AMARILLO, TX (KFDA) - New FDA labeling requirements may help curb opioid abuse, addiction, and misuse.
The FDA is requiring safety labeling changes and a new postmarket study for all extended-release and long acting (ER/LA) opioids used to treat pain.
They are hoping these changes will help curb the abuse, misuse, addiction, overdose, and deaths associated with the drugs. The labeling changes will include a new language to help health care professionals tailor prescriptions based on an individual patient's needs.
"The new language is part of the boxed warning to prescribers stating that these heavy potent opioids should only be used for patients who have chronic pain condition, not for patients who have acute conditions like they have just broken their arm or something like that," said Jeanie Jaramillo, an assistant professor at Texas Tech University Health and Science Center's School of Pharmacy.
The FDA also believes it will stop physicians from writing larger prescriptions.
"Physicians are often prescribing a 30 count bottle after a dental procedure or minor surgical procedure and that much is usually not needed," Jaramillo said. "So, we're hoping physicians will cut down on the amount their prescribing, and when [patients] pick up prescriptions they can ask for a smaller amount. If they have us a prescription for 30 we can ask to start with 10 or even 5, if we do accept a prescription for 30 and we recover [and don't use them all] we need to get rid of those extra pills. Don't keep them in your medicine cabinet they are a temptation for teens for abuse, so it can set up a really bad situation."
The FDA is also requiring a new boxed warning on ER/LA opioid analgesics to caution women using them during pregnancy because they can result in neonatal opioid withdrawal syndrome, which can be life-threatening to babies.
"One of the new regulations is that they put language in there about pregnant women taking these medications," Jaramillo said. "If a woman is pregnant and they're taking opioids the baby can actually get addicted to the medication, and then when they're born they are addicted. We call that neonatal opioid withdrawal syndrome, because as soon as they're born their not getting the drugs anymore and they are having withdrawal symptoms, that can be extremely dangerous and even fatal to a baby."
Because the risks of addiction, abuse, and misuse are high even at recommended doses, the new requirements state these drugs should be reserved for patients whom other treatment options are ineffective or inadequate to provide sufficient pain management.
"The FDA's primary tool for informing prescribers about the approved uses of medications is the product labeling," said Douglas Throckmorton, M.D., deputy director for regulatory programs in the FDA's Center for Drug Evaluation and Research. "These labeling changes describe more clearly the risks and safety concerns associated with ER/LA opioids and will encourage better, more appropriate, prescribing, monitoring and patient counseling practices involving these drugs."
Jaramillo feels it's a step in the right direction.
"I think physicians have been aware of this for a long time so most of them know that they should only prescribe them to these patients, but it's just another added step to say 'Hey, we need to cut down on this because it's very dangerous,'" Jaramillo said. "We have an epidemic going on with abuse right now so we need to take more steps to cut down on the use of these agents."
Jaramillo said patients have the ability to request a substitute for opioids if they feel they are not necessary.
"I also think the public has a responsibility and when we go in and see our physicians we need to not be pushing for those heavy drugs, we need to not ask for hydrocodone for conditions that might be treated easily with ibuprofen or other analgesics," Jaramillo said.
Opioid addiction and abuse are serious issues in the Panhandle.
"We receive calls everyday on opioid overdoses," Jaramillo said. "Mental health is always an issue so we have people who have suicidal thoughts and if that medication is in the medicine cabinet it's just a ripe situation for an overdose to occur."
"One of the big pieces of this epidemic is abuse by teens, so it usually starts because they have had a procedure done or a minor surgery, sports injury, or a dental procedure like wisdom teeth removal, and they may have a genetic predisposition to an addiction so then if you give them the medication they develop that like of the drug, they want more of it," Jaramillo said.
Jaramillo said people can become addicted to opioids and then begin to use other drugs such as heroin.
Pace Lawson, Executive Director at Options Recovery, feels these new regulations will help.
"I think that's open the door and there's a conversation happening about integration, so integrating behavioral health care which addresses substance abuse disorder with primary care physicians and everybody kind of working on the same team," Lawson said. "For so long we're been separated so behavioral health care as far as treatment for addiction has been kind of separate from primary care, so I think what's happening is with this conversation people are starting to come together which is what needs to happen."