Mosby, an imprint of Elsevier Inc.

12. Copyright © 2016 by Mosby, an imprint of Elsevier Inc.
The Patient’s Chart
May differ in content and format depending on the type of health care organization.
Nurses learn the basics about nursing activities related to giving medications, and then adjust that knowledge to the setting in which they practice.
The nurse is responsible for checking that the medication order is correct.
The nurse must record the drug information.
Many hospitals use the chart format called the problem-oriented medical record (POMR).
Many facilities now use computerized systems for medication ordering to avoid human error when analyzing written orders.
Any questions regarding an order must be directly addressed with the ordering health care provider.
Copyright © 2016 by Mosby, an imprint of Elsevier Inc.

13. Kardex and Electronic Medication Systems
The Kardex is a pen and paper flip-file card system used for many years that has important information from the patient summary form and the physician’s orders.
It is regularly updated and changed to reflect current orders.
Kardex is not a legal document and is discarded when the patient is discharged.
A Kardex is an ongoing summary of current patient orders maintained at the nurses’ station.
Much of the Kardex is written in pencil to allow for changes in patient orders and is not a permanent part of the patient record.
Copyright © 2016 by Mosby, an imprint of Elsevier Inc.

14. Drug Distribution Systems
Floor or ward stock system
Individual prescription order system
Unit-dose system
Computerized or automated dispensing system
Each agency has its own method for delivery of medications.
Smaller facilities tend to have a “floor stock” of non-narcotic medications for patient use. Larger facilities often have an individual prescription order system for each patient.
The unit-dose system was instituted to decrease nursing error. Individual doses of medications are packaged and sent up from the pharmacy for use.
Many facilities are instituting computerized or automated dispensing systems, which can be used at the patient’s bedside.
Major advantages of these systems are that they automatically record the name of the nurse, medication, patient, and time the medication is removed from the drawer.
Copyright © 2016 by Mosby, an imprint of Elsevier Inc.

15. Narcotics Control Systems
The primary goal of all regulations and policies is to verify and account for all controlled substances.
The use of narcotics is carefully monitored with medications kept in a locked cabinet.
Automated medication dispensing systems require the nurse to use a password or fingerprint instead of a key system.
The nurse must sign out all medications administered during the shift.
Any wasted narcotics must be verified by two nurses.
At the end of the shift, the contents of the locked cabinet are counted together by one nurse from each shift.
Copyright © 2016 by Mosby, an imprint of Elsevier Inc.

16. Copyright © 2016 by Mosby, an imprint of Elsevier Inc.
The Drug Order
Required information includes:
Patient’s full name
Date
Name of medication
Dosage
Frequency
Duration
Route
Signature of physician
Healthcare professionals such as physicians, dentists, nurse practitioners, nurse anesthetists, and physician assistants may write medication orders.
Prescriptions are either written on regular prescription pads or transmitted electronically to the pharmacy.
The State Nurse Practice Act defines the practice of the LPN/LVN and RN and the parameters within which they can administer medications.
Professional and legal responsibility is assumed when working with medications.
It is the professional responsibility of nurses to understand the Nurse Practice Act of the state in which they are practicing, because responsibilities may vary from state to state.
Copyright © 2016 by Mosby, an imprint of Elsevier Inc.

17. Copyright © 2016 by Mosby, an imprint of Elsevier Inc.
The Drug Order (cont.)
Types of Medication Orders
Standing orders
Emergency, or “stat,” order
Single order
As-needed, or “prn,” order
Standing orders typically are pre-ordered by the physician for specific situations or patient diagnoses.
Emergency, or “stat,” orders must be given immediately.
“Now” orders are not the same as “stat” orders, because the nurse has 1.5 hours in which to administer the medication.
Single orders are a “one-time” medication administration.
As-needed, or “prn,” orders require the nurse to determine when the medication is to be given based on patient need.
Copyright © 2016 by Mosby, an imprint of Elsevier Inc.

18. Copyright © 2016 by Mosby, an imprint of Elsevier Inc.
Medication Errors
Immediately assess the patient
Notify the healthcare provider and implement any orders
Continue to assess the patient
Notify supervisor
Document findings in patient record
Complete facility documentation
Medication errors will occur in practice. Reports suggest that errors occur in 3% to 4% of all patients.
More than half of medication errors are preventable.
Filling out an incident report when a medication error is made is not meant to be punitive. Rather, incident reports assist the facility in determining where safety measures have not been implemented or need to be improved.
Copyright © 2016 by Mosby, an imprint of Elsevier Inc.

19. Legislation to Protect Health Care Workers
Needlestick Safety and Prevention Act of 2001
Requires hospitals to follow the guidelines in the Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard.
Health care institutions must have a written plan spelling out their efforts to cut the risk of needlestick injuries.
Employers are required to provide the safest equipment available, regardless of cost.
Such equipment includes needleless products or those with engineering controls, which have built-in safety features to reduce risk.
Copyright © 2016 by Mosby, an imprint of Elsevier Inc.