ASSESSMENT

The “Assessment” Standard of Practice is defined as, “The registered nurse collects pertinent data and information relative to the health care consumer’s health or the situation.”[8] A registered nurse uses a systematic method to collect and analyze client data. Assessment includes physiological data, as well as psychological, sociocultural, spiritual, economic, and lifestyle data. For example, when a nurse assesses multiple pieces of data for a hospitalized client with pain, this is considered part of a comprehensive pain assessment.

DIAGNOSIS

The “Diagnosis” Standard of Practice is defined as, “The registered nurse analyzes the assessment data to determine actual or potential diagnoses, problems, and issues.”[9] A nursing diagnosis is the nurse’s clinical judgment about the client’s response to actual or potential health conditions or needs. Nursing diagnoses are used to create the nursing care plan and are different than medical diagnoses.[10]

OUTCOMES IDENTIFICATION

The “Outcomes Identification” Standard of Practice is defined as, “The registered nurse identifies expected outcomes for a plan individualized to the health care consumer or the situation.”[11] The nurse sets measurable and achievable short- and long-term goals and specific outcomes in collaboration with the client based on their assessment data and nursing diagnoses.

PLANNING

The “Planning” Standard of Practice is defined as, “The registered nurse develops a collaborative plan encompassing strategies to achieve expected outcomes.”[12] Assessment data, diagnoses, and goals are used to select evidence-based nursing interventions customized to each client’s needs and concerns. Goals, expected outcomes, and nursing interventions are documented in the client’s nursing care plan so that nurses, as well as other health professionals, have access to it for continuity of care.[13]

IMPLEMENTATION

The “Implementation” Standard of Practice is defined as, “The nurse implements the identified plan.”[14] Nursing interventions are implemented or delegated to licensed practical nurses/vocational nurses (LPNs/VNs) or unlicensed assistive personnel (UAP) with supervision. Interventions are also documented in the client’s electronic medical record as they are completed.[15]

The “Implementation” Standard of Professional Practice also includes the subcategories “Coordination of Care” and “Health Teaching and Health Promotion” to promote health and a safe environment.[16]

EVALUATION

The “Evaluation” Standard of Practice is defined as, “The registered nurse evaluates progress toward attainment of goals and outcomes.”[21] During evaluation, nurses assess the client and compare the findings against the initial assessment to determine the effectiveness of the interventions and overall nursing care plan. Both the client’s status and the effectiveness of the nursing care must be continuously evaluated and modified as needed.[22]

DEVELOPING NEW DRUGS

American consumers benefit from having access to the safest and most advanced pharmaceutical system in the world. The main consumer watchdog in this system is the FDA’s Center for Drug Evaluation and Research (CDER). The center’s best-known job is to evaluate new drugs before they can be sold. CDER’s evaluation not only prevents misinformation from being provided to the public, but also provides doctors and clients the information they need to use medicines wisely. CDER ensures that drugs, both brand-name and generic, work correctly and their health benefits outweigh their known risks.

Drug companies conduct extensive research and work to develop and test a drug. The company then sends CDER the evidence from these tests to prove the drug is safe and effective for its intended use. Before the drug is approved as safe for use in the United States, a team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company’s data and proposed labeling. If this independent and unbiased review establishes a drug’s health benefits outweigh its known risks, the drug is approved for sale. Before a drug can be tested in people, the drug company or sponsor performs laboratory and animal tests to discover how the drug works and whether it’s likely to be safe and work well in humans. Next, a series of clinical trials involving volunteers is conducted to determine whether the drug is safe when used to treat a disease and whether it provides a real health benefit.

FDA APPROVAL OF A DRUG

FDA approval of a drug means that data on the drug’s effects have been reviewed by the CDER, and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population. The drug approval process takes place within a structured framework that includes the following:

• Analysis of the target condition and available treatments: FDA reviewers analyze the condition or illness for which the drug is intended and evaluate the current treatment landscape, which provide the context for weighing the drug’s risks and benefits. For example, a drug intended to treat clients with a life-threatening disease for which no other therapy exists may be considered to have benefits that outweigh the risks even if those risks would be considered unacceptable for a condition that is not life-threatening.
• Assessment of benefits and risks from clinical data: FDA reviewers evaluate clinical benefit and risk information submitted by the drug maker, taking into account any uncertainties that may result from imperfect or incomplete data. Generally, the agency expects that the drug maker will submit results from two well-designed clinical trials to be sure the findings from the first trial are not the result of chance or bias. In certain cases, especially if the disease is rare and multiple trials may not be feasible, convincing evidence from one clinical trial may be enough. Evidence that the drug will benefit the target population should outweigh any risks and uncertainties.
• Strategies for managing risks: All drugs have risks. Risk management strategies include an FDA-approved drug label, which clearly describes the drug’s benefits and risks and information pertaining to the detection and management of any risks. Sometimes, more effort is needed to manage risks. In these cases, a drug maker may need to implement a Risk Evaluation and Mitigation Strategy (REMS).

Although many of the FDA’s risk-benefit assessments and decisions are straightforward, sometimes the benefits and risks are uncertain and may be difficult to interpret or predict. The agency and the drug maker may reach different conclusions after analyzing the same data, or there may be differences of opinion among members of the FDA’s review team. As a science-led organization, the FDA uses scientific and technological information to make decisions through a deliberative process.[2]

BOXED WARNINGS

As discussed in the previous subsection, the FDA approves a drug after determining that the drug’s benefits of use outweigh the risks for the condition that the drug will treat. However, even with the rigorous FDA evaluation process, safety problems can surface after a drug has been on the market and used in a broader population.

Boxed Warnings (formerly known as Black Box Warnings) are the highest safety-related warning that medications can have assigned by the FDA. These warnings are intended to bring the consumer’s attention to the major risks of the drug. Medications can have a boxed warning added, taken away, or updated throughout their tenure on the market. Boxed Warnings appear on a prescription drug’s label and in current, evidence-based drug references. For this reason, it is important for nurses to verify current drug information in drug references.

EXAMPLES OF FEDERAL AND STATE LAWS REGARDING CONTROLLED SUBSTANCES

The following examples of federal laws are applicable to controlled substances administered by nurses:

• Prescriptions: A prescription for a controlled substance may be written only by a provider (physician or mid-level provider such as a nurse practitioner) who has a DEA registration number. The prescription for a Schedule II medication (i.e., opioids) must be written or electronically sent to the pharmacy through DEA approved software. Prescriptions over the phone or fax are not accepted. Refills for Schedule II medication are not allowed and require new prescriptions. Schedule III or IV medications may be refilled only five times. State law determines how long a written Schedule II prescription is valid and if there are any limits on the quantity of medication that can be dispensed. For example, in Wisconsin, a Schedule II prescription is only valid for 60 days after it is written.
• Records: There is a “closed system” for record keeping of controlled substances to prevent drug diversion. Hospitals, clinics, and pharmacies must maintain records on the whereabouts of controlled substances from the time the medication is received by the pharmacy, to when it is administered to the client, to disposal of wasted medication by the nurse. Inventory counts of controlled substances occur frequently and may require a physical count by two licensed staff at the start of each shift. Detailed documentation is required for administration of controlled substances. When a full dose of a controlled substance is not administered, this is referred to as waste. Waste is typically disposed of differently than other medications (i.e., flushed down the sink) and often requires the co-signature of a second licensed staff member.

SCHEDULES OF DRUGS

The federal Controlled Substances Act (CSA) categorizes drugs regulated under federal law into one of five schedules. This placement is based on the substance’s medical use, potential for abuse, and safety or dependence liability. Schedule I drugs have a high potential for abuse and the potential to create severe psychological and/or physical dependence, whereas Schedule V drugs represent the least potential for abuse. Sample medications for each schedule are summarized in Table 2.3.[6]

Drug overdose continues to be a public health crisis in the United States. The misuse of prescription opioids contributes to a large percentage of overdose deaths. Many problems associated with substance use are the result of legitimately made controlled substances being diverted from their lawful purpose into illicit drug traffic. The mission of DEA’s Diversion Control Division is to prevent, detect, and investigate the diversion of controlled medications from legitimate sources while ensuring an adequate and uninterrupted supply for legitimate medical, commercial, and scientific needs. The DEA provides education regarding related topics that apply to nurses such as drug diversion, state prescription drug monitoring systems, current drug trends, and proper drug disposal.[9]

DRUG DIVERSION

Drug diversion involves the transfer of any legally prescribed controlled substance from the individual for whom it was prescribed to another person for any illicit use. The most commonly diverted substances in health care facilities are opioids. Diversion of controlled substances can result in substantial risk, not only to the individual who is diverting the drugs, but also to clients, coworkers, and employers. Impaired health professionals can harm clients by providing substandard care or exposing clients to tainted substances.

Tampering is the riskiest and most harmful type of diversion. Tampering occurs when the diverter removes medication from a syringe, vial, or other container and injects themselves with the medication. The diverter then replaces the stolen medication with saline, sterile water, or another clear liquid. The replaced liquid is then unknowingly administered to the client by an unaware nurse.[10],[11]

The DEA provides an online reporting form for individuals to report suspected drug diversion anonymously. [12]

SAFETY CULTURE

The Joint Commission Center for Transforming Healthcare develops effective solutions for health care’s most critical safety and quality problems with a goal to ultimately achieve zero harm to clients. Some of the projects the Center has developed include improved hand hygiene,[23] effective handoff communications,[24] and safe and effective use of insulin.[25]

The Center has also been instrumental in building a focus on creating a “Safety Culture” in health care organizations. A Safety Culture empowers staff to speak up about risks to clients and to report errors and near misses. These actions reduce the risk of client harm. According to the Institute of Medicine, “The biggest challenge to moving toward a safer health system is changing the culture from one of blaming individuals for errors to one in which errors are treated not as personal failures, but as opportunities to improve the system and prevent harm.”[26]

A component of Safety Culture is the submission of incident reports according to agency guidelines whenever a medication error or a “near miss” occurs. A near miss is a narrowly avoided error. The incident report triggers a root cause analysis by the organization to identify not only what and how an event occurred, but also why it happened. When investigators determine why an error occurred, they can create workable corrective measures to prevent future errors from occurring.[27]

An example of Safety Culture in action is a tragic event in 2006, when three infants died after incorrect heparin doses were used to flush their vascular access devices. A root cause analysis found that pharmacy technicians accidentally placed vials containing concentrated heparin (10,000 units/mL) in medication storage locations that were designated for less concentrated heparin vials (10 units/mL). Additionally, the heparin vials were similar in appearance, so the nurses did not notice the incorrect dosage until after it was administered. In response to a root cause analysis, the hospital no longer stores vials of heparin in pediatric units and uses saline to flush all peripheral lines. In the pharmacy, 10,000 units/mL heparin vials were separated from vials containing other strengths. In this manner, corrective measures were implemented to prevent future tragedies from occurring as a result of incorrect doses of heparin.[28]

SPEAK UP CAMPAIGN

The goal of The Joint Commission’s Speak Up™ campaign is to help clients become more informed and involved in their health care to prevent medication errors. Speak Up™ materials are intended for the public and have been put into a simplified, easy-to-read format to reach a wider audience.[29]

NATIONAL PATIENT SAFETY GOALS

The National Patient Safety Goals (NPSG) are established by The Joint Commission to help accredited organizations address current areas of concern related to patient safety. Annually, The Joint Commission determines the current highest priority patient safety issues with input from practitioners, provider organizations, purchasers, consumer groups, and other stakeholders and develops National Patient Safety Goals.

Two of the current National Patient Safety Goals relate specifically to medication administration: “Identify Patients Correctly” and “Use Medicines Safely.”

THE JOINT COMMISSION’S OFFICIAL DO NOT USE LIST

The Joint Commission maintains an Official Do Not Use List of abbreviations. These abbreviations have been found to commonly cause errors in client care. Accredited agencies are expected to not use these abbreviations on any written or preprinted materials.[34]

VERIFYING PRESCRIPTIONS

Medications and biologicals are administered in response to a prescription from a health care provider or on the basis of a standing order that is subsequently authenticated by a provider. Biologicals are a diverse group of medications that include vaccines, growth factors, immune modulators, monoclonal antibodies, and products derived from blood and plasma. All provider orders for the administration of drugs and biologicals must include the following:

• Name of the client
• Age and weight of the client to facilitate dose calculation when applicable. Agency policies and procedures must address weight-based dosing for pediatric client. Dose calculations for newborns are typically based on the metric weight in grams.
• Date and time of the order
• Drug name
• Dose, frequency, and route
• Dose calculation requirements, when applicable
• Exact strength or concentration, when applicable
• Quantity and/or duration, when applicable
• Specific instructions for use, when applicable
• Name of the provider

CHECKING THE RIGHTS OF MEDICATION ADMINISTRATION

The CMS states that agency policies and procedures must reflect accepted standards of practice that require specific information is confirmed prior to administration of medication. This is commonly referred to as “checking the rights of medication administration.”

When administering medications, it is essential for nurses to vigilantly check the rights of medication administration at least three times to prevent medication errors. What historically began as checking five rights of mediation administration has been extended to eight rights according to the American Nurses Association. These eight rights include the following[36]:

• Right patient: Check that you have the correct client using two patient identifiers according to agency policy (e.g., name and date of birth).
• Right medication: Check that you have the correct medication and that it is appropriate for the patent in the current context. Understand the purpose of the medication and why the client is receiving it.
• Right dose: Check that the dose is safe for the age, size, and condition of the client. Different dosages may be indicated for different conditions, and pediatric dosages are typically much lower than adult dosages.
• Right route: Check that the route is appropriate for the client’s current condition.
• Right time: Adhere to the prescribed scheduling of the medication.
• Right documentation: Always verify any unclear or inaccurate documentation prior to administering medications.
• Right reason: Verify this medication is being administered to this client at this time for the right reason. If signs and symptoms no longer warrant administration of the prescribed medication, notify the prescribing provider.
• Right response: After administering medication, the nurse must evaluate for expected outcomes with the time frame of expected onset and peak. The onset of medication administration occurs when the action of the medication begins to take effect. The peak of the medication administration occurs when the medication is at the highest level in the client’s bloodstream. It is important for nurses to be aware of both the peak and onset of medications to know when the client’s response to medication may start to be observed. The nurse must also be aware of potential side effects and adverse effects and evaluate for these unexpected outcomes. The prescribing provider should be notified if expected outcomes are not achieved or if adverse effects occur.

Many agencies have implemented barcode medication scanning to improve safety during medication administration. Barcode scanning systems reduce medication errors by electronically verifying the “rights” of medication administration. For example, when a nurse scans a barcode on the client’s wristband and on the medication to be administered, the data is delivered to a computer software system where algorithms check databases and generate real-time warnings or approvals. Barcode scanning reduces errors resulting from administration of a wrong medication, incorrect dose, or wrong route. However, it is important for nurses to remember that barcode scanning should be used in addition to checking the rights of medication administration, not in place of this important safety process. Additionally, nurses should carefully consider their actions when errors occur during the barcode scanning process. Although it may be tempting to quickly dismiss the error and attribute it to a technology glitch, the error may have been triggered due to a patient safety concern that requires further follow-up before the medication is administered. Nurses must investigate errors that occur during the barcode scanning process just as they would do if an error were discovered while checking the rights of medication administration.

COMMUNICATING CONCERNS ABOUT MEDICATION ORDERS

The CMS encourages hospitals to promote a culture in which it is not only acceptable, but also strongly encouraged, for staff to notify prescribing providers regarding concerns they have regarding medication orders.[38] It is essential for nurses to contact the prescribing provider if they have any concerns when checking the rights of medication administration before administering the medication to the client. Furthermore, nurses can be held liable in a court of law if they administer medication that results in client harm if a “prudent nurse” would have had concerns about the order and questioned it.

MONITORING CLIENTS RECEIVING MEDICATIONS

The CMS states that observing the effects medications have on the client is part of the multifaceted medication administration process. Clients must be carefully monitored to determine whether the medication results in the therapeutically intended benefit and to allow for early identification of adverse effects and timely initiation of appropriate corrective action. Depending on the medication and route/delivery mode, monitoring may include assessment of the following:

• Clinical and laboratory data to evaluate the efficacy of medication therapy, potential toxicity, and adverse effects. For some medications, such as opioids, this monitoring may include clinical data such as respiratory status, blood pressure, and oxygenation and carbon dioxide levels.
• Physical signs and clinical symptoms relevant to the client’s medication therapy, such as confusion, agitation, unsteady gait, pruritus, etc.
• Factors contributing to high risk for adverse drug events. The consequences of errors can be harmful and sometimes fatal to clients. In addition, certain factors place some clients at greater risk for adverse effects of medication. These factors include, but are not limited to, age, altered liver and kidney function, drug-to-drug interactions, and first-time medication use.

The nurse should consider client risk factors, as well as the risks inherent in a medication, when determining the type and frequency of monitoring. It is also essential to communicate information regarding client medication risk factors and monitoring requirements during hand-off reports to other staff.

Adverse client reactions, such as anaphylaxis or opioid-induced sedation and respiratory depression, require timely and appropriate intervention per agency protocols and should also be immediately reported to the prescribing provider. An example of vigilant post-medication administration monitoring is when a nurse closely monitors a post-surgical client who is receiving opioid pain medication via a patient-controlled analgesia (PCA) pump. Opioid medications are used to control pain but also have a sedating effect. Clients can become overly sedated and suffer respiratory depression or arrest, which can be fatal. The nurse should closely monitor the client’s respiratory rate, oxygen saturation, carbon dioxide levels, level of sedation, blood pressure, and pulse to quickly observe and intervene in the event of an adverse event. In addition, the client and/or family members are educated to notify nursing staff promptly when there is difficulty breathing or other changes that might be a reaction to medication.[39]

DOCUMENTING

CMS regulations require the agency’s documentation regarding medication administration contains providers’ orders, nursing notes, reports of treatment, medication administration records, radiology and laboratory reports, vital signs, and other information necessary to monitor the client’s condition. Documentation of medication administration is expected to occur immediately after the medication is administered to the client; documenting prior to the administration of the medication is inappropriate and can result in medication errors. Proper documentation of medication administration and client outcomes is essential for planning and delivering future care of the client.[40],[41]

PRESCRIPTION DRUG MONITORING PROGRAM

Examples of state law related to controlled substances are prescription drug monitoring programs (PDMP). Many states have implemented PDMP to help combat the ongoing prescription substance abuse epidemic, as well as to help prevent drug diversion. Pharmacies and health care providers are often required by state law to participate in a PDMP when dispensing or prescribing controlled substances. A PDMP is a statewide electronic database that collects data on substances dispensed in the state. By providing valuable information about controlled substance prescriptions that are dispensed in the state, PDMPs help health care providers make prescribing and dispensing decisions. PDMPs also foster the ability of pharmacies, health care professionals, law enforcement agencies, and public health officials to work together to reduce the misuse, abuse, and diversion of prescribed controlled substances.

PROFESSIONAL ASSISTANCE PROGRAMS

In addition to state statutes related to controlled substances, many states offer professional assistance programs as voluntary, nondisciplinary programs to provide support for health professionals with substance abuse disorders (SUD) who are committed to their own recovery. The goal of professional assistance programs is to protect the public by promoting early identification of professionals with SUD and encouraging their rehabilitation and recovery. Professional assistance programs provide an opportunity for nurses with SUD to continue to be employed while being monitored by the SBON and supported in their recovery.

HIGH-RISK (HIGH-ALERT) MEDICATIONS

High-risk medications are drugs that bear a heightened risk of causing significant client harm when they are used in error.[11]

High-risk medication can be remembered using the mnemonic “A PINCH.” The information in the box below describes these medications included with the “A PINCH” mnemonic.

Note: Based on research, the Institute of Safe Medication Practices (ISMP) has expanded this list of high-risk medications. The updated list can be viewed in the box below.

Strategies for safe administration of high-alert medication include the following:

• Standardizing the ordering, storage, preparation, and administration of these products

• Improving access to information about these drugs

• Employing clinical decision support and automated alerts

• Using redundancies such as automated or independent double-checks when necessary

PROVIDER-PATIENT RELATIONS

In addition to high-risk medications, a second component of medication safety in high-risk situations includes provider and client factors. This component relates to either the health care professional providing care or the client being treated. Even the most dedicated health care professional is fallible and can make errors. The act of prescribing, dispensing, and administering a medicine is complex and involves several health care professionals. The client should be the center of what should be a “prescribing partnership.”[12] See Figure 2.4 for an illustration of the prescribing partnership.[13]

Figure 2.4

Prescribing Partnership

SYSTEMS FACTORS

In addition to high-risk medications and provider-patient relations, systems factors also contribute to medication safety in high-risk situations. Systems factors can contribute to error-provoking conditions for several reasons. The unit may be busy or understaffed, which can contribute to inadequate supervision or failure to remember to check important information. Interruptions during critical processes (e.g., administration of medicines) can also occur, which can have significant implications for patient safety. Tiredness and the need to multitask when busy or flustered can also contribute to error and can be compounded by poor electronic medical record design. Preparing and administering intravenous medications are also particularly error prone. Strategies for reducing errors include checking at each step of the medication administration process; preventing interruptions; using electronic provider order entry; and utilizing prescribing assessment tools, such as the Beers Criteria, to evaluate for potentially inappropriate medication use in older adults.[14] The Beers Criteria is a list of potentially harmful medications or medications with side effects that outweigh the benefit of taking the medication.