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Pharmacovigilance of antimalarial treatment in Uganda: community perceptions and suggestions for reporting adverse events.
Tropical Medicine and International Health. 2008 Sep; 13(9):1143-52.OBJECTIVES: The deployment of new antimalarials in Africa provides an important opportunity to develop systems for pharmacovigilance. To inform strategies for reporting adverse events in Uganda, we investigated local perceptions and experiences with antimalarial treatment, and evaluated existing and potential systems for pharmacovigilance. METHODS: Focus group discussions (FGD) were conducted with community members and health workers from urban and rural Uganda exploring knowledge of fever/malaria, perceptions and expectations of treatment, understanding of adverse effects, and experiences with adverse events. Sessions were recorded, transcribed into English, and analysed using a coding scheme developed from pre-defined topics together with themes emerging from the data. RESULTS: Between April and July 2006, we conducted 25 FGDs; 16 with community members and nine with health workers. All respondents had extensive experience with malaria and its treatment. Community members commonly recognized adverse effects of antimalarial therapy. However, events were uncommonly reported, and certain events were often interpreted as signs of successful treatment. Community members often felt that the costs of reporting or seeking additional care outweighed the potential benefits. Health workers were unfamiliar with formal pathways for reporting, and were deterred by the additional work of reporting and fear of incrimination. Respondents provided suggestions for incentives and methods of reporting, emphasizing that pharmacovigilance should ideally encompass the public and private sector, and the community. CONCLUSIONS: To be successful, pharmacovigilance relying on voluntary reporting will require active participation of patients and health workers. Addressing the costs and benefits of reporting, and providing sensitization, training and feedback will be important.
Journal of Nutrition. 2003 Nov; 133:3319-3322.Even in a world with adequate food supplies in global markets, which is the situation today, biotechnology offers important opportunities to developing countries in four domains. First, many agronomically hostile or degraded environments require major scientific breakthroughs to become productive agricultural systems. Few of these breakthroughs are likely to be achieved through traditional breeding approaches. Second, biofortification offers the promise of greater quantities and human availabilities of micronutrients from traditional staple foods, with obvious nutritional gains for poor consumers, especially their children. Third, many high yielding agricultural systems are approaching their agronomic potential. Radically new technologies will be required to sustain productivity growth in these systems, and only modern genetic technology offers this hope. Finally, many cropping systems use large quantities of chemical inputs, such as herbicides, pesticides and fertilizers that can be unhealthy for people and soils alike. Biotechnology offers the potential to reduce the need for these inputs in economically and environmentally sustainable ways. Applying these new technologies to society’s basic foods raises obvious concerns for both human and ecological health. For some, these concerns have become outright fear, and this has mobilized a backlash against genetically modified foods in any form. These concerns (and fears) must be addressed carefully and rationally so that the public understands the risks (which are not zero) and benefits (which might be enormous). Only the scientific community has the expertise and credibility to build this public understanding. (author's)
[IUD use at the Sidi Fateh urban community clinic: qualitative study] Utilisation du DIU au niveau du dispensaire urbain Sidi Fateh (etude qualitative).
Rabat, Morocco, Institut de Formation aux Carrieres de Sante, 2000. , 61,  p.Contraceptive prevalence across Morocco increased from 20% in 1980 to 60% in 1997, with a corresponding decline in total fertility from 6 children per woman in 1975 to 3 per woman in 1997. Morocco's National Family Planning Program has achieved great success in reducing prevailing levels of fertility, but the program's particular promotion of the oral contraceptive pill has led to the disproportionate use of the latter at the expense of longer-acting hormonal and barrier methods. Findings are presented upon IUD use at Sidi Fateh urban dispensary, based upon questionnaires, personnel observation, and interviews with consultants on the relevant attitudes and behaviors of clients and service providers. Although 48.12% of the 133 married women surveyed know a range of modern contraceptive methods, their knowledge is superficial and very general beyond what they know about the particular method they employ. 66.3% use oral contraception, although most are unsatisfied due to the pill's side effects, but believe that they have no other contraceptive option. 63.9% of women oppose IUDs because of the method's side effects and negative rumors about its use. Likewise, 30.7% of husbands have negative attitudes about the IUD. Women's opinions of the IUD improve with rising educational status. The general population of IUD users is satisfied with its method choice, finding the IUD to be reliable, reversible, and of long-term effect without the need for daily administration. However, the adverse experiences of a few women with the method creates concerns and fear of the IUD among users and potential users. Obstacles and constraints to IUD use, personnel competence, and client satisfaction on family planning consultations are discussed.
European Journal of Contraception and Reproductive Health Care. 1996 Dec; 1(4):299-300.Third-generation progestogens desogestrel, gestodene, and norgestimate were introduced in the late 1970s in a bid to reduce and refine the hormonal content of combined oral contraceptives. Pharmaceutical companies invested considerable resources into developing the products and research activities have been based, at least partly, upon advice from the medical profession regarding the relevant safety studies on risk of cardiovascular disease. However, in October 1995, and despite such efforts, the UK's Committee on Safety of Medicines (CSM) warned physicians and pharmacists about third generation oral contraceptives because the investigators involved in a World Health Organization cohort study had found an increased risk of deep venous thrombosis among users of such contraceptives containing desogestrel or gestodene compared with the second generation type of oral contraceptives. That finding was supported by unpublished data from the Transnational Study and the General Practice Research Data Base Study. However, even considering all of these data together, no definitive evidence has been presented of an increased risk of deep venous thrombosis in users of third generation oral contraceptives. Epidemiological flaws and biases could have been mainly responsible for the increases found in the incidence rates of deep venous thrombosis. Careful consideration should be given to the absolute risks of disease and the risk of unwanted pregnancies before a clinical alert is issued on oral contraceptive use.
BRITISH JOURNAL OF NURSING. 1995 Nov 9-22; 4(20):1174-5.The Committee on Safety in Medicines issued warnings against using oral contraceptives containing desogestrel and gestodene. These warnings were based upon findings from three unpublished studies pointing to the existence of an increased risk of thrombolytic disease in 30/100,000 pill users. The warning was published in the mass media before general practitioners and family planning staff were made aware. In so doing, users of oral contraceptive pills have become concerned, confused, distressed, and anxious. This warning has injured confidence in medical services. It would have been better for general practitioners and family planning staff to have been made privy to the data before it went public. The author notes that the risk of thrombosis in pregnancy is twice as high as the reported risk of using oral contraceptives containing desogestrel and gestodene, and that even non-pill users have a 5/100,000 risk of thrombosis. Other evidence points to the many health benefits of oral contraceptive use.