LEGAL ASPECTS OF MEDICATION ADMINISTRATION CHAPTER 3

LEVELS OF LAW FDA WATCHES OVER TESTING, APPROVAL AND MARKETING OF NEW DRUGS 1. FEDERAL LAWS CONTROLLED SUBSTANCES PRESCRIPTION DRUGS OTC MEDICATIONS 2. STATE LAWS AND REGULATIONS 3. INDIVIDUAL HOSPITALS OR AGENCY RULES

Federal Legislation 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 includes 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? Copyright © 2013, 2010, 2006, 2003, 2000, 1995, 1991 by Mosby, an imprint of Elsevier Inc.

CONTROLLED SUBSTANCES CONTROLLED SUBSTANCES ACT OF 1970 5 DRUG SCHEDULES 1. HIGH LEVEL OF DEPENDENCY 2. HIGH LEVEL OF DEPENDENCY 3. HIGH LEVEL BUT LESS THAN 1&2 4. LOW LEVEL COMPARED TO 3 5. LOW LEVEL COMPARED TO 4

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 a crime for the nurse to have a controlled substance UNLESS 1 OF THE 3 ABOVE CONDICTIONS ARE MET. 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 licenses. Copyright © 2013, 2010, 2006, 2003, 2000, 1995, 1991 by Mosby, an imprint of Elsevier Inc.

CONTROL OF NARCOTICS MUST COUNT THE NARCOTICS BETWEEN AN ON- COMING AND OFF-GOING STAFF MEMBERS EVERY 8 HOURS CHART IN MAR AND NARCOTIC BOOK ALL NARCOTICS FOR A DISCHARGED/ DECEASED PATIENT ARE RETURNED TO PHARMACY FOR A COUNT AND DISPOSAL WASTED/ USED MEDICATION MUST BE WITNESSED ON DISPOSAL NO DRUG SHARING

DEPENDENCE PHYSICAL DEPENDENCE – PHYSIOLOGICAL NEED TO RELIEVE PHYSICAL SYMPTOMS PHYSCHOLOGICAL DEPENDENCE – ANXIETY, STRESS, OR TENSION THAT IS FELT IF THE PERSON DOES NOT HAVE THE MEDICATION CAN HAVE ONE, BOTH OR NEITHER

OTC MEDICATIONS DO NOT NEED PRESCRIPTION PURCHASED AT DRUG STORES LOW DOSAGE LOW RISK FOR SIDE EFFECTS WARNING LABELS AND SPECIAL INFORMATION AVAILABLE TO PURCHASERS HERBAL MEDICATIONS

STATE LAW & HEALTH CARE AGENCIES CHECK THE NURSE PRACTICE ACT IN THE STATE IN WHICH YOU WORK PROFESSIONAL REPSONSIBILITY: ADMINSTER DRUGS APPROPRIATELY, ETHICALLY AND TO BEST OF ABILITY LEGAL RESPONSIBILITY: GOOD JUDGMENT PROPER ACTIONS IN CARRYING OUT PROFESSIONAL DUTY

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 of 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 that 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 from another state through a regional nursing agreement called a compact. Copyright © 2013, 2010, 2006, 2003, 2000, 1995, 1991 by Mosby, an imprint of Elsevier Inc.

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. Copyright © 2013, 2010, 2006, 2003, 2000, 1995, 1991 by Mosby, an imprint of Elsevier Inc.

NURSE LICENSURE COMPACT HOLD A LICENSE IN ONE STATE BUT ABLE TO WORK IN A STATE WITHIN THE COMPACT WWW.NCSBN.ORG NEW JERSEY IS NOT YET IN THE COMPACT

AGENCY/ INSTITUTIONAL POLICIES MAY BE MORE RESTRICTIVE OR SPECIFIC THAN STATE NURSE PRACTICE ACT WRITTEN POLICIES – EDUCATIONAL PREPARATION POLICIES ORIENTATION PARTICULAR POLICIES, PROCEDURES, AND RECORD KEEPING RULES *EXPECTED TO USE NURSING PROCESS IN MEDICATION ADMINISTRATION

Question 1 Of the following, who is not permitted by law to prescribe medication? Physician assistant LPN Dentist Nurse practitioner Correct Answer: 2 Rationale: An LPN/LVN is not a health care giver who may prescribe medications. Each state has a practice act that lists which licensed health care providers may write and dispense prescriptions. Physicians, dentists, osteopaths, and certain advanced-practice health care providers such as nurse practitioners, physician assistants, and nurse-midwives may write prescriptions. Registered pharmacists usually dispense medications. You must understand how your state nurse practice act describes your drug administration responsibilities as an LPN/LVN. Copyright © 2013, 2010, 2006, 2003, 2000, 1995, 1991 by Mosby, an imprint of Elsevier Inc.

DELEGATION THE RESPONSIBILITY FOR PERFORMING A T ASK IS PASSED FROM ONE PERSON TO ANOTHER BUT THE ACCOUNTABILITY FOR WHAT HAPPENS (OUTCOME) REMAINS WITH THE ORIGINAL PERSON MUST HAVE THE AUTHORITY TO DELEGATE THE RECEPTOR OF DELEGATION MUST BE ABLE/ HAVE AUTHORITY TO PERFORM THE DELEGATED TASK

ADMINISTRATION CHECK MAR AGAINST THE ORIGINAL ORDER BAR CODING FOR MEDICATION DELIVERY USE THREE CHECKS FOR SAFETY BEFORE TAKING FROM DRUG CART BEFORE PREPARING, MEASURING DOSE BEFORE OPENING THE MEDICATION AT THE BEDSIDE, OR PUTTING THE BOTTLE BACK

DRUG DISTRIBUTION CENTERS FLOOR STOCK (FROWNED UPON) INDIVIDUAL PRESCRIPTION ORDER SYSTEM UNIT DOSE COMPUTERIZED OR AUTOMATED DISPENSING SYSTEM (PIXIS) NARCOTIC DISPENSING: Locked cabinet within locked med room Signed out in narcotics book and MAR Counted each shift

REQUIREMENTS FOR ORDERS PATIENT’S FULL NAME DATE WRITTEN NAME OF DRUG ROUTE, DOSE AND FREQUENCY DURATION SIGNATURE OF PRESCRIBER ADDITIONAL NEEDED DETAILS Avoid grapefruit Empty stomach Take with food, etc

TYPES OF ORDERS STANDING ORDER STAT ORDER SINGLE ORDER EX: TYLENOL 400mg PO DAILY STAT ORDER BENADRYL 50 mg PO NOW SINGLE ORDER DEMEROL 50 mg IM X1 ON CALL TO OR AS NEEDED (PRN) ORDER IBUPROFEN 200mg PO PRN EVERY 6 HOURS FOR TEMP 101 OR GREATER

MEDICATION ERRORS OOPSIES DO HAPPEN CHECK THE PATIENT STATUS FIRST NOTIFY THE PHYSICIAN MONITOR THE PATIENT NOTIFY NURSING SUPERVISOR CHART EXACT CIRCUMSTANCES INCIDENT REPORTS GO TO RISK MANAGEMENT; DO NOT CHART IN PATIENT RECORD THAT AN INCIDENT REPORT HAS BEEN FILED

INCIDENT REPORTS BE EXACT BE FACTUAL SEQUENTIAL HAPPENINGS AS BEST YOU CAN RECALL KEEP A PERSONAL COPY. USED TO ASSESS FOR PATTERNS OF ERRORS COULD BE A SYSTEM ERROR OR A PERSONAL DEFICIENCY

MEDICATION SAFETY CHECK, CHECK AND CHECK AGAIN IF NOT SURE, LOOK IT UP DOUBLE CHECK CRITICAL MEDS ALWAYS USE 2 CHECKS FOR PATIENT ID NEVER LEAVE MEDS FOR THE PATIENT TO TAKE LATER NEVER EVER RECAP A USED NEEDLE DISPOSE OF ITEMS PROPERLY

Question 2 Morphine is in the category of: Supplements. Unscheduled drugs. Scheduled drugs, or controlled substances. Over-the-counter medications. Correct Answer: 3 Rationale: Morphine is a powerful narcotic analgesic in the category of controlled substances, also known as scheduled drugs under the Controlled Substances Act of 1970. Federal laws created three drug categories in the United States: (1) controlled substances, which include major pain killers and some sedatives or tranquilizers that can only be prescribed by a health care provider with a special license; (2) prescription, or legend, drugs such as antibiotics and oral contraceptives; and (3) over-the-counter medications, which can be bought without a prescription. Copyright © 2013, 2010, 2006, 2003, 2000, 1995, 1991 by Mosby, an imprint of Elsevier Inc.

Question 3 Which of the following statements is true regarding herbal products? Very few people try herbal products. Herbal products are regulated by the federal government. Herbal products are considered supplements. There is a great amount of information known about side effects. Correct Answer: 3 Rationale: Herbal products are considered supplements. Research shows that most people will try an herbal product at some time in their lives. Although research may some day find that these products are safe and effective, at present herbal products are not regulated, standardized, or tested for safety and effectiveness. Because the federal government considers herbal products to be supplements rather than drugs, there are no regulations to control how they are made. Because research on these products is only beginning, little is known about side effects and whether they actually have the intended effect. Copyright © 2013, 2010, 2006, 2003, 2000, 1995, 1991 by Mosby, an imprint of Elsevier Inc.

Foundations and Principles of Pharmacology Chapter 4 Foundations and Principles of Pharmacology Copyright © 2013, 2010, 2006, 2003, 2000, 1995, 1991 by Mosby, an imprint of Elsevier Inc. 25

Learning Objectives Define the key words used in pharmacology and medication administration Explain differences between the chemical, generic, official, and brand names of medicines List the basic types of drug actions Describe the four basic physiologic processes that affect medications in the body Copyright © 2013, 2010, 2006, 2003, 2000, 1995, 1991 by Mosby, an imprint of Elsevier Inc.

Drug Names Generic name Trade name; ® symbol Chemical name Official name Generic names are the same in all countries and are not capitalized when written. What is the trade name for acetaminophen? Chemical names are the most difficult to remember and also include the chemical that make up the drug. The official name, often assigned by the Food and Drug Administration (FDA), may be similar to the brand or chemical name. The first letter of the name is always capitalized. Copyright © 2013, 2010, 2006, 2003, 2000, 1995, 1991 by Mosby, an imprint of Elsevier Inc.

Drug Receptor Sites Copyright © 2013, 2010, 2006, 2003, 2000, 1995, 1991 by Mosby, an imprint of Elsevier Inc.

Drug Attachment Agonist Antagonist Partial Agonist Drugs known as agonists attach at the receptor site and activate the receptor, producing an action similar to that of the body’s own chemicals. What type of action occurs when the drug attaches to a site but produces only a small chemical response? What happens when an antagonist drug attaches to a receptor site? Some partial agonists and antagonists are able to compete with other chemicals or drugs already bonded to a receptor site and replace them. Copyright © 2013, 2010, 2006, 2003, 2000, 1995, 1991 by Mosby, an imprint of Elsevier Inc.

Four Processes of Drug Utilization Copyright © 2013, 2010, 2006, 2003, 2000, 1995, 1991 by Mosby, an imprint of Elsevier Inc.

Absorption How a drug enters the body and passes into body fluids and tissues Absorption processes: Diffusion—high concentration to lower concentration Filtration—a filter prevents passage of certain molecules Osmosis—diffusion through a semipermeable membrane from a less dense solution to a more dense solution What factors determine how fast the drug is absorbed into the body? If the drug action is needed immediately, what route is used? Copyright © 2013, 2010, 2006, 2003, 2000, 1995, 1991 by Mosby, an imprint of Elsevier Inc.

Distribution Blood system Lymph system Barriers: Blood-brain Placental Why do drugs have difficulty passing through the blood-brain and placental barriers? Can you determine what advantages these natural barriers provide? Copyright © 2013, 2010, 2006, 2003, 2000, 1995, 1991 by Mosby, an imprint of Elsevier Inc.

Metabolism Biotransformation First-pass effect Affected by genetic and developmental factors Can you identify some clinical conditions that may alter drug metabolism? Would the dosage of a drug administered orally be larger or smaller if that same drug were administered intravenously? Can you identify the term used to describe drugs that are toxic to the kidneys? Copyright © 2013, 2010, 2006, 2003, 2000, 1995, 1991 by Mosby, an imprint of Elsevier Inc.

Excretion GI tract Kidneys Lungs Skin Identify populations within the lifespan that are at higher risk for impaired elimination or excretion of drugs. If drugs are not eliminated adequately, what clinical condition may occur? Why should a mother who is breastfeeding check with her healthcare provider before taking any drug? Copyright © 2013, 2010, 2006, 2003, 2000, 1995, 1991 by Mosby, an imprint of Elsevier Inc.

Question 1 A nephrotoxic drug is harmful to the: Skin. Kidneys. Lungs. Liver. Correct Answer: 2 Rationale: A nephrotoxic drug is harmful to the kidneys. Nephro means “kidney.” Copyright © 2013, 2010, 2006, 2003, 2000, 1995, 1991 by Mosby, an imprint of Elsevier Inc.

Basics of Drug Action Desired action Adverse reactions Idiosyncratic reactions How do drug side effects differ from adverse effects? What is the term used to describe a drug reaction opposite to that expected? How does an allergic reaction differ from an anaphylactic reaction? Idiosyncratic (paradoxical) reactions are most common in pediatric and geriatric populations. Copyright © 2013, 2010, 2006, 2003, 2000, 1995, 1991 by Mosby, an imprint of Elsevier Inc.

Bioequivalence Define Brand name versus generic Generic equivalent What is the term used to describe drug products, brand and generic, that are chemically similar? Is it acceptable for the pharmacist to dispense a generic drug rather than a brand-name drug? Which drugs should be dispensed exactly as the prescriber has written them? Copyright © 2013, 2010, 2006, 2003, 2000, 1995, 1991 by Mosby, an imprint of Elsevier Inc.

Drug Interactions Drug action may depend on ability to dissolve quickly or slowly Controlled by medication form Oil-based drugs Liquid/solutions are more soluble than capsules, which must dissolve their outer coating first. Oil-based injections must be chemically changed first before absorption can occur. Can you think of other things that may affect absorption? Why should the nurse be concerned when combining two different drugs in a syringe? The use of alcohol and sedatives may produce what type of drug interaction? Copyright © 2013, 2010, 2006, 2003, 2000, 1995, 1991 by Mosby, an imprint of Elsevier Inc.

Food, Alcohol, and Drug Interactions Food interactions Alcohol interactions Drugs and laboratory tests Chronotherapy Why is there an increased risk for drug–alcohol interactions when oral drugs are given? What foods would you advise a patient taking MAOIs to avoid? What effect does cigarette smoking have on the metabolism of drugs? Why is chronotherapy significant for nurses? What are some examples of medications and conditions affected by chronotherapy? Copyright © 2013, 2010, 2006, 2003, 2000, 1995, 1991 by Mosby, an imprint of Elsevier Inc.

Question 2 An idiosyncratic response is a drug reaction that is: Expected. Predicted. Unique. Anticipated. Correct Answer: 3 Rationale: An idiosyncratic response is one that is strange, unique, or unpredicted. Copyright © 2013, 2010, 2006, 2003, 2000, 1995, 1991 by Mosby, an imprint of Elsevier Inc.

Question 3 Which medicine is more likely to cause an allergic reaction? Acetaminophen Aspirin Cough suppressant Antidepressant Correct Answer: 2 Rationale: Some medications such as sulfa products, aspirin, and penicillin are more likely to cause allergic reactions. Copyright © 2013, 2010, 2006, 2003, 2000, 1995, 1991 by Mosby, an imprint of Elsevier Inc.

QUESTIONS?