Objective:The aim of this study was to measure the value of over-the-counter (OTC) pravastatin as a healthcare-related item by investigating the public's willingness to pay(WTP)in self-medication for the primary prevention of myocardial infarction (MI)if pravastatin were switched to OTC status.
Methods:A questionnaire survey was distributed among those receiving health checkups at Kitasato Institute Hospital. For the WTP question format, the double-bound dichotomous choice approach was employed. Participants were randomly assigned to three groups. Group A was provided with a starting price per month of \5,000, group B with \8,000, and group C with \12,000. To investigate factors affecting WTP, Weibull regression analysis was used.
Results:The questionnaire survey was completed by 242 individuals(150 men, age range 30-82 years), and the mean WTP was \9,583 per month. Weibull regression analysis showed that age significantly affected WTP. The monthly cost for a physician consultation to receive prescribed pravastatin is \3,540 to \6,590 in the Japanese health insurance system.
Conclusion:The WTP was about \10,000 per month, and the WTP based on the questionnaire responses was more than two-fold higher than the present cost for a physician visit. This study clarified the WTP if pravastatin for the primary prevention of MI were switched to OTC status. Further studies are necessary to elucidate whether this would contribute to the promotion of self-medication among Japanese.

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In enabling consumers to make thetr own judgments regarding the risks of drugs, it is essntial to share information regarding the risks of drugs among stakeholders (governmental agencies, pharmaceutical companies, healthcare professionals and consumers or patients) and to have communication (risk communication).In particular, the communication between governmental agencies and consumers or patients is given a high priority. Hence, its provisions and strategies should be considered thoroughly.
FDA's risk communication efforts are part of a larger drug safety initiative that began in November 2004. In fact, FDA is engaged in verification and strategies aiming at strengthening drug safety. As a part of these efforts, FDA has published the "Guidance Drug Safety Information-FDA's Communication to the Public" and "FDA Strategic Plan for Risk Communication".
In this article, we present the "FDA Strategic Plan for Risk Communication" translated into Japanese and explain the situation of risk communication for drugs from the FDA perspective. We also examine the future of risk communication in Japan.

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During FY 2004 through 2008, as one of the projects in the first medium term plan, the Pharmaceuticals and Medical Devices Agency(PMDA)had been engaged in the research and establishment of data mining method as an operational support tool to assist staff in charge of post-marketing safety measures, with the goal to implement this tool in April 2009.
This article was written with objective to demonstrate the current operation process of data mining in PMDA.

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