American Society of Health-System Pharmacists

Additional Statement, Submitted by Henri R. Manasee, Jr., Ph.D., Sc.D., Executive Vice President and Chief Executive Officer, American Society of Health-System Pharmacists

The American Society of Health-System Pharmacists (ASHP) is pleased to submit written comments to the Agency for Healthcare Quality and Research (AHRQ) for the upcoming National Summit on Medical Errors and Patient Safety Research. 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 agencies, and other components of health care systems.

The safety of the medication use process in hospitals and health systems is the distinct responsibility of the institution's pharmacy department. For nearly half a century, ASHP and its members have played a leading role in ensuring patient safety as it relates to the use of medications. Health-system pharmacists have developed numerous interconnected procedures and well-recognized guidelines for ensuring patient safety related to all the steps in the medication use process. The Institute of Medicine (IOM) report, To Err is Human: Building a Safer Health System, states that since it is not 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.

Fostering fail-safe medication use in hospitals and health systems is a top priority for ASHP and the ASHP Research and Education Foundation. This year, the Foundation announced plans to launch a major research project to design and test new fail-safe inpatient medication use processes in health systems. The establishment of a fail-safe medication use system is, by necessity, a collaborative effort. Toward that end, ASHP is working on many fronts, both to improve our members' understanding of how medication errors happen and to devise tested approaches for our members to use to prevent those errors.

The most recent step to expand and accelerate ASHP's efforts to improve medication use safety was through the development of the Center on Patient Safety at ASHP. This new Center will focus on interdisciplinary efforts to advocate for, develop, and implement best practices in the medication use process. The creation of the ASHP Center on Patient Safety reflects ASHP's continuing dedication to achieving fail-safe medication use in America's health systems, and the Center will help pharmacists improve medication use safety by providing:

• Leadership and Guidance—The Center will help health care professionals understand why medication errors occur, devise tested approaches to prevent them, and pursue best practices in health care.
• Professional Advocacy—The center will engage in advocacy efforts directed to legislators, government regulators, consumers, and health-system decision makers to foster effective safety roles for pharmacists in health systems.
• Tools and Education—The Center will develop practical tools that pharmacists can use to help build fail-safe medication use systems. Additionally, the Center will expand educational program offerings related to medication safety.
• Alliances and Partnerships—The Center will establish interdisciplinary partnerships and alliances with groups dedicated to improving medication use safety in health systems.
• Research—The Center will work closely with the ASHP Research and Education Foundation to explore the complex problem of medication use safety in health systems.

ASHP's Research and Education Foundation has begun developing a proposal for a focussed research project. A rare practice has emerged in some institutions where an individual, often a pharmacist, has been charged to perform the job of medication safety officer. At this time, however, our understanding of the specific job responsibilities and associated tasks for a medication safety officer is piecemeal and fragmentary.

ASHP proposes, as a first stage, a task analysis and learning analysis of the job of a medication safety officer. This will be followed by identification of existing learning resources for teaching the identified knowledge, skills, attitudes, abilities, and judgement. This project will lead to the design and development of training for pharmacists in the job responsibilities and associated tasks of an individual charged by a health system to oversee medication safety.

Other Research Needs

Research on a national level calls for a coordinated agenda. ASHP believes that there are three major areas that that agenda should cover:

• Studying cultural barriers in health systems that hinder the development and implementation of safe medication use systems.
• Studying the effects of automation in the medication use process to develop quality standards and principles for the research, design, development, and implementation of fail-safe systems.
• Studying how to most effectively apply the expertise of patient-care pharmacists in fostering patient safety, including through participation in physician rounds.

Cultural Barriers

Facts:

1. Health care quality begins with patient safety.
2. The problems that exist are serious, systemic, and largely preventable.
3. Serious cultural barriers exist in health care, which will hinder any meaningful progress towards the development of a safety and quality agenda in health systems.

The United States has the most highly educated, and best trained health care practitioners in the world. These practitioners live by the ethos, first do no harm. Rarely is an individual to blame when a patient is injured by a system designed to help and not harm. More commonly, after an accident, serious and preventable systemic flaws are discovered. Culture plays a key role.

Decisions made by managers and practitioners in health systems can have serious implications on the safety and quality of care provided to patients. Many decisions are made unilaterally, which points to a clear flaw in the system. Among the many factors leading to the space shuttle Challenger accident, for example, poor mechanisms for communication between front-line engineers and managers was a major problem. There are numerous analogies that can be made in health systems.

Given the increasing complexity of medical care, we still expect physicians to be responsible for every aspect of patient care. This is unrealistic. It is especially unrealistic in the typical inpatient facility, where physicians work off-site in private practice offices. Teamwork, recognized and understood handoffs, multidisciplinary specialists, and multiple safety nets are important aspects of any system with safety at its core. Many of these mechanisms are proven in the medical literature, but not common in practice. Why not? Well-developed interdisciplinary best practices currently exist that, if adhered to, could greatly improve outcomes, but are not common in practice. Why not? What can we do as a health care community to ensure the public that they are receiving the highest quality care possible? A good first step would be to examine and re-engineer our culture.

Important research, utilizing sound scientific principles, needs to be applied to measuring quality and improving safety in health care. The importance of studying both blunt end and sharp end factors, which act as cultural barriers to quality improvement, should not be minimized nor under-emphasized when developing our national research agenda. We should be doing funded research on changing cultures.

Effects of Automation

The use of automation holds great potential for improving safety and quality in the medication-use process. However, we must be cautious not to blindly recommend the widespread implementation of automated systems without first developing an agreed upon set of guidelines and principles for their safe use. Incidences have occurred where automated systems, either by flawed design or improper implementation, resulted in increases in medication error rates.

Prescriber order entry (POE) has been proven in numerous studies to significantly decrease prescribing errors, which are among the most common forms of error. But when POE systems are not integrated into the pharmacy system, important safety nets are eliminated, resulting in a greater number of steps added to an already complex medication use process. Medication administration errors are a significant type of error. The use of machine-readable technology, or bar coding, is another example where technology holds great promise if designed and implemented properly.

The need to develop clear standards and guidelines for the design, development, and implementation of safe automated medication use systems is important. Research needs to be done to determine what specifications should be required in the design phase for manufacturers, as well as in the implementation phase for institutions. The Food and Drug Administration recently took the lead by developing a guidance document for manufacturers to incorporate human factors principles into the design of medical devices. The same approach needs to be taken in recommending minimum specifications to manufacturers of automated drug delivery systems. However, gaps exist in what those specifications should be. Quality measures should be developed for institutions to use to determine if their systems are improving safety. Before hospitals can commit resources toward purchasing automated systems, they need ways to determine the efficacy of the system to avoid or reduce errors.

As a part of the national research agenda, we recommend that resources be devoted to studying the effects of automation on safety in the medication use process. Guidelines for both manufacturers and institutions should be developed.

Applying the Expertise of Pharmacists

Over the past several decades, hospital pharmacists have developed numerous interconnected processes for ensuring patient safety related to all the steps in the medication use process. A partial list of those steps would include: including product selection and acquisition, formulary system management, i.v. admixture services, quality assurance for hospital-prepared sterile products, infection control, unit dose drug distribution, adverse drug reaction monitoring and reporting, handling cytotoxic and hazardous drugs, individual patient drug regimen review, review of overall drug use patterns, handling investigational drugs, and pharmacokinetic dosing services. Hospital pharmacists have developed well-defined and time-tested structure and process guidelines (based on both evidence and expert opinion) for the optimal ways of conducting these activities, from the standpoint of patient safety. It is no wonder, then, as noted above, that the IOM report specifically cited the pharmacist who practices in health care organizations as a health care professional who has the essential role in improving patient safety.

Others have recognized the importance of pharmacists as well. During questioning at a Senate Health, Education, Labor, and Pensions Committee hearing on February 1, 2000, Dr. Janet Woodcock, Director of the Food and Drug Administration's Center for Drug Evaluation and Research, called pharmacists the "crucial safety link" in the medication use process because they provide consumers with all-important information on the benefits and risks of their medications. And the General Accounting Office (GAO) report, Adverse Drug Events: The Magnitude of Health Risk is Uncertain Because of Limited Incidence Data (January 2000) states that "Most medication errors in hospitals involve the prescriptions ordered by physicians and nurses' administration of drugs. Pharmacists make relatively few medication errors when they transcribe, verify, and dispense hospital prescriptions." The GAO report recommended "increasing the role of pharmacists as advisers to physicians in prescribing drugs and in monitoring drug therapy."

The IOM report also cites the study conducted by Lucian Leape, M.D., and published in the Journal of the American Medical Association in July 1999, that establishes the importance of pharmacist participation in patient rounds "to significantly reduce serious medication errors." Dr. Leape's study, which was co-funded by ASHP's Research and Education Foundation, is just one of the most recent reports on the importance of pharmacists' expertise in preventing medication errors. There are other studies indicating that the availability of pharmacists can reduce medication errors, both in terms of pharmacy oversight¹ or inclusion and collaboration of pharmacists on the health care team^{2, 3}.

The research that has been conducted to date on this issue should be expanded. The IOM report noted the lack of information on medical errors in settings other than hospitals—nursing homes, and outpatient and home care settings. Further research on how patient-care pharmacists' collaboration with other health care professionals in these settings—as well as further studies in hospitals—could reduce medication use errors is imperative if we are to meet the IOM report's goal of reducing medical errors by 50 percent within the next five years.

ASHP appreciates the opportunity to present these comments to the National Summit on Medical Errors and Patient Safety Research, and we look forward to the continued opportunity to advise the AHRQ and the Quality Interagency Coordination Task Force as they develop a national research agenda on this important public health and pharmacy practice issue. Please feel free to contact me if you have any questions regarding our comments.

References:

Lesar TS, Lomaestro BM, Pohl H. Medication-prescribing errors in a teaching hospital: A 9-Year Experience. Arch Intern Med 1997; 157:1569-76.

Lesar TS, Briceland L, Stein DS. Factors related to errors in medication prescribing. JAMA 1997; 277:312-17.

Top-priority actions for preventing adverse drug events in hospitals: Recommendations of an expert panel. Am J Health-Syst Pharm 1996; 53:747-51.

Current as of September 2000

Internet Citation:

American Society of Health-System Pharmacists. Additional Statement, Submitted by Henri R. Manasee, Jr. National Summit on Medical Errors and Patient Safety Research. September 2000. http://www.quic.gov/summit/aashp.htm

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