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Developing a new wound care formulary and guidelines.

Following an audit of the existing wound care formulary and guidelines, an updated version was developed, containing additional products and information. This was revised following advice from a range of professionals, then pilot tested on ward-based nurses. The nurses found the updated formulary useful, and made recommendations for changes to the wound care ordering system in the trust. Future guidelines will be regularly updated as developments in wound care occur.

Formularies as Topic↗

An examination of physician use of and attitudes toward closed formulary drug programs.

Efforts to control the rising costs of drug budgets has centered primarily on the use of "closed formularies"--systems in which a set of drug products are pre-approved for dispensing to those eligible for expense coverage. Controversy, however, has surrounded these systems with respect to their effectiveness in controlling costs and their impacts on the quality of care for recipients. This study examined California physician attitudes towards the California Medicaid program's use of a closed formulary and treatment authorizations which must be obtained in order to dispense drugs not on the Medi-Cal pre-approved list. A survey of physicians focused on the extent to which they sought to use non-formulary medications, their experience with formulary products that were not their drugs of choice, and the extent to which the overall system impacted their practices. Results of the survey indicated that the closed formularly discouraged physicians from dispensing drugs of choice. Furthermore, physicians often experienced adverse or sub-therapeutic results with formulary medications that they would not have expected had they dispensed their preferred medications.

Attitude of Health Personnel↗

Providing incentives to control health care costs and remain competitive in the marketplace: a pilot study.

Few marketplaces in the United States have been subject to as much scrutiny, and undergone as much transformation in the 1990s, as has health care. Even based on the slowest growth rates experienced in the 1980s and 1990s, the United States is projected to be spending $3,140,221 per minute on health care by the year 2000. The purpose of this study was to examine how coordination between providers of medical care, and working with their customers (i.e., payors) might reduce costs without compromising quality. Providing incentives to these groups of businesses that form the health systems can be a means for achieving both individual health system objectives. Because of the importance of pharmacists in health care delivery systems, they were considered an excellent group for testing and measuring the impact of incentive programs. The study involved a before and after six month period involving dispensing patterns through a pharmacy benefit manager. Incentives were provided to pharmacies based on percent improvement in generic substitution rates and formulary compliance. A network of 342 independent pharmacies, with their dispensing patterns monitored through a pharmacy benefit manager under its contract program. The results of the study were that generic substitution rates rose from the pre-trial period of 68.5% to 73.7% in the first three months of the trial period, and to 75.6% in the second three months of the trial period. The overall increase in substitution was from 68.5% in the base period to 74.7% over six months. These differences were statistically significant at the 0.05 level. Estimated savings to health plans on an annualized basis would be approximately $3.4 million, and the payout per conversion to pharmacies was $3.23. While not measured directly, no adverse clinical effects were reported due to substitutions. Thus, an incentive system to reward those health care providers can effectively control expenses to achieve mutually desirable goals of all parties. If properly structured, the providers, health systems of which they are a part, and payors can benefit. Using an incentive program like the one designed for this study, health systems may be able to be more competitive in marketing their services to payors.

Cost Control↗

The use of drug formularies in managed care.

As a way of controlling the rising costs of health care, most managed care companies have implemented drug formularies. A drug formulary is generally defined as a listing of medications the health plan will cover for reimbursement. Some medications may need authorization from the health plan before they will be dispensed. This paper argues that drug formularies contain cost while causing no physical harm to the patient. The method of research used is descriptive. The paper will examine the issue from the side of the physician, the health plan and the patient. The research includes personal interviews, anecdotal records and reviews of available literature. The findings will show that patients still have access to a wide range of therapeutic medications and do not suffer physical harm as a result of a drug formulary.

Cost Control↗

The impact of 1990 Medicaid drug rebates policy on access to prescriptions.

The U.S. Congress passed a new law (PL 101-508) in 1990 requiring the pharmaceutical manufacturers to grant rebates on prescription drugs sold at retail under the federal Medicaid program. The goals include containing Medicaid program costs and expanding access of the indigent to ethical drug treatments. This paper evaluates the impact of HCFA's mandatory federal upper limit (FUL) prices on the retail sales volume of prescription drugs during 1994. Data of the most frequently dispensed drugs, as measured by the National Prescription Audit of IMS America, are used. Regression model results suggest that the competing drug prices impact sales significantly, and Medicaid drug rebates expand access to drug interventions by stimulating retail transactions. Prescription sales are also own-price insensitive (inelastic) in Medicaid and non-Medicaid market segments. The implications of extending Medicaid prescription drug rebates policy to enrollees in the traditional Medicare program are examined.

Drug Industry↗

Managed care and mental health: personal realities.

A review of the literature revealed mixed reviews on the impact of managed care on mental health service delivery. Research supports that managed care contributes to a reduction in inpatient costs and an increase in outpatient service use. Other studies suggest that there are problems with access and quality of care. An additional issue is whether or not, and to what extent, mental health services are "carved out" from physical health for patients. This study discusses the findings of a qualitative analysis of Medicaid managed care recipients on the barriers and enabling factors to obtaining mental health services in a full carve-out managed care model. Results indicate that reduced access, quality of care problems, and a lack of integration of care exist. Additionally, recipients' interactions with managed care, service providers, and caseworkers affect their mental health care. The results also report on the tactics used by recipients to cope with service problems. Implications for social work practice and research are discussed and recommendations for service delivery and evidence-based education are delineated.

Case Management↗

Naltrexone and pharmacy benefit management.

Naltrexone was approved by the FDA in 1994 for the treatment of alcohol dependence. Despite the potential to make treatment more effective and accessible, naltrexone use remains low by almost any measure. While many of the factors responsible for the slow pace of diffusion are unique to naltrexone and to the organization and delivery of alcohol treatment services, other factors are the same as those that affect the use of prescription medications more generally. Access to third-party coverage and formulary inclusion are necessary conditions for the adoption and diffusion of any new pharmaceutical technology. This paper describes current issues in drug benefit design and formulary coverage decisions, reviews publicly available information on naltrexone coverage by large health insurance programs and pharmaceutical benefit management companies, and examines whether drug benefit design constitutes a barrier to naltrexone use. Our review suggests that naltrexone is widely covered on public and private health plan formularies, though restrictions on use (i.e., quantity limits, prior authorization) are common.

Alcoholism↗

The AIDS drug assistance programs and coverage of HIV-related medications.

BACKGROUND: AIDS drug assistance programs (ADAPs) have been implemented in each state to facilitate access to medications for low-income, uninsured, and underinsured people with HIV disease. Policies for each ADAP differ, and these differences influence the access people with HIV have to medications. OBJECTIVE: To compare the coverage of medications and sources of program funding for the state ADAPs. DESIGN: A self-administered mailed survey, sent to administrators of the 50 state ADAPs and the District of Columbia ADAP in December 1998. RESULTS: Forty-nine of the 51 ADAPs (96%) responded to the survey. Title II of the Ryan White Comprehensive AIDS Resources Emergency Act provided a large majority of the funding for the ADAPs, with a number of states also using state funds and/or Title I funds for their programs. The formularies of all ADAPs were nearly identical with respect to coverage of antiretrovirals, but differed in the number and types of other medications included. Some states limited access to medications through waiting lists, enrollment caps, and other policies. Sixteen ADAPs reported that the coverage of protease inhibitors resulted in an appropriation of state government funds to their ADAP, while eight states reported an ADAP budget shortfall. In general, ADAPs in poorer and more rural states included a fewer number of medications on their formularies. CONCLUSIONS: Access to antiretrovirals and other medications is available through state ADAPs, but may be limited in some states due to waiting lists, controls on the enrollment of new beneficiaries, and policies on the number and types of medications beneficiaries may receive.

Acquired Immunodeficiency Syndrome↗

Prescribing indicators for evaluating drug use in nursing homes.

OBJECTIVE: To evaluate drug use in 2 Dutch nursing homes (254 residents) by developing and evaluating prescribing indicators based on pharmacy prescription data. METHODS: We evaluated the prescribing of benzodiazepines, nonsteroidal antiinflammatory drugs (NSAIDs), ulcer-healing drugs, and diuretics. Prescribing indicators were used to identify prescribing that was potentially not in line with recommendations in national and regional prescribing guidelines. We used both descriptive indicators, such as the number and percentage of users, and indicators reflecting potentially suboptimal prescribing, such as use of drugs outside the regional drug formulary, use of >1 drug from the same drug class, and prescription of drug dosages above recommended values. When potentially suboptimal prescribing was found, we verified the findings by means of an interview with 1 of the prescribers. RESULTS: The prescribing indicators we assessed were generally in agreement with national and regional guidelines. However, prescribing of NSAIDs without concomitant prescribing of gastroprotective drugs was found in a relatively high number of patients. After prescriber interview and patient chart review, it was found that some prescribing indicators, such as dosages above recommended values, were not always indicative for suboptimal prescribing. CONCLUSIONS: This pilot study showed that prescribing indicators based solely on pharmacy prescription data can be a useful tool to evaluate drug prescribing. With some of these prescribing indicators, we identified cases of potentially suboptimal prescribing. However, with other indicators such as those based on drug dosages, we could not identify suboptimal prescribing, and clinical information from the prescriber was necessary to get insight into the appropriateness of prescribing.

Aged↗

Fondaparinux for prevention of venous thromboembolism in major orthopedic surgery.

OBJECTIVE: To review clinical information related to fondaparinux, a synthetic pentasaccharide recently approved for the prevention of deep-vein thrombosis (DVT) in patients undergoing major orthopedic surgeries and for extended DVT prophylaxis after hip fracture surgery. DATA SOURCES: Primary and review articles were identified by MEDLINE (1983-June 2003) using the key words pentasaccharide, Org31540, SR90107A, DVT prophylaxis, and fondaparinux. Additional sources were found listed in articles, abstracts, and unpublished data on file from the manufacturer. Articles selected were based on their coverage of the pharmacology, pharmacokinetics, safety, and efficacy of fondaparinux. STUDY SELECTION AND DATA EXTRACTION: All of the articles identified were evaluated and all information deemed relevant was included. DATA SYNTHESIS: Fondaparinux is a selective antithrombin-dependent, indirect inhibitor of activated factor Xa. It has a favorable and predictable pharmacokinetic profile when administered subcutaneously, and has a long half-life, allowing once-daily dosing. Fondaparinux lacks in vitro cross-reactivity with heparin-induced antibodies. Major Phase III studies have demonstrated that subcutaneous fondaparinux sodium 2.5 mg given at least 6 hours postoperatively resulted in a 55% reduction in the risk of venous thromboembolism (VTE) in patients undergoing hip fracture surgery, total hip replacement surgery, or knee replacement surgery compared with standard enoxaparin therapy. It has a safety profile similar to that of enoxaparin with respect to clinically relevant major bleeding, including fatal bleeding, nonfatal bleeding, and bleeding requiring repeat surgery. The use of fondaparinux for prolonged prophylaxis after hip fracture has demonstrated further reduction in VTE events without increasing the risk of bleeding. CONCLUSIONS: Fondaparinux is the first of a new class of synthetic factor Xa inhibitors that demonstrated greater efficacy compared with enoxaparin for the prevention of VTE in major orthopedic surgery without an increase in clinically relevant bleeding. Given the favorable cost-effectiveness analysis and improved efficacy profile, fondaparinux should be considered for formulary addition for DVT prophylaxis in patients undergoing hip and knee replacement surgery. In patients undergoing hip fracture surgery, fondaparinux should be considered the DVT prophylaxis of choice. Extended thromboprophylaxis up to 28 days resulted in additional reduction in VTE (both symptomatic and venography-proven DVT) in patients with hip fracture surgery.

Adult↗

Voriconazole: a new triazole antifungal agent.

OBJECTIVE: To review the pharmacology, in vitro susceptibility, pharmacokinetics, clinical efficacy, and adverse effects of voriconazole, a triazole antifungal agent. DATA SOURCES: A MEDLINE search, restricted to English language, was conducted from 1990 to June 2002. Supplementary sources included program abstracts from the Interscience Conference on Antimicrobial Agents and Chemotherapy and the Infectious Diseases Society of America from 1996 to 2001 and manufacturer information available through the Food and Drug Administration's Web site. DATA EXTRACTION: All published and unpublished trials and abstracts citing voriconazole were selected. DATA SYNTHESIS: Voriconazole has shown in vitro activity against many yeasts and a variety of mold and dermatophyte isolates. Voriconazole can be administered either orally or parenterally. It exhibits good oral bioavailability, wide tissue distribution including distribution into the central nervous system, and hepatic metabolism. Drug interactions occur through inhibition of the CYP2C9, CYP2C19, and CYP3A4 isoenzymes, resulting in alterations in kinetic parameters of either voriconazole or the interacting agent. Efficacy has been illustrated in open, noncomparative studies of aspergillosis in immunocompromised patients. Human case reports describe successful treatment of rare fungal pathogens. The most commonly reported adverse events include visual disturbances and elevations in liver function tests. CONCLUSIONS: Voriconazole is at least as effective as amphotericin B in the treatment of acute invasive aspergillosis in immunocompromised patients. It has similar efficacy as fluconazole in treatment of esophageal candidiasis. Voriconazole did not achieve statistical non-inferiority to liposomal amphotericin B for empirical therapy in patients with neutropenia and persistent fever, diminishing enthusiasm for use in this indication until additional trials are completed. Based on case reports and in vitro efficacy, voriconazole may prove to be a clinically useful agent in the treatment of other fungal disease.

Antifungal Agents↗

Scope of international hospital pharmacy practice.

OBJECTIVE: To review the published English literature regarding international hospital pharmacy practice. DATA SOURCES: A computer search of all English-language articles in MEDLINE (1966-June 2004) and other Internet sources and International Pharmaceutical Abstracts (1971-June 2004). STUDY SELECTION AND DATA EXTRACTION: All studies that discussed hospital pharmacy or clinical hospital pharmacy activities outside of the US were considered for inclusion. DATA SYNTHESIS: The scope of international hospital pharmacy practice is quite varied, both inter- and intra-country, and varying degrees of specialization exist. Although clinical pharmacy is well developed in some countries, it is still in infancy stages in others. In addition, there is disparity in the actual definition of clinical pharmacy throughout the world. CONCLUSIONS: Since very few data have been published regarding hospital pharmacy practice on an international scale, we suggest a survey be conducted to objectively capture this information and increase awareness of clinical pharmacy in this setting.

Formularies as Topic↗

Do open formularies increase access to clinically useful drugs?

Before 1990 many state Medicaid programs maintained "restrictive" formularies, which denied reimbursement for unlisted prescription drugs. This type of formulary has been criticized for denying important medications to poor, medically needy persons. As part of the Omnibus Budget Reconciliation Act of 1990, restrictive formularies in Medicaid programs were disallowed. Based on research into the 200 top-selling prescription drugs in the United States, we conclude that eliminating Medicaid restrictive formularies improved access to a subset of the 200 best sellers, but that the majority of these products offered only questionable or no additional therapeutic benefit.

Drug Costs↗

The view from managed care pharmacy.

This stratified, national telephone survey of fifty-one managed care organizations concerns the perspectives of managed care pharmacy directors on pharmacoeconomics, disease management, and the roles of the pharmaceutical industry and the Food and Drug Administration (FDA). Respondents rated clinical effectiveness assessments as most useful, cost-effectiveness assessments second, and quality-of-life assessments as least useful. Peer-reviewed and industry literature were rated as equally important for decision making. Most plans would consider establishing a partnership with a drug company for disease management, if they have not already done so. Most plans (76 percent) support some form of FDA regulation of pharmacoeconomic claims. Conversely, 69 percent favor either no regulation (24 percent) or less stringent regulation (45 percent) than exists today.

Cost-Benefit Analysis↗