Q&A with Patricia Kienle,
RPh, MPA, FASHP

Pharmacy Purchasing & Products: How consistent is medication error reporting? 
Patricia Kienle: A wide chasm exists between the number of medication errors that occur and the number of medication errors that are reported. In my experience, significant medication errors, and certainly those that reach the patient, are reported; however, less severe errors and near misses—now referred to as “good catches”—often go unreported. A recent study stated that hospital employees recognize and report only one out of seven adverse events, including medication errors.¹ Federal investigators performed an in-depth review of 293 cases that involved patient harm: 40 cases were reported to hospital managers and 28 were investigated by the facility, but only five cases led to changes in hospital policies and procedures. Reporting of errors needs to occur far more consistently, and these reports need to be investigated on a broader scale and more thoroughly. As we know, incidents that appear to be isolated events are often indicative of larger, systemic problems in the medication use process. Robust investigation of medication errors should drive changes in policies and procedures, if indicated by the evidence found during analyses.

PP&P: What are the reasons so many medication errors go unreported?  
Kienle: There are a number of explanations, but first and foremost is that—despite recent recognition of the importance of creating a hospital culture of safety—staff still experience trepidation at the possibility of punitive action if they report errors. A 2012 Agency for Healthcare Research and Quality survey on patient safety culture reported that only 44% of respondents feel that their facilities practice nonpunitive response to the reporting of errors.² Most staff members clearly fear that if they report errors, these events may be held against them and/or kept in their personnel files for the rest of their careers. 

Practicing a nonpunitive approach and assuring staff that error reporting is both welcomed and expected should be a priority for all administrators and pharmacy leaders if the rates of error reporting are to improve. For a culture of safety to fully permeate an organization, the impetus must come from the top management and filter down through every level in the hospital. Guiding hospital leaders toward a culture of safety is particularly important if they do not have a clinical background and are not experienced in analyzing an error as a clinician. When hospital leaders routinely walk through the patient care units, speak to the staff, and ask about safety, it sends a clear message to employees that the leaders truly care about patient safety. Involving the leaders in part of the error analysis—both prospectively and retrospectively—also helps them understand the complexity of the medication use system.

In addition, staff members may falsely assume that the error made is so common that it does not need to be reported, or, conversely, that the mistake is an aberration, ie, that no one else could possibly repeat the error. Ongoing education of staff on the importance of promptly reporting all medication errors—even those that seem unimportant or that they believe to be a one-time mistake—is critical in improving reporting rates. 

Underreporting of errors also occurs because staff members had reported errors previously, but did not receive a response or witness any action taken as a result of the disclosure. When a staff member takes the time to follow through with an error report, pharmacy leadership and administration must treat this report seriously and respond, even when it is decided that no comprehensive change in policy or procedure is required. Witnessing tangible changes that result from error reporting induces the reporting employee, as well as his or her coworkers, to believe in the reporting process as a means for improving patient safety. 

Near misses, or good catches, are particularly useful to share with staff as a way to recognize employees for their good work, rather than only acknowledging errors. Share this information, along with actual errors, during regularly scheduled staff meetings. If privacy is a concern, consider sharing the event but keeping the staff member anonymous. Many facilities have pharmacy–nurse committee meetings, which present ideal, ongoing opportunities to share information relevant to both departments in an effort to improve practice and patient safety. Oftentimes, errors have only been reported to the safety committee, so make it typical practice to discuss errors and near misses on a regular basis to familiarize staff with the process. Sharing successes as well as errors illustrates to staff that their contributions are valued, encourages continued reporting, and improves the hospital culture of safety. 

In addition, encourage reporting beyond the facility walls to a greater audience. Help facilitate the needs of team members who would like to write an article or create a presentation detailing a success story or a particular error that occurred and how it was remedied. In addition to publishing in Pharmacy Purchasing & Products magazine, the summer and midyear ASHP conferences, and state and regional society meetings are great venues to reach a larger audience. If time does not permit creating an entire presentation, consider participating in one of ASHP’s pearls sessions, in which each presenter speaks for only five minutes. Keeping abreast of current issues via the listserv and posting your challenges—as well as your successes—online helps other pharmacy leaders overcome similar challenges. 

Finally, experience has shown that for a reporting system to be effective, it must be simple, easy to use, and not time consuming. If a staff member is required to fill out a long, complicated form each time they want to report an error, it is unlikely many errors will be reported. 

PP&P: Are hospital staff sufficiently knowledgeable as to what constitutes a reportable medication error?
Kienle: In previous years, lack of education on what defined a reportable error may have been an issue. However, reporting guidelines have existed long enough that now most staff members are aware of what constitutes a reportable error. The National Quality Forum (NQF) developed a list of serious reportable events in 2002, and updated it in June 2011. The NFQ updated list specifies that patient death or serious injury associated with the use of contaminated drugs or with a medication error (wrong drug, wrong dose, wrong patient, wrong time, wrong preparation, wrong route of administration) are considered serious reportable care management events.³

The problem lies in incentivizing staff to follow through with error reporting. While additional education is always beneficial, we need to focus especially on diminishing the culture of blame and encouraging a culture of safety so more errors are reported. Having a broad understanding of what errors are occurring day-to-day is vital to uncovering and implementing practical solutions.

PP&P: What is the best system for reporting medication errors?
Kienle: The best system is the one that works effectively for that facility. Because hospitals have different levels of automation, what works well for one facility may not work well for another. Some facilities have medication error hotlines, where staff call in and report errors. In my experience, this does not work well because it just adds another task to a nurse’s already busy schedule. However, if there is an easy-to-use link to report a good catch or error, entering this information is not as time consuming as moving to a quiet place to make yet another phone call. In any case, the system that has been instituted only works if it is easy to use, completed quickly, and used consistently.

PP&P: Are there special considerations when reporting IV medication errors?
Kienle: All medication errors—whether involving an oral drug, an IV preparation, a medication compounded at the hospital, or a medication compounded by an outside pharmacy—must be treated the same way. IV medication errors are especially serious, due to their higher risk of patient harm and severe outcomes. IV administrations have a higher risk and severity of error than other medication administrations. In one meta-analysis of nine studies, the overall probability of at least one error occurring during IV therapy was 73%.4 The IV medication route is more complex, as multiple steps are required in preparation, administration, and monitoring. Compounding and administration of IV medications is a higher risk process than oral routes, and staff must be sufficiently educated to ensure safety. However, all drugs have the capacity to cause harm, regardless of route of administration, and all of these events should be reported.

PP&P: How can error data reports be used to drive practice improvement and increase patient safety?
Kienle: First of all, ensure you are receiving all of the information that has been reported at your facility. Regularly review literature reports, as well as data available from ISMP. ISMP publishes a medication safety alert newsletter every two weeks (http://www.ismp.org/newsletters/ ), as well as an action agenda four times per year (http://www.ismp.org/newsletters/acutecare/actionagendas.asp ). The purpose of these resources is to provide information about medication errors at other practice sites so that facilities can determine the possibility of the same or a similar error happening at their facility. 

However, it is not sufficient to simply keep abreast of national error events; use these reports to drive dialogue and debate in your facility, and thus create and implement solutions to errors that have been reported elsewhere.  

PP&P: What is pharmacy’s role in medication error event reporting?
Kienle: The medical staff and board of directors need to understand pharmacy’s role as the hospital’s medication safety net. Although medication errors are commonly shared with the P&T committee, the medical staff and board of directors often are not regularly informed of errors, and may be unaware of the role pharmacy plays in both the prevention of medication errors and the process changes implemented by pharmacy as a result of actual errors. Pharmacy leaders should set up meetings to conference with both physicians and the board of directors to explain the services pharmacy provides; they also should be made aware, on a regular basis, of the many successes and good catches pharmacy has performed. Educating these groups on the full scope of pharmacy’s purview will both inform and elevate the perceived role of pharmacy throughout the organization. 

References

1. The New York Times Web site. Report finds most errors at hospitals go unreported. http://www.nytimes.com/2012/01/06/health/study-of-medicare-patients-finds-most-hospital-errors-unreported.html Accessed February 22, 2012.
2. Agency for Healthcare Research and Quality Web site. Hospital survey on patient safety culture: 2012 user comparative database report executive summary. http://www.ahrq.gov/qual/hospsurvey12/hosp12summ.htm
3. National Quality Forum Web site. Serious reportable events in healthcare—2011 update. http://www.qualityforum.org/projects/hacs_and_sres.aspx Accessed February 24, 2012. 
4. McDowell SE, Mt-Isa S, Ashby D, Ferner RE. Where errors occur in the preparation and administration of intravenous medicines: a systematic review and Bayesian analysis. Qual Saf Health Care. 2010;19(4):341-345.

Patricia C. Kienle, RPh, MPA, FASHP, an employee of Cardinal Health since 1999, currently serves as the director of accreditation and medication safety. She is the recipient of an MPA in health service administration from Marywood College in Scranton, Pennsylvania, a BSc in pharmacy from Philadelphia College of Pharmacy and Science, and has completed an executive fellowship in patient safety from Virginia Commonwealth University. Patti is also an adjunct associate professor at Wilkes University in Wilkes-Barre, Pennsylvania.