Guidelines for therapeutic interchange-2004.
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Cost-Benefit Analysis↗
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Application of pharmacoeconomics to formulary decision making in managed care organizations.
OBJECTIVE: To discuss the apparent value of incorporating pharmacoeconomic studies into pharmacy and therapeutic committee decision making; current internal and external barriers to the use of pharmacoeconomic studies; and possible solutions to the problems. STUDY DESIGN: Literature review. RESULTS: The formulary system assists healthcare providers in the evaluation, appraisal, and selection of drugs. Unfortunately, managed care organizations usually evaluate drugs exclusively on clinical efficacy, safety, and daily acquisition cost without considering overall cost effectiveness. Factors that have been impeding the use of pharmacoeconomic data include departmental budgetary constraints, tardy publications, limited reliability of available studies, and a lack of knowledge required to evaluate such studies. CONCLUSIONS: To remain competitive, managed care organizations need to incorporate pharmacoeconomic consideration into their formulary decision-making process. Performing an institutionwide economic evaluation; conducting pharmacoeconomic studies earlier, perhaps along with clinical trials; using decision analysis; developing standardized guidelines; and increasing education can help overcome current barriers.
Budgets↗
A comparison of Canadian general pediatric dosing publications.
A comparison of the general pediatric dosing guidelines published in Canada was conducted. Institutions that publish pediatric dosing guidelines as a separate publication or as part of the hospital formulary were mailed a survey of questions to describe their publication. Publications that met the inclusion criteria were evaluated using 12 assessment criteria: approval or submissions by medical specialty groups, drug inclusion, dosing guidelines, dosing in organ failure, pharmacokinetic/pharmacodynamic parameters, therapeutic guidelines, intravenous and oral administration guidelines, adverse drug reactions/drug interactions, referencing, drug acquisition costs, organization and readability. Four Canadian pediatric centres satisfied the criteria for publishing general pediatric dosing guidelines. These were reviewed by the process of formulary selection (in alphabetical order by city): Formulary of Drugs and Dosing Manual (Halifax), Formulary of Drugs (Toronto), Drug Dosage Guidelines and Formulary (Vancouver), and Pediatric Drug Dosage Handbook (Winnipeg). Dosing guidelines from published pediatric drug trials have been collated with institutional experience and historical practice to produce a practical source of pediatric dosing information.
Canada↗
Prescribing. Formulary won.
A primary care group and hospital trust produced a joint drug formulary in 10 months. All consultants and GPs were invited to take part in the exercise and a working group of 25 GPs, nine consultants and six pharmacists was established. The formulary includes local and national guidelines, usual adult doses of drugs and the cost of 28 days' primary care supply. An electronic version is in the pipeline.
Cooperative Behavior↗
The role of pharmacoeconomic guidelines for formulary approval: the Australian experience.
This paper provides a review and critique of the recently introduced Australian Guidelines for the Presentation of Submissions to the Pharmaceutical Benefits Advisory Committee (Guidelines), which require pharmaceutical companies seeking recommendation for national formulary listing and subsidization to provide a detailed economic analysis to support their case. As Australia is the first country to mandate such a requirement, it is important not only to consider the details of the Guideline's requirements for economic analysis and the expectations of the authors, but also to consider, from both theoretical and practical perspectives, whether the Guidelines are appropriate for drug evaluation purposes. Although the Guidelines have raised the level of awareness of the need to integrate economic analysis into the formulary approval process, their contribution as a model for other jurisdictions must be qualified by the prescriptive and unduly narrow view that is taken of allowable analytical techniques. By forcing drug evaluations into a straightjacket, the Guidelines run the risk of undermining the credibility and contribution of economic analysis to formulary decisions.
Australia↗
Assessment of U.S. helicopter emergency medical services' planning and preparedness for disaster response.
INTRODUCTION: Helicopter emergency medical services (HEMS) roles in disaster response vary significantly from routine operation, and as reported in the literature, such responses have not been without difficulty. We identified nine criteria (written policy, triage and incident command training disaster drill participation, ground and air communications plan, critical incident stress management, annual review, policy sharing) that may significantly affected an air medical program's disaster preparedness, response, and recovery. Of these criteria, a written policy is considered of primary importance. METHODS: A written survey was developed and mailed in July 1995 to 187 U.S. rotor-wing members of the Association of Air Medical Services. The survey was designed to identify the programs that had a written policy and fulfilled the guideline criteria, had a written policy and partially fulfilled the criteria, or did not have a written policy. RESULTS: Surveys were returned from 104 (56%) programs. Of the 103 qualifying respondents, 16 (16%) meet the criteria, 55 (53%) partially met the criteria, and 32 (31%) did not have written policies. CONCLUSION: Most U.S. HEMS programs have not fully addressed disaster preparedness, response, and recovery. HEMS disaster response guidelines should be established, and these criteria should be incorporated.
Air Ambulances↗
The 1999 ICSI/IHI colloquium on clinical quality improvement--"quality: settling the frontier".
BACKGROUND: A Colloquium on Clinical Quality Improvement, "Quality: Setting the Frontier," held in May 1999, covered methods and programs in clinical quality improvement. Leadership and organizational behavior were the main themes of the breakout sessions; specific topics included implementing guidelines, applying continuous quality improvement (CQI) methods in preventive services and primary care, and using systems thinking to improve clinical outcomes. Three keynote addresses were presented. LEADERSHIP FOR QUALITY: James L. Reinertsen, MD (CareGroup, Boston), characterized the financial challenges faced by many health care organizations as a "clarion call" for leadership on quality. "The leadership imperative is to establish an environment in which quality can thrive, despite unprecedented, severe economic pressures on our health systems." LINKING GROUP AND ORGANIZATIONAL KNOWLEDGE TO IMPROVEMENT STRATEGIES: How do we make improvement more effective? G. Ross Baker, PhD (University of Toronto), reviewed what organizational literature says about making teams more effective, understanding the organizational context to enable improvement work, and augmenting existing methods for creating sustainable improvement. For example, he noted the increasing interest among may organizations in rapid-cycle improvement but cautioned that such efforts may work best where problems can be addressed by existing clinical teams (not cross-functional work groups) and where there are available solutions that have worked in other settings. IMPROVING THE ENVIRONMENT FOR QUALITY: Mark Chassin, MD (Mount Sinai School of Medicine, New York), stated that critical tasks for improving quality include increasing public awareness, engaging clinicians in improvement, increasing the investment in producing measures and improvement tools, and reinventing health care delivery, clinical education and training, and QI.
Benchmarking↗
[Do guidelines bring an improvement in the perioperative course? A study of perioperative antibiotic prophylaxis].
INTRODUCTION: Although the effectiveness of perioperative antibiotic prophylaxis is proven, it is not used adequately. The aim of this study was to evaluate whether hospital-based guidelines are useful tools to improve the management of perioperative antimicrobial prophylaxis. MATERIAL: In a retrospective study the actual quality of perioperative antibiotic prophylaxis as given by the criteria choice of drugs, dosage, timing, continuation and 2nd dose after > 3 h was evaluated. After information and establishment of adequate guidelines we started a prospective analysis to test compliance and rate of adequate prophylaxis. Differences were calculated according to the chi 2-test with P < 0.05 significance niveau. RESULTS: The percentage of cases in which antibiotics were indicated but not administered was reduced from 15.5% to 8.4%. Compared to the result of the retrospective analysis, the prospective study showed a significantly higher percentage of adequately administered antibiotics (35.7% vs. 63.5%). This was mainly due to the compliance with dosage recommendations and to the 2nd dose in longer surgical procedures. DISCUSSION: Guidelines lead to a significant improvement in perioperative antibiotic prophylaxis. To increase this effect, further approaches such as integration of guidelines into computer-based systems should be evaluated.
Anti-Bacterial Agents↗
Student field performances: how valid are your preceptors' evaluations?
Developing relevant performance standards and rating criteria and preparing preceptors for the role of evaluator are critical to establishing valid student field performance evaluations and providing assurance to educational institutions that graduating students truly are competent and ready to assume an entry-level position. Using scripted, pre-scored video case studies in conjunction with written guidelines for rating the performance standards and providing specific feedback to explain rationale can significantly improve interrater agreement between preceptors.
Educational Measurement↗
Preventative use of antifungal drugs in patients treated for cancer.
Prophylactic use of antifungal compounds has more or less become standard clinical practice for patients who are treated for a haematological malignancy. However, apart from the prevention of infections by Candida species in bone marrow transplant recipients and a possible reduction in invasive aspergillosis in high-risk patients, there is little evidence to justify this approach. Antifungals ought to be administered to patients on their perceived individual risk and better studies should be conducted to provide a more rational basis for our clinical decisions. Results of studies in specific populations should not be used to create guidelines for other patient groups or general populations. Antifungals are potentially toxic and overuse might be associated with unnecessary direct and indirect drug-related costs.
Antifungal Agents↗
Development and implementation of guidelines for management of sedation and agitation in critically ill patients.
The article describes the development, implementation, and success of guidelines for pharmacological management of sedation and agitation in critically ill patients in a community hospital. Guidelines were developed with careful review of published literature and in cooperation with thought leaders in the institution. The primary focus of the guidelines was choice of medication and monitoring parameters and an educational campaign to ensure use of the guidelines. A prospective pharmacist intervention program was initiated for further enforcement of the guidelines. Implementation of these guidelines has resulted in a significant reduction in the cost of sedation and agitation (annual cost savings, > $40,000 per year).
Behavioral Symptoms↗
Assessing the impact of clinical guidelines: research lessons learned.
Clinical guidelines are proliferating. Here, a theoretical and practical perspective is presented on how to evaluate the effectiveness of guidelines and lessons learned from impact studies conducted. A nosology of guidelines is presented, along with the rationale for evaluating key dimensions, including degree of implementation, impact on process, outcomes, and cost of care, as well as provider and patient satisfaction. Key methodologic problems in evaluation and some possible ways to address them are addressed. Rapid and practical evaluation of clinical guidelines is a critical step that can both confirm their usefulness and direct their revision and improvement.
Acute Disease↗
Lipid management program: results of applying national guidelines in a private practice.
In our large single-specialty cardiology practice, we implemented a lipid management program based on the recommendations of the Expert Panel of the National Cholesterol Education Program and the Helsinki Heart Study. This program used allied health professionals and customized computer software to deliver efficient, comprehensive care to the 1214 patients enrolled in the program after 33 months. Data are reported for the 543 patients enrolled for more than 1 year. Cholesterol data were analyzed for all patients whose initial triglyceride values were less than 400 mg/dL. For this group of patients, the mean cholesterol level decreased from 242.7 to 217.4 mg/dL, triglycerides fell from 170.0 to 144.7 mg/dL, HDL cholesterol increased from 41.6 to 42.9 mg/dL, and LDL cholesterol fell from 167.2 to 145.7 mg/dL. Using guidelines modified from the National Cholesterol Education Program, a significant number of patients were able to achieve desirable LDL and HDL goals. Modified national guidelines can be used effectively in a private practice setting.
Cardiology↗
Ethical guidance in the era of managed care: an analysis of the American College of Healthcare Executives' Code of Ethics.
Market competition and the rise of managed care are transforming the healthcare system from a physician-dominated cottage industry into a manager-dominated corporate enterprise. The managed care revolution is also undermining the safe-guards offered by medical ethics and raising serious public concerns. These trends highlight the growing importance of ethical standards for managers. The most comprehensive ethical guidance for health service managers is contained in the American College of Healthcare Executives' (ACHE) Code of Ethics. An analysis of the ACHE Code suggests that it does not adequately address several ethical concerns associated with managed care. The ACHE may wish to develop a supplemental statement regarding ethical issues in managed care. A supplemental statement that provides more specific guidance in the areas of financial incentives to reduce utilization, social mission, consumer/patient information, and the health service manager's responsibility to patients could be extremely valuable in today's complex and rapidly changing environment. More specific ethical guidelines would not ensure individual or organizational compliance. However, they would provide professional standards that could guide decision making and help managers evaluate performance in managed care settings.
Data Collection↗
[Report on the experience of clinical trials performed according to GCP].
As well known GCP is described more accurately by Good Clinical Research Practice, Good Clinical Trial Practice and Good Clinical Regulatory Practice. The Authority (National Institute of Pharmacy) from 1st January 1994 required that clinical trials phase I-II-III had to be performed in accordance with the GCP guideline (appeared in 1992 in edition of NIP). We tried to present in what follows a brief account of our experience considering the performance of clinical trials in accordance with Good Clinical Practice requirements.
Clinical Trials as Topic↗
Showing outcomes and proving value brings success.
Today's pharmacoeconomics have shown how critical it is to find value in formulary drug products. For Regence BlueShield, Seattle, this means outcomes; making sure a drug truly works better than well-established alternatives, not just placebos. In 1998, Regence adopted formulary submission guidelines that have proven a solid success, and have been adopted by the Academy of Managed Care Pharmacy, Alexandria, Virginia, for evaluation nationwide.
Blue Cross Blue Shield Insurance Plans↗
[Planning sample size in ophthalmologic studies].
An essential aspect in the cooperation of clinic and biometry consists in designing of studies, e.g. during the preparation of grant applications or for review by official drug surveillance institutions. A central aspect in study planning is the design-adequate and well-documented prediction of sample size, which should be recommended for any intended study. Based on several examples for sample size planning in study designs, which are of common relevance for ophthalmology, guidelines are derived to enable clinical researchers to perform sample size planning on their own. The latter can be based on the various available software packages for sample size prediction.
Bias↗
Thermal biofeedback for primary Raynaud's phenomenon: a review of the literature.
The clinical presentation of primary Raynaud's phenomenon (RP) derives from various pathogenic triggers. The use of thermal biofeedback (TBF) may be of benefit in reducing the severity and frequency of attacks. This article summarizes the relevant research regarding the pathophysiology of primary RP and mechanism of TBF for RP. Systematic reviews of the efficacy of TBF for RP and treatment guidelines for clinicians are provided. The panel concludes that the level of evidence for TBF efficacy is categorized as Level IV: efficacious. The rationale, based on three randomized controlled trials conducted in independent laboratories, demonstrated "superiority or equivalence" of treatments that include TBF. However, randomly controlled trials (RCT) with positive clinical outcomes tended to be small. A large RCT with negative results did not effectively teach handwarming skills. Procedures for reviewing and rating of the levels of evidence of efficacy of studies was based on the Template for Developing Guidelines for the Evaluation of the Clinical Efficacy of Psychophysiological Interventions developed by the joint task force of the AAPB and the Society for Neuronal Regulation (SNR).
Biofeedback, Psychology↗