Panel 3: Particular Systems Issues

Testimony of Michael R. Cohen, Institute for Safe Medication Practices

On behalf of the Institute for Safe Medication Practices (ISMP), I am very pleased to provide testimony to this distinguished panel on priority initiatives for medical error and patient safety research. While a variety of patient safety issues abound, medication errors alone account for thousands of deaths annually in the U.S. (1) and represent a significant public health risk. Thus, the Institute of Medicine (IOM) report, To Err is Human: Building a Safer Health System, appropriately places a high priority on medication error reduction efforts. (2).

In providing this testimony, it is important to note that ISMP is a nonprofit organization devoted solely to the prevention of medication errors. As such, all ISMP efforts are built on a non-punitive approach and systems-based solutions, designed to:

• Build the broadest possible knowledge base about medication errors.
• Increase the understanding of such errors through sound scientific analysis.
• Provide education and outreach that increases awareness and helps in the development and implementation of error-prevention strategies and tools.
• Foster cooperation and communication among all stakeholders so that we might all work together to prevent medication errors before any patient is injured.

While ISMP works closely with healthcare practitioners and institutions, regulatory and accrediting bodies, professional organizations, technology vendors, the pharmaceutical industry, and consumers, the Institute is a completely independent organization that receives no advertising revenues and depends entirely on volunteer efforts, educational and consulting projects, grants, and donations to pursue its work. Through its activities, ISMP has learned a great deal about how to reduce the risk of medication errors. Although ISMP and others have worked diligently for many years to communicate known and effective medication error reduction strategies to the healthcare industry and the public, such known strategies have not been universally adopted or implemented in the majority of hospitals and ambulatory care practice sites, or by healthcare providers, patients, and other healthcare stakeholders (2).

Therefore, we respectfully suggest that the national agenda for research must include:

1. Thorough study of why the healthcare industry and consumers have failed to adopt widely the known effective medication error reduction strategies that have been communicated over the years; and
2. Careful study of how best to structure and fund a more comprehensive, nationwide initiative that can effectively lead to improvements in medication safety.

I. Background

For more than 25 years, ISMP has provided expert, multidisciplinary review of medication errors that have been voluntarily submitted by practitioners to the national Medication Errors Reporting Program (MERP), which was originally established by ISMP and is currently operated by the United States Pharmacopeia (USP) in cooperation with ISMP. All information derived from the MERP is shared with the U.S. Food and Drug Administration (FDA) and pharmaceutical companies whose products are mentioned in reports. Device-related errors are also shared with ECRI, a nonprofit agency that devotes its resources to improve safety in the use of medical devices. Through MERP, ISMP has learned a great deal about medication errors and the conditions under which they occur. The Institute has identified a wide scope of medication safety issues, explored underlying causes, and recommended high-leverage error reduction strategies. Moreover, since January of 1996, ISMP has publicized findings in a biweekly newsletter (ISMP Medication Safety Alert!) that reaches tens of thousands of healthcare professionals and managers in virtually every U.S. hospital, through articles and continuing columns in 19 professional journals or newsletters, via the ISMP Web site and communication campaigns that reach millions of healthcare professionals and consumers, and through a variety of other educational media and symposia. At the same time, many error prevention strategies have been developed and recommended by others such as USP, FDA, ECRI, the American Society of Health-Systems Pharmacists (ASHP), the American Hospital Association (AHA), the Institute for Healthcare Improvement (IHI) and other expert organizations and agencies. Likewise, much research has been conducted on the scope, cost, and causes of medication errors (3-5). As a result, research-based medication error reduction strategies have been identified, validated, and publicized in peer reviewed professional journals and other forums such as symposia (6-8).

The MERP, other voluntary medical error reporting systems, and research studies have been largely successful in learning about medical errors, understanding the underlying causes, identifying effective system-based changes to reduce the risk of error, and sharing that knowledge with the healthcare community. While we undoubtedly need to continue to learn more about medication and medical safety, we do already possess a great deal of information that can be applied today to significantly reduce the risk of errors.

The IOM report notes that the public has a right to expect the healthcare industry to respond to safety hazards and take necessary steps to make it difficult or impossible for errors to occur (2). The report also recommends that healthcare organizations incorporate well-understood safety principles in their patient safety programs and implement proven medication safety practices that grow out of expert analysis of medical errors and research (2). While there is evidence that some organizations consistently attempt to apply the knowledge gained from expert analysis of medication errors and related scientific research (9), the healthcare industry and the public have not generally or readily embraced and adopted these medication error reduction strategies. Every day there is clear evidence that another tragic medication error could have been prevented if this important knowledge had been transformed into action. This cycle of inaction strongly suggests that we need to understand reasons that the healthcare industry and consumers have failed to widely adopt and implement effective medication error reduction strategies despite the fact that such strategies have been communicated as widely as possible. Patient safety could be enhanced significantly if we placed a high priority on the following research goals:

• Identify the current level to which known medication error reduction strategies have been adopted;
• Identify the motivators and barriers that crucially affect adoption of known medication error reduction strategies; and
• Identify the most effective ways to structure and fund a more comprehensive, nationwide communication initiative that takes full advantage of current and future knowledge about medication error prevention and leads to widespread and effective improvements in medication safety within the healthcare community and among consumers.

In considering such research goals, it is important to note that the goals can apply broadly to both medical as well as medication errors, be useful in all healthcare settings, and benefit all healthcare participants.

IV. Current Level to which Known Medication Error Reduction Strategies Have Been Adopted

Currently, little is known about the level to which known medication error reduction strategies have been adopted within the healthcare community and among consumers. A few studies have focused on the prevalence of using specific error prevention technology, such as pharmacy computer systems, automated dispensing modules, and computerized prescriber order entry (CPOE). For example, while it is estimated that over 90% of hospitals and ambulatory pharmacies use computer systems to screen and process drug orders, only 13% of U.S. hospitals have the capability of CPOE and an even smaller percentage of hospitals are actually using the CPOE system (10). Among those hospitals that use a CPOE system, only 10% of all orders are entered through CPOE systems (11). It is also clear from analysis of medication errors submitted to the MERP, and the repetitive nature of reported errors, that even some of the most basic and less costly error reduction strategies have not been widely implemented.

According to MERP error reports, knowledgeable patients and family members do often ask appropriate questions and thereby intercept and prevent medication errors. Still, beyond this anecdotal evidence of patient/caregiver involvement in medication error prevention, little is known about the consumers' actual level of knowledge about medication errors and prevention. Moreover, little is known about which error reduction strategies have the highest likelihood of being adopted among patients/caregivers.

The research framework for these topics initially should entail a literature search to identify and collate known medication error reduction strategies for each type of care setting. It would also need to prioritize or rank strategies based on feasibility of implementation, potential strength of the strategy to achieve and maintain consistently lower incidence of medication errors, and the cost/benefit of adoption.

Representative samples of each segment of the healthcare community (e.g., all types of healthcare providers, pharmaceutical industry, medical device and technology vendors, reimbursement systems, patients/caregivers, etc.) should also be assessed for the adoption of selected medication error reduction strategies. In a cooperative project with the American Hospital Association (AHA), ISMP recently developed and distributed to virtually all U.S. hospitals the ISMP Medication Safety Self-Assessment. This weighted self-assessment instrument provides a list of nearly 200 effective medication error reduction strategies for use in the general hospital setting. Analysis of the data returned to ISMP as part of this project could be a powerful tool in helping to determine the level to which effective medication error reduction strategies have been adopted in hospitals and in identifying which strategies are most likely to be adopted in the future. Recently, the American Pharmaceutical Association Foundation and ISMP agreed to work together to provide a similar self-assessment project for the nation's ambulatory care pharmacies (community and chain pharmacies and other outpatient pharmacies.) Similar instruments should be developed to evaluate the level to which known error reduction strategies have been adopted in other healthcare settings and by consumers. Importantly, secondary analysis of the data and reassessment of a random sampling of respondents could also identify barriers and motivators that crucially affect the adoption of known medication error reduction strategies in all settings.

III. Barriers and motivators that affect the adoption of known medication error reduction strategies

Medical error researchers and those involved with medical error reporting systems should not be in a position to mandate implementation of recommendations that arise from scientific studies or their expert analysis of adverse events. If they were in a position to mandate implementation, it would undoubtedly discourage disclosure of errors by healthcare practitioners and others, and reduce participation in scientific studies. This would then lessen the knowledge that could otherwise be gained from these two important sources of error reduction information. As such, the responsibility to apply the knowledge learned through research and expert analysis of errors falls primarily to the healthcare community and public at large.

There has been much discussion but little or no research about possible barriers to the adoption of known error reduction strategies within the healthcare community. For example, in many states the current tort system and legal environment are likely to suppress the disclosure of errors, proper analysis, and effective actions to enhance safety. Likewise, a culture that primarily focuses on blaming individuals for medical errors, instead of focusing on implementation of recommended system-based changes that have a greater likelihood of reducing the risk of error, promotes implementation of practitioner-focused remedial actions which are unlikely to have a sustained positive effect on patient safety.

Other possible barriers include difficulty with applying broad-based error reduction strategies that fail to include a detailed road map for implementation (e.g., clinical pharmacy programs); difficulty in application of research models (e.g., CPOE); difficulty in application between different settings of care (e.g., acute care vs. long term care); staffing shortages; denial of medication error related problems; lack of "ownership"; and departmental "turf" issues. Lack of leadership commitment and priority for medication safety may also deter adoption of medication error reduction strategies.

In 1999, the Advisory Board Company conducted a survey of healthcare Chief Executive Officers to identify their top concerns (12). The survey showed that "reducing clinical error and adverse events" ranked 133 out of a total list of 142 concerns! It is possible that denial of patient safety and medication-related problems, lack of understanding that the potential for catastrophic events lies dormant in all organizations, and failure to understand the cost benefit of error reduction strategies are at the root of leaderships' low priority for medication safety initiatives.

Finally, external pressures from reimbursement systems, government regulations, the pharmaceutical industry, technology or medical device vendors, and purchasing groups may place considerable constraints on healthcare providers as they attempt to implement effective medication error reduction strategies. For example, managed care companies repeatedly change covered formulary drugs, which requires switching patients drug therapy on a frequent basis. Some vendors have designed medication delivery devices without fail-safe mechanisms necessary to decrease the risk of user error. A pharmaceutical company may continue to distribute a drug with a confusing and error-prone label. Purchasing groups may penalize healthcare providers that elect to purchase products that are not part of their contractual agreement even when they are safer.

Regulatory agencies (e.g., state health departments), accrediting bodies (e.g., Joint Commission on Accreditation of Healthcare Organizations), federal agencies (e.g., FDA, Health Care Finance Administration), and healthcare purchasing groups (e.g., Leapfrog) have recently begun to evaluate recommendations stemming from medication error research and error reporting systems for adoption as standards or to offer incentives to those who employ the strategy. When regulatory, oversight, and reimbursement systems offer incentives or adopt recommendations as standards, the potential for translating known error reduction strategies into action seems to increase. For example, after the Joint Commission announced that surveyors would ask probing questions about error prevention initiatives where concentrated potassium chloride was found in patient care units, compliance with this long-standing medication safety recommendation increased (13). Yet, about 70% of hospitals had already adopted this recommendation before it became an accrediting requirement (14). Nevertheless, we know little about what motivated the early adopters that did not wait for a sentinel event to occur or an accrediting requirement. We have also observed that some organizations have demonstrated great momentum while implementing many medication safety strategies and other patient safety initiatives. However, once again, we have not clearly identified the factors that motivate and sustain this patient safety momentum.

There is also minimal understanding about the consumers' possible barriers and motivators to adopting known medication error reduction strategies. While it is clear that patients know that medical errors occur, our experience suggests that lack of specific knowledge about errors, their causes, and effective error reduction strategies is the primary barrier to adoption. On a broader level, some studies have looked at the reasons that patients may be non-compliant with medical care in general. Still, the failure to clearly understand the consequences of non-compliant behavior rank high on the list of reasons that consumers may fail to comply with prescribed therapy. The framework for researching this topic would entail a search of the literature to identify broad-based motivators and barriers to change, and an assessment of their applicability to the adoption of medication error reduction strategies. A literature search of specific barriers and motivators to adopting patient safety and medication error reduction strategies for each setting of care would also be needed. After designing and testing an appropriate instrument for each sector of the healthcare industry and consumers, the barriers and motivators to adopting known medication error reduction strategies would be assessed for a representative sampling of each healthcare sector. Secondary analysis of the data from the ISMP Medication Safety Self Assessment and reassessment of a random sampling of respondents could also identify barriers and motivators to adopting known medication error reduction strategies in the hospital setting.

IV. Communication of effective medication error reduction strategies

Another barrier to the adoption of known medication error reduction strategies is the failure to communicate broadly and effectively. Medication errors cannot be prevented unless all participants in the medication use process—from those who develop and market drugs and devices to healthcare professionals and patients themselves—hear about and learn from those safe practice recommendations that are resulting every day from expert error analysis and related research. Therefore, communication must be a powerful and absolutely essential component of any initiative to foster and encourage widespread adoption of known medication error reduction strategies. Thus, while appropriate protections must be in place to protect the confidentiality of both patients and providers, name-blinded error descriptions, analysis of the causes of errors, and suggested prevention strategies must be made easily available to all healthcare participants, including consumers, who need the information on a daily basis to enhance safety.

Publications, Web sites, and other print and electronic forms of communication are excellent channels to communicate about known error reduction strategies. For example, publications such as the Joint Commission's Sentinel Event Alert describe a broad scope of medical safety issues and are widely distributed to selected healthcare audiences. The ISMP Medication Safety Alert! is the Nation's only publication devoted solely to the prevention and reduction of medication errors; it is widely distributed to healthcare professionals in virtually all U.S. hospitals. However, there is no official or formally-sanctioned, comprehensive communication function, like ISMP Medication Safety Alert!, to provide this kind of crucial error-prevention information directly, promptly, and effectively to all healthcare participants, including patients, who need it to ensure medication safety.

Identifying the degree to which healthcare professionals are aware of current safety issues and safety profiles with medications that they prescribe is important in assessing the effectiveness of our current system for translating learning about adverse drug reactions into practice. Clinicians may be aware of a drug's safety profile through indirect means such as product advertisements, presentations at seminars, interaction with sales representatives, communication with pharmacists. Awareness of changes in the medication package insert appear to be limited in dissemination and the more substantive safety issues that come to the clinicians' attention (e.g., Dear Health Professional letters mandated by the FDA) have an unclear impact and reach. Some recent drug recalls have resulted when it became clear to FDA that clinicians failed to utilize safety information made available through such efforts. For example, the drug Propulsid was withdrawn earlier this year when it became clear that dangerous drug interactions associated with the drug persisted despite previous attempts at alerting clinicians through labeling changes and manufacturer warnings. Additional information needs to be obtained from the clinician about their current exposure to safety information and the design of that information that is currently most effective for them. It would also seem reasonable to undertake additional work to define, test, and implement different methods for communicating safety information in an effort to identify new and more effective ways of reaching those who prescribe medications.

Currently, there is no comprehensive resource about medication error prevention available to healthcare consumers. Today, consumers who seek medical related information, including information about medication errors, most often look to the advice of friends, printed materials from professional or healthcare advocacy organizations, and an increasing number of Web sites from the federal government, organizations, and private companies. Electronic and printed information from the federal government and respected professional/health/medical organizations is likely trustworthy. However, the accuracy and reliability of a great deal of the information being circulated, especially from Web sites developed and maintained by private businesses and individuals, is often questionable.

Most likely, consumers are not well informed about the steps that they can take to reduce the likelihood of a medical error. In 1997, Harris performed a consumer public opinion poll on patient safety for the National Patient Safety Foundation (15). The poll showed that 92% of adult respondents felt that they, themselves, had a positive effect and played an important role in their own safety. Yet nearly one out of ten adults stated that they have not or would not take any precautions to ensure their safety. Of those who had, the most prevalent precaution was to obtain a second opinion, most likely because this has been widely publicized, and often required, by healthcare insurers.

The framework for researching this topic would entail a search of the literature to identify all the methods currently used to communicate important medication and patient safety information for each sector of healthcare and the public. Examples include written media (e.g., newsletters, self-assessment instruments), audiovisual media (e.g., teleconferencing, videoconferencing, symposia, videotape, audiotape), electronic media (e.g., Internet, E-mail, CD-ROM), and others. Next, it would be important to identify all sources of information about medication or patient safety, the content, accuracy and expertise of informative materials distributed, what actually reaches each audience, and the degree to which audience members are motivated and able to absorb, understand, and interact with the information provided. It would also be necessary to determine if there are any potential conflict of interest issues between the source and the content of the patient safety information communicated.

In short, we must explore better ways to structure and fund consumer-oriented health and medical communication so that it is as timely, accurate, reliable, and effective as possible. This kind of information must be communicated effectively if we expect consumers to adopt known error prevention strategies.

Finally, it must be determined if there are differences between the effectiveness of various methods and content of communication and specific types of audiences (e.g., physician, pharmacist, nurse, technician, administrator, pharmaceutical company, consumers). The impact of selected communications could also be measured to determine its ultimate effectiveness and ability to fulfill its purpose.

IV. Conclusion

As a result of the IOM recommendations to enhance reporting of medical errors, a great deal of emphasis is being given to development of new error reporting efforts. However, healthcare stakeholders have not adopted much of the information that has already been learned through existing reporting programs, as well as research efforts. It makes little sense to develop expensive new reporting programs without a better understanding of how the information can be applied in practice. Research is needed to identify the current level to which known error reduction strategies have been adopted and motivators and barriers that affect their adoption. We also need to identify effective ways to structure and fund a more comprehensive, nationwide communication initiative to take advantage of current and future knowledge about medication error prevention and how it could lead to widespread and effective improvements in medication safety within the healthcare community and among consumers.

The issues raised scratch the surface of research needed in the area of medication error prevention. Among other research priorities is the need to identify barriers and motivators to error reporting to internal and external programs and ways to measure medication safety without using error reports alone. We also need effective ways to effectively benchmark error prevention efforts between organizations.

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, but learning must be disseminated and translated into practice.

References:

1. Phillips DP, Christenfeld N, Glynn L. Increase in US medication-error deaths between 1983 and 1993. The Lancet 3553:643-44, 1998.

2. Kohn LT, Corrigan JM, Donaldson MS (eds): To Err Is Human: Building a Safer Health System: A report from the Committee on Quality of Healthcare in America, Institute of Medicine, National Academy of Sciences. National Academy Press, Washington, DC, 1999

3. Bates DW, Spell N, Cullen DJ, et al. The costs of adverse drug events in hospitalized patients. JAMA 1997;227:29-34.

4. Leape LL, Bates DW, Cullen DJ, et al. Systems analysis of adverse drug events. JAMA 1995;274:35-43.

5. Flynn EA, Barker KN. Medication errors research. In Cohen MR (ed.), Medication Errors, Washington DC, American Pharmaceutical Association, 1999

6. Bates DW, Leape LL, Cullen DJ, et al. Effect of computerized physician order entry and a team intervention on prevention of serious medication errors. JAMA 1998;280:1311-1316

7. Leape LL, Cullen DJ, Clapp MD, et al. Pharmacist participation on physician rounds and adverse drug events in the intensive care unit. JAMA 1999;282:267-270

8. Anon. Top-priority actions for preventing adverse drug events in hospitals. Recommendations of an expert panel. Am J Health-Syst Pharm 1996;53:747-51

9. Survey shows how hospitals use the ISMP Medication Safety Alert! to improve medication safety. ISMP Medication Safety Alert! Feb 9, 2000 (http://www.ismp.org/MSAarticles/MSAuse.html)

10. Anon. Over reliance on pharmacy computer systems may place patients at great risk. ISMP Medication Safety Alert! Feb 10, 1999 (http://www.ismp.org/MSAarticles/Computer.html).

11. Ash, JS, Gorman PN, Hersh WR. Physician order entry in U.S. hospitals. Proceedings of AMIA Symposium 1998; 235-9.

12. Top concerns of hospital chief executive officers. Fax poll prepared by The Advisory Board Company. In Prescription for Change Clinical Initiatives Center Symposia August 26-27, 1999, Washington, DC(p. 73)

13. Sentinel Event Alert. Joint Commission on Accreditation of Healthcare Organizations, April 21, 2000 (http://wwwb.jcaho.org/edu_pub/sealert/sea13.html).

14. Anon. Potassium chloride injection survey results. ISMP Medication Safety Alert! March 25, 1998.

15. Public Opinion of Patient Safety Issues: Research Findings. Prepared for: National Patient Safety Foundation at the AMA. Prepared by Louis Harris & Associates. September, 1997.

Current as of September 2000

Internet Citation:

Testimony of Michael R. Cohen, Panel 3: Particular Systems Issues. Written Statement. National Summit on Medical Errors and Patient Safety Research. September 2000. http://www.quic.gov/summit/wcohen.htm

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