David B. Nash

Do Cardiologists Do It Better

Pressure to lower the cost of health care delivery has fostered widespread efforts to limit patients access to specialists such as cardiologists. However, there is concern that diminished specialist involvement may lead to poorer patient outcomes for specific clinical conditions. As part of a state-sponsored effort to improve the quality of health care in Pennsylvania, the Pennsylvania Health Care Cost Containment Council gathered clinical and administrative data on all 40,684 hospital admissions for acute myocardial infarction (AMI) in that state in 1993. They prepared a detailed public report that included risk-adjusted in-hospital mortality and length of hospital stay by physician group, by hospital and by region. These data demonstrate that patients cared for by cardiologists, as a group, had a lower risk-adjusted mortality than patients cared for by either internists (risk ratio 1.26, 95% confidence interval 1.17 to 1.35) or family practitioners (risk ratio 1.29, 95% confidence interval 1.18 to 1.40). The patients of cardiologists also had a shorter length of stay than the other two groups. These data suggest that there is enhanced value in the care provided by cardiologists for patients with AMI and call into question the growing trend toward reliance on generalists instead of specialists.

The Formulary Decision-Making Process in a US Academic Medical Centre

SummaryThis article reviews and describes the formulary decision-making process in an academic medical centre. The pharmacy and therapeutics (P & T) committee is the organisational nucleus of the drug use control process in the institutional environment. Thomas Jefferson University Hospital (TJUH). a 720-bed academic medical centre in an urban locality in the US, is used as a model representative of how most of these committees function. Survey responses collected from 29 peer academic medical centres arc presented to compare and contrast the structure and function of the P & T committee at TJUH with corresponding procedures in other university hospitals in the US.TJUH is typical of the institutions which comprise the University Hospital Consortium (UHC). The P & T committee of TJUH is composed of 29 members, meets once per month for 10 months of the year, and has a network of 13 subcommittees. TJUH has an intermediately controlled (mixed) formulary, and uses both restricted drugs and treatment guidelines. Of the 29 UHC member institutions responding to the survey. the average P & T membership is 18, the average meeting frequency is 11 times per year, and 83% of these committees have a network of subcommittees, None describe their formulary system as open, 86% have a closed formulary and 14% have a mixed formulary system. There is a restricted drug programme in 76% of the institutions, 79% utilise treatment guidelines, 76% practice therapeutic interchange and all employ generic substitution.Specific areas addressed in this review include the history of the formulary system, the structure and function of the P & T committee, types of formularies, cost containment and the formulary decision-making process. the impact of organisational culture on physician decision making. the role of the pharmacy department, the role of pharmaceutical sales representatives and their impact on prescribing habits, the impact of the Joint Commission on Accreditation of Healthcare Organisations (JCAHO) Agenda for Change on the formulary process, and future challenges.

The Role of Pharmacoeconomic Evaluations in Disease Management

Disease management is a systematic approach to a health condition or a healthcare intervention that organises preventative, interventional and care approaches throughout the continuum of care and which measures outcomes in terms of populations, not individuals. Disease management’s advantage over the current component system is that it stresses prevention over acute treatment of a chronic disease. Patients with better control of their chronic diseases will likely have a decrease in the use of emergency room and inpatient hospitalisation services, thereby improving clinical outcomes of patients.To achieve these goals, disease management uses pharmacoeconomic evaluations and outcomes measures to provide information that helps build formularies and clinical practice guidelines. Several problems exist in integrating pharmacoeconomic studies in disease management models, such as the need for more integrated information systems, standardisation and who should perform these evaluations. Some possible solutions will be addressed in this article. With greater emphasis being placed on controlling costs, the need for pharmacoeconomic evaluations in the design of disease management models will continue to increase in the future.

Assessing return on investment of defined-population disease management interventions.

BACKGROUNDnStrategies to reduce health expenditures through the improvement of health and quality of care are in high demand. A group of experts formed a nonpartisan, independent work group, under the sponsorship of the National Managed Health Care Congress. Its goal was to establish a list of easy-to-understand, actionable, and usable recommendations to enable disease management program advocates to conduct basic-level evaluations.nnnRECOMMENDATIONSnThe work group made recommendations concerning identification of reference and intervention population, population definitions, quantitative methods and data quality, confounding and bias, and stakeholder agreements/contracting.nnnCASE STUDYnA case study was created to quantitatively illustrate some of the major issues raised by the work group. Five typical errors were simulated by applying different rules to the intervention population than to the reference population: differential inclusion (high versus low risk), differential exclusion (high versus low risk) and differential claims run-out. Compared with the true impact, four of the five errors resulted in a bias toward intervention effect, while one (differential inclusion of high-risk patients) was biased against the intervention effect. The direction and magnitude of the bias in natural settings will not necessarily follow this pattern.

Monoclonal Antibody Therapy for Gram‐Negative Sepsis: Principles, Applications, and Controversies

Gram‐negative sepsis is a common event in hospitalized patients and is a leading cause of death in the United States. Endotoxin (lipopolysaccharide, LPS), a component of the cell wall of gram‐negative microorganisms, is responsible for the cascade of events leading to the sepsis syndrome consisting of fever, tachycardia, tachypnea, and evidence of organ hypoperfusion. The lipid A region of endotoxin produces most of these biologic and toxic effects. Monoclonal IgM antibodies directed against the lipid A portion of endotoxin (anti‐LPS MoAb) have been developed for the treatment of gram‐negative sepsis. Results of two large‐scale clinical trials suggest that these antibodies offer clinically and statistically significant reductions in mortality by a factor of about one‐third. However, in both trials, this apparent beneficial effect was limited to particular subsets of patients, and no overall benefit was seen. These considerations, in addition to the likely high cost of the agents, pose questions about their ultimate use in the treatment of patients with gram‐negative sepsis. Nevertheless, the logic of the approach, the demonstration of efficacy in disease models, and the advances in modern techniques of molecular biology all suggest that these or other closely related products will play a significant role in the treatment of this disorder.

Formulary Management of Antiulcer Drugs

SummaryPeptic ulcer disease (PUD) is a common medical problem costing billions of dollars annually around the world. Since the availability of the first histamine H2-receptor antagonist, cimetidine, many economic analyses have been conducted to compare the impact of this drug class on resource consumption.H2-Antagonists have been shown to reduce mortality, hospitalisations, ambulatory care visits and endoscopy use caused by PUD. Because of changing risk factors and variations in diagnosis, it remains controversial whether these drugs have had a long term impact on PUD incidence and prevalence. Three studies conducted after the introduction of cimetidine showed it to reduce total direct medical healthcare expenditures, despite increases in drug costs.Studies investigating the short term treatment of PUD show mixed results because of diverse study designs and different comparator drugs. No specific therapy appears consistently superior economically because of variations in population studies, ulcer relapse rates and drug acquisition costs. However, maintenance therapy for PUD has been shown to be cost-effective. When compared with surgery — an extremely efficacious option — maintenance therapy (both daily and intemittent) is cost-effective over at least a 10-year period. Within the maintenance therapy options, daily ranitidine has been shown to be more cost-effective than intermittent therapy for up to 2 years.Omeprazole is the least costly and most efficacious treatment for gastroesophageal reflux disease (GORD or GERD) compared with ranitidine and/or lifestyle modification alone. It has also been shown that the costs for empirical treatment of GORD are offset by the costs of additional investigation of those who do not have the disease. Thus the decision of whether to treat empirically should be based on physician and patient preferences. and not on costs.The use of misoprostol for ulcers caused by nonsteroidal anti-inflammatory drugs is somewhat controversiaL Three studies examining the short term (3-month) costs of misoprostol generally show it to be cost saving or cost neutral. Misoprostol is consistently more cost beneficial in elderly or other high risk: patients. Results are highly sensitive, however, to several parameters, such as patient type. ulcer severity and rate, drug costs and patient compliance. One study examining prophylaxis using misoprostol over 1 year showed it to be a generally expensive therapy for primary prevention, but was more cost effective for those with a proven GI bleed in the previous year.Cost-minimisation studies conducted within the hospital setting explore the cost savings realised from limiting the formulary to the least expensive therapy. as well as encouraging the use of oral medication in place of intravenous therapy. Results vary widely depending upon drug acquisition cost and extent of inappropriate prescribing of intravenous therapy.More research is needed which examines quality of life, effects on health-related productivity changes, and the most cost-effective option for the treatment of Helicobacter pylori. Ideally. these analyses will be based on prospective comparative trials conducted over longer durations in order to account for all appropriate benefits and costs of drug therapy.

Key factors in the implementation of a clinical quality improvement project: successes and challenges.

This article describes the successful implementa tion of a clinical quality improvement project at a 720-bed academic medical center in Philadelphia, Pennsylvania, and provides some insight into key factors that contributed to the successes and the chal lenges that we encountered during the process.