https://orcid.org/0000-0003-4671-9283
Abstract
Background
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.
Acknowledgments
The authors thank the medical workers, marketing specialists, and staff of the Pharmaceutical Affairs Department of Toho Pharmaceutical Co. Ltd. for their contribution to the postmarketing surveillance in this study, as well as the staff of various pharmaceutical companies for providing product information for this study.
Disclosure
Hiroki Satoh reports Honoraria (lecture fee) from Neopharma Japan Co., Ltd. and Torii Pharmaceutical CO., LTD., outside the submitted work. Hiroki Satoh and Yasufumi Sawada are members and Satoko Hori was a member of the Laboratory of Drug Lifetime Management which was funded by 11 companies including Toho Pharmaceutical Co. Ltd. Yasumasa Miura is employed by Toho Holdings Co. Ltd. The authors report no other conflicts of interest in this work.