SEARCH · PubMed Health

Results for “DRUG LEGISLATION, CONTROL AND DISTRIBUTION”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 163 records · Page 9Linked to original sources

PubMed2004

[Assessment of the legal awareness regarding drug consumption].

The latest legislation against drug addiction has changed the approach of Pursuing Organs in Poland to the problem of taking and distribution of drugs. Many tests have been carried out in order to evaluate the extent of legal regulations as the appropriate instrument in the struggle against drug addiction. The survey and interview were introduced during the research. The results make it possible to form the following conclusions. Law, only as a supplementary means supporting other methods may help prevent and counteract the addictions. Legal regulation on drug addiction which are based on compulsion and punishment should be widely taken into account.

Adult↗

PubMed1998

Pharmacy access to syringes among injecting drug users: follow-up findings from Hartford, Connecticut.

OBJECTIVE: To break the link between drug use and the human immunodeficiency virus (HIV), in 1992 the state of Connecticut rescinded a 14-year ban on pharmacy sales of syringes without a physician's prescription. In 1993, the Center for Disease Control and Prevention (CDC) evaluated the impact of the new legislation on access to syringes among injecting drug users (IDUs) and found an initial pattern of expanded access. However, it also found that some pharmacies, after negative experiences with IDU customers, reverted to requiring a prescription. This chapter reports findings from a four-year follow-up study of current IDU access to over-the-counter (OTC) pharmacy syringes in Hartford, Connecticut. METHODS: Through structured interviews, brief telephone interviews, and mailed surveys, data on nonprescription syringe sale practices were collected on 27 pharmacies, including 18 of the 21 pharmacies in Hartford and none from pharmacies in contiguous towns, during June and July 1997. Interview data on pharmacy syringe purchase from two sample of IDUs, a group of out-of-treatment injectors recruited through street outreach, and a sample of users of the Hartford Needle Exchange Program, also are reported. RESULTS: The study found that, while market trends as well as negative experiences have further limited pharmacy availability of nonprescription syringes, pharmacies remain an important source of sterile syringes for IDUs. However, the distribution of access in not even; in some areas of the city it is much easier to purchase nonprescription syringes than in other. All of the seven pharmacies located on the north end of Hartford reported that they had a policy of selling OTC syringes, whereas only six (54.5%) of the II pharmacies located on the south end have such a policy. Overt racial discrimination was not found to be a barrier to OTC access to syringes. CONCLUSIONS: To further decrease acquired immunodeficiency syndrome (AIDS) risk among IDUs, there is a need for public education to counter empirically unsupported stereotypes about IDUs that diminish their access to health care and AIDS prevention resources and services. In states or cities where pharmacy sale of nonprescription syringes is illegal, policy makers should examine the benefits of removing existing barriers to sterile syringe acquisition. In cases in which pharmacy sale of nonprescription syringes is legal, local health departments should implement educational programs to inform pharmacy staff and management about the critically important role low-cost (or cost-free), sterile syringe access can play in HIV prevention.

Centers for Disease Control and Prevention, U.S.↗

PubMedDate not supplied

Application of quality assurance practices in processing cells and tissues for transplantation.

Attention to issues of quality assurance from the early stages of development of experimental cell therapies provides a margin of safety for recipients. Adherence to minimum standards of practice at acquisition, processing, storage, and implantation ensures not only this baseline safety factor for patients, but also provides a baseline for comparative evaluations between different studies or different banks. This paper describes the basic components of a quality assurance program tailored to laboratories and facilities that collect, process, or distribute human cells and tissues for transplantation. These components include policy and procedure manuals, donor screening practices, processing procedures evaluation and control, training and education programs, auditing and investigation roles, responsibility for release of grafts, and recordkeeping and traceability requirements. References and resources for detailed information related to good manufacturing practices and good clinical and laboratory practices are provided. Standards, regulations, and current legislation specifically related to human cells and tissues intended for transplantation are also discussed.

Cryopreservation↗

PubMed2005

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. Of particular relevance to drug regulatory authorities and pharmaceutical manufacturers, this report discusses the monographs on antiretrovirals proposed for inclusion in The International Pharmacopoeia and specifications for radiopharmaceuticals, quality specifications for antituberculosis drugs and the revision of the monograph on artemisinin derivatives, as well as quality control of reference materials, good manufacturing practices (GMP), inspection, distribution and trade and other aspects of quality assurance of pharmaceuticals, and regulatory issues. The report is complemented by a number of annexes, including an amendment to good manufacturing practices: main principles regarding the requirement for the sampling of starting materials, guidelines on good manufacturing practices regarding water for pharmaceutical use, guidelines on the sampling of pharmaceutical products and related materials and draft guidelines for registration of fixed-dose combination medicinal products.

Advisory Committees↗

PubMed2002

Legal aspects related to marketing and use of medicinal products in Greece.

Drugs and all medicinal products are in a special category. The manufacturing, marketing authorization and the distribution of them within the market, require fulfillment of particular conditions compared with other consumer goods. Additionally, the safety of drug use is an important issue for the public health, involving State and insurance authorities, physicians, pharmacists and drug companies. In today's health care environment, any authority involved in therapeutic interchange issues should be knowledgeable about the legal and medical issues associated with this practice. The aim of this study was to provide an analysis of Greek pharmacy legislation and an insight into the infrastructure of the Greek system that is responsible for the safety of the use of medicinal products from the Public Health Standpoint.

Drug Industry↗

PubMed1987

Dual regulatory pharmaceutical labeling schemes; the role of the Federal Preemption Doctrine.

The Federal Drug Administration (FDA) has developed comprehensive procedural and substantive regulations to control the format of and information contained within package inserts distributed by pharmaceuticals. FDA regulations should be pervasive and preempt any state action on pharmaceutical labeling. However, courts have recently allowed jurors to reevaluate specific FDA scientific judgements in the context of product liability actions. This article discusses the Federal Preemption Doctrine as it relates to the regulation of package insert labeling by both the FDA and the state. First, the examination begins with background information on the Preemption Doctrine and the statutory authority of the FDA, followed by a discussion with a review of case law on the subject.

Consumer Product Safety↗

PubMed1979

The Kennedy version of the Drug Regulation Reform Act.

Provisions of Senator Edward Kennedy's version of the Drug Regulation Reform Act of 1979 (S.1075) are discussed. Included in the discussions are pre- and postmarketing approval controls on drug products, product equivalency, drug promotion and information, penalties, and the National Center for Drug Sciences. Provisions of the act are compared with the Carter Administration's 1978 (S.2775, H.R.11611 and H.R.12980) and 1979 (S.1045 and H.R. 4258) drug reform bills. The Kennedy bill does not depart radically from the existing drug approval process but would open it to the public and give FDA more flexibility to impose conditions, such as limited distribution and postmarketing surveillance, to product approval. It establishes drug compendia that would meet federal standards but that preferably would be published by the private sector. Hospitals and other health care institutions are exempted from the bill's patients package insert requirements, except as otherwise regulated by FDA.

Advertising↗

PubMed2002

Implementation of the Comprehensive Methamphetamine Control Act of 1996; regulation of pseudoephedrine, phenylpropanolamine, and combination ephedrine drug products and reports of certain transactions to nonregulated persons. Final rule.

DEA is amending its regulations to implement the requirements of the Comprehensive Methamphetamine Control Act of 1996 (MCA) with respect to the regulation of pseudoephedrine, phenylpropanolamine, and combination ephedrine drug products as List I chemicals, and the reporting of certain transactions involving pseudoephedrine, phenylpropanolamine, and combination ephedrine drug products. The MCA removed the previous exemption from regulation as List I chemicals which had applied to pseudoephedrine, phenylpropanolamine, and combination ephedrine drug products. This action makes persons who distribute the products subject to the registration requirement. Also, distributions, importations, and exportations of the products became subject to the existing chemical controls relating to regulated transactions, except in certain circumstances specified in the MCA. The MCA also requires that reports be submitted for certain distributions involving pseudoephedrine, phenylpropanolamine, and ephedrine (including drug products containing those chemicals) by Postal Service or private or commercial carrier to nonregulated persons. This final rule amends the regulations to make them consistent with the language of the MCA and to establish specific procedures to be followed to satisfy the new reporting requirement. DEA has, where possible, taken action to limit the public impact of these new requirements while remaining consistent with the intent of the MCA to attack the diversion of regulated drug products to the clandestine manufacture of methamphetamine.

Commerce↗

PubMed1995

[Substitution treatment of drug-dependent patients].

The author discusses the network of acts of parliament, subordinate legislation and decisions of the courts. Even if a substitution is legal, this does not necessarily mean that the expenses are covered by the statutory medical insurances. While in certain cases the insurances bear the costs of a treatment with methadone, the expenses for codeine and dihydrocodeine can be covered in no case. But it is possible to prescribe both at the expense of the patient. According to the law and the opinions of leading experts it is obligatory that the distribution of substitutes be combined with further medical, psychological and social care. For the latter the insurances cannot be charged. The essay concludes with presumptions about the future development of the regulations in force.

Codeine↗

PubMed1978

Drug residues in animal tissues and their regulatory significance--the Canadian point of view.

Today it is almost impossible to produce food of animal origin which is free from traces of drugs or chemicals. In Canada the problem of drug residues is controlled by a method of assessment of human safety which involves many factors. The toxicity of the drug in laboratory animals or, if possible, in man, is established and a no-effect dose is then estimated. These studies require oral administration of the drug and include acute, subacute, and teratogenicity studies. Depending on these results, chronic reproductive or carcinogenicity studies may be required before a no-effect dose can be estimated. Residue studies must encompass data on metabolism, pharmacokinetics, and depletion studies in edible tissues and for products such as milk and eggs. For veterinary drug residues, we must consider the target food animal with its particular metabolism, tissue disposition, and excretion patterns. The analytical method for residue detection must be acceptable and its sensitivity limits suitable for the drug and its major metabolites.

Animals↗

PubMed1975

Federal and state pesticide regulations and legislation.

The combined research, education, and regulatory efforts of federal and state governments have made possible an impressive record of abundant production while imposing minimal harm to human health and the environment. Considering that approximately one billion pounds of pesticides are being applied in the United States annually to control about 2000 pest species, the safety record is remarkable. The increased public concern about environmental values and long-term health effects is constructive and is resulting in some of the regulatory changes discussed in this article. The Federal Environmental Pesticide Control Act can result in an improved and expanded joint effort by federal and state governments to limit the misuse of pesticides while permitting their use to facilitate increased production of food, feed, and fiber; provide protection from spoilage; improve health; and control nuisance insects and unwanted plants. Implementation of current regulations, plus those in the process of being enacted under authority of the new federal act, will be complex and costly. Regulations will control the registration, labeling, distribution, storage, use and application, and disposal of pesticides. A small segment of our society would like to have the use of all chemicals banned. A few individuals oppose all government controls. However, the vast majority of agricultural producer groups, representatives of industry, and the public support the need for pesticide regulations. Only through continued legal controls over pesticides may we hope to retain their use. Our society has gained tremendous benefits from the use of pesticides to prevent disease and to increase the production of food and fiber. Our need to use pesticides will continue to increase for the foreseeable future. Government agencies responsible for protecting human health and the environment must make sound judgments on an individual basis in evaluating the evidence concerning both the benefits and risks of using pesticides.

Government Agencies↗

PubMed1978

Veterinary public health activities aimed at prevention of intoxications by chemical residues in foods of animal origin. Suggestions for inspection programmes.

Practically all today's raw agricultural products have been treated or exposed to one or more agricultural chemicals or veterinary products, in order to increase food production. A tremendous amount of work has been done by veterinarians in coping with diseases and health risks due to microorganisms, parasites and other agents of biological origin. There is no doubt that veterinary services, research and educational institutions have a long and successful tradition also in dealing with problems of chemicals associated with animal and food production, processing, transportation, storage and distribution. Due to the increasing quantity and large numbers of chemicals now used in animal production and related fields, it has however become indispensable to broaden and intensify the education and training of veterinarians, as well as to ensure their participation in all sectors of this field. Veterinarians should be fully involved in the surveillance, prevention and control of intoxications by chemical residues. They are well qualified to do this. They are working continuously in the areas where exposure to animals and food may occur, possess adequate knowledge of the routes of entry of such chemicals into food chains, the fate of their residues, the health hazards involved, as well as of the toxicology, pathology, pathophysiology, and food hygiene and technology. Residues present an enormous challenge for surveillance, prevention and control in agriculture, food processing and related activities.

Animals↗

PubMed2006

Pandemics, antiviral stockpiles and biosecurity in Australia: what about the generic option?

In view of the possibility of a human pandemic of avian influenza, a first-line strategy for many countries is stockpiling of antiviral neuraminidase inhibitors (oseltamivir [Tamiflu] and zanamivir [Relenza]), which can reduce mortality, morbidity and influenza transmission. However, global supply of the antivirals is controlled by the European-based patent owners, Roche and GlaxoSmithKline. This prevents competition in the manufacturing and distribution of antivirals and has reduced global supply capacity and affordability. The Australian Government has acknowledged that, in the event of a pandemic, its own stockpile of antivirals will be limited and reserved for those on a confidential rationing list. Pharmacies are running out of stocks, limiting opportunities for individuals to secure supplies privately. Compulsory licensing provisions, permitted under domestic patent law, would allow Australian generic manufacturers to start producing antivirals locally or import them from generic producers at affordable prices. Australia also has an opportunity and a responsibility to promote compulsory licensing and generic antiviral production in the Asian region, to ensure our neighbours can establish pandemic stockpiles in a timely and affordable manner.

Antiviral Agents↗

PubMed2003

Italy reforms national policy for cancer pain relief and opioids.

Treatment of pain caused by cancer in Italy has been reported to be inadequate for more than a decade. The problem has been documented in the literature by International Narcotics Control Board (INCB) reports that show Italy's low consumption of morphine, and by INCB statements reflecting concern that pain medications are not adequately available to suffering cancer patients. The reasons for undertreatment include lack of physician education, low public awareness about pain management and overly restrictive regulations that inhibit the prescribing of opioid analgesics. In 1999, a workgroup appointed by the Ministry of Health began to address inadequate cancer pain management. In 2000, the workgroup issued a proposal to reform national policy, including simplification of opioid prescribing requirements. The proposal was adopted by Parliament in January 2001 and was effective from March 6th. Distribution of a new opioids prescription form to selected regions in Italy began in December 2001. The change, when fully implemented, will be an important step toward relieving cancer pain.

Analgesics, Opioid↗

PubMed1994

Regulatory aspects of modifications to innovator bronchodilator metered dose inhalers and development of generic substitutes.

Regulatory requirements for modifications to an approved innovator metered dose inhaler (pressurized MDI; USP nomenclature: inhalation aerosol) and for development of a new generic product are discussed. Although many of the requirements apply generally to MDI's, they are discussed with specific reference to albuterol. Changes to the container and closure system may impact on the dosimetry of the redesigned product, as well as upon toxicologic and chemistry, manufacturing and controls (CMC) concerns. Changes to the formulation, including the use of alternate propellants, may raise issues requiring both clinical and in vivo performance evaluation. In view of the level of interest of a number of firms in approval requirements for generic Albuterol Inhalation Aerosol products, the article discusses in considerable detail the CMC and bioequivalence requirements for a generic product. Similarities in the CMC requirements for innovator and generic products are evident. Three comparative in vivo bioequivalence tests, particle size distribution, spray pattern and plume geometry, and unit spray content, established by the Division of Bioequivalence are discussed. Similarities and differences in the in vivo requirements for innovator and generic products are evident. Differences are the result of U.S. statute, which requires safety and efficacy testing for a product approved under a new drug application (NDA), but documentation of bioequivalence for a product approved under an abbreviated new drug application (ANDA). The advantages and disadvantages of three pharmacodynamic study designs which have potential usefulness for documentation of in vivo bioequivalence are discussed.

Bronchodilator Agents↗

PubMed1995

Terminations of pregnancy for exposure to oral retinoids in South Australia, 1985-1993.

The oral retinoids, isotretinoin and etretinate, are highly teratogenic drugs which have been available in Australia since 1985 because of their unique effectiveness in severe cystic acne, psoriasis and other keratinization disorders. Only dermatologists can prescribe them, but in spite of strict guidelines by the manufacturers and the College of Dermatologists, exposed pregnancies have occurred. We attempted to determine the circumstances of exposure to these drugs for the 18 pregnancies terminated in South Australia in 1985-1993, using questionnaires to medical practitioners who notified the terminations under legislation. The main reason for their occurrence was the lack of compliance with the use of effective contraception by the women. In South Australia, some prescriptions of oral retinoids by unauthorized doctors have been dispensed during this period. Using statistics on prescriptions dispensed, an estimate was made of 1 termination of pregnancy for 319 courses of treatment for women with isotretinoin. Extension of guidelines for prescription and more detailed counselling in relation to the use of contraception are recommended. It is also suggested that doctors intending to recommend terminations obtain consent to discuss exposure with the dermatologists concerned, who may not be aware of the exposed pregnancy.

Abortion, Induced↗

PubMed2005

Driving under the influence of drugs in Sweden with zero concentration limits in blood for controlled substances.

OBJECTIVE: This article describes the background and implementation in Sweden of zero-concentration limits for controlled drugs in the blood of drivers. Eliminating the need to prove that a person's ability to drive safely was impaired by drugs has greatly simplified the prosecution case, which now rests primarily on the forensic toxicology report. Driving under the influence of a prescription drug listed as a controlled substance is exempt from the zero-limit law provided the medication was being used in accordance with a physician's direction and the person was not considered unfit to drive. METHODS: The prevalence of driving under the influence of drugs (DUID) in Sweden was evaluated from police reports with the main focus on the toxicological findings. A large case series of DUID suspects was compared before and after introducing zero concentration limits in blood for controlled substances on July 1, 1999. The spectrum of drugs used by typical offenders and the concentrations of various licit and illicit substances in blood were evaluated and compared. RESULTS: Immediately after the zero-limit law came into force, the number of cases of DUID submitted by the police for toxicological analysis increased sharply and is currently ten-fold higher than before the new legislation. Statistics show that about 85% of all blood samples sent for toxicological analysis have one or more banned substances present. Amphetamine is by far the leading drug of abuse in Sweden and was identified in about 50-60% of all DUID suspects either alone or together with other controlled substances. The next most frequently encountered illicit drug was tetrahydrocannabinol (THC), with positive findings in about 20-25% of cases. Various prescription drugs, mainly sedative-hypnotics like diazepam and flunitrazepam, were also highly prevalent and these occurred mostly together with illicit substances. Opiates, such as 6-acetyl morphine and morphine, the metabolites of heroin, were high on the list of substances identified. Most DUID suspects in Sweden were men (85%) who were poly-drug users combining illicit substances, like amphetamine and/or cannabis, with a prescription medication such as various benzodiazepines. CONCLUSIONS: Sweden's zero-concentration limit has done nothing to reduce DUID or deter the typical offender because recidivism is high in this population of individuals (40-50%). Indeed, many traffic delinquents in Sweden are criminal elements in society with previous convictions for drunk and/or drugged driving as well as other offenses. The spectrum of drugs identified in blood samples from DUID suspects has not changed much since the zero-limit law was introduced.

Automobile Driving↗

PubMed2001

The importance of using scientific principles in the development of medicinal agents from plants.

The authors review the major scientific milestones and the legislative framework that have made possible the spectacular successes of many modern therapies that trace their origins to plants. They emphasize that drugs used in mainstream medicine, in contrast to most of those used in alternative medicine, are required to meet stringent federal requirements for purity, safety, and efficacy before they can be distributed to the public, and that the necessary testing requires much time and effort. Yet alternative medicines based on plant substances are extremely popular, even though their safety and efficacy have not been scientifically proven. Reasons for this are reviewed and numerous examples and case histories are cited illustrating both successes in the scientific development of drugs from plants and the dangers of unregulated drugs. Such drugs are more easily available because of the deregulating effect of the 1994 Dietary Supplement Health and Education Act (DSHEA), which has substantially weakened the authority of the Food and Drug Administration to ensure the safety of dietary supplements. The authors describe the rigorous scientific investigations of curcumin, from the ginger family, and of sulforaphane, from crucifers, to illustrate the long and demanding scientific process that is required to establish the safety and effectiveness of potential drugs from plants. They re-emphasize the necessity for strict scientific review of all drugs. They also recommend that all providers of care be required to question patients about their intakes of dietary supplements. The authors close by saying that the DSHEA is "a disaster waiting to happen," but warn that any attempts to strengthen current legislation will be opposed by special interests.

Dietary Supplements↗