PH 2 Legal, Regulatory, and Ethical Aspects of Drug Administration PDF

2 Legal, Regulatory, and Ethical Aspects of Drug Administration LEARNING OUTCOMES 1. Describe the legal, regulatory, and ethical responsibilities of a nurse for drug administration. 2. Explain the meaning of controlled substances (scheduled drugs) and why drugs are placed in this category. 3. Descr...

2 Legal, Regulatory, and Ethical Aspects of Drug Administration LEARNING OUTCOMES 1. Describe the legal, regulatory, and ethical responsibilities of a nurse for drug administration. 2. Explain the meaning of controlled substances (scheduled drugs) and why drugs are placed in this category. 3. Describe the legal responsibilities for managing controlled substances. 4. List the information required for a legal drug order or prescription. 5. Describe the four different types of drug orders. 6. List what you need to do if you make a drug error. KEY TERMS as needed or “PRN” drug order (p. 16) An order for a drug to be given as needed based on a nurse's judgment of safety and patient need. black box warning (p. 20) A special designation from the FDA that the drug has a higher-than-normal risk for causing serious and even life-threatening problems in addition to its positive benefits for some people. controlled substances (kŏn-TRŌLD SŬB-stăn-sĕz, p. 12) Drugs that are highly regulated because they are commonly abused. Also known as “scheduled drugs.” emergency or “stat” drug order (p. 16) A a one-time drug order to be given immediately. high-alert drugs (p. 19) Drugs that have the potential to cause significant harm to patients. legal responsibility (LĒ-gŭl, p. 14) The nurse's authority as defined by the state Nurse Practice Act. It involves the nurse's judgment and actions while performing professional duties. All nurses must know what is legal in regard to drugs in the state they practice in. Nurse Practice Act (p. 16) The state law that licenses LPN/VN, registered nurses, nurse anesthetists, nurse practitioners, and nurse midwives. It describes the minimal educational preparation and professional requirements needed to 45 perform specific functions, including drug administration, to protect the public safety. over-the-counter (OTC) drugs (p. 12) Category of drugs identified by federal legislation as having low risk to patients and may be purchased without a prescription; have low risk for abuse; and are safe when directions are followed. physical dependence (FĬZ-ĭ-kăl, p. 12) The actual physical symptoms that occur with drug withdrawal (e.g., shaking, increased heart rate, pain, confusion, seizures). prescription drugs (prĭ-SKRĬP-shŭn, p. 12) Category of drugs regulated by federal legislation because they are dangerous and their use must be controlled; may be purchased only when prescribed. Examples are antibiotics or oral birth control pills. prescriptive authority (prĭ-SKRĬP-tĭv ă-THŌR-ĭ-tē, p. 16) The authority designated by an individual state that determines who is legally permitted to write an order or prescription for drugs. professional responsibility (prō-FĒSH-năl rĭ-spŏn(t)-să-BĬ-lĭ-tē, p. 17) The obligation of nurses to act appropriately, ethically, and to the best of their ability as a healthcare provider. psychologic dependence (sĭ-kō-LŎJ-ĭk, p. 12) Feeling of anxiety, stress, or tension when a patient does not have a medication. single drug order (p. 16) A one-time order to be given at a specified time. standing drug order (p. 16) A drug order that indicates that the drug is to be given until discontinued or for a certain number of doses. Introduction As a nurse, each time you give a drug (medication), you are faced with making decisions about the drug that can affect your patient's safety or that can have legal or ethical consequences. For example, in assisted living or nursing home facilities, it is a common practice to mix drugs with food or drink mainly to help patients swallow their prescribed drugs more easily. Before you decide to give drugs mixed in food or drink, there are several things you should consider. First, you have an ethical responsibility to inform the patient's care provider, the patient, and/or the family that you will be giving the drugs in this manner. Failure to inform the provider, patient, or family of this practice is considered covert drug administration, which, although not illegal, is not considered a best practice in drug administration. The mixing of drugs with food or drink must be documented in the patient's care plan and on the drug administration chart to address the legal aspects of this practice. Certain foods or drinks, such as grapefruit juice, should not be taken with certain drugs because this practice may influence the effect of that drug. So, it would be important for you to check your drug handbook before mixing drugs with food or drink. Another common practice for easing drug administration is the crushing of pills or opening of capsules before mixing them with food or drink. It is important to know which types of drugs cannot be crushed or have the capsule opened. For 46 example, a 325-mg enteric-coated aspirin pill may be difficult for some patients to swallow, but crushing the drug affects the speed at which the drug is absorbed and increases the chance of the patient developing a stomach ulcer. Some drugs have a coating that slows the release of the drug. Crushing capsules and tablets releases all of the drug at once, instead of slowly over time, and can result in accidental overdose. The Institute for Safe Medical Practice has published a “do not crush” list that can be used for reference: http://www.ismp.org/tools/donotcrush.pdf. An important legal and ethical issue facing nurses is known as drug diversion. Drug diversion is defined as the illegal transfer of regulated drugs (like narcotics) from the patient for whom it was prescribed to another person, such as a nurse, for their own (or others') use. When a nurse diverts a prescribed drug, it can result in significant threats to patient safety and is a liability to the healthcare organization that employs the nurse. The American Nurses Association has defined an impaired nurse as one who cannot meet the professional Code of Ethics because of excessive use of alcohol or drugs. When drug diversion is suspected, the organization is required to launch a full-scale investigation. The nurse involved will most likely face disciplinary charges that will include treatment resources for the nurse with drug or alcohol addiction and may include suspension or permanent loss of the nurse's license. Nurse leaders have a legal and ethical obligation to protect patients and the profession from impaired nurses. Some keys to behaviors that may signal a drug or alcohol dependency problem in the nurse include increased absences, lateness to work, unexplained “disappearance” from the assigned unit, and decreased alertness. Drug diversion should also be suspected if patients continually report pain despite appropriate drug treatment and if inaccurate narcotic counts are noted. Regulation of Drug Administration Nurses who give drugs are required to follow these three levels of rules: 1. federal laws, which describe rules that control how certain drugs may be given; 2. state laws and regulations, or rules, which say who may prescribe, dispense (give a supply), and administer (or give) drugs and the process to be used; and 3. individual hospital or agency rules, which may use other guidelines or policies about how and when drugs are given and the records that must be kept to record drug treatment. Federal Laws Laws are passed by Congress to make drugs as safe as possible for patients to take and to ensure that the drug does what it claims to do (effectiveness). Congress created the US Food and Drug Administration (FDA) to monitor or watch the testing, approval, and marketing of new drugs. These regulations are very strict and so US drugs are some of the purest and most protected drugs in the world. Many laws have been passed to control drugs that might easily be abused and are dangerous. These laws define the three drug categories in the United States: 47 1. controlled substances, which include opioids (narcotics) and some sedatives or tranquilizers; 2. prescription drugs such as antibiotics and oral contraceptives; and 3. over-the-counter (OTC) drugs that are available without a prescription. Controlled Substances Most regulations are written for controlled substances, because these drugs are most often abused by both patients and the general public. The Controlled Substances Act of 1970 classified these drugs into five “schedules”; they became known as scheduled drugs, which rates the likelihood of the drugs in each category being abused, causing dependency or addiction. For example, schedule I drugs, such as heroin, have no medical use and are considered highly addictive. Schedule V drugs, such as cough medicine with lowdose codeine, have a low potential for abuse. The degree of control, the recordkeeping required, the order forms, and other regulations are different for each of these five classes. Table 2.1 describes the five drug schedules, with examples of drugs in each category. Sometimes the drugs are moved from one class to another if it becomes clear they are being abused. More recently, many states have now approved the medical use of marijuana for the treatment of certain conditions, mostly in the case of terminal illness. Table 2.1 Classification of Controlled Substances (United States) SCHEDULE DESCRIPTION EXAMPLES I More than 80 drugs or substances of which the following are the most well-known: alphaacetylmethadol, gamma-hydroxybutyric acid (GHB), heroin, lysergic acid diethylamide (LSD), marijuana, mescaline, peyote, quaaludes II III IV V High potential for abuse No accepted medical use in treatment in the United States Lack of accepted safety for use of the drug or other substance under medical supervision High potential for abuse Currently accepted use for treatment in the United States Abuse may lead to severe psychologic dependence or physical dependence Potential for abuse is less than the drugs or substances in schedules I and II Currently accepted medical use for treatment in the United States Abuse may lead to moderate or low physical dependence or high psychologic dependence Low potential for abuse relative to the drugs or substances in schedule III Currently accepted medical use for treatment in the United States Abuse may lead to limited physical dependence or psychologic dependence relative to the drugs or substances in schedule III Low potential for abuse relative to the drugs or substances in schedule IV Currently accepted medical use in the United States Abuse may lead to limited physical dependence or psychologic dependence relative to the drugs or substances in schedule IV More than 30 drugs or substances of which the following are the most well-known: amphetamines, cocaine, codeine, fentanyl, hydromorphone (Dilaudid), meperidine (Demerol), methadone, methylphenidate (Ritalin), morphine, oxycodone (Percodan), pentobarbital, secobarbital Most drugs are compounds containing some small amounts of the drugs from schedule II along with acetaminophen or aspirin such as Tylenol # 3 or # 4 and Fiorinal Other drugs include anabolic steroids such as testosterone preparations and sodium oxybate (Xyrem), a drug that contains GHB for use with the sleep disorder narcolepsy Include diet drugs with propionic acid Other well-known drugs include benzodiazepines (lorazepam [Ativan], flurazepam [Dalmane], diazepam [Valium], midazolam [Versed], alprazolam [Xanax]), chloral hydrate, paraldehyde, pentazocine (Talwin), phenobarbital Include cough preparations with small amounts of codeine and drugs for diarrhea that also contain small amounts of opioids such as diphenoxylate with atropine (Lomotil) Source: US Drug Enforcement Administration (DEA), Title 21, Section 81. 48 Memory Jogger Physical dependence results in actual physical symptoms that occur with drug withdrawal. Symptoms such as shaking, increased heart rate, pain, confusion, seizures, and other troubling symptoms can occur. Psychologic dependence, or addiction, is a mental desire associated with taking certain substances, such as cocaine or alcohol. Symptoms of mental dependence such as anxiety, anger, or depression can occur with psychologic dependence. Federal and state laws make it a crime for anyone to have controlled substances without a prescription. Each state has a practice act that lists which healthcare providers may dispense or write prescriptions for controlled substances. Almost all states have prescription monitoring programs that monitor for controlled substance prescriptions that may be received by patients from several different providers to prevent prescription drug abuse. Physicians, dentists, nurse practitioners, physician assistants, and sometimes nurse midwives may write prescriptions for controlled substances. Pharmacists dispense the drugs according to the provider's orders. Licensed practical nurses (LPNs) or licensed vocational nurses (LVNs) may give controlled substances to a patient only if the state board of nursing permits it in the scope of practice, and must be under the direction of a healthcare provider who is licensed to prescribe these drugs. LPNs/VNs work in many different settings; some settings may have high levels of technology for securing controlled substances, while others may use a double-lock system. Each state and healthcare agency has laws and policies that cover the ordering, receiving, storing, and recordkeeping of controlled substances. Opioids (narcotics) are scheduled drugs and they must all be counted every shift. Records must be kept for every dose given. Agency policy determines which nurses will be held responsible for handing over the control of controlled substances from one shift to the next and for the counting and securing of controlled substances. All controlled substances ordered for a patient but not used during the hospital stay are sent back to the pharmacy when the patient is discharged. Nurses may not borrow a drug ordered for one patient to use for another patient, and may never use these drugs for themselves. In a time when drug abuse is so common, the nurse who has responsibility for the controlled substances must remain alert. About 8% to 15% of healthcare professionals have a history of substance abuse, and there is a risk for drug diversion. A pattern of drugs frequently being “dropped” or “spilled” or records that show a patient received large or more frequent doses of drugs without pain relief can serve as clues to possible drug diversion. As a nurse, you must know the federal, state, and agency rules about giving any type of drug, including controlled substances. The rules that govern controlled substances are very clear and very strict. If you violate the controlled substance laws, you may be punished by a fine, a prison sentence, or both. Nurses with proven drug abuse problems lose their license to practice, at least temporarily, and may have a hard time getting it back. Nurses have both an ethical and a legal responsibility to report suspected drug diversion. In most states, the state board of nursing has a program to help nurses with substance abuse that affects their ability to carry out their nursing duties. 49 Distribution for controlled substances and drugs. Both federal and state laws, as well as agency policies, are clear about how controlled substances are handled in hospitals and other agencies. The goal of all regulations and policies is to verify and account for all controlled substances. When controlled substances, particularly opioids (narcotics), are ordered from the pharmacy, they come in single-dose unit or prefilled syringes and are attached to a special inventory sheet. The nurse receiving the order from the pharmacy must inspect the drug and return to the pharmacy a signed record stating that all of the drug ordered was received and that it was in acceptable condition. As each drug is used, it must be accounted for on the inventory sheet by the nurse giving the drug. The use of opioids (narcotics) is carefully monitored on the hospital unit. Drugs are stored in a special locked cabinet. The key to this cabinet is carried by the charge nurse or by a drug nurse. This individual has the legal responsibility for overseeing the use and recording of all opioids during that shift, regardless of whether they personally give the drugs to the patients. There are also automated drug dispensing systems. These systems may include dispensing of opioids or some kinds of routinely stocked drugs that nurses withdraw by giving a password or fingerprint instead of using a key to open a locked cabinet. When controlled substances are ordered for a patient, the nurse who will give the drug first checks the order, the dosage, and the last time the drug was given before obtaining the controlled drug. All nurses giving controlled substances must officially sign out all drugs given during the shift. The agency's inventory report form is completed before the drug is removed from the cabinet. This report may be in the form of a written document or a patient's bar code may be used instead. The report form should include the patient's name, date, drug, dosage, and the signature of the nurse giving the drug. A follow-up note about the patient's response to the drug may also be required. If a dose is ordered that is smaller than that provided (so that some of the drug must be discarded), or if the drug is accidentally dropped, contaminated, spilled, or otherwise made unusable and unreturnable, two nurses must sign the inventory report and describe the situation. Institutional policy may require additional actions. At the end of each shift, the responsibility for all controlled substances and the key to the controlled substances cabinet are transferred to another authorized nurse from the new shift. Keys to or electronic access to controlled substances are never given to physicians or any other unauthorized healthcare worker. The contents of the locked cabinet are counted together by one nurse from each shift. The numbers of each ampule, tablet, and prefilled syringe in the cabinet must match the numbers listed on the inventory report form. Sealed packages are kept sealed. Opened drug packages must each be inspected and counted. Prefilled syringes must be examined to make sure they all have the same color, the same fluid levels, and the same amounts of air within them. Both nurses must sign the inventory report, officially stating that the records and inventory are accurate at that time. Occasionally the inventory and the written report do not agree. Any errors in the number of remaining doses and the number listed in the inventory report must be explained. All nurses who have access to the key must be asked about drugs they have given. Steps must be retraced to see if someone forgot to record any drug. Patient charts can also be checked to see if a drug was given that was not signed for on the inventory report. If errors in the report cannot be found, both the pharmacy 50 and the nursing service office must be notified, and an investigation is opened to determine if drug diversion has occurred. Depending on the type and magnitude of the issue, the institution or agency administrator and security police may be contacted as well. Top Tip for Safety Controlled Substances Always verify all orders for controlled substances. Only authorized nurses can be responsible for access to and delivery of controlled substances. Follow all regulatory policies and procedures for safety and security of controlled substances. Report any suspicious findings that may point to possible drug diversion. Prescription Drugs In the United States, the safety and effectiveness of prescription drugs are regulated by the Federal Prescription Drug Marketing Act (1987), and it is the responsibility of the Food and Drug Administration (FDA) to decide which drugs will require a prescription to be obtained. This regulation is in place to prevent both prescription drug misuse and abuse. Access to these drugs is provided by a few healthcare professionals (physicians, dentists, nurse practitioners, and physician assistants). Misuse or abuse of prescription drugs can lead to adverse drug events, including those caused by dangerous drug interactions. The most commonly abused prescription drugs include narcotics (opioids) and drugs given for sleep or anxiety disorders. The Omnibus Budget Reconciliation Acts of 1989, 1990, and 1991 placed further controls on drugs for Medicare or older adult patients. According to one study, as many as 15% of older adults are at risk for potential major drug–drug interactions. Older patients are at high risk for problems with prescription drugs because they may not take the drug properly because of poor eyesight, memory, or coordination; they may take many drugs that interact with each other; or they may have chronic diseases that interfere with how the drug works. The most recent legislation, Medicare Plan D, provides coverage of some types of drugs for those who pay for this option. More and more, insurance or government groups who pay for drugs limit the types and numbers of drugs that may be ordered to those on a “preferred drug” list. The preferred drug list may require the use of cheaper generic drugs to control costs because new or brand name drugs usually are more expensive. Many drugs are not FDA approved as safe and effective for either children or pregnant women. Prescription drugs make up most of the drugs you give to patients in assisted living, nursing homes, or hospitals. Prescription drugs are carefully tested for safety and effectiveness before they are put on the market. However, even though much may be known about a particular drug, each patient is different and may have different reactions to the drug. You must know the expected and adverse effects of drugs given to your patients and watch for signs that the drug is working the way it should. Any adverse reactions that may develop must be reported to the ordering provider. Because the patient often gets several drugs at the 51 same time, the interaction among the drugs may make it hard to tell how each drug affects the patient, making your nursing knowledge of these drugs a critical part of safe nursing practice. Over-the-Counter Drugs The FDA has also found that many drugs are safe enough not to need a prescription. These drugs are known as over-the-counter (OTC) drugs. They are used to treat many common minor problems such as colds, allergies, headaches, minor burns, constipation, or upset stomach. These drugs may easily be purchased at a drugstore or pharmacy. They are often the first thing patients try before they go to the doctor. Although OTC drugs are widely available, they are not without some risk. Like all drugs, some OTC drugs may produce adverse effects in some patients. There is also the possibility of drug or food interactions, or harm caused by excessive doses. Patients should be taught to read the Drug Facts label that is included with all OTC products and to consult with their pharmacist or other healthcare provider if they have additional questions concerning OTC drug use. Accidental overdoses of common cold drugs in children have occurred because of confusion by parents over the correct dosage to give, so these drugs are no longer recommended for use in pediatric patients. Studies have shown that 40% of parents give their children incorrect dosages of liquid drugs. Cold and allergy products that contain pseudoephedrine can be used to make illegal drugs, are now stored behind the pharmacy counter, and are sold in limited quantities. OTC drugs that are given in assisted living, nursing homes, and the hospital require a legal prescriber's order before they are given. In fact, without an order in these settings, patients cannot take even their own OTC drugs brought with them. Canadian Drug Legislation The Canadian Health Protection Branch of the Department of National Health and Welfare is like the FDA of the US Department of Health and Human Services. This branch is responsible for the administration and enforcement of federal legislation such as the Food and Drugs Act, the Proprietary or Patent Medicine Act, and the Controlled Drugs and Substances Act. These acts, together with provincial acts and regulations that cover the sale of drugs and those that cover the healthcare professions, are designed to protect the Canadian consumer from health hazards; misleading ads about drugs, cosmetics, and devices; and impure food and drugs. The Canadian Food and Drugs Act divides drugs into various categories. Regulations covering the various categories or schedules of drugs differ from those in the United States. There are three major classes of drugs under the Food and Drugs Act: nonprescription drugs, prescription drugs, and restricted drugs. The Proprietary or Patent Medicine Act provides for a class of products that may be sold to the general public by anyone. The drug formula is not found in the official drug manuals or printed on the label. The formulas for all such proprietary (trade secret) nonpharmacologic drugs must be registered and have a license under the Proprietary or Patent Medicine Act. The nurse needs to be aware of patients taking such drugs in the case of possible drug interactions. The Canadian Controlled Drugs and Substances Act covers the possession, sale, manufacture, production, and distribution of opioids (narcotics) in Canada. Only 52 authorized people may have opioids in their possession. All people authorized to be in possession of an opioid must keep a record of the names and quantities of all opioids dispensed, and they must ensure their safekeeping. Nurses are in violation of this act if they are guilty of illegal possession of opioids. OTC drugs are regulated in Canada by the Canadian Food and Drugs Act. These drugs can be purchased without a prescription, but there are rules about the packaging, labeling, and dispensing of the drug. The nurse needs to be aware of the risks these drugs have and watch for possible adverse effects and interactions with other drugs. OTC drugs available in Canada differ from those available in the United States. The Drug Order Legal Prescriptions Both state law and agency policy require that all drugs given in hospitals and longterm care facilities must be ordered by licensed healthcare providers acting within their scope of practice. This generally restricts prescriptive authority (the authority to write an order or prescription for drugs) to physicians, dentists, nurse practitioners, nurse midwives, nurse anesthetists, and physician assistants. Providers who write the prescriptions are also called prescribers. Prescriptions for a hospitalized patient are written in the specified area of a patient's chart, or recorded in the electronic record, and the pharmacy is notified. In some agencies, the order must be transcribed, or rewritten by an authorized individual onto a special pharmacy order form, which is then sent to the pharmacy. Assisted living facilities and long-term care facilities may have providers who evaluate the patients and order or issue recurring orders for patient drugs. Every time a patient has a prescription filled, the pharmacy is required to give information about the drug and how it is to be given. A legal prescription order must contain: • the patient's full name • date • name of drug • route of administration • dose • frequency • duration • signature of prescriber Additional details about how to give the drug may also be written: for example, “Take with meals,” “Avoid milk products with this drug,” “Do not refill,” “May cause drowsiness,” or “Please label.” Pharmacies also require the patient's age and address on the prescription. This information may help the pharmacist ensure the right drug dosage for the patient (e.g., a child or older adult) and help verify the 53 patient's identity. In emergencies, or if the provider is not available on-site, a verbal order, usually over the telephone, may be given. All agencies that employ nurses have policies about verbal orders. The agency decides who is authorized to take, transcribe, and implement verbal orders. The nurse taking the order is responsible for writing the order on the order form in the medical record, including both the name of the nurse and the name of the prescriber. Many institutions also require that a note be written to indicate that the order was read back to the prescriber for validation. The prescriber must then cosign this order, usually within 24 hours, for the order to be valid. The receiving and transcribing of verbal telephone orders may be the responsibility of the registered nurse (RN). It your responsibility as an LPN/VN to make sure you are very familiar with the verbal order policy of the institution where you are practicing. Types of Drug Orders Drug orders are classified into one of four types of orders: the standing order, the emergency or “stat” order, the single order, and the as needed or “PRN” order. A standing drug order indicates that the drug is to be given until discontinued or for a certain number of doses. Hospital or institutional policy usually dictates that most standing orders expire after a certain number of days. A renewal order must be written by the prescriber before the drug may be continued. Examples are: • amoxicillin 500 mg orally every 8 hours for 10 days • ibuprofen 600 mg orally every 6 hours An emergency or stat drug order is a one-time order to be given immediately. An example is: • diphenhydramine 50 mg IV stat A single drug order is a one-time order to be given at specified time. An example of a single drug order is: • cefazolin 1 g IV at 10:00 a.m. before surgery An as needed or “PRN” drug order is an order for a drug to be given as needed based on a nurse's judgment of safety and patient need. An example of a PRN order is: • docusate 100 mg orally at bedtime as needed for constipation State Law and Healthcare Agency Policies Although many regulations about giving drugs come from Federal laws, details about who may prescribe and who may give drugs are set by each individual state. This authority is spelled out for nurses in the Nurse Practice Act of each state and can be found at the National Council of State Boards of Nursing website. Bookmark This! National Council of State Boards of Nursing: https://www.ncsbn.org/npa.htm 54 Differences in practice from state to state make it essential that nurses learn what is legal with regard to drug administration and make sure that they abide by the rules and regulations. Because nurses may move from state to state, nurses must know exactly what is in the Nurse Practice Act of the state where they are licensed to work. Today, nurses often move between jobs, and some states recognize the nursing license of another state through an agreement called the Nurse Licensure Compact. There is a growing list of states that participate in the compact (available at https://www.ncsbn.org). State rules about nursing practice often list the basic or minimum standards of practice. Therefore agency or institutional policies and guidelines may be more specific or restrictive than state Nurse Practice Acts. Agencies that employ nurses must provide written policy statements about the educational preparation for nurses permitted to give drugs and an orientation to particular policies, procedures, and recordkeeping rules of the agency. When you accept a nursing job, it is implied that you are willing to obey the policies or procedures of that institution. It may be an agency's policy to require employment for a certain period, completion of special orientation and training sessions, and passing a probation period before being permitted to give drugs. Even when you have the legal authority to give drugs, a valid drug order signed by an authorized prescriber is needed. Giving drugs is a responsibility reserved for those nurses who are named by law to give drugs and who can document the appropriate educational preparation to do so. Nurses who give drugs to patients accept professional responsibility for giving drugs correctly, ethically, and legally. This means nurses must accept both ethical and legal responsibility for good judgment and actions in drug administration and monitoring the effects of drugs given. Agencies expect nurses to carry out the steps of the nursing process, and you are responsible for good assessment, planning, implementation, and evaluation of the patient when drugs are given. You, as the nurse, will be held responsible for failure to perform any of these steps well. The nursing process is a helpful system to be used when giving drugs. There is a professional, and an implied ethical and legal, requirement that nurses use this process. You must learn information about the patient's medical diagnosis, past medical history, current symptoms, allergies, and current drugs taken. You are responsible for learning about all of the patient's prescribed drugs, the dosage, route of administration, expected response, adverse reactions, and the monitoring that may be needed to ensure the drug is working as it should and to observe for drug interactions. You are also responsible for following all laws and agency policies that are related to giving drugs, including the 9 Rights of Drug Administration (Table 2.2). Finally, you teach the patient and the family the information they need to know for continued and safe administration of this drug. Table 2.2 The 9 Rights of Drug Administration Right patient Right drug Right dose Right route Right time Check the patient's name using two methods to identify the patient. Check drug order. Check drug label. Check drug order. Confirm drug dose is appropriate. Confirm the drug can be given by the route ordered. Confirm the patient can take or receive the drug by the route ordered. Confirm the times the drug is ordered are correct. Check for correct time before giving the drug. 55 Right documentation Right reason Right response Right to refuse Check the last time the drug was given. Document drug administration after the drug is given. Chart the time, route, and any other specific information as necessary. Confirm the reason or need for the drug. Confirm the drug has had the desired effect. Document any monitoring needed or adverse effects as needed. The patient has a right to refuse any prescribed drug. Drug Administration Systems As a nurse, you are responsible for checking that the drug order is correct. This may mean you need to confirm the order you have (using a drug Kardex/other paper drug system or in the electronic medical record [EMR] in a computerized system) against the original order by the provider. Every agency has its own drug order, distribution, and recording system for the patient's health record. Agency policy will tell you what information is to be placed in each section. After you give the drug or drugs ordered, you must record all required drug administration information. Integrated within an electronic health record, many facilities now use a bar-coded drug administration system to allow drug orders to be sent to the pharmacy when they are written; the drugs are then sent back to the patient's room or floor, and the drug is then taken to the patient's bedside. Both the patient's bar-coded wristband and the bar code on each drug are scanned by the nurse using a handheld device (Fig. 2.1). This ensures that the right patient is getting the right drug as noted in the drug order. As the patient is observed taking the drug, the nurse notes that the drug has been given and the chart is electronically updated with this information. An electronic health record and an integrated bar-coded drug system have several obvious advantages. The use of a computer to create the record prevents illegible clinician handwriting—a common cause of drug errors. In addition, these systems avoid having orders transcribed several times as they are sent to the pharmacy, given to the nurse, and so on. This also results in fewer errors. Many systems are designed to indicate whether the dose ordered by the clinician is out of the acceptable dosage range or would interact with another ordered drug, whether there are other dosing errors, or if the patient has a recorded allergy to a prescribed drug. FIG. 2.1 Electronic scan of wristband. (From deWit SC, O'Neill P: Fundamental concepts and skills for nursing, ed 4, St. Louis, 2014, Saunders.) 56 Kardex and Electronic Drug Systems The Kardex is a pen and paper flip-file card system used for many years that has important patient information and the physician's orders. It is regularly updated and changed to reflect current orders. This format keeps important information about the patient easily available for all team members. When a unit-dose system is used, all drugs are listed in the Kardex or drug profile sheet (Fig. 2.2). FIG. 2.2 An example of a Kardex drug card. Memory Jogger In every organization the patient will have either a paper or an electronic chart. The chart may differ in content and format depending on the type of healthcare organization. You are required to document all drug administration according to the agency policy and to record the patient's response to the drugs given and any adverse effects as needed. Drug Errors Drug or medication errors are costly to patients who suffer adverse effects or even death as a result. In addition, organizations pay a financial price for drug errors that 57 occur. Every drug error that is prevented saves the agency approximately $7000. Drug errors can occur at any of three points in the drug administration process: (1) during drug preparation, (2) bringing the drug to the patient, and (3) giving the drug to the patient. Studies have pointed to the fast pace of current clinical practice, lower staffing levels, multitasking, and interruptions during the process of preparing and giving drugs as potential causes of drug errors. Efforts to minimize interruptions during all of the three points of drug administration can reduce errors. Did You Know? The three most common points where drug errors are made are: • during drug preparation • bringing the drug to the patient • giving the drug to the patient Each agency has policies and procedures that cover what to do when a drug error is made. Agencies where drug errors are treated with blame and fear may have fewer nurses report errors when they are made. Nurses have an ethical responsibility to report drug errors because of possible harm to the patient. Regardless of whether the nurse believes the error may result in harm to the patient, all errors must be reported. If you suspect an error was made, immediately check the patient, notify the healthcare provider promptly, and follow any orders the provider gives to reduce the effect of the drug error. It is critical to watch the patient's condition through measuring vital signs, drawing blood for tests, or using any other method ordered by the provider. Also notify the nursing supervisor and fill out any other agency-required reports. After the reports are made, an investigation into how and why the error occurred will be done. The investigation will include how it might be avoided in the future and will also consider any training of the nursing staff that may be needed. Consequences of drug errors vary and are often related to how severe the error was and if the patient was harmed. If the nurse was careless or negligent, she or he may be held professionally and/or legally liable. Although almost every nurse has made one drug error, repeated errors will not be ignored. Research in each institution helps determine whether the mistakes made in that institution are most commonly due to a “system error,” a unique mistake, a failure to follow the 9 Rights of Drug Administration, or a deliberate wrongdoing. In a very important Institute of Medicine (IOM) report (“To Err Is Human,” IOM, 2000) about the number of errors made in medical care, estimates suggest that adverse events, which include medical errors, occur in 3% to 4% of patients. The IOM report and other studies estimate that the costs of medical errors in the United States, including lost income, disability, and need for additional health care, may be between $17 billion and $136.8 billion or more annually. These costs come from a variety of drug-related problems, including patient compliance issues and medical or drug errors. Unfortunately, estimates suggest that more than half of the adverse medical events each year are because of medical errors that could be prevented. 58 Because of this report, most agencies have tightened up ways to report and follow up on drug errors, and some improvement has been confirmed in the most recent studies. Nurses must make every effort to follow agency policies and work to minimize interruptions to prevent errors. An independent, not-for-profit organization, The Joint Commission (TJC) accredits and certifies nearly 21,000 healthcare organizations and programs in the United States. The Joint Commission accreditation and certification is recognized nationwide as a symbol of quality that reflects an organization's commitment to meeting certain performance standards. In an effort to cut down on drug errors, TJC has discouraged healthcare workers from using any abbreviations that might lead to confusion. That means that abbreviations that were used in the past (such as “hs” for nighttime, “cc” for cubic centimeter, and “QD” and “QOD” for daily and every other day) are no longer used in hospitals that wish to maintain their accreditation. Table 2.3 lists TJC's official “do not use” abbreviations. Table 2.3 The Joint Commission's Official “Do Not Use” Lista DO NOT USE POTENTIAL PROBLEM USE INSTEAD U, u (unit) IU (International Unit) Q.D., QD, q.d., qd (daily) Q.O.D., QOD, q.o.d., qod (every other day) Trailing zero (X.0 mg)b Lack of leading zero (.X mg) MS MSO4 and MgSO4 Mistaken for “0” (zero), the number “4” (four), or “cc” Mistaken for IV (intravenous) or the number 10 (ten) Mistaken for each other Period after the Q mistaken for “I” and the “O” mistaken for “I” Decimal point is missed Write “unit” Write “International Unit” Write “daily” Write “every other day” Write X mg Write 0.X mg Write “morphine sulfate” Write “magnesium sulfate” Can mean morphine sulfate or magnesium sulfate Confused for one another a Applies to all orders and all drug-related documentation that is handwritten (including free-text computer entry) or on preprinted forms. b A trailing zero may not be used in drug orders or other drug-related documentation. Adapted from the Joint Commission. Facts about the Official “Do Not Use” List of Abbreviations. Retrieved from https://www.jointcommission.org/PatientSafety/DoNotUseList. Updated June 9, 2017. Bookmark This! Institute for Safe Medical Practices List of Abbreviations, Symbols, and Dose Designations https://www.ismp.org/tools/errorproneabbreviations.pdf In addition, a larger list of dangerous abbreviations can be found at: http://www.nccmerp.org/dangerous-abbreviations High-Alert Drugs A small category of drugs have a high risk for harm when associated with a drug error. We call these high-alert drugs because the consequences of the errors are very serious. Errors with these drugs can cause harm to the patient who receives it in error (i.e., was not prescribed to receive it), as well as to those who either receive too high a dose, too low a dose, or do not actually receive a prescribed dose. High-alert 59 drugs are often packaged, stored differently, and given differently than others. Some agencies may require extra steps in the drug procedures before high-alert drugs are given. Categories of common high-alert drugs can be remembered using the acronym PINCH. P is for potassium, I is for insulin, N is for narcotics (opioids), C is for cancer chemotherapy drugs, and H is for heparin or any drug type that interferes with blood clotting. Information about high-alert drugs in the hospital, community, and long-term care settings can be found online (https://www.ismp.org/Tools/highAlertMedicationLists.asp). Memory Jogger High-alert drug groups are potassium, insulin, narcotics, cancer chemotherapy agents, and heparin, and all other drugs that have interference with blood clotting as their main effect. Black Box Designation An additional way that some drugs are categorized is by their ability to harm the person taking it. Some drugs are assigned a black box warning by the FDA. When a drug has a black box warning it means that the drug has a higher-than-normal risk for causing serious and even life-threatening problems in addition to its positive benefits for some people. This black-bordered box is found on the drug insert sheet and may be included on the patient instruction sheet provided by some pharmacies. Fig. 2.3 shows an example of a black box warning. Prescribers must take extra care in deciding whether or not to prescribe a drug that has a black box warning. The patient is made aware of the potential problems the drug can cause. When you give a drug that carries a black box warning, you will need to monitor the patient even more closely than usual for possible problems. FIG. 2.3 An example of a “black box” warning; this warning was included in the Victoza package insert. (From Novo Nordisk: A black box warning. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022341lbl.pdf.) Medication Reconciliation Medication (drug) reconciliation is the practice of comparing the patient's drug orders to all of the drugs that the patient has been taking. By doing so, drug errors 60 caused by wrong dosages, duplication of drugs, and leaving out a drug can be avoided. The nurse compares the list of current drugs to the list of prescribed drugs to check for accuracy. This list includes all OTC drugs and any herbal supplements or vitamins, as well as prescription drugs the patient takes on a daily basis. Teach your patients to carry the most recent drug list with them to all healthcare provider appointments and to update this list as changes are made. Protection of Healthcare Workers Patients with communicable diseases can place nurses and other healthcare workers at risk for infection. Many healthcare agencies require proof of vaccination to preventable diseases such as hepatitis B upon employment. Some unsafe clinical practices, such as the recapping of syringe needles, can result in needlestick injuries and exposure to bloodborne pathogens. Needlestick injuries expose nurses to serious infectious diseases such as hepatitis B, hepatitis C, and human immunodeficiency virus (HIV). Regulations require hospitals to have a written plan for reducing the risk for needlestick injuries among healthcare workers. 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. Also, sharps disposal units must be available in areas where needed in the unit. If a needlestick injury does occur, it is to be carefully recorded in the agency's needlestick injury documentation system. The exposure control plan, selection of safety products, and needlestick injury documentation system must be reviewed at least once every year. Safety Alert! Safe disposal of drugs is a primary concern for the health and safety of the population. The following tips are used for the safe disposal of prescription drugs: • Follow the disposal directions on the drug packaging or insert. • Unless directed, do not flush drugs down the toilet, because they can pollute the environment. • Bring unused or expired drugs to a local drug take-back program. • Consult with a pharmacist about drug disposal guidelines. Get Ready for the NCLEX® Examination! Key Points • You are legally required to exercise judgment and responsibility in carrying out drug administration. • Know the scope of your practice for drug administration as defined by your state's Nurse Practice Act. 61 • Always verify orders for all drugs to be given. • Always account for all controlled substances prescribed and given to patients. • Be aware of using unapproved abbreviations in transcribing drug orders for administration. • Document all drugs given to a patient according to agency policy. • Assess for and document the patient's response(s) to drugs you have given. • Use extreme caution in preparing and giving high-alert drugs. • Follow all clinical guidelines and agency policies to reduce drug errors and prevent injury to healthcare personnel. • Do not dispose of unused drugs by flushing them down the toilet. Review Questions for the NCLEX® Examination 1. According to the patient's record, a controlled substance has been ordered for pain relief. A review of the narcotics log and the patient's drug record indicates the drug has been given as ordered. However, the patient reports not receiving relief of pain. What may be a likely reason for the lack of pain relief? 1. The patient may not be telling the truth. 2. The drug is likely being diverted for illegal purposes. 3. The patient has an allergy to opioids, and so they are not effective. 4. The patient was offered the drug, but then refused the dose, and it was discarded. 2. Which patient is most likely to receive an incorrect dose of an over-the-counter (OTC) drug? 1. A 2-year-old child given a liquid drug by his parents 2. A 20-year-old woman who experiences frequent migraine headaches 3. A 50-year-old man who is taking an anti-inflammatory drug for occasional arthritis pain 4. A 13-year-old female student who was given acetaminophen for a headache by the school nurse 3. You have discovered that you made a potential drug administration error. What is the first step you should take? 1. Fill out an incident report. 2. Call the healthcare provider immediately. 3. Check your patient and assess vital signs. 4. Discuss your concerns with the nurse manager. 4. Which drug is classified as a schedule II controlled substance? 1. Mescaline 2. Morphine 3. Pentazocine 62 4. Tylenol #3 5. Which action is most likely to ensure you are giving the right drug to the right patient? 1. Checking the patient's bed number 2. Asking the patient if he is Mr. Jones 3. Asking the patient if he has taken this drug before 4. Checking the name on the patient's wristband 6. Which information is required for a prescription to be legal. (Select all that apply.) 1. Patient's name 2. The instruction “take with meals” 3. Prescriber's signature 4. How often the drug is to be taken 5. When to notify the prescriber 6. Drug dose 7. Name of the pharmacist 8. Route of administration 9. How long to take the drug 7. What is the most important action to perform after giving a patient a drug that has a black box designation? 1. Report the event as a drug error. 2. Observe the patient closely for an adverse reaction. 3. Be sure to sign out the drug according to agency policy. 4. Remind the patient to stay in bed for 2 hours after receiving the drug. 63 3 Principles of Pharmacology LEARNING OUTCOMES 1. Define the keywords used in pharmacology and drug administration. 2. Explain the differences between the chemical, generic, and brand names of drugs. 3. Compare the drug actions of agonists, partial agonists, and antagonists. 4. Describe the four basic physiologic processes that affect drug actions in the body. 5. Explain the differences between side effects and adverse effects. 6. Discuss personal factors that influence drug therapy. 7. Describe how drugs affect persons at different lifespan changes. KEY TERMS absorption (ăb-SŎRP-shŭn, p. 24) Drugs enter the body and pass into the circulation to reach the part of the body it needs to affect through the processes of diffusion, osmosis, and filtration. additive effect (ĂD-ĭ-tĭv, p. 28) When two drugs are given together and either make one drug stronger or make the action of the two drugs more powerful. adverse reaction (ăd-VŬRS, p. 27) Severe symptoms or problems that can cause great harm. agonist (ĂG-ō-nĭst, p. 24) Drugs that work by activating or unlocking cell receptors causing the same actions as the body's own chemicals. allergy (ĂL-ĕr-jē, p. 27) An antigen-antibody response that can cause hives, rashes, itching, or swelling. anaphylactic reaction (ăn-ă-fĭ-LĂK-tĭk, p. 27) A severe life-threatening form of an allergic reaction. antagonist (ăn-TĂG-ŏ-nĭst, p. 24) Drugs that attach at a drug receptor site but do not activate or unlock the receptor. bioequivalent (BĪ-ō-ĭ-KWĬV-ĭ-lent, p. 28) Drug products that are chemically the same or identical. biotransformation (BĪ-ō-trăns-fŏr-MĀ-shŭn, p. 25) The transformation or altering of a drug into either active or inactive chemicals after it has been absorbed. brand name (p. 23) The proprietary name that a manufacturer gives to a specific 64 drug. Also known as a trade name. buccal (BŬ-kěl, p. 24) Drug placement against the cheek. chemical name (KĔM—ĭ-kăl, p. 23) The names of the chemicals that actually form the drug. desired action (ĂK-shŭn, p. 27) The drug does what it is supposed to do. distribution (dĭs-trĭ-BŪ-shŭn, p. 25) Movement of a drug in the body to reach its site of action by way of the blood and lymph system. drug interaction (ĭn-tĕr-ĂK-shŭn, p. 28) When one drug changes the action of another drug. enteral (route) (ĔN-tĕr-ăl, p. 24) Giving a drug by way of the gastrointestinal system; oral, feeding tube, sublingual, and rectally. first-pass (effect) (p. 26) After they are consumed, drugs are inactivated in the liver before being distributed to other parts of the body. generic name (jĕn–ĔR-ĭk, p. 23) The most common drug name used by the manufacturer in all countries. Also known as the nonproprietary name. half-life (p. 26) The time it takes the body to remove 50% of the drug from the body. hepatotoxic (hĕp-ă-tō-TŎK-sĭk, p. 27) Adverse drug effects that can result in liver damage. hypersensitivity (hĭ-pĕr-sĕn-sĭ-TĬV-ĭ-tē, p. 27) An exaggerated response to a drug. An allergy is an example of a hypersensitive response. idiosyncratic response (ĭd-ē-ō-sĭn-KRĂ-tĭk, p. 27) Responses to a drug that are peculiar and unpredicted. intramuscular (IM) (īn-trě-MŬ-skyě-lěr, p. 24) Giving a drug by way of an injection deep into the muscle. intravenous (IV) (in-tră-VĒ-nŭs, p. 24) Giving a drug by way of an injection into a vein or giving the drug into tubing that is connected to a catheter that is inserted into to a vein. nephrotoxic (nĕf-rō-TŎK-sĭk, p. 27) Adverse drug effects that can result in kidney damage. parenteral (route) (pĕ-RĔN-tĕr-ăl, p. 24) Giving a drug by way of an injection or an infusion underneath the skin. partial agonist (PĂR-shăl ĂG-ō-nĭst, p. 24) Drugs that attach to the receptor site but produce only a partial effect rather than a full effect (agonist). percutaneous (route) (pĕr-kū-TĀ-nē-ŭs, p. 24) Giving a drug by way of absorption through the skin. Topical creams, patches, or devices under the skin are common examples. pharmacodynamics (FĂRM-ă-kō-dĭ-NĂM-ĭks, p. 23) The effects of a drug on body function (what a drug does to the body). pharmacokinetics (FĂRM-ă-kō-kĭ-NĔT-ĭks, p. 23) The metabolism of a drug within the body (what the body does to a drug). pharmacotherapeutics (FĂRM-ă-kō-thĕr-ă-PŪ-tĭks, p. 23) The use of drugs in the 65 treatment of disease. prodrug (p. 25) Drugs that must be metabolized before they are active. receptor site (rē-SĔP-tŏr, p. 23) Small “lock-like” areas of cell membranes that control what substances either enter the cell or change its activity. side effect (SĪD ĕf-FĔCT, p. 27) Mild but annoying responses to the drug. Nausea and headache are common and usual side effects to many drugs. solubility (sŏl-ū-BĬL-ĭ-tē, p. 24) The ability of a drug to dissolve in body fluids. subcutaneous (sŭb-kyū-TĀ-nē-ăs, p. 24) Drug placement into fatty tissue. sublingual (sŭb-LĬNG-gwăl, p. 24) Drug placement under the tongue. synergistic effect (sĭn-ĕr-JĬS-tĭk, p. 28) The effect of two drugs taken at the same time is greater than the sum of the effects of each drug given alone. trade name (TRĀD), (p. 23) The proprietary name that a manufacturer gives to a specific drug. Also known as a brand name. This chapter provides an overview of very basic information from chemistry, physics, anatomy, and physiology that explains the action of drugs in the body (pharmacokinetics, or what the body does to the drug). This involves the processes of absorption, distribution, metabolism/biotransformation, and excretion. It also covers basic information on the effects of drugs on body functions (pharmacodynamics, or what the drug does to the body). This information is vital in understanding pharmacotherapeutics, or the use of drugs in the treatment of disease. Drug Names Drugs have several different names that may be confusing when you first learn to work with drugs. It is very important to know the different names of a drug so that the wrong drug is not given to a patient. Sometimes a drug is ordered by one name for the drug and the pharmacist labels it with another name for the same drug. For example, Valium (trade name) is also known as diazepam, its generic name. It is also common that one trade name drug is substituted for another trade name in the pharmacy. For example, Atarax (hydroxyzine) and Vistaril (hydroxyzine): hydroxyzine is the generic name, whereas Atarax and Vistaril are two different trade names (brand names) of hydroxyzine made by two different manufacturers. When one drug name is ordered and a drug with another name is supplied, it is important for you to know whether the drug is the same or a different drug. The most common drug name used is the generic name. This is the name the drug manufacturer uses for a drug, and it is the same in all countries. It is also called the nonproprietary name, which is given to a drug before there is any specific trade name or when the drug has been available for many years and more than one company makes the drug. Examples would be ibuprofen and acetaminophen. The American Pharmaceutical Association, the American Medical Association, and the US Adopted Names Council assign generic names. Generic names are not capitalized when written. It is becoming common in hospitals, extended care facilities, and other settings for drugs to be ordered by their generic names. The trade name, or brand name, is the proprietary name or the name for the drug 66 manufactured by one company. This name is often followed by the symbol ®, which indicates that the name is registered to a specific drug maker or owner and no one else can use that name for a drug. This is the drug name used in advertisements and is often descriptive, easy to spell, or catchy sounding so that prescribers will remember it easily and be more likely to use it. The first letters of the trade name are capitalized. Examples of trade names are Motrin, Tylenol, and Mylanta. Chemical names are often difficult to remember because they include all of the chemicals that make up the drug. These names are usually long and hyphenated, and they describe the atomic or molecular structure. An example is ethyl 1-methyl-4phenylisonipecotate hydrochloride, the chemical name for meperidine (Demerol). The chemical name is rarely, if ever, used by nurses or physicians and does not need to be remembered for safe drug administration. Drug Attachment Drugs take part in chemical reactions that change the way the body ac