| Comment Record |
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Commentor |
Ms. Cheryl Olson |
Date/Time |
2002-10-23 14:46:10 |
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Organization |
Mayo Clinic Rochester - Hospital Pharmacy Services |
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Category |
Health Professional |
| Comments for FDA General |
| Questions |
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1. General Comments
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The new recommendations for the labeling of nebulization products in semipermeable container closure systems is problematic. The embossed label is very difficult to read, and the appearance of all the nebulizer solutions will be similar creating look alike problems and compromising patient safety. At Mayo Clinic Rochester, our Hospital Pharmacy Services Patient Safety Committee discussed the following concerns/alternatives:
Has consideration been given to using a non-permeable container instead of a semipermeable container so the readable adhesive label can still be attached?
Could a large flange be created as part of the container? The paper medication label could be attached to the large flange. If the medication did not go into the flange portion it would eliminate the concern of adhesive contaminating the medication. It would also make the lot # and expiration date legible.
A point of concern is continued use of the embossed clear containers will only necessitate pharmcy department relabeling the nebulizer contianers. This is problematic because any manipulation of the product introduces the opportunity for errors.
Thank you,
Cheryl Olson, Pharm.D.
Pharmacy Specialist - Medication Safety
Mayo Clinic Rochester, Hospital Pharmacy Services
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