Legal, Regulatory, and Ethical Aspects of Drug Administration

Pharmacology and Regulations

  • Federal Guidelines (government): Control how certain drugs may be given.

  • State Guidelines (Board of Nursing): Define who may prescribe, dispense, and administer medications and the process to be implemented.

  • Facility Guidelines (where you are practicing): Indicate how and when drugs are to be given and the records to be kept about a drug’s use. Must adhere to state and federal guidelines.

Medication Prescriptions

  • Both state law and agency policy restrict prescriptive authority to:

    • Physicians

    • Dentists

    • Nurse practitioners

    • Nurse midwives

    • Nurse anesthetists

    • Physician assistants

  • Geriatric, pediatric, and critically ill clients are at special risk.

    • Geriatric clients: poor eyesight, coordination, or memory.

    • Safety may not have been determined for children.

  • Each facility has written policies for medication prescriptions, including which providers may write, receive, and transcribe medication prescriptions.

Nomenclature

  • Chemical Name: Name of the medication that reflects its chemical composition and molecular structure (e.g., isobutylphenyl propanoic acid).

  • Generic Name: Official or nonproprietary name the US adopted name council gives the medication. Each med has one generic name (e.g., ibuprofen).

  • Trade Name: The brand or proprietary name the company that manufactures the medication gives it. There can be many (e.g., Advil, Motrin).

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 clients may buy without a prescription.

  • The nurse administers prescription medications under the supervision of the provider.

  • Some medications can be habit forming or have potential harmful effects and require more supervision.

Considerations

  • UNCONTROLLED SUBSTANCES

    • Require monitoring by the provider but do not generally pose risks of abuse or addiction.

    • Ex. antibiotics

  • CONTROLLED SUBSTANCES

    • Have a potential for abuse and dependence and have a “5” schedule classification.

    • Each subsequent level has a decreasing risk.

      • Schedule I: Heroin

      • Schedule II - V have legitimate applications

    • Federal and state laws make it a crime for anyone to have controlled substances without a prescription.

    • 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.

Distribution for Controlled Substances and Drugs

  • When drugs are ordered from the pharmacy:

    • They come in single-dose unit or prefilled syringes and are attached to a special inventory sheet.

    • Individual receiving the order must check the drug and return to the pharmacy a signed record stating that all the drug ordered was received and that it was in acceptable condition.

  • Narcotics:

    • Kept in a special locked cabinet.

    • Drugs must be officially “signed out.”

    • Contents of the cabinet are counted each shift.

    • Checks the order, the dosage and the last time the drug was given before obtaining the controlled drug.

Over-The-Counter Medications

  • Low risk for client when taken appropriately.

  • Low dosage.

  • Clients 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.

Types of medication prescriptions

  • ROUTINE OR STANDARD PRESCRIPTIONS

    • Regularly scheduled

    • With or without termination date or specific number of doses

    • Providers may have to re-prescribe some medications within a specific amount of time or they will automatically d/c. Ex. Opioids, abx

  • SINGLE OR ONE-TIME PRESCRIPTIONS

    • At one specific time

    • Common for preop, or preprocedural rx

    • Ex. A one-time prescription instructs the nurse to administer lorazepam 2mg IM a 0700

  • STAT PRESCRIPTIONS

    • At once, Immediately, RIGHT NOW

    • Emergencies with a pts condition has changed suddenly

    • Ex. A stat rx instructs the nurse to admin. Diphenhydramine 50mg IM stat

  • PRN PRESCRIPTIONS

    • ‘pro re nata’ As needed

    • Specify the dose, frequency, and under what conditions a nurse may administer the med. USE CLINICAL JUDGEMENT

    • Ex. Admin. Tramadol 50mg PO q4hrs PRN for back pain. After admin., document findings that demonstrate the pts need for the medication and the time of admin.

  • Standing prescriptions

    • Circumstantial or for specific units

    • Ex. A critical care unit has standing prescriptions for treating clients who have asystole.

Components of a medication prescription

A legal prescription order must contain the following information:

  • Client’s full name

  • Date and time

  • Name of drug (generic or brand)

  • Route of administration

  • Dose and strength

  • Frequency and time of administration (exact times, intervals, or number of times per day)

  • Duration

  • Signature of prescriber

  • Quantity to dispense and the number of refills

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

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

Drug Administration Systems

  • Electronic Medical Record (EMR)

  • Many facilities now use a bar-coded drug administration system that is integrated with the EMR

Communicating medication prescriptions

  • Origin: Provider/Nurse who take the verbal or telephone prescriptions from a provider write medication prescriptions on the client’s medical record.

  • Nurse transcribe medication prescriptions onto the medication administration record (MAR).

  • Telephone RX

    • Have another nurse listen in if possible

    • Make sure the Rx is complete and read it back for clarification

    • Remind the provider to sign and verify the Rx and sign it

    • Enter the Rx in the EMR

Drug Errors

  • During drug preparation

  • Bringing the drug to the client

  • At the time you give the drug to the client

High-Alert Drugs

  • High risk of harm when associated with a drug error

  • PINCH

    • P—potassium

    • I—insulin

    • N—narcotics (opioids)

    • C—Cancer chemotherapy drugs

    • H—Heparin or any drug type that interferes with blood clotting

  • Black Box Designation

    • Drug has a higher-than-normal risk for causing serious and even life-threatening problems in addition to its positive benefits

Medication Reconciliation

  • The practice of comparing the client’s drug orders to all of the drugs that the client has been taking.

  • Comparing dosages and frequency.

  • This is compared to the list of new meds and reconciled with the provider to resolve any discrepancies.

  • This can avoid drug errors due to:

    • Wrong dosages

    • Duplication of drugs

    • Leaving out a drug