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Emergency contraceptive (EC) pills are used to prevent pregnancy after unprotected sexual intercourse. Levonorgestrel is an EC pill, which has been only approved in Japan; it is more effective the sooner it is used after intercourse and safe without serious side effects. EC pills are already available at accessible community pharmacies in more than 90 countries around the world. In Japan, citizens have signed a petition calling for the sale of emergency contraceptives at community pharmacies. However, little is known about the thoughts of pharmacists who engage with patients and sell medicines at pharmacies. Therefore, we conducted a web-based cross-sectional survey to determine the level of preparation in community pharmacies and the awareness of pharmacists regarding the sale of EC pills. A total of 1338 pharmacists responded to the survey from November 7, 2020, to December 16, 2020. In terms of the level of preparation for selling EC pills at pharmacies, 1067 (83.9%) respondents cited "lack of preparation of medical questionnaires and explanatory materials", and 975 (76.7%) respondents cited "lack of knowledge of pharmacists" as the most common reasons that were "barriers to EC pill sales at pharmacies". In terms of confidence level, only 289 (22.7%) respondents were confident about conducting the necessary checks while administering medicine. On the other hand, 944 (74.3%) respondents agreed to be able to sell EC pills at their pharmacies. The survey revealed that most of the pharmacists who participated in the survey believe that it is possible to sell EC pills in pharmacies.

Health literacy is defined as the ability to obtain, evaluate, and scrutinize health information and make appropriate decisions and actions. The spread of the Internet means that medical and drug information is becoming increasingly accessible to patients. However, there is also a large amount of inappropriate and biased medical- and drug-related information on the Internet. Therefore, patients require a high level of health literacy to ensure the effectiveness and safety of pharmacotherapy. In particular, outpatients need a high level of health literacy because they use their own medications without the supervision of healthcare professionals. In this article, I discuss the situation of health literacy and access to pharmaceutical information on the Internet in Japan. Furthermore, issues related to providing drug information to specific populations are explained using the example of chronic kidney disease. It is essential for all pharmaceutical information stakeholders to work together to solve these problems.

Recently, because the marked rise in medical expenses in Japan has become a major social problem, self-medication using OTC drugs in cases of minor health problems has attracted increasing attention. When people use OTC drugs for self-medication, they need support and/or advice from pharmacists on their proper use. This paper outlines recent revisions in the legal sales system of OTC drugs, the social background of self-medication, characteristics of OTC drugs and role of the pharmacists in providing consultation on OTC preparations. Next, consumers' views of self-medication and the OTC drug sales system are described based on the results of surveys performed after they attended an educational event on the proper use of OTC drugs. The survey of consumer views on the legal sales system of OTC drugs revealed that they were the most concerned about safety and convenience. From the survey of consumer views on self-medication, a significant percentage of the group who understood the meaning of the term "self-medication" practiced it in cases of minor health problems. Although no significant difference was seen between the groups who understood the term "self-medication" and those who did not in regard to the reading the drug package label and/or insert, a significant difference was found in their understanding of "The System for Sufferers from Adverse Drug Reactions". Therefore, it was clear that the consumers familiar with "self-medication" not only practiced it, but also understood the contents of drug package labels and/or inserts.

Similarities among non-prescription pharmaceutical vitamin products generally available in community pharmacies were examined based on their vitamin components, and a chart was constructed to differentiate products to assist in appropriate product choice. In the analysis of the similarities, two hundred and seventy-six data entries on vitamin products were extracted from the database on the package inserts of the pharmaceutical products provided by the Pharmaceuticals and Medical Devices Agency, and they were reviewed for the amounts of vitamins they contained, in which the B vitamins, or vitamin B 1 , B 2 , B 6 , B 12 , and niacin, were considered as well as vitamins C and E. Pantothenic acid and L-Cysteine that are frequently used in combination with those vitamins are also taken into consideration. The data entries were then processed by classical multi-dimensional scaling to evaluate the inter-product similarities. As a result, it was shown that the products categorized as pharmaceutical nutrients and tonics containing vitamins (NTcV) are similar to one another, reflecting the fact that they are less characteristic regarding their vitamin components. As for the products in other categories, they were generally found to be featured for their unique content of vitamin components, and thereby, each category includes products with a wide range of variation. It was also indicated that some products categorized as vitamin B 1 , B 2 , and C products are less distinguishable from those categorized as NTcV. These findings will assist pharmacists to decide on an appropriate product for a customer following consultation.

The interaction of levodopa and vitamin B6 is a well-known issue. This study investigated the incidence of unacceptable intake levels of vitamin B6 among levodopa users by means of a systematic review. We searched two databases (PubMed and "Igaku Chuo Zasshi") for articles about adverse events due to the interaction of levodopa and vitamin B6 published up to August 2017. Of 98 citations retrieved, 11 studies met the selection criteria. The results indicated that a vitamin B6 intake level of more than 50 mg/day could reduce the efficacy of levodopa. The recommended intake of vitamin B6 for Japanese adults is 1.4 mg/day for men and 1.2 mg/day for women. Therefore, the acceptable intake of vitamin B6 for levodopa patients would be within the range of the recommended intake level, which is also within the usual range in foods in Japan, except for dietary supplements or health foods. Levodopa users should be cautious about taking dietary supplements and over-the-counter drugs.

Kampo medicines must be used according to an individual's physical characteristics and symptoms to avoid lack of efficacy, adverse reactions or interactions with other drugs. As category-2 over-the-counter drugs (OTCs), Kampo OTCs are not targets of active explanations by pharmacists, and consumers usually decide to use OTCs by themselves on the basis of drug label information. However, information on the label is occasionally brief. To promote the proper use of Kampo OTCs, we herein propose an informative tool based on the Australian Shelf-Talker (information on the proper use of OTCs with a self-check questionnaire for consumers), the Self-Check Card (SCC). We also prepared the informative material, Information to the Pharmacist (IP), directed at pharmacists regarding these Kampo OTCs. We created SCCs and IPs for 16 prescriptions in the 5 most demanded categories (cold, cough/sore throat, urination problems, women's diseases, and shoulder stiffness or joint/nerve pain). The SCC with questions in a simplified language specifies individuals who should avoid the drug, or those who should consult a pharmacist before purchase, according to the safety information on the respective drug labels. The IP provides information to pharmacists on safety issues and those concerning recognition of the consumer's symptoms and physical characteristics needed for the selection of appropriate Kampo OTCs. Such SCCs and IPs are now in use in 2 pharmacies to know pharmacists' suggestions about improvements and consumer's opinions and degree of satisfaction. We believe these risk-benefit communication tools, SCC and IP, will contribute to improve the proper use of Kampo OTCs.

At the time of consultation with a patient regarding OTC drugs, a pharmacist goes through the following five steps. In Step 1 information is collected, including the patient's gender, age, health condition, living situation, etc. In Step 2, upon analyzing and evaluating this collected information, the pharmacist decides whether to recommend that the patient see a medical doctor or whether an OTC drug is sufficient. In Step 3, when an OTC drug is required, the pharmacist suggests the most suitable OTC drug. In Step 4, the pharmacist provides the patient recommendations and information about the selected OTC. In Step 5, sales record entry and aftercare are performed. In these five steps, the pharmacist is making a decision on whether the consultation recommendation is required or optional; the step of making an optimal selection of an OTC drug is distinct from prescription dispensing. In many cases, at the time of OTC drug consultation, since the patient is not consulting a medical doctor, a pharmacist becomes a "first access" health professional. In this instance, the advice of a pharmacist may have a great influence on a patient's prognosis regarding the particular health challenge. Therefore, pharmacists who perform patient consultations regarding OTC drugs are required to have broad medical knowledge and communication skills. The features of consultation and information dissemination about OTC drugs by a pharmacist, and the practice and study of this subject in present-day pharmaceutical education, are described herein.

The promotion of self-medication by pharmacies, with the aim of encouraging a patient's self-selection of proper OTC drug, is written about in the national action plan "Japan is Back". The subject of self-medication has been improved in the 2013 revised edition of "Model Core Curriculum for Pharmaceutical Education". At Tokyo University of Pharmacy and Life Sciences, the systematic education of self-medication was started from the onset of the six-year course in the third, fourth and fifth grade. We introduce here a new approach in our systematic education of self-medication. In the practice of the fourth grade, groups of around 5-6 students are formed. The pharmacy students assume various roles-of pharmacist, rater, observer, and chairman-and perform role-playing. We prepared a standardized patient (SP) showing various symptoms. The student of the role of pharmacist asks about the SP's symptoms, chooses an OTC drug suitable for the SP, and explains the OTC drug to the SP. After the role-playing, those in the roles of rater, observer, SP, and faculty give feedback to the student who played the role of pharmacist. Because we conduct this role-playing using SPs with a variety of symptoms, we can create a situation similar to a real drugstore.

“Terumeru” was a patent medicine that an apothecary in Osaka sold as an expectorant and medicine for internal diseases towards the end of the Edo era. Due to its manufacturer, Gengendo, closing its expectorant business in the early Meiji era, further details are unknown. The author investigated Terumeru products dating back approximately 200 years. The objective of this study is to clarify what kind of patent medicine Terumeru was, and furthermore, compare it to other medicines with names spelled using katakana that were distributed around the same time as a topic of discussion. The characteristics of Terumeru were as follows : the dosage form was three times as much as that prescribed for similar drugs ; and although it was said to be of Dutch origin, the name of a Chinese clinician, Zhu Zhenheng, was cited on its efficacy statement and advertising. These findings revealed that there were problems with its formulation and inconsistency in its brand image. These reasons led to the conclusion that Terumeru was considered a katakana-named patent medicine during the pioneering days of pharmacology Japan.

Requirements for education on proper use of drugs were included in the junior high school educational guideline in 2012 incorporating pharmaceutical education in the obligatory school curriculum. This move is closely related to the country's new OTC drug marketing system. The amendment of the Pharmaceutical Affairs Law (PAL) in 2013 highlighted the public's own role in "promoting proper use of drugs and other related products and making greater efforts to acquire knowledge and improve understanding of their effective and safe use". Furthermore, the Law to Amend the PAL and Pharmacists Law enforced in 2014 allowed all OTC drugs to be sold online under appropriate rules. Deregulation of online sale of OTC drugs is expected further to promote self-medication for minor illnesses and require stricter measures to ensure people's safety through their proper use. These legal amendments in recent years have made people's education about proper use of drugs one of the top priorities Japan should pursue at state level. Since 2000, the author has been offering education on drugs to early primary school children as part of their healthcare education program. In the future, dedicated education on drugs will be necessary for people of all ages including not only school children but also their guardians and elderly citizens as well.

Japan's Ministry of Health, Labour and Welfare published "the required function and the desired operating form of a pharmacy" and proposed that "a pharmacy should demonstrate a positive role for the promotion of self-medication". In the future, it will be indispensable to pharmacies that pharmacists play a role not only in dispensing medicine but also in serving a central health-station role in the community, including promoting the self-selection of proper OTC medications for the maintenance of health. My pharmacy in a traditional area in Tokyo carries OTC drugs, health and nursing care goods, medical supplies, etc. besides dispensing medicine by prescription. Moreover, a "sample measurement room" where a person can conduct a blood test by self-puncture was prepared in April of 2014. In addition, my pharmacy has held "health consultation meetings" for patients in collaboration with a registered dietitian, as well as "meetings for briefing sessions on how to better take or administer medicines" for parents of infants, etc. These activities have been useful to local residents in the prevention of lifestyle-related diseases and in promoting a better understanding of medicine. Moreover, on-site student trainees from schools of pharmacy are helping with planning, data collection, and explanation on the days of these meetings. For trainees from schools of pharmacy, participating in these activities is important to becoming a pharmacist trusted at the community level in the future.

In the amendment of the Pharmaceutical Affairs Law in 2013, a new category, Pharmacist Intervention Required Medicines (PIRM), was introduced, and other OTC medicines, which were classified after the 2006 amendment, were allowed to be sold via the Internet. Regarding PIRM, Japan's Ministry for Health, Labour and Welfare designates medicines which require special intervention by a pharmacist who explains their proper use to a patient through a face-to-face consultation, wherein the pharmacist provides guidance based on pharmaceutical knowledge and experience. This encourages consumers to approach their longer term personal healthcare with a rational knowledge of medicines, and dovetails with the direction described in "Japan is Back". Along with the 2006 amendment, an upgraded 6-year curriculum for the study of pharmacy in preparation for becoming a pharmacist was introduced. This allows student pharmacists to have more experience working in community pharmacies, thus supporting and providing pharmacists with the knowledge they need to better help the consumer to rationally use OTC medicines and self-select proper OTC medications. And this is not only restricted to OTC medicines, as there are many items sold in local pharmacies available to be utilized by the consumer with reasonable support by pharmacists. There is an expectation that the pharmacist be prepared to assist the consumer not only with prescriptions, but also with OTC medications, supplements, medical accessories, etc. using their knowledge and experience.

We herein analyzed the issues that pharmacists in a community pharmacy in peacetime need to prepare for regarding headache medical care in emergencies (the state that supply of medical supplies is difficult) using a questionnaire intended for doctors and pharmacists in a community pharmacy. Recovery rates were 48.0% (96/200) for doctors and 37.3% (112/300) for pharmacists. In order to distinguish between patients for whom pharmacists need to "recommend OTC drugs" and those who need to be encouraged "to consult a hospital or clinic", doctors indicated that pharmacists need to use an "assistance tool to diagnosis headaches, such as a migraine screener" and "guidelines for chronic headaches". However, few pharmacists used these tools. Approximately 66.7% of doctors indicated that it is "meaningful" for pharmacists to distinguish patients with headaches. Moreover, doctors indicated the need for guidance by pharmacists in peacetime regarding headache medical care in emergencies. Although 73.2% of pharmacists instructed the patients with headaches of the importance of medication notebooks in emergencies, guidance ("understanding the triggers of headaches", "understanding the importance of removing the cause of the headache", "standing OTC drugs" and "standing prescription drugs") by pharmacists to prepare for an emergency was insufficient. These results provide useful information to improve the efforts by pharmacists in community pharmacies in peacetime for headache medical care in emergencies.

The role of pharmacists in self-medication is to provide informed and objective advice on medicines and their use, and to promote the concept of pharmaceutical care. In 2012, the teaching of medicines and their use was started in junior high schools, and pharmacists should be providing samples and the example package inserts, and/or giving lessons in cooperation with teachers. In this article, a number of examples of how to do this will be shared. In 2009, the Pharmaceutical Affairs Law was revised and the role of pharmacists being key figures in supplying medicines was significantly increased. Pharmacists should have a professional obligation to provide advice about self-medication and medicines for self-medication. We introduced some approaches for student pharmacists to enhance the self-medication leading ability. 1) Problem-based learning, and combination learning of basic problems and clinical topics for 1st-year students, 2) An e-learning system to provide objective information about medicines, and 3) A case study system to cultivate pharmacists and student pharmacists who can contribute to providing advice about the safe use of over the counter (OTC) medicines.

Since 2005, the Japanese pharmacy education program has changed to a six year-system from a four year-system with the aim to help students obtain a higher level of clinical knowledge and skill regarding humanity and morality. Under the new pharmacy education system, the correct assessment of vital signs is observed in pharmacy practice so that pharmacists can sell "over the counter drugs (OTC)" safely. From this point of view, we started a pharmacy practice that recognizes a series of vital signs, i.e., blood pulse, blood pressure, respiratory sound, and electrocardiogram, using a physical figure subjecting to 4th-year students (n=142) . After the practice, a questionnaire was conducted in order to assess the satisfaction of the practice. The results suggested that students could successfully learn physical assessment by using physical figures (ratios more than grade 4: 60%). Students could also evaluate the necessity of physical assessment (ratios more than grade 4: 70%), suggesting the practice of using physical figures was accepted by most students.

In recent years, it is necessary to acquire knowledge not only about medicine but also over-the-counter (OTC) drugs and health food for children, because lowering trend in the age of the health hazard by improper use of health food is reported. Therefore, in order to estimate the extent of use of OTC drugs and health food, the school pharmacists administered a questionnaire to students in grade-school (n=123), junior high school (n=303), and high school (n=115) in Fukuyama city. As a result of the questionnaire survey, surprisingly, the usage ratio of OTC drugs and health food showed the most increase in grade-schooler. The trigger of use of health food is "parents' recommendations" in the lower grades, otherwise the ratio of "use by themselves" was increased in the higher grades. Moreover, a remarkable difference was observed by the kinds of use in students with or without exercise. Interestingly, exercise group expected "physical strength" effects than no exercise group. In addition, the ratio of consultation to the pharmacist at the time of purchase of OTC drugs and health food was low in all grade students. In particular, the ratio of consultation to the pharmacist at the time of purchase of health food was very low in high school students. Therefore, to provide accurate information of medicine and health food for students, the school pharmacist should engage not only in routine work but also in positive guidance about OTC drugs and health food in the future.

Marketing authorization holders do not disclose any information on the pharmaceutical properties of over-the-counter drugs (OTC). When a drug is switched from a prescription drug to OTC, pharmacists can acquire that information from the corresponding ethical drug (ED) through the package insert, interview form, and so on. However, the pharmaceutical equivalence between ED and OTC is unclear. In this study, we examined the drug dissolution behavior of both ED and OTCs containing scopolamine butylbromide. Dissolution tests were performed by the paddle method using Japanese Pharmacopeia (JP) XV test fluids at pH 1.2, 4.0 and 6.8 and water based on the guidelines for bioequivalence studies of generic products. The dissolution profiles of OTCs differed significantly from ED showing a similarity factor (f2) value ranging from 8.9 to 42.9. Time until 85% dissolution ranged from 23 to 95 min and from 17 to 174 min at pH 1.2 and pH 6.8, respectively. Then JP XV disintegration tests were conducted to investigate differences in the disintegration process. The disintegration time of preparations showing delayed dissolution was prolonged compared to that of others, suggesting that the disintegration of the tablet or capsule is one of the important factors affecting the drug dissolution. These differences in the disintegration and drug dissolution might cause differences in the bioavailability of the drug. For patient safety, more detailed product information of OTCs should be supplied by the manufacturer, and not be assumed from that of corresponding ED.

After the Ministry of Edcation, Culture, Sports, Science and Technology of Japan has ratified the UNESCO "International Convention Fight against Doping in Sport" in December 2006, the government increased its support to Anti-Doping activities. About 5 years ago, the total number of doping control samples a year in Japan was around 2000, and this number was not enough to demonstrate Japanese athletes' cleanness to the rest of the world. However, after the government's ratification of the UNESCO international convention, the government increased its support both financially and politically. By receiving the increased support from the government, testing number has increased and reached 5000 samples a year. 5 years ago, our target athletes range was only international level athletes who compete in the Olympics or international events. As we expanded our testing numbers, the target range of the athletes was also expanded and national level athletes also became our targets. As a result, athletes without having adequate knowledge about anti-doping regulations became our target. This situation caused inadvertent anti-doping rule violation cases. Most of those anti-doping rule violations were the result of taking over-the-counter medicines, etc. In order to cope with those inadvertent anti-doping rule violation problems, we, Japan Anti-Doping Agency launched "Sport Pharmacist Project" in cooperation with Japan Pharmaceutical Association. In this project, we provide anti-doping information/regulation to the pharmacists and make those pharmacists knowledgeable about the current anti-doping rules and regulations.

Peoples have been much concerned on their healthy life. Recently, many kinds of dietary supplements and food for specified health uses are distributed and consumed in large quantities. Concurrently, medical case insurance in Japan has been accommodating a lot of patients increasingly year by year, when the importance and enlightenment of self-care and primary care of people with nonprescription medications is proposed. The Pharmacists Law defines the responsibility of the pharmacists for the public health and welfare with medication and hygienic affairs. The recent pharmacy education for 6 years in Japan is likely to orient pharmaceutical care practice for contribution to the treatment of patients by appropriate management of medication. The multidisciplinary knowledge on medicines and diseases, and the patient consultation technique are required in the pharmacy practice. The contribution and accountability of the community pharmacists to self-care and primary care with nonprescription medications, as social needs, is expected. In this review, social responsibility on the treatment with nonprescription medications and their information provided by the community pharmacists in future is discussed.

Community pharmacy is evolving to provide additional services to patients such as compliance improvement, self-care and OTC consultations and advising on daily activities to supplement medical treatment. Currently in Japan, it has been estimated that 1.5 to 2 million people have chronic hepatitis C. We have attempted to increase the population's knowledge of this important issue with educational brochures about hepatitis C and placing posters encouraging them to ask medical professionals about their health problems. Peg-interferon and ribavirin combination therapy has an efficacy rate of approximately 60%. The side effects might present in different ways and frequency depending on the treatment duration; therefore, pharmacists should monitor patients carefully during the entire treatment period with particular attention to OTC drug use, daily activity, etc. Additionally, for outpatients community pharmacy has responsibility to avoid drug-related adverse events in the patients' daily life, so monitoring for clinical signs of side effects is necessary. We created the "Clinical Pathway for Healthcare Network of Chronic Hepatitis C Treatment via the Medication Notebook Type" (Clinical Pathway) for patients who received Peg-interferon and ribavirin combination therapy. We are beginning to provide the new version of this service to patients as one of the pharmaceutical care components in the community pharmacy. I would like to describe how we cooperate with other community pharmacies using the "Clinical Pathway", which is to improve patient care in the community pharmacies.

To estimate the extent of use of over-the-counter (OTC) drugs and health food, we administered a questionnaire to the parents of children in a nursery school and to elderly people in a daycare center in Fukuyama city. The aim of the questionnaire was to determine the percentage of children and elderly people who use OTC drugs and health food, the purpose of using them, and the types of OTC drugs and health food used. Other questions concerned the person advising them on the use of OTC and health food, the side effects of OTC drugs and health food, and the awareness of children and elderly people regarding possible interactions between prescription drugs and OTC drugs. In children, the most frequently consumed OTC drugs were cold medicines (32.1%), followed by topical creams (22.6%) and eye lotion (14.3%). In elderly people, the most frequently consumed OTC products were eye lotion (18.0%), followed by laxatives (14.8%) and fomentation agents (13.1%). The purchase ratio of health food for children and elderly people were 4.8% and 11.5%, respectively. These results suggest that the need for OTC drugs and health food in children are very different from those in elderly people. In addition, in promoting self-medication, the demand for the opinion of a specialist occupied about 80% or 70% of the total specialist time among children and elderly people, respectively. Therefore, when providing information on health food and OTC drugs, the needs of each generation should be taken into account. The information obtained from the responses received will allow us to provide better pharmaceutical care for both children and elderly people in Fukuyama city.

We conducted a Web-based survey of approximately 40,000 Internet users on the purchase of over-the-counter (OTC) medications online in March 2009. The valid response rate was 97.8% and the number of responses was 39,208. The number of people who had purchased OTC medications online was 4,653 (11.9%), prescription medicines 792 (2.0%), and medical contact lenses 1,993 (5.1%). As a result of the multiple logistic regression analysis, independent variables with odds ratios (ORs) >1.5 were experience of purchasing prescription-only medicine online (OR=4.997, 95%CI=4.288-5.824), regular supplement use (OR=2.384, 95%CI=2.233-2.548), experience of purchasing colored contact lenses online (OR=2.206, 95%CI=1.632-2.983), no time to visit drugstores (OR=2.092, 95%CI=1.928-2.270), usage of Web sites of uncertain reliability (OR=1.992, 95%CI=1.857-2.137), and experience of purchasing therapeutic contact lenses online (OR=1.796, 95%CI=1.597-2.020). As some people have purchased prescription-only medicine or medical devices and had problems with drug information sources, the development of awareness of medical and pharmaceutical supplies and health and medical information literacy are key priorities to ensure safe OTC medication sales systems.

To ascertain the prevalence of allergy symptoms and consumer measures for eye, nose, skin, food, and asthma by prefecture. The self-evaluation questionnaire was mailed to 100,000 subjects throughout Japan by the OTC distribution network of Fujiyakuhin Co., Ltd. The prevalence of allergy symptoms for eye, nose, skin, food, and asthma was 17.3, 26.7, 14.5, 4.5, and 5.4%, respectively. These values were comparable with those of previous studies. The ratio of consultation behavior in respondents reporting allergy symptoms was estimated to be 26.4-82.1%. The usage rate of OTC drugs in respondents reporting non-consultation and the rate of combined use of prescription and OTC drugs were 2.9-51.1% and 7.0-44.1%, respectively. The positive likelihood ratio for subjective allergy in persons having an allergy history of "both parent and child" was 13.9, and this ratio for subjective child allergy in persons having an allergy history of "either parents" and "both parents" was 4.39 and 15.7. The relationship between consumer measures and the allergy history of subjects and families was observed in various combinations. In this study, the allergy prevalence of eye and food not reported in a previous study was estimated. Furthermore, it appears that there are points which make one think anew about the allergy information offered to consumers and patients by both OTC manufacturers/distributors and pharmacists.

We conducted syndromic surveillance for the Hokkaido, Japan, Toyako Group of Eight (G8) summit meeting in July 2008 as a counter-measure to bioterrorism attacks and other health emergencies. Surveys were conducted from June 23, two weeks before the summit, to July 23 two weeks after it, with part of those for prescription drugs fully automated, and part by manual input over the World-Wide-Web. Those for ambulance transfer were done similarly. We bought over-the-counter (OTC) sales data from two private research firms in Japan and had the monitor, who had contacts with a private research company, report health conditions via personal computer (PC) or cellphone. We had a virtual conference daily at 9:00 with the local Hokkaido government, local public health center, local Hokkaido public laboratory, the National Institute of Infectious Diseases, and the Ministry of Health, Labor and Welfare to decide whether local public health centers would be required to investigate. Fully automated syndromic surveillance was conducted by 23 pharmacies for prescriptions drugs, and 71 pharmacies provided manual corporate input. One fire department covering Toyako and a VIP support team used fully automated syndromic surveillance and seven Toyako fire departments used manual input. For 79 pharmacies providing OTC sales data, data provision was delayed one day and analysis could not be automated. Four hundred and seventy two households corporate web search for their health conditions. It also automatically analyzed and feed backed. No notable outbreak occurred during the summit, but public health centers investigated seven aberration detected by syndrome surveillance for ambulance transfer. Although a fully automated system was concidered best for early outbreak detection manual input and analysis were also required. Routine, fully automatied syndromic surveillance remains to be realized in Japan.

Objectives: We analyzed the possibility of using sales data on over-the-counter (OTC) medicine in syndromic surveillance for early detection and/or prediction of influenza pandemics., Methods: Data who collected on daily November 2003-April 2004 sales of common cold medication commercially obtained from 600 pharmacies in Japan enrolled in reporting throughout the 2003/04 influenza season. OTC sales data were compared to daily influenza incidence data to determine correlations and predictability. Data included Sentinel Surveillance of influenza, National Surveillance of Dally Influenza Outpatients (Daily Case Reporting: DCR), and Mailing-List-Based Influenza Epidemic Database (MLflu)., Results: The seasonal influenza epidemic peak for 2003-2004 was observed on January 30, February 1, and February 2 for sentinel surveillance, DCR, and MLflu. Sales peaks of OTC medicines occured twice in 2003-2004 season, once at the end of the year and once on January 27. Peak OTC sales for common cold medication per pharmacy were preceded by 18, 21, and 13 days for sentinel surveillance, DCR, and MLflu. OTC sales successfully explained 74-85% in the variation of influenza incidence which is interpretable as sufficient power of explanation., Conclusions: OTC sales proved to be a good indicator of real-time surveillance for influenza epidemics. Further analysis on multiyear data is needed to demonstrate the robustness of results. To confirm the advantage in the system of real-time syndromic surveillance, it is also necessary to check explanatory power of OTC sales on the variation of influenza incidence with prospective datasets.

Our series of studies aimed to examine the possibility of interactions between prescription drugs and over-the-counter (OTC) drugs by monitoring plasma drug concentrations in rats. When a levodopa preparation indicated for patients with Parkinson's disease was administered in combination with Takeda Kampo Ichoyaku K-matsu (A), Taisho Kampo Ichoyaku (B), or Kanebo Kampo Ichoyaku H(C), which are OTC kampo medicines for upset stomach, the plasma levodopa concentration-time curves were shifted downward and the AUC for levodopa was significantly lowered. These results indicate that there may be some interactions between the levodopa preparation and these OTC kampo medicines when ingested together, which leads to a reduction in the bioavailability of levodopa. On the other hand, concomitant administration of the levodopa preparation with Takeda Kampo Ichoyaku A-matsu (D) did not alter any of the pharmacokinetic parameters for levodopa. According to the package inserts for the OTC kampo medicines, A, B and C, but not D, contain metallic additives, such as aluminum silicate and magnesium stearate. In addition, combination with a kampo basis of D (Koshaheiisan-ka-shakuyaku) showed no detectable change in levodopa bioavailability. From these results, it was concluded that metallic additives may play an essential role in generating the drug-interaction between levodopa preparation and OTC kampo medicine for upset stomach.

"Neoceader smoking" is widely marketed in drug stores as an over the counter expectorant for cigarette smokers in Japan. Using high-pressure liquid chromatography, we determined that one piece of Neoceader (3 cm) contains 0.79 mg of nicotine, which is equivalent to one-sixth of the amount of nicotine in one Japanese cigarette (Mildseven extra-light, Mildseven super-light, or Sevenstar). Two patients who had switched from cigarette smoking to Neoceader smoking, subsequently became addicted to nicotine. The continine concentration in their urine were 937 ng/ml and 2,724 ng/ml, respectively. These findings demonstrate that Neoceader contains nicotine and that its use can lead to nicotine addiction.

A 67-year-old man, complicated with liver cirrhosis, diabetes mellitus, and ischemic heart disease, was scheduled for gastrectomy. He had been taking an over-the-counter (OTC) analgesic containing acetaminophen, ethenzamid and caffeine for 20 years, and refused to stop taking it preoperatively. He received general anesthesia with isoflurane, supplemented with fentanyl and midazolam. Muscle relaxation was obtained with vecuronium. Isosorbide was infused continuously to prevent myocardial ischemia. The anesthetic course was uneventful. Postoperatively, the patient experienced no difficulty in abstaining from taking the OTC analgesic. The patient's perioperative course indicates that he was not dependent on this OTC drug, but he needed this medication only to ameliorate his preoperative anxiety or depressive mood.

We surveyed 22 patients (of whom 4 were women) with a history of antitussive drug abuse at a psychiatric hospital in the suburbs of Tokyo and at the Clinical Institute for Addiction Problems from 1 July 1986 to 30 June 1991. for changes in their pattern of abuse after the composition was altered. Here are our findings: 1) Researchers have long differed on whether ephedrine or codeine was responsible for the abuse of over-the-counter antitussive agents. The present study revealed that although codeine was still present in the new Bron syrup, its abuse was clearly on the decline in Japan, leading us therefore to conclude that psychological dependence on ephedrine was central to the spate of over-the-counter antitussive abuse observed in the 1980s. Although we cannot ignore the mellow feeling codeine creates, it is difficult to give it more central role in the abuse of such drugs. 2) Users were divided into two groups, one that had used other agents before using antitussives, and another that had never used any other agent but antitussives. A comparison of these two groups revealed clear differences in learning behavior, social adaptation, familial environment and delinquent tendencies, prior to their drug abuse. 3) After the composition was altered, abuse spread to Tonin syrup manufactured by another laboratory, Bron tablets, new Bron syrup and ephedrine tablets. Relatively recently, there have been some new cases of abuse of Bron tablets and an increase in the number of cases who continued to use Bron syrup even after its composition was altered. The Medical literature also reveals that in many countries the abuse of both codeine and ephedrine is becoming a social problem, and clearly either agent may be abused separately.