Setting standards for product selection: allergy prevention

It is axiomatic to state that if products made of natural rubber latex were not used in health care settings then there would be no problems of acquired hypersensitivity from such products. Although synthetic materials are available they do not currently possess the same technical qualities of elasticity and comfort, nor do they deliver the desired degree of protection against biological agents as gloves made out of natural rubber latex. Selection of gloves either for non-sterile procedures or sterile surgical use should be based on this understanding, and gloves with minimal levels of extractable latex proteins should be used.     

Typical variability in drug dissolution testing: study with USP and FDA calibrator tablets and a marketed drug (glibenclamide) product

To evaluate variability in drug dissolution testing 28 laboratories analyzed USP calibrators, US FDA prednisone tablets and a marketed glibenclamide tablet product. The experiments were conducted using paddle and basket methods at 50 (calibrators) and 75 (glibenclamide) rpm. The media employed were deaerated by equilibrating at 37 degrees C for 24 h and by the USP recommended method. The 95% CI values for percent drug release for the USP calibrator tablets were similar to the reported tolerances for the USP Acceptance Ranges; however, individual results from 15 of 28 laboratories suggest that the apparatus would not comply with the USP Apparatus Suitability Criteria. For FDA prednisone calibrator tablets, percent drug release using equilibrated medium was different (P=0.003) than by the USP recommended method. For the glibenclamide tablet results, a CV of 14-37% was observed, depending upon the sampling time and the type of apparatus employed. The results indicate that failure to meet the USP Dissolution Apparatus Suitability Test may not truly mean that the apparatus is 'out of compliance'. Due to the high variability in dissolution testing, in many cases the impact of formulation or manufacturing changes on drug release characteristics may not be observed, in particular with multi-point profiles.     

Drug research: from the idea to the product

The path of a new drug from the idea to product may be divided into 2 phases, namely drug discovery and drug development. In drug discovery a dramatic change is taking place. Due to a remarkable progress in understanding and explaining the underlying cause of many diseases by identifying and sequencing the genes encoded within DNA, it has become possible with new methods, like molecular biology or gene technology, to develop simple test assays by which a large number of compounds may be tested in regard to their biological efficacy. Automation of these test systems utilizing computer-controlled robotic systems has made it possible to evaluate up to 1 million substances per robot per year on their biological effect. While the classical medicinal chemistry cannot produce such a large number of new compounds, combinatorial chemistry may offer the opportunity to screen large numbers of novel compounds rapidly and to reduce the time taken to identify drug candidates substantially. Overall, it is estimated that combinatorial chemistry techniques have resulted in a reduction in the time taken to identify drug candidates of between 18-24 months. In drug development 2 partly overlapping phases can be differentiated, namely the preclinical and clinical phase. During the first part of drug development necessary requirements for first use in man are met by performing preclinical pharmacological, toxicological, and pharmacokinetic investigations in the animal and in in vitro testing. These investigations are playing a central part for the benefit/risk evaluation of new drugs. Only if the risks connected to the clinical study are medically justifiable in relation to the likely therapeutic benefit of the compound, the clinical trial may basically take place under consideration of the legal requirements of the country in which the study is carried out. In drug research clinical pharmacology is the connecting link between preclinical and clinical research. Clinical pharmacology produces the necessary basis for the clinical trial of a new substance in the patient with the target indication. After a first clinical-pharmacological profile of the new substance has been established during phase I on the basis of which a decision for the continuation of the clinical trial and the probable effective dose range and dosing interval is made, the aim of phase II-IV is now to answer the important questions of the therapeutic efficacy and tolerability in a large number of patients with the target indication. Only with a very careful drug investigation during phase I-IV it is really possible to register the therapeutic risk and benefit of a new drug and to control resulting serious problems. An analysis of registered drugs during the last years shows that despite enhanced efforts and dramatically rising development costs the innovation potential of the classical approach is steadily decreasing. Therefore, it is absolutely necessary to develop new innovative drugs with the help of new technologies like molecular and cell biology, gene technology, or immunology as well as combinatorial chemistry and robot supported substance screening.     

Therapy recommendations of the Drug Committee of the German Medical Association--an instrument for quality assurance in drug therapy. Drug Committee of the German Medical Association, Cologne

This article addresses the inadequacy of the standard genogram for African American families because of its underlying assumption that "family" is strictly a biological entity. The author suggests that this assumption is not culturally valid for African American families who have a long history of defining "family" as a kinship based on biological and functional ties. Using this conceptualization, an African American genogram is proposed.     

Drug preferences of multiple drug abusers.

Attempted to develop a reliable measure of preferences among types of controlled drugs, and examined the correspondence between the most preferred drug and the drug most frequently used. 130 17–29 yr old active multiple drug abusers rated their preferences among 11 combinations of controlled drugs and common methods of administration (e.g., smoking marihuana, snorting cocaine, shooting cocaine, injesting amphetamines, shooting amphetamines) using the method of paired comparisons. Edwards' coefficient of consistency indicated that preferences were highly consistent (.92) and therefore internally reliable. Nearly half of the Ss most preferred drugs other than the type that they most frequently used, and their preferences were related to the method of administration. Results suggest that preference is one of several determinants of drug use. (8 ref) (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

开展产品质量成本运行管理的探讨

阐述了质量成本管理的目的,分析了某公司质量成本运行管理的现状及存在的问题,探讨了质量成本管理工作中的一些具体措施,并提出了质量成本运行管理的几点初步的建议和设想。     

Applying laboratory research: Drug anticipation and the treatment of drug addiction.

Basic research concerning drug tolerance and withdrawal may inform clinical practice, and vice versa. Three areas that integrate the work of the laboratory and the clinic are discussed: (a) drug overdose, (b) cue exposure treatment of addiction, and (c) pharmacological treatment of withdrawal symptoms. The areas are related in that they indicate the contribution of drug-paired cues to the effects of addictive drugs and the role of Pavlovian conditioning of drug effects in drug tolerance and withdrawal symptoms. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Beyond the guidelines of ethical/legal standards: Update.

Ethical issues in practice are viewed as dynamic questions that evolve from changes occurring both outside and within the profession. New questions have arisen from (1) changes in public attitudes, (2) changes in economic circumstances, (3) increased diversity in styles and standards of professional practice, and (4) psychologist functioning in new settings such as the public media. Enforcement and proactive ethical action strategies are discussed in the contexts of clinical training facilities, placement or internship agencies, peer review committees, licensing boards, and ethics committees. The dilemmas of the individual practitioner in confrontation with other practitioners or in public advocacy roles are discussed. The need for openness to collegial consultation is stressed, and expanded roles for ethics committees are offered to fill this void. (French abstract) (24 ref) (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Psychology for the public: A content analysis of Psychology Today..

Surveyed the extent to which Psychology Today (PT) has maintained an empirical basis for its articles and the degree to which psychologists and individuals with doctorates have been responsible for PT articles. Two samples of PT were selected for review by 2 raters (the present authors). Findings indicate that not only have PT articles significantly shifted away from a presentation of empirically based data, but the proportion of articles authored by psychologists, as well as the educational level of authors, has declined, particularly in the last 3 yrs. (4 ref) (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

A collaborative approach to standards, practices. Setting the stage for continuous quality improvement

In retrospect, the most important thing we did was work together. We analyzed, refined, and validated our philosophical approach to patient care. We provided an information data base that is readily available for on-the-job reference and serves as a starting point for CQI activities. The very act of joint documentation of practices encourages open discussions about improvements to patient care. One physician states, We know that flaws in the process through which we produce care are everywhere--waste, duplication of effort, unnecessary complexity, and unpredictability . . . I believe that modern total quality management offers enormous hope to a medical care field that is rather desperate. . . . Collaborative practice and CQI activities are one hope. The scope of what nurses and physicians traditionally consider when discussing standards and practices must widen. We should no longer look only at patient care. We must simultaneously focus on how the management of total systems influences quality care for all patients. The CQI process, a proactive method, requires an accurate data base of information that is easily retrieved when looking for systems and individual patient care improvements. Our Computerized Collaborative Standards and Practices Manual is the reservoir for documenting practice plans developed and approved by all the disciplines involved. The process described here began with two closely knit operating room disciplines; this framework, however, offers the potential for expansion into a hospital-wide system of information organization and use.     

Evaluation of drug treatment of myocardial infarction in public hospitals of Andalusia. GAUME (Andalusian Group for performance of Studies on Drug Utilization)

BACKGROUND: The management of patients with acute myocardial infarction (AMI) has changed over the last decade. The aim of this study was to evaluate the pharmacologic treatment of AMI in the clinical practice, with special emphasis in thrombolytic therapy. MATERIAL AND METHODS: Prospective drug utilization survey, collecting data from 26 hospitals belonging to the Andalusian Health Service, Spain, during one month period. Pharmacologic treatment in the first 24 h was obtained. RESULTS: Out of 379 patients recruited, 52.8% received thrombolytic therapy, although another 19% could have obtained some benefit from that therapy. Alteplase was the most frequently used thrombolytic (65.5%). The regimen prescribed was mainly that followed in GUSTO Study (45.8%) or double bolus (43.5%). In a high percentage of patients the thrombolytic selection was not made according to the results of the literature. Women and patients older than 75 years were less likely to receive thrombolytic therapy. There was a high utilization of aspirin (89.7%), nitrates (84.4%) and heparin (83.6%). CONCLUSIONS: Thrombolytic therapy was prescribed in a higher percentage of patients than is reported in other trials. In spite of that, thrombolytics should have been used in more patients. As alteplase does not have a definitive benefit over streptokinase, protocol is needed when selecting a thrombolytic agent.     

Effects of human models on perceived product quality.

Studied the effects of human models in advertisements on the individual's perception of and attitude toward the product. 32 male and 32 female undergraduates were tested under 3 experimental and 1 control conditions for each of 4 different products (car, sofa, TV, and stereo). In the 3 experimental conditions a male, a female, and a male-female pair were used as models. In the control condition the product was presented without any model. Results reveal that the "fittingness" of the models for the product was an important variable in product advertisements. The implications of congruity theories for product advertisements are discussed. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Effect of price information on product quality ratings.

Obtained taste quality ratings on 3 food products discriminable in a blind-taste test condition and varying widely in price from 46 female undergraduates. Each of the 3 products was identified twice as a low-, twice as a medium-, and twice as a high-price product. Confirming 2 hypotheses, taste quality ratings were positively related to price information given and to actual product differences. Contrary to the 3rd hypothesis, actual product differences accounted for approximately 3 times as much variance as price information given. Several differences between the laboratory setting and actual consumer behavior may have led to an underestimation of the effects of price cues on consumer quality judgments. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Gender- and race-based standards of competence: Lower minimum standards but higher ability standards for devalued groups.

Stereotypes may influence judgment via assimilation, such that individual group members are evaluated consistently with stereotypes, or via contrast, such that targets are displaced from the overall group expectation. Two models of judgment—the shifting standards model and status characteristics theory—provide some insight into predicting and interpreting these apparently contradictory effects. In 2 studies involving a simulated applicant-evaluation setting, we predicted and found that participants set lower minimum-competency standards, but higher ability standards, for female than for male and for Black than for White applicants. Thus, although it may be easier for low- than high-status group members to meet (low) standards, these same people must work harder to prove that their performance is ability based. (PsycINFO Database Record (c) 2011 APA, all rights reserved)     

Ethical standards: Cosmetics for the face of the profession of psychology.

While psychology has a viable set of ethical standards, there is evidence that psychologists are performing less creditably in applying these standards. Notwithstanding the difficulties encountered by ethics committees, substantial segments of the professional community knowingly engage in cosmetic practices in dealing with ethics violations, emulating society at large, which has wavered in its own demands for strict accountability. The profession's response to unethical behavior is seen as reactive rather than proactive. Psychologists also are influenced by "hidden persuaders" in their decision-making processes and delude themselves with their own rhetoric. Four areas in which cover-up is practiced are highlighted: (a) selection and training of graduate students, (b) faculty selection and retention, (c) licensing and credentialing of professionals, and (d) consumer welfare and protection. Each area contains illustrative case material. The failure of self-regulation is seen as a threat to the profession's autonomy and as a signal to the consumer and external judicial and legislative bodies to enact sunset laws and impose restrictive regulations. (6 ref) (PsycINFO Database Record (c) 2010 APA, all rights reserved)