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Pharmacy-enforced outpatient drug treatment protocols: a case study of Medi-Cal restrictions for cefaclor.

OBJECTIVE: To evaluate whether a pharmacy-enforced treatment protocol successfully limited the use of a high-cost medication to high-risk patients. DESIGN: A case study cost-effectiveness analysis was conducted to evaluate a treatment protocol for cefaclor. Episodes of care were defined, healthcare expenditures for all services were aggregated, and demographic data were retrieved from a five percent random sample of California Medicaid (Medi-Cal) recipients. Data were available for episodes occurring before cefaclor was made available under Medi-Cal. SETTING: Medi-Cal added cefaclor to its formulary, limiting its use to patients over 50 years of age with lower respiratory tract infections (LRTIs). The unit of analysis was an episode of outpatient antibiotic treatment. PATIENTS: Confirmed LRTI episodes and unconfirmed LRTI cefaclor episodes were analyzed, including multiple episodes of treatment for individual patients. A total of 7855 non-cefaclor LRTI episodes and 2556 cefaclor episodes were analyzed. MAIN OUTCOME MEASURES: The primary outcome measures were healthcare expenditures three months after the initiation of antibiotic therapy, differentiated by type of service. RESULTS: Physicians directed cefaclor toward higher-risk patients over age 50 years, even in unconfirmed LRTI episodes. Cefaclor use was estimated to reduce posttreatment costs by $388 per patient (p < 0.001), primarily because of reduced hospital expenditures of $366 (p < 0.001). CONCLUSIONS: Pharmacy-enforced outpatient drug treatment protocols may be a viable alternative to restrictive formularies and prior authorization. In the case of cefaclor, the Medi-Cal treatment protocol appeared to allow high-risk patients better access to a high-cost medication while reducing total posttreatment costs.

Aged↗

The pharmacist as prescriber of drug therapy: the USC pilot project.

Recent legislation in California allows pilot projects to investigate prescribing by pharmacists. The University of Southern California School of Pharmacy project was approved in October, 1978. To be certified as prescribers, pharmacists must successfully complete a physical assessment course and a certifying examination. From an original group of 30 interested pharmacists, 25 were certified; five different pharmacists were added later. Prescribing pharmacists must meet with their supervising physician once every two weeks, and are restricted to the project formulary. A variety of health care settings are represented in the project, with pharmacists prescribing for ambulatory patients with chronic diseases, geriatric patients in extended care facilities, psychiatric patients, and selected inpatients. Project evaluation will continue through 1982 and will focus on safety and quality of care, patient acceptance, and cost of care.

California↗

Managed care guidelines for the economic evaluation of pharmaceuticals.

Foundation Health Corporation, through its National Pharmacy and Therapeutics Committee, requires all pharmaceutical manufacturers and others who wish products to be considered for formulary listing to meet evidentiary and analytical standards in their submission documentation. This article details the evidentiary and analytical standards required from those making submissions and describes the methodological basis of the guidelines. This is the first time, as far as the authors are aware, that a managed care health system in the United States has required formulary submissions not only to meet clinical and economic evaluation standards, but also to take explicit account of the perspective of the managed care group in applying these techniques. Submissions are required to take what is described as a systems impact perspective. This approach is quite different, in both evidentiary and analytical terms, from standards required by health systems in other countries and standards for the economic evaluation of pharmaceuticals proposed by expert groups in the United States.

Cost-Benefit Analysis↗

Drug product selection in Illinois: the first year's experience.

This paper reports an evaluation of Illinois' drug product selection (DPS) law. The results show that while consumers saved an average of $1.47 whenever DPS occurred in the study period, the prescription format mandated in the Illinois law appears to be a hindrance to unambiguous communication from prescribers. In addition, because of the positive formulary approach adopted by Illinois, the potential for DPS behavior was limited to only 20.8 per cent of the prescriptions audited in the study and ultimately, DPS occurred in 12.6 per cent of this sample. It also is reported that DPS was more likely to occur in urban community pharmacies and that consumers saved more money when DPS occurred in this environment, but prices for prescriptions dispensed as written were also higher in this environment. Finally, it was found that prescription prices were affected by the type of pharmacy patronized, but were not affected by the urban or rural location of pharmacy.

Analysis of Variance↗

Assessment of formulary development in a small hospital.

The development of a formulary system in a 138 bed hospital is evaluated. A description of the process used in completing the formulary is provided as well as the assertion that the small hospital has advantages in initiating this process. The results of the study show a 40% decrease in the number of drug line items and a $14,901 (36%) reduction in inventory. Improvement in departmental organization is noted as well as a positive psychological impact. As the prospective payment system increases the need to control costs and improve efficiency, the formulary system is seen as an important step in addressing these concerns.

Cost Control↗

The long-term value of the selected list as a method of controlling drug costs in a district general hospital.

The results of a study aimed at evaluating the long-term effects of the Limited List (now officially referred to as the Selected List Scheme) on inpatient drug costs in a district general hospital (DGH) are presented. Study periods of six months duration were examined before, shortly after, and a further year after implementation of the List on 1 April 1985. Eight therapeutic classes affected by the regulations were examined; in four of these (antacids, expectorants, mucolytics and anxiolytics, hypnotics and sedatives) statistically significant reductions in costs were demonstrated over the study periods. There was no significant change in the costs of the other four classes (vitamins, laxatives, nasal preparations and analgesics). Overall, inpatient expenditure for the hospital showed no significant change. The changes in cost demonstrated can be attributed to the Selected List and occurred despite the prior existence of a local formulary.

Cost Control↗

Evaluation of a limited drug formulary in an adult internal medicine clinic.

The utility of a 30-drug, limited formulary in an adult internal medicine, ambulatory-care clinic was investigated. The formulary was developed using a mail survey of a random sample of members of the ASHP Ambulatory Care Pharmacy Practice Special Interest Group. The consensus formulary comprised the 30 most frequently recommended drugs; the utility of the formulary was then tested by chart review in a primary-care internal medicine clinic. Over a two-month period, the charts of alternating patients were reviewed daily; patient data collected included demographic information and prescribed drug therapy. A panel of two physicians and one pharmacist reviewed each patient's data and determined the appropriateness of drug treatment. If an agent was prescribed that was not on the consensus formulary, the panel determined whether an appropriate formulary agent could have been prescribed. Of the prescribed drug orders, 57.8% were for agents in the consensus formulary; by including patients who could have received formulary drugs appropriately, 73.7% of all prescription orders were or could have been for formulary drugs. Age, race, and sex of patients had no significant effect on utility of formulary agents. Had the 30 drugs most commonly prescribed in this clinic been in the formulary, 82.6% of all prescription orders would have been covered. This approach to establishing a new formulary and selecting drugs for inclusion is potentially useful.

Adult↗

Formulary evaluation of third-generation cephalosporins using decision analysis.

A structured, objective approach to formulary review of third-generation cephalosporins using the decision-analysis model is described. The pharmacy and therapeutics (P&T) committee approved the evaluation criteria for this drug class and assigned priority weights (as percentages of 100) to those drug characteristics deemed most important. Clinical data (spectrum of activity, pharmacokinetics, adverse effects, and stability) and financial data (cost of acquisition and cost of therapy per day) were used to determine ranking scores for each drug. Total scores were determined by multiplying ranking scores by the assigned priority weights for the criteria. The two highest-scoring drugs were selected for inclusion in the formulary. By this decision-analysis process, the P&T committee recommended that all current third-generation cephalosporins (cefotaxime, cefoperazone, and moxalactam) be removed from the institutions's formulary and be replaced with ceftazidime and ceftriaxone. P&T committees at other institutions may structure their criteria differently, and different recommendations may result. Using decision analysis for formulary review may promote rational drug therapy and achieve cost savings.

Cephalosporins↗

Impact of removing oral neuroleptic liquids from the formulary of a large psychiatric hospital.

Oral liquid formulations of neuroleptic medications have been claimed to offer advantages in treatment of psychotic patients, particularly as a means of ensuring compliance. After a review of the literature, this 900-bed psychiatric facility found no substantial support to indicate that liquids are superior to solid dosage forms. Because of their higher cost, liquid neuroleptics were removed from this formulary. Few changes in prescribing practices were measured after removal of liquids; dosages remained constant and injectable neuroleptic and sedative use actually decreased. Replacing liquid neuroleptic dosage forms with solid dosage forms resulted in an estimated annual savings of nearly $60,000 at this institution. The authors conclude that liquid neuroleptics appear to offer no benefits over solid dosage forms in adult psychiatric patients and can be removed from drug formularies without disruptive effects on psychotropic prescribing practices or clinical care. However, further research is needed to determine the benefits of liquid neuroleptics in special clinical or psychiatric settings.

Antipsychotic Agents↗

Pharmacy newsletter evaluation by nurses.

A survey of staff nurses was conducted to determine readership and evaluate the usefullness of a pharmacy newsletter. Questionnaires were sent to a random sample of 50 nurses. Of the respondents, 91% claimed to read the newsletter at least occasionally. Formulary and pharmacy policy information was considered most important. Interest in drug quizzes and features concerning drug therapy appeared to be high enough to make the newsletter an aid to inservice education. Readership was felt to be at a sufficient level to justify publication of a regular monthly newsletter for staff nurses.

Communication↗

Converting an integrated hospital formulary into an object-oriented database representation.

Controlled Medical Vocabularies (CMVs) have proven to be extremely useful in their support of the tasks of information sharing and integration, communication among various software applications, and decision support. Modeling a CMV as an Object-Oriented Database (OODB) provides additional benefits such as increased support for vocabulary comprehension and flexible access. In this paper, we describe the process of modeling and converting an existing integrated hospital formulary (i.e., set of pharmacological concepts) into an equivalent OODB representation, which, in general, we refer to as an Object-Oriented Healthcare Vocabulary Repository (OOHVR). The source for our example OOHVR is a formulary provided by the Connecticut Healthcare Research and Education Foundation (CHREF). Utilizing this source formulary together with the semantic hierarchy composed of major and minor drug classes defined as part of the National Drug Code (NDC) directory, we constructed a CMV that was eventually converted into its OOHVR form (the CHREF-OOHVR). The actual conversion step was carried out automatically by a program, called the OOHVR Generator, that we have developed. At present, the CHREF-OOHVR is running on top of ONTOS, a commercial OODB management system, and is accessible on the Web.

Databases as Topic↗

Group purchasing: an overview.

The various types and operational methods of purchasing groups are described, and evaluation of groups is discussed. Since group purchasing is increasing in popularity as a method of controlling drug costs, community and hospital pharmacy managers may need to evaluate various groups to determine the appropriateness of their services. Groups are categorized as independent, system based, or alliance or association based. Instead of "purchasing," some groups develop contracts for hospitals, which then purchase directly from the vendor. Aside from this basic difference between groups that purchase and groups that contract, comparisons among groups are difficult because of the wide variation in sizes and services. Competition developing from diversification among groups has led to "super groups," formed from local and regional groups. In evaluating groups, advantages and disadvantages germane to accomplishing the member's objectives must be considered. To ensure a group's success, members must be committed and support the group's philosophies; hospital pharmacists must help to establish a strong formulary system. To select vendors, groups should develop formal qualification and selection criteria and should not base a decision solely on price. The method of solicitation (bidding or negotiating), as well as the role of the prime vendor, should be studied. Legal implications of group purchasing, especially in the areas of administrative fees and drug diversion, must also be considered. The most advantageous group for each organization will include members with common missions and will be able to implement strategies for future success.

Biological Availability↗

Adrenal function following topical steroid treatment in children with atopic dermatitis.

Adrenal suppression is a potential complication of topical corticosteroid treatment in atopic dermatitis. We used a low-dose adrenocorticotrophic hormone (ACTH) test (500 ng/1.73 m2) to detect subtle changes in adrenal glucocorticoid function in 14 prepubertal children with moderate or severe atopic dermatitis affecting 16-90% (median 58%) of the body surface area. All had received regular treatment with mild potency BNF (British National Formulary) classification topical corticosteroid ointments (hydrocortisone 48.7-223.2 mg/m2 body surface area/day; median 134.2) for 3-10 years (median 6.5 years). Nine children had also intermittently used moderate potency preparations. However, none had been treated with corticosteroids by any other route in the preceding 6 months. Fourteen prepubertal children with constitutional short stature, without atopic disease, served as controls. The basal, peak, increment and area-under-curve in plasma cortisol concentrations in children with atopic dermatitis were not significantly different from controls, indicating normal adrenal sensitivity to low-dose ACTH. However, the peak in plasma cortisol occurred earlier in children with atopic dermatitis (median 17.5 min) than in controls (median 25 min) (P = 0.02). In addition, there was a significant inverse relationship between time to peak and extent of atopic dermatitis (rs = -0.52; P < 0.05), but not topical steroid treatment dose or score in children with atopic dermatitis. These findings indicate accelerated adrenal responsiveness to ACTH in children with atopic dermatitis, which is independent of treatment. Mild to moderately potent topical corticosteroid ointments in these doses did not suppress adrenal glucocorticoid function in this sample of children with atopic dermatitis.

Administration, Topical↗

Zidovudine: a review of pharmacoeconomic and quality-of-life considerations for its use in patients with human immunodeficiency virus.

In patients with human immunodeficiency virus (HIV) infections or the acquired immunodeficiency syndrome (AIDS), zidovudine is a first-line therapy that reduces morbidity and may reduce mortality. By delaying progression to AIDS, the drug reduces the duration and incidence of hospitalisations in a given time period, resulting in overall decreases in the cost of medical treatment per unit of survival time. In current therapeutic dosages zidovudine is generally well tolerated. Most pharmacoeconomic and quality-of-life studies of this agent were conducted using data relating to higher dosages and higher drug acquisition costs than those currently applicable, but nevertheless generally support the cost-effectiveness of zidovudine in patients with HIV disease. Studies examining the use of the drug in higher dosages demonstrate neither clear positive nor negative effects of the drug on quality of life. The cost effectiveness of the drug as prophylaxis against seroconversion after occupational exposure to HIV is dependent primarily on the establishment of clinical effectiveness in this condition. Further pharmacoeconomic studies should examine changes to dosage and cost factors, along with direct nonmedical treatment costs, indirect medical treatment costs and the effects of the drug on quality of life. An evaluation of existing studies suggests that if these factors were accounted for, zidovudine might be shown to be more clearly cost effective, and indeed its use in the treatment of patients with HIV disease might be found to result in cost savings.

Acquired Immunodeficiency Syndrome↗