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Lancet. 1992 May 23; 339(8804):1287.1200 delegates from 175 member countries attended the 45th World Health Assembly in Geneva. Everyone at the Assembly ratified measures to prevent and control AIDS. 12 countries intended to do long term planning for community based care for AIDS patients. Further the Assembly denounced instances where countries and individuals denied the gravity of the AIDS pandemic. In fact, it expressed the importance for urgent and intensive action against HIV/AIDS. The assembly backed proposals to prevent and control sexually transmitted diseases that affect AIDS patients, especially hepatitis B. For example, in countries with hepatitis B prevalence >8% (many countries in Sub-Sahara Africa, Asia, the Pacific region, and South America), health officials should introduce hepatitis B vaccine into their existing immunization programs by 1995. By 1997, this vaccine should be part of all immunization programs. The Assembly was aware of the obstacles of establishing reliable cold chains for nationwide distribution, however. Delegates in Committee A objected to the fact that >50% of the populations of developing countries continued to have limited access to essential drugs. They also expressed disapproval in implementation of WHO's 1988 ethical criteria for promotion of drugs which WHO entrusted to the Council for International Organisations of Medical Sciences (CIOMS). CIOMS lacked WHO's status and thus could not effectively monitor drug advertising. In fact, the pharmaceutical industry as well as WHO provided the funds for a meeting of 25 experts to discuss principles included in the ethical criteria. At least 4 countries insisted that WHO have the ultimate authority in monitoring drug advertising. Delegates did adopt a compromise resolution on this topic which required that industry promotion methods be reported to the 1994 Assembly via the Executive Board. The Assembly requested WHO to establish an international advisory committee on nursing and midwifery and to improve the network of WHO collaborating centers which help national nursing groups.
CONTRACEPTIVE TECHNOLOGY UPDATE. 1989 Jun; 10(6):77-81.Although generic oral contraceptives (OCs) are bioequivalent to brand-name formulations, many family planning professionals do not prescribe the significantly lower-priced generics. The Planned Parenthood Federation of America, for example, has refused to approve generic OCs for use in the organization's clinics, presumably because of concerns about their equivalent efficacy and safety. However, much of this skepticism may be fueled by misleading marketing by brand-name OC manufacturers. Sales representatives have reportedly told clinicians that generic OCs can be as much as 20% different from brand-name formulations, despite evidence collected by the US Food and Drug Administration confirming that there is virtually no difference except in terms of inert ingredients. In the case of many formulations, the variability between the generic and brand-name products is no different than the variability found between different lots of the same brand-name drug. Another obstacle to wider use of generic OCs is that discounts for large volume purchases make brand-name OCs the best buy for family planning clinics. Clinicians also note that clients complain of minor side effects whenever OC brands are changed, even if the compounds are the same. As the price of medication continues to rise, the more widespread availability of generic OCs will be especially important for teenagers and other low-income clients.
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.
In: Proceedings of the International Conference on Oral Rehydration Therapy, June 7-10, 1983, Washington, D.C., edited by Richard Cash. Washington, D.C., AID, International Center for Diarrhoeal Disease Research, Bangladesh [ICDDR/B], United Nations Children's Fund [UNICEF], and the World Health Organization [WHO], 1983. 156-9. (International Conference on Oral Rehydration Therapy, 1983, proceedings)In 1969 the World Health Organization (WHO) arranged for trials of oral rehydration salts (ORS) production. The formula that was developed contained the following basic ingredients per liter of water: 20.0 grams of glucose anhydrous, 3.5 grams of sodium chloride, 2.5 grams of sodium bicarbonate and 1.5 grams of potassium chloride. As the product has become more widely used, a problem with its stability has been discovered, due to the interaction of glucose and sodium hydrogen carbonate. The stability problem was solved in some developing countries by packing glucose or bicarbonate separately, but the solution was not feasible in some countries due to a lack of necessary facilities or funds to maintain them. Based on WHO initiated testing, trisodium citrate offered the best prospects as a substitute for bicarbonate. It should be noted that the present ORS formulation is not discredited by the citrate alteration. If the bicarbonate formula is to be produced it should be packaged in a number of ways including aluminum foil, polyethylene bags, or 2 separate bags, depending upon where or when they will be distributed. The citrate formula should be packaged in aluminum foil, polyethylene bags, or paper/polyethylene laminations, depending upon use. Choice of formula and packing material depends also on the quantity to be produced. Small amounts of ORS can be prepared in hospital pharmacies for in and outpatients. Quantities of more than 2 million packets per year are easier to fill with semiautomatic equipment. Quantities of 4 million or more are more conveniently filled with an automatic machine. In most cases locally produced ORS is no less expensive than imported packets, but they offer advantages like the ability to respond immediately in an emergency and freedom to choose a dosage that is adapted to a standard size container for the country. Flexibility to produce ORS according to local needs and the principle of self reliance are also important advantages of locally produced ORS.
Oxford, United Kingdom, OXFAM, 1982. 277 p.Third World countries face foreign domination of their drug markets, a glut of overpriced and unnecessary medicines, a short supply of essential drugs, technical obstacles to local production, unethical promotion techniques, and inadequate warnings about the side effects of certain drugs that may be banned in the developed world. However, a number of small-scale grass roots projects are attempting to redress this situation. For example, Gonoshasthaya Kendra (People's Health Center) in rural Bangladesh operates a pharmaceutical factory which manufactures inexpensive, essential generic drugs. Profit margins are set lowest on drugs considered most useful, and research and development are tailored to local needs. In addition, countries such as Sri Lanka and Mozambique have adopted comprehensive national drug policies that give priority to essential drugs for primary health care. To make the benefits of modern medicine more available to the poor, Third World governments must prioritize preventive and primary health care services and reallocate resources to the poor majority. National drug policies should include identification of essential drugs, compulsory use of generic names, balanced drug information sheets for prescribers and patients, establishment of an efficient public sector drug distribution system, controls on private distribution, and strict curbs on promotion. Medical training should be rooted in social and economic realities so health workers become oriented toward prevention. Also, the schools, mass media, and community organizations should be used to challenge people's dependence on drugs. The success of new drug policies requires the support of the major drug producing nations. These nations should increase their financial support to UN programs aimed at the needs of developing countries and should not obstruct the World Health Organization in its work on an international code of drug marketing practices. Nongovernmental agencies should publicize examples of constructive policy initiatives and continue to fund community health projects that avoid high technology options. The major transnational drug companies should be consistent in the standards they apply, regardless of loose controls in developing countries, and should demonstrate social responsibility by not creating a demand for nonessential preparations.