1. Shastay, Ann MSN, RN, AOCN

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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 ( or ISMP ( 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. A filter could stop fat emboli that might occur if the emulsion cracks, and could also prevent particulate matter from reaching the circulation. Filters also reduce the potential for patient harm due to microprecipitates, microorganisms, and air emboli. Recently published American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) consensus recommendations (Ayers et al., 2014) suggest using a 0.22 micron filter for dextrose/amino acids (2-in-1) admixtures and a 1.2 micron filter for total nutrient admixture (3-in-1) formulations.


Demonstration pack mistaken as starter pack. While planning the discharge of a patient who had a pulmonary embolism, pharmacy was notified that the patient had been given a 30-day sample starter pack of XARELTO (rivaroxaban). The hospital did not permit samples to be dispensed and had previously given out Xarelto discount vouchers provided by the manufacturer. So, the pharmacist went to the patient care area to follow up and find out how the patient received a Xarelto sample packet instead of the voucher that was usually given to patients at discharge. When the starter pack that had been given to the patient was examined, it was discovered that it was not a sample starter pack at all. It was a demonstration pack designed to look exactly like the real starter pack, but when it was opened, the pack had pictures of each tablet, not actual Xarelto tablets (Figure 1). Fortunately, the patient didn't wait until she got home to take her first dose of medicine from the "sample package" that didn't contain any medication.

Figure 1 - Click to enlarge in new windowFigure 1. When what was thought to be a sample starter pack of Xarelto was opened, it contained pictures of the tablets, no actual medication.

This demonstration "starter pack" is supposed to be used to teach patients with deep vein thrombosis or pulmonary embolism how to start the medication by taking 15 mg tablets twice a day the first 21 days and then transition to 20 mg tablets once daily starting on day 22. Looking at the package, no one, including the physician, nurse, pharmacist, and patient, would have guessed that the package was a demonstration product. It lists the drug's national drug code, states it is the first 30-day supply, and upon opening, it states to find the correct day and press out and take the correct dose. The pack also has a tamper-proof locking mechanism where you would expect to find the drugs and on the back of the package it has a place for a pharmacy label. There was, however, no lot number or expiration date, although "lot" and "exp" were printed on the packaging.


Once the pack was identified as a demo, the patient became extremely anxious as she could not afford this new medication. Pharmacy resolved the situation, but if the patient had left the hospital with the demonstration pack, she may have never filled her prescription for the Xarelto or may have eaten the cardboard tablets, believing the medicine was imbedded in the cardboard (stranger things have happened). We contacted Janssen, the manufacturer, to ask the company to properly and prominently identify that the demonstration pack does not contain any medication. Manufacturers should not be able to produce and hand out such an item without clearly identifying on the product label that it is for demonstration purposes only and contains no medication. In December and January this past year, the U.S. FDA ( and the Centers for Disease Control and Prevention ( alerted the public to demonstration IV solutions that were inadvertently administered to patients due to the similar appearance to real products, resulting in hospitalizations, patient harm, and several deaths.




Ayers P., Adams S., Boullata J., Gervasio J., Holcombe B., Kraft M. D., ..., Worthington P. (2014). A.S.P.E.N. parenteral nutrition safety consensus recommendations. JPEN. Journal of Parenteral and Enteral Nutrition, 38(3), 296-333. [Context Link]