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PubMed1989

Alternative topical therapy.

Although there have been revolutionary changes in the management and treatment of dermatologic disorders with topical therapies, these potent remedies do not always work in recalcitrant and intractable cases. When all the "modern" preparations have been exhausted, falling back on some old remedies often proves curative. This article offers a list of 73 alternative topical measures that are often beneficial.

Administration, Topical↗
PubMed2000

Evaluation of a formulary switch from conjugated to esterified estrogens in a managed care setting.

BACKGROUND: Formulary switches between agents in the same therapeutic class have become commonplace in the managed care setting as a strategy to reduce costs. OBJECTIVES: We evaluated the impact of a formulary switch from conjugated to esterified estrogen tablets at the Fallon Community Health Plan, a mixed-model health maintenance organization. DESIGN: A retrospective study was conducted with the use of the automated database of the health plan. SUBJECTS: Study subjects were members of the health plan during the period from May 1, 1995, to December 31, 1997, who were dispensed > or =1 estrogen replacement product. From this population, a cohort of users of conjugated estrogens during the period from May 1, 1995, to October 31, 1995, was selected. MEASURES: The cumulative incidence of switching from conjugated to esterified estrogen tablets and subsequent discontinuations of esterified estrogens was evaluated. The frequencies of ambulatory encounters during the 6 months before and after a switch or discontinuation were compared. RESULTS: During the period after promotion of the formulary switch, 2,149 of 2,984 patients (72%) originally dispensed conjugated estrogen tablets switched to esterified estrogen tablets. Among those patients switching to esterified estrogens, an excess of 20 office visits per 100 patients was noted in the postswitch period (P = 0.005). The risk of switching back to conjugated estrogen tablets was 15% by 2 years. CONCLUSIONS: The findings of this study suggest that plan efforts were successful in switching most users of conjugated estrogens to esterified estrogens. The switch was associated with an increase in utilization of health care services.

Adult↗
PubMedDate not supplied

Drug formulary review process for sargramostim and filgrastim: focus on analysis of adverse drug reactions.

Selection of a drug for formulary inclusion involves evaluation of safety, efficacy, and cost. The colony-stimulating factors (CSFs) sargramostim and filgrastim have a broad range of potential indications and represent a costly formulary addition when acquisition price alone is considered; their comparative safety is unclear. These factors suggest that the CSFs should be closely scrutinized prior to formulary addition. In the absence of direct comparative studies, an assessment of the safety of CSFs involves evaluation of information provided in the product circular, official drug compendia, adverse biologic reports submitted to the United States Food and Drug Administration, and data from key clinical trials. Data in the product circulars report on adverse events in small numbers of patients treated for chemotherapy-induced neutropenia (filgrastim) or neutropenia subsequent to bone marrow transplantation (sargramostim). The official compendia and clinical trials include experience with CSFs produced in a variety of expression systems; these data are not limited to sargramostim and filgrastim. Importantly, there was a similar incidence of adverse events in patients who received sargramostim or filgrastim and in those who took placebo reported in the product circulars and the pivotal trials, suggesting that the underlying disease may have an important role in determining the side-effect profile of these agents. Adverse biologic reports represent experience with sargramostim and filgrastim obtained under actual clinical conditions and suggest that the same types of adverse events are seen with sargramostim as with filgrastim. This analysis suggests that a decision to select filgrastim over sargramostim for formulary inclusion based on the safety profile is not appropriate because currently available data are equivocal and that such decisions would more appropriately be based on efficacy and cost.

Adverse Drug Reaction Reporting Systems↗
PubMed2003

A role for two-stage pharmacoeconomic appraisal? Is there a role for interim approval of a drug for reimbursement based on modelling studies with subsequent full approval using phase III data?

Healthcare decision makers and pharmaceutical companies are increasingly using techniques of economic evaluation, particularly modelling, to assist them in their decisions about drug purchasing and drug development. The use of models in other types of policy decisions is also well established. One option, to shorten the time to a purchasing decision, would be for an interim decision for approval for reimbursement to be based on an economic model. Such a system would mainly benefit the drug development process and thus the pharmaceutical industry; however the approach could also lead to poor decision making, unethical marketing and withdrawal of drugs from the consumer. In this article, we consider the option of a two-stage economic appraisal process from the point of view of the seller, the purchaser and the patient and public. Although a two-stage process may offer some advantages in terms of early return on investment and access, there are significant disadvantages in terms of certainty about effects and public policy and expenditure. Until there are better methods of predicting the effectiveness of a new product, it is unlikely that interim decisions can be seen as a reasonable health policy alternative, although it seems likely that industry may continue to lobby for such an approach.

Australia↗