FDA Alerts

FDA Advise-ERR: Covers still being applied without the cloNIDine patch

ISMP and the US Food and Drug Administration (FDA) continue to receive medication error reports about patients and caregivers who apply only the adhesive cover to the skin, without the intended cloNIDine medication patch. The error has contributed to uncontrolled blood pressure.  

The cloNIDine transdermal system (CATAPRES-TTS) is packaged in a carton containing individually labeled pouches of 4 cloNIDine patches and 4 adhesive covers (Figure 1). Application of the adhesive cover is optional; it doesn’t contain any drug and should be applied directly over the cloNIDine patch only if the patch begins to separate from the skin.

clonidine patches
Figure 1. Box of Catapres-TTS-2 (left) containing pouches of individually wrapped cloNIDine patches and adhesive covers. The white, round adhesive cover (right) does not contain any drug and should be applied directly over the tan, square cloNIDine patch (middle) only if the patch begins to separate from the skin. 

In 2010, ISMP published a SAFETY brief about a healthcare provider who applied only the adhesive cover to a patient for several weeks (ISMP. Cover applied without the medicated patch. ISMP Medication Safety Alert! 2010;15[22]:2-3). The adhesive cover is larger than the cloNIDine patch, which makes it difficult to confirm that the patch is under the cover. Also, while the individual pouches are labeled, the patches themselves are not labeled with the drug name, and the adhesive cover does not state that it does not contain any medication.

Please consider the following points to tell patients and caregivers to help them learn about the appropriate use of the cloNIDine transdermal system:

  • The cloNIDine transdermal system is packaged in a carton that contains both cloNIDine patches and adhesive covers. 

  • The adhesive cover does not contain any medication.

  • Only apply the adhesive cover if the cloNIDine patch begins to loosen from the skin after application during the 7-day period; if used, place the adhesive cover directly over the patch.

  • Read the Patient Instructions, found in the carton, before using the cloNIDine transdermal system.

In inpatient settings, consider adding a note to the medication administration record (MAR) to remind nurses to apply the medication patch and not just the cover. If the adhesive cover is used over the medication patch, it is best to label the adhesive cover with the drug name, strength, and date, before applying it. (Note: do not write directly on the medication patch itself because it might affect the delivery of the drug.)

A hospital pharmacist, who recently reported an event, told ISMP that her hospital now dispenses the patch and cover in a zip-lock bag with a label explaining the two components of the product (medication patch and adhesive cover).

ISMP thanks Sarah Thomas, PharmD, and LCDR Chi-Ming (Alice) Tu, PharmD, FISMP, BCPS, at the US Food and Drug Administration (FDA) Division of Medication Error Prevention and Analysis, for providing this FDA Advise-ERR.

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