Pharmaceutical Update:
The Costs of 'Therapeutic Misadventures'
by Gary L. Snodgrass, M.D.| Geriatric Times |  |
May/June 2000 | |
Vol. I | |
Issue 1 |
It is my great pleasure to serve as contributing editor of "Pharmaceutical Update." In this inaugural issue, it may be useful to outline the mission, goals and focus of future columns. It is this column's mission to integrate all aspects of medication usage in the elderly, with the overall goal of focusing on an interdisciplinary approach to healthy aging. The goal is to provide primary care practitioners, physician assistants, nurse practitioners, nurses, pharmacists and ancillary health care professionals with data that facilitate clinical decision-making.
Future columns will present traditional topics in geriatric pharmacology: indications, mechanisms of action, side effects and interactions of new drug products, as well as drug classes. The emphasis, however, will be on practical application in a clinical setting. Research data will be melded with pharmacoeconomic, regulatory and patient perspectives in an attempt to promote rational drug prescribing.
In addition, it is my philosophy to challenge our system of providing medication services to our nation's elderly. I invite readers to participate in this Socratic style, which may at times produce controversy with pharmaceutical manufacturers, regulatory agencies and professional organizations. It is important to note that, regardless of process, which may include painful introspection, the ultimate goal will always be to improve medication services. In keeping with this disclosure of caveats, I need to state that my views are my own. As contributing editor, I am neither the spokesperson nor the agent for any clients or health care firms that contract for my professional services as a consultant. In addition, my opinions do not necessarily reflect those of Geriatric Times.
Well, now that the ground rules have been outlined, let's devote the rest of the time to some topical issues.
Primum Non Nocere (First Do No Harm)
Last year's Institute of Medicine (IOM) report entitled "To Err Is Human" has understandably received considerable attention in the lay press. Conclusions that medical errors are the eighth leading cause of death and that medical errors can be identified as the cause of 44,000 to 98,000 deaths annually are riveting to the public.
Of the conservative estimate of 44,000, a minimum of 7,000 deaths were attributed to prescribing or dispensing errors. This should be a wake-up call to all prescribers and pharmacists. To add further drama to these estimates, most clinicians would agree that medication errors are underreported.
For years, the U.S. Food and Drug Administration has done a good job of encouraging forthright and thorough reporting of medication errors and adverse reactions. The system is voluntary, however, and the perceived stigma of admitting an error, along with the additional paperwork, contribute to underestimates of these types of errors. For this reason, the IOM report recommended establishing a national, mandatory error-reporting system.
In the past, even some pharmacy literature has unintentionally diluted the impact of medication errors by referring to them as "therapeutic misadventures."
Caution: opinion alert-euphemisms such as therapeutic misadventure don't cut it when you are talking about potentially contributing to the death of 7,000 patients.
Although it is possible to critique the IOM report methodology and argue about the validity of extrapolating the results of studies in only a few states, this is a waste of time for our patients. As clinicians, we know it's probably worse than the IOM estimated, and the only way we are going to help is to examine the simplest aspects of our own individual practices. This means each prescriber takes the time to minimize the use of abbreviations and ensures the legibility of the prescription. It means each pharmacist double-checks their work and listens to that little voice that says, "You had better pause, even if the phones are ringing and the orders are backing up."
The Cost Is More Than Clinical
The American Society of Consultant Pharmacists (ASCP) published data in its January 2000 Update regarding insurance claims made against long-term care facilities. The data, supplied by St. Paul Medical Services, categorized claims made by its policyholders during 1997 by cost.
Three of the 10 costliest categories involved allegations of medication errors. Claims of medications omitted or delayed had an average cost of $198,000. Claims of medications not ordered or ordered in the wrong amount carried an average cost of $122,700. Finally, allegations of adverse reactions from medications had an average cost of $88,000. It should be obvious from this data that, from a purely pharmacoeconomic perspective, even one settled claim for a medication error puts a serious dent in a long-term care facility's cost-containment efforts.
Nursing Facility Survey Violations and Penalties
The Health Care Financing Administration (HCFA) has published new rules that will place immediate sanctions on nursing facilities that receive deficiencies on consecutive surveys. Any nursing facility documented as causing harm to a resident on two consecutive surveys could be fined up to $10,000 for each serious incident.
HCFA has a number of additional plans for improving nursing home residents' quality of care, but the specifics are beyond the scope of this column. Suffice it to say that there are more penalties on the way. HCFA Administrator Nancy-Ann DeParle was quoted in the Feb. 11 issue of McKnight's Long-Term Care News as saying, "We are taking these actions to make sure that residents get the quality care and safe environment that they deserve."
A contrasting view was presented, in the same issue, in a study by researchers at the University of California at San Francisco. They reported that nursing home deficiencies dropped in most surveyed areas between 1991 and 1997. The principal investigator, Charlene Harrington, Ph.D., stated, "We don't know why the number of deficiencies is going down, but we definitely don't see an improvement in quality of care." The article provided several perspectives, including some harsh criticism of HCFA survey results. Rather than taking sides in this hailstorm of finger-pointing (I want this column to be controversial, not self-destructive), we will assume that all sides will contribute to a stronger HCFA survey process in the future.
There is, however, one commonality between the two aforementioned articles of particular interest to GT readers concerned with rational medication use: Neither article even mentioned medication errors. The article on the HCFA discussed outcomes-based survey systems, quality of care and empowering consumers, but made no reference to medication errors. There was a reference to the HCFA's "Guide to Choosing a Nursing Home" and a Web site that includes statistics reported by individual nursing homes. These statistics included "prevalence of bedsores, incontinence and other health conditions."
I know that the HCFA includes medication-pass observations in its surveys, and I do not mean to minimize the importance of the health conditions listed. So why not equal billing for accuracy of medication use? The omission can't be based upon low incidence of medication use. How many nursing home residents have zero medications prescribed? It also can't be based upon lack of family interest. If you are truly going to empower consumers, you can bet they want to know if their relative is getting the medications as prescribed.
In the article by the University of California researchers, a detailed table of survey deficiency percentages was provided. The categories of deficiencies included infection control, comprehensive care plans, comprehensive assessments, physical restraints, housekeeping, dignity, incontinence care, food sanitation, pressure sores and accident environment. No data are reported for medication use. Again, I am not minimizing the importance of any of the data categories reported. Again, though, why report physical restraints and omit chemical restraints? Can housekeeping be more important than medication errors?
Conclusion
We have come full circle for this first column, and I hope my mission is clear. With the assistance and input of GT readers, the editors and I hope to improve the quality of medication usage for the elderly. We hope to serve as a conduit for dialogue among prescribers and those monitoring the efficacy and safety of drugs. We are not constricted by any particular process for achieving these goals, and we are not adverse to some editorial risk-taking.
In summary, is there a way you and I can mitigate some of the tragic impact the IOM study cites? Well, we had better try. In preventing medication errors, can we save some money in the process? I hope so. Can we improve the nursing home survey process so HCFA penalties focus on medication use and future research studies at least include a category for medication accuracy? I don't know. You are really going to have to help me on that one.
Dr. Snodgrass is an independent consultant and president of Triad Management Group. His firm assists health care managers in pharmacy systems analysis, vender evaluation, medication utilization and quality assurance in long-term care, residential care and psychiatric facilities.
Further Reading
Blankenheim TA (2000), HCFA imposes tougher penalties. McKnight Long-Term Care News 21(2).
Blankenheim TA (2000), Report: Nursing home violations decline by 50%. McKnight Long-Term Care News 21(2).
American Society of Consultant Pharmacist (2000), St. Paul Medical Services policyholders data. ASCP Update February.
Institute of Medicine (1999), To Err Is Human: Building a Better Health System. Washington, D.C.: National Academy of Sciences.