Twenty years ago, the Institute of Medicine (IOM) released its landmark report To Err is Human: Building a Safer Health System, and with it, raised the consciousness of medical errors within the nation’s healthcare system (IOM, 1999). Since that report was published, the patient safety movement has grown and helped raise awareness not only among healthcare professionals but also among the general public. In many healthcare settings, greater attention is being paid to “the possibility of error and a better understanding of the fact that most medical errors result from faulty systems, not from bad or incompetent people” (IOM, 1999).
Scope of the Problem
The original IOM report estimated 44,000 to 98,000 deaths each year in the United States, or at least 120 deaths per day, because of human error related to the delivery of healthcare (IOM, 1999). The report spurred debate and further studies, which have placed the actual figure for deaths in a range from 130,000 to 575,000, with those numbers said to be based on definitions of “medical error” that are both too broad and too narrow (Myhre & Sifris, 2017).
A 2016 study by Johns Hopkins University took an entirely different approach by arguing that the compilation of death rate statistics used to arrive at these numbers is flawed. The JHU study formulated a specific definition of medical error as one or more of the following:
- An unintended act (either the result of omission or action)
- An act that does not achieve its intended outcome.
- The failure of a planned action (an error of execution)
- The use of a wrong plan to achieve an outcome (an error planning)
- The deviation from a process of care that may or may not cause harm.
The most recent data from the CDC suggests that within this scenario medical errors would still be the third leading cause of death in both the United States overall and in Florida (CDC, 2017).
The Affordable Care Act of 2010 (ACA)
Reducing medical errors and adverse events in healthcare continues to be an important topic in today’s legal landscape. A major theme of the landmark legislation Patient Protection and Affordable Care Act of 2010 (ACA) is improving the quality of the nation’s healthcare. The act has many provisions supporting programs that reduce medical errors and governance on their reporting. For example, ACA “in awarding [demonstration grants for alternatives to medical tort litigation], the Secretary shall give preference to States that make proposals that are likely to enhance patient safety by detecting, analyzing, and helping to reduce medical errors and adverse events” (U.S. House, 2010; KFF, 2013/2018).
In 2012 provisions in ACA required providers to begin moving toward electronic health records in an effort to reduce medical errors. Another ACA program also began in 2012 that offered financial incentives to hospitals that meet certain quality criteria.
A variety of programs mandated by ACA and implemented by Medicare and others were designed to improve the numbers for medical errors. It appears that there has been improvement, although there is disagreement on what exactly the data mean (Bihari, 2018).
Error Reporting: Fear and Finger Pointing
Traditionally, patient safety improvement efforts have been hampered by fear of discovery, resulting in under-reporting of medical errors and an inability to collect sufficient data for analysis of adverse events.
In an effort to provide a framework as well as a level playing field, the National Quality Forum, a nonprofit organization focused on systemic healthcare quality improvement, in 2002 developed a list of reportable events. First called never events because they were things that should never happen, the term has come to be used to describe adverse events that are:
- Unambiguous (clearly identifiable and measurable)
- Serious (resulting in death or significant disability)
- Usually preventable
Revised a number of times the list now encompasses 29 serious reportable events that can be grouped into the following seven categories:
- Surgical or procedural events
- Product or device events
- Patient protection events
- Care management events.
- Environmental events
- Radiologic events
- Criminal events (PSNet, 2019; NQF, 2011)
Since 1995 the Joint Commission has recommended that hospitals report “sentinel events,” which it defines as “an unexpected occurrence involving death or serious physiological or psychological injury, or the risk thereof.” All “never events” are considered sentinel events. The Joint Commission requires that a root cause analysis (RCA) be performed after any sentinel event, and the Leapfrog Group recommends that an organization also disclose the error, apologize to the patient, report the event, and waive all associated costs (PSNet, 2019).
Types of Medical Errors
There are many ways that medical care can go wrong. Errors can occur around the administration of medications, during laboratory testing, when infections occur within the healthcare setting, as a result of surgery, in an environment that contributes to pressure sores or a patient fall, or even in documentation or data entry tasks.
A number of healthcare organizations and government agencies have lists of medical errors on which they focus, but the seven discussed here appear across lists from most oversight organizations and are the ones most commonly encountered:
- Medication events (including adverse drug events/reactions)
- Healthcare-associated infections (HAIs)
- Surgical errors
- Laboratory errors
- Patient Falls
- Pressure sores.
- Documentation/computer errors (NQF, 2011; AHRQ, 2018; CMS, 2018; Joint Commission, 2016; NHSN, 2019)
Medication Events
Eighty-two percent of American adults take at least one medication and 29% take five or more—and the potential for medication events is likely to grow.
Medication Errors
The National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) defines a medication error 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 healthcare professional, patient, or consumer. Such events may be related to professional practice, healthcare products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use (NCCMERP, 2019; USFDA, 2018).
Medication errors can occur throughout the medication-use system, such as when prescribing a drug; upon entering information into a computer system; when the drug is being prepared or dispensed; or when the drug is given to or taken by a patient. The U.S. Food and Drug Administration (FDA) receives more than 100,000 U.S. reports each year associated with a suspected medication error (USFDA 2018).
Common causes of such errors include:
- Poor communication,
- Ambiguities in product names, directions for use, medical abbreviations or writing,
- Poor procedures or techniques, or
- Patient misuse because of poor understanding of the directions for use of the product.
In addition, job stress, lack of product knowledge or training, or similar labeling or packaging of a product may be the cause of, or contribute to, an actual or potential error (USFDA, 2017).
Not all medication errors result in harm to the patient. For example, if the dosage or route were prescribed incorrectly but the error was caught prior to administration (often called a “near miss”), there was no patient harm. That said, any type of medication error must be tracked so preventions can be developed, regardless of whether a patient was harmed.
Adverse Drug Events (ADEs)
Adverse drug events are harms resulting from the use of medication and include allergic reactions, side effects, over medication, and medication errors (CDC, 2018).
While all adverse drug reactions are adverse drug events, not all adverse drug events are adverse drug reactions. A patient given the wrong medication is an adverse drug event but not an adverse drug reaction because the medication in question was not used as it was intended. The figure below helps to clarify how the medication-related errors differ and relate to one another.
Adverse drug reactions are a leading cause of injury and death; it is estimated they cause 100,000 deaths annually in the United States (USFDA, 2018).
There are three main causes for adverse reactions:
• As many as two-thirds of all patient visits to a doctor result in a prescription, and there are more drugs and combinations of drugs being used than ever before.
• More than 4 billion prescriptions were filled in 2017 at retail pharmacies alone, nearly 10 prescriptions per person in the United States.
• ADRs increase exponentially when a patient is taking four or more medications (USFDA, 2018; KFF, 2018).
The drug approval process may also play a role in the increase of adverse drug reactions. A drug that is tested in only a few thousand people may have an excellent safety profile in those patients, but some drugs require many more exposures to detect an adverse reaction—particularly reactions that occur with low frequencies.
Factors Increasing the Risk of Medical Errors
Vulnerable Populations
Anyone who takes medication has some risk of a harmful effect. There are some groups, however, that have an increased risk of adverse medication events. Children, elders, psychiatric patients and those with limited English skills and/or poor health literacy are at a high risk for adverse events.
Systems Approaches to Reducing Medical Errors
An important contributor to medical errors is lack of communication between co-workers, departments, shifts, and even among different organizations and levels of care. Doctors, nurses, and others see a particular patient through their own professional prisms and attend to different aspects of the patient’s care. This makes creating a culture of safety a huge organizational challenge, one that needs to be evaluated constantly and systematically. According to the IOM [sic], most medical errors are the result of systems failures that require analysis on a systems level to understand their cause
Root Cause Analysis
Root cause analysis (RCA) is a systems approach that asks three questions that provide the framework for information collection?
1. What is the problem?
2. Why did it happen?
3. What can be done to prevent it from occurring again?
According to the book Internal Bleeding, “RCA attempts to write a second story about the actions that led to error—to look past the obvious . . . scapegoats and find the other culprits, however deeply they may be embedded in the system” (Wachter & Shojania, 2004).
In 1997 the Joint Commission (then called the Joint Commission on the Accreditation of Healthcare Organizations, or JCAHO) mandated the use of root cause analysis in the investigation of sentinel events or medical errors in accredited hospitals. There are two main categories of error:
1. Active error, errors occurring at the point of interface between humans and a complex system
2. Latent error, the hidden problems within healthcare systems that contribute to adverse events (AHRQ, 2019c)
RCAs should generally follow a prespecified protocol that begins with data collection and reconstruction of the event in question through record review and participant interviews. A multidisciplinary team should then analyze the sequence of events leading to the error, with the goals of identifying how the event occurred (through identification of active errors) and why the event occurred (through systematic identification and analysis of latent errors). The ultimate goal of RCA, of course, is to prevent future harm by eliminating the latent errors that so often underlie adverse events. (AHRQ, 2019c).
REFERENCES
Agency for Healthcare Research and Quality (AHRQ). (2019c). Root Cause Analysis. Patient Safety Primer. Retrieved January 25, 2019, from https://psnet.ahrq.gov/primers/primer/10/Root-Cause-Analysis.
Agency for Healthcare Research and Quality (AHRQ). (2018c). 20 Tips to Help Prevent Medical Errors. Retrieved January 25, 2019, from http://www.ahrq.gov/patients-consumers/care-planning/errors/20tips/index.html.
Alexander CA, Wang L. (2014). Medication Errors: Preventing Untimely Deaths. International Journal of Research in Nursing 2014; 5(2):52-60. doi: 10.3844/ijrnsp.2014.52.60. Retrieved January 25, 2019, from http://thescipub.com/pdf/10.3844/ijrnsp.2014.52.60.
Bihari M. (2018) Health Insurance—Medical Errors and Health Reform: Affordable Care Act May Improve Patient Safety. verywellhealth.com. Retrieved January 12, 2019, from https://www.verywellhealth.com/medical-errors-and-health-reform-1738919.
Florida Statutes. (2018). The 2018 Florida Statutes. 381.028: Adverse Medical Incidents. Retrieved January 12, 2019, from http://www.leg.state.fl.us/Statutes/index.cfm?App_mode=Display_Statute&URL=0300-0399/0381/Sections/0381.028.html
2:2. doi:10.1186/2110-5820-2-2. Retrieved January 25, 2019, from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3310841/.
Howie WO. (2009). Mandatory Reporting of Medical Errors: Crafting Policy and Integrating It into Practice. Journal for Nurse Practitioners 2009; 5(9):649–54. Retrieved January 12, 2019, from http://www.medscape.com/viewarticle/712828_2.
Institute of Medicine (IOM). (1999). Kohn L, Corrigan J, Donaldson M (eds.), To Err Is Human: Building a Safer Health System. Washington DC: The National Academies Press. Retrieved January 11, 2019 from https://www.nap.edu/catalog/9728/to-err-is-human-building-a-safer-health-system.
Institute of Medicine (IOM). (2007). Aspden P, Wolcott J, Bootman L, et al. (eds.), Preventing Medication Errors: Quality Chasm Series. Institute of Medicine. Washington, DC: The National Academies Press. Retrieved January 11, 2019, from https://www.nap.edu/read/11623/chapter/1.
Joint Commission, The. (2017). Sentinel Event Policy and Procedures. Retrieved January 12, 2019, from https://www.jointcommission.org/sentinel_event_
policy_and_procedures/.
Joint Commission, The. (2016). Sentinel Events (SE): Comprehensive Accreditation Manual for Hospitals, Update 2, January 2016. Retrieved January 12, 2019, from http://www.jointcommission.org/assets/1/6/CAMH_24_SE_all_CURRENT.pdf.
National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP). (2019). About Medication Errors: What is a Medication Error? Retrieved January 14, 2019, from https://www.nccmerp.org/about-medication-errors.
National Quality Forum (NQF). (2011). Serious Reportable Events in Healthcare-2011 Update: A Consensus Report. Retrieved January 12, 2019, from http://www.qualityforum.org/Topics/SREs/List_of_SREs.aspx. The report, the 2011 Fact Sheet, and the current online List of SREs are all available at this URL.
Peerally MF, Carr S, Waring J, et al. (2017). The problem with root cause analysis. BMJ Qual Saf 2017;26:417–22. Retrieved January 25, 2019, from https://qualitysafety.bmj.com/content/qhc/26/5/417.full.pdf.
U.S. Food and Drug Administration (USFDA). (2018). Working to Reduce Medication Errors. Retrieved January 14, 2019, from https://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143553.htm.
U.S. Food and Drug Administration (USFDA). (2017). Medication Error Reports. Retrieved January 14, 2019, from https://www.fda.gov/drugs/drugsafety/medicationerrors/ucm080629.htm.
Yale Journal of Health Policy, Law, and Ethics. (2009). A National Survey of Medical Error Reporting Laws. Yale Journal of Health Policy, Law, and Ethics 2008; 9 (1):201–86. Retrieved January 11, 2019, from http://www.yale.edu/yjhple/issues/vix-i1-win09/docs/feature.pdf.
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