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Geneva, Switzerland, WHO, Action Programme on Essential Drugs, 1993. ii, 87 p. (WHO/DAP/93.1; DAP Research Series No. 7)The WHO Action Program on Essential Drugs has developed and field tested a core set of drug use indicators capable of describing drug use patterns and prescribing behaviors in a country, region, or individual health facility. These indicators can be used to measure the impact of interventions designed to change prescribing practices, detect performance problems, and compare the performance of providers and institutions. Three categories have been developed: 1) prescribing indicators--average number of drugs per encounter, percentage of drugs prescribed by generic name, percentage of encounters with antibiotic prescribed, percentage of encounters with injection prescribed, and percentage of drugs prescribed from essential drugs list or formulary; 2) patient care indicators--average consultation time, average dispensing time, percentage of drugs actually dispensed, percentage of drugs adequately labelled, and patients' knowledge of correct dosage; and 3) facility indicators--availability of copy of essential drugs list or formulary and availability of key drugs. All data required to measure the core indicators can be derived from medical records or direct observation. Field testing in developing countries such as Nigeria and Tanzania found these measures both feasible to obtain and informative as first-level indicators. Also presented are descriptions of key issues related to study design and sampling, field methods, analysis, and follow up.
Washington, D.C., National Academy Press, 1981. 22 p. (Contract AID/ta-C-1428)2 essential direct interventions in management of acute diarrheal diseases, oral rehydration and continued feeding, are summarized. Recent estimates of the global problem are that more than 500 million episodes of diarrhea occur yearly in infants and children under 5 years of age in Asia, Africa, and Latin America. 5 million deaths from diarrhea have been reported each year. Dehydration is the major cause of the immediate morbidity and mortality of children with diarrhea. Oral rehydration techniques may assist and reverse progression to severe dehydration and thereby are highly efficient in managing diarrheal disease. Formula selection, preparation of ingredients, distribution of oral rehydration solution, economic considerations, and cost-effectiveness of therapy programs are the primary concerns for those using oral rehydration. Formula selection should take into account the quantity of sodium, potassium, bicarbonate, and glucose in the formula. Preparations should be made so they can be done in the household rather than in national agencies. Centralized national packaging is recommended to standardize the salt/sugar mix. Measuring spoons and containers are also important in the packaging. Distribution should be accomplished by government or private agencies. The home preparation is the most economical. The effectiveness of the program is an important consideration. It is recommended that 2 different formulas be introduced into the community: a simpler lower sodium formula for home preparation and the more complex World Health Organization solution for supervised use in the health center. Continuation of feeding is important during and after diarrheal illness. Anorexia, nausea, vomiting, and abdominal cramps, may accompany acute infection. Cow milk may help produce symptomatic fermentative diarrhea, however breastfeeding should be continued. Fruits, vegetables, and sources of protein should also be fed to patients with diarrhea. Deleterious effects may occur if a patient fails to continue eating. A community system of surveillance and education should be developed to control diarrheal disease.
Geneva, Switzerland, WHO, 1980. (WHO Technical Report Series No. 645)In this report of the World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Preparation, focus is on the following: 1) quality assurance in pharmaceutical supply systems; 2) revisions of the International Pharmacopoeia (methods of drug analysis, monographs for pharmaceutical raw materials, monographs for dosage forms, monographs for pharmaceutical aids); 3) international chemical reference substances for pharmaceuticals (reports from the WHO Collaborating Center, certificates, secondary reference substances, international cooperation, revision of guidelines); 4) quality requirements for oral dosage forms (tests for solid oral dosage forms, tests for liquid oral dosage forms, guidelines for in-process control of the manufature of some types of dosage forms); and 5) basic tests (basic tests for pharmaceutical substances, simple tests for the absence of gross degradation, basic tests for tablets and capsules, publication of basic tests). The Committee concluded that the term "quality assessment" was appropriate to the activities of governmental agencies who have been authorized to assess by inspection, surveillance and other means how closely manufacturers and distributers comply with drug quality requirements. Manufacturers are considered fully responsible for the quality of their products.
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.
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.
Tropical Doctor. 1984 Jan; 14(1):8.Enormous problems in developing countries concerning drug supply, such as inadequate control of money spent on drugs, insufficient government supervision of the importation and distribution of drugs, dumping, and so on, prompted the World Health Organization to set up an expert committee to compile a list of drugs which would provide adequate health care. This Essential Drug list is intended to extend the accessibility of the most necessary drugs to those populations whose basic health needs could not be met by the existing supply system. In cooperation with Medicus Mundi Nederland the use of this basic list is investigated in a population of medical doctors in Africa, sent out by Medicus Mundi. Investigated were: actual use of the essential drug; use of other drugs in the same pharmacotherapeutical group; priority; availability; and suppliers. In addition, insight into a number of other factors, such as the number of patients, beds, stocklists, local production, and supply of information, was obtained. The total number of patients in the combined areas was about 3,500,000. It was found that 3% of WHO's suggested drugs were not used at all, 22 essential drugs were used by only 5% of the doctors, and 41 essential drugs were used by more than 95% of the doctors. In the 1979 Revised List 25 drugs had been added and 10 deleted, compared with the 1st list, although it should be remembered that the differences were not always great. Several essential drugs mentioned for the 1st time in the Revised List are little used. Some complementary drugs scored better than the essential drugs from the same group. A number of drugs not mentioned in the List of Essential Drugs have a high priority. The results of the inquiry will be useful to evaluate the list further.
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.
In: Zatuchni GI, Sobrero AJ, Speidel JJ, Sciarra JJ, ed. Vaginal contraception: new developments. Hagerstown, Md., Harper and Row, 1979. 66-81.Although condoms are still produced from a variety of materials, the popularity of the condom increased mainly after the dipped latex process was developed in the 1930s. Condoms went with US troops all over the world during World War Two. It is only in recent years that strict quality standards were established. Many countries, including the US, measure quality in the number of pinholes acceptable per unit, the number of acceptable holes varying considerably between countries. Japan has made a standard based on leakage as measured by sodium ion concentration. Various types, colors, names, and sizes of condoms are popular in different countries. Large scale distribution in recent years has raised the question of shelf life. It is generally thought that a condom kept in a sealed tinfoil package will stay good indefinitely. Nonetheless, for management as well as safety purposes smaller shipments are preferred over large shipments in mass distribution programs. Condom popularity is partly associated with the number and accessibility of distribution points; therefore, it has become more prevalent to use both government units and regular commercial distribution points for popularizing the condom, and there is reason to believe that this type of program will grow. In light of the current interest in integration of contraceptive programs with health care and development efforts, population specialists should look closely at the condom and the commercial resources available for its distribution. A series of tables gives gross numbers of condoms supplied by international donor agencies in the developing countries, 1975-78.
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)
San Francisco, San Francisco Press, 1974. 292 p.Despite its high effectiveness, lack of side effects, ease of use, and low cost, condom utilization has declined in the U.S. from 30% of contracepting couples in 1955 to 15% in 1970. The present status of the condom, actions needed to facilitate its increased availability and acceptance, and research required to improve understanding of factors affecting its use are reviewed in the proceedings of a conference on the condom sponsored by the Battelle Population Study Center in 1973. It is concluded that condom use in the U.S. is not meeting its potential. Factors affecting its underutilization include negative attitudes among the medical and family planning professions; state laws restricting sales outlets, display, and advertising; inapplicable testing standards; the National Association of Broadcasters' ban on contraceptive advertising; media's reluctance to carry condom ads; manufacturer's hesitancy to widen the range of products and use aggressive marketing techniques; and physical properties of the condom itself. Further, the condom has an image problem, tending to be associated with venereal disease and prostitution and regarded as a hassle to use and an impediment to sexual sensation. Innovative, broad-based marketing and sales through a variety of outlets have been key to effective widespread condom usage in England, Japan, and Sweden. Such campaigns could be directed toward couples who cannot or will not use other methods and teenagers whose unplanned, sporadic sexual activity lends itself to condom use. Other means of increasing U.S. condom utilization include repealing state and local laws restricting condom sales to pharmacies and limiting open display; removing the ban on contraceptive advertising and changing the attitude of the media; using educational programs to correct erroneous images; and developing support for condom distribution in family planning programs. Also possible is modifying the extreme stringency of condom standards. Thinner condoms could increase usage without significantly affecting failure rates. More research is needed on condom use-effectiveness in potential user populations and in preventing venereal disease transmission; the effects of condom shape, thickness, and lubrication on consumer acceptance; reactions to condom advertising; and the point at which an acceptable level of utilization has been achieved.