After the FDA endorsement, people worried that prescription abuse would rise and others felt like no real change would occur.
Children aged 11 years and older may now officially be issued Oxycontin prescriptions, but pediatric pain management and addiction specialists don’t see the move exacerbating the already significant opioid abuse problem in the United States.
The US Food and Drug Administration’s (FDA) August 2015 label change adds the pediatric use of the long-acting opioid, with the stipulation that the patients must have already been tolerating opioids for at least 5 consecutive days at a 20 mg per day dosage at least 2 days immediately preceding the new Oxycontin dosage.
Sharon Hertz, MD, director of the FDA’s division of anesthesia, analgesia, and addiction products, says the goal of the agency’s action was the provide physicians with more information about the safe use of these medications in pediatric patients.
“I must stress that this program was not intended to expand or otherwise change the pattern of use of extended-release opioids in pediatric patients. Prior to this action, doctors had to rely on adult clinical data to shape their decision-making in treating pediatric patients,” Hertz says. “This program was intended to fill a knowledge gap and provide experienced healthcare practitioners with the specific information they need to use Oxycontin safely in pediatric patients.”
Oxycontin now joins only 1 other extended release, long-acting opioid- Duragesic (fentanyl)-approved for pediatric use.
Concerns have been raised about FDA’s decision, with a group of lawmakers even calling for an investigation of the agency.
A report from the National Survey on Drug Use and Health reveals on average, 26 adolescents aged 12 to 17 visit an emergency department each day for treatment related to narcotic pain medication misuse. Thirty-five percent to 40% of high school seniors recently reported using opioids for non-medical purposes, stating they had gotten the medications from their own leftover prescriptions, and nearly 74% of adolescents prescribed controlled medications say they have unsupervised access to those medications at home.
Even when children and adolescents aren’t given their own prescriptions, studies show they have ample access to these medications. A recent study revealed that 72% of adults prescribed opioids had leftover medications, and 71% of them kept those leftovers in their homes rather than properly disposing of them.
Pain management specialists support FDA’s decision, however, saying the new labeling won’t likely change the current use of the medication or increase misuse.
Jeffrey L. Galinkin MD, FAAP, professor of anesthesiology and pediatrics at the University of Colorado School of Medicine and chair of the pharmacy and therapeutics committee in the department of anesthesiology at Children's Hospital Colorado, says a quarter of all opioids prescribed in the United States-250 million annually-are diverted.
“The problem is absolutely huge,” says Galinkin, a pain specialist who also works with addiction. “However from an addiction perspective, more data helps doctors. So now you have more data on these drugs and that’s what the FDA was going for. What you have now is actual dosing guidelines. There is no more risk for abuse and diversion in kids than there is in adults when it is prescribed appropriately.”
Oxycontin has been used for a long time in children with chronic health problems resulting in severe pain for a long time, says William T. Zempsky, MD, MPH, head of the division of pain and palliative medicine at Connecticut Children’s Medical Center. What FDA’s investigation did, he says, is to spur more research about the opioid use in children and adolescents.
“It’s not a license to prescribe this willy nilly,” says Zempsky. “It doesn’t say use Oxycontin for places where there’s no place for it. It doesn’t mean I’m going to change my prescribing practice.”
Many medications are used off-label in pediatrics because there has not been appropriate research on the use of these drugs in that demographic, Zempsky says.
“There’s not a big market for these drugs,” Zempsky says. “These drugs aren’t studied because no one thinks they can make money off of them.”
So over the last several years, the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act were enacted to offer incentives to pharmaceutical companies that conduct research into pediatric medication uses.
More information about these medications in children can’t be a bad thing, Zempsky says.
“I don’t see much in the way of downsides if people’s prescription practices aren’t altered,” he says, adding opioid use in children should be reserved for certain diseases like cancer, fragile bone disease, sickle cell disease, and congenital or neurodevelopmental disorders. “I don’t give any opioids with chronic pain in a lot of conditions.”
Physicians should assess the child’s functioning, sleep patterns, and mood to determine whether opioids are appropriate for their condition. Although opioid medications may be used more in specialty settings, Zempsky says general pediatricians may be tasked with distributing them in some situations.
“In some areas of the country, pediatricians are the ones who are managing these kids. Certainly we don’t want to undertreat pain, but we want to treat it safely. It’s just getting the knowledge and education,” Zempsky says. “Educate yourself knowing these drugs have been studied, and prescribe them appropriately in the right amount, educating parents about locking them up and not leaving any opioids in their medicine cabinet.”
Zempsky says the diversion of leftover pain medications is a larger problem then misuse by the patient for whom the drug was prescribed. Addiction does happen in children and adolescents, but it’s not common, he says.
“It’s not zero, and it’s not the majority of patients, but it’s a significant concern we have,” Zempsky says. “Clearly we have an opioid problem in this country and it behooves us to prescribe them appropriately.”
The creation of Oxycontin, an extended release formulation of oxycodone, aimed to stem abuse of the drug by making it crush-proof and harder to use in a syringe, Galinkin says.
“Kids like to crush and snort it, or mix and inject it,” Galinkin says. “However the most common way the drugs are still abused are by orally taking the drugs.”
To stem diversion, what really must be scrutinized is the way these medications are prescribed across the board, Galinkin says.
“People are given huge amounts of opioids for long period of time for procedures worth no more than 5 days of opioids,” he says. “This is a really common practice across the United States. Then they sit in the cabinets and are abused.”
The FDA recommends patients flush unused opioids, but many practitioners don’t educate their patient to that extent, he says.
“They give them the prescription, but they don’t get them instructions on what to do with these drugs and they don’t prescribe reasonable amounts,” Galinkin says.
According a recent report on opioid abuse, 27% of non-medical opioid users who abused their own leftover prescriptions got them from their dentist, and 45% obtained them from an emergency department physician (45%).
Parents who believe they keep their leftover medications well-hidden are mistaken, Galinkin says, adding that 80% of children polled know where opioid medications in their home are and how to access them, and 70% of children who are prescribed these medications are tasked with their own administration.
Galinkin says CRAFFT screening can help physicians identify children and adolescents that are at risk for diversion, but there are a number of other things healthcare workers can do to promote safety with medications.
• Prescribe reasonable amounts.
• Have parents check pill counts.
• Tell parents to keep drugs in a locked cabinet or box under with the key under the parents control.
• Tell families and patients to throw out their unused prescriptions.
• Provide families information about the dangers of prescription drug abuse.
• Check local Prescription Drug Monitoring Website
• Administer CRAFFT screening
• Test your patients who are on opioids for an extended period of time
• Don’t ignore your suspicions.