Objective: In this work the cost-effectiveness of smoking cessation in Japan was investigated. Five groups of subjects, simulating cohorts wishing to quit smoking, were chosen as follows: (i) naturally quitting smoking, (ii) nicotine patch OTC medicine ( OTC patch), (iii) nicotine gum OTC medicine ( OTC gum), (iv) prescribed nicotine patch ( prescribed patch), and (v) prescribed bupropion.
Design: A Markov model study
Method: Using a Markov model, the cost per life-year saved associated with pharmacotherapy for quitting smoking cohorts of 30 · 40 · 50-year-old men and women was estimated. The expenses associated with smoking cessation were calculated based on either current retail prices of the medications in a community pharmacy practice or a fee schedule ; the costs and benefits were discounted by 3 % annually. Sensitivity analyses for the treatment effectiveness were performed.
Results: The incremental cost per life-year saved for the OTC patch method ranged from 518,826 yen to 652,282 yen for men and from 351,317 yen to 725,109 yen for women. For the case of the OTC gum the values were 871,442 yen to 1,205,142 yen for men and 592,558 to 1,282,263 yen for women. The prescribed patch values ranged from 504,373 yen to 603,371 yen for men and 340,734 yen to 685,626 yen for women. The corresponding values for prescribed bupropion were 562,564 yen to 670,768 yen for men and 379,960 yen to 763,283 yen for women. Sensitivity analyses indicated that changes in the treatment effectiveness had the strong influence on cost-effectiveness.
Conclusions: Smoking cessation utilising pharmacotherapy in Japan was found to be cost-effective in comparison with natural methods of quitting smoking. OTC patch and prescribed patch were the two most cost-effective treatments.

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Objective: The objective of this study was to clarify issues in providing more effective guidance in the drug treatment, especially the usage instructions of inhaled steroids, of adult bronchial asthma patients by verifying which points of explanation are especially important in controlling attacks, and whether or not issues exist stemming from a evaluation gap between patients and pharmacists regarding the degree of explanation and understanding on the usage instructions of inhaled steroids.
Method: Our survey targeted pharmacists working at community pharmacies in eight different areas of Japan, along with adult bronchial asthma patients using these pharmacies. Patients were questioned regarding the content and the degree of explanation in inhalation methods, the degree of understanding, and the degree of improvement in symptoms. For each point of explanation, the ratio of the score gap between (1) the patients’ evaluation (‘perception’) of the degree of the pharmacists’ explanation and pharmacists’ own evaluation of the degree of his/her own explanation, and (2) the patients’ evaluation of the degree of their own understanding and the pharmacists’ evaluation of the degree of patient understanding was calculated. We also verified the relationship between the patients’ evaluation and the degree of control of asthma attacks using a χ² test. We then reviewed the points of explanation which indicated significant difference, in an attempt to elucidate the characteristics of the patient-pharmacist “evaluation gap.”
Results: The results indicated that the degree of explanation of the “objectives of using inhaled steroids,” and “how to cope with asthma attacks,” as well as the degree of understanding of the “objectives of using inhaled steroids,” “directions for use and dosage,” and “drug interactions” provided an important clue to controlling asthma attacks. Of special note was the existence of “a gap in evaluation (perception)” regarding the degree of explanation and understanding between the patients and the pharmacists for the “objectives of using inhaled steroids” and “how to cope with asthma attacks.”
Conclusions: It is crucial to pay special attention to the objectives of using inhaled steroids and how to cope with asthma attacks when guiding patients.

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Objective: Databases, such as the Medicaid recipient database in the USA and the General Practice Research Database (GPRD) in the UK, take on an important role as resources for balancing the benefits and risks of medicines in Europe and the United States.
Their record sizes are several ten million and a few million each. They are actually used for epidemiological studies. However, in Japan, a database that can be used for such studies is insufficient. We attempted to create a database of pre-marketing clinical trial data for antihypertensive drugs. These data have been managed by a Controller Committee.
(Design : not applicable )
Methods: The database is made from the data and the documents, including electronic and paper media. The creation process was as follows : computerizing documents, item-name identification, defining the integrated database, protocol review, batch processing, and logical/validation checking.
Results: The database has 13 datasets and consists of 56 trials and 12,389 subjects. Overall, 15 trials involved beta-blockers which is the largest drugs as the investigational drug, and 43 trials compared the same group of antihypertensive drugs.
Conclusion: A database that can be used for quantitative evaluation of various hypotheses has been built. It is possible to completely analyze all of the data in this large-scale database to conduct, for example, individual patient data (IPD) meta-analyses.

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From the standpoint of a physician, drug safety data include not only information on adverse effects, but also information required to perform drug therapy safely. Drug safety data required by physicians include pharmacological data, name of the drug, history and physical data of patients, and an electronic or paper-based prescribing system at the clinic. Although most physicians are generally interested in drug safety data, a focus is not placed on adverse effects, given that they represent only a minor fraction of what is required for clinical practice and prescribing drugs. Moreover, Japanese physicians, who are busy with daily clinical practice, cannot find the time to extract essential information from what is supplied or to manage, make use, and report adverse events.
Many problems exist in the management of drug safety data, especially for adverse effects, including collection of data, database management, and feedback to physicians. In particular, current adverse effect reporting systems rely too heavily on physicians. In order to improve the sensitivity and management of drug safety data in Japan, it is expected that not only physicians but also pharmacists, paramedical staff, and patients will report drug safety data. One promising possibility is the establishment of a special division at all medical facilities that manages drug safety data. This concept is similar to that of the Governmental Consumer Agency (Shohisha-cho) launched in 2009. As an issue, drug safety traverses all of healthcare, so it may be necessary for the drug safety division to adopt not only specialists whose subspecialties are more focused, but also general physicians.

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