Roles de las instancias de Gestión Educativa Descentralizada

[CLERK’S NOTE.—The following statements were received by the subcommittee subsequent to the conclusion of the hearings. The statements will be inserted in the record at this point.]

PREPAREDSTATEMENT OFHON. PETESTARK, U.S. REPRESENTATIVEFROM

CALIFORNIA

Mr. Chairman: I would like to congratulate you for your quick action in holding today’s hearing, which will educate Members and the public concerning the need to reduce medical errors and improve the quality of care in our nation’s health care system.

We too are busily looking into this matter. I am currently drafting legislation to establish a comprehensive quality system—including a provision to curb medical er- rors. This legislation will require the Secretary of Health and Human Services to establish and maintain a comprehensive system for monitoring, improving, and safe- guarding the quality of care for Medicare beneficiaries and to reduce medical errors. Providers will have to join in this effort as a Condition of Participation in Medicare. The recent Institute of Medicine (IoM) report raises public awareness concerning the need to prevent medical errors and to promote public safety. This also opens the door to a number of critical issues—such as safeguarding health care profes- sionals from accidental needlestick injuries and protecting patients from the im- proper use of restraints and seclusion. I have introduced legislation this Congress to reduce medical errors in both of these areas and I hope you will include these proposals in whatever legislation you develop and advance.

Earlier this year, I introduced H.R. 1899, the ‘‘Health Care Worker Needlestick Prevention Act’’ with my colleague Rep. Marge Roukema (R-NJ) to ensure that those who care for us don’t have to risk their lives to save our lives. Last year, an esti- mated 800,000 accidental needlesticks occurred in medical facilities from needle- bearing devices. Accidental needlesticks produce the single greatest risk of blood ex- posure to the HIV virus for health care workers. And infection with the hepatitis B and C viruses may also be transmitted through needlestick. Technology exists to greatly reduce these injuries. Such preventable medical errors involving health care workers must be brought to an end.

In addition, I joined Rep. Diana DeGette (D-Colo.) this year to introduce legisla- tion addressing the use of restraint and seclusion in Medicare and Medicaid psy- chiatric treatment facilities, facilities for the developmentally disabled, and residen- tial treatment facilities for children. A series of Hartford Courant articles from Octo- ber 1998 highlighted the misuse of restraint and seclusion in residential facilities over the course of ten years and found that 142 cases of patient deaths were related to the improper use of restraint or seclusion. A General Accounting Office (GAO) September 1999 report on restraints and seclusion identified 24 deaths during fiscal year 1998 related to improper use of restraint or seclusion. Due to currently inad- equate reporting requirements, the GAO estimates that the number of deaths is likely to be significantly higher.

This past August, the Administration came forward with new conditions of par- ticipation for hospitals concerning the use of restraints, and I commend the Admin- istration for their important, major step forward. Yet, as the GAO notes, we still have further to go. Current Federal regulations do not limit the use of restraint and seclusion in all settings such as residential treatment centers and group homes, and there is no comprehensive reporting system to track injuries, deaths and use of re- straint and seclusion.

The ‘‘Patient Freedom From Restraint Act of 1999’’ (H.R. 1313) sets strict require- ments for the use of restraints and seclusion and requires treatment facilities to document and report on restraint and seclusion use. H.R. 1313 also requires facili- ties to report cases of severe injury and death to the state’s Protection and Advocacy

Board, and the Secretary of Health and Human Services. By establishing such a re- porting framework, the bill intends to reduce medical accidents related to restraint and seclusion use.

The IoM report should prove a catalyst for Congress to take overdue action on preventing deaths by accidents in our nation’s health care system. I look forward to working with you and our colleagues on this timely, important issue. Let’s work together to end these senseless injuries and deaths.

PREPAREDSTATEMENT OF THEUNITEDSTATESPHARMACOPEIA

The United States Pharmacopeia (USP) is pleased to have the opportunity to pro- vide this statement in conjunction with the Senate Subcommittee on Labor, Health and Human Services, and Education Hearing on Medical Mistakes. USP strongly supports Congressional consideration of actions it might take to ensure the signifi- cant reduction of preventable medical mistakes that occur throughout the con- tinuum of the prescription, dispensing, administration, and use of medicines. USP further believes that development and execution 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 mis- takes, and to reduce substantively the multi-billion dollars that such mistakes cur- rently cost the health care system each year.

USP comments, offered for Subcommittee consideration, cover the following: —Information about the U.S. Pharmacopeia’s 30-year record of stimulating vol-

untary health care practitioner reporting and using the analysis of those reports to improve patient safety.

—Background on USP’s ability to affect change in drug product labeling, pack- aging, and nomenclature when such is identified as contributing to medication errors.

—An explanation of USP’s new MedMARxTM _{program—a national, Internet-} based, anonymous medication error reporting system, introduced in July 1998, and now used by over 100 U.S hospitals.

—A recommendation for Congressional action that can directly and quickly re- move 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 private not-for-profit organization whose sole mission is to promote the public health by establishing and disseminating officially recog- nized standards of quality and authoritative information for the use of medicines and related articles for professionals, patients, and consumers. It is composed of ap- proximately 500 members representing state associations and colleges of medicine and pharmacy, ten agencies of the federal government, and about 75 national pro- fessional, scientific and trade organizations, and members-at-large who include members from other countries that recognize USP standards. The USP’s expertise as a standards-setting body has been recognized by Congress in the enactment of the Pure Food and Drug Act of 1906, by the Federal Food Drug and Cosmetic Act in 1938, and by the Food and Drug Modernization Act in 1997. USP standards are also referenced in most state pharmacy laws governing practice.

USP began developing drug information, in 1970, as support to its standards-set- ting activities. The USP DI, the compendia of USP drug information, is today rec- ognized 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 fed- eral 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.

USP practitioner reporting 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—national pro- gram 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, simi- larity in color or design of the label, or look-alike, sound-alike drug names.

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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, admin- istered, and used. USP does not set practice standards per se, but admittedly many of our standards do indirectly affect professional practice and many practice stand- ards are based on USP 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 practi- tioners. The 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 reports of actual and potential medication errors. We also continue to receive medication error re- ports 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. By these reports, we have seen that errors are multidisciplinary and multi-factorial. They can be committed by experienced and inexperienced staff, by health profes- sionals, support personnel, students, and even patients and their care givers. Errors can occur anywhere along the continuum from prescribing to transcribing to dis- pensing 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 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. We do not, however, actively solicit reports of adverse drug reactions.

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 treat- ed 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 manufac- turer 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 given. If given, however, USP respects the desire of the reporter to keep their identity con- fidential and will purge the identity of the institutions or individuals 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 publications, which are disseminated to all individuals who have reported to the MER Program and are publicly available on USP’s web site.

USP’S ABILITY TO AFFECT CHANGE

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 Potas- sium 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) labels must now bear a boxed warning ‘‘Con- centrate: Must be Diluted Before Use;’’ and (3) the cap must be black in color (the use of black caps is restricted to this drug only), and the cap must be im- printed 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 la- beled ‘‘FOR INTRAVENOUS USE ONLY’’ and that covering may not be re- moved 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. —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 thera- peutic class of neuromuscular blocking agents.

—MER 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 USP DI information in a special section in each drug monograph to caution health pro- fessionals on each drug’s proper use based upon reports of errors received through the program.

Reported medication errors also have brought about other changes in USP stand- ards and guidance to practitioners. For example, USP has ceased to recognize use of the apothecary system, a centuries old system of measurement, in favor of the metric system in order to avoid misinterpretations that have led to overdoses. USP has made changes in general label requirements for marketed drug products. For example, strengths less than one must be expressed as a decimal preceded by a zero (e.g. 0.1 grams, not .1 grams) to avoid ten-fold-overdoses. USP standards also re- quire 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 recogni- tion of the decimal point (e.g. 1mg, not 1.0 mg).

Prior to the formation of the Food and Drug Administration Office of Post Mar- keting Drug Risk Assessment, FDA 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 Injec- tion 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 database is maintained by USP and assists each Board of Pharmacy to determine the relative extent of er- rors in its state and contributes to the overall incident collection effort.

In addition to using the MER program to stimulate changes in enforceable stand- ards and information, USP has used the MER information to develop educational tools for the health professions. In 1993, a curricular resource entitled—Under- standing and Preventing Medication Errors—was distributed at no charge to col- leges 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.

USP has worked diligently during the past eight years, particularly in the stand- ards-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 17 national organizations and agencies that share a common mission to promote the reporting, understanding and prevention of medication errors. Member organizations include practice organiza- tions of medicine, nursing, and pharmacy, the licensing boards of pharmacy and nursing, organizations of the pharmaceutical industry, the Department of Veterans Affairs, USP, FDA, Joint Commission on the Accreditation of Healthcare Organiza- tions (JCAHO), and the American Hospital Association. In the four years since its inception, the Council has produced internationally recognized work products, such as:

—A standardized definition of ‘‘medication error’’

—A categorization index to classify medication errors by the severity of the out- come to the patient

—Recommendations to reduce the error prone aspects of prescription writing; product labeling and packaging; and broad recommendations related to the dis- pensing and administration phases of the medication use process.

The Council is now examining issues of process failures in the use of verbal or- ders, benchmarking, inter-organizational comparisons, and error rates.

In 1996 USP appointed an Advisory Panel on Medication Errors, an interdiscipli- nary 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 activities of the NCC MERP.

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 MedMARx data and provide guid- ance for the development of best practice solutions that will result in the reduction and prevention of medication errors.

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USP’S MEDMARX PROGRAM

In early 1998, USP developed a program for hospitals to report medication errors to a nationwide program. Hospitals were eager to submit reports to USP if it could be done anonymously and in a standardized format that would allow hospitals to track, trend, 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 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 incor- porating 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 So- ciety of Health-System Pharmacists. MedMARx is structured to support an inter- disciplinary systems-approach to medication error reduction and fosters a non-puni- tive environment for reporting.

Hospitals use the program as part of the organization’s internal quality improve- ment process, thereby extending the ‘‘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 re- sponse to the error or to avoid future similar errors. This feature affords institutions the opportunity to examine errors in a proactive manner. For example, the institu- tion 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