Lipid-lowering agents and the risk of hip fracture in a Medicaid population.

CONTEXT: Three recent nested case-control studies conducted in automated databases suggest that users of 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) have a risk of hip and other osteoporotic fractures half that of non-users of any lipid-lowering drug. However, this comparison may be biased by unmeasured factors associated with treated hyperlipidemias. OBJECTIVE: To compare the risk of hip fracture among users of statins and other lipid-lowering agents, which is less susceptible to bias than the comparisons performed in the previous studies. DESIGN AND SETTING: Retrospective cohort study conducted in the Tennessee Medicaid program between 1 January 1989 through 31 December 1998. SUBJECTS: New users of all lipid-lowering drugs and randomly selected non-user controls who at baseline were at least 50 years of age and did not have life threatening illness, nursing home residence, or diagnosed dementia or osteoporosis. There were 12506 persons with new use of statins, 4798 with new use of other lipid lowering drugs, and 17280 non-user controls. MAIN OUTCOME MEASURE: Fracture of the proximal femur (hip), excluding pathological fractures or those resulting from severe trauma. RESULTS: During 66690 person years of follow up, there were 186 hip fractures (2.8 per 1000). Relative to non-users, the adjusted incidence rate ratios (95% confidence interval) were 0.62 (0.45 to 0.85) for statin users and 0.44 (0.26 to 0.95) for other lipid-lowering drugs. When compared directly with the other drugs, the adjusted incidence rate ratio for statins was 1.42 (0.83-2.43). CONCLUSION: These data provide evidence that the previously observed protective effect of statins may be explained by unmeasured confounding factors.

Antipsychotics and the risk of sudden cardiac death.

BACKGROUND: Case reports link antipsychotic drugs with sudden cardiac deaths, which is consistent with dose-related electrophysiologic effects. Because this association has not been confirmed in controlled studies, we conducted a retrospective cohort study in Tennessee Medicaid enrollees, which included many antipsychotic users; there were also computer files describing medication use and comorbidity. The study was conducted before the introduction of risperidone and, thus, did not include the newer atypical agents. METHODS: The cohort included 481,744 persons with 1,282,996 person-years of follow-up. This included 26,749 person-years for current moderate-dose antipsychotic use (>100-mg thioridazine equivalents), 31,864 person-years for current low-dose antipsychotic use, 37,881 person-years for use in the past year only, and 1 186,501 person-years for no use. The cohort had 1487 confirmed sudden cardiac deaths; from these, we calculated multivariate rate ratios adjusted for potential confounding factors. RESULTS: When current moderate-dose antipsychotic use was compared with nonuse, the multivariate rate ratio was 2.39 (95% confidence interval, 1.77-3.22; P<.001). This was greater than that for current low-dose (rate ratio, 1.30; 95% confidence interval, 0.98-1.72; P=.003) and former (rate ratio, 1.20; 95% confidence interval, 0.91-1.58; P<.001) use. Among cohort members with severe cardiovascular disease, current moderate-dose users had a 3.53-fold (95% confidence interval, 1.66-7.51) increased rate relative to comparable nonusers ( P<.001), resulting in 367 additional deaths per 10,000 person-years of follow-up. CONCLUSIONS: Patients prescribed moderate doses of antipsychotics had large relative and absolute increases in the risk of sudden cardiac death. Although the study data cannot demonstrate causality, they suggest that the potential adverse cardiac effects of antipsychotics should be considered in clinical practice, particularly for patients with cardiovascular disease.

Possible medication errors in home healthcare patients.

OBJECTIVE: To determine the frequency of possible medication errors in a population of older home healthcare patients according to expert panel objective criteria. DESIGN: A cross-sectional survey. SETTING: Two of the largest urban home healthcare agencies in the United States. PARTICIPANTS: Home healthcare patients age 65 and older admitted to selected offices of these agencies between October 1996 and September 1998. MEASUREMENTS: We used two sets of consensus-based expert panel criteria to define possible medication errors. The Home Health Criteria identify patients with patterns of medication use and signs and symptoms that indicate sufficient likelihood of a medication-related problem to warrant reevaluating the patient. The Beers criteria identify medications that experts have deemed generally inappropriate for older patients. RESULTS: The 6,718 study subjects took a median of five drugs; 19% were taking nine or more medications. A possible medication error was identified for 19% of patients according to Home Health Criteria, 17% according to the Beers criteria, and 30% according to either. Possible errors increased linearly with number of medications taken. When patients taking one to three medications were compared with those taking nine or more drugs, the percentages with possible errors were, respectively, 10% and 32% for the Home Health Criteria, 8% and 32% for the Beers criteria, and 16% and 50% for both. CONCLUSION: Nearly one-third of the home healthcare patients surveyed had evidence of a potential medication problem or were taking a drug considered inappropriate for older people. More-effective methods are needed to improve medication use in this vulnerable population.

Educational program for physicians to reduce use of non-steroidal anti-inflammatory drugs among community-dwelling elderly persons: a randomized controlled trial.

CONTEXT: Nonsteroidal anti-inflammatory drugs (NSAIDs) are among the most frequently prescribed drugs for patients 65 years of age or older, primarily for musculoskeletal symptoms of osteoarthritis. Because NSAIDs frequently cause serious gastrointestinal (GI) and other complications among elderly patients, expert guidelines for osteoarthritis recommend acetaminophen-based regimens, which are safer and often as effective as NSAIDs. OBJECTIVE: Evaluate a physician education program that communicated guidelines for management of osteoarthritis in elderly patients that emphasized avoidance of NSAIDs when possible. The program reviewed NSAID risks and benefits and recommended: re-evaluating continuous NSAID users, considering substitution of up to 4 g/d of acetaminophen for the NSAID, and trying topical agents and nonpharmacologic measures. DESIGN AND SETTING: Randomized controlled trial among community-dwelling Tennessee Medicaid enrollees. SUBJECTS: Study physicians had 5 or more patients who: were community-dwelling Medicaid enrollees 65 years of age or older; had used NSAIDs regularly for at least 180 days; had had no medical care encounters during this period suggesting an indication other than osteoarthritis; and had 1 year of baseline and follow-up data. The study thus included 209 physicians (103 intervention/106 control) with 1,566 qualifying regular NSAID users (768/798). INTERVENTIONS: Face-to-face visit to study physicians by another physician, and reminder placements in the charts of patients eligible to have NSAID use reevaluated. OUTCOMES: Change between baseline and follow-up years in: days of prescribed NSAIDs, acetaminophen, other drugs for musculoskeletal disorders, and GI drugs; outpatient visits and inpatient days of stay; SF36 measures of general health, physical function, and bodily pain (from 40% random patient sample); and over-the-counter NSAIDs (from the sample). RESULTS: Intervention-attributable reduction of 7% (95% CI, 3% to 11%) in days of prescribed NSAIDs use with concomitant increase in acetaminophen use. No significant changes in other study endpoints. The intervention effect was greater among 75 physicians with a completed study visit, whose 564 patients had a 10% (95% CI, 6% to 14%) attributable reduction in NSAID use. CONCLUSIONS: The educational program modestly reduced NSAID exposure in community-dwelling elderly patients without undesirable substitution of other medications or detectable worsening of musculoskeletal symptoms.

Educational program for nursing home physicians and staff to reduce use of non-steroidal anti-inflammatory drugs among nursing home residents: a randomized controlled trial.

CONTENT: The risk for serious gastrointestinal complications due to nonsteroidal anti-inflammatory drugs (NSAIDs) is high in the elderly. Acetaminophen-based regimens are safer and may be as effective as NSAIDs for the treatment of osteoarthritis in many patients. OBJECTIVE: To determine the effects of an educational program on NSAID use and clinical outcomes in nursing homes. DESIGN AND SETTING: Randomized controlled study. Ten pairs of Tennessee nursing homes with > or = 8% of residents receiving NSAIDs were randomized to intervention or control. SUBJECTS: Nursing home residents (intervention n = 76 and control n = 71) aged 65 years and older taking NSAIDs regularly. INTERVENTIONS: An educational program for physicians and nursing home staff that included the risks and benefits of NSAIDs in the elderly and an algorithm that substituted acetaminophen, topical agents, and nonpharmacologic measures for the treatment of noninflammatory musculoskeletal pain. Intervention and control subjects were assessed at baseline and 3 months later. MAIN OUTCOME MEASURES: Differences in NSAID and acetaminophen use, and pain, function, and disability scores in intervention and control nursing home subjects. RESULTS: The intervention was effective resulting in markedly decreased NSAID use and increased acetaminophen use. Mean number of days of NSAID use in the 7 day periods before the baseline and 3 month assessments decreased from 7.0 to 1.9 days in intervention home subjects compared with a decrease from 7.0 to 6.2 days in control homes (P = 0.0001). Acetaminophen use in the 7 days immediately before the 3 month assessment increased by 3.1 days in intervention home subjects compared with 0.31 days in control homes (P = 0.0001). A similar proportion of subjects in control (32.5%) and intervention (35.4%) groups had worsening of their arthritis pain score (P = 0.81). CONCLUSIONS: An educational intervention effectively reduced NSAID use in nursing homes without worsening of arthritis pain.

Use of healthcare resources among medically and surgically treated patients with gastroesophageal reflux disease: a population-based study.

BACKGROUND: Gastroesophageal reflux disease (GERD) is a common disorder that may be effectively managed medically or surgically. Direct evaluations of medical resource use are needed to better understand the relative costs of these alternatives. This study compared medical care use for a group of patients receiving surgical treatment for GERD with that for a comparable group of patients receiving medical management. STUDY DESIGN: We conducted a retrospective matched cohort study of Tennessee Medicaid (TennCare) patients with GERD undergoing surgical treatment in 1996 and a group of patients who received medical therapy during the same period. Administrative TennCare data provided computerized records that could be used to identify patients and measure healthcare use. There were 7,502 people who met all of the conditions for inclusion in the study, including at least two encounters with a diagnosis of GERD. One hundred thirty-five of these who underwent fundoplication constituted the surgically treated cohort. The 250 persons in the medically treated cohort were selected randomly from the remaining nonsurgical patients and matched to the surgical cohort by age, gender, race, managed care organization, and acid suppression drug use in the baseline year. The principal outcome of interest was total use of medical resources, including prescription medication. RESULTS: The surgical and medical cohorts did not differ significantly by demographic characteristics or by baseline use of pharmaceuticals. During the baseline year the surgically treated patients were prescribed 302 (95% CI: 270-334) days ofGERD treatment and the matched medical patients were prescribed 292 (95% CI: 267-317) days of GERD treatment. Surgically treated patients used more GERD-related outpatient resources (physician visits and diagnostic testing) in the baseline year, particularly in the 3 months before operation, when they had a mean of more than four outpatient encounter-days. In the followup year, use of GERD-related pharmaceuticals decreased markedly in the surgical cohort. These patients were prescribed an average of 123 days (95% CI: 94-153) of therapy, which was only 36% of that for medical patients (339 days [95% CI: 308-370]). More than 29% of surgical patients were prescribed no GERD-related drugs in the followup year compared with 6% of the medically treated group. The mean number of inpatient days for the fundoplication procedure was 3.2 (95% CI: 2.7-3.6), with a range of 0 to 13 days. There were no differences between the two groups in other healthcare use. CONCLUSIONS: Our results show that in a 1-year period of followup, surgical treatment of severe gastroesophageal reflux disease led to a 64% postsurgical reduction in GERD medication use, with no increase in use of other medical services.

Contraindicated use of cisapride: impact of food and drug administration regulatory action.

CONTEXT: Cisapride, a gastrointestinal tract promotility agent, can cause life-threatening cardiac arrhythmias in patients susceptible either because of concurrent use of medications that interfere with cisapride metabolism or prolong the QT interval or because of the presence of other diseases that predispose to such arrhythmias. In June 1998, the US Food and Drug Administration (FDA) determined that use of cisapride was contraindicated in such patients and informed practitioners through additions to the boxed warning in the label and a "Dear Health Care Professional" letter sent by the drug's manufacturer. OBJECTIVE: To evaluate the impact of the FDA's 1998 regulatory action regarding contraindicated use of cisapride. DESIGN AND SETTING: Analysis of data for the 1-year periods before (July 1997-June 1998) and after (July 1998-June 1999) the regulatory action from the population-based, pharmacoepidemiology research databases of 2 managed care organizations (sites A and B) and a state Medicaid program (site C). PARTICIPANTS: Patients with at least 180 days of prior enrollment in 1 of the 3 sites who were prescribed cisapride at least once in the period before (n = 24 840) or after (n = 22 459) regulatory action. Patients could be included in both cohorts. MAIN OUTCOME MEASURES: Proportion of cisapride users in each period for whom cisapride use was contraindicated by the product label, based on computerized patient medical encounter records. RESULTS: In the year prior to regulatory action, cisapride use was contraindicated for 26%, 30%, and 60% of users in study sites A, B, and C, respectively. In the year after regulatory action, use was contraindicated for 24%, 28%, and 58% of users, a reduction in contraindicated use of approximately 2 per 100 cisapride users at each site. When the analysis was restricted to new users of cisapride after regulatory action, only minor reductions in contraindicated use were found. CONCLUSION: The FDA's 1998 regulatory action regarding cisapride use had no material effect on contraindicated cisapride use. More effective ways to communicate new information about drug safety are needed.

Benzodiazepines and the risk of falls in nursing home residents.

CONTEXT: For nursing home residents who require a benzodiazepine, short-acting agents are recommended, primarily to avoid increased risk of falls and other injuries associated with the long-acting agents. However, much of the data for the clinical outcomes of falls and injuries comes from community-dwelling older people. OBJECTIVE: To quantify the rate of falls among nursing home residents taking benzodiazepines and how this varies with drug elimination half-life. DESIGN: Historical cohort study. POPULATION: A total of 2510 residents of 53 Tennessee nursing homes, classified according to benzodiazepine use on each day of follow-up. OUTCOME MEASURES: Falls occurring during study follow-up. RESULTS: After adjustment for differences in resident characteristics, benzodiazepine users had a 44% increased rate of falls (adjusted rate ratio 1.44 [95% confidence interval, 1.33-1.56]). The adjusted rate ratio increased from 1.30 (1.12-1.52) for a dose equivalent to < or = 2 mg of diazepam, to 2.21 (1.89-2.60, P < .001) for a dose of > 8 mg. The rate of falls was greatest in the 7 days after the benzodiazepine was started (rate ratio of 2.96 [2.33-3.75]) but remained elevated (1.30 [1.17-1.44]) after the first 30 days of therapy. Drugs with elimination half-lives of <12, 12-23, and > or = 24 hours had adjusted rate ratios of 1.15 (0.94-1.40), 1.45 (1.33-1.59), and 1.73 (1.40-2.14), respectively. Users of hypnotics with elimination half-lives <12 hours had an increased rate of falls occurring during the night (adjusted rate ratio 2.82 [2.02-3.94]). CONCLUSIONS: Although the risk of falls among nursing home residents receiving short-acting benzodiazepines is less than that for the long-acting agents, these drugs are associated with a materially increased risk of nocturnal falls.

Nonsteroidal antiinflammatory drugs and acute renal failure in elderly persons.

Renal prostaglandin inhibition by nonsteroidal antiinflammatory drugs (NSAIDs) may decrease renal function, especially under conditions of low effective circulating volume. To evaluate the risk of important deterioration of renal function due to this effect, the authors performed a nested case-control study using Tennessee Medicaid enrollees aged > or =65 years in 1987-1991. Cases were patients who had been hospitalized with community-acquired acute renal failure; they were selected on the basis of medical record review of Medicaid enrollees with selected discharge diagnoses. Information on the timing, duration, and dose of prescription NSAIDs used, demographic factors, and comorbidity was gathered from computerized Medicaid-Medicare data files. Of the 1,799 patients with acute renal failure (4.51 hospitalizations per 1,000 person-years), 18.1% were current users of prescription NSAIDs as compared with 11.3% of 9,899 randomly selected population controls. After control for demographic factors and comorbidity, use of NSAIDs increased the risk of acute renal failure 58% (adjusted odds ratio = 1.58; 95% confidence interval (CI): 1.34, 1.86). For ibuprofen, which accounted for 35% of NSAID use, odds ratios associated with dosages of < or =1,200 mg/day, >1,200-<2,400 mg/day, and > or =2,400 mg/day were 0.94 (95% CI: 0.58, 1.51), 1.89 (95% CI: 1.34, 2.67), and 2.32 (95% CI: 1.45, 3.71), respectively (test for linear trend: p = 0.009). Prescription NSAID use resulted in an estimated 25 excess hospitalizations associated with renal failure per 10,000 years of use. Thus, NSAIDs represent a relatively uncommon but avoidable cause of acute renal failure in frail elderly persons.

Changes in continuity of enrollment among high-risk children following implementation of TennCare.

BACKGROUND: TennCare, Tennessee's Medicaid managed care program, was introduced in 1994 with the goals of controlling spending and of improving access to health care. OBJECTIVE: To assess changes in the continuity of enrollment following the implementation of TennCare for 2 groups: infants in the first year of life (defined as persons aged 0-12 months in this study) and children hospitalized with a chronic health condition (defined as persons aged 0-18 years in this study). DESIGN: Retrospective cohort analysis. SETTING AND POPULATION: Infants born during 1992 or 1995 to women enrolled in Medicaid or TennCare and 0- to 18-year-old children enrolled in Medicaid or TennCare who were discharged from a hospital during 1992 or 1995 with a chronic health condition. MAIN OUTCOME MEASURES: For infants, failure to enroll an infant in the first 30 days of life or subsequent gaps in enrollment for 7 days or longer during the first year of life. For children hospitalized with a chronic health condition, any gap in enrollment lasting 7 days or longer by 1 year after discharge from a hospital. RESULTS: There was a reduction in the proportion of infants without continuous enrollment in the first year of life following TennCare (19.4% after vs 25.1% before TennCare; odds ratio, 0.69; 95% confidence interval, 0.67-0.72). Improvements in continuity of enrollment for infants occurred despite an increase in the proportion of infants who were not enrolled in TennCare in the first 30 days of life, even though their mother was enrolled at delivery (14.0% after vs 8.0% before TennCare; odds ratio, 1.86; 95% confidence interval, 1.78-1.96). There was a decrease in the proportion of children hospitalized with a chronic health condition who had subsequent gaps in enrollment by 1 year following discharge from a hospital (14.3% after vs 23.3% before TennCare; odds ratio, 0.52; 95% confidence interval, 0.46-0.59). CONCLUSION: For infants in the first year of life and for children hospitalized with a chronic health condition, implementation of TennCare improved continuity of coverage.

Comparison of perinatal outcomes among TennCare managed care organizations.

OBJECTIVE: To compare perinatal outcomes among the managed care organizations (MCOs) providing care to beneficiaries enrolled in TennCare, Tennessee's capitated Medicaid managed care program. DESIGN: Retrospective cohort analysis. SUBJECTS: Infants born in Tennessee during 1995 to women enrolled in TennCare. PRIMARY OUTCOME MEASURES: Prenatal care use, birth weight (BW), death in the first 60 days of life, and delivery of extremely low BW (<1000 g) infants in hospitals without level 3 neonatal intensive care units. RESULTS: During 1995, 34 402 infants were born to mothers enrolled in TennCare. The MCOs differed widely in the demographic characteristics of their enrollees. In addition, there were small differences in prenatal care utilization, but no differences in BW outcomes among the MCOs. In multivariate analysis, however, infants born to women enrolled in 1 MCO were 2.8 times more likely to die in the first 60 days of life than were infants born to women enrolled in the largest MCO (OR: 2.81; 95% CI: 1.31-6.03). Women enrolled in this same MCO seemed to have a higher proportion of extremely low BW (<1000 g) infants delivering in a hospital lacking a level 3 neonatal intensive care unit (38% vs 20% in the largest MCO). CONCLUSION: The differences among MCOs in early infant death and in the delivery of high-risk infants in hospitals lacking appropriate neonatal facilities suggest that monitoring of care delivery to vulnerable children should include assessment of appropriate use of specialized services.

Early childhood mortality from community-acquired infections.

In this study, the authors identified maternal and child characteristics that were independent predictors of death from infectious diseases acquired in the community and determined if these factors could be used to identify groups of children with excess risk of mortality from infection. A historical cohort study was conducted of children less than 5 years of age between 1985 and 1994 (the study period), who were born in Tennessee, and had complete information on their birth certificates. The primary outcome was death from infection identified from death certificates and confirmed through medical record review. Among the 1,014,976 children less than 5 years of age, who contributed 3,351,568 child-years of follow-up, there were 247 deaths from infections (7.4 deaths from infections per 100,000 child-years). Respiratory infections accounted for approximately one half of the deaths. Children having three or more older siblings or birth weight of less than 1,500 g had a 3-fold and 10-fold increased risk of death from infection, respectively, while children with both characteristics had a nearly 20-fold increased risk that persisted beyond the first year of life. Interventions should be focused on prevention of these infections in vulnerable children. At-risk children should be targeted for careful follow-up and early hospitalization when signs of infection develop.

Sociodemographic factors identify US infants at high risk of injury mortality.

OBJECTIVES: To identify sociodemographic predictors of infant injury mortality and to compare trends in injury mortality rates for high- and low-risk US infants from 1985 to 1991. DESIGN: Historical cohort. SETTING/STUDY PARTICIPANTS: The National Center for Health Statistics linked US infants (<1 year) born from 1985 to 1991 with death certificates. MAIN OUTCOME MEASURES: Multivariate regression was used to identify sociodemographic factors associated with injury mortality. The adjusted relative risks (RRs) of maternal age, education, marital status, number of other children, and infant birth weight were used to categorize infants into risk groups. We compared trends in injury rates for the highest and lowest risk groups. RESULTS: There were 5963 injury deaths and 18.6 million infant years or 32.1 injury deaths per 100 000 infant years. Highest risk infants were born to mothers who were younger than 20 years compared with older than 30 years (RR, 3.25; 95% CI, 2.92-3.63), had less than a high school education compared with a college education (RR, 2.22; 95% CI, 1.95-2.53), had more than 2 other children compared with no other children (RR, 3.15; 95% CI, 2.88-3.45), were unmarried (RR, 1.67; 95% CI, 1.57-1.78), or had birth weights 2500 g (RR, 3.36; 95% CI, 2.94-3.84). Infants in the highest risk group (21.0% of the population) had a >10-fold increased risk of injury mortality compared with the lowest risk group (18.1% of the population) and there was no evidence that this disparity was narrowing. CONCLUSIONS: Sociodemographic predictors of infant injury mortality include maternal age, education, number of other children, marital status, and infant birth weight. Based on these factors, 1 in 5 infants in the United States can be identified at birth as having a >10-fold increased risk of injury mortality compared with infants in lowest risk group. Programs to reduce injuries in these high-risk groups are urgently needed.

Use of nonsteroidal anti-inflammatory drugs and incidence of colorectal cancer: a population-based study.

BACKGROUND: Previous observational studies have provided limited information on the effect of specific nonsteroidal anti-inflammatory drugs (NSAIDs) and different patterns of use (duration and dose) on the incidence of colorectal cancer. OBJECTIVE: To determine how patterns of use (duration, dose, and specific drug) of NSAIDs affect incidence of colorectal cancer. DESIGN: Population-based retrospective cohort study. SETTING: Tennessee Medicaid Program, 1985-1992. SUBJECTS: Enrollees (n = 104217) aged 65 years or older with at least 5 years of enrollment. MAIN OUTCOME MEASURES: Incident histologically confirmed colorectal cancer. RESULTS: Users of nonaspirin NSAIDs for at least 48 months of the previous 5 years had a relative risk (RR) of 0.49 (95% confidence interval [CI], 0.24-1.00) for colon cancer when compared with those with no use of NSAIDs. Among those with more than 12 months of cumulative use, those using NSAIDs in the past year (recent users) had an RR of 0.61 (95% CI, 0.48-0.77), whereas those with no recent use had an RR of 0.76 (95% CI, 0.50-1.15). No specific NSAID offered a unique protective effect and low doses of NSAIDs appeared to be at least as effective as higher doses. Protection was most pronounced for right-sided lesions. The RR among recent users with more than 12 months of cumulative use was 0.81 (95% CI, 0.49-1.32) for rectal cancer, 0.77 (95% CI, 0.55-1.08) for left-sided colon cancer, and 0.48 (95% CI, 0.34-0.68) for right-sided colon cancer. CONCLUSIONS: In this elderly population, long-term use of nonaspirin NSAIDs nearly halved the risk of colon cancer. This study was consistent with previous studies that suggest that duration of use but not daily dose of NSAIDs is an important factor for chemoprevention. Our data also suggest that the protective effect is shared by most NSAIDs, and not confined to a small number of these drugs.

A model for improving medication use in home health care patients.

OBJECTIVES: (1) To develop a model for the identification and resolution of problems associated with suboptimal medication use in elderly patients receiving home health care; (2) To select the most important identifiable problems and develop structured procedures for their resolution. DESIGN: Expert panel review, problem selection, and development of a problem resolution model and guidelines. SETTING: Home health care. PARTICIPANTS: A panel with expertise in home health nursing, pharmacy, clinical pharmacology, gerontology, pharmacoepidemiology, and health services research. INTERVENTIONS: A list of potential problems associated with the most frequently used classes of drugs was compiled for review by the panel. Problems that were controversial or that could not be identified in the home care setting were excluded. Panel members individually ranked the remainder. Detailed procedures for identification and resolution of the 15 top-ranking problems were developed. MAIN OUTCOME MEASURES: Not applicable. RESULTS: Potential medication problems were defined by both drug use and symptoms or clinical signs associated with specific adverse effects, to ensure that clinically relevant problems would be identified. The model developed for problem assessment and resolution was centered on the drug utilization review (DUR) coordinator and the attending home health nurse. Following guidelines developed by the panel, the DUR coordinator advises the home health nurse about identified problems and how to resolve them. One of these practitioners, usually the nurse, then contacts the attending physician to explain their concerns, offer potential solutions, and request instructions. CONCLUSION: A potentially useful model for the identification and resolution of medication problems in the home health care setting was developed. This model is currently being evaluated in a randomized controlled trial.

Prenatal exposure to metronidazole and risk of childhood cancer: a retrospective cohort study of children younger than 5 years.

BACKGROUND: To evaluate the role of in utero exposure to metronidazole (a carcinogen in some animal models) and the risk of subsequent cancer, the authors conducted a retrospective cohort study of childhood cancer. METHODS: The cohort included 328,846 children younger than 5 years born to women enrolled in Tennessee Medicaid at any time between the last menstrual period (LMP) and the date of delivery. The cohort was identified by linking files of Tennessee Medicaid mothers ages 15-44 years and children and the children's birth and death certificates for the period January 1, 1975 through December 31, 1992. Exposure data were obtained from Medicaid pharmacy records and exposure was defined as filling a metronidazole prescription that had at least a day's supply between the 30 days prior to the LMP and the date of delivery. Study cases were cohort children diagnosed with a first primary cancer before age 5 years, identified by linking the cohort with a statewide childhood cancer database for the study period. RESULTS: Cohort members contributed 1,172,696 person-years of follow-up for analysis, with children exposed (8.1%) and not exposed (91.9%) in utero to metronidazole contributing 79,716 and 1,092,980 person-years, respectively. Of 952 children younger than 5 years in the statewide cancer database, 175 met study eligibility criteria. Of these, 42 had leukemia, 30 had central nervous system (CNS) tumors, 28 had neuroblastoma, and 75 had other cancers. Using Poisson regression modeling, children exposed to metronidazole in utero had no significant increase in adjusted relative risk (RR) for all cancers (RR: 0.81; 95% confidence interval [95% CI], 0.41-1.59), leukemia (no exposed case), CNS tumors (RR: 1.23; 95% CI, 0.29-5.21), neuroblastomas (RR: 2.60; 95% CI, 0.89-7.59), and other cancers (RR: 0.57; 95% CI, 0.18-1.82). CONCLUSIONS: The authors conclude that although there was no increase in risk for all cancers associated with in utero exposure to metronidazole, the observed increased risk for neuroblastomas, although not significant, requires further evaluation.

Antidepressants and the risk of falls among nursing home residents.

BACKGROUND: In nursing home residents, the use of tricyclic and other heterocyclic antidepressants is associated with an increased risk of falls. The newer selective serotonin-reuptake-inhibitor antidepressants are largely free of the side effects of the tricyclic agents thought to cause falls and so have been hypothesized to be safer for those at high risk for falls. METHODS: We retrospectively identified an inception cohort of 2428 nursing home residents in Tennessee who were new users of tricyclic antidepressants (665 subjects), selective serotonin-reuptake inhibitors (612 subjects), or trazodone (304 subjects) or nonusers of antidepressants (847 subjects). We ascertained the number of falls during therapy and during a similar follow-up period for nonusers, then calculated the rate ratios for falls with adjustments for an extensive set of potential confounding factors. RESULTS: The new users of each type of antidepressant had higher rates of falls than the nonusers, with adjusted rate ratios of 2.0 (95 percent confidence interval, 1.8 to 2.2) for tricyclic antidepressants, 1.8 (1.6 to 2.0) for selective serotonin-reuptake inhibitors, and 1.2 (1.0 to 1.4) for trazodone. The rate ratios increased with the daily dose for tricyclic antidepressants, reaching 2.4 (95 percent confidence interval, 2.1 to 2.8) for doses of 50 mg or more of amitriptyline or its equivalent, and for the serotonin-reuptake inhibitors, reaching 1.9 (1.7 to 2.2) for 20 mg or more of fluoxetine or its equivalent. The elevated rates of falls persisted through the first 180 days of therapy and beyond. CONCLUSIONS: In this large study of nursing home residents, there was little difference in rates of falls between those treated with tricyclic antidepressants and those treated with selective serotonin-reuptake inhibitors. Hence, the preferential use of the newer antidepressants is unlikely to reduce the higher rate of falls among nursing home residents taking antidepressants.

No association between calcium channel blocker use and confirmed bleeding peptic ulcer disease.

Calcium channel antagonists are commonly used drugs that have recently been reported to be associated with an increased incidence of gastrointestinal hemorrhage. We performed a retrospective cohort study among 105,824 enrollees of the Tennessee Medicaid program 65 years of age or older between 1984 and 1986. Exposure to calcium channel blockers and other medications was determined from pharmacy files. Hospitalization for bleeding peptic ulcers was identified by hospital claims and verified by a review of the medical record. Univariate estimates of relative risk for current users of calcium channel blockers and beta-blocker users were 1.8 (95% confidence interval (CI) 1.2-2.7) and 1.1 (95% CI 0.7-1.6) (reference group was nonuse of either). After adjustment for potential confounders, the relative risks for bleeding peptic ulcer among current users of calcium channel blockers and beta blockers were 1.1 (95% CI 0.7-1.7) and 1.0 (95% CI 0.7-1.6), respectively, when compared with those who used neither drug. In this population, after controlling for important confounders, there was no increased risk for hospitalization with bleeding peptic ulcer among users of calcium channel blockers.

Predictors of mortality from fires in young children.

BACKGROUND: In the United States in 1994, fires claimed 3.75 lives per 100 000 child years and accounted for 17.3% of all injury deaths in children <5 years of age. OBJECTIVES: To conduct a historical cohort study that uses maternal demographic characteristics to identify young children at high risk of fire-related deaths, thus defining appropriate targets for prevention programs. METHODS: The cohort consisted of children born to mothers who resided in the state of Tennessee between 1980 and 1995. Information was obtained by linking birth certificates, 1990 census data, and death certificates. Children were eligible for the study if they were <5 years of age at any time within the study period and if key study variables were present (99.2% of births). Birth certificates provided information on maternal characteristics including age, race, education, previous live births, use of prenatal care, and residence (in standard metropolitan statistical area). Child characteristics included gender, gestational age, and birth type (singleton/multiple gestation). Neighborhood income was estimated by linking the mother's address at the time of birth to the 1990 census (block group mean per capita income). The study outcome was a fire resulting in at least one fatality (fatal fire event) during the study period, identified from death certificates (coded E880 through E889 in the International Classification of Diseases, 9th rev). We calculated the fatal fire event rate corresponding to each stratum of maternal/child characteristics. We assessed the independent association between each characteristic and the risk of a fatal fire event from a Poisson regression multivariate analysis. RESULTS: During the study period, 1 428 694 children contributed 5 415 213 child years to the cohort: there were 270 deaths from fire (4.99 deaths per 100 000 child years) and 231 fatal fire events. In the multivariate analysis, factors associated with greater than a threefold increase in fatal fire events included maternal education, age, and number of other children. Compared with children whose mothers had a college education, children whose mothers had less than a high school education had 19.4 times (95% confidence interval [CI], 2.6-142.4) an increased risk of a fatal fire event. Children whose mothers had more than two other children had 6.1 times (95% CI, 3.8-9.8) an increased risk of a fatal fire event compared with children whose mothers had no other children. Children of mothers <20 years of age had 3.9 times (95% CI, 2.2-7.1) increased risk of a fatal fire event compared with children whose mothers were >/=30 years old. Although both maternal neighborhood income and race were associated strongly with increased rates of fatal fire events in the univariate analysis, this association did not persist in the multivariate analysis. Other factors that were associated with increased risk of fatal fire events in the multivariate analysis were male gender and having a mother who was unmarried or who had delayed prenatal care. The three factors associated most strongly with fire mortality were combined to create a risk score based on maternal education (>/=16 years, 0 points; 13 to 15 years, 1 point; 12 years, 2 points; <12 years, 3 points); age (>/=30 years, 0 points; 25 to 29 years, 1 point; 20 to 24 years, 2 points; <20 years, 3 points); and number of other children (none, 0 points; one, 1 point; two, 2 points; three or more, 3 points). The lowest-risk group (score <3) included 19% of the population and had 0.19 fatal fire events per 100 000 child years. In contrast, highest-risk children (score >7) comprised 1.5% of the population and had 28.6 fatal fire events per 100 000 child years, 150 times higher than low-risk children. Children with risk scores >5 contributed 26% of child years but experienced 68% of all fatal fire events. If the fatal fire event rate for all children had been equal to that of the low-risk group (risk score <3), then 95% of deaths from