Requirement #1 - Stick to patient!
From the June 2007 issue
ISMP recently became aware of product quality concerns that may lead to errors with the use of DAYTRANA (methylphenidate transdermal system) patches. These patches are the only transdermal system approved for the treatment of attention deficit hyperactivity disorder (ADHD) and are available in 10, 15, 20, and 30 mg strengths.
Parents and other caregivers applying the Daytrana patches to their children have reported difficulty in peeling the protective liner from the adhesive layer (see Figure 1). The adhesive can stick to the protective liner, preventing the patch from adhering to the skin. Many parents have voiced their complaints on several online message boards.1-3 The true extent of this problem is unknown; however, the large number of postings and views these online forums have received seem to indicate that this is a significant problem. A few examples of correspondence follow:
Figure 1. Schematic of Daytrana patch (not to scale)4
“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.”
In an attempt to make the patch peel cleanly from the protective liner and remain on the skin, parents have created workarounds, many of which may be unsafe. For example, several parents reported refrigerating or freezing a patch for varying lengths of time before applying it. Manufacturer labeling states that the product should be stored at a temperature between 59 and 86 degrees.4 Placing the patch in the refrigerator or freezer, may affect the release rate of the medication, resulting in a delayed onset of action. In fact, some parents have reported that when they have utilized this “trick” it seems to take longer for the patch to take effect.
Parents are also using other adhesives/overlays (e.g., tape or band aids) to keep the patch adhered to their child’s skin throughout the day. However, utilizing overlays on the Daytrana patches may present a danger. Overlays, especially if they are occlusive, may increase the local temperature at the site of application and increase the rate and extent of absorption of the methylphenidate into the skin. Also, ISMP has reported on the hazards of increasing the temperature around patches–patients using fentanyl transdermal patches have experienced serious events and death when they applied external heat sources over their patches.5 Applying warmth to the patch is even more alarming in light of other product information. The methylphenidate content per patch is more than double the dose it releases in the prescribed nine-hour period. For example, a patch that delivers 30 mg over a nine-hour period actually contains 82.5 mg of methylphenidate.
Another issue is the fact that some of the adhesive, which itself contains active drug, may stick to the patient when the patch is removed. If it is not entirely removed from the patient's skin, it may continue to release drug while the child is also absorbing drug from a newly placed patch.
Parents have also been presented with conflicting information as to whether these patches can be cut. Daytrana should never be cut. The DOT Matrix® technology of Daytrana creates a suspension of tiny concentrated drug cells dispersed through the adhesive layer. Although the drug cells are evenly dispersed, cutting a patch can open drug cells along the cut edges, interfering with the patch membrane and disrupting the delivery rate of the medication. Parents have reported cutting the patches to titrate their child’s dosage of methylphenidate throughout the day. It appears that some healthcare practitioners are unaware of this and may relay wrong information to patients.
“Our doc said that the patch is okay to cut...He explained that from a sheet of plastic the various sizes [of patches] 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.”
As with other topical products, irritation can occur on the patch application site. To decrease this irritation, some parents have reported applying corticosteroids such as FLONASE (fluticasone propionate) and NASONEX (mometasone furoate) on the application site before applying the patch. Currently no studies exist that have evaluated the safety of this practice. It is unknown if placing a corticosteroid over the application site increases or decreases the absorption of the methylphenidate through the skin. Parents may also be masking a larger problem in utilizing corticosteroids in this manner, particularly if their child’s skin irritation is attributable to a hypersensitivity to methylphenidate or one of the components of the patch.
Safe Practice Recommendations: We have contacted FDA and the manufacturer of Daytrana, Shire Pharmaceuticals. Their representatives reported they are aware of the problem and that the company is developing a “thicker” liner that will allow for easier removal from the patch’s adhesive. Unfortunately, the person we spoke with was unaware of the expected release date. Shire recommends that parents refrain from using patches with problematic adhesive. Here are some safety strategies to consider when prescribing, dispensing, or administering these patches:
- Explain the patch application procedures to parents and caregivers and ask that they repeat back the instructions.
- Until production problems regarding the adhesive on the patch can be corrected by the manufacturer, the possibility of the adhesive remaining on the protective liner should be discussed with parents and caregivers.
- Ensure that parents know how to properly store Daytrana. The patches should be stored between 59 and 86 degrees. In order to protect children and pets, from gaining access to this medication, tell parents that patches should be stored in a safe place and out of the reach of children.
- Inform family members or other caregivers who may remove patches that they should avoid contact with the medication adhesive. Advise caregivers and patients that if the adhesive accidentally contacts the skin, the area should be washed with large amounts of water. Do not use soap, alcohol, or other solvents to remove the adhesive because they may increase the drug’s absorption.
- Educate colleagues and the patient that Daytrana patches should never be cut. Cutting a patch can open drug cells, interfere with the patch membrane and disrupt the delivery rate of the medication.
- Inform patients and caregivers that skin irritation is associated with the use of Daytrana and that the safest measure is to treat the irritation after it presents itself rather than taking prophylactic measures. Explain the danger that can occur with placing medications such as corticosteroids over the application site. Encourage parents to have their child 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.
- Inadvertent use of Daytrana could occur if the patches are not disposed of properly. The product’s package insert recommends patients and caregivers fold the used Daytrana patch in half and press firmly so that the sticky side sticks to itself. Then, both the federal government and the manufacturer recommend that the patch be flushed down the toilet for disposal. For the new federal guidelines for disposal of medications, visit: www.whitehousedrugpolicy.gov/drugfact/factsht/proper_disposal.html.
- Advise parents to use the company toll-free line of “Daytrana Cares” (800-828-2088) to report problems with the patch. Shire will send, within 5-7 business days of receiving the request, a free trial card for 40 patches to replace any patches that may have been discarded due to backing problems. However, this is no easy fix for replacing the patches. Since methylphenidate is a schedule II controlled substance, some states limit dispensing to a 30 day supply (and federal law prohibits refills). In attempting to obtain replacement patches, parents must request a new prescription from their child’s physician before they can use the trial card to replace patches. Shire recommends that parents try to “work through” any remaining patches they have in their child’s carton until the free trial card is received and a new prescription is issued by a physician. If no patches remain in the carton, a parent may request a new prescription from a physician; however, this will not likely be covered by insurance. If this is not financially feasible, Shire recommends that parents contact their physician for recommendations of what other measures to take to treat their child’s ADHD in the interim.
References:
|
