Working to minimize medication errors and adverse drug events (ADEs) is a worthwhile goal for healthcare practices. Eliminating all errors and ADEs, however, is unlikely due to the fast-paced nature of the healthcare environment, the numerous demands providers face, and the staggering number of medications on the market.
A CRICO Strategies analysis of more than 28,500 malpractice claims showed that 1 in 9 cases involve a medication-related issue. Further, the analysis noted that prescribing even one medication involves multiple steps; thus, “When the medication process is scaled up to the volume, pace, and complexity of a typical healthcare environment, the opportunity for human, technical, and systemic errors proliferates.”1 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.
Not only should healthcare practices have processes and procedures in place to guide medication safety, they also 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 a healthcare practice 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 Practice’s (ISMP’s) Medication Errors Reporting Program — also collect data and disseminate information about the causes of medication errors.
Healthcare practices should have guidelines and policies that clearly establish what types of errors and events should be reported, how they should be reported, and to whom reporting should occur. Further, a functional system should be in place for documenting medication mishaps. The system should capture the information necessary to adequately assess and study each mishap.
Practice leaders and managers can facilitate these efforts by encouraging staff to report medication mishaps (even if the errors 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 often is the first step in determining how and why a medication mishap occurred. The best way to initiate the analysis might be to examine the healthcare practice’s current policies and procedures, which should clearly define the appropriate actions for evaluating the events surrounding a mishap, such as saving materials or supplies that might help determine the cause the problem.
In addition, staff members who are involved in a medication mishap should help review and assess the incident and the circumstances involved. Management should seek their input on strategies for improving system- and/or process-related issues that potentially contributed to the mishap. Much like the reporting process, the process for analyzing medication mishaps should be nonpunitive and reflect the organization’s commitment to a culture of safety.
The Health Research & Educational Trust, ISMP, and the Medical Group Management Association also suggest that, when attempting to identify errors and their causes, healthcare practices might find it helpful to seek external feedback from local pharmacies and hospitals about any possible errors originating in the practice. This feedback can provide valuable information that will help improve internal processes.3
Addressing Medication Mishaps
Following an analysis of the root cause of a medication mishap, designated 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 (a) tailoring electronic health record (EHR) alerts for certain commonly prescribed or high-risk medications, (b) physically modifying medication storage spaces to separate look-alike/sound-alike products, or (c) further establishing or refining key steps in the medication reconciliation and informed consent processes.
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 the affected patient and, if applicable, his/her caregivers. Despite the difficulty, harmful incidents should be addressed 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, healthcare providers should be cognizant that not every situation can or should be managed through disclosure. For example, near misses should be managed 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. Any disclosure activities need to be documented in the patient’s record, and only factual — not speculative — information should be included.
Additionally, clinicians and staff members who are involved in serious medication mishaps should be offered counseling services and emotional support to help address feelings of guilt, sadness, stress, or anger. Often referred to as the “second victims” of medical errors, as many as half of all clinicians might be involved in serious adverse events at least once during their careers.4 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. For more information about supporting second victims, see the article titled The Toll of Adverse Patient Outcomes on Healthcare Providers: Supporting Second Victims.
Learning From Medication Mishaps
Learning from medication mishaps that occur in your healthcare practice and in other practices and organizations is one of the best ways to prevent repeat occurrences. In a culture of safety, all mishaps should be viewed as learning opportunities, and information gathered from incident reporting should be 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.
Routine evaluations of a healthcare practice’s care processes and medication safety initiatives will present an opportunity for providers and 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 efforts to better understand and reduce medication mishaps. For more information, see MedPro’s guideline titled Using an EHR System as a Quality Improvement Tool in Your Healthcare Practice.
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.
1 CRICO Strategies. (2017). Medication-related malpractice risks: CRICO 2016 CBS benchmarking report. Retrieved from www.rmf.harvard.edu/Malpractice-Data/Annual-Benchmark-Reports/Risks-in-Medication
2 Institute for Safe Medication Practices. (2009). Improving medication safety in community pharmacy: Assessing risk and opportunities for change. Retrieved from http://ismp.org/communityRx/aroc/
3 Health Research & Education Trust, Institute for Safe Medication Practices, Medical Group Management Association. (2008). Creating medication safety. Pathways for Patient Safety.
4 Agency for Healthcare Research and Quality. (2019, September 7). Second victims: Support for clinicians involved in errors and adverse events. AHRQ Patient Safety Network. Retrieved from https://psnet.ahrq.gov/primers/primer/30/support-for-clinicians-involved-in-errors-and-adverse-events-second-victims#
The information and guidance provided here should not be construed as medical or legal advice. Because the facts applicable to your situation may vary, or the regulations applicable in your jurisdiction may differ, please contact your attorney or other professional advisors if you have any questions related to your legal or medical obligations or rights, state or federal laws, contract interpretation, or other legal questions.
About MedPro Group
MedPro Group is the marketing name used to refer to the insurance operations of The Medical Protective Company, Princeton Insurance Company, PLICO, Inc. and MedPro RRG Risk Retention Group. All insurance products are underwritten and administered by these and other Berkshire Hathaway affiliates, including National Fire & Marine Insurance Company. Product availability is based upon business and regulatory approval and may differ between companies.
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