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Additional Statement

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National Summit on Medical Errors and Patient Safety Research

American Association of Health Plans (AAHP) (Continued)

Additional Statement, Submitted by Charles M. Cutler, M.D., and Carmella A. Bocchino, MBA RN

Disclaimer and Copyright Statements


One example of a successful approach has been in anesthesiology - where the mortality rates have been reduced from two deaths per 10,000 anesthetics administered to one death per 200,000 - 300,000 anesthetics administered. (IOM Report, To Err is Human) This success was accomplished through a combination of technological changes, information-based strategies, application of human factors to improve performance, formation of the Anesthesia Patient Safety Foundation and having a leader who is a champion for the cause (IOM Report, To Err is Human) The approach fosters the reporting of potential medical errors by maintaining a supportive environment for the providers involved.

We must consider what we can learn from the social sciences and further research into the health care system to foster and encourage the reporting of errors and to diminish the "culture of blame" as we further develop a national research agenda.

Current Status of Research into Medical Errors

Historical and current research relevant to medical errors has focused primarily on inpatient settings, such as hospitals or skilled nursing facilities. In fact, the vast majority of the scientific references cited in the IOM Report focused on research conducted in inpatient settings. (Table B, IOM report To Err is Human) While research conducted in the inpatient setting is important, this limited focus on patient safety needs to be expanded to take into account the current direction of healthcare delivery in the United States. In the 1990s, the delivery of healthcare has changed dramatically. As evidenced by the following trends, the costs and utilization of healthcare in the years of 1990 and 1998 have shifted from the inpatient to ambulatory setting.

  • The rates for admissions and days per 1,000 population in 1990 and 1998 have decreased from 136 to 125 and 1,238 to 894, respectively. (The Universal Healthcare Almanac, Silver and Cherner)
  • The total number of outpatient visits per 1,000 population has increased from 1,480.4 in 1990 to 2,018.4 in 1998. (The Universal Healthcare Almanac, Silver and Cherner)
  • The total number of outpatient surgical operations has increased from approximately 11.7 million operations in 1990 to 16 million in 1998 (The Universal Healthcare Almanac, Silver and Cherner)
  • Prescription drug costs have also increased from 1990 to 1998. Specifically, total drug expenditures for all types of payers have increased from $37.7 billion to $90.6 billion in 1998. (The Universal Healthcare Almanac, Silver and Cherner)

As the delivery of care shifts to the ambulatory setting, research priorities related to patient safety and medical errors must also expand accordingly.

Research in the Outpatient Setting

In the outpatient setting, many different types of health care organizations and individuals can provide care and/or information to support the goal of improving patient safety. Physicians, nurses and other health care professionals provide direct care to patients, while other organizations such as health plans, pharmaceutical companies, pharmacy benefits managers (PBMs) and government agencies provide information to support the direct care providers. As we contemplate the specific roles of these professionals and organizations, we also need to consider two broad research questions related to patient safety. First, we need to identify the most important patient safety concerns and measures in the outpatient setting and second, how we can efficiently and effectively obtain the necessary data to evaluate patient safety and medical errors. By addressing these questions first, we can identify the issues central to the delivery of outpatient care as a whole and then proceed to focus on the specific research priorities that each segment of the healthcare system may address.

Physicians and other health care professionals. Health plans are able to help physicians identify patients at risk of non-compliance with treatment regimens and potential safety problems. Some medical groups and hospitals have been able to do the same by:

  • Implementing computerized systems in the providers' offices that track patients who are not refilling prescriptions needed for chronic conditions, that remind these patients about upcoming appointments for laboratory tests and other examinations, and that prompt physicians to follow-up with patients after abnormal laboratory results.

Additional related research questions that may be addressed are as follows:

  • How effective are these systems?;
  • Given the limited capital available to health care providers for improvement, how cost-effective are these systems?;
  • What are the costs associated with a large-scale implementation of these systems?; and
  • What systems or processes are less costly, but are as effective alternatives?

Health Plans. With respect to patient safety, it is important to understand what health plans can do. For example, health plans have credentialing and re-credentialing requirements so that only qualified providers participate in our networks. Health plans provide information to providers on "exemplary practices" that are based on medical and scientific evidence, and perform technology assessments to understand what are the risks and benefits of new and emerging medical technologies and interventions. Health plans utilize centers of excellence-hospitals and other health care centers that have demonstrated expertise in a specific area such as cardiac care-to promote patients' access to the institutions and professionals who produce the best outcomes, including avoidance of errors.

In addition, the following elements can also be addressed by health plans:

  • Continue to provide resources for error analysis and systems redesign;
  • Continue to assess the effectiveness of our mechanisms for identifying and dealing with unsafe practitioners; rely on proficiency-based credentialing;
  • Encourage the use of drug to drug interaction software by all pharmaceutical vendors not in place;
  • Inform/educate members about those hospitals and other medical facilities that have installed special patient safety procedures and technologies;
  • Encourage the use of automation to standardize protocols and practice guidelines;
  • Encourage member input in safety design and the process of care whenever possible; and
  • Use benchmarking and collaboration to improve performance and encourage standardized prescription writing.

However, it is important to note that many health plans do not deliver the care themselves. Health plans do not perform the surgery, prescribe or administer the drugs, or provide care directly to patients. While health plans have a role to play in sharing data, providing feedback, identifying best practices and helping patients and providers make the most informed decisions, it is health care professionals who know when an error has occurred and who are in the best position to evaluate and decrease errors. This sentiment is echoed in a 1994 book entitled, Human Error in Medicine.

  • "[T]o explore the operational context for error, it is necessary to have information about the elemental unit of the provider, the patient and whatever medical treatment device(s) or medication were used at the time of the error....Such a system cannot be developed without input from those who understand the situation and can identify the factors that induce errors: the medical care providers." (Bogner, Human Error in Medicine, 1994)

AAHP and its member health plans support the need for applied research in the outpatient setting to support the health care providers who deliver care to patients. By providing and sharing information with physicians and other health care professionals, health plans assist providers as they manage the care of their patients. Examples of these activities include the following:

  • Health plans work with physicians to avoid inappropriate medication misuse or overuse that could be unsafe. For example, health plans help physicians identify their asthmatic patients who appear to be using Beta2Agonists and physicians then work with these individual patients to identify whether there would be a more appropriate treatment regimen, such as the use of inhaled corticosteroids.
  • Similarly, health plans can also help physicians identify their diabetic patients who are due for dilated retinal examinations or whose Hemoglobin A1C levels may be uncontrolled, so physicians can then help these individual patients understand what is the appropriate care necessary to manage their chronic conditions. Frequently, these patients under-use preventive care services.

Research into the infrastructure necessary to support formal programs to monitor and improve patient safety will be very valuable and we encourage some of this research to be conducted in collaboration with managed care organizations.

One such example of a promising collaborative research initiative involves nine HMOs that are members of a national HMO Research Network and have expertise conducting large-scale research projects across their individual sites. With funding sought through AHRQ, the health plan researchers, along with investigators from schools of public health, medical schools, and schools of pharmacy, will form a Center for Education and Research in Therapeutics (CERT). Three major activities will be conducted- 1) Infrastructure will be created and maintained to support research on, and improved use, of therapeutics 2) Core studies will be performed in all HMOs related to prescribing patterns, the impact of drug dosing on health outcomes, and the impact of health policy decisions on drug adherence and 3) Research and education collaborations will be strengthened among CERT centers.

Specific research questions for the core studies will address major areas related to patient safety including antibiotic use and indications for prescribing in children, use and dosing appropriateness of Angiotensin Converting Enzyme (ACE) Inhibitors for Congestive Heart Failure (CHF) and the effect of cost-sharing on prescription drug compliance and hospitalization related to the use of hypoglycemic agents. AAHP strongly supports this initiative and, as the studies are completed, AAHP will assist the CERT in disseminating and educating the managed care industry about the results that are found.

Pharmaceutical Companies/Pharmacy Benefit Managers (PBMs). Pharmacies and PBMs work with health plans and other health care professionals to provide data and create systems related to medication prescribing. Examples include the following:

  • PBMs identify patients on ten or more concurrently prescribed medications and provide this information to those physician (s) who prescribed the medications to alert them to issues of potential duplicate therapy or adverse drug interactions;
  • Using computerized pharmacy systems, edit checks are automatically programmed to identify potential drug to drug interactions, duplicate therapies, contraindications, etc. Therefore, when a patient arrives in a pharmacy to fill a prescription, the pharmacist will be able to identify potential adverse interactions at the point of sale and prevent the patient from ingesting potentially harmful medications.
  • Additionally, pharmacies and PBMs educate individual physicians and other health care professionals about the physician's medication prescribing patterns, installing and educating physicians on the use of computerized systems in the providers' offices, and creating patient education materials that physicians and health plans can distribute about the use of appropriate medications.

With respect to these initiatives, potential research questions and opportunities exist which include evaluating the effectiveness of these systems and identifying the most effective method for all providers to avoid these types of medical errors.

Governmental Agencies

The agencies in the federal government also play a role in improving patient safety and reducing medical errors. Examples of the roles and potential activities of these selected individual federal agencies are listed below.

Agency for Healthcare Research and Quality (AHRQ). As recommended by the Administration, one of AHRQ's primary roles in the reduction of medical errors is to establish a patient safety center within AHRQ. Additionally, AHRQ will "identify national goals, track progress in achieving those goals, and issue an annual report to the President and Congress." (AHRQ Update- Medical Errors and Patient Safety: A Growing Research Priority," HSR: Health Services Research 35:3 (August, 2000)) The AHRQ will also "fund research on medical errors, work with private sector entities and public sector partners on ways to improve patient safety and incorporate patient safety into the quality measurement and improvement activities at AHRQ." (AHRQ Update: Medical Errors and Patient Safety) We strongly support AHRQ's role in regard to patient safety and further agree with the goals outlined in the AHRQ Update that focus on the "fundamental research on errors, evaluations of reporting systems, and applied research on patient safety." We also recommend that the AHRQ- sponsored research projects focus on the identification of best practices in the private and public sectors, both inside health care and in other industries, whose results can then be communicated to the health care industry. We are especially interested in research projects conducted in the outpatient setting, projects related to the data capture and analysis of medical errors and studies that concentrate on the methods of analysis across institutions pertaining to events that may be the same within similar types of institutions. We once again encourage research initiatives that can be conducted within the managed care delivery system. Examples of effective methods for the design and implementation of system-wide improvements will provide valuable resources for organizations and individual providers as they try to replicate these practices.

Centers for Disease Control (CDC). To identify effective methods to improve patient safety and reduce medical errors, the CDC can sponsor and conduct research related to patient safety by partnering with health care organizations and health care professionals in both the private and public sectors. One such example is a current research project sponsored by the CDC and AAHP that focuses on the use of integrated health information systems for post-discharge surveillance of surgical site infections. (CDC Task Order 021 - in progress) Currently focused on inpatient care, this project may be expanded to include ambulatory surgeries. Other potential research topics in which the CDC could focus are the expansion of current activities related to disease surveillance to include patient safety, the identification of appropriate indicators for surveillance and how and where the data could be retrieved for surveillance.

Food and Drug Administration (FDA). The FDA may increase its role in patient safety by continuing to investigate and move forward with the creation of a new medication labeling system that would prevent the occurrence of near misses and medication errors due to closely-related medication names currently available. Additionally, the FDA could work with health plans and physicians on the following medication error reduction initiatives including: the provision of aggregate information and education related to the types of medication errors that have been anonymously reported to the FDA; the expansion in focus on medication errors in the ambulatory setting; and the improvement of post-marketing surveillance of medications that have been introduced into the marketplace.

Health Care Financing Administration (HCFA)/Peer Review Organizations (PROs). HCFA and the PROs can collaborate on research studies with health care professionals and others related to patient safety targeted to Medicare and Medicaid beneficiaries. Additional research opportunities exist for HCFA and the PROs in an attempt to further identify and delineate specific roles for the PROs in patient safety including surveillance, data collection and analysis. Because older and disabled populations tend to use more healthcare services, these types of opportunities would provide important data that could be communicated to the entire healthcare industry.

Occupational Safety and Health Administration (OSHA). OSHA's role is to ensure for the safety and quality of the workplaces across the country. OSHA may take an expanded role in patient safety by conducting site visits to health care provider offices to identify potentially harmful environments of care for patients.

As the roles and research opportunities of the above organizations and health care professionals are further contemplated, it is imperative that best practices and the dissemination of the results of valid and reliable research be identified and communicated to the healthcare industry. By identifying the most effective methods and resources used and identifying and addressing limitations related to the implementation of these practices, other healthcare organizations and professionals will be able to utilize and learn from the information previously gathered as they implement their own research initiatives.

Conclusion

In conclusion, the improvement of patient safety and the reduction of medical errors remain serious health care quality concerns and must be afforded proper attention. AAHP enthusiastically supports the direction and goals of the IOM committee and the efforts of the QuIC Taskforce to decrease errors and develop a systematic approach to prevent recurrence.

Health plans will continue to maintain their role of supporting those who actually deliver care-physicians, hospitals and other health care providers. The commitment of providers is critical to this undertaking, but the commitment of other stakeholders-patients, purchasers, regulators and health plans-is also important. We must work together to develop an effective way to identify errors and use that knowledge to improve patient safety and prevent future errors from occurring.

Through a research agenda focused not just on the delivery of inpatient care, but on the delivery of care provided in all settings, medical errors will be reduced. This research agenda must 1) actively involve all of the stakeholders previously identified; 2) disseminate best practices; 3) develop common terminology in regard to medical errors, adverse events, patient safety and related topics; and 4) clearly address the following research questions:

  • Where are the greatest opportunities to improve patient safety?;
  • What are the root causes of the problems?;
  • What are the most effective diagnostic tools we can use to identify and analyze the root causes of the medical errors?;
  • What are the most effective methods to eliminate medical errors?;
  • What are the most effective surveillance methods to improve patient safety and reduce medical errors?
  • What are the advantages and disadvantages of indexing adverse events versus categorizing similar types of errors?
  • What is an effective model that can be used to identify, index and further address outpatient errors?;
  • What is the most effective application or implementation of any model found to appropriately identify errors and improve performance and systems?;
  • What are the roles and responsibilities of the various stakeholders in the healthcare industry such as providers, patients, pharmaceutical companies, device manufacturers, health plans, purchasers, regulators, as errors occur?;
  • What tools are needed to systematically decrease variations in care and prevent adverse events?;
  • What current practices in healthcare effectively facilitate communication and interaction between health care professionals in the inpatient and ambulatory settings?;
  • Are vulnerable populations such as those without health insurance and underserved populations more susceptible to medical errors and, if true, how can we effect change to reduce this susceptibility?; and
  • What models can be developed to help health care professionals evolve from the current "culture of blame" and implement incentives to report medical errors/adverse events?

AAHP and its member plans remain committed to upholding high standards of patient care, which include the support of research projects to decrease medical errors - that may include collaborative research initiatives conducted in the managed care setting. We welcome the QuIC Taskforce's interest in these issues, and we thank you for providing us the opportunity to provide this statement.

Sincerely,

Charles M. Cutler, M.D.
Chief Medical Officer

Carmella A. Bocchino, MBA RN
Vice President, Medical Affairs

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Current as of September 2000


Internet Citation:

American Association of Health Plans (AAHP). Additional Statement. National Summit on Medical Errors and Patient Safety Research. September 2000. http://www.quic.gov/summit/aaahp1.htm


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