Objective: Recently, use of health foods and supplements, as well as the amount of information available about them, has been steadily increasing.  Therefore, a noticeable increase in adverse drug reactions caused by health foods and supplements has also been seen.  The purpose of this study was to clarify the current status and backgrounds of patients with health food- or supplement-related adverse health effects.
Methods: We selected the cases of health food- or supplement-related adverse health effects from the Case Reports of Adverse Drug Reactions and Poisoning Information System (CARPIS) database, which contains over 57,000 case reports of adverse drug reactions.  We investigated the background, suspected products and adverse events in each case and conducted univariate logistic regression analysis to determine significance.
Results: We obtained a total of 327 cases consisting of 103 causative products.  Women comprised 66% of study subjects and had a significant association with dietary supplements.  Patients with a history of liver disease had a significant association with liver damage caused by “Ukon,” a drink made from turmeric root and sold as an anti-hangover remedy in Japan.
Conclusion: The causative products had several unique features.  This information should be utilized to prevent health food- and supplement-related adverse health effects in the future.

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Objective: To develop a label comprehension study (LCS) of package inserts for over-the-counter medications in Japan, we evaluated whether it would be possible to detect differences in the level of understanding due to layout, and font size of different types of package insert using the interview method for LCS we developed previously.
Design: A face-to-face questionnaire investigation.
Methods: Two different types of package insert (including layout, and font size) for H₂-antagonists (package insert groups A and B) were used.  Study participants (≥18 years old) comprised consumers who visited a drugstore with a dispensing service in Saitama Prefecture.  They were randomly assigned to group A or B and divided by age range (young, 18-39 years; middle-aged, 40-59 years; eldely, ≥60 years).  First, the volunteers read the package insert with no time limitation and then answered 14 scenario-type questions during an interview to determine the level of understanding of the insert.  When both the correct answer and correct reason were given, the response was judged as correct.  The level of understanding of the package insert was calculated as the number of persons giving correct responses divided by all respondents.
Results: Questionnaire responses from 86 consumers (43 in each group) were obtained.  The mean age in groups A and B was 46.5 years and 47.0 years, respectively.  The mean level of understanding of the package insert (14 questions) in groups A and B was 50.2 and 38.1%, respectively.  By age range, the mean level of understanding of the package insert in groups A and B in the young group was 60.6 and 56.9%, respectively, and there was no statistically significant difference between the two groups.  However, the mean level of understanding in groups A and B was 56.9 and 35.0% in the middle-aged group and 26.3 and 14.5% in the elderly group, respectively.  The mean understanding in group A was therefore higher than that in group B in both age ranges.  The association between understanding and age within groups indicated that with increasing age, understanding was lower in both groups (group A, p=0.001; group B, p<0.001).  There was no difference in the level of understanding between the young and middle-aged in group A, but the difference in group B was greater than 20%.
Conclusion: By comparing two package inserts of products in a similar pharmacological category using our LCS method, it suggested that font size and layout influenced consumers’ understanding of package inserts.  It might be able to evaluate the difference in the understanding of the package insert by using our LCS method.

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Objective: To clarify consumer views on the new sale system of non-prescription drugs, self-medication, and purchases in drugstores after the revised Pharmaceutical Affairs Act in 2009.
Methods: The questionnaire was performed for 1,084 consumers on an enlightenment event of the proper use of non-prescription drugs and promotion of adequate self-medication held at Shinjuku Station that was a main terminal station.
Results: Among the respondents, the degree of recognition of the new sale system for non-prescription drugs was 67.7%.  There was approximately threefold increase from the previous survey in 2008.  The most common positive reason was, “The safety of non-prescription drugs was clarified by classification according to three risk levels.”  On the other hand, the most common negative reason was, “I was unable to reach the medicine I wanted without having to listen to the pharmacist’s explanation.”  When consumers want to purchase non-prescription drugs, 77.1 and 44.5% of the respondents nominated “pharmacy and/or drugstore” and “a convenience store,” respectively.  The practice of self-medication positively correlated with the words “the self-medication.”  In this study, a surge in consumer interest for self-medication and non-prescription drugs was felt.  However, while consumers were interested in the safety of non-prescription drugs, they also demanded convenience.
Conclusions: We thought that the role of experts such as pharmacists and registered salesclerks was to ensure safety, convenience, and understandability of consumers for non-prescription drugs.  In addition, to promote adequate self-medication, it was suggested that recognition of the words “self-medication” will be helped through events, the Internet, and the mass media.  It needs to be further explored.

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Objective: We conducted a questionnaire survey to comprehend the situation regarding the collection, provision, and utilization of drug safety information at hospitals.  In addition, we asked pharmaceutical companies how they select medical institutions to provide drug safety information.  We also investigated the current situation of information provision to Tokyo Medial Center by pharmaceutical companies.
Method: A questionnaire was mailed to all hospitals in Japan.  The survey was conducted between January 13 and February 10, 2011.  Moreover, we asked thirteen pharmaceutical companies by telephone and e-mail about the implementation status of the provision of information and performed a survey at Tokyo Medical Center on the current situation of information provision by pharmaceutical companies regarding revisions to precaution sections in package inserts.
Results: The results of the questionnaire survey (response rate: 41.2%) showed that the major information sources for hospitals were medical representatives (77.8%), Drug Safety Update (50.3%) and direct mails (49.3%).  Furthermore, in the case of drugs prescribed exclusively for extramural dispensing, fewer hospitals responded that medical representatives of the pharmaceutical companies provided drug safety information and more hospitals responded that they did not obtain any drug safety information at all, compared with drugs listed in the hospital formularies.
Conclusion: To minimize the risks of drugs, healthcare professionals must collect a wide range of drug safety information and must utilize this information in their medical practice.  Therefore, it is important that pharmaceutical companies and regulatory authorities make an effort to provide suitable information dissemination to medical institutions.  Furthermore, medical institutions must also strengthen their systems for collecting drug safety information and providing such information to healthcare professionals.

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Objective: Doping is strongly prohibited in sports.  Sports pharmacist was born in 2010 in Japan, and the anti-doping activity is expected.  On the other hand, doping by arising from a lack of knowledge about prohibited substances in athletes, so-called “unwilling doping” is developing into a social issue.  In this study, we investigated the percentage of prohibited substances in all drugs and prescriptions in a general hospital, to collect information to prevent an unwilling doping.
Methods: We constructed system to extract the drugs corresponding to prohibited substances in the prescription order entry system in Otaru Municipal Hospital, and we analyzed 3,306 prescriptions of 10 to 59 years old patients, from July to September 2010.
Results: Thirteen point five percent of our hospital drugs met definition of the prohibited substance.  The number of prescriptions including prohibited substance(s) was 350 (10.6%), and its category was different from each age-group and clinical department.
Consideration: Because prohibited substances are included in approximately 10% of prescriptions, athletes are exposed to danger of becoming an unwilling doping.  Pharmacist should be well informed about prohibited substances to prevent athletes from unwilling doping.  And they should provide information promptly and adequately for athletes.

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