A champion of pain patients and a proponent of limited opioid access talk about the issues in a genial debate.
The use, overuse, misuse, and abuse of opioids for pain management are subjects that pharmacists need to know more about. However, differences of opinion rage when it comes to determining what should be done to help both patients in pain and society as a whole.
Many areas of the country report serious problems with opioid and heroin addiction. States are attempting to relieve these problems by limiting the amounts or types of opioids that can be prescribed or by dictating who is allowed to prescribe them.
These and other issues involving the use of opioid therapy for chronic pain management were discussed in a debate at the American Pharmacists Association annual meeting this year.
“As pharmacists, I think we are interested in getting the right drug to the right patient in the right dose at the right time,” said Anthony Tommasello, RPh, PhD, medical affairs manager with Indivior in Richmond, Va., who moderated the debate. “I think we all agree that pharmacotherapy decisions must weigh the risk and benefit not only to the individual, but also to society.”
Jeffrey FudinJeffrey Fudin, PharmD, DAAPM, FASHP, a clinical pharmacy specialist and PGY2 pain residency director at Stratton VA Medical Center in Albany, N.Y., spoke in favor of opioid use by noncancer patients with chronic pain. “I am not going to take the pro side, I am going to take the practical side,” he said. “I really am anti-myth and anti-hysteria.”
Fudin noted that several medical organizations have created opioid prescription guidelines or risk-assessment tools, both of which usually discuss how to screen individual patients for pain and for risk of misuse.
“Before we go down the road of putting patients on opioids, we need to try to stratify risk,” he said. “We need to decide whether or not this patient is going to be a problem patient. There are various validated tools to do that.”
Some experts believe that extended-release opioids are more dangerous than immediate-release opioids. Fudin called this a myth. “Are 30 mg of extended-release morphine somehow more potent than 30 mg of immediate-release morphine?” he asked.
Studies that have shown increased risk of adverse effects with extended-release opioids did not define chronic pain appropriately and/or do not differentiate between post-surgical and acute pain, he said.
Opioid conversion calculators used to determine equivalencies between different opioids have problems, said Fudin, noting that there is no validated mathematical model of what constitutes an equivalent dose upon which all medical professionals agree.
Even with an agreed-upon daily dosage, the treatment would still need to be individualized, which does not always happen, said Fudin. “Probably one of the most important points is this business of treating all patients the same way vs. as individuals.”
Conversion tools do not take into account a patient’s pharmacogenetics, which make individuals react differently to the same amount of drug. Diet and interactions with other medications, which also affect opioid metabolism in an individual, are also left out of these equations, he said.
Fudin noted that 16,000 deaths were associated with opioid therapy in 2014. That same year, 17,000 deaths were associated with nonsteroidal anti-inflammatory drugs. “Any death is bad, but let’s not focus all our attention on opioids,” he said.
He also referred to a finding by Dasgupta et al that 80% of opioid analgesic deaths in an observational cohort in North Carolina involved patients who also received benzodiazepines, a rate that was 10 times higher than for those using opioids alone.1
Christopher HerndonSpeaking on the opposite side of the issue was Christopher Herndon, PharmD, BCPS, CPE, associate professor in the department of Pharmacy Practice at Southern Illinois University, Edwardsville, School of Pharmacy and clinical assistant professor, Department of Community and Family Medicine at St. Louis University. He argued that too many patients with chronic pain are being prescribed opioids when they should not be. “I think there is some relevance to the idea that we might have gone overboard,” he said.
“First, we need to look at whether there is a benefit vs. risk assessment of these drugs,” Herndon said, citing as an example the use of metformin to treat diabetes. “We know that if you take metformin and your A1c goes from 8 to 7, that is a response, and we are all good,” he said. “But what is the number needed to treat for opioids? Is it no pain? Thirty percent pain relief? Is it ‘I just feel better and I can sleep?’ How do we assess a response to an opioid?”
Opioids are undeniably effective for short-term severe pain, Herndon said. But studies have found little evidence that they help with long-term or persistent noncancer pain. Long-term prescribing and dose escalation for opioids are based on anecdotal evidence. There is no evidence to suggest that opioids are effective in the long term for persistent noncancer pain, he said.
Herndon noted a study of a population of patients with chronic pain made by Naliboff et al that found no difference in three primary outcome measures when a low dose was compared to an escalating dose of opioids.2 A study by Bostick et al found lower results on the Pain Disability Index and Physical Component Summary Score for patients receiving no or lower doses of opioids,he said.3
When patients are prescribed opioids for a long time, they can run into problems if they then cannot get their medication, Herndon added.
He works on a chronic pain service in a large family medicine program, where he sees patients who have been put on opioids and then lose their prescription coverage when they lose their jobs, or who lose their prescription renewals when the doctor who prescribed for them retires. “And then they have nowhere else to go,” he said.
Another issue is hyperalgesia, said Herndon. “When I give someone an opioid for their pain, am I actually making their pain worse by giving it to them?” Patients who have been exposed to morphine for 30 days have been found to have worse pain tolerance than people who have not been exposed. “We might be treating the problem that we are causing.”
Then there is the issue of opioid drug abuse, Herndon said. In the past few years, there has been a slight downward trend in nonmedical use of opioids, which is promising, he noted. But the use of heroin has been going up. Almost 40% of heroin users said that they had used or misused opioids before their first use of heroin, he said.
Herndon also noted other problems that can accompany the use or misuse of opioids. These include risk of falls, sleep-disordered breathing problems, increased endocrine problems, depression, drug tolerance, overdose, and death. “These are all issues that I think are very important.”
Both Fudin and Herndon mentioned the draft guidelines on the use of opioids created by the CDC. Most of the CDC recommendations are common sense, said Herndon. The recommendations include prescribing the lowest possible effective dose and periodically evaluating the patient for opioid-related harm.
Fudin encouraged the use of tools for risk stratification such as those available at www.painedu.org, which offers access to opioid risk management tools. He also called for more education for both prescribers and pharmacists, including more education on drug interactions.
The debate concerned itself with the use of opioids for patients with chronic pain but not cancer. Fudin and Herndon both noted, in later interviews, that this distinction between cancer and noncancer patients may be an artificial one.
“The inappropriate assumption is that we are not as worried about long-term health risks with opioids in patients with cancer,” Herndon said.
This distinction also creates difficulties for noncancer patients who have trouble getting adequate treatment for their chronic pain, Fudin said. “Why, if you are dying, do you deserve to have your pain treated, and if you have got 50 years in front of you and you have a chronic pain syndrome, all you have to look forward to is a deteriorating life? This doesn’t make sense to me.”
The debate was cordial. The men bantered with each other during the debate and later noted that they were actually in agreement on many of the issues concerning the use of opioids.
Dasgupta N, Funk MJ, Proescholdbell S, et al. Cohort study of the impact of high-dose opioid analgesics on overdose mortality. Pain med. 2015; Sept 1, doi: 10.1111/pme.12907.
Naliboff BD, Wu SM, Schieffer B, et al. A randomized trial of 2 prescription strategies for opioid treatment of chronic nonmalignant pain. J Pain. 2011 Feb;12:288-296.
Bostick GP, Toth C, Carr EC, et al. Physical functioning and opioid use in patients with neuropathic pain. Pain Med. 2015 July;16:1361-1368.