3.2: Drug Errors and Prevention
By the end of this section, you should be able to:
- 3.2.1 Define core ethical principles as they relate to drug administration.
- 3.2.2 Discuss ANA Code of Ethics principles related to safe drug administration.
- 3.2.3 Describe the benefit–risk ratio.
- 3.2.4 Identify steps to prevent medication errors.
Drug errors are a significant cause of morbidity and mortality in the United States. A medication error is “an error (of commission or omission) at any step along the pathway that begins when a clinician prescribes a medication and ends when the patient actually takes the drug” (Agency for Healthcare Research and Quality [AHRQ], 2019b, para. 1). This section addresses a nurse’s response to medication errors, the role of prevention, and the ethics of dealing with an error once it happens.
Core Ethical Principles
According to Gallup’s annual poll (Brenan, 2023), the American public ranked nurses number 1 (79%) as the most honest and ethical profession, above physicians (62%), high school teachers (53%), and pharmacists (58%). Ethics refers to the set of moral principles that direct how a person behaves. The foundations for an individual’s ethical standards are one’s values, or the personal beliefs someone has about what is right or wrong.
Integrity means doing the right thing—always—even when no one is looking. It means being truthful and having honor or strong moral principles. There are many components to having integrity in the life of a nurse. The nurse should check all actions, decisions, and planning ahead of time to ensure the “rightness” of an action or decision. Being honest and owning up to a medication error is not only “right” but also may save the life of the client if an intervention can prevent a bad outcome. One of the most important things an individual can say is, “I made a mistake, and this is what happened. What can we do to solve this problem?” The sooner a problem is recognized and brought to the attention of the charge nurse and provider, the more quickly a solution can be found.
Another crucial element to having integrity is owning the responsibilities that come with the job and being accountable for one’s job performance. The nurse should take a moment to reflect on the day. Ethical care of the client is more than managing challenging decisions; it is about completing the mundane, day-to-day tasks to the best of one’s abilities. Were the client and family truly cared for? Was the client’s pain adequately controlled? Was teaching performed? Was the client adequately assessed prior to being given a drug? Was the nurse an advocate for the client? Was HIPAA violated in the elevator (or anywhere else)? Did the nurse demonstrate respect for the client? It is not unusual for ethical dilemmas to occur in the daily practice of nursing. Remembering the ethical principles of autonomy, beneficence, nonmaleficence, justice, veracity (truth), and confidentiality will provide a framework for the nurse as these conflicts arise.
Autonomy
Autonomy in medicine essentially means having the right to make one’s own health care decisions, being independent, and having control over oneself. In the past, Western medicine operated under a paternalistic style of authority with a “doctor always knows best” philosophy. The physician guided the client’s care, sometimes with little input from the client or family. In 1979, Beauchamp and Childress (2013) introduced the idea of autonomy as it related to biomedical ethics and identified that a client should be able to make uncoerced and informed decisions about their health.
A crucial piece of autonomy is having sufficient information to make a sound choice. Informed consent can assist the client in making appropriate choices for their body and deciding whether to pursue or decline specific medical treatments recommended by their provider. According to Varkey (2021, p. 19), “the requirements of an informed consent for a medical or surgical procedure, or for research, are that the client or subject (i) must be competent to understand and decide, (ii) receives a full disclosure, (iii) comprehends the disclosure, (iv) acts voluntarily, and (v) consents to the proposed action.” The consent itself simply means that the client has the right to be told about a treatment or research in language that is easily understood and specifically told why it needs to be done, the risks or benefits, and alternative treatments. The client then has the right to refuse or allow the proposed treatment. The provider should not attempt to persuade or coerce the client to accept the treatment. The nurse is also obligated to respect a client’s opportunity to choose or decline a treatment. Not only does a client have the right to select the appropriate treatment, but the nurse must respect that choice once the decision is made (Walker, 2022).
Within the setting of medication administration, autonomy means clients have the right to refuse a drug that has been ordered for them. Although the nurse may perceive that the drug is good and will be beneficial to the client, the client may have a different viewpoint. That must be respected once the client is informed about the benefits and risks of a drug. This empowers the client to participate in their care, with the aim of better adherence to the overall plan of care.
Today, the shift is toward client-centered care. This empowers the client to be self-directed and still allows for a relationship with health care providers that encourages dialogue and partnership. This is particularly important for those with chronic diseases. Being part of a partnership and having a sense of empowerment increases safety, improves outcomes, and decreases costs (Lian et al., 2018). Other benefits are increased self-confidence on the part of the client and improved adherence to the medical regimen. An example of a model of client-centered care can be seen in Figure 3.2.
An essential component of choice or exercising autonomy is competence on the client’s part. The client must have the ability to act autonomously. An individual who is not competent (someone who has been determined to be incompetent) may not be able to make a decision in their best interests because they cannot understand their own situation or the consequence of their decision. In this case, having a surrogate to make decisions would be in the client’s best interests.
When considering the aspects of drug administration and the ANA Code of Ethics, it is apparent that although the focus is on the goals and values of the nursing profession, the client is central to the process. This is tightly bound to the core ethical principles discussed in the previous section and is also tied closely to the client’s safety, dignity, and well-being. The nurse should establish a caring relationship with the client built on trust and respect. This relationship should factor in elements such as culture, religious or spiritual beliefs, values, support systems, and sexual orientation or gender expression when planning the care of the client (ANA Code of Ethics, Provision 1.2, 2015). This provision goes on to say that the nurse should respect the client’s decisions. Clients have the right to “accept, refuse, or terminate treatment without deceit, undue influence, duress, coercion, or prejudice, and to be given necessary support throughout the decision-making and treatment process” (ANA Code of Ethics, Provision 1.4, 2015). Nurses can educate the client and family without placing pressure on the client to accept the treatment or medication. Once the client has been given accurate and complete information about their condition and treatment options, they have the right to self-determination.
Benefit–Risk Ratio
Each provider prescribing, dispensing, or administering medications carefully assesses the benefits of a drug and its associated risks. Drugs are beneficial in many ways—they prevent, cure, and alleviate symptoms of disease—but drugs also carry risks associated with adverse drug reaction s (ADRs). These reactions may be mild (e.g., headache, constipation, or nausea) or life-threatening (e.g., anaphylaxis, nephrotoxicity, or hepatic failure). The benefit–risk assessment is the analysis of the benefits and risks associated with a drug (Kürzinger et al., 2020). This assessment is completed for each drug during research and continues throughout the lifetime of the drug. The health care provider also performs a benefit–risk assessment for each client prescribed a drug.
Risk can be defined as the probability of harm occurring as a result of an action—in this case, the administration of a drug. Benefit applies to the potential of a drug to treat the disease, ease suffering, or improve the quality of life. For example, the nurse administering a diuretic to a client with heart failure recognizes the benefit of the drug is to reduce the fluid that has accumulated in the lungs and improve the symptoms of shortness of breath; however, the risk may include loss of potassium or decrease in blood pressure (adverse effects). The risk is not the same for every client. In a client with an elevated potassium level and a normal or high blood pressure, the risk of the diuretic is minimal; however, if the client already has a low potassium level and low blood pressure, the risk will be higher. The provider makes a benefit–risk assessment based on the drug’s probable benefits versus its potential risks. After drug therapy begins, the client is monitored to complete an ongoing evaluation of the benefit–risk balance. Ideally, the drug therapy continues as long as it is thought that the benefits outweigh the risks.
Drug Administration and Safety
Medication safety remains one of the most crucial challenges in institutions around the globe. There are many steps and many individuals involved in the process of a drug reaching the client. Most institutions have several processes in place to prevent a drug error from occurring, but not all processes are perfect, and no person is perfect. Many institutions have made the prevention of medication errors their number one priority, but errors continue to occur. The effects of a drug error are devastating and often long-lasting to the client, the client’s family and friends, and the individual who made the error.
A sentinel event is defined by The Joint Commission (TJC) (n.d.-b) as “a patient safety event that results in death, permanent harm, or severe temporary harm.” The harm may be physical or psychological in nature and is usually unexpected. These are events that should be reported immediately so that an investigation (called a root cause analysis) can be initiated without delay. Examples of the most common sentinel events are wrong-site surgeries, invasive procedures on the wrong clients, or death related to something other than the client’s original illness. Administering medications to the wrong client that results in death or severe injury is another example of a sentinel event. An institution accredited by TJC must have policies in place to investigate and respond to sentinel events. The root cause analysis is helpful in identifying the underlying factors related to the harmful event and developing a plan to prevent another event. This process focuses primarily on system problems rather than individuals in an effort to improve the quality of care and safety of clients.
Adverse Drug Reactions
The World Health Organization (n.d., p. 1) defines an adverse drug reaction (ADR) as “harmful, unintended reactions to medicines that occur at doses normally used for treatment.” Coleman and Pontefract (2016, p. 481) define an ADR as “unintended, harmful events attributed to the use of medicines.” Side effects , a type of ADR, are considered to be secondary drug effects produced at therapeutic doses. An example of this might be sedation related to the use of an antihistamine or diarrhea related to the use of a stool softener. An allergic reaction is an immune response due to sensitivity to a specific drug. A mild allergic reaction can cause itching and rash, but anaphylaxis is a severe, life-threatening reaction causing dangerous bronchospasm and hypotension. These drug reactions affect the safety of the client but are not due to a medication error on the part of a health care provider.
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Reporting Adverse Drug Reactions
It is important for the nurse to report adverse drug reactions . The U.S. Food and Drug administration (FDA) has a reporting mechanism in place through a portal called MedWatch for individuals (health care providers or consumers) to voluntarily report any adverse drug event. Each report is reviewed, and if a potential safety concern is identified, the FDA may take action—up to removing the drug from the market. Listen to this podcast from the FDA for more information about MedWatch.
Medication Errors
According to the National Coordinating Council for Medication Error Reporting and Prevention (2023), a medication error is defined as “any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer.” In 1999, a landmark report by the Institute of Medicine, To Err Is Human , increased awareness of medical errors in the United States. This report stated that as many as 98,000 people die in hospitals yearly due to medical errors. The following year this was validated with the clarification that medication errors in health care facilities are the most common type of these errors. This article describes 25 common medication errors in nursing and prevention recommendations .
The FDA receives more than 100,000 reports of drug errors each year, but more than 7 million clients in the United States are impacted by medication errors annually (da Silva & Krishnamurthy, 2016). Adverse drug events account for almost 700,000 emergency department visits each year (AHRQ, 2019b). The cost of caring for individuals whom a drug error has harmed exceeds $40 billion annually (Tariq et al, 2023). The financial and human costs of these errors are staggering.
An adverse drug event (ADE) is client harm resulting from exposure to a drug. This is injury from a medication, a missed medication, or an inappropriately dosed medication. It may or may not result from an error or poor-quality care. Medication errors that do not cause harm to a client (perhaps due to luck or the drug not reaching the client) are considered to be potential ADEs; in contrast, if harm to the client occurs, it is considered a preventable ADE. A drug can be prescribed, dispensed, and administered correctly, but the client may still experience an ADE. This is considered an adverse drug reaction (discussed in the previous section). This is an expected adverse outcome due to the drug’s pharmacological action and is not always preventable (Tariq et al., 2023). Medication errors, however, are preventable.
If a physician orders an incorrect dose of a medication but the pharmacist catches the mistake before dispensing it, it is considered a medication error. If the physician orders the correct medication and dose but the pharmacist dispenses the wrong dose, it is a medication error. Errors may be related to any of the following (and this may not be an exhaustive list) (Tariq et al., 2023):
-
Deteriorated drug
- Product expired
- Product stored incorrectly
- Error in prescribing
- Extra dose
- Insufficient monitoring
- Known allergen
- Known contraindication
- Omission of drug
- Wrong client
- Wrong dose
- Wrong diluent
- Wrong drug
- Wrong infusion rate
- Wrong preparation
- Wrong route
- Wrong strength or concentration
- Wrong time
-
Wrong technique
- Crushing an extended-release tablet
- Administering a subcutaneous medication using an intramuscular technique
According to the Agency for Healthcare Research and Quality (MacDowell et al., 2021), medication administration is a very complex process characterized by the involvement of many health care team members, not just the nurse. Many institutions are working on ways to improve technology and workflow to make the process safer for the client. The manufacturer, packager, provider, pharmacist, technician, and nurse are all part of the process—and each is in a position to make an error. There are many different ways for an error to occur, but in the clinical setting, the nurse is the final person in the chain able to prevent an error from occurring.
Some errors harm the client directly, but others may harm the client indirectly. Administering the wrong drug or doubling the dose of a medication may harm the client directly, whereas giving too little medication may cause a client to be undertreated and not take care of the disease, thereby causing harm indirectly. The most common types of lethal medication errors include giving an overdose of a medication, giving the wrong medication, and giving the drug by the incorrect route. Failure to monitor kidney or liver function can also impact the client’s safety.
Causes of Medication Errors
Medication errors most commonly occur when the medication is being ordered or prescribed. It is estimated that as many as 50% of drug errors occur when the medication is ordered, and nurses and pharmacists identify 30%–70% of those errors (Tariq et al., 2023). Almost 75% of drug errors have been attributed to distraction (Tariq et al., 2023). The provider may be distracted by phone calls, speaking to family members, or other situations requiring their attention. The same may be true for the pharmacist who dispenses the drug or the nurse who administers it.
Some causes of medication errors can be related to human factors, communication errors, confusion over packaging, and confusion about medication names (Tariq et al., 2023). Human factors might include an incorrect drug calculation, a transcription error, a knowledge deficit, or a performance deficit, such as an incorrect drug administration technique. Communication errors may include illegible handwriting that causes an incorrect interpretation of an order, or misunderstood verbal or telephone orders. However, although human error may cause a medication error, the underlying issue may be the system itself. The system may be flawed and/or there may not be an adequate process in place to find mistakes (Tariq et al., 2023).
Prevention of Medication Errors
To prevent some of the previously described communication errors, many institutions have order read-back policies for verbal or telephone orders. The nurse or pharmacist first transcribes the order and then reads it back to the physician. Many institutions have policies recommending that if a written order is illegible, the pharmacist or nurse must call the provider to clarify rather than guess what the provider intended. Computerized order entry has decreased the incidence of illegible orders; however, there is still the chance that an incorrect dosage or route may be entered. Errors from the confusion of medication names occur because many drugs have names that sound alike or look alike, such as Celebrex, Cerebyx, and Celexa or dopamine and dobutamine. (See the List of Confused Drug Names from the Institute for Safe Medication Practices (ISMP) for more information.)
In the past, an individual was often blamed when medication errors occurred. Many errors were thought to be the result of procedural violations, negligence, or carelessness. As a result, individuals may have received disciplinary action (even firing), loss of license, or threat of a lawsuit. Institutions are slowly shifting their culture from “naming, blaming, and shaming” to “how can we improve the system to prevent errors.” When shaming and blaming occur, it reduces the willingness of some individuals to come forward and acknowledge their mistakes. This may harm the client because the error is unreported, but it may also lead to another person making the same error if the fault is in the system. There has been a gradual move to a “ just culture ,” which refers to a system of shared accountability. The organization may not have provided adequate training or had inadequate policies and procedures in place, or poorly designed units. In a just culture, the organization is accountable for the system or process it has designed as well as behaviors. Ideally, organizations will move away from policies that require punishment for errors and focus on reinforcing principles that decrease “at-risk” or reckless behaviors.
James Reason (2000) developed the Swiss cheese model (see Figure 3.3), which drew attention to the occurrence of client harm as a result of failures in the health care system itself. Each barrier to client harm has a weakness (or hole); thus, Reason likened this to Swiss cheese. When all of the holes are aligned, the hazard (in this case, a medication error) reaches the client, and harm will occur. Figure 3.3 depicts an example of the Swiss cheese model using a prescribed medication moving through the layers of holes until the client is harmed. This model could be applied to any harm related to client care, not just errors in medication administration. This model focuses on the health care system rather than the individual in the occurrence of medical errors. Improving the safety of the client must begin with developing a culture of safety within the institution. The emphasis should be on working together as a team, collaborating with a focus on communication and client safety.
Many institutions have begun the process of developing strategies to prevent or reduce the number of medication errors . Some strategies include (Tariq et al., 2023):
- Replacing handwritten orders with computerized order entry
- Rounding with the physician (pharmacist/nurse)
- Double-checking the dose of all high-alert medications with another provider
- Double-checking drug calculations
- Speaking with the pharmacist or looking the drug up in a resource if unsure about a medication
- Remembering that any drug has the potential for adverse effects
- Monitoring kidney and liver function
- Knowing high-risk medications
- Knowing the indication of a prescribed drug (if not known, then asking the provider)
- Order read-back and verification of verbal or telephone orders
- No use of abbreviations
- Providing clear, explicit instructions for each medication
Other potential strategies include:
- Bar code systems
- Instituting medication reconciliation at any transition in care
Some medications have an increased likelihood of causing harm to the client if administered incorrectly, such as potent blood thinners like heparin or insulin, which may cause a bleeding event or lethal drop in blood sugar, respectively. The ISMP has classified these drugs as “high-alert” medications. These are drugs that should have two providers verify the dose to be administered, and both nurses must document on the medication administration record (MAR) when these medications are given.
The ISMP has several strategies for the prevention of medication errors. Improving access to information about drugs is helpful to any provider. This may take the form of drug books or guides on the unit or access to relevant electronic resources. Another prevention strategy is limiting access to high-alert medications. Some high-alert medications, including neuromuscular blockers, are not needed on each hospital unit, so removing access to them on those units may help avoid dangerous drug errors. The more standardized the systems for ordering, storing, preparing, or administering medications, the less likely an error will occur. The electronic system has automated alerts to prevent errors (e.g., pop-up alerts to prevent administering a medication that a client is allergic to). “The responsibility for accurate medication administration does not lie with a single individual. Rather, it lies with multiple individuals, including organizational leaders, who are responsible for the design, implementation, and maintenance of reliable systems to support safe medication use for all practitioners” (ISMP, 2023).