Productivity-cost controversies in cost-effectiveness analysis: review and research agenda.

Productivity costs represent true costs to society and should not be ignored in a cost-effectiveness analysis. However, there is dissension among health economists regarding measurement of productivity costs. Certain health economists argue for inclusion of productivity costs in the denominator of the cost-effectiveness ratio, measured in quality-adjusted life-years. Others argue that productivity costs should be included in the numerator of the cost-effectiveness ratio, measured in dollars using the friction-cost method or the human-capital method. This paper reviews the productivity-cost controversies and offers suggestions for future research addressing the debated issues.

The "Drug export lag" and the Drug Export Amendments Act of 1986: an evaluation.

The purpose of this study was to evaluate the implementation of the Drug Export Amendments Act of 1986 (DEAA). The study methods involved calculating the time period between the submission of an application for export of a drug to the Food and Drug Administration (FDA) and its publication in the Federal Register, and the time taken by the FDA to reach a decision on the application. These parameters were then compared with the time limits specified in the DEAA. The analysis was conducted at four levels--overall for all pharmaceuticals, by therapeutic category of pharmaceutical, by country of export, and by type of company. At all four levels, we found that the publication and decision times were greater than the time limits specified in the DEAA. This suggests the existence of a "drug export lag," which includes a "publication time lag" (18.56 days) and an "FDA decision time lag" (182.26 days). The implications of these lags for the competitiveness of the US pharmaceutical industry in the global market are discussed and suggestions are provided.

Two approaches to comparing hospital charges between cadaveric renal transplant patients who received orthoclone OKT 3 sterile solution or Atgam sterile solution for induction therapy.

The objectives of this study were: (1) to compare total hospital charges for a sample of cadaveric renal transplant patients categorized according to the type of induction therapy used (Orthoclone OKT3 Sterile Solution or Atgam Sterile Solution); (2) to compare specific charge categories between the two groups; and (3) to examine the relationship between charges and a set of independent variables. A retrospective review was conducted of hospital charges associated with a sample of renal transplant patients. The overall sample for this study comprised 510 patient discharges from 22 hospitals in the United States. Comparisons between the OKT3 and Atgam groups were made for total and specific charge categories using two different approaches to help control variations in charges that were not related to the type of induction therapy used. The first approach consisted of t test or chi-square comparisons between the groups for subsets of observations that had been identified in a stepwise fashion. These judgment samples were defined to remove sources of variation in charges other than those resulting from the type of induction therapy selected. The second approach used multiple linear regression analysis to help statistically control variation in charges from other sources. The results showed that higher drug charges in the Atgam group were offset by lower charges in other categories (P < 0.05). These findings suggest that hospital formulary committees should consider all relevant costs, not just drug acquisition costs, when selecting products. However, further investigation is warranted to explore differences in charges due to: (1) between-hospital variation; (2) patients' severity of illness before receiving induction therapy; and (3) differences in side-effect profiles for the two induction therapies.

Quality-adjusted life-years and other health indices: a comparative analysis.

This article provides a descriptive overview of both unadjusted and adjusted health indices that are being applied in the current health-services research literature. We describe, give examples, and discuss a variety of the better-known health indices. Summary tables that compare health indices across dimensions, such as level of analysis, weighting methodology, preference measurement, and longevity measurement, are also included. Our goal is to provide information about similarities among and differences between health indices and enhance understanding of comparative health-outcome measurement. An extensive list of references is included to guide the reader toward additional discussions of metrics and methodologies. Given the multitude of health indices reported in the literature, this descriptive and comparative overview provides a framework for understanding these metrics in the context of health-outcomes research.

Cost-effectiveness analyses of the conversion of patients with non-insulin-dependent diabetes mellitus from glipizide to glyburide and of the accompanying pharmacy follow-up clinic.

At the Department of Veteran's Affairs Outpatient Clinic in Columbus, Ohio, patients with non-insulin-dependent diabetes mellitus who were receiving glipizide therapy were converted to glyburide therapy over a 6-month period starting in mid-1993. A pharmacy follow-up clinic was instituted to help patients with problems associated with the transition. The conversion was intended to reduce costs by converting from a more expensive to a less expensive drug (in terms of acquisition cost) within the same therapeutic class. An initial analysis of the conversion indicated a savings of $65,000.00 to the Department of Veterans' Affairs (VA) based on the drug acquisition cost differential alone. The purpose of our study was to retrospectively evaluate the cost-effectiveness of the conversion and pharmacy follow-up clinic from the perspective of the VA pharmacy department. Relevant costs and effectiveness (percentage of patients who achieved good glycemic control) were examined for three groups: group I--patients who were treated with glipizide, group II--patients who were treated with glipizide; group II--patients who were switched from glipizide to glyburide, accompanied by a pharmacy follow-up clinic; and group III--patients who were switched from glipizide to glyburide, with no follow-up clinic. Overall, group II had the lowest costs, and group II had to be the most effective. Cost-II effectiveness analysis indicated that, in general, the conversion from glipizide to glyburide was cost-effective. Incremental analysis performed for the follow-up group over the no follow-up group showed that for every 1% of patients who achieved good glycemic control, the VA would spend $1.01 more for the follow-up groups. This was considered to be cost-effective for the VA.

The perceived influence of clinical pharmacy services on physician prescribing behavior: a matched-pair comparison of pharmacists and physicians.

In contrast with cross-sectional designs used in previous studies, this exploratory study compared survey data from 127 matched pairs of clinical pharmacists and physicians working together. Physicians' perceptions of the importance of clinical pharmacy activities for patient care and the competence of pharmacists performing the activities were examined for their influence on prescribing behavior in an institutional setting. Data from a national survey showed that physicians rated pharmacists higher regarding recommendations based on drug use evaluations (p = 0.004) and competency to provide all clinical pharmacy services. Scores for pharmacokinetics ratings were similar between pharmacists and physicians (p = 0.168). Pharmacists rated the importance of recommendations based on cost-effectiveness higher than physicians (p = 0.012). Overall, physicians' perceptions of activity importance for patient care and pharmacist competency appear to dictate pharmacists' influence on physician prescribing behavior (R = 0.723).

Measurement of outcomes in adults receiving pharmaceutical care in a comprehensive asthma outpatient clinic.

We hypothesized that a pharmacist-provided comprehensive education program in conjunction with care provided by a pulmonologist would lead to improved economic, clinical, and humanistic outcomes in adults with asthma, compared with similar patients receiving care from a pulmonologist alone. The experimental group reported receiving more information about asthma self-management (p=0.001), were more likely to monitor peak flow readings (p=0.004), and had increased satisfaction with care, and perceived higher quality of care. Both groups had less lost productivity, fewer emergency department visits, fewer hospitalizations, and fewer physician visits, as well as improvement in symptoms scores within 45 days. Both groups improved in all functional status domains except the mental component score of the SF-12. Our results show a positive impact on outcomes in adults with asthma who received pharmaceutical care.

Health-related quality-of-life claims in prescription drug advertisements.

Health-related quality-of-life (HRQOL) claims in drug advertisements and HRQOL advertisements' compliance with FDA regulations were studied. HRQOL advertisements from three medical journals from the years 1984, 1988, and 1992 were analyzed. Information was collected on the drug products and classes for which HRQOL claims were made and (1) whether the claims were explicit or implied, (2) how the products were claimed to affect HRQOL, and (3) whether claims related to overall well-being, a specific physiological aspect, or functional ability. For 1992 only, the compliance of HRQOL advertisements with FDA regulations was assessed. Ninety-four HRQOL advertisements were identified: 27 for 1984, 41 for 1988, and 26 for 1992. The drug classes for which HRQOL advertisements were most commonly used were diuretics (1984), nonsteroidal anti-inflammatory drugs (all three years), antianginals (1984 and 1988), antihypertensives (1988 and 1992), and anti-depressants (1992). Almost all the advertisements contained a claim (usually implicit) related to a specific physiological aspect of HRQOL, and claims concerning physical functioning outnumbered other function-related claims. In 1992, 42% of the HRQOL advertisements appeared out of compliance with at least one FDA regulation. In 1984, 1988, and 1992, HRQOL claims in prescription drug advertisements in three medical journals were mainly implicit and related mainly to specific physiological aspects of HRQOL. Over 40% of the HRQOL advertisements reviewed for compliance with FDA regulations for prescription drug advertising appeared not to comply.

Costs of epilepsy in an intermediate care facility for persons with mental retardation.

Epilepsy is a significant comorbid condition in institutionalized persons with developmental disabilities and may contribute significant additional costs. This study was conducted to provide an estimate of the costs of epilepsy from the institutional perspective. Costs were measured retrospectively for 50 persons with epilepsy and 50 persons without epilepsy matched by severity of developmental disability. A time and motion study was employed to assign opportunity costs to documented nursing and physician activities. Two separate methods of attribution were used and incremental costs attributable to epilepsy were found to be approximately $825 and $918 per person over a 6-month period. The following categories accounted for costs: personnel (47.0%), drug (39.6%), hospitalization (9.4%), and laboratories/procedures (4.0%). Results are useful for describing the economic burden of epilepsy.

Commercial drug compendium information: a First World/Third World comparison.

The purpose of this study was to determine what differences exist in the content of commercial drug compendium monographs available in First World and Third World countries. A content model representing First World information was developed from monographs contained in the Physicians' Desk Reference, ABPI Data Sheet Compendium, and the Rote Liste. The content of the three First World compendia was found to be variable, with the Physicians' Desk Reference consistently more comprehensive than either the ABPI or Rote Liste. This result suggests that there is a lack of agreement among industrialized countries regarding what amount of information is necessary or appropriate for inclusion in a commercial drug compendium. A sample of 58 monographs was selected from four Third World compendia and evaluated in terms of comprehensiveness and accuracy. These monographs represented five commonly prescribed drugs from the World Health Organization's Essential Drugs List. The monographs were found to be less comprehensive than any of the three monographs contained in the First World compendia. Approximately 5 percent of the information contained in the sampled monographs was determined to be inaccurate. The sampled monographs for drugs supplied by multi-national pharmaceutical firms were found to contain the same amount of information as those for drugs supplied by domestic firms.

Validation of the eleven-point pain scale in the measurement of migraine headache pain.

The four-point pain scale (none, mild, moderate, severe) and the 11-point pain scale (0 = no pain, 10 = pain as bad as it could be) have been used in migraine studies to assess treatment efficacy. The primary objective of this study was to investigate the validity and responsiveness of the 11-point pain scale using the four-point pain scale as a benchmark. Using data from 95 migraine patients recruited from headache clinics, this study found that 11-point pain scale scores were highly correlated with four-point pain scores. The correlations between the pain scales were significantly higher than the correlations with quality of life measures such as functional ability and emotional feelings. The 11-point pain scale was 55% more sensitive than the four-point pain scale in detecting clinically important differences. The strong linear relationship between the two pain scales allowed researchers to transform four-point pain scores to 11-point pain scores using regression weights.

Drug-usage evaluation: traditional versus outcome-based approaches.

The use of outcome assessment with DUE can provide more detailed information on the impact of drug therapy on the overall health status of the patient, rather than just the narrow view of the drug-prescribing process within the institution. These studies may justify additional pharmacists to help in the selection of drugs and their potential to affect overall quality patient care. In addition, the Joint Commission is recommending that measurement of health outcomes is important in QA. The Joint Commission has stated in their Agenda for Change program "that patient outcomes are influenced by all activities of a health care program." The Joint Commission plans to develop standards that "describe in functional terms what the key jobs are that need to be done to produce good patient outcomes." The major problem with adding outcome measures in the assessment of DUE programs is the evolutionary nature of the available technology to measure these patient outcomes. Incorporation of outcome measures into DUE programs can provide measures of the impact of drug therapy on the patients' HQOL. This HQOL is potentially a better reflection of patient outcomes and the assessment of quality of care.

Determining the differences among cost savings, cost avoidance, and cost reduction.

Cost savings, cost avoidance, and cost reduction are important factors to measure when valuing clinical pharmacy services. Currently, there are no universally accepted definitions for these terms. The authors of this study evaluated 44 articles which claimed to measure cost savings, cost avoidance, or cost reduction associated with clinical pharmacy services, and offered recommendations for when it would be appropriate to use these terms. Based on the results of our analysis, it is evident that controversy exists in the literature when determining if services result in cost avoidance or cost reduction. Therefore, there is a need for universally accepted definitions of these terms so that future research may evaluate such factors uniformly.

Developing reimbursable clinical pharmacy programs: a goal-oriented approach.

Using a goal-oriented approach, a model for achieving third-party reimbursement for clinical pharmaceutical services is proposed. Within the framework of this model, the discussion includes: (1) determination of the hospital pharmacy mission, goals and objectives; (2) classification of clinical services into eight categories to establish the reimbursement potential for each service; (3) development of a clinical service protocol, techniques to establish charges and stages involved in communicating with the parties affected by the clinical services; and (4) methodologies for evaluating program outcome.