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PubMed2001

Drugs for neglected diseases: a failure of the market and a public health failure?

Infectious diseases cause the suffering of hundreds of millions of people, especially in tropical and subtropical areas. Effective, affordable and easy-to-use medicines to fight these diseases are nearly absent. Although science and technology are sufficiently advanced to provide the necessary medicines, very few new drugs are being developed. However, drug discovery is not the major bottleneck. Today's R&D-based pharmaceutical industry is reluctant to invest in the development of drugs to treat the major diseases of the poor, because return on investment cannot be guaranteed. With national and international politics supporting a free market-based world order, financial opportunities rather than global health needs guide the direction of new drug development. Can we accept that the dearth of effective drugs for diseases that mainly affect the poor is simply the sad but inevitable consequence of a global market economy? Or is it a massive public health failure, and a failure to direct economic development for the benefit of society? An urgent reorientation of priorities in drug development and health policy is needed. The pharmaceutical industry must contribute to this effort, but national and international policies need to direct the global economy to address the true health needs of society. This requires political will, a strong commitment to prioritize health considerations over economic interests, and the enforcement of regulations and other mechanisms to stimulate essential drug development. New and creative strategies involving both the public and the private sector are needed to ensure that affordable medicines for today's neglected diseases are developed. Priority action areas include advocating an essential medicines R&D agenda, capacity-building in and technology transfer to developing countries, elaborating an adapted legal and regulatory framework, prioritizing funding for essential drug development and securing availability, accessibility, distribution and rational use of these drugs.

Communicable Diseases, Emerging↗
PubMed1990

Medical and nonmedical uses of anabolic-androgenic steroids. Council on Scientific Affairs.

Recent trends in the use, abuse, and diversion of steroids for nonmedical purposes illustrate a growing problem that not only imposes health risks but presents ethical dilemmas as well. Concern over the known adverse effects, the limited research into the long-term effects, and the ethics of engineering body size and performance through anabolic-androgenic steroid use has led to legislative, legal, and education responses. Increased penalties for distribution to minors and stricter controls in prescribing practices have been enacted through state legislation and federal initiatives. Government, some health professional organizations, and some sports groups have denounced the nonmedical use of anabolic-androgenic steroids and have developed materials to educate their members, other professionals, athletes, educators, and the public at large.

American Medical Association↗
PubMedDate not supplied

[Study of narcotics and buprenorphine prescriptions in the Provence-Alps-Côte d'Azur region].

Following the setting up by the Government of their project for the management of drug addicts, and under the guidance of the CEIP (Centre d'Evaluation et d'Information sur les Pharmacodépendances [Centre for Evaluation and Information on Drug Addiction]) in Marseille, a survey of prescriptions written on controlled-drug prescription pads was performed. The aims were threefold: to study the medicines prescribed, to follow up the legislation and to inform doctors and pharmacists. Copies of the prescriptions, dated between 1 January 1996 and 30 June 1996, which were sent by 81 per cent of the 216 pharmacies contacted in 15 towns in the Provence-Alpes-Côte d'Azur (PACA) region were studied. Various criteria, relating to writing of the prescriptions and distribution of the medicines to the patients, were coded and analysed. This survey showed that of 4 prescriptions, 3 were prescribed for maintenance and one for analgesic therapy. The patients receiving maintenance therapy were male in three-quarters of the cases, and were around 30 years old. Analgesics were prescribed in equal proportions for patients of both sexes, who were around 65 years old. Since it was put on the market, Subutex has been quickly prescribed.

Adult↗
PubMedDate not supplied

Legislation on contraception and abortion for adolescents.

The serious health and social consequences of adolescent pregnancy call for the examination of the laws that affect adolescents' access to contraception and abortion. The general law of any country relating to the availability, sale, or distribution and financing of contraceptives affects adolescents. Similarly, a country's general law on abortion applies to adolescents faced with unwanted pregnancy and affects them accordingly. In addition, special legislation relating to adolescents, particularly legislation or court decisions concerning parental consent for contraception or abortion for a minor, has an important influence on the access that sexually active young people have to services.

Abortion, Legal↗
PubMedDate not supplied

Forfeiture of the profits and proceeds of drug crimes.

Drug trafficking is controlled by well-organized international criminal syndicates, whose only motives for becoming involved are to make profits and secure influence, which in turn help perpetuate illicit drug distribution networks. For example, one producer of illicit opium receives approximately $Can 650 for 10 kilograms of opium, from which one kilogram of heroin is produced and sold to end-users for up to $Can 12 million. The risks involved for those at the highest level of international criminal syndicates is extremely low since they are financiers who may never come in direct contact with illicit drugs or the law enforcement authorities. The proceeds of drug crimes are laundered through sophisticated international transactions often covered by legitimate operations. Current legislative provisions at both national and international levels are inadequate to support effective action to trace, freeze, seize and secure the forfeiture of the proceeds of crimes and to prosecute individuals who knowingly possess such proceeds. In pursuance of recent resolutions of the Commission on Narcotic Drugs, the Division of Narcotic Drugs of the United Nations Secretariat convened two expert group meetings, one in 1983 and the other in 1984, to consider ways and means of dealing with this problem. The meetings recommended the establishment of machinery that would facilitate, at both national and international levels, concerted action to deprive drug traffickers of the proceeds of their crimes. The annex to this article contains provisions recommended by the second expert group meeting for inclusion in an international instrument to supplement existing provisions of the international drug control treaties in order to deal more effectively with the profits of drug crimes.

Crime↗
PubMed1989

[State control of vaccines].

Immunobiological preparations, especially vaccines are characterized by some specialties in manufacturing, guarantee of quality and in use. According to valid pharmaceutical legislation this group of preparations is allowed to get distributed and used with a state certificate for every lot only. The paper deals with tasks of the State Control Institute for immunobiological preparations connected with some fundamental informations on those preparations. Control procedures and methodological aspects have been taken into consideration. The statements take regard to pharmaceutical regulations to secure distribution and use of immunobiologicals.

Drug and Narcotic Control↗
PubMed1993

Problems in distribution of scientific knowledge: intrauterine contraceptive devices and drug catalogs.

Intrauterine contraceptive devices (IUDs) are a popular method of contraception worldwide. However, some serious problems have been associated with them. Finland has developed and now manufactures and exports IUDs. Therefore, drug control and the quality of drug information existing in Finland are significant for other countries, as well. This study analyzes the information in the Finnish commercial drug catalog on copper-releasing IUDs and compares it with the scientific literature, the instructions from the licensing authority, and material in its U.S. counterpart, during the last two decades. The results indicate that the distribution of scientific knowledge to the drug catalogs has often been slow. In the early 1980s Finnish manufacturers did not give any practical information on their products, and then and later the Finnish catalog was less comprehensive than the U.S. catalog. The variations in the control system in different nations were reflected in the contents of the Finnish catalog. For practitioners, drug catalogs are important sources of medical information. The results of this study demonstrate (1) that more attention should be paid to the contents of these catalogs, and (2) the continuous need for up-to-date, unbiased drug information.

Catalogs, Drug as Topic↗
PubMed2003

Implementation of the Methamphetamine Anti-Proliferation Act; thresholds for retailers and for distributors required to submit mail order reports; changes to mail order reporting requirements. Final rule.

This regulation implements the new threshold requirements and mail order reporting requirements of the Methamphetamine Anti-Proliferation Act of 2000 (MAPA), which was enacted on October 17, 2000. DEA is amending its regulations to reduce the thresholds for pseudoephedrine and phenylpropanolamine for retail distributors and for distributors required to submit mail order reports. Also, DEA is amending its regulations to require mail order reports for certain export transactions. DEA is codifying exemptions from the mail order reporting requirements for certain distributions to nonregulated persons and certain export transactions. This rule is consistent with the intent of MAPA to prevent the diversion of drug products to the clandestine manufacture of methamphetamine and amphetamine, and simultaneously reduce the industry reporting burden.

Drug Industry↗
PubMed2000

Cost containment of pharmaceutical use in Iceland: the impact of liberalization and user charges.

OBJECTIVES: Iceland was the first Nordic country to liberalise its drug distribution system, in March 1996. Subsequent regulation in January 1997 increased patients' share of drug costs. The objectives of this study were to test the assumptions that liberalizing community pharmacy ownership would lower reimbursement costs for the state's Social Security Institute and that increasing patient charges would reduce use and, therefore, lower the cost to the Institute. METHODS: Based on the assumptions, we built and tested two models using interrupted time series designs that contrast the monthly reimbursement costs before and after the legislation and regulation took effect. A control variable (the number of office visits to general practitioners) was tested to assess other events in the health care arena. Monthly data on these variables were provided by the Icelandic State Social Security Institute for January 1993 to August 1998 for reimbursement costs and to December 1998 for office visits to general practitioners. RESULTS: Reimbursement costs have risen steadily throughout the period under study. The interrupted time series analysis did not show a substantial effect from the legislative change in March 1996 or from the regulatory intervention in January 1997. CONCLUSIONS: The main argument used for liberalizing community pharmacy ownership in Iceland was built on false assumptions regarding the effect on drug reimbursement costs to the state. It will be necessary to find more promising interventions to halt the rapidly increasing cost of drugs.

Cost Control↗
PubMedDate not supplied

The ratification of the Convention on Psychotropic Substances 1971 and its transposition into national legislation in the Federal Republic of Germany.

The Single Convention on Narcotic Drugs, 1961, as amended by the 1972 Protocol Amending the Single Convention on Narcotic Drugs, 1961, and the Convention on Psychotropic Substances 1971 have been implemented in the Federal Republic of Germany as follows: (a) No distinction is made between narcotic drugs and psychotropic substances; all substances which are controlled and non-exempted preparations containing such substances fall under the legal designation of "narcotic drugs"; (b) The same control measures as for narcotic drugs apply to all substances in Schedules II, III and IV of the 1971 Convention, i.e. control of manufacture, trade, import and distribution; (c) Under the new Narcotics Act of the Federal Republic of Germany, which entered into force on 1 January 1982, preparations containing substances listed in Schedules II and III of the 1971 Convention are subject to the same full control measures, including mandatory special prescriptions, with the exception of approximately 50 preparations from substances in Schedule III of the 1971 Convention. These 50 preparations are also subject to import, export and transit controls under the Narcotics Act; (d) The approximately 50 preparations containing substances in Schedule III of the 1971 Convention, as well as all preparations containing substances in Schedule IV of this Convention (about 340), are treated as "exempted preparations" under the Narcotics Act. These preparations, however, may only be dispensed under medical prescription which is in conformity with the provisions of article 9, paragraphs 1 and 2 of the 1971 Convention; (e) Within the meaning of the Narcotics Act, the term "exempted preparations" denotes that no mandatory special prescriptions are required for these preparations but only the normal medical prescriptions. A number of regulations of the Narcotics Act apply to these exempted preparations, including: (i) Licence of manufacture; (ii) Records of dispensing of exempted preparations by the manufacturer to the first acquirer; (iii) Import, export and transit regulations for the exempted preparations containing substances listed in Schedule III (Schedule III B in the Narcotics Act); (iv) Export bans for countries which have prohibited import.

Drug Prescriptions↗
PubMed1991

Some considerations on veterinary drug use and supply in Nigeria.

There is widespread misuse of veterinary drugs in Nigeria resulting from controlled and unsupervised drug administration, underdosing and incomplete treatment. Development of resistance and toxicity are common consequences of this misuse. Drug shortage, uneven distribution, preponderance of fake and/or expired drugs and inadequate local drug production are some of the problems identified in veterinary drug supply. All these problems have an adverse effect on animal health and productivity and are related to an improperly coordinated veterinary service and the non-existence of national veterinary drug policy. Suggested solutions include rehabilitation and restructuring of the veterinary service, improved funding to support drug purchase, installation of self-servicing revolving funds, partial privatization, drug manufacture and appropriate legislations for veterinary drugs. These proposals are expected to overcome bottlenecks encountered in drug supply, distribution, delivery, prescription and use. Projections and plans must also be made toward the local development and manufacture of drugs for animal disease.

Animal Husbandry↗
PubMed1999

Regulation of food and drugs in the Philippines.

The regulation of food and drugs in the Republic of the Philippines is enshrined in the 1987 Philippine Constitution. Statutory laws are also in place providing legal basis for the creation of a regulatory agency, the Bureau of Food and Drugs, mandated to ensure the safety, efficacy and good quality of all food and drug products being made available to the general public. The most important of these laws are Republic Act (RA) 3720 "Foods, Drugs, Medical Devices and Cosmetics Act", RA 6675 "Generics Act", RA 8203 "Act Prohibiting Counterfeit Drugs", and RA 7394 "Consumers Act." Regulation is achieved through inspection and licensing of food and drug establishments, registration and market monitoring of products, approval of product label prior to marketing, and approval and monitoring of promotions and advertisements. International standards and guidelines such as those recommended by the WHO, USP or BP, FAO and Codex Alimentarius are used as a basis in the formulation and implementation of rules and regulations governing the manufacture, importation, exportation, distribution, or sale of food and drugs. Compliance with the requirements of good manufacturing practice is the basis criterion for licensing food and drug establishments, while safety, efficacy and good quality are the criteria for registration of products. Although cigarettes are not regarded as food or drug, the labeling and promotion of such is being regulated by the Bureau because of the hazard posed to public health.

Drug and Narcotic Control↗
PubMed2006

WHO expert committee on specifications for pharmaceutical preparations. Fortieth report.

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. The report is complemented by a number of annexes. These include: a list of available International Chemical Reference Substances and International Infrared Spectra; supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms; updated supplementary guidelines on good manufacturing practices for the manufacture of herbal medicines; supplementary guidelines on good manufacturing practices for validation; good distribution practices for pharmaceutical products; a model quality assurance system for procurement agencies (recommendations for quality assurance systems focusing on prequalification of products and manufacturers, purchasing, storage and distribution of pharmaceutical products); multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability; a proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms; and additional guidance for organizations performing in vivo bioequivalence studies.

Drug Industry↗
PubMed1994

Organization and targets of the prior informed consent notification scheme. Part II. Field operation.

The problems associated with the misuse of pesticides are numerous and have been well documented. These are mainly the result of lack of regulations on: a) the introduction and use of pesticides; b) inadequate training of regulators, distributors and users; c) shortage of appropriate information on the nature and impact of pesticide use; and d) inadequate facilities for enforcement of control measures. To address these issues, including the issue of the export of pesticides which have been banned or severely restricted in industrial countries, the International code of conduct on the distribution and use of pesticides was adopted in 1983 by the FAO Conference and amended in 1985 to incorporate provisions for prior informed consent (PIC) procedures. Field activities on the code of conduct and on PIC are described.

Information Systems↗
PubMed1975

Environmental mutagenesis: evolving strategies in the USA.

A recent Environmental Mutagen Society report (the "Committee 17" report) made recommendations regarding the screening of environmental mutagens and the use of the resulting data. It is important in this respect to employ highly sensitive tests which detect heritable genetic damage of all possible molecular types. Mutagens of artificial origin which are being considered for continued production must be characterized with respect to their level and pattern of distribution and their persistence in the environment in order to perform realistic risk evaluations. Risk evaluation itself, particularly the summation of the effects of numerous distinct mutagens, may be assisted by adopting a common measure of mutagenicity such as the REC (rem-equivalent-chemical). Finally, the Committee 17 report laid out highly specific recommendations concerning maximum permissible exposures to environmental mutagens. Federal regulatory agencies and their enabling legislation are in fact evolving toward the effective control of this highly complicated problem.

Environmental Exposure↗
PubMed1993

The drug regulatory and review process in Guyana.

After the old "Sale of Food and Drugs" Ordinance, Cap. 144 was repealed, the new Food and Drugs Act was enacted in 1971. This new Act has considerable flexibility and gives the Minister extensive authority to make Regulations (for carrying out the purposes and provisions of the Act). The Act controls the manufacture, importation, sale, advertising, labeling, packaging, and distribution of drug samples, and the testing of drugs. The Act also controls raw materials and finished products of drugs at the point of entry into the country, with a single agency coordinating both the inspection and analytical services. Developing countries could ensure the procurement of safe, good quality, and effective drugs and devices with the enactment of a similar Food and Drugs Act only. Rapid assessment of Drug Safety, Quality and Efficacy is done through Guyana's participation in the WHO Certification Scheme on the Quality of Pharmaceutical Products moving in International Commerce. This certification scheme is highly commendable especially to third-world countries. The Food and Drug Regulations (1977) have several unique features for drug, cosmetic and device control and they allow for a system of centralized control with limited staff to enforce the legislation. In summary, enforcement of legislative control of imported pharmaceuticals and product evaluation can be considered strong points in the drug regulatory and review process in Guyana. A cautious attitude is observed so as to ensure efficacy, safety, and quality of drugs entering the market. This Drug Regulatory and Review Process is recommended for implementation by third-world countries with outdated drug legislation.(ABSTRACT TRUNCATED AT 250 WORDS)

Drug Evaluation↗
PubMed1976

[Drug safety--achievable goal or utopia?].

The new German Drug Law, recently passed by the Bundstag (House of Representatives) endeavors to assure safety in drug distribution and use, especially to guarantee the harmlessness of drugs according to the regulations provided by the law. The following contribution tries to analyze how far we have come up to now as to a safe use of drugs, which improvements are possible, what they will cost, and finally who of us must contribute towards a rational compromise between therapeutic success and unavoidable risk.

Drug Packaging↗