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[Geneva, WHO, 1980]. 45 p.As part of a series of WHO-designed training modules on developing a national program (in a developing nation) for the control of diarrheal diseases, this volume teaches how to determine logistical problems of supply and distribution of therapeutic modules for control of diarrheal disease. In this module, the student is expected to learn how to determine the quantity of oral rehydration salts (ORS) necessary in Fictitia, a wholly made up country, data on which is published in another module in this series called "Fictitia" PIP/802686, to recommend a distribution system for Fictitia, to determine the number of ORS packets the program manager needs to stock for proper inventory in Fictitia, to specify a schedule for reordering ORS packets in Fictitia, to determine the cost of local production of ORS in Fictitia, and to recommend whether Fictitia should produce its own ORS by target date 1986 or import the ORS the country needs.
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.
[Unpublished] . 8 p.A study tour was undertaken by the Social Marketing Project in Bangladesh to observe production facilities of oral rehydration salt (ORS) in Bangkok, Manila, and Bombay. This report describes raw materials, plants and equipment, methods and procedures, and quality control for each country. In Thailand the Government Pharmaceutical Organization, under the Ministry of Health, supervises ORS production. ORS has been produced for the last 3 years and presently about 200,000 packets/month (equivalent of 1 litre solution) are being produced, following the World Health Organization (WHO) UNICEF formulations. The Ministry of Health in Manila has been providing ORS based on the WHO formulations for the past 6 years. Currently production is about 2 million packets with proper equipment. Distribution is through district health officials and village health workers. As an adjunct to ORS distribution there is a plan to introduce water purification tablets. The Fairdeal Corporation in India is a commercial pharmaceutical organization which produces 2 ORS solutions: 1) Electral which does not include bicarbonate and accounts for about 80% of total production, and 2) Electral Forte which has sodium bicarbonate and is recommended in severe dehydration cases in adults. Their research has shown that the WHO formulation is inadequate for many countries. Presently sales are about 500,000-600,000 packets/month mainly distributed through medical practitioners. This study also found that: 1) organic lipidity of the product is critical for acceptance; the addition of a flavoring agent is considered important especially for acceptance by small children, and 2) closely controlled humidity conditions (30-35%) and temperature (23 degrees Centigrade) are essential to the formulation and increases the life of the salts to 10-15 days even after opening the packs.
Conclusions of the International Medical Advisory Panel (IMAP) on DMPA at its meeting on 14th October 1980.
London, England, IPPF, . 4 p.The International Planned Parenthood Federation (IPPF) supplies 400,000 3-monthly injections of depot medroxyprogesterone acetate (DMPA) each year; this use is estimated to prevent between 30 to 100 deaths per year. Up to 10 million women have used the drug at some time, and more than 1 million and a quarter use it currently. DMPA is registered as a therapeutic agent in cancer treatment in nearly all countries and as a contraceptive agent in over 80 developed and developing countries. The supply of DMPA has never kept pace with the demand in developing countries. Present information fails to indicate that DMPA causes endometrial cancer. It is too early to know if it will always prevent it. Both the WHO and the Biometrics and Epidemiological Methodology Advisory Committee of the U.S. Food and Drug Administration found no evidence of an increased risk of disease of the uterine cervix in women on DMPA. No evidence of increased breast cancer has been found in humans on DMPA. Investigations conducted in Chile, Egypt, Iraq, and Thailand have found that DMPA may increase both milk production and the duration of lactation. The question of possible consequences of the transfer of the steroid to the breast-feeding infant has yet to be resolved. The only clinical metabolic effect attributed to DMPA is weight gain.
[Unpublished] 1980 Sep 9. 16 p.In 1978 the Federal Drug Administration (FDA) banned use of Depo-Provera in the U.S., but the International Planned Parenthood Federation (IPPF) has distributed it in 53 countries since 1971. Although the drug is associated with some side effects, in 6 and a half million women-years of use and monitoring, it has not been associated with any deaths. IPPF supplies approximately half a million doses of Depo-Provera each year. Some of the benefits of Depo-Provera are as follows: reliability; safety for administration in remote or unhygienic locations; cultural acceptability in many parts of the world, e.g., Southeast Asia and Africa; not coitus related nor requiring daily activity by the user; not requiring privacy; and interfering less with lactation than the Pill. An estimated 1 and a half million women worldwide choose Depo-Provera. Compared to the 65 million using the oral pill and 15 million using the IUD, the number is small, but use of injectables is on the rise. Nonapproval of Depo-Provera in the U.S. sometimes restricts its use in other countries. The purchase of Depo-Provera is governed by the prevailing international prices. If the restrictions on the drug were removed and it was available on a large scale, the price would be lowered. There is no perfect contraception. The effects of unlimited pregnancy are well-documented. Women need the greatest possible choice so they can make the best decision in light of their own circumstances.
Some factors influencing the regulation of pharmaceuticals in developing countries, with particular reference to Africa.
International Digest of Health Legislation. 1980; 31(3):453-83.This long review discusses a few of the factors liable to influence attempts at drug regulation in developing countries, i.e., the existing situation with regard to pharmaceuticals and some of the manifold factors (psychosocial, geopolitical, etc.) that are likely to affect legislation, particularly in countries recently achieving independence, as well as all developing countries. Sections in the monograph include, an analysis of the present situation of pharmaceutical distribution and regulation in developing countries; problems in the regulation of pharmaceuticals in Africa; analysis of legislation already in force (including those countries which have communicated their legislation to WHO and those who have not and why); adequacy of pharmaceutical supplies and approriateness of legislation; priorities (e.g., pricing, regulation, importation, distribution, quality control, and substance control); and problems connected with enforcement of legal measures (e.g., unguarded frontiers, inadequacy of administration, regional uniformity of legislation, and shortage of qualified pharmacy and medical personnel). The monograph ends with published pharmaceutical legislation in developing countries, from Algeria to Zambia.
[Unpublished] 1980. 13 p.UNICEF and WHO are jointly sponsoring an education and supply program of oral rehydration therapy for the treatment of diarrheal diseases in developing countries. Studies on the feasibility, acceptability, and effectiveness of (ORS) oral rehydration salts have been conducted in many developing countries and have proven the worth of the therapy. The UNICEF/WHO program seeks to provide wide distribution and educational activities in these areas. General public health education will help the population in medical self help in the area of diarrheal diseases. For countries which have reached the appropriate state of program development, aid in establishing manufacturing facilities for ORS should be the next step. The UNICEF-supported program has plans for operation in at least 51 national programs. Tables present the level of UNICEF support which has already been provided in a great many countries, categorized by region.
In: Files LA, ed. Research on the management of population programs: an international workshop. Chapel Hill, NC, Univ. of NC, School of Public Health, Dept. of Health Administration and the Carolina Population Center, 1980. 91-108.There are 2 types of government-sponsored national family planning programs, those which operate within narrowly-defined parameters and recognize local constraints and those which, with the support of politicians, aim at all the national population problems. The trend has been toward the 2nd, more comprehensive type of program. Since population programs in most countries began as medically-based family planning programs, they have been cut off from broader affiliations. Once domestic funding increases, the programs will gain autonomy in program direction. The World Bank offers program funds aimed at establishing effective management policies for the national population programs. A 1st step in Bank funding is an assessment of organizational and managerial problems. The Bank also focuses on management and personnel at the micro level. Most Asian programs are felt to be strong and effective; Latin American programs fall slightly behind the Asian programs; programs in Africa lag far behind. Immediate future steps for the programs in each of the continental regions are outlined. A summary of management components in Bank population projects in several selcted countries is presented. A funding summary for these management activities is tabulated.