Risk Management Tools & Resources

 


Managing and Learning From Medication Mishaps in Healthcare Practices

Managing and Learning From Medication Mishaps in Healthcare Practices

Laura M. Cascella, MA, CPHRM

Medication errors are common in outpatient settings, and research suggests that half of all avoidable harm in healthcare is related to medications.1 Taking steps to minimize medication errors and adverse drug events (ADEs) is a worthwhile goal for healthcare practices, and they should have processes and procedures in place to guide medication safety.

Yet, eliminating all errors and ADEs is unlikely due to the fast-paced nature of the healthcare environment, the numerous demands and challenges providers face, and the volume of medications on the market. Thus, being prepared to handle these situations and learn from them is a priority for creating a culture of safety that is continually evolving and improving.

Healthcare practices should have adequate systems and processes for reporting, analyzing, addressing, and disclosing medication errors, ADEs, and near misses (collectively referred to as “medication mishaps” or simply “mishaps” in this article). Further, staff members should have ample opportunities to learn from medication mishaps that occur in the practice and in the healthcare community at large.

Reporting Medication Mishaps

Reporting medication mishaps within an organization and to external entities can provide valuable data for assessing and improving medication safety. Mandatory requirements for medication error and ADE reporting vary by state. Confidential and voluntary error-reporting programs — such as the Food and Drug Administration’s MedWatch and the Institute for Safe Medication Practices’ (ISMP’s) Medication Errors Reporting Program — also collect data and disseminate information about the causes of medication errors.

Healthcare practices should have policies that clearly establish what types of errors and events staff should report, how they should report them, and to whom reporting should occur. Practice leaders and managers can facilitate these efforts by encouraging staff to report medication mishaps (even if they were caught or corrected) and commending staff whose actions bring these issues to light. A nonpunitive approach to medication mishaps will help facilitate the reporting process and reinforce safety as the practice’s top priority.2

Analyzing Medication Mishaps

Root cause analysis (RCA) often is the first step in determining how and why a medication mishap occurred. Staff members should review the practice’s RCA policies, which should clearly define the appropriate actions for documenting and evaluating the events surrounding a mishap, such as saving materials or supplies that might help determine the cause of the problem.

Staff members who are involved in a medication mishap should help review and analyze the incident. Management should seek their input on strategies for improving systems and processes that support medication safety. Much like the reporting process, the RCA process should be nonpunitive and reflect the organization’s commitment to patient safety and quality improvement.

Healthcare practices also might find it helpful to seek external feedback from local pharmacies and hospitals regarding medication mishaps. This feedback can provide valuable information that will help improve internal processes.

Addressing Medication Mishaps

Following an RCA of a medication mishap, staff members should recommend and implement any changes or additional steps to the practice’s procedures for prescribing, administering, storing, or dispensing medications. For example, staff members might recommend:

Additionally, practice leaders should determine a viable way to communicate critical information about medication mishaps with staff, whether individually (e.g., in an alert sent to staff mailboxes) or as a group (e.g., in a staff meeting). Timely and proactive communication will encourage staff members to participate in medication safety initiatives and feel comfortable making recommendations and asking questions.

Disclosing Medication Mishaps

Perhaps one of the most difficult aspects of managing medication mishaps is disclosing them to patients and, if applicable, their caregivers. Despite the difficulty, healthcare providers should address harmful incidents with honesty and transparency as part of a well-defined disclosure process. (Note: Although disclosing pertinent medical information is an essential aspect of patient-centered care, disclosure is not appropriate in every situation. For example, providers should handle near misses on a case-by-case basis, and disclosure may depend on whether the patient is aware of the situation and whether disclosure can help prevent a recurrence.)

To assist with the disclosure process, healthcare practices should have policies in place that guide disclosure activities and provide specific strategies for disclosing medication errors and ADEs, such as who will be present, what wording is appropriate, and how follow-up will occur. Providers should document any disclosure activities in patients’ records and include only factual, not speculative, information.

Additionally, healthcare practices should have resources in place to offer counseling and emotional support to workers who are involved in serious medication mishaps. These individuals might experience second victim syndrome — i.e., feelings of guilt, remorse, fear, sadness, stress, anxiety, or anger. A culture of safety not only encourages adequate systems and processes, but also supports the physical and psychological safety of patients, providers, and staff members.

To learn more about disclosure of unanticipated outcomes, see MedPro’s related checklist, guideline, and resource list.

Learning From Medication Mishaps

Learning from medication mishaps that occur within a healthcare practice and in other organizations is one of the best ways to prevent repeat occurrences. In a culture of safety, mishaps are viewed as learning opportunities, and information gathered from incident reporting is used to improve medication safety processes.

To support a continuous learning environment, staff need ongoing training on the causes and prevention of medication errors, as well as education about new medications, technologies, and devices. Staff also should be thoroughly trained and well-versed in office policies and procedures related to reporting, analyzing, addressing, and disclosing medication mishaps.

Routinely evaluating care processes and medication safety initiatives will present an opportunity for staff members to demonstrate competency in safety procedures and strategize how best to develop new initiatives or improve existing protocols.

Additionally, healthcare practices can use their EHR systems to support medication safety and quality improvement. For more information, see MedPro’s guideline Using an EHR System for Quality Improvement: Advice for Healthcare Practices.

In Summary

When medication errors, ADEs, or near misses occur, determining the “how” and “why” of the situation is necessary to mitigate the risk of future mishaps, improve patient safety, and reduce liability exposure. Equally important is fostering an environment that adequately supports effective systems and processes, encourages staff participation and compliance, and nurtures staff learning and development. A culture of safety will inspire staff to learn from medication mishaps, participate in finding solutions, and share accountability for medication safety within the practice.

Endnotes

1 Naseralallah, L., Stewart, D., Price, M., & Paudyal, V. (2023). Prevalence, contributing factors, and interventions to reduce medication errors in outpatient and ambulatory settings: A systematic review. International Journal of Clinical Pharmacy, 45(6), 1359–1377. doi: https://doi.org/10.1007/s11096-023-01626-5; World Health Organization. (2023, September 11). Fact sheet: Patient safety. Retrieved from www.who.int/news-room/fact-sheets/detail/patient-safety

2 Institute for Safe Medication Practices. (2009). Improving medication safety in community pharmacy: Assessing risk and opportunities for change. Retrieved from www.ismp.org/sites/default/files/attachments/2018-02/ISMP_AROC_whole_document.pdf

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