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PubMed1995

The use of plants for environmental monitoring and assessment.

This paper presents a critical review on phytotoxicity tests for environmental monitoring and assessment. Vascular macrophytes used in the laboratory testing are emphasized; algae are mentioned only for comparison. Several issues are discussed, including the rationale for and misconceptions about phytotoxicity tests, relation to regulation, status of phytotoxicity test protocols, advantages and disadvantages of phytotoxicity tests, and possible research directions. Aquatic and terrestrial macrophytes, along with algae, are essential components of ecosystems. Macrophytes are becoming more important for the monitoring and assessment of herbicides, effluents, and industrial chemicals. In the United States, Canada, and international organizations, phytotoxicity tests can be required for environmental monitoring and assessment in statutes such as Federal Insecticide, Fungicide, and Rodenticide Act; Toxic Substances Control Act; Water Quality Act; Canadian Pest Control Products Act; and Canadian Environmental Protection Act. Possible research directions for phytotoxicity tests are discussed relative to the role in regulations of industrial chemicals, effluents, hazardous waste sites, and pesticides.

Environmental Monitoring↗
PubMed1989

Physician dispensing: issues of law, legislation and social policy.

Despite the fact that physicians have dispensed prescription drugs for profit for several years, the practice is currently under intense challenge and controversy. This recent flare-up can be explained by several factors including the involvement of the Federal Trade Commission (FTC), increased competition among physicians, alternative delivery systems and drug repackagers. Federal laws including the Food Drug and Cosmetic Act and Controlled Substances Act regulate dispensing practices, but have been interpreted to regulate dispensing by pharmacists, not physicians. All states have laws applicable to the dispensing of prescription drugs by physicians, but the wording of these laws raises unclear legal issues. Both uncertainty about these legal issues and pharmacists' concern over the increase in physician dispensing has promoted state legislative efforts to restrict or regulate the practice. These legislative efforts and the corresponding regulatory actions by state boards have triggered FTC involvement. From a social policy perspective physician dispensing raises significant concerns of ethics, conflicts of interest, patient welfare and economics. Based upon social policy, physician dispensing for profit is not a practice which should be condoned or allowed to flourish.

Drug Industry↗
PubMedDate not supplied

THC therapeutic research by independent and state-sponsored investigators: a historical review.

A brief history of the control and use of cannabis in the United States is presented. Essential to the discussion are the federal law: the Marihuana Tax Stamp Act of 1937; the Controlled Substances Act of 1970; and the Federal Food, Drug and Cosmetic Act of 1962. On mandate of Congress in 1968, initial studies were directed to determine effects of long-term use in man. The annual reporting of the status of "Marihuana and Health" was established. In the early 1970s, the scope of research was broadened to include evaluation of THC for use in certain medical conditions. Interest in therapeutic research may have been influenced by anecdotal reports of benefit for nausea and vomiting of cancer chemotherapy and for elevated intraocular pressure of glaucoma, by the lobbying for laws to legalize marihuana by special interest groups, and by the passage of state "Controlled Substances Therapeutic Research" acts (CSTRA). A listing of approved INDs in four therapeutic categories, a chart comparing the components of laws passed by 25 states, and a bibliography of suggested reading for further contact with the subject matter are included.

Cannabinoids↗
PubMedDate not supplied

Role of exposure databases in risk assessment.

Risk assessments have assumed an increasingly important role in the management of risks in this country. The determination of which pollutants or public health issues are to be regulated, the degree and extent of regulation, and the priority assigned to particular problems are all areas of risk assessment that influence the country's $100 billion annual investment in environmental protection. Recent trends in public policy have brought the practice of risk assessment under greater scrutiny. As policy makers increasingly insist that specific numerical risk levels (so-called bright lines) be incorporated into regulatory decisions, the stakes for good risk assessment practice, already high, are raised even further. Enhancing the scientific basis of risk assessments was a major goal of the Workshop on Exposure Databases. In this article, we present the Risk Assessment Work Group's evaluation of the use of exposurerelated databases in risk assessment and the group's recommendations for improvement. The work group's discussion focused on the availability, suitability, and quality of data that underly exposure assessments, a critical component of risk assessment. The work group established a framework for evaluation, based on exposure scenarios typically used in regulatory decisions. The scenarios included examples from Superfund, the Clean Air Act, the Toxic Substances Control Act, and other regulatory programs. These scenarios were used to illustrate current use of exposure data, to highlight gaps in existing data sources, and to discuss how improved exposure information can improve risk assessments. The work group concluded that many of the databases available are designed for purposes that do not meet exposure and risk assessment needs. Substantial gaps exist in measurements of actual human exposure and in the data necessary to model exposures, to characterize distributions of exposure, to identify high-risk groups, and to identify possible environmental inequities in exposure. The work group, on the basis of its findings, made both short-term and longer-term recommendations for improving the collection of exposure data in the future.

Animals↗
PubMed1994

QAU verification: Ricerca's approach to EPA requirements for specimen disposition.

The U.S. Environmental Protection Agency (EPA) Federal Insecticide. Fungicide and Rodenticide Act and Toxic Substance Control Act Standards issued in 1989 presented a new task for the Quality Assurance Unit (QAU). Sections .190 and .195 of these Good Laboratory Practice (GLP) Standards require "quality assurance verification" prior to the disposal of certain specimens. These include "specimens from mutagenicity tests, specimens of soil, water, and plants, and wet specimens of blood, urine, feces, and biological fluids." QAU involvement in the specimen disposition process was a new concept. Other GLP Standards required specimen retention only as long as the quality of the preparation afforded evaluation: the QAU was not included in the procedure. The QAU verification step was included by the EPA to ensure that disposal of the prescribed specimens would not compromise the integrity of the study. A procedure to address verification of specimen disposition as required by the EPA GLP Standards has been implemented by Ricerca's QAU. This presentation provides a description of this approach to QAU verification.

Documentation↗
PubMedDate not supplied

Quality assurance responsibilities as defined by the EPA Good Automated Laboratory Practices (GALPs).

In December 1990, the Environmental Protection Agency's (EPA) Office of Information Resources Management (OIRM) issued a draft of the Good Automated Laboratory Practices (GALP). The GALPs developed from a union of existing Federal and EPA regulations and policies, including: the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) & Toxic Substance Control Act (TSCA), Good Laboratory Practices (GLP), the EPA Information Resources Management Policy (IRMP), and the Computer Security Act of 1987. The GALPs consolidate the regulations and policies to provide a single source of reference, and sever as an extension of the GLP standards (40 CFR 160 & 792). Whereas the GLPs describe acceptable laboratory management practices, the GALPs describe acceptable automated data management practices, and give guidance for standardizing and implementing procedures to ensure the quality and integrity of automated data collection and storage. The GALPs have been formatted to parallel the structure of the GLPs. Just as the GLPs define the responsibilities of the Quality Assurance Unit (QAU) in maintaining good laboratory practices, the GALPs define the responsibilities of the QAU in maintaining good automated data practices. The QAU is charged with (i) maintaining copies of written procedures for the automated data collection system, (ii) performing inspections of laboratory operations utilizing the automated data collection system and reporting findings, (iii) ensuring authorization and documentation of deviations from written procedures, (iv) auditing data and reports from the automated data collection system to ensure they accurately represent the raw data, and (v) maintaining records of the above-defined QAU functions.(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical Laboratory Information Systems↗
PubMed1995

U.S. EPA challenges and review--highlights of the Fiscal Year 1994 Inspection Program and EPA's laboratory accreditation considerations.

The reorganization and consolidation of the United States Environmental Protection Agency's (EPA's) Headquarters Enforcement and Compliance programs into a new Office of Enforcement and Compliance Assurance (OECA) is now complete. The Good Laboratory Practice (GLP) inspection program is now part of the Office of Compliance, one of the principal offices in this new organization. The role of the Office of Compliance and the implications of these changes for the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Toxic Substances Control Act (TSCA) GLP programs are addressed. Highlights of the fiscal year 1994 inspection program are reviewed. The status of the Agency's consideration of laboratory accreditation is discussed.

Accreditation↗
PubMed1983

Legal issues surrounding the number of dosage units dispensed.

Pharmacists often are called upon to adjust the number of dosage units dispensed pursuant to a prescription. Common examples are requests to dispense half or double the amount requested by the prescriber. In some cases, reductions in quantity may be dictated by the provisions of a prescription drug insurance program, either private or governmental. A review of the literature reveals very little information on the legality of such actions by pharmacists. Focusing on both the federal Food, Drug and Cosmetic Act and the federal Controlled Substances Act, a review of the law in this area is presented. Some states also have provisions, either in statutes or regulations, that address the issue. Specific examples are presented and discussed, with the goal being to clarify the law in this area with which the pharmacist must deal on a daily basis.

California↗
PubMed2003

Control of red phosphorus, white phosphorus and hypophosphorous acid (and its salts) as list I chemicals; exclusions and waivers. Final rule.

On October 17, 2001, DEA published a Final Rulemaking (66 FR 52670) in which DEA added red phosphorus, white phosphorus (also known as yellow phosphorus) and hypophosphorous acid (and its salts) as List I chemicals. This action was taken because of the use and importance of these chemicals in the illicit manufacture of methamphetamine (a Schedule II controlled substance). As List I chemicals, handlers of these materials became subject to Controlled Substances Act (CSA) chemical regulatory controls including registration, recordkeeping, reporting, and import/export requirements. DEA had determined that these controls are necessary to prevent the diversion of these chemicals to clandestine drug laboratories. In order to provide flexibility for legitimate businesses, the October 17, 2001 rule established, on an interim basis, specific exclusions and waivers for chemical handlers engaged in certain activities. DEA has completed its review of comments pertaining to these interim provisions. This rulemaking finalizes these exclusions and waivers related to the handling of the listed chemicals red phosphorus, white phosphorus, and hypophosphorous acid (and its salts).

Drug and Narcotic Control↗
PubMed1993

Role of the U.S. Congress in setting goals and priorities for research on nutrition and aging.

The U.S. Congress plays an important role in setting the broad research agenda for research agencies. It often does so by articulating major goals for federally-supported activities. Goals, longer-term objectives that agencies should work towards, should not be confused with priorities, near-term resource allocations designed to support efforts to achieve goals. Typically, federal research priorities are established by individual departments, agencies, and other organizations within the executive branch; however, when the funding levels are particularly large or public concern about an issue is particularly intense, Congress may become involved in the process of setting specific priorities. Congress influences the directions of research on aging primarily through the activities of authorization, appropriations, and special or select committees. The Special Committee on Aging in the Senate, and the Select Committee on Aging in the House of Representatives focus their attention exclusively on elderly Americans. Periodically, the activities of these committees are directed to research issues. Congress indirectly influences the directions of research on aging and nutrition through laws that establish science-based regulatory programs such as the Food, Drug, and Cosmetic Act, and the Toxic Substances Control Act. In setting priorities Congress relies on information, analysis, and advice from the four congressional support agencies, particularly the Office of Technology Assessment (OTA). OTA has undertaken a number of studies in recent years which address aging and nutrition issues. It is useful to try to devise mechanisms to encourage the establishment of national and international long-range goals and near-term priorities for research on aging and nutrition.(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗
PubMed2002

The initiation and administration of drugs for advanced life support by critical care nurses in the absence of a medical practitioner.

Current legislation does not permit the administration of first line resuscitation medications by suitably qualified Division 1 registered nurses (RNs) in the absence of a medical officer. This omission by the Drugs, Poisons and Controlled Substances Act 1981 (Vic) and the Drugs, Poisons and The Controlled Substances Regulations 1995 (Vic) leaves many critical care nurses in a vulnerable legal position. The primary aim of this study was to gauge the view of critical care nurses with respect to lobbying for change to the current legislation. In addition, the study aimed to explore and describe the educational preparation, practice perceptions and experiences of RNs working in critical care regarding cardiopulmonary resuscitation and the administration of first line advanced life support (ALS) medications in the absence of a medical officer. It was anticipated that data collected would demonstrate some of the dilemmas associated with the initiation and administration of ALS medications for practising critical care nurses and could be used to inform controlling bodies in order for them to gain an appreciation of the issues facing critical care nurses during resuscitation. A mailout survey was sent to all members of the Victorian Branch of the Australian College of Critical Care Nurses (ACCCN). The results showed that the majority of nurses underwent an annual ALS assessment and had current ALS accreditation. Nurses indicated that they felt educationally prepared and were confident to manage cardiopulmonary resuscitation without a medical officer; indeed, the majority had done so. The differences in practice issues for metropolitan, regional and rural nurses were highlighted. There is therefore clear evidence to suggest that legislative amendments are appropriate and necessary, given the time critical nature of cardiopulmonary arrest. There was overwhelming support for ACCCN Vic. Ltd to lobby the Victorian government for changes to the law.

Attitude of Health Personnel↗
PubMed2001

Dispensing of controlled substances to assist suicide. Interpretive rule.

For the reasons provided in the memorandum set forth below, the Attorney General has determined that assisting suicide is not a "legitimate medical purpose" within the meaning of 21 CFR 1306.04 (2001), and that prescribing, dispensing, or administering federally controlled substances to assist suicide violates the Controlled Substances Act. Such conduct by a physician registered to dispense controlled substances may "render his registration . . . inconsistent with the public interest" and therefore subject to possible suspension or revocation under 21 U.S.C. 824(a)(4). The Attorney General's conclusion applies regardless of whether state law authorizes or permits such conduct by practitioners or others and regardless of the condition of the person whose suicide is assisted. The Attorney General recognizes, however, that pain management is a legitimate medical purpose justifying a physician's dispensing of controlled substances. Finally, the Attorney General's determination makes no change in the current standards and practices of the DEA in any State other than Oregon.

Drug and Narcotic Control↗
PubMed1996

Government regulatory influences on opioid prescribing and their impact on the treatment of pain of nonmalignant origin.

Interpretation of regulations establishing standards for prescribing opioids by government regulatory boards and drug-enforcement agencies is more restrictive for treatment of nonmalignant pain than for malignant pain. Authority to regulate opioids is provided by health practice acts enacted by state governments, and controlled substances acts, enacted by both state and federal governments. The methods used by boards/agencies to determine standards of practice for opioid use result in interpreting the language in these regulations based on myths, prejudices, and misinformation about opioids, and the unexamined belief that mere exposure of patients to these drugs causes psychological dependence (addiction) on them to all patients in all instances. Interpretation is also strongly influenced by a failure of regulatory and enforcement bodies to recognize their coequal obligation of making opioids readily available to those who need them for legitimate medical purposes, while simultaneously policing their diversion to illegitimate uses. Emphasis on the police function of preventing diversion is paramount. Disciplining practitioners using standards based on myths, prejudices, etc., reinforces physicians' fears of prescribing opioids for nonmalignant pain. Patients with nonmalignant pain who are not relieved if opioids are not provided will continue to suffer until regulatory boards/drug enforcement agencies define the standards of practice for opioid use for nonmalignant pain in clear and unequivocal terms. It is unlikely these standards will be developed until there is a consensus among pain specialists about opioid use for nonmalignant pain because boards/agencies have no consistent, reliable source of expert information. Pain specialists should initiate efforts to develop this consensus.

Analgesics, Opioid↗
PubMed1998

Legal limitations for nurse prescribers in primary health care.

The nurse plays an important role in the delivery of primary health care services in South Africa. The primary purpose is to provide the public with access to safe competent basic health care and to achieve this, the nurse should be empowered to practice within legal and ethical boundaries. This paper explores and describes the limitations imposed by legislation on the nurse's ability to prescribe treatment in the primary health care field. The focus is mainly on the Nursing Act, the Pharmacy Act and the Medicines and Related Substances Control Act which highlights a number of limitations. It is concluded that empowerment of the nurse should not only include addressing the legal boundaries for practice, but also education and training opportunities to equip them with the expert knowledge and skills that they need to render a quality health care service.

Clinical Competence↗
PubMed1979

The effect of federal drug law on the incidence of drug abuse.

The Controlled Substances Act (CSA) is the prevailing "drug abuse" control statute in the United States. Its manifest objective is to prevent or reduce drug use's "substantial and detrimental effect on the health and general welfare of the American people." Evaluating CSA's effectiveness in 1975, a Domestic Council Task Force reported in a White Paper to President Gerald Ford that its control measures do "reduce abuse of dangerous drugs." The Task Force's evidence was based upon a before-and-after analysis of the frequency of "drug abuse episodes" reported to the nation's Drug Abuse Warning Network (DAWN). This research note challenges the conclusion of the Domestic Council Task Force, subjecting the DAWN evidence to more rigorous scrutiny, and concluding that we do not presently have adequate materials to assess whether CSA meets its health objectives. The context of this conclusion is that of drug control, but its implications apply to health policy and health policy evaluation in general.

Drug and Narcotic Control↗
PubMed2000

Regulatory framework for the thermal treatment of various waste streams.

Since 1990, regulations and standards have changed considerably. This article is an update of the regulatory requirements for the thermal treatment of various waste streams. The waste categories covered, along with the laws they are governed under, include: Hazardous waste under Subtitle C of the Resource Conservation and Recovery Act (RCRA) and under the Clean Air Act; municipal solid waste under Subtitle D of the RCRA; medical waste under Subtitle J of the RCRA; Superfund waste under the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA); toxic waste under the Toxic Substances Control Act (TSCA); and sludge waste under the Clean Water Act (CWA).

Humans↗