Too many opioid-related medication errors fly under the radar of voluntary reporting systems, so pharmacists need to mine other hospital data sources for a truer picture of opioid safety risks in their organizations, according to Matthew Fricker, MS, RPh, FASHP, program director at the Institute for Safe Medication Practices (ISMP).

Opioid errors often lie hidden in these data, he suggested.

Speaking during a recent ISMP webinar panel discussion, Mr. Fricker listed several often-overlooked information sources that could help heighten hospital-wide awareness of opioid misadventures and prompt a more rigorous push for safer practices.

First, he advised, look at the hospital’s adverse reaction database because many events reported as drug reactions are actually the result of medication errors. “If we give someone 4 mg of hydromorphone IV push—particularly an opioid-naive patient with some comorbidities—we will have an adverse drug reaction, but it is really more of a medication error.”

Records of pharmacist interventions, Mr. Fricker said, can be another “significant bucket” of valuable safety data. How many interventions, he asked, involve “pharmacists calling prescribers to get an opioid dose modified? Essentially what you have there are near misses or close calls that didn’t reach the patient because of some intervention upstream.”

Additionally, he said, if the data are available, examine how often opioid-reversal drugs like naloxone had to be used and how many rapid response team actions were related to respiratory depression following opioid administration.

Other helpful clues can be gleaned from database sources outside of your own hospital, noted Dr. Fricker and the other panelists—Lewis S. Nelson, MD, a professor in the Department of Emergency Medicine at NYU Langone Medical Center, in New York City, and ISMP President Michael R. Cohen, ScD, MS, RPh, FASHP. One useful source of information is the Joint Commission’s Sentinel Event database, which gives breakdowns of opioid-related adverse drug events that have occurred nationally and thus are likely to be potential trouble spots for your own facility (Figure).

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Figure. Joint Commission Sentinel Event database (2004-2011) for opioid-related adverse drug events.a
  1. The reporting of most sentinel events to The Joint Commission is voluntary and represents only a small proportion of actual events. Therefore, these root-cause data are not an epidemiologic data set and no conclusions should be drawn about the actual relative frequency of root causes or trends in root causes over time.

These suggestions were among several made during the 90-minute webinar exploration of troublesome opioid safety issues. The panelists also offered practical strategies for improving pain management practices.

Managing Expectations

Aggressive use of opioids for managing pain as well as the promise of a pain-free patient experience both came under fire from Dr. Nelson and Mr. Fricker. “The expectation of absolute pain control is a little bit misguided,” Dr. Nelson said. “Surgeries hurt. Injuries hurt. But the idea that we can get you to a pain score of near zero is not really an appropriate end point.”

Mr. Fricker added that the desire to keep patients pain free “may be contributing to some overly aggressive prescribing of higher doses of opioids.” Promising patients that they will be pain free “is a serious mistake,” he said. “It’s a goal that you will not be able to achieve.”

Instead, he suggested, “we should be saying, ‘You may be experiencing some pain, but we will respond to your pain. We will manage it. We will not allow you to continuously be in pain.’”

Patient satisfaction scores, they both suggested, may be driving some practitioners and hospitals to promote more aggressive pain management practices.

“A lot of people,” Mr. Fricker said, are concerned about achieving high scores on the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) or Press Ganey surveys, which tie patient satisfaction ratings to reimbursement. Dr. Nelson added that the link between patient satisfaction scores and reimbursement together with “intense competition” among medical centers are part of the reason “that we’ve put an extreme focus” on pain control.

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Pain Rating Scales

“And that’s great,” he continued. “There is no doubt that managing pain is important,” but he added that opioids—and all pain medications—have adverse side effects and are not completely safe. “I’d rather explain to a patient that their pain score is slightly higher than they would like it to be than explain to a family member why a patient is dead from respiratory depression or another complication.”

The potential for addiction should be another reason for taking a less aggressive approach, Dr. Nelson said. “We know that it’s rare to get addicted to pain medications through medical care, but we know it happens,” he said. “We just have to keep a focus on that as well.”

A less aggressive approach to opioid reversal is also a good idea, Dr. Nelson suggested. “Naloxone is often used unnecessarily in patients with respiratory depression,” he said, when “a good bag valve mask and some exogenous oxygen” are all that is needed. “The problem with naloxone use is that people administer it too aggressively, in too high a dose and too rapidly. What that does is throw the patient into precipitated opioid withdrawal, which is terrible.”

The way to go, Dr. Nelson said, is to begin with smaller naloxone doses and titrate upward, “as long as you’re able to provide a little bit of bag valve mask respiration to tide them over.” He suggested the appropriate starting dose should be 0.04 mg, or 40 mcg, rather than the standard 0.4- to 2-mg dose. “Taking a patient with chronic pain who is getting an opioid and rapidly reversing them is not an acceptable alternative,” he said.

Pharmacist’s Role

Pharmacists can play a key educational role in fostering safer opioid practices, Mr. Fricker said, noting that there is “a large knowledge deficit out there about opioids and how to use them safely.” For example, he pointed to an ISMP practitioners survey in which one question asked whether obese patients required higher or lower opioid doses. Many of them, he said, “got it wrong. They felt that obese patients would need more drug.”

To help fill that knowledge gap, pharmacists can ask to attend a surgical or other appropriate department meeting “to spread the message” about opioid problems, Mr. Fricker said. “Ask for five minutes. Just hit the highlights about what is happening with opioids in your own institution, what’s happening out there, what are we reporting in the ISMP newsletter.” Developing an educational program to help practitioners remember comorbid conditions that affect opioid requirements as well as equianalgesic potencies of various opioids is another potential opportunity, he said. Education may be a “low-level strategy,” he added, “but we need to start with it.”

Virginia Ghafoor, PharmD, a clinical pharmacy specialist for pain management at the University of Minnesota Medical Center, in Minneapolis, said that while strengthening opioid education for prescribers is a laudable goal, it has some limitations.

“Educating staff on pain management and appropriate medication therapy looks easy on paper, but in reality is very difficult,” Dr. Ghafoor said. “For physicians and other health care providers, many of the continuing education programs offered on pain management and medication safety are based on voluntary participation, and the participants are not required to maintain credentials. Also, true competency-based training with strict requirements tied to opioid prescribing could hurt patients by making providers opt out of this practice. So, there are no easy answers to this.”

As for the webinar’s cited strategy of tracking medication interventions and the use of naloxone, ‘that may provide data on ‘risk’ for respiratory depression, but this is a retrospective approach,” Dr. Ghafoor said. “A true opioid safety plan needs to take a proactive approach to preventing medication errors before they lead to patient harm.”

Dr. Ghafoor said she is particularly excited about the potential for pharmacist-led admission medication reconciliation to have “a profound influence” on opioid safety. Such programs, she noted, can document the correct drug, dose and frequency of opioid medication use—information “that is fundamental to pain management by reducing the potential to under- or overdose the opioid.” With nearly all 50 states now having a controlled substance database program for retail oral opioid prescriptions, she added, pharmacists also can use this information to provide a more accurate assessment of the patient’s opioid exposure. By doing so, “the medication history and institutional practice guidelines for safe opioid prescribing can be incorporated into a pain management plan that is customized for the individual patient.”


Could REMS Help Ease Fears Over Opioids?

The FDA’s most recent Risk Evaluation and Mitigation Strategy (REMS) for opioids, which covers extended-release and long-acting formulations, requires opioid product makers to develop educational programs for health care providers and nonpromotional medication guides for patients designed to reduce the risks for opioid-related medication errors and curb overprescribing.

Prescriber enrollment in the educational programs related to the extended-release and long-acting opioid REMS is voluntary. A REMS introduced late last year covered fentanyl formulations but mandated education for prescribers, pharmacies, distributors and patients. The FDA has indicated that a REMS on short-acting opioids may follow in a “stepwise approach” to safer use of all products.

Asked to comment on the opioid REMS, Lewis S. Nelson, MD, one of two presenters in the ISMP webinar, cited an article in the Journal of the American Medical Association (2012;308:457-458) that he co-wrote with Jeanmarie Perrone, MD, of the Department of Emergency Medicine at the Perelman School of Medicine, University of Pennsylvania, in Philadelphia.

Although “prescriber and patient education alone will likely prove insufficient to assuage the concerns of patients with chronic noncancer pain, who fear the reduced availability of opioid pain relievers, and public health advocates, who fear the excessive use of these drugs,” the authors wrote, the REMS approach “may be an important component for addressing the opioid epidemic in the United States.”

They also noted the importance of minimizing “the burden on physicians and the health care system by implementing a REMS that does not compromise care.” One risk, they wrote, was that physicians might “avoid prescribing a drug if they are unwilling or unsure of how to meet the REMS requirements.” As evidence, they pointed to a recent study which showed that 13.4% of 259 physicians would stop prescribing opioids if they were required to obtain four to eight hours of training and two hours of continuing education every two years (J Opioid Manag 2011;7:109-115).

The authors indicated other concerns, including “financial motivations and creative risk-benefit messaging” in REMS programs, which, “although ostensibly independent,” are being funded by opioid product manufacturers. “Furthermore,” they wrote, ”although education is a crucial element of safety, medication guides and related warnings have generally been ineffective in educating patients about the risks associated with certain medications.”

—Bruce Buckley