The new United States Pharmacopeia (XVII) and National Formulary (XII): new and vital changes for children.
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PURPOSE: With the establishment and signing into law the Medicare and Prescription Drug Improvement and Modernization Act of 2003, also known as Medicare Part D, medical costs are expected to soar. In fact, the program is expected to cost more than a trillion dollars through 2015. Establishment of the Medicare Part D drug formulary will allow cost containment but still absorb patient and physician preferences as well as a consideration of efficacy and safety data. MATERIALS AND METHODS: Potential Medicare formulary choices were examined in the anticholinergic class, as commonly used by urologists, and small in number of available drugs. Formulary selection parties and issues were individually analyzed, including the government in respect to cost containment, patients in relation to efficacy and cost, physicians in relation to preferences and influence and drug companies in relation to lobbying power, country of base of operations and market shares. Costs to Medicare and patients were calculated using discount Internet sites for pricing and simulated using Medicare Part D benefits. RESULTS: Generic oxybutynin is likely to be included because it is the least expensive to patients and Medicare, but it has the lowest efficacy. Detrol LA is likely to be the long acting choice due to efficacy, cost and manufacture by a United States based company. CONCLUSIONS: A simulation of cost analysis of anticholinergics for treatment of overactive bladder would help urologists better understand the Medicare formulary selection process.
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BACKGROUND: Drug selection for optimal treatment of common medical conditions may be difficult and involve many diverse factors. OBJECTIVE: The efficacy, safety, quality of life, and cost of treatment of seasonal allergic rhinitis with cetirizine, chlorpheniramine, or terfenadine were compared in a prospective, two-phase, randomized, single-blind clinical trial conducted in a managed care setting. METHODS: In phase I, which lasted 2 weeks, patients were randomized to receive one of the study drugs. In phase II, which lasted 4 weeks, the initial treatment was continued unless patients were dissatisfied, in which case they could be randomly assigned to receive another study drug. In both phases pseudoephedrine could be taken as needed. Patients kept daily diaries of symptoms and costs, and study drugs were evaluated at the end of each phase for efficacy, safety, and effect on quality of life by means of a validated questionnaire. A multiattribute outcomes assessment model for formulary decision making was used to rank the antihistamines. RESULTS: Physicians' and patients' assessments in phases I and II indicated that cetirizine and chlorpheniramine were significantly more effective than terfenadine (p < 0.05). Incidence of sedation in phase I and phase II was 40.5% and 16.7% for chlorpheniramine, 11.6% and 9.8% for cetirizine, and 6.7% and 5.1% for terfenadine, respectively. At the end of phase I, 28.9% of the patients treated with chlorpheniramine, 50% of the patients treated with terfenadine, and 69.4% of the patients treated with cetirizine were satisfied with their therapy and chose not to switch their medication. Quality of life scores improved most after treatment with cetirizine and least after treatment with terfenadine. CONCLUSION: The result of this trial indicate that antihistamine selection is best made with the use of a multiattribute evaluation that includes quality of life. In this study cetirizine was favored by patients and physicians most often, followed by chlorpheniramine and then terfenadine.
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Over a period of 1 year, a diverse group of general practitioners from separate practices constructed a limited formulary for general practice. The formulary contains 137 drugs and is intended to provide adequate and appropriate treatment for 90% of general practice patients. The study provides a model for development of agreed local formularies which do not infringe clinical freedom and offer an alternative to imposed limited lists as a means of reducing the cost of prescriptions. Development of such a list can be an enjoyable and dynamic educational exercise and can lead to more rational and safer prescribing.
The emergence of formulary submission guidelines in the 1990s has been seen by many as an attempt to come to grips with the issue of drug management within health systems and to provide, for the first time, a coherent and methodologically rigorous approach to formulary selection. Judging from the available evidence, however, guidelines have fallen far short of their potential. The purpose of this paper is to consider what role guidelines have played in health system management and whether they play a useful role in providing a methodologically sound basis for drug-impact assessment. Two polar cases in guideline development are examined: the Australian guidelines first published in 1992 and now undergoing a second major revision and the guidelines recently published by Blue Cross and Blue Shield of Colorado and Nevada. The former guidelines represent what can be described as the traditional, clinical paradigm of drug-impact assessment; the latter represent what can be called the system-impact paradigm. The argument put forward is that the Australian guidelines are essentially an anachronism, offering little to those whose principal concern is with the management of health systems. In their emphasis on a hierarchy of evidence and a clinical trial-focused, cost-effectiveness evaluation perspective, they represent a methodologic dead end in a number of important respects. The systems-based approach, on the other hand, with its emphasis on validation of claims and the need to consider a range of drug-impact and risk-management scenarios, offers an analytic framework that, while possibly less rigorous, is likely to contribute significantly to the management of health care systems.
BACKGROUND: Numerous mechanisms have been introduced to deliver prescription drug benefits while controlling pharmaceutical costs. An understanding of the most prominent mechanisms of benefit management is an important step in determining the most effective approach to take in future years. OBJECTIVES: The aims of this review were to illustrate the mechanisms by which managed care has attempted to efficiently and equitably deliver pharmacy benefits and to discuss the impact of such programs, including consumer cost sharing. METHODS: A review of the literature was conducted using the PreMedline and MEDLINE databases from the years 1966 to 2002, reference lists from relevant articles, and online sources, including news releases, conference materials, and pharmacy benefit management reports. RESULTS: Numerous pharmacy benefit management tools and their impact on utilization, expenditures, and health outcomes are reviewed, including disease state management; utilization management (ie, quantity limitations and prior authorization); drug utilization review; formulary management (ie, open and closed); delivery systems (ie, retail and mail order); and mechanisms for implementing consumer cost sharing (ie, generic incentives, multitiered copayments, and co-insurance). Although there is some evidence to suggest that certain benefit management tools have been successful in reducing health plan expenditures, a more thorough investigation of their potential unintended consequences is needed. CONCLUSIONS: Implementing adequate levels of consumer cost sharing is necessary if employers and health plans are to continue offering prescription drug benefits. It is important to remember, however, that quality health care cannot be forfeited for the sake of short-term cost savings.
BACKGROUND: Previous research has suggested that 3-tier prescription drug copayment systems produce drug cost savings without affecting the use of other medical services during the first 12 months after implementation. Assessment of such systems with a longer follow-up period has been needed. OBJECTIVE: This study examined the effect of a 3-tier copayment system on pharmaceutical and medical utilization and cost for 30 months after implementation in a population of commercially insured, preferred-provider organization members. METHODS: This was a quasi-experimental, pre-post with comparison group design that gathered data retrospectively from the claims database of a preferred-provider organization in the Midwestern United States. The intervention group comprised members whose employer switched from a 2-tier (generic/brand copayment) plan to a 3-tier (generic/formulary/nonformulary) plan. The comparison group comprised members whose employer retained the 2-tier plan. Employers did not offer a choice between the 2- and 3-tier plans. Outcome measures included total drug cost; net insurer cost (drug cost minus copayment); number of prescription claims; numbers of office visits, inpatient hospitalizations, and emergency department visits; and rates of continuation with chronic medication therapy. RESULTS: Relative to the comparison group (n=4132), the intervention group (n=3577) showed reduced growth in net cost and lower utilization of third-tier (nonformulary) medications (P<0.001 and P<0.01, respectively). The intervention and comparison groups did not differ significantly with respect to numbers of office visits, emergency department visits, or inpatient hospitalizations. Medication continuation rates were lower for the intervention than the comparison group at 6 months for oral contraceptives (P<0.05), but chronic medication therapy continuation rates did not differ significantly at any other time point or for estrogens, antihypertensives, or antihyperlipidemics. CONCLUSION: In the population studied, previous research findings were confirmed over a longer time period.
Prescription drug formularies are a key element in the rapidly growing trend of prescription drug benefit management. The use of formularies can increase the quality of prescribing and reduce the costs of prescription drug therapy. This is particularly important to older Americans, who represent about 13% of the population but consume roughly one third of the drugs prescribed in the United States. However, the question of whether the use of formularies affects patient access to pharmaceuticals has not been analyzed sufficiently. This paper identifies benefits and risks to older Americans from the use of prescription drug formularies by third-party payers, analyzes the evidence of those benefits and risks, and proposes areas for future research. An extensive review and synthesis of the literature were performed, focusing on three aspects of drug formulary design: (1) the extent to which health maintenance organizations and insurers consider consumer interests when using formularies; (2) the extent to which formulary design is affected by clinical and economic considerations; and (3) the impact of formularies on the quality of drug care received. Safeguards to guarantee that economic considerations of drug benefit managers do not restrict access to needed drugs are insufficient. Alternatively, no evidence to date shows that the use of formularies adversely affects patients' access to pharmaceutical care. More research is required to understand the process of drug formulary development and the extent to which different formulary recommendations impede on physicians' ability to provide high-quality care.
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