Over the past few years, there has been a growing focus on the abuse, misuse, and overuse of opioids or painkillers. Public health experts estimate that more than 35 million Americans age 12 and older have reported non-medical use of opioid analgesics during 2010 – up from 29 million in 200. In 2009, nearly 342,000 emergency department visits were associated with nonmedical use of opioid analgesics. In 2007, nearly 28,000 Americans died from unintended consequences of drug use, and of these, nearly 12,000 involved prescription drug pain relievers.
To address these issues, the Food and Drug Administration (FDA) recently finalized its final Risk Evaluation and Mitigation Strategies (REMS) for extend-release (ER) and long-acting (LA) opioid medications. This was the first time that FDA has mandated a class wide REMS and much of what is recommended will be looked at closely for future class REMS.
In addition to FDA’s recent action, the Joint Commission recently warned hospitals about the dangers of using opioids on inpatients, calling for greater staff education particularly on opioid analgesics, which are most commonly associated with adverse drug events. The warning about risks associated with opioids is part of a series of Alerts issued by The Joint Commission. The Joint Commission sought input for the Alert from experts across the United States, including the Cancer Pain Program at Northwestern University’s Feinberg School of Medicine, the University of Wisconsin Hospital and Clinics, the Hackensack (N.J.) University Medical Center and the University Medical Center in Tucson, Arizona.
Founded in 1951, The Joint Commission evaluates and accredits more than 19,000 health care organizations and programs in the United States, including more than 10,300 hospitals and home care organizations, and more than 6,500 other health care organizations that provide long term care, behavioral health care, laboratory and ambulatory care services. The Joint Commission currently certifies more than 2,000 disease-specific care programs, focused on the care of patients with chronic illnesses such as stroke, joint replacement, stroke rehabilitation, heart failure and many others.
Although the Joint Commission acknowledged that opioids are generally safe for most patients, it pointed out the drugs, such as fentanyl, hydrocodone, hydromorphone, oxycodone, sufentanil, can cause side effects like sedation, dizziness, nausea, vomiting, constipation, hallucenations, falls, hypotension and aspiration pneumonia. Reports also show that some patients, such as those who have sleep apnea, are obese or very ill, may be at higher risk for harm from opioids. Additionally, a British study found that 16 percent of inpatient adverse drug reactions were traced back to opioids. The reasons for such adverse events include dosing errors, improper prescribing and administering or inadequate monitoring, and interactions with other drugs, according to The Joint Commission’s Sentinel Event Database.
Of the opioid-related adverse drug events – including deaths – that occurred in hospitals and were reported to The Joint Commission’s Sentinel Event database (2004-2011), 47 percent were wrong dose medication errors, 29 percent were related to improper monitoring of the patient, and 11 percent were related to other factors, including excessive dosing, medication interactions and adverse drug reactions.
“Assessing and managing pain is critical to patients who otherwise would suffer, but avoiding the harm that accompanies the adverse effects of powerful opioid analgesics is equally important,” Joint Commission President Mark Chassin, M.D., said in a statement. “Accidental opioid overuse in the hospital is absolutely preventable. Information in this Alert will help doctors and nurses keep patients safe.”
While there are numerous problems associated with opioid use, including underprescribing, overprescribing, tolerance, dependence, and drug abuse, the Alert focused on the safe use of opioids that are prescribed and administered within the inpatient hospital setting. The Joint Commission recognized that the emergency department presents unique challenges that should also be addressed by the hospital, but may not be directly addressed in this Alert. Among recommendations, The Joint Commission urged the following (described in further detail below):
- Implement effective practices, such as monitoring patients who are receiving opioids on an ongoing basis, use pain management specialists or pharmacists to review pain management plans, and track opioid incidents.
- Use available technology to improve prescribing safety of opioids such as creating alerts for dosing limits, using tall man lettering in electronic ordering systems, using a conversion support system to calculate correct dosages and using patient-controlled analgesia (PCA).
- Provide education and training for clinicians, staff and patients about the safe use of opioids.
- Use standardized tools to screen patients for risk factors such as oversedation and respiratory depression.
Actions suggested by The Joint Commission
Hospitals can take the following evidence-based actions to help avoid adverse events associated with the use of opioids.
1. Create and implement policies and procedures for the ongoing clinical monitoring of patients receiving opioid therapy by performing serial assessments of the quality and adequacy of respiration and the depth of sedation. The organization will need to determine how often the assessments should take place and define the period of time that is appropriate to adequately observe trends. Monitoring should be individualized according to the patient’s response. The assessments are particularly important when the dose has been increased or another type of opioid is administered. In addition to monitoring respiration and sedation, pulse oximetry can be used to monitor oxygenation, and capnography can be used to monitor ventilation.
Staff should be educated not to rely on pulse oximetry alone because pulse oximetry can suggest adequate oxygen saturation in patients who are actively experiencing respiratory depression, especially when supplemental oxygen is being used – thus the value of using capnography to monitor ventilation.6 When pulse oximetry or capnography is used, it should be used continuously rather than intermittently.
2. Create and implement policies and procedures that allow for a second level review by a pain management specialist or pharmacist of pain management plans that include high-risk opioids, such as methadone, fentanyl, IV hydromorphone and meperidine.
3. Create and implement policies and procedures for tracking and analyzing opioid-related incidents for quality improvement purposes.
4. If available, use information technology to monitor prescribing of opioids.
- Build red flags or alerts into e-prescribing systems for all opioids. The red flags can be either for dosing limits or alerts, or for verifications.
- Separate sound-alike and look-alike opioids, and use tall man lettering and other techniques to reduce the risk of error.
- Use conversion support systems to calculate correct doses of opioids to help prevent problems with conversions from oral, IV and transdermal routes of administration.
- Use patient-controlled analgesia (PCA) to reduce the risk of oversedation. The use of smart infusion pump technology with dosage error reduction software can add another layer of safety.
Appropriate education and training
The Commission recommended that organizations assess the need for training based on the analysis of reported adverse events, near misses and staff observations. This analysis may be helpful in identifying knowledge gaps and in developing improvement strategies to reduce recurrences.
The alert recommends that organizations advise clinicians who prescribe pain medications to use both pharmacologic and non-pharmacologic alternatives, including multi-modal adjuvant therapies (e.g., physical therapy, acupuncture, manipulation or massage, ice, music therapy). Non-narcotic analgesics, such as acetaminophen, nonsteroidal anti-inflammatory agents, antidepressants, anticonvulsants (e.g., gabapentin and pregabalin), and muscle relaxants (e.g., baclofen, tizanidine), can be used before prescribing an opioid. In addition, when used in combination with opioids, these non-narcotics may reduce the dose of opioids required to effectively manage pain.
The Joint Commission also recommended that organizations educate and assess the understanding of staff that care for patients receiving opioids about the potential effect of opioid therapy on sedation and respiratory depression, the continuum of consciousness, the difference between ventilation and oxygenation, and technological and clinical monitoring. Staff training should emphasize how to assess patients for adverse drug reactions, how to recognize advancing sedation, and the importance of making timely adjustments to the plan of care based on the patient’s risk. For example, a comprehensive pain management program can help to educate clinicians, endorse best practices, and improve safety.
The alert recommends that organizations educate and provide written instructions to patients who are on opioids (and to the patient’s family or caregiver) about:
- The various generic and brand names, formulations, and routes of administration of opioids in order to prevent confusion and reduce the accidental duplication of opioid prescriptions;
- The principal risks and side effects of opioids, including the likelihood of constipation, and the risk of falls, nausea and vomiting;
- The impact of opioid therapy on psychomotor and cognitive function (which may affect driving and work safety);
- The potential for serious interactions with alcohol and other central nervous system depressants;
- The potential risks of tolerance, addiction, physical dependency, and withdrawal symptoms associated with opioid therapy.
- The specific dangers as a result of the potentiating effects when opioids are used in combination, such as oral and transdermal (fentanyl patches).
- The safe and secure storage of opioid analgesics in the home.
The Joint Commission Alert also includes details about respiratory depression risk factors, which the Commission said was the “most serious [adverse] effect” of opiods, and offers information relevant to opioid risks and safety. Specifically, when opioids are administered, the potential for opioid-induced respiratory depression should always be considered because:
- The risk may be greater with higher opioid doses
- The occurrence may actually be higher than reported
- There is a higher incidence observed in clinical trials
- Various patients are at higher risk (see below), including patients with sleep apnea, patients who are morbidly obese, who are very young, who are elderly, who are very ill, and who concurrently receive other drugs that are central nervous system and respiratory depressants (e.g., anxiolytics, sedatives).
Characteristics of patients who are at higher risk for oversedation and respiratory depression
- Sleep apnea or sleep disorder diagnosis
- Morbid obesity with high risk of sleep apnea
- Older age; risk is
- 2.8 times higher for individuals aged 61-70
- 5.4 times higher for age 71-80
- 8.7 times higher for those over age 80
- No recent opioid use
- Post-surgery, particularly if upper abdominal or thoracic surgery
- Increased opioid dose requirement6 or opioid habituation
- Longer length of time receiving general anesthesia during surgery
- Receiving other sedating drugs, such as benzodiazepines, antihistamines, diphenhydramine, sedatives, or other central nervous system depressants
- Preexisting pulmonary or cardiac disease or dysfunction or major organ failure
- Thoracic or other surgical incisions that may impair breathing5,6
In addition, the Joint Commission alert recommends that organizations should make staff aware of the following factors and activities that can help avoid accidental opioid overuse:
- Assess the patient’s previous history of analgesic use or abuse, duration and possible side effects to identify potential opioid tolerance or intolerance.
- Conduct a full body skin assessment of patients prior to administering a new opioid to rule out the possibility that the patient has an applied fentanyl patch or implanted drug delivery system or infusion pump.
- Use an individualized, multimodal treatment plan to manage pain. A multimodal approach combines strategies such as psychosocial support, coordination of care, the promotion of healthful behaviors, nonpharmacologic approaches, and non-opioid pain medications. Upon assessment, the best approach may be to start with a non-narcotic.
- Take extra precautions with patients who are new to opioids or who are being restarted on opioids. These precautions should include starting the patient with a short-term trial15 of carefully titrated opioids at the lowest effective dose to achieve satisfactory pain control.18 Sufficient time should be allowed to assess the patient’s response to an initial dose before increasing the dosage or prescribing opioids for long-term use.
- Consult a pharmacist or pain management expert (when available) when converting from one opioid to another, or changing the route of administration (from oral to IV or transdermal). Consider that the patient may be less tolerant of the new drug (incomplete cross tolerance) or that the new drug may be more potent.
- Avoid rapid dose escalation of opioid analgesia above routine dose levels in opioid-tolerant patients.
- Take extra precautions when transferring patients between care units and facilities, and when discharging patients to their home. Consider that drug levels may reach peak concentrations during transport.
- Avoid using opioids to meet an arbitrary pain rating or a planned discharge date. Dosing should be based on the individual patient’s need and condition.