Originally Published PMPN
July 2003
EDITORIAL
Educate Each Other
During my five-plus years as senior editor for Pharmaceutical & Medical Packaging News, I’ve had plenty of chances to learn from a number of people in the industry. I also hope I have helped you readers learn through my writing and reporting.
Soon, I will no longer engage you, or be engaged by you, regularly. I am moving over to the staff of our sister publication, Medical Device & Diagnostic Industry. I hope to enjoy reporting on medical device design and manufacturing as much as I have on pharmaceutical and medical packaging. I will continue to write articles for PMP News from time to time, but this column is my last piece as a full-fledged staff member.
One of the industry’s great strengths is how its members are willing to share their knowledge and learn from each other. I would like to leave you with some ideas about how to expand that in the future.
The drug packaging industry and the medical device packaging industry need to learn more from each other. Thanks to the growing popularity of combination products such as drug-coated stents, the two industries are converging. This means that pharmaceutical packagers may need to learn more about medical packaging concepts, such as sterility. It also means medical packagers may need to learn more about drug packaging concepts such as stability. And there is no reason why each industry can’t become more familiar with the other’s techniques in areas such as testing, inspection, and validation. We will be devoting a lot of attention to this convergence in next month’s industry outlook articles. We encourage you to engage each other and us with your thoughts.
Original manufacturers and repackagers also need to learn more from each other. For years, it seemed, industry and regulators tried to pretend that repackagers didn’t exist. But the majority of drugs reach patients in packages other than those provided by original manufacturers. Also, a number of medical devices are reprocessed and repackaged, even if that was not intended by the original manufacturer.
In recent years, FDA has forced medical device manufacturers and reprocessors of single-use devices to better communicate with each other by issuing reprocessing regulations. Now it may be time for the pharmaceutical industry to open more of a dialogue with repackagers. Many times a drug is repackaged in something that is less protective than the original package. If a drug company did this itself, FDA would come down on it hard. But because FDA doesn’t oversee pharmaceutical wholesalers, distributors, pharmacy operations, or other third-party repackagers, such practices are allowed to occur. The only way to rectify the situation is for pharmaceutical firms to tell repackagers more about their drugs’ packaging requirements. The United States Pharmacopeia’s (USP; Rockville, MD) Packaging, Storage, and Distribution Project Team is meeting about repackaging in the fall. I hope it is the start of a significant dialogue.
I also hope that the industry continues to share insights and ideas and continues to use PMP News as a forum for them. I wish you all the best.
Erik Swain
Senior Editor
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