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Discussion Paper on Adverse Event and Error Reporting in Healthcare

Institute for Safe Medication Practices
January 24, 2000

I. Introduction

The recently released Institute of Medicine (IOM) report, "To Err is Human: Building a Safer Health System," outlines broad recommendations to improve patient safety and reduce medical error. The recommendations are designed for implementation at the public policy level to encourage organizations and practitioners to enhance patient safety at the care delivery level.

Although no single recommendation or activity offers a full solution to medical error, error prevention experts agree that successful error reduction strategies depend heavily on responsible detection and open reporting of errors. To that end, two of the nine recommendations call for the establishment and/or expansion of external mandatory and voluntary reporting programs.

According to the IOM report, reporting programs, whether voluntary or mandatory, must satisfy two primary purposes:

  1. To hold providers accountable for performance and patient safety; and
  2. To provide information that leads to new knowledge and improved patient safety.

II. Mandatory and Voluntary Reporting Systems

Both voluntary and mandatory reporting systems are operating currently throughout the nation with varying levels of success. A brief look at the success of these programs in meeting the IOM goals listed above may provide guidance in designing a reporting system model.

Mandatory Reporting Systems

Experience shows that current mandatory reporting programs have not been as successful as perhaps originally envisioned. While mandatory reporting systems have the potential to produce useful data, compliance with reporting requirements has been inconsistent, as evidenced by significant variation in the volume of reports and amount of useful information received by most mandatory systems. Such underreporting, despite any mandate, is understandable when you consider that disclosure has typically exposed organizations and individual practitioners to financial penalties, punitive actions concerning professional and organizational licenses, and legal and public scrutiny.

Any reporting program that has at its core the punishment of healthcare practitioners and organizations is bound to fail in terms of gaining new knowledge about errors, as well as holding providers accountable for patient safety. While punishment may be warranted in rare instances for illegal or malicious behavior, mandatory reporting in today's health systems typically results in punitive measures against health care professionals and organizations involved in medical error, whether punishment is warranted or not. Therefore, mandatory reporting, with its attendant threat of punishment, has had the undeniable effect of suppressing error reporting and inhibiting open discussion about errors and their system-based causes. In truth, all reporting systems are fundamentally voluntary, and even mandated reporting may be avoided (Billings C. Presentation to Subcommittee on Creating an External Environment for Quality Healthcare. Jan 29, 1999) to escape the threat of punishment.

In essence, many of the mandatory systems are perceived as less than credible because they tend to assign blame rather than identify and correct the system-based causes of errors. Blame typically underpins accountability systems and may be a powerful disincentive to reckless behavior. However, blame also discourages reporting and is a powerful barrier to collaborative problem solving. The inclination to blame individuals is rooted in hindsight bias - a tendency to see a problem as much simpler once you are in possession of the full facts and outcomes. Hindsight bias renders it difficult for you to understand that the situation faced by an individual at the time of the event is very different than perceived after the event. The events typically reported to mandatory systems have resulted in serious harm, and outcome-based event analysis is especially prone to hindsight bias.

Equally important, reports received through mandatory systems often do not include information that is crucial and necessary for the identification of system-based causes of error and the selection of error reduction strategies that can offer the greatest chance for success. Any reporting program that is not built fundamentally on the reports of front-line practitioners is likely to be a waste of valuable resources. Currently, reports to existing mandatory systems typically originate from a designated person within a healthcare organization who is not necessarily one of the front-line practitioners most familiar with the error. Further, the information usually contains a description of "what" happened, not "why" it happened. Additionally, the person designated to report an adverse event to a mandatory system is often under considerable pressure to minimize the organization's exposure to liability and public distrust. Therefore, it is not uncommon for pertinent information, which is crucial for effective analysis, to be overlooked, unavailable, or simply excluded.

Such second-hand reporting is not nearly as valuable as front-line practitioner reporting to the experts who must analyze errors and suggest solutions. As a result, the IOM report notes that current mandatory reporting programs have been less successful in synthesizing and analyzing information contained in the reports and recommending broad system improvements to enhance patient safety. Moreover, personnel with current mandatory systems may not have sufficient expertise to understand the system-based causes of errors and the most effective means to error-proof systems. In such situations, the human tragedy of medical error is compounded because much of the important information contained in each error that could lead to successful system-based error reduction strategies may well have been overlooked.

In the end, perhaps it is not the "mandatory reporting" component that has made many such systems unsuccessful in gaining the public's confidence, learning about the causes of error, and enhancing patient safety. Instead, the root of the problem more likely lies in the design of the reporting systems, the punitive culture in which they function, and the ineffective use of data submitted to the program.

Voluntary Reporting Systems

Conversely, the success level with existing voluntary reporting systems has generally been much better than that experienced by mandatory systems. Success stems not from a vast number of reports, but from:

  • The wealth of information contained within a representative sampling of errors reported to voluntary programs;
  • The recognition that error reduction efforts should not wait until a numerical threshold has been exceeded; and
  • Its focus on enhancing systems to improve practitioner performance.
Reports to voluntary systems typically come from front-line practitioners or others similarly close to the error, whom can best describe the specific conditions that led to that error. Better error descriptions make possible more effective analysis of the system-based causes of errors. This first-hand reporting and the improved analysis it affords has been used by error prevention experts to create a "road map" for improvement that easily and realistically can be extrapolated and implemented at the broadest variety of healthcare organizations. These practical recommendations for safe practice have been established, published, and widely disseminated throughout the healthcare community.

Further, voluntary reporting programs have learned that many errors are caused by factors outside the healthcare practice site and beyond the direct control of a healthcare practitioner. Thus, safe practice recommendations have been communicated to medical device manufacturers, pharmaceutical companies, automation technology companies, healthcare reimbursement systems, and others less directly involved in patient care, but nonetheless influential in the safe provision of care.

The success of current voluntary reporting systems also stems from the trust and respect that has typically developed between reporters and recipients who use the information to improve patient safety across the nation. Reporting is perceived to have immense value when those who report an error or potentially hazardous situation can readily see that the information is swiftly acted upon and used confidentially and proactively to develop and publish safe practice recommendations that can prevent errors. Additionally, many voluntary systems are considered more credible because of their autonomy and because they operate independently without reliance upon or relationship to regulatory and accrediting bodies or other health care community stakeholders. Thus, the analysis of the information can provide new knowledge about patient safety, without conflict of interest or pressure from other political, economic, or marketplace forces.

Perhaps most important, the success of current voluntary reporting systems stems from their non-punitive, system-based approach to error reduction. Typically, voluntary reporting systems acknowledge the inevitability of human error and understand that errors occur because people cannot consistently outperform unsafe systems that bound and constrain them. Therefore, the tendency to blame individuals is lessened, event analysis is system or process oriented rather than outcome oriented, and error reduction efforts are not targeted at the individual - the least manageable link in the error chain. Instead, error reduction efforts are designed to strengthen the systems in which practitioners work to make it difficult or impossible to err. The IOM report title, "To Err is Human: Building a Safer Health System," speaks loudly in support of a non-punitive, system-based approach to error reduction. As the title clearly implies, humans are fallible. Therefore, holding individuals accountable to perform perfectly at all times is a wholly unrealistic expectation.

Despite clear successes with voluntary systems, more can and must be done to expand voluntary reporting. Although reports submitted to voluntary systems are typically confidential, the major barrier in reporting to an external system is the loss of state statutory legal protection of the insightful analysis that is often contained within the body of the error report.

In the end, voluntary reporting systems have been largely successful in gaining new information about preventable adverse events, understanding the data through expert analysis, understanding the causation of errors, and sharing that knowledge with the healthcare community. However, using this knowledge to enhance patient safety is the responsibility of the healthcare community. While there is ample evidence that many organizations routinely attempt to apply the knowledge gained from voluntary reporting systems, some have not made patient safety a priority or provided the necessary resources to accomplish such a goal. Thus, the missing link is widespread adoption of proven error reduction strategies that have been identified through internal analysis of adverse events, external analysis of voluntarily submitted reports, and scientific research.

Conclusions

The IOM report suggests that the two stated purposes of external reporting systems - holding providers accountable for patient safety and gaining information that leads to improved patient safety - are not conceptually incompatible. However, it may be difficult to satisfy both simultaneously. For that reason, the report suggests that mandatory reporting systems may be necessary to hold providers accountable and deliver the necessary incentives for organizations to invest sufficient resources in enhancing safety. This recommendation likely reflects a general and growing feeling that the nation needs better healthcare information as well as a safer healthcare system, and that individual practitioners and providers must be held accountable for their actions. The report further recommends public and legal disclosure of serious errors, citing the public's right to know about such errors.

On the other hand, the report readily acknowledges that voluntary reporting systems, for both internal and external programs, are more useful and effective in learning about adverse events and improving patient safety. Thus, both mandatory and voluntary reporting systems are recommended to meet the goals of learning about errors and holding providers accountable for enhancing patient safety.

The Institute for Safe Medication Practices (ISMP) firmly agrees with the difficulty in satisfying both stated goals simultaneously with either mandatory or voluntary reporting alone. However, ISMP does not believe that mandatory reporting systems, as they currently exist or as proposed in the IOM report, will significantly increase provider accountability for patient safety or the public's trust in the healthcare system. Moreover, individual state-administered mandatory programs are unlikely to be successful in meeting this goal. If we must address provider accountability through a reporting system, success is more likely if you encourage healthcare organizations to report adverse events to a public agency, such as the Joint Commission (JC). While the JC encourages voluntary reporting of sentinel events, the organization also provides the level of expertise needed to validate, during on-site visits, that system-based changes have been made to prevent reoccurrence. However, organizations that mandate actions after an adverse event, such as JC, will undoubtedly inhibit disclosure of errors and lessen the amount of knowledge that can be gained from the reporting system.

However, other IOM recommendations address the goal of holding providers accountable for patient safety in a far more meaningful way than the recommendation for mandatory reporting. Examples include:

  • Regulators and accreditors should require healthcare organizations to implement meaningful patient safety programs with defined executive responsibility;
  • Public and private purchasers of healthcare services should provide incentives for healthcare organizations to demonstrate continuous improvement in patient safety;
  • Professional societies should recognize patient safety considerations in practice guidelines and in standards related to the introduction and diffusion of new technologies, therapies, and drugs;
  • Educational bodies, professional societies, and group purchasers should define standards of practice, inform members about patient safety, and call attention to the issues among the general public;
  • Competency testing of professionals should encompass error-prone activities;
  • Accrediting bodies and group purchasers should recognize and reward healthcare organizations that participate in voluntary reporting systems;
  • Healthcare organizations should incorporate well-understood safety principles; and
  • Healthcare organizations should implement proven medication safety practices.
ISMP also does not believe that legal disclosure of serious errors will regain the public's trust or enhance patient safety. The IOM report notes that committee members held alternative views on the protection of information submitted to external reporting systems. Some members felt that all information should be protected to prevent interference with disclosure of errors, proper analysis, and actions to enhance safety. Others felt that information should be disclosed and that liability is a part of the accountability system that serves a legitimate role in holding people responsible for their actions. The report states that mandatory reporting and legal disclosure of very serious adverse events caused by errors represent a compromise for both sides. ISMP believes the ramifications of this compromise could be significant and, in the end, will have little impact on patient safety other than to drive errors even further underground, especially in the absence of comprehensive tort reform legislation. At a minimum, federal legislation is needed to extend peer review protection to all information, including very serious and fatal adverse events, submitted to reporting systems.

The healthcare community does not need the "bigger hammer" of mandatory reporting or legal disclosure of serious errors to enhance patient safety and gain the public's trust. Many healthcare organizations are making significant changes that enhance patient safety, even without mandatory reporting requirements. The larger priority is to learn from preventable adverse events and errors through voluntary reporting systems and research, and to assure widespread application of that knowledge through implementation of the remaining IOM recommendations.

The following section provides a conceptual framework for a model reporting system - a model that can most effectively prevent tragic adverse events, save lives, use national resources most widely, and regain the public's trust in health care.

III. Conceptual Framework for Adverse Event and Error Reporting

The IOM report does not propose establishing a national voluntary reporting system, as there are already a number of good efforts in existence. However, expansion of existing programs and the establishment of new voluntary reporting systems to cover gaps in the current complement are encouraged. The proposed Center for Patient Safety has been charged with oversight of this process. While several options are available for the general design of voluntary systems, ISMP recommends, and the IOM report supports, the establishment or enhancement of focused "mini-systems" that are targeted toward selected areas in health care, such as surgical events, anesthesia events, medication events, pediatric events, and so on. The framework for such "mini-systems" should:

  • be national in scope;
  • be voluntary in nature;
  • be confidential;
  • be non-punitive with respect to those who report;
  • be independent of regulatory or accrediting bodies;
  • be objective with findings and recommendations;
  • be embraced and supported by the full health care community;
  • be effective and credible in analyzing and using the information;
  • be timely and widespread with communications about errors and their prevention;
  • encourage unrestricted practitioner reporting;
  • receive reports of serious and fatal events caused by error, "near misses," and hazardous situations that could lead to error;
  • provide incentives for reporting;
  • encourage universal acknowledgment, adoption, and implementation of proven safety practices; and
  • offer a level of evidentiary protection for the error information reported to it.

Voluntary Reporting

While reporting is fundamental to the broad goal of error reduction, barriers to reporting must be addressed before we can have a substantial positive impact on patient safety. Reporting will occur only if practitioners feel safe doing so and it becomes a culturally accepted activity within the healthcare community. Today, the obvious difficulty with widespread reporting falls primarily into three categories: fear of individual or organizational repercussion; the ill-conceived, false belief that medical error can be used as a measure of practitioner competence; and potential legal discovery of error reports. Thus, fundamental in our quest for safer patient care is an undeniable need for broader protection of error reports and a non-punitive culture that places higher value on reporting errors and resolving system-based problems than pursuing the largely unsuccessful path of punishing practitioners for errors. Until the healthcare community embraces such a culture, error reporting will continue to be an untapped resource, even if mandated. Although health care is slowly moving toward such a culture, mandatory reporting will not be successful until such a paradigm shift is in full swing. Primarily for that reason, the Institute for Safe Medication Practices (ISMP) strongly recommends voluntary reporting systems.

Also, voluntary reporting is preferred for another important reason. As noted in the IOM report, the volume of reports alone does not determine the success of a reporting system. Although a voluntary reporting system will not capture information about all error-related deaths and serious injuries, because of the repetitive nature of health care errors, a sound reporting system does not need reports of all deaths/injuries to be effective. In fact, as voluntary reporting systems are alerted to problems and provide feedback to the healthcare community, reports about the same problem decreases.

Aiming to capture information on all adverse events and errors through a large, mandatory reporting programs is unnecessary, redundant, and potentially wasteful of our nation's resources. This is because programs that collect larger numbers of error reports are unlikely to yield much new information beyond that which can be readily learned from a more streamlined and effective voluntary program. In fact, the collection of too much information simply slows analysis and subsequent actions that should be taken to protect against future errors. Further, important information is likely to be lost in the process of filtering such a large body of reports.

Equally important, mandating reports on all serious errors will not yield sufficient or accurate information about the current status of patient safety. The usefulness of reported events lies in the quality and contextual richness of the reported events, not in counting error reports. Scientific research has verified that healthcare practitioners fail to detect a large number of medical errors. As such, even in an ideal world where all detected errors would be reported, there would be no value in assessing the current state of patient safety by counting the number or calculating the percentage of errors through any reporting system. To date, research methodologies have been proven to be the only valid means of measuring patient safety in health care, as it relates to medical error. Hence, the number of errors reported to a program is not a true reflection of medical error occurrence or patient safety. In fact, the volume of reports is far less significant than the quality of information contained in reports that reflect a sampling of medical error across the nation.

Legal Protection of Error Information

Reporting has potential adverse consequences for those who report errors. Therefore, reporting systems that incorporate incentives and safeguards are likely to receive more and better data if the system is perceived as trustworthy and safe. One of the most significant incentives for reporting is to offer confidentiality and some level of evidentiary protection for the information submitted to reporting systems.

Information contained in specific error reports should not be legally discoverable solely because the organization has reported it externally to a reporting system. Instead, the information contained in externally submitted reports should be given the same legal protections currently afforded by state peer review statutes. In other word, reporting to an external reporting system should not waive the protections currently in place through state peer review statutes. Such protection is similar in spirit to the original intentions of state peer review statutes -to encourage open analysis of adverse events for the purpose of improvement, without fear of legally disclosing information gathered during the peer review process.

Because many state peer review statues would require careful revision to extend protection to information submitted to external reporting systems and other collaborative efforts, federal legislation would be a more efficient and effective alternative. Such federal legislation also should protect those who receive and analyze error reports from being forced to release sensitive patient, provider, or error information, even if requested during the legal discovery processes.

While the IOM committee points out that protection from liability may seem inappropriate for specific errors that cause serious patient harm, information obtained during analysis of the error already carries varying degrees of legal protection through state statutes. Thus, information about harmful events that result from errors should not be excluded from protection when organizations share the information with external sources for the purpose of enhancing patient safety.

Public Disclosure of Errors and Provider Accountability

With or without reporting systems, healthcare providers have a moral and ethical obligation to disclose medical errors honestly and promptly to patients and/or patients' families who are the victims of such errors. Moreover, such disclosure may reduce the financial risk to organizations. However, compelling widespread public disclosure of specific adverse events due to errors does not serve the public well. If specific errors are honestly revealed to patients and/or families, the decision to publicly disclose such information lies in the hands of the proper parties, the victims themselves, without risking inadvertent disclosure of sensitive or legally-protected healthcare information by providers.

Still, there is an appropriate place for public disclosure of patient safety issues. The IOM report notes that the public has a right to expect health care organizations to respond to evidence of safety hazards by taking whatever steps are necessary to make it difficult or impossible to make a similar error in the future. The report also notes that the public has a right to be informed about unsafe conditions. ISMP strongly agrees with this.

Providers and other participants in the healthcare process should be held accountable for the successful implementation of selected safety strategies that grow out of expert analysis of reported adverse events and scientific research. Reporting systems should not have the power to mandate implementation of recommendations that arise from analysis of adverse events. However, regulatory agencies (such as state health departments), accrediting bodies (such as JC), federal agencies (such as the Food and Drug Administration and the Health Care Finance Administration), and healthcare purchasing groups should evaluate such recommendations for feasibility and the cost/benefit of adoption as standards and the power to enforce these standards. Any healthcare organization's compliance with such standards should then be assessed during on-site visits.

Additionally, accountability should be expanded to include other participants in health care. Just as the public has a right to expect healthcare providers to implement solutions and practice the safest therapy possible, the public also has a right to expect companies that produce medical devices, pharmaceutical products, healthcare computers/software, and other health-related products and services to do their part in error-proofing health care. From committing financial resources to improving the safety of medical devices or redesigning a drug label, these often-overlooked participants outside the individual healthcare setting also should be held accountable for implementing safety strategies that have been adopted as standards by oversight agencies.

If healthcare organizations and/or companies do not comply satisfactorily with safety standards adopted by accrediting and regulatory bodies, or other oversight agencies, those safety breaches could be disclosed publicly. Additional information may be used to compare that organization's or company's compliance with the aggregate of other healthcare organizations or companies. This public exposure of safety breaches equips health care consumers to make safer and more informed healthcare decisions. Further, it is far more meaningful than simply disclosing sentinel events.

If desired, healthcare organizations or companies may choose to disclose publicly their adherence to adopted safety standards, after such compliance has been verified through on-site assessment by regulatory or accrediting bodies, or other oversight agencies.

Error Reporting Process

As noted in the IOM report, thorough analysis of errors depends on the quality of the information received. As such, the real value of the error report lies in the insightful narrative that describes the event and the details that identify the system-based circumstances under which it occurred.

Because inadequate and second-hand information provides little or no benefit, it is imperative that error or adverse event reports be initiated by front-line practitioners who are most directly involved in the day-to-day operations and can best describe the event and shortcomings of the system. The person reporting should submit the completed report directly to the applicable voluntary reporting system. Some organizations may prefer that a designated person submit all external reports. However, individual practitioners should not be banned from directly submitting verbal, written, or electronic reports to any voluntary reporting system to speed timely notice of the error, provide additional detail about the error, or report an error that they may not be comfortable fully disclosing within their own organization. Duplicate reports of the same error from multiple sources are likely to be detected. Still, duplicate reports would not seriously jeopardize the integrity of the reporting system, as the volume of reports would play a very minor role in comparison to the quality of the reports received.

Patient names should be removed from the reports. However, organizations and individual reporters should be encouraged, but not required, to identify their names to allow reporting system staff to talk directly with those who report the event or situation to gain important follow-up details. Once analysis is complete, the report could be purged of provider and/or reporter names to provide a stronger assurance of confidentiality.

A standardized format should be used for all reporting systems. This standardization will help ensure consistency of information and enhance the effectiveness of an aggregate database upon which trends can be identified and the primary causes of errors tallied. Both manual and electronic forms of reporting should contain standard, minimum data fields that guide identification of the system-based causes of error. Experts in respective fields should establish these minimum data fields, or a reporting taxonomy for each category of medical error, that can best gather useful information about the events or hazardous situations. However, a narrative description of the event or situation should be encouraged and its importance should not be overlooked. At the same time, the reporting format must be clear and easy for practitioners to complete.

Analysis of Reports

Submitted reports, properly interpreted, can provide important new knowledge about the function of systems and the latent causes of error. The IOM report notes, and ISMP strongly believes, that those who analyze and review error reports must be content experts who can understand and interpret the information being provided through the reporting system and other means of data collection. To that end, independent, multidisciplinary experts who are closely related to the type of information received by the voluntary reporting system should analyze the data. Such experts, who are independent of regulatory or accrediting bodies, can objectively determine the causes of errors and suggest effective solutions, absent any conflict of interest.

Open communication and methods for sharing information among reporting systems should be established to address overlapping problems (e.g., surgical misadventure that involves medication) and streamline error-reduction strategies (e.g., bar-coded name bracelets to prevent multiple types of medical error, such as administering medications to, or performing surgery on, the wrong patient). Equally important, voluntary reporting systems should establish open communication channels with regulatory and accrediting agencies so the knowledge gained from analysis of the reports can be evaluated for possible adoption as safety standards.

Rapid Dissemination of Information

Errors cannot be prevented in the field unless practitioners and others in health care hear about and learn from the safe practice recommendations that result from analysis of errors and near misses. For that reason, communication is a powerful and necessary component of an effective reporting program. Therefore, with appropriate protections for patients/provider confidentiality, named-blinded error descriptions, analysis of the causes of errors, and suggested prevention strategies should be made easily available to healthcare participants who need the information on a daily basis to enhance patient safety. Reporting systems should include as part of their mission a formally-sanctioned communication function (publication, web-site, and other print and electronic forms of communication, as necessary) to provide this crucial information directly, promptly, and effectively to those healthcare professionals, organizations, and others in the healthcare community who need it. In addition, every effort should be made to place information in other health-care-related forms of communication, such as well-read professional journals and magazines, and health-related consumer publications. Rapid dissemination of accurate, valid, and peer reviewed information also provides credible evidence that the information is being used appropriately and effectively, which in turn stimulates further reporting.

Reportable Events and Priorities

The IOM report recommends that harmful adverse events be reported to mandatory systems and those that cause little or no harm be reported to voluntary systems. However, throughout the IOM report, the immense value of learning from voluntary reporting systems is made clear. Yet, there is no provision in the IOM recommendations for front-line practitioners to report serious and fatal adverse events caused by error to voluntary reporting systems. This serious oversight will significantly reduce the opportunity for voluntary reporting systems to learn about the causes of error. Further, mandatory reporting systems, as proposed in the IOM report, will not achieve this goal, either, as their focus will be on holding providers accountable for patient safety.

Voluntary reporting systems undoubtedly will become less effective without reports of serious and fatal events. This is because, unfortunately, predictions of patient harm may not sufficiently and effectively motivate the entire healthcare industry to use the knowledge gained through analysis of "near misses" alone. Additionally, learning is impeded with reports of only "near misses," as failures in the system and the causes of errors closest to direct patient interaction may be overlooked.

Clear definitions and examples of reportable events or hazardous situations should be provided to the healthcare community. To have a positive impact on patient safety, priority should be given to reporting and analysis of preventable adverse events or hazardous situations that have the most significant potential to cause harm, or that have actually caused patient harm. Still, this stated priority should not imply any limitations on reporting. Indeed, practitioners and organizations should be encouraged and feel free to report any and all adverse events, errors, or hazardous situations. Only in this way can we hope to prevent medical errors instead of attempting simply to count them.

IV. IOM Focus on Medication Errors

While various patient safety issues abound in health care, medication errors comprise a large proportion of medical error. Therefore, the IOM report clearly focuses significant attention on this specialty area. In fact, one of the nine recommendations requires healthcare organizations to implement proven medication safety practices.

Strategic focus on reducing medication errors has several advantages. First, based on the prevalence of medication errors in health care today, this focused effort is likely to make a large and positive impact on patient safety. Next, an effective national model for voluntary medication error reporting currently exists in the U.S. and is well known as a credible system among medication error prevention experts and many healthcare professionals. The Medication Errors Reporting Program (MERP) is operated by the United States Pharmacopoeia (USP) in cooperation with ISMP and is an active partner in FDA's MEDWATCH program. As a tested and proven reporting system that includes expert analysis of errors and widespread communication of practical error prevention strategies, the IOM report acknowledged the immense value of this coordinated, voluntary reporting system.

Finally, as noted in the IOM report, distinct expertise for each broad category of medical error is needed to analyze and use the information obtained through reporting programs properly and effectively. Expertise for safe medication practices is readily available today through ISMP, USP, and FDA, and each organization could easily mobilize their forces quickly to meet the challenges of enhancing and expanding this coordinated, voluntary reporting system.

To that end, ISMP fully supports the IOM recommendation for the creation of a Center for Patient Safety to carry out the proposed functions, which include, but are not limited to the following:

  • To describe and disseminate information on external voluntary reporting systems to encourage greater participation;
  • To convene sponsors and users of external reporting systems to evaluate ways to make them more effective;
  • To periodically assess whether additional efforts are needed for gaps in information or participation to improve patient safety and encourage healthcare organizations to participate in voluntary reporting systems; and
  • To fund and evaluate pilot projects for reporting systems.
With the support of the proposed Center for Patient Safety, ISMP hopes to expand and strengthen the MERP, which is an effective model reporting system upon which to build, and thereby enhance our continuing efforts to dramatically improve medication safety throughout the U.S.

V. About the Institute for Safe Medication Practices (ISMP)

As a nonprofit organization, ISMP is well known as an education resource for the prevention of medication errors. The Institute provides independent, multidisciplinary, expert review of errors reported through the USP/ISMP Medication Errors Reporting Program (MERP). Through MERP, healthcare professionals across the nation voluntarily and confidentially report medication errors and hazardous conditions that could lead to error. The reporting process is simple. Practitioners complete pre-addressed mailers, dial toll-free numbers at USP (800-23-ERROR) or ISMP (800 FAIL-SAFE), or electronically send reports via e-mail. As an official MEDWATCH partner, ISMP shares all information and prevention strategies with the U.S. Food and Drug Administration (FDA). Working with practitioners, healthcare institutions, regulatory and accrediting agencies, professional organizations, the pharmaceutical industry, and many others, ISMP provides timely and accurate medication safety information to the healthcare community.

 

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