Statement of the American Society of Health-System Pharmacists, Bethesda, Maryland
The American Society of Health-System Pharmacists (ASHP) is pleased to submit this statement for the record of the Subcommittee on Health’s hearing on health quality and medical errors. ASHP is the 31,000-member national professional association that represents pharmacists who practice in hospitals, long-term care facilities, home care, hospice, health maintenance organizations, and other components of health care systems. ASHP 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 Institute of Medicine (IOM) report, “To Err is Human: Building a Safer Health System,” states that since it isn’t possible for nurses or doctors to keep up with all the information necessary for safe medication use, “the pharmacist has become an essential resource in modern hospital practice,” and access to the pharmacist’s expertise must be possible at all times. For decades, ASHP has been actively involved in promoting a fail-safe medication use system for hospitals and other components of our nation’s health system, and ASHP agrees with the IOM that the active participation of pharmacy practitioners is essential to the creation of that fail-safe system. ASHP stands ready to assist the Subcommittee in developing meaningful recommendations to implement error reduction techniques.
In general, ASHP applauds the analysis and recommendations in the IOM report. Of particular interest to ASHP are recommendations dealing with mandatory and voluntary reporting systems, extension of peer review protections to data about patient safety and quality improvement as well as initiatives to improve the medication use process through the appropriate application of technology and the proper utilization of pharmacists as health care providers.
The Creation of a Non-Punitive Environment For Reporting is Essential
In order to achieve the IOM’s call for a 50% reduction in the rate of medical errors over the next five years, it is essential to create a confidential, non-threatening, non-punitive environment where errors can be reported, the underlying cause studied, and effective interventions devised and implemented. To do so, Congress must work with states and the private sector to create a single, nationwide error reporting program.
In June 2000, ASHP’s House of Delegates approved the following statement regarding the development of an error reporting system:
Policy
The incidence of death and serious harm caused by mistakes and accidents in health care is unacceptable. 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, (2) continued development and strengthening of systems for voluntary reporting of medical errors, and (3) strengthening efforts to implement process changes that reduce the risk of future errors and improve patient care.
The fundamental purpose of reporting systems for medical errors is to learn how to improve the health care delivery process to prevent these errors. Reporting of medical errors must become culturally accepted throughout health care. A major investment of resources will be required in the health care system to apply the lessons derived from the 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.
Requirements
The primary goal of mandatory reporting of adverse medical events that cause death or serious harm should be to foster accountability for health care delivery process changes to prevent errors or adverse medical events.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 and with national programs that are designed to improve the quality and enhance the safety of patient care.
ASHP’s support of a mandatory reporting system is contingent upon the system having the following characteristics:
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 of medical errors should be quality improvement and enhancement of patient safety. Reports by frontline practitioners of errors and “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 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 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.
It is important to emphasize the necessity of nationwide peer review protections to the successful implementation of any error reporting program. ASHP supports "federal legislative and regulatory initiatives that provide liability protection for the reporting of actual and potential medication errors by individuals and health care providers." Further, ASHP supports "federal liability protection for medication-error reporting that is similar in concept to that which applies to reporting safety incidents and accidents in the aviation industry."
Since current legal protection for medication error reporting (both actual and potential as defined in ASHP's "Guidelines on Preventing Medication Errors in Hospitals") is based primarily on state peer-review protection statutes or on case law, the extent of protection varies substantially throughout the country. For example, some states may limit protection to records prepared by peer-review committees and do not protect records provided to these committees. Given the state-to-state variance, medication errors may not be reported in a consistent and uniform manner, making trend analysis and subsequent corrective measures difficult.
Individual practitioners and health care entities may be hesitant to report medication errors for fear that the information could be used in civil liability lawsuits against them. There is no federal protection for individuals and entities reporting medication errors to national reporting programs. This lack of protection, and the consequent incomplete reporting, means that individual practitioners, health systems, pharmaceutical manufacturers, and other public and private organizations cannot learn of the component parts of a system error and develop corrective measures to enable a fail-safe medication-use system.
Such protection would only cover the information submitted to a designated national reporting entity. Individual practitioners and healthcare entities still would remain susceptible to liability action as a result of underlying incidents that form the basis of the report if the incident resulted in harm to an individual.
Federal legislation providing liability protection for the reporting of actual and potential medication errors would neither help nor harm individual patients who are injured, but it should help patients collectively because the reported data could be used to reduce the incidence of avoidable errors. Individual patients would still be able to seek a legal remedy for their injuries. Seeking this limited federal protection is preferred over attempting to obtain uniform protection from all 50 states.
ASHP and its members have a great deal of experience with existing reporting systems and will participate in the further development of mandatory or voluntary reporting programs.
Appropriate Application of Technology Improves the Medication Use Process
Everyone agrees that the number of medication-related errors is too high. Handwritten clinical data, incomplete, outdated or improperly implemented information technology increases the likelihood that this number will remain unnecessarily high. Research demonstrates that patient-safety geared information technology, when used appropriately and under the leadership of health-system pharmacists, who are responsible for the appropriate, accurate, and timely distribution of medications, can improve quality of care and reduce medication-related errors.
The biggest obstacle for hospitals when it comes to implementing information technology enhancements is the enormous cost of researching these systems, purchasing the necessary hardware and software, as well as training staff to use the technology properly.
The March 2001 IOM report, “Crossing the Quality Chasm: A New Health-System for the 21st Century,” urges a significant national investment in information technology geared toward improving the quality of health care delivery.
ASHP supports a voluntary grant program that would provide funding for early adopters of new technology to meet the high price tag of this new technology as well as the necessary and important expense associated with properly educating and training staff on the correct use of the information system. The Medical Error Reduction Act (H.R. 3292), introduced last year by Ways and Means Committee members Amo Houghton (R-NY) and Karen Thurman (D-FL), would go a long way toward achieving this goal. Senators Bob Graham (D-FL) and Olympia Snowe (R-ME) have introduced similar bipartisan legislation (S. 824) in the Senate.
Recognizing Pharmacists as Health Care Providers Under Medicare Improves Quality of Care, Reduces Errors
Our nation’s health care system relies heavily on thousands of powerful new prescription medicines to treat all sorts of diseases and conditions. Many patients, especially those over the age of 65, find themselves taking a bewildering array of medications. As medication use rises, so to does the risk of medication-related complications. Yet, despite being among our nation’s highest risk patients, Medicare beneficiaries often have limited access to the valuable services of pharmacists.
As the IOM and others have recognized, pharmacists play an important role in improving the quality of patient care and reducing the risk of dangerous (and costly) medication-related complications. Working closely and collaboratively with physicians, the pharmacist is a trusted counselor who helps to streamline drug therapies prescribed by a number of specialists, matching effective therapies with patients’ unique needs. Pharmacists also play vital roles in follow-up care, monitoring patient response and advising physicians on changes in dosage, medicine, or delivery method.
Currently, Medicare does not compensate pharmacists for these important patient care services. Because pharmacists are not considered “health care providers” under Medicare, their experience is underutilized, patient care is diminished, and reductions in unnecessary expenditures are not realized. Simply put, Medicare payment policies have not advanced to match the pharmacist’s critical role in health care.
ASHP supports the passage of legislation to update Medicare statutes to recognize pharmacists as health care providers in a similar manner as other non-physician practitioners, including registered dieticians, nurse practitioners, physician assistants, certified nurse midwives, and clinical social workers, are recognized. Legislation, the Medicare Pharmacist Services Coverage Act (H.R. 2799 / S. 974), has been introduced in both the House and Senate to achieve this goal. This important legislation will ensure that the entire health care team is able to properly utilize the pharmacist’s expertise in drug therapy management.
ASHP thanks Chairwoman Johnson, and members of the Subcommittee for holding this important hearing. We appreciate the opportunity to submit a statement for the record and look forward to working with the Subcommittee and other members of Congress to develop effective patient safety legislation.