FentaNYL Patch Not Adhering Properly During Use

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FentaNYL patch not adhering properly during use. A hospital pharmacist reported issues with transdermal fentaNYL patches from Actavis stating that the patches do not maintain contact with the patient's skin. This problem has affected two patients and involved three fentaNYL strengths. A patient with cancer-related pain had been wearing fentaNYL patches at home, prior to being admitted to the hospital. The patient was complaining of inadequate pain relief with the 100 mcg per hour patch. The nurse checked the patch and noticed a large bubble in the middle such that the area of the bubble was no longer touching the patient's skin. It had been 48 hours since the patch had been applied. A new patch was placed on the patient, but after 24 hours, the new patch also had a bubble, and the patient's pain was not adequately controlled. No lotions, creams, or other substances had been applied to the patient's skin prior to the patch being applied. However, the patient had recently started radiation (not at the site where the patch was applied), so it was thought that this might be affecting skin oils, causing the patches to not adhere to his skin. The patient was switched to extended-release oral pain medications, and his pain was controlled.
Another patient at this hospital had the Actavis fentaNYL patch fall off after 24 hours. A new patch was applied but fell off again. A different brand was applied, and no additional problems occurred with this patient.
Lot numbers of the Actavis patches have been sent to the company and the U.S. Food and Drug Administration (FDA). We don't know at this point if other lots are involved or if there is some other reason for the problem, so we've asked the company and FDA to investigate. An Actavis representative said the company has not had any recalls of the transdermal fentaNYL product. We think this problem and the resulting loss of pain control is important enough to mention, although further investigation is needed. We have only received a single report to date, so please report any similar experiences to FDA MedWatch (www.ismp.org/sc?id=1660) or ISMP (www.ismp.org/MERP) if you use Actavis fentaNYL patches so the scope of the problem can be estimated. Be sure to include the patch lot number(s).
IV fat emulsion needs a filter. A change in the package insert for intravenous fat emulsions used in nutrition (e.g., INTRALIPID, NUTRILIPID) indicates a 1.2 micron filter should be used when administering these products. This is also a change from some product labeling that stated filters are not recommended, or if filtration is used, then a filter of less than 1.2 micron pore size must not be used. Newer fat emulsion labeling states: “Use a 1.2 micron filter with Intralipid (strength). Filters of less than 1.2 micron pore size must not be used.” There may be confusion about this change. For example, when Fresenius Kabi went from EXCEL to BIOFINE containers 2 years ago, the product label was simultaneously updated (June 2015) to reflect the new filter requirement. However, some package inserts sent along with information about the bag change did not yet have the label change. Nutrilipid has included wording about the need for filtration since 2014. Also, older labeling that says, “Use a 1.2 micron filter with admixtures ...” might mean only with a 3-in-1 admixture to some people. But the change is applicable to all fat emulsion infusions, admixture or not. Adding to the confusion is that some products with older labels may still be in the supply chain, and internet searches and drug information references may still have outdated information.
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