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  • Title: Postmarketing evaluations help determine contraceptive safety, efficacy.
    Journal: Netw Res Triangle Park N C; 1988; 9(2):1-2, 7. PubMed ID: 12280950.
    Abstract:
    Postmarketing surveillance or postmarketing evaluation, is the study of a product's safety and efficacy after it has been approved for marketing. The only way to answer important questions about the effects of longterm contraceptive use is postmarketing evaluation. Many of the risks of oral contraceptives (OCs), for example, would not have been detected without postmarketing evaluations. Due to the fact that contraceptives, unlike most drugs, are used by healthy women, researchers are particularly concerned about rare adverse effects. Clinical trials which involve only a few thousand cases cannot detect rare adverse effects that occur in less than 1% of all cases. Spermicides, plastics, and other materials used in IUDs can be tested for carciogenicity in the laboratory, but it is more difficult to determine the carcinogenicity of contraceptive steroid hormones. There is a long latent period between the use of exogenous hormones and any known effect on the incidence of cancer. Most drugs introduced in developing nations have been tested and approved in other countries, but postmarketing studies are important in developing countries. Patterns of use and the physiological effects of the product may vary from 1 country or region to the next. Further, the acceptability of a contraceptive method may differ in different cultures. The increasing recognition of the importance of postmarketing evaluation on the part of researchers, manufacturers, and regulators worldwide suggests and increased understanding of the limitation of animal testing and clinical trials. Despite their limitations, premarketing trials continue to be the primary information source about drug safety and efficacy. According to Family Health International President Malcolm Potts, cost is the main reason why postmarketing evaluation is not more routinely conducted. Public funding is 1 way to ensure that drugs receive adequate postmarketing evaluation. Methods of postmarketing evaluation are reports of adverse events, case-control studies of less than 100 cases, and prospective studies of tens of thousands of patients. 1 function of postmarketing surveillance is alerting. Alerting systems are important for identifying events and generating hypotheses that can be tested with epidemiological methods. Manufacturers in the US are required to report adverse events identified through published papers and voluntary physician and pharmacist submissions to the Food Administration. Other countries maintain drug surveillance systems based on voluntary physician submissions of adverse drug reaction (ADR) reports. The best research method for quantifying risks or benefits is the cohort study. The most practical way to test for associations between drugs and rare events are case-control studies.
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