Medications for refractory, opioid-induced constipation include naloxone derivatives: naloxegol (Movantik), methylnaltrexone (Relistor), or naldemedine (Symproic). Naloxegol is an oral tablet that is used daily while methylnaltrexone is a subcutaneous injection or oral tablet used daily. Naldemedine is taken by mouth daily (0.2 mg) and may cause side effects such as abdominal pain or discomfort, diarrhea, and nausea. 88 In the COMPOSE-1 trial, patients on naldemedine had significantly more spontaneous bowel movements (defined as ≥3 per week) than those on placebo (47.6% vs. 34.6%, P=0.002). 91 For nausea or vomiting, physicians should consider a prophylactic antiemetic, add or increase non-opioid pain control agents (e.g., acetaminophen as an opioid-sparing drug), and decrease opioid dose by 25% if analgesic is satisfactory. Sedation Sedation is the first warning sign of a patient being at risk for opioid overdose. Take this symptom very seriously. If a patient complains of sedation, determine whether sedation is related to the opioid, eliminate nonessential depressants (such as benzodiazepines or alcohol), reduce dose by 10%- 15% if analgesia is satisfactory, add or increase non-opioid or non-sedating adjuvant for additional pain to reduce opioid dose. There is insufficient evidence to recommend opioid rotation as a possible means of reducing sedation. 31 Patients should also be co-prescribed naloxone for opioid overdose reversal. Fracture A retrospective cohort study over seven years compared the risk of fracture associated with starting opioids vs. NSAIDs (2,436 older adults initiated on opioids and 4,874 older adults initiated on NSAIDs). Opioids significantly increased the risk of fracture in a dose-dependent fashion. The opioid formulation mattered with much of the risk in the first month after drug initiation for short-acting opioids, though fracture increased for both long- and short-acting opioids over time. 92 Infection Opioids may increase risk of infection in older adults. A case-control study of 3,061 older community dwelling adults ages 64-95 years evaluated the association between pneumonia and opioid use. Current prescription opioid users had a 38% increased risk of pneumonia compared with nonusers. The risk was highest for opioid users categorized as being immunosuppressed, such as those with cancer, recent cancer treatment, or chronic kidney disease, or those receiving immunosuppressive medications or medications for HIV. 93
Myocardial Infarction (MI) A case-control study assessed the risk of MI among adults on opioids for chronic pain in the UK General Practice Research Database (11,693 cases with up to four matched controls). Current opioid use was associated with a 28% increased risk of MI compared to non-use. 94 Erectile Dysfunction (ED) In a cross-sectional analysis of 11,327 men with back pain, 909 (8%) were receiving ED medications or testosterone (documented between 6 months before and 6 months after the study index visit). Prescriptions for an ED drug or testosterone were 54% greater for men using doses ≥120 MMEDs compared with those using doses of 1 to <20 MMED. In addition, the proportion of men receiving either of types of medications was 95% greater for those with chronic opioid use compared with those with no opioid use. These findings suggest that dose and duration of opioid use are associated with ED. 95 Tamper-resistant/abuse-deterrent opioids One strategy to mitigate the risk of opioid abuse has been the development of “abuse-deterrent” formulations of opioids that make it more difficult to alter for non-oral consumption (e.g., injecting, snorting, or smoking). 96 However, these opioids are more aptly named as “tamper-resistant” formulations instead of “abuse-deterrent” since they are no less potentially addictive than regular opioids when taken by mouth. Tamper-resistant formulations often contain a higher opioid dose than immediate-release preparations. Furthermore, most are extended- release and also considerably more expensive than generic, off-patent opioids. 96 As of this writing, only one immediate-release opioid is available in an abuse deterrent formulation (oxycodone hydrochloride [RoxyBond]). 96 Patient education Before prescribing an opioid for pain, clinicians should discuss with patients the risks and benefits of such therapy. An important consideration in framing treatment, and a key message to communicate to patients, is that the goal is not “zero pain” but, rather, a level of analgesia that maximizes a patient’s physical and mental functioning. 97 A multi- modal approach, using both drug and non-drug treatments, should be encouraged. In addition, patients should be educated about the safe storage and disposal of opioid medications. Safe use means following clinician instructions about dosing, avoiding potentially dangerous drug interactions (e.g., alcohol), and assuring full understanding of how the medication should be consumed or applied. Remind patients that opioid
pain medications are sought after by many people, and, therefore, opioids should be stored in a locked cabinet or, if a locked unit is not available a place that is not obvious or easily accessed by others. Proper disposal methods should be explained: • Follow any specific disposal instructions on the prescription drug labeling or patient information that accompanies the medication • Do not flush medicines down the sink or toilet unless the prescribing information specifically instructs to do so. • Return medications to a pharmacy, health center, or other organization with a take-back program. • Mix the medication with an undesirable substance (e.g., used coffee grounds or kitty litter) and put it in the trash, or use special drug deactivation pouches that your health care provider may recommend. Managing acute pain It is now becoming clear that many of the problems and risks associated with managing chronic pain with opioids are also at work in the management of acute pain with opioids. For example, a number of studies demonstrate increased risk of new persistent opioid use in opioid-naïve patients after having been prescribed opioids for acute pain. 98-101 Although the risk of opioid misuse in patients prescribed opioids for acute post-surgical or post-procedural pain is relatively small (roughly 0.6% per year) 102 , the volume of such procedures (approximately 48 million ambulatory surgeries or procedures in 2010) 103 translates into large numbers of patients (i.e., approximately 160,000) who may develop dependence, abuse, or overdose every year. A central tenet of pain management, whether acute or chronic, is that the goal of treatment is a tolerable level of pain that allows the patient maximum physical and emotional functioning with the lowest risk of side effects, progression to chronic pain, or misuse or abuse 104 This requires an adroit balancing of patient-related factors (e.g., comorbidities, medical history, risk of abuse) and drug-related factors (e.g., potency, mechanism of action, expected side effects). A commonly- recommended way to achieve this balance is with multimodal analgesia, in which several therapeutic approaches are used, each acting at different sites of the pain pathway, which can reduce dependence on a single medication and may reduce or eliminate the need for opioids and attendant risks/side effects. 105
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