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PubMedDate not supplied

The profits of organized crime: the illicit drug trade in Canada.

Massive funds that are produced from street-level crime are laundered upwards into the criminal organizations for the benefit of their top-level members. The laundering systems used to distribute the proceeds of crime are designed to conceal the size of the organization as well as the identity of its members. Crime syndicates are attracted to criminal activity that produces the highest profits with the lowest risks. Although organized crime syndicates derive profits from a wide variety of criminal activity, their most sought after ventures principally involve the consensual type of crimes, such as drug trafficking, where no one individual can be readily identified as a legal victim for the purpose of recovering the proceeds of a criminal act. A recent survey indicated that illicit drug trafficking accounted for 87 per cent of the cash flow generated from organized crime. When the proceeds are disbursed, the criminals are free of the usual civil liability respecting the ownership of the proceeds. Canada currently has several laws which enhance the ability of law-enforcement authorities to trace the proceeds of crime and prosecute those who possess the assets. This legislation has some limitations with respect to seizure and forfeiture of certain types of proceeds. For example, forfeiture of the illegally acquired property is difficult when there is no original legal owner to initiate legal action, and even more difficult if the assets are located abroad.

Canada↗

PubMed2001

Private pharmacy practice and regulation. A randomized trial in Lao P.D.R.

OBJECTIVES: The objective of this study was to assess the effectiveness of government regulation of private pharmacy practice in a low-income country. METHODS: The intervention comprised inspections of the pharmacies, information, and distribution of documents to drug sellers and sanctions. It was implemented at two different intensity levels, active and regular intervention. The methods used to assess the effect of the interventions were interviews with the district drug inspectors, drug sellers and customers, inspection of drug purchases, and indicator surveys of pharmacies. Indicators for pharmacy-specific quality as well as for dispensing quality were developed. RESULTS: The main finding was one of strong overall improvements from initially low levels. The improvements were particularly marked by increases in the availability of essential materials for dispensing by 34% and in order in the pharmacy by 19%. Information given to customers increased from 35% to 51% and the mixing of different drugs in the same package went down from 17% to 9%. The pharmacies in the active intervention districts showed greater improvements for four of the six indicators, although statistically significant compared with the regular intervention districts only for the essential materials indicator. CONCLUSIONS: It was concluded that the regulatory activities have probably been an important factor behind the service quality improvements. It appeared feasible as well as effective to regulate private pharmacy practice in this particular low-income setting.

Developing Countries↗

PubMed1997

[Plasma-derived products: therapeutic biological products].

The status of proprietary medicinal product has been conferred upon plasma derived products (PDP) by the European Community in its directive issued on the 14 of June 1989. This directive requires each Member State to comply with the current regulations applicable to medicinal products related to production, control and registration of PDP. A different evolution characterized the American regulation in which PDP have been classified as biological products, submitted to a particular regulation since 1992. These different conceptions led the authors to systematically review the specificities of PDP in comparison to classical medicinal products: plasmatic raw material, production of active ingredients and manufacturing of products in the same facility, divergent production of several products from a single starting material, infection risks and variability characterizing biological products, registration and distribution. The analysis of complementary regulation issued to adapt the pharmaceutical principles to the PDP shows that it does not provide all the expected answers to the specificities of the PDP. This shows the advantages that could be expected by giving a status of biological therapeutic product to the PDP. This could above all allow to federate qualified people and data in order to take into account more accurate and more immediate information about risks which may arise in very dispersed fields. This could also serve as a reminder of the ethical principles attached to the preparation of products coming from a human source.

Biological Products↗

PubMed1995

Informed consent in emergency research. Consensus statement from the Coalition Conference of Acute Resuscitation and Critical Care Researchers.

OBJECTIVE: A coalition conference of acute resuscitation researchers was held to discuss the feasibility of applying current federal research regulations regarding informed consent to the emergency setting. This article presents consensus recommendations for regulatory changes for consent in emergency research. PARTICIPANTS: Representatives from the Society for Academic Emergency Medicine and the American Heart Association identified several professional organizations as stakeholders in this issue, including research, clinical, bioethics, legal, and patient advocacy groups. The Office for Protection From Research Risks (OPRR), the Food And Drug Administration (FDA), and staff from specific legislative offices were also invited to observe. Forty-three participants attended, including representatives from 12 professional organizations, five medical institutions, and the FDA and OPRR. This was a closed meeting. Participants were self-funded or sponsored by their professional organizations. EVIDENCE: Before the meeting, a draft of a position statement was developed by the conference organizers based on the current literature and discussions with experts in the field. This draft, copies of the current federal research regulations, and supporting articles were distributed before the conference. CONSENSUS PROCESS: Participants rotated through moderated discussion sessions to comment on subsections of the draft. Following discussion, a working draft was developed and distributed to each participant and represented organizational board for final review. All comments were considered in the final version of the document. CONCLUSIONS: We believe there are circumstances when it is not feasible to obtain prospective or proxy consent for enrollment into an emergency research protocol. In these circumstances, patients are vulnerable, not only to research risks, but also to being denied potentially beneficial therapy when there is no known effective treatment for their life-threatening condition. We offer recommendations that should be met when the critical nature of the illness or injury or the need to apply an investigational therapy rapidly precludes prospective consent for participation in emergency research.

Consensus↗

PubMed1993

Safe Medical Devices Act: management guidance for hospital compliance with the new FDA requirements.

The Safe Medical Devices Act of 1990 (Public Law 101-629) was signed by President George Bush almost three years ago on November 28, 1990. The law expanded the Food and Drug Administration's (FDA) authority to regulate medical devices and grew out of congressional concerns about the FDA's ability to quickly learn when a medical device caused an adverse patient event, and to ensure that hazardous devices are removed from hospitals and other health care facilities in a timely manner. The Safe Medical Devices Act is an extension of the Medical Device Amendments of 1976, which imposed production, distribution, and sales rules on medical device manufacturers. It gives the FDA the legal authority to directly regulate the use of medical devices in health care facilities. Among the Safe Medical Devices Act's provisions are specific requirements for hospitals, health professionals, and other users of medical devices to report patient incidents involving medical devices to the manufacturer and to the FDA if a device caused or contributed to a serious injury, death, or other "adverse experience." Adverse experiences are defined by the FDA to include concussions, fractures, burns, temporary paralysis, and temporary loss of sight, hearing, or smell. Hospitals have been required to comply with this provision of the law, called user reporting, since 1991. Hospitals are also required to participate in tracking certain medical devices whose failure could result in a serious adverse health outcome. The law requires distributors and manufacturers of specific devices to adopt a method for device tracking. Hospitals are required to cooperate with and provide device manufacturers with information about patients with permanently implantable devices and life-sustaining and life-supporting devices used outside device user facilities. The law also gives the FDA the authority to designate other devices subject to tracking if the agency determines such tracking is warranted to preserve the patient's health. This provision of the law is called device tracking. Device tracking became effective on August 29, 1993. This special report addresses some of the major questions about implementing user reporting and device tracking in hospitals. Over the past two years the FDA has issued a series of rules and regulations that have caused a great deal of confusion and misunderstanding. Some of the law's provisions are straightforward; however, some basic issues and rules--such as the definition of a reportable event--are unclear. While there are still some open questions about the reporting and tracking requirements, the following is the best information available at this time.(ABSTRACT TRUNCATED AT 400 WORDS)

Commerce↗

PubMed1975

Relations between sales authorisation and pharmacopoeia.

At a time when the production and distribution of drugs and drug products is no longer confined within the national boundaries of particular countries, many thoughtful people are concerning themselves with the idea of standardisation of quality control procedures and specifications. For medicines currently marketed in different countries, a multitude of standards and specifications for both the raw materials and finished products exists. Plans for the regionalisation of drug standards have been put into operation but realistic estimates of progress agree that it will be measured and dignified. In one area there is the possibility for earlier action in reaching agreement on adequate specifications. The process of registration of a new drug substance for the first time presents an opportunity to make known to drug regulation authorities, academic and industrial pharmaceutical specialists, and other interested parties, the qualities and characteristics of the newly proposed agent and its dosage forms. A wide range of information will be needed on the chemical, physical, biological and physicochemical properties of the dosage forms as well as the raw materials of the active and inactive ingredients. Many of these requirements have already been described (3). There may be apprehension that the disclosure of some of this information could imperil the confidentiality of certain manufacturing processes or trade secrets, and adequate steps would be demanded to prevent this happening. The promulgation of a standard, at or shortly after the time of registration, should have been preceded by experimental tests, in the laboratories of the Authority, to verify the robustness of the analytical methodology. In some cases more extensive confirmation by collaborative study may be warranted. The elaboration of these concepts will be presented and examples brought forward of problems that have occurred in the past, and means to prevent them in the future.

Legislation, Pharmacy↗

PubMed2000

New York State pharmacists' attitudes toward needle and syringe sales to injection drug users before implementation of syringe deregulation.

In May 2000, New York State passed legislation permitting the sale, purchase, and possession of up to 10 needles and syringes without a prescription. The law is intended to reduce the transmission of human immunodeficiency virus (HIV) and hepatitis among injection drug users (IDUs), their sexual partners, and their children. To obtain baseline information about the attitudes and likely practices of New York State pharmacists, we distributed a self-administered questionnaire to attendees of the state pharmacy association meeting in June 2000. Of 48 usable responses, 19% were from New York City and the rest from New York State. Of the 48, 42% were unaware of the new law before the day of the survey, and 60% were somewhat or very willing to sell needles and syringes to an IDU. Of those who were not willing to sell to an IDU, 82% cited familiarity of the customer as a very important consideration in their decision making. Those who were not willing to sell to an IDU were more concerned about the detrimental impact of syringe sales on the community, were less likely to be aware of the new law, and were more likely to be concerned about legal liability for syringe sales. Over 80% of all pharmacists believed that syringe sales to IDUs are an important preventive health measure. The majority also favored learning more about the law. Compared to other state surveys of pharmacists, these preliminary data show a similar level of interest in becoming involved with syringe availability programs.

Attitude of Health Personnel↗

PubMed2003

Complementary and integrative medical therapies, the FDA, and the NIH: definitions and regulation.

The National Center for Complementary and Alternative Medicine (NCCAM) presently defines complementary and alternative medicine (CAM) as covering "a broad range of healing philosophies (schools of thought), approaches, and therapies that mainstream Western (conventional) medicine does not commonly use, accept, study, understand, or make available. The research landscape, including NCCAM-funded research, is continually changing and subject to vigorous methodologic and interpretive debates. Part of the impetus for greater research dollars in this arena has been increasing consumer reliance on CAM to dramatically expand. State (not federal) law controls much of CAM practice. However, a significant federal role exists in the regulation of dietary supplements. The U.S. Food and Drug Administration (FDA) regulates foods, drugs, and cosmetics in interstate commerce. No new "drug" may be introduced into interstate commerce unless proven "safe" and "effective" for its intended use, as determined by FDA regulations. "Foods", however, are subject to different regulatory requirements, and need not go through trials proving safety and efficacy. The growing phenomenon of consumer use of vitamins, minerals, herbs, and other "dietary supplements" challenged the historical divide between drugs and foods. The federal Dietary Supplements Health Education Act (DSHEA) allows manufacturers to distribute dietary supplements without having to prove safety and efficacy, so long as the manufacturers make no claims linking the supplements to a specific disease. State law regulates the use of CAM therapies through a variety of legal rules. Of these, several major areas of concern for clinicians are professional licensure, scope of practice, and malpractice. Regarding licensure, each state has enacted medical licensing that prohibits the unlicensed practice of medicine and thereby criminalizes activity by unlicensed CAM providers who offer health care services to patients. Malpractice is defined as unskillful practice which fails to conform to a standard of care in the profession and results in injury. The definition is no different in CAM than in general medicine; its application to CAM, however, raises novel questions. Courts rely on medical consensus regarding the appropriateness of a given therapy. A framework for assessing potential liability risk involves assessing the medical evidence concerning safety and efficacy, and then aligning clinical decisions with liability concerns. Ultimately research will or will not establish a specific CAM therapy as an important part of the standard of care for the condition in question. Legal rules governing CAM providers and practices are, in many cases, new and evolving. Further, laws vary by state and their application depends on the specific clinical scenario in question. New research is constantly emerging, as are federal and state legislative developments and judicial opinions resulting from litigation.

Complementary Therapies↗

PubMed2003

Regulation of veterinary antibiotics in Australia.

The Australian Pesticides and Veterinary Medicines Authority (APVMA)* registers veterinary antibiotic products before they can be supplied, distributed or sold in Australia. Extensive scientific assessment on all new veterinary antibiotic products is undertaken for the APVMA by experts in other government agencies including the Therapeutic Goods Administration (toxicology), the National Occupational Health and Safety Commission (occupational health and safety), Environment Australia (environmental hazards) and state departments of agriculture or primary industry (efficacy and safety) as well as APVMA assessments on food residues, trade and manufacturing. The National Health and Medical Research Council Expert Advisory Group on Antimicrobial Resistance provides advice to the APVMA on the potential transfer of antibiotic resistance from the use of antibiotics in animals to humans, and the impact transfer may have on public health. Food Standards Australia New Zealand (previously Australia New Zealand Food Authority) set maximum residue levels for human foods. The APVMA monitors registered product use through compliance activities and an adverse experience reporting program, and reviews registered products as necessary. The import, manufacture, supply and use of veterinary antibiotics are regulated by Commonwealth and State governments in Australia.

Animals↗

PubMed1999

STD syndrome packets: improving syndromic management of sexually transmitted diseases in developing countries.

OBJECTIVE: To design, introduce, and evaluate "STD syndrome packets" containing recommended drugs for each syndrome, four condoms, a partner treatment card, and a patient information leaflet, with the goal of improving sexually transmitted disease (STD) case management. METHODS: Packet design evolved around available packaging technology, informed by pilot testing with nurses working in primary care clinics, doctors in private medical practices, and patients with an STD, in Hlabisa, South Africa. Evaluation 1 year later included analysis of distribution records and interviews with 16 nurses and 64 patients. RESULTS: A cheap packet (2 U. S. cents each, excluding contents) compatible with current legislation was designed and introduced to six public sector clinics and as a short pilot to five private medical practices. Four thousand eighty-five packets were distributed to the clinics, equivalent to approximately 115% of the STDs reported over that period. All 16 nurses reported using the packets, but only 63% did so all the time because of occasional supply problems. All believed the packets improved treatment by saving time (75%), improving supply of condoms and partner cards (44%), and making treatment easier (56%). Patients also responded positively, and most said they would buy a packet (up to $5) at a pharmacy (84%) or store (63%) if available. CONCLUSIONS: The STD syndrome packets have the potential to improve STD syndromic management by standardizing therapy and improving the supply of condoms, partner cards, and information leaflets. Packets are popular with practitioners and patients, but consistent supply is essential for maximal impact. There may be scope for social marketing of the packets, which could further increase use.

Anti-Infective Agents↗

PubMed2003

Regulatory considerations for emergency use of non-USDA licensed vaccines in the United States.

The Virus-Serum-Toxin Act of 1913 (21 US Code 151-159) provides the legal basis for the regulation of veterinary biologicals in the United States; the United States Department of Agriculture's Center for Veterinary Biologicals (CVB) has the regulatory authority for the issue of licences and permits for such products. The law was intended to establish standards and control the importation of products into the United States and the distribution of products interstate assuring the purity, safety, potency, and efficacy of veterinary biological products. Administrative regulations and standards appear in the Title 9, Code of Federal Regulations, Parts 101-118, with additional programme guidance found in CVB Notices, Veterinary Services Memoranda, General Licensing Considerations, and other guidance documents. Pre-licensing data evaluation procedures are designed to assess the purity, safety, potency, and effectiveness of each product and support all product label claims. To fulfil these criteria, data from all phases of product development are evaluated against these key elements. Under the standard licensing process, this spectrum of evaluation includes complete characterization and identification of seed material and ingredients, laboratory and host animal safety and efficacy studies, stability studies, and post-licensing monitoring of field performance. This comprehensive evaluation may not be possible during the emergence of a new animal disease. While there are no specific regulations addressing the licensing standards of products for an emerging animal disease, there are mechanisms that allow for the availability of products in an emergency animal health situation. These mechanisms include autogenous biologicals, conditional licences, experimental and emergency use authorizations, and the importation of products in use elsewhere in the world. Pre-approved vaccine banks provide an additional mechanism.

Animal Diseases↗

PubMed2002

Who is my brother's keeper?

Clinical and research practices designed by developed countries are often implemented in host nations of the Third World. In recent years, a number of papers have presented a diversity of arguments to justify these practices which include the defence of research with placebos even though best proven treatments exist; the distribution of drugs unapproved in their country of origin; withholding of existing therapy in order to observe the natural course of infection and disease; redefinition of equipoise to a more bland version, and denial of post-trial benefits to research subjects. These practices have all been prohibited in developed, sponsoring countries, even though they invariably have pockets of poverty where conditions comparable to the Third World prevail. Furthermore, the latest update of the Declaration of Helsinki clearly decries double ethical standards in research protocols. Under these circumstances, it does not seem appropriate that First World scholars should propose and defend research and clinical practices with less stringent ethical standards than those mandatory in their own countries. Recent years have witnessed frequent reports of less stringent ethical standards being applied to both clinical and research medical practices, for the most part in the field of drug trials and drug marketing, initiated by developed countries in poorer nations. Still more unsettling, a number of articles have endorsed the policy of employing ethical norms in these host countries, which would be unacceptable to both the legislations and the moral standards of the sponsor nations. Also, these reformulations often contravene the Declaration of Helsinki or one of its updates. This paper is not so much concerned with the actual practices, which have been subjected to frequent scrutiny and publicly decried when gross misconduct occurred. Rather, my concern relates to the approval and support such practices have found in the literature on bioethics from authors who might be expected to use their energy and scholarship to explore and endorse the universalisability of ethics rather than to develop ad hoc arguments that would allow exceptions and variations from accepted moral standards. To this purpose, issue will be taken with arguments in three fields: medical and pharmaceutical practices, research strategies, and local application of research results.

Bioethics↗

PubMedDate not supplied

[Benzodiazepine consumption in Porto Alegre].

Benzodiazepines has been largely used to control anxiety and other clinical pictures since it began to be traded in the 60's. In recent years, many studies have shown that they are used indiscriminately, contributing to increase associated morbidity, and to search for other more accessible tranquilizers. PURPOSE--To estimate the prevalence of benzoadiazepine and over-the-counter tranquilizers use in adults living in Porto Alergre-RS, Brazil. METHODS--480 inhabitants of Porto Alegre, aged 18 or older, selected through a random cluster sampling procedure (sectors of the Brazilian Census), were interviewed in their homes during June, 1991. RESULTS--The prevalence for BDZ use during life, in the past year and in the past month was, respectively, 46.7%, 21.3% and 13.11%. Prevalence was significantly higher among women and widowers or divorced. The majority of those who used BDZ during the past month did so at least 2 or 3 days per week. More than 40% reported frequent over-the-counter substances use to "tranquilize", with a 28.8% prevalence for past month use. CONCLUSION--Chemical substance use to alleviate anxiety and other symptoms is generally spread. Legislation, not always respected, has been insufficient to discipline its use. Understanding the complexity of reasons for the situation to be unchanged is needed. Also necessary is the investment in education on adequate use of BDZ, both for physicians and population, and the search for legal measures that should be more efficient.

Adolescent↗