Objective: In recent years, the Ministry of Health, Labor and Welfare has actively promoted the use of generic drugs.  However, implementation of this policy has not progressed smoothly, as information on generic drugs is poorly organized.  As a result, it is difficult for pharmacists to select the appropriate generic drugs.  Therefore, we attempted to develop a code system to organize information on generic drugs.
Methods: We analyzed the guidelines used for the approval of generic drugs.  We then identified the important aspects for comparison of generic drugs and developed a code system.  Next, we tested this code system using temocapril hydrochloride tablets, which is a generic drug.
Results: We were able to develop a code system for selection of generic drugs.  Furthermore, we confirmed the utility of this code system for selecting generic drugs in the case of temocapril hydrochloride tablets.
Conclusion: We believe that this code system with be useful for pharmacists, but further development is necessary for other generic drugs.

In the previous paper, the authors reported that there was a correlation between the length of guide-tubes and tapping pain, and that a correlation between guide-tube lengths and early pain following the tapping was noted when the length difference between the needle and the tube was less than 3mm, whereas no correlation when the differnece was more than 3mm. In the present paper we report the relationship between sticking pain and caliber of guide-tubes.
MATERIAL & METHOD
1. Guide-tubes: 18 types of guide-tubes of different caliber (1.0-2.2mm) were specially made for this experiment. They are made of silver and have a standard octagonal cross section (external diameter: maximum 5.4mm, minimum 4.6mm, length: 53.5mm, weight: 7.3-9.1g).
2. Needles: Stainless steel needles (length: 58.0mm, body diameter: 0.18mm, head diameter: 1.27mm) were used. In some special conditions, silver needles of the same dimension or thin head need (head diameter: 0.75mm) were used.
3. Acupuncturists and subjects: A half of twelve teachers of our school participated as acupuncturists, and the other half as subjects.
4. Procedure: Needle tapping was performed 360 times (10 times per subject by each acupuncturist) by each guide-tube on the front part of the crus. Sticking pain caused by the tapping was rated on a 5 grade (0-4) basis.
RESULT
1. Among the guide-tubes of 1.35, 1.4, 1.8, 2.0 and 2.2mm caliber (with stainless steel needles of 1.27mm head diameter) and the guide-tubes of 1.0mm caliber (with stainless steel needles of 0.75mm head diameter), the 1.35mm caliber tubes caused significantly less sticking pain than the rest.
2. Sticking pain was sigificantly severe when a 1.35mm caliber tube and a thin head (0.75mm) needle were used, or when a thin head (0.75mm) needle was tapped in as slantingly as possible in a 1.8mm caliber tube.
3. Based on these results, one can conclude that guide-tubes whose caliber is very close to the needle head diameter are effective in lessening sticking pain.

Ten healthy adults lying in the supine position underwent ‘painless sohri-kifu technique’, ‘Oshide only’, ‘acupuncture only’ and ‘painfull sohri-kifu technique’ on the left ‘Tai-en’ point for one minute. Instantaneous heart rate was measured with a polygraph. Statistical analysis showed that ‘sohri-kifu technique’ and it's constituent—‘Oshide only’, and ‘acupuncture only’ caused significant the decrease of heart rate. The painless sori-kifu technique was more effective than ‘Oshide only’ and ‘acupuncture only’ in decreasing the heart rate. The ‘painful sori-kifu technique’ caused no significant change of heart rate. Sticking pain seems to effective in suppressing the decrease of heart rate.

Objective: The purpose of this study is to identify the problems in the adverse drug report (ADR) system in early post-marketing vigilance phase (EPM phase) in Japan.
Methods: The incidence of all ADRs and the ratio of serious ADRs were compared between the new drug application phase (ND phase) and the EPM phase.  The target medicines were Moxifloxacin (Avelox®tablets, 400mg), Gatifloxacin (Gatiflo®tablets, 100mg) and Prulifloxacin (Sword®tablets, 100mg).
Results: The average incidence of all ADRs in the ND phase was 100-fold greater than that in the EPM phase.  There were also 2-fold differences in the ratio of serious ADRs of individual medicines.
Conclusion: There are several problems with the ADR system in the EPM phase in Japan.  It is currently possible that the implementation of EPM will vary between in individual medicines and companies.  This suggests that the present data cannot be applied universally.  Thus, there is an urgent need to standardize the implementation of EPM.

Comparative trials were undertaken using 16 types of guide-tubes of different caliber and external diamter: small caliber (1.35mm) and large cliber (1.80mm) tubes of eight types of external diameter (i. e, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5 and 6.0mm). 540 tappings was performed with a hard needle (length: 58.0mm, diameter: 0.16mm, head diameter: 1.25mm).
The result can be summarized as follows:
1. Among the six small guide-tubes with 2.5-5.0mm external diameter, the larger external diameter was, the less sticking pain was experienced.
2. The four small caliber guide-tubes with 4.5-6.0mm external diameter caused significantly less sticking pain compared with the four small caliber guide-tubes of 2.5-4.0mm and the four large guide-tubes of 4.5-6.0mm.

Purpose: From shortly after the fentanyl patch became commercially available, we have been using it as part of our armamentarium for cancer therapy to produce a reliable analgesic effect from the active treatment period to the terminal stage in patients who are expected to develop resistance to oral analgesics. To confirm the usefulness of fentanyl patch, a retrospective study was conducted to determine its efficacy and safety. Method: A survey was conducted of 28 cancer patients who were undergoing pharmacological pain control. The following parameters were recorded: opioids administered prior to fentanyl patch use, reasons for switching to fentanyl patch, duration of administration and dosage of fentanyl patch, pain score before switching to fentanyl patch, adverse effects (nausea, vomiting, constipation and drowsiness), and the results of clinical tests. Results: The major reasons for switching to fentanyl patch were: "pain control with oral agents was expected to become difficult in future" and "adverse effects of chemotherapy were noted or were likely to develop". The mean duration of fentanyl patch use was 133 days, during which time the pain score and the constipation symptom were significantly reduced. No significant difference was found with nausea, vomiting, drowsiness or the results of clinical tests. Conclusion: It is concluded that fentanyl patch is a highly useful opioid for analgesia when administered during chemotherapy for cancer and continued to the terminal stage.

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.

OBJECTIVES: The aim of this study was to examine the discontinuation and occurrence of fracture during denosumab treatment in Japanese women with primary osteoporosis or rheumatoid arthritis (RA) with osteoporosis. METHODS: This retrospective study included 143 patients with primary osteoporosis and 96 patients with RA and osteoporosis who were treated with denosumab. Treatment discontinuation, fracture occurrence, lumbar spine (L1–4) bone mineral density (LS-BMD), and bilateral total hip BMD (TH-BMD) were examined before and at 1 and 2 years after treatment commencement. RESULTS: In the primary osteoporosis group, 32 cases dropped out and no fractures occurred from 0 to 1 year. Eighteen cases were lost to follow-up and no fractures were noted from 1 to 2 years. In the RA with osteoporosis group, 7 cases dropped out and no fracture occurred from 0 to 1 year. Twenty-one cases were lost to follow-up and 2 nonvertebral fractures were noted from 1 to 2 years. In this group, 13 cases dropped out from 1 to 2 years and 16 cases dropped out during the 2-year study period due to economic reasons. LS-BMD and TH-BMD values increased continuously for 2 years of treatment in both primary osteoporosis and RA with osteoporosis groups. CONCLUSIONS: These results suggest that during denosumab therapy, the discontinuation rate is expected to remain low during 2 years of treatment in primary osteoporotic patients. In RA patients with osteoporosis, however, the discontinuation rate may increase due to economic reasons from 1 to 2 years of therapy.
Arthritis, Rheumatoid* ; Asian Continental Ancestry Group* ; Bone Density ; Compliance* ; Denosumab* ; Female ; Hip ; Humans ; Lost to Follow-Up ; Osteoporosis* ; Retrospective Studies ; Spine

As a bisphosphonate, minodronate (MIN) is one of the strongest inhibitors of bone resorption. However, there have been no reports directly comparing the antiresorptive effects of monthly MIN with those of monthly risedronate (RIS). We enrolled 30 cases of osteoporosis (OP; 16 in the MIN group [mean age: 68.2 years] and 14 in the RIS group [mean age: 68.1 years]) to investigate the early effects of treatment by monthly MIN or RIS over a 4-month period using bone turnover marker values. Only female patients were enrolled to avoid gender bias. Urinary cross-linked N-telopeptide of type I collagen (NTX) before treatment and at 1, 2, and 4 months of therapy, as well as serum bone alkaline phosphatase and alkaline phosphatase before treatment and at 4 months afterwards, were evaluated. All bone turnover marker values were significantly decreased at 4 months in both groups. The changes in urinary NTX at the study end point for RIS and MIN were -30.1% and -63.1%, respectively. From 2 months of treatment, the antiresorptive effects on urinary NTX by MIN were significantly higher than those by RIS, indicating that MIN more immediately and strongly inhibited bone absorption. Thus, monthly MIN seems to suppress bone resorption faster and more strongly than RIS in OP treatment.
Absorption ; Alkaline Phosphatase ; Bone Remodeling ; Bone Resorption* ; Collagen Type I ; Female ; Humans ; Osteoporosis ; Risedronate Sodium* ; Sexism

OBJECTIVES: We examined whether eldecalcitol (ELD) provided additive bone mineral density (BMD) and bone turnover marker gains in patients undergoing long-term bisphosphonate (BP) usage, especially in osteoporotic individuals exhibiting a poor response to BPs. METHODS: Forty-two post-menopausal patients with primary osteoporosis and low lumbar BMD (L-BMD) and/or bilateral total hip BMD (H-BMD) values receiving long-term BP treatment were prospectively enrolled. Serum bone alkaline phosphatase (BAP) was measured as a bone formation marker and urinary N-terminal telopeptide of type I collagen (NTX) was assessed as a bone resorption marker. L-BMD, H-BMD, and femoral neck BMD (N-BMD) were recorded before, at the commencement of, and during ELD administration. RESULTS: BAP and urinary NTX were significantly decreased by BP therapy prior to ELD. ELD addition further significantly decreased the bone turnover markers (both p < 0.01). The mean L-BMD increase rate was 0.2% (p = 0.81) from 2 to 1 years before ELD administration, −0.7% (p = 0.30) during the year before ELD, and 2.9% (p < 0.01) during 1 year of ELD. Similar findings were observed for the mean increase rate of H-BMD, with values of 0.2% (p = 0.55), −0.7% (p < 0.01), and 1.2% (p < 0.01), respectively. The mean N-BMD increase rate was significantly increased after ELD administration (1.1%, p = 0.03) despite no gains by BP therapy alone. CONCLUSIONS: This study suggests that ELD addition may be useful for osteoporotic patients exhibiting a diminished long-term BP therapy response.
Alkaline Phosphatase ; Bone Density ; Bone Remodeling ; Bone Resorption ; Collagen Type I ; Femur Neck ; Hip ; Humans ; Osteogenesis ; Osteoporosis ; Prospective Studies