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Geneva, Switzerland, WHO, . 27 p. (WHO/DAP 92.5)Drugs play an important role in protecting, maintaining, and restoring health. The marked increase in the number of pharmaceutical products marketed in recent years has not, however, made the necessary drugs available to all people and has not been matched by a proportionate improvement in health. In recent decades, it has been difficult for developing country governments to procure drugs and vaccines at reasonable prices. Even when they can afford modern products, their regulatory control, equitable distribution, and rational use by both prescribers and the public have posed large problems. Purchased drugs do not necessarily meet health priorities or end up where they are most urgently needed. The World Health Organization (WHO) therefore established the Action Program on Essential Drugs in 1981 to provide operational support to countries in the development of national drug policies based upon essential drugs and to work toward the rational use of drugs. The action program seeks to ensure that all people are able to obtain the drugs they need at a price they and their country can afford; that the drugs are safe, effective, and of good quality; and that they are prescribed and used rationally. This brochure describes the activities of the WHO program in sections on the essential drugs concept, how many drugs are really needed, the work of the action program, key elements of a national drug policy, using drugs rationally, the program and research, global partners, and the future outlook.
WORLD HEALTH ORGANIZATION TECHNICAL REPORT SERIES. 1992; (823):i-vi, 1-134.The WHO Expert Committee on Specifications for Pharmaceutical Preparations reports that several national and regional drug regulatory authorities have adopted guidelines for good manufacturing practices for drugs similar to those recommended by the Committee. Annex 1 discusses these practices and makes up most of the Committee's 32nd report. The report also presents provisional guidelines on inspection of pharmaceutical manufacturers. It reviews the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce. The Committee-endorsed scheme depends on a more effective exchange of information to more rigorously control all international trade of pharmaceuticals. Chapter 6 looks at the international pharmacopoeia and related activities, including quality specifications for drug substances and dosage forms, validation of analytical procedures, a simple test methodology, national laboratories for drug surveillance and control, and quality control of products derived from medicinal plants. The report discusses and lists the International Chemical Reference Substances and International Infrared Reference Spectra. it also addresses stability of dosage forms and extemporaneous preparations. Annex 4 presents guidelines to guarantee the quality of pharmaceutical and biological drugs prepared by recombinant DNA technology. Another annex looks at validation of analytical procedures used to examine pharmaceutical materials. The last annex discusses the protocol for a proposed study on the quality of some drugs at the point of use in developing countries. WHO has already asked Benin, Guinea, Mozambique, Uganda, and Tanzania in Africa, Bangladesh and Myanmar in Asia, and Guatemala and Peru in the Americas to participate.
In: Mectizan (Ivermectin) and the Control of Onchocerciasis: Strengthening the Global Impact. A symposium sponsored by Merck and Co., Inc. marking the fifth anniversary of the donation of Mectizan for the treatment of onchocerciasis and held with the technical cooperation of the World Health Organization at the Hudson Theater in New York on September 23, 1992. Summary proceedings of the symposium. Rahway, New Jersey, Merck and Company, 1992. 59.In 1987 the availability of Mectizan and its potential for preventing onchocerciasis triggered a series of strategy discussions within the network of nongovernmental organizations (NGOs) concerned with blindness prevention in developing countries. The nucleus of the NGO network had formed in 1975 with the creation of the International Agency for the Prevention of Blindness (IAPB) and meets annually to plan collaboration in developing countries. Since 1982, the IAPB expanded to include a group of organizations involved solely in the nonmedical aspects of blindness, the Partnership Committee. In 1986, a strong relationship was developed between the consortium and the World Health Organization Programme for the Prevention of Blindness (PBL). Since 1988 very real progress has been made in strengthening commitment to long-term treatment with Mectizan. The latest example is the sponsorship of a medical officer post in PBL to coordinate NGO activities related to distribution of the drug. In previous years, several initiatives were undertaken by IAPB and the European Partners for Blindness Prevention (EPBP), including EPBP's obtaining substantial funding from the European Community for treatment programs in 9 African countries. The IAPB network is supported by Sight Savers, which commissioned the first survey of the causes of blindness in West Africa in 1956; it worked with OCP in one of its first programs in northern Ghana; and it set up training for blind adults there. In 1990 Sight Savers appointed a coordinator for its programs for distributing Mectizan in communities in 6 African countries, where 560,000 treatments were targeted in 1992. The NGO members of IAPB have taken the first positive steps in the distribution of Mectizan. The ready availability of free Mectizan has created concern over the ability to expand commitment for blindness prevention and eye care to onchocerciasis treatment programs, however, treatment with Mectizan enhances the success of fund-raising from all sources.
In: Mectizan (Ivermectin) and the Control of Onchocerciasis: Strengthening the Global Impact. A symposium sponsored by Merck and Co., Inc. marking the fifth anniversary of the donation of Mectizan for the treatment of onchocerciasis and held with the technical cooperation of the World Health Organization at the Hudson Theater in New York on September 23, 1992. Summary proceedings of the symposium. Rahway, New Jersey, Merck and Company, 1992. 57.Christoffel-Blindenmission (CBM) is an interdenominational Christian service organization for blind and disabled persons in many of the world's poorest developing countries. It supports more than 300 eye care programs in approximately 70 countries at an annual cost of US $15-16 million. Funded by many individual donors, fund raising activities are conducted in Europe, North America, and Australia. CBM operates through 8 regional offices: 3 in Asia, 3 in Africa, and 2 in Latin America. Program development and evaluation are the responsibility of regional representatives, each of whom uses the services of a medical consultant. CBM's program support is usually long term, based on a recipient's annual budget application and evaluation. Since 1988, CBM has been distributing 200,000 tablets of Mectizan each year to voluntary hospitals in 14 African countries to treat patients with onchocerciasis. CBM also supports community-based treatment programs in Ecuador and Zaire, and, in collaboration with OCP, in Sierra Leone. Plans for 1993 include establishing a program for 600,000 people in the Central African Republic (CAR) in collaboration with the CAR Ministry of Health and the River Blindness Foundation. As an organization, CBM identifies 5 specific barriers to be overcome in developing and sustaining programs of treatment with Mectizan: 1) Poor communication systems in the endemic areas, which require development of an appropriate infrastructure. 2) Lack of health knowledge, which requires a community awareness action. 3) Limited availability of financial resources in the worst-affected countries, requiring a mobilization of funds for long-term commitment. 4) Inadequately-trained personnel, requiring staff training as an integral part of all programs. 5) Affected communities have so many health problems that integration of distribution of Mectizan with already existing or developing primary health care activities is becoming increasingly important.
In: Mectizan (Ivermectin) and the Control of Onchocerciasis: Strengthening the Global Impact. A symposium sponsored by Merck and Co., Inc. marking the fifth anniversary of the donation of Mectizan for the treatment of onchocerciasis and held with the technical cooperation of the World Health Organization at the Hudson Theater in New York on September 23, 1992. Summary proceedings of the symposium. Rahway, New Jersey, Merck and Company, 1992. 61.Helen Keller International (HKI), founded in 1915, is the oldest US organization dedicated to blindness prevention in the developing nations. HKI's early work in xerophthalmia was followed by extensive programs in the provision of primary eye care and cataract services. More recently, the organization has become involved in onchocerciasis control programs. Their philosophy is to provide the kind of technical assistance that builds sustainable infrastructure within a national health program. They prefer to work in countries that have priorities in blindness prevention programs; and where those do not exist, they strive to develop them in cooperation with local authorities. In Burkina Faso and Niger, HKI is working with the local governments to implement surveillance systems that can detect reappearance of onchocerciasis in previously infected areas. In Mexico, HKI will be working with the existing onchocerciasis control program to develop an information system that can improve the efficiency of distributing Mectizan. In Cameroon, HKI is coordinating a program for distributing Mectizan in the Sanaga River Valley; and in Brazil, they are discussing a collaborative program of onchocerciasis control among Indians living on the Venezuela-Brazil border. In each country, they are trying to develop a cadre of persons at the national and local levels who can assume responsibility for programs of treatment with Mectizan as soon as possible. Previous experience with the distribution of vitamin A to control xerophthalmia taught that successful programs exist at the community level only when they involve the people themselves, as well as the health professionals. HKI believes that private, volunteer organizations are uniquely qualified to develop community-based interventions in cooperation with governments and multinational organizations. Such programs in the onchocerciasis-endemic areas will result in economic improvement, self-sufficiency, and improved health.
In: Mectizan (Ivermectin) and the Control of Onchocerciasis: Strengthening the Global Impact. A symposium sponsored by Merck and Co., Inc. marking the fifth anniversary of the donation of Mectizan for the treatment of onchocerciasis and held with the technical cooperation of the World Health Organization at the Hudson Theater in New York on September 23, 1992. Summary proceedings of the symposium. Rahway, New Jersey, Merck and Company, 1992. 47-8.The large-scale, phase IV clinical field trials of ivermectin (Mectizan) conducted by the UN Development Program/World Bank/World Health Organization Special Programme for Research and Training in Tropical Diseases (TDR) and the Onchocerciasis Control Program in West Africa (OCP) are complete. They showed the drug to have a good safety profile and efficacy. With annual treatment, Mectizan can improve early anterior segment eye lesions and arrest the development of blindness. Clinical field trials also demonstrated that, in Africa, mass treatment with Mectizan reduces transmission of Onchocerca volvulus to about 40% of its original level, but this is insufficient to eliminate the disease solely by drug treatment. However, in Guatemala, trials with Mectizan showed that transmission could be reduced to zero. Thus, it would seem that continued use of the drug for longer than the lifetime of adult parasites in the body might be enough to eliminate onchocerciasis without the need for insecticide spraying. TDR also has been funding studies of operational issues in delivering Mectizan, including: inexpensive, rapid, and efficient methods to identify villages at high risk of disease; better and more cost-effective drug distribution systems carried out at the village level; and community perceptions of the sociocultural importance of onchocercal skin lesions. TDR allocated about $100,000 for the first round of the operational research studies in Nigeria. 11 of 41 proposals were selected for funding, and study results are expected by the end of 1992. Altogether, through 1991, TDR had invested some $3.2 million in studies applicable to the development and use of Mectizan to treat onchocerciasis. In its other onchocerciasis-related research, TDR is working to develop sensitive and specific diagnostic tests and to develop an effective, safe macrofilaricide that will kill adult worms in the human body.
In: Mectizan (Ivermectin) and the Control of Onchocerciasis: Strengthening the Global Impact. A symposium sponsored by Merck and Co., Inc. marking the fifth anniversary of the donation of Mectizan for the treatment of onchocerciasis and held with the technical cooperation of the World Health Organization at the Hudson Theater in New York on September 23, 1992. Summary proceedings of the symposium. Rahway, New Jersey, Merck and Company, 1992. 49-50.For optimal treatment compliance, the large-scale distribution of a drug such as Mectizan presupposes a well-structured support system through both governmental and nongovernmental channels, together with proper education and awareness at the community level. Beginning at the international level, the purpose and effectiveness of programs of treatment with Mectizan in onchocerciasis-endemic countries must be publicized to all development agencies and the community of international nongovernmental organizations. Within the United Nations system and related organizations, the specialized agencies concerned, such as the United Nations Development Programme, the Food and Agriculture Organization of the United Nations, the International Labor Organization, The World Bank, UNICEF, and, in particular, the World Health Organization, are well placed to initiate programs of treatment with Mectizan as part of development work having a bearing on health. Nongovernmental organizations can play a very significant role in various contexts for development of treatment programs by means of: advocacy, at the international, national, and community levels; project expertise and experience from work in developing countries; flexible, grassroots approaches that allow for tackling practical problems in a pragmatic manner; valuable experience from training health personnel and working with local staff in a wide variety of settings; being efficient resource mobilizers; and the possibility and experience of working with the local community considering particular needs and resources. At the national level, it is important that there be proper awareness of the socioeconomic impact of onchocerciasis. The Ministry of Health should play the main coordinating role with respect to support from NGOs and agencies. A policy of integration with primary health care should be implemented.
In: Mectizan (Ivermectin) and the Control of Onchocerciasis: Strengthening the Global Impact. A symposium sponsored by Merck and Co., Inc. marking the fifth anniversary of the donation of Mectizan for the treatment of onchocerciasis and held with the technical cooperation of the World Health Organization at the Hudson Theater in New York on September 23, 1992. Summary proceedings of the symposium. Rahway, New Jersey, Merck and Company, 1992. 29-30.Developing a good drug is a great achievement. However, delivering a particular drug to a target population can be a complex and expensive undertaking. So is delivering a drug such as Mectizan, when the majority of its users live in developing countries where the economic, political and social determinants are unfavorable for health care services. The success or failure of drug delivery systems for tropical diseases depends on: 1) regular production, 2) adequate local administration and management, 3) timely ordering and supply, 4) appropriate storage, 5) good transport facilities, 6) reasonable case identification, and 7) correct prescription and use. Specialized drugs for tropical diseases are often produced in limited batches according to orders received. As a result, critical delays in delivery can occur. In the case of Mectizan, there seems to be no problem with prompt delivery by Merck & Co. once a request for donation has been approved. The multi-disease approach for delivering Mectizan may be one way of economizing on personnel and transport costs. In the Central African Republic, using the established transport network for immunization programs has produced good results. However, since the range of coverage for vaccination purposes does not extend as far as the village level, bicycles had to be provided to take over from the dispensaries. In Uganda, orderlies trained for sleeping sickness surveillance offer potential staff for distributing Mectizan, as do the staff of successful leprosy programs, which are beginning to show interest in combined approaches. In the meantime, the role of the World Health Organization (WHO) is mainly to set internationally acceptable technical standards applicable to the distribution and use of Mectizan and to support research through the UN Development Programme/World Bank/WHO Special Programme for Research and Training in Tropical Diseases.
Immediate and growing needs for help to a fragile new democracy: health in the Russian Federation with emphasis on children and women. Report of a UNICEF / WHO collaborative mission with the participation of UNFPA, UNDP, and WFP, 17 February - 2 March 1992.
[Unpublished] 1992 Mar 17. , 45,  p.From February 17 to March 2, 1992, the World Health Organization and UNICEF conducted a fact-finding mission to the Russian Federation to assess the health of the population, particularly of women and children. These international agencies found a unique situation in which economic adjustment to a market economy has created shortages in this developed nation similar to those encountered in developing countries. After an introductory section, the second section of this report provides background information on the Russian Federation, its economic situation, social protection mechanisms, and social statistics. Section 3 provides an assessment of the state of the health services, immunization programs, pharmaceuticals and equipment, nutrition, and the food situation. The next section discusses the organization of the public school system which may be used to provide nutritional supplements and health education. The rapid decline in environmental quality is then discussed, and examples are provided of some of the effects of this deterioration. The sixth section briefly mentions the three types of nongovernmental organizations available for partnerships and strategic alliances with international donors. Section 7 summarizes the recommendations of the mission. Six areas of assistance (each with several related recommendations) were identified: 1) to support those activities which will allow economic transition to be sensitive to the needs of vulnerable groups and social issues; 2) to provide emergency supplies to the health system through international channels and to foster the rapid rehabilitation of selected national production and distribution systems; 3) to provide technical assistance for the restructuring of the health system; 4) to establish monitoring systems to identify and protect vulnerable groups; 5) to engender support for donor coordination and the facilitation of international assistance; and 6) to support nongovernmental organizations and private partnerships as they attempt to strengthen social safety nets. A basic budget (which totals US $164 million and is separated into urgent and priority needs) is provided. Annexed information includes the construction and utilization of a food basket to monitor food prices, data on breastfeeding, and the highest priority needs for vaccines, drugs, and supplies.
Prevention of tuberculosis in children. Detection and chemotherapy of infectious cases of tuberculosis.
CHILDREN IN THE TROPICS. 1992; (196-197):60-9.Prevention of tuberculosis (TB) in children in developing countries involves 3 interventions: detection and treatment of sources of infection, i.e., adults with pulmonary TB; BCG vaccination of newborns to prevent primary infection and its complications; and prophylactic treatment of newly infected infants. The first element of prevention is reviewed here. In less developed areas, detection and diagnosis of TB entails education of the public and of health providers so that people with chronic cough have sputum sent to regional laboratories for microscopic examination. Rarely, x-ray facilities may also be used. Quality control of laboratory work and universal coverage are essential. The proportion of actual cases of TB diagnosed by microscopy ranges from 5 to 10% in African and Latin American countries to 25% in Asian countries, depending on the prevalence of TB, the age structure of the population, and the quality of the laboratories. Calculated rates of detection are 60-90% however. There are 3 types of infectious TB cases; new cases with smear-positive pulmonary TB (80-90%), previously treated cases who are true or false failures or relapses, and chronic TB cases who probably have resistant organisms. In developing countries, the last group will probably not receive second-line drugs because of the cost, but will be treated with isoniazid alone and are considered unlikely to recover. At the end of standardized treatment, there are 6 classes of patients: cured cases, probable cures, failures or relapses, decreased, lost to follow-up, and move to another district for care. World Health Organization objectives for rate of cure will probably be modified in given countries due to financial limitations.
HEALTH POLICY AND PLANNING. 1992 Jun; 7(2):164-76.The basic intent of the Bamako Initiative, which is supported by African Ministers of Health, WHO, and UNICEF, was to provide longterm sustainability of primary health care (PHC) by strengthening community mobilization and using community resources, and strengthening district level health services. National government would focus on the referral system. Consideration in this article is given to important issues that have arisen since its inception in 1987, the policy framework, key components, the global action, country progress (Benin, Guinea, Kenya, Nigeria, Sierra Leone, Togo, Mali, and Zaire), key management questions, and future directions in the next decade. The Bamako Initiative has 4 key features: 1) the rehabilitation and extension of the basic health care delivery system, particularly for maternal and child health services, and including peripheral health facilities and the network of community health workers; 2) provision for affordable drugs and improved knowledge on prescribing and use; 3) appropriate financing of services for longterm sustainability; and 4) community mobilization in order to increase the effectiveness and esteem of health services and involving the community as a full partner in the decision making process. The Ministers agreed to 8 principles which would facilitate the implementation of the Bamako Initiative in September 1988, as follows: 1) national commitment to the development of universally accessible PHC services, 2) essential drug policies in agreement with the development of PHC, 3) community financing which is consistent at all levels of care for health care services, 4) substantial government financial support, 5) substantial decentralization to the district level for management of PHC, 6) decentralized management of community resources, 7) measures which ensure access of the poor for PHC, and 8) clearly defined intermediate objectives and agreement on indicators to evaluate the effectiveness. A number of issues have arisen concerning the implementation of the Initiative such as community control, equity, drug use, and the low status of health workers. Since 1988 UNICEF has established funding for national task forces and conducted 3 conferences to deal with the issues and constraints. Collaboration is important and considerable involvement has been effected by the World Bank, the African Development Bank and multilateral, bilateral, and government agencies. The most active supporter of the Initiative has been Nigeria. Key lessons are that there is a need for policy development, for support from national and local leaders, for a supportive legal system, for detailed planning, for logistics strategies and workable management, for information management, for operations research, and for balanced implementation in rural and urban areas. International solidarity is need to provide the resources to fulfill the aims.
The use of essential drugs. Model list of essential drugs (seventh list). Fifth report of the WHO Expert Committee.
WORLD HEALTH ORGANIZATION TECHNICAL REPORT SERIES. 1992; (825):i-iv, 1-75.The WHO Expert Committee on the USe of Essential Drugs has published its fifth report which has an updated list of essential drugs including route of administration and dosage forms and strengths. Names and affiliated organizations of Committee members and delegates of other groups as well as appropriate staff at the WHO Secretariat precede the report. Each member country can use this list to determine its own list based on its own policy and priorities. To help member countries, the Committee provides criteria for selecting essential drugs. The report also includes guidelines to establish a national program for essential drugs and guidelines for a national drug authority (Annex 1). A successful program depends on efficient administration of supply, storage, and distribution of drugs at every point from manufacturer to end user. The report also addresses quality control, the need to have reserve antimicrobials and to monitor resistance, and applications of the essential drugs concept. One chapter examines essential drugs and primary health care by focusing on existing systems of medicine, the national health infrastructure, training and supplies, and the pattern of endemic disease. The report provides guidance on drugs used in displaced communities by looking at nutrition, immunization, protection from infectious diseases, drugs, and surveillance. It also addresses postregistration drug studies and research and development. The final chapters cover nomenclature, drug information and educational activities, updating lists of essential drugs, considerations and changes made in revising the list, glossary, and alphabetical list of essential drugs. Annex 2 is an application form for inclusion in the Model List of Essential Drugs.
BMJ. British Medical Journal. 1992 May 30; 304(6839):1398.A disregard for public health, cry the consumers. "Everything's under control," says industry. "Let's sit down and talk it over," says the WHO. The problem--the ethics of drug promotion--was being debated in Geneva at the world health assembly, which ended its 45th, 2 week session last week. The 3 leading actors in this decade long imbroglio remained true to form, with the usual jostling for media attention. 10 days before the assembly Health Action International (HAI), a public interest group represented in 60 countries, held a meeting in Geneva at which it launched a 50 page booklet attacking "misleading, wasteful and dangerous drug marketing." The book gave examples of products promoted for unapproved indications and of hospitality, prizes, and other inducements offered by drug firms to doctors to influence their prescribing habits. It also described poor postmarketing surveillance by drug firms. The problem, says HAI, is not confined to a few "bad apples" but "is a global phenomenon." Undaunted, on the opening day of the assembly the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) briefed journalists on the code of pharmaceutical marketing practices it had established in 1981. Since that year the IFPMA has dealt with 72 complaints citing 926 alleged breaches of the code--92% of them in developing countries. All were investigated, said the IFPMA, and 527--over half--confirmed. "All these violations were rectified or avoided in future promotional campaigns," said the IFPMA's spokesman Mr. Jean-Francois Gaulis, "The code works." HAI disagrees. The IFPMA's code, said Dr. Wilbert Bannenberg, a Dutch public health physician and trustee of the organization, was "far too weak." "Just waiting for complaints to come in is not enough : there must be an active monitoring system and a way of enforcing respect for the code. National authorities in developing countries often don't have the facilities to do this." HAI also criticized WHO for its failure to prevail on national governments to abide by its ethical code for drug promotion, drawn up in 1988. "That code is also too weak," said Dr. Bannenberg. The debate during the world health assembly was prompted by concern among WHO member states over a lack of evidence of "progress in controlling medicinal drug promotion," since WHO's code was established. In the end the assembly passed a resolution calling for a meeting to be held on neutral territory where "interested parties"--notably HAI and the IFPMA--can thrash out their differences. (full text)
AFRICA HEALTH. 1992 Jul; 14(5):10-1.An update on clinical aspects of HIV in africa highlights new proposed clinical definitions of adult AIDS and of tuberculosis in HIV+ adults, and staging of adult HIV infection. The 1986 WHO clinical definition of AIDS has been widely used in Africa, but now research suggests that this definition has several limitations: the definition will pick up several unrelated diseases such as diabetes mellitus and renal failure. It does not ascertain cases of AIDS marked by nonopportunistic infections. Most persons with pulmonary tuberculosis may be wrongly diagnosed with AIDS by this definition. The study showed that the WHO clinical definition has good specificity and positive predictive value for HIV+ people, but its positive predictive value fell to 30% in identifying people with AIDS in Africa. New definitions should take into account any serious morbidity, tuberculosis, neurological disease, both endemic localized Kaposi's, and aggressive typical Kaposi's sarcoma, and HIV serological testing. Tuberculosis is a problem because few HIV+ people suspected of having pulmonary TB (sputum-negative TB) actually have it based on bronchoscopy, while HIV+ persons with TB experience high mortality, often from pyogenic bacteremia. HIV+ persons with TB suffer high rates of relapse, possibly related to insufficient drug treatment or reinfection. 1 study showed that 6 months of isoniazid significantly improved incidence of TB over 30 months of follow-up. Staging of AIDS in Africa based on degree of immunosuppression was proposed as: 1) clinically inapparent HIV infection marked by pulmonary TB, soft tissue infections, and community acquired pneumonia; 2) lymphadenopathy, oral thrush, widespread pruritic maculopapular rash, herpes zoster, enteric illness, dysentery, and Kaposi's sarcoma; and 3) HIV wasting syndrome, chronic pulmonary disease, meningitis, and fever of unknown origin.
MEDICAL ANTHROPOLOGY QUARTERLY. 1992 Jun; 6(2):99-113.In drug development and marketing, multinational companies tend to patronize developing countries and even raise health risks by distributing products of questionable utility. The World Health Organization has pushed for standardization and quality assurance of drugs to compel companies to fully disclose adverse reactions. Clinical trials use small and unrepresentative samples, thus longterm side effects are not taken into consideration such as steroid-induced hypertension in asthma patients. Unintended side effects are true side effects in the view of some (hair loss and lacrimation in anticoagulant therapy). Reactions that encompass primary and secondary effects include allergic reactions, hypersensitivity, and the corollaries of differential drug metabolism (serum albumin polymorphisms, G6PD deficiency, hemoglobinopathies, and hepatic enzyme irregularities). Primary action and side effects are subject to interpretations, as the antihistamine Benadryl causes drowsiness when used for allergies, but as a sedative its ability to induce drowsiness is the primary action. Minoxidil promotes hair growth, but it was originally developed as an oral hypotensive, and it also could treat impotence. RU-486 or mifepristone, the abortion pill, has been used for glaucoma and brain tumor treatment. The Hausa of Nigeria use both indigenous plant medicines and drugs, but their cultural interpretation of drug effects can lead to confusion: bitter plants have been used as abortifacients and the bitter drugs chloroquine, penicillin, and chloramphenicol have also been endowed with such qualities. Stomach aliments are treated with chile pepper, coffee senna, and balsam apple along with erythromycin and salicylates to induce purging. The tooth discoloration caused by tetracycline therapy is imputed to witchcraft. A more relativistic approach concerning the side effects of drugs is needed as their perception in many cultures is conceptually different.
Social Science and Medicine. 1992 May; 34(9):959-64.Insufficient information contributes to failure in markets. Government officials also use it to justify intervention in the health sector in the developing countries. Further, in these countries,health care workers have misused pharmaceuticals considerable as well as make improper diagnoses. Moreover both health practitioners and the general public do not always follow instructions on drug use. A shortage of information on appropriate use may indeed cause these problems. A staff member of the World Bank proposes a methodology to use to balance 2 competing risks. Either public health officials allow drugs to be available to consumers over the counter or they require a prescription from a licensed health professional. The risks include obvious diagnostic errors made my consumers untrained in medicine and patients not receiving needed, potentially life saving, drugs. Since there is a shortage of medical personnel in most developing countries, people face considerable obstacles (e.g., travel time and expense) when it comes time to go to a licensed medical facility. The proposed methodology to evaluate the tradeoff between the 2 risks involves looking at the problems as one of determining the value of a more accurate diagnosis through the intervention of a skilled professional as a specific and costly mechanism for acquiring an accurate diagnosis. The article applies the model to illustrative examples to identify the information to answer the regulatory issue question. Further the model also allows public health policy makers to determine the appropriate level of training needed for medical professionals and to evaluate projects which improve public access to information on the use of drugs.
GLOBAL AIDSNEWS. 1992; (1):7.Responding to a call for collaboration in preventing and controlling the spread of AIDS, pharmaceutical companies from around the world have joined WHO in a bid to develop effective and affordable vaccines and drugs against the disease. At a meeting in Geneva in May of last year, WHO Director General Dr. Hiroshi Nakajima urged companies to make a concerted effort to develop vaccines and drugs against AIDS as quickly as possible and at an affordable price. The meeting resulted in the formation of 2 working groups staffed by members of WHO and the International Federation of Pharmaceutical Manufacturers Association which will map out areas of collaboration between WHO and the pharmaceutical industry. One of the groups will focus on the development, use, and supply of vaccines for HIV infection, while the other group will deal with drugs for HIV infection and related diseases. The working groups have met twice since the May meeting. This joint effort by WHO and the pharmaceutical industry illustrates the consensus that HIV/AIDS vaccines should be accessible to populations at risk. Of particular concern is the need to make drugs and vaccines available to people in developing countries, where 80% of HIV infections have occurred so far. This would require not only affordable products, but also vaccines and drugs that are appropriate to the particular HIV strains found in developing countries and that are easy to administer. WHO's Global Programme on AIDS has begun to strengthen selected institutes in developing countries which could serve as sites for HIV vaccine evaluation, an initiative lauded by the pharmaceutical industry and researchers in developing countries.
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.