U.S. House of Representatives: Committee on Energy and Commerce, RepublicansPrepared Witness Testimony: Williams, Robert L.

Mr. Robert L. Williams
U.S. Pharmacopeia
12601 Twinbrook Parkway
Rockville, MD, 20852

SUMMARY OF TESTIMONY

In recent years, the United States Pharmacopeia (USP) has been in the forefront of innovative efforts to promote patient safety. Patient safety depends on the availability of methods and procedures to understand patient risk at the point of care. USP's primary effort in this regard has been to develop reporting programs that capture medication error risk and lead to the implementation of systems to prevent errors.

USP's patient safety efforts have culminated in the development of MedMARx^sm, an interactive, anonymous, Internet-based medication error reporting program. MedMARx compiles medication error reports from participating hospitals in order to analyze patient safety trends, develop best practices and disseminate this information to participating hospitals. Approximately ten percent of the nation's hospitals participate in the program.

In the three full years since its inception, MedMARx has captured over 200,000 reports of errors from participating institutions. USP has already issued an annual report based on 1999 data and is preparing another report for the year 2000 data. Our annual reports are provided to Congress and other stakeholders, and data from the MedMARx program can be shared in anonymous form with relevant Federal and State agencies.

MedMARx is based on the premise that patient safety can more effectively be enhanced in a culture that emphasizes systemic change rather than blame. Early results support this view. We are encouraged, for example, by a marked increase in the number of second year reports from hospitals that participated in the first and second consecutive years of MedMARx availability.

The core innovation of MedMARx lies not just in a software program, but more broadly through engagement of frontline practitioners who, at the end of the day, are critical to any effort to promote patient safety. Whatever success MedMARx achieves rests on these practitioners and their commitment to good patient care.

Based on its experience, USP strongly supports congressional efforts to reduce preventable mistakes that occur throughout the continuum of prescribing, dispensing, administration and use of medicines. Specifically, USP supports enactment of a federal medical error reporting privilege to enable health care providers to report errors to systems like MedMARx without fear of adverse legal consequences. USP further believes that federal policies should encourage public and private initiatives at the national, state, and local levels to enhance patient safety and reduce the medical mistakes that cost the health care system billions of dollars each year.

STATEMENT OF DR. WILLIAMS

On behalf of the United States Pharmacopeia (USP), I appreciate the opportunity to testify before the Health Subcommittee of the House Energy and Commerce Committee regarding innovative strategies to improve patient safety.

In recent years, USP has been in the forefront of innovative efforts to promote patient safety. Patient safety depends on the availability of methods and procedures to understand patient risk at the point of care. USP's primary effort in this regard has been to develop reporting programs that capture medication error risk and lead to the implementation of systems to prevent errors.

USP's patient safety efforts have culminated in the development of MedMARx^sm, an interactive, anonymous, Internet-based medication error reporting program. MedMARx compiles medication error reports from participating hospitals in order to analyze patient safety trends, develop best practices and disseminate this information to participating hospitals. Approximately ten percent of the nation's hospitals participate in the program.

I. Background on USP

Founded in 1820, USP is a private not-for-profit organization whose mission is to promote the public health by establishing and disseminating officially recognized standards of quality and authoritative information for the use of medicines and related articles for professionals, patients, and consumers. USP's governing bodies include its Convention, which meets every five years, and a Board of Trustees, which provides direction to staff in the years between Convention meetings. Standards-setting activities are conducted by the USP Council of Experts.

Membership in the Convention (representing approximately 400 associations), on the Board (11 members representing Convention constituencies), and on the Council and its Expert Committees (approximately 800 members) is entirely voluntary. To support the activities of these bodies, USP maintains a paid staff of approximately 320 in its Rockville offices. USP derives its income from the sale of its publications and reference standards materials. USP's expertise as a standards-setting body has been recognized in numerous federal laws.

USP standards are published in the United States Pharmacopeia and National Formulary (USP-NF). These standards are officially recognized in the Food, Drug and Cosmetic Act and are enforceable by the Food and Drug Administration. Thus, USP's primary publications are official compendia of the United States. More recently, Congress named USP and NF as the official compendia for dietary supplements.

Key components of USP's legal authority derive from efforts to improve patient safety. For example, prior to 1938 only USP standards for determining the identity, strength, quality, and purity of articles used in medical practice were legally enforceable, but that year Congress recognized and made legally enforceable USP packaging and labeling requirements in response to numerous fatalities resulting from the accidental ingestion of bichloride of mercury tablets. At that time, compendial packaging and labeling standards for bichloride of mercury tablets (a disinfectant), which was frequently and mistakenly taken for mercurous chloride tablets (a cathartic), recommended the following:

"[t]ablets of an angular shape having the word "poison" and skull and crossbones design distinctly stamped upon it. The tablets are to be colored blue. They are to be dispensed in securely stoppered glass containers on the exterior of which is placed a red label bearing the word "poison"."

Even today, many of our monographs (e.g., potassium chloride for injection concentrate) incorporate legally enforceable packaging and labeling requirements for the purposes of reducing medication errors.

In 1971, USP's historical concern with the quality of drug products led it to collaborate with the FDA and the American Society of Health System Pharmacists to create the Drug Product Problem Reporting Program - a national program in which health professionals were asked to voluntarily report problems experienced with drug products on the market. These defects often related to inadequate packaging or labeling such similarity in color or design of the label, or similar sounding drug names.

USP's focus today is on both the product and on the system in which the product is prescribed, dispensed, administered, and used. USP does not set practice standards per se, but as a practical matter, many of USP's standards indirectly affect professional practice and many practice standards are based on USP standards.

In 1991, USP began working with the Institute for Safe Medication Practices to coordinate the Medication Errors Reporting (MER) Program. Since then, the MER Program has received more than 7,000 reports of actual and potential medication errors. These reports have identified errors in various health care delivery environments, including hospitals, nursing homes, physicians' office, pharmacies, emergency response vehicles, and home care.

Through these reports, USP has come to understand that errors are multi-disciplinary and multi-factorial. They can be committed by experienced or inexperienced staff, by health professionals, support personnel, students, and even patients and their care givers. Medication errors can occur anywhere along the continuum from prescribing to transcribing to dispensing and administration. The causes of errors may be attributed to human error, to product names or designs, or to the medication handling and delivery systems in which the products are used and in which individuals operate and interact.

As each MER report is received, it is shared with the product manufacturer and with the Food and Drug Administration. USP does not require that the name of the reporter, patient identity, or facility be reported. When such information is provided, however, USP respects the confidentiality of the report and will purge the identity of the institutions and individuals named in the report upon request. Reporters are advised of any corrective actions resulting from their report. Such actions are disseminated to all individuals who have reported to the MER Program and are publicly available on the USP web site.

In 1995, USP helped form the National Coordinating Council for Medication Error Reporting and Prevention. The Council, for which USP serves as secretariat, brings together 23 national organizations and agencies to promote the reporting, understanding and prevention of medication errors. The Council has developed a standardized definition of medication error, a taxonomy for error reporting and a newly revised index for categorizing medication error severity.

Through USP's work with the MER Program and other collaborative efforts, USP realized the need for national standardization of medication error reporting, especially in hospitals. Hospitals were eager to submit reports to USP in an anonymous and standardized format that would allow them to compare their errors to those in other participating facilities. USP set out to develop and refine such a model for hospitals, and then broaden the model to include other health care settings and other types of reporting such as adverse drug reactions.

On July 27, 1998, USP made MedMARx available to hospitals nationwide. MedMARx is an internet-accessible, anonymous reporting program that enables hospitals to voluntarily report, track and trend data incorporating nationally standardized data elements (i.e., definitions and taxonomy). MedMARx is structured to support an interdisciplinary systems approach to medication error reduction and foster a non-punitive environment for reporting.

Hospitals use the program as part of the organization's internal quality improvement process. Hospitals can review errors entered by other institutions in "real time" and can also view any reported action taken by other institutions in response to the error. This feature affords institutions the opportunity to examine errors in a proactive manner. For example, the institution can review the error profile of a drug or class of drugs before a product is added to the institution's formulary to determine whether risk prevention measures or training programs should be instituted or, if the error profile is so serious, whether the decision to stock the drug should be rejected. MedMARx also supports the performance improvement standards of the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO), which requires institutions to learn from the experiences of others in order to reduce risk.

Currently, over 500 hospitals have enrolled in the MedMARx program and other hospitals and health systems are joining rapidly. Hospitals of various types and sizes spanning fewer than 50 beds to approximately 1000 beds are enrolled. Participating hospitals include some operated by the U.S. Departments of Veterans Affairs and Defense (which includes hospitals around the world), as well as state-owned facilities.

Since 1998, more than 210,000 records have been submitted to the MedMARx database. USP has issued a summary of MedMARx data collected in 1999. In that first calendar year, 6224 reports were submitted by 56 facilities. The 2000 data report will be released on May 20^th. During the second year of the program, participation strengthened to 184 hospitals submitting 41,296 reports.

The data show that the most common products involved in errors - Insulin, Heparin, Warfarin, and Opiate analgesics - require careful dosing, close monitoring, and adherence to protocol where established. The most common types of errors are omission, wrong dose, and unauthorized/wrong drug. With the aforementioned drugs, the outcome of such errors could be serious to fatal.

Yet another key finding is that most errors do not reach the patient -- only 3% of errors reported to MedMARx caused patient harm. USP continues to gather reports of "near misses" because, as the experience with aviation has shown, all errors are critical to an understanding of patient risk.

MedMARx is readily expandable to other points of care in addition to hospitals and can collect information about medical errors beyond medication errors -- in fact, USP is moving in this direction at the time of this report.

Reporting is not a goal in itself. Rather, the purpose of reporting systems is to analyze the information provided and to implement effective, sustainable interventions that will prevent errors from recurring. Ideally, these interventions will be replicated throughout health care settings. Data received through USP reporting systems have led to changes in individual hospitals, across health systems, and have even led to changes in USP-NF packaging, labeling and nomenclature standards for health care systems nationwide.

By compiling and trending errors in a standardized way, USP's reporting systems can lead to innovative strategies to address errors. For example:

A health system identified a trend of "wrong patient" errors and determined that nurses were not verifying the patient's identification (i.e., checking the patient's wrist band) before administering medications. A thorough review of the cases found that wrist bands were often coming off or being removed for various reasons. This finding resulted in a reevaluation of all wrist band materials and procedures that will likely impact the entire system. A program is also being developed to encourage patients to ask questions and be informed about the medication administration process.

A health system noted an unexpected increase in medication errors due to the use of abbreviations in prescription writing. The health system was puzzled since it had banned the use of error-prone abbreviations in prescription writing procedures. A closer look at MedMARx data revealed that the health system had acquired a hospital in the region, but newly privileged physicians had not been apprised of the no-abbreviations rule. Educational programs were immediately implemented for physicians from the newly-acquired hospital.

In considering whether to add a new drug to its formulary, a hospital looked at the accumulation of reports and actions taken by other institutions as documented in MedMARx. The information was used in two ways: (a) to determine if the errors were severe enough to deny the drug's addition to this hospital's formulary; and, (b) to determine what preventative measures could be incorporated in this hospital's processes to allow adding the drug.

A hospital interested in purchasing a robot to dispense medications reviewed its MedMARx data and identified which dispensing errors might be prevented by the robot. The reduction in health care costs realized by preventing such errors justified the investment in new technology.

A notable trend of treatment omissions for respiratory therapy led respiratory therapy directors from hospitals across a health system to convene. The reasons for the omissions were two-fold: (1) patients were not in their rooms at treatment times because they were receiving therapy elsewhere in the hospital; and, (2) patients were refusing therapy. Two possible solutions are being tested. First, a new method of scheduling treatments will bring various caregivers to the patient's bedside in turnstile fashion so that respiratory, occupational, and other therapies are appropriately sequenced. Second, the hospitals are now actively explaining to patients the need for each treatment.

Data collected through its reporting programs enable USP to evaluate and implement drug product standards, and in some cases practice standards and requirements, aimed at preventing errors. The following examples describe some of the steps taken by USP in response to medication error reports. The standards that have been developed as a result of USP's error reporting programs have emerged from USP's Council of Experts, which has a number of Expert Committees that develop appropriate standards to reduce medication errors.

Deaths reportedly due to the accidental misadministration of concentrated Potassium Chloride Injection led to (1) changing the official USP name to Potassium Chloride for Injection Concentrate to give more prominence to the need to dilute the product prior to use; (2) a requirement that labels bear a boxed warning that reads: "Concentrate: Must be Diluted Before Use;" and (3) a unique requirement that the cap for this drug must be black in color and must be bear an imprint in a contrasting color with the words: "Must be Diluted."

Deaths reportedly due to the confusion and resultant injection of the anticancer drug, Vincristine Sulfate for Injection, directly into the spine instead of into the vein, resulted in changes in the requirements for packaging by pharmacies and manufacturers preparing ready-to-use doses. Each dose, whether prepared by the manufacturer or the pharmacist, now must be wrapped in a covering labeled "FOR INTRAVENOUS USE ONLY" and that covering may not be removed until the moment of injection.

Deaths reportedly due to the name similarity of Amrinone (cardiotonic) and Amiodarone (cardiac depressant) have led USP and the United States Adopted Names (USAN) Council to change the official and nonproprietary name of Amrinone to Inamrinone to distinguish the two.

Deaths reportedly due to the inadvertent mix-up of neuromuscular blocking agents (which paralyze the respiratory system) with other drugs, have led to recommended changes in standards of this therapeutic class of neuro-muscular blocking agents. The standards would add warnings and color differentiation to the labeling and packaging of the products.

A study of MER and MedMARx data in pediatric populations led to the development of recommendations for error avoidance in this population. The recommendations are aimed at all disciplines across all health care settings and include packaging and labeling recommendations as well as recommendations for compounding and dosing medications safely.

Because MER and MedMARx are the only private-sector, national medication error reporting systems, USP is uniquely situated to play a leadership role in national and international efforts to improve patient safety.

The USP commitment to medication error prevention is broader than merely collecting data. USP has enrolled a number of MedMARx-participating hospitals in a long-term project called "Strategic Research Partnerships" to propose indicators of quality and best practice standards for use of specific medications. The first project involves Heparin, a drug revealed by both MER and MedMARx data to be commonly involved in errors. These hospitals aim to create a standard protocol for Heparin therapy, implement the protocol, and develop best practices for prescribing, dispensing, administering and storing the drug which will address the reasons for recurring errors.

Because of its long history in medication error reporting and prevention, USP participates in many collaborative efforts at the national and state levels to reduce health care errors. Thus USP is involved in (ongoing activities are italicized):

USP believes that its reporting systems have already contributed to improvements in patient safety. But the full potential of USP's reporting programs remains to be realized, and Congress can help accelerate this progress. Specifically, USP urges Congress to create a more conducive legal environment for reporting medical errors through enactment of a federal medical error reporting privilege. Such a privilege would strengthen reporting systems and thereby foster the development of systems to prevent medical errors.

Many states have established peer review privilege statutes to encourage self-evaluation in the interest of improving the quality of healthcare. But the extent and application of state protections vary, and state laws do not necessarily protect information that is reported outside the hospital, for example to a national reporting system. In some states, the privilege is explicitly waived if information is provided to a third party. These policies discourage practitioners and facilities from sharing medication error reports with USP and other organizations.

In its landmark 1999 study "To Err is Human," the Institute of Medicine specifically endorsed establishment of a federal reporting privilege. Since then, USP has urged Congress to implement the IOM recommendation. For example, we have worked closely with Congresswoman Morella in the development of legislation she introduced in the 106^th Congress (H.R. 3672) to establish a privilege for USP reporting systems. We understand that just yesterday, Congresswoman Morella reintroduced her bill with bipartisan cosponsorship. We urge serious consideration of the Morella bill, and any similar legislation that provides clear protection to practitioners and facilities that report medical errors for the purposes of improving patient safety.

We have also worked in coalition with the American Medical Association, the American Hospital Association, the American Nurses Association, the Joint Commission on the Accreditation of Health Care Organizations and other health care organizations to develop principles for the development of patient safety legislation. In brief, our principles call for the establishment of a federal privilege to encourage reporting in a non-punitive environment that encourages a culture of safety.

A federal privilege will encourage facilities and practitioners to report medication errors to USP in a consistent and uniform manner, thereby increasing the chances of identifying trends and implementing effective corrective measures that will help improve the quality of care for patients nationwide.

If strengthened in this manner, the USP reporting programs may lead to creation of a national database of medication errors. Such a database can be highly useful to Federal and State officials, practitioners, patients and others as they seek to understand patient risk and ways to reduce it. We contemplate a continually evolving database that can be used in many different circumstances and to different purposes. A great deal of work -- and active participation from many constituencies -- is needed to achieve USP's goals in this area and thereby improve health care in the United States and other countries as well.

Conclusion

USP looks forward to working with Congress and other stakeholders in the ongoing effort to improve patient safety. We especially look forward to working with Congress to strengthen legal protections that will result in greater use of reporting systems, and thereby fuel the development of system changes that will prevent errors before they occur.

Reducing Medical Errors: A Review of Innovative Strategies to Improve Patient Safety.

STATEMENT OF DR. WILLIAMS

I. Background on USP

Conclusion