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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
    797957

    Family planning in Colombia: a profile of the development of policies and programmes.

    International Planned Parenthood Federation [IPPF]

    London, IPPF, 1979 Oct. 47 p.

    The development of family planning programs in Colombia is outlined in this IPPF (International Planned Parenthood Federation)-sponsored report. Introductory demographic data are provided including information on the geography, economy, population dynamics, and available health services; this section is followed by a discussion of the government policy, which first became evident in 1968 with the inception of the national Maternal Child Health (MCH) program; the development of this program was in the face of active Catholic opposition and active leftwing proponents. Through 1979 the MCH program is still functioning with 100,000 new acceptors/year; in addition, the government only minimally inhibits the actions of nongovernment programs, such as PROFAMILIA, and allows for liberal regulations on such matters as prescription of contraceptives. The report then details the developments of individual family planning programs, some of which failed to survive the politically turbulent 1970s, e.g., ASCOFAME (Asociacion Colombiana de Facultades de Medicina), and others of which remain viable, e.g., PROFAMILIA; both of these programs are basically medical and have resulted in the following statistics of contraceptive protection from .1 in 1965 (per 1000 woman/years)-484.2 in 1975. Details of funding are provided, and expenditures and costs are presented tabularly. In addition to clinic programs, rural programs such as CBD (an adjunct of PROFAMILIA) were pioneered in Colombia, the structure of which has been emulated by all other field programs. Aspects of marketing (social marketing and mail order, e.g.,) are described and the personnel structure of PROFAMILIA is outlined. External funding of PROFAMILIA represents about 65% of its funding, and locally derived income provides the additional 35%.
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  5. 5
    268487

    Evaluation of UNFPA assistance to the family planning programme of the Dominican Republic, 1978-1982/3.

    Requena M; Echeverry G; Frieiro LB

    New York, New York, United Nations Fund for Population Activities [UNFPA], 1983 Aug. xii, 48, [11] p. (DOM/73/P01)

    This evaluation was carried out by an independent mission coordinated by the United Nations Fund for Population Activities (UNFPA) Evaluation Branch. The program's long-term objectives are to reduce the birth rate to 29/1000, reduce mortality rates, achieve a sustained reduction in fertility rates and to devise and implement a specific population policy. Immediate objectives are to acheive the functional integration and financial self-sufficiency to carry out family planning programs, offer family planning services to the entire population and increase the demand for them, to offer new methods, especially female sterilization, and alter the distribution of users by method; increase active users to 22% of the country's women and to increase the availability of health personnel. In general, the Evaluation Mission found that the project documents describing the objectives to be achieved, strategy, activities and inputs do not elaborate sufficiently on the relationship between objectives and activities and the inputs required and do not give details about the strategy for achieving objectives. The birth rate was estimated at 34.5/1000 in 1982. Infant mortality seems to be declining particularly fast in areas with active rural health promotors. No specific population policy has been enuciated. The program has, to a large extent, achieved the immediate objectives set for it, except that of financial self-sufficiency. The program's strongest elements are the considerable expansion of the physical and health personnel infrastructre; political and institutional willingness to carry out integrated maternal and child health and family planning programs; and the great demand for family planning services by the population. Week elements which have hindered the program's progress are the abence of a tradition of public health and preventive medicine in the country, which has resulted in inadequate training of medical personnel and a lack of motivation, and the extreme centralization of the health system and the consequent lack of delegation of authority and resources which limits the initiative and action of personnel at supposedly operational levels. Other weaknesses are the cultural models which favor authoritarianism and paternalism; the stressing of a clinic-based service delivery system as opposed to the Primary Health Care approach; the lack of direct information education and communication (IEC) action in the communities; the lack of a strategy to gather the knowledge existing in such communities to incorporate it in the joint planning of services, and deficiencies in supervision and evaluation which are aimed at measuring goals and results but not at identifying and analyzing problems.
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