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  1. 1
    269291

    International regulation of the supply and use of pharmaceuticals.

    Medawar C

    DEVELOPMENT DIALOGUE. 1985; (2):15-37.

    This paper discusses the principles involved in formulating international standards to regulate the appropriate use of drugs. It focuses particular attention on the role of the World Health Organization (WHO) in organizing this. The following questions are addressed: What is meant by the appropriate use of drugs? What are the main determinants of appropriate drug use that all the main actors agree on? How appropriately are drugs used today? To what extent are the standards agreed on in principle actually observed in practice? Is regulation called for? What kind of regulation is appropriate? What standards would meet the needs of all countries? Appropriate drug use is the provision of drugs to people who really need them and restiction of the supply of drugs to those who don't need them. Primary health care requires a continuous supply of essential drugs. As many as 70% of the pharmaceuticals on the market today are inessential and/or undesirable products, and many pharmaceutical products are marketed today with little concern for the differing health needs and priorities of individual countries. Few countries systematically monitor drug prescribing standards and consumption patterns. There is chronic and serious under-reporting of adverse reactions to drugs. Regulation implies control over the activities of the main drug producers. This requires international initiatives, since an essentially transnational industry is involved. Transnational corporations dominate the world market for drugs. All pharmaceutical products must be approved and registered for use by the competent government authority. All pharmaceutical products shall have full regard to the needs of public health.
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  2. 2
    269289

    The rational use of drugs and WHO [editorial].

    DEVELOPMENT DIALOGUE. 1985; (2):1-4.

    On November 25-29, 1985, the World Health Organization held a Conference in Nairobi of Experts on the Rational Use of Drugs. In the early 1980s, both the International Federation of Pharmaceutical Manufacturers Association (IFPMA) and Health Action International (HAI) had developed codes of pharmaceutical marketing practices in order to come to terms with the malpractices in this field. A more comprehensive approach was needed, however. Prime responsibility for rational drug use must rest with the member governments, operating through national regulatory authorities and assisted in their work by guidelines on minimum requirements for national drug regulation prepared by WHO. The Dag Hammarskjold Foundation organized a seminar on Another Development in Pharmaceuticals as an independent contribution to the international debate on this global issue. The seminar emphasized that development should be need-oriented, self-reliant, and based on structural transformations. Governments view the pharmaceutical crisis as 1 facet of the more general problem of spiralling health costs which put an intolerable burden on already overstretched welfare services. The pharmaceutical industry sees the crisis largely in terms of excessively restrictive regulations which stifle innovation of products. Some doctors and pharmacists feel that increased regulatory measures will erode their rights to prescribe and to control the supply and information to patients. On the other hand, some clinical pharmacologists and administrators express concern about excessive, irrational and uneconomic prescribing and its effects on public health. Consumer groups define the problem in terms of an overbearing and greedy business community. The general public fail to understand the effects of pharmaceuticals.
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  3. 3
    267011

    On a national drug policy for Bangladesh.

    Islam N

    Tropical Doctor. 1984 Jan; 14(1):3-7.

    On April 27, 1982 the Ministry of Health of the government of Bangladesh, set up an 8-man expert committee to evaluate all the registered pharmaceutical products presently available, and to formulate a draft National Drug Policy. Objectives are: 1) to provide support for ensuring quality and availability of drugs; 2) to reduce drug prices; 3) to eliminate useless, nonessential, and harmful drugs from the market; 4) to promote local production of finished drugs; 5) to ensure coordination among government branches; 6) to develop a drug monitoring and information system; 7) to promote the scientific development and application of unani, ayurvedic, and homeopathic medicines; 8) to improve the standard of hospital and retail pharmacies; and 9) to insure good manufacturing practices. 16 criteria were agreed on as guidelines for evaluating the drugs on the country's market. Drugs in Bangladesh have been classified into 3 categories. The 1st is drugs that are positively harmful. They should be banned immediately and withdrawn from the market. There are 265 locally manufactured drugs and 40 imported drugs in this category. The 2nd, drugs to be slightly reformulated by eliminating some of their requirements. There are 134 drugs in this category. The 3rd is drugs that do not conform to 1 or more of the 16 criteria/guidelines. There are over 500 drugs in this category. The new drug policy will produce a saving of 800 million taka (US $32.4 million). Drug supply in Bangladesh is a problem. The public sector distributes 20% of the total. In the private sector, drugs are supplied through import and local production. Investment for research by the pharmaceutical companies is essential. The principles laid down by the International Federation of Pharmaceutical Manufacturers Associations for the supply of good medicine needs to be put into practice.
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  4. 4
    765989

    Contraceptive development for developing countries: unmet needs.

    PERKIN GW; DUNCAN GW; MAHONEY RT; SMITH RH

    Proceedings of the Royal Society of London, B. 1976 Dec 10; 195(1118):187-198.

    In the past 15-20 years there have been advances in fertility regulation. These advances are modest gains that frequently involve a bioengineering input, include collaboration between public agencies and industry, and are closely related to the needs of developing nations. They are the result of the existence of specialized programs whose major goal is the development of new technology. However, a similar specialized public mechanism to undertake the wide range of activities related to product development and introduction of the new technology into family planning does not exist. The 3 major phases of the contraceptive development process are biomedical development, product development, and product introduction-market development. There are 4 areas that require more attention. The 1st of these is a product development laboratory that would accept responsibility for dosage form development, stability testing, quality control procedures, product and packaging modifications, and the production of supplies for biomedical research. Such a laboratory would increase the acceptability of existing methods and promote new developments. Also needed is a contraceptive information service, offering ''full disclosure'' product-related information to managers of family planning programs. A 3rd need is for a patent and licensing administration for the public sector; this would assure that new contraceptives developed with public funds would be made widely available to family planning programs at a reasonable cost. Finally, there is a need to establish a contraceptive introduction planning unit that would consider the program implications of new methods of fertility control and aid countries in planning for their introduction. The availabiltiy of a specialized capacity to take responsibility for public leadership in these 4 areas would contribute greatly to the development of new contraceptive methods that are appropriate to the needs of developing countries and to the success of present international contraceptive research and development efforts.(Authors', modified)
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