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Written Testimony Submitted by

Diane D. Cousins, R.Ph.

Vice President

Practitioner and Product Experience
U. S. Pharmacopeia
12601 Twinbrook Parkway
Rockville, MD 20852
301/881-0666; DDC@usp.org
U. S. Pharmacopeia

The United States Pharmacopeia (USP) is pleased to have the opportunity to provide this statement to the House Commerce Subcommittees on Health and Environment and Oversight and Investigations and the Veterans’ Affairs Subcommittee on Health. USP strongly supports Congressional consideration of actions it might take to ensure the significant reduction of preventable medical mistakes that occur throughout the continuum of the prescription, dispensing, administration, and use of medicines. USP further believes that development and implementation of federal legislation and regulatory policies, which will direct and guide public and private initiatives at the national, state, and local levels, must be achieved to ensure patient safety from medical mistakes, and to reduce substantively the multi-billion dollars that such mistakes currently cost the health care system each year.

USP comments, offered for consideration, cover the following:

• Information about the U. S. Pharmacopeia’s 30-year record of stimulating voluntary health care practitioner reporting and using the analysis of those reports to improving patient safety.
• Background on USP’s ability to affect change in drug product labeling, packaging, and nomenclature when such are identified as contributing to medication errors.
• An explanation of USP’s new MedMARx™ program---a national, Internet-based, anonymous medication error reporting system, introduced in July 1998, and now used by over 150 U.S hospitals.
• A recommendation for Congressional action that can directly and quickly remove one of the most significant barriers to hospital and practitioner reporting of medication errors.

USP’s Medication Error Reporting Experience

Background

USP, founded in 1820, is a volunteer-based, not-for-profit organization whose sole 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. It is composed of approximately 500 members representing state associations and colleges of medicine and pharmacy, ten agencies of the federal government, and about 75 national professional, scientific and trade organizations, and members-at-large, including government agencies from other countries that recognize USP standards and non-U.S. pharmacopeias. The USP’s expertise as a standards-setting body has been recognized by Congress in the enactment of the Drug Import Act of 1848, the Pure Food and Drug Act of 1906, the Federal Food Drug and Cosmetic Act in 1938, and by the Food and Drug Modernization Act in 1997, and others. Standards published in the official compendia,

U. S. Pharmacopeia and National Formulary (USP-NF) are also referenced in most state pharmacy laws governing practice.

USP began developing information relating to proper medicine use, in 1970, as support to its

standards-setting activities. The USP DI, the compendia of USP drug information, is today recognized by the Federal Omnibus Budget Reconciliation Acts of 1990 and 1994 as a reimbursement resource for Medicaid Agencies considering issues associated with off-label uses of medicines and guidance for patient counseling. Based upon its federal recognition, and its reputation as a credible, authoritative, and non-biased source of information developed by approximately 800 volunteer experts, USP DI® also serves as a reimbursement resource for insurers and third party payers, and as the basis for drug formulary decisions.

The process by which drug standards and information are developed is open, participative (notice and comment) and subject to integrity safeguards, including conflict of interest disclosure.

USP Practitioner and Product Experience Programs

Because of our concern with the quality of drug products on the market, in 1971, the USP co-founded the Drug Product Problem Reporting Program—a national program in which health professionals were asked to voluntarily report problems and defects experienced with drug products on the market. Often the product problems or defects had to do with inadequate packaging or labeling—labeling that could lead to confusion on the part of health professionals or lead to errors; for example, look-alike color or design labels (color and design) and sound-alike drug names. Today, we continue to operate our Drug Product Problem Reporting, and a newer program, the Veterinary Practitioners Reporting Program, which collect voluntary reports on human and animal drug products.

Eight years ago, in 1991, USP decided to focus more intensely on the problem of medication errors and what it could do to prevent them. Our 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 practicably, many of our standards do indirectly affect professional practice and many practice standards are based on USP-NF standards.

The USP learned that The Institute for Safe Medication Practices (ISMP) was seeking support of a national organization to bring its program, The Medication Errors Reporting (MER) Program, to the national level. USP agreed to coordinate the national program for ISMP. The

MER Program is now one of four USP voluntary, spontaneous reporting programs for health care practitioners. The MER Program is operated under the umbrella of the USP Practitioner and Product Experience Division.

Since late 1991, the MER Program has received more than 4,000 voluntary reports of actual and potential medication errors. We also continue to receive medication error reports through USP’s other reporting programs. 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, we have seen that errors are multi-disciplinary and multi-factorial. They can be and are committed by experienced and inexperienced health professionals, support personnel, interns, students, and even patients and their caregivers. Medication errors can and regularly do 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, and to the medication handling and delivery systems in which the products are used and individuals operate and interact. For purposes of voluntary reporting, USP does not seek to limit the types of errors that may be reported, because all information received may have some future value in determining how to reduce or prevent errors. We do not, however, actively solicit reports of adverse drug reactions, but USP cooperates with the Food and Drug Administration as a MedWatch partner and refer all reports submitted to USP.

We recognize that an actual error may be reported as a potential error because of liability concerns, or a facility’s risk management policies, so each report is treated with the utmost seriousness by USP, no matter how it is characterized by the reporter. As each MER report is received, it is shared with the product manufacturer and with the Food and Drug Administration. USP does not require, in the MER Program, that the name of the reporter, patient identity, or facility be provided. If provided, however, USP respects the desire of the reporter to keep his or her identity confidential and will purge the identity of the individuals or institutions named in the report in accordance with the instructions of the reporter. Reporters are advised of any actions resulting from their report either individually or through USP’s Quality Review publication, which is disseminated to all persons who have reported to the MER Program and is publicly available on USP’s web site.

USP’s Ability to Affect Change

USP has 30 years of experience and demonstrated effectiveness in designing and operating voluntary reporting systems for health care professionals relating to drugs and their use, and using those data to improve product standards and safe drug use information.

Standards-Setting Authority

Encouraging the reporting of errors is only one aspect of USP’s efforts to promote safety of the medication use system. USP evaluates and implements, through its standards-setting authority, changes in drug products to prevent the recurrence of errors. The following examples describe some of the changes or other steps taken by USP in response to MER Program reports.

• Death reported due to the accidental misadministration of concentrated Potassium Chloride Injection led to (1) changing the official USP name to Potassium Chloride for Injection Concentrate (emphasis added) to give more prominence to the need to dilute the product prior to use; (2) labels must now bear a boxed warning "Concentrate: Must be Diluted Before Use;" and (3) the cap must be black in color (the use of black caps is restricted to this drug product only), and (4) the cap must be imprinted in a contrasting color with the words, "Must be Diluted."

• Deaths reported 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 reported due to the name similarity of Amrinone and Amiodarone have lead USP and the United States Adopted Names (USAN) Council to consider changing the official and nonproprietary names of one, or both, products. {See attached Quality Review: "Proposed Drug Name Changes for Error Protection."}

• Deaths reported 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 for labeling and packaging of the therapeutic class of neuro-muscular blocking agent products.

• Medication Error Reporting reports of deaths identified the need to establish dosing limitations for the sedative-hypnotic Chloral Hydrate for use in children, and for the anti-gout drug Colchicine. These dosing limitations have been incorporated into the USP DI information in a special section in each drug monograph to caution health professionals on each drug’s proper use based upon reports of errors received through the program.

{See attached examples of Quality Reviews that describe other medication errors identified through the MER Program and for which USP has identified and communicated to health care professionals information and prevention strategies: "Three is a Crowd;" "Insulin Oversight " and "Vincristine Sulfate Monographs Revised…Dispensing Pharmacy Practice Affected."}

Throughout its 180-year history, USP has focused on improving the quality of our medicines and their appropriate use. All of USP’s programs focus on these goals. The standards in the official compendia, the USP-NF, define the identity, strength, purity, quality, packaging and labeling of drugs and their dosage forms. The USP is a member, with the American Medical Association, American Pharmaceutical Association, and the Food and Drug Administration of the United States Adopted Names Council (USAN) and publishes USAN names in the USP Dictionary of Drug USAN and International Drug Names, which is an international resource for pharmaceutical manufacturers, regulators, and health care practitioners. As noted elsewhere in this testimony, USP has taken actions, independently and in concert with USAN, to change the names of drugs and dosage forms when they have resulted in medication errors.

Reported medication errors also have brought about other changes in USP standards and guidance to practitioners. For example, (1) USP discontinued recognition in the USP-NF of the apothecary system, a centuries old system of measuring weights and measures, in favor of the metric system in order to avoid misinterpretations that led to overdoses; (2) USP has made changes in general label requirements for marketed drug products, strengths less than one unit must be expressed as a decimal preceded by a zero (e.g. 0.1 grams, not .1 grams) to avoid ten-fold overdoses; and (3) USP standards also require that the strength of a product when expressed as a whole number be shown without a zero trailing the decimal to avoid ten-fold overdoses by the lack of recognition of the decimal point (e.g. 1mg, not 1.0 mg).

Collaborative Relationships: Food and Drug Administration; National Association of Boards of

Pharmacy; Colleges of Pharmacy

Prior to the formation of the Food and Drug Administration (FDA) Office of Post Marketing Drug Risk Assessment, the Agency developed a formal mechanism for receiving and evaluating MER reports—the Subcommittee on Medication Errors. USP and FDA also created a joint advisory panel on the Simplification and Improvement of Injection Labeling to reduce medication errors. The Food and Drug Modernization Act of 1997 recognizes product labeling recommendations of that joint initiative.

In 1991, to expand the scope of the MER Program, USP developed a joint program with the National Association of Boards of Pharmacy. The Boards of Pharmacy database is maintained by USP and assists each Board of Pharmacy to determine the relative extent of errors in its state and contributes to the overall incident collection effort.

In addition to using the MER program to stimulate changes in enforceable standards and information, USP has used the MER information to develop educational tools for the health professions. In 1993, a curricular resource entitled--Understanding and Preventing Medication Errors--was distributed at no charge of colleges of pharmacy throughout the U.S. USP also has attempted to reach the public directly to teach patients how to protect themselves from medication errors through the development of a public service campaign—Just Ask…About Preventing Medication Errors.

National Coordinating Council for Medication Error Reporting and Prevention

USP has worked diligently during the past eight years, particularly in the standards-setting area, to build coalitions among health care organizations and to provide health care expert review of medication errors. In 1995 USP spearheaded formation of the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP). USP is the founding organization and continues to serve as NCC MERP Secretariat. To date, NCC MERP, comprises of 17 national organizations and federal agencies that share a common mission to promote the reporting, understanding and prevention of medication errors. Member organizations include practice organizations of medicine, nursing, and pharmacy, the licensing board of pharmacy and nursing, organizations of the pharmaceutical industry, the Department of Veterans Affairs, the Joint Commission, regulators, the FDA, the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO), the American Hospital Association, and USP. In the years since its inception, the Council has produced internationally recognized work products, such as:

• a standardized definition of "medication error." [See Quality Review: National Council Focuses on Coordinating Error Reduction Efforts "
• a categorization index to classify medication errors by the severity of the outcome to the patient
• a taxonomy of medication errors
• recommendations to reduce the error prone aspects of prescription writing; product labeling and packaging; and broad recommendations related to the dispensing and administration phases of the medication use process.

The Council is now re-examining how the standardized definitions noted above and in the attached Quality Review: "Use Caution—Avoid Confusion" can be honed, based upon experience gained from the MER and MedMARx (see below) Programs to provide clearer differentiation between categories. In addition the Council is examining issues of process failures in the use of verbal orders, benchmarking and inter-organizational comparisons, and error rates.

Ad hoc Advisory Panel on Medication Errors

In 1996 USP appointed an Advisory Panel on Medication Errors, an interdisciplinary group of health care practitioners who: review reports submitted to the USP Medication Errors Reporting Program; make recommendations for USP standards-setting; and make recommendations and participate in the activity of the NCC MERP. Mr. Michael Cohen, ISMP President, served as the first chair of this Panel and continues to serve as a member.

In 2000, USP will constitute a new expert committee on "Safe Medication Use" that will fulfill a broader scope of responsibilities of the Advisory Panel that it will replace. The new expert

committee will review data and provide guidance for the development of best practice solutions that will result in the reduction and prevention of medication errors.

USP DI and Drug Information Expert Advisory Panels

The USP DI database is recognized internationally as containing the most up-to-date and authoritative information on off-label uses, warnings, contraindications, etc. New USP programs that will enrich the USP DI database will focus on the special needs to standardize products and develop information for neonatal, pediatric, and geriatric patients and populations. A unique contribution of the pediatric effort, developed in conjunction with experts in pediatric medicine communications is the "Ten Guiding Principles on the Use of Medicines by Children and Adolescents." These principles have been distributed broadly and are being used in educational materials by pharmaceutical manufacturers and volunteer organizations. [See Guiding Principles Ruler enclosed.]

USP’s MedMARx Program

In early 1998, USP developed a nationwide program for hospitals to report medication errors. Hospitals were eager to submit reports to USP if reporting could be done anonymously and in a standardized format that would allow hospitals to track trends, and compare their data to other participating hospitals. USP’s goal was to develop a model for hospitals first, ensure success of the model, then broaden the model to include other health care settings, e.g. long-term and ambulatory care settings, and other types of reporting such as medical error and adverse drug reactions.

On July 27, 1998, USP made MedMARx™ available to hospitals nationwide. MedMARx (pronounced med’ marks) 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) of the USP Medication Errors Reporting Program, the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP), and the American Society of Health-System Pharmacists. MedMARx is structured to support an interdisciplinary systems-approach to medication error reduction and fosters a non-punitive environment for reporting.

Hospitals are encouraged to use MedMARx as part of the organization’s internal quality improvement process, thereby extending their "peer-review" group to the group of hospitals in the program. Hospitals review the errors entered by other institutions in "real time" and also can view any reported action taken by another institution in response to an error or to avoid future similar errors. 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 if certain risk prevention measures or training programs should be instituted prior to the drug’s availability within the institution. Or, if the error profile is significantly serious, a determination to not stock the drug can be made. MedMARx also supports the performance improvement standards of the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO), which requires institutions to look outward at the experiences of others in order to reduce risk.

Currently over 150 hospitals have enrolled in the MedMARx program and other progressive hospitals and health systems are joining rapidly. Profiles of the participants show that hospitals of various types and sizes spanning fewer than 50 beds to approximately 1000 beds are enrolled. MedMARx hospitals include institutions of the Department of Veterans Affairs and the Department of Defense, and state-owned facilities.

The USP commitment to MedMARx is broader than merely collecting data. In the coming year, USP will enroll champion hospitals participating in MedMARx in a long-term project to propose indicators of quality in the medication use process and to identify best practice standards and best process standards for the medication-use system.

USP is heartened by the national attention resulting from release of the Institute of Medicine Report—To Err is Human—Building a Safer Health System." USP is particularly gratified at the immediate action being taken by the House Commerce Committee’s Subcommittees on Health and Environment and Oversight and Investigations and the House Committee on Veterans’ Affairs Subcommittee on Health. We are pleased to offer the following specific recommendations:

• Focus Attention on the Quality of Health Care System

As the first step in preventing medication errors, the priority should be on fixing the system, not the blame. The IOM report is clear that mandatory programs at state and federal levels have not effectively captured the full number of errors occurring. The report argues that the public needs some assurance of a minimum level of protection (i.e., through reporting, investigations and follow-up) and that health care organizations need to be "incentivized" to improve patient safety. In fact, mandatory reporting could provide a false sense of protection if the mandatory programs are no more effective than those already in existence. Therefore, perhaps the question at this time should be: "What needs to be done to improve the quality of healthcare systems that will provide these assurances and incentives?" Numbers and statistics from such mandatory programs may not be as useful to the public and, in fact, may erode the confidence of the public if shear numbers are used as a gauge of quality. What confidence can a citizen have in the health care system when the error profiles for both (or maybe the only) rural hospital(s) in their area show that harmful errors have occurred there? "To Err Is Human" leads us to believe that no hospital is likely to be error free. The fact that a harmful error has not yet occurred in a facility is no assurance that it will not occur, or that it has, in fact, occurred but has not been recognized as such or reported. To better serve the public, it would be far more useful to have the knowledge and assurance that the hospital has adopted safer processes and best practices when errors have occurred in order to reduce the possibility of errors. We believe a system that provides a public indicator that these best practices are adopted, in effect a facility’s "report card," would be a more effective tool for consumers to help choose the best and safest health care facilities for themselves and their families.

A national voluntary reporting system ensuring confidentiality in support of the above framework should help accomplish this by reporting and documenting actions taken in response to an error. A more robust database will also provide opportunities for risk prevention and designing error out of medication use processes. As an incentive to report, information submitted to the system should be treated as privileged per federal statute as is currently the case in states that provide for peer-review protection. What should be mandated for hospitals and other healthcare facilities is not reporting, per se, but the development of quality control systems (of which reporting is a part) that implement these best practices and improvements to prevent and correct system weaknesses. For example, the federal government can create a public report card using the inspection and survey processes of state boards of pharmacy, HCFA, and JCAHO. Incentives for facilities can be provided by third party payers and insurers that require the adoption of such standards and practices into every healthcare system as a contingency of reimbursement under Medicare and Medicaid programs.

Finally, under all circumstances, every victim and/or the family should have the legal right to be told by the health care professional or facility if an error has been committed in the deliverance of their care that has resulted in harm to the patient, increased hospitalization, or medical or therapeutic intervention.

• Protect the Confidentiality of Data Submitted to National Voluntary Reporting Programs

Among the IOM Report’s discussions and recommendations is recognition that the absence of federal or state protection from disclosure of medication error reported information poses a major barrier to voluntary reporting of errors, or potential errors. Health care practitioners are concerned about reprisals and practitioners and health care institutions and delivery systems are concerned about liability. USP believes, therefore, that Congress can make a significant contribution to the development and successful implementations of systems that facilitate voluntary medication error reporting and tracking through immediate consideration of legislation that would protect information developed in connection with error reporting by hospitals and other institutions and health care settings. USP currently is developing such legislative language for House and Senate consideration.

Conclusion

In closing, I wish to assure Committee and Subcommittee members that USP shares with Congress the goal of a safe medication use system. USP has made a public and long-term commitment to working proactively with all stakeholders toward that goal. We particularly look forward to working with Congressional leadership on the issue of fostering effective systems that support best practices, accountability, and confidentiality to stimulate greater reporting, analysis, and system changes to prevent medication and medical errors and to ensure confidence in our health care delivery system.

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