Medication Error Reporting: CQI Programs Offer Avenue to Vital Follow-Up

January 24, 2011 9:28 am Topics: Continuous quality improvement

Originally published in the January 2011 NABP Newsletter

Patient safety advocates have long emphasized the importance of documenting medication errors as a crucial tool in preventing future adverse medical events. Even before the Institute of Medicine’s landmark 1999 report, “To Err Is Human: Building a Safer Health Care System,” brought the issue to the attention of the public, medication error reporting was seen as an integral and vital element of programs designed to lessen the likelihood of dangerous mistakes and increase the quality and safety of patient care. At least 27 states require hospitals and/or other medical facilities to report serious medical errors, and 17 states mandate that pharmacies implement continuous quality improvement (CQI) programs. In varied pharmacy environments, CQI programs and error reporting have proven useful in helping to modify systems and procedures in order to prevent recurring errors and improve patient safety.

Data Analysis is Key

Error reporting forms the backbone of the health care systems’ efforts to improve patient safety. “Without reporting, health care systems have no mechanism to analyze, understand, and eliminate medication errors,” stated the authors of a 2004 study surveying Vermont community pharmacists’ medication error reporting.

Despite the emphasis on reporting, medication error reporting in and of itself is only useful as part of a broader strategy to reduce errors and improve care. As the National Coordinating Council for Medication Error and Reporting and Prevention (NCC MERP) states, “The value of medication error reporting and other data gathering strategies is to provide the information that allows an organization to identify weaknesses in its medication use system and to apply lessons learned to improve the system.” To have an impact on patient safety, the information conveyed by the errors must be analyzed and put to use, not merely collected.

Unanalyzed or improperly analyzed error data can be downright misleading, particularly if the general public attempts to, say, compare two hospitals by looking at the number of errors they have reported. A hospital with a larger number of errors could mean an institution that follows poorer safety practices and should be avoided – or could mean a hospital that has fostered an environment that encourages error reporting and subsequent systems improvement, translating to a safer patient experience. “Use of medication error rates to compare health care organizations is of no value,” cautions NCC MERP in a position statement. “The goal of every healthcare organization should be to continually improve systems to prevent harm to patients due to medication errors.”

Appropriate Analysis Through CQI

With this goal in mind – and at times prodded by regulation and certification or accreditation requirements – health care facilities from large hospitals to the neighborhood pharmacy have in recent years been moving toward instituting programs that provide continuous assessment and improvement of overall quality. Often, these initiatives follow the principles of CQI, a data-driven, process-based management approach that advocates that entities engage in ongoing, continual efforts to improve. While medication error reporting forms only one part of a comprehensive CQI program, as far as eliminating preventable adverse drug events, it allows managers to identify problems, assess best solutions, and measure successes.

CQI adherents contend that most problems lie with processes rather than people. Rather than seeking to lay blame, a CQI approach would be more likely to make a non-punitive response to an adverse incident and work to change the process or system such that achieving the desired outcome would be easier, and repeating an error would be difficult, if not impossible.

Health care facilities – including pharmacies – may, of course, engage in quality-improvement efforts without specifying them as “CQI,” but basic principles generally remain: examining current practices, noting real or potential errors, and improving systems to ensure better outcomes. Individual pharmacies may develop quality-related programs on their own, or contract outside providers to assist them.

Boards Support CQI Programs

While CQI or similar quality assurance (QA) programs have been prevalent in hospital settings for more than 10 years, in recent years regulators have increasingly begun to require similar programs in community pharmacies. Currently, implementation of a CQI or similar QA program that aims for ongoing assessment and improvement, is mandated for pharmacies in at least 17 states. “I believe that a majority of Massachusetts community/ambulatory pharmacies maintained some model of a [CQI] and or quality assurance program prior to Board regulations . . . requiring implementation of the same,” states James D. Coffey, director of the Massachusetts Board of Registration in Pharmacy, which has required CQI programs since 2005. “However, the Board’s CQI regulations established uniform program standards and procedures to identify and evaluate quality-related events, improve patient care, and provide for ongoing education at least annually in the area of CQI to pharmacy personnel.”

Unfortunately, the individual and often complex nature of CQI programs can make enforcement – or determination of their efficacy – difficult. To be effective, beyond certain minimum requirements, CQI programs must be site-specific, created by, and tailored to the specific situation of each pharmacy. In its report, the 2007 NABP Task Force on Continuous Quality Improvement, Peer Review, and Inspecting for Patient Safety noted some of the enforcement difficulties. “It was noted that a major obstacle for states is a lack of resources for enforcement,” explains the report. “[S]tates simply do not have a sufficient number of inspectors to ensure that CQI Programs are being correctly and effectively implemented.”

State CQI program requirements vary widely, and therefore evidence for compliance also varies. At present, inspectors must therefore look for the state’s spelled out requirements, and evaluate each pharmacy’s program as they are able. In Massachusetts, for example, compliance officers and the Board’s CQI quality assurance coordinator/surveyor assess CQI program adherence during routine pharmacy inspections and surveys, and also when a quality-related event is reported to the Board; in the latter case, the Board “examines pertinent documentation,” states Coffey, to get a broader understanding of both the error and the corrective actions taken by the pharmacy. “A challenging assessment issue associated with these types of CQI program reviews involves meaningful validation of the implementation of documented pharmacy policies and procedures established to enhance patient safety and pharmacy personnel’s comprehension [of] the same,” notes Coffey.

In Oregon, says Gary Miner, RPh, compliance director for the Oregon State Board of Pharmacy, no language currently specifies what the state-mandated QA programs should look like, or what elements they should contain; the regulations merely state that the pharmacist-in-charge is responsible for “implementing a quality assurance plan for the pharmacy.” Since 2009, Board inspectors have begun monitoring for the plans’ existence, and it is now included on a required self-inspection report. Kansas, which instituted CQI requirements in 2009, mandates that pharmacy CQI meetings must be held quarterly, for example, and must include a review of incident reports and be followed up with a written meeting report. “Kansas compliance officers do look for CQI reports when they inspect,” states Debra Billingsley, JD, executive secretary of the Kansas State Board of Pharmacy; to make this easier, the Board has requested (though not required) that pharmacies do their CQI in the same months. “Most are doing what we have asked,” notes Billingsley. Officers check to make sure CQI reports are fully filled out, and that suggestions to correct a problem seem sufficient. In addition, Billingsley states, “We have been requiring some stores to provide us with their CQI notes whenever we have had a complaint filed. Sometimes the complaint doesn’t warrant a fine or discipline but we want to make sure that the error was discussed . . . We have asked for additional follow-up if we didn’t think that they really considered ways to prevent the error in the future.”

The process often comes down to education, notes Oregon’s Miner. “Most pharmacists are not educated in quality assurance,” he says. The Board is considering adding guidance on its Web site to help pharmacies establish QA programs, from suggested actions to medication-error reporting forms. “Suggesting easy QA-type activities can help them get started,” says Miner, such as tracking during monthly reconciliation how many expired medications are on the shelves. Along with handing out information during inspections, the Board may also incorporate QA topics into the pharmacist-in-charge training classes it offers on roughly a monthly basis.

Specific compliance issues vary by location. In Kansas, for example, notes Billingsley, “The biggest hurdle has been the small independent stores. They may only have one pharmacist and they don’t think it’s necessary to have a CQI when they are the only pharmacist . . . [and] shouldn’t have to have a meeting with themselves. We have advised them that it is helpful for them to go over the errors with their staff regardless of the size of the store.” In Oregon, meanwhile, the Board has had more issues with chain pharmacies that report medication errors to a company-run, centralized database or program that can then analyze issues on a company-wide basis; the Board has had to emphasize that they need to look at QA “at the store level,” says Miner, rather than just the corporate level.

Analyzing Error Data Leads to Solutions

Numerous studies have examined the process of reporting, looking at factors such as what strategies are most effective in encouraging reporting and examining alternative methods for extracting medication error information.

The analysis of error data has enabled researchers to identify strategies for reducing medication errors in hospital settings, and studies have shown that certain tools are effective. For example, the use of bar code technology has been shown to reduce medication errors. A Food and Drug Administration (FDA) rule that took effect in 2004 requires that prescription drugs, many biological products, and over-the-counter medications commonly used in hospitals carry a bar code label. According to FDA, a Veterans Affairs medical center in Topeka, KS, cut its medication error rate by 86% over a nine-year period by combining the bar-coded medication with a bar-coded identification wristband worn by each hospital patient. A quick scan at the time of medication administration helps alert the administering nurse if there is not a match between the patient and the medication, or another problem. Similarly, the US Department of Health and Human Services’ (HHS) Agency for Healthcare Research and Quality in 2010 published the results of a study showing that bar code technology combined with an electronic medication administration record reduced non-timing administration errors by 41% (and thereby a 51% reduction in potential drug-related adverse events) and cut timing errors (when a patient was given a medication an hour or more off schedule) by 27%.

Nationally Aggregated Error Data

Much medication error collection happens on the local level, by a particular hospital, within a particular hospital program, or at a particular pharmacy. Analysis of this data helps in the creation of situation-specific solutions to identified problems. At the same time, error reporting on a larger or even national scale is helpful, as well. The Institute for Safe Medication Practices, which operates the Medication Errors Reporting Program (MERP), has for well over a decade publicized errors and hazards and recommended error-reduction strategies to health care workers (and sometimes the public) based on MERP information, allowing practitioners or pharmacies to take advantage of it by increasing their awareness of hazards and taking appropriate action. The MEDMARX error reporting system, developed by the United States Pharmacopeia (USP) and currently owned and managed by software company Quantros, Inc, contains more than 1.5 million reports of adverse drug events and the data is being analyzed. The National Patient Safety Foundation, for example, is funding research looking at more than 50,000 medication errors reported to MEDMARX and attributed wholly or in part to Computerized Prescriber Order Entry (CPOE), to gain a better understanding of the errors common to CPOE, a technology originally anticipated to do away with prescribing-related medication errors.

Encouraging Error Reporting

Medication error reporting – and factors that might inhibit it – continue to receive much attention from those entities seeking to increase patient safety. As fear of negative consequences – whether of discipline or lawsuits – has been identified as a large factor inhibiting the reporting of errors, rules governing the inadmissibility of error reporting in lawsuits or discipline have appeared on levels ranging from the workplace to states to the federal government. In particular, the federal Patient Safety and Quality Improvement Act of 2005 makes the “quality reports” associated with the monitoring and quality-improvement aspects of a QA program protected against discovery in the event of legal proceedings. According to HHS, the Patient Safety Act “establishes a framework by which hospitals, doctors, and other health care providers may voluntarily report information to PSOs [Patient Safety Organizations, organizations that can work with clinicians and health care organizations to identify, analyze, and reduce the risks and hazards associated with patient care], on a privileged and confidential basis for the aggregation and analysis of patient safety events.” HHS issued a Final Rule to begin implementation of the Patient Safety Act in early 2009.

States may also offer their own protections; when CQI programs were mandated for pharmacies in Kansas starting in 2009, for example, the regulations spelled out confidentiality protections: “Reports, memoranda, proceedings, findings, and other records generated as part of the pharmacy CQI program shall be considered confidential and privileged peer review documents and not subject to discovery, subpoena, or other means of legal compulsion for their release to any person or entity and shall not be admissible in any civil or administrative action other than an administrative proceeding initiated by the board of pharmacy.”

Board of pharmacy efforts to support and educate pharmacists on QA practices attest to the value of CQI or QA programs in improving patient safety. Whether it be reviewing reports at an independent community pharmacy or analyzing an error that occurred in a pharmacy environment with more complex hierarchies, assessment of error data and other reports can help to determine how policies and procedures should be adjusted. Future trends in CQI will likely involve continued assessment of what data should be collected, how the data should be reported, and how such data can best be analyzed and acted upon to improve patient outcomes.