Effect of different types of Medicaid managed care on childhood immunization rates.

Medicaid managed care can improve access to prevention services, such as immunization, for low-income children. The authors studied immunization rates for 7,356 children on Medicaid in three managed care programs: primary care case management (PCCM; n = 4,605), a voluntary HMO program (n = 851), and a mandatory HMO program (n = 1,900). Immunization rates (3:3:1 series) in PCCM (78%) exceeded rates in the voluntary HMO program (71%), which in turn exceeded those in the mandatory HMO program (67%). Adjusting for race, urban residence, and gender, compared to children in PCCM, children in the voluntary HMO program were less likely to complete the 3:3:1 series (OR = 0.75, CI = 0.63, 0.90), and children in the mandatory HMO program were even less likely to complete the series (OR = 0.59, CI = 0.51, 0.68). Results differed by individual HMOs. Monitoring of outcomes for all types of managed care by Medicaid agencies is imperative to assure better disease prevention for low-income children.

Outcomes of a community pharmacy-based diabetes monitoring program.

PRIMARY OBJECTIVE: Evaluate the effects of a point-of-dispensing (POD) pharmaceutical care model on outcomes of self-monitored blood glucose (SMBG) results, SMBG frequency, and medication adherence rates for patients with diabetes. SECONDARY OBJECTIVE: Measure the rate at which physicians implemented therapy recommendations made by community pharmacists. DESIGN: 12-month, noncrossover, single-group trial. SETTING: Two independent community pharmacies in Richmond, Va. PATIENTS: 101 patients were initially identified as potential participants; of the 82 that elected to participate in the study, 62 (76%) completed the first 6 months and 52 (63%) completed the entire 12-month study period. INTERVENTION: This pharmaceutical care program was integrated into the dispensing function: subjective and objective data related to diabetes care were gathered with each prescription refill. Recommendations were made to patients and their physicians. MAIN OUTCOME MEASURES: SMBG values and frequency at baseline, 6, and 12 months. Diabetic medication adherence rates for 1 year before and during participation were evaluated. Community pharmacist recommendations and implementation status were followed over the 12-month period. RESULTS: Average morning blood glucose values (n = 27) decreased from 178.6 mg/dL to 159.3 mg/dL, from baseline to 6 months, respectively (p = .07). Blood glucose values (n = 23) at baseline and 12 months decreased from 179.0 mg/dL to 149.7 mg/dL, respectively (p < .05). There was no statistical difference in SMBG frequency. A diabetes medication adherence rate of 90% was maintained over the 12-month study period. Physicians implemented 15 of 20 (75%) recommendations. CONCLUSION: This model offers an effective and efficient mechanism for providing pharmaceutical care for patients with diabetes.

Combining state administrative databases and provider records to assess the quality of care for children enrolled in Medicaid.

Our objective was to assess the capability of state administrative health care databases to evaluate the quality of immunization rates for a Medicaid managed care population. Data on 5599 2 year olds were obtained from a Medicaid claims database, a health department database, and the records of the children's assigned providers. The study was conducted on 1 managed care program in 1 state. Test performance ratio analyses were used to assess the relative accuracy and contribution of each source of administrative data. We found that of the 67,188 doses needed, 45,511 (68%) were documented as administered per at least 1 of the data sources. Medicaid claims data alone accounted for 18% of immunized children, while health department data used by itself accounted for 12%. Together, these 2 sources identified 34% of immunized children. Large administrative databases, such as Medicaid claims and data from a health department, while valuable sources of information on quality, may underestimate outcomes such as immunization rates. Assessments of the quality of health care should rely on a combination of administrative data and providers' records as sources of information.

Effect of over-the-counter cimetidine on phenytoin concentrations in patients with seizures.

OBJECTIVE: To determine the effects of the maximum recommended over-the-counter (OTC) cimetidine dosage on phenytoin concentrations in ambulatory seizure patients on long-term phenytoin therapy. METHODS: Adults with seizure disorders requiring phenytoin therapy were recruited. Trough total phenytoin concentrations were measured initially and once weekly for six weeks. All assays were performed using Biotrack patient-side cartridges. After a two-week baseline period, patients took cimetidine 200 mg twice daily for two weeks. Toxicity was monitored via weekly neurologic examinations and midweek telephone surveys. Patients were asked to return to clinic weekly during a two-week cimetidine washout period. RESULTS: Nine patients entered and completed the study. All but two patients took other anticonvulsants known to interact with phenytoin (carbamazepine, n = 5; phenobarbital, n = 2). No adverse effects or changes in seizure frequency were reported. Paired Student's t-tests revealed no significant difference between serum phenytoin concentrations before (12.3+/-3.2 mg/L [mean +/- SD]) and after (12.8+/-4.0 mg/L) two weeks on the OTC cimetidine regimen. No differences were noted in estimated pharmacokinetic parameters (maximum metabolic rate, Michaelis-Menten constant) for the same time periods (paired Student's t-test, p > 0.05). The Biotrack assay had an r2 = 0.7311 (p < 0.001, two-sided) when compared with TDx. CONCLUSIONS: It is possible that the lack of change in phenytoin concentrations was a result of the low daily dosage of cimetidine used or other factors related to the "real world" setting of the study. However, the potential for a serious drug interaction occurring in patients taking long-term oral phenytoin and OTC cimetidine appears to be small.

Implementation of pharmaceutical care services for patients with hyperlipidemias by independent community pharmacy practitioners.

OBJECTIVE: To implement and evaluate pharmaceutical care services for patients with hyperlipidemias in the community pharmacy setting, to evaluate the results of a pharmaceutical care training process for pharmacists by using an assessment quiz, and to measure patient outcomes resulting from provision of pharmaceutical care to patients with hyperlipidemia. DESIGN: A prospective study was conducted over a 1-year period. Patients served as their own controls. SETTING: Two independent community pharmacies in Richmond, Virginia. PARTICIPANTS: Twenty-five adult patients with confirmed dyslipidemias completed the study. INTERVENTIONS: Study pharmacists assessed each patient and assisted in setting therapeutic goals; patients also completed a visit with a registered dietitian. Drug therapy recommendations were made to physicians by the pharmacist when appropriate. Follow-up was scheduled with the pharmacist to ensure positive outcomes and reduce adverse effects. MAIN OUTCOME MEASURES: Fasting lipoprotein profiles were measured initially and at 6 and 12 months. The SF-36 survey, the MacKeigan-Larson satisfaction survey, and a patient opinion survey were administered initially and at the conclusion of the study. RESULTS: Total cholesterol and low-density lipoprotein cholesterol values were significantly decreased at 12 months compared with either the baseline or 6-month values (p < 0.02). Significant improvement was found in several domains of the surveys; quality of life, patient satisfaction with pharmacy services, and patient opinions on the role of the pharmacist improved after the intervention. CONCLUSIONS: Pharmaceutical care may positively affect lipid values, quality of life, and patient satisfaction.

Pre-OBRA '90 Medicaid survey: how community pharmacy practice is changing.

Medicaid pharmacy providers in Virginia were surveyed to estimate the potential impact of the Omnibus Budget Reconciliation Act of 1990, which mandated prospective drug use review (DUR) beginning January 1, 1993. The data measure which DUR activities were being performed by pharmacists before the law took effect, and the survey compares and contrasts these data with the activities mandated by full compliance with the law. Many respondents already perform several of the required DUR activities, and nearly all agree that full compliance requires more time to process each prescription order. Barriers to full compliance include lack of time to counsel patients adequately, lack of patient-specific information, and no compensation for offering clinical/cognitive services.

Computerized documentation of pharmacists' interventions.

A computerized system for documenting interventions, developed by the pharmacy department at a 695-bed tertiary care university teaching hospital, is described. A computerized system was developed to better gain the needed details on pharmacists' recommendations, to capture a greater number of such recommendations, and to prepare for recent changes in standards of the Joint Commission on Accreditation of Healthcare Organizations. Only clinically important recommendations or those that involve cost savings are documented. Data can be entered and retrieved from any medical information system terminal in the hospital, and each entry becomes part of the patient's permanent record. A hard copy of all recommendations and a data file are generated daily. Analysis of the data has provided numerous opportunities for improving both patient care and the quality of pharmaceutical services. The system has been well received by pharmacists and has resulted in physician support of pharmacists' recommendations, as well as substantial cost savings. A convenient, easy-to-use computerized program for reporting interventions has helped a pharmacy department conduct departmental and institutional quality assurance activities and decrease costs.

Documenting the clinical interventions of pharmacists.

The need to justify continued and expanded clinical services persists in the current climate of concern over the high costs of health care; thus, documentation of the clinical interventions of pharmacists is vital. Time is a limited commodity, and an intervention reporting system must be as efficient as possible. A system that can be integrated into departmental and institutional quality assurance activities is a necessity; the capability of sharing the information with other hospital committees and departments is also an important consideration.

Current issues in the treatment of epilepsy.

General principles of antiepileptic drug (AED) therapy are reviewed, current issues involving the use and monitoring of AEDs are examined, promising investigational agents are briefly reviewed, and situations that require potentially difficult decisions about long-term care are discussed. The initial treatment should be monotherapy with a first-line AED for the particular seizure disorder. The usual approach is to maximize seizure control and minimize the adverse effects of AED therapy. Current issues involving the pharmacokinetics, use, and monitoring of the conventional AEDs phenytoin, phenobarbital, primidone, carbamazepine, valproic acid, ethosuximide, benzodiazepines, and acetazolamide are discussed. AED therapy may have adverse effects on behavior and cognition. The risk of teratogenicity with well-monitored AED therapy is probably low, and severe hepatotoxicity is uncommon. Because carbamazepine, phenobarbital, phenytoin, and primidone all have enzyme induction properties, a number of clinically important interactions are possible. Issues related to discontinuing AED therapy, serum concentration monitoring, and generic interchange of AED products are addressed. Whether AEDs should be used to prevent recurrent febrile seizures, alcohol withdrawal seizures, or seizures in patients with head trauma or stroke must be considered. The treatment of seizure disorders is a complex process involving identification of the seizure disorder, selection and monitoring of an appropriate AED(s), and consideration of adverse effects and drug interactions. Whether therapy should be discontinued after a prolonged seizure-free period, compliance issues, and whether to treat certain conditions prophylactically also must be considered.

Usefulness of a single-dose prediction model for the determination of long-term maintenance therapy of valproic acid.

The single-dose prediction model (SDPM) of Slattery et al. has been shown accurately to predict short-term (3 to 7 days) steady-state valproic acid (VPA) concentrations in normal volunteers and in hospitalized patients receiving monotherapy. To assess the long-term usefulness of the SDPM in a real-life clinic setting, six ambulatory patients ranging in age from 2 to 8 years were studied. Blood samples were drawn at least 6 h after the initial dose but before the second dose of VPA, A steady-state trough concentration (Cminss) was measured 3 to 7 days after the initiation of therapy. Dosage adjustments and alterations in therapeutic regimen were allowed and another Cminss was measured after 1 to 12 months. Predicted Cminss values were calculated for both the short-term and long-term VPA regimens. Predictive performance analysis demonstrated that the SDPM was unbiased in predicting both short-term and long-term VPA Cminss values and precise in predicting only short-term VPA Cminss values. The SDPM is not a reliable predictor of long-term total VPA concentrations in seizure patients in an outpatient clinic setting.

Testing for drug use, Part 1: Analytical methods.

Issues surrounding the screening and testing of individuals for drug use, including analytical and legal aspects of the procedures and social, political, and ethical problems and concerns, are reviewed. Historically, professional and societal debate regarding drug taking, drug-use problems, and the utility of drug testing programs occurs in cycles. Analytical methods commonly used to test for drug use include breath analysis for alcohol and urine drug assays. Blood alcohol concentrations are determined by laboratory assay methods or by portable devices used in the field. While poor laboratory procedures can invalidate test results for both breath and urine tests, urine screening test results can be further invalidated by improper handling of specimens or by tampering on the part of the subject. Also, test results are meaningful only if they are correlated with a clinical state. Legal issues have been raised concerning the validity of testing procedures used and the reliability of evidence obtained, especially in relation to pre-employment drug screening. From an ethical standpoint, drug testing tends to focus efforts to combat drug abuse on the drugs themselves instead of on the social context of the problem. With a recycled interest in drug-use testing and screening, primarily attributable to technological advances, little attention is being given to other approaches to controlling drug use. Additional research is needed to better describe the nature and extent of our drug-use problems and their impact on society.

Simulated effect of gentamicin assay errors on calculated pharmacokinetic values.

The effects of errors in gentamicin concentrations were assessed using computer simulation. Steady-state concentrations at the end of a one-hour infusion (Cmax) and at the end of the dosing interval (Cmin) were calculated for four simulated patients with three dosing schemes each. Errors from -80% to +80% were systematically induced in Cmax or Cmin, or both. Pharmacokinetic values were calculated from the error concentrations and then used to determine new dosing regimens given specific desired concentrations. True Cmax and Cmin values were calculated using the new dosing regimens and original pharmacokinetic values. As the absolute value of the induced error increased, increases were generally seen in the absolute value of the resultant error and in the deviation of the true Cmax and Cmin from desired values. Resultant error was more evident with induced error less than zero, when error was induced into Cmax, and with shorter dosing intervals. Resultant error in pharmacokinetic variables was greater than induced error at induced errors as low as +/- 5%. Toxic and suboptimal values for the true Cmax and Cmin rarely occurred with induced errors of -20% to +20%. Errors in serum gentamicin concentration measurements are more likely to cause larger resultant errors as the errors in concentration values (1) increase in magnitude, (2) result in underreporting of the concentration values, or (3) affect peak concentration values. Shorter dosing intervals may also increase the influence of assay errors.

Current concepts in clinical therapeutics: disease-modifying drugs for rheumatoid arthritis.

The epidemiology, pathophysiology, clinical features, diagnosis, and clinical course of rheumatoid arthritis (RA) and the role of disease-modifying antirheumatic drugs (DMARDs) in its treatment are reviewed. RA, a widespread disease affecting people of all races and sexes around the world, has an unknown and perhaps multifactorial etiology. Conflicting evidence supports an immune-complex, infectious, metabolic, or genetic basis for RA. The disease affects diarthrodial joints and begins as an immune response to unknown antigenic stimuli. A proliferative process ensues, leading to formation of a vascular lesion called a pannus, which then infiltrates into cartilage, subchrondral bone, and tendon. This destructive phase leads to classic RA symptoms of pain, limitation of motion, swelling, heat, and redness of the affected joint. Symptoms and laboratory tests form the basis for diagnosis. For most RA patients, conservative therapy provides substantial benefit. In those patients who suffer from unrelenting and progressively destructive disease, more aggressive intervention is necessary to prevent permanent disability. The DMARDs are reserved for treatment of this group of patients. DMARDs include such diverse agents as the gold compounds aurothioglucose, auranofin, and gold sodium thiomalate; the antimalarials hydroxychloroquine sulfate and chloroquine phosphate; penicillamine; and the cytotoxic agents azathioprine, methotrexate, and cyclophosphamide. DMARDs are effective but toxic therapeutic agents. Because of the toxicities of these agents, careful monitoring at regular intervals is necessary throughout the duration of therapy. For patients in whom these drugs demonstrate efficacy and are tolerated, the DMARDs may attenuate the disabling effects of long-term erosive disease.

Phenytoin and phenobarbital protein binding alterations in a uremic burn patient.

A case is reported in which dramatic decreases in the protein binding of phenytoin and phenobarbital were noted. A 57-year-old burn patient with a history of a seizure disorder had increased free fractions of phenytoin and phenobarbital. The patient later developed renal failure and the free fractions of both drugs were further increased. Decreases in the protein binding of phenytoin in patients with hypoalbuminemia and/or uremia have been well documented, but the effects of these conditions on phenobarbital protein binding have not been well studied. In the case described here, the presence of both hypoalbuminemia and uremia were necessary before a doubling of the free fraction of phenobarbital was noted. Although it is not a highly protein-bound drug, in some circumstances protein binding alterations of phenobarbital may be of clinical significance.

Single-dose model for predicting steady-state valproic acid serum concentrations in seizure patients.

Valproic acid serum concentrations predicted by a single-dose prediction model were compared with steady-state serum concentrations measured after the start of therapy in seizure patients. Ten patients receiving valproic acid for the first time or who had not been taking the drug for two or more weeks were entered into the study. The patients' therapies were initiated with the prescribed doses of valproic acid and then maintained on fixed doses and dosing intervals until steady-state trough serum samples were obtained. Initial 5-ml blood samples were collected six to 14 hours after the ingestion of the first dose; a 5-ml steady-state trough sample was drawn in the same manner three to seven days later. Both free and total drug concentrations were determined within 48 hours of sample collection using gas-liquid chromatography. The elimination rate constant was estimated from age-specific population half-life values found in the literature. Six patients (five children, aged four to 16 years) and one adult (aged 87 years) completed the study. There was a statistically significant correlation between predicted and measured steady-state valproic acid serum concentrations for both free and total concentrations. The single-dose prediction model accurately predicted steady-state valproic acid serum concentrations in these seizure patients.