The effect of insurance coverage changes on drug utilization in HIV disease.

BACKGROUND: Insurance coverage facilitates access to life-saving medications for many patients with HIV disease. Thus, the effects of insurance coverage changes, such as the gain or loss of coverage, may be important in explaining patient access and adherence to the medications used in the treatment of HIV disease. OBJECTIVES: The study's objective was to examine whether changes in health insurance coverage affect rates of prescription drug use by patients with HIV disease. METHODS: Data were ascertained from adults participating in a series of up to six interviews as part of the AIDS Costs and Services Utilization Survey (ACSUS). ACSUS was an 18-month panel survey of patients in care for HIV/AIDS at 26 sites located in 10 U.S. cities. Poisson regression analyses with generalized estimating equations were conducted to determine the effects of demographic and socioeconomic variables on the acquisition rate of antiretrovirals, antipneumocystics, and antidepressants. The analytic sample consisted of 1566 respondents who provided 6518 interviews. RESULTS: Although changes in insurance coverage were common, complete loss of insurance was reported in only 1.5% of the interviews whereas gaining insurance was reported in 3.3% of interviews. Having no coverage was associated with significantly lower rates of antiretroviral (rate ratio [RR], 0.73), antipneumocystic (RR, 0.58) and antidepressant use (RR, 0.31). Gaining insurance coverage was associated with lower antiretroviral (RR, 0.75) and antipneumocystic (RR, 0.70) use whereas losing insurance was associated with lower antiretroviral use (RR, 0.58). In multivariate analyses, these associations remained. CONCLUSIONS: Changes in health insurance coverage are associated with lower rates of drug use for some medications used by patients with HIV disease.

Historical overview of generic medication policy.

OBJECTIVE: To provide a historical perspective on controversies surrounding the use of generic drugs. DATA SOURCES: Articles were indexed initially using terms such as generic medications, generic drugs, multisource medications, and multisource drugs. These terms were used to search indexing services such as MEDLINE, International Pharmaceutical Abstracts, CINAHL (a database of nursing and allied health literature), Science Citation Index, Psychological Abstracts, and Wilson Indexes to Journal Articles. STUDY SELECTION: Performed by the authors, with preference given to events from 1951 to the present. DATA EXTRACTION: Not applicable. DATA SYNTHESIS: The history of generic drug use is a history of conflict from a variety of perspectives. The primary conflict is economic, in which manufacturers of brandname pharmaceuticals aggressively seek to protect their patents from a variety of groups (e.g., the federal government, managed care organizations, consumer groups) that want access to less expensive medications. Another conflict is professional, especially for the members of the pharmacy profession who view drug product selection as an important opportunity for pharmacists to use their professional judgment. The most confusing conflict is the scientific discussion of bioequivalence and product quality. The brand manufacturers suggest that not all products are bioequivalent and of the same quality. This position has been opposed by the pharmacy profession, generic drug manufacturers, health care institutions, and the Food and Drug Administration. CONCLUSION: Generic drug use has increased dramatically during the past 50 years and is an accepted part of health care. However, the economic consequences of generic drug use are sufficiently high for this activity to continue as a source of controversy in the future.

Economics and structure of the generic pharmaceutical industry.

OBJECTIVE: To review key economic trends of the generic medication market and analyze the changing structure of the generic medication industry. DATA SOURCES: Articles were indexed initially using terms such as generic medications, generic drugs, multisource medications, and multisource drugs. These terms were used to search indexing services such as MEDLINE, International Pharmaceutical Abstracts, CINAHL (a database of nursing and allied health literature), Science Citation Index, Psychological Abstracts, and Wilson Indexes to Journal Articles. STUDY SELECTION: Performed by the authors. DATA EXTRACTION: Not applicable. DATA SYNTHESIS: The generic pharmaceutical market has the potential to play an important role in containing drug costs, although the amount that could be saved through the use of generic medications is not easy to measure. If estimates for the future growth in the use of generic products prove correct, the proportion of pharmaceutical sales attributable to generic products will remain in the 9% to 10% range through the first decade of the 21st century. The generic pharmaceutical industry includes several categories of companies based on business strategies. Further consolidation is expected as more resources are needed to address patent challenges stimulated by the Drug Price Competition and Patent Restoration Act. Companies are also entering into partnerships with research manufacturers to share profits from proprietary products. Future growth of the generic market will require more than increased use of generic products. Therapeutic interchange, involving switching from single-source, patent-protected products to products within the therapeutic class for which there are generic equivalents, represents a major growth opportunity for generic drug manufacturers because the savings potential is more significant than that for straightforward substitution of generic for brandname products. CONCLUSION: As it responds to challenges and opportunities, the generic pharmaceutical industry will continue to be a major force shaping the economics of medication use.

Decomposing pharmaceutical cost growth in different types of health plans.

OBJECTIVE: To decompose pharmaceutical spending growth into price and quantity components and to compare growth across different types of health plans. STUDY DESIGN: Retrospective analysis of pharmaceutical claims for active employees of a large national employer from 1996 to 1998, who were enrolled in traditional fee-for-service plans, health maintenance organizations (HMOs), and preferred provider organizations. OUTCOME MEASURES: Outcomes measures included total cost growth, price growth, and quantity growth. Quantity growth was divided into growth in use of existing products and in use of newly introduced products. For existing products, quantity growth was further decomposed into growth in the number of prescriptions and change in the mix of prescriptions. RESULTS: During the study period, HMOs had the greatest cost growth. This differential cost growth was largely attributable to changes in utilization as opposed to changes in prices, which were similar among types of health plans. Introduction of new products contributed 15 to 20 percentage points to cost growth in each setting. Differences in cost growth were largely attributed to differences in the growth rate of spending on existing products. For existing products, the impact of increases in the number of prescriptions was much greater in the HMOs, while the impact of changes in the mix of prescriptions was only mildly greater in the HMOs. CONCLUSIONS: Pharmaceutical cost growth was largely attributable to changes in utilization as opposed to changes in prices. Changes in utilization patterns were complex and differed across types of health plans.

Drug product selection: legal issues.

OBJECTIVE: To review the potential legal liability of the pharmacist in the drug product selection process. DATA SOURCES: Published articles identified through MEDLINE, published law reviews identified through InfoTrac, and appellate court decisions. Search terms used included pharmacist liability, drug product selection, and generic substitution. Additional articles, books, and appellate court decisions were identified from the bibliographies of retrieved articles and citations in appellate court decisions. DATA SYNTHESIS: Pharmacists engaging in drug product selection are civilly liable under three legal theories: negligence, express or implied warranties, and strict product liability. Potential criminal liability includes prosecution for insurance fraud, deceptive business practices, and violation of state drug product selection laws and regulation. CONCLUSION: Pharmacists increase their liability when engaging in drug product selection, but the increase is small. Still, the law continues to evolve as pharmacists seek expanded roles and responsibilities. When courts give closer examination to pharmacists' expanded role, it is likely that pharmacists' liability will increase.

Pharmaceutical cost growth under capitation: a case study.

Rising drug spending has generated concern among purchasers and policymakers. This paper compares drug cost growth in a capitated system with that in managed care systems that generally did not place physicians directly at risk for drug spending. We focus on cost growth because a substantial body of literature indicates that managed care interventions that reduce the level of costs may not influence the rate of cost growth. Drug cost growth under capitation initially was below that of other systems but still above targeted rates. Over time the capitation rates rose, the amount of risk transferred to physicians declined, and spending growth accelerated.

Access and use of medications in HIV disease.

OBJECTIVE: To examine if measures of access to medical care are associated with outpatient use of antiretroviral and Pneumocystis carinii pneumonia (PCP) medications among a cohort of individuals with HIV disease. DATA SOURCES: Adults who participated in a series of up to six interviews as part of the AIDS Costs and Services Utilization Survey (ACSUS). ACSUS, a panel survey of persons with HIV disease, was undertaken from 1991 through 1992. STUDY DESIGN: The Andersen Behavioral Model of Health Services Use provided the conceptual framework for the study. Logistic regression analyses with generalized estimating equations were conducted to determine the effects of predisposing, enabling, and need-for-care factors on the odds of antiretroviral or PCP medication use. The analytic sample consisted of 1,586 respondents whose 7,652 interviews provided the data. PRINCIPAL FINDINGS: The multivariate analysis showed that being female (OR = 0.76; 95% C.I. = 0.60-0.95), ages 15 to 24 years (OR = 0.64; 95% C.I. = 0.44-0.92), and having a hospitalization (OR = 0.73; 95% C.I. = 0.63-0.84) were associated with lower odds of using antiretrovirals. African American race (OR = 1.30; 95% C.I. = 1.04-1.62), having both public and private insurance (OR = 2.11; 95% C.I. = 1.47-3.03), attending counseling (OR = 1.17; 95% C.I. = 1.02-1.34), having a usual source of care (OR = 1.70; 95% C.I. = 1.38-2.11), and clinical trials participation (OR = 1.52; 95% C.I. = 1.23-1.87) were associated with a higher odds of use. Similar results were obtained for analyses of PCP medication use. CONCLUSIONS: Sociodemographic differences exist in access and use of prescription drugs within the ACSUS cohort. The results suggest that women and those ages 15 to 24 years have poor access to some medications that improve survival in HIV disease.

A reasoned action approach to physicians' utilization of drug information sources.

PURPOSE: The effects of attitude and subjective norm were investigated on physicians' intention to use seven drug information sources: the PDR, medical textbooks, medical journals/newsletters, pharmaceutical manufacturers' literature, pharmaceutical manufacturers' representatives, other physicians, and pharmacists. The effects of past behavior and practice characteristics were also examined. METHODS: An eight-page mail questionnaire queried health maintenance organization physicians on their intention to use, attitude (emotional response) and subjective norm (colleagues' approval/disapproval) toward use of each source when searching for drug information on a fictitious, new H2 antagonist agent. RESULTS: Responses were received from 54% (108) of the 200 physicians surveyed. Positive attitudes toward use had the greatest influence upon intention to use each of the sources (b > or = .40) (except for pharmacists, for which subjective norm was the most important predictor (b = .31)). Past behavior directly affected intention to use the PDR (b = .27), and pharmaceutical manufacturers' literature (b = .26). The effects of attitude and/or subjective norm on intention to use non-commercial sources of drug information were moderated by the practice characteristics. CONCLUSIONS: These findings suggest that physicians' use of drug information sources is strongly influenced by their attitudes toward use. In addition, the importance of situational contingencies should not be overlooked when investigating the use of drug information sources.

Unclaimed prescriptions at a university hospital's ambulatory care pharmacy.

Characteristics of unclaimed prescriptions at a university hospital's ambulatory care pharmacy were determined, and reasons why prescriptions went unclaimed were identified. Over a 15-week period, 522 unclaimed prescriptions for 344 patients were identified. Patient and prescription data for these unclaimed prescriptions were obtained from pharmacy records. Telephone interviews were conducted with 157 patients to determine (1) why they had not claimed their prescriptions and (2) whether their treatment had been interrupted as a result. Of the unclaimed prescriptions, 224 were for discharge medications. Only 38 (17.0%) of the discharge prescriptions were eventually dispensed without pharmacy intervention, compared with 147 (49.3%) of the other unclaimed prescriptions. Patients' reasons for not claiming their prescriptions suggested that they had complied with the physicians' intentions for 72.6% of their prescriptions. The two most frequently reported reasons were that the prescription had been obtained elsewhere and the physician had changed or discontinued the regimen. Unclaimed prescriptions, especially for discharged patients, usually resulted from a lack of communication among patients, pharmacists, and other health care providers.

Assessing physician choice of nonsteroidal antiinflammatory drugs in a health maintenance organization.

OBJECTIVE: To develop a categorization scheme for grouping various nonsteroidal antiinflammatory drugs (NSAIDs) by relative safety; to develop a method to quantify the appropriateness of the initial and subsequent choices of NSAID therapy; to assess whether NSAID prescribing was consistent with the developed criteria; to examine the cost of inappropriate, acute NSAID use as defined by the established criteria. DESIGN: Retrospective drug utilization review focusing on NSAIDs. SETTING/PARTICIPANTS: Members aged > or = 18 years of a 40,000-person southeastern Michigan health maintenance organization. MAIN OUTCOME MEASURES: (1) Appropriateness of therapy using a four-level safety classification system for the NSAIDs developed by a consensus process; criteria based on safety under the assumption that any particular NSAID is equally likely to be effective when dosed appropriately; (2) evaluation of progression of NSAID therapy using the NSAID Therapy Progression Formula. RESULTS: For acute patients, almost half of the prescriptions were for ibuprofen and 33 percent were for naproxen. Ibuprofen usage accounted for 16 percent of total NSAID cost and naproxen agents accounted for over 50 percent of that cost. Potential cost savings of approximately $82,000 probably would have occurred had a 50 percent interchange rate for ibuprofen been acceptable. For chronic patients, 85 percent were treated with one or two NSAIDs; treatments were of reasonable high quality when compared by safety profiles. There was low use of ibuprofen in patients who only received one NSAID. CONCLUSIONS: NSAID usage assessment in a large population was achieved by developing a classification and scoring system based on NSAID safety; in this population, prescribing patterns were generally consistent with established criteria; however, when considering cost, improvement in initial NSAID selection for acute patients was possible.

Assessing the quality of pharmaceutical care. II. Application of concepts of quality assessment from medical care.

OBJECTIVE: To present a framework that facilitates quality assessment of pharmaceutical care (PC) so that the profession and the public may identify pharmacists in ambulatory settings who provide quality care in all aspects of the their practices. DATA SOURCES: A MEDLINE search augmented by a review of International Pharmacy Abstracts was used to identify pertinent quality assessment and pharmacy practice literature; indexing terms included quality assurance, healthcare, pharmacists, community pharmacy services, ambulatory, pharmacy, and process and outcome assessment. STUDY SELECTION: All identified quality assessments of community pharmacy practice were considered. Studies that documented the effectiveness of specific pharmacist activities and patient satisfaction were also included. DATA EXTRACTION: The literature was independently reviewed by the primary author. DATA SYNTHESIS: The structure-process-outcome paradigm is presented as a framework for quality assessment of PC. Structure should be assessed at periodic intervals because it identifies the potential for the provision of quality care. Process, the care that pharmacists provide, must be documented and linked to outcomes before either structure or process can be used to make inferences about the quality of PC. Technical and interpersonal processes should be examined. Outcomes require an interdisciplinary approach that not only considers other medical care inputs but also recognizes the psychologic, economic, and social factors that affect health status and quality of life. Process and outcome must both be assessed to distinguish the contribution of pharmacists from that of other healthcare providers. Examples of criteria are provided and a model to integrate PC within the healthcare system is discussed. CONCLUSIONS: It is pharmacists' duty to ensure that patients receive an acceptable level of PC. The structure-process-outcome paradigm provides a framework to identify and link pharmacists' processes with patients' outcomes.

Assessing the quality of pharmaceutical care. I. One perspective of quality.

OBJECTIVE: To evaluate the concept of pharmaceutical care (PC) as a standard of quality care for ambulatory pharmacy practice. DATA SOURCES: Donabedian's article on the seven pillars or characteristics of quality provides a framework for a discussion of the merits of PC as a definition of quality. A MEDLINE search augmented by a manual review of International Pharmacy Abstracts was also used to identify pertinent English-language pharmacy literature; indexing terms included quality, community pharmacy services, ambulatory, pharmacy services, and pharmacist(s). STUDY SELECTION: Representative articles and studies promoting PC were considered. DATA EXTRACTION: The literature was independently reviewed by the primary author. DATA SYNTHESIS: An interpretation of the principles of Donabedian's article was applied to PC. PC appears to be consistent with the quality characteristics of efficacy and acceptability. The effectiveness, cost-effectiveness, and efficiency of PC should be firmly established by its practitioners as barriers are eliminated and/or overcome. The pillars of optimality, equity, and legitimacy seem to be overlooked under the current definition of PC. This article contends that PC assumes an individualist definition of quality, by definition, because of its covenantal relationship with the patient. CONCLUSIONS: Quality is defined in terms of the values of individuals and society. For now, PC appears to be the appropriate standard for defining quality in pharmacy because of the importance of individual maximal benefits within our society.

Impact of consumer fees on drug utilisation.

A review of research on consumer fees for drugs and drug utilisation suggests that the demand for drugs tends to be quite insensitive to consumer fees. Although higher consumer fees are associated with slightly reduced rates of drug utilisation, use of most other medical services is not meaningfully affected and health status has not been shown to be adversely affected. The larger impact of consumer fees demonstrated in the published literature is to shift drug costs from third parties to consumers. Since much of the literature is limited to insurance programmes with quite small consumer fees, the generalisability of results may be limited. Ability-to-pay and health needs may also be important considerations in the relationship between use and fees for particular drugs.

Evaluation of direct pharmacist intervention on conversion from parenteral to oral histamine H2-receptor antagonist therapy.

A program in which pharmacists were authorized to change parenteral histamine H2-receptor antagonist (H2RA) therapy to the oral route without first contacting the prescriber was evaluated on cost and appropriateness of use of the parenteral route. Parenteral therapy was received by 264 and 244 patients in the study and comparison groups, respectively. Length of parenteral H2RA therapy was less in the study group (4.8 vs. 7.5 d) as was length of total (parenteral + oral) therapy (8.4 vs. 12.1 d). Parenteral H2RA drug acquisition savings were $6225 in the six-week study period or $53,950 when annualized. Decreased oral therapy contributed additional savings. There was a significant decrease in the number of inappropriate parenteral doses of ranitidine per patient, the drug used in more than 80 percent of the patients. In addition to the direct effect of pharmacists' interventions, there appeared to be an indirect effect of the program, as physicians initiated route of administration changes on their own.

Choices in prescription-drug benefit programs: mail versus community pharmacy services.

Pharmaceutical price increases and greater coverage of outpatient prescription medications have stimulated interest in containing drug benefit-program costs. While mail pharmacy services (MPS) may achieve savings through volume purchasing, high usage of generic drugs, and dispensing larger quantities of medication per prescription, efforts are also underway to adapt community-pharmacy-based services to keep costs down in these areas. No controlled studies document a difference in quality between the two types of services. Third-party administrators and benefit managers need to consider factors such as providing information to patients, monitoring drug therapy, dispensing patients' correct medication, and cost-control incentives when assessing MPS's role in prescription drug programs.

Costs associated with the inappropriate route of administration of parenteral histamine2-receptor antagonists.

The objectives were to assess the parenteral route for cimetidine and ranitidine and to determine excess medication costs associated with inappropriate use. Criteria were based on clinical situations that do not permit oral therapy, result in questionable dry absorption, or require a more rapid onset of action. The parenteral route was assessed as appropriate, inappropriate, or questionable. During two months, parenteral therapy was prescribed for 199 adult inpatients. Initially, 63 percent received the parenteral form appropriately; only 16 percent continued to receive the parenteral form appropriately throughout therapy. Less than half of the parenteral doses were determined to be appropriate. A major reason appears to be that orders are not changed as patients' conditions improve. Excess medication costs attributed to inappropriate parenteral therapy for the study period amounted to $6796 or $8002, depending on whether questionable doses were considered appropriate or inappropriate, respectively. An annual projected savings of $40,776 or $48,012 could be achieved if oral doses had been administered in place of inappropriate parenteral therapy.