Setting up the herbal formulary system for an alternative medicine clinic.
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Factors considered important by transplant pharmacists in decisions about generic product selection and in defining critical-dose drugs, as well as transplant pharmacists' attitudes about bioequivalence testing, were studied. Surveys, completed by telephone and fax in 1997, were used to assess pharmacists' role at solid-organ transplant centers, factors the pharmacists considered important for generic product selection, and pharmacists' attitudes about the FDA guidelines on bioequivalence testing. Surveys were completed by 59 pharmacists. The factors considered important by pharmacists for inclusion of generic products on the formulary were safety (97% of respondents), clinical consequences (97%), efficacy (92%), and bioequivalence (92%). Nearly all the pharmacists (95%) expressed a belief that generic products of some critical-dose drugs should not be dispensed. Only 12% of the respondents said they thought that the FDA guidelines on bioequivalence testing were appropriate for critical-dose drugs, and 92% thought that bioequivalence testing for this category of drugs should be conducted in actual patients. Efficacy, safety, the presence of a narrow therapeutic index, bioequivalence, and clinical consequences were identified by transplant pharmacists as important factors in decisions about generic product selection; current FDA guidelines for establishing bioequivalence were viewed as possibly not appropriate for critical-dose drugs.
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The clinical outcomes and cost-effectiveness of an antimicrobial control program (ACP) were studied. The impact of an ACP in a teaching hospital was analyzed by comparing clinical outcomes and intravenous antimicrobial costs over two two-year periods, the two years before the program and the first two years after the program's inception. Admission baseline data, length of stay, mortality, and readmission rates were gathered for each patient. Patients were identified by using the International Classification of Diseases. Multivariate logistic regression models were constructed for mortality and for lengths of stay of 12 or more days. The acquisition costs of intravenous antimicrobial agents for the second baseline year and the entire program period were tabulated and compared. The average daily inpatient census was determined. The ACP was associated with a 2.4-day decrease in length of stay and a reduction in mortality from 8.28% to 6.61%. Rates of readmission for infection within 30 days of discharge remained about the same. Inpatient pharmacy costs other than intravenous antimicrobials decreased an average of only 5.7% over the two program years, but the acquisition cost of intravenous antimicrobials for both program years yielded a total cost saving of $291,885, a reduction of 30.8%. The institution's average daily census fell 19% between the second baseline year and the second program year. An ACP directed by a clinical pharmacist trained in infectious diseases was associated with improvements in inpatient length of stay and mortality. The ACP decreased intravenous antimicrobial costs and facilitated the approval process for restricted and nonformulary antimicrobial agents.
Management Case Studies describe approaches to real-life management problems in health systems. Each installment is a brief description of a problem and how it was dealt with. The cases are intended to help readers deal with similar experiences in their own work sites. Problem solving, not hypothesis testing, is emphasized. Successful resolution of the management issue is not a criterion for publication-important lessons can be learned from failures, too.
The results of clinical studies of the use of angiotensin-converting-enzyme (ACE) inhibitors in a variety of cardiovascular and renal disorders are reviewed, with emphasis on evidence-based formulary decision-making. In evaluating agents for formulary inclusion, efficacy, safety, dosing, and cost are considered. ACE inhibitors have been investigated in thousands of patients in clinical trials, so an evidence-based approach to their use is appropriate. All ACE inhibitors are effective antihypertensive agents and are generally well tolerated. Thus, in formulary decisions, once-daily dosing and good 24-hour blood pressure control are important considerations to ensure efficacy and patient compliance. ACE inhibitors are key in the prevention and management of heart failure but are underused for these indications. The rationale for use of ACE inhibitors after myocardial infarction is discussed, as is evidence of separate antihypertensive and renoprotective effects of ACE inhibitors. Evidence for the use of ramipril in patients at high risk for cardiovascular events, from the Heart Outcomes Prevention Evaluation Study (HOPE), is reviewed. Clinical trial results provide evidence that some ACE inhibitors have renoprotective and vasculoprotective effects and improve outcomes of patients with a variety of cardiovascular disorders; differences among the ACE inhibitors should be considered in formulary decision-making.
The relationship between the problem of antimicrobial resistance and efforts to control antimicrobial costs is explored. Antimicrobial drug management typically centers around controlling costs and controlling antimicrobial resistance. Selection of therapeutic alternatives without adherence to a well-developed program or without a rationale based on data from the medical literature may promote antimicrobial resistance. Attempts to select alternatives can produce cost shifting rather than cost containment. The annual cost associated with antimicrobial resistance in the United States is estimated to be as high as $47 billion. In one study, patients with bacteremia caused by methicillin-resistant Staphylococcus aureus had an average length of stay 2.7 days longer than patients with susceptible strains and a mean cost of care that was $3500 higher. Infection control is one of the most important duties of health care practitioners. Given today's prevailing reimbursement structure, hospitals with high rates of nosocomial and resistant infections are likely to lose money. A basic problem with the current approach to controlling resistance is that the two most common strategies, highly restrictive formularies and drug cycling, work in opposition. Antimicrobial management programs should be directed at ensuring the most appropriate use of antimicrobials rather than focusing on limiting choices.
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The results of a 2001 national survey of the ambulatory care responsibilities of pharmacists in managed care organizations (MCOs) and integrated health systems are reported and compared with the results of similar surveys conducted in 1997 and 1999. Three hundred and seventy-six MCOs and integrated health systems participated in the telephone survey. The surveyelicited data about organizational structure and pharmacist functions in the ambulatory care environment. Survey respondents were asked about 24 specific ambulatory care pharmacist functions. The performance of functions was related to five "enabling" factors: pharmacists on interdisciplinary care teams, automated dispensing systems, integrated electronic medical records, very supportive medical staff, and very supportive senior management. Twenty previously measured functions decreased since 1999. Decreases were greatest in negotiating pharmaceutical contracts (-28%), administering immunizations (-27%), and immunization screening (-24%). Enabling factors supported continued expansion. Two clusters of functions, patient-related and population-related activities, were identified and supported differentially by enabling factors. Group-model and staff-model HMOs had the most enabling factors and the broadest scope of pharmacist functions. Independent practice associations had fewer enabling factors and a different mix of functions, with an emphasis on population-focused functions. Ambulatory care functions of pharmacists have expanded to new areas and have decreased in more traditional areas, perhaps because of the current pharmacist shortage and the increase in the number of prescriptions and patients.
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Various interventions for reducing antimicrobial resistance are described. Prudent and appropriate use of antimicrobials may help reduce the selective pressure that promotes the emergence of resistance. Limiting antimicrobial use for the promotion of growth in animals may also decrease the potential for transmission of resistant microorganisms to humans through the food supply. Clinical practice guidelines provide a standard of care for the use of antimicrobials in specific infectious syndromes, promoting appropriate antimicrobial use. Excluding certain antimicrobials from institutional formularies and restricting prescribing of some agents or classes of agents included in the formulary may reduce the emergence of resistance. Therapeutic failure can be avoided by considering pharmacokinetic and pharmacodynamic factors when selecting an antimicrobial regimen. A sufficient dose and an appropriate administration interval are necessary to ensure that the antimicrobial concentration at the site of infection is high enough to kill or inhibit the growth of the pathogen. Routine antimicrobial susceptibility surveillance can detect the emergence of resistant pathogens and allow for prompt intervention. Implementation of infection control practices can prevent or stem outbreaks of infection caused by resistant microorganisms. Vaccinations may reduce antimicrobial resistance indirectly by decreasing the need for antimicrobial therapy. Antimicrobial resistance can be reduced through a combination of interventions. The management of antimicrobial resistance requires a multidisciplinary approach, including participation from physicians, nurses, pharmacists, and infection control and housekeeping staff.