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USDA licensing policy for biologicals produced by R-DNA.

The advent of recombinant DNA technology has prompted a review of current Standard Requirements used in licensing Veterinary Biological Products. Unique problems associated with the production and testing of biologics derived from the new biotechnology are reviewed to insure compliance with the United States Department of Agriculture's requirement for purity, safety, potency and efficacy. Requirements for plasmid/vector characterization and stability will be discussed and correlated with the Master Seed concept. Practical methodology used to monitor antigenic expression, concentration, purification and stability during production and recovery is considered. Bulk and/or final container testing will meet established criteria for biologicals produced by conventional procedures. Experience in preparation and regulation of recombinant-derived biologicals may require revision of current Standard Requirements or special additional requirements. This flexible approach will facilitate licensing of these new products.

Animals↗

The newly licensed hepatitis B vaccine. Characteristics and indications for use.

The inactivated hepatitis B vaccine that was licensed in November 1981 will be distributed for general use later this year. Extensive studies have confirmed the safety, immunogenicity, and remarkable efficacy of this vaccine for the prevention of acute hepatitis B disease, asymptomatic infection, and the chronic hepatitis B carrier state. The vaccine is recommended for immunization of infants, children, and adults who are considered to be at increased risk of contracting hepatitis B infection. These population groups include medical, dental, laboratory, and other health care personnel, selected patients (eg, hemodialysis, thalassemia), clients and staff of institutions for the mentally disabled, homosexually active males, intimate contacts of carriers, users of illicit drugs, infants in high-risk areas, and other high-risk groups. The availability and appropriate use of the newly licensed hepatitis B vaccine should enable physicians to prevent a serious cause of acute and chronic liver disease.

Acute Disease↗

Addictions training for physicians and other licensed health care professionals in Maryland.

Physicians and other health care providers have multiple opportunities in the course of a typical practice year to identify and treat individuals who abuse alcohol and other drugs. Although substance abuse is very common in clinical practice, providers routinely fail to intervene in a timely fashion due to negative attitudes, incomplete knowledge, and poorly developed practice skills. Over the past ten years, addictions training of licensed health care providers nationally and in Maryland has improved significantly. This article describes recent national training trends and current educational programs statewide for medical students, physicians in residency and fellowship programs, and licensed providers in dentistry, nursing, pharmacy, psychology, and social work. Several strategies for improving professional training in addictions in the future are discussed and the importance of shifting to an interprofessional training model is emphasized.

Alcoholism↗

Determination of human immunodeficiency virus antibody status in forensic autopsy cases using a rapid and simple FDA-licensed assay.

Evaluation of an FDA-licensed rapid assay to detect antibodies to human immunodeficiency virus (HIV) was accomplished by testing 414 serum samples collected sequentially from autopsy cases at the Office of the Chief Medical Examiner, State of Maryland. The time of postmortem collection ranged from 8 to 30 hours. All samples were tested for the presence of antibodies to HIV using a rapid peptide microfiltration assay (SUDS HIV-1 test, Murex Corporation, Norcross, GA), and an enzyme-linked immunosorbent assay (ELISA). Samples yielding repeatedly reactive results were confirmed by Western blot. Of the 414 specimens, 23 (5.6%) produced reactive results by both SUDS and ELISA, and were confirmed by Western blot. One additional sample was repeatedly reactive by ELISA but negative by the SUDS test. This sample produced an indeterminate profile by Western blot (reactivity to only p24) and was negative by several additional retroviral assays. Of the 23 HIV infected cases, 16 had risk factors for HIV infection; 19 were blacks and 18 were male. The SUDS, 10 minute test, exhibited a 100% sensitivity and 100% specificity in comparison to FDA-licensed ELISA and Western blot assays for detecting HIV antibody in autopsy serum specimens. We conclude that this rapid, simply performed assay is accurate and applicable for use in several testing situations, including autopsy rooms.

Adolescent↗

Look who's driving now--visual standards for driver licensing in the United States.

The current visual standards for driver licensing of the general population in all 50 states and the District of Columbia are described. Minimum visual acuity standards range from 20/40 (73%) to vision less than 20/200 (Washington). The majority of states (92%) offer some type of restricted license which provide an opportunity for low vision drivers to keep their independence while at the same time affording society a high level of safety in the driving system. Tips for the ophthalmic nurse are provided.

Automobile Driving↗

The role of MCM/P1 proteins in the licensing of DNA replication.

The DNA replication licensing system ensures that eukaryotic chromosomes replicate precisely once per cell cycle. A central component of the licensing system, RLF-M, has recently been shown to consist of a complex of Mcm/P1 proteins. This result allows us to integrate data about the MCM/P1 family obtained in different eukaryotes, ranging from yeast to man, into a general picture of the way that chromosome replication is controlled.

Cell Cycle Proteins↗

[Driver's license, driving habits and traffic safety of patients with diabetes mellitus].

Motoring practices of diabetic drivers are similar to those of the average driving population. Due to the sudden onset of disabling hypoglycemia and the long-term complications of the disease, particularly retinopathy, one might assume that diabetic drivers are more prone to road traffic accidents than the average driver; however, the risk is not increased. The Council of the European Union recently laid down guidelines for dealing with this problem, which will lead to the introduction of a new law in Austria governing driving licensing. This legislation is currently under consideration. We recommend that discrimination between patients requiring therapeutic regimens with potential hypoglycemic side effects (insulin and/or sulphonylureas) and those who are not at risk of hypoglycemia (controlled by diet only or oral antidiabetic drugs other than sulphonylureas) should be legally defined by the licensing authorities. Furthermore, the legal enforcement of participation by diabetic drivers in a structured teaching programme, with the special aim of informing on traffic attitudes and avoidance of hypoglycemia while driving, might be of great importance for safety on the road.

Accidents, Traffic↗

Access to alcohol from licensed premises during adolescence: a longitudinal study.

Control of young people's access to alcohol via licensed premises has been shown to be an effective alcohol harm reduction strategy in the United States. In a longitudinal study of young New Zealanders their access to alcohol at the ages of 15 and 18 years was shown to be significantly predictive of the quantities of alcohol they consumed during a drinking occasion both then and in subsequent years. In turn the quantities of alcohol consumed were predictive of the respondents' experience of intoxication related adverse consequences. The impact of access via licensed premises on drinking and related problems was greater in this cohort of young people than the impact of peer or parental influences.

Adolescent↗

What the licensed practical/vocational nurse should know about pharmacological therapy for AIDS sufferers.

Illnesses can rob persons of their dignity and pride. Nowhere has this been more apparent than with people who suffer from Acquired Immunodeficiency Syndrome (AIDS). Because AIDS is a progressive and debilitating disease whose fatal outcome seems hopeless, it is often hard for the sufferer to maintain a sense of human worth. Add to that a prevailing public prejudice that keeps the individual at an arm's length from the support of the community, and a grim picture is given. However, unknown to lay persons and professionals alike, this bleak picture is no longer so grim. With the advent of drug combination therapy treatments (taking several commonly prescribed anti-HIV drugs at the same time), new hope has been given. The purpose of this paper is to describe for the licensed practical/vocational nurse the different and various drugs used for therapy and their effects on the AIDS population. Particular emphasis is placed on the modern combination therapy programs that are being utilized. Current knowledge of AIDS treatment can enable the licensed practical/vocational nurse to increase a client's feelings of hope, self worth, and dignity.

Acquired Immunodeficiency Syndrome↗

Protecting your dental license.

In this second installment in our series about licensing, we explore how actions taken by governmental agencies other than criminal courts or professional disciplinary agencies, can affect your dental license.

Drug and Narcotic Control↗

[Use of the Purdue Non-verbal Test in a group of candidates for a driving license].

The Purdue nonverbal test (PNT) was used to analyze intellectual abilities of 500 candidates for a driving license. The candidates were divided in five age groups of 100 subjects in each: 16-19, 20-24, 25-39, 40-54, and over 54. The distribution of result differs greatly from the normal distribution (P < 0.01) for all age groups of candidates. The distribution of the results of the candidates over 54 is positively asymmetric, while the distribution of the results of all other age groups is negatively asymmetric. These results suggest that the PNT is poor in discrimination. The percentage of candidates categorized according to the PNT as "capable for handling a motor vehicle" was higher than expected, while the percentage of candidates categorized as of "limited capability" was below expectations. According to these criteria, no candidate was found "incapable", which is in sharp nonconformity with the expected 5 per cent (5%). The above results indicate that the screening of candidates according to the criteria of intellectual ability is inadequate because of inadequate criteria, especially those which are supposed to determine borderline and lower intellectual ability. The results of the research show that admission of candidates whose intellectual ability borders or is below intellectual insufficiency parameters renders inadequate the prevention of risks in traffic. The risk in traffic is expected to increases with every single driving license issued to a person whose intellectual ability is inadequate for safe driving.

Adolescent↗

Functional ability profiles for driver licensing. Exemplification by visual profile.

The impaired driver is evaluated for driver licensing according to a functional ability profile. This test correlates, in increments, the physical or medical ability of the driver with the risk categories and the vehicles the driver is permitted to operate. The person is responsible for his fitness to drive. The physician may help in patient evaluation by participation in a medical advisory board or in public education. Guidelines for 11 areas of potential driving impairments were developed in the state of Utah. These principles are illustrated with visual standards.

Automobile Driver Examination↗

Retinal degeneration in licensed pesticide applicators.

BACKGROUND: Retinal degeneration is the leading cause of visual impairment in older adults, but little is known about its relationship to neurotoxic exposures. METHODS: The Agricultural Health Study is a cohort study of licensed pesticide applicators from Iowa and North Carolina. We used cross-sectional data from self-administered questionnaires given at enrollment in 1994-1996 to compare pesticide use in 154 applicators who reported retinal degeneration and 17,804 controls. RESULTS: Retinal degeneration was associated with fungicide use (odds ratio = 1.8, 95% confidence interval = 1.3-2.6). This relationship was seen in subgroups defined by state, demographic characteristics, or medical history, as well as in the entire group. Risk increased with cumulative days of fungicide use (P for trend = 0.011) and was greater when application methods involving greater personal exposure were used. Retinal degeneration was also related to use of organochlorine or carbamate insecticides, but these associations were less consistent. Since nearly all applicators used organophosphate insecticides and herbicides, these exposures could not be effectively evaluated. CONCLUSIONS: These results suggest that exposure to some fungicides and insecticides may increase risk of retinal degeneration.

Adolescent↗

Neuropsychological deficits in active licensed professional boxers.

Young, active, licensed professional boxers (N = 19) were found to display a pattern of neuropsychological deficits consistent with the more severe punch-drunk syndrome of years past. These deficits resulted in significantly lower test performance than that of control athletes (N = 10) matched for race, age, and level of education. Tests that showed significant differences between groups include subtests of the Quick Neurological Screening Test, subtests of the Halstead-Reitan Neuropsychological Test Battery, and the Randt Memory Test. Fifteen of the 19 boxers scored in the impaired range of the Reitan Impairment Index, as compared to 2 of the 10 controls.

Adolescent↗

Poetic license: using the Exner system of Rorschach analysis to understand client writings.

Is it possible to generalize client responses to Rorschach stimuli to their responses to other stimuli in the life space? If so, can we interpret their responses without a formal administration? This paper explores the application of Exner-based Rorschach techniques to client verbalizations and writings. This exploration is conducted by taking "poetic license" with the Exner system and analyzing three pieces of literature: poems by Basho, Ezra Pound, and Siv Cedering Fox. It appears that there is some face validity to the notion that psychological processes can be inferred by interpreting language according to some Exner concepts and techniques.

Creativity↗

Licensing exams in dentistry Israel 1996-2001.

AIMS AND OBJECTIVES: To describe the experiences with licensing exams in the years 1996-2001 for the Dentist Ordinance in Israel, an exam which it is required for each candidate to pass before being allowed to practice. SUBJECTS: The candidates in large numbers and with a wide variety of professional education applying to take the exam in dentistry in Israel. RESULTS: The exams are conducted in several languages and consist of two parts. 3,612 candidates were examined for Part I, out of which 1,598 passed (44%), while 3,298 candidates were examined for Part II, and 1,558 passed (47%). CONCLUSION: It is feasible and practical to conduct uniform exams for a multinational group of candidates from various dental educational backgrounds in several languages and in large numbers.

Cultural Diversity↗

Tobacco intervention practices of licensed psychologists.

Tobacco dependence is a serious public health concern. The U.S. Department of Health and Human Services has issued a practice guideline of best practices to encourage all health care providers to intervene with tobacco-dependent individuals they encounter. Psychologists may be ideally suited to implement brief tobacco interventions due to their expertise in behavior change strategies and interpersonal counseling skills. This study sought to investigate current tobacco assessment and intervention practices and perceptions of responsibility for tobacco intervention among a regional sample of licensed, practicing psychologists. Results suggest that a majority of psychologists fall far short of the ideal best practices recommended in the practice guideline, and many are unaware of the availability of the guidelines. Further, psychologists in this study perceived tobacco intervention to be a greater responsibility of physicians and other health care providers than of psychologists and other mental health professionals.

Adult↗

The 'Fishing License' method for analysing the time course of effects in repeated measurements.

Inference on the time of onset and the duration of a treatment effect is a challenging problem in biomedical research. These studies often generate repeated measurements from subjects in a treated group and a control group during the same time period. We propose a simple approach, called the 'Fishing License' method, to test for a treatment effect occurring during an unspecified time interval. The method is based on a statistic of the largest absolute value of the t statistic between two groups obtained by considering every possible time interval in the observed time period. A bootstrapped null distribution of the test statistic is used to determine the critical value. The method also provides estimates of onset and ending times, when the null hypothesis of no effect is rejected. Simulated and real experimental data sets were generated for assessing the performance of the method.

Air Pollutants↗