Small Patches, Large Doses: Preventing accidental exposure to fentaNYL patches

By: BarbraKaryne N. Nchinda Fobi

Source: FDA

FentaNYL is a potent opioid used in anesthesia or as an analgesic for the treatment of intense chronic pain (Bakovic et al., 2015). It is 100 times more potent than morphine and is available for transmucosal, parenteral and transdermal administration. The FentaNYL patch is commonly used worldwide and is listed as an essential medicine by the World Health Organization (WHO, 2020). Transdermal delivery of fentaNYL is particularly useful for patients unable to take or tolerate oral opioids due to malabsorption, dysphagia, vomiting or severe constipation (WHO, 2020). Also, the convenience of a patch offers the potential for increased patient compliance (Hardwick, King & Palmisano, 1997). While fentaNYL patches have been linked to the current opioid crisis, this paper will focus only on the prevention of accidental exposure to fentaNYL patches.

The safety profile of the fentaNYL patch is like that of most opioid therapies, including the risk for life-threatening respiratory depression, addiction, abuse, and misuse. Local irritation at the site of administration has been reported with FentaNYL patches (FentaNYL, 2020). The risk of opioid overdose is higher for fentaNYL patches because they contain a very high dose before and after use (Prescrire, 2010). Previously worn fentaNYL patches may retain up to 28–84% of the initial potency of the drug (Hilado, Getz, Rosenthal & Im, 2020).

Globally, drug regulators and patient safety organizations have issued several pieces of advice on the proper use, storage, and disposal of fentaNYL patches. Yet, reports of unintentional opioid toxicity and overdose from fentaNYL patches continue to occur. The World Health Organization Pharmaceuticals Newsletter has published several of these warnings. Situations that lead to toxicity and overdose include confusion between two dose strengths, forgetting to remove the patch, cutting the patches, applying multiple patches, self-medication, ingestion, and accidental exposure (Prescrire, 2010).

How children are exposed

Accidental exposure can occur if a patch is swallowed or transferred to a child, another person, or even to pets (ISMP, 2005). Many cases of life-threatening conditions as well as fatalities due to accidental exposure of fentaNYL patches in children have been reported. Between 1997 and 2012, the U.S. Food and Drug Administration (FDA) received 32 reports of accidental exposure to fentaNYL with 12 deaths, mostly involving children. Stoecker et al. indicated that between 2012 and 2013, seven new cases of accidental exposure to fentaNYL were reported to the FDA.

Why children are exposed

Children are particularly vulnerable because they are predisposed to putting things in their mouths. They observe and emulate what adults do, and can easily access trash (Stoecker et al., 2016). Also, children might think a fentaNYL patch is a tattoo, sticker, or band-aid. For example:

• A 2-year-old was found dead in his home with a used fentaNYL patch lodged in his mouth. Two days earlier, the child had visited his great-grandmother in a nursing home. While at the nursing home, the child played with his toy truck and most likely rolled over a patch of fentaNYL which he later ingested (ISMP, 2012).
• In another case, a 3-year-old girl was accidentally exposed to fentaNYL patch after sleeping with her grandmother. The child was found unresponsive in the morning, taken to the emergency room, and was later declared dead by brain death criteria secondary to a fentaNYL overdose (Hilado, Getz, Rosenthal & Im, 2020).

How to safeguard children from accidental exposure

To protect children, it is of utmost importance to properly store and dispose fentaNYL patches. While it is common practice for prescribers to discuss the importance of keeping medications out of the reach of children with patients and their caregivers, they often overlook transdermal patches (Hilado, Getz, Rosenthal & Im, 2020). As the most accessible healthcare practitioners, pharmacists should consider the following recommendations to counsel and educate patients and their caregivers on the use, storage, and disposal of fentaNYL patches to prevent accidental overdose in children.

• Check applied fentaNYL patches. Applied patches that are not stuck to the skin tightly enough may accidentally fall off and stick to someone in close contact, such as a child. Pharmacists should educate patients on the proper administration of fentaNYL patches. Patients should be instructed to periodically check by looking or touching their applied patch to ensure it is still sticking to the skin properly. Patients should tape down the edges of a patch that becomes loose or cover with a sticky adhesive film (FDA, 2013).
• Store fentaNYL patches properly. As with every medicine, patients should be instructed to store fentaNYL patches in a secure location out of the sight and reach of children, pets, and others. Pharmacists should emphasize to patients that they should not let children see how they apply patches or call them stickers, tattoo, or band-aids.
• Dispose of used fentaNYL patches properly. Pharmacists should highlight the fact that fentaNYL patches are dangerous after use. as they still contain a high amount of strong narcotic pain medicine. Educate patients on the proper disposal of fentaNYL patches depending on your country specific recommendations (e.g., the U.S. prescribing information states that used fentaNYL patches should be folded with adhesive sides together and flushed down the toilet immediately after removal [fentaNYL, 2020]). Pharmacists can advise patients on suitable child-resistant containers to use in the disposal of their used fentaNYL patches e.g., empty soda cans, small sharps containers or some other container that is difficult to get into (ISMP, 2005). Also, if your country has a medicine take-back program, pharmacists should provide instructions on how to access these programs.
• Seek medical attention. Pharmacists should counsel patients to seek immediate medical attention if they are accidentally exposed to fentaNYL patches. During counseling, pharmacists should provide country-specific emergency contact and poison control information to patients.
• Use the teach-back method. During counseling, pharmacists should use the teach-back (show-me) method to ensure patients and caregivers understand proper use, storage, and disposal of fentaNYL patches. Pharmacists should also provide educational leaflets on fentaNYL patches (e.g., the Institute for Safe Medication Practice [ISMP] fentaNYL patches leaflet).

Some healthcare providers and patients may not be completely aware of the dangers regarding the accidental exposure to fentaNYL patches. It is of major interest to raise awareness about the possibility for accidental exposure of fentaNYL in young children. Pharmacists are in an ideal position to educate patients and take steps to ensure safe use, storage, and proper disposal of the product.

References

Bakovic, M., Nestic, M., & Mayer, D. (2015). Death by band-aid: fatal misuse of transdermal fentaNYL patch. International Journal of Legal Medicine,129,1247–1252.

Food and Drug Administration (FDA). (2012). FentaNYL Patch can be deadly to children. Retrieved August 8, 2020 from https://www.fda.gov/consumers/consumer-updates/fentaNYL-patch-can-be-deadly-children

Food and Drug Administration (FDA). (2013). FDA drug safety communication: FDA requiring color changes to Duragesic (fentaNYL) pain patches to aid safety-emphasizing that accidental exposure to used patches can cause death. Retrieved August 8,2020 from https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-requiring-color-changes-duragesic-fentaNYL-pain-patches-aid-safety

FentaNYL patches: preventable overdose. (2010). Prescrire international, 19(105),22–25

FentaNYL. (2020). DRUGDEX® System. Retrieved August 7, 2020, from http: micromedexsolutions.com.Greenwood village, CO: Thomson Micromedex.

Hardwick, W.E., Jr, King, W.D., & Palmisano, P.A. (1997). Respiratory depression in a child unintentionally exposed to transdermal fentaNYL patch. Southern medical journal, 90(9),962–964

Hilado, M. A., Getz, A., Rosenthal, R., & Im, D. D. (2020). Fatal Transdermal FentaNYL Patch Overdose in a Child. Cureus. 12(1), e6755.

Institute For Safe Medication Practices (ISMP). (2005). Little patches…big problems. ISMP Medication Safety Alert, 4 (10) 1–4

Institute For Safe Medication Practices (ISMP). (2012). Proper Disposal of fentaNYL patches is critical to prevent accidental exposure. ISMP Medication Safety Alert. Retrieved August 8, 2020 from https://www.ismp.org/alerts/proper-disposal-fentaNYL-patches-critical-prevent-accidental-exposure

Stoecker, W. V., Madsen, D. E., Cole, J. G., & Woolsey, Z. (2016). Boys at Risk: Fatal Accidental FentaNYL Ingestions in Children: Analysis of Cases Reported to the FDA 2004–2013. Missouri medicine, 113(6), 476–479.

World Health Organization (WHO). (2018). FentaNYL (transdermal patches): Life-threatening and fetal opioid toxicity from accidental exposure. WHO Pharmaceutical Newsletter, 6 (2018), 9

World Health Organization (WHO). (2020). WHO Model List of Essential Medicines. Retrieved August 7,2020 from https://list.essentialmeds.org/