Published September 18, 2024 LAW Medication Errors and Liability Issues Jesse C. Vivian, RPh, JDEmeritus Professor of Pharmacy PracticeWayne State UniversityDetroit, Michigan US Pharm. 2024;49(9):43-46.In bygone days, pharmacists who discovered their own or others’ dispensing errors were told to retrieve the dispensing package from the patient, correct the mistake, and hope that this was the end of the situation. Fear of lawsuits inhibited such basic clinical developments as pharmacy patient profiles.Nowadays, of course, it is still prudent to correct the problem, but the mishap also should be reported to a governing authority, human resources department, or policymaker for an employer or organization. Either way, pharmacists could be exposed to liability concerns.Reporting strategies and laws that regulate mandatory reporting without fear of retribution are becoming the norm at a slow but discernible rate. Voluntary reporting of medication errors and near-misses encourages patient safety without punishing the reporting entity.Medication Errors DefinedThe FDA notes that the National Coordinating Council for Medication Error Reporting considers medication errors 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.”1 Errors involving prescription drugs can occur at nearly any point of the dispensing process, including prescribing medication, administering medication, entering prescription information into computer systems, preparing medication, and distributing activities. Some variances are intended therapeutic changes, but others are unintended and can be considered medication errors. If these errors have clinical consequences (i.e., if they cause harm or have the potential to do so), they can be considered actual or potential adverse drug events (ADEs).1The following types of prescribing and managerial medication errors have been identified2:1. Failure to prescribe, dispense, or administer a medication2. Patient given a medication at the wrong time (i.e., too early or too late)3. Patient given a drug that is not authorized for that patient4. Improper usage of a medication5. Wrong dose prescription or preparation6. Administration errors7. Patient’s medical conditions or potential drug interactions not considered8. Proper dispensing or prescribing rules for a medication not followed.Importantly, patients and caregivers are also at high risk for making medication errors. The following categories of patient medication errors have been outlined2:1. Errors involving medication filling and refilling2. Errors in medication administration3. Failure to carry out certain portions of the medication regimen4. Failure to follow clinical advice5. Not reporting information to providers6. Lack of adherence to follow-up.How Common Are Pharmacy Errors?Incorrect or erroneous distribution or application of medications is surprisingly common in the United States. Given the increased computerization of pharmacies and hospital medication cabinets, medication errors are expected to increase.Ten percent of hospital patients will experience a medication error. Some sources cite a rate of one in five Americans experiencing a medical error while receiving health treatment. In the U.S., medication errors are estimated to harm at least 1.5 million patients per year, with about 400,000 preventable adverse events. Medication errors are the eighth leading cause of death in the U.S. Medication errors cause at least one death every day in the U.S., and it has been reported that annually 7,000 to 9,000 Americans die as a result of a medication error.2,3 Reporting of medication errors in large academic medical centers has been estimated to average 100 per month. The FDA receives more than 100,000 reports annually related to medication errors.2Forty-one percent of Americans report being involved in a medical error personally or secondhand, and each year, more than 7 million patients in the U.S. are impacted by medication errors. During medication administration, there is a median error rate of 8% to 25%. Incorrect medication, incorrect doses, and incorrect directions are the most common dispensing error types. Medication errors in the home occur at a rate of 2% to 33%. Improper dispensing of medications results in error rates of 0.014% to 55%. A systematic review determined a global pooled prevalence of medication dispensing errors of 1.6% across community, hospital, and other pharmacy settings.2Technological Advances Can Create ErrorsComputers and other technological advances are not without their own problems. Hackers and ransomware demanders can cripple entire systems without regard to the havoc and dangers they impose on patient well-being. In a case originating in Michigan with ramifications in several other states, a hospital-based system suffered $24 million in financial-records breaches that were supposedly housed in a database on an unprotected server. In addition to the misconfiguration of the server’s security settings, the database allegedly did not have a password, meaning that anyone could have accessed the sensitive information. The documents revealed in the breach may be recent or may date as far back as 2008. Personal information was also involved in the breach, including names, addresses, birthdates, Social Security numbers, bank account numbers, loan agreements, bankruptcy filings, and tax documents.4 A neonatal ICU nurse at one hospital admitted that he almost gave a baby an incorrect dose of a narcotic because of confusing paperwork, a problem that arose when computer records were unavailable after a ransomware attack.5 He said that this type mistake had never occurred on that computer system prior to the ransomware attack.Barriers to Reporting ADEsNumerous errors are not reported by healthcare workers. The percentage reported is notably low based on the number of doses dispensed by most hospital pharmacies. Generally, medication errors are reported only if harmful or serious, and those that are not harmful but require a systems fix for future prevention are not reported.6 In the 1970s, when clinical aspects of the dispensing process became more widespread, some pharmacy managers argued against keeping medical profiles for patients in the community because doing so would expose the pharmacy to liability for drug mishaps. The evolution of clinical practice made this thinking obsolete.Nevertheless, medication errors, especially how to prevent harm from these mistakes, remain a concern for both the public and healthcare providers.6 A fundamental problem inhibiting the reporting of errors is the variation in how errors are defined, what information is reported, and who is required to report. For example, in the 1970s, a physician’s prescription for a dose of a medication not appropriate for a patient’s renal function was not even considered a medication error.6It was not until after safety movements in the 1990s that prescribing errors—which were attributed mainly to physicians—were recognized to be medication problems.6 Near-misses were very often not reported because they were perceived as nonissues, and healthcare workers who thought that a near-miss or error was not important or not harmful might decide that it did not need to be reported. Medication error reports frequently are time-consuming to complete, and healthcare providers may thereby omit error details, some of which may not be easy to retrieve.6,7 Additionally, it is hard to identify data trends in medication errors because of the absence of standardization of reported information.6The chief reason that mistakes are not reported is the fear that doing so will lead to repercussions, which could include loss of professional licensure and sometimes imprisonment.6 After making a serious error, healthcare providers may experience self-doubt, worry, anxiety, depression, blame, and guilt, not only for themselves (for disciplinary actions) but also for the harmed patient. In these situations, support often comes from the healthcare provider’s family, although some hospitals have support programs in place. Many healthcare providers remain silent about their mistake rather than admitting to it and discussing it with their peers, leading to further harm to patients if the system that caused the mistake is not identified and adjusted. Self-denial may also harm patient care outcomes.6Overcoming Reporting BarriersPatients and healthcare providers need to be aware of emerging best practices. Pharmacy managers should collaborate with other staff to put in place systems that prevent medication errors while fostering an ethos across departments and disciplines that is supportive of performance and outcomes management.6 Pharmacists must understand how to classify error-associated behaviors, instill staff values, set realistic expectations, and promote workplace accountability. These concepts will enable pharmacy directors to manage the amount of errors in patient-centered pharmacy services.The mid-1990s saw movement toward a blame-free culture based on increasing recognition of the fallibility of humans and the concept that no practice is free of errors.6 The focus shifted from the individual to the system processes that enable the occurrence of errors. Still, it was acknowledged that even knowledgeable and experienced employees could make a mistake that harms a patient. Although a step in the right direction, this blame-free model had its own faults, as it did not confront healthcare providers who repeatedly and willfully made unsafe behavioral choices in clinical practice. It is counterproductive to discipline healthcare providers for an honest error; however, failing to discipline those who make repeated errors exposes patients to potential danger. In a culture that does not place blame when appropriate, no one is held accountable and there are no consequences for any reported conduct. To develop a model for reporting errors and near-misses, it is essential to strike a balance between blamelessness and punitiveness.6There are other consequences to medication errors, including lack of trust in the healthcare system, decreased morale, physical and psychological pain, and lost wages/income.6 Most medication errors are the result of faulty systems and processes rather than reckless behavior. Pharmacy managers can proactively introduce systems that minimize human error and promote an appropriate ethos both inside and outside the pharmacy department.6For example, consider electronic prescribing. In the past, strategies, regulations, and laws all but prohibited this form of transmitting information while promoting oral telephone communications. This outmoded practice has since been replaced with policies that all but demand electronic prescribing as a way of eliminating handwriting-based errors. However, prescribing electronically via computer results in different sorts of mistakes (e.g., inputting mistakes, communication misinformation) that must be addressed. These problems often require the pharmacy to communicate with the prescriber’s office.8Another problem is at-risk behavior. An employee may make the decision to take a risk because he or she thinks that it is justified or of little consequence. Systems issues frequently are the reason that employees engage in such behaviors. Some examples of at-risk behavior are dispensing medications without having full knowledge of the drug, failure to have a colleague double-check a high-alert medication, and overriding computer alerts without consideration. Effective methods for addressing at-risk behavior include coaching these employees and encouraging them to actively identify how they can prevent future mistakes.6Reckless behavior is when a worker, for reasons that are subjective, consciously disregards significant, unjustifiable risk. Examples of reckless behaviors include working while intoxicated; encouraging a patient’s loved ones to administer patient-controlled analgesia; contaminating or tampering with medications or equipment prior to administration or operation; deliberately withholding drugs for pain; and recommending obviously improper medications or dosages. Disciplinary action is usually taken for reckless behavior; additionally, legal action may be employed if a patient experiences harm at the hands of a healthcare provider who is impaired or intoxicated. It has been noted that, according to the Institute for Safe Medication Practices, patient safety ought to be integrated into each work process rather than being considered a “priority” in healthcare.6,9The OIG’s Healthcare Fraud Self-Disclosure ProtocolIn 1998, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) published the first provider self-disclosure protocol (SDP) for voluntary identification, disclosure, and resolution of occurrences of potential fraud involving federal healthcare.10,11 Healthcare providers of any type (e.g., hospitals, physicians, durable medical equipment providers) can use the SDP to disclose and resolve instances of potential fraud in healthcare programs such as Medicare, Medicaid, and TriCare. The OIG established this protocol to give healthcare providers a means and incentives for self-reporting potential healthcare fraud.12The SDP provided guidance on investigating this conduct, quantifying damages, and reporting the conduct to the OIG to resolve the individual’s liability under the OIG’s civil monetary penalty authorities. The OIG resolved more than 2,200 disclosures from 1998 to 2020, which led to recovery of more than $870 million to federal healthcare programs. On April 17, 2023, the SDP increased the minimum settlement amounts of kickback-related claims from $50,000 to $100,000 and made other clarifying changes.13Case Law ExamplesCase 1: In 2022, a Michigan nurse was charged by the state’s Attorney General (AG) with causing serious physical and mental harm to a vulnerable adult, which is a 4-year felony. The criminal complaint alleged that while performing her duties, the licensed practical nurse realized that two incorrect medication doses were administered to a patient. Under state and federal laws, the nurse had a duty to report this error to a physician or supervisor in a timely fashion but did not do so. The AG stated, “Caring for vulnerable adults is a significant responsibility that requires special care. Failure to fulfill that responsibility can have dire and even criminal consequences.”14 Although it was not reported what transpired in court, it is noteworthy that the nurse was not charged with a drug-administration mistake but rather was alleged to have committed the crime of failure to report it. The difference is of major significance.Case 2: In 2021, a 54-year-old hospitalized COVID patient almost died after mistakenly being given cisatracurium—a muscle-paralyzing agent used in lethal injections—instead of the remdesivir dose he was set to receive before being discharged. The patient, who experienced severe brain injury as a result of the error, spent more than a month recovering in the hospital, then several months in a rehabilitation center relearning how to walk and talk, and may never regain his former functional capacity. A local newspaper cited a review of the patient’s 4,421-page medical report, state pharmacy regulations, licensing records, and hospital policy, noting that the incident would have been entirely preventable if the proper protocol had been followed.15Case 3: An Ohio pharmacist served jail time for negligence in failing to detect a pharmacy technician’s chemotherapy mixing error that resulted in the death of a 2-year-old patient. There was concern voiced on both sides of this case that caused significant anxiety and fear in pharmacists that limited reporting errors.16 The child’s father, now a patient safety advocate, speaks to pharmacists, pharmacy technicians, and students about how the pharmacy technician is like a member of a professional sports team, with the supervising pharmacist serving as head coach, and advocates strongly for having well-educated, career-oriented pharmacy technicians on all pharmacy teams, as they can reduce medication errors and prevent tragedies.17ConclusionAnyone who regularly takes prescription drugs or has received prescription medication in a hospital or clinic setting can appreciate the vital importance of best practices when it comes to receiving the medicine. Whether at the community pharmacy or in the hospital, it is essential to be aware of safety measures that could make a major difference in the care rendered to the patient. Every patient deserves peace of mind when it comes to his or her medications as well as living free from the consequences of medical and pharmaceutical malpractice. Healthcare leaders should readily adopt policies encouraging self-reporting of medication errors and near-mishaps instead of fostering fear of repercussions for self-reporting.REFERENCES1. Birkemeier D, Grissinger M. Evaluating medication errors occurring during the outpatient pharmacy prescription refill process. FDA. www.fda.gov/media/148397/download. Accessed August 16, 2024. See also: Vira T, Colquhoun M, Etchells E. Reconcilable differences: correcting medication errors at hospital admission and discharge. Qual Saf Health Care. 2006;15(2):122-126. Also: Lipton Law. What are medication errors? https://liptonlaw.com/michigan-medical-malpractice-lawyer/michigan-medication-errors-lawyer. Accessed August 15, 2024.2. SingleCare. Medication errors statistics 2024. www.singlecare.com/blog/news/medication-errors-statistics. Accessed August 15, 2024.3. Aspden P, Wolcott JA, Bootman JL, Cronenwett LR, eds. Preventing Medication Errors. Washington, DC: The National Academies Press; 2006.4. Datko S. Ascension data breach reportedly exposes the private information of millions. https://topclassactions.com/lawsuit-settlements/privacy/data-breach/ascension-data-breach-reportedly-expo. Accessed August 15, 2024.5. Pradhan R, Wells K. Cyberattack led to harrowing lapses at Ascension hospitals, clinicians say. www.npr.org/2024/06/19/nx-s1-5010219/ascension-hospital-ransomware-attack-care-lapses. Accessed August 15, 2024.6. Rogers E, Griffin E, Carnie W, et al. A Just Culture approach to managing medication errors. Hosp Pharm. 2017;52(4):308-315.7. See, e.g., University of Michigan Health. The Michigan Model: medical malpractice and patient safety at Michigan Medicine. www.uofmhealth.org/michigan-model-medical-malpractice-and-patient-safety-umhs. Also: Nosek RA Jr, McMeekin J, Rake GW. Standardizing medication error event reporting in the U.S. Department of Defense. www.ahrq.gov/sites/default/files/wysiwyg/professionals/quality-patient-safety/patient-safety-resources/resources/advances-in-patient-safety/vol4/Nosek.pdf. Accessed August 15, 2024.8. Baysari MT, Raban MZ. The safety of computerised prescribing in hospitals. Aust Prescr. 2019;42(4):136-138.9. Institute for Safe Medication Practices. Patient safety should not be a priority in healthcare. Part I: why we engage in “at-risk behaviors.” ISMP Medication Safety Alert. September 23, 2004. See also: Institute for Safe Medication Practices. Patient safety should not be a priority in healthcare. Part II: reducing “at-risk behaviors.” ISMP Medication Safety Alert. October 7, 2004.10. Fed Reg. 1998;63(210):58399.11. As defined in section 1128B(f) of the Social Security Act, 42 U.S.C. 1320a-7b(f).12. Phelps Dunbar LLP. What providers should know about the updated health care fraud self-disclosure protocol. www.phelps.com/insights/what-providers-should-know-about-the-updated-health-care-fraud-self-disclosure-protocol.html. Accessed August 16, 2024.13. U.S. Department of Health and Human Services Office of Inspector General. Updated OIG’s health care fraud Self-Disclosure Protocol. https://oig.hhs.gov/documents/self-disclosure-info/1006/Self-Disclosure-Protocol-2021.pdf. Accessed August 16, 2024.14. Michigan Department of Attorney General. Nurse charged over failure to properly respond to medication error. www.michigan.gov/ag/news/press-releases/2022/09/01/nurse-charged-over-failure-to-properly-respond-to-medication-error. Accessed August 19, 2024.15. Henderson J. Devastating medication error; FDA’s recall weakness; insurers break state laws. MedPage Today. www.medpagetoday.com/special-reports/features/107512. Accessed August 19, 2024.16. Emily Jerry Foundation. Emily’s story. https://emilyjerryfoundation.org/pages/emilys-story. Accessed August 16, 2024.17. Emily Jerry Foundation. EJF to present to pharmacy tech students in Indianapolis—April 4th. https://emilyjerryfoundation.org/ejf-to-present-to-pharmacy-tech-students-in-indianapolis-april-4th. Accessed August 19, 2024.The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.To comment on this article, contact rdavidson@uspharmacist.com.