These can include higher dosages of both fast-acting, immediate-release opioids as well as slow-acting, longer-release formulations of oxycodone, hydromorphone, morphine, oxymorphone, hydrocodone, methadone and fentanyl.
The petition specifically requests the removal of OxyContin 80mg, which when taken twice a day equals 240 MME in 24 hours, as well as the removal of oxycodone 30mg, typically taken four times a day for the equivalent of 180 MME daily.
Who needs ultra-high dosages?
It’s difficult to say just how many people are using high-dosage opioids because there haven’t been any published data to show what percent of the opioid market they represent or the number of prescriptions for them.
According to the petition, these higher opioid dosage units were an answer to increased patient tolerance as more and more doctors were prescribing opioids in the early 2000s. “Many (ultra-high-dosage unit) opioids entered the market as high dose opioid prescribing became more common,” the petition says.
And that’s in part because of how opioids work. The more a patient takes, the less sensitive their body is to that dosage, meaning a patient needs a higher dose to get the same pain relief.
“The thinking early on was, as patients became tolerant, you respond to tolerance by giving even more,” said Dr. Andrew Kolodny, executive director of Physicians for Responsible Opioid Prescribing, one of the groups filing the petition. However, as opioid overdoses in the United States have increased to epidemic proportions, there has been more scrutiny on how doctors prescribe.
High doses increase risk for addiction and overdose
The petition notes that in 2015, 11.5 million Americans misused a prescription opioid. The most common reason: pain relief. And that includes borrowing a friend’s extra pills and using a family member’s leftover narcotics.
“If you borrow someone’s pills and they are an ultra-high dose, there’s a good chance you’re going to suffer an overdose,” Kolodny said.
Who’s using the drugs?
Kolodny believes that taking these high-dosage drugs off the shelves will help reshape opioid prescribing practices and encourage clinicians to prescribe at lower and safer doses. “The thought that (medications) exist in a higher dose gives you a false sense of security,” he said. “Say you are on the 60-milligram oxycodone. The fact that there is 80 milligram makes you think, ‘How high a pill can I be on?’ “
If the FDA follows through on the petition, it will not be the first time it pulled drugs off of the shelves over public health concerns.
“We are facing an opioid epidemic — a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” FDA Commissioner Dr. Scott Gottlieb said when the agency made its request. “We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse.”
Dr. Jay Butler, president of the Association of State and Territorial Health Officials, explained that the new petition isn’t meant to make it more difficult for patients to get treatment.
It’s “important to recognize, in some instances, a high dosage is appropriate: people receiving palliative care, cancer pain. But there are options to receive these high doses without using the ultra-high dosages,” Butler said. For example, instead of using higher-dose pills fewer times a day, patients may be prescribed lower doses to take more frequently. He added that for patients who have difficulty swallowing pills, other forms of opioids, such as patches and suppositories, would still be available.
Doctors need to consider how the medication overall is impacting a patient’s quality of life, he said. “Assess depression, anxiety, all these other types of social variabilities. How (the opioid is) impacting function,” he said. “If they’re thinking of just the morphine dose, they’re going to forget these other factors that are patient-specific.”
In addition, Stanos said, there is a concern that this could lead to further stigmatization for both patients and doctors. “We want to be helpful as we can as pain physicians … and turn the curve on overdose deaths,” he said. “But we don’t want patients to feel stigmatized. … We don’t want physicians to feel like they can’t use opioids appropriately.”
The FDA has 180 days to respond to the petition.