American Society for Clinical Pharmacology and Therapeutics (ASCPT)

The American Society for Clinical Pharmacology and Therapeutics (ASCPT) is pleased to have the opportunity to present recommendations to the AHRQ Summit on Medical Errors and Patient Safety Research. The ASCPT was founded in 1900 and consists today of more than 2,000 health professionals focused on research and education to promote the safe, effective use of medications. Our membership includes physicians, pharmacists, and research scientists with expertise in the evaluation and development of drugs.

Background

Our nation’s pharmaceutical/biotechnology industry has led the world in the development of medications to prevent, treat, or cure deadly and disabling diseases. American health care providers have sought to give their patients the full advantage of effective medications, writing over 2 billion prescriptions annually, an average of over nine per person in the United States,at a cost of over $100 billion annually. It is fair to say that every American has gained considerable benefit from the highly effective drugs on the market today.

At the same time, Americans are at considerable risk. Somewhere between 50 and 100 thousand of our citizens die each year as a result of errors in prescribing, dispensing, and patient use of medications. Further, even when medications are properly prescribed and utilized, adverse drug events occur because of individual genetic make-up; variations in how we respond to drugs based on our environment, diet, and general state of health; and interactions with other medicines and herbal products that we use.

Medication errors account for a significant portion of the medical errors that occur. The Institute of Medicine report, To Err is Human: Building a Safer Health System, emphasizes this point. The report notes that the findings of a study in two major teaching hospitals, if generalized, suggest that preventable adverse drug events cost our nation $2 billion annually in increased hospital costs alone. As noted in the IOM report, research and education to assure the safe use of medications must be a key component of efforts to reduce the incidence of medical errors.

As outlined in the recommendations of the IOM report, various Federal agencies and health care entities can play important roles in efforts to reduce medical errors. The report recommends the creation of a Center for Patient Safety within AHRQ to support research and evaluate methods for identifying and preventing medical errors, presumably including medication errors. In addition, the IOM recommends: 1) new initiatives by the Food and Drug Administration, particularly with respect to post-marketing surveillance and response (Recommendation 7.3), and 2) implementation of safe medication practices by all hospitals and health care organizations as appropriate (Recommendation 8.2). The ASCPT concurs with these proposals and commends the many hospitals and health care organizations already working to promote rational prescribing and implement safe medication practices.

In addition, with respect to the reduction of adverse drug events, it is important to recognize and address the need for: 1) appropriately trained personnel (including, specifically, clinicians with training in clinical pharmacology); 2) expanded Federal support for clinical, patient-oriented research related to the safe use of medications; and 3) the infrastructure and support necessary for improved post-marketing surveillance and response. The National Institutes of Health and the Agency for Healthcare Research and Quality can play important roles in this regard as follows:

• Appropriately Trained Personnel: The National Institutes of Health should be encouraged to increase funding for the existing Clinical Pharmacology Fellowships supported by the National Institute of General Medical Sciences. This program provides the opportunity for physician scientists to train for research careers in which they will focus on the development of new approaches to safe medication use and the prevention of adverse drug reactions.

  Not only should the NIGMS program be expanded, but similar initiatives should be established by other NIH instititutes. For example, the National Institute of Child Health and Human Development should support training in pediatric clinical pharmacology as proposed in S. 2809, The Children’s Health Research Act, introduced by Senators Christopher Dodd (D-Ct) and Mike DeWine (R-Oh). This is particularly important given the fact that 3% of all pediatric hospital admissions are associated with a drug-induced adverse event. Similar support could be offered by the National Institute on Aging.

  Increased opportunity for fellowship training alone will not address the shortfall of clinical pharmacologists required to implement some of the initiatives recommended by the IOM. One of the key reasons young physicians do not pursue careers in medical research is the increasing level of medical school debt, estimated by the Association of American Medical Colleges to be $85,000 on average. Tuition loan repayment programs are needed to attract physicians to clinical research careers in general and especially to the field of clinical pharmacology, in which only 20 physicians complete training each year in the nation. The loan repayment incentive will strengthen our ability to nurture a group of physician scientists trained in the prevention, recognition and treatment of medication errors and adverse drug reactions.

• Expanded Federal Support for Research: As noted in the IOM report, additional research is needed to better understand how and why medical errors occur and how they can be prevented. The ASCPT wholeheartedly concurs with this recommendation but believes that to be effective, the focus must be on clinical, patient-oriented research. The reports of several distinguished panels have highlighted the decline of clinical research in our country and expressed concern about the extent to which patient-oriented research is falling through the gap between the basic research customarily supported by NIH and the health services research funded by AHRQ and other public and private sponsors.

  As you may know, via both the legislative and appropriations processes, Congress has been pressing the NIH to give greater attention to patient-oriented research. It is important for this to occur, and research focussed on the safe use of medications should be a priority for increased NIH support for clinical research projects involving patients.

  Also, with respect to NIH, special attention must be given to the field of clinical pharmacogenetics, which must be a central component of any forward-looking research agenda intended to enhance patient safety. Pharmacogenetics is the study of how people respond differently to medicines due to their genetic make-up. An associated area of research is developmental pharmacogenetics, which focuses on how normal growth and development affect the expression of drug disposition and action. It is clear that we each inherit genetic traits that determine how well specific medicines will work in our bodies and predispose us to adverse reactions.

  The ultimate goal of pharmacogenetics research is information that will allow health care providers to use "precision prescriptions" to select medications and adjust dosage based on an individual’s genetic make-up. The field is already yielding results. For example, there is substantial variation in the rate of individual metabolism of a drug often prescribed for leukemia patients, many of whom are children. Through pharmacogenetic research, a blood test was developed that predicts in advance whether individual patients should receive less of the medication to prevent potentially lethal side effects. This is one example of the enormous potential of the field of clinical pharmacogenetics, an area in which NIH funding must be expanded.

  Wiith respect to AHRQ, the Center for Patient Safety, if established as recommended by the IOM, would develop a research agenda, fund Centers of Excellence, and support dissemination activities. The ASCPT believes such a Center should include clinical, patient-oriented research initiatives in its research agenda and assure that such research is supported by the Centers of Excellence. Further, the existing AHRQ-funded Centers for Education and Research in Therapeutics (see below) should be expanded in number and scope, should be funded by the Center for Patient Safety, and should work cooperatively with the Centers of Excellence.

• Necessary Infrastructural Support: The ASCPT believes that the AHRQ could play a central role in funding research to reduce medication errors through its program to support Centers for Research and Education in Therapeutics, known as CERTS. This program was created by Congress in 1997 to support state-of-the-art clinical and laboratory research on medications and to provide objective clinical information to health care providers and consumers.

  The ASCPT has two major concerns about the CERT program. First, it is SEVERELY underfunded. An FY 2000 budget of $5 million is totally inadequate for research on a health care problem that causes thousands of deaths each year and as much as $2 billion in unnecessary hospitalization expenditures. Second, the ASCPT has been concerned that the CERT program has been overly focussed on health services and population-based research and has applied minimal funding to research carried out by clinical pharmacologists on the biological mechanisms underlying the variability in patient response to medications.

  The CERTs were envisioned and should function as centers to conduct laboratory and clinical research to identify, predict, and prevent adverse reactions to medications and provide new information to the FDA, health care professionals, private/public health care insurers, and consumers in order to improve the safe and effective use of medications. In our view, linkages with laboratory scientists, clinical investigators, and health care providers are far more likely to benefit patients than the expansion of database analysis that has been emphasized in the evaluation and selection of the Centers.

  Also, with respect to infrastructure, the NIH-sponsored General Clinical Research Centers (GCRCs) should be a major site for the clinical, patient-oriented investigation necessary to advance a research agenda on medical errors and the safe use of medications. Unfortunately, this program has been underfunded in recent years, falling from 3% to 1% of NIH funding over the past several decades and growing by only 2.5% this year, when most other programs received increases of 15% or more. There is little infrastructure for clinical research in academic medical centers outside the GCRCs, and it is important for this program to be strengthened and expanded as a site for the training of investigators and the conduct of research related to medical errors.

  As noted previously, the NIH and the AHRQ are not the only agencies that should sponsor the training of clinical pharmacologists, research on medication errors, or the infrastructure needed to conduct research to identify and prevent adverse drug events. The Department of Veterans Affairs, the Department of Defense, the Centers for Disease Control and Prevention, and the Food and Drug Administration must play appropriate roles as well. The activities of these agencies should be monitored and coordinated by AHRQ, and collaborative efforts should be encouraged wherever possible.

Research Questions That Need to be Addressed

The ASCPT believes that the following questions should be included in a research agenda on medical errors and medication safety:

• Which patients are most at risk for adverse drug reactions and how can we predict and prevent them?
• How can discoveries from research in clinical pharmacology and pharmacogenetics be applied to optimize the safe and effective use of medications in children?
• What are the barriers to translating basic laboratory research into clinical research aimed at improved, error-free prescriptions that maximize benefit and minimize side effects?
• What pharmacogenetic tests should be implemented in specific clinical situations to optimize the benefit of medicines for patients?
• Which genetic testing technologies can provide the most cost-effective and accurate predictions of efficacy and toxicity?
• What are the methods needed to assure that new clinical findings are adopted as good clinical practice?

Conclusion

The American Society for Clinical Pharmacology and Therapeutics appreciates this opportunity to present recommendations to the National Summit on Medical Errors and Patient Safety Research. As the professional society whose sole purpose is the improved use of medications, we welcome the opportunity to work with AHRQ and other Federal agencies to assist with the development of programs that will improve our nation’s ability to prevent adverse drug events and foster the safe use of medications for Americans.

Current as of September 2000

Internet Citation:

American Society for Clinical Pharmacology and Therapeutics (ASCPT). Additional Statement. National Summit on Medical Errors and Patient Safety Research. September 2000. http://www.quic.gov/summit/aascpt.htm

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