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Interest in the development of the specialty of emergency medicine and of emergency health care systems has greatly increased worldwide in the last few years. The guidelines in this article were developed in an effort to assist others in design and evaluation of all types of emergency medicine projects.
To improve the cost-effectiveness of psychotropic medications, a process was established to involve all stakeholders in a seven-county public-sector behavioral health managed care plan in the development of formulary guidelines. After delineation of the issues and of possible strategies, proposed formulary guidelines were drafted and presented to the stakeholders in a series of meetings. The stakeholders were also educated about pharmacy cost management issues and possible strategies. The guidelines were modified on the basis of the feedback obtained from stakeholders, and the consensus formulary guidelines were adopted. Within ten weeks of implementation of the guidelines, monthly medication costs had declined by 3 percent from baseline, although the number of medication users increased by 3 percent over the same period. There were few complaints about the guidelines. Effective, consensus-driven, medication cost-containment strategies can be implemented through a process of engagement and education of stakeholders in a community mental health plan.
In the last 20 years, expenditures on pharmaceuticals - as well as total health expenditures - have grown faster than the gross national product in all European countries. The aim of this paper was to review policies that European governments apply to reduce or at least slow down public expenditure on pharmaceutical products. Such policies can target the industry, the wholesalers and retailers, prescribers, and patients. The objectives of pharmaceutical policies are multidimensional and must take into account issues relating to public health, public expenditure and industrial incentives. Both price levels and consumption patterns determine the level of total drug expenditure in a particular country, and both factors vary greatly across countries. Licensing and pricing policies intend to influence the supply side. Three types of pricing policies can be recognised: product price control, reference pricing and profit control. Profit control is mainly used in the UK. Reference pricing systems were first used in Germany and The Netherlands and are being considered in other countries. Product price control is still the most common method for establishing the price of drugs. For the aim of fiscal consolidation, price-freeze and price-cut measures have been frequently used in the 1980s and 1990s. They have affected all types of schemes. For drug wholesalers and retailers, most governments have defined profit margins. The differences in price levels as well as the introduction of a Single European Pharmaceutical Market has led to the phenomenon of parallel imports among member countries of the European Union. This may be facilitated by larger and more powerful wholesalers and the vertical integration between wholesalers and retailers. To control costs, the use of generic drugs is encouraged in most countries, but only few countries allow pharmacists to substitute generic drugs for proprietary brands. Various interventions are used to reduce the patients' demand for drugs by either denying or limiting reimbursement of products and providing an incentive for patients to reduce their consumption of drugs. These interventions include defining a list either of drugs reimbursed (positive list) or one of drugs not reimbursed (negative list), and patient co-payments, which require patients to pay a proportion of the cost of a prescribed product or a fixed charge. Policies intended to affect physicians' prescribing behaviour include guidelines, information (about price and less expensive alternatives) and feedback, and the use of budgetary restrictions.
BACKGROUND: It is mandatory for drug manufacturers requesting formulary inclusion under the British Columbia (BC) provincial drug plan to submit a pharmacoeconomic analysis according to published guidelines. These submissions are reviewed by the Pharmacoeconomic Initiative (PI) of BC. OBJECTIVE: To assess the compliance of submitted studies with specific criteria outlined in the guidelines, to assess the methodological quality of individual submissions, and to demonstrate the importance of submitting guidelines-compliant pharmacoeconomic analyses. DATA AND METHODS: All submissions between January 1996 and April 1999 assessed by the PI of BC were included. Submissions were reviewed according to a checklist to establish compliance with respect to choice of comparator drug, study perspective, sensitivity analysis, analytical horizon and discounting. Submissions were examined for association between analytical technique and author, and between source of submission and compliance. Association between compliance and recommendation for approval was also examined. RESULTS: 95 applications were reviewed. Seven submitted no analyses. There were 25 cost-comparison/consequence, 14 cost-effectiveness, 11 cost-minimisation, 9 cost-utility/benefit and 29 budget-impact analyses. 65 of these 88 submissions failed to comply with guidelines. Of these, 45% used an inappropriate comparator drug, 61% lacked a sensitivity analysis, 73% used a third-party payer and excluded a societal perspective, 66% did not provide a long term evaluation and 25% did not specify any time horizon. 80% of noncompliant studies were cost-comparison/consequence or budget-impact analyses (p < 0.001, Fisher's Exact). Of 25 cost-comparison/consequence and 29 budget-impact analyses, 19 (76%) and 24 (83%), respectively, were industry-conducted, whereas cost-effectiveness (11 of 14) and cost-utility/benefit (6 of 9) analyses were mostly subcontracted to private consultants or academics (p < 0.001, Fisher's Exact). 74% of all submissions (compliant and noncompliant) were not recommended by the PI for listing as a provincial drug plan benefit, 16% received approval for restricted benefit and 9% were recommended as full benefit. 80% of the noncompliant submissions were not recommended (p = 0.06, Fisher's Exact test). Moreover, a strong association between type of analysis and type of recommendation was found (p = 0.03, Fisher's Exact test). Cost-comparison/consequence and budget-impact analyses were less likely to be recommended. IMPLICATIONS OF FINDINGS: Our findings show poor compliance with guidelines, especially among industry-conducted studies. Possible explanations are lack of expertise in pharmacoeconomics and/or scepticism regarding the importance of guidelines and submission quality in decision making. As corroborated by the strong associations between type of recommendation and compliance, and between type of recommendation and type of analysis, these 2 characteristics have a significant impact on decision making.
BACKGROUND: The prevalence of malnutrition in children with cancer ranges between 8% and 60%. Malnutrition is strongly associated with the nature of treatment and increases an individual's risk of infection. Clinical studies have suggested that nutrition intervention may decrease toxicity and improve survival in the oncology population. In order to identify the standards of practice in the nutritional management of a child with cancer, we conducted an international survey in institutions that are part of the Children's Oncology Group (COG) consortium. PROCEDURE: Surveys were submitted to 233 participating COG institutions. We requested one member in three disciplines complete the survey: physician, registered dietitian, and nurse or nurse practitioner. The survey was returned to the nutrition sub-committee of COG. RESULTS: Fifty-four percent of institutions responded to the survey. We found no consistency in the provision of nutrition services. Assessment of nutritional status does not routinely occur and different indices are employed to indicate the nutrition status of a patient. Institutions rely upon different guidelines when categorizing malnutrition. When nutrition intervention is clinically indicated, a variety of approaches are employed. CONCLUSIONS: This survey did not find standardized nutrition protocols being employed in the pediatric oncology population. The effect of varied nutrition practices on the quality of life, toxicity, and outcome in children with cancer is unknown. Prior to the initiation of clinical trials, uniform guidelines need to be developed and validated. Future clinical trials need to investigate the most efficacious method of nutrition assessment and intervention and its effect on quality of life, toxicity, and survival in children with cancer.
ALS is a motor neuron disease defined as a progressive, neurological disorder, resulting from variable and combined degeneration of upper and lower motor neurons. The heterogeneity of clinical involvement early in the course of the disease makes it difficult to diagnose, as well as to identify one unique outcome measure to quantify neurological changes in the course of the disease. Since clinical evidence of upper and lower motor neuron degeneration must exist in four anatomical regions (bulbar, cervical, thoracic, and lumbosacral), outcome measures should assess these regions. The WFN Airline House recommendations specify the purpose, properties, and the preferred parameters which serve as outcome measures in ALS clinical trials. The purpose of this document is to serve as a review of these outcome measures in terms of their advantages, disadvantages, sensitivity, reliability, and other characteristics, as well as their proper performance in ALS clinical trials. Generally these outcome measures are allocated to four areas: respiratory function, muscle strength, general function, and bulbar function. Our review leads us to believe that respiratory function and strength provide the most useful information, both for research and clinical purposes, and are essential as outcome measures. Inclusion of bulbar and general function parameters in trial design may increase the possibility of identifying a beneficial effect of therapeutic intervention. It is essential to note that the guidelines and recommendations put forth are intended to provide initial evaluation and critique of the proper employment and performance of these outcome measures in ALS clinical trials, based on the available literature and our experience.
The intention of this proposal is to describe principles for Good Evaluation Practice (GEP) of toxicological and risk evaluations with the aim to improve the quality, reliability, and transparency of any evaluation in toxicology. The GEP has been outlined in the same way as the principles for Good Laboratory Practice (GLP) to facilitate its introduction and compliance. The main characteristic of GEP is transparency. The GEP procedure should include the following elements: (1) definition of terms; (2) description of evaluation organization; (3) description of the quality assurance of the programme; (4) description of the standard evaluation procedures; (5) performance of the evaluation; (6) reporting of the evaluation; (7) storage and retention of records and material; and (8) guidelines for the evaluation procedure. The authors' intent is to raise awareness, stimulate a debate about the proposal, expect and welcome feedback in order to refine it, and make it into an important tool for all toxicological evaluations in the future.
Pharmaceutical expenditures have been increasing over the last few decades, both in the private sector and the Department of Defense (DoD). The Pharmacoeconomic Center (PEC), staffed with personnel from the Army, Navy, and Air Force, was established in 1993 to develop the means to control these pharmaceutical expenditures and to develop the DoD TriService Formulary (TSF). The TSF serves as the basis for a consistent and equitable pharmacy benefit for DoD patients. The initial TSF contains medications that are well accepted as standard therapy and are currently available at most military facilities. Revisions to the initial TSF are based on pharmacoeconomic analyses of ambulatory disease states accounting for the majority of pharmaceutical expenditures. The PEC also develops treatment guidelines, preferred drug lists, and drug use evaluation criteria based on the results of each disease state analysis.
There is strong evidence for the existence of the Werther effect, or the phenomenon of an observer copying suicidal behavior he or she has seen modelled in the media. As a consequence, a number of countries have developed guidelines that promote responsible reporting of suicide. Using nine such guidelines as examples, this paper demonstrates that they tend to have similar content (emphasizing, for example, that suicide should not be glamorized or sensationalized and that explicit descriptions should be avoided, and stressing the importance of providing information about help services), but differ in the way in which they have been developed (e.g., the extent to which media professionals have been involved) and implemented (e.g., whether their "roll-out" has involved a considered dissemination strategy). The paper also reviews the evidence from evaluations of media guidelines, and concludes that it is too limited to determine whether the guidelines have had an impact on the behavior of media professionals or on completed and attempted suicide rates. It makes recommendations for further evaluative work, and suggests that the lessons from well-designed evaluations should be shared.
OBJECTIVE: We studied compliance with guidelines and prescriptions for six steps of the health care process to identify the step with the greatest need for improvement. DESIGN: In a cross-sectional study we used hidden observation in health centres and counting of remaining drugs in home visits. We assessed provider compliance with guidelines for medical history, physical examination, drug choice, and explanation of drug dosing, and patient compliance for drug buying and drug taking. SETTING: The study took place in six rural health centres in Burkina Faso. MAIN OUTCOME MEASURES: We measured unconditional (UPC), conditional (CPC) and accumulated proportions of compliant procedures (APC). UPC determined the proportion of compliant procedures independent from earlier steps. CPC was defined as the proportion of compliant procedures among those which were compliant in all previous steps. APC was the proportion of procedures compliant in all steps including the step concerned. RESULTS: Twenty-three per cent UPC medical history, 27% UPC (CPC = 39%) clinical examination, 59% (83%) drug choice, 22% (40%) explanation of dosing, 71% (75%) drug buying, and 63% (67%) drug taking compliance. Two per cent of the patients had compliant procedures for all steps of the process (APC). CONCLUSION: The majority of patients did not get treatment compliant with guidelines. Diagnosis had the largest need for improvement. UPC, CPC and APC were useful to identify steps with the greatest need for improvement and to assess quantitatively aspects of quality of care.
General guidelines have been developed to make a comprehensive assessment of the conditions of education and teaching and to predict probable changes in preschool- and schoolchildren's health. The guidelines envisage the use of standard procedures and programmes for the assessment and optimization of educational and teaching conditions for children and adolescents in educational establishments of different types.
The FDA's interest in data monitoring of clinical trials derives from its public health responsibility to assure the safety and efficacy of new drugs based on evidence from adequate and well-controlled studies. Therefore the FDA is concerned that clinical trials of new drugs are designed and carried out in a manner that will insure the integrity and validity of study inferences. The FDA regulation and guidelines recognize the role of data monitoring and the variety and diversity of situations utilizing a data monitoring process in clinical studies. This paper describes relevant aspects of the regulations and guidelines, some concerns the FDA has with regard to monitoring of both government- and industry-sponsored trials and the consequences of early termination of trials of new drugs in the investigational and marketed stages. Comments include advice on communication between the FDA and data monitoring committees.
The authors reviewed various statements describing the ethical use of placebo-controls in clinical trials involving minors. Attention was focused upon the Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations, published by the American Academy of Pediatrics (AAP) (Kaufman et al. 1995). A brief review of certain key documents and a possible expansion of the guidelines are presented. Specifically, it is recommended that a review and update of guidelines for the use of placebo-controlled trials in children be undertaken by a working group comprised of stakeholders, including academic clinical and research professionals, bioethicists, consumers, members of key government agencies, and the pharmaceutical industry.
Formulary management implications are described for a California health system comprising 7 hospitals, 4 skilled-nursing centers, 22 medical clinics, 8 urgent care facilities, and a health maintenance organization. Sharp HealthCare serves nearly one million people in the San Diego area. A single institutional care division (ICD) pharmacy service has been created under the guidance of a steering committee comprising a pharmacy operations coordinator and a staff pharmacist from each site, the system pharmacy director, the system senior pharmacy information systems specialist, and the system senior clinical pharmacy specialist. Operations at each site are overseen by an operations coordinator instead of a pharmacy director. Functional teams reporting to the steering committee are standardized pharmacy processes, including formulary management; this is particularly important because the ICD has pharmacists and nurse per diem pools. Until 1995, formularies were independently managed at each site. Now, one system formulary is being developed. Standard policies and procedures, a nonformulary drug request form, and a monograph format have been completed. The hospitals' autonomous medical staffs have thus far elected to retain individual pharmacy and therapeutics (P&T) committees but approved a revamped formulary review process and system-wide P&T subcommittees. The computer system is being enhanced so that pharmacists will have access to applicable P&T committee-approved guidelines for drug use. Since vendors were advised that the system is establishing one formulary, Sharp has been able in some cases to achieve better pricing than it previously could through its purchasing group.
OBJECTIVE: The effectiveness of interventions which have been proposed or are currently in progress to reduce socioeconomic inequalities in health is largely unknown. This paper aims to develop guidelines for evaluating these interventions. APPROACH: Starting from a set of general guidelines which was recently proposed by a group of experts reporting to the national Programme Committee on Socioeconomic Inequalities in Health in The Netherlands, an analysis was made of the appropriateness of different study designs which could be used to assess the effectiveness of interventions to reduce inequalities in health. RESULTS: A "full" study design requires the measurement, in one or more experimental populations and one or more control populations, of changes over time in the magnitude of socioeconomic inequalities in health. This will usually imply a community intervention trial. Five alternative study designs are distinguished which require less complex measurements but also require more assumptions to be made. Several examples are given. CONCLUSIONS: Building up a systematic knowledge base on the effectiveness of interventions to reduce socioeconomic inequalities in health will be a major enterprise. Elements of a strategy to increase learning speed are discussed. Although the guidelines and design recommendations developed in this paper apply to the evaluation of specific interventions where rigorous evaluation methods can often be used, they may also be useful for the interpretation of the results of less rigorous evaluation studies, for example of broader policies to reduce socioeconomic inequalities in health.
Under the auspices of the Howard Hughes Medical Institute, a set of consensus guidelines for Radiation Protection Practices has been developed for biomedical research using radioactive materials. The purposes of the guidelines are (1) to promote good radiation protection practices consistent with the needs of biomedical research, the ALARA principle, and regulatory requirements; (2) to establish common goals and consistent practices within radiation safety programs; and (3) to build a meaningful partnership between radiation safety professionals and the biomedical research community. These practices are intended to enhance radiation protection and the efficiency of the research staff. The consensus guidelines will lessen the variability in radiation safety practices that is evident among many academic research institutions and will encourage better acceptance and regulatory compliance by users of radioactive materials in biomedical research.
Although hemovigilance is not a word used commonly in the United States, the concept of monitoring morbidity associated with blood transfusion is accepted widely. Currently, quality management focuses on error avoidance rather than error detection in both the "manufacturing" and "clinical" aspects of blood banking. "Manufacturing" is regulated predominantly by current Good Manufacturing Practices while clinical transfusion medicine follows clinical practice guidelines. There are multiple overlapping mechanisms for quality assurance and error reporting among governmental, professional, and non-profit regulatory agencies. The strategies of each stress the on-going need for a systems approaches to preventing errors.
NDA filing and government approval for drug manufacturing marketing rights are processes based on collaboration among the concerned parties; a drug manufacturer (or importer), a medical institution and a government agency. However, quality guidelines are necessary for a scientific, ethical and economically efficient clinical study to be conducted. It is more than 3 years since the Ministry of Health and Welfare of Japan introduced "The Guidelines on Clinical Evaluation for Anti-tumor Drugs" in February, 1991. However, some practical problems have been pointed out by clinicians for revision. Among them we discuss the following items for revision of the Guidelines and made suggestions and opinions from the manufacturers' point of view: Phase I: Number of institutions for clinical study, determination of MTD and study design. Phase II: Introduction of foreign data, late phase II study for plural numbers of indications at time of NDA filing and evidence of usefulness in concurrent therapy.