9/5/2000

ASHP Proposes Critical Steps in National Solution to Medical Error Problem

The American Society of Health-System Pharmacists (ASHP) today proposed a comprehensive, national approach to reducing medication and other medical errors. The Society, which represents 30,000 pharmacists who practice in hospitals and other components of health systems, is advocating the establishment of a national medical error reporting system and the strengthening of voluntary reporting systems.

"We need to move beyond the culture of blame that has traditionally surrounded the issue of medical error and begin to establish standardized reporting systems that take a 'lessons-learned' approach to the problem," said ASHP President Bruce E. Scott, M.S., FASHP. "The ideal system would allow sunshine into the processes that create error so that we can change those processes and protect patients." 

In advance of yesterday's Senate Committee on Health, Education, Labor, and Pensions hearing, ASHP stated that a mandatory reporting system should only be applied when patients are seriously harmed or die as a result of error. "This system should focus on three primary goals: accountability, quality improvement, and enhancement of patient safety," noted Scott. The Society's recommendations are in direct response to the Institute of Medicine's recent report on medical error, "To Err is Human: Building a Safer Health System," which highlighted the important role of pharmacists in preventing medication errors, especially through their work on patient-care teams. 

ASHP supports a mandatory medical error reporting system at the state level with strong federal coordination, analysis, and oversight. This system would: 

  • Focus on improving health care processes, 
  • Provide confidentiality to patients, health care workers, and institutions as long as the confidentiality doesn't compromise public accountability, and 
  • Eliminate penalties for the reporting of a medical error that causes serious harm or death.
Further, the Society recommends the adoption of a definition of "serious harm" that focuses on incidents of long-term or irreversible patient harm. It also advocates that a mandatory system include national coordination and standardization of reporting methods and analysis, adequate resources for report analysis and quality improvement, and periodic assessment to ensure the system is working and not creating undesirable consequences.

ASHP also weighed in on the importance of maintaining and improving current voluntary reporting systems. The Society noted that the current Medication Errors Reporting Program operated by the U.S. Pharmacopeia in cooperation with the FDA's MedWatch program and the Institute for Safe Medication Practices could serve as a model for voluntary reporting of other types of medical error. 

"By developing a mandatory system that assesses error and by incorporating the information we learn from voluntary systems on 'near misses,' we can design a system that is truly fail-safe," said Henri R. Manasse, Jr., Ph.D., Sc.D., ASHP executive vice president and CEO. Manasse also serves as chairman of the National Patient Safety Foundation. 

ASHP is the 30,000-member national professional association that represents pharmacists who practice in hospitals, health maintenance organizations, long-term-care facilities, home care, and other components of health care systems. ASHP, which has a long and distinguished history of medication error prevention efforts, believes that the mission of pharmacists is to help people make the best use of medicines. Assisting pharmacists in fulfilling this mission is ASHP's primary objective. The Society has extensive publishing and educational programs designed to help members improve their delivery of pharmaceutical care, and it is the national accrediting organization for pharmacy residency and pharmacy technician training programs. 

ASHP Statement on Reporting Medical Errors

Position

The incidence of death and serious harm caused by mistakes and accidents in health care is unacceptable.1 This serious public health problem merits top-priority national attention. Addressing this issue will require major reforms and sizable investment of resources throughout the health care system, including the medication use process, which is a particular focus of the American Society of Health-System Pharmacists (ASHP).

ASHP believes that the following steps should be taken as part of a comprehensive national solution to the problem: (1) The establishment of a standardized, uniform nationwide system (with the characteristics noted below) of mandatory reporting of adverse medical events that cause death or serious harm and (2) continued development and strengthening of systems for voluntary reporting of medical errors.

Requirements

The primary goals of mandatory reporting of adverse medical events that cause death or serious harm should be accountability, quality improvement, and enhancement of patient safety. If a patient dies or is seriously harmed because of a mistake or accident in the health care system, the practitioner or institution responsible for the patient's care should report the incident to a designated state health body. Further, states should be obligated to share information based on these reports promptly with a national coordinating body that focuses on quality improvement in health care. ASHP's support of a mandatory reporting system is contingent upon the system having the following characteristics:

  1. An overall focus on improving the processes used in health care, with the proper application of technical expertise to analyze and learn from reports,
  2. Legal protection of confidentiality of patients, institutions, and health care workers to the extent feasible while preserving the interest of public accountability,
  3. Nonpunitive in the sense that the submission of a report, per se, does not engender a penalty on the reporting institution or practitioner or others involved in the incident,
  4. A definition of "serious harm" that concentrates on long-term or irreversible patient harm, so as not to overburden the reporting system,
  5. National coordination and strong federal efforts to ensure compliance with standardized methods of reporting, analysis, and follow up that emphasize process improvement and avoid a culture of blame,
  6. Adequate resources devoted to report analysis, timely dissemination of advisories based on report analysis, and development of appropriate quality improvement efforts, and
  7. Periodic assessment of the system to ensure that it is meeting its intent and not having serious undesired consequences. 

Experience associated with current mandatory state reporting of adverse medical events and mandatory public health reporting of certain infectious diseases should be assessed, and the best practices of such programs should be applied to the new system of mandatory reporting of adverse medical events that cause death or serious harm.

The primary goals of voluntary reporting should be quality improvement and enhancement of patient safety. Reports by frontline practitioners of "near misses" are a strength of such programs when report analysis and communication lead to prevention of similar occurrences. The public interest will be served if liability protection is granted to individuals who submit reports to voluntary reporting programs. The Medication Errors Reporting Program operated by the United States Pharmacopeia in cooperation with the Food and Drug Administration's MedWatch program and the Institute for Safe Medication Practices is an important initiative that merits strengthening; this program may be a model for voluntary reporting of other types of medical error.

The fundamental purpose of reporting systems for medical errors is to learn how to prevent them. A major investment of resources will be required in the health care system to apply the lessons derived from mandatory and voluntary reporting of medical errors. Marshaling those resources is an urgent issue for the governing boards of health care institutions, health care administrators, health professionals, purchasers of health care (including federal and state governments), third party payers, public policy makers, credentialing organizations, the legal profession, and consumers.

1. Institute of Medicine Division of Health Care Services Committee on Quality of Health Care in America. To err is human: building a safer health system. Washington, DC: National Academy Press; 1999.

Approved by the ASHP Board of Directors, January 24, 2000, as an interim policy; subject to ratification by the ASHP House of Delegates.

Copyright ? 2000, American Society of Health-System Pharmacists, Inc. All rights reserved. 

[Other relevant ASHP policies are the ASHP Guidelines on Preventing Medication Errors in Hospitals and policy positions 9918, 9805, 9609, 9206, 9007, and 8614.]


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