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15 Medication Errors inHealthcare

349

Table 15.4 Examples of electronic adverse drug event triggers and their possible associated events

Example of an electronic adversedrug event trigger Possible associated event Prothrombin time (PTT) >100seconds Serum glucose <50mg/dLAdministration of an oral

Naloxone administration

International normalized ratio (INR)>6 Diphenhydramine administration for the treatment of rash

Excessive dose of heparin administered to patient

hypoglycemic agent and insulin without proper monitoring of the patient’s serum glucose Combination opioid therapy administered to a patient or suspicion of opioid overdose Excessive dose administration of warfarin or improper dose calculation A possible allergic reaction to medication administration

events per 100 admissions, and percent of admissions with an adverse event. The most commonly used metric is “adverse events per 1000 patient days.” The manual collection of trigger tool data can be labor-intensive but can be useful data to monitor over time to identify trends and patterns.

3.2.3 Direct Observation

Direct observation is a method used to monitor the medication use process in real time, recording data as actions are taken. Traditionally, the direct observation method employs independent, trained observers to watch a medication administration take place and document the process with standardized forms. Typically, an observer will watch 50–100 doses be dispensed or administered while documenting any observed ndings. These notes then are reconciled against the original orders to determine if there are any discrepancies between the intended therapy and the medications actually given to the patient. These discrepancies are validated, categorized, and recorded as errors. Albeit resource-intensive and possibly subject to the Hawthorne effect, the direct observation method helps identify trends, creating an objective and quantitative set of safety data [39].

3.2.4 Technology-Generated Data

Information from medication safety technology can be used both proactively and retrospectively to identify potential errors that could or may have resulted in patient harm. CPOE systems with decision support can be used to identify the frequency with which allergies and drug–drug interaction alerts are activated and lead to modications in therapeutic regimens. This type of data can be used to proactively design formulary alternatives and electronic schemes for presenting preferred medications to prescribers.

BCMA systems can generate a variety of near miss and operational dose omission data. A study conducted at a teaching hospital in London concluded that the implementation of CPOE and BCMA resulted in more legible and coherent prescriptions by prescribers and more detected errors identied by pharmacists [40].

Smart infusion pumps, especially those that are connected to the medical record, can provide organizations access to valuable patient safetyrelated data. The data can identify near miss situations in which a smart infusion pump was programmed incorrectly. The dose error reduction software (DERS) is an integral component of smart infusion pumps that prevents users from delivering too much or too little of a medication or uid. Multiple sources of data can be used to monitor the patient safety aspects of smart pump use [41].

4 Components ofaMedication

Error

There are many factors that create and heighten the potential for a medication error. Throughout the complex stages of the medication use process, medications are handled through numerous hands of interdisciplinary healthcare team members and vetted by technology, human factors, systems design, and safety culture, to name a few, until they nally reach the patient. Some errors may remain unnoticed or undetected, while some may cause serious harm to patients and must be investigated for causes in order to prevent their future recurrence. Therefore, identication of the com-

350

M. Ro et al.

ponents of a medication error serves to not only rectify patient harm but also ascertain signicant knowledge and strategies for risk reduction.

4.1 Institute ofSafeMedicationPractices’ 10 Key Elements ofMedication Use

The Institute for Safe Medication Practices (ISMP) classies components of medication error into the following ten key elements [42, 43]. The key elements andtheir associated potential medication errors are listed in Table 15.5. An understanding of these key elements is useful when investigating all potential causes and contributors of medication error and developing their associated risk mitigation strategies.

The rst element in Table 15.5, documentation of wrong patient information, can inevitably lead to the downstream occurrence of medication errors. Examples of patient-specic information include age, weight, allergies, medical history, lab results, and contraindications related to individual medication use, e.g., pregnancy status for medications with teratogenic potential. Updated documentation of renal status for patients taking direct oral contraceptives has been shown to prevent medication errors in a UK-based study [44]. An analysis of event reports submitted to the Pennsylvania Patient Safety Reporting System (PA-PSRS) revealed that incorrect or missing documentation of patient’s weight led to several types of medication errors such as overdose, underdose, and wrong rate of administration [45]. Five of the 10 most commonly reported medications in the study were considered high alert, meaning that they carry a heightened risk of causing signicant harm when used in error [45, 46]. Some of the recorded types of weight-based errors included confusion between pounds versus kilograms, wrong documentation of weight, missing weight, incorrect estimated weight, and calculation error [45].

A special patient population that particularly depends on weight-based dosing of medications are pediatric patients. They face a heightened risk

for medication errors due to a multitude of unique factors. These include pharmacokinetic parameters that differ at various stages of development, use of extemporaneous compounding due to the lack of available certain dosage forms and concentrations for pediatric patients, inability for very young children to communicate adverse effects, and requirement of specialized knowledge required by the healthcare providers [47–

49]. Unofcial temporary naming of newborns

[50] and shared last names between the mother and the child [51] pose additional safety risks that are unique to the pediatric population.

The second key element in Table15.5, maintaining easily accessible up-to-date and accurate drug information, is critical for identifying, preventing, and mitigating potential for error. These may include institution-specic guidelines, electronic health record (EHR) order sets, literaturebased references, and drug information resources such as Lexicomp or Micromedex. Medicationspecic information such as adverse effects,drug interactions, maximum dose, typical dose, precautions, special populations, and contraindications are necessary for all stages of the medication use process, including prescription, verication, preparation, administration, and monitoring of safe and effective medication use [43].

A combination of the rst and third key elements in Table15.5, which pertains to documentation, communication, and transmission of accurate information about the medications, applies to the example of medication reconciliation. Medication reconciliation, informally known as med rec, is dened by the American Pharmacists Association (APhA) as “the comprehensive evaluation of a patient’s medication regimen any time there is a change in therapy” [52]. Medication reconciliation requires collaboration by patients and interdisciplinary providers as well as clear and consistent communication across all levels of care and points of care transitions [53]. According to one study, 68% of medication discrepancies during admission to an emergency department were found to be signicant, serious, or life threatening [54]. In order to improve patient safety and outcomes, TJC has identied medication reconciliation as a major

15 Medication Errors inHealthcare

351

Table 15.5

ated potential medication errors [42, 43]

ISMP’s key element of medication use

1. Patient information

2. Drug information

3. Communication related to medications

4. Drug labeling, packaging, and nomenclature

5. Drug standardization, storage, and distribution

6. Medication delivery device acquisition, use, and monitoring

7. Environmental factors

8. Staff competency and education

9. Patient education

Key elements of medication use and associ-

Examplesof associatedareas for potential errors

Patient name, age, weight, allergies, past medical history, lab values, and insurance status Contraindication, warning, adverse effects, drug interactions, cross-allergies,storage, preparation, administration, andrequirement of delivery device Communication of drug orders, communication dynamics, confused abbreviations, illegible prescriptions, and misheard verbal orders Unlabeled medications, look-alike/ sound-alike medications, confusing labels on medications, and poorly positioned labeling components that obscure important drug information Storage proximity to look-alike/ sound-like medications, failure to properly dilute or reconstitute medications prior to administration, multiple available concentrations leading to wrong selection, and nonstandard medication administration times Unfamiliarity with medication delivery devices, pump programming errors, use of inappropriate measuring device for oral liquids, and line mix-ups leading to wrong route administration Inadequate stafng, noise, lighting, physical space, work schedules, interruptions, and sensory distractions Orientation training, education, competency assessment, certications, practice drills and simulations, and off-site education Low health literacy, lack of patient counseling, discharge instructions, complex dosing schedules, cultural andlanguage barrier, lack of resources or access to information, and improper selection of medications (e.g.,duplication of active ingredients exceeding recommended dose) due to lack of knowledge

(continued)

Table 15.5 (continued)

ISMP’s key element of medication use

10. Quality processes and risk management

Examplesof associatedareas for potential errors

Leadership, culture, error reporting, safety strategies, focus on blaming individuals rather than improving system, and operating without a medication safety ofcer

area for healthcare improvement in the National Patient Safety Goals for the Hospital Program [55].

Examples of errors relating to medication communication include illegible handwritten orders, misheard verbal orders, failure of prescriptions transmitted to the pharmacy, misuse of leading or trailing zeroes, and misunderstood abbreviations [43]. The following reports involving inappropriate abbreviations have been submitted to PA-PSRS [56].

• An elderly female patient with an INR less

than 2.8 received a Coumadin (warfarin) dose

that should have been held. The original order

stated to give Coumadin if INR<2.5 (<2.5).

However, the “<” (less than) symbol was mis-

interpreted as “greater than,” which led to the

administration of Coumadin.

• A physician wrote an order to increase Diovan

(Valsartan) to 80 mg BID. An up arrow (↑)

symbol was used to indicate “increase” in the

prescription strength but was read as the

numeral 1. The pharmacy interpreted the

order to be Diovan 160 mg BID (since no

180 mg form is available), and the patient

received one dose of Diovan 160mg.

• A prescriber used an abbreviation for magne-

sium sulfate and wrote “MgSo4 2g IV × 1

dose” for a patient. However, the unit clerk

and nurse misinterpreted the order as mor-

phine sulfate (MSO4) 2mg IV ×1 dose, and

the patient received a 2mg dose of morphine

sulfate instead of magnesium sulfate.

• An elderly patient received an order for

Dilaudid (HYDROmorphone) without the use

of leading zeroes (0.2–0.4mg). As a result, the

order was misread as 2–4 mg instead of the

intended 0.2–0.4mg.

352

M. Ro et al.

The fourth key element in Table15.5 refers to drug labeling and packaging which constitute a major component of medication error [43]. According to the FDA Fact Sheet, there are over 19,000 prescription medications that are currently on the market [57] which do not include all of the foreign medications that are sometimes imported during drug shortages or utilized by patients who obtain them outside of the country. This raises the problem of numerous look-alike/ sound-alike medications which can lead to confused drug names and mix-ups. These can occur between generic names (e.g., acetaminophen and acetazolamide) or brand names (e.g., Celexa and Celebrex), or both (e.g., heparin and Hespan) [58]. Even an entry of the name “aspirin” into the FDA’s Phonetic and Orthographic Computer Analysis (POCA) will result in 334 look-alike and sound-alike medication names [59]. ISMP Canada has published the following examples of error reports that involve look-alike sound-alike medication mix-ups [60].

• A pregnant patient was prescribed

Diclectin®(Pyridoxine/Doxylamine), but

Dicetel® (Pinaverium)was dispensed. She had

received Dicetel® many times in the past.

• A physician wrote a prescription for

Hydrocortisone 1% in Mycostatin®; however,

Hydrocortisone 1% in Miconazole (Monistat®)

was dispensed instead. The staff member

thought Mycostatin® and Miconazole were the

same medication.

• A patient intended to rell Zopiclone over the

phone; however, the technician relled the

existing prescription for Zoloft® (Sertraline).

In the inpatient settings, providers are at an increased risk of committing an error via mislabeling, missing labels, and lack of standardization when medications are compounded or prepared on patient oors outside of the pharmacy. According to the results of a 2018 ISMP survey of intravenous (IV) push practices in adult care units, more than a quarter (28%) of the respondents reported that they rarely or never label syringes that are prepared outside the pharmacy and away from the patient’s bed-

side. Rather than labeling the syringes, the respondents claimed to distinguish the medication-containing syringes only by visual appearances, such as the volume of the medication inside, size of the syringe(s), color difference in needle caps or medication, or the location of the syringe in relevance to the practitioner, such as its orientation on a tray or sterile eld or placement in different hands or pockets [61]. Therefore, the fth key element of drug standardization is critical for accurately producing the same IV product every time. Efforts to promote the standardization of IV medications and analyze its impact on safety, effectiveness, and waste reduction have been established through initiatives such as the Standardize 4 Safety initiative, the Indiana Standard Concentrations of Adult Drug Infusions List (“the Indiana List”), and the Vial, Exchange, Rate, and Bag (VERB) analysis [62–64].

As an example of the sixth key element in Table 15.5, compromised medication delivery services can also lead to medication errors. Several wrong-route medication administration errors involving lines and tubing have been documented, such as the inadvertent administration of oral solutions into IV lines and accidental administration of IV contrast media into the external ventricular drain into a patient’s brain [65]. Joint Commission Sentinel Event Alert #53 identied that 116 case studies in 34 publications involved misconnections that directed enteral feeding solutions into IV lines [66]. In a New York Times article, a 35-week pregnant 24-year-old woman and her unborn child were reported to have died after enteral feeding was inadvertently administered intravenously instead of via nasogastric route [67]. In 2019 the Healthcare Safety Investigation Branch, based in the United Kingdom, completed an investigation on inadvertent administration of an oral liquid into a vein and published several safety ndings, including the root causes and safety recommendations to National Health Services (NHS) Improvement and the Royal College of Physicians [68].

Aside from connection mix-ups, additional errors with IV medication administration sets have been reported. Errors involving medications

15 Medication Errors inHealthcare

353

that were trapped inside the IV tubing and later inadvertently administered have been reported to have been caused by an inappropriately setup primary administration set [69]. Insufcient knowledge surrounding the use of smart pumps and medication administration sets is another component of medication error, as, according to a survey performed by nurses and pharmacists, many are unaware of existing guidelines for positioning the primary infusion bag relative to the infusion pump as well as the required head height differentials for secondary infusion [70].

Next, the seventh key element in Table15.5 describes the environmental factors such as the physical surroundings, organizational unit, ergonomics, workload, stafng patterns, and work schedules [43]. This also includes physical stimulations such as lighting, noise, and foot trafc [43]. When the workspace and schedules do not provide adequate support and may possibly even impede work effort, the practitioners may be left to maneuver important tasks amid distractions and competing priorities that divert from medication safety. The United States Pharmacopeia General Chapter <1066> has ofcial denitions, factors to consider, and guidelines for providing an optimal physical environment for medication safety [71].

The eighth key element in Table15.5 refers to staff competency and education which are critical in preventing unwanted medication errors. In the case of unsafe IV push practices, ISMP survey results have revealed a wide variability in preparation technique, lack of or unfamiliarity with institutional policies or guidelines, persistence of learned practices without sound scientic evidence, and lack of organized training or competency assessment during formal or professional training [61, 72]. There is further evidence to suggest that providers prepare IV push medications with such variation in technique, not only from practitioner to practitioner but within each individual practitioner from injection to injection [72, 73]. Lack of standardized training and competency assessment can create variable safety risks that can be multifaceted, diverse, and difcult to detect. Purchasing and implementing

inventory practices that support safe IV medication use is also essential. Ready-to-administer products are generally preferred whenever possible to help ensure safe IV drug delivery. This underscores the importance of optimizing medication safety at every step of the medication use process [74].

In the ninth key element in Table15.5, medication errors can also occur at home when patients are not educated, informed, or empowered about their medication therapy. Patients may be reluctant to ask questions about prescription and over- the- counter (OTC) medications that they may not understand due to medical jargon, language barriers, or low health literacy [43]. Approximately 7 out of 10 people have been shown to measure the volume of liquid medication incorrectly by failing to use metric and standardized measurements or inappropriately using the measuring devices [75].

An example of a measuring error is described below [76].

• A father purchased a store brand diphenhydr-

amine (Benadryl®) per doctor’s order to treat

his 5-year-old’s bad cold. The medication

came with a dosing cup and a label that stated

12.5mg of the medication equals 5mL.After

reading the instruction to give 12.5 mg to

25 mg for a child less than 6 years old, the

father lled the dosing cup to 12.5mL, confus-

ing the dose in mg with the volume in mL.The

dose that the father poured into the cup

(12.5mL) was almost three times greater than

the amount the child needed (5mL).

For patients selecting OTC medications, packaging and brand names also play a role in medication error. A consumer may not be familiar with generic names, brand names, and various combinations of active ingredients that are available in similar packaging. Additionally, poor product container design and labeling can also obscure critical safety information which could lead to dangerous medication errors. An example of an active ingredient packaged in multiple different ways is shown in Fig.15.4. Lack of patient

354

Fig. 15.4 Brand name medications that share the active ingredient acetaminophen at a US pharmacy. These do not include numerous acetaminophencontaining medications that are sold under generic packaging. Note: Acetaminophen is commonly referred to as paracetamol outside of the United States

M. Ro et al.

knowledge and education can result in misuse of medications, missed doses, and failure to promptly respond to warning signs that can lead to serious harm.

Lastly, quality processes and risk management are paramount to ongoing surveillance and quality improvement of safe medication practices. Institutions should strive to create and foster an environment of safety that is perpetuated by encouraging an open and honest culture of reporting and acknowledging each healthcare member as a meaningful contributor to patient and medication safety. Safety goals should be regularly set, benchmarked, reviewed, and monitored for tangible gains in action plans and targeted risk mitigation strategies. When errors do occur, institutions that target individual members or events as standalone deviations, rather than addressing the system as a whole and as lessons in safety, will not learn and grow from their mistakes. A classic non-healthcare example is starting a car in reverse. Rather than isolating the incidents and blaming the individual drivers, the automotive industry created a forcing function from the systems perspective to eliminate the problem altogether [5]. Culture of blame breeds fear, silence, and secrecy, none of which is conducive to collective systems’ progress toward safety.

4.2 Human Error, At-risk Behavior, andReckless Behavior

Human errors can be classied into knowledgebased, rule-based, and skill-based [77]. Knowledge-based human errors occur due to practitioner’s decit in experience or knowledge, rulebased errors occur when practitioners misinterpret or misapply the rules, and skill-based errors occur due to attention and memory failures [77].

The terminology used when describing Just Culture denes human errors as slips of action and lapses of memory that occur when carrying out familiar tasks without giving much conscious attention [78]. Conditions that can prime slips and lapses include familiarity of task, confusion of two similar tasks, convoluted procedures that do not follow naturally, and interruptions or distractions [78].

On the other hand, at-risk behavior is distinguished from human errors by the loss of perception of risk associated with the choice or mistaken belief that the risk is insignicant or justied [79]. David Marx from Just Culture argues that it is natural human tendency to “drift” and engage in at-risk behavior, as over time practitioners become comfortable performing their tasks and habitually engage in shortcuts whose risk they calculate to be present, but low and tolerable [79].

15 Medication Errors inHealthcare

355

Human errors and at-risk behaviors are distinct from reckless behavior, in which the healthcare practitioner has consciously discarded a known, substantial, and unjustiable risk of harm [78,

79]. Once a behavior has been found to be reck-

less following an investigation, it warrants swift and appropriate remediation or disciplinary action as it deliberately violates a healthcare worker’s commitment to protect patients from harm [79].

4.3 Technology—Greatest Gift

toMedication Safety or Weapon ofMass Destruction?

Health information technology (HIT) has introduced some of the most popular preventative mechanisms against human and medication errors as well as expanded access and availability to medications. BCMA employs barcode scanning that reliably distinguishes the correct medication despite look-alike packaging and confusing labeling. CPOE and EHRs eliminate handwritten prescriptions that are rife with illegible handwriting and misinterpreted abbreviations as well as extend accessibility of patient and medication records to all relevant healthcare practitioners providing care to the patient.ADCs offer a convenient and secure platform to dispense veried and proled medications directly to the providers on the clinical units. However, the caveat of technology is that its safety prole strictly depends on the user who operates it properly within its safe workow processes. When it is improperly programmed or utilized, technology and automation have the adverse potential to cause harm on an exaggerated scale until the mistake is detected and corrected.

Such is the case with a former nurse, RaDonda Vaught, who made the fatal error of choosing a wrong medication from the ADC that led to the death of a patient. While attempting to obtain a vial of VERSED (a discontinued brand of midazolam), she typed “VE” into the ADC search eld and inadvertently selected vecuronium, a neuromuscular blocker. The death of the patient from a wrong

medication administration and the resulting trial and conviction of the former nurse captured the media attention in the United States for several years, prompting discussions on safe medication use, functionalities of ADC, and Just Culture. The case of RaDonda Vaught illustrates that technology, such as the ADC, will only operate safely and effectively as limited by the system rules and designs that outline its optimal use and the individual users who navigate it safely [96, 126, 127].

Additionally, when institutions rst acquire new technology or converge their existing technology with another, technology-related adverse events can be created as new demands arise, resources are diverted, current processes are temporarily adjusted or permanently changed, and staff members learn to adapt to new technologies. TJC Sentinel Alert #42 was published in response to technology-related adverse events in healthcare involving CPOE, ADCs, EHRs, clinical decision support (CDS), barcoding or radio frequency identication, and more [128]. Errors can stem from failing to include the frontline practitioners in the planning process, not considering resource and stafng relocations needed for implementation and ongoing maintenance, and rejecting the need to address existing aws and latent problems prior to installing new technology [128].

Once HIT is implemented, many can offer CDS with warnings to alert the provider from making unsafe practice choices. These can be part of the CPOE, smart infusion pumps, cardiac monitoring devices, automated compounding devices, and more. However, between a staggering number of the various interactive alerts, sounds, and visuals that are constantly triggered during clinical practice, the providers can become overwhelmed and eventually desensitized to safety alerts, leading to ignorance or failure to heed appropriately to such warnings in a phenomenon coined the “alert fatigue” [129]. A 2013 study found that providers selected to “override” important and useful drug–drug interaction alerts that are likely to cause serious patient harm [130].

356

M. Ro et al.

Alert fatigue from overuse of technology can have the unintended counter-effect of bypassing safety warnings; technology should be supported and monitored comprehensively before, during, and after its implementation for its optimal impact on medication safety.

The advancement of technology continues to widely impact the landscape of healthcare, encouraging a growing number of institutions to adopt new and innovative ways to ensure medication and patient safety. However, technology should not be regarded as a panacea in risk reduction, as it affords safety measures only within the conned limits of safe work processes and adequate user knowledge. Safe use of technology should be deliberated within interdisciplinary teams, assessed in the context of the existing needs and processes at the institution, and continuously monitored for adjustment and improvement.

5 Error Mitigation Strategies

Once the contributing factors or causes for medication error have been identied, the corresponding mitigation strategies need to be implemented in a timely manner and monitored

continuously for quality improvement. For an investigation into an unintended medication error or event, the 10 key elements to medication use can be a useful approach to pinpointing various aspects and identifying active and latent failures that contributed to the error.

There are many ofcial and consensus-based error reduction recommendations and resources readily available for practitioners, patients, and industry vendors. TheNCC MERP has various recommendations to enhance accuracy of prescription or medication order writing as well as a list of dangerous abbreviations [80, 81]. The ISMP regularly updates its List of Error-Prone Abbreviations, Symbols, and Dose Designations, Look-Alike Drug Names with Recommended Tall Man Letters, High-Alert Medications in various healthcare settings, and Confused Drug Names [46, 58, 82, 83]. ISMP also offers several self-assessments and practice guidelines such as ISMP Targeted Medication Safety Best Practices for Hospitals [84]. Table 15.6 offers a list of some international agencies and organizations offering medication safety-related guidance and updates.

The FDA also has several ofcial guidelines for all users, for example, the Safety

Table 15.6 International regulatory agencies and professional organizations

Regulatory, professional,

Name Country or region The US Food and Drug Administration (FDA) United States Regulatory The European Medicines Agency (EMA) Europe Regulatory Japan’s Pharmaceutical and Medical Devices Agency (PMDA) Japan Regulatory National Agency for the Safety of Medicine and Health Products

(ANSM) Medicines and Healthcare products Regulatory Agency (MHRA) United Kingdom Regulatory Health Canada Canada Regulatory Australia’s Therapeutic Goods Administration (TGA) Australia Regulatory International Pharmaceutical Federation (FIP) International Professional International Medication Safety Network (IMSN) International Professional International Society of Pharmacovigilance (ISoP) International Professional International Society Pharmacoepidemiology (ISPE) International Professional Patient Safety Authority (PSA) United States Other Institute of Safe Medication Practices (ISMP) United States Other American Society of Health-System Pharmacists(ASHP) United States Professional National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP)

These are a few examples of ofcial international organizations that provide useful medication safety-related guidance and announcements

France Regulatory

United States, international

or other

Other

15 Medication Errors inHealthcare

357

Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors which has several recommendations for industry to design optimal package labels that minimize confusion and prioritize safety for vendors [85]. Some of these include minimization of corporate trade dress, judicious use of color, display of product strength and concentration, metric measurements, and avoidance of dangerous abbreviations, acronyms, and dose designations [85].

The American Society of Health-System Pharmacists (ASHP) is a professional organization in the United States that represents pharmacists practicing in hospitals, health systems, ambulatory clinics, and other healthcare settings. It offers many resources such as guidelines on preventing medication errors in hospitals [86] and position statement on medication safety [87]. It also provides useful information by clinical specialties, such as the guidelines on medication error prevention in chemotherapy and biotherapy [88].

5.1 Patient andConsumer Education

At the level of patients and consumers, it is of utmost signicance that they are educated on the medication they are taking. They should be encouraged to ask questions about their therapy, seek counsel from their pharmacists or prescribing physicians with any questions about medications, and keep a written record of all their prescription and nonprescription, OTC, vitamins, and herbal medications [43]. The FDA recommends that consumers ask questions and seek knowledge surrounding indications for drug therapy, potential adverse effects,risks and causes for medication errors, instructions on appropriate administration, storage, disposal, dangers of drug–drug and drug–food interactions, and submission of medication errors to reporting programs such as FDA’s MedWatch [89] and the ISMP Medication Errors Reporting Program (ISMP-MERP).

Patients can use the following list of questions as an example if not already addressed during patient counseling [90]:

1. What is this medication for?

2. What are the brand and generic names of the medication?

3. Can I take the generic version?

4. Should I stop taking any other medications?

5. How much and how often should I take the medication?

6. When should I stop taking the medication?

7. How many and how often are the rells available?

8. How is the medication stored?

9. Does this medication require or recommend any tests?

10. How can I tell if the medication is working?

11. Are there any foods, other medications, or activities that I should avoid while taking this medication?

12. What side effects can I expect?

13. What should I do if I experience a side effect?

14. What should I do if I miss a dose?

15. What other (printed) information is available regarding this medication?

Whenever possible, patients should engage in mutual conversations with their providers in order to continuously learn new information and complement their existing knowledge gaps. When consulting online resources for information, they should seek websites that are supported by the local and federal government, accredited organizations, peer-reviewed journals, and other reputable sources. If healthcare providers cannot be immediately accessed for medication safety inquiries, patients are encouraged to visit their nearby community pharmacies for trusted medication- related information. Furthermore, it is important to note that effective communication requires an understanding between the patient and the prescriber of the perception of the message and the motivations behind the intended alterations in behavior [91].

5.2 Risk Reduction Strategies

atHealthcare Settings

At the level of healthcare institutions and facilities, numerous layers of strategies should be

358

Fig. 15.5 ISMP’s hierarchy of effectiveness of risk reduction strategies. Some risk mitigation strategies are more effective than others but also more difcult to implement. (c) 2022 Reprinted with permission from ISMP [92]

M. Ro et al.

High Leverage

System ReliabilityHuman Reliability

Medium Leverage

Forcing functions

Barriers and fail-safes

Automation and computerization

Standardization

and protocols

Redundancies

Warnings, alerts,

reminders, checklists

Most

Effective

Hardest to Implement

implemented to prevent the potential for harm from reaching the patient. The spectrum of strategies, ranging from those that are system-based, most difcult to implement, and highly automated to those that are the easiest to implement yet most reliant on human consistency, should be utilized concomitantly to create a robust safety system. ISMP’s hierarchy of effectiveness of risk reduction strategies (Fig. 15.5) places the highest priority on forcing functions, barriers and fail-safes, and automation and computerization which are collectively referred to as high leverage, although they can be the most complex, time-consuming, and difcult to implement in practice [93]. These should be mixed with medium- to low-leverage strategies that are easier to implement and less resourceintensive, such as standardization and protocols, warnings and alerts, rules and policies, and educational programs [93]. Also referred to as the hierarchy of hazard control, it is an important concept in human factors engineering as shown in a study involving medication and patient safety in the ICU [94].

Low Leverage

Rules and policies

Educational programs

Available information

Suggestions to “be

more careful”

Least

Effective

Easiest to Implement

For example, in response to the fatal medication error that involved the unintentional retrieval of vecuronium over Versed (midazolam), an institution could implement the following strategies in the order of effectiveness hierarchy. The rst is to discontinue using the brand name of midazolam “Versed” which is no longer available on the market [95]. Sequestering high-risk neuromuscular blockers to safe storage inside the pharmacy and limiting them to rapid sequence intubation (RSI) kits are considered high- leverage strategies because they eliminate access to the medications at the systems level. Instituting protocols surrounding ADC overrides and allowing medication searches by both brand and generic names are considered medium- to high-leverage strategies. The easiest to implement but least effective are reminders to healthcare practitioners to doublecheck their dispensed medications and instructions to search by the rst ve, not two, letters of the medication name. Combining strategies of various leverage levels helps to create more diverse and robust barriers against potential medication errors [96, 97].

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