1. Legal Aspects Affecting the Administration of Medications
Chapter 3
Legal Aspects Affecting the Administration of Medications

2. Chapter 3
Lesson 3.1

3. Learning Objectives
List the names of major federal laws concerning drugs and drug use
Explain in what way the nurse is responsible for controlled substances

4. Learning Objectives (cont.)
Describe the differences between authority, responsibility, and accountability
Describe some of the risks associated with common over-the-counter (OTC) medications

5. Medication Regulation
Federal Guidelines (government)
State Guidelines (Board of Nursing)
Facility Guidelines (where you are practicing)
Federal laws control how certain drugs may be given.
The Food and Drug Administration (FDA) was created by Congress to supervise the testing, approval, and marketing of new drugs.
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.

6. Federal Legislation 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 greatest number of regulations are written for controlled substances because they are so easily abused. Prescribing medications requires special licensing of a healthcare provider.
The Controlled Substances Act of 1970 classified medications into five drug schedules.
Each drug schedule identifies the degree of control, required record keeping, order forms, and other regulations for the medications listed in its class.
Drugs may be moved from one classification to another by the FDA.
All medications, including over-the-counter medications, have side effects.

7. Federal Legislation (cont.)
Harrison Narcotic Act of 1914 – limited indiscriminate use of addictive drugs
Federal Food, Drug, and Cosmetic Act of 1938 – gave authority to government to determine the safety of a drug prior to marketing, labeling, specification, and advertising
Durham-Humphrey Amendment of 1952 – restricted number of prescription refills
Major federal legislation included the listed acts and amendment.
What federal legislation required hospitals to conduct needlestick prevention programs?
In what year was this legislation passed?
What factors contributed to the passing of this legislation?

8. Controlled Substances
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 physician has prescribed the drug
They have been delegated the responsibility for the unit supply
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.

9. 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 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 l989, l990, and l991 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?

10. Over-the-Counter Medications
Low risk for patient when taken appropriately
Low dosage
Patients buy on their own
May have hidden chemicals
Require a prescription 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?

11. Chapter 3
Lesson 3.2

12. Learning Objectives
List rules of states and agencies that affect how nurses give drugs
Explain in what way the nurse is responsible for controlled substances
List what information is included in a medication order or prescription

13. Learning Objectives (cont.)
Define and give examples of the four different types of medication orders
List what you need to do if you make a medication error

14. State Nurse Practice Act
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.

15. Nursing 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.

16. 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.

17. Ordering Procedure Step 1: Physician orders medication
Step 2: Order is transcribed onto Kardex
Step 3: Charge nurse verifies accuracy
of order and transcription
Step 4: Order is sent to pharmacy
Step 5: Medication is dispensed to floor
Step 6: Nurse administers according to guidelines
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.
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.

18. Medication Card

19. 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.

20. Medication Orders 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.
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.

21. 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.

22. Medication Errors Immediately assess the patient
Notify the physician 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.