26 November 2002

Medication Error: 6.3% of malpractice claims are for adverse drug events, 73% preventable

We are getting much better data on medication error from multiple studies published recently in leading medical journals. Here, we note that 6.3% of malpractice claims are for adverse drugs events, of which 43% are life threatening or fatal and 73% preventable.

Since there are about an equal number of inpatient and outpatient adverse events noted in malpractice claims, we can infer that the number of deaths due to medication error is at least double that estimated by the two studies noted in the recent Institute of Medicine reports, since those studies reported only inpatient errors.

Analysis of Medication-Related Malpractice Claims: Causes, Preventability, and Costs. Arch Intern Med. 2002;162:2414-2420
Jeffrey M. Rothschild, MD, MPH; Frank A. Federico, RPh; Tejal K. Gandhi, MD, MPH; Rainu Kaushal, MD, MPH; Deborah H. Williams, MHA; David W. Bates, MD, MSc

Background: Adverse drug events (ADEs) may lead to serious injury and may result in malpractice claims. While ADEs resulting in claims are not representative of all ADEs, such data provide a useful resource for studying ADEs. Therefore, we conducted a review of medication-related malpractice claims to study their frequency, nature, and costs and to assess the human factor failures associated with preventable ADEs. We also assessed the potential benefits of proved effective ADE prevention strategies on ADE claims prevention.

Methods: We conducted a retrospective analysis of a New England malpractice insurance company claims records from January 1, 1990, to December 31, 1999. Cases were electronically screened for possible ADEs and followed up by independent review of abstracts by 2 physician reviewers (T.K.G. and R.K.). Additional in-depth claims file reviews identified potential human factor failures associated with ADEs.

Results: Adverse drug events represented 6.3% (129/2040) of claims. Adverse drug events were judged preventable in 73% (n = 94) of the cases and were nearly evenly divided between outpatient and inpatient settings. The most frequently involved medication classes were antibiotics, antidepressants or antipsychotics, cardiovascular drugs, and anticoagulants. Among these ADEs, 46% were life threatening or fatal. System deficiencies and performance errors were the most frequent cause of preventable ADEs. The mean costs of defending malpractice claims due to ADEs were comparable for nonpreventable inpatient and outpatient ADEs and preventable outpatient ADEs (mean, $64 700-74 200), but costs were considerably greater for preventable inpatient ADEs (mean, $376 500).

Conclusions: Adverse drug events associated with malpractice claims were often severe, costly, and preventable, and about half occurred in outpatients. Many interventions could potentially have prevented ADEs, with error proofing and process standardization covering the greatest proportion of events.

Medication Error: 20% of medication doses are errors

California nurses do not go into the hospital without a buddy nurse who watches their treatment, and particularly their medications. One of my colleagues recently had a young child in for surgery who would have been overdosed on morphine if a family member was not logging every medication dose at the bedside. There have been many retrospective studies of historical data that have clearly identified the problem. Some new studies are prospective. They look at the problem as it is happening, resulting in more accurate measurement of the frequency and severity of the error.

Medication Errors Observed in 36 Health Care Facilities. Arch Intern Med. 2002;162:1897-1903
Kenneth N. Barker, PhD; Elizabeth A. Flynn, PhD; Ginette A. Pepper, PhD; David W. Bates, MD, MSc; Robert L. Mikeal, PhD

Background: Medication errors are a national concern.
Objective: To identify the prevalence of medication errors (doses administered differently than ordered).
Design: A prospective cohort study.
Setting: Hospitals accredited by the Joint Commission on Accreditation of Healthcare Organizations, nonaccredited hospitals, and skilled nursing facilities in Georgia and Colorado.

Participants: A stratified random sample of 36 institutions. Twenty-six declined, with random replacement. Medication doses given (or omitted) during at least 1 medication pass during a 1- to 4-day period by nurses on high medication–volume nursing units. The target sample was 50 day-shift doses per nursing unit or until all doses for that medication pass were administered.
Methods: Medication errors were witnessed by observation, and verified by a research pharmacist (E.A.F.). Clinical significance was judged by an expert panel of physicians.

Main Outcome Measure:
Medication errors reaching patients.
Results: In the 36 institutions, 19% of the doses (605/3216) were in error. The most frequent errors by category were wrong time (43%), omission (30%), wrong dose (17%), and unauthorized drug (4%). Seven percent of the errors were judged potential adverse drug events. There was no significant difference between error rates in the 3 settings (P = .82) or by size (P = .39). Error rates were higher in Colorado than in Georgia (P = .04)

Conclusions: Medication errors were common (nearly 1 of every 5 doses in the typical hospital and skilled nursing facility). The percentage of errors rated potentially harmful was 7%, or more than 40 per day in a typical 300-patient facility. The problem of defective medication administration systems, although varied, is widespread.

20 November 2002

Nutrition: How it can eliminate over 50% of illness

In futher support of my argument that 50% of hospital days and clinic visits can be eliminated by nutrition and/or exercise, consider the considerable impact of nutrition on the immune system of older people.

"In the elderly, impaired immunity can be enhanced by modest amounts of a combination of micronutrients. These findings have considerable practical and public health significance." Chandra, RK. Nutrition and the Immune System: An Introduction. Am J Clin Nutr 1997 Aug;66(2):460S-463S

For example, giving elderly subjects a low potency multivitamin/mineral supplement vs. a placebo for 12 months showed enhanced immune response in the supplement group. This was correlated with direct clinical benefit. The mean number of days for infectious illness was 23 days in the supplement group and 48 for the placebo group. And antibiotic use in the supplement group was an average of 18 days vs. 32 days in the placebo group. So minimal vitamin supplementation in the elderly directly enhances immune function leading to elimination of over 50% of illness and 50% of drug use. Chandra RK. Effect of vitamin and trace-element supplementation on immune responses and infection in elderly subjects. Lancet 1992 Nov 7;340(8828):1124-7

Your physician will not ensure that you take advantage of this benefit. You must take responsibility for your own health.

17 November 2002

Diabetes: Improved Lifestyle Beats Drugs

Last week at the eHealth Developers Summit, I made the point that nutrition and exercise can eliminate 50% of disease, alternative medicine another 35%, and electronic frequency instruments at least another 10%. Hospitals admissions and clinic visits could be reduced by 95%. It takes knowledge, committment, and ability to change behaviors. This is a very good number, because Brent Lowensohn, Director of IT Advanced Technologies at Kaiser Foundation Health Plan and Hospitals, predicts a 15-fold increase in clinic visits over the next decade due to aging baby boomers, a problem that the current health system cannot possibly handle (see MIT Media Lab Future of Health Technology Summit).

A senior staff member of the Kellogg Foundation asked me for examples to support my argument and I gave a few. To my surprise, I returned home and found a recent New England Journal article showing that a 7% decrease in body weight and 150 minutes of exercise per week reduced the incidence of type 2 diabetes by 58%. The best drugs could do was a 31% reduction and this does not take into account the negative side effects of drugs or the positive side effects of lower weight and exercise on everything else except type 2 diabetes.

Alas, people continue to argue about the impact of nutrition and exercise as they did with smoking years ago. The smoking argument has largely stopped now that R.J. Reynolds was fined $144.9B in July 2000, and Phillip Morris was fined $28B last month (see today's New York Time business section). But I digress, let's look at the New England Journal of Medicine on diabetes.

Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin.
Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group.
Diabetes Prevention Program Coordinating Center, Biostatistics Center, George Washington University, 6110 Executive Blvd., Suite 750, Rockville, MD 20852, USA.

BACKGROUND: Type 2 diabetes affects approximately 8 percent of adults in the United States. Some risk factors--elevated plasma glucose concentrations in the fasting state and after an oral glucose load, overweight, and a sedentary lifestyle--are potentially reversible. We hypothesized that modifying these factors with a lifestyle-intervention program or the administration of metformin would prevent or delay the development of diabetes.
METHODS: We randomly assigned 3234 nondiabetic persons with elevated fasting and post-load plasma glucose concentrations to placebo, metformin (850 mg twice daily), or a lifestyle-modification program with the goals of at least a 7 percent weight loss and at least 150 minutes of physical activity per week. The mean age of the participants was 51 years, and the mean body-mass index (the weight in kilograms divided by the square of the height in meters) was 34.0; 68 percent were women, and 45 percent were members of minority groups.
RESULTS: The average follow-up was 2.8 years. The incidence of diabetes was 11.0, 7.8, and 4.8 cases per 100 person-years in the placebo, metformin, and lifestyle groups, respectively. The lifestyle intervention reduced the incidence by 58 percent (95 percent confidence interval, 48 to 66 percent) and metformin by 31 percent (95 percent confidence interval, 17 to 43 percent), as compared with placebo; the lifestyle intervention was significantly more effective than metformin. To prevent one case of diabetes during a period of three years, 6.9 persons would have to participate in the lifestyle-intervention program, and 13.9 would have to receive metformin.
CONCLUSIONS: Lifestyle changes and treatment with metformin both reduced the incidence of diabetes in persons at high risk. The lifestyle intervention was more effective than metformin.

12 November 2002

Prostate Cancer: Flaxseed oil helps

I take flaxseed oil and cottage cheese regularly as a cancer preventative based on the excellent results that Dr. Budwig reported in Germany over 50 years ago. She is an excellent example of a researcher whose information has been repressed by vested interests. Of course, the beauty of good research is that anyone can replicate it any time they want, so the truth comes out eventually. Duke University scientists have replicated her work. Some complain that Duke researchers did not cite Dr. Budwig properly.
Pilot study of dietary fat restriction and flaxseed supplementation in men with prostate cancer before surgery: exploring the effects on hormonal levels, prostate-specific antigen, and histopathologic features.
Urology 2001 Jul;58(1):47-52
Demark-Wahnefried W, Price DT, Polascik TJ, Robertson CN, Anderson EE, Paulson DF, Walther PJ, Gannon M, Vollmer RT. Division of Urologic Surgery, Duke University Medical Center, Durham, North Carolina, USA.

OBJECTIVES: Dietary fat and fiber affect hormonal levels and may influence cancer progression. Flaxseed is a rich source of lignan and omega-3 fatty acids and may thwart prostate cancer. The potential effects of flaxseed may be enhanced with concomitant fat restriction. We undertook a pilot study to explore whether a flaxseed-supplemented, fat-restricted diet could affect the biomarkers of prostatic neoplasia.

METHODS: Twenty-five patients with prostate cancer who were awaiting prostatectomy were instructed on a low-fat (20% of kilocalories or less), flaxseed-supplemented (30 g/day) diet. The baseline and follow-up levels of prostate-specific antigen, testosterone, free androgen index, and total serum cholesterol were determined. The tumors of diet-treated patients were compared with those of historic cases (matched by age, race, prostate-specific antigen level at diagnosis, and biopsy Gleason sum) with respect to apoptosis (terminal deoxynucleotidyl transferase [TdT]-mediated dUTP-biotin nick end-labeling [TUNEL]) and proliferation (MIB-1).

RESULTS: The average duration on the diet was 34 days (range 21 to 77), during which time significant decreases were observed in total serum cholesterol (201 +/- 39 mg/dL to 174 +/- 42 mg/dL), total testosterone (422 +/- 122 ng/dL to 360 +/- 128 ng/dL), and free androgen index (36.3% +/- 18.9% to 29.3% +/- 16.8%) (all P <0.05). The baseline and follow-up levels of prostate-specific antigen were 8.1 +/- 5.2 ng/mL and 8.5 +/- 7.7 ng/mL, respectively, for the entire sample (P = 0.58); however, among men with Gleason sums of 6 or less (n = 19), the PSA values were 7.1 +/- 3.9 ng/mL and 6.4 +/- 4.1 ng/mL (P = 0.10). The mean proliferation index was 7.4 +/- 7.8 for the historic controls versus 5.0 +/- 4.9 for the diet-treated patients (P = 0.05). The distribution of the apoptotic indexes differed significantly (P = 0.01) between groups, with most historic controls exhibiting TUNEL categorical scores of 0; diet-treated patients largely exhibited scores of 1. Both the proliferation rate and apoptosis were significantly associated with the number of days on the diet (P = 0.049 and P = 0.017, respectively).

CONCLUSIONS: These pilot data suggest that a flaxseed-supplemented, fat-restricted diet may affect prostate cancer biology and associated biomarkers. Further study is needed to determine the benefit of this dietary regimen as either a complementary or preventive therapy.