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    Estrogenic drugs--patient package inserts.

    Morris LA

    In: Morris LA, Mazis MB, Barofsky I, ed. Product labeling and health risks. [Cold Spring Harbor, New York], Cold Spring Harbor Laboratory, 1980. 23-36.

    This paper evaluates the communication value of the federally required oral contraceptive (OC) and estrogen patient package inserts (PPIs). PPIs are required to be made available to users of certain prescription drugs, in particular, OCs and estrogen drugs to enable consumers to make informed choices about the drug. In the case of the OCs, PPI was required because OCs are used by healthy women for nontherapeutic purposes and are associated with serious risks (e.g., fatal blood clots). Originally, it was required that 2 types of printed materials be made available to patients: a relatively brief insert (9 sentences of information) and a longer brochure (22 paragraphs) to be dispensed by the physician upon patient request. A national survey of the Food and Drug Administration (FDA) in 1975 to evaluate the effects of the PPI and brochure on consumer behavior revealed high levels of reported receipt and readership. Another finding showed that people tended to remember what they considered the most important information about OCs, but were unable to identify the contents of specific sections of the insert. The survey was unable to determine to what degree or manner the PPIs affected decision making of the consumer. The FDA survey resulted in lengthening of the brochure and the insert to include new information about cardiac and cancer risks. In addition, it is now required that both brochure and insert be dispensed to the patient. With respect to estrogen PPIs, the PPIs were required by the government in 1977 to accompany estrogen drugs after epidemiological studies indicated an increased risk of endometrial cancer with prolonged usage of the drug. The estrogen PPI was 35 paragraphs long and frankly discussed the dangers and risks associated with estrogen. Critics maintained that such warnings merely served to frighten women without improving the quality of care or patient decision-making. Data regarding the effects of estrogen PPI are presently limited. Studies are being done to evaluate its effects on patient decision making. On a gross measure of retail sales, however, a decrease of use of estrogen has been observed. Jick (1979) reported a 27% decline in endometrial cancer from 1975 to 1977. The role of PPI in this decline however is not known. Further research should be done to determine more fully the effects of PPIs on patients' level of knowledge about prescription drugs and on their decision-making process.
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