Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans. Final rule

The Food and Drug Administration (FDA) is amending its regulations governing safety reporting requirements for human drug and biological products subject to an investigational new drug application (IND). The final rule codifies the agency's expectations for timely review, evaluation, and submission of relevant and useful safety information and implements internationally harmonized definitions and reporting standards. The revisions will improve the utility of IND safety reports, reduce the number of reports that do not contribute in a meaningful way to the developing safety profile of the drug, expedite FDA's review of critical safety information, better protect human subjects enrolled in clinical trials, subject bioavailability and bioequivalence studies to safety reporting requirements, promote a consistent approach to safety reporting internationally, and enable the agency to better protect and promote public health.     

Consequences and dilemmas in therapeutic relationships with families resulting from mandatory reporting legislation

Mandatory reporting legislation has been adopted in every state to insure the protection of children from maltreatment. These statutes have become a significant factor in the lives of mental health professionals who work with children and families. Thirty psychotherapists who had made a recent report of child maltreatment on a client in treatment were interviewed about their experiences with reporting and the consequences of reporting for therapeutic relationships. Several potentially problematic consequences and dilemmas were identified by the therapists, including immediate and long-term effects on the therapeutic alliance and course of therapy, and conflicts of interest in working with children and families.     

Futile treatment: the need for legislation and uniform policies

As a matter of social policy, providers should place a top priority on educating colleagues and the public, including lawyers and the courts, so that there is genuine understanding that certain medical conditions, like anencephaly and brain death, cannot be ameliorated, changed, or improved through medical treatment even though the patient may continue to breathe with mechanical assistance for years. If health care professionals do not articulate and adhere to clear, universal standards of practice in this area, the courts will continue to define the duty of the medical profession, and, as Baby K illustrates, that is not acceptable.     

大陆与台湾诬告陷害罪之立法的比较研究

诬告陷害罪是一种古老的犯罪，在历史上，许多国家和地区都将之视为犯罪并予以处罚。我国大陆和台湾地区也十分注重惩治诬告陷害罪，都分别在其现行刑法与现行“刑法”中明文对之予以禁止。撇开两地间意识形态的差异不谈，单就其各自的刑法与“刑法”对诬告陷害罪之规定本身而言，…….     

Analysis of the stages of change model of drug and alcohol treatment readiness among prisoners

A classification and regression tree (CART) analysis was applied to data for 237 male participants (M = 31.93 years, SD = 7.64) in a prison-based substance abuse treatment program to study the integrity of the Stages of Change model of treatment readiness. Using the Stages of Change Questionnaire (STOCQ), participants were assigned to Contemplation (102), Action (118), or Maintenance (17) groups. A CART analysis then examined differences in the overall group profiles on the basis of scores on the Psychological Inventory of Criminal Thinking, the Situational Confidence Questionnaire, and the Carlson Psychological Survey. The assumption of discrete stages of change was not supported. Alternative models are suggested: one based on states of change and one on personality characteristics. A focus on equal attention to both cognitive and behavioral aspects of substance abuse treatment readiness is suggested.     

Procedures for transportation workplace drug and alcohol testing programs: state laws requiring drug and alcohol rule violation information. Interim final rule

The Office of the Secretary (OST) is amending its drug and alcohol testing procedures to authorize employers to disclose to State commercial driver licensing (CDL) authorities the drug and alcohol violations of employees who hold CDLs and operate commercial motor vehicles (CMVs), when a State law requires such reporting. This rule also permits third-party administrators (TPAs) to provide the same information to State CDL licensing authorities where State law requires the TPAs to do so for owner-operator CMV drivers with CDLs.     

Skeletal muscle as an alternative specimen for alcohol and drug analysis

In a random group of medical examiner cases, muscle tissue, as well as blood and vitreous humor, was analyzed for ethyl alcohol, and the results were compared. When the blood concentration was greater than 0.10 g/dL, the muscle to blood ratio was 1.00 or less (average 0.94), and when the blood concentration was less than 0.10 g/dL, this ratio was greater than 1.00 (average 1.48). The author proposes that this ratio is dependent upon the time course of absorption and distribution, as has been observed for vitreous humor, but with a more rapid equilibration. Muscle tissue was also analyzed in another group of cases found to be positive for one or more drugs in blood. The concentrations of the drugs in muscle varied from none detected to 6.5 times those in blood and seemed to be dependent on the time course between ingestion and death, as well as on the nature of the drug. For most common basic drugs, the ratios were often near unity. Muscle is proposed as a useful alternative specimen to postmortem blood.     

Interview mode effects on estimates of need for alcohol and drug treatment among welfare recipients: evidence from a quasi-experiment

Employing a quasi-experimental design, this study compared responses from face-to-face and telephone surveys of welfare recipients to assess the effects of survey modality on prevalence estimates of alcohol and drug abuse and need for treatment. Samples were drawn from adult welfare recipients in Oklahoma in 2001. We generated 1-year and 30-day prevalence estimates of alcohol and drug use, employed several common measures of substance-related behavioral and physical problems to estimate treatment need, and used odds ratios to compare prevalence estimates. Results indicated that telephone surveys provided estimates that were (1) statistically no different from those of face-to-face administration in the categories used to estimate treatment need and (2) significantly higher than those of face-to-face surveys for admission of ever having a substance problem and driving after consuming alcohol or drugs. We conclude that, for welfare recipients, telephone surveys provide similar data quality about treatment need as do more costly face-to-face interviews, a finding that is important and of practical concern to both practitioners and methodologists. More broadly, we argue that further survey methodology research is required for specific populations and subgroups that are often the focus of criminal justice and public health research and response.     

Application, review, and reporting process for Waivers for State Innovation. Final rule

This final rule sets forth a procedural framework for submission and review of initial applications for a Waiver for State Innovation described in section 1332 of the Patient Protection and the Affordable Care Act including processes to ensure opportunities for public input in the development of such applications by States and in the Federal review of the applications.     

Procedures for transportation workplace drug and alcohol testing programs. Final rule

The Department of Transportation is amending certain provisions of its drug and alcohol testing procedures to change instructions to collectors, laboratories, medical review officers, and employers regarding adulterated, substituted, diluted, and invalid urine specimen results. These changes are intended to create consistency with specimen validity requirements established by the U.S. Department of Health and Human Services and to clarify and integrate some measures taken in two of our own Interim Final Rules. This Final Rule makes specimen validity testing mandatory within the regulated transportation industries.