Objective : To determine how much label information on over-the-counter (OTC) medicines is contained on packaging, we investigated the items, description methods, and area of label information on packages.
Methods : We selected 75 common cold remedy products for investigation and classified the items into 3 categories (“items for use”, “items with a regulation requirement”, “items related to product image”) and measured the space given to each item in the total package area.
Results : All 75 products had “items with a regulation requirement (total 13 items),” but 8 products (only 2 manufacturers) had “consult a physician or pharmacist before use,” which was not a regulation requirement.  There were differences in description methods, especially in “caution” and “product name.”  Sixty percent of the OTC products used non-red characters with no box-frame, and 11% used red characters and box-frames.  The description order was not standardized, but “caution” was located in the lowest space on 80% of products.  Many item descriptions appeared in one place, but “product name” generally appeared in more than 4 places. While 4.5 to 8.0 points were commonly given for “items for use,” 16 to 100 points were given for “product name,” and the difference in number of points was greater than 6-fold among products.  The percentage of average area for “items related to product image” (6.1%) was 2-fold greater than for “items for use” (3.1%) and “items with a regulation requirement” (2.9%).  Almost half of the total package area was blank space.
Conclusion : Current descriptions in label information vary among items, products, and pharmaceutical companies.  Rules on describing information on OTC medicine packaging are thus necessary.

To clarify the views and needs on Rx-to-OTC switches in patients afflicted with lifestyle-related diseases such as hypertension, diabetes and/or hyperlipidemia, our survey was conducted with 199 patients at a pharmacy in Tokyo, Japan.Of the 199 patients, 159 people were patients afflicted with lifestyle-related diseases.One hundred and ten patients afflicted with lifestyle-related diseases were seventy-year-old and older, and 149 of the patients have been to a hospital at least once in the past year.Thirty-six point five percent of the patients afflicted with lifestyle-related diseases replied that they wanted to use Rx-to-OTC switches when they had been ill and/or injured.The main reasons that they wanted to use Rx-to-OTC switches were “convenience” and “always the same drugs”.On the other hand, the main reason that they did not want to use Rx-to-OTC switches was “I want to have a detailed examination”.Twenty-three point nine percent of them replied that they wanted to switch their prescription drugs to Rx-to-OTC switches. We believe that the usage of Rx-to-OTC switches after the establishment of a support system to secure safety can be the answer to the issues of the rise in medical care expenditures and doctor shortage.

The quantitation of serum tocilizumab using liquid chromatography tandem-mass spectrometry(LC-MS/MS)method has not been widely applied in clinical settings because of its time-consuming and costly sample pretreatments.The present study aimed to develop a validated LC-MS/MS method for detecting serum tocilizumab by utilizing immobilized trypsin without an immunoglobulin G purification step and evaluate its applicability in the treatment of rheumatoid arthritis(RA)patients administered intrave-nously or subcutaneously with tocilizumab.The tocilizumab-derived signature peptide was deciphered using a nano-LC system coupled to a hybrid quadrupole-orbitrap mass spectrometer.The serum tocili-zumab was rapidly digested by immobilized trypsin for 30 min.The chromatographic peak of the signature peptide and that of the internal standard were separated from the serum digests for a total run time of 15 min.The calibration curve of serum tocilizumab concentration was linear with a range of 2-200 μg/mL.The intra-and inter-day accuracy and relative standard deviation(RSD)were 90.7％-109.4％and＜10％,respectively.The serum tocilizumab concentrations in the RA patients receiving intravenous and subcutaneous injections were 5.8-28.9 and 2.4-63.5 pg/mL,respectively.The serum tocilizumab concentrations using the current method positively correlated with those using the enzyme-linked immunosorbent assay,although a systematic error was observed between these methods.In conclu-sion,a validated LC-MS/MS method with minimal sample pretreatments for monitoring serum tocili-zumab concentrations in RA patients was developed.

Background/Aims: There are few published registry studies from Asia on pediatric inflammatory bowel disease (IBD). Registry network data enable comparisons among ethnic groups. This study examined the characteristics of IBD in Japanese children and compared them with those in European children. Methods: This was a cross-sectional multicenter registry study of newly diagnosed Japanese pediatric IBD patients. The Paris classification was used to categorize IBD features, and results were compared with published EUROKIDS data. Results: A total of 265 pediatric IBD patients were initially registered, with 22 later excluded for having incomplete demographic data. For the analysis, 91 Crohn’s disease (CD), 146 ulcerative colitis (UC), and 6 IBD-unclassified cases were eligible. For age at diagnosis, 20.9% of CD, 21.9% of UC, and 83.3% of IBD-unclassified cases were diagnosed before age 10 years. For CD location, 18.7%, 13.2%, 64.8%, 47.3%, and 20.9% were classified as involving L1 (ileocecum), L2 (colon), L3 (ileocolon), L4a (esophagus/stomach/duodenum), and L4b (jejunum/proximal ileum), respectively. For UC extent, 76% were classified as E4 (pancolitis). For CD behavior, B1 (non-stricturingon-penetrating), B2 (stricturing), B3 (penetrating), and B2B3 were seen in 83.5%, 11.0%, 3.3%, and 2.2%, respectively. A comparison between Japanese and European children showed less L2 involvement (13.2% vs. 27.3%, P< 0.01) but more L4a (47.3% vs. 29.6%, P< 0.01) and L3 (64.8% vs. 52.7%, P< 0.05) involvement in Japanese CD children. Pediatric perianal CD was more prevalent in Japanese children (34.1% vs. 9.7%, P< 0.01). Conclusions Upper gastrointestinal and perianal CD lesions are more common in Japanese children than in European children.