Objective : To identify the issues in conducting pharmacoeconomics (PE) studies at pharmaceutical companies in Japan.
Methods : A questionnaire survey on the conditions of PE studies was conducted for the pharmaceutical companies that are members in the Pharmaceutical Manufacturers Association of Tokyo. Seventy-seven of 94 member companies participated, an 82% response rate. The survey covered the following topics with regard to the companies : the number of applications of PE data for the new drug pricing process, the timing and phases to conduct a PE analysis, a recognition of the necessity for PE analysis, and issues for conducting optimum PE analysis.
Results : Out of 77 responding companies, 36 companies (47%) answered that they conduct PE analysis at their regulatory affair department in order to submit supplemental applications for the drug pricing process to the Ministry of Health, Labor and Welfare. However, only 42% companies of approved drugs since April 1997 were actually submitted with PE data for the drug pricing review. Seventy-seven percent of companies recognized the necessity for PE analysis for the drugs. On the other hand, they did not perceive PE as a useful tool for negotiating drug prices with the Japanese government. Major issues for PE analysis to be conducted are ; lack of Japanese guidelines and epidemiological databases, lack of transparency in the method which reflects the data for the policy making, and lack of companies'initiative.
Conclusion : Establishment of a Japanese guideline for PE studies will be important for companies to conduct accurate and reliable PE studies. The Japanese government should disclose the process of using the PE data for policy making. At the same time, it is necessary for the companies to be more spontaneous in their PE studies.

Objectives : Pharmaceutical companies in Japan can attach pharmacoeconomic (PE) data to their application for new drug prices covered by the National Health Insurance (NHI) system since 1992. To examine the present state of PE studies in Japan by investigating the situation of PE data attachments and their details and also to identify problems concerning how to reflect the PE information in new drug pricing, a questionnaire-based survey of pharmaceutical companies was conducted.
Method : The survey covered 115 drugs filed by the members of the Japanese Pharmaceutical Manufacturers Association (JPMA), which are among the 137 drugs listed between June 20, 1997, when the NHI drug price formula was published, and November 17, 2000. Questionnaires were returned on 114 of the 115 drugs studied and the response rate was 99%.
Results : PE data was attached to 37 of the 114 drugs (32%) at the time of application. The ratio of applications accompanied by PE data tended to be decreased from 1998. No significant relation was observed between a premium for a drug and the attachment of PE data. The most common method used in the attached PE data was cost-effective analysis (14 of 37 drugs ; 38%), followed by cost-benefit analysis (7 drugs) and cost-minimization analysis (6 drugs). Cost-utility analysis was not applied to any of the 37 drugs.
Discussion : Compared with overseas PE studies, Japanese studies were found to be less comparable with one another due to the lack of a uniform system of research and reporting results. Other problems observed included insufficient epidemiological data for analysis and difficulty in the cost data collection. The questionnaire-based survey revealed that Japan needs to set guidelines for PE studies and to establish epidemiological and cost databases for these research activities. It also suggested the necessity of reviewing the present method of clinical tests so that economic parameters for PE analysis and QOL may be obtained from these tests.

Objectives: This study evaluates the relationship between the various words expressing pain and the efficacy of opioid analgesics, in order to provide information on the appropriate selection of analgesic drugs for cancer pain relief. A new and simplified evaluation list for the assessment of pain, including the common words used to express pain, was developed accordingly. Methods: The words expressing pain were classified into three categories based on the Guidelines for Drug Therapy in Cancer Pain. These words were grouped into clusters according to the efficacy of opioid drugs, as expressed by the patients. On the basis of these results, an evaluation list was developed, and its validity was assessed by clinical pharmacists and cancer patients experiencing pain. Results: On the basis of the classification of the words, their relationship with opioid efficacy was summarized, and the results of the cluster analysis were found to be helpful for the development of a new pain evaluation list. Conclusion: Patients use various words to express their pain. By classifying and clustering these words according to the guidelines and the efficacy of opioid drugs, we proposed a practical pain evaluation list for appropriate selection of analgesic drugs in patients with cancer.

This study was conducted to shed light on the actual conditions of home care and quality-of-life factors related to the burdens on families. For this purpose, a survey was carried out on main caretakers in the families who were using our home care support service. Fundamental information about the main caretakers and those who need care were garnered. In addition, WHO/QOL-26 and burdens for main caretakers were checked up on.The survey found that those who have looked after the sick or invalid for less than six months and those over five years keenly felt that they were shouldering a heavy burden. With the progression of dementia, the caretakers increasingly felt the burden getting heavier. Physical factors in QOL were linked to the burden which caretakers feel has to be borne, but psychological and social factors were not. This finding might have been ascribed to the fact that the persons surveyed were residents of the provincial city, part of which is rural. They were mostly old women and must have gained the support of their relatives. It is easy to assume that their role perception and sense of responsibility together with regional characteristics were reflected in psychological and social QOL factors.
Home care aspects ; SOCIAL ; Related ; Home care of patient ; Family Members

Postoperative meningitis after spinal surgery is a rare complication that can result in a life-threatening condition. Linezolid (LZD) is an oxazolidinone which has been approved in Japan for infections caused by methicillin-resistant Staphylococcus aureus. The authors encountered a case of postoperative meningitis with cerebrospinal fluid leakage (liquorrhoea) that occurred after resection of a cervical cord tumor. The infection was caused by methicillin-resistant Staphylococcus epidermidis(MRSE). Debridement and suture of the dura matter was carried out. LZD was given intravenously. The infection was cured without any sequelae. Based on this result, we concluded that LZD might be considered as one of the first choices for the treatment of postsurgical meningitis caused by MRSE.
Acetamides ; Debridement ; Humans ; Japan ; Meningitis ; Methicillin Resistance ; Methicillin-Resistant Staphylococcus aureus ; Oxazolidinones ; Staphylococcus ; Sutures ; Linezolid

Objective: The purpose of this study is to compare the clinical efficacy between original drugs and generic products.  Candidate drugs included two types of hydroxymethylglutaryl-CoA (HMG-CoA) reductase inhibitors, simvastatin and pravastatin, because of their importance at reducing the health expenditure for hyperlipidemia.
Design: We retrospectively evaluated the efficacy (total cholesterol, triglyceride, low-density lipoprotein and high-density lipoprotein levels), safety (biochemical parameters), and medication adherence based on patient data.  We set the follow-up period at 6 months before and after substitution.  Data were analyzed by paired-sample t-tests (statistical significance level of 0.05).
Methods: The subjects included in this study were ambulatory patients visiting Nakajima Hospital for dyslipidemia treatment.  Selected patients included those taking both the original drug and the generic product; i.e., patients who had substituted the original drug Lipovas® for the generic product Simvastatin OHARA, or those who had substituted the original drug Mevalotin® for the generic drug Pravatin®.
Results: A total of 118 patients in the simvastatin study and 43 patients in the pravastatin study were candidates for the present study.  We found that there were no significant differences before and after substitution.  Even though there were differences in some of the biochemical parameters, the range remained within normal levels.  With regard to medication adherence, we found no significant differences.
Conclusion: In this study, we found no significant differences before and after substituting medications with generic drugs.  Additionally, we found no subjective symptom changes after substitution.  To develop clinical information on generic products and to store such information, it is important that pharmaceutical products be used appropriately.