Opioids
Sonya Collins
FDA announced several required updates to opioid prescribing information in April 2023. The changes apply to both immediate release (IR) and extended release/long-acting (ER/LA) opioid pain medications.
“The updated labeling finally notes the risks of concurrent CNS depressant use and opioids in terms of overdose and respiratory depression risk,” said Chris Herndon, PharmD, a professor of pharmacy practice at Southern Illinois University Edwardsville School of Pharmacy. “Additionally, the class-wide labeling changes now bring to focus the phenomenon of opioid-induced hyperalgesia.”
The most prominent changes will be seen in the boxed warning, which will put more emphasis on the risk of life-threatening respiratory depression and the risks associated with using opioids along with benzodiazepines or other CNS depressants.
FDA said that prescribing information should also note that
- IR opioids are not to be used for extended periods except when pain is severe enough to require them and alternative treatment is insufficient.
- Many acute pain conditions treated in the outpatient setting, including postsurgical pain and musculoskeletal injuries, require no more than a few days of opioids.
- ER/LA medications should be reserved for severe, persistent pain that requires extended treatment with daily medication and for which alternatives were insufficient.
- ER/LA and IR opioids come with the risk of opioid-induced hyperalgesia (OIH), which differs from opioid tolerance and withdrawal.
Manufacturers will need to make changes to several other sections of the prescribing information, including to the Indications and Usage, Dosage and Administration, and Warning and Precautions sections. Further required changes to patient Medication Guides are expected to help educate patients and their caregivers about opioid-related risks.
Pharmacists should be aware that while the amended information shines a brighter light on the inherent life-threatening risks of opioid use, they will not necessarily change prescribing or reduce patients’ access to these drugs.
In fact, FDA’s changes may still leave room for inappropriate prescribing, whether it is under- or over-prescribing of these pain medications. “I am concerned that the ambiguity around severe versus not severe pain, as it is worded in the prescribing information, could open the door to inappropriate interpretation by pharmacists, prescribers, nurses and payers,” Herndon said.
OIH
New prescribing information will bring OIH to the forefront. This is an increase in, or greater sensitization to, pain rather than a reduction in it after acute or long-term opioid use.
Patients who do not get relief from a dose increase but rather experience greater pain in response to the larger dose may have OIH. When patients fill a prescription for a higher dose, pharmacists should screen for symptoms of OIH.
“Educate patients that opioids can, in fact, increase the sensitivity of pain transmitting nerves or change the way the pain signal is conducted and potentially worsen pain symptoms,” Herndon said. “The take-home is that some patients will be exposed to opioid analgesics for pain, and the paradoxical effect of worsening pain can actually result.”
Opioids and CNS depressants
FDA’s required changes underscore the life-threatening risks of concurrent use of opioids and CNS depressants. Pharmacists should stress to patients that both drug classes depress the CNS and can lead to sedation, impaired thinking, slowed response time, and, critically, slowed or difficult breathing and death.
“Even though an individual has been on an opioid for pain for years, or even decades, the risk of oversedation, respiratory depression, overdose and even death still exists,” Herndon says.
Counseling points
In addition to highlighting the risk of overdose and OIH, pharmacists should make patients aware that opioid use disorder (OUD) has a genetic component and having a first-degree relative with a history of OUD raises the patient’s own risk, too.
All of this is in addition to the standard counseling points, including possible constipation and pruritus, risk of sexual dysfunction, and education about naloxone.
“Discussing with patients that OIH does exist, along with discussions about naloxone, can oftentimes open the door to more frank conversations about the risks versus benefits of opioids.”
The life-threatening risks that come with opioid use cannot be overstressed, Herndon said. “These medications should be treated like a loaded firearm and stored judiciously in a locked environment such as a lockbox or lockable cabinet.” ■
APhA offers tools and resources, as well as training and webinars, at www.pharmacist.com/Practice/Patient-Care-Services/Opioid-Use-Misuse to help pharmacists treat patients using opioids.