Friday, March 6, 2015

Pain patch wearers must take extra care around children

Despite warnings from the FDA, drug manufacturers, and various patient safety agencies like ours (ISMP), we're still hearing from grieving parents or grandparents or health professionals who've experienced the death of a child or who somehow got ahold of a fentanyl pain patch that someone was wearing or discarded.

Pain patch wearers must take extra care around children

Despite warnings from the FDA, drug manufacturers, and various patient safety agencies like ours (ISMP), we’re still hearing from grieving parents or grandparents or health professionals who’ve experienced the death of a child or who somehow got ahold of a fentanyl pain patch that someone was wearing or discarded.

Fentanyl is a powerful narcotic that is often prescribed for patients with severe chronic pain. For example, pain from cancer. When worn as a skin patch called transdermal fentanyl or Duragesic, it provides relief over 72 hours before a new application is needed. However, there is so much of the drug embedded in the patch that if a baby finds a used patch and puts it in their mouth or a small child applies it as if it were a sticker or Band-Aid, they may die.  According to FDA, they’ve evaluated a series of 26 cases of pediatric accidental exposures to fentanyl patches reported over the past 15 years. Of these, ten resulted in death and 12 in hospitalization. Sixteen of the 26 cases occurred in children two years old or younger.

FDA notes that young children are at particular risk of accidental exposure to fentanyl patches.  Their  mobility and curiosity provide opportunities for them to find lost patches, take improperly discarded patches from the trash, or find improperly stored patches, all of which may result in patches being placed in their mouths or sticking to their skin.

Young children are also at risk of exposure when being held by someone wearing a partially detached patch which can then transfer to the child. The latest victim, who we learned about this week, was a 15 month-old boy whose mother was wearing a patch for pain associated with multiple sclerosis. She fell asleep with the baby on her chest, which is where she was wearing the patch. Somehow, the baby got it in his mouth and either swallowed it or sucked on it while she slept. Mom found him unresponsive when she awoke and noticed that the patch was missing. An emergency medical service was called and the baby was brought to an emergency room. Despite all efforts, the baby could not be revived. Later, a toxicology report from the medical examiner identified acute fentanyl intoxication.

Both new and used patches can be dangerous to children or even pets. In a tragic accident, a 4-year-old child died after placing a fentanyl patch on his body. His mother had been using fentanyl patches to treat pain from Crohn's disease, a digestive tract disorder. After she found her son dead, she also found a fentanyl patch wrapper in an overturned trashcan in her bedroom. It was not clear whether the boy stuck a used patch on his body or opened a new one and applied it. Last year I blogged about a little boy who, when visiting his grandmother in a nursing home, found a careless discarded pain patch and stuck it in his mouth. He died 24 hours later.

Children have also been exposed to medicine patches that have fallen off a family member. One child sat on a fallen patch and it stuck to her thigh. Another child removed a patch while his grandmother was sleeping and put it on himself. Fortunately, in these cases which we have on file at ISMP, the patches were noticed quickly and the children were not injured.

Patients who are using a fentanyl patch or their caregivers need to understand the dangers with children nearby. There’s so much to learn about using them safely that we’ve written a patient/caregiver education sheet about the patch and FDA requires a MedGuide to be given to patients whenever fentanyl transdermal is prescribed. FDA has also developed a Safe Use initiative around proper disposal of the patches. 

It’s one thing to tell people to read these materials and hope that they do, but quite another when they’re told about the dangers face-to-face. Unfortunately, not enough has been done by the pharmacy profession and regulatory authorities to require that pharmacists dispensing fentanyl products educate patients and caregivers on what can go wrong. No one should ever be allowed to walk out of a pharmacy without proper instructions on the use of this drug and the safety concerns and it’s embarrassing to me as a pharmacist that this happens all too often. Although we don’t have the authority on our own, my colleagues are taking steps to make this happen by advocating to the powers that be that this be accomplished.  

There have been many other problems associated with fentanyl patches in both children and adults and I’ve already blogged about these other issues here and here and there’s no doubt in my mind that the patch manufacturers and FDA could do a better job in preventing tragic errors with this product. Perhaps the patches could be made to have a bitter taste that would be unpalatable to children who mouth them, such that they’d immediately spit them out before any drug is absorbed. Maybe FDA can consider adding to the current risk management requirements or at least do more to better assure that pharmacists are aware of these problems and know how to help patients. This is a useful medication for patients with chronic pain but it’s also one of the most dangerous drugs on the market. If it is to remain, safety must be improved.  

Michael R. Cohen, R.Ph. President, Institute for Safe Medication Practices
About this blog

Check Up covers regional health news and a wide array of healthcare topics from pharmaceutical happenings to patient safety. Read about some of our bloggers here.

Portions of this blog may also be found in the Inquirer's Sunday Health Section.

Michael R. Cohen, R.Ph. President, Institute for Safe Medication Practices
Daniel R. Hoffman, Ph.D. President, Pharmaceutical Business Research Associates
Hooman Noorchashm, M.D., Ph.D. Cardiothoracic surgeon in the Philadelphia area
Amy J. Reed, M.D., Ph.D. Anesthesiologist and Surgical Intensivist in the Philadelphia Area
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