Requirement #1-Patch should stick to the patient!
From the July 12, 2007 issue
Problem: ISMP recently became aware of product quality concerns that may lead to errors with DAYTRANA (methylphenidate transdermal system) patches, the only transdermal system approved for the treatment of attention deficit hyperactivity disorder (ADHD). These patches are available in 10, 15, 20, and 30 mg strengths. Parents of children using Daytrana patches have posted complaints on several online message boards about the adhesive sticking to the protective liner, preventing the patch from sticking to the skin.(1-3) The extent of this problem is unknown, but the frequency of complaints on these online forums suggests that the problem is significant. A few examples follow:
“My son just started using the patch and I’m getting very frustrated because, every morning when it is time to put the patch on, I’m having problems with the adhesive sticking to the part I throw away… if I still put the patch on him, does he still receive the medicine?”
“Yesterday, I woke up early to apply the 15 mg patch [to my child] and I went through 4 patches because the backing of the patches would not come off at all, and when you finally pulled as hard as you could, the backing would come off but with all the med attached to it.”
To circumvent this problem, some parents have been refrigerating or partially freezing a patch before attempting to remove the backing. The manufacturer labeling states that the product should be stored at a temperature between 59 and 86 degrees.(4) Colder temperatures may affect release of the drug and alter the onset of action. In fact, parents have reported that it seems to take longer for the patch to take effect when utilizing this work-around.
Parents have also been using other adhesives/overlays (e.g., tape or band aids) to hold the patch on the skin. Two problems exist with this practice. First, the adhesive contains active drug, so taping a faulty patch to the skin that has all or part of its adhesive missing may reduce the amount of drug delivered to the child. Also, any loose adhesive may stick to the patient when the patch is removed and continue to release the drug beyond the intended treatment window. Next, if an occlusive overlay is used to help the patch adhere to the skin, the temperature at the site of application may be raised, thus increasing the absorption of methylphenidate. ISMP has previously alerted readers to serious harm that has occurred from over-delivery of transdermal medication due to raised body and skin temperatures.(5) The risk of increased drug absorption with Daytrana could be serious because each patch contains more drug than the amount it delivers. For example, a patch intended to deliver 30 mg over 9 hours actually contains 82.5 mg of drug.
In addition to problems with the adhesive, some parents have been cutting Daytrana patches to titrate their child’s dose of methylphenidate. These patches should never be cut. The DOT Matrix technology of Daytrana creates a suspension of tiny concentrated drug cells evenly dispersed through the adhesive layer. Cutting a patch can open the drug cells along the cut edges, interfering with the patch membrane and disrupting the delivery rate of the drug. According to postings on online forums, it seems some healthcare practitioners have contributed to this problem by erroneously advising patients that it is safe to cut the patches, as in the examples that follow:
“Our doc said that the patch is okay to cut...He explained that from a sheet of plastic the various [patch] sizes are punched out [by the manufacturer] so that the amount of medication is the same on all areas of the plastic.”
“My doc had this cool deal…where patients could get 40 patches free. The only thing is they are 30 mgs. He suggested I cut the patch to start low, then increase as needed. I first cut it into thirds and just recently started cutting them in half for 15 mgs.”
One final potential safety issue has come to light with Daytrana patches. To reduce skin irritation at the site of patch application, some parents have been applying corticosteroids such as FLONASE (fluticasone propionate) and NASONEX (mometasone furoate) to the application site before applying the patch. No studies evaluating the safety of this practice exist; thus, it is unknown if this increases or decreases the absorption of the drug. The use of corticosteroids in this manner may also mask hypersensitivity to methylphenidate or another component of the patch.
Safe Practice Recommendations: ISMP has contacted FDA and the manufacturer of Daytrana, Shire Pharmaceuticals, about the adhesive problem. Shire representatives acknowledged the problem and stated that the company is developing a “thicker” liner that will allow easier removal from the patch adhesive. An expected release date is unknown. Until production problems have been corrected, warn parents about the possibility of the adhesive remaining on the protective liner, and suggest they call Shire’s toll-free line (800-828-2088) to report problems. The company recommends avoiding use of patches from which the adhesive has stuck to the backing. Shire will send, within 7 business days of receiving a request, a free trial card for 40 patches to replace patches that may have been discarded due to backing problems.
This offer may not be helpful, as the same problem may still exist with the replacement patches, and obtaining the free supply of methylphenidate—a schedule II controlled substance—may be difficult. A new prescription will be needed for the trial supply, since federal law prohibits refills. If the interim free supply is not available or effective, Shire recommends that parents contact their child’s physician for alternative therapy until the patch adhesive problem is remedied.
Additional strategies for the safe use of Daytrana patches include the following:
References: 1) Suite 101- Special needs education forum. Daytrana patch chat. Discussion thread. Posted 12 February 2007. Available at: http://specialneedseducation.suite101.com/discussion.cfm/1964. 2) ADHD News.com-ADHD medication message boards. Daytrana anyone? Discussion thread. Posted 13 July 2007. Available at: www.adhdnews.com/forum/forum_posts.asp?TID=20458&PN=1. 3) Counseling Resource-Features. Problems with the Daytrana ADHD patch. Discussion thread. Posted 27 March 2007. Available at: http://counsellingresource.com/features/archives/2007/drugs/adhd-patch-problems/. 4) Daytrana (methylphenidate transdermal system) patch prescribing information. Wayne, PA: Shire; 2007. Available at: www.daytrana.com/Consumers/PDFs/DaytranaPrescribingInfo.pdf. 5) ISMP. New fentanyl warnings: more needed to protect patients. ISMP Medication Safety Alert! August 11, 2005; 10(16):1-3.
- Educate parents about safe storage (e.g., recommended temperature, locked cabinet) and disposal of patches to protect children and pets from accidental exposure
- Inform parents that they should avoid contact with the adhesive, as it contains medication; and if contact occurs, wash the area with large amounts of water, but no soap, alcohol, or other solvents which may increase absorption of the drug
- Inform parents that skin irritation may occur with Daytrana and should be treated if necessary after the patch has been removed; and mention the child should be evaluated by a physician if skin irritation is accompanied by edema or other local reactions that do not improve within 24 hours of patch removal
- Educate parents and healthcare providers about the dangers of cutting Daytrana patches.