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Additional file 1.

Additional file 1. English translations of the Japanese language questionnaires used for each type of participant. There are three types of questionnaires for registered dietitians, pharmacists with registered dietitians/dietitians and pharmacists without registered dietitians/dietitians. The results in our manuscript are based on the answers to some of these questions.

ESM 1.

Kenji Kabeya,1 Hiroki Satoh,2,3 Satoko Hori,4 Yasumasa Miura,5 Yasufumi Sawada2 1Faculty of Pharmaceutical Sciences, The University of Tokyo, Tokyo 113-0033, Japan; 2Laboratory of Drug Lifetime Management, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo 113-0033, Japan; 3Interfaculty Initiative in Information Studies, The University of Tokyo, Tokyo 113-0033, Japan; 4Laboratory of Drug Informatics, Keio University Faculty of Pharmacy, Tokyo, 105-8512, Japan; 5Toho Holdings Co., Ltd, Tokyo 155-8655, JapanCorrespondence: Yasufumi Sawada Tel +81 3-5841-1096Fax +81 3-5841-1097Email sawada@mol.f.u-tokyo.ac.jpBackground: Press-through-package (PTP) sheets are common forms of packaging for medicines in Japan. However, patients and/or pharmacists have reported difficulty in extracting tablets or capsules from some PTP sheets.Objective: We used postmarketing surveillance data to identify the characteristics of PTP sheets that patients and pharmacists feel are “hard to use”.Methods: Marketing specialists of Toho Pharmaceutical Co., Ltd. canvassed patients and medical workers during November 2014–April 2016. Among 1,129 anonymous reports of products being “hard to use”, we identified 39 products with 5 or more reports (Problem group). We compared the sizes of the drugs and PTP pockets, the size ratio, the material used for the front of PTPs, the shape of the pockets, the thickness of the pocket wall, and the force needed to release the drug from the PTP (press-out force: POF) in this Problem group with those in a Control group of 97 problem-free products.Results: Logistic regression analyses revealed that a bigger pocket, a smaller drug size and a smaller drug-pocket size ratio increase the risk of being “hard to use”. Regarding the material, aluminum, PCTFE and PE increase the risk, while PP and PVC decrease the risk. Other factors had no significant influence.Conclusion: Pockets in PTP sheets should be designed so as to minimize the gap between the drug and the pocket, and PP or PVC should be used as the front material instead of aluminum, PCTFE or PE. Our results suggest that marketing specialists can play effective roles in postmarketing surveillance.Keywords: marketing specialist, postmarketing surveillance, PTP, package

Kenji Kabeya,1 Hiroki Satoh,2,3 Satoko Hori,4 Yasumasa Miura,5 Yasufumi Sawada2 1Faculty of Pharmaceutical Sciences, The University of Tokyo, Tokyo 113-0033, Japan; 2Laboratory of Drug Lifetime Management, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo 113-0033, Japan; 3Interfaculty Initiative in Information Studies, The University of Tokyo, Tokyo 113-0033, Japan; 4Laboratory of Drug Informatics, Keio University Faculty of Pharmacy, Tokyo 105-8512, Japan; 5Toho Holdings Co., Ltd, Tokyo 155-8655, JapanCorrespondence: Yasufumi SawadaLaboratory of Drug Lifetime Management, Graduate School of Pharmaceutical Sciences, The University of Tokyo, 7-3-1 Hongo, Bunkyo-Ku, Tokyo 113-0033, JapanTel +81 3 5841 1096Fax +81 3 5841 1097Email sawada@mol.f.u-tokyo.ac.jpBackground: Medical tablets and capsules are superior with regard to portability and are the most common dosage form in Japan. However, their large size often results in difficulties during ingestion, sometimes leading to reduced medication adherence.Objective: The authors used postmarketing surveillance data to determine the threshold size of medical tablets and capsules that patients feel are too large to ingest.Patients and Methods: The marketing specialists of Toho Pharmaceutical Co., Ltd. collected opinions of patients and medical workers (November 2014–April 2016). Regarding 709 reports from patients stating that the tablet or capsule for too large for ingestion, a dataset was prepared from package inserts of the reported drugs. Two analyses were conducted: histogram analysis of size distribution and geometric analysis using linear approximation. Six indices of tablet/capsule size were considered: length; length + width; length + width + depth; length × width; length × width × depth; and weight.Results: Histogram analysis revealed that length + width + depth is an excellent index of tablet/capsule size, and negative reports on tablet/capsule size drastically increase when this index is ≥ 21 mm. Geometric analysis using linear approximation also revealed similar results.Conclusion: The threshold size of tablets/capsules that patients feel are too large to ingest is length + width + depth = 21 mm. Therefore, when designing or altering tablets/capsules, if length + width + depth is ≥ 21 mm, the drug should be scored, split into smaller doses, or redesigned as an orally disintegrating formulation.Keywords: marketing specialist, size, shape, tablet, capsule, postmarketing surveillance